record_id,pubmedID,title,authors,abstract,year,label_included,label_abstract_screening
1,10024259,Symptomatic gastro-oesophageal reflux disease: double blind controlled study of intermittent treatment with omeprazole or ranitidine. The European Study Group.,K D Bardhan; S Müller-Lissner; M A Bigard; G Bianchi Porro; J Ponce; J Hosie; M Scott; D G Weir; K R Gillon; R A Peacock; C Fulton,"To assess intermittent treatment over 12 months in patients with symptomatic gastro-oesophageal reflux disease. Randomised, multicentre, double blind, controlled study. Patients with heartburn and normal endoscopy results or mild erosive changes received omeprazole 10 mg or 20 mg daily or ranitidine 150 mg twice daily for 2 weeks. Patients remaining symptomatic had omeprazole 10 mg or ranitidine dose doubled for another 2 weeks while omeprazole 20 mg was continued for 2 weeks. Patients who were symptomatic or mildly symptomatic were followed up for 12 months. Recurrences of moderate or severe heartburn during follow up were treated with the dose which was successful for initial symptom control. Hospitals and primary care practices between 1994 and 1996. 677 patients with gastro-oesophageal reflux disease. Total time off active treatment, time to failure of intermittent treatment, and outcomes ranked from best to worst. 704 patients were randomised, 677 were eligible for analyses; 318 reached the end of the study with intermittent treatment without recourse to maintenance antisecretory drugs. The median number of days off active treatment during follow up was 142 for the entire study (281 for the 526 patients who reached a treatment related end point). Thus, about half the patients did not require treatment for at least 6 months, and this was similar in all three treatment groups. According to outcome, 378 (72%) patients were in the best outcome ranks (no relapse or one (or more) relapse but in remission until 12 months); 630 (93%) had three or fewer relapses in the intermittent treatment phase. Omeprazole 20 mg provided faster relief of heartburn. The results were similar in patients with erosive and non-erosive disease. Intermittent treatment is effective in managing symptoms of heartburn in half of patients with uncomplicated gastro-oesophageal reflux disease. It is simple and applicable in general practice, where most patients are seen.",1999.0,0,1
2,10027653,Helicobacter pylori clearance and serum gastrin and pepsinogen I concentrations in omeprazole treatment of duodenal ulcer patients.,C T Lee; B I Kuo; C Y Chen; F Y Chang; S D Lee,"To determine which demographic factors may influence serum gastrin and pepsinogen I (PGI) levels in duodenal ulcer patients undergoing omeprazole treatment. We conducted an outpatient-based prospective study in the Veterans General Hospital, Taipei, to investigate the pharmacological effects on patients with duodenal ulcers receiving omeprazole treatment for 4 weeks. Sixty-eight patients (61 males/7 females, aged 25 73 years) with endoscopically confirmed duodenal ulcer were included. Gastrin and pepsinogen I levels were measured before and after treatment. Demographic factors including age, sex, smoking, ulcer healing and antral Helicobacter pylori colonization/clearance were analyzed, in order to measure their probable influences on serum gastrin and pepsinogen I levels. Ulcer healing was seen in 92.6% of patients while 48 (70.6%) antral clearances were seen in 66 H. pylori colonized patients at the end of trial. Omeprazole monotherapy led to a marked elevation of serum gastrin (85.8 pg x ml(-1), SD 32.0 pg x ml(-1) vs 133.9 pg x ml(-1), SD 71.6 pg x ml(-1), P < 0.01), and pepsinogen I (111.0 ng x ml(-1), SD 36.7 ng x ml(-1) vs 253.6 ng x ml(-1) , SD 64.8 ng x ml(-1), P < 0.01) levels when measured on day 29. Only patients showing antral H. pylori clearance exhibited an influence on the magnitude of pepsinogen I elevation following omeprazole monotherapy (143.9%, SD 67.3% vs 78.6%, SD 51.2%, P < 0.01). Moreover, the sensitivity and specificity of serum pepsinogen I variations were plotted on a receiving operating characteristic (ROC) curve. The 140% increased pepsinogen I level yielded a maximum accuracy of 80% specificity or 50% sensitivity to predict antral H. pylori clearance. Antral H. pylori clearance is at least partially responsible for the omeprzaole-induced hyperpepsinogenemia I. The magnitude of hyperpepsinogenemia I probably provides a non-invasive alternative for predicting H. pylori clearance.",1999.0,0,0
3,10029360,Antimicrobial treatment of H. pylori infection--a pooled efficacy analysis of eradication therapies.,P Unge,"To evaluate the clinical efficacy of available therapies directed towards Helicobacter pylori eradication. Pooled overall analyses of a limited number of drug combinations regardless of dosage, duration, formulation etc. Helicobacter pylori infected patients with or without complications. Efficacy data from all studies included in the analysis are transformed to or retained as intention to treat data. Efficacy is presented as proportion of patients cured from the infection. Confidence intervals are enlarged by 1.5 due to the inferior strength of a pooled analysis. Dual therapies are ineffective. Triple therapies cure 70-90% of the patients. Well documented high efficacy is shown for a proton pump inhibitor plus two antimicrobials. Less studied but effective alternatives are ranitidine-bismuth plus two antimicrobials. A proton pump inhibitor plus two antimicrobials is the best validated highly effective type of eradication therapy.",1999.0,0,0
4,10036953,[Triple therapy regimens involving H2 blockaders for therapy of Helicobacter pylori infections].,K Kihira; K Sato; Y Yoshida; Y Kumakura; K Kimura; K Sugano,"Comparison of ranitidine and lansoprazole in short-term low-dose triple therapy for Helicobacter pylori infection. To evaluate the efficacy and safety of two 1-week low-dose triple-therapy drug regimens involving antisecretory drugs for Helicobacter pylori infection, 99 patients with H. pylori infection were treated with either lansoprazole (LPZ) or ranitidine (RNT) used together with clarithromycin (CAM) and metrinidazole (MTZ). The drug combination and administration periods in the PPI group were LPZ 30 mg, CAM 400 mg, MTZ 500 mg (LCM group). The ranitidine group received RNT 300 mg, CAM 400 mg, MTZ 500 mg (RCM group). The cure rate of H. pylori infection was 88% in the LCM group; 95% CI 79-97 and 92% in the RCM group; 95% CI 84-99.",1999.0,0,0
5,10063300,Simple closure of perforated duodenal ulcer.,S H Kulkarni; A Y Kshirsagar,"A study was undertaken to evaluate the efficacy of simple closure followed by drug therapy in cases of perforated duodenal ulcer and to identify the risk factors in relation to the mortality. The male to female ratio was 5:1. Of the patients 59.2% were up to 50 years of age, while 40.8% were above the age of 50 years. Of the patients 47% were admitted 24 hours after the onset of peritonitis. All these patients were surgically treated with simple closure of the perforation with omental patch. Nine patients expired leading to 7.5% mortality. The risk factors identified for mortality were age 60 years and above, presence of shock on admission and delayed presentation. The mortality is directly related to the number of risk factors present in a given patient. At the time of discharge the patients were advised to take orally famotidine 40 mg at bed time for a period of 8 weeks. Eighty-one patients could be followed up and Visick grading was done. Sixty-two patients were in grade I, 11 in grade II, 3 in grade III and 5 in grade IV. The results indicate that simple closure followed by drug therapy is acceptable treatment for perforated duodenal ulcer.",1999.0,0,0
6,10073749,"Reliability of the omeprazole hydroxylation index for CYP2C19 phenotyping: possible effect of age, liver disease and length of therapy.",M Kimura; I Ieiri; Y Wada; K Mamiya; A Urae; E Iimori; T Sakai; K Otsubo; S Higuchi,"To evaluate the reliability of the omeprazole hydroxylation index as a marker for polymorphic CYP2C19 activity in a Japanese population of healthy young subjects (n = 78) and patients with peptic ulcer (n = 72). Healthy subjects were administered a single dose of omeprazole (20 mg), whereas patients received 20 mg daily for at least 1 week. The ratio of the serum concentration of omeprazole to hydroxyomeprazole at 3 h postdose was determined and used as a measure of CYP2C19 activity. The CYP2C19 wild type (wt) gene and four mutant alleles associated with the poor metaboliser phenotype of (S)-mephenytoin, CYP2C19*2 in exon 5, CYP2C19*3 in exon 4, CYP2C19m4 in exon 9, and CYP2C19m3 in the initial codon were analysed. In the healthy volunteer study there was complete concordance between genotype and phenotype. However, eight of the patients who had the EM genotype had a high value for their hydroxylation index, and were classified as phenotypic PMs. No CYP2C19m4 and CYP2C19m3 mutations were detected in the eight mismatched patients. They were all genotypic heterozygous EMs, elderly (> or = 65 years) and/or had hepatic disease. Therefore, impaired CYP2C19 activity combined with partial saturation of omeprazole metabolism during multiple dosing may have contributed to the discrepancy between CYP2C19 genotyping and phenotyping. Although omeprazole has been used instead of mephenytoin as a probe for polymorphic CYP2C19, it does not appear to be reliable enough for clinical application in Japanese patients.",1999.0,0,0
7,10082075,Safety profile of Lansoprazole: the US clinical trial experience.,J W Freston; P A Rose; C A Heller; M Haber; D Jennings,"Lansoprazole has undergone extensive clinical evaluation for the treatment of acid-peptic diseases. The aim of this study was to define the safety profile of lansoprazole and compare it to that of other therapeutic agents evaluated in the same controlled trials. The clinical safety profile of lansoprazole and comparative agents (placebo, ranitidine and omeprazole) was reviewed for 3281 patients who participated in short term (up to 8 weeks) and long term (up to 56 months) clinical trials conducted in the US. Adverse events, laboratory value changes and gastric biopsy changes that occurred during treatment were compared statistically for differences between treatments. The incidence of adverse events and number of patients discontinuing treatment because of adverse events was similar for lansoprazole and comparative agents. Other than elevated serum gastrin levels, a known effect of proton pump inhibitors, no trends in laboratory changes were observed. Median values for gastrin levels remained within the normal range; about 2% of patients had gastrin levels >400 pg/ml at any time, while <1% had 2 or more gastrin values >500 pg/ml. Values returned to baseline levels after therapy was discontinued. No significant changes in gastric endocrine cell growth from baseline to final visit were observed, nor was there evidence of dysplasia or neoplasia. Lansoprazole is well tolerated for both short and long term treatment of acid-related disease. The tolerability of lansoprazole is comparable to that of ranitidine, omeprazole and placebo in the treatment of these diseases.",1999.0,0,1
8,10088873,Gastroesophageal reflux disease: diagnosis and management.,M Scott; A R Gelhot,"Gastroesophageal reflux disease (GERD) is a chronic, relapsing condition with associated morbidity and an adverse impact on quality of life. The disease is common, with an estimated lifetime prevalence of 25 to 35 percent in the U.S. population. GERD can usually be diagnosed based on the clinical presentation alone. In some patients, however, the diagnosis may require endoscopy and, rarely, ambulatory pH monitoring. Management includes lifestyle modifications and pharmacologic therapy; refractory disease requires surgery. The therapeutic goals are to control symptoms, heal esophagitis and maintain remission so that morbidity is decreased and quality of life is improved.",2000.0,0,0
9,10102212,Diseases and problems secondary to massive obesity.,M F Herrara; R R Lozano-Salazar; J González-Barranco; J A Rull,"Morbid obesity is a health hazard. It carries several health risks and decreases life expectancy. Individuals with morbid obesity may develop one or more complications. These are mainly cardiovascular, metabolic, respiratory, gastrointestinal, renal, genitourinary and gynaecological. Patients with morbid obesity also have a high surgical risk. This review analyses the most common complications of morbidly obese patients and their changes after surgically induced weight loss.",1999.0,0,0
10,10102232,Basal and stimulated gastrin and pepsinogen levels after eradication of Helicobacter pylori: a 1-year follow-up study.,J P Gisbert; D Boixeda; A Al-Mostafa; T Vila; L de Rafael; I Alvarez Baleriola; C M de Argila; V Abraira,"A decrease in gastrin and pepsinogen (PG) levels 1 month after Helicobacter pylori eradication has been described repeatedly, but the long-term progression of such a decrease has been scarcely studied. We therefore studied the effect of H. pylori eradication on basal and stimulated gastrin and PG levels for 1 year. Initially, the usefulness of measuring these parameters for the noninvasive diagnosis of H. pylori eradication was validated. Furthermore, an assessment was made of the association between H. pylori reinfection and a re-increase in gastrin and PG values. Finally, an evaluation was made of the variables influencing gastrin and PG concentration, with particular attention to H. pylori infection and histological lesions of gastric mucosa. Two-hundred and twenty-two patients with duodenal ulcer were studied prospectively. Exclusion criteria were the administration of antibiotics, H2 antagonists, omeprazole or bismuth prior to endoscopy. In all patients serum basal levels of gastrin, PGI, and PGII were measured before and 1 month after completing eradication therapy. In the successfully eradicated patients, gastrin, PGI, and PGII were also measured at 6 and 12 months. In 80 patients stimulated measurements of gastrin (after ingestion of two beef cubes) and PGI (after injection of pentagastrin) were also performed. H. pylori-negative patients after therapy underwent a urea breath test at 6 and 12 months, and patients who had stimulated gastrin and PG concentration measured had also an endoscopy performed at 6 months. H. pylori was eradicated in 73% of patients. A histological improvement was observed 1 month after completing H. pylori eradication therapy, both at gastric antrum and body (P < 0.001), while a further improvement at antrum was demonstrated at 6 months (P < 0.01). With regard to the different cut-off points for decreased basal and stimulated measurements for diagnosing H. pylori eradication, the best results were obtained, respectively, with PGII (sensitivity of 90% and specificity of 76%) and PGI 30 min after stimulation (sensitivity and specificity of 82%), with an area under the ROC curve of 0.87 in both cases. In the multiple regressions analysis H. pylori status correlated with gastrin, PGI and PGII after therapy (P < 0.001), while histological lesions correlated only with gastrin levels (P < 0.05). A decrease in basal and stimulated serum parameters was demonstrated immediately after eradication (Wilcoxon test, P < 0.001), and an additional decrease (at 6 months) was observed just in PGI (Friedman test, P < 0.01). However, gastrin and PGII values remained unchanged after the first month post-eradication. Seven patients were reinfected with H. pylori during follow-up. Quantitation of basal and stimulated gastrin and PGI levels was not reliable as a reinfection marker. Regarding basal PGII, the parallelism was strong at 6 months (re-increase in all four reinfected patients), although only in one out of three with reinfection at 1 year did PGII rise at that stage. (1) Measurement of gastrin and PG levels (especially basal PGII values) is a useful non-invasive method to confirm H. pylori eradication after therapy. (2) H. pylori eradication is associated with a significant decrease in basal and stimulated gastrin levels and in basal PGII levels that is detected immediately (1 month) after finishing treatment, and remains unchanged for 1 year. However, the decrease in basal and stimulated PGI levels occurs progressively for 6 months, although such levels remain also unchanged afterwards. (3) Measurement of gastrin and PGI concentrations has a limited usefulness in the diagnosis of H. pylori reinfections after successful eradication, although PGII determination could be more useful in this situation.",1999.0,0,0
11,10102945,Helicobacter pylori eradication with proton pump inhibitor-based triple therapies and re-treatment with ranitidine bismuth citrate-based triple therapy.,V Rinaldi; A Zullo; V De Francesco; C Hassan; S Winn; V Stoppino; D Faleo; A F Attili,"It has been suggested that short-term triple therapy comprising a proton pump inhibitor, plus clarithromycin and amoxycillin be used as first choice in treating H. pylori infection, while eradication failure patients should be further treated with a quadruple therapy. Nevertheless, conflicting results have been reported using these treatment regimens in different countries. A total of 278 patients with H. pylori infection were randomised to receive one-week triple therapy, comprising clarithromycin 500 mg b.d., amoxycillin 1 g b.d., and either omeprazole 20 mg b.d. (OAC; 90 patients), or pantoprazole 40 mg b.d. (PAC; 95 patients), or lansoprazole 30 mg b.d. (LAC; 93 patients). H. pylori infection at entry, and eradication 4-6 weeks after therapy had ended, were assessed by rapid urease test and histology on biopsies from the antrum and the corpus. When eradication did not occur, patients were given a 2-week treatment comprising ranitidine bismuth citrate 400 mg b.d., tetracycline 500 mg t.d.s. and tinidazole 500 mg b.d. (RBTT). Eradication in these patients was assessed 4-6 weeks after conclusion of treatment by a further endoscopy. Six patients were lost to the follow-up. At the end of the first course of treatment, the overall H. pylori eradication rate was 78% (95% CI: 73-83) and 79% (95% CI: 75-84) at 'intention-to-treat' (ITT) and 'per protocol' (PP) analysis, respectively, without any statistically significant difference between treatment regimens, although a trend for better results with the omeprazole combination was observed. Moreover, H. pylori eradication was achieved in 82% (95% CI: 75-97) (ITT) and 86% (95% CI: 69-94) (PP) of 38 patients re-treated with RBTT regimen. Our data found that this short-term triple therapy is not a satisfactory treatment (< 80% eradication rate) for H. pylori infection. The 2-week triple therapy used as re-treatment in eradication failure patients yielded more promising results.",1999.0,1,1
12,10102948,Comparison of rabeprazole 20 mg versus omeprazole 20 mg in the treatment of active duodenal ulcer: a European multicentre study.,C P Dekkers; J A Beker; B Thjodleifsson; A Gabryelewicz; N E Bell; T J Humphries,"Rabeprazole sodium is the newest member of a class of substituted benzimidazole molecules known as proton pump inhibitors. Other proton pump inhibitors have been shown to be effective in healing active duodenal ulcer. This randomized, double-blind, multicentre study, conducted at 25 European sites, compared the efficacy and tolerability of rabeprazole and omeprazole in patients with active duodenal ulcers. One hundred and two patients with active duodenal ulcer received rabeprazole 20 mg and 103 patients omeprazole 20 mg once daily for 2 or 4 weeks, with ulcer healing monitored by endoscopy. After 2 weeks, complete ulcer healing was documented in 69% of patients given rabeprazole 20 mg and in 62% of patients given omeprazole 20 mg (N.S.). After 4 weeks, healing rates were 98% in the rabeprazole group and 93% in the omeprazole group (P = 0.083). Rabeprazole-treated patients had significantly greater improvement in daytime pain symptom relief than those treated with omeprazole at the conclusion of the study (P = 0.038). Both drugs were well tolerated over the 4-week treatment period. Mean changes from baseline to end-point in fasting serum gastrin were significantly greater in the rabeprazole group, but at end-point mean values were well within normal limits for both groups. No clinically meaningful changes or other between-group differences were observed in laboratory parameters. In this study, rabeprazole produced healing rates equivalent to omeprazole at weeks 2 and 4, and provided significantly greater improvement in daytime pain. Both treatments were well tolerated.",1999.0,1,1
13,10102960,The DU-MACH study: eradication of Helicobacter pylori and ulcer healing in patients with acute duodenal ulcer using omeprazole based triple therapy.,S J Zanten; M Bradette; A Farley; D Leddin; T Lind; P Unge; E Bayerdörffer; R C Spiller; C O'Morain; P Sipponen; M Wrangstadh; L Zeijlon; P Sinclair,"To investigate the efficacy of two omeprazole triple therapies for the eradication of Helicobacter pylori, ulcer healing and ulcer relapse during a 6-month treatment-free period in patients with active duodenal ulcer. This was a double-blind, randomized study in 15 centres across Canada. Patients (n = 149) were randomized to omeprazole 20 mg once daily (O) or one of two 1-week b. d. eradication regimens: omeprazole 20 mg, metronidazole 400 mg and clarithromycin 250 mg (OMC) or omeprazole 20 mg, amoxycillin 1000 mg and clarithromycin 500 mg (OAC). All patients were treated for three additional weeks with omeprazole 20 mg once daily. Ulcer healing was assessed by endoscopy after 4 weeks of study therapy. H. pylori eradication was determined by a 13C-urea breath test and histology, performed at pre-entry, at 4 weeks after the end of all therapy and at 6 months. The intention-to-treat (intention-to-treat) analysis contained 146 patients and the per protocol (per protocol) analysis, 114 patients. The eradication rates were (intention-to-treat/per protocol): OMC-85% and 92%, OAC-78% and 87% and O-0% (O). Ulcer healing (intention-to-treat) was greater than 90% in all groups. The differences in the eradication and relapse rates between O vs. OMC and O vs. OAC were statistically significant (all, P < 0.001). Treatment was well tolerated and compliance was high. The OMC and OAC 1-week treatment regimens are safe and effective for eradication, healing and the prevention of relapse in duodenal ulcer patients.",1999.0,0,0
14,10102962,Triple therapy for Helicobacter pylori eradication is more effective than long-term maintenance antisecretory treatment in the prevention of recurrence of duodenal ulcer: a prospective long-term follow-up study.,B C Wong; S K Lam; K C Lai; W H Hu; C K Ching; J Ho; S T Yuen; C K Chan; G K Lau; C L Lai,"The effectiveness of Helicobacter pylori eradication treatment and long term acid suppression maintenance in the natural course of duodenal ulcer has not been directly compared. To compare in a prospective randomized study the effectiveness of H. pylori eradication on the prevention of recurrence of duodenal ulcer with long-term maintenance acid suppression therapy. One hundred and fourteen duodenal ulcer patients were randomized to the treatment over a 12-month period. Fifty-seven of them received triple therapy consisting of 1 g sucralfate q.d.s. for 28 days, 300 mg metronidazole q.d.s. for 14 days and 250 mg clarithromycin q.d.s. for 14 days. Another 57 received 20 mg omeprazole q.d.s. for 12 months. An upper endoscopy was performed before treatment, at 6 weeks, and 2, 6 and 12 months after the first endoscopy. Side-effects were self-recorded and clinical follow-ups were arranged for up to 4.25 years. The ulcer healing rate was 90.2% (95% confidence interval (95% CI): 79-97%) in the omeprazole group at 6 weeks as compared to 83.3% (95% CI: 70-93%) in the triple therapy group (P = 0.38). There was a higher success rate of pain control in the omeprazole group. Side-effects were more frequently reported and compliance was poorer in the triple therapy group during the first 4 weeks. During follow-up, more relapses were seen in the omeprazole group (9.8%, 95% CI: 3-21%) than the triple therapy group (4.2%, 95% CI: 1-13%) at 1 year (P = 0.44). All relapses were due to the persistence of H. pylori infection. At the 1 year follow-up, none of the patients who were H. pylori negative had an endoscopic relapse compared to 7 out of 56 patients who remained H. pylori positive (12.5%, 95% CI: 5-24%, P = 0.018). After a mean follow-up of 4.07 years, none of those who remained H. pylori negative had an ulcer relapse while the 11 out of 41 who remained H. pylori positive had an ulcer relapse (26.8%, 95% CI 14-43, P = 0. 0005). Both regimens were highly effective in healing ulcers. The eradication of H. pylori infection was associated with more side-effects and poor compliance but was more effective than the maintenance therapy in reducing the recurrence of duodenal ulcers. For the prevention of ulcer recurrence, testing of H. pylori status after triple therapy is more important than maintenance therapy.",1999.0,0,0
15,10102963,"High cure rate of Helicobacter pylori infection using tripotassium dicitrato bismuthate, furazolidone and clarithromycin triple therapy for 1 week.",S D Xiao; W Z Liu; P J Hu; D H Xia; G N Tytgat,"When metronidazole is used in bismuth-based or proton pump inhibitor-based triple therapy, the cure rate of Helicobacter pylori is usually high. However, metronidazole-resistant H. pylori strains, which are increasing in frequency, are a major cause of failed H. pylori eradication. To evaluate the efficacy of non-metronidazole containing bismuth-based triple therapy for H. pylori infection. One-hundred and eighty H. pylori-positive patients with endoscopically documented peptic ulcer disease or functional dyspepsia were randomly assigned to one of three 1-week regimens containing tripotassium dicitrato bismuthate (also called colloidal bismuth subcitrate) 240 mg b.d. and two antibiotics: furazolidone 100 mg b.d. plus clarithromycin 250 mg b.d. (Group A); or clarithromycin 250 mg b.d. plus amoxycillin 1000 mg b.d. (Group B); or furazolidone 100 mg b.d. plus josamycin 1000 mg b.d. (Group C). H. pylori status was assessed by rapid urease test, histology and culture of gastric biopsy specimens taken from both the antrum and corpus, both before and at least 4 weeks after completion of therapy. Thirteen patients dropped out (3 in group A, 5 in group B and 5 in group C). Based on an intention-to-treat analysis, the eradication rates achieved in groups A, B and C were 88% (53/60), 58% (35/60) and 77% (46/60), respectively. These differences were significant between groups A and B (P < 0.001), as well as between groups B and C (P < 0.05). Side-effects occurred in 7 (12%) patients in group A, 3 (5%) in group B and 8 (13%) in group C, and were mild, with the exception of vomiting in one patient (group C) that resulted in withdrawal from the study. One-week triple therapy, consisting of tripotassium dicitrato bismuthate, low-dose furazolidone and low-dose clarithromycin, achieves a high cure rate of H. pylori.",1999.0,0,0
16,10102964,Furazolidone-containing short-term triple therapies are effective in the treatment of Helicobacter pylori infection.,W Z Liu; S D Xiao; Y Shi; S M Wu; D Z Zhang; W W Xu; G N Tytgat,"A furazolidone-containing therapeutic regimen for Helicobacter pylori infection has attracted special interest in the face of a rising world-wide metronidazole resistant H. pylori, and the expense of currently used antimicrobial regimens. To evaluate the efficacy of furazolidone-containing regimens in eradicating H. pylori. One-hundred and forty H. pylori positive patients with endoscopically confirmed duodenal ulcer or functional dyspepsia received one of four different regimens to eradicate H. pylori. In the first trial, the patients were randomly assigned to receive a 1-week course of furazolidone 100 mg b.d. and clarithromycin 250 mg b.d., with either tripotassium dicitrato bismuthate (TDB) 240 mg b.d. (FCB group) or lansoprazole 30 mg daily (FCL group). In the second trial, the patients were randomly assigned to receive a 1-week course of clarithromycin 250 mg b.d. and omeprazole 20 mg daily, with either furazolidone 100 mg b.d. (FCO group) or metronidazole 400 mg b.d. (MCO group). Endoscopy was repeated 4 weeks following completion of therapy with re-assessment of H. pylori status on gastric biopsies by histology and culture. Four patients (1 in FCB, 1 in FCO and 2 in MCO groups) dropped out because they refused a follow-up endoscopy. Eradication rates of H. pylori on an intention-to-treat basis in the FCB, FCL, FCO and MCO groups were 91% (32/35, 95% CI: 82-99%), 91% (32/35, CI: 82-99%), 86% (30/35, CI: 74-97%) and 74% (26/35, CI: 60-89%) (all P > 0.05), respectively. Mild side-effects occurred in 15% of the 140 patients. In MCO group, the eradication rate in the patients infected with metronidazole-sensitive isolates of H. pylori was 86%, but dropped to 67% in those with metronidazole-resistance strains (P = 0.198). One-week regimens containing furazolidone and clarithromycin in combination with TDB or a proton pump inhibitor fulfil the criteria for successful H. pylori therapy.",1999.0,0,0
17,10102974,Prescription of acid-suppressing drugs in relation to endoscopic diagnosis: a record-linkage study.,A T Prach; M M McGilchrist; F E Murray; D A Johnston; T M MacDonald,"Although widely used, few data are available on the appropriateness of prescribing of acid-suppressing drugs (ASDs), despite guidelines on the investigation and treatment of dyspeptic patients. We created a database of 62 000 endoscopy examinations and record-linked these to a prescribing database. Endoscopic diagnoses were classified into peptic, nonpeptic and others. The H2-antagonists, omeprazole and misoprostol, were studied. 35 000 patients had one or more endoscopies during 1978-93; two-thirds were over 45 years of age at first endoscopy. A quarter of all patients who had been endoscoped had consistently normal examinations. Peptic oesophageal pathology was the commonest positive finding. A quarter of those prescribed ASDs between 1989 and 1993 had been endoscoped between 1978 and 1993. In those with a peptic diagnosis prescribed any ASD, the pathologies found were: oesophageal (42.9%), duodenal (36.3%) and gastro-pyloric (21.3%). Patients prescribed omeprazole were more likely to have undergone endoscopy than those prescribed other ASDs, and they were also more likely to have peptic oesophageal pathology. Long-term prescribing (>56 days per year) occurred in two-thirds of patients prescribed ASDs and 40% had at least one endoscopy. In those prescribed short-term ASDs, 20% had undergone at least one endoscopy. Peptic and nonpeptic endoscopic pathology was associated with increased ASD prescribing, but a normal endoscopy did not reduce prescribing. ASD prescribing appeared to be mainly symptom-driven. Positive endoscopic findings increased the prescribing of ASDs, but normal findings did not reduce it.",1999.0,0,0
18,10146883,Omeprazole: a pharmacoeconomic evaluation of its use in duodenal ulcer and reflux oesophagitis.,L B Barradell; D McTavish,"Omeprazole regulates gastric acid secretion and is an effective treatment of acute duodenal ulcer and reflux oesophagitis, achieving more rapid healing and symptomatic relief than histamine H 2-receptor antagonists.  When administered as maintenance therapy, omeprazole reduces the incidence of relapse.  The drug is also highly effective in patients poorly responsive to histamine H 2-receptor antagonists.  The daily acquisition cost of omeprazole is higher than that of histamine H 2-receptor antagonists in many countries, and thus it is important to evaluate the pharmacoeconomic impact of omeprazole in the short and long term treatment of duodenal ulcer and reflux oesophagitis.  Pharmacoeconomic analyses have been performed in several clinical settings using pooled data from clinical trials or simulated models of clinical practice.  In a single analysis using Finnish cost data, omeprazole was more cost effective than ranitidine in the treatment of duodenal ulcer disease over a 6-month period.  The cost effectiveness of omeprazole was comparable to that of sucralfate-containing regimens, with patients receiving omeprazole being healed more quickly and experiencing a greater number of healthy days.  Using a computer-model simulation and Swedish cost data, omeprazole was more cost effective than ranitidine when administered as intermittent treatment of duodenal ulcer over 5 years.  Preliminary reports indicate that regimens which eradicate Helicobacter pylori are more cost effective than those which do not.  As short term treatment of reflux oesophagitis, omeprazole 20 to 40 mg/day was the dominating treatment strategy, being less costly and more effective than ranitidine 300 to 1200 mg/day.  Omeprazole 20 mg/day produced symptom-free days more cost effectively than either cimetidine 1.6 g/day or ranitidine 300 mg/day.  More importantly, as long term (maintenance or intermittent) treatment of reflux oesophagitis, omeprazole 20 mg/day was more cost effective than both ranitidine 150 mg twice daily and 'phase 1' therapy (diet and antacids) over 6 and 12 months. Thus, based on analyses evaluated, omeprazole appears to be more cost effective than ranitidine in the short term treatment of duodenal ulcer. Results for long term treatment are less clear cut, but full details from some studies are not yet available.  For the short term treatment of reflux oesophagitis omeprazole is more cost effective than ranitidine or cimetidine and for long term treatment omeprazole is more cost effective than ranitidine.  As treatment for reflux oesophagitis, omeprazole is considered to be the dominating treatment strategy.",1993.0,0,0
19,10155608,Cost and quality effects of treating erosive oesophagitis. A re-evaluation.,B S Bloom,"The objective of this study was to re-evaluate the clinical and economic effects of common therapies for erosive oesophagitis in the light of a newly approved treatment regimen. A previously constructed 7-month community practice decision analytical model was revised to include the latest published data on efficacy and symptomatic outcomes. The original results of phase I therapy (antacids plus dietary, sleeping and lifestyle changes) alone or combined with ranitidine 150mg bid or omeprazole 20mg od were reassessed by adding new clinical data on the efficacy of and symptomatic response to ranitidine 150mg qid. The same payment data used in the first analysis were applied here as well, with the addition of the US price of ranitidine 150mg qid. The study perspective was that of the payer or insurer. Omeprazole-based therapy remained a dominant strategy for symptomatic care during the 7-month model. It was 14% less costly per patient, led to 23% fewer symptomatic months, and had 21% lower cost per symptom-free month than ranitidine 150mg qid, the next best alternative. Evolving treatment strategies necessitate rapid assessment and reassessment so that clinical practice can remain current, patients can be assured of the best quality, and insurers can be aware of treatment cost and budgetary impact given limited resources in all countries. Only by consistent and continuous re-evaluation of new or changing medical interventions can clinicians and insurers adapt patient management to new scientifically derived results. This is the best manner by which to meet patients' care needs and the clinical needs of practitioners, as well as the financial needs of payers.",1995.0,0,0
20,10160075,The cost effectiveness of Helicobacter pylori eradication versus maintenance and episodic treatment in duodenal ulcer patients in Sweden.,P Unge; B Jönsson; N O Stålhammar,"This study compares the cost effectiveness of Helicobacter pylori eradication and conventional treatment in duodenal ulcer patients treated by a general practitioner. Using a Markov chain approach, Swedish cost data and a study period of 5 years, we conclude that H. pylori eradication with omeprazole and appropriate antibiotics is a cost-effective alternative compared with both maintenance and episodic treatment. Of the patients entering the eradication strategy, most are cured and will have no relapse during a 5-year period. H. pylori eradication results in higher initial costs but, because of a very low risk of recurrence after successful eradication, the expected future costs are reduced. The investment pays off within 1 year when compared with maintenance treatment, and within 3 years when compared with episodic treatment.",1995.0,0,0
21,10166411,Cost-effectiveness analysis of different strategies for treating duodenal ulcer. Helicobacter pylori eradication versus antisecretory treatment.,X Badia; J L Segú; A Ollé; M Brosa; J Monés; L García Ponte,"Helicobacter pylori has recently been recognised as a causative agent for duodenal ulcer, and the efficacy of various combinations of antibacterials and antisecretory agents in eradicating this pathogen has been assessed. The objective of this study was to determine the efficiency of 2 treatment strategies for patients with H. pylori-positive duodenal ulcer. Cost effectiveness was analysed for antisecretory therapy (omeprazole 20 mg/day for 4 weeks), and eradication therapy (triple therapy: omeprazole 40 mg/day plus clarithromycin 1 g/day plus amoxicillin 2 g/day for 1 week). In a Markov model, a hypothetical cohort of 5000 patients was followed for 10 years through 6 disease states. Cyclic eradication therapy (i.e. in the first duodenal ulcer episode and in relapses) was the most cost effective [21 Spanish pesetas (Pta) per day free of symptoms (DFS); Pta128 = $US1 (October 1995)] of the eradication options evaluated [antisecretory in the first episode, then eradication for relapses (Pta22.3/DFS), and eradication therapy first, then antisecretory therapy (Pta27.3/DFS)]. Antisecretory therapy alone was less cost-effective (Pta39/DFS) than each of the 3 eradication options. Eradication treatment in the first episode of duodenal ulcer and relapses has savings in direct costs per patient of up to 56% compared with antisecretory therapy alone. Sensitivity analyses showed the model to be very robust. It is, therefore, advisable to treat initial episodes of H. pylori-positive duodenal ulcer and relapses with triple therapy. The improved cost-effectiveness ratio was largely explained by the long term reduction in relapses obtained with the eradication strategies.",1997.0,0,0
22,10179922,Prevention of nonsteroidal anti-inflammatory drug-induced gastropathy: clinical and economic implications of a single-tablet formulation of diclofenac/misoprostol.,J L Goldstein; L R Larson; B D Yamashita,"Nonsteroidal anti-inflammatory drugs (NSAIDs) are commonly used to manage arthritis. While controlling symptoms and improving quality of life, NSAID use is associated with gastroduodenal injury and a 2%-4% annual risk for symptomatic gastroduodenal ulceration, hemorrhage, and perforation. This requires clinicians to balance the efficacy of NSAIDs against the potential risk of serious gastrointestinal events. Identification and stratification of risk can help guide the optimal approach for arthritis management of individual patients or large populations such as managed care organizations. NSAID-induced gastroenteropathy carries considerable economic consequences; 46% of arthritis costs are related to managing serious adverse events. It is reasonable to assume that these costs may not be incurred if high-risk patients are recognized and optimally managed. Newer therapies with proven safety margins present an attractive option, especially for patients at higher risk. The single-tablet formulations of diclofenac and misoprostol (Arthrotec) offer an alternative in managing NSAID patients because of their inherent safety profile. Studies with diclofenac/misoprostol indicate its effectiveness in treating signs and symptoms of arthritis and in reducing the incidence of NSAID-induced gastroenteropathy. As such, this agent may provide improved medical and economic outcomes. This review discusses the clinical aspects of NSAID-induced gastroenteropathy, including available preventive therapies. Approaches to assessing patients' risk for developing complications, and the relationship of medical risk and economic outcomes, are also examined. Although not all patients require preventive therapy, patients with heightened risk may benefit clinically and economically from gastroprotective NSAIDs. Additional research or modeling may provide further insight into the economic implications of managing and preventing NSAID-induced gastroenteropathy.",1998.0,0,0
23,10192750,Cytosolic calcium and lymphoproliferative response during calcium antagonism in men.,P Lijnen; R Fagard; V Petrov,"A double-blind, placebo-controlled parallel study was conducted on the effect of mibefradil, both an L- and T-type Ca2+-channel blocker with a more selective blockade of T-type channels, administered once daily for 1 week to normal male subjects, on blood pressure, intracellular cationic concentrations, sodium-proton exchange rate and 3H-thymidine incorporation in peripheral blood mononuclear cells (PBMC). After a 1-week run-in period on placebo, the subjects (n = 40) were allocated to a placebo or a mibefradil group. Placebo or 50 mg mibefradil was administered once daily in the morning for 1 week. All subjects were investigated at baseline and after 1 week of placebo or mibefradil administration. Standing or recumbent blood pressure and heart rate of subjects in the mibefradil group was decreased (P < 0.05 or less) compared with that of subjects in the placebo group. Decreased (P < 0.001) intracellular free Ca2+ concentration and reduced (P < 0.001) 3H-thymidine incorporation in the PBMC were observed in the mibefradil-treated subjects. The intracellular sodium, potassium or magnesium concentration as well as the sodium-proton exchange rate were not changed during mibefradil administration. The blood pressure lowering action of mibefradil in men is accompanied by a decrease in intracellular free Ca2+ concentration. Mibefradil also reduced the 3H-thymidine incorporation or de novo DNA synthesis in PBMC by modulating the calcium homeostasis.",1999.0,0,0
24,10193396,Gastro-oesophageal reflux related cough and its response to laparoscopic fundoplication.,C J Allen; M Anvari,"This study was designed to determine prospectively the rate of cough before and after laparoscopic Nissen fundoplication performed for the control of gastro-oesophageal reflux disease. One hundred and ninety five consecutive patients (76 men) of mean (SD) age 46.9 (14.1) years with proven gastro-oesophageal reflux disease, who were either on long term omeprazole (n = 187) or who had not responded to a trial of omeprazole (n = 8), took part in the study which was carried out in a university teaching hospital that included a regional respiratory referral centre. Patients underwent oesophageal manometry, 24 hour oesophageal pH testing, and symptom score evaluation by an independent observer before and six months after laparoscopic Nissen fundoplication. One hundred and thirty three patients presented with reflux symptoms and 62 with respiratory symptoms; 68% of patients complained of cough before surgery (86% with respiratory symptoms, 60% with gastrointestinal symptoms). The percentage reflux time in 24 hours fell significantly (p < 0.0001) from a mean (SD) of 9.38 (10.99)% to 1.22 (2.92)%, lower oesophageal sphincter tone rose significantly (p < 0.0001) from a mean (SD) of 7.71 (5.90) mm Hg to 21.74 (10.84) mm Hg, and the cough score fell from a median value of 8.0 (IQR 12.0) to 0 (IQR 3) following surgery. Of the patients with cough, 51% were cough free after surgery and 31% improved. The patients with respiratory symptoms had a higher cough score before (median 12.0 (IQR 5.5) versus 4.0 (IQR 8.75), p < 0.0001) and after surgery (median 1 (7.5) versus 0.0 (IQR 1.0), p = 0.0045) than those with gastrointestinal symptoms. Patients who present to gastroenterologists with severe reflux commonly complain of cough. Laparoscopic Nissen fundoplication is effective in the control of cough in patients with gastro-oesophageal reflux disease, with or without primary respiratory disease.",1999.0,0,0
25,10201459,Omeprazole versus high-dose ranitidine in mild gastroesophageal reflux disease: short- and long-term treatment. The Dutch Reflux Study Group.,H P Festen; E Schenk; G Tan; P Snel; F Nelis,"Patients with reflux esophagitis suffer from a chronic condition that may cause considerable discomfort because of recurrent symptoms and diminished quality of life. This study was designed to evaluate acute and long-term treatment comparing standard doses of omeprazole and high-dose ranitidine. Patients with endoscopically verified symptomatic esophagitis grade I or II were initially treated with omeprazole 20 mg daily or ranitidine 300 mg twice daily for 4-8 wk. Patients who were symptom free were randomized to maintenance treatment with omeprazole 10 mg daily or ranitidine 150 mg twice daily. Patients were seen every 3 months or at symptomatic relapse. The percentage of asymptomatic patients after 4 and 8 wk treatment were 61% and 74%, respectively, for omeprazole and 31% and 50%, respectively, for ranitidine. Of 446 patients treated initially, 277 were asymptomatic, of whom 263 entered the maintenance study. The estimated proportion of patients in remission after 12 months of maintenance treatment with omeprazole 10 mg daily (n = 134) and ranitidine 150 mg twice daily (n = 129) were 68% and 39%, respectively (p < 0.0001). Omeprazole 20 mg daily is superior to high-dose ranitidine in the symptomatic treatment of reflux esophagitis grade I and II. Furthermore, omeprazole at half the standard dose is more effective than ranitidine in a standard dose in keeping patients in remission for a period of 12 months.",1999.0,0,1
26,10201462,The effect of antibiotic therapy on bleeding from duodenal ulcer.,A Sonnenberg; C A Olson; J Zhang,"We conducted this study to test whether eradication of Helicobacter pylori (H. pylori) infection prevents hemorrhage related to duodenal ulcer. Patients with H. pylori infection and endoscopically proven duodenal ulcers without ulcer-related hemorrhage were enrolled into four randomized, double-blind, multicenter studies using the same study protocol. They were treated with clarithromycin plus omeprazole (441 patients), omeprazole alone (447 patients), or ranitidine alone (263 patients). Success of H. pylori eradication was evaluated by the 13C-urea breath test 4-6 wk after the last dose of study drug. Follow-up continued at monthly intervals up to 1 yr after the last dose of study drug. Bleeding due to duodenal ulcer was not observed in any patients who received clarithromycin plus omeprazole, whereas five patients in the omeprazole treatment group and six patients in the ranitidine treatment group experienced an episode of ulcer-related hemorrhage during follow-up. All patients who experienced ulcer-related bleeding were male. When compared by bleeding, there were no significant differences with respect to ethnicity, alcohol consumption, or tobacco use. H. pylori infection was no longer detectable in 68% of patients after treatment with clarithromycin plus omeprazole, compared with 5% after treatment with omeprazole alone or 4% after treatment with ranitidine alone. In a population of duodenal ulcer patients without predisposing risk factors for ulcer bleeding, antibiotic eradication or suppression of H. pylori infection prevented the occurrence of ulcer-related hemorrhage for up to 1 yr after therapy.",1999.0,0,0
27,10203431,Quality of life in arthritis patients using nonsteroidal anti-inflammatory drugs.,I Wiklund,"Arthritis is a painful and disabling condition. To suppress the pain and the inflammatory process, patients are often chronic nonsteroidal anti-inflammatory drug (NSAID) users. Chronic use of NSAIDs may induce peptic ulcer, dyspeptic problems and heartburn. Therefore, these patients are often provided with treatment to relieve and/or protect against gastrointestinal problems. Rheumatic disorders also affect a range of health-related quality of life domains. In one study, patients with NSAID-associated gastroduodenal lesions complained about lack of energy, sleep disturbances, emotional distress and social isolation in addition to pain and mobility limitations. The degree of distress and dysfunction differed markedly from scores in an unselected population. Clinical trial data suggest that acid-suppressing therapy with omeprazole is superior to therapy with misoprostol and ranitidine in healing gastroduodenal lesions and preventing abdominal pain, heartburn and indigestion symptoms during continued NSAID treatment. Because arthritic patients are severely incapacitated by their condition regarding most aspects of health-related quality of life, it is important to offer a treatment that is effective in healing and preventing NSAID-induced ulcers and gastrointestinal symptoms during continued NSAID treatment without further compromising the patients' quality of life. Treatment with omeprazole once daily has been shown to be superior to that with ranitidine and misoprostol in this respect.",2000.0,0,0
28,10206732,Therapy for ulcers and erosions associated with nonsteroidal anti-inflammatory drugs.,H J Freeman,,1999.0,0,0
29,10215733,Treatment options for Helicobacter pylori infection when proton pump inhibitor-based triple therapy fails in clinical practice.,J M Lee; N P Breslin; D K Hyde; M J Buckley; C A O'Morain,"The effectiveness of Helicobacter pylori eradication regimens has not been extensively investigated in the clinical practice setting. The optimal treatment choice after an initial failed eradication attempt has not been determined. To evaluate proton pump inhibitor-based triple therapies as first-line eradication regimens in clinical practice, and to establish the efficacy of second-line regimens in the context of an initial failed eradication attempt. Three hundred and eight patients with dyspepsia and evidence of H. pylori at endoscopy were recruited. As first-line therapy, 116 patients received omeprazole 20 mg b.d. in combination with amoxycillin 1 g b.d. and clarithromycin 500 mg b.d. (OAC) while 192 patients received omeprazole 20 mg b.d. in combination with metronidazole 400 mg b.d. and clarithromycin 250 mg b.d. (OMC). H. pylori status was reassessed at least 4 weeks after therapy (25 patients failed to attend for further testing). Of 52 patients with an initial failed eradication attempt, 20 patients received a 1 week quadruple therapy regimen incorporating omeprazole 20 mg b.d., tripotassium dicitrato bismuthate 120 mg q.d.s., tetracycline 500 mg q.d.s. and metronidazole 400 mg t.d.s., 20 patients received a 2-week proton pump inhibitor-based triple therapy regimen as described, and 12 patients received a further 1-week proton pump inhibitor-based triple therapy regimen. Including 308 patients, the intention-to-treat (ITT) eradication rates for OAC and OMC as first-line regimens were 72% (95% CI: 63-80%) and 73% (95% CI: 67-79%) respectively. A per protocol (PP) analysis on the 283 patients who completed follow-up gives an initial eradication rate of 78% (95% CI: 69-86%) for OAC and 79% (95% CI: 73-85%) for OMC. There were 60 patients (21%; 95% CI: 17-26%) in whom the initial eradication attempt was unsuccessful. With second-line therapy, H. pylori was successfully eradicated in a further 35/52 (67%; 95% CI: 58-73%) patients. The eradication rates with the quadruple regimen and 2-week triple therapy regimens were 75% (95% CI: 56-94%) and 80% (95% CI: 63-98%) respectively (P = 0. 71). The eradication rate with a repeat 1-week regimen was 33% (95% CI: 7-60%). The eradication rates achieved in this 'in practice' study with recommended first-line 1-week proton pump inhibitor-based triple therapy regimens were lower than the rates achieved with similar regimens in the clinical trial setting. A repeat 1-week proton pump inhibitor-based triple therapy regimen was not successful as a salvage therapy. Both the 2-week proton pump inhibitor-based triple therapy regimen and the 1-week quadruple therapy regimen were successful second-line treatments in >/=75% of patients.",1999.0,0,0
30,10215744,Liquid and chewable iron in post-gastrectomy anaemia.,D E Langdon,,1999.0,0,1
31,10218323,Eradication of Helicobacter pylori.,A K Kundu,,1999.0,0,0
32,10218743,Importance of pH control in the management of GERD.,R H Hunt,"The degree of esophageal mucosal injury that occurs in patients with gastroesophageal reflux disease depends on duration of exposure and pH of the refluxate. Evidence suggests that an intraesophageal pH of less than 4.0 directly correlates with the degree of mucosal injury. The advent of acid secretory inhibitors such as the histamine2-receptor antagonists (H2RAs) and, more recently, the proton pump inhibitors (PPIs) has revolutionized the treatment of patients with reflux disease. However, the evidence linking the degree of mucosal damage to pH of the refluxate has prompted investigators to reevaluate the effectiveness of these agents. The PPIs are significantly more effective than the H2RAs in achieving and sustaining an intragastric pH above 4.0. The results of clinical trials performed with the PPIs indicate a faster rate of healing of erosive esophagitis and of symptom relief than treatment with H2RAs.",1999.0,0,0
33,10221370,Discontinuation rates of Helicobacter pylori treatment regimens: a meta-analysis.,S M Buring; L H Winner; R C Hatton; P L Doering,"We conducted a meta-analysis to determine what factors in treatment regimens for Helicobacter pylori are associated with increased discontinuation rates. Studies were selected from the 1990-1996 MEDLINE data base, and references in published articles and reviews were obtained. Each article was uniformally abstracted for factors that could potentially affect dropout rates. Drug regimens with high numbers of doses per day had highest dropout rates (p=0.0001). The total dropout rate was lowest for regimens containing a proton pump inhibitor (OR = 0.75, CI 0.57, 0.98). The rate was high in regimens containing a bismuth compound due to side effects (OR = 2.79, CI 1.78, 4.36). The main finding was that drug regimens for eradication of H. pylori that have a high number of doses per day result in higher discontinuation rates than regimens with fewer doses per day.",1999.0,0,0
34,10228801,"Rapid improvement of symptomatology with pantoprazole, amoxycillin and metronidazole in Helicobacter pylori-positive duodenal ulcer patients.",A Pilotto; G Leandro; M Franceschi; L Bierti; R Di Battista; A Notarbartolo; G Pisciotta; A Grassi; B Crestani; G Tafner; S Michelagnoli; F Garotta,"To evaluate the efficacy and tolerability of a new 1-week triple therapy regimen consisting of pantoprazole, amoxycillin and metronidazole. The study involved 51 Helicobacter pylori (H. pylori) positive patients (M:30, F:21, mean age: 52.5 years, range: 24-75) affected with duodenal ulcer in active phase. At baseline and 6 weeks after the completion of treatment, clinical assessment, endoscopy with gastric biopsies, rapid urease test, 13C urea breath test, and serum laboratory analyses were performed. All patients were treated with pantoprazole 40 mg once daily, plus amoxycillin 1 gram tid and metronidazole 250 mg tid for 1 week, and pantoprazole 40 mg once daily for a second week. A clinical diary for daily assessment of symptoms and side effects was completed by patients during the treatment period. Three patients were discontinued from the study. Six weeks after therapy, the ulcer was healed in 47 of 48 patients (97.9%, 95% CI = 93.9-100). The cure rates of H. pylori infection, expressed using both the intention-to-treat and per protocol analyses, were 80.4% (95% CI = 69.5-91.3) and 85.4% (95% CI = 75.4-95.4), respectively. The therapy led to a significant, rapid disappearance or reduction in daytime epigastric pain, from 68.8% on day 1 to 82.2% on day 3 (p < 0.001) and in nocturnal epigastric pain, from 80.6% on day 1 to 93.3% on day 3 (p < 0.001). After 2 weeks of treatment, the percentage of patients completely free of pain was 82.2% for daytime pain and 90.3% for nocturnal pain. A rapid improvement in acid regurgitation, heartburn, nausea and vomiting was also observed with a median value of symptom disappearance of 2 days. The percentages of patients completely symptom-free were 37.5% after 1 day, 54.1% after 3 days, 75% after 2 weeks, and 83.3% after 2 months. H. pylori-cured patients showed a significant decrease in the histological activity of both antral (p = 0.0001) and body (p < 0.008) gastritis. Mild to moderate adverse events were reported by 15 patients. One week triple therapy with pantoprazole in combination with amoxycillin and metronidazole, followed by a second week of pantoprazole, was well tolerated and highly effective for the 1) rapid improvement or resolution of symptoms; 2) healing of the DU; 3) eradication of H. pylori infection; and, 4) reduction of histological signs of chronic gastritis activity.",1999.0,0,0
35,10232863,The conflicting relationship between Helicobacter pylori and non-steroidal anti-inflammatory drugs in peptic ulcer bleeding.,G Bianchi Porro; M Lazzaroni,,1999.0,0,0
36,10233187,Randomized controlled comparison of nitroimidazoles for the eradication of Helicobacter pylori and relief of ulcer-associated and non-ulcer dyspepsia.,A F Goddard; R P Logan; S Lawes; R C Spiller,"A combination of omeprazole, clarithromycin and either metronidazole or tinidazole is commonly used for Helicobacter pylori eradication. Metronidazole is considerably cheaper than tinidazole but the two have not previously been compared in a randomized trial. One hundred and twenty dyspeptic H. pylori-positive patients with endoscopically defined peptic ulcer [DU (n = 65), GU (n = 12)] or non-ulcer dyspepsia (NUD, n = 43) were randomized to receive a 1-week course of twice daily omeprazole 20 mg, clarithromycin 250 mg and either metronidazole 400 mg (OCM) or tinidazole 500 mg (OCT) in a double-blind fashion. Eradication of H. pylori, safety and side-effects of treatment, dyspeptic symptom score and consumption of antisecretory drugs were assessed at 6 weeks and 1 year after treatment. H. pylori eradication was successfully achieved in 57/60 (95%, ITT analysis) of patients receiving OCT and 58/60 (97%, ITT analysis) receiving OCM. Both regimens had similar side-effect profiles, which accounted for only one patient withdrawal. All patients remained uninfected (as assessed by 14C-urea breath test) at 1-year follow-up, but major symptom improvements and decreased antisecretory drug use were only seen in patients with DU (P<0.0001). Treatment with OCM is as effective as the more expensive OCT at eradicating H. pylori. H. pylori eradication results in long-term relief of dyspeptic symptoms and reduced antisecretory consumption only in patients with DU, and not in those with NUD.",2000.0,0,0
37,10325458,Helicobacter pylori as a possible bacterial focus of chronic urticaria.,S Wustlich; R Brehler; T A Luger; T Pohle; W Domschke; E Foerster,"Chronic urticaria is one of the most frequent skin diseases. Its cause, however, remains unsolved in a large number of cases. Recent investigations pointed to a potential role of Helicobacter pylori infection of the upper gastrointestinal tract as a possible causative agent in chronic urticaria. The aim of this study was to examine the effect of a 14-day eradication therapy on chronic urticaria. Thirty patients with chronic urticaria and confirmed H. pylori infection were treated with amoxicillin and omeprazole. Follow-up was conducted over a period of 6 months concerning eradication of H. pylori and remission of urticaria. Only 8 out of 30 patients (26.7%) showed clinical improvement or disappearance of their urticarial symptoms. Though our results do not support the preliminary data of previous studies, the role of H. pylori as a possible bacterial focus of chronic urticaria has to be further investigated.",2000.0,0,0
38,10331931,Canadian Helicobacter pylori Consensus Conference update: infections in adults. Canadian Helicobacter Study Group.,R H Hunt; C A Fallone; A B Thomson,"The first Canadian Helicobacter pylori Consensus Conference took place in April 1997. The initial recommendations of the conference were published in early 1998. An update meeting was held in June 1998, and the present paper updates and complements the earlier recommendations. Key changes included the following: the recommendation for testing and treating H pylori infection in patients with known peptic ulcer disease was extended to testing and treating patients with ulcer-like dyspepsia; it was decided that the urea breath test (not serology) should be used for routine diagnosis of H pylori infection unless endoscopy is indicated for another reason; and recommended therapies were a twice daily, seven-day regimen of a proton pump inhibitor (omeprazole 20 mg, lansoprazole 30 mg, pantoprazole 40 mg) or ranitidine bismuth citrate 400 mg, plus clarithromycin 500 mg and amoxicillin 1000 mg, or plus clarithromycin 500 or 250 mg and metronidazole 500 mg. The need was reiterated to have funding for readily accessible, accurate testing for H pylori infection with the urea breath test. It was strongly recommended that regional centres be established to monitor the prevalence of antibiotic-resistant H pylori infections. The initial consensus document referred to pediatric issues that were not addressed in this update but were the subject of a subsequent Canadian Helicobacter Study Group meeting, and will be published later in 1999.",1999.0,0,0
39,10333196,Three-day antibiotic therapy with azithromycin and tinidazole plus lansoprazole or pantoprazole to cure Helicobacter pylori infection: a pilot study.,G Cammarota; A Papa; R Cianci; O Cannizzaro; A Armuzzi; A Gasbarrini; G Addolorato; G B Gasbarrini,"The aim of the present study was to investigate and compare the effects of two proton-pump inhibitors, lansoprazole (Limpidex 30 mg, Sigmatau) vs pantoprazole (Peptazol 40 mg, Boehringer Mannheim), included in a three-day antibiotic therapy regimen with azithromycin (Zitromax 500 mg, Pfizer) and tinidazole (Fasigin 500 mg, Pfizer). Seventy consecutive, H. pylori-positive patients were randomly pre-treated with lansoprazole 30 mg o.d. (once daily) or pantoprazole 40 mg o.d. for two days, and subsequently respectively assigned to one of the two following treatment regimens, given for only three days: regimen A (LAT) comprising lansoprazole 30 mg o.d. plus azithromycin 500 mg o.d. and tinidazole 500 mg b.i.d. (bis in die), or regimen B (PAT) comprising pantoprazole 40 mg o.d. plus azithromycin 500 mg o.d. and tinidazole 500 mg b.i.d. H. pylori status was evaluated by means of histology and rapid urease test at entry, and by 13C-urea breath test alone 8 weeks after treatment. Sixty-nine of the enrolled patients completed the study: 34 in the LAT group and 35 in the PAT group. One patient in the LAT group was lost to follow-up. In the LAT group, after the end of treatment, 28/34 patients were H. pylori-negative (per protocol: 82%; intention-to-treat: 80%). In the PAT group, after treatment, 29/35 patients were H. pylori-negative (per protocol and intention-to-treat: 83%). Mild or slight side-effects occurred in only one patient in the LAT group and in one in the PAT group. From this study there is no evidence that either of the two proton-pump inhibitors used is preferable in a three-day antibiotic regimen with azithromycin and tinidazole. The excellent side-effect and tolerability profiles, associated with acceptable eradication rates, make the two treatment regimens we tested particularly useful when patient compliance is difficult to achieve.",1999.0,0,0
40,10343146,"One-week triple regime therapy consisting of pantoprazole, amoxicillin and clarithromycin for cure of Helicobacter pylori-associated upper gastrointestinal diseases.",A I Dajani; S Awad; S Ukabam; M A Nounou; Z Abdul Rasheed; S Gautam; G Abdul Aal; S Nayal,"This study was designed to determine the efficacy and safety of 1-week triple therapy regime consisting of pantoprazole, amoxicillin and clarithromycin in the cure of Helicobacter pylori infection leading to duodenal ulcer disease and/or gastritis. Sixty-one patients (47 males, 14 females with a mean age of 34 years) belonging to different ethnic groups suffering from H. pylori-associated duodenal ulcer and/or gastritis for an average of 2.46 years were recruited. Having satisfied primary selection criteria, patients received pantoprazole 40 mg b.i.d., clarithromycin 500 mg b.i.d. and amoxicillin 1,000 mg b.i.d. for 7 days. All medications were stopped there after H. pylori eradication was determined 4-6 weeks after treatment by a repeat endoscopy, a rapid urease test, H. pylori culture and histology assessment as indicators of cure. All three tests must be negative to consider the infection to have been successfully eradicated. Fifty-seven patients completed the efficacy analysis per protocol. Dramatic symptomatic improvement was noted in most patients immediately after stopping treatment and it was sustained at 6 weeks. At the end of the study, the healing rate of duodenal ulcers (complete re-epithelialization) following 1-week treatment only, as indicated above, and without any maintenance therapy was 66.7%, that of gastritis was 55.7%, and that of erosions was 64.3%. The overall eradication rate for H. pylori, however, was 93% (95% CI 83.0-98.1%). Furthermore, histologic evaluation revealed a remarkable resolution in the activity of gastritis in all the patients who had successful eradication of the infection.",2000.0,0,0
41,10345967,Antibiotic therapy of Helicobacter pylori infection reduces healthcare expenditures related to duodenal ulcer.,A Sonnenberg; M P Pauly; S D Levenson; J S Schwartz,"To test whether eradication of Helicobacter pylori saves costs in the treatment of duodenal ulcer disease, compared with conventional antisecretory therapy. A prospective, double-blind clinical trial was conducted at 132 sites in the United States. Adult patients with active duodenal ulcer and confirmed H pylori infection were randomized to receive treatment with clarithromycin plus omeprazole, omeprazole alone, or ranitidine alone. Utilization of ulcer-related healthcare resources was documented during 1 year following therapy. Costs were calculated by multiplying the number of health resources utilized by the cost of each resource. Resource costs were obtained from a database containing actual average costs spent by managed care organizations on outpatient and inpatient treatment. Of the 819 patients enrolled, 727 completed the study: 243 received clarithromycin plus omeprazole, 248 omeprazole alone, and 236 ranitidine alone. Ulcer-related health resource utilization and total ulcer-related healthcare costs were decreased after treatment with clarithromycin plus omeprazole, compared to treatment with omeprazole or ranitidine alone. In multivariate linear regression analyses, type of treatment was found to be a significant predictor of total costs. Specific costs associated with endoscopic examinations, clinic visits, and medications were also significantly reduced by treatment with clarithromycin plus omeprazole as compared to other treatment forms. In a managed care environment, therapy with clarithromycin and omeprazole to eradicate H pylori in patients with duodenal ulcer disease would result in significant cost savings secondary to a reduction in the utilization of healthcare resources.",1999.0,0,1
42,10352088,High dose omeprazole plus amoxicillin and azithromycin in eradication of Helicobacter pylori in duodenal ulcers.,A Vcev; D Stimac; A Vceva; B Takac; D Pezerovíc; A Ivandíc,"The aim of our study was to establish whether one-week triple therapy regimen (omeprazole, amoxicillin, azithromycin) with low dose (2 x 20 mg/day) or high dose omeprazole (2 x 40 mg/day) is more effective in curing H. pylori infection in patients with active duodenal ulcer disease. One hundred and twenty patients with duodenal ulcer and H. pylori infection were treated with amoxicillin 2 x 1000 mg/day for the first 7 days plus azithromycin 500 mg/day for the first 6 days. Patients were randomly assigned to receive either omeprazole 2 x 20 mg/day for the first 7 days (group A; n = 60) or omeprazole 2 x 40 mg/day for the first 7 days (group B; n = 60). After 7 days all patients in both groups continued treatment with omeprazole (40 mg/day (days 8-14) and 20 mg/day (days 15-28)). H. pylori status was determined by urease test and histology before the treatment and 4 weeks after cessation of any medication. One hundred and thirteen patients completed the study. H. pylori infection was eradicated in 73.2% [41/56] of patients in group A (intention-to-treat [ITT] analysis: 68.3%; 95% CI: 58.6-80.4%) vs. 82.5% [47/57] of patients in group B (ITT analysis: 78.3%; 95% CI: 67.8-87.9%; NS). All ulcers had healed after 4 weeks of omeprazole treatment. Side effects, usually minor, were recorded in 12.5% (group A) and in 14% (group B) of patients (NS), but therapy was discontinued for only one patient in group B (NS). There was no statistically significant difference between one-week triple therapy regimen (omeprazole, amoxicillin, azithromycin) with high dose omeprazole (2 x 40 mg/day) and regimen with low dose omeprazole (2 x 20 mg/day) in curing H. pylori infection in patients with active duodenal ulcer disease.",1999.0,0,0
43,10355915,Helicobacter pylori infection and persistent hyperemesis gravidarum.,E B Jacoby; K B Porter,"Hyperemesis gravidarum is the most severe spectrum of gastrointestinal complaints in pregnant women. Our purpose is to describe an association of Helicobacter pylori with hyperemesis gravidarum. Three pregnant women are described with the working diagnoses of hyperemesis gravidarum unresponsive to standard therapy. The medical management used to treat Helicobacter pylori in these women are elaborated. The persistence of the symptomatology and/or hematemesis resulted in Helicobacter pylori testing of these women. A 2-week course of antibiotics and a proton pump inhibitor or H2 receptor antagonist resulted in resolution of the hyperemesis. A discussion of the incidence, diagnosis, and management of Helicobacter pylori in pregnancy is described. When the symptoms of hyperemesis gravidarum are persistent into the second trimester, active peptic ulcer disease from Helicobacter pylori should be included in the differential diagnoses.",1999.0,0,0
44,10363734,"Rabeprazole: pharmacokinetics in patients with stable, compensated cirrhosis.",A M Hoyumpa; H Trevino-Alanis; I Grimes; T J Humphries,"This single-center, open-label study was undertaken to compare the tolerability and pharmacokinetic profiles of rabeprazole, a new proton-pump inhibitor (PPI), in healthy volunteers and in subjects with chronic cirrhosis. Thirteen healthy men and 10 men with stable, compensated cirrhosis documented by biopsy or liver/spleen scan received a single 20-mg rabeprazole dose. Blood samples were drawn before and up to 24 hours after drug administration for the determination of plasma rabeprazole concentrations using high-performance liquid chromatography. Adverse events, vital signs, electrocardiograms, physical findings, and clinical laboratory test results were monitored before and during treatment to determine how rabeprazole was tolerated. Chronic liver disease substantially altered the pharmacokinetic profile of rabeprazole. The maximum rabeprazole concentration (+/- SD) in subjects with cirrhosis (635+/-199 ng/mL) was approximately 50% higher than that in the healthy volunteers (401+/-246 ng/mL), and both area under the curve and elimination half-life were increased by approximately 100%. Oral clearance in subjects with cirrhosis was 38% of that in the healthy volunteers. Rabeprazole was well tolerated by both groups. Three subjects reported a total of 5 clinical adverse events that were judged as definitely or possibly related to rabeprazole treatment. Some minor changes in laboratory values were judged to be clinically insignificant. In patients with mild-to-moderate liver dysfunction, clearance of this PPI, as with other members of the class, was markedly reduced and plasma levels were increased. Although caution is always warranted in patients with severe liver disease, drug accumulation is unlikely with rabeprazole 20 mg once daily, and dose adjustment does not appear to be indicated in patients with mild-to-moderate liver dysfunction.",1999.0,0,1
45,10364004,Updated guidelines for the diagnosis and treatment of gastroesophageal reflux disease. The Practice Parameters Committee of the American College of Gastroenterology.,K R DeVault; D O Castell,,1999.0,0,0
46,10369630,The efficacy of extended-interval dosing of omeprazole in keeping gastroesophageal reflux disease patients symptom free.,N Bieszk; P B Kale-Pradhan,"The potential economic advantage of alternate-day therapy for GERD maintenance must be weighed against the potential cost of failure before it can be widely instituted. The studies presented have helped develop a clinical picture of the patients who may benefit from alternate-day therapy without risk of complications or potential increases in management costs. Bank et al., reporting on a group of patients, found that patients with Grade II-IV disease had a 61% success rate at two to eight years. Bank defined success as both maintenance of endoscopic healing and symptom control. Ladas et al. found a 66.7% success rate defined as clinical and endoscopic remission in Grades II-III disease. Kurucar et al. monitored symptom control and esophageal complications in his patients and found the regimen to have a 26% success rate in Grades III-IV disease. Lind et al. found that 83% of patients could remain symptom free with on-demand therapy if they were endoscopy-negative at baseline. The results of the Mantides et al. study are important because they imply that alternate-day omeprazole therapy may be more effective than alternatives for step-down treatment, such as ranitidine or cisapride. Furthermore, patients can be educated to increase their frequency of use if symptoms should arise. Not only does this give the patient a sense of self-empowerment over his or her disease state, but it avoids the cost of switching to a PPI due to failure with an H2RA or a motility agent. Alternate-day use of omeprazole should be attempted only during the maintenance phase of GERD therapy. Patients requiring >20 mg/d to achieve healing appeared to be poor candidates for alternate-day omeprazole maintenance therapy. Based on available studies, it would seem that patients with Grades 0-II GERD would benefit most from alternate-day therapy. A role for alternate-day therapy in Grades III-IV is apparent from the results presented but requires greater caution in view of the differing success rates (26-61%) in various studies. With Grades II-III esophagitis, a mean 24-hour gastric pH >6 and a gastric pH <4 less than 10% of the time during the initial healing phase with omeprazole 20 mg/d appeared to be associated with success on alternate-day therapy. Evidence that all marketed PPIs have similar success is not available and should not be extrapolated from the data presented. Evidence that downward dosage adjustments of PPIs versus extending dosage intervals are effective in the maintenance of GERD should be recognized. Lansoprazole has been approved for treating erosive esophagitis at 30 mg/d, with the maintenance dose established at 15 mg/d. Studies showing that lansoprazole 15 mg/d is more effective than alternate-day therapy with lansoprazole 30 mg exist, although similar studies with omeprazole have not been performed. The abstracts describing the use of alternate-day omeprazole accounted for all enrollees and included endoscopic grading or pH monitoring to document disease severity at baseline. Most also included these same objective measures as end points in combination with symptom control. This strengthens the data since the positive predictive value of typical symptoms is variable. However, there are also several significant limitations. Abstracts provide only limited information on methods. All studies other than Lind et al. lacked randomization. This study was also the only one that blinded patients to their treatment. Sample sizes for the majority of the trials were quite small. Statistical analyses were not performed on any of the trial results with the exception of the trial by Lind et al. In light of the lack of evidence of statistical significance as well as study design flaws, conclusions should be drawn cautiously. Larger well-designed trials looking at both the efficacy and cost-effectiveness of alternate day omeprazole are required before a definitive recommendation can be made.",1999.0,0,0
47,10372933,"""Reappearance"" of Helicobacter pylori after eradication: implications on duodenal ulcer recurrence: a prospective 6 year study.",A Archimandritis; V Balatsos; V Delis; Z Manika; N Skandalis,"We estimated the rate of Helicobacter pylori ""reappearance"" and of duodenal ulcer relapse up to 6 years after eradication of H. pylori. Of 220 patients in whom H. pylori was eradicated, 165 were eligible at 12 months to follow-up. Endoscopy was scheduled every 12 months or whenever symptoms appeared. Baseline H. pylori eradication was confirmed by CLO test, histology (hematoxylin-eosin and Giemsa stain), and culture. H. pylori was tested for by the three methods at 12 months and subsequently by 2 methods (CLO, histology) on biopsies obtained from the gastric antrum and body. We reviewed 90 patients after 1 year, 32 after 2 years, 13 after 3 years, 12 after 4 years, 2 after 5 years, and 16 after 6 years (range, 12 to 72 months; average, 25.23 months; patient-years, 347). At 12 months after eradication, 16 of 165 patients (9.7%) were H. pylori positive and 5 had ulcer relapse. Of 75 patients evaluated at 24 months, 7 (9.3%) were H. pylori positive and 1 (1.3%) had ulcer relapse. At 36 months, 43 patients were seen and 1 (2.3%) was H. pylori positive and had ulcer relapse (2.3%). Thirty, 18, and 16 patients were seen at 48, 60, and 72 months, respectively. None was H. pylori positive and none had ulcer relapse. Overall, 24 H. pylori-positive patients were found, two thirds of them in the first year after eradication. In 7 of 24 (29%, 6 smokers), ulcer recurred. None of the H. pylori-negative patients had ulcer relapse. The H. pylori reappearance rate was 7% and the ulcer relapse rate was 2% per patient-year. If the 16 H. pylori-positive patients who were found the first year are considered as recrudescence, then the reinfection rate will be 2.3% per patient-year.",1999.0,0,0
48,10381904,Gastric Helicobacter pylori infection accelerates healing of reflux esophagitis during treatment with the proton pump inhibitor pantoprazole.,G Holtmann; C Cain; P Malfertheiner,"In previous studies an exaggerated effect of proton pump inhibitors (PPIs) on intragastric pH in Helicobacter pylori-infected patients was observed. Because healing and improvement of symptoms in patients with gastroesophageal reflux disease (GERD) is directly associated with an increase of intragastric pH during treatment, we hypothesized that the response to treatment with a PPI in patients with reflux esophagitis would be better in H. pylori-infected patients than in patients without H. pylori infection. We recruited 971 patients with endoscopically verified reflux esophagitis grades II and III (Savary/Miller). At study entry, H. pylori status was assessed by a 13C-urea breath test and baseline characteristics were recorded. Physicians and patients were not notified about the results of the breath test until completion of the study. All patients underwent treatment with pantoprazole, 40 mg orally once daily for 4 weeks. Healing was verified by endoscopy after 4 or 8 weeks of treatment. If the esophagitis had not completely healed at this time, treatment was continued for a further 4-week period. Healing rates and symptom relief were compared for patients with and without H. pylori infection. The prevalence of H. pylori was 39.9% (95% confidence interval [CI], 36.9-42.9), and neither gender, smoking, nor alcohol consumption were associated with the H. pylori infection (P > 0.4). The trial was completed by 846 patients without protocol violation. Overall healing rates of reflux esophagitis were 80.4% (95% CI, 77.7-83.1) and 93.6% (95% CI, 91.8-95.2) after 4 and 8 weeks, respectively. In H. pylori-positive patients, healing rates were significantly higher after 4 (86.6% vs. 76.3%; P = 0.0005) and 8 weeks (96.4% vs. 91.8%; P < 0.004). Relief of symptoms after 4 weeks was also significantly (P < 0.05) better in H. pylori-infected patients than in uninfected patients. Patients with reflux esophagitis and H. pylori infection respond significantly better than H. pylori-negative patients to the PPI pantoprazole.",1999.0,0,0
49,10381905,"Effects of very low dose daily, long-term aspirin therapy on gastric, duodenal, and rectal prostaglandin levels and on mucosal injury in healthy humans.",B Cryer; M Feldman,"The safety of low-dose daily aspirin therapy in the gastrointestinal tract is uncertain. Our objectives were to evaluate the long-term effects of very low daily aspirin doses in the gastrointestinal tract and effects on platelet-derived serum thromboxane levels in volunteers. Subjects were randomized to receive 10 mg (n = 8), 81 mg (n = 11), or 325 mg (n = 10) aspirin daily for 3 months. Before administration of aspirin, all subjects underwent gastroduodenoscopy, and most underwent proctoscopy for assessment of mucosal injury and prostaglandin content. After 1.5 and 3 months, subjects again underwent gastroduodenoscopy and, at 3 months, another proctoscopy. Each aspirin dose (even 10 mg) significantly reduced gastric mucosal prostaglandin levels, to approximately 40% of the baseline value. All three doses also induced significant gastric injury, and 325 mg caused duodenal injury. Three subjects developed gastric ulcers, 1 while taking 10 mg/day of aspirin. Furthermore, aspirin at 81 mg/day and 325 mg/day (but not 10 mg/day) significantly reduced duodenal mucosal prostaglandin levels to approximately 40% of the baseline value. Only 325 mg of aspirin per day significantly reduced rectal mucosal prostaglandin levels to approximately 60% of the baseline value. Serum thromboxane levels were inhibited 62%, 90%, and 98% with 10, 81, and 325 mg of aspirin. The findings explain aspirin's predominant gastric toxicity and question the safety of even 10 mg of aspirin daily.",2000.0,0,0
50,10382127,Colloidal bismuth pectin: an alternative to bismuth subcitrate for the treatment of Helicobacter pylori--positive duodenal ulcer.,Y Nie; Y Li; H Wu; W Sha; H Du; S Dai; H Wang; Q Li,"Bismuth triple therapy provides consistently good results in Helicobacter pylori eradication worldwide, whereas quadruple therapy using a combination of omeprazole and bismuth triple regimen has produced cure rates in excess of 90%. The prevalence of metronidazole-resistant strains was 26.8% in our area. Colloidal bismuth pectin (CBP) is a new, lower-priced bismuth salt made in China. The purpose of this study was to investigate the efficacy and safety of CBP triple and quadruple regimens in the treatment of H. pylori-positive duodenal ulcer. In this prospective trial, 205 patients with H. pylori-positive duodenal ulcer were allocated randomly to receive one of four regimens: metronidazole, 200 mg; amoxicillin, 250 mg; and colloidal bismuth subcitrate (CBS), 120 mg (group 1), or CBP, 100 mg qid (group 2) for 2 weeks, then continued CBS, 240 mg, or CBP, 200 mg bid for a further 2 weeks. A quadruple regimen using a combination of omeprazole, 20 mg bid, and CBS triple therapy (group 3) or CBP triple therapy (group 4), respectively, was given to patients for 1 week, followed by omeprazole, 20 mg once daily for a further 3 weeks. Further endoscopy was performed at least 4 weeks after cessation of the treatment. H. pylori status was determined by histology, a 14C urea breath test, and a urease test. The per-protocol H. pylori cure rates were 85% (22 of 26 patients), 90% (35 of 39), 96% (46 of 48), and 95% (75 of 79) for groups 1 through 4. In the intention-to-treat analysis, cure rates were 79% (22 of 28), 83% (35 of 42), 90% (46 of 51), and 89% (75 of 84), respectively. The cure rates of quadruple therapy were higher than those of triple therapy; an 8.2% difference was not statistically significant (95% confidence interval [CI], 2.3-18.7%). The ulcer-healing rates were 88%, 87%, 98%, and 97%, respectively, for groups 1 through 4. The ulcer pain was relieved more rapidly in quadruple- than in triple-therapy regimens. Two patients discontinued treatment prematurely owing to drug-related side effects. One-week quadruple therapy is highly effective and safe in H. pylori eradication in Chinese patients. CBP is as effective as CBS.",1999.0,0,0
51,10383498,The GU-MACH study: the effect of 1-week omeprazole triple therapy on Helicobacter pylori infection in patients with gastric ulcer.,P Malfertheiner; E Bayerdörffer; U Diete; J Gil; T Lind; P Misiuna; C O'Morain; P Sipponen; R C Spiller; J Stasiewicz; H Treichel; L Ujszászy; P Unge; S J Zanten; L Zeijlon,"To study the efficacy of omeprazole triple therapy in the eradication of Helicobacter pylori in patients with active gastric ulcer, and to assess healing and relapse of gastric ulcer. A double-blind, randomized study was carried out in 18 centres in Germany, Hungary and Poland. Patients (n = 160) with gastric ulcer and a positive H. pylori screening test were randomized to a 7-day twice daily treatment with omeprazole 20 mg, clarithromycin 500 mg and amoxycillin 1000 mg (OAC) or omeprazole 20 mg, clarithromycin 250 mg and metronidazole 400 mg (OMC), or with omeprazole 20 mg once daily (O). After completion of this 1-week treatment, patients were treated with omeprazole until healing (maximum 12 weeks), and followed for 6 months. H. pylori was assessed by urea breath test (UBT) and histology. Eradication rates ITT were OAC 79% (95% CI: 65-90%), OMC 86% (95% CI: 73-94%) and O 4% (95% CI: 0-14%). Eradication rates PP were OAC 83% (95% CI: 68-93%), OMC 93% (95% CI: 80-98%) and O 3% (95% CI: 0-13%). Gastric ulcer relapses occurred in 5, 0 and 11 patients in the groups, respectively. The results from the study demonstrate that OMC and OAC 1-week regimens are safe and effective for eradication of H. pylori in gastric ulcer patients, and that ulcer relapse is infrequent after successful eradication.",1999.0,0,0
52,10383500,"The importance of clarithromycin dose in the management of Helicobacter pylori infection: a meta-analysis of triple therapies with a proton pump inhibitor, clarithromycin and amoxycillin or metronidazole.",J Huang; R H Hunt,"It is not clear which dose of clarithromycin (500 mg b.d. or 250 mg b.d.) is more effective for Helicobacter pylori eradication in proton pump inhibitor-based triple therapies. We undertook a meta-analysis of the effect of 7-day triple therapies consisting of a proton pump inhibitor (P), and clarithromycin (C) and amoxycillin (A) or metronidazole (M). A meta-analysis of all clinical trials performed in an adult population and published in English up to March 1998 was undertaken. Studies with doses of clarithromycin 500 mg b.d. or 250 mg b.d. only were included. A total of 82 studies (31 papers and 51 abstracts) involving 110 treatment arms and 6123 patients were analysed that met the predetermined inclusion and exclusion criteria. In the PAC combination, the pooled eradication rate in patients treated with clarithromycin 500 mg b.d. was 89.5% (95% CI: 86.9-92. 0%) by per protocol analysis and 86.6% (95% CI: 81.0-89.3%) by intention-to-treat analysis. These rates are significantly higher than those achieved with clarithromycin 250 mg b.d. (83.3% by per protocol and 78.2% by intention-to-treat analysis, both P < 0.0001). This difference was confirmed in head-to-head comparative studies. In the PMC regimen, clarithromycin 500 mg b.d. eradicated 90.8% (95% CI: 87.0-94.5%) of the infections compared to 88.5% (95% CI: 85.5-91. 5%) in patients treated with clarithromycin 250 mg b.d. by per protocol analysis (P = 0.082). The corresponding rates by intention-to-treat analysis for clarithromycin 500 mg b.d. and 250 mg b.d. was 88.3% and 86.7%, respectively (P = 0.259). Seven-day triple therapies with a proton pump inhibitor, clarithromycin and amoxycillin or metronidazole are highly effective treatments for the eradication of H. pylori. Clarithromycin 500 mg b. d. should be used in these combinations to achieve the best first treatment results, which can minimize the subsequent development of bacterial resistance to clarithromycin and metronidazole.",2000.0,0,0
53,10383502,"Impact of rabeprazole, a new proton pump inhibitor, in triple therapy for Helicobacter pylori infection-comparison with omeprazole and lansoprazole.",H Miwa; R Ohkura; T Murai; K Sato; A Nagahara; S Hirai; S Watanabe; N Sato,"A recent trend in curative therapy for Helicobacter pylori infection is the so-called triple therapy, which consists of a proton pump inhibitor (PPI) and two different antimicrobials. Various regimens employing this triple therapy have been reported. However, little is known about the effectiveness of rabeprazole, a recently developed proton pump inhibitor, when used in the triple therapy. To validate its usefulness by comparing rabeprazole with omeprazole and lansoprazole, in combination with amoxycillin and clarithromycin. 221 H. pylori-positive patients with peptic ulcer disease were randomized to receive one of three different proton pump inhibitor/amoxycillin-clarithromycin (PPI/AC) regimens for 7 days. (i) OAC regimen (n = 75): omeprazole 20 mg b.d., amoxycillin (AMOX) 500 mg t.d.s. and clarithromycin (CAM) 200 mg b.d.; (ii) LAC regimen (n = 74): lansoprazole 30 mg b.d. , AMOX 500 mg t.d.s. and CAM 200 mg b.d.; and (iii) RAC regimen (n = 72): rabeprazole 20 mg b.d., AMOX 500 mg t.d.s. and CAM 200 mg b.d. Cure of the infection was determined by the 13C urea breath test 1 month after completion of the treatment. Intention-to-treat based cure rates for OAC, LAC and RAC regimens were 85% (95% CI, 75-92), 84% (95%, CI 73-91) and 88% (95% CI, 78-94), respectively, and per protocol based cure rates of these regimens were 88% (95% CI, 78-94), 91% (95%, CI 82-99) and 93% (95% CI, 84-98), respectively. Adverse effects in the entire study population, which included diarrhoea, glossitis or skin rash, were reported by 15% of the patients, and complete compliance was achieved in 95% of these patients. 1-week proton pump inhibitor/AC regimens for H. pylori infection were effective in the Japanese population. Rabeprazole can be considered as equivalent to omeprazole and lansoprazole in the PPI/AC triple therapy.",1999.0,0,1
54,10383506,A new quadruple therapy for Helicobacter pylori: influence of resistant strains on treatment outcome.,M Okada; H Nishimura; M Kawashima; N Okabe; K Maeda; M Seo; K Ohkuma; T Takata,"There have been no reports concerning the efficacy and safety of a 1-week quadruple therapy regimen of omeprazole, amoxycillin, roxithromycin and metronidazole for Helicobacter pylori infections and the impact of primary resistance on the eradication rate. One hundred and sixty-nine consecutive patients with peptic ulcer disease as well as gastritis with biopsy-proven H. pylori infection were entered into an open study of omeprazole 20 mg o.m., amoxycillin 500 mg t.d.s., roxithromycin 150 mg b.d., and metronidazole 250 mg t.d.s. Helicobacter pylori status was determined by urease test, histology and culture. Susceptibility to amoxycillin, metronidazole and roxithromycin was determined by the E-test. H. pylori was eradicated in 155 out of 169 (92%; 95% CI 88-96%) by intention-to-treat analysis, and in 155 out of 163 (95%; 95% CI 92-98%) by per protocol analysis. The prevalence of primary resistance against amoxycillin, roxithromycin and metronidazole was 2 out of 166 (1%), 16 out of 166 (10%) and 27 out of 166 (16%), respectively. H. pylori was eradicated in 25 out of 27 (93%) patients with metronidazole-resistant strains compared with 130 out of 136 (96%) in patients with metronidazole-sensitive strains of H. pylori. It was eradicated in 15 out of 16 (94%) patients with roxithromycin-resistant strains while in 140 out of 147 (95%) patients with roxithromycin-sensitive strains of H. pylori, and in two out of two (100%) patients with amoxycillin-resistant stains compared with 153 out of 161 (95%) in patients with amoxycillin-sensitive strains. H. pylori was eradicated in three out of four (75%) patients with double resistance against metronidazole and roxithromycin compared with 152 out of 159 (96%) patients with sensitive strains to metronidazole and or roxithromycin. None of these differences were statistically significant. Severe side-effects were found in only one out of 169 patients-anaphylaxis due to penicillin. The 1-week quadruple therapy with omeprazole, amoxycillin, metronidazole and roxithromycin was found to eradicate H. pylori in over 90% of all patients. This regimen was also found to be beneficial for patients with pre-treatment resistant strains to metronidazole, roxithromycin or amoxycillin, and was observed to be safe and well-tolerated.",1999.0,0,0
55,10383507,"Impact of clarithromycin resistance on the effectiveness of a regimen for Helicobacter pylori: a prospective study of 1-week lansoprazole, amoxycillin and clarithromycin in active peptic ulcer.",J A Ducóns; S Santolaria; R Guirao; M Ferrero; M Montoro; F Gomollón,"Clarithromycin is a key antimicrobial in the combinations used to cure Helicobacter pylori infections, so there is a need to define the impact of in vitro resistance on in vivo results. A prospective trial was designed to study the effectiveness of the 1-week combination of lansoprazole, clarithromycin and amoxycillin in 102 consecutive patients with active peptic ulcer. The pre-treatment and post-treatment sensitivity to amoxycillin, metronidazole and clarithromycin were studied by E-test, and H. pylori status was defined by histology, culture and urease test at diagnosis and one month after treatment, and by urea-breath test 2 months after treatment. The eradication rate (intention-to-treat analysis) was 77% (95% CI: 69-86). No clinical factor was found to be different between eradicated and non-eradicated patients. Clarithromycin-resistant strains were found in 10 (10%; CI: 5-17) patients. The eradication rate was 20% (CI: 3-56) in these patients vs. 83% (CI: 75-91) in patients harbouring clarithromycin-sensitive strains (P < 0.001). A logistic-regression analysis confirmed clarithromycin resistance as the only factor associated with treatment failure. Clarithromycin resistance significatively impairs the effectiveness of the combination of lansoprazole, amoxycillin, and clarithromycin. The 80% efficacy goal will be difficult to reach in areas with high (>10%) primary clarithromyicin resistance, if currently recommended proton pump inhibitor-triple therapies are used.",1999.0,0,0
56,10383510,Lansoprazole in the treatment of heartburn in patients without erosive oesophagitis.,J E Richter; T O Kovacs; P A Greski-Rose; B Huang section sign; R Fisher,"This randomized, double-blind, multicentre study compared lansoprazole with placebo for symptomatic relief of patients with non-erosive gastro-oesophageal reflux disease (GERD). 214 patients with symptomatic, non-erosive GERD (moderate to severe daytime and/or night-time heartburn greater than half the days over the past 6 months and during the 7- to 10-day pre-treatment period) were randomized to either lansoprazole 15 mg or lansoprazole 30 mg, or placebo o.d. for 8 weeks. Daily diary data indicated that on the first treatment day a statistically significantly smaller percentage of lansoprazole patients reported daytime and night-time heartburn and antacid usage, compared with placebo patients. Lansoprazole patients also reported statistically significant less severe daytime and night-time heartburn on the first treatment day. During 0-4, 4-8, and 0-8 weeks of therapy, a statistically significant smaller percentage of days and nights with heartburn, less severe daytime and night-time heartburn, and less antacid usage were observed in the lansoprazole group compared to the placebo group. The percentages of patients with adverse reactions were similar in the lansoprazole and placebo groups. The results of this study demonstrate that lansoprazole is an appropriate therapy for patients with symptomatic non-erosive GERD.",1999.0,0,1
57,10383513,"Efficacy of omeprazole versus ranitidine for symptomatic treatment of poorly responsive acid reflux disease-a prospective, controlled trial.",P N Maton; R Orlando; B Joelsson,"H2-receptor antagonists are widely used in patients with gastro-oesophageal reflux disease (GERD) and are frequently continued when symptoms persist. To compare the efficacy of omeprazole 20 mg once daily with that of ranitidine 150 mg twice daily in relieving GERD symptoms, in patients who remained symptomatic following a 6-week course of ranitidine therapy. Patients with heartburn on at least 4 days/week but who did not have endoscopy to assess oesophageal mucosa could participate. This two-phase, prospective trial included a 6-week open-label phase (phase I), followed by an 8-week double-blind phase (phase II). Patients still symptomatic following treatment with ranitidine 150 mg twice daily (phase I) were randomized to double-blind treatment (phase II) with either omeprazole 20 mg once daily or ranitidine 150 mg twice daily. The primary efficacy variable was the proportion of patients with heartburn resolution during weeks 4 and 8 of phase II. Of the 533 patients with GERD who received ranitidine in phase I, 348 patients (65%) were still symptomatic. A total of 317 patients (59%) were randomized to double-blind treatment (phase II). At week 8, a significantly (P < 0.0004) greater proportion of omeprazole-treated patients (70%) experienced no more than mild heartburn compared with ranitidine-treated patients (49%). Complete resolution of heartburn also occurred in a significantly (P < 0. 00001) greater proportion of omeprazole-treated patients (46% vs. 16% of the ranitidine group at week 8). After 6 weeks of ranitidine treatment, the majority of patients with GERD were still experiencing moderate to severe heartburn. Omeprazole was significantly more effective than ranitidine in resolving heartburn in this group of patients.",1999.0,0,0
58,10383518,Evaluation of treatment regimens to cure Helicobacter pylori infection--a meta-analysis.,R J Laheij; L G Rossum; J B Jansen; H Straatman; A L Verbeek,"To assess effectiveness of treatment to cure Helicobacter pylori infection. Meta-analysis of 666 manuscripts (full papers, abstracts, letters to the editor) identified through Medline and a manual search (1986 to January 1998). Data were overviewed by regression analysis with weighted random effects models. 53 228 patients with H. pylori infection. Patients were treated with 132 different medication combinations. Cure of H. pylori infection per protocol and intention-to-treat basis at least 28 days after treatment. The nationality of the patients and therapeutic regimen have a significant impact on the results, after correction for the heterogeneity in the precision of the cure rate caused by different study sizes and random effect for study. On the basis of the original sample size, cure rates of 80-85% were achieved using combinations of a proton-pump inhibitor or ranitidine bismuth citrate with two antibiotics including clarithromycin, amoxycillin and metronidazole or tinidazole. Comparable cure rates were also achieved using a combination of a proton-pump inhibitor or H2-receptor antagonist with bismuth subcitrate or tripotassium dicitrato bismuthate, metronidazole and tetracycline. The dose of clarithromycin influenced cure rates. Treatment duration did not influence the outcome. Several therapeutic regimens are eligible to cure H. pylori infection. However, none of the medication combinations were able to cure H. pylori infection in more than 85% of the patients assessed by intention-to-treat. The countries in which the studies were performed also had a significant impact on eradication rates.",1999.0,1,1
59,10383519,"Short-term triple therapy with lansoprazole 30 mg or 60 mg, amoxycillin and clarithromycin to eradicate Helicobacter pylori.",A Sieg; M Sellinger; D Schlauch; M Hörner; W Fuchs,"We investigated the efficacy of 30 vs. 60 mg lansoprazole daily in a 1-week triple therapy for eradication of Helicobacter pylori in a prospective randomized study. Two hundred and fifteen consecutive out-patients with peptic ulcer disease or non-ulcer dyspepsia, in whom H. pylori infection was confirmed by histology and/or a urease biopsy test, were randomly assigned to a 1-week treatment with either 15 mg lansoprazole b.d. (LAC15 group) or 30 mg lansoprazole b.d. (LAC30 group) in combination with 1 g amoxycillin b.d. and 500 mg clarithromycin b.d. Eradication of H. pylori was successful in 87% (per protocol) and 82% (intention-to-treat) of the patients with LAC15 and in 94% (per protocol) and 87% (intention-to-treat) of the patients with LAC30. The difference was not significant. In both treatment groups, all peptic ulcers were healed at the check-up. Adverse effects were seen in 11 patients of the LAC15 group and 10 patients of the LAC30 group: they caused discontinuation of the therapy in four of the LAC15 group and two patients of the LAC 30 group. A 7-day triple therapy using lansoprazole (LAC15) is an efficient and economical regimen for the eradication of H. pylori.",1999.0,0,0
60,10383520,Comparison of two 3-day Helicobacter pylori eradication regimens with a standard 1-week regimen.,C E Grimley; A Penny; M O'sullivan; M Shebani; J R Lismore; R Cross; R C Illing; D E Loft; C U Nwokolo,"The duration of Helicobacter pylori eradication regimens has decreased to 1 week with cure rates of over 90%. This can be attributed to the use of triple drug regimens including potent inhibitors of gastric acid secretion and clarithromycin. There is no theoretical reason why shorter regimens should not be possible. To compare two 3-day, low-dose, twice daily regimens with 1 week of omeprazole 20 mg b.d., clarithromycin 250 mg b.d., and metronidazole 400 mg b.d. (OCM) METHODS: Outpatients referred for gastroscopy were screened by biopsy urease test. H. pylori-positive patients were randomized to receive either lansoprazole 30 mg b.d., tri-potassium dicitrato bismuthate one tablet b.d., clarithromycin 250 mg b.d., and amoxycillin 1 g b.d. for 3 days (LTdbCA), or ranitidine bismuth citrate 400 mg b.d., clarithromycin 250 mg b.d. and amoxycillin 1 g b.d. for 3 days (RbcCA) or omeprazole 20 mg b.d., clarithromycin 250 mg b.d. and metronidazole 400 mg b.d. for 1 week (OCM). They were not pre-treated with a gastric acid inhibitor. After 8 weeks, H. pylori status was assessed by 13C urea breath test. 974 out of 1114 patients referred for gastroscopy were screened by biopsy urease test. 140 patients were not screened either because they were anticoagulated or for technical reasons. 334 patients were H. pylori-positive: 154 were excluded mostly because of allergy to penicillin and personal reasons but 180 were randomized to treatment All regimens were well tolerated. For LTdbCA (n=60), RbcCA (n=59), and OCM (n=61) the H. pylori cure rates (95% CI) were 23% (12-34), 14% (5-23) and 87% (79-95), respectively, using intention-to-treat analysis and 25% (14-36), 15% (6-24) and 88% (80-96), respectively, if analysed per protocol. OCM was significantly superior to LTdbCA and RbcCA (P < 0.001) but there was no significant difference between regimens LTdbCA and RbcCA. OCM is an extremely effective H. pylori eradication regimen. The 3-day regimens tested both have poor cure rates. Pre-treatment with a proton pump inhibitor, higher doses or more frequent dosing may be necessary to increase the cure rate of short duration regimens. However, this could make them less acceptable than the H. pylori eradication regimens currently available.",1999.0,0,1
61,10383522,Randomized trial of omeprazole and clarithromycin combined with either metronidazole or amoxycillin in patients with metronidazole-resistant or -susceptible Helicobacter pylori strains.,M H Houben; E F Hensen; E A Rauws; R W Hulst; B W Hoff; A V Ende; F J Kate; G N Tytgat,"The impact of metronidazole resistance on the efficacy of proton pump inhibitor based triple therapies remains unclear. To study whether metronidazole resistance affects Helicobacter pylori eradication rates in patients treated for 1 week with either omeprazole 20 mg b.d., metronidazole 400 mg b.d. and clarithromycin 250 mg b.d. (OMC), or omeprazole 20 mg b.d., amoxycillin 1000 mg b.d. and clarithromycin 500 mg b.d. (OAC). A randomized, single blind, single centre study with parallel groups was conducted. H. pylori positive patients were enrolled in a metronidazole-resistant (MR; MIC > 8 microgram/mL) or a metronidazole-susceptible group (MS; MIC < 4 microgram/mL), as determined by E-test. Within the strata patients were randomized to either OAC or OMC. One hundred and twenty-two patients were included. The per protocol cure rate for OAC was 52 out of 57 (91%) (MS 23 out of 26 (89%); MR 29 out of 31 (94%)) and for OMC 46 out of 55 (84%) (MS 19 out of 22 (86%); MR 27 out of 33 (82%)). One-week OAC and OMC are effective therapies. OAC and OMC were equally effective in patients with metronidazole-susceptible strains of H. pylori. Using the OMC regimen, neither equality nor significant differences in treatment outcome could be shown between patients with metronidazole-resistant or -susceptible strains of H. pylori.",1999.0,0,0
62,10383525,On demand therapy with omeprazole for the long-term management of patients with heartburn without oesophagitis--a placebo-controlled randomized trial.,T Lind; T Havelund; L Lundell; H Glise; K Lauritsen; S A Pedersen; O Anker-Hansen; A Stubberöd; G Eriksson; R Carlsson; O Junghard,"To observe the natural course of gastro-oesophageal reflux disease (GERD) in patients without oesophagitis following effective symptom relief, and to determine the place of acid pump inhibitor therapy in the long-term management of these patients. We investigated the efficacy of on-demand therapy with omeprazole 20 mg or 10 mg, or placebo in a double-blind, randomized multicentre trial. It involved 424 patients with troublesome heartburn without endoscopic evidence of oesophagitis in whom heartburn had been resolved with short-term treatment. Patients were told to take study medication on demand once daily on recurrence of symptoms until symptoms resolved over a 6-month period. They also had access to antacids. The primary efficacy variable was time to discontinuation of treatment, due to unwillingness to continue. According to life-table analysis, after 6 months the remission rates were 83% (95% CI: 77-89%) with omeprazole 20 mg, 69% (61-77%) with omeprazole 10 mg, and 56% (46-64%) with placebo (P < 0.01 for all intergroup differences). The mean (s.d.) number of study medications used per day in these groups was 0.43 (0.27), 0.41 (0.27) and 0.47 (0.27), respectively. The use of antacids was highest in the placebo group and lowest in the omeprazole 20 mg group. Treatment failure was associated with more than a doubling of antacid use, and a deterioration in patient quality of life. Approximately 50% of patients with heartburn who do not have oesophagitis need acid inhibitory therapy in addition to antacid medication to maintain a normal quality of life. On-demand therapy with omeprazole 20 mg, is an effective treatment strategy in these patients.",1999.0,0,1
63,10383527,The influence of Helicobacter pylori on oesophageal acid exposure in GERD during acid suppressive therapy.,F T Peters; E J Kuipers; S Ganesh; W J Sluiter; E C Klinkenberg-Knol; C B Lamers; J H Kleibeuker,"Helicobacter pylori exaggerates the effect of acid suppressive drugs on intragastric pH. It is unknown whether this is relevant for the treatment of GERD. To compare oesophageal acid exposure and symptoms in H. pylori-negative and H. pylori-positive GERD patients during low and profound acid suppression. Barrett's oesophagus patients with gastro- oesophageal acid reflux were studied by 24-h oesophageal pH-metry at baseline and during randomized treatment with omeprazole 40 mg b.d. or ranitidine 150 mg b.d. H. pylori status was determined by a serum IgG ELISA. Symptoms were scored on a four-graded scale. Of 58 patients, 26 (14 H. pylori-negative, 12 H. pylori-positive) were randomized to omeprazole, 32 (16 H. pylori-negative, 16 H. pylori-positive) to ranitidine. At baseline, oesophageal acid exposure and symptoms did not differ between H. pylori-negative and H. pylori-positive: mean time proportion pH < 4 per 24 h was 16.1% (95% CI 11.5-23.2) in H. pylori-negative, and 15.8% (11.3-21.4) in H. pylori-positive patients. Omeprazole treatment resulted in a decrease of acid reflux per 24 h from 23.4% (7.9-39.3) to 0.0% (0.0-2.9) in H. pylori-negative, and from 17.3% (8.9-38.8) to 0.1% (0.0-1.7) in H. pylori-positive patients; ranitidine resulted in a decrease from 14.4% (10.5-18.5) to 9.3% (5.6-12.8) in H. pylori-negative, and from 15.1% (9.8-21.0) to 9.0% (3.1-20.1) in H. pylori-positive patients, the difference between H. pylori-negative and H. pylori-positive patients being N.S. There was no significant difference between H. pylori-negative and H. pylori-positive patients with respect to erect and supine acid reflux, or symptom scores in both treatment groups. H. pylori infection does not influence oesophageal acid reflux and symptoms in patients with Barrett's oesophagus, either at baseline or during low as well as profound acid suppressive therapy. We conclude that the dose of acid suppression does not have to be titrated upon H. pylori status in GERD.",1999.0,0,0
64,10383532,"Double-blind comparison of lansoprazole 15 mg, lansoprazole 30 mg and placebo as maintenance therapy in patients with healed duodenal ulcers resistant to H2-receptor antagonists.",T O Kovacs; D Campbell; J Richter; M Haber; D E Jennings; P Rose,"Maintenance antisecretory therapy is often used to prevent duodenal ulcer recurrence and control symptoms. This study compared the efficacy and safety of lansoprazole 15 mg and 30 mg daily with placebo in preventing ulcer recurrence in patients with a recent history of duodenal ulcer disease. Fifty-six patients were treated with either lansoprazole 15 mg, 30 mg or placebo o.m. Within 1 month of study initiation, 27% (four out of 15) of placebo-treated patients experienced ulcer recurrence as compared to 13% (two out of 15) and 6% (one out of 18) of lansoprazole 15 mg and 30 mg treated patients, respectively. Median time to first ulcer recurrence was > 12 months in lansoprazole patients. At Month 12, significantly (P < 0.001) more lansoprazole 15 mg patients (70%) and lansoprazole 30 mg patients (85%) remained healed. Eighty-two per cent of lansoprazole 15 mg and 76% of lansoprazole 30 mg patients remained asymptomatic during the entire study period. All placebo patients became symptomatic, experienced ulcer recurrence, or withdrew from the study by month six. The incidence of adverse events was comparable among the three treatment groups. Lansoprazole safely and effectively reduces duodenal ulcer recurrence and ulcer-related symptoms.",1999.0,1,1
65,10390255,Randomized placebo-controlled trial of a 42-Day tapering course of dexamethasone to reduce the duration of ventilator dependency in very low birth weight infants.,J M Kothadia; T M O'Shea; D Roberts; S T Auringer; R G Weaver; R G Dillard,"To assess the effect on duration of ventilator dependency of a 42-day tapering course of dexamethasone in very low birth weight neonates. Infants (N = 118) were assigned randomly, within birth weight/gender strata, to treatment with either a 42-day tapering course of dexamethasone or an equal volume of saline as placebo. Entry criteria were 1) birth weight <1501 g; 2) age between 15 and 25 days; 3) <10% decrease in ventilator settings for 24 hours and FIO2 >/=0.3; 4) absence of patent ductus arteriosus, sepsis, major congenital malformation, congenital heart disease; and 5) no evidence of maternal HIV or hepatitis B infection. The dosage schedule was 0.25 mg/kg bid for 3 days, then 0.15 mg/kg bid for 3 days, then a 10% reduction in the dose every 3 days until a dose of 0.1 mg/kg had been given for 3 days, from which time a dose of 0.1 mg/kg qod was continued until 42 days after entry. The primary endpoint was the number of days on assisted ventilation after study entry. Secondary outcomes of interest included days on supplemental oxygen, days of hospitalization, and potential adverse effects, such as infection, gastrointestinal bleeding, left ventricular hypertrophy, and severe retinopathy of prematurity. Infants in the dexamethasone- and placebo-treated groups were similar in terms of baseline attributes, including birth weight, gestational age, gender, race, and ventilator settings at entry. Infants treated with dexamethasone were on assisted ventilation and supplemental oxygen for fewer days after study entry (median days on ventilator, 5th and 95th percentiles, 13 [1-64] vs 25 [6-104]; days on oxygen, 59 [6-247] vs 100 [11-346]). No differences were found in risk of death, infection, or severe retinopathy. In subgroup analyses, the association of dexamethasone with more rapid weaning from the ventilator was weaker among infants enrolled before the 16th day of life, infants with chest radiographs showing cystic changes and/or hyperinflation, and infants requiring an FIO2 >/=0.7 or a peak inspiratory pressure >/=19 at study entry. A 42-day tapering course of dexamethasone decreases the duration of ventilator and oxygen dependency in very low birth weight infants and is not associated with an increased risk of short-term adverse effects.",2001.0,0,0
66,10392669,Prophylaxis and treatment of NSAID-induced gastroduodenal disorders.,R La Corte; M Caselli; G Castellino; G Bajocchi; F Trotta,"A significant percentage of patients taking nonsteroidal anti-inflammatory drugs (NSAIDs) experience some type of adverse gastrointestinal symptoms, lesions of the gastroduodenal tract being clinically the most relevant. NSAIDs cause gastrointestinal damage by 2 independent mechanisms: a topical effect, which is pH and pKa related, and a systemic effect mediated by cyclooxygenase (COX) inhibition with a reduction in prostaglandin synthesis. Using endoscopy, gastroduodenal lesions identified include subepithelial haemorrhages, erosions and ulcers. The prevalence of ulceration in NSAID users has been reported as being between 14 and 31% with a 2-fold higher frequency of gastric ulcers compared with duodenal ulcers. Among the strategies used to decrease the risk of ulcer development are: (i) the use of analgesics other than NSAIDs; (ii) use of the lowest possible dosage of NSAID; (iii) the use of a COX-2 selective NSAID; (iv) the use of low doses of corticosteroids instead of NSAIDs; (v) avoidance of concomitant use of NSAIDs and corticosteroids; and (vi) use of preventive therapy. In an attempt to reduce the incidence of NSAID-induced gastrointestinal lesions, the following approaches have been proposed: (i) use of the prostaglandin analogue misoprostol, which is an antiulcer drug which has been proven to be as effective in the prevention of NSAID-induced gastric and duodenal ulcers as in the reduction of serious upper gastrointestinal complications; (ii) histamine H2 receptor antagonists (H2 antagonists), e.g. ranitidine, cimetidine and famotidine, which are useful in the prevention of NSAID-induced duodenal ulcers during long term treatment, but not in the prevention of NSAID-induced gastric ulcers; (iii) proton pump inhibitors, e.g omeprazole, and pantoprazole, whose efficacy in preventing NSAID-associated ulcers has been recently demonstrated; and (iv) barrier agents, e.g. sucralfate, which cannot be recommended as prophylactic agents to prevent NSAID-induced gastropathy. The first step in the treatment of NSAID-associated ulcers lies in a reduction in the dosage of the NSAID or discontinuation of the drug. If NSAID treatment cannot be withdrawn, a proton pump inhibitor appears to be the most effective treatment in healing ulcers, accelerating the slow healing observed with H2 antagonists.",1999.0,0,0
67,10393735,Peptic-ulcer disease in the elderly.,M L Borum,"Peptic-ulcer disease causes significant morbidity and mortality in the elderly. It frequently presents in an atypical manner and is associated with a high incidence of complications. The prevalence of Helicobacter pylori increases with age and can have an important role in the development of ulcers. Nonsteroidal anti-inflammatory drugs also contribute to the increased incidence of ulcers and the development of complications in the elderly. Although management of ulcer disease in the elderly is similar to that in the younger population, consideration must be given to the potential for increased incidence of side effects and medication interactions. When endoscopy and surgery are performed there should be an appreciation for the risks associated with concurrent illnesses that can accompany advanced age.",1999.0,0,0
68,10399892,"Barrett's esophagus: update on screening, surveillance, and treatment.",T G Morales; R E Sampliner,"The last 2 decades have seen dramatic advances in Barrett's esophagus. The definition has evolved; the rising incidence of adenocarcinoma has been recognized; and effective therapy to control gastroesophageal reflux disease has been developed. Both proton pump inhibitor therapy and laparoscopic fundoplication represent major developments. Studies of patients with dysplasia have helped to clarify appropriate surveillance intervals and treatment strategies for these patients, although controversy still exists. The possibility of reversing Barrett's esophagus in selected high-risk patients offers major hope for the future prevention of adenocarcinoma of the esophagus.",1999.0,0,0
69,10400490,The treatment and prophylaxis of nonsteroidal anti-inflammatory drug (NSAID)-associated ulcers and erosions.,C J Hawkey; N D Yeomans,,1999.0,0,1
70,10403727,Endoscopic assessment of oesophagitis: clinical and functional correlates and further validation of the Los Angeles classification.,L R Lundell; J Dent; J R Bennett; A L Blum; D Armstrong; J P Galmiche; F Johnson; M Hongo; J E Richter; S J Spechler; G N Tytgat; L Wallin,"Endoscopic oesophageal changes are diagnostically helpful and identify patients exposed to the risk of disease chronicity. However, there is a serious lack of agreement about how to describe and classify the appearance of reflux oesophagitis To examine the reliability of criteria that describe the circumferential extent of mucosal breaks and to evaluate the functional and clinical correlates of patients with reflux disease whose oesophagitis was graded according to the Los Angeles system. Forty six endoscopists from different countries used a detailed worksheet to evaluate endoscopic video recordings from 22 patients with the full range of severity of reflux oesophagitis. In separate studies, Los Angeles system gradings were correlated with 24 hour oesophageal pH monitoring (178 patients), and with clinical trials of omeprazole treatment (277 patients). Evaluation of circumferential extent of oesophagitis by the criterion of whether mucosal breaks extended between the tops of mucosal folds, gave acceptable agreement (mean kappa value 0.4) among observers. This approach is used in the Los Angeles system. An alternative approach of grouping the circumferential extent of mucosal breaks as occupying 0-25%, 26-50%, 51-75%, 76-99%, or 100% of the oesophageal circumference, gave unacceptably high interobserver variation (mean kappa values 0-0.15) for all but the lowest category of extent (mean kappa value 0.4). Severity of oesophageal acid exposure was significantly (p<0.001) related to the severity grade of oesophagitis. Preteatment oesophagitis grades A-C were related to heartburn severity (p<0.01), outcomes of omeprazole (10 mg daily) treatment (p<0.01), and the risk for symptom relapse off therapy over six months (p<0.05). Results add further support to previous studies for the clinical utility of the Los Angeles system for endoscopic grading of oesophagitis.",1999.0,0,0
71,10405232,Eradication of Helicobacter pylori infection with proton pump-based triple therapy in patients in whom bismuth-based triple therapy failed.,R Mera; J L Realpe; L E Bravo; J P DeLany; P Correa,"To study the effects of treatment of Helicobacter pylori infection in a hyperendemic population, 143 infected patients from the region of Nariño, Colombia, were treated for 2 weeks with clarithromycin (500 mg twice a day), amoxicillin (1 g twice a day), and either lansoprazole (30 mg twice a day) or omeprazole (30 mg twice a day). All patients belong to a low socioeconomic strata, had multifocal atrophic gastritis documented by gastric biopsies, and had been treated previously and unsuccessfully for 2 weeks with bismuth subsalicylate (262 mg four times a day), amoxicillin (500 mg three times a day), and metronidazole (400 mg three times a day). 13C-urea breath tests were performed 6, 12, 24, and 60 weeks after completing therapy. The 13C-urea breath test was negative in 79.7% of patients 1 month after finishing therapy, and in 69.2% of patients 1 year after finishing treatment. There were no differences in eradication rates between patients treated with omeprazole versus lansoprazole. Dyspepsia symptoms decreased from 74% in patients at baseline to 19% at the time of finishing treatment. In low-socioeconomic status populations with hyperendemic infection, triple therapy using omeprazole or lansoprazole plus clarithromycin and amoxicillin is an effective alternative when previous standard bismuth-based triple therapy has failed.",1999.0,1,1
72,10405233,Pharmacokinetic interaction between acetaminophen and lansoprazole.,M Sanaka; Y Kuyama; S Mineshita; J Qi; Y Hanada; I Enatsu; H Tanaka; H Makino; M Yamanaka,"Because of its minimal gastric toxicity, acetaminophen is the analgesic of choice for patients with gastric acid-related disorders. Because proton pump inhibitors are widely used, concomitant prescription of acetaminophen and lansoprazole would be prevalent. This crossover study was conducted to investigate an acetaminophen-lansoprazole interaction. On one occasion, each of six healthy, fasted, male volunteers ingested 1.0 g acetaminophen dissolved in 200 mL water. On another occasion, at least 1 week apart, 30 mg lansoprazole was administered orally, simultaneously with acetaminophen, after pretreatment with the same dose of lansoprazole once daily for 2 days. Plasma acetaminophen concentrations were measured at 0, 0.25, 0.5, 0.75, 1, 2, 3, 5, and 8 hours after dosing. The peak plasma concentration of acetaminophen and the time to its occurrence were significantly higher and shorter, respectively, during the lansoprazole session than during the control session. Neither the elimination half-life nor the area under the curve was significantly different between the two sessions. Lansoprazole hastens the absorption of acetaminophen solution, but little modifies its elimination rate and bioavailability.",1999.0,0,1
73,10406225,Laparoscopic antireflux surgery: silver bullet or the emperor's new clothes?,P J Kahrilas,,1999.0,0,0
74,10406235,Quality of life in patients with heartburn but without esophagitis: effects of treatment with omeprazole.,T Havelund; T Lind; I Wiklund; H Glise; H Hernqvist; K Lauritsen; L Lundell; S A Pedersen; R Carlsson; O Junghard; A Stubberöd; O Anker-Hansen,"Because improvement in quality of life (QoL) is an important therapeutic goal in patients with heartburn but without esophagitis, the aim of the present study was to compare the impact of omeprazole 20 mg or 10 mg daily with that of placebo on QoL in patients with heartburn as the predominant symptom. QoL was measured at baseline and after 4 wk using two validated questionnaires, the Psychological General Well-Being (PGWB) index and the Gastrointestinal Symptom Rating Scale. The two questionnaires were completed by 163 patients in the omeprazole 20 mg group, 163 in the omeprazole 10 mg group, and 82 in the placebo group. The reflux dimension of the Gastrointestinal Symptom Rating Scale showed a significant improvement in terms of reflux symptoms on omeprazole 20 mg versus omeprazole 10 mg and placebo, and on omeprazole 10 mg compared with placebo. The total score of the PGWB index improved significantly more on both doses of omeprazole than on placebo. The mean scores rose from 96.8 to 103.9 on omeprazole 20 mg, from 98.4 to 106.0 on omeprazole 10 mg, and from 98.0 to 100.6 on placebo. All dimensions of the PGWB index improved on treatment with omeprazole, but the improvements were most pronounced in the dimensions depicting anxiety, depressed mood, and self-control. It is concluded that treatment with omeprazole 20 mg and omeprazole 10 mg restores QoL to a level comparable with that observed in a healthy population.",1999.0,0,0
75,10419912,Lack of effect of acid suppression therapy on gastric atrophy. Nordic Gerd Study Group.,L Lundell; P Miettinen; H E Myrvold; S A Pedersen; K Thor; A Andersson; J Hattlebakk; N Havu; E Janatuinen; K Levander; B Liedman; P Nyström,"A hypothesis suggesting that profound acid inhibition therapy facilitates and hastens the development of gastric glandular atrophy in patients infected with Helicobacter pylori was investigated in this randomized study comparing omeprazole therapy with antireflux surgery (ARS) for chronic gastroesophageal reflux disease (GERD). Patients with esophagitis and/or chronic GERD were enrolled; 155 patients were randomized to ARS and 155 to long-term omeprazole therapy. Baseline data were obtained and repeated after 3 years in 131 ARS patients and in 139 omeprazole-treated patients. Histopathologic status of the oxyntic mucosa was assessed according to the Sydney system. Forty omeprazole-treated patients were infected with H. pylori compared with 53 in the ARS group. Basal gastrin levels were significantly higher in H. pylori-infected patients, particularly in the omeprazole group. No further increases in serum gastrin levels were observed during 3 years. Despite 3 years of therapy, only slight changes were found in the prevalence of inflammation in the corpus mucosa of H. pylori-infected subjects. A slow progression of gastric glandular atrophy was observed in these patients irrespective of therapy with no obvious difference between treatment regimens. Intestinal metaplasia (all of type I) was only exceptionally observed with no difference between the treatment arms. Acid-suppressive therapy in the form of omeprazole maintained for 3 years facilitates neither the development of gastric glandular atrophy of the corpus mucosa nor the occurrence of intestinal metaplasia in H. pylori-infected GERD patients.",2000.0,0,1
76,10423058,Is the esophageal squamous epithelial barrier function impaired in patients with gastroesophageal reflux disease?,R Carlsson; L Fändriks; C Jönsson; L Lundell; R C Orlando,"A disturbed epithelial barrier function has been promoted as one factor in the pathogenesis of gastroesophageal reflux disease (GERD). We therefore studied the effect of acid perfusion on the transmural potential difference (PD) of the distal esophagus in relation to onset of reflux symptoms. PD was assessed during perfusion with saline and with 0.1 M HCl in healthy controls (n = 17) and in GERD patients without (n = 15) or with esophagitis (n = 6) and in remission after a fundoplication (n = 10). Heartburn and other upper GI symptoms were recorded concomitantly. Endoscopy-negative patients were studied before and after omeprazole treatment. HCl perfusion induced more lumennegative peak PD values in patients with active GERD, regardless of the presence or absence of esophagitis, than in healthy controls. After successful therapy, the PD response to acid perfusion equalled that of healthy subjects. Acid perfusion was associated with the onset of heartburn in most patients with active GERD but in none of the healthy subjects, and less frequently after medical and surgical therapy. The epithelial permeability to hydrogen ions differs between healthy subjects and patients with active GERD. Effective treatment, such as omeprazole or fundoplication, might improve the barrier function.",1999.0,0,0
77,10425418,"Regression of Barrett's esophagus: the role of acid suppression, surgery, and ablative methods.",S Haag; S Nandurkar; N J Talley,,1999.0,0,0
78,10430350,Efficacy and safety of pantoprazole in patients with gastroesophageal reflux disease using an intravenous-oral regimen. Austrian Intravenous Pantoprazole Study Group.,H Wurzer; K Schutze; T Bethke; R Fischer; R Luhmann; C Riesenhuber,"To investigate the efficacy and safety of an intravenous-oral regimen using the gastric proton pump inhibitor pantoprazole. Outpatients, with endoscopically diagnosed moderate or severe gastro-esophageal reflux disease (GERD stage II and III, respectively, Savary-Miller classification), were recruited from ten hospitals or private practice centers and enrolled into an open-labeled study (intention-to-treat population n=110, age 20-88 years; per-protocol population n=98). Patients were treated once daily with 40 mg pantoprazole which was administered as an intravenous injection for the initial 5-7 consecutive days, then as a tablet, for up to 8 weeks. The efficacy parameters were complete healing of lesions evaluated endoscopically after week 4 and 8, and relief from symptoms assessed after week 2 and 4. Complete healing was achieved in 85/98 (87%) and 93/98 (95%) per-protocol patients, after 4 and 8 weeks, respectively. The corresponding results for the intention-to-treat population were 85/110 (77%) and 93/110 (85%), respectively. After 2 weeks of treatment, heartburn, acid regurgitation, and pain on swallowing resolved in 97%, 98%, and 100% of the per-protocol patients, respectively. Faster healing was observed in non-smokers, those infected with Helicobacter pylori, and those with initial GERD stage II. The intravenous and oral administration phases were well tolerated. Pantoprazole (40 mg), applied as an intravenous-oral regimen to patients with GERD led to fast resolution of symptoms and high healing rates. For patients, temporarily unable to take oral medications, this regimen offers safe and reliable gastric acid suppression and allows the possibility of changing between the oral and intravenous administration without the need for dose adjustment.",1999.0,0,0
79,10440603,,,,,0,0
80,10440606,Patients with functional dyspepsia responding to omeprazole have a characteristic gastro-oesophageal reflux pattern.,P G Farup; O Hovde; R Torp; S Wetterhus,"The effect of acid secretion inhibitors in patients with functional dyspepsia (FD) is equivocal. One previous trial showed an effect in patients with a characteristic gastro-oesophageal reflux pattern. This double-blind trial compares the number of reflux episodes in responders and non-responders to omeprazole. Twenty-four patients (men/women, 11:13; mean age, 49 years) with FD were included; those with reflux as the main symptom were excluded. An upper endoscopy and a 24-h oesophageal pH measurement were performed before randomization to treatment with 10-20 mg omeprazole or placebo for 4 weeks. Patients who at questioning considered themselves to have achieved sufficient relief of dyspeptic symptoms after 4 weeks were characterized as responders. The number of responders in the omeprazole and placebo groups was 8 of 14 (57%) and 2 of 10 (20%), respectively (P = 0.07). The mean number of reflux episodes at the 24-h oesophageal pH measurement in responders and non-responders to omeprazole was 57 and 25, respectively (P < 0.003). In the omeprazole group the number of responders was 0 of 5 (0%) in those with < 32 reflux episodes and 8 of 9 (89%) in those with > 32 reflux episodes (P < 0.003). Patients with FD responding to omeprazole were characterized by many reflux episodes.",1999.0,0,0
81,10445792,Antimicrobial treatment for peptic stenosis: a prospective study.,G Brandimarte; A Tursi; L di Cesare; G Gasbarrini,"Peptic stenosis, a complication of peptic ulcer disease, is treated by endoscopic balloon dilation or surgery. However, recent reports showed that Helicobacter pylori eradication may resolve peptic stenosis. Thus, we carried out a prospective study on a cohort of patients with peptic stenosis and H. pylori infection to evaluate the efficacy of anti- H. pylori therapy in the treatment of peptic stenosis. From May 1995 to May 1998 we studied 22 consecutive patients with benign peptic stenosis (16 with duodenal stenosis and six with pyloric stenosis) and H. pylori infection. Searches for H. pylori were made at first diagnosis of peptic stenosis and at every endoscopic control. All patients were treated with an anti- H. pylori treatment (13 with omeprazole/clarithromycin/ metronidazole and nine with omeprazole/amoxycillin/ clarithromycin), followed by 8 weeks' therapy with a proton-pump inhibitor. Endoscopic controls were performed after the end of H. pylori-eradication therapy, at 2 and 6 months, and then every 6 months. H. pylori eradication was achieved in all patients. Peptic stenosis disappeared completely in 20/22 cases (17/20 after 2 months and 3/20 after 6 months), and in all these patients the symptoms disappeared within 2 months. At the median follow-up of 12.4 months (range 2-24), the patients remained asymptomatic, without recurrence of the stenosis, and needed no medication. In one patient the stenosis disappeared partially and symptoms improved, and it was successfully treated with cisapride. In one patient the stenosis did not disappear despite H. pylori eradication and continuous proton-pump inhibitor treatment. The patient was treated with a liquid diet due to old age, but he died 4 months after H. pylori eradication due to stroke. H. pylori eradication is a safe and effective therapy for peptic stenosis. Endoscopic balloon dilation or surgery should be used only after failure of this conservative treatment.",1999.0,0,0
82,10450061,Relative efficacies of gastric proton pump inhibitors: their clinical and pharmacological basis.,W Kromer; S Horbach; R Lühmann,"The present review will verify by intra-study rank orders, and their comparison between studies, that the different gastric proton pump inhibitors (PPIs) display similar dose-response relationships with similar potencies and efficacies on a milligram basis, i.e., at the same milligram doses. This is in line with their basic pharmacology which suggests that, primarily, the serum AUCs of the free pro-drugs and their chemical activation half lives at pH 1 relative to their serum elimination half lives determine the efficacies of PPIs. According to the literature, these drug characteristics are similar for all PPIs. Although PPIs have been introduced into the therapy of acute peptic ulcer disease at different daily, oral doses of 20 mg (omeprazole and rabeprazole), 30 mg (lansoprazole) and 40 mg (pantoprazole), the data suggest that the optimal dose of lansoprazole, omeprazole and pantoprazole, with respect to the acute treatment of peptic ulcers and moderate to severe gastroesophageal reflux disease (GERD), is about 30-40 mg daily. The data base of rabeprazole appears to be too small at present to make any definite statement. Lower daily doses of the PPIs of about 15-20 mg are sufficient in less severe cases of GERD and in maintenance therapy. It appears that different dose recommendations were based on different strategies to balance optimal drug dosage and safety, rather than on real differences in milligram-related efficacies.",1999.0,0,0
83,10452673,Is a proton pump inhibitor necessary for the treatment of lower-grade reflux esophagitis?,T Soga; M Matsuura; Y Kodama; T Fujita; I Sekimoto; K Nishimura; S Yoshida; H Kutsumi; S Fujimoto,"The efficacy of histamine H2 receptor antagonist (H2RA) and proton pump inhibitor (PPI) therapies in healing reflux esophagitis was compared in a prospective randomized case-control comparative study. A total of 71 patients with grade A to D esophagitis (Los Angeles classification) were given either famotidine 20 mg twice a day (Fam; n = 35) or omeprazole 20 mg once daily (Ome; n = 36) for 8 weeks. Endoscopy was performed to assess healing in 57 patients. Healed patients were followed-up without H2RA or PPI therapy for 3 months. At the end of follow-up, endoscopy was able to be performed in 33 patients. Healing rates for patients in the Fam and Ome groups were 58.6% (17/OFF and 97.4% (27/28), respectively (P < 0.001), and when limited to grade A to B, healing rates were 60.9% (14/23) and 100% (25/25), respectively (P < 0.001). Concerning Helicobacter pylori infection, healing rates for the Fam and Ome groups in H. pylori (+) patients were 90.0% (9/10) and 90.9% (10/11), respectively (P = 1.00). Remission rates in the Fam and Ome groups were 45.0% (91/2)) and 33.3% (6/18), respectively (P > 0.4). In regard to alcohol drinking, remission rates of daily and social drinkers were 7.7% and 42.4%, respectively (P < 0.03). Thus, PPI should be the drug of choice even for healing lower-grade reflux esophagitis, especially in H. pylori (-) patients. Treatment with H2RA may be an alternative choice in H. pylori (+) patients. After healing, most patients cannot sustain remission without maintenance therapy.",1999.0,0,0
84,10452692,Optimum management of mild esophagitis in Japan.,K Sugano,,1999.0,0,0
85,10464342,Chest pain of esophageal origin.,C N Williams,,1999.0,0,0
86,10468675,The effect of omeprazole on gastro-oesophageal reflux and symptoms during strenuous exercise.,H P Peters; A F De Kort; H Van Krevelen; L M Akkermans; G P Van Berge Henegouwen; E Bol; W L Mosterd; W R De Vries,"Strenuous exercise exacerbates gastro-oesophageal reflux and symptoms and this may be diminished by antisecretory medication with omeprazole. Fourteen well-trained athletes (13 men, one woman), who indicated suffering from either heartburn, regurgitation or chest pain during competition running, performed two experimental trials at 2-week intervals using a randomized, double-blind, placebo-controlled crossover design. During the 6 days preceding the trial and on the trial day itself either 20 mg of omeprazole or a placebo was administered. Two hours after a low-fat breakfast and 1 h after the last study dose, the trial started with five successive 50-min periods: rest, three running periods on a treadmill, and recovery. Reflux (percentage time and number of periods oesophageal pH <4) was measured with an ambulant pH system during these periods. Compared to rest, reflux lasted significantly longer and occurred more frequently during the first running period, irrespective of the intervention, whereas during the second running period this effect was only observed with the placebo. Reflux occurred for longer and more frequently with the placebo than with omeprazole, but this was significant during the first two running periods only. Seven subjects reported heartburn, regurgitation and/or chest pain during exercise, irrespective of the intervention. Only a minority of the symptom periods was actually associated with acid reflux and in all cases this concerned periods with heartburn. Running-induced acid reflux, but not symptoms, were decreased by omeprazole, probably because most symptoms were not related to acid reflux.",1999.0,0,0
87,10468676,Safety and efficacy of pantoprazole 40 mg daily as relapse prophylaxis in patients with healed reflux oesophagitis-a 2-year follow-up.,C J Van Rensburg; P J Honiball; J H Van Zyl; H D Grundling; F P Eloff; S K Spies; A E Simjee; I Theron; R Fischer; J A Louw,"Pantoprazole is a benzimidazole derivative which selectively inhibits the proton pump H+, K+-ATPase, necessary for the final step in gastric acid secretion. To assess safety and efficacy of oral pantoprazole (40 mg o.d.) used as a prophylaxis against relapse in patients with healed reflux oesophagitis during an open-label, 2-year study. Outpatients (n=157) with healed stage II or III reflux oesophagitis (Savary-Miller classification) were enrolled into a long-term, multicentre maintenance study. Endoscopy was performed at entry into the study, after 12 and 24 months, or when disease-specific symptoms occurred on more than three consecutive days. Symptoms were assessed at 3-monthly intervals. Endoscopically confirmed relapses (at least stage I) were evaluated as treatment failures. Of the 178 adverse events, experienced by 88 (56%) patients (intention-to-treat population), 12 (7%) were assessed by the investigators as possibly related to the study medication. Median serum gastrin levels increased from a baseline of 46 ng/L to 90 ng/L, reaching a plateau after 9 months. For the intention-to-treat population the endoscopic remission rates after 12 and 24 months were 87% and 76%, respectively (Life-Table survival analysis, Kaplan-Meier). Pantoprazole 40 mg proved to be safe and efficacious during a 2-year prophylaxis treatment in patients with healed reflux oesophagitis.",1999.0,0,1
88,10468678,"On demand therapy of reflux oesophagitis--a prospective study of symptoms, patient satisfaction and quality of life.",I Wilhelmsen; J G Hatlebakk; S Olafsson; A Berstad,"In patients with low-grade reflux oesophagitis adequate symptom control is the aim of treatment. Effervescent tablets alleviate heartburn more rapidly than ordinary tablets. To investigate symptom control, patient satisfaction, health-related quality of life and disease progress when ranitidine 150 mg effervescent tablets were offered as on demand treatment. We also wanted to investigate whether any biological or psycho-social factor could predict patient satisfaction. Consecutive patients with endoscopically verified reflux oesophagitis grade I-II were followed up for 12 months. 24 h pH-metry, disease history, symptoms and several psycho-social factors were registered at baseline and 12 months follow-up. Eighty-one patients were included. Mean age was 50.7 years (range 21-82), 63% were men. Mean tablet consumption was 1.21 per day (range 7-1016 tablets/year). At the 1-year follow-up discomfort resulting from reflux symptoms was significantly reduced (P<0.001), and the patients' social and vocational life improved. Eighty-four percentage of the patients were satisfied with the treatment. 24 h pH-metry or number of reflux episodes did not change. We did not find any factors able to predict patient satisfaction. On demand therapy with ranitidine effervescent tablets was well accepted by the majority of patients with reflux oesophagitis grade I. Even though the number of reflux episodes did not change, the patients experienced less discomfort due to reflux symptoms, and their social and vocational life was better. There was no significant progression of the disorder during the 1-year follow-up. No predictive factor for patient satisfaction was found.",1999.0,0,0
89,10468679,Omeprazole therapy decreases the need for dilatation of peptic oesophageal strictures.,G O Barbezat; M Schlup; R Lubcke,"Better control of gastric acid secretion with omeprazole appeared to decrease the need for dilatation of oesophageal strictures complicating gastro-oesophageal reflux disease in our hospital-based endoscopy service. To investigate whether the perceived decrease in the need for oesophageal dilatation could be documented from endoscopy records, and, if confirmed, whether this could be related to the treatment used. Retrospective study of the records of 69 patients who had peptic oesophageal strictures dilated, followed by treatment with acid inhibition for at least 6 months. Mean duration of follow-up was 3.9 years during treatment with H2-receptor antagonists and 2.1 years while on omeprazole (258 and 78 patient-years, respectively). Re-dilatation rates were compared between those treated with H2-receptor antagonists or omeprazole. There has been a significant decrease in dilatations performed for gastro-oesophageal reflux induced strictures (P<0.001), while dilatation rates for other indications remained constant. Treatment with omeprazole not only decreased the need for further dilatations, but also prolonged the mean time between any further dilatations to 26.3 months compared to 9.3 months for those on an H2-receptor antagonist (P<0.0001). Following dilatation of peptic oesophageal strictures, treatment with omeprazole in place of an H2-blocker significantly decreases the need for repeat dilatation.",1999.0,0,0
90,10468682,"Famotidine versus omeprazole in combination with clarithromycin and metronidazole for eradication of Helicobacter pylori--a randomized, controlled trial.",M Gschwantler; B Dragosics; K Schütze; H Wurzer; A M Hirschl; E Pasching; M Wimmer; M Klimpfinger; G Oberhuber; G Brandstätter; E Hentschel; W Weiss,"One-week low-dose triple therapy is currently considered the gold standard regimen for treatment of Helicobacter pylori infection. However, the mechanisms involved in the synergy between antibiotics and proton pump inhibitors are controversial. To test the hypothesis that acid suppression represents the crucial mechanism by which the antibacterial activity of antibiotics can be enhanced, and to assess the impact of primary resistance on treatment outcome. One hundred and twenty patients with H. pylori infection and duodenal ulcer, gastric ulcer or non-ulcer dyspepsia were randomly assigned to a 1 week course of either famotidine 80 mg b.d., clarithromycin 250 mg b.d. and metronidazole 500 mg b.d. (FCM group; n = 60) or omeprazole 20 mg o.d., clarithromycin 250 mg b.d. and metronidazole 500 mg b.d. (OCM group; n = 60). Gastroscopy was performed at baseline and 5 weeks after completion of treatment. H. pylori status was assessed by biopsy urease test, histology and culture. In the intention-to-treat analysis, eradication of H. pylori was achieved in 47 of 60 patients (78%; 95% CI: 66-88%) in the FCM group, compared to 44 of 60 patients (73%; 95% CI: 60-84%) in the OCM group (N.S.). Using per protocol analysis, eradication therapy was successful in 47 of 52 patients (90%; 95% CI: 79-97%) treated with FCM and 44 of 57 patients (77%; 95% CI: 64-87%) treated with OCM (N.S.). Primary metronidazole resistance was present in 27% and primary clarithromycin resistance in 8% of strains. Overall per protocol eradication rates in strains susceptible to both antibiotics and strains with isolated metronidazole resistance were 93% and 84%, respectively. No patient with clarithromycin resistance responded to treatment. High-dose famotidine and omeprazole, combined with clarithromycin and metronidazole, are equally effective for eradication of H. pylori. In 1-week low-dose triple therapy, metronidazole resistance has no major impact on eradication rates whereas clarithromycin resistance is associated with a poor treatment outcome.",1999.0,0,1
91,10468683,Comparison of ranitidine bismuth citrate plus clarithromycin with omeprazole plus clarithromycin for the eradication of Helicobacter pylori.,P Paré; A Farley; J M Romãozinho; K D Bardhan; P C French; P M Roberts,"Many dual and triple therapy treatment regimens have been proposed for the eradication of Helicobacter pylori. However, assessing the relative efficacy of these regimens is complicated by differences in study design, and few well-controlled comparative studies have been reported. This multicentre, randomized, double-blind study involved 530 duodenal ulcer patients, of whom 520 had confirmed H. pylori infection. Patients received 14 days b.d. dual therapy of either ranitidine bismuth citrate (RBC) 400 mg or omeprazole 20 mg, both with clarithromycin 500 mg to eradicate H. pylori, followed by a further 14 days of treatment with RBC 400 mg b. d. or omeprazole 20 mg o.d. to facilitate ulcer healing. H. pylori eradication and ulcer healing were assessed at least 26 days after the end of treatment. Adverse events were recorded throughout the study. H. pylori was eradicated in 90% of patients who received RBC with clarithromycin and in 66% of patients who received omeprazole with clarithromycin (per protocol; P<0.001). intention-to-treat eradication rates were 77% and 60%, respectively (P<0.001). Ulcer healing rates were 97% in the RBC treatment group and 95% in the omeprazole treatment group. Only 3% and 1% of patients in the RBC and omeprazole treatment groups, respectively, were withdrawn due to adverse events. RBC with clarithromycin is a simple and highly effective dual therapy regimen for the eradication of H. pylori, and is significantly more effective than omeprazole with clarithromycin. Both treatment regimens are well tolerated and effectively heal duodenal ulcers.",1999.0,0,1
92,10468684,"One-week ranitidine bismuth citrate in combinations with metronidazole, amoxycillin and clarithromycin in the treatment of Helicobacter pylori infection: the RBC-MACH study.",J J Sung; F K Chan; J C Wu; W K Leung; R Suen; T K Ling; Y T Lee; A F Cheng; S C Chung,"We have previously shown that ranitidine bismuth citrate (RBC)-based triple therapy is comparable to proton pump inhibitor-based triple therapy in eradicating Helicobacter pylori infection. To test the efficacy of different combinations of antimicrobials with RBC in the treatment of H. pylori infection. Dyspeptic patients with H. pylori infection were prospectively randomized to receive one of the following regimens: (i) RBC 400 mg, amoxycillin 1 g, clarithromycin 500 mg [RAC]; (ii) RBC 400 mg, metronidazole 400 mg, clarithromycin 500 mg [RMC]; (iii) RBC 400 mg, metronidazole 400 mg, tetracycline 1 g [RMT] (all given twice daily for 1 week); or (iv) RBC 400 mg plus clarithromycin 500 mg twice daily for 2 weeks [RC-2]. Endoscopy (rapid urease test and culture) and 13C-urea breath test (UBT) were performed before randomization. Four weeks after finishing medication, the 13C-UBT was repeated in all cases and endoscopy was offered to patients with peptic ulcers. Four hundred patients were randomized but in two (one in the RAC group and one in the RMC group) H. pylori infection was not confirmed. Successful eradication of H. pylori (intention-to-treat analysis and 95% CI) of RAC (86% [79-93%]), RMC (90% [84-96%]), RMT (79% [71-87%]) and RC-2 (82% [75-90%]) were comparable, with a trend favouring clarithromycin-containing triple therapy regimens. Among 276 isolates tested for antibiotic sensitivity, primary resistance to metronidazole, clarithromycin and amoxycillin was found in 56%, 2% and 0.4%, respectively. When given RMC or RMT, patients infected by metronidazole-resistant H. pylori had success in eradicating H. pylori similar to patients infected by metronidazole-sensitive H. pylori. One-week RBC triple therapy is effective in curing H. pylori infection.",1999.0,0,1
93,10468701,The effects of oral rabeprazole on endocrine and gastric secretory function in healthy volunteers.,H G Dammann; F Burkhardt; N Wolf,"To evaluate the short-term effects of rabeprazole 20 mg on endocrine parameters, in particular serum testosterone and cortisol, and on 24 h intragastric pH, H+ activity and nocturnal gastric acid secretion. In this double-blind, two-period crossover study, 12 healthy young male volunteers were randomly given oral rabeprazole 20 mg o.m. or placebo for 14 days. There was a washout period of at least 1 week between the two studies. The effects of rabeprazole and placebo on cortisol and testosterone (primary criteria), and on tri-iodothyronine, thyroxine, 17beta-oestradiol, thyroid-stimulating hormone, thyroxine-binding protein, parathyroid hormone, insulin, glucagon, rennin, aldosterone, follicle-stimulating hormone, luteotrophic hormone, prolactin, somatotrophic hormone, dehydroepiandrosterone, cortisol-binding globulin and urinary 6-beta hydroxycortisol were compared. Intragastric 24 h pH, 24 h H+ activity and nocturnal gastric acid secretion were determined by pH probe and gastric aspiration. Rabeprazole produced no clinically relevant effects on endocrine function as assessed by measurement of serum testosterone, circadian serum cortisol levels, ACTH-stimulated serum cortisol levels and 17 other endocrine function tests. Rabeprazole significantly increased the 24 h median pH values compared to placebo (on Days 7 and 14 median values ranged from 3.92 to 6.88 with rabeprazole and from 1.48 and 4.22 with placebo, P < 0.001) and significantly decreased the integrated 24 h H+ activity (AUC08--08) from 343 mmol/L/h with placebo to 44 mmol/L/h with rabeprazole (P < 0.001). Following cessation of dosing, intragastric pH levels decreased and H+ activity increased, but acid secretion did not recover completely during the next 72 h. The mean value for nocturnal gastric acid secretion on Days 7 and 8 was 36 mmol/6 h with placebo and 5.6 mmol/6 h with rabeprazole (P < 0.001). Rabeprazole was well tolerated. Rabeprazole did not influence endocrine function in healthy young male volunteers during short-term dosing. Rabeprazole substantially increased intragastric pH over a 24 h period and significantly decreased intragastric acidity and nocturnal gastric acid secretion.",1999.0,0,0
94,10468703,Post-prandial ranitidine is superior to post-prandial omeprazole in control of gastric acidity in healthy volunteers.,R M Khoury; P O Katz; D O Castell,"Episodic heartburn is a common problem, affecting over 40 million Americans. Although omeprazole provides excellent acid suppression when used daily, the use of omeprazole as on-demand therapy for episodic symptoms has not been extensively studied. To compare the onset and duration of post-prandial gastric acid suppression by omeprazole (10 and 20 mg) or ranitidine (75 and 150 mg) taken as single doses in healthy volunteers. Twenty-four healthy volunteers (14 male, 10 female, mean age 33.4 years, range 18-56 years) were given ranitidine (RAN) 75 mg or 150 mg vs. omeprazole (OME) 10 mg or 20 mg when pH returned to below 2 after breakfast, in a randomized open label crossover design, with a washout of at least 2 days between medications. Intragastric pH was monitored for 6 h. The time between drug ingestion and rise of gastric pH > 3 and 4, and total time pH remained > 3 and 4 during the 6 h post drug, was compared between groups using two way ANOVA and Wilcoxon matched pairs test. The median time needed to pH > 4 was 204.5 min for RAN 75 mg, 186 min for RAN 150 mg and > 360 min for both OME 10 and 20 mg (P < 0.001 between the four groups). The median time that pH remained > 4 was 93 min for RAN 75 mg, 143.5 min for RAN 150 mg and 0 min for both OME 10 and 20 mg (P < 0.001 between the four groups). Both doses of RAN were significantly superior to both doses of OME, although no significant difference was found between the high and the low doses of either drugs. Similar results were found for pH > 3. Ranitidine 75 or 150 mg provides more rapid increase in gastric pH to > 3 and > 4 compared to omeprazole 10 or 20 mg when taken at the end of the post-prandial period. These data suggest that ranitidine may be more effective for episodic post-prandial heartburn than omeprazole.",1999.0,0,0
95,10469192,Comparative treatment of Helicobacter pylori-positive duodenal ulcer using pantoprazole at low and high doses versus omeprazole in triple therapy.,F Catalano; G Branciforte; R Catanzaro; C Bentivegna; R Cipolla; G Nuciforo; A Brogna,"Helicobacter pylori eradication has become the standard treatment for peptic ulcer disease. H. pylori-eradicating triple therapy with omeprazole plus two antibiotics has been used until recently; however, the efficacy of pantoprazole and antibiotics for H. pylori eradication has not been researched thoroughly until now. The aim of this randomized clinical trial was to verify the efficacy of triple oral therapy comparing the effects of pantoprazole using two different doses versus omeprazole twice daily in H. pylori eradication, in ulcer healing and relapses, and in gastritis improvement. We enrolled 243 patients with H. pylori-positive duodenal ulcer and randomized them into three treatment groups: 84 patients (group Ome40) were assigned to receive omeprazole, 20 mg twice daily, plus amoxicillin, 1 gm twice daily, and clarithromycin, 500 mg twice daily for 10 days; 79 patients (group Pan40) were treated with pantoprazole, 40 mg daily, plus amoxicillin and clarithromycin at the same doses as those of group Ome40; and 80 patients (group Pan80) were treated with pantoprazole, 40 mg twice daily, plus amoxicillin and clarithromycin at the same doses as those of group Ome40. Ulcer healing was observed in 81 of 84 patients (96.4%) in group Ome40; in 66 of 79 patients (83.5%) in group Pan40; and in 77 of 80 patients (96.2%) in group Pan80. H. pylori was eradicated in 79 of 84 patients (94%) in group Ome40; in 63 of 79 patients (79.7%) in group Pan40; and in 75 of 80 patients (93.7%) in group Pan80. We found that 10-day triple therapy with amoxicillin, clarithromycin, and either pantoprazole, 80 mg daily, or omeprazole, 40 mg daily, is highly effective in ulcer healing and is very well tolerated, achieving the 90% cure recommended for an ideal first-line anti-H. pylori positive duodenal ulcer treatment regimen.",1999.0,1,1
96,10471983,"Rabeprazole: pharmacokinetics and tolerability in patients with stable, end-stage renal failure.",W F Keane; S K Swan; I Grimes; T J Humphries,"The authors compare the pharmacokinetic profiles, safety, and tolerability of rabeprazole, a new proton pump inhibitor (PPI), in healthy volunteers and in subjects with stable, end-stage renal failure. This single-center, open-label trial included two groups of subjects: 10 healthy males with 24-hour creatinine clearance > or = 90 mL/min/m2 and 10 males with renal failure (24-hour creatinine clearance < or = 5 mL/min/m2) receiving hemodialytic therapy. Normal subjects received a single, oral 20 mg rabeprazole dose. Those with renal failure received a 20 mg dose of rabeprazole on the day after hemodialysis and a second dose after a 2-week washout period during dialysis. Blood samples were drawn before and up to 24 hours after rabeprazole administration for determination of plasma rabeprazole concentrations by high-performance liquid chromatography. Safety and tolerability of rabeprazole were determined by reporting adverse events and comparing vital signs, ECG, physical examinations, and clinical laboratory tests before and during treatment. Comparison of pharmacokinetic results from healthy volunteers with those from subjects with renal failure indicated no clinically significant differences between groups. In addition, there were no statistically significant differences between any pharmacokinetic parameters recorded during or after hemodialysis. Rabeprazole was well tolerated by both groups. Only two drug-related adverse events were reported, and there were no significant treatment-emergent changes in vital signs or ECG. Treatment-emergent changes in hematologic and clinical chemistry parameters were observed for a few subjects in each group and generally represented only slight deviations from the normal range. These results indicate that no dosage adjustment of rabeprazole is required in patients with renal dysfunction. These findings and the well-documented clinical efficacy of this new PPI in patients with gastric ulcers, duodenal ulcers, or gastroesophageal reflux disease support rabeprazole's use in the treatment of patients with acid peptic disorders.",1999.0,0,1
97,10471987,Lack of pharmacokinetic interaction between oral pantoprazole and cisapride in healthy adults.,G M Ferron; J C Paul; R J Fruncillo; P T Martin; L Yacoub; P R Mayer,"Pantoprazole, an irreversible proton pump inhibitor, may be administered with cisapride, a prokinetic agent. As increased cisapride concentrations may result in longer electrocardiogram (ECG) QTc intervals, a crossover study was conducted in healthy subjects to evaluate the oral pharmacokinetic interaction between cisapride (20 mg) and pantoprazole (40 mg). After dosing, serial blood samples and 12-lead ECGs were collected, and cisapride plasma concentrations were quantitated. For cisapride alone, mean parameter values were the following: peak concentration (Cmax), 56 ng/mL; time to Cmax (tmax), 1.7 hours; area under the concentration-time curve (AUC), 426 ng x h/mL; and terminal half-life (t1/2), 5.8 hours. Pantoprazole coadministration did not alter cisapride AUC or other pharmacokinetic parameters except for a slight 17% decrease in Cmax' resulting in 90% confidence limits of 79% to 88%, which were marginally outside strict bioequivalence limits. In addition, cisapride did not affect ECG QTc intervals, with or without pantoprazole. Therefore, no dosage adjustment is needed when pantoprazole and cisapride are coadministered.",1999.0,0,1
98,10485504,"Lansoprazole versus omeprazole for duodenal ulcer healing and prevention of relapse: a randomized, multicenter, double-masked trial.",G Dobrilla; L Piazzi; R Fiocca,"The aim of this randomized, multicenter, double-masked, parallel-group study was to compare the efficacy of lansoprazole with that of omeprazole monotherapy in duodenal ulcer healing and prevention of relapse. A total of 251 patients with duodenal ulcer were treated with either lansoprazole 30 mg/d (n = 167) or omeprazole 40 mg/d (n = 84). Patients with healed ulcers were then randomly allocated to 12 months of maintenance therapy with lansoprazole 15 mg/d (n = 74), lansoprazole 30 mg/d (n = 71), or omeprazole 20 mg/d (n = 73). Healing rates at 4 weeks (intent-to-treat analysis) were 93.9% (95% confidence interval [CI], 90.2% to 97.6%) with lansoprazole and 97.5% (95% CI, 93.7% to 100%) with omeprazole; there were no significant differences between groups. Endoscopic relapse rates after 6 months were 4.5% (95% CI, 0% to 10.6%) with lansoprazole 15 mg, 0% with lansoprazole 30 mg, and 6.3% (95% CI, 1.5% to 12.5%) with omeprazole 20 mg, compared with 3.3% (95% CI, 0% to 8.2%), 0%, and 3.5% (95% CI, 0% to 8.8%), respectively, at 12 months. Again, there were no significant differences between groups. The incidence of adverse events during acute treatment was 6.0% and 7.1% in the lansoprazole and omeprazole groups, respectively; during maintenance therapy, the incidences were 12.2% (lansoprazole 15 mg), 5.6% (lansoprazole 30 mg), and 11.0% (omeprazole 20 mg). Within treatment groups, pain was significantly ameliorated after the acute phase but not after maintenance therapy (P < 0.05); no differences were observed between groups. Gastrin values increased significantly after acute therapy (P < 0.05), persisted at these increased levels during maintenance therapy, and returned to normal after 6-month follow-up. Both lansoprazole and omeprazole were highly effective and well tolerated in the treatment of duodenal ulcer; relapse rates were similar for all doses studied. Thus no additional benefit is to be gained from using a proton-pump inhibitor at a dose > 15 mg lansoprazole to prevent relapse.",1999.0,1,1
99,10486353,Endoscopic regression of Barrett's oesophagus during omeprazole treatment; a randomised double blind study.,F T Peters; S Ganesh; E J Kuipers; W J Sluiter; E C Klinkenberg-Knol; C B Lamers; J H Kleibeuker,"Barrett's oesophagus, columnar metaplasia of the epithelium, is a premalignant condition with a 50-100-fold increased risk of cancer. The condition is caused by chronic gastro-oesophageal reflux. Regression of metaplasia may decrease the cancer risk. To determine whether elimination of acid gastro-oesophageal reflux induces a regression of metaplastic epithelium. Sixty eight patients with acid reflux and proven Barrett's oesophagus were included in a prospective, randomised, double blind study with parallel groups, and were treated with profound acid secretion suppression with omeprazole 40 mg twice daily, or with mild acid secretion suppression with ranitidine 150 mg twice daily, for 24 months. Endoscopy was performed at 0, 3, 9, 15, and 24 months with measurement of length and surface area of Barrett's oesophagus; pH-metry was performed at 0 and 3 months. Per protocol analysis was performed on 26 patients treated with omeprazole, and 27 patients treated with ranitidine. Omeprazole reduced reflux to 0.1%, ranitidine to 9.4% per 24 hours. Symptoms were ameliorated in both groups. There was a small, but statistically significant regression of Barrett's oesophagus in the omeprazole group, both in length and in area. No change was observed in the ranitidine group. The difference between the regression in the omeprazole and ranitidine group was statistically significant for the area of Barrett's oesophagus (p=0. 02), and showed a trend in the same direction for the length of Barrett's oesophagus (p=0.06). Profound suppression of acid secretion, leading to elimination of acid reflux, induces partial regression of Barrett's oesophagus.",1999.0,0,0
100,10490365,PPI-based triple therapy in the eradication of H. pylori infection.,V Savarino; M Neri; S Vigneri,,1999.0,0,0
101,10491487,Morphometric estimation of acid output in duodenal ulcer associated with Helicobacter pylori infection.,M Rodríguez Téllez; M Valenzuela Barranco; A Caballero Plasencia; J Martín Ruiz; A López-Andrade; I Carmona Soria; J Herrerías Gutiérrez,"to determine the changes in acid output before and after eradication therapy in patients with duodenal ulcer associated with Helicobacter pylori infection. the subjects of this prospective study were 16 patients with acute duodenal ulcer at endoscopy and H. pylori infection determined by rapid urease test and histology. They were randomly assigned to receive treatment with pantoprazole 40 mg b.i.d., clarithromycin 500 mg b.i.d. and amoxicillin 1 g b.i.d. during 7 or 14 days. Endoscopic examination and biopsy were repeated 4 weeks after treatment ended. The changes in acid output before and after treatment were calculated by the morphometric quantification of parietal cell canaliculi from the gastric corpus. To this end 20 parietal cells from the medial glandular zone were selected and canalicular index was calculated, before and after eradication therapy, with a morphometric method based on automatic analysis of histological images. canalicular index was 26.4 +/- 1.4 (mean +/- standard error of the mean) before treatment, and 20.5 +/- 1 (p < 0.01) after therapy. morphometric analysis showed a decrease in acid output in patients with duodenal ulcer associated with H. pylori infection 4 weeks after eradication therapy with clarithromycin, amoxicillin and pantoprazole.",1999.0,0,0
102,10491725,Review article: drug interactions with agents used to treat acid-related diseases.,T J Humphries; G J Merritt,"Patients with acid-related diseases often need to take multiple medications. Treatment of Helicobacter pylori infection often includes either a histamine type 2 (H2)-receptor antagonist or a proton pump (H+,K(+)-ATPase) inhibitor (proton pump inhibitor), administered in conjunction with one or more antimicrobials. Also, treatment for acid-related diseases often requires extended therapy during which many concomitant medications may be administered for concurrent disease states. Polypharmacy may be the result, particularly in elderly patients, who are at increased risk for both acid-related and many other diseases. Thus, it is important to understand the potential for clinically significant drug-drug interactions in this setting. H2-receptor antagonists and proton pump inhibitors can influence the pharmacokinetic profiles of other commonly administered medications by elevating intragastric pH, which can alter drug absorption, and by interacting with the cytochrome P (CYP) 450 enzyme system, which can affect drug metabolism and clearance. Such interactions are particularly important when they affect the pharmacokinetics of drugs with narrow therapeutic ranges (e.g. warfarin, digoxin). In these cases, drug-drug interactions can result in significant toxicity and even death. There are marked differences among H2-receptor antagonists and proton pump inhibitors in their potential for such interactions. The oldest drugs in each class, cimetidine and omeprazole, respectively, have the greatest potential to alter CYP activity and change the pharmacokinetics of other drugs. The most recently developed H2-receptor antagonist, famotidine, and the newer proton pump inhibitors, rabeprazole and pantoprazole, are much less likely to induce or inhibit CYP and thereby change the metabolism of other medications. These differences are important when choosing medications for the safe treatment of patients with acid-related diseases.",1999.0,0,1
103,10492314,The cost-effectiveness of the omeprazole test in patients with noncardiac chest pain.,J J Ofman; I M Gralnek; J Udani; M B Fennerty; R Fass,"Recent evidence suggests that an empiric trial of omeprazole (the ""omeprazole test"") is sensitive and specific for diagnosing gastroesophageal reflux disease (GERD) as the cause of noncardiac chest pain. Our objective was to examine the clinical, economic, and policy implications of alternative diagnostic strategies for patients with noncardiac chest pain. Decision analysis was used to evaluate the clinical and economic outcomes of two diagnostic strategies that begin with the omeprazole test (60 mg daily for 7 days) followed sequentially by invasive testing utilizing endoscopy, ambulatory 24-hour esophageal pH monitoring, and esophageal manometry as necessary, compared with two traditional strategies involving sequential invasive diagnostic tests. Cost estimates were based on Medicare reimbursement and the Red Book of average wholesale drug prices. Probability estimates were derived from a systematic review of the medical literature. The average cost per patient for the four diagnostic strategies varied from $1,859 to $2,313. Strategies utilizing the initial omeprazole test resulted in 84% of patients being symptom free at 1 year, compared with 73% to 74% for the strategies that began with invasive tests. The strategy of the omeprazole test, followed if necessary by ambulatory pH monitoring, then manometry, and then endoscopy, was both most effective and least expensive. It led to an 11% improvement in diagnostic accuracy and a 43% reduction in the use of invasive diagnostic tests, thus yielding an average cost savings of $454 per patient, compared with the strategy of beginning with endoscopy, then pH monitoring, and then manometry. Among patients with noncardiac chest pain, diagnostic strategies that begin with the omeprazole test result in reduced costs, improved diagnostic certainty, and a greater proportion of symptom-free patients at 1 year than do traditional strategies that begin with invasive diagnostic tests.",1999.0,0,0
104,10492325,"Cost-effectiveness of testing for gastroesophageal reflux disease: what do patients, physicians, and health insurers want?",J E Richter,,1999.0,0,0
105,10494231,COX-2 inhibitors: the next generation of non-steroidal anti-inflammatory drugs.,L Schachna; P F Ryan,,1999.0,0,0
106,10494693,Local treatment of early cancer in short Barrett's esophagus by means of argon plasma coagulation: initial experience.,A May; L Gossner; E Günter; M Stolte; C Ell,"In recent years endoscopically controlled local therapeutic methods, such as photodynamic therapy, mucosectomy, or laser therapy, have been used with a curative aim for the destruction of early esophageal or gastric cancers. We report on our experience of treating histologically proven mucosal cancer in Barrett's esophagus with argon plasma coagulation (APC), in three patients. All the mucosal esophageal cancers, with a mean diameter of 4 mm, were successfully destroyed after one or two treatment sessions. Additionally, in two of the three patients the specialized columnar epithelium was replaced by normal squamous cell epithelium when APC treatment was combined with omeprazole. In the third patient with Barrett's esophagus, a partial squamous cell re-epithelialization was induced. No method-related mortality and morbidity were observed. During the mean follow-up of 24.3 +/- 1.1 months (range 23-25 months) one tumor recurrence developed which was successfully treated with photodynamic therapy. In patients with small early Barrett's carcinoma APC might offer an effective, minimally invasive alternative to mucosectomy or photodynamic therapy, as the treatment procedure is less cumbersome and the equipment less expensive.",1999.0,0,0
107,10495164,Oesophageal disorders and gastro-oesophageal reflux disease.,G N Tytgat,,1999.0,0,0
108,10495170,,,,,0,0
109,10495172,Progress and novel discoveries in biliary tract diseases.,F P Vleggaar; G P van Berge-Henegouwen,,1999.0,0,0
110,10499456,24-h recording of intragastric pH: technical aspects and clinical relevance.,M A van Herwaarden; M Samsom; A J Smout,"Information about gastric acid secretion and gastric acidity can be obtained using several techniques but, presently, continuous intragastric pH recording is probably the one applied most frequently. This paper aims to review the technical aspects and some important applications of intragastric pH monitoring in research and clinical practice. Literature review. Most studies on intragastric pH are performed with either glass or antimony electrodes. Optimal measurement of 24-h intragastric pH requires accurate calibration of the pH measuring system, exact positioning of the pH electrodes, and a sufficient sample rate. Depending on the aim of the study the results of intragastric pH monitoring are expressed either as median H+ activity or as median pH values. Gastric acidity shows a circadian rhythm, modified by buffering meals and nocturnal duodenogastric reflux. In health, age, gender and smoking habits are known to influence gastric acidity. In duodenal ulcer disease an increased gastric acidity is found and in patients with gastric ulcer gastric acidity is decreased. In GERD, no relation between reflux oesophagitis and gastric acidity is found. Helicobacter pylori affects intragastric pH most pronounced during acid inhibitory therapy, both in DU patients and in healthy subjects. In the absence of H. pylori the effect of proton-pump inhibitors on intragastric pH is much less than in the presence of the microorganism, whereas the effect of ranitidine on intragastric pH is barely affected by the H. pylori status. Despite some limitations, intragastric pH monitoring provides important information about gastric acidity.",1999.0,0,0
111,10499474,Prevalence of resistance to clarithromycin and its clinical impact on the efficacy of Helicobacter pylori eradication.,V Ellenrieder; W Boeck; C Richter; R Marre; G Adler; B Glasbrenner,"Triple therapy with a proton-pump inhibitor (PPI) in combination with metronidazole and clarithromycin is the method of choice for eradication of Helicobacter pylori. Failures have been primarily blamed on the development of resistance to clarithromycin. The present study investigated the prevalence and clinical significance of resistance to clarithromycin and metronidazole in determining therapeutic success of both triple therapy as a primary eradication method and high-dose dual therapy in non-responders. On the basis of prior therapy, H. pylori-positive patients were assigned to one of two groups in the present prospective study. Group A (n = 93) included patients who had not undergone any prior eradication treatment, whereas group B (n = 15) consisted of patients who had received clarithromycin but in whom eradication had been unsuccessful. All patients underwent endoscopy with biopsy for bacterial culture and resistance studies. Patients in group A were treated with a 7-day regimen of pantoprazole (40 mg twice daily), metronidazole (500 mg twice daily), and clarithromycin (250 mg twice daily), whereas those in group B received omeprazole (40 mg three times a day) and amoxycillin (1000 mg three times a day ) for 14 days. Success of the eradication treatment was ascertained by means of the 13C urea breath test. In group A resistance to clarithromycin and metronidazole was identified in 3 patients (4.9%) and in 14 patients (22.9%), respectively. Eradication proved successful in 78 of 84 patients (92.6%) followed up. Two of the 3 patients with primary clarithromycin resistance and 1 of the 14 patients with metronidazole resistance did not respond to treatment. In group B isolated or combined resistance to clarithromycin was found in seven patients, whereas another four showed isolated resistance to metronidazole. Eradication proved successful in 10 of 13 controlled patients (76.9%) followed up, and only 2 patients reported severe side effects. Determination of antibiotic resistance before initiating therapy is not necessary, since primary resistance to clarithromycin is rare. The Italian triple therapy remains a highly effective primary therapeutic method. Further, routine determination of resistance in non-responders also seems to be superfluous because high-dose dual therapy is an effective and well-tolerated second-line therapy regardless of the patients' resistance status.",1999.0,0,0
112,10510158,"Lack of drug interaction between omeprazole, lansoprazole, pantoprazole and theophylline.",K Dilger; Z Zheng; U Klotz,"Theophylline is a model substrate of cytochrome P4501A2. The ability of the proton pump inhibitors (PPI) omeprazole, lansoprazole and pantoprazole to induce cytochrome P4501A2 has not yet been unequivocally resolved. The aim of this comprehensive study was to compare directly the effect of the three PPI on the absorption and disposition of theophylline. Twenty healthy, nonsmoking, male and female volunteers (extensive metabolisers of cytochrome P4502C19 and Helicobacter pylori negative) participated in a randomized, double-blind, four-period, placebo-controlled crossover study. In each of the four periods they received either omeprazole (40 mg), lansoprazole (60 mg), pantoprazole (80 mg) or placebo once daily for 10 days. Sustained release theophylline (350 mg twice daily) was coadministered from day 8-10. Pharmacokinetics of theophylline as well as of all three PPI were determined at steady-state (day 10). In all periods, point estimates and 90% confidence intervals of the area under the concentration-time curves (AUC), maximum steady-state concentrations and peak-trough fluctuations of theophylline were not altered by PPI pretreatment and met the required limits for bioequivalence. Point estimates (90% confidence intervals) of the AUC ratios of theophylline plus PPI to theophylline alone were 0.92 (0.87-0.97), 0.90 (0.85-0.95) and 1.00 (0.95-1.06) for omeprazole, lansoprazole and pantoprazole, respectively. Concomitant intake of omeprazole, lansoprazole or pantoprazole at high therapeutic doses does not affect the absorption and disposition of theophylline.",1999.0,0,1
113,10520910,Use of omeprazole in the management of giant duodenal ulcer: results of a prospective study.,D R Fischer; M S Nussbaum; T A Pritts; N H Gilinsky; R E Weesner; S P Martin; R A Giannella,"Giant duodenal ulcer (GDU) is generally thought to require surgical intervention. Proton pump inhibitors have beneficial effects in peptic ulcer disease, but their role in GDU disease is unknown. We examined the use of omeprazole in GDU management. Twenty-eight patients were diagnosed with GDU. One patient required immediate operative intervention. The remaining 27 were placed on omeprazole (40 mg daily). When ulcer healing was documented by endoscopy, the patients were placed on oral histamine-2 receptor antagonist therapy. Of the 28 study patients, 20 (71.4%) did not require operative intervention, and 8 (28.6%) required operation for ulcer complications. Of the 15 patients with adherent clot or a visible vessel at initial endoscopy, 7 (46.7%) required operative intervention, as compared with 1 (7.7%) of the 13 patients without a visible vessel or adherent clot. This difference was statistically significant (P < .05). Twenty-three patients underwent antral biopsy and/or enzyme-linked immunosorbent assay for Helicobacter pylori, and 9 (39.1%) had a positive result. Omeprazole is effective in the treatment of GDU disease. An adherent clot or a visible vessel at endoscopy indicates a higher likelihood of complications requiring operation. The relatively low H pylori infection rate, as compared with other peptic ulcer disease, may indicate a different pathophysiology in GDU.",1999.0,0,0
114,10521964,The influence of intravenous omeprazole on intragastric pH and outcomes in patients with peptic ulcer bleeding after successful endoscopic therapy--a prospective randomized comparative trial.,G Y Tseng; H J Lin; H Y Lin; C L Perng; F Y Lee; W C Lo; F Y Chang; S D Lee,"The role of omeprazole in preventing rebleeding in patients with peptic ulcer bleeding after successful endoscopic therapy has been controversial. In this study, we used 3 different formulas of intravenous omeprazole in the above patients. We wished to compare the intragastric pH and outcomes among them. Between July 1996 and May 1997, after having obtained initial hemostasis with endoscopic therapy, a total of 20 patients with peptic ulcer bleeding (spurting/oozing/non-bleeding visible vessel: 6/4/10) received intravenous bolus of omeprazole 20 mg every 3 hours; 20 patients (3/5/12) received intravenous bolus of omeprazole 40 mg every 6 hours; and, 20 patients (5/4/11) received intravenous bolus of omeprazole 80 mg every 12 hours for 3 days. One intragastric pH meter (Gastrograph Mark III, Medical Instruments Corp. Switzerland) was used to record 24-hour intragastic pH. The intragastric pH in the patients receiving omeprazole 20 mg every 3 hours was 6.1, 6.0-6.2 (mean: 95% CI); in patients receiving omeprazole 40 mg every 6 hours it was 6.4, 6.2-6.5; and, in patients receiving omeprazole 80 mg every 12 hours it was 5.8, 5.7-5.9. The duration of intragastric pH > 6.0 in omeprazole 20 mg every 3 hours was 70.9%, 57.3%-84.4% (mean: 95% CI); in omeprazole 40 mg every 6 hours it was 83.1%, 73.1%-93.1%; and, in omeprazole 80 mg every 12 hours it was 66%, 51.5%-80.4%. Patients with peptic ulcers receiving omeprazole 40 mg intravenous bolus every 6 hours had the highest intragastric pH as compared with the other 2 groups (p < 0.0001). There were no significant differences concerning rebleeding rates, volume of blood transfusion, hospital stay, numbers of operation and mortality among the 3 groups. After initial hemostasis had been obtained, patients with peptic ulcer bleeding receiving 40 mg intravenous bolus every 6 hours had the highest intragastric pH. However, they had similar outcomes with the other 2 groups.",1999.0,0,0
115,10521998,Effect of omeprazole and amoxicillin plus metronidazole on the eradication of Helicobacter pylori and the healing of duodenal ulcer: comparison with a historical control.,K Schütze; E Hentschel; A M Hirschl,"To test the hypothesis of equivalence of an omeprazole 7-day triple therapy without subsequent acid suppression and a historical ranitidine 12-day triple therapy (recruiting phase 1989-91) with subsequent acid suppression in their effect on the eradication of Helicobacter pylori (H. pylori) and the healing of duodenal ulcer. Seventy-seven patients with H. pylori-positive duodenal ulcers received a 7-day treatment with amoxicillin 750 mg tid and metronidazole 500 mg tid. Additional omeprazole 20 mg or 40 mg once daily was given to 39 and 38 of the patients, respectively. Endoscopy was performed before treatment and four weeks after cessation of therapy. The cumulative intention-to-treat (ITT) H. pylori-eradication rate was 66% (51/77) as compared to 89% (46/52) for the historical control (p < 0.05). The corresponding ulcer healing rates were 90% (69/77) and 92% (48/52). Primary metronidazole resistance (PMR) had escalated from 10% to 27% within 6 years resulting in eradication rates of 84% for sensitive and 19% for resistant strains (p < 0.001). PMR could be demonstrated in 45% of all female, but only in 17% of the male patients (p < 0.05). In the patients with H. pylori eradication, the ulcers healed in 98% (50/51) as compared to 73% (19/26) in those with persistent infection (p < 0.005). Analysis based on the presence of PMR showed ulcer healing rates of 95% (53/56) for sensitive and 76% (16/21) for resistant strains (p < 0.05). Improvement of pain also showed a significant correlation with successful eradication. H. pylori-eradication, healing and symptom relief were similar in the omeprazole 20 mg and 40 mg groups. The effect of amoxicillin plus metronidazole plus antisecretory agent on the eradication of H. pylori has decreased markedly during the past 6 years due to the escalation of PMR. Doubling of the omeprazole dose does not affect outcome. Cure of the infection as well as metronidazole susceptibility enhance duodenal ulcer healing and symptom relief. Acid suppression following a successful 1-week anti-HP therapy is not required for duodenal ulcer treatment.",1999.0,0,0
116,10521999,A three-day course of intravenous omeprazole plus antibiotics for H. pylori-positive bleeding duodenal ulcer.,B S Sheu; C H Chi; H B Yang; C M Jen; X Z Lin,"This prospective trial aimed to test the efficacy of 3-day intravenous omeprazole plus antibiotics for Helicobacter pylori (H. pylori) eradication rate, and to see whether individualized response to omeprazole in intragastric pH elevation will alter the success of eradication. One hundred and thirty-eight cases with H. pylori-positive duodenal ulcer bleeding were randomized into four therapy groups: Group 1 (n = 32) received a 3-day course of intravenous omeprazole (80 mg loading then 40 mg q 9 am & 9 pm) plus ampicillin/salbactum (1.5 gm i.v. loading then 750 mg q 9 am, 3 pm, & 9 pm); Group 2 (n = 35) followed protocol as for Group 1 except the antibiotics were metronidazole and erythromycin (both 500 mg i.v. q 9 am, 3 pm, & 9 pm). Group 3 (n = 31) followed protocol as for Group 1 and further added with erythromycin (both 500 mg i.v. q 9 am, 3 pm, & 9 pm). Group 4 served as a control group (n = 40) receiving oral dual therapy after leaving the emergency room (omeprazole 20 mg and amoxycillin 1 g bid x 2 weeks). In each case, three gastric biopsies were done for total histologic density of H. pylori (THPD) (range: 0-15) before, 1 day and 6 weeks after completion of therapy. Except for the control group, the 24-hour ambulatory intragastric pH meter (MIC Inc, Gastrograph Spark III, Swiss) was inserted as possible on the 2nd day of therapy. The 3-day intravenous regimens achieved high clearance rates of H. pylori (Group 1: 93.8%; Group 2: 93.9%; Group 3: 100%). The eradication rates of H. pylori in Groups 1-4 were 43.8%, 57.1%, 58.1%, and 72.8%, respectively. In Groups 1-3, the H. pylori-eradicated cases had lower pre-treatment THPD than non-eradicated cases (6.01 vs. 9.24, p < 0.001). Among 72 cases with pH meter insertion, the percentage of intragastric pH > 5.3 during 24-hour was not different among 35 H. pylori non-eradicated and 37 eradicated cases (78.7 vs. 76.7%, p > 0.05). The 3-day intravenous regimens may achieve clearance of H. pylori quickly. However, they were not so effective for eradication, especially in cases with higher bacterial loads. The interindividual response to omeprazole in intragastric pH elevation under the study dosage had insignificant variations to alter the success of eradication.",1999.0,0,0
117,10522000,,,,,0,0
118,10522368,"Gastrointestinal involvement in patients with diabetes mellitus: Part II (second of two parts). Diagnostic procedures, pharmacological and nonpharmacological therapy.",C Folwaczny; R Riepl; M Tschöp; R Landgraf,"Diagnostic work-up in patients with diabetes mellitus, in whom gastrointestinal involvement is suspected comprises the assessment of gastrointestinal transit times, endoscopy, esophageal pH-metry or manometry, sonography and lactulose- or glucose-H2-breath tests. Prokinetic agents such as metoclopramide, cisapride or erythromycin and substances like loperamide, octreotide or clonidine are used to improve gastrointestinal dysfunction. Furthermore, in recent trials which aimed for the modulation of gastrointestinal transit times, cholecystokinin, proteinase inhibitors or amylin were administered in patients with diabetes mellitus. Nonpharmacological interventions include pancreas and kidney transplantation, gastric pacemakers and biofeedback training.",1999.0,0,0
119,10523140,A prospective randomized comparative trial showing that omeprazole prevents rebleeding in patients with bleeding peptic ulcers after successful endoscopic therapy.,M Eloubeidi; D C Rockey,,1999.0,0,0
120,10527293,Clinical and economic assessment of the omeprazole test in patients with symptoms suggestive of gastroesophageal reflux disease.,R Fass; J J Ofman; I M Gralnek; C Johnson; E Camargo; R E Sampliner; M B Fennerty,"To evaluate the diagnostic accuracy of a trial of a high-dose proton pump inhibitor (the omeprazole test) in detecting gastroesophageal reflux disease (GERD) in patients with heartburn symptoms. A randomized, double-blind, placebo-controlled, crossover trial. Forty-three consecutive patients with symptoms suggestive of GERD were enrolled at a Veterans Affairs medical center. Symptom response to the omeprazole test vs placebo in GERD-positive and GERD-negative patients; sensitivity, specificity, and positive and negative predictive values of the omeprazole test; and cost per correct diagnosis achieved with the omeprazole test compared with traditional diagnostic strategies. Of 42 patients (98%) who completed the study, 35 (83%) were classified as GERD positive and 7 (17%) as GERD negative. Twenty-eight GERD-positive and 3 GERD-negative patients responded to the omeprazole test, providing a sensitivity of 80.0% (95% confidence interval, 66.7%-93.3%) and a specificity of 57.1% (95% confidence interval, 20.5%-93.8%). Economic analysis revealed that the omeprazole test saves $348 per average patient evaluated, and results in a 64% reduction in the number of upper endoscopies performed and a 53% reduction in the use of pH testing. The omeprazole test is sensitive and fairly specific for diagnosing GERD in patients with typical GERD symptoms. This strategy could result in significant cost savings and decreased use of invasive diagnostic tests.",1999.0,0,0
121,10533944,Helicobacter treatment with quadruple therapy in primary health care for patients with a history of ulcer disease.,J Y Lai; W J de Grauw; W A de Boer,"Few patients with a history of peptic ulcer are treated by their GP for H. pylori infection, even though theoretical evidence supports such an approach. We aimed to determine the validity of this recommendation and to test the feasibility of quadruple therapy in primary health care. In this prospective, non-randomized intervention study, 51 unselected patients with a history of proven ulcer disease received a 7-day quadruple therapy (lansoprazole, colloidal bismuth subcitrate, tetracycline and metronidazole) from their GP. Main outcome measures were: (i) endoscopically confirmed cure of the infection; (ii) results of serology at entry and at 6 months follow-up; (iii) quality of life at entry, at 6 weeks and at 6 months follow-up; (iv) gastric symptoms at entry, at 6 weeks and at 6 months follow-up; and (v) medication at entry and at 6 months follow-up. Quadruple therapy was well tolerated and there were no drop-outs with this regimen. Intention to treat cure rate was 48/51 (94%, 95% CI 87-100%), per protocol cure rate was 48/49 (98%, 95% CI 94-100%). 45/50 (90%) had positive serology at entry. IgG antibody titres decreased > 40% in 95.2% of patients. Quality of life improved significantly after treatment, gastric symptoms decreased and medication use decreased. GPs should be encouraged to identify patients with a history of ulcer disease and chronic use of acid suppressants and offer them treatment for H. pylori infection. This approach will cure the infection in almost all patients, it will improve the quality of life and decrease costs. Quadruple therapy does not lose efficacy when employed in primary care. Pre-treatment serological testing is potentially useful for narrowing down the treatment group to those with actual infection, and serology is promising as an easy and cheap follow-up instrument in primary health care.",1999.0,0,0
122,10540041,Review article: nonsteroidal anti-inflammatory drug-associated gastrointestinal complications--guidelines for prevention and treatment.,P Schoenfeld; M B Kimmey; J Scheiman; D Bjorkman; L Laine,"Chronic ingestion of NSAIDs increases the risk for gastrointestinal complications, which range from dyspepsia to gastrointestinal bleeding, obstruction, and perforation. Among patients using NSAIDs, 0.1 to 2.0% per year suffer serious gastrointestinal complications. Patients who require analgesic therapy should be carefully assessed for the lowest possible dosage and shortest duration of NSAID use and for the potential of treatment with a non-NSAID pain reliever. These patients should also be assessed for factors that increase their risk of gastrointestinal complications, including increased age, concomitant anticoagulant or corticosteroid use, and past history of NSAID-associated gastrointestinal complications. The exact association between Helicobacter pylori infection and NSAID-related ulcer disease is unclear, and the routine testing and treatment of all NSAID using patients for H. pylori infection is not recommended at this time. NSAID-using patients who suffer from dyspepsia should have NSAIDs discontinued, the dosage changed, or be changed to a different class of NSAID. If NSAIDs cannot be discontinued, then an antisecretory agent should be initiated. Misoprostol prevents NSAID-associated gastrointestinal complications. Proton pump inhibitors are the most effective at healing NSAID-associated ulcers among patients who cannot discontinue NSAID therapy.",1999.0,0,0
123,10540046,Helicobacter pylori treatment instead of maintenance therapy for peptic ulcer disease: the effectiveness of case-finding in general practice.,N J De Wit; A O Quartero; M E Numans,"Maintenance therapy with acid-inhibiting medication is common in general practice. Since the eradication of Helicobacter pylori has become the treatment of choice for peptic ulcer disease, H. pylori treatment could replace maintenance therapy in patients with an ulcer history. To determine the effectiveness of a full peptic ulcer disease history case-finding strategy, together with subsequent H. pylori testing and treatment, in discontinuing maintenance therapy. Patients were included from seven general practices, who had been using acid-inhibiting medication for more than 3 months in the period May 1996-May 1997. Patients with a history of proven peptic ulcer disease were tested, and treated with proton pump inhibitor-triple therapy if positive. Maintenance therapy was discontinued and restart within 12 months was monitored. Long-term acid suppression was used by 2.8% of the practice-populations. A peptic ulcer disease history was found in 18% of the patients, 73% of whom were offered the 'H. pylori test and treat' alternative. The majority responded: 92% of the H. pylori-infected patients were treated, 78% of whom successfully discontinued long-term medication. Implementing an 'H. pylori test and treat' strategy enabled one-third of the patients with a peptic ulcer disease history to stop maintenance therapy successfully. The strategy contributes to reduction of long-term drug use, but compliance needs improvement.",1999.0,0,0
124,10547167,Lack of effect of treatment for Helicobacter pylori on symptoms of nonulcer dyspepsia.,P D Greenberg; J P Cello,"Prior studies have yielded conflicting results on whether or not Helicobacter pylori causes nonulcer dyspepsia. We enrolled 100 consecutive patients with nonulcer dyspepsia into a randomized, double-blind, placebo-controlled trial. Patients with peptic ulcer disease, esophagitis, hepatobiliary disease, irritable bowel disease, or predominantly reflux-related symptoms were excluded by history and upper endoscopy. Helicobacter pylori infection was determined by biopsy and histologic examination. Serum H. pylori IgG antibodies and CagA status were determined by Western blot. Enrolled patients were randomized to a 14-day regimen of omeprazole (20 mg twice daily) and clarithromycin (500 mg three times daily) or placebo. Dyspeptic symptoms were assessed by use of a visual analog scale at baseline and at 1, 3, 6, and 12 months after treatment. Follow-up upper endoscopy with biopsy was performed 4 weeks after treatment. Compliance was measured by tablet counts. At 1 year, the change in dyspeptic symptoms was -24.0 (95% confidence interval, -69.0 to 21.0) in the omeprazole and clarithromycin group and -24.2 in the placebo group (95% confidence interval, -70.0 to 21.6). Furthermore, patients with persistent H. pylori infection demonstrated a greater, but not significant, improvement in symptoms (-40 +/- 144 [mean +/- SD], -65 +/- 142, -45 +/- 138, and -39 +/- 163) than those with successful eradication (-26 +/- 126, -26 +/- 148, -12 +/- 126, and -25 +/- 151) at months 1, 3, 6, and 12, respectively. Patients with nonulcer dyspepsia should not routinely be treated for H. pylori, since it is not a cause of this condition in most patients.",1999.0,0,0
125,10550087,Testing for Helicobacter pylori infection: validation and diagnostic yield of a near patient test in primary care.,A E Duggan; C Elliott; R F Logan,To evaluate the performance of a near patient test for Helicobacter pylori infection in primary care. Validation study performed within a randomised trial of four management strategies for dyspepsia. 43 general practices around Nottingham. 394 patients aged 18-70 years presenting with recent onset dyspepsia. Results of the FlexSure test compared with an enzyme linked immunosorbent assay (ELISA; HM-CAP) with an identical antigen profile and with results of an earlier validation study in secondary care. Diagnostic yield of patients undergoing endoscopy on the basis of their FlexSure result compared with those of patients referred directly for endoscopy. When used in primary care FlexSure test had a sensitivity and specificity of 67% (95% confidence interval 59% to 75%) and 98% (95% to 99%) compared with a sensitivity and specificity of 92% (87% to 97%) and 90% (83% to 97%) when used previously in secondary care. Of the H pylori test and refer group 14% (28/199) were found to have conditions for which H pylori eradication was appropriate compared with 23% (39/170) of the group referred directly for endoscopy. When used in primary care the sensitivity of the FlexSure test was significantly poorer than in secondary care. About a third of patients who would have benefited from H pylori eradication were not detected. Near patient tests need to be validated in primary care before they are incorporated into management policies for dyspepsia.,1999.0,0,0
126,10551440,Rabeprazole: a review of its use in acid-related gastrointestinal disorders.,H D Langtry; A Markham,"Rabeprazole is an inhibitor of the gastric proton pump. It causes dose-dependent inhibition of acid secretion and has a more rapid onset of action than omeprazole. Duodenal ulcers healed faster after treatment with rabeprazole 20 or 40 mg/day than placebo or ranitidine 150 mg 4 times daily and at a generally similar rate to omeprazole 20 mg/day in patients with duodenal ulcers; rabeprazole was similar or superior to these agents in relieving symptoms. Rabeprazole 20 and 40 mg/day healed gastric ulcers faster than placebo, and rabeprazole 20 mg/day healed ulcers at a similar healing rate, to omeprazole 20 mg/day in well controlled 6-week studies. Gastric ulcer symptom relief with rabeprazole was similar or superior to that provided by omeprazole or placebo. In 8-week studies in patients with gastro-oesophageal reflux disease (GERD), rabeprazole 10, 20 and 40 mg/day were more effective than placebo, rabeprazole 20 mg/day was more effective than ranitidine 150 mg twice daily, and rabeprazole 20 mg/day was similar in efficacy to omeprazole 20 mg/day. Symptom relief with rabeprazole in 8-week trials in patients with GERD was superior to that provided by placebo, and similar to ranitidine or omeprazole. Rabeprazole was similar to omeprazole and superior to placebo in both maintenance of healing and prevention of symptoms in patients with healed GERD in 1-year studies. One-week triple therapy with rabeprazole 20 mg twice daily plus 2 antibacterial agents achieved > or = 90% Helicobacter pylori eradication, but, as would be expected, a regimen of rabeprazole 20 mg twice daily plus 1 antibacterial agent was less successful. The drug was as effective as omeprazole and lansoprazole as part of triple therapy for H. pylori eradication. Rabeprazole successfully reduced acid output to target levels and prevented further pathological changes in 10 patients with Zollinger-Ellison syndrome. Usual dosages of rabeprazole are 20 mg/day for 4 weeks to treat duodenal ulcers, 6 weeks for gastric ulcers and 8 weeks for GERD, although some patients with duodenal ulcer may respond to a 10 mg/day dosage. For long term maintenance of GERD healing, 10 or 20 mg daily doses are adequate. Patients with hypersecretory states may need individualised dosages starting at 60 mg/day. The drug was well tolerated in clinical trials, with headache, rash, infection, diarrhoea and flu syndrome as the most common adverse events. In conclusion, rabeprazole appears to be a well tolerated proton pump inhibitor with a rapid onset of action and a low potential for drug interactions. The drug may be used to achieve healing and the relief of symptoms of duodenal ulcer, gastric ulcer and GERD, maintain GERD healing, and can form part of effective regimens to eradicate H. pylori.",1999.0,0,0
127,10555605,Review article: rabeprazole's tolerability profile in clinical trials.,B Thjodleifsson; I Cockburn,"Rabeprazole is a new member of a class of substituted benzimidazole drugs known as proton pump inhibitors. Comparative trials have demonstrated that it is at least as effective as omeprazole for the treatment of gastrooesophageal reflux disease (GERD), duodenal ulcers, or gastric ulcers. It is significantly more effective than histamine2-receptor antagonists for acid suppression, GERD healing and pain relief, and duodenal ulcer healing and pain relief. Adverse events reported during clinical trials provide an important indication of a medication's tolerability. We demonstrate that rabeprazole has a favourable adverse events profile. It is well tolerated in placebo-controlled studies and comparative trials with omeprazole and H2-receptor antagonists. Moreover, no dose adjustments are required for special populations, such as the elderly or patients with renal or mild-to-moderate hepatic disease. Adverse events data from clinical trials support the use of rabeprazole as a treatment for acid-related diseases.",1999.0,0,0
128,10555606,Review article: rabeprazole's profile in patients with gastrointestinal diseases.,T J Humphries; J Barth,"The selection of agents to treat patients with acid-related gastrointestinal diseases requires knowledge of their efficacy, tolerability, and ease of dosing among individuals with differing disease severities and other baseline characteristics. The efficacy and favourable benefit-risk profile of rabeprazole, a new proton pump inhibitor, has been demonstrated in controlled clinical trials of patients with gastro-oesophageal reflux disease (GERD), duodenal ulcers, and gastric ulcers. In comparative trials, rabeprazole is at least as effective as omeprazole for the treatment of GERD, duodenal ulcers, and gastric ulcers, and it is superior to histamine2-receptor antagonists for the treatment of GERD and duodenal ulcers. Its once-daily dosing regimen and low potential for interaction with drugs metabolized by the cytochrome P450 system make it a particularly attractive option for the treatment of acid-related diseases among older individuals. Rabeprazole is likely to be a valuable new addition to its class in treating patients with acid-related gastrointestinal diseases given its efficacy in acid suppression, high healing rates, rapid symptom relief, and convenient dosing.",1999.0,0,1
129,10558041,Cost effectiveness of Helicobacter pylori eradication therapies in patients with duodenal ulcer. An analysis of triple therapy versus two dual therapy alternatives.,G R Tennvall; A Norinder; B Ohlin,"Recent research has focused on eradication therapy as the principal treatment of patients with duodenal ulcers and Helicobacter pylori infection. The aim of this study was to analyse the cost effectiveness of triple therapy versus 2 dual therapies. A health economic evaluation of triple therapy with lansoprazole, amoxicillin and clarithromycin versus 2 dual therapies (lansoprazole or omeprazole, each with amoxicillin) in the eradication of Helicobacter pylori in patients with duodenal ulcers was performed in parallel with a randomised clinical trial. Direct and indirect costs were estimated for 1 year using data elicited from patient questionnaires and from the clinical trial. Despite the initial drug cost for triple therapy being 650 Swedish kronor (SEK; 1996 values) higher, the average total direct cost in this group was only SEK150 to SEK200 higher than in the dual therapy groups. This was a result of fewer outpatient visits and lower drug use after treatment failure in the triple therapy group. Triple therapy had a more favourable cost-effectiveness ratio than the dual therapies. In spite of higher initial antimicrobial costs, triple therapy with lansoprazole, amoxicillin and clarithromycin is more cost effective than dual therapy because of a higher eradication rate and greater symptom relief.",1999.0,0,0
130,10559084,"Gastroesophageal reflux in asthmatics: A double-blind, placebo-controlled crossover study with omeprazole.",T O Kiljander; E R Salomaa; E K Hietanen; E O Terho,"To investigate the prevalence of gastroesophageal reflux (GER) among patients with asthma and to determine the effect of omeprazole on the outcome of asthma in patients with GER. A double-blind, placebo-controlled crossover study. Asthmatic patients who attended the pulmonary outpatient clinic of Turku University Central Hospital, Finland. One hundred seven asthmatic patients. The patients who were found to have GER in ambulatory esophageal pH monitoring were randomized to receive either omeprazole, 40 mg qd, or placebo for 8 weeks. After a 2-week washout period, the patients were crossed over to the other treatment. Spirometry was performed at baseline and immediately after both treatment periods. Peak expiratory values, use of sympathomimetics, and pulmonary and gastric symptoms were recorded daily in a diary. Pathologic GER was found in 53% of the asthmatic patients. One third of these patients had no typical reflux symptoms. Daytime pulmonary symptoms did not improve significantly (p = 0.14), but a reduction in nighttime asthma symptoms (p = 0.04) was found during omeprazole treatment. In the patients with intrinsic asthma, there was a decline in [corrected] FEV(1) values (p = 0.049). Based on symptom scores, 35% of the patients were regarded as responders to 8-week omeprazole treatment. The reflux (time [percent] of pH < 4) was found to be more severe (p = 0. 002) in the responders. There is a high prevalence of GER in the asthmatic population. This reflux is often clinically ""silent."" After an 8-week omeprazole treatment, there was a reduction in nocturnal asthma symptoms, whereas daytime asthma outcome did not improve. There seems to be a subgroup of asthma patients who benefit from excessive antireflux therapy.",1999.0,0,0
131,10563537,The outcome of a 2-week treatment of Helicobacter pylori-positive duodenal ulcer with omeprazole-based antibiotic regimen in a region with high metronidazole resistance rate.,E O Adeyemi; M F Danial; T Helal; S Benedict; A M Abdulle,"Metronidazole resistance is a major problem in many developing countries. Our main objective was to study the outcome of a non-metronidazole and omeprazole-based antibiotic regimen in eradicating Helicobacter pylori in patients with duodenal ulcer. A prospective study of 50 consecutive patients with proven peptic ulcer (mean age 36.6 +/- 10.5 years, range 17-60, male:female = 2), referred from the primary health centres. The primary outcome of the study was H. pylori eradication, at least 4 weeks after stopping antibiotic treatment. Patients were considered eligible for the study if they had endoscopic evidence or a past medical history of peptic ulcer and had not received any antibiotics for at least 4 weeks prior to admission into the study. H. pylori infection was confirmed by serology, histology, a rapid urease test (RUT) and culture. After an initial oesophago-gastroduodenoscopy (OGD), each patient received a 2-week course of omeprazole (20 mg twice daily), and each of amoxycillin capsules (500 mg) and clarithromycin tablets (250 mg) thrice daily after food. The follow-up OGDs were performed after a mean period of 10.04 weeks (range 4-48) and at 10.4 +/- 2.5 months (range 6-14 months) after stopping treatment. All 50 patients completed the study. The sensitivity values for serology, RUT and histopathology were 98, 96 and 100%, respectively. H. pylori culture was positive in only 15 of 50 patients (30% sensitivity). H. pylori was eradicated in 47 (94%) patients. There was no evidence of H. pylori infection in the 27 of 35 (77%) patients, who returned for a third OGD. At the time of the second OGD, there was a significant reduction of pain-days (from 5.47 to 1.16), and antral (from 1.95 to 0.78) and corpus (from 1.8 to 0.6) mucosal cellular infiltrate scores, when compared with the first OGD (P < 0.001 in each case). Exclusion of metronidazole from the treatment regimen of patients with H. pylori-positive duodenal ulcer in a region with metronidazole resistance yielded an excellent H. pylori eradication rate of 94%, when omeprazole, amoxicillin and clarithromycin were used.",1999.0,0,0
132,10563540,Pantoprazole versus omeprazole: influence on meal-stimulated gastric acid secretion.,H G Dammann; F Burkhardt,"To determine the influence of recommended therapeutic doses of pantoprazole and omeprazole on meal-stimulated acid secretion. In this double-blind, placebo-controlled, three-period crossover study, 12 healthy male volunteers received 40 mg pantoprazole od, 20 mg omeprazole od or placebo at 08:00 h for 5 days in a randomized order. Meal-stimulated acid secretion was determined by means of a homogenized test meal, and intragastric titration on day 1, 4-6 h, 8-10 h, 16-18 h, and 24-26 h, and on days 3 and 5, 4-6 h after oral drug administration. On day 1 (4-6 h after oral drug administration), meal-stimulated acid secretion was decreased by 36% and 24% after administration of 40 mg pantoprazole or 20 mg omeprazole, respectively. After 3 and 5 days of dosing, the decreases were 88% and 85% with 40 mg pantoprazole, and 70% and 74% with 20 mg omeprazole. At all measuring points during the 5-day dosing periods, 40 mg pantoprazole proved superior to 20 mg omeprazole in inhibiting meal-stimulated gastric acid secretion. The differences were statistically significant for pantoprazole on day 1, 24-26 h after oral drug administration and on day 3 (P = 0.0425 and P = 0.0244, respectively). On day 1, only pantoprazole was significantly better than placebo (P = 0.0210, 4-6 h after dosing; P = 0.0093, 8-10 h after dosing and P = 0.0068, 16-18 h after dosing). Pantoprazole 40 mg is significantly more effective than omeprazole 20 mg in inhibiting meal-stimulated acid secretion. In addition, pantoprazole exhibits a more rapid onset of action.",1999.0,0,0
133,10566696,Accurately diagnosing and successfully treating chronic cough due to gastroesophageal reflux disease can be difficult.,R S Irwin; J K Zawacki,,1999.0,0,0
134,10566703,"A prospective evaluation of esophageal testing and a double-blind, randomized study of omeprazole in a diagnostic and therapeutic algorithm for chronic cough.",T M Ours; M S Kavuru; R J Schilz; J E Richter,"Recent studies suggest an association between chronic cough and gastroesophageal reflux. Our study aims were 1) to define the prevalence of acid reflux induced cough in the general community, 2) to examine the ability of esophageal testing to identify gastroesophageal reflux related cough, and 3) to assess the utility of omeprazole in a chronic cough algorithm. Patients with chronic cough of unknown etiology, who were mostly from the community, were evaluated. Subjects underwent a chest x-ray, methacholine challenge test, and empiric trial of postnasal drip therapy, and completed daily cough symptom diaries subjectively evaluating cough frequency and severity on a graded scale of 0-4 (combined maximum 8). After excluding other causes of cough, the remaining patients underwent esophageal and pH testing. Those testing positive were randomized to omeprazole 40 mg b.i.d. or placebo for 12 weeks. Follow-up was 1 yr. A total of 71 patients were screened; 48 were excluded. Twenty-three patients were evaluated for gastroesophageal reflux disease; six (26%) were eventually determined to have an acid-related cough. Of these patients, 17 had a positive pH test, six (35%) of whom showed a striking improvement or resolution of their cough during omeprazole treatment which was sustained for up to 1 yr. Six had a negative pH test, none of whom responded to omeprazole therapy. No significant differences were seen between responders (n = 6) and nonresponders (n = 11) for demographic factors, baseline symptom frequency and duration, or physiological parameters (motility/pH). Acid-related chronic cough was present in 26% (six of 23) of patients evaluated for gastroesophageal reflux disease. Esophageal testing does not reliably identify patients with acid induced chronic cough responsive to proton pump inhibitor therapy. We suggest that the best diagnostic and therapeutic approach, after excluding asthma and postnasal drip syndrome, is empiric treatment for 2 wk with a high dose proton pump inhibitor.",1999.0,0,1
135,10571603,Oesophageal motility defects associated with nocturnal gastro-oesophageal reflux on proton pump inhibitors.,Y M Fouad; P O Katz; D O Castell,"Recent studies from our laboratory reveal that 70% of patients with gastro-oesophageal reflux disease (GERD) on proton pump inhibitors twice daily (b.d.) have nocturnal gastric acid breakthrough (gastric pH < 4 > 1 h) which is often accompanied by oesophageal acid exposure. The pathogenesis of GER during gastric acid breakthrough is not clear. To determine the prevalence of oesophageal motility abnormalities in patients with nocturnal GER associated with nocturnal acid breakthrough on proton pump inhibitor b.d. We reviewed the pH-metry and manometric studies of 100 consecutive patients with GERD who were on proton pump inhibitor b.d. pH tracings were analysed for the nocturnal period (10.00 hours until 06.00 hours). Nocturnal GER was defined as> 0.5% time distal oesophageal pH < 4. Manometric tracings were reviewed for lower oesophageal sphincter (LES) pressure and oesophageal body motility. Chi-squared and Fischer's test were used for statistical analysis. Of the 100 patients, 74 (74%) had nocturnal gastric acid breakthrough. Thirty-one (42%) had concurrent abnormal nocturnal GER (refluxers) and 43 out of 74 (58%) had no GER (non-refluxers). The prevalence of ineffective oesophageal motility, and low LES pressure was significantly higher in refluxers than in non-refluxers (P < 0. 05, P < 0.001, respectively). Ineffective-oesophageal motility has a high specificity (91%), but low sensitivity (45%) as a diagnostic predictor for patients who are more likely to develop nocturnal GER on proton pump inhibitor b.d. Ineffective oesophageal motility is a risk factor for proton pump inhibitor refractory GER.",1999.0,0,1
136,10571605,Maintenance therapy with pantoprazole 20 mg prevents relapse of reflux oesophagitis.,J Escourrou; P Deprez; A Saggioro; H Geldof; R Fischer; C Maier,"Proton pump inhibitors can be effective as maintenance therapy in reducing the relapse rate of reflux oesophagitis at a dose lower than that used for acute healing. Patients (n=396, 18-88 years old) with healed reflux oesophagitis (grade II or III before healing) were included in this multinational, prospective, parallel-group, randomized double-blind study. They took oral pantoprazole 20 mg (n=203) or 40 mg (n=193), once daily for up to 12 months. Scheduled endoscopies were performed at entry, after 6 and 12 months, or when symptoms of at least moderate intensity were perceived on 3 consecutive days; symptoms were assessed every 3 months. The primary efficacy parameter was the time until endoscopically proven relapse of reflux oesophagitis occurred; the secondary parameters included tolerability, safety and time until symptomatic relapse occurred. Analysis was performed using the 'all-patients-treated' approach. Endoscopic relapse rates in the 20 mg group after 6 and 12 months were 16 and 29%, respectively; in the 40 mg group, they were 7 and 19%, respectively. Symptomatic relapse rates after 6 and 12 months were 14 and 21% in the 20 mg group and 10 and 17% in the 40 mg group, respectively. Pantoprazole 20 mg and 40 mg were well tolerated throughout the study; the type and frequency of adverse events reported were similar for both treatment groups. The 20 mg dose was proven to be 'at least equivalent' to the 40 mg dose with respect to endoscopic and symptomatic relapse. The 20 mg once daily dose represents an effective and safe maintenance regimen for the majority of patients with healed reflux oesophagitis.",1999.0,0,0
137,10571610,Eradication of Helicobacter pylori does not decrease the long-term use of acid-suppressive medication.,A C Tan; G D Hartog; C J Mulder,"Many patients are not symptom-free after eradication therapy for Helicobacter pylori and continue to use proton pump inhibitors or H2-receptor antagonists (H2-RAs). To ascertain whether a cohort of patients treated for H. pylori were still taking either proton pump inhibitors or H2-RAs more than 4 years after H. pylori eradication therapy. In 1993-94, a cohort of 167 patients were given eradication therapy for their H. pylori infection. By means of questionnaires to the patient, general practitioner and pharmacist we were able to retrieve data from 151 patients. The use (at the time of questionnaire) of proton pump inhibitors or H2-RAs was noted. Indications for eradication therapy were peptic ulcer disease: 28 patients (19%) or functional dyspepsia: 123 patients (82%). Mean time of follow-up was 1466 +/- 21 days. In this group, 77 patients (51%) still used acid-suppressive medication (proton pump inhibitors 44% and H2-RAs 7%) at the time of the survey (mean follow-up more than 4 years after eradication). In the group treated for peptic ulcer disease (n=28), only nine patients still used proton pump inhibitors or H2-RAs. In contrast, 68 patients who were treated for functional dyspepsia (total number 123) still used proton pump inhibitors or H2-RAs (55%) (P < 0.05). Even after successful H. pylori eradication, < 50% of patients stop acid-suppressive therapy. This contributes significantly to economic cost and raises doubts about the practice of routinely eradicating H. pylori in patients with functional dyspepsia. In contrast, the majority of peptic ulcer patients are able to stop acid-suppressive medication.",1999.0,0,0
138,10594396,Standard-dose lansoprazole is more effective than high-dose ranitidine in achieving endoscopic healing and symptom relief in patients with moderately severe reflux oesophagitis. The Dutch Lansoprazole Study Group.,J B Jansen; J C Van Oene,"In the treatment of reflux oesophagitis, H2-receptor antagonists are still widely used in spite of the apparent higher efficacy of proton pump inhibitors. In an attempt to compensate for the lower efficacy, H2-receptor antagonists are now increasingly being used at a higher dose. To assess whether or not standard-dose lansoprazole (30 mg o.d.) is more effective than high-dose ranitidine (300 mg b.d.) in moderately severe reflux oesophagitis (grades II-III). Lansoprazole or ranitidine was given to 133 patients for 4-8 weeks in a double-blind, randomized, parallel group, multicentre trial. The percentage of patients with endoscopically-verified healing was significantly higher on lansoprazole than on ranitidine both after 4 weeks (79% vs. 42%) and 8 weeks (91% vs. 66%), though smoking had a negative impact on oesophagitis healing with lansoprazole. Heartburn, retrosternal pain and belching improved significantly better with lansoprazole than with ranitidine, as did the patient-rated overall symptom severity. Relief of heartburn appeared somewhat faster with ranitidine, but was more pronounced with lansoprazole. The number of patients with adverse events was similar in both treatment groups. Standard-dose lansoprazole is better than high-dose ranitidine in moderately severe reflux oesophagitis.",1999.0,1,1
139,10594397,Complete resolution of heartburn symptoms and health-related quality of life in patients with gastro-oesophageal reflux disease.,D A Revicki; J A Crawley; M W Zodet; D S Levine; B O Joelsson,"Medical treatments for gastro-oesophageal reflux disease (GERD) vary in their ability to completely resolve heartburn and other symptoms. Although GERD reduces health-related quality of life (HRQL) little is known about the relationship between resolution of heartburn symptoms with medical therapy and HRQL. We evaluated the association between complete resolution of heartburn symptoms and functioning and well-being in three samples of patients with GERD. We analysed baseline and follow-up assessments of heartburn symptoms and HRQL scores from three clinical trials (total n=1351) comparing omeprazole and ranitidine for acute symptomatic treatment of GERD. Heartburn symptoms were measured using patient diaries and/or patient self-report. HRQL was assessed using the Psychological General Well-Being Index (PGWB) in all three clinical trials and the SF-36 Health Survey in two clinical trials. Resolution of heartburn symptoms was defined as no heartburn reported during the assessment period. We observed statistically significant differences favouring patients with no heartburn symptoms on the PGWB total score (P=0.018 to P < 0.0001) and anxiety (P=0.002 to P < 0.0001), general health (P=0.05 to P < 0. 0001), positive well-being (P=0.028 to P < 0.0001) and vitality (P=0. 05 to P < 0.0001) sub-scale scores at 4-14 weeks. Patients with no heartburn reported better SF-36 pain (P=0.005 to P < 0.0001) and general health perceptions (P=0.032 to P < 0.0001) compared with patients still experiencing heartburn symptoms at 4-24 weeks. SF-36 physical component summary scores were significantly better in patients with no heartburn symptoms compared with patients with heartburn symptoms at 4-24 weeks (P=0.013 to P=0.009), while mental component summary scores were only significantly different at 24 weeks (P=0.0005) in one of the two studies where the SF-36 was utilized. Complete resolution of heartburn symptoms was consistently associated with improvement in HRQL; the greatest impact was observed on measures of psychological well-being and physical functioning and well-being. Effective treatment of GERD that completely resolves heartburn results in clinically significant improvement in patient HRQL.",1999.0,0,0
140,10594400,"Omeprazole, clarithromycin and furazolidone for the eradication of Helicobacter pylori in patients with duodenal ulcer.",R Dani; D M Queiroz; M G Dias; J M Franco; L C Magalhães; G S Mendes; L S Moreira; L P De Castro; N H Toppa; G A Rocha; M M Cabral; P G Salles,"To evaluate the efficacy of omeprazole plus clarithromycin and furazolidone in Helicobacter pylori eradication and duodenal ulcer healing in Brazilian patients. Forty H. pylori-positive patients with duodenal ulcer were randomized to receive 20 mg omeprazole o.m. or b.d. for 1 month plus 500 mg clarithromycin (b.d. ) and 200 mg furazolidone (b.d.) for 1 week. Three months after the end of the treatment the eradication rates were 90% by intention-to-treat analysis, and 97% by per protocol analysis. Mild side-effects were observed in 25 patients, none of whom abandoned the protocol. No difference was observed between the 20 mg and 40 mg omeprazole daily doses. Cure or significant improvement of the symptoms and of the histological alterations were observed after H. pylori eradication. Our results demonstrate that clarithromycin and furazolidone in combination with omeprazole are a good alternative for H. pylori eradication in Brazilian patients with duodenal ulcer.",1999.0,0,0
141,10597390,"Quadruple therapy is effective for eradicating Helicobacter pylori after failure of triple proton-pump inhibitor-based therapy: a detailed, prospective analysis of 21 consecutive cases.",F Gomollón; J A Ducóns; M Ferrero; J García Cabezudo; R Guirao; M A Simón; M Montoro,"Data regarding the effectiveness of second-line treatment of Helicobacter pylori infection are limited, especially if microbiological studies are considered. We conducted a prospective, uncontrolled study of a consecutive series of 21 peptic ulcer patients with failure of 1-week lansoprazole, amoxicillin, and clarithromycin. H. pylori status was evaluated by urease test, histology, culture, and urea breath test. Susceptibility to amoxicillin, clarithromycin, and metronidazole was studied by E-test. Cure of infection was defined as negative results from endoscopy-based tests 1 month after treatment and negative results from a urea breath test at 2 months. Treatment consisted of a 1-week combination of lansoprazole (30 mg bid), tetracycline (500 mg qid), metronidazole (500 mg tid), and bismuth subcitrate (120 mg qid). H. pylori was resistant to metronidazole in three cases, to clarithromycin in three cases, and to both clarithromycin and metroinidazole in an additional three patients. No resistance to amoxicillin was found. Eradication was obtained in 20 cases (95.2% confidence interval [CI], 76.2-99.9). The only patient in whom infection was not eradicated harbored a metronidazole-resistant (minimum inhibitory concentration > 32 micrograms/ml) strain. No significant side effects were reported. Quadruple therapy obtains a high eradication rate even in patients with clarithromycin- and metronidazole-resistant strains. Further randomized and controlled studies are warranted and are urgently needed.",1999.0,0,0
142,10597397,Pantoprazole suppresses Helicobacter pylori without affecting cure.,R J Adamek; C Szymanski; B Pfaffenbach,"Short-term, low-dose triple regimens composed of proton-pump inhibitors (PPI) and two antibiotics are the current gold standard therapy for cure of Helicobacter pylori infection. To date, the effect of PPI pretreatment on eradication outcome is not known. The aim of this study was to evaluate the influence of pretreatment with pantoprazole on the efficacy of an ensuing triple therapy. In this open, randomized, monocenter, parallel group comparison, 107 patients with duodenal ulcer or functional dyspepsia were assigned to receive one of the following treatment regimens: a 7-day triple therapy with pantoprazole, 40 mg bid; clarithromycin, 250 mg bid; and metronidazole, 400 mg bid, which was either preceded or followed by a 7-day therapy with pantoprazole, 40 mg (P-PCM or PCM-P). Assessment of H. pylori status was performed by a biopsy urease test and 13C urea breath test at the initial visit and 13C urea breath test at all follow-up visits. The 7-day pantoprazole pretreatment resulted in a significant decline of the delta values of the 13C urea breath test. H. pylori infection was cured in 47 of 52 intention-to-treat patients of the P-PCM group (90%; 95% confidence interval, 79-97%) and in 46 of 53 of the PCM-P group (87%; 95% confidence interval, 75-95%). Pretreatment with pantoprazole suppresses H. pylori but does not impair the efficacy of a consecutive short-term, low-dose triple therapy.",1999.0,0,0
143,10599027,The effect of Helicobacter pylori eradication on duodenal gastric metaplasia.,A Uygun; A Kadayifci; M Demiriz; A Erdil; M Gulsen; S Baggi; N Karaeren; K Dagalp,"We investigated the incidence of duodenal gastric metaplasia and its response to Helicobacter pylori eradication in patients with duodenal ulcer or erosive duodenitis. Gastric and duodenal biopsies were taken from patients with endoscopically detected H. pylori positive duodenal ulcer or erosive duodenitis, and the presence and extent of duodenal gastric metaplasia was recorded. Patients were given omeprazole 20 mg twice daily for 2 weeks, and amoxicillin 1 g and clarithromycin 500 mg twice daily for 10 days, and then ranitidine for a further 8 weeks. Biopsies were repeated 6 months after the start of treatment. Duodenal gastric metaplasia was initially present in 22 patients (52%) and was more frequent in ulcer patients than in duodenitis patients, but not significantly so (69% versus 45%). After treatment, H. pylori was eradicated in 68% of duodenal gastric metaplasia patients and the duodenum was normal endoscopically in 85% of these patients. Duodenal gastric metaplasia was improved or eliminated in 12/15 H. pylori eradicators (80%) and in 5/7 H. pylori non-eradicators (71%), a non-significant difference. The improvement in duodenal gastric metaplasia appeared to be independent of H. pylori eradication.",1999.0,0,0
144,10611150,Increased prevalence of precancerous changes in relatives of gastric cancer patients: critical role of H. pylori.,E M El-Omar; K Oien; L S Murray; A El-Nujumi; A Wirz; D Gillen; C Williams; G Fullarton; K E McColl,"Helicobacter pylori is believed to predispose to gastric cancer by inducing gastric atrophy and hypochlorhydria. First-degree relatives of patients with gastric cancer have an increased risk of developing gastric cancer. The aim of this study was to determine the prevalence of atrophy and hypochlorhydria and their association with H. pylori infection in first-degree relatives of patients with gastric cancer. H. pylori status, gastric secretory function, and gastric histology were studied in 100 first-degree relatives of patients with noncardia gastric cancer and compared with those of controls with no family history of this cancer. Compared with healthy controls, relatives of patients with gastric cancer had a higher prevalence of hypochlorhydria (27% vs. 3%) but a similar prevalence of H. pylori infection (63% vs. 64%). Relatives of cancer patients also had a higher prevalence of atrophy (34%) than patients with nonulcer dyspepsia (5%) matched for H. pylori prevalence. Among the relatives of cancer patients, the prevalence of atrophy and hypochlorhydria was increased only in those with evidence of H. pylori infection, was greater in relatives of patients with familial cancer than in relatives of sporadic cancer index patients, and increased with age. Eradication of H. pylori infection produced resolution of the gastric inflammation in each subject and resolution of hypochlorhydria and atrophy in 50% of the subjects. Relatives of patients with gastric cancer have an increased prevalence of precancerous gastric abnormalities, but this increase is confined to those with H. pylori infection. Consequently, prophylactic eradication of the infection should be offered to such subjects.",1999.0,0,1
145,10612273,Prevention of the gastrointestinal adverse effects of nonsteroidal anti-inflammatory drugs: the role of proton pump inhibitors.,G J Brown; N D Yeomans,"The associations between nonsteroidal anti-inflammatory drugs (NSAIDs) and the presence and complications of gastroduodenal erosions and ulcers are well established. Evidence that acid aggravates NSAID-induced injury provides a rationale for minimising such damage by acid suppression. Other strategies discussed include avoidance of NSAIDs or minimising their dosage, selecting NSAIDs known to cause less damage, and co-prescription of various agents. Cytoprotection with misoprostol, a prostaglandin analogue, has been shown to be effective in reducing NSAID-related peptic ulcers and their complications. Unfortunately, adverse effects may limit compliance in some patients. Histamine H2 antagonists have only limited efficacy in the prevention of NSAID-induced ulcers in humans, particularly in the stomach, except at higher than standard dosages. This may relate to their relatively modest effect in elevating gastric pH, especially in comparison with proton pump inhibitors. Several studies now confirm the efficacy of proton pump inhibitors in the short and longer term prevention of NSAID-induced upper gastrointestinal injury. Placebo-controlled studies suggest reductions of over 70% in gastric and duodenal ulcer rates over 3 to 6 months. The recent ASTRONAUT (Acid Suppression Trial: Ranitidine versus Omeprazole for NSAID-Associated Ulcer Treatment) study documented the greater prophylactic efficacy of omeprazole over ranitidine at standard dosages for 6 months. The OMNIUM (Omeprazole versus Misoprostol for NSAID-Induced Ulcer Management) study showed omeprazole to be slightly more effective overall than misoprostol in preventing the upper gastrointestinal adverse effects of NSAIDs, with both substantially more effective than placebo, although misoprostol was somewhat less well tolerated. Although substantial reductions in NSAID ulceration are now achievable when co-therapy with a proton pump inhibitor is given, a few patients will still develop ulcers and their complications. Hence the judicious use of NSAIDs in the first instance cannot be overemphasised.",1999.0,0,0
146,10616770,Eradication of Helicobacter pylori using 30 mg or 60 mg lansoprazole combined with amoxicillin and metronidazole: one and two weeks of a new triple therapy.,K Nishikawa; T Sugiyama; J Ishizuka; T Kudo; Y Komatsu; M Katagiri; M Sukegawa; H Kagaya; M Kudo; M Kato; H Takeda; J Toyota; M Asaka,"A new triple therapy using a proton pump inhibitor and two antibiotics shows high efficiency against Helicobacter pylori infection. The aim of this study was to determine the optimal dose and duration of lansoprazole (LA) administration in combination with amoxicillin (AMPC) and metronidazole (MNZ). A total of 91 patients were enrolled in this study. They were divided into four groups: group A, 2 weeks of 30mg LA once daily, 500mg AMPC tid, and 250mg MNZ tid; group B, 2 weeks of 30mg LA bid, 500mg AMPC tid, and 250mg MNZ tid; group C, 1 week of 30mg LA once daily, 500mg AMPC tid, and 250mg MNZ tid; group D, 1 week of 30mg LA bid, 500mg AMPC tid, and 250mg MNZ tid. H. pylori status was determined by the rapid urease test, culture, histology, and 13C-urea breath test before and at least 4 weeks after the end of therapy. The cure rates in a per-protocol analysis and the incidence of adverse events in the evaluated patients were, respectively, 89.5% and 21.1% in group A, 100% and 20.0% in group B, 96.8% and 12.9% in group C, and 92.3% and 26.9% in group D. Most of the adverse events were tolerated. All four regimens in this study showed the same cure rates, and they were effective and well tolerated. One week of triple therapy using once-daily administration of 30mg LA is a good alternative.",2000.0,0,0
147,10616771,"Comparison of 1-week and 2-week triple therapy with omeprazole, amoxicillin, and clarithromycin in peptic ulcer patients with Helicobacter pylori infection: results of a randomized controlled trial.",K Kiyota; Y Habu; Y Sugano; H Inokuchi; S Mizuno; K Kimoto; K Kawai,"This study was a comparison of 1-week and 2-week triple therapies with omeprazole, amoxicillin, and clarithromycin (OAC) in patients with peptic ulcer disease and Helicobacter pylori infection. A total of 147 peptic ulcer patients with H. pylori infection assessed by histology and culture were randomly treated with omeprazole 20mg bid + amoxicillin 1000mg bid + clarithromycin 400mg bid for either 1 week (OAC1w) or 2 weeks (OAC2w). Both groups then received omeprazole 20mg daily for 2 weeks followed by ranitidine 300mg daily for 4 weeks. Eradication of H. pylori was assessed by histology, culture, and the 13C-urea breath test (13C-UBT) at least 6 weeks after cessation of antimicrobial therapy. Intention-to-treat eradication rates were 78.2% (95%CI 69%-87%) with OAC1w and 88.4% (95%CI 81%-96%) with OAC2w. Per-protocol eradication rates were 86.0% (95%CI 78%-94%) with OAC1w, 97.0% (95%CI 93%-100%) with OAC2w. There was no significant difference in the eradication rates between OAC1w and OAC2w. Side effects were mild and self-limiting in both groups. In conclusion, both 1- and 2-week triple therapy with OAC are well tolerated and provide good eradication rates in peptic ulcer patients in Japan. The eradication rate of the 2-week regimen was higher than that of the 1-week regimen, but the difference was not statistically significant. Further studies including long-term economic considerations are required to determine the optimal duration of treatment.",2000.0,0,0
148,10623364,Decision analysis of histamine H2-receptor antagonist maintenance therapy versus Helicobacter pylori eradication therapy: a randomised controlled trial in patients with continuing pain after duodenal ulcer.,M Tavakoli; A T Prach; M Malek; D Hopwood; B W Senior; F E Murray,"Much has been published on the efficacy and cost effectiveness of Helicobacter pylori eradication treatment as an alternative to histamine H2-receptor antagonist maintenance treatment in peptic ulcer disease. However, most studies have analysed and emphasised H. pylori eradication rates rather than management/control of symptoms and the associated cost savings. Although H. pylori eradication therapy is very successful in clearing the infection, dyspeptic symptoms may persist and management of these can be expensive. The aim of this study was to assess the cost implications in controlling symptoms using either H2-receptor antagonist maintenance therapy or H. pylori eradication therapy in patients with duodenal ulcer disease. This was a non-blind, prospective, randomised, parallel-group study comparing maintenance H2-receptor antagonist treatment using ranitidine with H. pylori eradication therapy, with a 1-year follow-up. This was a study of outpatients from general practices in Dundee, Scotland, or the Ninewells Hospital, Dundee, gastroenterology clinic. 119 patients with confirmed duodenal ulcer, free from active ulceration at study entry but positive for H. pylori infection, who were receiving maintenance H2-receptor antagonist therapy. Patients were randomised to receive either continuing maintenance therapy with ranitidine (initially 150 mg daily; 58 patients) or H. pylori eradication therapy using an omeprazole/amoxicillin/metronidazole regimen (or omeprazole/clarithromycin if allergic to penicillin). Overall, H. pylori eradication rates were 100% per protocol and 95.1% intention-to-treat. At completion of 1 year of follow-up, 12 of the 61 (19.7%) patients successfully eradicated of H. pylori were still dependent on acid suppression for symptom relief. H. pylori eradication treatment was the least-cost strategy in managing/controlling symptoms at 1 year (168 Pounds vs 210 Pounds per patient; 1996 values). However, over time, post-eradication treatment costs were greater than H2-receptor antagonist therapy costs. Any potential savings were directly related to the proportion of patients needing further treatment post-eradication, the cost of endoscopy and the urea breath test. If dyspepsia persists long term, H. pylori eradication treatment may not be the least-cost option for patients with duodenal ulcer.",2000.0,0,0
149,10624361,Non-steroidal anti-inflammatory drugs (NSAIDs) and gastro-intestinal toxicity: current issues.,A A Shah; D J Fitzgerald; F E Murray,"Non-steroidal anti-inflammatory drugs (NSAIDs) are among the most widely used drugs and their widespread use is associated with increased gastro-intestinal toxic effects such as ulceration, haemorrhage, perforation and death. They result in these complications mainly by reducing cytoprotective prostaglandins (PGE2 and PGI2) in the stomach, through the inhibition of cyclo-oxygenase (COX) enzyme. The increased morbidity and mortality, in addition to enormous cost, associated with NSAID-associated side effects, necessitates a need for safer GI-friendly NSAID. Various approaches have been used to counteract NSAID associated side effects with varying degrees of success and acceptance. These include the use of alternative analgesia, anti-acid secretory agents like proton pump inhibitors, sucralfate and prostaglandin analogues. In addition, new types of NSAIDs are being developed, based on new understanding of their mechanism of action and the pathogenesis of inflammation. These include a new class of NSAIDs called ""selective Cox-2 inhibitors"". These agents preserve the COX-1 that is responsible for the production of cytoprotective prostaglandins in the stomach and selectively inhibit COX-2 induced at the sites of inflammation. Selective COX-2 inhibitors exert the same analgesic and anti-inflammatory effects as the existing NSAIDs but may be less toxic to the stomach. In this review the background development and well-structured clinical trials on this new generation NSAIDs are discussed.",2000.0,0,0
150,10632645,Does eradication of Helicobacter pylori alone heal duodenal ulcers?,Z Z Ge; D Z Zhang; S D Xiao; Y Chen; Y B Hu,"Eradication of Helicobacter pylori infection prevents duodenal ulcer (DU) relapse, but it remains uncertain whether eradication of H. pylori alone heals duodenal ulceration. To test the hypothesis that eradication of H. pylori infection is accompanied by healing of duodenal ulcer. A total of 115 consecutive patients with endoscopically confirmed H. pylori-infected duodenal ulcer were randomly assigned to one of two groups. Group BTC patients received a 1-week course of colloidal bismuth subcitrate 220 mg b.d., tinidazole 500 mg b.d., clarithromycin 250 mg b.d. Group OBTC patients received omeprazole 20 mg daily for 4 weeks with the BTC regimen during the first week. Endoscopy with antral biopsies and 13C-urea breath test (UBT) were performed before and 4 weeks after completion of the 7-day triple or quadruple therapy. Eight patients dropped out (four in BTC and four in OBTC). Duodenal ulcer healing rates on an intention-to-treat basis in BTC and OBTC were 86% (95% CI: 77-95%) and 90% (95% CI: 82-98%), respectively. The eradication rates of H. pylori on an intention-to-treat basis in BTC and OBTC were 88% (95% CI: 79-96%) and 91% (95% CI: 84-99%), respectively. There were no statistically significant differences in ulcer healing rates and eradication rates between these two groups (P > 0.05). Epigastric pain resolved more rapidly in patients assigned to OBTC compared with those assigned to BTC. Both of the two regimens were well tolerated with only minor side-effects (3% of the 115 patients) and the compliance was good. BTC is a very effective H. pylori eradication regimen. Almost all duodenal ulcers heal spontaneously after cure of H. pylori infection using a 1-week low-dose bismuth-based triple therapy. Treating duodenal ulcer with simultaneous administration of omeprazole achieves ulcer pain relief more rapidly.",2000.0,0,0
151,10632647,"Pantoprazole, amoxycillin and either azithromycin or clarithromycin for eradication of Helicobacter pylori in duodenal ulcer.",A Vcev; D Stimac; A Ivandić; A Vceva; B Takac; D Pezerović,"Studies have shown that 1-week triple therapy consisting of a proton pump inhibitor, amoxycillin and clarithromycin may cure Helicobacter pylori infection in the majority of patients. To establish whether pantoprazole plus amoxycillin in association with either azithromycin or clarithromycin is useful in curing H. pylori infection in patients with a duodenal ulcer. One hundred and ten patients with active duodenal ulcers and H. pylori infection were treated with pantoprazole (days 1-7, 40 mg b.d.; days 8-28 40 mg o.d.) plus amoxycillin 1 g b.d. for the first 7 days. Patients were randomly assigned to receive either azithromycin 500 mg o.d. for the first 6 days (PAAz group; n=55) or clarithromycin 500 mg b.d. for the first 7 days of treatment (PAC group; n=55). H. pylori status was determined by urease test and histology before the treatment, and again 4 weeks after cessation of any medication. One hundred and three patients completed the study. H. pylori infection was eradicated in 78% (39/50) of patients in the PAAz group (ITT analysis: 71%, 95% CI: 61-83%) vs. 81% (43/53) of patients in the PAC group (ITT analysis: 78%, 95% CI: 69-90%) (N.S.). All ulcers had healed. Our study shows that 1-week triple therapy with pantoprazole, amoxycillin and either azithromycin or clarithromycin is not satisfactory (<80% ITT H. pylori eradication rate).",2000.0,0,0
152,10632650,,,,,0,0
153,10632651,Salvage therapies after failure of Helicobacter pylori eradication with ranitidine bismuth citrate-based therapies.,F K Chan; J J Sung; R Suen; J C Wu; T K Ling; S C Chung,"Salvage therapies after initial Helicobacter pylori eradication failure of ranitidine bismuth citrate (RBC)-based regimens remain undefined. To test the efficacy of 1-week omeprazole, amoxycillin and clarithromycin as a second-line treatment and 1-week quadruple therapy after repeated failures of RBC- and proton pump inhibitor-based regimens. Patients were recruited from a recently published prospective randomized study if confirmed to have failed H. pylori eradication with RBC-based regimens. They were given omeprazole 20 mg, amoxycillin 1 g and clarithromycin 500 mg (OAC) b.d. for 1 week. 13C-urea breath test was performed 4 weeks after the conclusion of medication. Those who failed to respond to OAC were given 1-week quadruple therapy (bismuth subcitrate 120 mg, tetracycline 500 mg and metronidazole 400 mg q.d.s. plus omeprazole 20 mg b.d.). Among 398 patients receiving RBC-based therapies, 40 (10%) had failed eradication (RAC=7, RC-2=12, RMC=7, and RMT=14). OAC was prescribed to 31 patients (RAC=4, RC-2=9, RMC=6, and RMT=12) and 68% had successful eradication. Nine out of 10 patients with failed second treatment received quadruple therapy; successful eradication occurred in 83% (5 out of 6) after repeated failures of clarithromycin-based regimens. One-week OAC is not an optimal second-line therapy when RBC-clarithromycin combinations fail. Quadruple therapy appears to be effective despite repeated failures of clarithromycin-based RBC or proton pump inhibitor therapies.",2000.0,0,0
154,10632652,"Omeprazole or ranitidine bismuth citrate triple therapy to treat Helicobacter pylori infection: a randomized, controlled trial in Vietnamese patients with duodenal ulcer.",H V Mao; B V Lak; T Long; N Q Chung; D M Thang; T V Hop; N N Chien; P Q Hoan; K S Henley; G I Perez-Perez; B A Connor; C D Stone; W D Chey,"To evaluate the effectiveness of triple therapy containing either omeprazole or ranitidine bismuth citrate (RBC) to treat H. pylori infection in Vietnamese duodenal ulcer patients. Patients infected with H. pylori were randomized to receive either omeprazole (20 mg b.d.), clarithromycin (500 mg b.d.) and amoxycillin (1 g b.d.) for 10 days (OAC), or RBC (400 mg b.d.), clarithromycin (500 mg b.d.) and amoxycillin (1 g b.d.) for 10 days (RAC). H. pylori eradication and ulcer healing was established by a follow-up oesophagogastroduodenoscopy (EGD) at least 4 weeks after therapy. Side-effects and compliance were assessed. One hundred and four out of 108 (96%) patients with a duodenal ulcer were infected with H. pylori. Eighty per cent of infected patients had detectable CagA IgG antibodies. Fifty-seven patients received OAC and 47 received RAC. OAC eradicated H. pylori in 91 and 86% of patients by per protocol (PP) and intention-to-treat (ITT) analysis, respectively. PP and ITT eradication rates for RAC were 96 and 91%. Ulcer healing at the follow-up EGD was 89% with OAC and 100% with RAC. Side-effects were minor. No patient failed to complete the protocol due to side-effects. Triple therapy with either omeprazole or RBC is highly effective in eradicating H. pylori and healing duodenal ulcer in Vietnamese patients.",2000.0,0,0
155,10632653,A retrospective study of the usefulness of acid secretory testing.,D C Metz; J A Starr,"Gastric analysis is useful for diagnosing and monitoring the control of hypersecretory conditions and to distinguish appropriate from inappropriate causes of hypergastrinaemia. Pentagastrin, used to measure maximal acid output (MAO), is no longer available in the USA. We examined the University of Pennsylvania Health System gastric analysis database, which includes demographic data, study indications, gastric analysis, and serum gastrin and secretin testing results according to referral indications, paying specific attention to discordant basal acid output (BAO) and MAO measurements. One hundred and twenty-four gastric analyses were performed in 103 patients (42 males, mean age 47.5 years, 14 with prior acid-decreasing surgery). Recurrent ulceration or pain unresponsive to antisecretory therapy was the indication in 42 patients. Twelve were hypersecretory, including three each with isolated elevations of BAO or MAO. Hypergastrinaemia was the indication in 35 patients. Five were hypersecretory (four with Zollinger-Ellison syndrome), three had isolated MAO elevations and 16 were hypo- or achlorhydric, indicating appropriate hypergastrinaemia. Of the seven patients with isolated MAO elevations, two had clear benefit from the stimulated portion of the study (four additional patients had equivocal benefit). Gastrin concentrations cannot be interpreted without knowledge of acid secretory capacity. MAO measurement has a small but significant benefit over measuring BAO alone.",2000.0,0,0
156,10636205,The efficacy of proton-pump inhibitors in acute ulcer bleeding: a qualitative review.,M Bustamante; N Stollman,"Despite remarkable progress in the treatment of chronic peptic ulcer disease, acute gastroduodenal ulcer hemorrhage remains a therapeutic challenge. Numerous trials of H-2 receptor antagonists have not consistently shown a significant benefit in such patients. Proton-pump inhibitors, which more profoundly suppress gastric acid, are being increasingly evaluated. We have performed a qualitative systematic review to analyze the results of these trials to determine if a reasonable consensus can be reached. We searched for all published, randomized, controlled studies that evaluated proton-pump inhibitors in patients with acute peptic ulcer hemorrhage. The primary outcomes evaluated were: (A) persistent or recurrent bleeding; (B) need for surgery; and (C) mortality. Sixteen trials were evaluated, enrolling 3154 patients. Four of the sixteen studies showed a statistically significant decrease in overall rebleeding rate, and two described specific benefit in patients with Type IIa and IIb endoscopic stigmata. Four studies also showed a significantly decreased surgery rate, but none demonstrated a significant mortality reduction. Proton-pump inhibitors may improve outcome in acute peptic ulcer bleeding, but the available clinical data remain inconsistent. Further study is necessary to define the optimal dosage, route of administration, duration of therapy, and subsets of patients most likely to benefit.",2000.0,0,0
157,10638560,Pantoprazole versus ranitidine in the treatment of duodenal ulcer: a multicenter study in Brazil.,U G Meneghelli; S Zaterka; L de Paula Castro; O Malafaia; L G Lyra,"The aim of this study was to compare the effectiveness and tolerance of pantoprazole versus ranitidine in the treatment of duodenal ulcers in the Brazilian population. A total of 222 patients with active duodenal ulcers (DU) were randomly allocated to a double dummy blind treatment, either with ranitidine (RAN) 300 mg (111, aged from 20-68 yr old, 56 female) or with pantoprazole (PANT) 40 mg (111 patients, 18-70 yr old, 45 female). After a 2-wk course of treatment, each patient was clinically and endoscopically assessed for ulcer healing. Failure to heal required a further 2-wk course of treatment and a new evaluation thereafter. In all, 77 of the 103 patients in the PANT group (74.8%) and 42 of the 94 patients in the RAN group (44.7%) who completed the study had ulcer healing after one 2-wk treatment course, and an additional 23 in the PANT group (22.3%) and 28 in the RAN group (29.8%) after the second 2-wk treatment course, totaling 100 (97.1%) and 70 (74.5%), respectively. Therapeutic gain in favor of pantoprazole was significant both at the end of the first and the second 2-wk treatment course (p<0.001). At 2 wk, symptoms remission was significantly higher in the PANT group (97.6%) than with the RAN group (77.5%) (p<0.001). The Intention-to-treat analysis showed results statistically similar to those observed in the per-protocol analysis. Minor adverse events were reported by four patients in the PANT group and three in the RAN group. No relevant laboratory abnormalities were seen. No patient withdrew from the study due to adverse events. Our results show that pantoprazole is more effective than ranitidine in the treatment of duodenal ulcer providing faster ulcer healing in most patients (97.1%), in 4 wk. Adverse events were rare and were similar in both groups, and had no influence on the therapeutic outcome.",2000.0,1,1
158,10644301,Proton pump inhibitors for Barrett's oesophagus.,G Triadafilopoulos,,2000.0,0,0
159,10651663,Comparison of lansoprazole-based triple and dual therapy for treatment of Helicobacter pylori-related duodenal ulcer: an Asian multicentre double-blind randomized placebo controlled study.,B C Wong; S D Xiao; F L Hu; S C Qian; N X Huang; Y Y Li; P J Hu; ; C Manan; L Lesmana; R E Carpio; J Y Perez; K M Fock; U Kachintorn; K Phornphutkul; P Kullavanijaya; J Ho; S K Lam,"[corrected] In Asian countries with limited resources, clarithromycin-based triple therapy may not be readily available. There are also few direct comparisons of different regimens in Asia. To compare two lansoprazole-based non-clarithromycin triple therapies and one dual therapy in a prospective double-blind placebo-controlled study of Helicobacter pylori eradication and duodenal ulcer healing. Fourteen centres in Asia participated in this study. Patients with acute duodenal ulcer who were H. pylori-positive were recruited. They were randomized to receive: (a) lansoprazole 30 mg b.d., amoxycillin 1 g b.d. and metronidazole 500 mg b.d. for 2 weeks (LAM-2 W), or (b) LAM for 1 week and placebo (LAM-1 W), or (c) lansoprazole 30 mg b.d., amoxycillin 1 g b.d. and placebo for 2 weeks (LA-2 W). Upper endoscopy was repeated at week 6 to check for duodenal ulcer healing. Symptoms and side-effects were recorded. A total of 228 patients were recruited, and two patients took less than 50% of the drugs. H. pylori eradication rates (intention-to-treat) were 68 out of 82 (83%) with LAM-2 W, 55 out of 71 (78%) with LAM-1 W and 43 out of 75 (57%) with LA-2 W. There were significant differences (P=0. 001) in eradication rates when comparing either LAM-2 W or LAM-1 W with LA-2 W. The eradication rate in patients with metronidazole resistant H. pylori strains were significantly lower than those with metronidazole sensitive strains (P=0.0001). The duodenal ulcer healing rates at week 6 were 85%, 85% and 72% in LAM-2 W, LAM-1 W and LA-2 W, respectively (P=0.065). Side-effects occurred in 13%, 11% and 9% in LAM-2 W, LAM-1 W and LA-2 W, respectively. H. pylori eradication and initial ulcer size were factors affecting duodenal ulcer healing. This Asian multicentre study showed that 1-week lansoprazole-based triple therapy without clarithromycin has similar efficacy in H. pylori eradication and ulcer healing compared with a 2-week regimen. Both triple therapies were significantly better than dual therapy in H. pylori eradication. Therefore, 1-week lansoprazole-based triple therapy is as safe and effective as 2-week therapy in eradication of H. pylori infection and healing of duodenal ulcer in these Asian centres.",2000.0,0,0
160,10651664,Triple therapy in the eradication of Helicobacter pylori in patients with duodenal ulcer disease: results of a multicentre study in South-East Asia. South-East Asia Multicenter Study Group.,K M Fock; P Chelvam; S G Lim,"The efficacy of proton pump inhibitor based triple therapy in patients from South-East Asia, where metronidazole resistance is reportedly high, has not been formally assessed in randomized, multicentre trials. To compare the eradication rates of Helicobacter pylori, ulcer healing rates and side-effects of three regimens of omeprazole triple therapy in patients with duodenal ulcer from South-East Asia and to study the impact of metronidazole resistance. A single blind, randomized parallel group, comparative multicentre study. A total of 246 patients from 15 centres in four South-East Asian countries were randomized to receive OAC (omeprazole 20 mg b.d., amoxycillin 1 g b. d., clarithromycin 500 mg b.d.), OAM (omeprazole 20 mg b.d., amoxycillin 1 g b.d., metronidazole 400 mg b.d.) or OMC (omeprazole 20 mg b.d., metronidazole 400 mg b.d., clarithromycin 500 mg b.d.) for 7 days. After triple therapy, the patients were further randomized to receive either omeprazole or placebo for 7 days. Upper gastrointestinal endoscopy was performed before treatment and 4 weeks after treatment. Biopsies for culture and for histopathological examination for H. pylori were taken from corpus and antrum before treatment and 4 weeks after treatment. The eradication rates were intention-to-treat/per protocol (95% CI): OAC 87% (79-94%)/94% (89-100%); OAM 80% (70-89%)/91% (83-98%); OMC 85% (77-93%)/94% (88-100%). The difference in eradication rates between the three groups was not statistically significant (P=0.419). Pre-treatment metronidazole resistance, was found in 34% of isolates and was a significant prognostic factor in patients receiving OAM (odds ratio 5.26) but not in patients receiving OAC or OMC. All three treatment regimens were safe, well tolerated and highly effective for eradication of H. pylori and ulcer healing. Pre-treatment metronidazole resistance reduced the efficacy of OAM but did not affect the efficacy of OMC.",2000.0,0,0
161,10653861,Randomized trial of omeprazole or ranitidine versus placebo in the prevention of chemotherapy-induced gastroduodenal injury.,S Sartori; L Trevisani; I Nielsen; D Tassinari; I Panzini; V Abbasciano,"Anticancer drugs may induce acute mucosal injury to stomach and duodenum. This study was planned to evaluate the efficacy of omeprazole or ranitidine in preventing such an injury. Two hundred twenty-eight cancer patients with normal stomach and duodenum or with less than three erosions, who were selected to be treated with cyclophosphamide, methotrexate, and fluorouracil (90 breast carcinoma patients) or fluorouracil alone (138 colon carcinoma patients), were randomly assigned to treatment with omeprazole 20 mg, ranitidine 300 mg, or one placebo tablet a day. Seven days after the second course of chemotherapy (CT), the patients underwent a further esophagogastroduodenoscopy to evaluate the mucosal injury. Endoscopic findings were quantified on the basis of an arbitrary score, and the occurrence of epigastric pain or heartburn was assessed weekly. A significant difference was found among the three groups (P =.0032), as well as between pre- and postCT endoscopic findings (P =.00001). Endoscopic scores after CT were significantly higher than pretreatment scores in the placebo (P =.003) and ranitidine (P =.003) groups but not in the omeprazole group (P =.354). Acute ulcers were significantly less frequent in patients receiving omeprazole or ranitidine than in those receiving placebo (P =.0001 and P =.0315, respectively). Epigastric pain and/or heartburn were significantly less frequent in patients receiving omeprazole (P =.00124) or ranitidine (P =.038) than in those receiving placebo. Omeprazole is effective in preventing chemotherapy-induced gastroduodenal injury. Ranitidine is effective in reducing the frequency of ulcers and upper gastrointestinal symptoms but is not effective in preventing the global endoscopic worsening caused by chemotherapy. The different efficacy of omeprazole and ranitidine can be explained by their different pharmacodynamics.",2000.0,0,0
162,10662395,Cost effectiveness of omeprazole and ranitidine in intermittent treatment of symptomatic gastro-oesophageal reflux disease.,N O Stålhammar; J Carlsson; R Peacock; S Müller-Lissner; M A Bigard; G B Porro; J Ponce; J Hosie; M Scott; D G Weir; C Fulton; K Gillon; K D Bardhan,"This 1-year study compared the cost effectiveness of omeprazole and ranitidine when used as initial therapy in an intermittent treatment strategy for the management of patients with symptomatic gastro-oesophageal reflux disease with or without erosive oesophagitis. A prospective health economic analysis was conducted alongside an international multicentre randomised, double-blind clinical study. The economic analysis was performed from a societal perspective. A total of 704 patients in the UK, the Republic of Ireland, Germany, France, Italy and Spain were randomised to 1 of the 3 treatment groups. Patients were randomised to receive either omeprazole 20 mg once daily, omeprazole 10 mg once daily or ranitidine 150 mg twice daily. Initial treatment failure resulted in dose titration and drug switching from ranitidine to omeprazole, and subsequently open maintenance treatment. The estimated mean direct medical costs (medication and number of visits and endoscopies) were found to be lower for both dosages of omeprazole than for ranitidine in all countries except Germany. However, none of the differences were statistically significant. The differences between omeprazole 10 mg and omeprazole 20 mg were small and nonsignificant. With regard to numbers of symptom-free days, both omeprazole 20 mg and omeprazole 10 mg were found to be more effective than ranitidine. However, none of the differences were statistically significant. Following a pragmatic interpretation, incorporating intermediate short term results, the results in this study give no support to the notion that a step-up approach, either as dose titration from omeprazole 10 mg to omeprazole 20 mg or as drug switching from ranitidine to omeprazole, will result in cost savings and thereby be cost effective.",2000.0,0,0
163,10665250,"Evaluation of omeprazole, lansoprazole, pantoprazole, and rabeprazole in the treatment of acid-related diseases.",L S Welage; R R Berardi,"To review the comparative efficacy and safety of the proton pump inhibitors (PPIs)--omeprazole, lansoprazole, pantoprazole, and rabeprazole--in the management of acid-related diseases. English-language journal articles retrieved from a MEDLINE search from 1990 to the present using these index terms: proton pump inhibitors, omeprazole, lansoprazole, pantoprazole, rebeprazole, and each of the acid-related diseases. Clinical trials and pertinent review articles that discussed the pharmacology, pharmacokinetics, efficacy, and safety of PPIs in the management of acid-related disease. By the authors. PPIs are substituted benzimidazoles that inhibit gastric acid secretion by covalently binding to the proton pump (H+/K+ ATPase). All undergo extensive hepatic metabolism and conjugation. The four agents differ in their metabolism by and effects on specific hepatic enzymes and thus in their ability to interact with other medications. PPIs are important agents used for eradicating Helicobacter pylori, in treating peptic ulcer disease, gastroesophageal reflux disease, Zollinger-Ellison syndrome, and upper gastrointestinal bleeding, and for preventing acid aspiration. Short-term side effects of the four agents are similar. The long-term safety of pantoprazole and rabeprazole appears similar to that of omeprazole and lansoprazole. Pantoprazole, which is in the final stages of approval for marketing in the United States, will be available in both an oral and injectable formulation. Based on superior efficacy profiles, PPIs are the drugs of choice in managing patients with peptic ulcer disease, gastroesophageal reflux disease, and Zollinger-Ellison syndrome. The decision to select one PPI versus another is most likely to be based on the agents' acquisition costs, formulations, FDA-labeled indications, and overall safety profiles. Intravenous or parenteral pantoprazole may become the preferred antisecretory agent for patients unable to take oral medications (e.g., critically ill patients and those with Zollinger-Ellison syndrome).",2000.0,0,0
164,10672050,Effect of Helicobacter pylori eradication on peptic ulcer disease complicated with outlet obstruction.,V Taskin; I Gurer; E Ozyilkan; M Sare; F Hilmioglu,"At present, the prevalence of Helicobacter pylori (H. pylori) in complicated peptic ulcer and the effect of H. pylori eradication on complicated peptic ulcer have not been fully established. In this study, we report the prevalence of H. pylori in peptic ulcer patients complicated with gastric outlet obstruction, effectiveness of oral eradication therapy on these patients, and their long-term follow up. Ten consecutive patients presenting with clinically and endoscopically significant obstructed peptic ulcers were included in this study. During each endoscopy, seven gastric biopsy specimens were obtained and analyzed for H. pylori colonization. The antral mucosal biopsy specimens were positive for H. pylori in nine patients. H. pylori infection was eradicated and complete ulcer healing was observed in all patients. The mean follow-up period was 14 (7-24) months. One patient had duodenal perforation and underwent surgical intervention following medical treatment, despite the eradication of H. pylori. Ulcer recurrence was noted in two (22.2%) of nine patients, and in one of them the recurrent ulcer was complicated with obstruction (11. 1%). The mean time to ulcer recurrence was 17 months (range, 10-24 months). The biopsies and CLOtests were H. pylori negative at the time of ulcer or erosion recurrence in two patients. We suggest that H. pylori eradication may improve the resolution in obstructive ulcer cases with colonization.",2000.0,0,0
165,10672051,"Eradication of H. pylori with pantoprazole, clarithromycin, and metronidazole in duodenal ulcer patients: a head-to-head comparison between two regimens of different duration.",H G Dammann; U R Fölsch; E G Hahn; D H von Kleist; H U Klör; T Kirchner; S Strobel; M Kist,"The study was conducted to compare the efficacy and tolerability of two pantoprazole-based triple therapies of different length in the eradication of H. pylori. In this double-blind, multicenter parallel group comparison, H. pylori-positive patients were randomly assigned to either the PCM-7 group (7 days of pantoprazole 40 mg bid, clarithromycin 500 mg bid, metronidazole 500 mg bid) or the PCM-14 m group (modified 14 day therapy of the same regimen with metronidazole only given for 10 days due to labeling reasons). H. pylori status was determined by urease test, histology, culture, and 13C-urea breath test. Treatment outcome was assessed 6 weeks after intake of the last study medication. The following eradication rates were achieved: for PCM-7 in the MITT population 83% (89/107), in the PP population 84% (81/97); for PCM-14 m in MITT 87% (92/106), in PP 88% (91/104). Ulcer healing rates were: for PCM-7 in MITT population 99% (106/107), in the PP population 99% (96/97); for PCM-14 m in MITT 99% (105/106), in PP 99% (103/104). Gastrointestinal symptoms and gastritis scores decreased in both treatment groups. Equivalence of treatment regimens could be proven for all populations. In total, 64 patients reported adverse events. Five serious adverse events occurred, all unrelated to the study medication. The two pantoprazole-based triple therapies tested in this study are equally effective in H. pylori eradication, ulcer healing and relief from ulcer pain. It is concluded that 7 days of triple therapy are generally sufficient.",2000.0,0,0
166,10672052,"Four-day, twice daily, quadruple therapy with amoxicillin, clarithromycin, tinidazole and omeprazole to cure Helicobacter pylori infection: a pilot study.",X Calvet; L Titó; R Comet; N García; R Campo; E Brullet,"The best regimen for the treatment of Helicobacter pylori infection has yet to be defined. Four-day quadruple therapy with tetracycline, metronidazole, bismuth, and a proton pump inhibitor has been shown to obtain a very high cure rate. However, the fact that it must be taken four times daily may interfere with compliance. The objective of the study was to test the efficacy and tolerability of a new 4-day therapy with 4 drugs taken every 12 hours to cure H. pylori infection. Patients and Methods. Fifty-six consecutive patients with peptic ulcer disease and H. pylori infection were treated with an oral 4-day course with omeprazole (20 mg/12 hours), clarithromycin (500 mg/12 hours), amoxicillin (1 g/12 hours) and tinidazole (500 mg/12 hours). Efficacy of the treatment was determined at least 2 months after therapy either by biopsy (in the case of gastric ulcer) or by 13C-urea breath test. A second breath test was performed at least 6 months after therapy. Two patients were lost to follow-up. Forty-nine of the remaining 54 patients were cured at the first control [intention-to-treat cure rate: 87.5% (CI 95% 75-94%); per protocol cure rate: 90.7% (CI 95% 81-98%)]. Forty-three of these 49 cured patients returned for a second 13C urea breath-test at 6-12 months. Two of them were not cured, giving a long-term cure rate of 85.5% per protocol and 73.2% by intention-to-treat. Compliance was good, although 25 patients had mild side effects. This particular four-day therapy is well tolerated, easy to follow, and achieves an acceptably high cure rate.",2000.0,0,0
167,10673291,Importance of Helicobacter pylori cagA and vacA status for the efficacy of antibiotic treatment.,L J van Doorn; P M Schneeberger; N Nouhan; A P Plaisier; W G Quint; W A de Boer,"Virulence factors of Helicobacter pylori are associated with peptic ulcer disease and may be also associated with the efficacy of treatment. To determine the relation between the vacA and the cagA status of H pylori, clinical disease, and treatment outcome. 121 patients with H pylori infection and peptic ulcer disease or functional dyspepsia were treated by quadruple antibiotic therapy in two groups for one and two days, respectively. DNA was isolated from gastric antral biopsy specimens, taken before and after treatment, and the vacA and cagA status was determined by polymerase chain reaction and reverse hybridisation. Peptic ulcer disease was significantly associated with the vacA s1 type, and cagA positivity, but not with the vacA m type. Treatment efficacy was significantly higher in patients with peptic ulcer disease, or infected with cagA+/vacA s1 strains. The strong association between the cagA and vacA status and peptic ulcer disease was confirmed. Cure rates seem to be higher for patients with cagA+/vacA s1 H pylori strains, which is consistent with the higher cure rate observed among ulcer patients compared with functional dyspepsia patients. Therefore, treatment studies may require stratification for presence of ulcers as well as H pylori genotypes.",2000.0,0,0
168,10674604,Eradication of Helicobacter pylori prevents recurrence of ulcer after simple closure of duodenal ulcer perforation: randomized controlled trial.,E K Ng; Y H Lam; J J Sung; M Y Yung; K F To; A C Chan; D W Lee; B K Law; J Y Lau; T K Ling; W Y Lau; S C Chung,"In this randomized trial, the authors sought to determine whether eradication of Helicobacter pylori could reduce the risk of ulcer recurrence after simple closure of perforated duodenal ulcer. Immediate acid-reduction surgery has been strongly advocated for perforated duodenal ulcers because of the high incidence of ulcer relapse after simple patch repair. Although H. pylori eradication is now the standard treatment of uncomplicated and bleeding peptic ulcers, its role in perforation remains controversial. Recently a high prevalence of H. pylori infection has been reported in patients with perforations of duodenal ulcer. It is unclear whether eradication of the bacterium confers prolonged ulcer remission after simple repair and hence obviates the need for an immediate definitive operation. Of 129 patients with perforated duodenal ulcers, 104 (81%) were shown to be infected by H. pylori. Ninety-nine H. pylori-positive patients were randomized to receive either a course of quadruple anti-helicobacter therapy or a 4-week course of omeprazole alone. Follow-up endoscopy was performed 8 weeks, 16 weeks (if the ulcer did not heal at 8 weeks), and 1 year after hospital discharge for surveillance of ulcer healing and determination of H. pylori status. The endpoints were initial ulcer healing and ulcer relapse rate after 1 year. Fifty-one patients were assigned to the anti-Helicobacter therapy and 48 to omeprazole alone. Nine patients did not undergo the first follow-up endoscopy. Of the 90 patients who did undergo follow-up endoscopy, 43 of the 44 patients in the anti-Helicobacter group and 8 of the 46 in the omeprazole alone group had H. pylori eradicated; initial ulcer healing rates were similar in the two groups (82% vs. 87%). After 1 year, ulcer relapse was significantly less common in patients treated with anti-Helicobacter therapy than in those who received omeprazole alone (4.8% vs. 38.1%). Eradication of H. pylori prevents ulcer recurrence in patients with H. pylori-associated perforated duodenal ulcers. Immediate acid-reduction surgery in the presence of generalized peritonitis is unnecessary.",2000.0,0,0
169,10674606,Gastroesophageal reflux disease in asthma: effects of medical and surgical antireflux therapy on asthma control.,D J Bowrey; J H Peters; T R DeMeester,"To critique the English-language reports describing the effects of medical and surgical antireflux therapy on respiratory symptoms and function in patients with asthma. The Medline computerized database (1959-1999) was searched, and all publications relating to both asthma and gastroesophageal reflux disease were retrieved. Seven of nine trials of histamine-receptor antagonists showed a treatment-related improvement in asthma symptoms, with half of the patients benefiting. Only one study identified a beneficial effect on objective measures of pulmonary function. Three of six trials of proton pump inhibitors documented improvement in asthma symptoms with treatment; benefit was seen in 25% of patients. Half of the studies reported improvement in pulmonary function, but the effect occurred in fewer than 15% of patients. In the one study that used optimal antisecretory therapy, asthma symptoms were improved in 67% of patients and pulmonary function was improved in 20%. Combined data from 5 pediatric and 14 adult studies of anti-reflux surgery indicated that almost 90% of children and 70% of adults had improvement in respiratory symptoms, with approximately one third experiencing improvements in objective measures of pulmonary function. Fundoplication has been consistently shown to ameliorate reflux-induced asthma; results are superior to the published results of antisecretory therapy. Optimal medical therapy may offer similar results, but large studies providing support for this assertion are lacking.",2000.0,0,0
170,10675237,Effect of laparoscopic fundoplication on gastroesophageal reflux disease-induced respiratory symptoms.,M G Patti; M Arcerito; A Tamburini; U Diener; C V Feo; B Safadi; P Fisichella; L W Way,"Laparoscopic fundoplication controls heartburn and regurgitation, but the effects on the respiratory symptoms of gastroesophageal reflux disease (GERD) are unclear. Confusion stems from difficulty preoperatively in determining whether cough or wheezing is actually caused by reflux when reflux is found on pH monitoring. To date, there is no proven way to pinpoint a cause-and-effect relationship. The goals of this study were to assess the following: (1) the value of pH monitoring in establishing a correlation between respiratory symptoms and reflux; (2) the predictive value of pH monitoring on the results of surgical treatment; and (3) the outcome of laparoscopic fundoplication on GERD-induced respiratory symptoms. Between October 1992 and October 1998, a total of 340 patients underwent laparoscopic fundoplication for GERD. From the clinical findings alone, respiratory symptoms were thought possibly to be caused by GERD in 39 patients (11%). These 39 patients had been symptomatic for an average of 134 months. They were all taking H2-blocking agents (21%) or proton pump inhibitors (79%). Seven patients (18%) were also being treated with bronchodilators, alone (3 patients) or in combination with prednisone (4 patients). Median length of postoperative follow-up was 28 months. In 23 patients (59%) a temporal correlation was found during 24-hour pH monitoring between respiratory symptoms and episodes of reflux. Postoperatively heartburn resolved in 91% of patients, regurgitation in 90% of patients, wheezing in 64% of patients, and cough in 74% of patients. Cough resolved in 19 (83%) of 23 patients in whom a correlation between cough and reflux was found during pH monitoring, but in only 8 (57%) of 14 of patients when this correlation was absent. Cough persisted postoperatively in the two patients who did not cough during the study. These data show that pH monitoring helped to establish a correlation between respiratory symptoms and reflux, and it helped to identify the patients most likely to benefit from antireflux surgery. Following laparoscopic surgery, respiratory symptoms resolved in 83% of patients when a temporal correlation between cough and reflux was found on pH monitoring; heartburn and regurgitation resolved in 90%.",2000.0,0,0
171,10677784,Treatments of peptic ulcer.,J H Baron,"From the late 19th century, Mount Sinai gastroenterologists declared their scepticism of the efficacy of all recommended treatments of peptic ulcer, and looked forward to trials which could distinguish between sequence and consequence, between association and causation. The rationale of all the early studies was to reduce gastric acidity, but it soon became clear that any neutralization by single doses of antacids was brief and ineffective. Winkelstein s demonstration that patients with duodenal ulcer had higher acidities not only before and after meals but also through the night hours led him to introduce a new treatment, the alkalinized intragastric milk drip together with atropine. One of the earliest controlled clinical trials at Mount Sinai compared different antacid regimes and showed that pH values above 3.5 were achieved in only about half of the patients on the various drips. When the new anticholinergic drugs were developed in the 1950s, they were found to produce sustained hypoacidity and were tried as maintenance treatment, as an alternative to acid-lowering operations. The third Mount Sinai approach was to attack the machinery of the acid-producing cell itself by an inhibitor of the enzyme producing hydrogen ions. In 1939, this enzyme had been thought to be carbonic anhydrase, but when Janowitz and Hollander tested its inhibitor, acetazolamide, and showed marked but very brief acid inhibition, they concluded that its action was too brief to be therapeutically useful. The problem was to be solved decades later by H2 receptor blockers from Britain and H+K+ATPase inhibitors from Sweden.",2000.0,0,0
172,10685738,Selection of patients for successful maintenance treatment of esophagitis with low-dose omeprazole: use of 24-hour gastric pH monitoring.,S D Ladas; P S Tassios; S A Raptis,"Treating patients with erosive esophagitis and maintaining remission in a cost-effective fashion is a desirable goal in clinical practice. There are no established criteria to identify patients with healed esophagitis who will subsequently remain in remission with low-dose omeprazole therapy. We investigated whether 24-h esophageal-gastric pH monitoring could provide criteria to select patients for low-dose omeprazole maintenance therapy. Seventy consecutive symptomatic outpatients with grade 2-3 reflux esophagitis were prospectively investigated. They were treated with 20 mg/day omeprazole for 2 months. Those with healed esophagitis were given alternate-evening 20-mg omeprazole maintenance therapy for 6 months. Clinical evaluation, endoscopy, and 24-h esophageal-gastric pH were done at the end of each treatment period. Results of pH studies of patients in remission were compared with those with endoscopically documented relapse of esophagitis. In 63/70 patient (intention-to-treat, 90%; 95% confidence interval [CI], 83-97%) esophagitis was healed at 2 months. During the 6-month maintenance period esophagitis remain healed in 28 (G1) (40%; 95% CI, 29-52%), but recurred in 32 patients (G2). During healing with omeprazole 20 mg/day the 24-h gastric pH was below 4 for <10% of the time in 96% of the patients, who subsequently remained in long-term remission with low-dose maintenance therapy (G1), but not in any patient with recurrence of esophagitis (G2). The 10% threshold value has a specificity of 1.00 and sensitivity of 0.96. The 24-h intragastric pH monitoring during 20 mg/day omeprazole therapy provides criteria by which to preselect patients with reflux esophagitis who will remain in remission with low-dose omeprazole therapy.",2000.0,0,0
173,10685739,,,,,0,0
174,10685740,"Prospective evaluation of the prevalence of gastric Helicobacter pylori infection in patients with GERD, Barrett's esophagus, Barrett's dysplasia, and Barrett's adenocarcinoma.",A P Weston; A S Badr; M Topalovski; R Cherian; A Dixon; R S Hassanein,"This study was undertaken to prospectively determine the prevalence of gastric H. pylori infection in Barrett's esophagus and Barrett's complicated by dysplasia or adenocarcinoma. The prevalence of H. pylori was determined in Barrett's esophagus patients compared to a control population of patients with gastroesophageal reflux disease (GERD) only. All patients had a minimum of 10 gastric surveillance biopsies obtained. H. pylori colonization was determined upon the basis of hematoxylin and eosin and use of a modified Giemsa and or Steiner's silver stain of all gastric biopsy specimens. Two hundred and eighty-nine Barrett's patients and 217 GERD control patients were included in the study. H. pylori was found in 95/289 (32.9%) of the Barrett's patients, compared with 96/217 (44.2%) of the GERD controls (NS). Forty-seven of the Barrett's patients had low-grade dysplasia/indefinite dysplasia, 14 high-grade dysplasia, and 20 Barrett's adenocarcinoma. When Barrett's was subgrouped according to absence of dysplasia, and presence of low-grade dysplasia, high-grade dysplasia, or adenocarcinoma, H. pylori prevalence was found to be significantly less for patients with Barrett's high-grade dysplasia (14.3%) and adenocarcinoma (15.0%) versus patients with GERD alone (44.2%), Barrett's alone (35.1%), or Barrett's with low-grade dysplasia (36.2%) (p = 0.016). This difference could not be explained by differences between Barrett's esophagus patients infected with H. pylori and those who were not with respect to gender, smoking history, alcohol consumption, use of proton pump inhibitor, or length of Barrett's mucosa. Barrett's high-grade dysplasia and adenocarcinoma are significantly more prevalent in patients who are not infected with H. pylori. H. pylori appears to have a protective effect against the development of Barrett's adenocarcinoma.",2000.0,0,0
175,10690622,Introduction of proton pump inhibitors--consequences for surgical treatment of peptic ulcer.,C Tonus; E Weisenfeld; P Appel; H Nier,"This retrospective study analyzes the influence of different factors on morbidity and mortality after surgical treatment of peptic ulcer. At the Municipal Hospital of Offenbach, Germany, from 1985-1996, 485 patients underwent surgery. Of the 485 patients, 70.7% (343) were diagnosed to have duodenal ulcer and 29.2% (142) had suffered from gastric ulcer. During this period, 79.2% (384) of the operations were performed under emergency conditions because of acute complications (56% of these with perforation, 20% with penetration, 24% with ulcer bleeding), whereas the rest was done electively. Two hundred and ninety-one (60%) patients were male, the average age was 59 years and 71.7% (348) of the patients had certain concomitant diseases. We observed complications in 48% of the cases with a total postoperative mortality of 21%. Between 1985 and 1996 the total number of ulcer surgeries performed at the Municipal Hospital Offenbach per year has stayed almost constant. However, a definite increase of acute operations in addition to a decrease of elective interventions was noticed. The dissatisfying results of surgical treatment of peptic ulcer after the introduction of proton pump inhibitors seems to be the consequence of the negative selection of patients mentioned above. A connection could be proved between the age and condition of the patient, the type of the surgical intervention (acute or elective) and the morbidity and mortality after the surgery.",2000.0,0,0
176,10692734,Does the eradication of Helicobacter pylori cure duodenal ulcer disease in communities with a high prevalence rate? Comparison with long-term acid suppression.,Y Kepekci; A Kadayifci,"The long-term effect of Helicobacter pylori eradication on the natural history of duodenal ulcer has been investigated and compared with long-term acid suppression treatment in an endemic community for infection. Seventy-three patients with endoscopically verified H. pylori positive active duodenal ulcer disease were included in this prospective study. Patients were divided into two groups. Group A patients (n = 39) were given an omeprazole-based triple eradication regimen, while group B patients (n = 34) were given omeprazole alone followed by long-term famotidine 20 mg daily as maintenance treatment. A control endoscopy was performed at the third month of treatment. The bacterium was eradicated in 32 (82%) of group A patients. All patients were followed up for two years and an endoscopy performed at the end of each year. H. pylori recurred in 13 patients and the reinfection rate was 44.8% over two years. Duodenal ulcer recurred in seven of these patients at two years (24.1%). There was a close association between H. pylori reinfection and ulcer relapse. Group B patients remained H. pylori positive during the study and the ulcer recurred in five of these patients (6.6%) despite continuous famotidine treatment. There was no statistically significant difference in ulcer relapse rate between the groups. These results suggested that H. pylori eradication is not an absolute solution for duodenal ulcer disease in high endemic regions and continuous maintenance treatment with H2-receptor antagonists is still an alternative approach in some chronic recurrent cases.",2000.0,0,0
177,10695007,Peptic strictures of the esophagus.,J E Richter,"Peptic esophageal strictures occur in the context of inadequately treated gastroesophageal reflux, especially in elderly patients. Studies show more pronounced abnormalities of esophageal function resulting in an increased number of prolonged reflux episodes. The diagnosis is best made by a combination of barium esophagram and endoscopy. Patients usually require esophageal dilation to relieve dysphagia followed by adequate medical therapy. Proton pump inhibitors are effective for preventing the recurrence of strictures after dilation. In young patients and patients with strictures that are difficult to dilate or need frequent dilations, surgery may be required; however, results can be disappointing.",2000.0,0,0
178,10695008,,,,,0,0
179,10695012,Helicobacter pylori and gastroesophageal reflux disease.,D C Metz; J A Kroser,The nature of the relationship between Helicobacter pylori (Hp) infection and gastroesophageal reflux disease (GERD) remains unclear. This article reviews the current body of knowledge regarding the association between these two common entities. The authors examine the potential interactions of Hp and GERD from epidemiologic and pathophysiologic viewpoints and summarize and critique the prevalence and eradication studies that have been performed to date. Special consideration is given to the possible effects that long-term use of proton pump inhibitors may have on Hp gastritis.,2000.0,0,0
180,10696837,Reflux disease and Barrett's esophagus.,H Koop,"Gastroesophageal reflux disease (GERD) is still an important clinical problem. Continuing efforts are being made to establish a classification of the condition that would allow improved communications for both clinical and research purposes. In medical treatment, the trends are toward proton-pump inhibitor therapy at all stages of GERD, calling into question the role of endoscopy for tailoring individual therapy. Arguments against the use of H. pylori eradication therapy in GERD have gained importance. Surgeons are continuing to report excellent results with fundoplication, but careful studies are needed to prove whether antireflux surgery is really capable of saving costs, as its proponents claim. Barrett's esophagus is still a topic of lively interest. Since there is no method of primary prevention, endoscopy has a crucial role in detecting affected patients and guiding them toward one of the various surveillance strategies--which are not yet clearly established. The debate over short-segment Barrett's esophagus, and especially over ""microscopic"" Barrett's esophagus (at the squamocolumnar junction), has not yet been resolved. However, there is now less doubt that GERD is a condition associated with a substantially higher risk for the development of esophageal adenocarcinoma. Given this risk of malignant transformation, there is continuing competition between different ablation techniques; however, careful data from much larger populations will be needed before ablation reaches the stage of broad clinical application. Until specific guidelines become available, patients with Barrett's esophagus should receive endoscopic follow-up until it can be ascertained which individuals are at risk for cancer and require ablation of Barrett's mucosa.",2000.0,0,0
181,10696838,Ulcers and gastritis.,G N Tytgat,"Once again this year, developments in the field of ulcers and gastritis have been entirely dominated by findings relating to Helicobacter pylori. However, interest in H. pylori can be expected to decline, since the prevalence of the infection is rapidly decreasing in the developing world - to the point that many gastroduodenal ulcers are now unrelated to H. pylori A further reason for declining interest is disappointment regarding the role of H. pylori in dyspepsia. The expected reduction in the endoscopic workload produced by screening for H. pylori or cagA positivity has so far not occurred. The exact role of the damage caused by nonsteroidal anti-inflammatory drugs in H. pylori-infected stomachs remains controversial. Equally controversial is the magnitude of the increased reflux symptomatology and reflux disease observed after H. pylori infection has been cured in patients with ulcer disease. Eradication therapy is largely dominated by proton-pump inhibitor triple therapies, although the efficacy of these is declining. Bismuth triple therapy and quadruple therapy continue to be valid alternatives.",2000.0,0,0
182,10705625,Pantoprazole versus omeprazole in the treatment of reflux esophagitis.,A Vcev; D Stimac; A Vceva; B Takac; A Ivandić; D Pezerović; D Horvat; P Nedić; Z Kotromanović; Z Maksimović; Z Vranjes; J Males; D Jurisić-Orzen; I Vladika; T Stimac; B Mandić,"Pantoprazole is a new proton pump inhibitor with a potent antisecretory activity, well defined pharmacokinetics and safety profile. The aim of this single blind, randomized clinical trial was to compare the efficacy of pantoprazole (PAN) 40 mg/day and omeprazole (OME) 20 mg/day in patients with grade I and II GERD (Savary-Miller classification). A total of 120 patients were included (PAN = 60 and OME = 60). In the per protocol/analysis, healing rates at 4 weeks were 76.3% PAN and 71.2% OME (ns), and at 8 weeks 94.7% PAN and 92.9% OME (ns). In the intention to treat analysis, healing rates at 4 weeks were 75% PAN and 70% OME (ns), and at 8 weeks 90% PAN and 86.6% OME (ns). Both pantoprazole and omeprazole were well tolerated with no serious drug related adverse events. Pantoprazole 40 mg/day was found to be safe and effective therapy comparable to omeprazole 20 mg/day in the short-term treatment for reflux esophagitis (grade I and II).",2000.0,0,0
183,10709160,"Lack of interaction between lansoprazole and propranolol, a pharmacokinetic and safety assessment.",M D Karol; C S Locke; J H Cavanaugh,"Due to the prevalence of both gastrointestinal and cardiovascular diseases, it is likely that patients may be coprescribed gastric parietal cell proton pump inhibitors and beta-adrenergic antagonists. Therefore, the objectives of this phase I study were to assess the potential effects of the coadministration of lansoprazole on the pharmacokinetics of propranolol and to evaluate the safety of propranolol with concomitant lansoprazole dosing. In a double-blind fashion, 18 healthy male nonsmokers were initially randomized to receive either 60 mg oral lansoprazole, each morning for 7 days, or an identical placebo (period 1). On day 7, all subjects were concomitantly administered oral propranolol, 80 mg. After a minimum of 1 week following the last dose of either lansoprazole or placebo, subjects were crossed over to the opposite treatment for another 7 days (period 2). Subjects were again administered oral propranolol on day 7. During both treatment periods, blood samples for the determination of plasma propranolol and 4-hydroxy-propranolol were obtained just before the dose and at 0.5, 1, 2, 3, 4, 6, 8 12, 16, 20, and 24 hours postdose. Plasma propranolol and 4-hydroxy-propranolol concentrations were determined by using HPLC with fluorescence detection. The Cmax, tmax, AUC0-infinity, and t1/2 values for propranolol, as well as the AUC0-infinity for 4-hydroxy-propranolol, were calculated and compared between the lansoprazole and placebo regimens. The mean age of the 15 subjects who successfully completed the study was 31 years (range: 24-38 years), and their average weight was 174.8 pounds (range: 145-203 pounds). There were no statistically significant differences between the lansoprazole and placebo regimens for the propranolol Cmax, tmax, AUC0-infinity, and t1/2 values. Also, there were no statistically significant differences between regimens for the 4-OH-propranolol AUC0-infinity. Safety evaluations, which included adverse events, vital signs, clinical laboratory determinations, ECG, and physical examinations, revealed no unexpected clinically significant findings and did not suggest a drug-drug interaction. In conclusion, lansoprazole does not significantly alter the pharmacokinetics of propranolol, suggesting that it does not interact with the CYP2D6- or CYP2C19-mediated metabolism of propranolol. Modification of a propranolol dosage regimen in the presence of lansoprazole is not indicated, based on the pharmacokinetic analysis and the lack of a clinically significant alteration in the pharmacodynamic response.",2000.0,0,1
184,10709423,One week triple therapy for Helicobacter pylori associated duodenal ulcer disease.,W Luman; K L Ling; H S Ng,"Eradication of Helicobacter pylori (H. pylori) cures and prevents the relapse of duodenal ulceration. Different treatment regimes for the eradication of H. pylori have been used and the most successful eradication regimens have been one week treatments with a proton pump inhibitor and two antibiotics. To examine the eradication rate of H. pylori with a one week regimen consisting of OCT (Omeprazole 20 mg BD, Clarithromycin 250 mg BD, Tinidazole 500 mg BD). This treatment regimen has been used for H. pylori eradication in our department since the end of 1996. Patients diagnosed to have duodenal ulcer in 1997 were retrospectively reviewed. Infection with H. pylori must be documented either by gastric biopsy or by a positive CLO test. Eradication of H. pylori was confirmed by negative 14C urea breath test or by histology at least four weeks after cessation of therapy. The review was performed on 251 patients. There were 177 males, 74 females. The median age was 51 (18-77) years. H. pylori infection was confirmed by CLO test in 170 patients and by histology in 72 patients. Thirty patients did not undergo further investigation after therapy to confirm the eradication. Of the remaining 221 patients, H. pylori was successfully eradicated in 198 patients (89.6%) as confirmed by 14C urea breath test (190 patients) or repeat gastroscopy and gastric biopsy (31 patients). There were no serious adverse events documented. Our retrospective study showed that the one week regimen used in our department is effective for the eradication of H. pylon in nearly 90% of infected cases.",2000.0,0,0
185,10710049,Oral and intravenous dosage forms of pantoprazole are equivalent in their ability to suppress gastric acid secretion in patients with gastroesophageal reflux disease.,D C Metz; V Pratha; P Martin; J Paul; P N Maton; E Lew; J R Pisegna,"The aim of this study was to assess the ability of pantoprazole to maintain gastric acid suppression in patients with gastroesophageal reflux disease who are switched from an oral (p.o.) to an intravenous (i.v.) dosage form. A total of 65 patients with gastroesophageal reflux disease were administered either 40 or 20 mg of p.o. pantoprazole daily for 10 days, then were switched to either a matching dose of i.v. pantoprazole or to placebo for 7 days. Acid output (basal and maximal) was measured at the end of the p.o. treatment period and on the first and last days of i.v. therapy. In the primary efficacy analysis, the acid output values at the end of the p.o. pantoprazole treatment were compared with those at the end of the i.v. treatment. Safety was monitored by periodic vital sign measurements, clinical laboratory evaluations, ophthalmic examinations, electrocardiograms, and reports of adverse events. The data were tested by an analysis of covariance and by Wilcoxon signed rank and t tests. Maximal acid output (mean +/- SD) in the 40 mg and 20 mg pantoprazole group after p.o. treatment was 6.5 +/- 5.6 mEq/h and 14.5 +/- 15.5 mEq/h, respectively; whereas, at the end of the i.v. treatment period, the values were 6.6 +/- 6.3 mEq/h and 11.1 +/- 10.2 mEq/h, respectively. In patients given i.v. placebo, acid output was significantly (p < 0.05) increased to 29.2 +/- 13.0 mEq/h by day 7. Both p.o. and i.v. pantoprazole dosage forms had similar favorable safety and tolerability profiles. The p.o. and i.v. formulations of pantoprazole (40 and 20 mg) are equivalent in their ability to suppress gastric acid output. The i.v. form of pantoprazole offers an alternative for gastroesophageal reflux disease patients who are unable to take the p.o. formulation.",2000.0,0,0
186,10711918,Eradication of Helicobacter pylori and non-ulcer dyspepsia.,J Danesh; R E Pounder,,2000.0,0,0
187,10724795,Economic evaluation of long-term management strategies for erosive oesophagitis.,R Goeree; B O'Brien; R Hunt; G Blackhouse; A Willan; J Watson,"To compare the expected costs and outcomes of alternative strategies for the management of patients with erosive oesophagitis. There were 3 components to the overall analytic approach. First, a decision model was constructed to compare expected costs and outcomes of 6 management strategies. Second, principles of quantitative literature review and meta-analysis were used to determine probabilities of clinical events (i.e. oesophagitis healing and recurrence). Finally, principles of cost-effectiveness analysis were used to compare treatment alternatives in terms of dominance and incremental cost effectiveness. The viewpoint for the study was that of a provincial government payer for healthcare over a 1-year period. Healing rates were significantly higher for proton pump inhibitors (PPI) [p < 0.001]. Recurrence rates were significantly higher for intermittent therapy (placebo) and lower for regular dose PPI (p < 0.001). Maintenance prokinetic agent (PA) is dominated (i.e. more costly and less effective) and step-down maintenance PPI is dominated through principles of extended dominance. The 'efficient frontier' is represented by: maintenance H2-receptor antagonist (H2RA), intermittent PPI, step-down maintenance H2RA and maintenance PPI. The price of H2RA is a key factor influencing whether step-down maintenance PPI forms part of, or is contained within, the 'efficient frontier' of long term management for erosive oesophagitis.",2000.0,0,1
188,10729734,Empirical trials in treatment of gastroesophageal reflux disease.,R Fass,"The assortment of diagnostic tests that are currently available for detecting gastroesophageal reflux disease (GERD) are invasive, costly and not readily available to community-based physicians. In contrast, a short course of high-dose proton pump inhibitor (PPI) as an empirical trial is an attractive alternative. This simple diagnostic test has been demonstrated to be accurate and cost-effective in patients with symptoms suggestive of GERD and those with noncardiac chest pain. Early studies in patients with extraesophageal manifestations of GERD have yielded promising results. Cost assessment of the PPI empirical trial revealed significant cost savings, mainly due to a marked decrease in utilization of invasive diagnostic tests. Thus the PPI empirical trial should be considered as the initial diagnostic step in patients with the disease spectrum of GERD.",2000.0,0,0
189,10729735,Unresolved issues in Barrett's esophagus in the new millennium.,G Falk,,2000.0,0,0
190,10734017,"Long-term omeprazole treatment in resistant gastroesophageal reflux disease: efficacy, safety, and influence on gastric mucosa.",E C Klinkenberg-Knol; F Nelis; J Dent; P Snel; B Mitchell; P Prichard; D Lloyd; N Havu; M H Frame; J Romàn; A Walan; Long-Term Study Group,"The efficacy and safety of long-term acid suppression remains a subject for debate. We report data from patients with refractory reflux esophagitis who were undergoing maintenance therapy with >/=20 mg omeprazole daily for a mean period of 6.5 years (range, 1.4-11.2 years). Patients with severe reflux esophagitis resistant to long-term therapy with H(2)-receptor antagonists and who were not eligible for surgery were evaluated at least annually for endoscopic relapse and histological changes in the gastric corpus. In 230 patients (mean age, 63 years at entry; 36% were >/=70 years), there were 158 relapses of esophagitis during 1490 treatment years (1 per 9.4 years), with no significant difference in relapse rates between Helicobacter pylori-positive and -negative patients. All patients rehealed during continued therapy with omeprazole at the same or higher dose. The annual incidence of gastric corpus mucosal atrophy was 4.7% and 0.7% in H. pylori-positive and -negative patients, respectively, which was mainly observed in elderly patients who had moderate/severe gastritis at entry. In patients with baseline moderate/severe gastritis, the incidences were similar: 7.9% and 8.4%, respectively. Corpus intestinal metaplasia was rare, and no dysplasia or neoplasms were observed. The adverse event profile was as might be expected from this elderly group of patients. Long-term omeprazole therapy (up to 11 years) is highly effective and safe for control of reflux esophagitis.",2000.0,0,0
191,10734021,Intravenous pantoprazole rapidly controls gastric acid hypersecretion in patients with Zollinger-Ellison syndrome.,E A Lew; J R Pisegna; J A Starr; E F Soffer; C Forsmark; I M Modlin; J H Walsh; M Beg; W Bochenek; D C Metz,"Parenteral control of gastric acid hypersecretion in conditions such as Zollinger-Ellison syndrome (ZES) or idiopathic gastric acid hypersecretion is necessary perioperatively or when oral medications cannot be taken for other reasons (e.g., during chemotherapy, acute upper gastrointestinal bleeding, or in intensive care unit settings). We evaluated the efficacy and safety of 15-minute infusions of the proton pump inhibitor pantoprazole (80-120 mg every 8-12 hours) in controlling acid output for up to 7 days. Effective control was defined as acid output >10 milliequivalents per hour (mEq/h) (<5 mEq/h in patients with prior acid-reducing surgery) for 24 hours. The 21 patients enrolled had a mean age of 51.9 years (range, 29-75) and a mean disease duration of 8.1 years (range, <0.5-21); 13 were male, 7 had multiple endocrine neoplasia syndrome type I, 4 had undergone acid-reducing surgery, 2 had received chemotherapy, and 13 had undergone gastrinoma resections without cure. Basal acid output (mean +/- SD) was 40.2 +/- 27.9 mEq/h (range, 11.2-117.9). In all patients, acid output was controlled within the first hour (mean onset of effective control, 41 minutes) after an initial 80-mg intravenous pantoprazole dose. Pantoprazole, 80 mg every 12 hours, was effective in 17 of 21 patients (81%) for up to 7 days. Four patients required upward dose titration, 2 required 120 mg pantoprazole every 12 hours, and 2 required 80 mg every 8 hours. At study end, acid output remained controlled for 6 hours beyond the next expected dose in 71% of patients (n = 15); mean acid output increased to 4.0 mEq/h (range, 0-9.7). No serious or unexpected adverse events were observed. Intravenous pantoprazole, 160-240 mg/day administered in divided doses by 15-minute infusion, rapidly and effectively controlled acid output within 1 hour and maintained control for up to 7 days in all ZES patients.",2000.0,0,0
192,10734031,The efficacy and safety of long-term omeprazole treatment for gastroesophageal reflux disease.,E J Kuipers; S G Meuwissen,,2000.0,0,1
193,10735923,Effect of ornidazole and clarithromycin resistance on eradication of Helicobacter pylori in peptic ulcer disease.,F S Lehmann; J Drewe; L Terracciano; C Beglinger,"Clarithromycin and nitroimidazoles such as metronidazole and ornidazole are among the most frequently used antibiotics for curing Helicobacter pylori infection. However, controversial data exist on whether their in vitro resistance has a negative impact on treatment outcome. Patients with H. pylori positive active peptic ulcer disease were randomly assigned to receive lansoprazole 30 mg o.d., amoxycillin 1 g b.d. and ornidazole 500 mg b.d. (LAO) or lansoprazole 30 mg o.d., amoxycillin 1 g b.d. and clarithromycin 500 mg b.d. (LAC) for 2 weeks. Pre-treatment resistance to ornidazole and clarithromycin was assessed by Epsilometer (E-) test. Four weeks after completion of treatment, patients underwent a 13C urea breath test to assess H. pylori status. Data from 80 patients with active peptic ulcer disease and positive H. pylori status were analysed. The prevalence of primary drug resistance was 25% for metronidazole and 7.5% for clarithromycin. In patients treated with LAO, effective treatment was achieved in 87% of metronidazole-susceptible, but only 30% of metronidazole-resistant strains (P < 0.01). In the LAC group, therapy was successful in 81% of clarithromycin-susceptible strains, whereas treatment failed in all patients with primary clarithromycin resistance (n = 3). Resistance against nitroimidazoles significantly affects treatment outcome in H. pylori eradication therapy.",2000.0,0,0
194,10735926,"Seven-day triple therapy with ranitidine bismuth citrate or omeprazole and two antibiotics for eradication of Helicobacter pylori in duodenal ulcer: a multicentre, randomized, single-blind study.",G C Spinzi; F Boni; A Bortoli; E Colombo; G Ballardini; R Venturelli; G Minoli,"To investigate the efficacy of a 1-week triple therapy with amoxycillin, clarithromycin, and omeprazole or ranitidine bismuth citrate (RBC) in curing Helicobacter pylori infection and healing duodenal ulcers. One hundred and ninety-two consecutive out-patients with duodenal ulcer, in whom H. pylori infection was confirmed by histology and a urease biopsy test, were randomly assigned to a 1-week treatment with either 400 mg b.d. ranitidine bismuth citrate (RAC group) or 20 mg omeprazole b.d. (OAC group) in combination with 1 g amoxycillin b.d. and 500 mg clarithromycin b.d. Eradication of H. pylori was successful in 77% (per protocol) and 61% (intention-to-treat) of the patients in the RAC group and in 79% (per protocol) and 70% (intention-to-treat) of those in the OAC group. The difference was not significant. Per protocol analysis showed ulcers were healed in 97% of patients in the RAC group and 96% in the OAC group. Adverse effects were seen in four patients in each group: they caused discontinuation of the therapy in one patient of the OAC group. Eradication rates obtained in this study were lower than those expected on the basis of previously reported studies. The two 1-week treatment regimens were equally effective in healing H. pylori associated duodenal ulcer disease.",2000.0,0,0
195,10735929,Lack of a pharmacokinetic interaction between lansoprazole or pantoprazole and theophylline.,W J Pan; D R Goldwater; Y Zhang; B L Pilmer; R H Hunt,"To study the potential pharmacokinetic interaction between lansoprazole or pantoprazole and theophylline at steady state. Theophylline 200 mg extended-release formulation was administered twice daily on days 1-11 to 30 healthy, non-smoking males. On days 5-11, 15 subjects received concomitant lansoprazole 30 mg once daily (o.d.) and 15 subjects received concomitant pantoprazole 40 mg o.d. No significant changes in the steady-state theophylline maximum plasma concentration (Cmax), time to Cmax (Tmax), minimum plasma concentration (Cmin), area under the plasma concentration-time curve over the 12-h dosing interval (AUC0-12), or apparent total oral clearance (CL/F) were observed within the two treatment groups when theophylline was administered alone or in combination with lansoprazole or pantoprazole. In addition, no significant differences in the changes of steady-state theophylline pharmacokinetics from day 4 to day 11 were noted between the two treatment groups. Treatment with theophylline in combination with either lansoprazole or pantoprazole was well tolerated. All adverse events were transient and rated mild to moderate in severity. Co-administration of either lansoprazole or pantoprazole in healthy subjects does not significantly affect the steady-state pharmacokinetics of theophylline at the therapeutic doses tested.",2000.0,0,1
196,10737285,Should noncardiac chest pain be treated empirically? A cost-effectiveness analysis.,A M Borzecki; M C Pedrosa; M J Prashker,"Chest pain is a common clinical problem, but up to 30% of patients who present with chest pain lack coronary disease. Subsequent investigation often reveals an esophageal source for the pain, with gastroesophageal reflux disease identified most frequently. Controversy exists regarding whether to establish the cause or to empirically treat as reflux. To assess the cost-effectiveness of empirical treatment in patients with noncardiac chest pain. Decision analysis was used to compare a strategy of empirical treatment as reflux using an H-blocker or proton pump inhibitor with initial investigation for gastrointestinal causes over a period of up to 16 weeks and over a period of more than a year. The prototype patient was an outpatient with chest pain and a normal coronary angiogram. Gastrointestinal investigations included an upper gastrointestinal tract series, endoscopy, manometry, 24-hour pH monitoring, and provocation tests. The main outcome measure was direct medical costs per case treated from a third-party payer perspective. Total medical costs were $2,187 per case treated for the initial investigation arm and $849 for the empirical treatment arm in the 8- to 16-week model. One-way sensitivity analyses revealed that the model was robust; the treatment arm was less expensive in all cases. At just over a year empirical treatment remained dominant. An initial therapeutic trial with antisecretory agents for patients with noncardiac chest pain is cost-effective compared with investigation for gastrointestinal causes in the short term of weeks, with cost savings persisting beyond a year.",2000.0,0,0
197,10741935,"Efficacy and tolerability of 20 mg pantoprazole versus 300 mg ranitidine in patients with mild reflux-oesophagitis: a randomized, double-blind, parallel, and multicentre study.",J H van Zyl; H de K Grundling; C J van Rensburg; F J Retief; S J O'Keefe; I Theron; R Fischer; T Bethke,"The aim of this study was to compare the efficacy and tolerability of low dose pantoprazole (20 mg) (a gastric proton pump inhibitor) with standard dose ranitidine (300 mg) (a histamine-receptor antagonist), in their ability to relieve symptoms and heal oesophageal lesions associated with gastrooesophageal reflux disease (GORD). Patients with endoscopically established mild GORD (stage I, modified Savary-Miller classification) were enrolled into a multicentre, randomized, double-blind, parallel-group comparison study (intention-to-treat population, n = 201; age range, 18-82 years). Patients took either oral pantoprazole 20 mg in the morning (n = 101) or ranitidine 300 mg in the evening (n = 100) once daily for 4 weeks or, if the healing was not complete, 8 weeks. Relief from key symptoms (heartburn, acid regurgitation, pain on swallowing) was assessed after 2, 4, and if applicable, 8 weeks. Healing of lesions was confirmed endoscopically after 4 and, if applicable, 8 weeks. Complete relief from key symptoms was noted after 2 weeks in 70/88 (80%) patients treated with pantoprazole vs 45/89 (51%) patients treated with ranitidine ('per-protocol and key-point available' populations, P < 0.001); the corresponding results after 4 weeks were 77/88 (88%) vs 51/88 (58%) (P < 0.001). Complete healing of lesions after 4 weeks of treatment was seen in 74/88 (84%) vs 49/89 (55%) in the pantoprazole and ranitidine group, respectively (P < 0.001, per-protocol); by week 8 the cumulative healing rates were 84/88 (95%) vs 69/89 (78%) in the pantoprazole and ranitidine group, respectively (P < 0.001). For the intention-to-treat populations, the corresponding values for healing after 4 and 8 weeks were 73% vs 49% (P < 0.001) and 83% vs 69% (P < 0.05), respectively. Both study medications were well tolerated. Compared to ranitidine 300 mg, the regimen with pantoprazole 20 mg provides faster relief from symptoms and is significantly more effective in healing of oesophageal lesions in patients with mild reflux-oesophagitis. Thus, the low dose of pantoprazole offers a treatment approach which minimizes drug exposure and costs while retaining high efficacy.",2000.0,0,0
198,10749519,Pharmacokinetic considerations in the eradication of Helicobacter pylori.,U Klotz,"As Helicobacter pylori plays an important role in the aetiopathogenesis of peptic ulcer, therapeutic strategies aimed at maintaining long term remission have shifted from the control of intragastric pH to targeting H. pylori. According to recent international guidelines the clinical goals--rapid ulcer healing and prevention of relapse--can be best accomplished by combination therapy consisting of an antisecretory drug (proton pump inhibitor or ranitidine) and 2 antimicrobial agents (preferable amoxicillin, clarithromycin or metronidazole). When applying such multidrug regimens, possible synergy between the agents suggests that pharmacokinetic considerations might help to improve H. pylori eradication rates, which should be above 85 to 90% on an intention-to-treat basis. The present review summarises the pharmacokinetic properties and interaction potential of all drugs presently used in the various H. pylori eradication regimens, with emphasis on particular patient populations such as the elderly and those with renal impairment. The drugs considered are omeprazole, lansoprazole, pantoprazole, rabeprazole, ranitidine and ranitidine bismutrex, bismuth salts, amoxicillin, clarithromycin, azithromycin, roxithromycin, metronidazole, tinidazole and tetracycline. When addressing the clinically important questions of the efficacy, safety and costs of the recommended regimens, the impact of drug disposition on H. pylori eradication should not be neglected.",2000.0,0,0
199,10749593,Is 1-week treatment for peptic ulcer healing sufficient and safe?,S García; J Fuentes; J A Ducóns; F Barrera; C Yus; F Gomollón,"To confirm whether 1-week anti-Helicobacter therapy to achieve ulcer healing is sufficient and safe. We retrospectively analyzed patients with peptic ulcer who were infected with Helicobacter pylori and treated with 3 different 7-day regimens, according to predefined protocols in 3 different centers in the same geographical area (Aragón, Spain). Three combinations commonly described in the literature were used: a) omeprazole (40 mg/24 h), tetracycline hydrochloride (2 g/24 h), colloidal bismuth subcitrate (480 mg/24 h) and metronidazole (750 mg/24 h) (OBTM, n = 105); b) omeprazole (40 mg/24 h), clarithromycin (1.5 g/24 h) and amoxicillin (3 g/24 h) (O40C1.5A3, n = 13); and c) omeprazole (40 mg/24 h), clarithromycin (1 g/24 h) and amoxicillin (2 g/24 h) (O40C1A2, n = 4). In all patients the diagnosis of peptic ulcer disease was confirmed endoscopically, and H. pylori infection was verified with urease testing and histological analysis. After treatment ended, no other antacids were allowed until after endoscopic examination to check eradication and ulcer healing. 122 patients were included (107 with duodenal ulcer, 12 with gastric ulcer and 3 with both). Compliance was good and side effects infrequent and mild. Eradication rates were 88.5% (93/105) in the OBTM group, 100% (13/13) with O40C1.5A3, and 75% (3/4) with O40C1A2. Healing was achieved in 98.16% (107/109) of the patients in whom the bacterial infection was eradicated, and in 23.07% (3/13) of those in whom it was not (p < 0.0001). No patient had any complications during the period without treatment. 1-week eradication therapy with previously described combinations commonly used in clinical practice achieves high ulcer healing rates with no complications in the period without antacid treatment. We consider that it is not necessary, at least in most patients, to prolong antacid therapy.",2000.0,0,0
200,10750653,Costs and benefits of a test-and-treat strategy in Helicobacter pylori-infected subjects: a prospective intervention study in general practice.,E A Joosen; J H Reininga; J M Manders; J C ten Ham; W A de Boer,"To identify health outcomes and costs/savings of a Helicobacter pylori test-and-treat strategy in patients using acid suppressants chronically. Prospective intervention study. Patients were tested for H. pylori infection and treated with 14 days of ranitidine bismuth citrate (RBC) 400 mg (b.i.d.) and clarithromycin 500 mg if infected. Cure was determined after six months. General practice. Patients using acid suppressants chronically were identified by a computer search; 184 patients gave written consent and were included. Serology, symptom questionnaire, medication history, quality of life determination, costs/savings. Out of 184 patients, 85 (46%) had positive serology. A cure rate of 61/80 (76%) was achieved. The intervention group showed significant symptom relief. Benefits were evident in patients with ulcer disease but also in patients with uninvestigated dyspepsia. Quality of life improved for cured patients in the intervention group. No improvements for dyspeptic symptoms or quality of life occurred in the H. pylori-negative group. After six months, significant savings for medication use had occurred in treated patients diagnosed as ulcer disease or non-ulcer dyspepsia. Savings on drug use and doctor visits equalize with costs for tests and antibiotics after nine months. Although less, costs for drugs also decreased significantly in the H. pylori-negative group. Therefore, for the study population, costs and savings are even after 6.5 months. A test-and-treat strategy for H. pylori, systematically applied at the population level in patients using acid suppressants chronically, results in significant health benefits and economic savings within 1 year of follow-up.",2000.0,0,0
201,10752019,Diagnosis and treatment of nonsteroidal anti-inflammatory drug-associated upper gastrointestinal toxicity.,M S Cappell; J R Schein,"Nonsteroidal anti-inflammatory drugs (NSAIDs) are widely prescribed in the United States to treat pain and reduce inflammation from chronic inflammatory disorders such as rheumatoid arthritis and osteoarthritis. Approximately 40% of older Americans take NSAIDs. Chronic NSAID use carries a risk of peptic ulcer and other gastrointestinal disturbances. This article reviews the diagnosis of medication-induced ulcers based on clinical presentation, laboratory tests, and endoscopic findings to assist the clinician in early diagnosis and appropriate therapy. Risk factors for NSAID-induced ulcers include old age, poor medical status, prior ulcer, alcoholism, smoking, high NSAID dosage, prolonged NSAID use, and concomitant use of other drugs that are gastric irritants, such as alendronate, a bone resorption inhibitor prescribed for osteoporosis. Appropriate treatment options for patients with medication-induced ulcers include dosage reduction, medication substitution, medication withdrawal, antiulcer therapy, and discontinuation of other gastrotoxic drugs.",2001.0,0,0
202,10758416,From bench to bedside to bug: an update of clinically relevant advances in the care of persons with Helicobacter pylori- associated diseases.,N Chiba; A B Thomson; P Sinclair,"In-depth meetings of the XIth International Workshop on Gastroduodenal Pathology and Helicobacter pylori led to the presentation and discussion of extensive new data on H. pylori and its diseases. The mode of transmission of H. pylori remains unclear, and it remains unknown why only a small proportion of infected individuals develop duodenal or gastric ulcer disease and even fewer develop gastric cancer. The role of H. pylori eradication in persons with uninvestigated dyspepsia remains controversial. New clinical trials of H. pylori treatment show symptom relief and improvement in the quality of life of persons with functional dyspepsia, especially in those with ulcer-like or reflux-like dyspepsia. Clearly the move is toward symptom-based management of persons with dyspepsia, with fewer endoscopies being needed in the otherwise healthy young dyspeptic patients. It remains controversial whether eradicating H. pylori in duodenal ulcer or functional dyspepsia increases the risk of subsequent development of gastroesophageal reflux disease. The one-week proton pump inhibitor-based triple regimens remain the gold standard of H. pylori therapy, but some of the ranitidine bismuth citrate plus two antibiotic regimens also achieve an 80% H. pylori eradication rate on an intention-to-treat basis. While the urea breath test remains the noninvasive test of choice, interesting new data are available on the use of stool antigen testing to diagnose H. pylori infection. The number of H pylori-associated gastroduodenal diseases grows to include possible liver, vascular, immune and skin conditions.",2000.0,0,0
203,10759617,The omeprazole test is as sensitive as 24-h oesophageal pH monitoring in diagnosing gastro-oesophageal reflux disease in symptomatic patients with erosive oesophagitis.,R Fass; J J Ofman; R E Sampliner; L Camargo; C Wendel; M B Fennerty,"Ambulatory 24-h oesophageal pH monitoring and a short course of high dose omeprazole can be used as diagnostic modalities for GERD. However, comparative studies of the diagnostic accuracy and reliability of both strategies have not been performed. To compare the omeprazole test to ambulatory 24-h oesophageal pH monitoring in diagnosing GERD in symptomatic patients using endoscopically proven erosive oesophagitis as a gold standard. Patients with heartburn underwent an upper endoscopy. Only those with erosive oesophagitis were included in the study. Subsequently, patients underwent ambulatory 24-h oesophageal pH monitoring and an 'omeprazole test.' Daily symptoms were recorded during the first week (baseline) and repeated during the second week on therapy (omeprazole 40 mg in the morning and 20 mg in the evening). Thirty-five patients were included in the study. The omeprazole test was significantly more sensitive in diagnosing GERD than total acid contact time on 24-h oesophageal pH monitoring (83% vs. 60%; P < 0.03). However, the sensitivity of the pH test increased to 80% after adding patients with a positive symptom index, and patients with abnormal acid exposure in the supine or erect positions despite normal total acid contact time. Patients with a normal pH test were significantly younger (49 +/- 2.6 years) than those with abnormal test (59 +/- 1.8; P=0.002). In this study an omeprazole test was at least as sensitive as ambulatory 24-h oesophageal pH monitoring in diagnosing GERD in patients with erosive oesophagitis.",2000.0,0,0
204,10759619,Pharmacokinetic interaction between proton pump inhibitors and roxithromycin in volunteers.,F Kees; A Holstege; K P Ittner; M Zimmermann; G Lock; J Schölmerich; H Grobecker,"Triple therapy including two antibiotics and a proton pump inhibitor is a rational approach to the treatment of Helicobacter pylori induced peptic ulcer disease. The interaction of antimicrobial therapy and acid suppression is not yet well elucidated. To investigate the effects of proton pump inhibitors on roxithromycin levels in plasma and gastric tissue under steady-state conditions in volunteers. In two crossover studies omeprazole 20 mg b.d., lansoprazole 30 mg b.d., roxithromycin 300 mg b.d., and the combination of roxithromycin with either omeprazole or lansoprazole were administered to 12 healthy volunteers over 6 days. Blood plasma levels of the drugs were measured. In addition, roxithromycin concentrations were also determined in gastric juice and gastric tissue obtained during endoscopy. The proton pump inhibitors and roxithromycin did not alter the blood plasma pharmacokinetics of each other. When compared to roxithromycin administered alone, its combination with a proton pump inhibitor significantly increased the roxithromycin concentrations in gastric juice (3.0-5.0 microg/mL vs. 0.3-0.4 microg/mL) and gastric tissue (antrum: 3.8-4.0 vs. 2.8 microg/g, fundus: 5.9-7.4 vs. 4.2-4.4 microg/g). Proton pump inhibitors and roxithromycin do not alter the systemic bioavailability of each other. However, proton pump inhibitors increase the local concentration of roxithromycin in the stomach which may contribute to the clinically proven synergic beneficial action in eradication therapy of H. pylori.",2000.0,0,1
205,10759620,Dyspepsia workload in urban general practice and implications of the British Society of Gastroenterology Dyspepsia guidelines (1996).,K Bodger; P G Eastwood; S I Manning; M J Daly; R V Heatley,"To define the characteristics of patients consulting with active dyspeptic symptoms in urban general practice, and to consider the implications of applying the British Society of Gastroenterology Dyspepsia management guidelines. Prospective observational study over a period of 12 months. Two multipartner, two-centre general practices in the City of Leeds (UK) with a combined target population of 11 011 registered patients. A total of 340 patients consulting with active dyspeptic symptoms (52% male; mean age 53 years, range 16-89 years). Of the practice population, 3% consulted with dyspepsia (first-time consulter: 19%; previous consulter not yet investigated: 30%; previously investigated: 51%). Of 168 undiagnosed patients, 43% had upper abdominal pain (dysmotility-like symptoms in 42%), 35% had reflux symptoms, 22% had mixed symptoms, 12% had 'alarm' symptoms and 18% had a history of NSAID use. Patients < 45 years old with simple dyspepsia accounted for 32% of undiagnosed cases. A fifth of the workload was in dealing with undiagnosed dyspeptics over 45 years old. One per cent of the population would require endoscopy if all undiagnosed cases either > 45 years or with complicated dyspepsia were investigated. Of 172 previously investigated patients, 29% had negative tests, 25% had 'minor' findings, and 45% had evidence of acid-peptic disease. Patients with duodenal ulcer disease accounted for 12% of the total workload. A knowledge of the characteristics of patients consulting with dyspepsia in primary care should allow the adaptation of guidelines, to ensure advice is relevant to local case mix and compatible with local resources.",2000.0,0,0
206,10763941,"Rabeprazole is superior to ranitidine in the management of active duodenal ulcer disease: results of a double-blind, randomized North American study.",J R Breiter; D Riff; T J Humphries,"The primary purpose of this study was to compare the efficacy and tolerability of rabeprazole versus ranitidine in the treatment of patients with active duodenal ulcer disease. This multicenter, double-blind, randomized, parallel-group study enrolled 376 patients. Patients were randomly assigned to receive rabeprazole 20 mg administered once daily in the morning (q.a.m.) with matching ranitidine placebo twice daily (b.i.d.) (n = 188), or ranitidine 150 mg b.i.d. with matching rabeprazole placebo q.a.m. (n = 188). Three visits were scheduled: wk 0 (baseline; days -3 to -1), wk 2 (day 15+/-3 days), and wk 4 (day 29+/-3 days). The primary efficacy response variable was defined as complete regeneration of the mucosa at the site of all ulcers identified during the study. Secondary efficacy variables included patients' ratings of frequency and severity of ulcer pain, frequency of antacid use, and improvement of overall physical well-being. Tolerability was evaluated with analyses of adverse events, laboratory evaluations, fasting serum gastrin levels, vital signs, body weight, and electrocardiograms. Up to 4 wk of treatment with rabeprazole 20 mg q.a.m. produced significantly greater healing rates, compared to treatment with ranitidine 150 mg b.i.d. (83% vs 73%; p = 0.017). Significant differences between treatment groups were also observed for secondary efficacy indices. At wk 2, rabeprazole was more likely than ranitidine to produce complete resolution of duodenal ulcer pain (39% vs 25%; p = 0.006), improvement in duodenal ulcer nighttime pain severity (76% vs 65%; p = 0.044), and improvement in overall well-being (55% vs 41%; p = 0.009). At wk 4, the proportion of patients with normalization of overall well-being was significantly higher in the rabeprazole group than in the ranitidine group (45% vs 29%; p = 0.003). Rabeprazole was safe and well tolerated in this study. In patients with active duodenal ulcer disease, rabeprazole 20 mg q.a.m. is superior to ranitidine 150 mg b.i.d. in healing, resolving ulcer pain frequency, improving nighttime pain severity, and improving overall well-being. Rabeprazole is an effective and well-tolerated alternative treatment for patients with active duodenal ulcer disease.",2000.0,1,1
207,10764703,Effect of Helicobacter pylori eradication on chronic gastritis during omeprazole therapy.,B E Schenk; E J Kuipers; G F Nelis; E Bloemena; J C Thijs; P Snel; A E Luckers; E C Klinkenberg-Knol; H P Festen; P P Viergever; J Lindeman; S G Meuwissen,"We have previously observed that profound acid suppressive therapy in Helicobacter pylori positive patients with gastro-oesophageal reflux disease is associated with increased corpus inflammation and accelerated development of atrophic gastritis. To investigate if H pylori eradication at the start of acid suppressive therapy prevents the development of these histological changes. In a prospective randomised case control study, patients with reflux oesophagitis were treated with omeprazole 40 mg once daily for 12 months. H pylori positive patients were randomised to additional double blind treatment with omeprazole 20 mg, amoxicillin 1000 mg and clarithromycin 500 mg twice daily or placebo for one week. Biopsy sampling for histology, scored according to the updated Sydney classification, and culture were performed at baseline, and at three and 12 months. In the persistently H pylori positive group (n=24), active inflammation increased in the corpus and decreased in the antrum during therapy (p=0.032 and p=0.002, respectively). In contrast, in the H pylori positive group that became H pylori negative as a result of treatment (n=33), active and chronic inflammation in both the corpus and antrum decreased (p<or =0.0001). The decrease in active and chronic inflammation in the corpus differed significantly compared with the persistently H pylori positive group (both p=0.001). For atrophy scores, no significant differences were observed between H pylori eradicated and persistently H pylori positive patients within one year of follow up. No changes were observed in the H pylori negative control group (n=26). H pylori eradication prevents the increase in corpus gastritis associated with profound acid suppressive therapy. Longer follow up is needed to determine if H pylori eradication prevents the development of atrophic gastritis.",2000.0,0,1
208,10766318,Efficacy of different Helicobacter pylori eradication regimens in patients affected by insulin-dependent diabetes mellitus.,A Gasbarrini; V Ojetti; D Pitocco; A Armuzzi; N G Silveri; P Pola; G Ghirlanda; G Gasbarrini,"Patients with insulin-dependent diabetes mellitus (IDDM) are often affected by chronic infections; antibiotic absorption, however, may be influenced by the disease. H. pylori eradication appears to be reduced in IDDM patients. The aim of the study was to evaluate the efficacy of the most common H. pylori eradication regimens in a population of IDDM-infected patients. One hundred and seventy-two IDDM patients were evaluated. H. pylori infection was assessed through the 13C-urea breath test. Infected patients were randomly assigned to three different standard 7-day eradication regimens: 1) amoxicillin, clarithromycin, pantoprazole; 2) tinidazole, clarithromycin, ranitidine bismuth citrate; or 3) tinidazole, clarithromycin, pantoprazole. Patients in whom eradication was not successful in the first cycle were subsequently submitted to a 7-day therapy with tinidazole, tetracycline, bismuth, and pantoprazole. Thirty-seven per cent of IDDM patients were infected. None of the triple therapies used provided an eradication higher than 62%. Conversely, the quadruple regimen was successful in 88% of the patients. Ten per cent of the subjects undergoing the triple therapies showed minor side effects, without significant differences among groups, whereas side effects occurred in 25% of the patients treated with the quadruple therapy (P < 0.05). IDDM patients show a low H. pylori eradication rate with a standard triple therapy regardless of the regimen utilized, the dosage and/or the duration of the therapy used appearing not to be sufficient to eradicate the infection efficiently. The use of a quadruple regimen leads to the cure of a large percentage of the infected patients in whom the eradication was unsuccessful in the first therapy, although it is accompanied by a greater incidence of minor side effects.",2000.0,0,1
209,10768243,Patients with dyspepsia benefit from eradication of Helicobacter pylori if other organic causes for dyspepsia were carefully ruled out.,C Bojarski; H J Epple; F W Kirstein; M Fromm; S Bisson; E O Riecken; J D Schulzke,"In order to investigate the potential of Helicobacter pylori (HP) to induce dyspepsia, we performed a randomized prospective study on the long-term effect of HP-eradication on symptoms of HP-positive dyspeptic patients in whom other organic causes for dyspepsia were carefully ruled out. 201 patients referred to our endoscopy unit with dyspeptic symptoms for at least six months entered the study. Patients with previous peptic ulcer were excluded. After endoscopy of the upper alimentary tract and 13C-urea breath test, patients with active peptic ulcer, hiatal hernia, macroscopic evidence for esophagitis and negative HP-status were excluded. The remaining patients underwent abdominal sonography, H2-exhalation test with lactose, and 24-h pH monitoring in order to exclude other organic causes for dyspepsia. In 20 patients, dyspepsia was assumed to be due to HP-gastritis. Patients received eradication therapy and were controlled as assessed by the 13C-urea breath test six weeks and six months after completion of the therapy. Dyspeptic symptoms were monitored by means of a validated symptom score. Out of 20 patients with HP-gastritis the first eradication treatment was successful in 13, while seven patients remained HP-positive after antibiotic treatment. Six months after completion of therapy the symptoms of HP-eradicated patients improved considerably (score values 17.4 +/- 1.5 and 10.2 +/- 0.8, respectively, p < 0.01) whereas symptoms of patients with persistent infection remained unchanged (21.1 +/- 1.7 and 20.4 +/- 1.5, n.s.) and only improved after successful retherapy (20.4 +/- 1.5 and 11.7 +/- 2.1, p < 0.05). In total, 17 of 20 patients (85%) improved after successful eradication. Also, neutrophil infiltration in the gastric mucosa correlated to both dyspeptic symptoms before therapy (r = 0.85) and the decrease in symptom score after HP-eradication (r = 0.61). In contrast, the symptoms of eight patients with gastroesophageal reflux disease were not improved after eradication (20.0 +/- 1.1 and 18.2 +/- 1.0, n.s.) HP-infection per se contributes to dyspepsia. 17 of 20 (85%) HP-positive dyspeptic patients improved after HP-eradication, when other potential organic causes for dyspepsia had been ruled out. However, many patients did not completely recover but the symptoms only partly decreased which parallels the persistence of part of the inflammatory infiltration in the gastric mucosa. This emphasizes the importance of HP-gastritis as an organic disease causing dyspeptic symptoms.",2000.0,0,0
210,10776369,Prescription of proton pump inhibitors before endoscopy. A potential cause of missed diagnosis of early gastric cancers.,J Wayman; N Hayes; S A Raimes; S M Griffin,"Early gastric cancer is frequently seen with nonspecific dyspeptic symptoms and subtle endoscopic features. Treatment at this stage of the disease produces a high chance of cure. If the diagnosis is missed at this early stage, then the prognosis may be much poorer depending on the subsequent delay in reaching a diagnosis. To report the healing effect of proton pump inhibitors on early gastric cancer. This article reports a case series of 7 patients with ulcerated early gastric cancers indistinguishable as malignant gastric ulcers at endoscopy who were inadvertently prescribed a short course of a proton pump inhibitor prior to a second confirmatory endoscopy. The cases studied were patients with dyspeptic symptoms referred from primary care physicians for upper gastrointestinal endoscopy. In each case the patient became asymptomatic, the endoscopic signs seen at the first endoscopy had resolved, and the lesions could not be recognized even by an experienced endoscopist. If the proton pump inhibitors had been prescribed by the referring physician before the first endoscopy, the diagnosis probably would have been missed. These cases demonstrate the potentially serious masking effect of prescribing a short course of these drugs before making an endoscopic diagnosis. Even though the patient has been referred for endoscopy, the endoscopist may fail to identify the lesion and thus miss the diagnosis. Primary care physicians must resist the pressures to prescribe proton pump inhibitors before endoscopy, particularly in patients older than 45 years, if the diagnostic yield of gastric cancer in the early curable stages is to be maximized.",2000.0,0,0
211,10779214,Helicobacter pylori-negative peptic ulcers: frequency and implications for management.,J W Freston,"Most patients with peptic ulcers are infected with Helicobacter pylori, but the infection may not be responsible for the ulcer. It is increasingly recognized that different causes of ulcers coexist in a given patient, confounding determination of the exact cause of the ulcer. For example, in infected patients with ulcers who also are using nonsteroidal anti-inflammatory drugs (NSAIDs), it is not possible to establish the ulcer's cause. Moreover, recent studies in the United States in infected patients with duodenal ulcers who were treated with various regimens to prove their efficacy in eradicating H. pylori and preventing ulcer recurrence found that approximately 20% of patients suffered an ulcer recurrence despite successful H. pylori eradication. The infection clearly did not cause their ulcers but was originally thought to have done so. Thus, as many as one-fifth of patients with ulcers may have the cause falsely attributed to H. pylori infection. When this number is added to that of ulcer patients who are H. pylori-negative upon original presentation--at least 20% in other recent U.S. studies--it is evident that the proportion of non-H. pylori ulcer patients is larger than originally believed. This proportion is likely to increase with the declining incidence of H. pylori infection. Other causes of ulcers include the use of aspirin and NSAIDs (which may be surreptitious), hypersecretory states, Crohn's disease, and patients with ""idiopathic"" ulcers. Patients with ""idiopathic"" ulcers are characterized by postprandial hypersecretion of acid and hypergastrinemia with accelerated gastric emptying. H. pylori ulcers may be difficult to manage because antisecretory drugs are less effective in inhibiting gastric acidity in the absence of H. pylori infection.",2000.0,0,0
212,10783996,Pantoprazole 20 mg is an effective maintenance therapy for patients with gastro-oesophageal reflux disease.,K Plein; J Hotz; H Wurzer; I Fumagalli; R Lühmann; A Schneider,"To compare the efficacy of 20 mg with 40 mg pantoprazole in maintaining symptomatic and endoscopic remission in patients with gastro-oesophageal reflux disease (GORD). Patients (18-84 years old; n = 433) with healed GORD II or III were included in this prospective multi-centre, randomized, parallel, double-blind study. Pantoprazole was administered once daily for up to 1 year as either a 20 mg or 40 mg enteric-coated tablet to 221 and 212 patients, respectively. Symptoms of GORD were assessed every 3 months. Endoscopy was performed at entry, after 6 and 12 months, or when symptoms of GORD were perceived on at least three consecutive days. The primary efficacy parameter was the time until endoscopically proven relapse of GORD occurred (stage I or greater); the secondary parameters included tolerability, safety, and time until symptomatic relapse occurred. In the 20 mg treatment group, 87% and 75% of patients were in endoscopic remission after 6 and 12 months, respectively; the corresponding rates in the 40 mg treatment group were 91% and 78%. In both treatment groups, GORD stage I accounted for about 50% of endoscopic relapses. The symptomatic remission rates in the 20 mg group were estimated as 85% and 77% after 6 and 12 months, respectively; the corresponding values in the 40 mg group were 87% and 76%. No correlation was seen either between the endoscopically proven relapse and perception of symptoms, or between the severity of the pre-treatment stage of GORD and the maintenance dose of pantoprazole. Both doses were well tolerated. Both the 20 mg and 40 mg doses of pantoprazole are safe and effective in maintaining patients with healed reflux oesophagitis in remission. Moreover, for the majority of patients, the 20 mg dose provides adequate long-term therapeutic efficacy at a minimal drug exposure and lower costs.",2000.0,0,1
213,10791443,Treatment of Helicobacter pylori infection in elderly subjects.,A Pilotto; F Di Mario; M Franceschi,,2000.0,0,0
214,10792115,The effects of omeprazole on healing and appearance of small gastric and duodenal lesions during dosing with diclofenac in healthy subjects.,G Dorta; M Nicolet; D Vouillamoz; D Margalith; E Saraga; H Bouzourene; W H Häcki; M Stolte; A L Blum; D Armstrong,"Non-steroidal anti-inflammatory drugs (NSAIDs) are associated with gastrointestinal mucosal damage. Omeprazole prevents the formation, and accelerates the healing, of NSAID-induced ulcers. To test whether omeprazole accelerates healing of standardized gastroduodenal lesions in the presence of diclofenac. In a double-blind, double-dummy, placebo-controlled, crossover study, 12 healthy volunteers received consecutive, 2-week courses of omeprazole (40 mg o.d.) and placebo, in random order, with an intervening, 4-week washout period; diclofenac (50 mg t.d.s.), was given for the second week of each course. Five endoscopies were performed, one at the outset and the others before and after each course of diclofenac. Biopsies were taken from the endoscopically normal mucosa of the corpus, antrum and duodenum and also from any new mucosal lesion that developed after diclofenac. The sites of biopsies taken before each course of diclofenac were evaluated endoscopically after each course to assess the extent of healing according to a predetermined healing score scale. The healing scores observed after administration of placebo/diclofenac (median=0; range 0-6) and after omeprazole/diclofenac (median=0; range 0-6; P=0.17) did not differ. Small gastroduodenal lesions developed de novo in six subjects during placebo/diclofenac and in seven during omeprazole/diclofenac. Focal chemical gastropathy was observed only in close proximity to macroscopic lesions. In healthy subjects, omeprazole does not accelerate the healing of pre-existing mucosal lesions or prevent the development of small diclofenac-induced mucosal lesions.",2000.0,0,0
215,10792124,"A meta-analysis of short versus long therapy with a proton pump inhibitor, clarithromycin and either metronidazole or amoxycillin for treating Helicobacter pylori infection.",X Calvet; N García; T López; J P Gisbert; E Gené; M Roque,"Although triple therapies with a proton pump inhibitor, clarithromycin and either amoxycillin or metronidazole are the most widely accepted treatment for Helicobacter pylori infection, there is no consensus on how long treatment should be maintained for. To evaluate whether increasing the length of triple therapies beyond 7 days improves treatment efficacy. An extensive search of the literature was performed. Reports of randomized trials comparing different lengths of therapy were selected. Short (7-day) vs. long (10/14-day) therapies were compared, and three-way comparison of 7-day vs. 10-day, 10-day vs. 14-day and 7-day vs. 14-day therapies was performed. Meta-analysis was conducted using conventional shareware (Review Manager 4.0). The Peto Odds Ratio using a fixed model analysis was calculated for each comparison. Thirteen studies were identified. Pooled 10- to 14-day therapies achieved better results than 7-day schedules. In head-to-head comparisons, only 14-day therapies were significantly better than 7-day treatments. Improvement in cure rates ranged from 7 to 9%. Comparisons of 7-day vs. 10-day and 10-day vs. 14-day also showed a non-significant trend towards better cure rates with longer therapies. Fourteen-day, proton pump inhibitor-based triple therapy achieves better results than 7-day schedules. Additional data are necessary to evaluate 10-day therapies.",2000.0,0,1
216,10808676,,,,,0,0
217,10826458,"Superiority of lansoprazole vs ranitidine in healing nonsteroidal anti-inflammatory drug-associated gastric ulcers: results of a double-blind, randomized, multicenter study. NSAID-Associated Gastric Ulcer Study Group.",N M Agrawal; D R Campbell; M A Safdi; N L Lukasik; B Huang; M M Haber,"The usefulness of nonsteroidal anti-inflammatory drugs (NSAIDs) is limited by adverse gastrointestinal tract events. To identify the optimal antisecretory therapy for healing of gastric ulcer in patients using NSAIDs and the impact of concurrent Helicobacter pylori infection on ulcer healing. Prospective, double-blind, multicenter, parallel-group study. Gastroenterology practices in ambulatory and referral center settings. Three hundred fifty-three patients with an active, nonmalignant gastric ulcer at least 5 mm in diameter confirmed by endoscopy and biopsy and who continued to receive stable doses of NSAIDs. Patients were randomized to receive ranitidine hydrochloride, 150 mg twice daily, or lansoprazole, 15 mg or 30 mg once daily, for 8 weeks. Healing was assessed by endoscopy at 4 and 8 weeks in an intent-to-treat population. Helicobacter pylori status was assessed by histological examination. After 8 weeks of treatment, healing was observed in 61 (53%) of 115, 81 (69%) of 118, and 85 (73%) of 117 patients receiving ranitidine lansoprazole, 15 mg, and lansoprazole, 30 mg, respectively (P<.05 for ranitidine vs both lansoprazole doses; 95% confidence interval, 3.2-28.0 for ranitidine vs lansoprazole, 15 mg, and 7.4-31.8 for ranitidine vs lansoprazole, 30 mg). The gastric ulcer healing rates were similar between H pylori-infected and -noninfected patients, with a statistically significant increase with the use of lansoprazole vs ranitidine. In patients who require continuous treatment with NSAIDs, lansoprazole is superior to ranitidine for healing of NSAID-associated gastric ulcers. Healing is not delayed by the presence of H pylori infection.",2000.0,1,1
218,10833090,One-week therapy with pantoprazole versus ranitidine bismuth citrate plus two antibiotics for Helicobacter pylori eradication.,J P Gisbert; D Carpio; S Marcos; J L Gisbert; R García Grávalos; J M Pajares,"A combination of omeprazole plus amoxycillin (Amo) and clarithromycin (CIa) for 7 days has been studied extensively. However, the role of other proton pump inhibitors, such as pantoprazole (Pan), in this therapy is not well known. On the other hand, ranitidine bismuth citrate (RBC) also seems to be effective when combined with Amo and CIa. Our aim was to evaluate and to compare these two novel short-term triple therapies (Pan+Amo+Cla and RBC+Amo+Cla) for treatment of Helicobacter pylori. In a randomized clinical trial 150 consecutive patients (38 with duodenal ulcer, 112 with non-ulcer dyspepsia) infected by H. pylori were studied prospectively. Exclusion criteria were: previous H. pylori eradication therapy, gastroerosive drug use, gastric surgery, and associated diseases. One of two regimens was given for 7 days: Pan (40 mg b.i.d.), Amo (1 g b.i.d.), Cla (500 mg b.i.d.) (group Pan+Amo+Cla, n = 75); or RBC (400 mg b.i.d.), Amo (1 g b.i.d.), Cla (500 mg b.i.d.) (group RBC+Amo+Cla, n = 75). All drugs were administered together after meals. Compliance was evaluated by return tablet count. Data were analysed by univariate (chi2) and multivariate (multiple logistic regression) analysis. Eradication was defined as a negative 13C-urea breath test 1 month after completing therapy. The distribution of studied variables (age, gender, smoking, duodenal ulcer/non-ulcer dyspepsia) was similar in both therapy groups. Per-protocol eradication was achieved in 48/71 (68%) in group Pan+Amo+Cla, and in 61/70 (87%) in group RBC+Amo+Cla (P= 0.01). Intention-to-treat (ITT) eradication was achieved in, respectively, 48/ 75 (64%) and in 61/75 (81%) (P= 0.03). The RBC+ Amo+Cla regimen was more effective than Pan+Amo+Cla in non-ulcer dyspepsia patients (ITT, 84% vs 58%; P = 0.005), but statistically significant differences were not demonstrated in duodenal ulcer patients (72% vs 80%). In the multivariate analysis the odds ratio for the effect of the type of therapy on H. pylori eradication in patients with non-ulcer dyspepsia was 3.8 (95% Cl, 1.6-9.3; P = 0.003). No relevant adverse effects were reported with any regimen. A RBC+Amo+Cla regimen for only 1 week is a promising therapy for H. pylori infection, due to its high efficacy, simple posology, and excellent tolerability. Combination of Pan with Amo and Cla, although effective in duodenal ulcer patients, but in non-ulcer dyspepsia has not achieved the favourable results previously reported with other proton pump inhibitors.",2000.0,0,1
219,10833116,"Helicobacter pylori eradication with lansoprazole, amoxycillin and clarithromycin: testing an ideal regimen in a multicultural south east Asian population and examining factors potentially influencing eradication.",S P Kaushik; C Vu,"From European and North American data, it is recommended in the Asia Pacific consensus statement, that one week therapy with a proton pump inhibitor, amoxycillin and clarithromycin be used for Helicobacter pylori eradication, in areas of high metronidazole resistance. The efficacy of this regimen is unknown in Singapore. To assess the efficacy, safety and compliance of an H. pylori eradication regimen and examine clinical factors that potentially determine eradication. Consecutive outpatients from a multicultural, south east Asian, population with H. pylori infection, with or without peptic ulcer, were treated with lansoprazole 30 mg, amoxycillin 1 gm, clarithromycin 500 mg, twice a day for seven days. Eradication was assessed by either rapid urease, histology or urea breath test. Compliance and side effects were recorded. The eradication rate and effect of ethnicity, age, sex, usage of alcohol, smoking and non-steroidal anti-inflammatory drugs, history of ulcer and endoscopic diagnosis on eradication were examined by univariate and multivariate analysis. Of 113 patients, the eradication rate by intention to treat was 98/113 (87%) (95% confidence interval [CI] 80-93%) and per protocol was 98/106 (92%) (95% CI 87-97%). Using Fisher's exact test, eradication was more successful in Chinese (intention to treat and per protocol respectively p=0.02 and p<0.001) compared to non-Chinese. By logistic regression analysis ethnicity was an independent factor associated with eradication success (p=0.0025). Side effects occurred in five (4.4%), resulting in cessation of treatment. This one week eradication regimen is safe and effective in south east Asians. Chinese ethnicity may be associated with a higher likelihood of eradication success.",2000.0,0,0
220,10846695,,,,,0,0
221,10848649,Review article: potential gastrointestinal effects of long-term acid suppression with proton pump inhibitors.,L Laine; D Ahnen; C McClain; E Solcia; J H Walsh,"This review examines the evidence for the development of adverse effects due to prolonged gastric acid suppression with proton pump inhibitors. Potential areas of concern regarding long-term proton pump inhibitor use have included: carcinoid formation; development of gastric adenocarcinoma (especially in patients with Helicobacter pylori infection); bacterial overgrowth; enteric infections; and malabsorption of fat, minerals, and vitamins. Prolonged proton pump inhibitor use may lead to enterochromaffin-like cell hyperplasia, but has not been demonstrated to increase the risk of carcinoid formation. Long-term proton pump inhibitor treatment has not been documented to hasten the development or the progression of atrophic gastritis to intestinal metaplasia and gastric cancer, although long-term studies are required to allow definitive conclusions. At present, we do not recommend that patients be tested routinely for H. pylori infection when using proton pump inhibitors for prolonged periods. Gastric bacterial overgrowth does increase with acid suppression, but important clinical sequelae, such a higher rate of gastric adenocarcinoma, have not been seen. The risk of enteric infection may increase with acid suppression, although this does not seem to be a common clinical problem with prolonged proton pump inhibitor use. The absorption of fats and minerals does not appear to be significantly impaired with chronic acid suppression. However, vitamin B12 concentration may be decreased when gastric acid is markedly suppressed for prolonged periods (e.g. Zolllinger-Ellison syndrome), and vitamin B12 levels should probably be assessed in patients taking high-dose proton pump inhibitors for many years. Thus, current evidence suggests that prolonged gastric acid suppression with proton pump inhibitors rarely, if ever, produces adverse events. Nevertheless, continued follow-up of patients taking proton pump inhibitors for extended periods will provide greater experience regarding the potential gastrointestinal adverse effects of long-term acid suppression.",2000.0,0,1
222,10848651,"A placebo-controlled study to assess the effects of 7-day dosing with 10, 20 and 40 mg rabeprazole on 24-h intragastric acidity and plasma gastrin in healthy male subjects.",M P Williams; C Blanshard; C Millson; J Sercombe; R E Pounder,"To compare the effects of rabeprazole 10, 20 and 40 mg o.d. on 24-h intragastric acidity and plasma gastrin concentration in a randomized, double-blind placebo-controlled trial. Twenty-four healthy male volunteers were studied on the 7th day of morning dosing with either placebo or rabeprazole 10, 20 or 40 mg in a crossover fashion. On day 7, hourly intragastric acidity was measured for 24 h from 08.00 hours by gastric aspiration. Plasma gastrin concentrations were also measured hourly from 08.00 to 24.00 hours, and 2-hourly thereafter. Compared with placebo, rabeprazole 10, 20 and 40 mg produced significant dose-related decreases in intragastric acidity (median 24-h integrated acidity=697, 186, 129 and 82 mmol h/L, respectively). This was associated with significant elevation of plasma gastrin concentration (median 24-h integrated gastrin=141, 1184, 1484 and 1763 pmol.h/L, respectively). Rabeprazole 40 mg resulted in significantly decreased acidity compared with both 10 and 20 mg, and in longer times for which intragastric pH was maintained at > 3 (19. 2 h vs. 17.3 h and 17.5 h) and > 4 (17 h vs. 14.2 h and 15.2 h), but was accompanied by significantly increased plasma gastrin. There was a consistent trend for greater antisecretory activity for 20 mg compared with 10 mg, but these differences did not reach statistical significance. The interindividual variability in antisecretory response was greatest with 10 mg. Rabeprazole 10, 20 and 40 mg produce significant, profound dose-related inhibition of gastric acid secretion. Taking into account reciprocal increases in plasma gastrin and the interindividual variation in antisecretory response, 20 mg appears to be the preferred dose for routine clinical use.",2000.0,0,0
223,10848653,Gastric acidity and acid breakthrough with twice-daily omeprazole or lansoprazole.,P O Katz; J G Hatlebakk; D O Castell,"In patients with severe gastro-oesophageal reflux disease (GERD), proton pump inhibitors are being used increasingly in twice-daily regimens to improve control of gastric acidity. Few data exist to compare the ability of the most-often used proton pump inhibitors, omeprazole and lansoprazole, to control gastric acid at twice-daily dosage regimens. Nocturnal acid breakthrough, defined as gastric pH < 4.0 continuously for > 60 min, may compromise treatment goals in patients with GERD. To compare the effects of omeprazole 20 mg b.d. or lansoprazole 30 mg b.d. on gastric acidity and the relative ability of each dosage regimen to prevent acid breakthrough. In a crossover pharmacodynamic study, 20 healthy volunteers (10 male, 10 female, mean age 38 years) were given omeprazole 20 mg b.d. or lansoprazole 30 mg b.d. for 7 days each, in a randomized manner. Each dosage regimen was separated by a minimum 7-day period where no medication was administered. On day 7 of each regimen, 24-h intragastric pH-metry was performed. The percentage of time for which gastric pH was below 4.0 and 3.0, the occurrence of daytime and nocturnal acid breakthrough, and the duration of action of each regimen were compared. Non-parametric statistics for paired data were used. The percentage time for which gastric pH was below 4.0 was significantly lower with omeprazole 20 mg b.d. (median 14.8%) than with lansoprazole 30 mg b. d. (median 24.2; P=0.0372). Fourteen subjects showed more effective acid control when taking omeprazole; these were significantly more often H. pylori-negative patients compared with those for whom acid control was better on lansoprazole (P < 0.001). Nocturnal acid breakthrough occurred in seven patients (35%) on omeprazole and in 10 (50%) on lansoprazole (N.S.). In healthy volunteers, twice-daily dosing of omeprazole 20 mg b.d. appears to be significantly more effective than lansoprazole 30 mg b.d. in controlling gastric acidity. The clinical importance of such a difference remains to be defined in GERD patients.",2000.0,0,0
224,10848654,A new highly effective short-term therapy schedule for Helicobacter pylori eradication.,A Zullo; V Rinaldi; S Winn; P Meddi; R Lionetti; C Hassan; C Ripani; G Tomaselli; A F Attili,"Although triple therapy regimens suggested in the Current European guidelines give fairly good results, several studies have reported an unsatisfactory Helicobacter pylori eradication rate (< 80%). To evaluate the efficacy of a new short-term treatment sequence on H. pylori eradication. A total of 52 patients with H. pylori infection and either non-ulcer dyspepsia (34 patients) or peptic ulcer (18 patients) were enrolled to receive a 10-day therapy: omeprazole 20 mg b.d. plus amoxycillin 1 g b.d. for the first 5 days, followed by omeprazole 20 mg b.d., clarithromycin 500 mg b.d. and tinidazole 500 mg b.d. for the remaining 5 days. H. pylori infection at entry was assessed by rapid urease test and histology on biopsies from the antrum and the corpus. Bacterial eradication was assessed by endoscopy (peptic ulcer patients) or 13C urea breath test (non-ulcer dyspepsia patients) 4-6 weeks after therapy had ended. All patients completed the study. H. pylori eradication was achieved in all but one patient, with an eradication rate of 98% (95% CI: 94.3-100) with intention-to-treat analysis. Patient compliance was good (consumption of prescribed drugs > 95%) for all but one patient, who took the triple therapy regimen for 4 days instead of 5 days. No major side-effects were reported but three (6%) patients complained of mild side-effects. The use of this 'five plus five' therapy schedule as an initial treatment for H. pylori deserves further investigation.",2000.0,0,0
225,10848657,Randomized study comparing omeprazole with ranitidine as anti-secretory agents combined in quadruple second-line Helicobacter pylori eradication regimens.,S Michopoulos; P Tsibouris; H Bouzakis; A Balta; J Vougadiotis; N Broutet; N Kralios,"Few data are available on the efficacy of second-line H. pylori eradication regimens. To compare the efficacy of either omeprazole or ranitidine in a second-line quadruple regimen in patients with duodenal ulcer or erosive duodenitis. A total of 37 patients with erosive duodenitis and 119 with duodenal ulcer who have failed eradication of H. pylori with double or triple regimens, without metronidazole, were randomly assigned to receive tripotassium dicitrato bismuthate 600 mg t.d.s. + metronidazole 500 mg t.d.s. + tetracycline hydrochloride 500 mg t.d. s. combined with either omeprazole 20 mg b.d. (group O, 78 patients) or ranitidine 300 mg b.d. (group R, 78 patients) for 14 days. H. pylori eradication was verified by histology, rapid urease test and 13C-urea breath test. t-test, chi2-test. A total of 143 patients had a post-treatment endoscopy. Eradication rates were: intention-to-treat: group O 77% (67-87), group R 76% (66-85), P=0.85; per protocol analysis: group O 86% (77-95), group R 82 (71-93), P=0.58. Side-effects were frequent but mild. Omeprazole 20 mg b.d. and ranitidine 300 mg b.d. were equally effective as antisecretory agents combined in a second-line quadruple eradication regimen.",2000.0,0,0
226,10848659,"Randomized trial of omeprazole and metronidazole with amoxycillin or clarithromycin for Helicobacter pylori eradication, in a region of high primary metronidazole resistance: the HERO study.",P H Katelaris; D Adamthwaite; P Midolo; N D Yeomans; G Davidson; J Lambert,"The efficacy of omeprazole-based eradication therapies has been determined mostly in populations with low to moderate prevalence of metronidazole resistant Helicobacter pylori, yet resistance is high in many regions. The H. pylori eradication and duodenal ulcer healing rates after 1 week of either omeprazole 40 mg mane, amoxycillin 500 mg t.d.s. and metronidazole 400 mg t.d.s. (OAM) or omeprazole 20 mg b.d., metronidazole 400 mg b. d. and clarithromycin 250 mg b.d. (OMC) were compared in a randomized trial in Australia and New Zealand. Patients had a further 1 week of omeprazole 20 mg. Outcome was assessed at 6 weeks with stringent criteria (endoscopy, biopsies and 13C-urea breath test). Of 220 subjects randomized, the H. pylori eradication rates (all patients treated/per protocol) were 82%/85% for OMC and 58%/63% for OAM (P= 0.001). Pre-treatment metronidazole resistance was present in 56% and clarithromycin resistance in 6%. The eradication rate for primary metronidazole resistance isolates treated with OMC was 80% (CI: 65-90%) compared with 45% (CI: 29-62%) for OAM, whereas for sensitive organisms, the eradication rates were 94% (CI: 79-99%) and 79% (CI: 62-91%), respectively. Duodenal ulcer healing was 96% for OMC and 87% for OAM. Compliance was excellent and both treatments were well-tolerated. OMC is a well-tolerated, effective therapy for H. pylori eradication and duodenal ulcer healing in this region despite the high metronidazole resistance rate. OAM is less effective, largely due to the impact of metronidazole resistance.",2000.0,0,0
227,10861266,Differential expression of matrix metalloproteinases and their tissue inhibitors in colon mucosa of patients with inflammatory bowel disease.,B von Lampe; B Barthel; S E Coupland; E O Riecken; S Rosewicz,"Alterations in synthesis and breakdown of extracellular matrix components are known to play a crucial role in tissue remodelling during inflammation and wound healing. Degradation of collagens is highly regulated by a cascade of matrix metalloproteinases (MMPs). The current study was therefore designed to determine gene expression patterns of MMPs and their tissue inhibitors (TIMPs) in single endoscopic biopsies of patients with inflammatory bowel disease (IBD). mRNA expression was measured by quantitative competitive polymerase chain reaction (PCR) in biopsies from patients with ulcerative colitis (n=21) and Crohn's disease (n=21). Protein expression was analysed by western blotting and immunohistochemistry. MMP-2, MMP-14, and TIMP-1 mRNAs were marginally increased in inflamed, but 9-12-fold increased in ulcerated colonic mucosa in IBD whereas TIMP-2 mRNA expression remained unchanged. MMP-1 and MMP-3 mRNA expression correlated well with the histological degree of acute inflammation, resulting in more than 15-fold increased MMP-1 and MMP-3 mRNA levels in inflamed versus normal colon samples from patients with ulcerative colitis and Crohn's disease. Profound overexpression of MMP-1 and MMP-3 mRNA transcripts suggests an important role for these enzymes in the process of tissue remodelling and destruction in inflammatory bowel disease.",2000.0,0,0
228,10861271,Role of urokinase and its receptor in basal and stimulated colonic epithelial cell migration in vitro.,A J Wilson; P R Gibson,"Migration of colonic epithelial cells is important for mucosal repair following injury. The urokinase (u-PA) system regulates migration in other cell types. To examine the role of u-PA and its receptor (u-PAR) in colonic epithelial cell migration. Migration was assessed over 24 hours in circular wounds made in confluent monolayers of LIM1215 and Caco-2 human colon cancer cells. The function of u-PA and u-PAR was ablated with antisense oligonucleotides to block expression, with synthetic u-PA peptides to block interaction, and with aprotinin to block u-PA mediated proteolysis. Migration was stimulated two to threefold by exogenous u-PA, an effect dependent on u-PAR binding but independent of u-PA mediated mitogenesis and proteolysis. Expression of u-PA and u-PAR was inhibited by 80% by the appropriate antisense oligonucleotide. Basal migration and the motogenic effects of butyrate, epidermal growth factor, and phorbol-12-myristate-13-acetate were suppressed by the u-PAR antisense oligonucleotide (40-60%) but were at best minimally affected following inhibition of u-PA expression and binding. In an in vitro model of wounded colonic epithelium, u-PAR promotes cell migration through mechanisms that are not exclusively dependent on u-PA binding. Therefore, u-PA and u-PAR may contribute to colonic mucosal repair in vivo.",2000.0,0,1
229,10867454,Simple closure or vagotomy and pyloroplasty for the treatment of a perforated duodenal ulcer: comparison of results.,C Gutiérrez de la Peña; R Márquez; F Fakih; E Domínguez-Adame; J Medina,"Treatment of the perforated duodenal ulcer continues to be a controversial subject. The purpose of our study was to compare the results of simple closure of perforated duodenal ulcer versus treatment by truncal vagotomy and pyloroplasty. We present a prospective and randomized study of 207 patients who underwent surgical treatment due to perforated duodenal ulcer. In 117 patients the surgical treatment was simple closure and postsurgery medical treatment with proton pump inhibitors for 1 month, and in 90 patients vagotomy and pyloroplasty with no additional medical treatment. We applied the Visick scale in order to compare postsurgery results. The postoperative morbidity and mortality rates were the same with both techniques. Statistically, in both cases, no significant differences were found in postsurgery symptomatology. The different rates of recurrent ulcers and the reinterventions due to recurrent ulcers presented no significant statistical values. We conclude that simple closure remains the selected treatment in the majority of patients who present with a perforated duodenal ulcer. The operation is a simple and safe procedure.",2000.0,0,0
230,10871974,Lansoprazole compared with ranitidine for the treatment of nonerosive gastroesophageal reflux disease.,J E Richter; D R Campbell; P J Kahrilas; B Huang; C Fludas,"Traditionally, proton pump inhibitors are used primarily for patients with esophagitis. However, patients with nonerosive reflux disease may also benefit from these powerful medications. To compare the safety and symptom relief efficacy of lansoprazole with ranitidine therapy and with placebo. In 2 randomized, double-blind, multicenter trials of 901 patients with symptomatic reflux disease, which was confirmed by endoscopy to be nonerosive, received lansoprazole, 15 or 30 mg once daily; ranitidine, 150 mg twice daily; or placebo for 8 weeks. Analysis of daily diary data during the first 4 weeks and for the entire 8 weeks of treatment revealed that patients who were treated with either dosage of lansoprazole reported significantly (P<.05) lower percentages of days and nights with heartburn, less pain severity of both day and night heartburn, fewer days of antacid use, and smaller amounts of antacid use compared with patients who were treated with ranitidine or placebo. The incidence of possible or probable treatment-related adverse reactions was comparable among the treatment groups; abdominal pain and diarrhea were the most commonly reported adverse events. No statistically significant differences were noted between treatment groups in laboratory analyses. Lansoprazole therapy is more effective than standard dosages of ranitidine or placebo in relieving symptoms in patients with endoscopically confirmed non-erosive reflux esophagitis.",2000.0,0,1
231,10871975,Efficacy of omeprazole for the treatment of symptomatic acid reflux disease without esophagitis.,J E Richter; D Peura; S B Benjamin; B Joelsson; J Whipple,"Up to three quarters of patients with gastroesophageal reflux disease (GERD) have symptoms, such as heartburn, but no macroscopic evidence of erosive esophagitis, making symptomatic GERD a common clinical problem in the primary care setting. To compare the efficacy and safety of omeprazole, 20 mg once daily; omeprazole, 10 mg once daily; and placebo in the treatment of symptomatic GERD without erosive esophagitis. Patients with a history of heartburn (> or =12 months) and episodes of moderate to severe heartburn on 4 or more of the 7 days before endoscopy were eligible to participate in this 4-week, randomized, double-blind, placebo-controlled trial. The absence of erosive esophagitis was established through endoscopy. Eligible patients were randomized to 1 of 3 treatment groups: omeprazole, 20 mg once daily; omeprazole, 10 mg once daily; or placebo. Patients were assessed at weeks 2 and 4. The efficacy of omeprazole for the treatment of heartburn was determined mainly through the following diary card data: daily resolution of heartburn and complete resolution of heartburn every day during 1 week of treatment. The efficacy of omeprazole for the treatment of acid regurgitation, dysphagia, epigastric pain, and nausea was also assessed. Of 359 randomized patients, 355 were included in the statistical analysis (intention-to-treat population). Daily proportions of patients with no heartburn were consistently greater in the 20-mg omeprazole group (62%, day 7; 74%, day 27) than in the 10-mg omeprazole group (41%, day 7; 49%, day 27) or the placebo group (14%, day 7; 23%; day 27). Complete resolution of heartburn every day during the last treatment week was significantly (P< or =.002) higher in the 20-mg omeprazole group (48%) than in the 10-mg omeprazole (27%) or placebo (5%) group. Omeprazole was significantly (P< or =.003) more effective than placebo for the treatment of acid regurgitation, dysphagia, epigastric pain, and nausea. Patients with symptomatic GERD require profound acid suppression to achieve symptomatic relief. Omeprazole, 20 mg once daily, was superior to omeprazole, 10 mg once daily, and to placebo in providing early and sustained resolution of heartburn, as well as treatment of other troublesome GERD symptoms.",2000.0,0,1
232,10872661,Parietal cell protrusions and fundic gland cysts during omeprazole maintenance treatment.,A Cats; B E Schenk; E Bloemena; R Roosedaal; J Lindeman; I Biemond; E C Klinkenberg-Knol; S G Meuwissen; E J Kuipers,"Parietal cell protrusion (PCP), swelling and bulging of parietal cells, has been observed in the oxyntic mucosa of patients receiving omeprazole. The frequency of this event and the underlying mechanisms remain to be clarified. As such, it is unknown whether there is a relation with either serum gastrin or Helicobacter pylori infection, and whether PCP predisposes to the development of fundic gland cysts (FGC). We therefore investigated the development of PCP and FGC in gastroesophageal reflux disease (GERD) patients treated with omeprazole and correlated findings to duration of therapy, gastrin, and H pylori infection. In a randomized, double-blinded study, GERD patients were evaluated by endoscopy with biopsy sampling for histology and culture at baseline, and after 3 and 12 months' therapy with omeprazole 40 mg daily. H pylori-positive patients were randomized to additional eradication therapy or placebo antibiotics at baseline. All histological slides were scored blinded for time and outcome of culture for the presence of PCP and FGC. Fasting serum samples from all visits were used for gastrin measurements. The prevalence of PCP increased during omeprazole therapy from 18% at baseline to 79% and 86% at 3 and 12 months (P < .001, baseline v both 3 and 12 months). The prevalence of FGC increased from 8% to 17% and 35% (P < .05, baseline v 12 months). The prevalence of PCP and FGC did not differ among the H pylori-positive and H pylori-negative patients at baseline (PCP 16% v 20% and FGC 7% v 8%, respectively). Whereas H pylori eradication did not significantly affect development of PCP (P = .7), FGC developed significantly more often in the H pylori-eradicated patients when compared with persistent H pylori-positive patients (P < .05). PCP development was related to serum gastrin rise during therapy. In conclusion, PCP occurs in most patients within the first months of omeprazole treatment and is related to increased gastrin levels. FGC develops more gradually and is enhanced by H pylori eradication.",2000.0,0,0
233,10880321,Value of quantitative serology for confirmation of Helicobacter pylori eradication: an 18-month follow-up study.,J P Gisbert; M Blanco; L M Benito; J M Pajares,"In this study several therapies were administered to 124 H. pylori-positive patients and IgG antibody titers were measured by ELISA at months 0, 2, 3, 6, 12, and 18 months. Serum titers of IgG antibody progressively decreased after H. pylori eradication; at 3 months, the area under the receiver operating characteristic curve for the decrease of IgG antibody titers for confirming H. pylori eradication was 0.99, with 100% sensitivity and 99% specificity (when the cutoff point was set at 3 U/mL). We conclude that a decrease in serum titers of IgG antibody to H. pylori relatively early after completion of therapy (1 month after ranitidine or bismuth therapy is completed and 2.5 months after antibiotic therapy is completed) can be used as a noninvasive, simple, and inexpensive method to confirm H. pylori eradication.",2000.0,0,0
234,10882957,Noninvasive tests as a substitute for histology in the diagnosis of Helicobacter pylori infection.,M Hahn; M B Fennerty; C L Corless; N Magaret; D A Lieberman; D O Faigel,"Rapid urease tests for Helicobacter pylori have a sensitivity of 80% to 90%. Therefore histologic examination of gastric biopsies is recommended as a ""backup"" diagnostic test in rapid urease test-negative patients. However, noninvasive tests (urea breath test, serology, whole blood antibody tests) may provide a more rapid diagnosis and be less expensive but offer similar accuracy. Sixty-seven patients (no prior treatment for H pylori, no proton pump inhibitors, antibiotics, or bismuth within 4 weeks) undergoing endoscopy for evaluation of dyspepsia symptoms and testing rapid urease test-negative by antral biopsy were enrolled. All had the following tests: gastric biopsies (2 antral, 1 fundus; H&E and Alcian Yellow stain) examined for gastritis and H pylori; (13)C-UBT; capillary blood for whole blood rapid antibody tests: FlexSure HP, QuickVue, AccuStat, and Stat-Simple Pylori; serum for FlexSure HP; HM-CAP enzyme-linked immunoassay. H pylori infection was diagnosed (reference standard) if chronic gastritis was present on histology and at least 2 of the 3 following tests were positive: urea breath test, H pylori organisms unequivocally demonstrated in biopsies on special stain, and/or enzyme-linked immunoassay. The test and treatment costs per patient were calculated. Of 67 patients with a negative rapid urease test, 4 were positive for H pylori. None had active peptic ulcer disease. Histology only identified 1 patient with organisms visible on special stain. Using chronic active gastritis (neutrophilic and mononuclear infiltrate) as a diagnostic criterion for H pylori, 6 patients would have been judged positive. However, only 2 of these were truly positive by the reference standard (positive predictive value 33%). Negative predictive value for presence of organisms and chronic active gastritis was 95% and 97%, respectively. All of the noninvasive tests identified all 4 truly positive patients correctly. Urea breath test and FlexSure whole blood assay yielded a substantial number of false-positive results (positive predictive value 31% and 36%, respectively); positive predictive value for the other tests ranged from 50% to 80%. All tests except histology had a negative predictive value of 100%. Histology was the most costly test (p < 0. 001 compared with all other tests), followed by urea breath test and HM-CAP serology (p < 0.001 compared with all rapid antibody tests). Whole blood or serum antibody testing is a rapid, accurate, and cost-effective means for establishing H pylori status in rapid urease test-negative patients. Whole blood or serology rapid antibody testing should substitute for histology when the patient has not been previously treated for H pylori.",2000.0,0,0
235,10886041,Esomeprazole provides improved acid control vs. omeprazole In patients with symptoms of gastro-oesophageal reflux disease.,T Lind; L Rydberg; A Kylebäck; A Jonsson; T Andersson; G Hasselgren; J Holmberg; K Röhss,"Esomeprazole (Nexium) is a new proton pump inhibitor for the treatment of acid-related diseases. In this double-blind crossover study, 38 patients with gastro-oesophageal reflux disease (GERD) symptoms were randomized to esomeprazole 40 and 20 mg and omeprazole 20 mg once daily for 5 days. On day 5 of each dosing period, 24-h intragastric pH and pharmacokinetic variables were measured. Thirty-six patients aged 29-58 (mean 45) years completed the study. Esomeprazole 40 and 20 mg maintained intragastric pH > 4 for (mean) 16.8 and 12.7 h, respectively, vs. 10.5 h for omeprazole 20 mg (P < 0.001 and P < 0. 01). Twenty-four-hour median intragastric pH was significantly higher with esomeprazole 40 mg (4.9) and 20 mg (4.1) than with omeprazole 20 mg (3.6) (P < 0.001 and P < 0.01). Area under the plasma concentration-time curve (AUC) was 80% higher for esomeprazole 20 mg vs. omeprazole, while that for esomeprazole 40 mg was more than five times higher (each P < 0.0001). Interpatient variability in intragastric pH and AUC was less with esomeprazole than with omeprazole. Esomeprazole was well tolerated and there were no safety concerns. Esomeprazole provides more effective acid control than omeprazole, with reduced interpatient variability, thereby offering the potential for improved efficacy in acid-related diseases.",2000.0,0,1
236,10886054,Helicobacter pylori eradication increases nocturnal acid breakthrough.,M A van Herwaarden; M Samsom; A J Smout,,2000.0,0,0
237,10903297,Digestive system disorders: gastroesophageal reflux disease.,D A Katzka,"This article comes from Clinical Evidence (1999; 1 : 145-153), a new resource for clinicians produced jointly by the BMJ Publishing Group and the American College of Physicians-American Society of Internal Medicine. Clinical Evidence is an extensively peer-reviewed publication that summarizes the best available evidence on the effects of common clinical interventions gleaned from thorough searches and appraisal of the world literature. It became available in the United States late last year. Please see advertisement for more information or, alternatively, visit the web site at www. evidence.org.",2000.0,0,0
238,10905240,Effect of population screening and treatment for Helicobacter pylori on dyspepsia and quality of life in the community: a randomised controlled trial. Leeds HELP Study Group.,P Moayyedi; R Feltbower; J Brown; S Mason; J Mason; J Nathan; I D Richards; A C Dowell; A T Axon,"Infection with Helicobacter pylori is the main cause of peptic-ulcer disease. Treatment of this infection might lower the prevalence of dyspepsia in the community and improve quality of life. We investigated this possibility in a double-blind randomised controlled trial. Individuals aged 40-49 years were randomly selected from the lists of 36 primary-care centres. A researcher interviewed participants with a validated dyspepsia questionnaire and the psychological general wellbeing index (PGWB). H. pylori status was assessed by the carbon-13-labelled urea breath test. Infected participants were randomly assigned active treatment (omeprazole 20 mg, clarithromycin 250 mg, and tinidazole 500 mg, each twice daily for 7 days) or identical placebo. Participants were followed up at 6 months and 2 years. Of 32,929 individuals invited, 8455 attended and were eligible; 2324 were positive for H. pylori and were assigned active treatment (1161) or placebo (1163). 1773 (76%) returned at 2 years. Dyspepsia or symptoms of gastro-oesophageal reflux were reported in 247 (28%) of 880 in the treatment group and 291 (33%) of 871 in the placebo group (absolute-risk reduction 5% [95% CI 1-10]). H. pylori treatment had no significant effect on quality of life (mean difference in PGWB score between groups 0.86 [-0.33 to 2.05]). Community screening and treatment for H. pylori produced only a 5% reduction in dyspepsia. This small benefit had no impact on quality of life.",2000.0,0,0
239,10910310,Effectiveness and costs of omeprazole vs ranitidine for treatment of symptomatic gastroesophageal reflux disease in primary care clinics in West Virginia.,B Kaplan-Machlis; G E Spiegler; M W Zodet; D A Revicki,"To compare clinical, health-related quality of life (HRQL), and medical cost outcomes in patients with symptomatic gastroesophageal reflux disease (GERD) receiving omeprazole sodium or ranitidine hydrochloride treatment. A multicenter, randomized, open-label, medical effectiveness trial conducted in 5 university-based family medicine clinics. Two hundred sixty-eight patients with GERD were recruited and randomly assigned to omeprazole sodium, 20 mg once daily, or ranitidine hydrochloride, 150 mg twice daily, for up to 6 months. Main outcome assessments included the Gastrointestinal Symptom Rating Scale (GSRS) Reflux score, Psychological General Well-Being Index, and Short-Form-36 Health Survey administered at baseline and 2, 4, 12, and 24 weeks. Medical resource use and cost data were collected. More omeprazole-treated patients reported improved heartburn resolution at 2 weeks (49.0% vs 33.3%; P=.007) and 4 weeks (58.6% vs 35.0%; P<.001) compared with ranitidine-treated patients. The GSRS Reflux scores across 3 months showed overall differences between omeprazole (mean, 2.67) and ranitidine (mean, 2.95) groups (P=.04). Mean total 6-month medical costs were $915 lower ($8371 vs $9286; P=.64), and no difference in mean outpatient medical costs ($1198 vs $1158; P=.76) were observed in the omeprazole group compared with the ranitidine group. A post hoc secondary analysis showed that, at 12 and 24 weeks, patients treated with omeprazole for 8 weeks or more reported greater heartburn resolution (ie, 24 [43%] of 56 patients at both intervals) than patients treated with ranitidine for 8 weeks or more (12 [24%] and 13 [26%] of 50 patients, respectively; P=.001). Ranitidine and omeprazole were both effective at improving heartburn symptoms; however, omeprazole provided greater resolution of heartburn symptoms at 2 and 4 weeks. Despite omeprazole's higher acquisition cost, there were no significant differences in total or outpatient costs between groups.",2000.0,0,1
240,10912656,Distribution of atrophy in Helicobacter pylori-infected subjects taking proton pump inhibitors.,C J Larkin; ; J M Sloan; M Stevenson; J E Ardill; D Buchanan,"Gastric atrophy is associated with Helicobacter pylori infection. Conflicting results have been obtained as to whether acid suppressant therapy hastens the development or changes the distribution of atrophy in the stomach. The aim of this study was to investigate whether concomitant proton pump inhibitor (PPI) therapy in H. pylori-infected individuals resulted in an increase or an alteration in atrophy distribution and whether this was reflected by the plasma gastrin. Multiple gastric biopsy specimens were taken from the antrum and corpus from 46 H. pylori-infected subjects, 18 of whom were taking PPIs, and assessed histologically by the updated Sydney System. The control group was age- and sex-matched to the index group. Fasting gastrin levels were measured. In the control group there was no significant tendency for either antral or corpus atrophy to predominate (P = 0.44). In the treatment group there was a significant tendency for corpus as opposed to antral atrophy to develop (P < 0.001). There was no significant difference in the overall atrophy score between the treated and untreated groups (P = 0.76). Fasting gastrin levels were significantly higher in the treated group (P < 0.001). Treatment with PPIs in H. pylori-infected subjects does not lead to an overall increase in gastric atrophy. It does, however, result in an increased prevalence of corpus as opposed to antral atrophy. This is associated with a significantly higher gastrin level.",2001.0,0,0
241,10922420,Effect of intravenous omeprazole on recurrent bleeding after endoscopic treatment of bleeding peptic ulcers.,J Y Lau; J J Sung; K K Lee; M Y Yung; S K Wong; J C Wu; F K Chan; E K Ng; J H You; C W Lee; A C Chan; S C Chung,"After endoscopic treatment of bleeding peptic ulcers, bleeding recurs in 15 to 20 percent of patients. We assessed whether the use of a high dose of a proton-pump inhibitor would reduce the frequency of recurrent bleeding after endoscopic treatment of bleeding peptic ulcers. Patients with actively bleeding ulcers or ulcers with nonbleeding visible vessels were treated with an epinephrine injection followed by thermocoagulation. After hemostasis had been achieved, they were randomly assigned in a double-blind fashion to receive omeprazole (given as a bolus intravenous injection of 80 mg followed by an infusion of 8 mg per hour for 72 hours) or placebo. After the infusion, all patients were given 20 mg of omeprazole orally per day for eight weeks. The primary end point was recurrent bleeding within 30 days after endoscopy. We enrolled 240 patients, 120 in each group. Bleeding recurred within 30 days in 8 patients (6.7 percent) in the omeprazole group, as compared with 27 (22.5 percent) in the placebo group (hazard ratio, 3.9; 95 percent confidence interval, 1.7 to 9.0). Most episodes of recurrent bleeding occurred during the first three days, which made up the infusion period (5 in the omeprazole group and 24 in the placebo group, P<0.001). Three patients in the omeprazole group and nine in the placebo group underwent surgery (P=0.14). Five patients (4.2 percent) in the omeprazole group and 12 (10 percent) in the placebo group died within 30 days after endoscopy (P=0.13). After endoscopic treatment of bleeding peptic ulcers, a high-dose infusion of omeprazole substantially reduces the risk of recurrent bleeding.",2000.0,0,0
242,10929909,"The benefit/risk profile of rabeprazole, a new proton-pump inhibitor.",D Johnson; C Perdomo; J Barth; L Jokubaitis,"Acid-related diseases such as gastro-oesophageal reflux disease (GORD) and peptic ulcer are a common cause of morbidity and if inadequately treated can lead to serious complications. The proton-pump inhibitor rabeprazole has been extensively evaluated in well-controlled trials in North America and Europe for the acute treatment of erosive or ulcerative GORD and gastric and duodenal ulcers and for the long-term maintenance of GORD healing. The results show that rabeprazole has a favourable benefit/risk profile for each indication. Rabeprazole 10 and 20 mg given once daily in the morning was highly effective in producing and maintaining healing, providing symptom relief, and improving overall well-being. Healing rates for rabeprazole were equivalent to omeprazole in all indications, and superior (GORD healing and duodenal ulcer healing) or equivalent (gastric ulcer healing) to the histamine 2-receptor antagonist ranitidine. Symptom relief provided by rabeprazole was equivalent or superior to comparator drugs. Rabeprazole was well tolerated in both short- and long-term studies. The incidence of treatment-emergent signs and symptoms related to rabeprazole was low, and these were generally mild or moderate in severity. The overall rate of discontinuations due to adverse events was approximately 3%. There were no deaths related to rabeprazole therapy. These findings indicate a favourable benefit/risk profile for each intended use.",2001.0,0,0
243,10930892,Review article: treatment of Helicobacter pylori infection with ranitidine bismuth citrate- or proton pump inhibitor-based triple therapies.,A H Van Oijen; A L Verbeek; J B Jansen; W A De Boer,"Triple therapy, combining a proton pump inhibitor with clarithromycin (C) and either amoxycillin (A) or a nitro-imidazole (I) is the standard in Helicobacter pylori eradication therapy. Recently, triple therapies based on ranitidine bismuth citrate (RBC) have emerged as an alternative. This review examines the current literature for studies directly comparing proton pump inhibitor- with RBC-based triple therapies. Seventeen studies were identified, of which three have been published as a full paper. Eradication rates in an intention-to-treat analysis ranged from 51 to 98%. No large difference in cure rates between the different regimens was demonstrated, although the RBC-I-C combination was somewhat superior. No definite conclusions could be made about the impact of metronidazole or clarithromycin resistance since only three studies performed a formal resistance analysis. No serious side-effects were reported, and dropout rates were equal for the two regimens. Both RBC- and proton pump inhibitor-based triple therapies are highly effective. If one prefers a imidazole/clarithromycin combination the evidence presented here suggests that RBC should be used instead of a proton pump inhibitor. Larger studies comparing both forms of triple therapy, using proper resistance analysis, are needed before final conclusions can be reached regarding efficacy in the setting of bacterial resistance.",2000.0,1,1
244,10930901,"Equally high efficacy of 4, 7 and 10-day triple therapies to eradicate Helicobacter pylori infection in patients with ulcer disease.",G J Hurenkamp; A Van Der Ende; H G Grundmeijer; G N Tytgat; R W Van Der Hulst,"In patients with ulcer disease the optimal dose and duration of Helicobacter pylori treatment containing omeprazole (O), metronidazole (M) and clarithromycin (C) has yet to be established. The efficacy might be influenced by metronidazole- and clarithromycin-resistance. To study the effect of duration of OMC treatment on its efficacy and influence of metronidazole-resistance and clarithromycin-resistance on the optimal duration. Ulcer patients (n=76) were randomized to three double-blind treatments of 10 days: OMC 4 consisted of 4 days b.d. 20 mg omeprazole, 400 mg metronidazole and 250 mg clarithromycin switched over to 6 days b.d. 20 mg omeprazole and placebo antibiotics (n=27); OMC 7 consisted of 7 days b.d. omeprazole 20 mg, metronidazole 400 mg and clarithromycin 250 mg and 3 days b.d. omeprazole 20 mg and placebo antibiotics (n=25); OMC 10 consisted of 10 days b.d. omeprazole 20 mg, metronidazole 400 mg and clarithromycin 250 mg (n=24). H. pylori was assessed by biopsies for culture and histology pre- and 4-6 weeks after OMC therapy. Metronidazole-resistance and clarithromycin-resistance were assessed by the E-test. Intention-to-treat-eradication rates were: OMC 4, 96%; OMC 7, 92%; and OMC 10, 96% (N.S.). All of the three per protocol eradication rates were 100% (95% CI: 85.2-100). Of 75 isolates, 16 were metronidazole-resistant and one was clarithromycin-resistant. In H. pylori-positive ulcer patients, OMC 4 is highly efficacious and as effective as OMC 7 and OMC 10. No influence of metronidazole-resistance or clarithromycin-resistance was observed.",2000.0,0,0
245,10930903,Pantoprazole versus one-week Helicobacter pylori eradication therapy for the prevention of acute NSAID-related gastroduodenal damage in elderly subjects.,A Pilotto; F Di Mario; M Franceschi; G Leandro; G Battaglia; B Germanà; R Marin; G Valerio,"To compare the efficacy of pantoprazole vs. a one-week Helicobacter pylori eradication therapy for the prevention of NSAID-related gastroduodenal damage. Patients over 60 years old with symptoms and/or a history of ulcer who needed NSAID treatment were evaluated by endoscopy. H. pylori positive subjects who had no severe gastroduodenal lesions were randomized to take, concomitantly with NSAID therapy, either: (i) pantoprazole 40 mg daily plus amoxycillin 1 g b.d. and clarithromycin 250 mg b.d. for 1 week (35 subjects, Group PAC) or (ii) pantoprazole 40 mg daily for 1 month (34 subjects, Group P). Endoscopy was repeated after 1 month. A significantly higher incidence of severe gastroduodenal damage was found in Group PAC than in Group P (29% vs. 9%, P<0.05). The percentages of patients worsened, unchanged and improved after 1 month were, respectively: Group PAC: 46%, 46%, and 9% and Group P: 7%, 65%, and 29% (P<0.0008). The percentage of H. pylori-negative subjects was 89% in Group PAC and 52% in Group P (P=0.0009). The incidence of gastroduodenal damage was higher in Group PAC treatment failures than in cured patients (50% vs. 25.8%, P=ns). One month of pantoprazole was more effective than a proton pump inhibitor-based triple therapy in the prevention of gastroduodenal damage in elderly H. pylori-positive NSAID users.",2000.0,0,1
246,10940693,Treatment of neuroendocrine GEP tumours with somatostatin analogues: a review.,R Arnold; B Simon; M Wied,"Somatostatin and its long-acting analogues are effective in symptom control in patients with functionally active neuroendocrine GEP tumours. Several in vitro and in vivo reports suggest that they are also able to control tumour growth. Critical review of published data on the effect of long-acting somatostatin analogues on symptom and growth control in patients with metastatic neuroendocrine GEP tumours. With the exception of insulinoma and gastrinoma, octreotide acetate and other long-acting somatostatin formulations are currently the therapeutic principle of first choice to control hormone-mediated symptoms. The consequences of gastric acid hypersecretion in patients with Zollinger-Ellison syndrome are best controlled by proton pump inhibitors. Available data on growth control indicate that stabilization of tumour growth seems to be the most beneficial antiproliferative effect occurring in up to 50% of patients. This effect is limited. However, it is unknown which tumour entity responds best to long- acting somatostatin analogues. Additional studies in patients with known spontaneous tumour growth and avoiding a mix-up of different entities of neuroendocrine malignancies are necessary to identify subpopulations of neuroendocrine tumours which respond to long-acting somatostatin analogues in terms of longer lasting growth inhibition.",2000.0,0,0
247,10941852,Aims in the management of gastroesophageal reflux disease: a gastroenterologist's viewpoint.,R C Heading,"Relieving heartburn and healing esophagitis may appear to be primary aims in the management of gastroesophageal reflux disease, but systematic consideration of the issues demonstrates that there are discrepancies between the fundamental aims of medical management and the aims selected for study in trials of drug efficacy. The initial aims of management are those concerned with diagnosis, patient assessment and the provision of explanation and advice. The therapeutic objectives are alleviating symptoms, preventing complications and, if possible, avoiding recurrence, and should ideally be judged in terms of health gain, including quality of life improvement. Obtaining value for money, by maximizing the health gain in relation to the cost of the overall medical intervention must also be acknowledged as a desirable aim of management, with the proviso that physicians must always treat each patient as an individual and individualize clinical management appropriately.",2000.0,0,0
248,10950032,"Rabeprazole versus ranitidine for the treatment of erosive gastroesophageal reflux disease: a double-blind, randomized clinical trial. Raberprazole Study Group.",A Farley; L D Wruble; T J Humphries,"The objective of this study was to compare the efficacy and safety of the proton pump inhibitor rabeprazole to that of the histamine-2 (H2)-receptor antagonist ranitidine in the treatment of erosive gastroesophageal reflux disease. The primary indicator of efficacy was the absence of esophageal erosions or ulcerations as determined by posttreatment endoscopy. Secondary indicators of efficacy included improvement in frequency and severity of daytime and nighttime heartburn. A total of 338 patients were enrolled and randomly assigned to therapy with rabeprazole 20 mg once daily in the morning or to ranitidine 150 mg four times daily. At baseline and at 4 wk, patients underwent endoscopy for evaluation of esophageal lesions. Patients whose lesions healed by wk 4 had therapy discontinued; others remained on therapy and had repeat endoscopy at 8 wk. Also recorded at study visits were patients' ratings of heartburn symptoms and overall sense of well being, patients' reports of time lost from daily activities, antacid use, and adverse events. Serum gastrin levels were measured and argyrophil enterochromaffin-like cell histology evaluated at baseline and when the patient ended therapy. At wk 4, healing was observed in 59% (98/167) of patients assigned to rabeprazole therapy, compared with 36% (60/169) of those receiving ranitidine (p < 0.001). By 8 wk, healing was seen in 87% (146/167) and 66% (112/169) of patients in the rabeprazole and ranitidine groups, respectively (p < 0.001). There were also significant differences between the two groups favoring rabeprazole with respect to resolution or improvement of heartburn symptoms and improvement in sense of well-being. No drug-related serious adverse events were seen with either therapy; fewer patients assigned to rabeprazole had treatment-emergent signs and symptoms. Serum gastrin levels increased over baseline in the rabeprazole group, but the mean value remained within normal limits. Rabeprazole was superior to ranitidine in esophageal healing and symptom relief in patients with erosive gastroesophageal reflux disease, and was equally well tolerated.",2000.0,1,1
249,10953829,,,,,0,0
250,10958215,"Long-term management of gastro-oesophageal reflux disease with omeprazole or open antireflux surgery: results of a prospective, randomized clinical trial. The Nordic GORD Study Group.",L Lundell; P Miettinen; H E Myrvold; S A Pedersen; K Thor; M Lamm; A Blomqvist; J G Hatlebakk; E Janatuinen; K Levander; P Nyström; I Wiklund,"The efficacy of antireflux surgery (ARS) and omeprazole treatment in the control of gastrooesophageal reflux disease (GORD) are well established. We have compared these two therapeutic options in a randomized, clinical trial. Three hundred and ten patients with erosive oesophagitis were enrolled into the trial. After a run-in period when all patients had < or = 40 mg of omeprazole daily to heal the oesophagitis and relieve symptoms, 155 patients were randomized to continuous omeprazole therapy and 155 to open antireflux surgery, of whom 144 later had an operation. One hundred and thirty-nine and 129 in the omeprazole and antireflux surgery groups, respectively, completed the 3-year follow-up. Symptoms, 24-h pH monitoring and endoscopy were used to document the outcome. Quality of life was evaluated by the psychological general well-being (PGWB) index and the gastrointestinal symptom rating scale (GSRS). Analysis of time to treatment failure (defined as moderate to severe GORD symptoms for > or = 3 days during the last 7 days, oesophagitis or changed therapy) revealed a significant difference in favour of antireflux surgery (P = 0.0016). Seventeen patients originally submitted to antireflux surgery experienced symptom relapse alone, 14 had oesophagitis at endoscopy and another six had omeprazole for different reasons, leaving 97 patients in clinical remission after 3 years. The corresponding figures in the omeprazole arm were 50 relapses, 18 with oesophagitis, two had surgery, leaving 77 patients in remission. Allowing a dose adjustment in the case of relapse in those on omeprazole therapy to either 40 or 60 mg, the curves describing the failure rates were not significantly different from each other. Quality of life assessment showed a comparable outcome in the two study groups. In this randomized multicentre trial we found antireflux surgery to be very efficacious in controlling GORD, a level of control which could also be achieved by omeprazole provided that advantage was taken of the opportunity of adjusting the dose.",2001.0,0,0
251,10958216,Rabeprazole for the prevention of recurrent erosive or ulcerative gastro-oesophageal reflux disease. Rabeprazole Study Group.,C Birbara; J Breiter; C Perdomo; W Hahne,"To evaluate the efficacy and tolerability of rabeprazole 10 mg and 20 mg versus placebo for the prevention of endoscopically demonstrable relapse in patients previously diagnosed with erosive or ulcerative gastro-oesophageal reflux disease (GORD) who had no oesophageal erosions or ulcerations at study entry. The study also assessed the effectiveness of rabeprazole in preventing GORD symptom recurrence and reductions in quality of life. The trial used a multicentre, randomized, double-blind, parallel-group design and enrolled 288 male and female outpatients of > or =18 years of age. Patients were assigned to treatment with either rabeprazole 10 mg or 20 mg once daily in the morning (QAM) or placebo and followed for 52 weeks. Both rabeprazole doses were significantly more effective than placebo in preventing endoscopically demonstrable GORD relapse (P<0.001 versus placebo). The cumulative relapse rate for rabeprazole 10 mg at week 52 was 23%; for rabeprazole 20 mg, 14%; and for placebo, 71%. Both rabeprazole doses were also significantly superior to placebo in preventing relapse of heartburn frequency (P<0.001 for all comparisons between rabeprazole and placebo), with no significant differences between the two doses. Rabeprazole was also significantly more effective than placebo in preventing relapse of day-and night-time heartburn severity, maintaining overall patient well-being, and reducing antacid use. Both rabeprazole doses were well tolerated; most treatment-emergent adverse events were mild or moderate. There were no clinically significant changes in clinical laboratory values, thyroid function tests, vital signs, or electrocardiograms. Once-daily treatment with rabeprazole 10 mg or 20 mg is effective and well tolerated in preventing relapse of erosive or ulcerative GORD and associated symptoms and maintaining quality of life.",2001.0,0,1
252,10963283,The proton-pump inhibitors: similarities and differences.,J Horn,"This paper examines the clinical pharmacology of the proton-pump inhibitors (PPIs) and briefly reviews some comparative studies of these agents. PPIs have emerged as the treatment of choice for acid-related diseases, including gastroesophageal reflux disease (GERD) and peptic ulcer disease. Although these drugs-omeprazole, lansoprazole, pantoprazole, and rabeprazole-share a common structure (all are substituted benzimidazoles) and mode of action (inhibition of H+,K+-adenosine triphosphatase [ATPase]), each differs somewhat in its clinical pharmacology. In comparative clinical trials found in MEDLINE, PPIs administered once daily produced endoscopic evidence of healing in >90% of patients with duodenal ulcer after 4 weeks of treatment, in >90% of those with gastric ulcer after 6 weeks of treatment, and in >90% of those with ulcerative or erosive GERD after 8 weeks of treatment. Maintenance therapy with daily doses of a PPI has been shown to be an effective means of preventing GERD relapse. PPIs also inhibit the growth of Helicobacter pylori, now recognized as an important factor in peptic ulcer disease, and, when administered in combination with antibiotics, provide the best treatment for eradication of the bacterium. Rabeprazole has a more rapid onset of H+,K+-ATPase inhibition than the other PPIs and, compared with omeprazole, a greater effect on intragastric pH after the first dose. Omeprazole and lansoprazole have a greater potential for drug-drug interactions than do pantoprazole and rabeprazole. Although the individual PPIs have similar efficacy in many cases, differences between them should be considered when choosing a treatment regimen.",2001.0,0,0
253,10965828,Quality of life and severity of symptoms in gastro-oesophageal reflux disease: a clinical review.,V Velanovich,"My purpose is to review the quality of life (QoL) instruments used in the assessment of gastro-oesophageal reflux disease (GORD) and assess the effects of GORD on quality of life. Many instruments have been used in the assessment of quality of life in patients with GORD, and these have varied both in quality and purpose. In general, the choice of instrument depends on its purpose. Several investigators, using generic quality of life instruments, have shown that GORD significantly reduces QoL, and its effects are comparable with those of congestive heart failure. However, these generic instruments do not seem to be sensitive enough to measure the effects of treatments on GORD. For this, disease-specific instruments are more appropriate. Both medical and surgical treatment has been shown to improve QoL. The choice of instrument is entirely dependent on the investigator's reason for measuring QoL in GORD patients.",2001.0,0,0
254,10968173,Management of Helicobacter pylori infection--a Working Party Report of the Malaysian Society of Gastroenterology and Hepatology.,K L Goh; S Mahendra Raj; N Parasakthi; S T Kew; P Kandasami; Z Mazlam,"The Working Party Report on the Management of Helicobacter pylori serves as a clinical practice guideline for Malaysian doctors. H. pylori is not uncommon in the Malaysian population. Marked racial differences and the consistently low prevalence rates amongst Malays are noted. The working party recommends that if endoscopy is to be performed, a rapid urease test should be used for diagnosis. Where suspicion of the infection is strong and the urease test is negative, histology should be performed on gastric biopsies. Culture should be used to monitor resistance patterns to antibiotics and regional laboratories should assume this responsibility. The urea breath tests are highly accurate tests for diagnosis of H. pylori but is as yet not widely available in Malaysia. The working party strongly recommends that all peptic ulcer patients infected with H. pylori whether active, in remission and complicated ulcers should be treated for the infection. Patients with low-grade gastric mucosal lymphoid tissue lymphoma should also be treated for H. pylori infection. It is considered advisable that patients on long term nonsteroidal antinflammatory drug (NSAID) treatment with a history of peptic ulcers or dyspepsia and patients following resection of early gastric cancer or those with a family history of gastric cancer should also be tested and treated for H. pylori. The working party recommends, as first line treatment a 7-day combination therapy of a proton pump inhibitor, clarithromycin and metronidazole or amoxicillin. High metronidazole resistance rates locally may adversely affect regimens containing the antibiotic. It should also be noted that regimens that yield lower eradication rates may result in higher long term expenditure.",2000.0,0,0
255,10968429,Long-term safety and efficacy of omeprazole in gastro-oesophageal reflux disease.,D Armstrong,,2000.0,0,1
256,10971227,Acid suppression in peptic ulcer haemorrhage: a 'meta-analysis'.,N M Selby; A K Kubba; C J Hawkey,"The use of acid-decreasing agents in the management of peptic ulcer haemorrhage continues to be controversial. Most clinical trials examining the efficacy of these drugs contain small numbers of patients, making it difficult to draw conclusions about their efficacy. We report a meta-analysis that examined the effect of these drugs in the management of peptic ulcer haemorrhage. Included studies were located using a search of the Medline database between 1980 and 1999. Studies were published in English, randomized and controlled by a placebo group. Mantel-Haenszel and blinded random models were used in conducting the statistical processing of this meta-analysis. Twenty-one randomized placebo-controlled trials were included. The total number of patients was 3566 and the mean study size was 170 (range 20-1005). Seventeen of the papers assessed the efficacy of H2-antagonists, three assessed proton pump inhibitors and one was concerned with antacid therapy. The meta-analysis showed a significant reduction in re-bleeding rates (odds ratio, OR 0.727, 0.618-0.855, P < 0.001) and surgery rates (OR 0.707, 0.582-0.859, P < 0.001) when acid decreasing agents are used for acute peptic ulcer haemorrhage. Mortality rates appear to be unaffected (OR 1.140, 0.818-1.588, P=0. 49). This meta-analysis demonstrates a significant beneficial effect of acid-decreasing agents in lowering re-bleeding and surgery rates, but demonstrated no effect upon mortality.",2000.0,0,1
257,10971231,Eradication of Helicobacter pylori with pantoprazole and two antibiotics: a comparison of two short-term regimens.,M Frevel; H Daake; H D Janisch; H U Kellner; H G Krezdorn; D Tanneberger; R Wack,"High rates of Helicobacter pylori eradication can be achieved by combining proton pump inhibitors with two antibiotics. However, in the search for an optimal therapy a direct comparison of different regimens is necessary. For this open study, 331 patients with duodenal ulcer were screened and randomly allocated to either pantoprazole 40 mg b.d., clarithromycin 500 mg b.d., and metronidazole 500 mg b.d. (PCM) or pantoprazole 40 mg b.d., amoxycillin 1000 mg b.d., and clarithromycin 500 mg b.d. (PAC) for 7 days. Both combinations were followed by a 7-day therapy with pantoprazole 40 mg o.d. alone. Eradication of H. pylori was assessed by use of a 13C-urea breath test 4 weeks after the intake of the last medication. Eradication rates were 90% in intention-to-treat patients from the PCM (132 out of 147; 95% CI: 84-94%) and the PAC group (135 out of 150; 95% CI: 84-94%). H. pylori was eradicated in 112 out of 117 per protocol patients of the PCM group (96%; 95% CI: 90-99%) and in 119 out of 126 patients of the PAC group (94%; 95% CI: 89-98%). Rapid relief from ulcer pain and a decrease in the mean intensity of other gastrointestinal symptoms was observed. Sixty-nine patients reported adverse events, none of which were related to the intake of pantoprazole. Four serious adverse events, none related to the trial medication, were observed. Both pantoprazole-based short-term triple therapies are highly effective and well-tolerated treatment regimens in the eradication of H. pylori.",2000.0,0,0
258,10974147,Strategy for treatment of Helicobacter pylori infection in adults. I. Updated indications for test and eradication therapy suggested in 2000.,S Nakajima; D Y Graham; T Hattori; T Bamba,"Since the report of culture of Helicobacter pylori in 1983, there has been increasing agreement that H. pylori infection is etiologically associated with a number of important diseases including chronic active gastritis, peptic ulcer disease, mucosa-associated lymphoid tissue (MALT) lymphoma, gastric polyps, gastric cancer, as well as suggestions that it may be involved in diseases outside the upper gastrointestinal tract. There have been a number of national and international consensus meetings to propose guidelines to treat H. pylori infection. The recommendations of these conferences are reviewed here and updated to include new indications and concepts regarding H. pylori eradication therapy. Eradication therapy is considered the standard of care for active or inactive peptic ulcer patients including those who use non-steroidal anti-inflammatory drugs (NSAIDs). Other strong indications include MALT lymphoma, hyperplastic polyps, hyperplastic gastropathy, post-endoscopic resection for gastric malignancy, and acute H. pylori gastritis. Other considerations include plan to use chronic NSAID therapy, plan for chronic anti-secretory therapy, and some extra-gastroduodenal diseases such as chronic ureterica. Non-investigated dyspepsia is an indication for diagnostic evaluation and eradication therapy for those with H. pylori infection, whereas non-ulcer dyspepsia (NUD) in which peptic ulcer disease has been excluded is not an indication for evaluation per se. Intervention studies are now in progress to test the hypothesis that prevention of gastric malignancy is an outcome of H. pylori eradication. Because the prevalence of H. pylori infection and the associated diseases such as peptic ulcer or gastric cancer differ among countries as well as different approvals for treatment are required by governments or insurance agencies, the acceptable indications of eradication therapy will, by necessity, vary among countries.",2001.0,0,0
259,10974150,Antibiotic-resistant H. pylori infection and its treatment.,D Y Graham; W A Qureshi,"Helicobacter pylori infection causes progressive damage to gastric mucosa and results in serious disease such as peptic ulcer disease, MALT lymphoma, or gastric adenocarcinoma in 20% to 30% of patients. The current approach is to make a firm diagnosis, give combination antibiotic and antisecretory therapy, and confirm that the infection has been cured 4 to 6 weeks later. Antimicrobial resistance is largely responsible for treatment failures. Resistance to metronidazole can frequently be overcome by increasing the dose and duration of treatment with acid suppression. Clarithromycin is the most effective antibiotic against H. pylori but, unfortunately, resistance to it is increasing and can not be overcome by increasing the dose or duration of therapy with clarithromycin. The choice of therapy should be based on local susceptibility patterns. Re-treatment regimens for treatment failure should exclude antibiotics where acquired resistance is expected (i.e., clarithromycin and possibly metronidazole). Where available, treatment failure should prompt endoscopy and culture and susceptibility testing. Overall, higher doses and longer durations of treatment result in the best cure rates. When multiple treatment regimens fail, salvage therapy regimens such as bismuth or furazolidone quadruple therapy (a bismuth and tetracycline HCl 4 times a day along with a proton pump inhibitor twice a day, and either metronidazole 400 or 500 mg three times daily or furazolidone 100 mg three times daily for 14 days) can be used. Newer agents are needed to cope with the increasing prevalence of antibiotic resistance among H. pylori.",2001.0,0,0
260,10978947,"Bismuth-based triple therapy with bismuth subcitrate, metronidazole and tetracycline in the eradication of Helicobacter pylori: a randomized, placebo controlled, double-blind study.",S Veldhuyzen Van Zanten; A Farley; N Marcon; R Lahaie; A Archambault; R Hunt; R Bailey; D Owen; J Spénard; A Stiglick; N Aimola; P Colin,"To determine the rate of Helicobacter pylori eradication following bismuth-based triple therapy with colloidal bismuth subcitrate, tetracycline hydrochloride and metronidazole. One hundred and eleven patients were randomly assigned, in a two to one ratio, to colloidal bismuth subcitrate 120 mg qid plus metronidazole 250 mg qid plus tetracycline 500 mg qid (Gastrostat), or matching placebo tablets and capsules for 14 days. Presence or absence of H pylori was documented by histology at entry and at least 28 days after treatment. Patients had dyspeptic symptoms with or without a history of peptic ulcer. Patients with any previous attempt(s) at eradication of H pylori, who used bismuth, antibiotics, H2 receptor antagonists or proton pump inhibitors in the previous four weeks were excluded. Fifty-three of 59 (90%) patients on bismuth-based treatment and only one of 35 (3%) on placebo achieved eradication by per protocol analysis. Fifty-three of 65 (82%) patients on bismuth-based treatment achieved eradication, while only two of 34 (5%) achieved eradication on placebo by intention to treat analysis. Eradication rates for bismuth-based treatment across sites ranged from 83% to 100%. Only two patients in the bismuth-based treatment group (4%) and one in the placebo group (3%) discontinued treatment because of adverse events. Colloidal bismuth subcitrate plus metronidazole plus tetracycline, given in the doses studied for 14 days, is safe and highly effective against H pylori infection and would be appropriate as a first-line therapy for eradication.",2000.0,0,0
261,10981888,Helicobacter pylori test-and-eradicate versus prompt endoscopy for management of dyspeptic patients: a randomised trial.,A T Lassen; F M Pedersen; P Bytzer; O B Schaffalitzky de Muckadell,"Strategies based on screening for Helicobacter pylori to manage dyspeptic patients in primary care have been proposed, but the clinical consequences are unclear. We did a randomised trial to assess the efficacy and safety of a test-and-eradicate strategy compared with prompt endoscopy in the management of patients with dyspepsia. 500 patients presenting in primary care with dyspepsia (> or = 2 weeks of epigastric pain, no alarm symptoms) were assigned H. pylori testing plus eradication therapy or endoscopy. Symptoms, quality of life, patients' satisfaction, and use of resources were recorded during 1 year of follow-up. 250 patients were assigned test-and-eradicate, and 250 prompt endoscopy. The median age was 45 years and 28% were H. pylori infected. 1 year follow-up was completed by 447 patients. We found no differences in symptoms between the two groups (median registered days without dyspeptic symptoms=0.63 [IQR 0.27-0.81] in the test-and-eradicate group vs 0.67 [0.36-0.86] in the prompt endoscopy group; mean difference 0.04 [95% CI -0.01-0.10], p=0.12). Nor did we find any difference in quality of life or numbers of sick-leave days, visits to general practitioners, or hospital admissions. In the test-and-eradicate group, 27 (12%) of the patients were dissatisfied with management, compared with eight (4%) in the endoscopy group (p=0.013). After 1 year, the use of endoscopies in the test-and-eradicate group was 0.40 times (95% CI 0.31-0.51) the use in the endoscopy group, the use of H. pylori tests increased by a factor of 8.1 (5.7-13.1), the use of eradication treatments increased by a factor of 1.5 (0.9-2.7), and the use of proton-pump inhibitors was 0.89 (0.59-1.33) times the use in the endoscopy group. 43 (91% [80-98%]) of 47 peptic-ulcer patients would have been identified by endoscopy or treated by eradication therapy. A H. pylori test-and-eradicate strategy is as efficient and safe as prompt endoscopy for management of dyspeptic patients in primary care, although fewer patients are satisfied with their treatment.",2000.0,0,0
262,10983736,Esomeprazole.,C M Spencer; D Faulds,"Esomeprazole, a new proton pump inhibitor, is the S-isomer of omeprazole and is the first such inhibitor to be developed as a single isomer. Esomeprazole provided better control of intragastric pH than omeprazole, lansoprazole and pantoprazole in trials conducted in patients with gastro-oesophageal reflux disease (GORD) or healthy volunteers (n = 20 to 115). In 2 large randomised, double-blind multicentre trials esomeprazole 20 and/or 40mg for 8 weeks produced higher healing rates of erosive oesophagitis and better symptom control than omeprazole 20 mg in patients with GORD. Esomeprazole 10, 20 or 40mg once daily for 6 months maintained healing versus placebo (p < 0.001) in patients with endoscopically confirmed healed erosive oesophagitis in 2 large randomised, double-blind multicentre trials. Similarly, symptom-driven on-demand use of esomeprazole effectively controlled symptoms of GORD (heartburn) for 6 months in 2 large placebo-controlled trials. Esomeprazole-based triple therapy for 7 days was as effective for eradication of Helicobacter pylori as longer omeprazole-based therapy in 2 randomised double-blind trials including about 450 patients each. Endoscopically confirmed ulcer healing 4 weeks after treatment initiation was reported in about 90% of patients with active duodenal ulcer in both treatment groups. Esomeprazole-based triple therapy for 10 days was more effective than esomeprazole plus clarithromycin for eradication of H. pylori in 233 patients.",2001.0,0,0
263,10985098,Intravenous eradication therapy for bleeding gastroduodenal ulcer associated with Helicobacter pylori infection.,M Romero Gómez; C Martínez Delgado; L Grande; M A Otero Fernández; J Vargas; M Castro Fernández,"To evaluate the efficacy of an ultrashort intravenous triple therapy against Helicobacter pylori infection in patients with bleeding peptic ulcer. Thirty patients with bleeding peptic ulcer were studied prospectively. At endoscopy, two corpus and antrum biopsies were obtained for urease testing and culture. If H. pylori infection was found (positive urease test), the patient was treated with omeprazole 40 mg bid, metronidazole 500 mg tid and ampicillin 2000 mg fid for three days and then with ranitidine 150 mg bid for 2 months until eradication. In all patients a [13C]urea breath test was done at 2-month intervals, and in patients with gastric ulcer an endoscopy was also done and biopsies for culture and urease testing were obtained. Eradication efficacy (intention-to-treat) was 86.6% (26 out of 30). All schedules were administered in full and no patient had any adverse reactions. No patients had rebleeding. Ultrashort three-day triple therapy can achieve an eradication rate greater than 80%, with good acceptance and compliance, and without adverse events.",2001.0,0,0
264,10989974,,,,,0,0
265,10990235,The prevention of chronic NSAID induced upper gastrointestinal toxicity: a Cochrane collaboration metaanalysis of randomized controlled trials.,A Rostom; G Wells; P Tugwell; V Welch; C Dubé; J McGowan,"To review the effectiveness of common interventions for the prevention of nonsteroidal antiinflammatory drug (NSAID) induced upper gastrointestinal (GI) toxicity. Randomized controlled clinical trials (RCT) of prostaglandin analogs, H2-receptor antagonists (H2RA), or proton pump inhibitors (PPI) for the prevention of chronic NSAID induced upper GI toxicity were identified through electronic databases, the Cochrane control trials register, conference proceedings, and by contacting content experts and companies. Outcome measures investigated were endoscopic ulcers, ulcer complications, symptoms, overall dropouts, dropouts due to symptoms, and study quality. Thirty-four RCT met the inclusion criteria. All doses of misoprostol significantly reduced the risk of endoscopic ulcers. Misoprostol 800 microg/day was superior to 400 microg/day for the prevention of endoscopic gastric ulcers (RR 0.18, RR 0.38, respectively; p = 0.0055). A dose-response relationship was not seen with duodenal ulcers. Misoprostol caused diarrhea at all doses, although significantly more at 800 than 400 microg/day (p = 0.0012). Misoprostol was the only prophylactic agent documented to reduce ulcer complications. Standard doses of H2RA were effective at reducing the risk of endoscopic duodenal (RR 0.24, 95% CI 0.10-0.57) but not gastric ulcers (RR 0.73, 95% CI 0.50-1.09). Both double dose H2RA and PPI were effective at reducing the risk of endoscopic duodenal and gastric ulcers (RR 0.44, 95% CI 0.26-0.74 and RR 0.37, 95% CI 0.27-0.51, respectively, for gastric ulcer) and were better tolerated than misoprostol. Misoprostol, PPI, and double dose H2RA are effective in preventing chronic NSAID related endoscopic gastric and duodenal ulcers. Lower doses of misoprostol are less effective and are still associated with diarrhea. Only misoprostol 800 microg/day has been directly shown to reduce the risk of ulcer complications.",2001.0,0,0
266,10993428,Five-day triple therapy in Helicobacter pylori-positive duodenal ulcer: an eighteen-month follow-up.,F Catalano; R Catanzaro; G Branciforte; C Bentivegna; R Cipolla; A Brogna; G Nuciforo,"The aim of this study was to compare the efficacy of two different 5-day proton pump inhibitor (PPI)-based triple therapies for Helicobacter pylori (Hp)-positive duodenal ulcers (DUs). Eighty-four patients received pantoprazole (Pan) 80 mg O.D. (once daily) for 1 week; 88 patients received omeprazole (Ome) 40 mg O.D. for 1 week. Patients of both groups received clarithromycin (Cla) 500 mg B.I.D. (twice daily) and amoxicillin (Amo) 1 g B.I.D. for 5 days. All of them were clinically and endoscopically investigated before enrollment (T0) and at 1 (T1), 6 (T2), 12 (T3), and 18 months (T4) after the end of the therapy. Hp status was determined by rapid urease test and by histology. At T1, we observed ulcer healing in 87.5% of the patients and Hp eradication in 83.7% of the Pan group (per protocol [PP]). In the Ome group, ulcer healing was noticed in 95.1% and Hp eradication in 95.1% (PP). We found no statistical differences between the groups (PP). At the end of the follow-up, we found a healing rate of 100% both in the Pan group and in the Ome group; an eradication rate of 98.4% and 100% was observed in the Pan group and in the Ome group, respectively. We found no statistical differences between the groups (PP). Hp eradication was associated with an improvement in the grade of gastritis at T1, remaining unchanged until T4. In conclusion, the efficacy of the Pan treatment was similar to the Ome treatment.",2001.0,0,1
267,11003425,Pathogenesis and current management of gastrooesophageal-reflux-related asthma.,T Menes; S Lelcuk; H Spivak,"In the past decade the use of proton pump inhibitors on the one hand, and an aggressive surgical approach on the other hand have revolutionised the treatment of gastro-oesophageal reflux disease (GORD). Many studies have suggested that the successful management of GORD results in improvement of the symptoms of asthma which coexist in many of these patients. In this paper we review the pathogenesis and the medical and surgical treatment of GOR-related asthma. Both anti-reflux operations and anti-acid medications improve GORD and GOR-related asthma. Although anti-reflux surgery is superior to H2 blockers, there are not sufficient data to evaluate proton pump inhibitors compared with operation in controlling the symptoms of asthma.",2001.0,0,0
268,11003808,Diagnosis of reflux disease.,M A van Herwaarden; A J Smout,"There are numerous tests for which a diagnostic value in the context of gastro-oesophageal reflux disease has been claimed. Some of these tests (e.g. the acid perfusion test) have become obsolete after the advent of 24-hour oesophageal pH monitoring. With the latter test not only can excessive reflux be identified, but also, and more importantly, a temporal relationship can be demonstrated between a patient's symptoms and reflux episodes. Radiographical examination of the oesophagus has largely been replaced by endoscopy, although the use of the former test is still indicated in certain circumstances (e.g. in the differentiation of sliding from para-oesophageal hiatus hernia). In clinical practice, the so-called proton pump inhibitor test has gained considerable popularity. Despite several studies on the specificity and sensitivity of this test, its value has not yet been established with sufficient accuracy. Conventional manometric evaluation of lower oesophageal sphincter pressure has been over-emphasized as a diagnostic test in gastro-oesophageal reflux disease.",2001.0,0,0
269,11004817,[Long-term maintenance treatment of reflux esophagitis resistant to H2-RA with PPI (lansoprazole)].,M Endo; K Sugihara,"97 patients in 49 hospitals with erosive esophagitis unhealed after at least 8 weeks treatment with H2-RA were given primary treatment with 30 mg lansoprazol once daily. After 8 weeks of treatment with lansoprazol, 75(77%) patients were endoscopically healed. Healed patients were then given maintenance treatment with either 30 mg lansoprazol once daily, 15 mg lansoprazol once daily or 20 mg famotidine twice daily for 24 weeks. 86% of patients randomized to 30 mg lansoprazol, 70% of patients randomized to 15 mg lansoprazol were maintained in endoscopic healing throughout 24 weeks as compared with only 12% of patients randomized to famotidine in endoscopic healing. After 24 weeks of lansoprazol treatment basal gastrin levels were moderately increased. However no significant histopathologic lesion was found in the oxyntic gland mucosa. PPI(lansoprazol) was far superior to H2-RA(famotidine) in preventing recurrence of healed erosive esophagitis. A goal achieved without adverse events and significant abnormalities in the oxyntic mucosal exocrine or endocrine cell but a moderate increase in basal gastrine levels.",2001.0,0,0
270,11008354,"[Triple therapy of short-term with azithromycin, amoxycillin and omeprazole for the eradication of Helicobacter pylori].",S Flores; H Opazo; D Valderrama; R Aguilera; A Marchese; S Valderrama,"The high cost and complexity of therapeutic schemes for the eradication of Helicobacter pylori has stimulated the search of simpler and cheaper treatment options. To evaluate the efficacy of 3 days of azithromycin 500 mg od, 7 days of amoxycillin 750 mg tid and omeprazole, 20 (Group A) or 40 mg (Group B) on randomization, as a treatment for Helicobacter pylori infection in patients with endoscopically diagnosed peptic ulcer. H. pylori status of peptic ulcer patients was pathologically confirmed by the examination of five gastric biopsies using the Giemsa stain and by rapid urease testing in two gastric biopsies. H. pylori status was reassessed not less than 28 days after completing treatment. Adverse events and compliance were evaluated. Fifty four patients (29 men, 25 women, mean age 48 years) were enrolled, 28 in Group A and 27 in Group B. Per protocol the infection was cured in 58.8% of patients (30/51; 95% CI: 45-73%). On an intention to treat basis, H pylori infection was cured in 55%. Minor side effects including diarrhea and nausea were reported by 32% of patients. Ninety-five per cent of patients consumed more than 95% of prescribed medications. H. pylori was successfully eradicated in 61% of group A and 57% of group B patients (p = NS). Short term therapy with azithromycin was poorly effective in curing H. pylori infection. The compliance was excellent. Increasing Omeprazole from 20 to 40 mg/day did not improve treatment effectiveness.",2000.0,0,0
271,11012468,Esomeprazole improves healing and symptom resolution as compared with omeprazole in reflux oesophagitis patients: a randomized controlled trial. The Esomeprazole Study Investigators.,P J Kahrilas; G W Falk; D A Johnson; C Schmitt; D W Collins; J Whipple; D D'Amico; B Hamelin; B Joelsson,"The pharmacologic profile of the new proton pump inhibitor esomeprazole has demonstrated advantages over omeprazole that suggest clinical benefits for patients with acid-related disease. 1960 patients with endoscopy-confirmed reflux oesophagitis (RO) were randomized to once daily esomeprazole 40 mg (n=654) or 20 mg (n=656), or omeprazole 20 mg (n=650), the standard recommended dose for RO, for up to 8 weeks in a US, multicentre, double-blind trial. The primary efficacy variable was the proportion of patients healed at week 8. Secondary variables included healing and heartburn resolution at week 4, time to first resolution and sustained resolution of heartburn, and per cent of heartburn-free days and nights. Safety and tolerability were also evaluated. Significantly more patients were healed at week 8 with esomeprazole 40 mg (94.1%) and 20 mg (89.9%) vs. omeprazole 20 mg (86.9%), using cumulative life table estimates, ITT analysis (each P < 0.05). Esomeprazole 40 mg was also significantly more effective than omeprazole for healing at week 4 and for all secondary variables evaluating heartburn resolution. The most common adverse events in all treatment groups were headache, abdominal pain and diarrhoea. Esomeprazole was more effective than omeprazole in healing and symptom resolution in GERD patients with reflux oesophagitis, and had a tolerability profile comparable to that of omeprazole.",2001.0,1,1
272,11012470,Proton pump inhibitors: better acid suppression when taken before a meal than without a meal.,J G Hatlebakk; P O Katz; L Camacho-Lobato; D O Castell,"Proton pump inhibitors including omeprazole and lansoprazole inhibit gastric acid secretion by selectively and non-competitively inactivating the H+, K+ ATPase molecules of the parietal cell, but possibly only those that are actively secreting acid. This might imply that stimulation of acid secretion by a meal is necessary for optimal inhibition of gastric secretion. To quantify and compare the effect on daytime gastric acidity of omeprazole 20 mg or lansoprazole 30 mg daily taken 15 min before breakfast, with that of the same drug taken without a meal. Twenty-one healthy volunteers were randomized to receive either omeprazole or lansoprazole. They were given the drug for two separate periods of 7 days in randomized order and at least 7 days apart. During one period the study medication was taken before breakfast; during the other it was taken at the same hour, but with no meal until 12:00 hours. Lunch was standardized. On day 7, intragastric pH-metry was performed, starting at 08:00 hours. Tracings were analysed for the 8-h period from 08:00 hours until 16:00 hours with regard to percentage time for which gastric pH was below 4.0 and 3.0, and median gastric pH. Tracings were also analysed after removing the 1 h breakfast period, to exclude the buffering effect of the meal. When taking the drug with breakfast, the median percentage time for which gastric pH < 4.0 was 17.2 (interquartile range 4.6-45.5), compared with 42.0 (interquartile range 31.4-48.8) when taken without food (P=0.01). Fifteen subjects had better control of gastric acidity when the medication was taken with breakfast. A pH threshold of 3 and median pH showed similar differences. When the breakfast period was removed, the differences were no longer statistically significant. When therapy with omeprazole or lansoprazole is indicated, medication should be taken before a meal for optimal control of daytime gastric acidity.",2001.0,0,0
273,11012477,"Proton pump inhibitor, clarithromycin and either amoxycillin or nitroimidazole: a meta-analysis of eradication of Helicobacter pylori.",J P Gisbert; L González; X Calvet; N García; T López; M Roqué; R Gabriel; J M Pajares,"To perform a meta-analysis of studies comparing twice daily, one-week triple therapy with a proton pump inhibitor, clarithromycin (C) and amoxycillin (A) (PCA) vs. those using proton pump inhibitor, clarithromycin and a nitroimidazole (N) (PCN) for H. pylori eradication.  Comparative randomized trials of PCA vs. PCN were included. PubMed database and abstracts from congresses until September 1999. Meta-analysis was performed combining the Odds Ratios (OR) of the individual studies in a global OR (Peto method) both on an intention-to-treat (ITT) and on a per protocol (PP) basis. Twenty-two studies fulfilled the inclusion criteria. Eighteen studies reported ITT and 20 PP analysis. Mean H. pylori eradication rates were 81% (95% CI: 79-83%) ITT, and 84% (82-86%) PP with PCA, and 81% (78-83%) ITT and 84% (82-86%) PP with PCN; the odds ratio for the effect of PCA vs. PCN was 1 (0.83-1.22) on an ITT, and 0.98 (0.8-1.2) on a PP basis. Subanalysis showed that mean H. pylori eradication efficacy with PC(250 b.d.)A was 81% (78-85%) ITT, vs. 86% (83-89%) with PC(250 b.d.)N. The odds ratio for this comparison was 0.68 (0.48-0.98). Finally, when comparing PC(500 b.d. )A against PC(250 b.d.)N ITT cure rates were 77% (74-80%), and 75% (72-78%) with an odds ratio of 1.18 (0.93-1.5). Overall, one-week combination regimens of PCA and PCN present similar H. pylori eradication efficacy. Nevertheless, the PCN regimen obtains significantly better results when using low doses of C (250 mg b.d.).",2001.0,0,1
274,11012478,Helicobacter pylori-positive duodenal ulcer: three-day antibiotic eradication regimen.,F Catalano; G Branciforte; R Catanzaro; R Cipolla; C Bentivegna; A Brogna,"The most widely used treatments for ulcer healing and Helicobacter pylori eradication consist of a 1-2 week regimen of a proton pump inhibitor plus two or three antimicrobials. To evaluate the efficacy, safety, cost, and tolerance of a three-day regimen with three antibiotics vs. a 10-day treatment with a proton pump inhibitor or vs. a ranitidine bismuth citrate triple therapy. Two hundred and twenty-one patients with endoscopically-proven H. pylori-positive duodenal ulcers were recruited to the study. Recruited patients were assigned to one of the following four regimens: (I) omeprazole 40 mg o.m. plus amoxycillin 1 g b.d. and clarithromycin 500 mg b.d. for 10 days (OAC: 55 patients); (ii) omeprazole 40 mg o.m. on days 1-5, plus amoxycillin 1 g b.d., clarithromycin 500 mg b.d. and metronidazole 500 mg b.d. on days 3-5 (OACM: 56 patients); (iii) ranitidine bismuth citrate 400 mg b.d. plus amoxycillin 1 g b.d. and clarithromycin 500 mg b.d. for 10 days (RAC: 54 patients); (iv) ranitidine bismuth citrate 400 mg b.d. on days 1-5, plus amoxycillin 1 g b.d., clarithromycin 500 mg b.d. and metronidazole 500 mg b.d. on days 3-5 (RACM: 56 patients). Fisher's exact test was used to compare data regarding healing and eradication in the four groups. The intention-to-treat eradication and ulcer healing rates for the RACM regimen were 95% and 98%, respectively. Statistically significant differences were observed, relating to the eradication and healing of ulcers, between RACM and either the RAC or OAC regimens. The three-day antibiotic therapy with amoxycillin, clarithromycin and metronidazole in addition to ranitidine bismuth citrate is a very effective anti-H. pylori regimen.",2001.0,0,1
275,11012479,"Third line treatment for Helicobacter pylori: a prospective, culture-guided study in peptic ulcer patients.",F Gomollón; B Sicilia; J A Ducóns; E Sierra; M J Revillo; M Ferrero,"A third line treatment is needed in roughly 5% of patients infected with Helicobacter pylori. Few data have been reported on efficacy of treatment regimens in these patients. A prospective trial was designed to study the effectiveness of third line treatment of H. pylori infection in ulcer patients. Two-week quadruple, culture-guided, combinations were used in 31 consecutive patients. Susceptibility to metronidazole and clarithromycin were studied by E-test, and thereafter a predetermined treatment regimen was used. Compliance was evaluated by pill count, and eradication defined by negative urea breath test at 6 weeks. Two main quadruple regimens were used in 29 patients. In spite of good compliance, the combination of omeprazole, tetracycline, bismuth and clarithromycin (OTBC) showed an eradication rate (per protocol analysis) of 36% (five out of 14; CI: 12.8-64.9), and if amoxycillin was used (OTBA) the rate was 67% (eight out of 12; CI: 34.9-90.1). The difference was not significant. No clinical factor was found to be associated with failure to eradicate. Third line treatment often fails to eradicate H. pylori infection. New strategies need to be developed and tested for this common clinical situation.",2001.0,0,0
276,11012481,Changes in Helicobacter pylori-induced gastritis in the antrum and corpus during long-term acid-suppressive treatment in Japan.,N Uemura; S Okamoto; S Yamamoto; N Matsumura; S Yamaguchi; H Mashiba; N Sasaki; K Taniyama,"Several studies have shown that acid-suppressive therapy aggravates corpus gastritis in patients with Helicobacter pylori infection, promoting the development of atrophic gastritis. To study the effects of long-term use of antisecretory agents on the H. pylori-positive gastric mucosa in Japan, a country with a high incidence of gastric cancer. A total of 141 H. pylori-positive patients who had peptic ulcers or reflux oesophagitis were treated for 3 years with either omeprazole (20 mg/day) alone (n=7) or with omeprazole for primary therapy (8 weeks), followed by famotidine (40 mg/day) for maintenance therapy (n=134). Endoscopy was performed before, during, and after treatment. Biopsy specimens were taken from the greater curvature of the antrum and corpus and were examined histologically. The long-term use of famotidine after 8 weeks of treatment with omeprazole distinctly decreased H. pylori density and neutrophil infiltration in the antrum, but did not change H. pylori density in the corpus. The gastritis score increased in patients who had no, or only mild corpus gastritis before treatment (n=74), and significantly decreased in those who had moderate or severe gastritis before treatment (n=60). In four of the seven patients who received long-term treatment with omeprazole alone, neutrophil infiltration and H. pylori density decreased not only in the antrum but also in the corpus. There was no increase in intestinal metaplasia or mucosal atrophy as assessed endoscopically during follow-up. Changes in corpus gastritis in response to acid-suppressive therapy depend on the severity of gastritis before treatment. Long-term use of acid-suppressive therapy apparently does not accelerate the development of atrophy or intestinal metaplasia in Japanese patients.",2001.0,0,0
277,11020913,Treatment of the gastric stump ulcer: an open study with five drugs.,A Janke; J Stasiewicz; Z Namiot; W Szalaj,"Despite a great progress in the treatment of peptic ulcer disease, the management of gastric stump ulcers still remains to be established. Eighty-one patients with peptic ulcer developed postoperatively in the gastric remnant were treated in an open trial with 5 antiulcer drugs (cimetidine, omeprazole, sucralfate, colloidal bismuth and misoprostol) characterized by different mechanisms of action. The ulcer healing rate was evaluated endoscopically after 2, 4 and 6 weeks. It was found that after 2 weeks the most rapid ulcer healing was in the omeprazole and cimetidine treated groups, 67 and 43% of healing, respectively. Also after 4 weeks the antisecretors were more effective than gastroprotective drugs; ulcer healing rate for omeprazole was 87% and cimetidine 68%, while for sucralfate, colloidal bismuth and misoprostol 50%, 52%, and 33%, respectively. After 6 weeks all drugs represented very close ulcer healing rates. Both antisecretory and gastroprotective drugs may be useful in the management of stump ulcers, however, to initiate and accelerate the stump ulcer healing omeprazole appears to be the drug of choice.",2001.0,0,0
278,11021899,High dose proton pump inhibitor response as an initial strategy for a clinical diagnosis of gastro-oesophageal reflux disease (GERD). Swedish multi-centre group in primary health care.,J Brun; H Sörngård,"The diagnosis of gastro-oesophageal reflux disease (GERD) in primary care rests primarily on symptoms. Oesophageal acid exposure is the most important pathogenic factor and it is likely that symptom response to acid inhibition also identifies patients with GERD. The aim of this study was to evaluate the outcome of a symptom-based strategy in the management of GERD patients in primary care. Patients in general practice with main symptoms of at least moderate heartburn or regurgitation were given omeprazole 20 mg b.i.d. openly for 7 days (first phase). Responders with later relapse were randomized to double-blind treatment with omeprazole 20 mg o.m. or placebo for 2 weeks (second phase). A response in both phases was defined as a decrease by at least three grades on a seven-grade Likert scale and no more than mild intensity of the main symptom. Of the 362/371 recruited patients who were evaluated in the first phase, 73% were responders. A total of 174/179 patients with a relapse were assessed in the second phase, and 74 and 28% in the omeprazole and placebo group, respectively, were defined as responders (P: < 0.001, 95% confidence interval 33-59). GERD patients are highly responsive to omeprazole 20 mg b.i.d. They are equally responsive to omeprazole 20 mg o.m. at symptomatic relapse, but have a low response rate to placebo. Omeprazole is a valuable therapeutic instrument to detect and treat patients with GERD in general practice.",2001.0,0,1
279,11022797,Helicobacter pylori infection and eradication in paediatric patients.,H M Malaty,"Helicobacter pylori is now recognised to be typically acquired during childhood. Studies also indicate that the infection is frequently lost in childhood; however, it is still unclear whether this is related to the use of antibacterials, the natural history of the infection, or both. H. pylori colonises gastric mucosa and is causally related to chronic gastritis and peptic ulcer disease in both children and adults. Successful eradication of H. pylori has resulted in the healing of duodenal ulcers and the lowering of the ulcer relapse rate in children. Therapy to cure the infection should be started in all children with peptic (duodenal or gastric) ulcer who are still infected. The ideal anti-H. pylori regimen should be safe, cheap, easy to comply with, well tolerated by children and able to achieve a high cure rate. Although US data are lacking, it is anticipated that the treatment regimen for children should be similar to that in adults (a triple therapy regimen that combines a proton pump inhibitor with 2 antimicrobial agents for 14 days). It is inappropriate to prescribe anti-H. pylori therapy without a firm diagnosis. The use of multiple antibacterials in a paediatric patient with an ulcer but without H. pylori infection cannot provide any benefit to the patient or the community. Such an approach only provides the possibility for adverse effects, for example development of antibacterial resistance among bystander bacteria. It is very important to confirm the diagnosis of H. pylori infection. The [13C]urea breath test is the noninvasive method of choice to determine H. pylori status in children and the ideal test for post-therapy testing. There is a need for post-therapy confirmation because of the likelihood of poor outcome for some treatment regimens, which is why post-therapy testing should be the standard of care. There is weak and inconsistent evidence of an association between H. pylori infection and recurrent abdominal pain (RAP) in children, in part because of the unclear definition of RAP in the literature. Therefore, there is still considerable debate regarding the treatment of infected children with RAP.",2001.0,0,0
280,11026931,Nonsteroidal anti-inflammatory drugs.,C C Tseng; M M Wolfe,"NSAID-associated dyspeptic symptoms are common and can be managed empirically with an H2-receptor antagonist or a proton-pump inhibitor. Treatment of established gastroduodenal ulcers is accomplished best by withholding the offending drugs. Proton-pump inhibitors appear to heal ulcers at the same rate whether or not NSAID therapy is continued. After the ulcer is healed and if NSAID therapy must be continued, prophylaxis is accomplished best by the concomitant use of proton-pump inhibitors, misoprostol (at least 200 micrograms 3 times a day), or a NSAID that preferentially inhibits COX-2. The future development of newer, safer NSAID preparations, including highly selective COX-2 inhibitors and nitric oxide-releasing NSAIDs, should provide better treatment options for the increasing number of individuals requiring anti-inflammatory agents.",2001.0,0,0
281,11034468,Medical or surgical treatment for chronic gastrooesophageal reflux? A systematic review of published evidence of effectiveness.,P C Allgood; M Bachmann,"To compare the effectiveness of medical (antacids, histamine antagonists and proton pump inhibitors) and surgical (fundoplication) treatment of chronic GORD. Patients with objective (endoscopic or pH) evidence of chronic reflux reported in 6 randomised trials and 3 cohort studies, 1966-1999. Systematic review of comparative studies identified from electronic searches, citations, manual searches of journals, and correspondence with authors and experts. Improvements in prevalence or severity of symptoms, oesophagitis, pH reflux duration, lower oesophageal sphincter pressure, patients' satisfaction, and side-effects. Improved outcomes were more common after surgical than medical treatment with significant differences in objective outcomes in 5/6 randomised trials and in 2/3 cohort studies. Subjective outcomes (symptoms and patients' satisfaction) were also more common among surgical patients in all but one study that assessed them. Odds ratios for improvement with surgical rather than medical treatment ranged from 1.2 to 200, and numbers needed to treat ranged from 1.2 to 58, where these could be calculated. Studies were too heterogeneous for meta-analysis. In trials of chronic severe GORD, surgery is consistently more effective than medical treatment in relieving symptoms and objective oesophagitis, although omeprazole can give similar symptom relief with adjustment of the dose.",2001.0,0,1
282,11034574,"Photodynamic therapy for dysplastic Barrett's oesophagus: a prospective, double blind, randomised, placebo controlled trial.",R Ackroyd; N J Brown; M F Davis; T J Stephenson; S L Marcus; C J Stoddard; A G Johnson; M W Reed,"Photodynamic therapy (PDT) is a treatment in which cell damage is achieved by the action of light on a photosensitizing agent. We have assessed the potential use of PDT in the ablation of Barrett's oesophagus. Thirty six patients with dysplastic Barrett's oesophagus receiving acid suppression medication with omeprazole were randomised to receive oral 5-aminolaevulinic acid (ALA) 30 mg/kg or placebo, followed four hours later by laser endoscopy. Follow up endoscopy was performed at one, six, 12, and 24 months. Of 18 patients in the ALA group, a response was seen in 16 (median decrease in area in the treated region 30%; range 0-60%). In the placebo group, a decrease in area of 10% was observed in two patients with no change in 16 (median 0%; range 0-10%; treatment v placebo, p<0.001). No dysplasia was seen in the columnar epithelium within the treatment area of any patient in the PDT group. However, in the placebo group, persistent low grade dysplasia was found in 12 patients (p<0.001). There were no short or long term major side effects. The effects of treatment were maintained for up to 24 months. This is the first randomised controlled trial of PDT for Barrett's oesophagus. It demonstrates that ALA induced PDT can provide safe and effective ablation of low grade dysplastic epithelium.",2001.0,0,0
283,11051336,Latin-American Consensus Conference on Helicobacter pylori infection. Latin-American National Gastroenterological Societies affiliated with the Inter-American Association of Gastroenterology (AIGE).,L G Coelho; R León-Barúa; E M Quigley,,2001.0,0,0
284,11051345,"Influence of Helicobacter pylori eradication therapy on 13C aminopyrine breath test: comparison among omeprazole-, lansoprazole-, or pantoprazole-containing regimens.",E Giannini; P Romagnoli; A Fasoli; B Chiarbonello; F Malfatti; F Botta; D Risso; P B Lantieri; V Savarino; R Testa,"Proton pump inhibitors and antimicrobial agents are widely used to eradicate Helicobacter pylori (H. pylori) infection. In the general population the prevalence of infection and of polypharmacy increases the possibility of drug-drug interactions during H. pylori eradication therapy. The purpose of the present study was to assess the prevalence, degree, and clinical relevance of metabolic interference with the cytochrome P450 enzymatic system occurring during 1 wk of administration of omeprazole, lansoprazole, or pantoprazole followed by the association of clarithromycin and metronidazole for another week. The 13C aminopyrine breath test (ABT) was chosen to screen for possible interactions. We studied 30 patients referred to our Unit for H. pylori eradication therapy. They were randomized to receive either omeprazole (20 mg b.i.d.), lansoprazole (30 mg b.i.d.), or pantoprazole (40 mg b.i.d.) for 2 wk. During the second week clarithromycin (250 mg b.i.d.) and metronidazole (500 mg b.i.d.) were added. ABT was performed before, and at the end of the first and second week of therapy. Percentage of the administered dose of 13C recovered per hour at the peak (percent 13C dose/h at the peak) and cumulative percentage of administered dose of 13C recovered over time at 120 min (percent 13C dose cum120) were the ABT evaluated parameters. At baseline all patients showed a normal liver function. In individual patients during treatment we observed various liver metabolic interactions both as inhibition and induction, as well as after the first and the second week of therapy. However, mean modifications of the ABT parameters during the 2 weeks of therapy were not statistically significant compared to baseline values. None of the patients who had ABT variations complained of side effects. H. pylori eradication therapy interferes with cytochrome P450-dependent liver metabolic activity. However, the clinical relevance of these metabolic interactions is not yet apparent, and further investigation is needed. H. pylori eradication therapy appears safe, but these interactions should be considered in the choice of proton pump inhibitor and antimicrobial agents.",2001.0,0,1
285,11062202,"In vitro susceptibility of Helicobacter pylori to, and in vivo suppression by, antimicrobials used in selective decontamination of the digestive tract.",P H van der Voort; R W van der Hulst; D F Zandstra; A van der Ende; A A Geraedts; G N Tytgat,"The incidence of bleeding related to stress ulcers is reduced in critically ill patients in whom gut decontamination has been performed; this may be a result of suppression of Helicobacter pylori infection. We determined the susceptibility of H. pylori to the applied antibiotics. In nine of 10 critically ill patients (using intravenous cefotaxime and topical polymyxin, tobramycin and amphotericin B (PTA) given by nasogastric tube) and all six volunteers (using PTA alone), H. pylori was suppressed as long as the topical antibiotics were ingested. The in vitro studies revealed that all strains were susceptible to cefotaxime and tobramycin. The strains were not susceptible to polymyxin or amphotericin B.",2001.0,0,0
286,11064311,Does the depth of gastric ulceration influence a modified dual therapy with amoxicillin and lansoprazole for Helicobacter pylori-associated gastric ulcer?,T Okai; K Ohtsubo; J Sakai; H Watanabe; Y Motoo; A Kawashima; N Sawabu,"To clarify whether the depth of ulceration evaluated by endoscopic ultrasonography (EUS) influences a modified dual therapy with amoxicillin and lansoprazole for the treatment of Helicobacter pylori-positive patients with gastric ulcer. Twenty-two consecutive cases of gastric ulcer (nine superficial ulcers and 13 deep ulcers) in H pylori-positive patients were studied. Ten of 22 patients received a two-week eradication therapy with amoxicillin 1500 mg/day, lansoprazole 30 mg/day and a new antiulcer agent with features in common with sucralfate, ecabet sodium, 2.0 g/day. They continued to receive the same doses of lansoprazole and ecabet sodium for the next six weeks. The other 12 patients received the same therapy except for those who underwent the four-week amoxicillin treatment. All patients underwent EUS both at the start of the study and eight weeks later. They then received ecabet sodium alone for the next six months as a maintenance therapy, followed by a six-month interval with no treatment. The final endoscopy was done one year after H pylori eradication therapy was completed to evaluate H pylori status and ulcer recurrence. The rates of endoscopic healing and H pylori eradication in the nine patients with superficial ulcer were 100%, irrespective of the period of amoxicillin treatment. In contrast, the rates of endoscopic evidence of healing and H pylori eradication in the 13 patients with deep ulcer were different for each period of amoxicillin treatment; that is, the rates of reduction in ulcer determined by echo and H pylori eradication in the four patients treated with the two-week amoxicillin course were significantly lower (P=0.03) than those in the nine patients treated with the four-week course. Ulcer depth is likely to influence the success of amoxicillin treatment for H pylori-positive patients with gastric ulcer.",2001.0,0,0
287,11069320,Identifying responders to acid suppression in dyspepsia using a random starting day trial.,P Bytzer; J M Hansen; S Rune; O Bonnevie; H Breinstrup; P Funch-Jensen; P Matzen; V Meineche-Schmidt; O B Schaffalitzky De Muckadell,"Functional dyspepsia is a heterogeneous condition and a uniform response to drug treatment is not likely. This may be the reason for the general failure of acid suppression in clinical trials in these patients. It may be more rewarding to identify true responders to drug treatment by a single subject trial. To develop and to test a novel single subject trial design (random starting day trial) in dyspeptic patients. A total of 301 dyspeptic patients entered a 16-day trial. All patients received placebo for the first 4 days and switched to omeprazole at a randomized and blinded day between day 5 and day 14. Response was defined as a sustained >/= 50% decrease in symptom score occurring in relation to drug shifting. Spontaneous response varied between 0.3% and 10.6% per day, uniformly distributed over time. Overall, 53-61% of patients with organic dyspepsia had a symptom response in relation to shifting to active treatment, compared to only 23% of patients with functional dyspepsia. The only predictor of response was symptoms suggesting gastro-oesophageal reflux. A random starting day trial may be a valuable tool to identify response to acid suppression in dyspeptic patients.",2001.0,0,0
288,11069326,"Triple therapy with clarithromycin, omeprazole, and amoxicillin for eradication of Helicobacter pylori in duodenal ulcer patients in Asia and Africa.",B C Wong; F Y Chang; S Abid; Z Abbas; B R Lin; C Van Rensburg; P C Chen; H Schneider; A E Simjee; S S Hamid; A Seebaran; J Zhang; M Destefano; S K Lam,"Studies assessing the efficacy of triple therapy containing clarithromycin and amoxicillin for the eradication of Helicobacter pylori infection and healing of duodenal ulcers in Asian and African countries are limited. To determine the efficacy and safety of 1-week triple therapy with omeprazole, amoxicillin and clarithromycin for eradicating H. pylori infection in patients with active duodenal ulcer living in Asian and African regions. This was an open-label, multicentre study in 11 centres in Asia and Africa. Patients with endoscopy-proven duodenal ulcer and who were H. pylori-positive were treated with clarithromycin 500 mg, omeprazole 20 mg, and amoxicillin 1000 mg, all given twice daily for 7 days. Upper endoscopy was repeated at week 6 to check for ulcer healing and H. pylori status. A total of 117 patients were recruited. H. pylori eradication rates were 85% by per protocol analysis and 80% by intention-to-treat analysis. Ulcer healing was found in 94% of subjects (per protocol analysis). Clinical success, measured by change of pre-treatment ulcer symptoms, was strongly supported by complete resolution or improvement in 100% of the evaluable patients (per protocol analysis). Since treatment-related adverse events, when present, were largely mild or moderate, the triple therapy regimen was considered safe. Seven-day triple therapy with omeprazole, amoxicillin, and clarithromycin was efficacious for treating Asian and African patients with duodenal ulcer disease associated with H. pylori infection, and the treatment regimen was well-tolerated.",2001.0,0,0
289,11079051,"Are the orally administered proton pump inhibitors equivalent? A comparison of lansoprazole, omeprazole, pantoprazole, and rabeprazole.",A B Thomson,"Four proton pump inhibitors (PPIs) are currently marketed in various parts of the world, and all of these (lansoprazole, omeprazole, pantoprazole, and rabeprazole) are available for prescription use in the United States. As a therapeutic group, the PPIs are highly useful for the relief of symptoms and healing of gastroesophageal reflux disease, gastric and duodenal ulcer disease, eradication of Helicobacter pylori infection, prevention and treatment of nonsteroidal anti-inflammatory drug (NSAID)-associated damage, management of hypersecretory states such as Zollinger-Ellison syndrome, and care of patients with non-variceal upper gastrointestinal bleeding, or non-ulcer dyspepsia. The pathophysiologic basis of these management benefits lies in the potent gastric acid inhibitory effects of the PPIs. There are differences between the PPIs in their pharmacokinetics, pharmacodynamics, influence by food and antacids, clinical efficacy, and potential for drug interactions. It is not always clear whether these often subtle variations are necessarily of clinical importance. The physician's choice of one PPI over another must rest with her/his interpretation of the clinical importance of the generally small differences between PPIs, their approval for treatment of specific clinical indications within the physician's practice jurisdiction, and the strength of the evidence based on the quantity and quality of the supporting clinical trials.",2003.0,0,0
290,11085470,Gastroesophageal reflux disease and Barrett's esophagus.,T Rösch,,2001.0,0,0
291,11085491,Peptic ulcer recurrence during maintenance therapy with H2-receptor antagonist following first-line therapy with proton pump inhibitor.,E Kaneko; Y Hoshihara; N Sakaki; S Harasawa; K Ashida; M Asaka; S Asaki; T Nakamura; K Kobayashi; G Kajiyama; N Ogawa; T Yao; Y Muto; S Nakazawa; T Takemoto,"We investigated the peptic ulcer recurrence rates during maintenance therapy with H2-receptor antagonists (H2RAs) following first-line therapy with a proton pump inhibitor (PPI). Patients with gastric ulcer (GU) or duodenal ulcer (DU) were enrolled in this study; 583 eligible patients (GU, 325; DU, 258) were administered lansoprazole (30 mg/day for 8 weeks for GU, and the same dosage for 6 weeks for DU) as first-line therapy, and a half dose of H2RA as maintenance therapy for 12 months. Endoscopic photographs were taken before administration and after 8 (GU) and 6 (DU) weeks of lansoprazole administration. Ulcer stage was evaluated using the classification of Sakita and Miwa. Endoscopic examinations were performed 6 months or 12 months after the start of maintenance therapy or when a recurrence was suspected because of the appearance of subjective symptoms. The healing rates for GU and DU patients after completion of lansoprazole therapy were 79% in both groups, while the S2-stage healing rates were 18% and 31%, respectively. At 1 year after the start of maintenance therapy, the recurrence rates were 25% for GU and 39% for DU patients. In DU patients, the recurrence rates from S1-stage and S2-stage were 49% and 20%, respectively (P = 0.004), but no significant difference was found between these rates in GU patients. The recurrence rates in H. pylori-positive patients before lansoprazole administration were 27% for GU and 43% for DU patients. We concluded that the maintenance therapy with a half-dose of H2RA following PPI therapy was insufficient to prevent recurrences of GU and DU.",2001.0,0,0
292,11095320,"Oral pantoprazole for erosive esophagitis: a placebo-controlled, randomized clinical trial. Pantoprazole US GERD Study Group.",J E Richter; W Bochenek,"The aim of this dose-response study was to compare the effectiveness of 10 mg, 20 mg, and 40 mg of pantoprazole with that of placebo tablets in the healing and symptom relief of gastroesophageal reflux disease associated with erosive esophagitis, and to determine the optimal dose. A total of 603 patients with endoscopically confirmed (Hetzel-Dent scale) erosive esophagitis of grade 2 (64.5%) or grades 3 or 4 (35.3%) were enrolled in a double-blind, multicenter study and randomly assigned to receive pantoprazole (10 mg, 20 mg, or 40 mg) or placebo, administered once daily in the morning, for 4 or 8 wk depending on healing. The healing rates after 4 wk for placebo and pantoprazole 10 mg, 20 mg, and 40 mg/day were 14%, 42%, 55%, and 72%, respectively (p < 0.001 for all doses of pantoprazole vs placebo). Cumulative healing rates after 8 wk for placebo and pantoprazole 10 mg, 20 mg, and 40 mg/day were 33%, 59%, 78%, and 88%, respectively (p < 0.001 for all doses of pantoprazole vs placebo). The 40-mg pantoprazole dose produced greater rates of healing and earlier healing of esophagitis than either the 10- or 20-mg dose, regardless of severity. Pantoprazole, at any dose, was significantly more effective than placebo in relieving reflux symptoms. Patients on pantoprazole 40 mg experienced relief of symptoms on day 1 of treatment. No serious treatment-related adverse events occurred. Pantoprazole was safe and effective for healing erosive esophagitis and provided rapid symptomatic relief. These results indicate that pantoprazole offers a new option for treatment of erosive esophagitis. Among the three doses studied, the 40-mg dose was the most effective.",2001.0,0,1
293,11095321,Rabeprazole for the prevention of pathologic and symptomatic relapse of erosive or ulcerative gastroesophageal reflux disease. Rebeprazole Study Group.,A Caos; M Moskovitz; Y Dayal; C Perdomo; R Niecestro; J Barth,"We evaluated the effectiveness and safety profile of 10 and 20 mg of rabeprazole, a new proton pump inhibitor, once daily versus placebo in preventing endoscopic and symptomatic relapse for up to 1 yr among patients with healed erosive or ulcerative gastroesophageal reflux disease (GERD). The 52-wk trial used a multicenter, randomized, double-blind, parallel-group design in which 209 men and women were assigned to 10 or 20 mg of rabeprazole once daily in the morning or placebo. Both rabeprazole doses were significantly superior to placebo in preventing endoscopic relapse (p < 0.001), and 20 mg was significantly more effective than 10 mg (p < 0.04). Both doses were also significantly superior to placebo in reducing the frequency and severity of heartburn relapse (p < 0.001). When adjusted for differences in exposure to study medication, no significant differences were found in the incidence of adverse events. No clinically significant changes were found regarding clinical laboratory parameters, vital signs, electrocardiograms, ophthalmological evaluations, body weight, serum gastrin, and enterochromaffin-like cell histology. Once-daily therapy with 10 or 20 mg of rabeprazole effectively prevents pathological and symptomatic GERD relapse. The 20-mg dose is significantly more effective than the 10-mg dose in preventing endoscopic recurrence. Treatment was well tolerated, and no clinically significant safety findings emerged. Our findings support rabeprazole's efficacy in preventing GERD recurrence with excellent tolerability and a short-term favorable safety profile.",2001.0,0,0
294,11095322,Optimizing endoscopic biopsy detection of early cancers in Barrett's high-grade dysplasia.,B J Reid; P L Blount; Z Feng; D S Levine,"The of high-grade dysplasia management (HGD) in Barrett's esophagus remains controversial, in part, because of uncertainty about the ability of endoscopic biopsies to consistently detect early, curable cancers. Here we report cancers we have diagnosed in 45 patients with Barrett's HGD using a protocol involving serial endoscopies with four-quadrant biopsies taken at 1-cm intervals. We compare these results to a modeled endoscopic biopsy protocol in which four-quadrant biopsies are taken every 2 cm in the Barrett's segment. Thirteen cancers were detected at the baseline endoscopy and 32 in surveillance. In 82% of patients, cancer was detected at a single 1-cm level of the esophagus, and in 69% the cancer was detected in a single endoscopic biopsy specimen. A 2-cm protocol missed 50% of cancers that were detected by a 1-cm protocol in Barrett's segments 2 cm or more without visible lesions. The maximum depth of cancer invasion was intramucosal in 96% of patients. Only 39% of patients who had endoscopic biopsy cancer diagnoses had cancer detected in the esophagectomy specimen. Adverse outcomes included the development of regional metastatic disease during surveillance (1 of 32), operative mortality (3 of 36), including two patients who had their primary surgeries at other institutions, and death from metastatic disease after endoscopic ablation performed at another institution (1 of 3). A four-quadrant, 1-cm endoscopic biopsy protocol performed at closely timed intervals consistently detects early cancers arising in HGD in Barrett's esophagus and should be used in patients with HGD who do not undergo surgical resection.",2001.0,0,0
295,11095324,Pharmacokinetics of orally administered omeprazole in children. International Pediatric Omeprazole Pharmacokinetic Group.,T Andersson; E Hassall; P Lundborg; R Shepherd; M Radke; M Marcon; A Dalväg; S Martin; R Behrens; S Koletzko; M Becker; E Drouin; G Göthberg,"The aim of this study was to examine the pharmacokinetics of orally administered omeprazole in children. Plasma concentrations of omeprazole were measured at steady state over a 6-h period after administration of the drug. Patients were a subset of those in a multicenter study to determine the dose, safety, efficacy, and tolerability of omeprazole in the treatment of erosive reflux esophagitis in children. Children were 1-16 yr of age, with erosive esophagitis and pathological acid reflux on 24 h-intraesophageal pH study. The ""healing dose"" of omeprazole was that at which subsequent intraesophageal pH study normalized. Children remained on this dose for 3 months, and during this period the pharmacokinetics were measured. A total of 57 children were enrolled in the overall healing phase of the study. Pharmacokinetic study was optional for subjects and was performed in 25 of the 57 enrolled. The doses of omeprazole required were substantially higher doses per kilogram of body weight than in adults. Values of the pharmacokinetic parameters of omeprazole were generally within the ranges previously reported in adults. However, the plasma levels, area under the plasma concentration versus time curve (AUC), plasma half-life (t(1/2)), and maximal plasma concentration (Cmax), were lower in the younger age group, when the AUC and Cmax were normalized to a dose of 1 mg/kg. Furthermore, within the group as a whole, these values showed a gradation from lowest in the children 1-6 yr of age to higher in the older age groups. The pharmacokinetics of omeprazole in children showed a trend toward higher metabolic capacity with decreasing age, being highest at 1-6 yr of age. This may explain the need for higher doses of omeprazole on a per kilogram basis, not only in children overall compared with adults but, in many cases, particularly in younger children.",2001.0,0,0
296,11099054,Eradication of Helicobacter pylori compared with long-term acid suppression in duodenal ulcer disease. A randomized trial with 2-year follow-up. The Danish Ulcer Study Group.,P Bytzer; C Aalykke; S Rune; L Weywadt; T Gjørup; J Eriksen; O Bonnevie; C Bekker; H Kromann-Andersen; J Kjaergaard; J Rask-Madsen; M Vilien; J Hansen; T Justesen; M Vyberg; P S Teglbjaerg,"Trials evaluating long-term management of duodenal ulcer disease have mainly been focused on recurrence of ulcers, disregarding effects on dyspeptic and reflux symptoms. Profound acid inhibition with a proton pump inhibitor is the gold standard therapy in acid-related diseases. We aimed to compare the symptomatic effects of eradication therapy with those of long-term omeprazole treatment in a design with periods both with and without acid inhibition. Patients with active duodenal ulcer were randomized either to omeprazole, 20 mg twice daily until healing, followed by omeprazole, 20 mg/ day for 1 year, or to eradication therapy (metronidazole, amoxicillin, and omeprazole for 2 weeks) followed by placebo for 1 year. All patients were followed up passively for an additional year. Clinical controls were performed every 2 months the 1st year (maintenance phase) and every 6 months during the passive follow-up phase. The study was multicentric and double-blind. The primary end-point was discontinuation of treatment, irrespective of reason. Two hundred and seventy-six patients were randomized (139 in the eradication treatment group). In the maintenance phase there were no differences in the reporting of dyspeptic symptoms or in premature withdrawal. In the passive follow-up phase only five patients in the eradication therapy group discontinued owing to relapse of dyspeptic symptoms or ulcer, compared with 51 patients initially randomized to long-term omeprazole. There were no differences in reflux symptoms or in the development of reflux oesophagitis. Eradication therapy and long-term omeprazole are equally effective in controlling dyspeptic symptoms and reflux in duodenal ulcer patients with healed ulcers. One-quarter of the duodenal ulcer patients who start eradication therapy continue to be symptomatic or fail therapy for other reasons over a 2-year period. Eradication therapy does not increase the risk of reflux in ulcer patients.",2001.0,0,1
297,11100345,Endoscopic injection therapy vs. multipolar electrocoagulation vs. laser vs. injection + octreotide vs. injection + omeprazole in the treatment of bleeding peptic ulcers. A prospective randomized study.,C Sofia; F Portela; C Gregório; A Rosa; E Camacho; L Tomé; M Ferreira; P Andrade; P Cabral; J Romãozinho; H Gouveia; M Leitão; I Pimenta; A Donato; D Freitas,"A prospective randomized study was performed to assess the effectiveness and safety of 5 different methods of hemostasis in selected patients with high-risk bleeding peptic ulcers. Two hundred and eight patients (n = 208; mean age: 61.6 yrs) with endoscopic stigmata of active hemorrhage, non-bleeding vessel or adherent fresh clot were randomized during emergency endoscopy to receive one of the following modalities of endoscopic therapy (with or without pharmacological therapy): I) injection of absolute alcohol (n = 44); II) multipolar electrocoagulation (BICAP; n = 42); III) Nd-YAG laser (n = 40); IV) injection of absolute ethanol + octreotide (n = 42); V) injection of absolute ethanol + omeprazole (n = 40). The 5 treatment groups were clinically and endoscopically comparable. The initial hemostatic success was > 90% in every group. No significant differences between groups were found in any of the following parameters assessed during hospitalization: incidence of rebleeding (I = 14.8% vs. II = 19.0% vs. III = 16.6% vs. IV = 18.1% vs. V = 20.0%; P > 0.05 mean = 17.7%); incidence of definitive hemostasis (I = 89.3% vs. II = 85.7% vs. III = 86.6% vs. IV = 84.0% vs. V = 86.6%; P > 0.05; mean = 86.5%); incidence of emergency surgery (I = 8.5% vs. II = 11.9% vs. III = 10.0% vs. IV = 6.8% vs. V = 11.1%; P > 0.05; mean = 9.6%); mortality rate (I = 4.2% vs. II = 4.7% vs. III = 3.3% vs. IV = 13.6% vs. V = 4.4%; P > 0.05; mean = 6.2%). Mean age of deceased patients was significantly higher than living patients (71.2 +/- 13.4 vs. 60.9 +/- 14.4; P < 0.05). Approximately 2/3 of the fatal cases were strongly weakened by coexistent medical diseases. The duration of hospital stay was similar for all groups. The BICAP group required less units of blood transfusion (1.9 +/- 1.8 vs. I = 3.0 +/- 2.6; III = 3.5 +/- 3.6; IV = 2.8 +/- 2.3; V = 3.1 +/- 2.5; P < 0.05), perhaps due to the higher mean value of hemoglobin of these patients at hospital admission, compared to all other groups. No significant complications were reported. This study provides good evidence that injection of absolute ethanol, multipolar electrocoagulation (BICAP) and Nd-YAG laser are equally safe and effective in the endoscopic therapy of acute bleeding peptic ulcers. In contrast, no additional hemostatic benefits arose from the association of pharmacological agents (octreotide or omeprazole) to sclerosis injection.",2001.0,0,0
298,11106204,Chronic cough and gastro-oesophageal reflux: a double-blind placebo-controlled study with omeprazole.,T O Kiljander; E R Salomaa; E K Hietanen; E O Terho,"Gastro-oesophageal reflux (GOR) is an important cause of chronic cough. There has been a lack of placebo-controlled trials treating GOR related chronic cough with antireflux therapy. The aim of this study was to determine the efficacy of omeprazole on GOR related chronic cough. After excluding other common causes of cough, oesophageal pH monitoring was performed on 48 patients with chronic cough. Twenty-nine patients found to have GOR were randomized in a double-blind fashion to receive omeprazole 40 mg o.d. or placebo for 8 weeks. After a 2-week washout period, patients were crossed over to the other treatment. Symptoms were recorded daily in a diary. Twenty-one patients completed both treatment periods. Cough (p=0.02) and gastric symptoms (p=0.003) improved significantly during the omeprazole treatment in twelve patients who received placebo during the first and omeprazole during the second 8-week period. In nine patients who received omeprazole during the first 8-week period, amelioration in cough reached statistical significance only after cessation of omeprazole. Gastric symptoms also remained minor during placebo in these nine patients. Omeprazole 40 mg o.d. seems to improve chronic cough in patients with gastrooesophageal reflux and the effect of omeprazole in ameliorating both cough and reflux symptoms continues after treatment ceases.",2001.0,0,0
299,11110229,Clinical experience with pantoprazole in gastroesophageal reflux disease.,D L Avner,"Pantoprazole is a new proton pump inhibitor indicated for the treatment of erosive esophagitis associated with gastroesophageal reflux disease (GERD) and is available in both oral and intravenous (IV) formulations. This paper reviews the pharmacologic properties of pantoprazole and summarizes the findings from clinical studies of this drug. This review was compiled from the published literature, abstracts from clinical trials, and data on file with the manufacturer of pantoprazole. Pantoprazole selectively accumulates in the acidic environment of gastric parietal cells and acts at the final step of acid secretion by binding 2 key cysteine residues of the proton pump involved in gastric acid production. The bioavailability of pantoprazole is not altered by concomitant administration of food or antacids or with repeated dosing. Both oral and IV formulations of pantoprazole exhibit linear pharmacokinetics. Several clinical trials have proved pantoprazole superior to histamine-2-receptor antagonists (H2RAs) in reducing acid secretion and elevating gastric pH levels. Pantoprazole has been shown to be more effective than ranitidine (P < 0.05), famotidine (P < 0.001), and nizatidine (P < 0.05), and at least as effective as omeprazole, in healing erosive esophagitis and relieving associated symptoms of GERD, including regurgitation. Pantoprazole is also more effective than the H2RA nizatidine for the treatment of nighttime heartburn (P < 0.05). Studies have shown pantoprazole to be well tolerated; adverse events, including headache, diarrhea, flatulence, abdominal pain, eructation, nausea, and rash, occurred in < or = 6% of patients. The oral and IV formulations of pantoprazole are equally potent in inhibiting gastric acid secretion; thus, switching between formulations requires no dosage adjustments. Special patient populations, including the elderly and patients with renal or mild to moderate hepatic impairment, can take pantoprazole without an adjustment in dosage. Because of its unique pharmacokinetic properties, mechanism of action, and reduced potential for producing cytochrome P-450-based drug interactions, pantoprazole in both oral and IV formulations is effective over a full 24 hours and is well tolerated in a variety of patient types.",2001.0,0,0
300,11111105,Implications of antibiotic resistance in the management of Helicobacter pylori infection.,S Veldhuyzen van Zanten,,2001.0,0,0
301,11111108,Meeting review--Helicobacter pylori: basic mechanisms to clinical cure 2000.,R G Lahaie; N Chiba; C Fallone,"The meeting Helicobacter pylori: Basic Mechanisms to Clinical Cure 2000, held in Bermuda from March 26 to 29, 2000, gathered physicians and scientists from all corners of the world. State-of-the-art reviews and the most recent developments in the field were presented. This article summarizes the highlights of this meeting, including important scientific and clinical developments.",2001.0,0,0
302,11111109,Implications of antibiotic resistance in the management of Helicobacter pylori infection: Canadian Helicobacter Study Group.,R H Hunt; F M Smaill; C A Fallone; P M Sherman; S J Veldhuyzen van Zanten; A B Thomson,"Eradication of Helicobacter pylori from the gastric and duodenal mucosa is an important clinical goal in the treatment of infected patients with peptic ulcer disease and other H pylori-associated conditions. Although several oral drug combination regimens are associated with eradication rates of approximately 85% in controlled trials, the success rate in patients infected with a resistant strain of H pylori is closer to 75%. Resistance to metronidazole and clarithromycin, which are common components of combination treatment regimens, is of greatest concern. Reported rates of H pylori resistance to various antibiotics vary considerably. In Canada, the data documenting H pylori susceptibility are limited but suggest that resistance to these antibiotics varies geographically and within specific treatment groups. Although susceptibility testing is not a prerequisite for initial treatment of individual patients infected with H pylori, formal efforts to identify and monitor both the causes and prevalence of antibiotic resistance across Canada are a much needed step in the ongoing management of this important infection. Recommended treatment regimens may be useful, even for treating apparently resistant H pylori strains. However, it is important to understand the mechanisms of the development of resistant strains to manage patients with treatment failure better.",2001.0,0,0
303,11111778,"An epidemiological study of acute upper gastrointestinal bleeding in Crete, Greece.",G A Paspatis; E Matrella; A Kapsoritakis; C Leontithis; N Papanikolaou; G J Chlouverakis; E Kouroumalis,"Information about the epidemiology of acute upper gastrointestinal bleeding (UGIB) in southern Europe is very limited and especially in Greece non-existent. Our study sought to determine the current epidemiology of acute UGIB (incidence, mortality and case fatality) in the prefecture of Heraklion-Crete. From February 1998 to February 1999, we prospectively obtained data on all patients with acute UGIB in the prefecture of Heraklion-Crete. All patients who were permanent residents of the prefecture of Heraklion, aged 16 years and over with acute UGIB were included in the study. During this period, 353 cases of acute UGIB were included in the study. The overall incidence of acute UGIB is 160/100,000 adults per year with a male-to-female ratio of 1.7 and a mean age 66.2 +/- 17.1 years. The incidence rises from 30 in those aged under 30 years to 609 in those aged over 75 years. The overall population mortality was 9/100,000 adults per year. Overall case fatality during hospitalization was 5.6%. All deaths occurred in patients older than 60 years. One or more comorbid illnesses were noted in 61% of cases. Recent intake of non-steroidal anti-inflammatory drugs (NSAIDs) was reported in 49% of the cases. The most common recorded diagnoses were erosive disease in 108 (30.5%) patients, duodenal ulcer in 97 (27.4%) and gastric ulcer in 75 (21.2%). Rebleeding occurred in 41 patients (12%). Twelve patients (3.3%) had surgery during hospitalization. The overall annual incidence of acute UGIB in the prefecture of Heraklion-Crete is one of the highest reported in Europe and increases appreciably with age. Both population mortality and case fatality are slightly lower compared to those reported in most previous studies.",2001.0,0,0
304,11113836,"Omeprazole for treatment of chronic erosive esophagitis in children: a multicenter study of efficacy, safety, tolerability and dose requirements. International Pediatric Omeprazole Study Group.",E Hassall; D Israel; R Shepherd; M Radke; A Dalväg; B Sköld; O Junghard; P Lundborg,"To determine the efficacy, safety, and tolerability of omeprazole in children and to determine the doses required to heal chronic, severe esophagitis. Open multicenter study in children aged 1 to 16 years with erosive reflux esophagitis. The healing dose of omeprazole used was that with which the duration of acid reflux was <6% of a 24-hour intraesophageal pH study. Follow-up endoscopy was performed after 3 months of treatment with the healing dose. At entry, two thirds of 57 patients who completed the study had esophagitis grade 3 or 4 (scale 0-4); some 50% had neurologic impairment or repaired esophageal atresia. Of the 57 patients, 54 healed; 3 did not heal and left the study, and 3 healed with a second course. Doses required for healing were 0.7 to 3.5 mg/kg/d: 0.7 mg/kg/d in 44% of patients and 1.4 mg/kg/d in another 28%. Healing dose correlated with grade of esophagitis but not with age or underlying disease. Reflux symptoms improved dramatically in almost all of the 57 patients, including the unhealed patients. Omeprazole is well tolerated, highly effective, and safe for treatment of erosive esophagitis and symptoms of gastroesophageal reflux in children, including children in whom antireflux surgery or other medical therapy has failed. On a per-kilogram basis, the doses of omeprazole required to heal erosive esophagitis are much greater than those required for adults.",2001.0,0,0
305,11115820,Epidermal growth factor reduces multiorgan failure induced by thioacetamide.,M E Caballero; J Berlanga; D Ramirez; P Lopez-Saura; R Gozalez; D N Floyd; T Marchbank; R J Playford,"Multiorgan failure is a severe life threatening state where present therapeutic approaches are suboptimal. Epidermal growth factor (EGF) is a potent stimulant of repair in in vitro and in vivo models. We therefore examined its potential beneficial effect in reducing mortality and injury induced by the noxious agent thioacetamide (TAA). Mice (20 per group) were fasted overnight and received a single intraperitoneal dose of human recombinant EGF at 10 or 30 microg/kg or saline (control). Either 30 minutes before or after EGF, all animals also received TAA (40 mg/kg intraperitoneally). Twenty four hours later, surviving animals were killed, tissues collected, and degree of organ injury assessed. Fifty per cent (10/20) of control animals died within the first 24 hour period. Mortality was almost completely prevented by the higher dose of EGF whether given before or after TAA (p<0.01) and was reduced by about 50% with the lower dose of EGF. In control animals, the entire length of the jejunum and ileum had necrosis with or without mucosal denudation. In contrast, necrosis affected only about 10-20% of the total length in EGF treated groups (both p<0.01 v control). Control animals showed marked glomerular tuft collapse, interstitial haemorrhage, and increased plasma creatinine levels. These effects were significantly reduced in animals given EGF (30 microg/kg; p<0.01). All groups showed similar changes in liver histology (centrilobular necrosis) and alanine transaminase levels (10-fold increase). Although EGF did not prevent the hepatotoxicity associated with TAA, it reduced mortality, renal injury, and gastrointestinal damage. These studies provide preliminary evidence that EGF may be a novel approach for the prevention and/or treatment of multiorgan failure.",2001.0,0,1
306,11117653,Pantoprazole: a new proton pump inhibitor.,P W Jungnickel,"This paper reviews the pharmacology, clinical efficacy, and tolerability of pantoprazole in comparison with those of other available proton pump inhibitors (PPIs). Relevant English-language research and review articles were identified by database searches of MEDLINE, International Pharmaceutical Abstracts, and UnCover, and by examining the reference lists of the articles so identified. In selecting data for inclusion, the author gave preference to full-length articles published in peer-reviewed journals. Like other PPIs, pantoprazole exerts its pharmacodynamic actions by binding to the proton pump (H+,K+ -adenosine triphosphatase) in the parietal cells, but, compared with other PPIs, its binding may be more specific for the proton pump. Pantoprazole is well absorbed when administered as an enteric-coated, delayed-release tablet, with an oral bioavailability of approximately 77%. It is hepatically metabolized via cytochrome P2C19 to hydroxypantoprazole, an inactive metabolite that subsequently undergoes sulfate conjugation. The elimination half-life ranges from 0.9 to 1.9 hours and is independent of dose. Pantoprazole has similar efficacy to other PPIs in the healing of gastric and duodenal ulcers, as well as erosive esophagitis, and as part of triple-drug regimens for the eradication of Helicobacter pylori from the gastric mucosa. It is well tolerated, with the most common adverse effects being headache, diarrhea, flatulence, and abdominal pain. In clinical studies, it has been shown to have no interactions with various other agents, including carbamazepine, cisapride, cyclosporine, digoxin, phenytoin, theophylline, and warfarin. Pantoprazole appears to be as effective as other PPIs. Its low potential for drug interactions may give it an advantage in patients taking other drugs.",2001.0,0,0
307,11120724,Investigation and therapy in patients with different types of dyspepsia: a 3 year follow-up study from general practice.,V Meineche-Schmidt; T Jørgensen,"Decisions by GPs on investigation and treatment are based on the symptoms presented by the patient. The relevance of dyspepsia subgroups has been questioned, but their value in general practice has not been tested. The aim of this study was to investigate how dividing dyspepsia into different subgroups (ulcer-like, reflux-like, dysmotility-like, uncharacteristic and relapsing dyspepsia) affected the approach of GPs to patients with dyspeptic complaints. A random sample of GPs' patients consulting for different dyspepsia subtypes were studied by postal questionnaires 3 years after the initial consultation, obtaining information from the GPs' records on investigations, prescriptions of dyspepsia medication and gastrointestinal morbidity. In the 3 years studied, 48% of the patients were prescribed dyspepsia medication, 14% were endoscoped and 3% were referred to a specialist. The dyspepsia subtype was significantly related to the type of drug prescribed, but not to investigations or referrals. Ulcer-like and reflux-like dyspepsia were treated in the same way. Dyspepsia subtypes significantly influenced the treatment. Danish GPs treat all acid-related dyspepsia in the same way, and differently from other types of dyspepsia.",2001.0,0,0
308,11121907,"Omeprazole 40 mg once a day is equally effective as lansoprazole 30 mg twice a day in symptom control of patients with gastro-oesophageal reflux disease (GERD) who are resistant to conventional-dose lansoprazole therapy-a prospective, randomized, multi-centre study.",R Fass; U Murthy; C W Hayden; I B Malagon; G Pulliam; C Wendel; T O Kovacs,"Comparative studies of omeprazole and lansoprazole are scarce and even scarcer are comparisons of higher doses. Most of the comparative studies have assessed the effect of the two proton pump inhibitors (PPIs) on gastric acid secretion or gastric pH. Few studies have compared clinical end-points such as oesophageal healing and symptom control. To determine the clinical efficacy of omeprazole 40 mg daily as compared to lansoprazole 30 mg twice a day in symptom control of patients with severe symptomatic GERD. Ninety-six patients who failed a standard dose of lansoprazole (30 mg once daily), were enrolled in a prospective fashion from three VA medical centres and were randomized to receive 6 weeks of either omeprazole 40 mg daily or lansoprazole 30 mg twice daily. Patients reported daily on symptom severity and frequency, antacid consumption and side-effects. Forty-six patients received omeprazole and 44 lansoprazole. Although not statistically significant, there was a consistent trend of better symptom control in the omeprazole group for daytime and night-time heartburn and acid regurgitation. There was no statistical difference between the two groups in mean antacid consumption overall and at the end of each of the 6 weeks of the study. In addition, there was no significant difference in the overall frequency of side-effects between the two groups nor for each individual side-effect. Omeprazole 40 mg once daily is equally effective and tolerated as lansoprazole 30 mg twice daily in symptom control of patients with GERD.",2001.0,0,1
309,11121908,One-week triple therapy with esomeprazole provides effective eradication of Helicobacter pylori in duodenal ulcer disease.,S Veldhuyzen Van Zanten; K Lauritsen; J C Delchier; J Labenz; C M De Argila; T Lind; H C Treichel; A Stubberöd; A Cockeram; G Hasselgren; L Göthe; M Wrangstadh; P Sinclair,"Esomeprazole is the first proton pump inhibitor to be developed as an optical isomer for the treatment of acid-related diseases. Four hundred and forty eight duodenal ulcer patients with Helicobacter pylori infection, confirmed by 13C-urea breath test (UBT), and no current ulcer, were randomised to double-blind treatment with esomeprazole 20 mg twice daily (b.d.) (n=224) or omeprazole 20 mg b.d. (n=224), in combination with amoxicillin 1 g b.d. and clarithromycin 500 mg b.d. for 1 week (EAC and OAC, respectively). A negative UBT at both 4 and 8 weeks after completing therapy indicated successful H. pylori eradication. Intention-to-treat (ITT) analysis comprised 400 patients (EAC, n=204; OAC, n=196) and per protocol (PP) analysis 377 patients (EAC, n=192; OAC, n=185). Eradication rates (95% confidence intervals) for ITT and PP populations were: EAC, 90% (85-94%) and 91% (86-94%); OAC, 88% (82-92%) and 91% (86-95%). Between-group differences in eradication rates were not statistically significant. Both regimens were well tolerated, with an adverse event profile and frequency typical of proton pump inhibitor plus antibiotic combination therapy. Esomeprazole-based triple therapy for 1 week is highly effective in eradicating H. pylori infection in duodenal ulcer disease, offers comparable efficacy to omeprazole-based therapy, and is well tolerated.",2001.0,1,1
310,11124281,Nonsteroidal anti-inflammatory drug gastropathy at the new millennium: mechanisms and prevention.,M Rich; J M Scheiman,"Nonsteroidal anti-inflammatory drug (NSAID)-induced gastrointestinal (GI) toxicity remains the most frequent adverse drug event in the United States. The objective of this review is to update clinicians in recent advances in basic and clinical investigation regarding the pathogenesis and management of NSAID gastropathy. Based upon an extensive review of the published literature and abstracts of key work within the past decade, the framework for new approaches to the prevention and treatment of NSAID-associated ulceration is summarized. The pathophysiology of NSAID-induced injury to the GI tract is multifaceted and includes both prostaglandin-dependent and independent components. The pharmaceutical industry has capitalized on the identification of two different isoforms of cyclooxygenase, enabling the development of specific inhibitors of one isoform that minimizes prostaglandin-dependent mechanisms that contribute to NSAID-induced injury. Clinical trials support the efficacy and reduced toxicity of these agents. Because acid exacerbates the injury initiated by NSAIDs, potent acid suppressive therapy, typically with proton pump inhibitors, is another common approach to the treatment of NSAID-related dyspepsia as well as NSAID-induced ulcer disease. Recent improvements in the understanding of NSAID-induced damage and new drug development have provided the opportunity for effective anti-inflammatory therapy with reduced GI toxicity. This illustrates the importance of identifying patients at risk for potential complications and the appropriate use of strategies to prevent and treat NSAID-induced complications.",2001.0,0,0
311,11126309,Apoptosis and osteoporosis.,R S Weinstein; S C Manolagas,"During normal bone remodeling, the rate of supply of new osteoblasts and osteoclasts and the timing of the death of osteoclasts, osteoblasts, and osteocytes by apoptosis are critical determinants of the initiation of new BMUs and the extension or reduction of the lifetime of existing ones. Disruption of the fine balance among these processes may be an important mechanism behind the deranged bone turnover found in most metabolic disorders of the adult skeleton. Like most armies, the amount 5 of work done by bone cells is far more dependent on numbers than vigor. Therapeutic agents that alter the prevalence of apoptosis of osteoblasts and osteoclasts can correct the imbalance in cell numbers that is the basis of the diminished bone mass and increased risk of fractures in osteoporosis.",2001.0,0,0
312,11130524,Cost effectiveness of initial endoscopy for dyspepsia in patients over age 50 years: a randomised controlled trial in primary care.,B C Delaney; S Wilson; A Roalfe; L Roberts; V Redman; A Wearn; A Briggs; F D Hobbs,"Dyspepsia can be managed by initial endoscopy and treatment based on endoscopic findings, or by empirical prescribing. We aimed to determine the cost effectiveness of initial endoscopy compared with usual management in patients with dyspepsia over age 50 years presenting to their primary care physician. 422 patients were recruited and randomly assigned to initial endoscopy or usual management. Primary outcomes were effect of treatment on dyspepsia symptoms and cost effectiveness. Secondary outcomes were quality of life and patient satisfaction. Total costs were calculated from individual patient's use of resources with unit costs applied from national data. Statistical analysis of uncertainty on incremental cost-effectiveness ratio (ICER) was done along with a sensitivity analysis on unit costs with cost-effectiveness acceptability curves. In the 12 months following recruitment, 213 (84%) patients had an endoscopy compared with 75 (41%) controls. Initial endoscopy resulted in a significant improvement in symptom score (p=0.03), and quality of life pain dimension (p=0.03), and a 48% reduction in the use of proton pump inhibitors (p=0.005). The ICER was Pound Sterling1728 (UK Pound Sterling) per patient symptom-free at 12 months. The ICER was very sensitive to the cost of endoscopy, and could be reduced to Pound Sterling165 if the unit cost of this procedure fell from Pound Sterling246 to Pound Sterling100. Initial endoscopy in dyspeptic patients over age 50 might be a cost-effective intervention.",2001.0,0,0
313,11136281,A multicentre study on eradication of Helicobacter pylori using four 1-week triple therapies in China.,S D Xiao; W Z Liu; P J Hu; Q Ouyang; J L Wang; L Y Zhou; N N Cheng,"Short-term proton pump inhibitor-based triple therapies for the eradication of Helicobacter pylori are used widely. The eradication rates vary greatly from country to country and from region to region. To assess the efficacy at eradicating H. pylori of 1-week regimens containing three medications: omeprazole (O) or colloidal bismuth subcitrate (B), furazolidone (F) or metronidazole (M), and amoxicillin (A) or clarithromycin (C). A multicentre study involving 20 hospitals in different regions of China. A total of 892 patients with H. pylori-positive non-ulcer dyspepsia or healed duodenal ulcer confirmed by endoscopy were recruited to receive, randomly, one of four regimens: OMC, OFC, OFA, and BFC, b.d. for 7 days. 13C-urea breath test was performed 4-8 weeks after completion of treatment. The eradication rates with per protocol/intention-to-treat analyses were: OMC (n=217/219) 66%/65%; OFC (n=227/229) 69%/69%; OFA (n=223/225) 87%/86%; and BFC (n=214/219) 80%/78%. The eradication rate (per protocol analysis) in duodenal ulcer (79%) was higher than that in non-ulcer dyspepsia (73%, P=0.033). Patient compliance was good. The adverse events of the four regimens were mild, and mainly gastrointestinal. The omeprazole, furazolidine and amoxicillin regimen achieves a high H. pylori eradication rate in different geographical regions of China.",2001.0,0,0
314,11136282,,,,,0,0
315,11145281,Effects of long-term treatment with proton pump inhibitors in gastro-oesophageal reflux disease on the histological findings in the lower oesophagus.,M Stolte; M Vieth; J M Schmitz; T Alexandridis; E Seifert,"The application of hyperplasia of the basal cell layer and elongation of the papillae in the squamous epithelium of the distal oesophagus, as histological criteria for the diagnosis of gastro-oesophageal reflux disease (GORD), continues to be controversial. An unanswered question is whether these changes may regress under long-term treatment with proton pump inhibitors (PPI). This fact prompted us to investigate the effect of PPI treatment on the histological changes observed in the lower oesophagus. 295 patients with endoscopically confirmed erosive GORD were investigated by endoscopy/biopsy prior to and during the course of a 12-month PPI treatment regimen (8 weeks acute treatment with 30 mg lansoprazole/day followed by long-term treatment with 15 or 30 mg lansoprazole or 20 mg omeprazole/day). The parameters studied were the frequency of ulcers and erosions and the hyperplasia of the basal cell layer and elongation of the papillae prior to treatment and on day 56 (D56), after 6 months (M6) and after 12 months (M12) of treatment. In the various treatment groups, the results showed no statistically significant differences. Ulcers and erosions (prior to treatment 21% and 31%, respectively) were detected statistically significantly less frequently under PPI treatment (ulcers, D56: 1%, M6 and M12, 0%; erosions, D56: 2%, M6: 4%, M12, 3%). While high-grade hyperplasia of the basal cell layer and elongation of the papillae was found in 51% of the cases prior to treatment, the corresponding figures were only 3% (D56, M6) and 2% (M12). In contrast, the percentage of cases with normal oesophageal epithelium increased from 8% before treatment to 55% (D56), 66% (M6) and 63% (M12). Our study shows not only that erosions and ulcers heal under PPI treatment, but also that hyperplasia of the basal cell layer and elongation of papillae in the squamous epithelium of the oesophageal mucosa may normalize, and are thus presumably not 'normal physiological variants'.",2001.0,0,1
316,11147941,Management in peptic ulcer hemorrhage: a Dutch national inquiry.,M E van Leerdam; E A Rauws; A A Geraedts; G N Tytgat,"There is no consensus as to what endoscopic hemostatic therapy and pharmacotherapy should be used in peptic ulcer hemorrhage (PUH). We conducted a mail survey to investigate current management of ulcer hemorrhage in the Netherlands. A questionnaire was sent to gastroenterologists or, if not present, to internists, performing endoscopies, in every hospital in the Netherlands (n = 123). Endoscopic hemostatic therapy, pharmacotherapy, endoscopic reintervention, and management of Helicobacter pylori were evaluated. 90/123 (73%) questionnaires were returned. Endoscopic hemostatic therapy is given in ulcers classified as Forrest Ia, Ib, IIa, IIb, and IIc by, respectively, 89%, 93%, 83%, 47%, and 19% of respondents. Gastroenterologists perform endoscopic therapy more often in Forrest Ib (P=0.03), IIa (P=0.002), and IIb (P=0.001) ulcers when compared with internists. Endoscopic injection therapy is used by 93% of respondents as first modality. Epinephrine combined with polidocanol is most commonly used (60%). Pharmacotherapy is given by 97%. A total of 71% use proton pump inhibitors (PPIs), and 26% use H2-receptor antagonists (H2RAs), both mainly initially given intravenously. In case of suspected rebleeding, endoscopic reintervention is performed by 76%, including a significantly greater percentage of gastroenterologists (89% of gastroenterologists vs. 60% of internists, P=0.005), whereas the others refer the patient directly for surgery. Almost all respondents investigate for H. pylori. Eradication is confirmed by only 64% (80% of gastroenterologists vs. 50% of internists, P=0.004). There are important differences in management of peptic ulcer hemorrhage between gastroenterologists and internists in the Netherlands. Management is only partly in accordance with evidence-based medicine.",2001.0,0,0
317,11148437,Eradication of Helicobacter pylori prevents ulcer development in patients with ulcer-like functional dyspepsia.,P I Hsu; K H Lai; H H Tseng; G H Lo; C C Lo; C K Lin; J S Cheng; H H Chan; M K Ku; N J Peng; E J Chien; W Chen; P N Hsu,"Although the eradication of Helicobacter pylori infection benefits patients with gastric or duodenal ulcers, the value of eradicating the infection in the patients with functional dyspepsia (FD) remains controversial. To determine whether eradicating H. pylori can prevent the subsequent development of ulcers or relieve the symptoms of functional dyspepsia patients. In a double-blind, placebo-controlled trial, 161 patients infected with H. pylori who had functional dyspepsia were randomly assigned to 7 days of treatment with a lansoprazole-based triple therapy or placebo and then followed for 1 year. The main outcome measures were the development of peptic ulcers and the resolution of symptoms. H. pylori was eradicated in 63 out of 81 patients (78%) in the treatment group and none of the 80 patients (0%) in the placebo group. During the follow-up period, two patients in the treatment group and six patients in the placebo group developed peptic ulcers at repeat endoscopy (2.5% vs. 7.5%; 95% CI: -12 to 2). The reduction in ulcer rates was statistically significant in the 'ulcer-like' sub-group (0% vs. 16.7%; 95% CI: -32 to -2), but not in the 'dysmotility-like' and 'unclassifiable' sub-groups. Regarding symptom response, the resolution rates of symptoms were similar between the treatment and placebo groups (58.0% vs. 55.0%, 95% CI: -12 to 18). Additionally, no significant differences existed in the symptom responses between the treatment and control arms in each of the dyspepsia sub-groups. Eradicating H. pylori can prevent the subsequent development of peptic ulcers in the patients with 'ulcer-like' functional dyspepsia. However, this approach does not significantly reduce the symptoms of functional dyspepsia patients.",2001.0,0,0
318,11149018,One-week once-daily triple therapy for Helicobacter pylori--a pilot study.,K M Chu; K F Kwok; S Y Law; J Wong,"Proton-pump inhibitor-based triple therapy given over one to two weeks is currently one of the recommended regimens for eradication of Helicobacter pylori. Most of these regimens require twice daily intake of medication. The present study explored the possibility of using a one-week once-daily triple therapy in the eradication of H. pylori. Thirty-two consecutive patients with acid-peptic disease associated with H. pylori infection (duodenal ulcer 18 patients; gastric ulcer 8 patients; duodenitis 1 patient; gastritis 5 patients) were prospectively recruited. They were given a 1-week course of lansoprazole 30 mg, clarithromycin modified-release 500 mg, and metronidazole 800 mg, all taken once daily. The age of these 32 patients ranged from 17-89 years with a mean of 57.5 years. Side effects occurred in 5 patients (15.6%; 95% CI: 5.3-32.8%). All patients finished the treatment and underwent a second endoscopy. Positive endoscopic finding was found in one patient (3.1%; 95% CI: 0.07-16.2%). On intent-to-treat and per protocol analysis, the eradication rate was 87.5% (95% CI: 71.0-96.5%). A one-week once-daily course of lansoprazole, clarithromycin modified release and metronidazole is a safe, well-tolerated, easy to comply with, and efficacious treatment for H. pylori infection. In view of the small sample size, further studies should be performed to validate its effectiveness.",2001.0,0,0
319,11151867,"Esomeprazole-based Helicobacter pylori eradication therapy and the effect of antibiotic resistance: results of three US multicenter, double-blind trials.",L Laine; M B Fennerty; M Osato; J Sugg; L Suchower; P Probst; J G Levine,"To determine the efficacy of once-daily esomeprazole plus antibiotics for eradication of Helicobacter pylori, to assess the effect of antibiotic resistance on eradication rate, and to define the rate of emergent resistance. Three separate randomized trials were performed in H. pylori-positive patients with a duodenal ulcer or history of documented duodenal ulcer within 5 yrs: 1) esomeprazole (40 mg once daily), amoxicillin (1 g b.i.d.), and clarithromycin (500 mg b.i.d.; this combination will be referred to as EAC) versus esomeprazole (40 mg once daily) plus clarithromycin (500 mg twice daily; this combination will be referred to as EC); 2) EAC versus esomeprazole (40 mg once daily; E); and 3) EC versus E. Therapy was given for 10 days. Endoscopy and biopsies for CLOtest, histology, and culture with susceptibility testing were done at baseline and 4 wk after completion of therapy. Per-protocol and intent-to-treat eradication rates, respectively, were as follows. For EAC versus EC in study 1 (N = 448), 84 versus 55% and 77 versus 52% (p < 0.001); for EAC versus E in study 2 (N = 98), 85 versus 5% and 78 versus 4% (p < 0.001); for EC versus E in study 3 (N = 66), 50% versus 0 and 46% versus 0 (p < 0.05). The 15% of patients in the combined studies with baseline clarithromycin resistance had significantly lower rates of eradication than those with susceptible strains (EAC: 45 vs. 89%; EC: 13 vs. 61%). Emergent resistance was less common after treatment with EAC [2/6 (33%)] than with EC (23/27 [85%]). Ten-day triple therapy with once-daily esomeprazole plus twice-daily amoxicillin and clarithromycin achieves an eradication rate virtually identical to that of the twice-daily proton pump inhibitor-based triple therapies. Baseline clarithromycin resistance, present in 15% of patients, predicts a markedly decreased rate. Use of an amoxicillin-containing regimen may decrease emergence of clarithromycin resistance.",2001.0,0,0
320,11154164,Switching between intravenous and oral pantoprazole.,J R Pisegna,"Proton pump inhibitors (PPIs) are the most effective antisecretory drugs available for controlling gastric acid acidity and volume. They are the drugs of choice in the treatment of moderate-to-severe gastroesophageal reflux disease, hypersecretory disorders, and peptic ulcers. Currently in the United States, they are only available in an oral formulation. However, pantoprazole will soon be available in an intravenous formulation and will extend the power of PPIs to inpatient hospital settings. Intravenous pantoprazole has been shown to be effective and safe in clinical trials. Intravenous pantoprazole is indicated for the treatment of patients who require PPI therapy but who are unable to take oral medication. Intravenous pantoprazole has been shown to maintain acid suppression in patients switched from oral PPIs, so no change in dosage is required when switching from one formulation to the other. Potential hospital-based uses for intravenous PPI therapy include perioperative use as prophylaxis for acid aspiration syndrome during induction of anesthesia, prophylaxis for stress-related mucosal disease, and management of gastrointestinal bleeding from stress or acid peptic disease.",2001.0,0,0
321,11154169,Long-term follow-up and serologic assessment after triple therapy with omeprazole or lansoprazole of Helicobacter-associated duodenal ulcer.,L Fanti; R Ieri; G Mezzi; P A Testoni; S Passaretti; M Guslandi,"We assessed both the effectiveness of two Helicobacter pylori (Hp) eradication triple therapies and the usefulness of serology in the follow-up. Fifty patients with active or scarred duodenal ulcer were randomized to lansoprazole or omeprazole for 1 to 4 weeks, with clarithromycin 250 mg twice a day and tinidazole 500 mg twice a day for the first week. Endoscopies were scheduled before treatment, after 8 weeks, and after I year. H. pylori status was determined before therapy by rapid urease test and histology and during the follow-up by histology and culture. Serology was determined at baseline and at 6 and 12 months. The regimens were equally effective in inducing ulcer healing (95.8% vs. 87.5%) and eradicating Hp with no recurrences at 12 months. Among 44 patients eradicated, a significant reduction of immunoglobulin G (IgG) titer occurred at 6 (p < 0.0001) and 12 months (p < 0.0001). If a titer reduction of more than 30% was taken as an indicator for Hp eradication, the specificity of enzyme-linked immunosorbent assay was 75% at 6 and 95.4% at 12 months with a 100% sensitivity. Either lansoprazole or omeprazole combined with antibiotics are effective in eradicating Hp. Serology is useful for monitoring Hp eradication provided that an appropriate percent reduction in IgG titer is used after more then 6 months after therapy.",2001.0,1,1
322,11161072,Non-steroidal anti-inflammatory drugs and gastrointestinal damage-problems and solutions.,R I Russell,,2001.0,0,0
323,11172698,Gastroesophageal reflux disease (GERD): current agents and future perspective.,A Lanas; S Santolaria,"The objectives of medical treatment of patients with gastroesophageal reflux disease (GERD) are relief of symptoms and healing of esophagitis, which can be achieved, at least in part, by drugs which suppress acid secretion. In patients with GERD symptoms and/or mild esophagitis, the best and most cost-effective therapeutic strategy is to start with a proton pump inhibitor with subsequent trial of step down of the intensity of therapy (e.g. H2-receptor antagonists). In patients with moderate or severe esophagitis, proton pump inhibitors are the mainstay of treatment and the most effective in preventing symptoms and esophagitis. In patients with mild disease, the recurrence of symptoms is less frequent and many patients may not need continuous maintenance therapy or may require treatment with either low dose proton pump inhibitors, H2-receptor antagonists or cisapride only. H. pylori eradication might be needed in GERD patients on long-term treatment with proton pump inhibitors, but the benefit of this strategy has not yet been adequately demonstrated. Antireflux surgery is a maintenance option for the young patient on long-term medical therapy. Improved medical therapy for GERD might depend on future agents with different therapeutic targets, including GABA inhibitors and nitric oxide modulating drugs in the control of the lower sphincter esophagus and in motility disorders, free radical scavengers in the prevention of mucosal damage and COX-2 specific inhibitors in the prevention of the progression of Barret's esophagus to adenocarcinoma. Finally, the modulation of some growth factors might have a potential role in delayed esophageal ulcer healing, refractory esophagitis and in Barrett's esophagus.",2001.0,0,0
324,11174314,Recurrent ulcer bleeding: is the hemoclip an answer?,J G Lee; J W Leung,,2001.0,0,0
325,11179983,,,,,0,0
326,11179984,Curing Helicobacter pylori infection in patients with duodenal ulcer does not provoke gastroesophageal reflux disease.,R Befrits; S Sjöstedt; B Odman; H Sörngård; G Lindberg,"It has been suggested that the incidence of gastroesophageal reflux disease (GERD) increases after successful eradication of Helicobacter pylori infection. We present data on development of GERD from a controlled study of H. pylori eradication in 165 duodenal ulcer patients. Patients (mean age, 55 years; 102 men; current smokers; n = 74) were randomly assigned 2: 1 to receive omeprazole, 40 mg twice daily, in combination with either amoxicillin, 750 mg twice daily, or placebo. Endoscopy and dyspeptic symptoms, including heartburn, were assessed at inclusion and at 6, 12, and 24 months after treatment. In addition, symptoms were assessed at 18 months. Patients with erosive esophagitis or reflux symptoms requiring treatment at inclusion were not included in the study. Fifty-one of 145 (35%) evaluable patients developed heartburn, and 13 of 145 (9%) developed esophagitis during follow-up. The life-table analysis of the cumulated risk of developing heartburn showed that patients whose H. pylori infection was eradicated had a significantly lower risk for developing heartburn than those with persistent H. pylori infection. The groups did not show any difference in cumulative risk of developing esophagitis. Our data show that successful eradication of H. pylori infection does not increase the incidence of GERD in duodenal ulcer patients.",2001.0,0,0
327,11179985,Changing patterns of Helicobacter pylori gastritis in long-standing acid suppression.,P Moayyedi; C Wason; R Peacock; A Walan; K Bardhan; A T Axon; M F Dixon,"Helicobacter pylori colonization and associated inflammation are influenced by local acid output. Infected subjects with acid-related diseases, such as gastroesophageal reflux disease (GERD) are likely to have an antral-predominant gastritis. We hypothesized that long-term acid suppression would result in relatively greater bacterial colonization in the corpus leading to diffuse or corpus-predominant gastritis and that this would be prevented by prior H. pylori eradication. To investigate this, we conducted a prospective, double-blind trial of the effect on gastric histology of 12-month maintenance treatment with omeprazole in H. pylori-positive GERD patients randomly assigned to either an eradication or omeprazole-alone regime. A control group of 20 H. pylori-negative GERD patients also received omeprazole throughout the study period. Biopsies taken at baseline and at 12 months were graded ""blind"" by a single observer according to the updated Sydney System. The 41 H. pylori-positive subjects with grade B or C esophagitis were randomly assigned (20 to omeprazole alone, 21 to eradication) and 33 subjects completed the 12-month study. There was a significant decline in antral chronic inflammation in initially positive patients between baseline and end in both the eradication group (p =.035) and the omeprazole-alone group (p =.008). However, corpus chronic inflammation increased in the omeprazole-alone group (p =.0156) but decreased in the eradication group. The change toward corpus predominance between baseline and end for the omeprazole-alone group is highly significant (p =.0078). Furthermore, 5 of 11 in the omeprazole-alone group developed mild corpus atrophy, compared to 0 of 8 who had undergone H. pylori eradication. The change in frequency of corpus atrophy between the two groups is significant (p =.02). In H. pylori-positive subjects with GERD, long-term acid suppression leads to a shift from antral- to corpus-predominant gastritis that can be prevented by prior eradication. The shift is accompanied by an increase in corpus atrophy. H. pylori infection should be eradicated prior to long-term acid suppression with proton pump inhibitors.",2001.0,0,1
328,11179987,Ranitidine bismuth citrate can help to overcome Helicobacter pylori resistance to clarithromycin in vivo.,F Mégraud; P Roberts; R Williamson,"Helicobacter pylori eradication usually fails when clarithromycin is used against resistant strains. The objective of this study was to test whether the apparent synergy found in vitro between ranitidine bismuth citrate (RBC) and clarithromycin also exists in vivo against resistant strains. H. pylori was cultured and clarithromycin susceptibility was determined before and after treatment, from duodenal ulcer patients receiving RBC and clarithromycin or omeprazole and clarithromycin for 2 weeks in a multicenter randomized clinical trial. The overall eradication rate was 88.7% in the RBC group (71 patients) and 52.7% in the omeprazole group (74 patients). The demographic characteristics of the two groups were not different. Clarithromycin-resistant strains were isolated in 22 cases (15.1%). A difference between the eradication rates of susceptible and resistant strains was found in the omeprazole group but not in the RBC group. After treatment, resistance to clarithromycin developed in three of the seven strains (42.3%) cultured from the patients of the RBC group, compared with 11 of the 26 strains (42%) of the omeprazole group. That is, clarithromycin-resistant strains were found in 6% and 27% in the RBC group and the omeprazole group, respectively, on considering the global results. A synergy between RBC and clarithromycin may exist in vivo and, while clarithromycin resistance is increasing, it is an argument for using RBC in triple therapies.",2001.0,0,0
329,11182012,Medical treatment for reflux oesophagitis does not consistently improve asthma control: a systematic review.,J L Coughlan; P G Gibson; R L Henry,"A systematic literature review was conducted to assess the effect of treating reflux oesophagitis on asthma outcomes. Randomised controlled trials of reflux oesophagitis treatment in adults or children that reported asthma health outcomes were included and assessed in accordance with the standard Cochrane systematic review process. Patients were typically adults with asthma and concurrent symptomatic gastro-oesophageal reflux who received interventions that included pharmacological therapy, conservative management, and surgery. The following outcome measures were assessed: lung function, peak expiratory flow, asthma symptoms, asthma medications, and nocturnal asthma. From 22 potentially relevant published and unpublished randomised controlled trials, 12 were included. Treatment duration ranged from 1 week to 6 months. Eight trials reported that treatment improved at least one asthma outcome, but these outcomes differed between trials. Overall, treatment of reflux oesophagitis did not consistently improve forced expiratory volume in one second (FEV(1)), peak expiratory flow rate, asthma symptoms, nocturnal asthma symptoms, or use of asthma medications in asthmatic subjects. Significant improvement in wheeze was reported in two studies. The published literature does not consistently support treatment of reflux oesophagitis as a means of controlling asthma. Further large randomised controlled trials in subjects with a demonstrated temporal relationship between gastro-oesophageal reflux and asthma are needed. These trials should be conducted over at least 6 months to allow adequate time to observe a treatment effect.",2001.0,0,0
330,11186502,,,,,0,1
331,11186505,Proton pump inhibitors: cost-effective agents for management of reflux-induced esophagitis.,J C Gregor,,2001.0,0,1
332,11190068,The role of economic evaluation in the diagnosis and treatment of Helicobacter pylori infection.,A M Fendrick,"The unfolding of the H. pylori story coupled with the high prevalence and economic burden associated with upper gastrointestinal symptoms makes H. pylori-associated disorders an ideal candidate for economic evaluation. As a result of the high quality and quantity of data emerging, H. pylori eradication is cost-effective in individuals with either newly diagnosed or past PUD. The role of eradication in other areas, for example, patients with nonulcer dyspepsia and screening to prevent gastric cancer, may never be worked out to some clinicians' satisfaction. Conflicting reports and the lack of definitive clinical trials have frustrated clinicians. H. pylori diagnosis and treatment have not been integrated into everyday clinical practice. As a result, the enormous potential benefits associated with H. pylori eradication have not been achieved. Economic evaluation is not a panacea to the problems confronting medical services delivery. Assessments of medical practice are methodologically challenging, time-consuming, and expensive. Once the answers are in, it remains difficult to alter an individual provider's patterns of care and integrate the research findings into everyday practice. Further research into physician decision making is necessary to complement the advances being made in determining the value of medical interventions. The fruits of these efforts will be the more efficient delivery of health care services, which, it is hoped, ultimately will improve the health of patients. There is no reason to believe, however, that more attention to effectiveness research would lead to a reduction in health care expenditures. Increasing demands for accountability of medical interventions will propel effectiveness movements. Economic analyses, performed in concert with carefully designed clinical studies, will spur more critical review of health care resource allocation decisions. Despite the limitations, the findings generated from effectiveness research will have a major impact on physician practices, guideline development, and reimbursement decisions. The tendency of clinicians not to pay attention to economic evaluations may lead to missed clinical benefits and unnecessary expenditures. Physicians who have been reluctant to appreciate the information provided by economic evaluation must understand what other stakeholders in health care delivery already have accepted: that the rational basis for cost-effectiveness analysis is the overall improvement in the quality of health care services--not simply a tool to reduce health care costs.",2001.0,0,0
333,11192320,Limited usefulness of a seven-day twice-a-day quadruple therapy.,N Garcia; X Calvet; E Gené; R Campo; E Brullet,"To test the usefulness of a twice-a-day, simplified quadruple therapy to cure Helicobacter pylori infection. Helicobacter pylori-positive ulcer patients were treated with omeprazole 20 mg twice a day (b.d.), amoxicillin 1 g b.d., tinidazole 500 mg b.d. and bismuth subcitrate 240 mg b.d. for 7 days in an experimental, noncomparative pilot study. The gastroenterology unit of a county hospital. Forty-four consecutive patients with peptic ulcer disease and H. pylori infection. Cure was tested by either endoscopy or breath test after 2 months, and by urea breath test 6 months after therapy. One patient was lost to follow-up. Of the remaining 43, 37 were cured at the first control, giving an intention-to-treat cure rate of 84.1% (95% CI 69-93%) and a per protocol cure rate of 86% (95% CI 71-94%). Thirty-three cured patients agreed to return for a six-month breath test. All but one were cured (long-term per protocol cure rate 82.1%; 95% CI 66-92%). This particular quadruple therapy is well tolerated and easy to comply with. However, cure rates did not reach 90%.",2001.0,0,0
334,11194729,Helicobacter pylori: changing patterns of ulcer disease and antibiotic resistance.,P H Katelaris,,2001.0,0,0
335,11195482,The evaluation and treatment of adults with gastroesophageal reflux disease.,C A Flynn,"Gastroesophageal reflux disease (GERD) is defined as symptoms or tissue damage that results from the abnormal reflux of gastric contents into the esophagus. A systematic review of population-based studies estimates that heartburn or regurgitation symptoms occur in 21% to 59% of the population during a given year. The frequency of GERD in specific populations is provided in Table 1. Although only 1 in 5 patients with upper intestinal symptoms that occur at least weekly seeks medical attention, nearly 1% of all visits to a family physician's office are for GERD or related conditions. GERD significantly affects the quality of patients' lives. In a survey of patients presenting for upper endoscopy with symptoms of at least 3 months' duration, those with a diagnosis of GERD reported low scores at baseline for general well-being. Fortunately, follow-up data reported 4 weeks after treatment note improvement in gastrointestinal symptoms, general well-being, general health, vitality, and depression.",2001.0,0,0
336,11197282,"Esomeprazole once daily for 6 months is effective therapy for maintaining healed erosive esophagitis and for controlling gastroesophageal reflux disease symptoms: a randomized, double-blind, placebo-controlled study of efficacy and safety.",D A Johnson; S B Benjamin; N B Vakil; J L Goldstein; M Lamet; J Whipple; D Damico; B Hamelin,"Esomeprazole, the S-isomer of omeprazole, achieves a significantly greater healing rate and symptom resolution of erosive esophagitis than that achieved by omeprazole. The objective of this study is to assess the efficacy of the new proton pump inhibitor esomeprazole in preventing relapse over a prolonged period in patients with healed erosive esophagitis. A total of 318 gastroesophageal reflux patients whose erosive esophagitis was healed in a comparative study of esomeprazole 40 mg, 20 mg, or omeprazole 20 mg, were randomized to maintenance therapy with once daily esomeprazole 40 mg, 20 mg, or 10 mg, or placebo in a U.S., double-blind multicenter trial. After 6 months, healing was maintained (cumulative life table rates) in 93.6% (95% CI 87.4-99.7) of patients treated with esomeprazole 40 mg, 93.2% (95% CI 87.4-99.0) treated with esomeprazole 20 mg, and 57.1% (95% CI 45.2-69) treated with esomeprazole 10 mg; p < 0.001 vs placebo (29.1%; 95% CI 17.7-40.3). Of patients relapsing, mean time to first recurrence of esophagitis increased with dose, from 34 days (placebo) to 78 days (10 mg), 115 days (20 mg), and 163 days (40 mg). Patients treated with esomeprazole had less frequent and less severe heartburn than those treated with placebo. At month 6, more than 70% of patients being treated with esomeprazole remained symptom-free. Esomeprazole is effective and well tolerated in the maintenance of a healing erosive esophagitis. Esomeprazole 40 mg and 20 mg maintain healing in over 90% of patients while providing effective control of heartburn symptoms.",2001.0,0,0
337,11197284,Effect of age on differences in upper esophageal sphincter and pharynx pressures between patients with dysphagia and control subjects.,H K Meier-Ewert; M A Van Herwaarden; R M Gideon; J A Castell; S Achem; D O Castell,"The aim of this study was to explore the effect of age and food consistency on manometric data of the swallow sequence in patients with dysphagia. Manometric data from 41 patients (age range, 32-88 yr) and 41 age-matched control subjects was examined for differences between subgroups < 60 yr and > or = 60 yr of age, as well as for changes with food consistency. Only pharynx peak pressure showed an age-dependent decrease (144.1 +/- 21.4 mm Hg vs 95.8 +/- 15.1 mm Hg, p < 0.05) in patients. Significant higher upper esophageal sphincter residual pressure and delayed onset of upper esophageal sphincter relaxation were noted in patients aged <60 yr compared to age-matched controls, whereas only pharynx peak pressure was significantly lower in patients compared to controls aged > or = 60 yr. Food consistency did not have a consistent effect on manometric results in patients with dysphagia. This is the first study to systematically explore the influence of age and food consistency on manometric parameters in dysphagia patients. These results may provide useful insights when identifying actual manometric abnormalities in patients with dysphagia. They also suggest possible different underlying mechanisms of dysphagia in younger versus older patients.",2001.0,0,1
338,11197288,"Randomized study of two ""rescue"" therapies for Helicobacter pylori-infected patients after failure of standard triple therapies.",F Perri; V Festa; R Clemente; M R Villani; M Quitadamo; N Caruso; M L Bergoli; A Andriulli,"A novel rifabutin-based therapy is able to cure Helicobacter pylori infection in most patients who have failed eradication after standard proton pump inhibitor (PPI)-based triple therapy. We compared this regimen with the quadruple therapy. A total of 135 patients were randomized into three groups who were treated for 10 days with pantoprazole 40 mg b.i.d., amoxycillin 1 g b.i.d., and rifabutin 150 mg o.d. (RAP50150 group), or 300 mg o.d. (RAP300 group), and pantoprazole 40 mg b.i.d., metronidazole 250 mg t.i.d., bismuth citrate 240 mg b.i.d., and tetracycline 500 mg q.i.d. (QT group). Before therapy, patients underwent endoscopy with biopsies for histology, culture and antibiotic susceptibility tests. H. pylori eradication was assessed by the 13C-urea breath test. On intention-to-treat analysis, eradication rates (with 95% confidence intervals [CI]) were 66.6% (53-80%) in the RAP150 and QT groups, respectively, and 86.6% (76-96%) in RAP300 group (p < 0.025). Most patients harboring metronidazole- and clarithromycin-resistant strains were eradicated at an equal rate by each of the three regimens. Side effects were observed in 9% and 11% of rifabutin-treated patients, and in 47% of those on quadruple therapy (p < 0.0001). In patients who failed standard eradicating treatments, a 10-day course of rifabutin with pantoprazole and amoxycillin is more effective and well tolerated than the quadruple therapy.",2001.0,0,1
339,11198734,"Esomeprazole, a new proton pump inhibitor: pharmacological characteristics and clinical efficacy.",S Thitiphuree; N J Talley,"Esomeprazole, the S-isomer of omeprazole, is the first proton pump inhibitor synthesised as an optical isomer to become available for clinical use. Esomeprazole is optically stable in humans with negligible inversion to the R-isomer. Esomeprazole has significantly higher oral bioavailability than omeprazole, resulting in greater acid suppression. In clinical studies, 4 weeks' treatment with 40 mg esomeprazole demonstrated greater healing of all grades of erosive oesophagitis, compared with 20 mg omeprazole (76-82% versus 69-71%) and higher rates of symptom resolution (65-68% versus 58-61%) Furthermore, esomeprazole maintained healing rates of up to 90% over 6 months in erosive oesophagitis. Comparisons with other proton pump inhibitors in oesophagitis are, as yet, unavailable. In patients with endoscopy-negative gastro-oesophageal reflux disease (GERD), on-demand therapy with esomeprazole 20 mg has been shown to be very efficacious compared with placebo, and is well tolerated; however, comparisons with other proton pump inhibitors have not been performed. Long-term use of esomeprazole for up to 12 months in patients with GERD have not raised any significant safety concerns with respect to the development of atrophic gastritis or clinically relevant changes in enterochromaffin-like cells.",2001.0,0,0
340,11199359,"Trends, controversies and contradictions in the management of gastroesophageal reflux disease patients.",F Pace; G Bianchi Porro,,2001.0,0,0
341,11199360,Effect of elimination of acid reflux on epithelial cell proliferative activity of Barrett esophagus.,F T Peters; S Ganesh; E J Kuipers; W J Sluiter; A Karrenbeld; A de Jager-Krikken; E C Klinkenberg-Knol; C B Lamers; J H Kleibeuker,"Barrett esophagus (BE) is a premalignant condition resulting from chronic acid gastroesophageal reflux and is associated with increased epithelial cell proliferation. Elimination of acid reflux might decrease cancer risk by affecting cell proliferation in BE. The effect of elimination of acid reflux on epithelial cell proliferation in BE was studied. Forty-five patients with long segment Barrett esophagus were treated in a randomized 2-year follow-up study with either omeprazole 40 mg b.i.d. (OME) or ranitidine 150 mg b.i.d. (RAN) and were compared for the effect on epithelial cell proliferation. Biopsies were taken 3 cm above the GE junction and just below the Z-line, at 0, 3, 9, and 24 months. Epithelial cell proliferation was determined by in vitro labeling with 5-bromo-2-deoxyuridine and immunohistochemistry. Labeling indices (LI) were established for luminal and crypt epithelium separately. Ambulatory 24-h esophageal pH-metry was performed at 0 and 3 months. Comparisons were made for the timeframes 0-3 months, 3-24 months, and 0-24 months. OME reduced mean acid reflux to 0.1 %/24 h, RAN to 9.4%. In the distal and the proximal biopsies, change in LI after 3 months was n.s. at either level for both treatments. In the distal biopsies (OME 22, RAN 23 patients) luminal LI increased significantly for RAN from 3 to 24 months (+12.64% month, mean area under the curve (AUC)), while that for OME remained stable, RAN versus OME P < 0.05. Crypt LI increased in both groups, only in RAN significantly so (+30.75% month), RAN versus OME n.s. In the proximal biopsies luminal LI at 24 months (OME 20, RAN 21 patients) had increased slightly but not significantly in RAN (+8.86% month), RAN versus OME n.s., whereas in the crypts LI in OME it had increased significantly (+28.80% month), OME versus RAN n.s. Elimination of acid reflux resulted in a stabilization of luminal cell proliferative activity of Barrett epithelium in the distal esophagus, whereas this activity increased during continued acid reflux. Whether this finding has any implication for the cancer risk in Barrett esophagus remains to be seen.",2001.0,0,0
342,11199361,"Rabeprazole, 20 mg once daily or 10 mg twice daily, is equivalent to omeprazole, 20 mg once daily, in the healing of erosive gastrooesophageal reflux disease.",J C Delchier; G Cohen; T J Humphries,"Proton pump inhibitors are the most potent pharmacologic inhibitors of gastric acid secretion currently available, and have proven effective in the treatment of gastro-oesophageal reflux disease (GERD). The object of this study was to compare the efficacy and tolerability of a new proton pump inhibitor, rabeprazole at two different dosages, with that of omeprazole in the healing of erosive GERD. Rabeprazole 20 mg once daily (QD) and 10 mg twice daily (BID) were compared with omeprazole 20 mg QD in a double-blind, multicentre, parallel group study involving 310 patients with erosive GERD. The primary efficacy endpoint was oesophageal mucosal healing determined by endoscopy. Secondary endpoints included reduction in symptoms and improvements in quality-of-life scores. The healing rates between both rabeprazole groups and the omeprazole group were equivalent in both the per-protocol and intent-to-treat populations. In the per-protocol population, rabeprazole 20 mg was noted to have a numerical trend toward more rapid daytime heartburn relief. However, by 4 and 8 weeks of treatment, no significant differences were found between groups for secondary endpoints, adverse events, or laboratory abnormalities including elevation of serum gastrin levels. Rabeprazole 20 mg in two different dosing schedules is as effective as omeprazole 20 mg QD with regard to efficacy and tolerability in patients with erosive GERD.",2001.0,1,1
343,11204804,Does Helicobacter pylori affect gastric mucin expression? Relationship between gastric antral mucin expression and H. pylori colonization.,S Morgenstern; R Koren; S F Moss; G Fraser; E Okon; Y Niv,"Helicobacter pylori colonizes the gastric mucous gel layer, the surface epithelium and glands. It has been shown that H. pylori infection causes aberrant expression of gastric mucins MUC 5 and MUC 6. This study aimed to determine the distribution of MUC 5 and MUC 6 in the gastric antrum of dyspeptic patients, and to investigate changes in this pattern in the presence of H. pylori and after successful eradication. Gastric antrum biopsy specimens were examined by immunohistochemistry for mucin gene (MUC 5 and MUC 6) expression. Polyclonal antibodies were used to detect amino acid tandem repeats of each protein. A scoring system (0-3) was used to assess staining intensity at three sites: foveola, mucous neck cells and glands. H. pylori status was determined by histology and rapid urease test, and considered positive or negative when both tests were positive or negative, respectively. The study included 49 patients positive for H. pylori, in 36 of whom successful eradication was performed, and 11 H. pylori-negative patients. There was a gradient of MUC 5 expression, higher to lower, from the surface to the glands, which was more pronounced before eradication. Increased MUC 5 synthesis in the mucous neck cells and in the glands was found after H. pylori eradication (P = 0.016). MUC 6 was synthesized in the glands more than in the mucous neck cells or foveola. MUC 6 was also secreted into the lumen and probably comprised the superficial part of the unstirred mucous layer. The change in MUC 5 synthesis may reflect H. pylori colonization.",2001.0,0,0
344,11204993,,,,,0,0
345,11207503,"Review article: Barrett's oesophagus, dysplasia and pharmacologic acid suppression.",R C Fitzgerald; R Lascar; G Triadafilopoulos,"Barrett's oesophagus, a significant complication of gastro-oesophageal reflux disease (GERD), is the single most important risk factor for oesophageal adenocarcinoma. The strong association between Barrett's oesophagus and chronic GERD suggests that abnormal oesophageal acid exposure plays an important role in this condition. The progression of Barrett's oesophagus from specialized intestinal metaplasia to dysplasia and finally invasive carcinoma is incompletely understood, but increased and disordered proliferation is a key cellular event. In ex vivo organ culture experiments, cell proliferation is increased after exposure to short pulses of acid, whilst proliferation is reduced in Barrett's oesophagus specimens taken from patients with oesophageal acid exposure normalized by antisecretory therapy. In long-term clinical studies, consistent and profound intra-oesophageal acid suppression with proton pump inhibitors decreases cell proliferation and increases differentiation in Barrett's oesophagus, but the clinical importance of such favourable effects on these surrogate markers is not clear. In clinical practice, proton pump inhibitors relieve symptoms and induce partial regression to squamous epithelium, but abnormal oesophageal acid exposure and the risk for dysplasia or adenocarcinoma persist in many patients. The ability of proton pump inhibitors to suppress acid profoundly and consistently may be critical in the long-term management of Barrett's oesophagus.",2001.0,0,0
346,11207509,Esomeprazole 20 mg maintains symptom control in endoscopy-negative gastro-oesophageal reflux disease: a controlled trial of 'on-demand' therapy for 6 months.,N J Talley; K Lauritsen; H Tunturi-Hihnala; T Lind; B Moum; C Bang; T Schulz; T M Omland; M Delle; O Junghard,"Most patients with gastro-oesophageal reflux disease (GERD), regardless of endoscopic status, suffer symptomatic relapse within 6 months of stopping acid suppressant therapy. To assess the efficacy of 'on-demand' treatment of GERD with esomeprazole, the first proton pump inhibitor developed as an optical isomer. In this multicentre, double-blind study, 342 endoscopy-negative GERD patients demonstrating complete resolution of heartburn during the final week of a 4-week treatment period with esomeprazole 20 mg or omeprazole 20 mg once daily were randomized to receive esomeprazole 20 mg or placebo on demand (maximum of one dose per day) for a further 6 months. Use of rescue antacids was permitted. All 342 patients (191 males), aged 19-79 (mean 49) years, were evaluable in the intention-to-treat analysis. The proportion of patients who discontinued treatment due to insufficient control of heartburn was significantly higher among placebo compared to esomeprazole recipients (51% vs. 14%; P < 0.0001). Patients randomized to esomeprazole on-demand therapy remained in the study longer than those in the placebo group (mean 165 vs. 119 days). Over 50% took the study medication for periods of 1--3 consecutive days (esomeprazole) or 4--13 consecutive days (placebo). Use of antacids was > 2-fold higher among placebo recipients. The frequency of adverse events was similar in the two groups, when adjusted for time spent in the study, as were the clinical laboratory profiles. On-demand therapy with esomeprazole 20 mg is effective and well tolerated in maintaining symptom control in endoscopy-negative GERD.",2001.0,0,0
347,11207513,Non-Helicobacter pylori bacterial flora during acid-suppressive therapy: differential findings in gastric juice and gastric mucosa.,S Sanduleanu; D Jonkers; A De Bruine; W Hameeteman; R W Stockbrügger,"Intragastric growth of non-Helicobacter pylori bacteria commonly occurs during acid-suppressive therapy. The long-term clinical consequences are still unclear. To investigate the luminal and mucosal bacterial growth during gastric acid inhibition, in relation to the type and duration of acid-inhibitory treatment, as well as to concomitant H. pylori infection. A total of 145 patients on continuous acid inhibition with either proton pump inhibitors (n=109) or histamine2-receptor antagonists (H(2)RAs, n=36) for gastro-oesophageal reflux disease, and 75 dyspeptic patients without acid inhibition (control group) were included. At endoscopy, fasting gastric juice was obtained for pH measurement and bacteriological culture. Gastric biopsy specimens were examined for detection of H. pylori (immunohistochemistry) and of non-H. pylori bacteria (modified Giemsa stain-positive and immunohistochemistry-negative at the same location). Non-H. pylori flora was detected in the gastric juice of 92 (41.8%) patients and in the gastric mucosa of 109 (49.6%) patients. In gastric juice, prevalence rate for non-H. pylori bacteria was higher in patients taking proton pump inhibitors than controls and those taking H(2)RAs (58.7% vs. 22.6% and vs. 30.6%, P < 0.0001 and P < 0.003, respectively), but did not differ statistically between H(2)RAs and controls. In gastric mucosa, prevalence rates for non-H. pylori bacteria were higher in patients taking proton pump inhibitors and H(2)RAs than in the controls (antrum: 46.9% and 48.6% vs. 25%, P < 0.05 for both; corpus: 52.2% and 56.8% vs. 23.7%, P < 0.001 for both), but did not differ between proton pump inhibitors and H(2)RAs. Both luminal and mucosal growth of non-H. pylori bacteria were significantly greater in H. pylori-positive than -negative patients taking proton pump inhibitors (P < 0.05 for both). Luminal growth of non-H. pylori flora increased with the intragastric pH level, whilst mucosal bacterial growth increased with the duration of acid inhibition. Non-H. pylori flora not only contaminates the gastric juice but also colonizes the gastric mucosa of a large proportion of patients treated long-term with acid inhibition. The relationship between H. pylori and non-H. pylori bacteria in the pathogenesis of atrophic gastritis and gastric cancer needs further elucidation.",2001.0,0,0
348,11207517,Clarithromycin vs. furazolidone in quadruple therapy regimens for the treatment of Helicobacter pylori in a population with a high metronidazole resistance rate.,H Fakheri; R Malekzadeh; S Merat; M Khatibian; A Fazel; B Z Alizadeh; S Massarrat,"The eradication of Helicobacter pylori plays a pivotal role in the treatment of peptic ulcer disease. Metronidazole resistance, common in Iran, is claimed to be a major reason for the failure of metronidazole-containing regimens. Both clarithromycin and furazolidone are potential alternatives for metronidazole. To assess and compare the effectiveness of clarithromycin- and furazolidone-based regimens in eradicating H. pylori in a population with a high metronidazole resistance rate. Patients with proven duodenal ulcer and H. pylori infection were randomly assigned to one of two groups. The patients received 2 weeks of omeprazole 20 mg b.d., amoxicillin 1000 mg b.d, bismuth subcitrate 240 mg b.d. and either clarithromycin 500 mg b.d. (the OABC group) or furazolidone 200 mg b.d. (the OABF group). A total of 118 patients were randomized, 55 in the OABC group and 63 in the OABF group. The intention-to-treat eradication rate was 84% and 85% for the OABF and OABC groups, respectively. The per protocol eradication rates were 90% for both groups. OABC and OABF are both effective in eradicating H. pylori in areas where metronidazole resistance is a problem. OABF is a good alternative in the face of growing resistance to clarithromycin in developed countries, and is attractive for developing countries where clarithromycin is not readily available.",2001.0,0,0
349,11209448,Indirect cost of ischemic heart disease to employers.,C J Guico-Pabia; J F Murray; S M Teutsch; A I Wertheimer; M L Berger,"The management of healthcare programs by employers requires accurate information about the indirect and direct costs of important chronic diseases. To determine the indirect costs of ischemic heart disease from the perspective of the employer in private industry in the United States. Indirect cost of illness analysis using the human capital approach, taking the perspective of the employer rather than that of society. Ischemic heart disease was identified in a proprietary claims database of 3.1 million insured persons using an algorithm based on administrative codes. Economic data were derived from the Bureau of Labor Statistics, the Employment Management Association, and published sources. Work-loss data were taken from the National Center for Health Statistics' Health Interview Survey. The indirect cost was calculated as the sum of the costs due to morbidity and mortality. From the perspective of the employer, morbidity costs come from lost productivity, idle assets, and nonwage factors resulting from absenteeism and mortality costs are expenditures for replacing and retraining workers. This differs from calculations from the societal perspective, in which indirect costs are the value of an individual's lost income--both current and potential. The total indirect cost of ischemic heart disease to employers in private industry was $182.74 per enrollee. Ninety-five percent of the indirect cost was the consequence of work loss due to morbidity rather than of mortality costs. From the perspective of the employer, the indirect cost of ischemic heart disease is overwhelmingly due to morbidity costs.",2001.0,0,0
350,11213308,Primary esophageal motility disorders.,D G Adler; Y Romero,"Esophageal motility disorders often manifest with chest pain and dysphagia. Achalasia is a disorder of the lower esophageal sphincter and the smooth musculature of the esophageal body. In achalasia the lower esophageal sphincter typically fails to relax with swallowing, and the esophageal body fails to undergo peristalsis. In contrast to spastic disorders of the esophagus, achalasia can be progressive and cause pronounced morbidity. Pseudoachalasia mimics achalasia in terms of symptoms but can be caused by infectious disorders or malignancy. Treatment for achalasia is nonstandardized and includes medical, endoscopic, and surgical options. Spastic disorders of the esophagus, such as diffuse esophageal spasm and nutcracker esophagus, and nonspecific esophageal motility disorder are benign and nonprogressive, with similar findings on esophageal manometry. Although the exact cause remains unknown, these disorders may represent a manifestation of gastroesophageal reflux disease. Treatment of spastic disorders includes medical and surgical approaches and is aimed at symptomatic relief.",2001.0,0,0
351,11214773,Pharmacokinetics of esomeprazole after oral and intravenous administration of single and repeated doses to healthy subjects.,M Hassan-Alin; T Andersson; E Bredberg; K Röhss,"To study the pharmacokinetics of esomeprazole, one of the optical isomers of omeprazole, after 20 mg or 40 mg single and repeated oral and intravenous administration to healthy subjects. The main metabolites of esomeprazole were also assessed after the 40-mg oral dose. In two separate studies, 16 healthy male subjects and 16 healthy male and female subjects received intravenous doses of 20 mg and 40 mg esomeprazole, respectively, on the first investigation day. After a washout period of 5-14 days, the same doses (20 mg as a solution and 40 mg as a capsule) were given orally for 5 days and then again intravenously on day 6. Blood samples for determination of esomeprazole and its metabolites were collected 12 h or 24 h post-dose and were analysed using normal-phase liquid chromatography with ultraviolet (UV) detection. Pharmacokinetic parameters of esomeprazole and its metabolites were estimated using non-compartmental analysis. Geometric means and ratios of the geometric means together with 95% confidence intervals (CI) of the pharmacokinetic parameters were calculated using analysis of variance (ANOVA). Plasma clearance (CL) of esomeprazole decreased from 22 l/h to 16 l/h and from 17 l/h to 9 l/h following repeated dosing of 20 mg and 40 mg, respectively. Total area under the plasma concentration-time curve (AUC) increased (from 1.34 micromol x h/l to 2.55 micromol x h/l) with absolute bioavailability (F) being 50% on day 1 and 68% on day 5 after the 20-mg oral dose. AUC increased (from 4.32 micromol x h/l to 11.21 micromol x h/l) with F being 64% on day 1 and 89% on day 5 after the 40-mg oral dose. The plasma levels for esomeprazole sulphone were substantially higher on day 5 than on day 1, while those for 5-hydroxy esomeprazole were marginally higher on day 5 than on day 1 following repeated oral dosing of 40 mg esomeprazole. No side effects attributable to esomeprazole were noticed. The increased AUC of esomeprazole with repeated dosing is probably due to a combination of a decreased first-pass elimination and a decreased systemic clearance.",2001.0,0,1
352,11215851,GERD and H. pylori: is there a link?,G W Falk,"The incidence of gastroesophageal reflux disease (GERD) and esophageal adenocarcinoma have increased in recent years as the incidence of peptic ulcer disease and distal gastric cancer have declined. Given the simultaneous decline in Helicobacter pylori infection, it is tempting to propose a relationship between H. pylori infection and these opposing time trends. Although H. pylori infection clearly does not cause GERD, it may protect certain susceptible individuals from developing GERD and its complications. The most likely mechanism in which H. pylori infection protects against GERD is by decreasing the potency of the gastric refluxate in patients with corpus predominant gastritis. A variety of implications of H. pylori infection on GERD treatment have also arisen in recent years. These focus on the risk of gastric atrophy while on proton pump inhibitor therapy and the efficacy of proton pump inhibitors before and after eradication of H. pylori. This article puts into perspective our current understanding of the complex, incompletely understood relationship between H. pylori infection and GERD.",2001.0,0,0
353,11215853,Management of GERD: medical versus surgical.,P J Kahrilas,"Both laparoscopic Nissen fundoplication and proton pump inhibitors are effective modern therapies for reflux disease that have yet to be directly compared in a well-designed clinical trial. In terms of a risk/benefit analysis, the risk of an undesirable outcome or death from laparoscopic Nissen fundoplication exceeds that of maintenance treatment with proton pump inhibitors making the later the preferable therapy. Neither therapy increases or reduces the risk of death from cancer and there are no compelling economic arguments favoring surgical management. Instances in which laparoscopic Nissen fundoplication should be considered include: 1) Individuals who are intolerant of proton pump inhibitor therapy because of side effects, 2) When patients are inadequately responsive to proton pump inhibitor therapy even after dosage and dose interval have been optimized, and 3) When a patient desires a permanent solution to their reflux problem that frees them of the need to chronically consume pharmaceuticals. However, regardless of the motivation for pursuing surgical management, patients must be advised of potential suboptimal results and the irreversibility of the procedure.",2001.0,0,0
354,11220717,Continued (5-year) followup of a randomized clinical study comparing antireflux surgery and omeprazole in gastroesophageal reflux disease.,L Lundell; P Miettinen; H E Myrvold; S A Pedersen; B Liedman; J G Hatlebakk; R Julkonen; K Levander; J Carlsson; M Lamm; I Wiklund,"The efficacy of antireflux surgery (ARS) and proton pump inhibitor therapy in the control of gastroesophageal reflux disease is well established. A direct comparison between these therapies is warranted to assess the benefits of respective therapies. There were 310 patients with erosive esophagitis enrolled in the trial. There were 155 patients randomized to continuous omeprazole therapy and 155 to open antireflux surgery, of whom 144 later had an operation. Because of various withdrawals during the study course, 122 patients originally having an antireflux operation completed the 5-year followup; the corresponding figure in the omeprazole group was 133. Symptoms, endoscopy, and quality-of-life questionnaires were used to document clinical outcomes. Treatment failure was defined to occur if at least one of the following criteria were fulfilled: Moderate or severe heartburn or acid regurgitation during the last 7 days before the respective visit; Esophagitis of at least grade 2; Moderate or severe dysphagia or odynophagia symptoms reported in combination with mild heartburn or regurgitation; If randomized to surgery and subsequently required omeprazole for more than 8 weeks to control symptoms, or having a reoperation; If randomized to omeprazole and considered by the responsible physician to require antireflux surgery to control symptoms; If randomized to omeprazole and the patient, for any reason, preferred antireflux surgery during the course of the study. Treatment failure was the primary outcomes variable. When the time to treatment failure was analyzed by use of the intention to treat approach, applying the life table analysis technique, a highly significant difference between the two strategies was revealed (p < 0.001), with more treatment failures in patients who originally were randomized to omeprazole treatment. The protocol also allowed dose adjustment in patients allocated to omeprazole therapy to either 40 or 60 mg daily in case of symptom recurrence. The curves subsequently describing the failure rates still remained separated in favor of surgery, although the difference did not reach statistical significance (p = 0.088). Quality of life assessment revealed values within normal ranges in both therapy arms during the 5 years. In this randomized multicenter trial with a 5-year followup, we found antireflux surgery to be more effective than omeprazole in controlling gastroesophageal reflux disease as measured by the treatment failure rates. But if the dose of omeprazole was adjusted in case of relapse, the two therapeutic strategies reached levels of efficacy that were not statistically different.",2001.0,0,1
355,11227677,Comparison of the efficacy and safety of different formulations of omeprazole-based triple therapies in the treatment of Helicobacter pylori-positive peptic ulcer.,H S Kim; D K Lee; K H Kim; Y S Jeong; J W Kim; J I Seo; S K Baik; S O Kwon; M Y Cho,"Little is known about the efficacy and safety of different formulations of omeprazole-based triple therapy regimens for the treatment of Helicobacter pylori-positive peptic ulcer. We compared the efficacy and safety of two formulations of omeprazole used in triple therapies in patients with H. pylori-positive active peptic ulcer. Seventy-four patients with endoscopically proven H. pylori-positive active peptic ulcer were randomized to two groups, each with 37 patients, to receive either OAC-I (6 weeks of ""A"" formulation of omeprazole [20 mg twice daily] plus 2 weeks of amoxicillin [1.0 g twice daily] and clarithromycin [500 mg twice daily] or OAC-II (6 weeks of ""B"" formulation of omeprazole [20 mg twice daily] plus 2 weeks of the same antibiotics. The H. pylori and ulcer healing status were assessed at the baseline and at the 6-week endpoint of therapy. Gastrointestinal symptoms, documentation of adverse events, and standard laboratory examinations were assessed at each visit. Eradication of H. pylori (intention to treat [n = 74]/per protocol [n = 66]) and healing of the ulcer were successful in 83.8%/96.9% and 93.8%, respectively, of the OAC-I group patients, and in 91.9%/100% and 97.1%, respectively, of the OAC-II group patients (P = 0.477; P = 0.608). The OAC-I group experienced rapid resolution of symptoms, but no significant differences were found between the two groups for number of days taken for resolution of gastrointestinal symptoms, adverse events, and laboratory findings. The two different formulations of omeprazole used in triple therapy regimens produced similar efficacy and safety results after 6 weeks of treatment in patients with H. pylori-positive active peptic ulcer.",2001.0,0,0
356,11232663,Focal neurological signs in cirrhotic patients with episodes of hepatic encephalopathy.,A Kyprianou; J Hanna; K D Mullen,,2001.0,0,1
357,11232676,Do some patients with Helicobacter pylori infection benefit from an extension to 2 weeks of a proton pump inhibitor-based triple eradication therapy?,G Maconi; F Parente; A Russo; L Vago; V Imbesi; G Bianchi Porro,"Seven-day proton pump inhibitor (PPI)-based triple therapies are the first-line anti-Helicobacter pylori regimens; to date, however, there is still no agreement concerning all the predictors of H. pylori cure under these regimens. The aim of this prospective study was to evaluate whether patients with certain pretreatment characteristics may benefit from an extension from 1 to 2 wk of treatment with lansoprazole, amoxycillin, and clarithromycin. A total of 142 patients with H. pylori infection ascertained by means of gastric histopathology and 13C urea breath test (UBT) participated in this study. In all patients H. pylori density was determined at histology both on antral and corpus biopsies, and H. pylori culture with antibiotic susceptibility testing; IgG anti-H. pylori titers were also determined before therapy. Patients were randomized to receive 1-wk versus 2-wk of treatment with lansoprazole (30 mg b.i.d.), clarithromycin (500 mg b.i.d.), and amoxycillin (1 g b.i.d.). The association between eradication and potential predictors was analyzed by means of unconditional logistic regression models and stratified according to the duration of treatment. A stepwise regression analysis was performed to identify variables discriminated between subjects, using eradication status as the dependent variable. The overall eradication rates for 1- and 2-wk treatments were 74.6% and 85.9% (intention-to-treat analysis) and 81.5% and 89.1% (per-protocol analysis), respectively (p = NS). Multivariate discriminant analysis selected as the variables independently related to eradication cigarette smoking (OR = 3.98), delta of 13C-UBT higher than 35 (OR = 9.21) and IgG anti-H. pylori titer > or = 93 (OR = 0.24) for the whole series of subjects. Stratified analysis according to the duration of therapy selected H. pylori density as the only predictor of eradication in the group treated for 1 wk (OR = 8.11). In contrast, no significant predictors were found in the group treated for 2 wk. Patients with a high intragastric bacterial load, as detected by histology (grade 3) or 13C-UBT (delta > 35) may benefit from an extension to 2 wk of triple therapy with lansoprazole, amoxycillin, and clarithromycin.",2001.0,0,0
358,11232677,"A randomized, pharmacokinetic and pharmacodynamic, cross-over study of duodenal or jejunal administration compared to nasogastric administration of omeprazole suspension in patients at risk for stress ulcers.",J O Phillips; K M Olsen; J A Rebuck; N J Rangnekar; B W Miedema; M H Metzler,"The aim of this study was to characterize absorption and pH control of simplified omeprazole suspension (SOS), 2 mg/ml in 8.4% sodium bicarbonate, administered via the nasogastric versus jejunal or duodenal route. Nine critically ill surgical patients, NPO and mechanically ventilated, were enrolled in this randomized cross-over study. Patients received a single 40 mg dose of SOS by the nasogastric and either the jejunal or duodenal route. Twenty-four-hour continuous intragastric pH monitoring was performed during the study period. Sequential blood samples were collected over 24 h to characterize SOS absorption and pharmacokinetic parameters. Nasogastric administration of SOS resulted in lower maximum mean +/- SD serum concentrations compared to jejunal/duodenal dosing (0.970 +/- 0.436 vs 1.833 +/- 0.416 microg/ml, p = 0.006). SOS absorption was significantly slower when administered via nasogastric tube (108.3 +/- 42.0 vs 12.1 +/- 7.9 min, p < 0.001). However, all routes of administration resulted in similar SOS area under the serum concentration-time curves (AUC(0-infinity)) (415.1 +/- 291.8 vs 396.7 +/- 388.1 microg x min/ml, p = 0.91) [corrected]. Mean intragastric pH values remained >4 at 1 h after SOS administration and remained >4 for the entire 24-h study (6.32 +/- 1.04, 5.57 +/- 1.15, nasogastric vs jejunal/duodenal, p = 0.015), regardless of administration route. In critically ill surgical patients, pharmacokinetic parameters and subsequent pH control after the administration of SOS are similar by the jejunal, nasogastric, or duodenal route. SOS suspension offers an alternative acid control measure when patients are unable to take oral medications, yet have an enteral tube in place.",2001.0,0,0
359,11232716,Recurrent ulcer bleeding: is intravenous omeprazole the solution?,O Nehme; J S Barkin,,2001.0,0,0
360,11236293,Celecoxib--a rational alternative to NSAIDs.,I Moodley; G Hirsch,,2001.0,0,0
361,11249486,Proton pump inhibitors in the treatment of gastro-oesophageal reflux disease.,K G Tolman; J Chandramouli; J C Fang,"Gastro-oesophageal reflux disease (GERD) is the most common peptic acid disease in the western world and is the commonest indication for acid suppression therapy. Major advances have been made over the past 30 years in the understanding of lower oesophageal sphincter function and the mechanism of acid secretion. Developments in surgical and pharmacological therapy have paralleled these advances. Pharmacotherapy for GERD has evolved from antacids to H2-receptor antagonists (H2RAs) to prokinetics to proton pump inhibitors (PPIs). The H2RAs, while modestly effective in symptom relief and healing of GERD, are limited by pharmacological tolerance. The prokinetics (metoclopramide and cisapride) are limited by low efficacy, pharmacological tolerance and toxicity. The PPIs have emerged as the most effective therapy for symptom relief, healing and long-term maintenance. They have also proved to be remarkably safe and cost-effective in long-term therapy. This review evaluates the pharmacology, efficacy, tolerability, safety and cost-effectiveness of the four currently available PPIs, lansoprazole, omeprazole, pantoprazole and rabeprazole, in the treatment of GERD.",2001.0,0,0
362,11249534,Clarithromycin for Helicobacter pylori infection.,W K Leung; D Y Graham,"Helicobacter pylori, a Gram-negative organism that survives in the deep mucus layer and attaches to the gastric surface cells, is estimated to be present in up to one-half of the US population. Chronic H. pylori infection causes chronic gastritis, peptic ulcer diseases and even gastric cancer. Cure of the infection leads to healing of gastric inflammation, prevention of development of peptic ulcer, as well as accelerated healing of peptic ulcers, and prevention of ulcer recurrence. Treatment of H. pylori has undergone substantial evolution over the past decade. Despite the in vitro susceptibility, results from single or even dual drug therapy is typically unsatisfactory and the best therapy is yet to be defined. The best current therapies for H. pylori infection consist of a proton pump inhibitor (PPI) or ranitidine bismuth citrate and two antibiotics (triple therapies), or bismuth, tetracycline, metronidazole and a PPI (quadruple therapy). Clarithromycin is one of the most useful antimicrobials against H. pylori. It is an acid-stable macrolide with a broad spectrum of antibacterial activity, well absorbed with a wide tissue distribution and with mild side effects. Clarithromycin has a low minimum inhibitory concentration (MIC50) for H. pylori and its effect is potentiated by acid inhibition. When combined with a PPI or ranitidine bismuth citrate and amoxicillin or metronidazole, eradication rates of more than 95% can be achieved with susceptible organisms. However, the prevalence of primary and acquired clarithromycin resistance, which is due to mutations within a conserved loop of 23S rRNA of H. pylori, is increasing. In practice, the presence of clarithromycin resistance usually implies reduced success when clarithromycin-containing regimes are used. There is a need for improved therapies for H. pylori where antibiotic resistance is less of a problem.",2001.0,0,0
363,11257735,Omeprazole therapy and salivary flow rate in duodenal ulcer patients.,Z Namiot; J Stasiewicz; M Kralisz; M Kozuszyńska-Topór; A R Markowski; F K Aljanaby; A Kemona; J Górski,"Previous reports have shown that in some reflux-oesophagitis patients omeprazole therapy alters salivary secretion. The aim of the study was to examine this effect in duodenal ulcer patients. Thirty nine Helicobacter pylori positive subjects of both sexes, predominantly men, were recruited for the study. They were taking for two weeks only omeprazole (n = 17), or omeprazole in combination with either amoxycillin or amoxycillin and tinidazole (n = 22). Salivary secretion was assessed before and at the end of the treatment, both in basal conditions and during a gastric secretory test. Gastric secretion was monitored concurrently with salivary flow rate. Additionally gastritis score and serum gastrin levels were assessed. Basal salivary secretions remained unchanged in patients on omeprazole monotherapy, but decreased in five of eight saliva collection periods in patients on eradication regimens. During the gastric secretory test, salivary secretions fell in both groups, but only after pentagastrin stimulation (in one collection period in patients on omeprazole, and in three collection periods in patients on eradication therapy). The observed changes in salivary secretion were inversely related to the pre-treatment gastric pH values. The influence of omeprazole and omeprazole-based eradication therapies on salivary flow rate is presumably secondary to changes in gastric pH values and is likely to be related to oesophago-salivary reflex generation.",2001.0,0,0
364,11269550,Surgical management of peptic ulcer disease in the Helicobacter era--management of bleeding peptic ulcer.,R A Cowles; M W Mulholland,"Bleeding continues to be a significant cause of morbidity and mortality for patients with peptic ulcer disease. Recent advances have changed the management of this disease. Upper endoscopy with or without endoscopic therapy is the preferred procedure during the initial evaluation of upper gastrointestinal bleeding. With its excellent success rates, many patients are being cured with endoscopic therapy followed by eradication of Helicobacter pylori. H. pylori is now thought to have an important role in the pathogenesis of a majority of gastric and duodenal ulcers. This finding has led to the recommendation that patients with peptic ulcer disease be treated with regimens effective against this organism. Currently, patients who are older and who have more severe underlying medical conditions present a challenge. This review will address the options for treatment of peptic ulcer bleeding. In addition, knowledge gained regarding H. pylori infection and use of nonsteroidal anti-inflammatory drugs will be discussed.",2001.0,0,0
365,11269565,Pharmacodynamic modeling of lansoprazole using an indirect irreversible response model.,T A Puchalski; W Krzyzanski; R A Blum; W J Jusko,"A mechanism-based pharmacokinetic/pharmacodynamic model was used to assess lansoprazole effects on gastric pH. The irreversible inactivation of the H+/K+-ATPase enzyme by lansoprazole controls the secretion rate of H+ ions and gastric pH values. The basal circadian rhythm of gastric acid production was taken into account as well as the effects of food intake. A model was applied to multiple-dose data from a crossover study of four dosage regimens of lansoprazole in two groups of normal male subjects. Model parameters were estimated by nonlinear regression and were compared to historical values reported in the literature. The predicted mean gastric ion concentration was 23.2 mM (pH 1.6) with the peak time at 12.6 hours (8:30 p.m.), and the half-time for H+ removal from the stomach averaged 1.7 hours. The estimated half-life of gastric food removal was 0.8 hours. The rate constant for normal H+/K+-ATPase degradation was 0.045 h(-1). The pharmacodynamic parameter describing lansoprazole action on gastric acid secretion was the second-order enzyme inactivation constant, which averaged 0.16 microg(-1) x L x h(-1). The parameters obtained for both the baseline and drug treatment data were consistent with the literature and physiologically relevant with the exception of effective food volume, which was large presumably due to buffer effects. The model successfully incorporated the physiological regulation of gastric acid production, the effects of food on gastric acid, and the effects of multiple-dosing regimens of lansoprazole on gastric acid production to give reasonable profiles of gastric pH.",2001.0,0,0
366,11272213,Gastroesophageal reflux disease and Barrett's esophagus.,G W Falk,"Gastroesophageal reflux disease (GERD) is a common clinical problem. Circumstantial evidence continues to suggest that infection with Helicobacter pylori may protect some patients from developing GERD and its complications. An empirical trial of a proton-pump inhibitor may now be a reasonable alternative to endoscopy or 24-hour pH testing for the diagnosis of GERD. Long-term follow-up data covering more than over a decade indicate that proton-pump inhibitors are effective and safe agents for the treatment of GERD. Furthermore, a strategy of proton-pump inhibitors first may be the most cost-effective approach to GERD. It remains unclear why some patients with GERD develop Barrett's esophagus, whereas others do not. Recent studies demonstrate the importance of pulses of acid or bile in increasing cell proliferation and cyclooxygenase-2 expression in Barrett's epithelium cell cultures. Short-segment Barrett's esophagus is now clearly associated with an increased risk of dysplasia or cancer compared to intestinal metaplasia of the cardia, and the cancer risk in this condition is similar to that with long-segment Barrett's esophagus. However, the overall cancer risk in patients with Barrett's esophagus is lower than previously estimated, at approximately 0.5% annually. Ablation techniques continue to show promise, but are not yet ready for routine clinical use. Endoscopic mucosal resection is a new treatment option for selected patients with high-grade dysplasia or superficial esophageal adenocarcinoma.",2001.0,0,0
367,11275878,Radiofrequency energy delivery to the gastroesophageal junction for the treatment of GERD.,G Triadafilopoulos; J K Dibaise; T T Nostrant; N H Stollman; P K Anderson; S A Edmundowicz; D O Castell; M S Kim; J C Rabine; D S Utley,"In this multi-center study, the feasibility, safety, and efficacy of radiofrequency (RF) energy delivery to the gastroesophageal junction (GEJ) for the treatment of gastroesophageal reflux disease (GERD) were investigated. Forty-seven patients with classic symptoms of GERD (heartburn and/or regurgitation), a daily anti-secretory medication requirement, and at least partial symptom response to drugs were enrolled. All patients had pathologic esophageal acid exposure by 24-hour pH study, a 2 cm or smaller hiatal hernia, grade 2 or less esophagitis, and no significant dysmotility or dysphagia. RF energy was delivered with a catheter and thermocouple-controlled generator to create submucosal thermal lesions in the muscle of the GEJ. GERD symptoms and quality of life were assessed at 0, 1, 4, and 6 months with the short-form health survey (SF-36). Anti-secretory medications were withdrawn 7 days before each assessment of symptoms and pH/motility study. Medication use, endoscopic findings, esophageal acid exposure, and motility were assessed at 0 and 6 months. Thirty-two men and 15 women underwent treatment. At 6 months there were improvements in the median heartburn score (4 to 1, p < or = 0.0001), GERD score (26 to 7, p < or = 0.0001), satisfaction (1 to 4, p < or = 0.0001), mental SF-36 (46.2 to 55.5, p = 0.01), physical SF-36 (41.1 to 51.9, p < or = 0.0001), and esophageal acid exposure (11.7% to 4.8%, p < or = 0.0001). Esophagitis was present in 25 patients before treatment (15 grade 1 and 10 grade 2) and 8 had esophagitis at 6 months (4 grade 1 and 4 grade 2, p = 0.005). At 6 months, 87% no longer required proton pump inhibitor medication. There was no significant change in median lower esophageal sphincter pressure (14.0 to 12.0 mm Hg, p = 0.19), peristaltic amplitude (64 to 66 mm Hg, p = 0.71), or lower esophageal sphincter length (3.0 to 3.0, p = 0.28). There were 3 self-limited complications (fever for 24 hours, odynophagia lasting for 5 days, and a linear mucosal injury that was healed after 3 weeks). RF energy delivery significantly improved GERD symptoms, quality of life, and esophageal acid exposure while eliminating the need for anti-secretory medication in the majority of patients with a heterogeneous spectrum of clinical disease severity but with minimal active esophagitis or hiatal hernia.",2001.0,0,0
368,11275880,Endoscopic implantation of Plexiglas (PMMA) microspheres for the treatment of GERD.,C Feretis; P Benakis; C Dimopoulos; A Dailianas; P Filalithis; K M Stamou; A Manouras; N Apostolidis,"A gelatinous implant containing polymethylmethacrylate (PMMA) beads is successfully used to augment the diminished thickness of the chorium in patients with skin defects and wrinkles. The aim of the present study was to determine whether submucosal injection of PMMA microspheres into the lower esophageal folds decreases the severity of symptoms and acid reflux in patients with GERD. Endoscopic submucosal implantation of PMMA was carried out in 10 patients with GERD who were either refractory to or dependent on proton pump inhibitors. Symptom severity score, 24-hour pH monitoring, upper GI endoscopy, and EUS were performed to evaluate the efficacy of implantation. A significant decrease in the symptom severity score and mean total time with esophageal pH less than 4 was noted after the implantation of PMMA (p < 0.05). Seven of 10 patients were taking no medication after PMMA implantation. There were no serious procedure-related complications. Endoscopic implantation of PMMA into the submucosa of the lower esophageal folds may be a new method for treating GERD. Further studies are required to determine the long-term efficacy of the procedure.",2001.0,0,0
369,11279330,"Critical review of acid suppression in nonvariceal, acute, uppergastrointestinal bleeding.",B R Yacyshyn; A B Thomson,"Nonvariceal, upper gastrointestinal (GI) bleeding is a very common source of morbidity and mortality. The concept of ulcer clot dissolution being facilitated by a low gastric pH has allowed us to better understand the pathophysiology of nonvariceal upper GI bleeding. Placebo-controlled trials have shown the benefit of oral proton pump inhibitor administration in contrast to H(2) receptor antagonists. Furthermore, our recent experience with intravenous proton pump inhibitors has reinforced these observations.",2001.0,0,0
370,11280106,"Economic evaluation of celecoxib, a new cyclo-oxygenase 2 specific inhibitor, in Switzerland.",J V Chancellor; E Hunsche; E de Cruz; F P Sarasin,"The aim of this study was to predict the cost effectiveness of celecoxib, a cyclo-oxygenase 2 (COX-2) specific inhibitor, in the treatment of arthritis patients in Switzerland. We applied a decision analytical model to compare the effects of 6 months' treatment with the following: (i) celecoxib; (ii) nonsteroidal anti-inflammatory drug (NSAID) alone; NSAID protected with (iii) proton pump inhibitor (PPI), (iv) histamine H2 receptor antagonist (H2RA), or (v) misoprostol; and (vi) diclofenac/misoprostol. Treatment costs included drug acquisition and the management of gastrointestinal (GI) adverse effects, classified as GI discomfort, symptomatic ulcer, anaemia and serious GI events (requiring hospitalisation). Probabilities were derived from celecoxib clinical trials and the literature. Drug utilisation patterns and treatment costs reflecting Swiss practice were obtained from local sources. Analysis was from the public health insurers' perspective. A range of sensitivity analyses was performed. For the base case of patients at typical risk (0.56% per 6 months) of serious GI events, the total expected costs of 6 months' treatment were as follows: celecoxib 435 Swiss francs (SwF); NSAID alone SwF510; diclofenac/misoprostol SwF522; and other protected NSAID regimens between SwF1034 and SwF1415. Celecoxib remained the lowest costing treatment over all categories of GI risk. Celecoxib generated 115 expected adverse events per 1000 patients per 6 months, followed by NSAID + PPI (119), NSAID + H2RA (154), NSAID + misoprostol (202), diclofenac/misoprostol (203), and NSAID alone (220), again for the base case. The cost per adverse event averted for celecoxib compared with NSAIDs alone was estimated in a stochastic version of the model using Monte Carlo simulation. In 95% of 500 iterations, celecoxib was predicted to save both costs and adverse events, thus dominating NSAIDs alone; the maximum cost per adverse event averted was SwF440. Celecoxib is predicted to be the most cost effective of the treatments considered for managing arthritis patients in Switzerland. A policy of switching patients from NSAIDs to celecoxib is predicted to be cost saving for public health insurers, while reducing the burden of iatrogenic GI side effects. Greater cost savings would be realised when patients are switched from NSAIDs used with gastroprotective agents. Models such as this can provide a useful but simplified view of treatment outcomes and predicted results require prospective validation in clinical practice.",2001.0,0,0
371,11280530,Efficacy and safety of esomeprazole compared with omeprazole in GERD patients with erosive esophagitis: a randomized controlled trial.,J E Richter; P J Kahrilas; J Johanson; P Maton; J R Breiter; C Hwang; V Marino; B Hamelin; J G Levine; Esomeprazole Study Investigators,"In patients with gastroesophageal reflux disease (GERD), esomeprazole, the S-isomer of omeprazole, has demonstrated pharmacological and clinical benefits beyond those seen with the racemic parent compound. This study was designed to further evaluate the efficacy and tolerability of esomeprazole relative to that of omeprazole in healing erosive esophagitis and resolving accompanying symptoms of GERD. Esomeprazole 40 mg was compared with omeprazole 20 mg once daily in 2425 patients with erosive esophagitis (Helicobacter pylori negative by serology) in an 8-wk, multicenter, randomized, double-blind, parallel-group study conducted in 163 centers throughout the US. The primary efficacy endpoint was the proportion of patients with healed esophagitis at wk 8. Secondary endpoints were the proportion of patients healed at wk 4, resolution of heartburn at wk 4, time to first resolution and sustained resolution of heartburn, and proportion of heartburn-free days and nights. Safety and tolerability were also assessed. Significantly more patients were healed with esomeprazole versus omeprazole at wk 8 (93.7% vs 84.2%, p < 0.001; life table estimates, intention-to-treat analysis). Healing rates at wk 4 were 81.7% and 68.7%, respectively. Esomeprazole was superior to omeprazole for all secondary measures and had a similar safety profile. The most common adverse events in both treatment groups were headache, diarrhea, and nausea. Esomeprazole demonstrates significantly greater efficacy than omeprazole in the treatment of GERD patients with erosive esophagitis. The tolerability and safety of esomeprazole are comparable to that of omeprazole. (Am",2001.0,1,1
372,11281436,Helicobacter pylori infection and its treatment in Singapore.,K G Yeoh,,2001.0,0,0
373,11281438,A randomised trial of amoxycillin versus clarithromycin in combination with omeprazole for eradication of Helicobacter pylori infection in Singapore.,K M Fock; H S Ng; T M Ng; N M Law; C C Lim,"Dual therapy has been reported to produce H.pylori eradication rate of 75-80%. This study is designed to determine the efficacy of omeprazole 20 mg bd in combination with amoxycillin 500 mg tid (Group A), amoxycillin 750 mg tds (Group B) and clarithromycin 500 mg tid (Group C) in Singapore. One hundred and forty-eight patients with H. pylori positive duodenal ulcers between ages of 22 and 69 were enrolled from two centres. There were 48 patients in Group A, 50 patients in Group B and 50 patients in Group C. The medication was given for 14 days. The patients were re-evaluated with an upper GI endoscope 4 weeks after cessation of treatment Successful eradication was defined as H.pylori negative on histology and culture. Based on intention to treat analysis, the eradication rate was 47.8% in Group A, 68% in Group B and 66% in Group C. The difference between GroupA and B were statistically significant (p = 0.04). Based on all patient treated analysis, the eradication rate was 57.5% in Group A, 70.7% in Group B and 75% in Group C. The difference in eradication rates was not statistically significant. Adverse events were reported in 21% of all patients with no difference in the adverse event rate between all groups. The eradication rate achieved with dual therapy in this study was similar to that attained in Western population. Higher dose amoxycillin regime gives a significantly higher eradication than a lower dose amoxycillin.",2001.0,0,0
374,11284780,Nitrofurantoin quadruple therapy for Helicobacter pylori infection: effect of metronidazole resistance.,D Y Graham; M A Saeed; J Hoffman; H M El-Zimaity; D H Kwon; M S Osato,"Antibiotic resistance has increasingly been recognized as the major cause of treatment failure for Helicobacter pylori infection. New therapies for patients with metronidazole- or clarithromycin-resistant H. pylori are needed. To investigate the role of nitrofurantoin quadruple therapy for the treatment of H. pylori. Patients with confirmed H. pylori infection received nitrofurantoin (100 mg t.d.s.), omeprazole (20 mg b.d.), Pepto-Bismol (two tablets t.d.s.), and tetracycline (500 mg t.d.s.) for 14 days. Four or more weeks after the end of therapy, outcome was assessed by repeat endoscopy with histology and culture or urea breath testing. Thirty patients were entered, including 25 men and five women; the mean age was 54.9 years. The most common diagnoses were duodenal ulcer (23%) and GERD (18%). The intention-to-treat cure rate was 70% (95% CI: 50.6-85%). Nitrofurantoin quadruple therapy was more effective with metronidazole-sensitive strains (88%; 15 out of 17) than with metronidazole-resistant strains (33%; three out of nine; P=0.008). Two of the treatment failures had pre-treatment isolates susceptible to metronidazole, which were resistant after therapy. Because nitrofurantoin quadruple therapy performed inadequately in the presence of metronidazole resistance, we conclude that nitrofurantoin is unlikely to find clinical utility for the eradication of H. pylori.",2001.0,0,0
375,11284971,"Reproducibility, validity, and responsiveness of a disease-specific symptom questionnaire for gastroesophageal reflux disease.",C J Allen; K Parameswaran; J Belda; M Anvari,"The purpose of this study was to establish the reproducibility, validity, and responsiveness of a symptom questionnaire to assess patients with gastroesophageal reflux disease (GERD). A total of 300 patients with GERD completed questionnaires before and 6 months after laparoscopic Nissen fundoplication. Forty-six GERD patients who continued on omeprazole served as controls. Lower esophageal sphincter pressure, 24-h pH, and quality of life (SF36) were measured at baseline and follow-up. Reproducibility was calculated as an intraclass correlation coefficient (ICC) from a repeated-measures analysis of variance on symptom scores (SS) on two consecutive days. Validity was established by correlating SS with 24-h pH and SF36 scores. Responsiveness was calculated as the the ratio of the mean paired difference in score in the surgical group to the within-subject variability in control subjects. Reproducibility was very high, as revealed by an ICC of 0.92. Strong correlations between SS and SF36 scores at baseline and after surgery demonstrated high cross-sectional validity. Correlation between change in SS and change in pH, SF36 pain, general health, and physical health scores demonstrated longitudinal validity. The mean (95% confidence interval) paired differences in SS were 25.6 (23.7, 27.5) in the study and 2.0 (-3.2, 7.3) in the control groups, and the responsive index was 1.0. The estimated minimally important clinical difference was 7. We conclude that the symptom score is a reproducible, valid, and responsive instrument for assessing symptoms caused by GERD.",2001.0,0,0
376,11284974,Heller's myotomy: thoracoscopic or laparoscopic?,R Cade,"Cardiomyotomy is now usually performed using a minimally invasive approach. A consecutive series of 18 patients with an intention to treat thoracoscopically were followed by the same number of patients treated laparoscopically. Both groups have been followed prospectively for a minimum of 2 years. The groups were well matched for age, symptom duration, preoperative lower esophageal sphincter pressure, and number having undergone balloon dilatation. There was one conversion from a thoracoscopic to a laparoscopic approach so that, for the purpose of analysis, there are 17 in the thoracoscopic group and 19 in the laparoscopic group. There was no difference in the average operating time, rate of conversion to open operation, mucosal breaches, or length of hospitalization. Nor was there any difference in dysphagia symptoms, with 14/17 having a satisfactory result after thoracoscopic myotomy and 18/19 after laparoscopic myotomy. Frequency of reflux symptoms was similar and, although mild reflux was common, only two patients required treatment with a proton pump blocker. In the treatment of achalasia, thoracoscopic and laparoscopic myotomy without fundoplication are equally effective in relieving dysphagia and have a similar safety profile.",2001.0,0,0
377,11286324,Pharmacokinetic study of esomeprazole in the elderly.,G Hasselgren; M Hassan-Alin; T Andersson; C Claar-Nilsson; K Röhss,"Esomeprazole is the first proton pump inhibitor to be developed as an optical isomer for the treatment of patients with acid-related diseases. The aim of this study was to examine the pharmacokinetics and tolerability of esomeprazole in the elderly, relative to middle-aged patients with gastro-oesophageal reflux disease (GORD). Nonblinded single-centre pharmacokinetic study with historical control group. 14 healthy elderly volunteers [mean age 74 (range 71 to 80) years]. Participants received treatment with esomeprazole 40 mg once daily for 5 days, with 24-hour blood sampling on days 1 and 5. The total area under the plasma concentration-time curve (AUCinfinity), maximum plasma drug concentration (Cmax), terminal elimination half-life (t(1/2z)) and time to Cmax (tmax) were determined for the parent drug and its hydroxy and sulphone metabolites. AUCinfinity and Cmax data were compared with those in an historical group of 36 middle-aged patients [mean age 45 (range 29 to 58) years] with GORD, treated with an identical dosage of esomeprazole for 5 days. A total of 13 volunteers completed the study. On day 5, the mean plasma AUCinfinity of esomeprazole was 16.0 micromol x h/L, Cmax was 5.6 micromol/L, tmax was 1.5 hours and t(1/2z) was 1.7 hours. The AUCinfinity and Cmax values for the parent drug were 2- and 1.5-fold higher on day 5 compared with day 1. AUCinfinity and Cmax values for the sulphone metabolite increased to a slightly greater extent, and values for the hydroxy metabolite were unchanged. Ratios of the AUCinfinity and Cmax values between elderly volunteers and patients with GORD were 1.25 [95% confidence interval (CI) 0.94, 1.67] and 1.18 (0.91, 1.52), respectively. Esomeprazole was well tolerated and there were no safety concerns. The AUCinfinity and Cmax values in the elderly were not significantly different from those obtained in a group of middle-aged patients. The difference for AUCinfinity was 25% (95% CI -6% to +67%). Esomeprazole has a wide therapeutic window and our results do not indicate that dosage adjustment should be necessary in the elderly.",2001.0,0,1
378,11296167,Increased prevalence of gastroesophageal reflux symptoms in patients with COPD.,B Mokhlesi; A L Morris; C F Huang; A J Curcio; T A Barrett; D W Kamp,"To determine the prevalence of gastroesophageal reflux (GER) symptoms in patients with COPD and the association of GER symptoms with the severity of airways obstruction as assessed by pulmonary function tests (PFTs). Prospective questionnaire-based, cross-sectional analytic survey. Outpatient pulmonary and general medicine clinics at a Veterans Administration hospital. Patients with mild-to-severe COPD (n = 100) were defined based on American Thoracic Society criteria. The control group (n = 51) consisted of patients in the general medicine clinic without respiratory complaints or prior diagnosis of asthma or COPD. Both groups completed a modified version of the Mayo Clinic GER questionnaire. Compared to control subjects, a greater proportion of COPD patients had significant GER symptoms defined as heartburn and/or regurgitation once or more per week (19% vs 0%, respectively; p < 0.001), chronic cough (32% vs 16%; p = 0.03), and dysphagia (17% vs 4%; p = 0.02). Among patients with COPD and significant GER symptoms, 26% reported respiratory symptoms associated with reflux events, whereas control subjects denied an association. Significant GER symptoms were more prevalent in COPD patients with FEV(1) < or %, as compared with patients with FEV(1) > 50% of predicted (23% vs 9%, respectively; p = 0.08). In contrast, PFT results were similar among COPD patients with and without GER symptoms. An increased number of patients with COPD utilized antireflux medications, compared to control subjects (50% vs 27%, respectively; p = 0.008). The questionnaire demonstrated a higher prevalence of weekly GER symptoms in patients with COPD, as compared to control subjects. There was a trend toward higher prevalence of GER symptoms in patients with severe COPD; however, this difference did not reach statistical significance. We speculate that although GER may not worsen pulmonary function, greater expiratory airflow limitation may worsen GER symptoms in patients with COPD.",2001.0,0,0
379,11296191,GI complications in patients receiving mechanical ventilation.,G M Mutlu; E A Mutlu; P Factor,"Mechanical ventilation (MV) can be lifesaving by maintaining gas exchange until the underlying disorders are corrected, but it is associated with numerous organ-system complications, which can significantly affect the outcome of critically ill patients. Like other organ systems, GI complications may be directly attributable to MV, but most are a reflection of the severity of the underlying disease that required intensive care. The interactions of the underlying critical illness and MV with the GI tract are complex and can manifest in a variety of clinical pictures. Incorporated in this review are discussions of the most prevalent GI complications associated with MV, and current diagnosis and management of these problems.",2001.0,0,0
380,11315452,,,,,0,0
381,11316215,Lansoprazole treatment of patients with chronic idiopathic laryngitis: a placebo-controlled trial.,H B El-Serag; P Lee; A Buchner; J M Inadomi; M Gavin; D M McCarthy,"Previous uncontrolled studies suggested a therapeutic benefit for treating gastroesophageal reflux disease (GERD) among patients with laryngitis. The present study is the first randomized, placebo-controlled, double-blind study of gastric acid suppression among patients with laryngitis in the United States. Patients diagnosed with idiopathic chronic laryngitis were randomized to receive either lansoprazole 30 mg p.o. b.i.d. or a matching placebo for 3 months. Before randomization, all patients underwent upper endoscopy, dual probe ambulatory 24-h esophageal pH-metry, and laryngoscopy, as well as completing a symptom questionnaire for GERD and laryngitis. The primary outcome of treatment was the complete resolution of laryngeal symptoms. A total of 22 patients with symptoms and signs of chronic laryngitis were enrolled, 20 of whom completed the study. At baseline, there were no significant differences between the two groups with regards to GERD symptoms, erosive esophagitis, proximal and distal esophageal pH-metry, or laryngeal signs and symptoms. In an intention-to-treat analysis, six patients in the lansoprazole group (50%) and only one patient (10%) in the placebo group achieved a complete symptomatic response, p = 0.04. Apart from receiving lansoprazole, there were no significant differences between responders and nonresponders in any of baseline esophageal or laryngeal signs and symptoms. Empirical treatment with lansoprazole is efficacious in relieving symptoms of laryngitis compared to placebo. Such treatment can be considered as a first-line option in managing patients with idiopathic chronic laryngitis.",2001.0,0,0
382,11328254,A systematic comparison of triple therapies for treatment of Helicobacter pylori infection with proton pump inhibitor/ ranitidine bismuth citrate plus clarithromycin and either amoxicillin or a nitroimidazole.,M J Janssen; A H Van Oijen; A L Verbeek; J B Jansen; W A De Boer,"Triple therapies with proton pump inhibitor/ranitidine bismuth citrate (RBC), clarithromycin (C) and either amoxicillin (A) or a nitroimidazole (I) are widely accepted as treatment for Helicobacter pylori infection. However, it is not clear which of these antibiotic combinations should be preferred. To evaluate whether there is a difference in efficacy between triple therapies with proton pump inhibitor/RBC, clarithromycin and either amoxicillin or a nitroimidazole. The literature was examined for randomized trials comparing proton pump inhibitor/RBC-C-A and proton pump inhibitor/RBC-C-I. Studies were grouped according to the type of acid inhibitor used (proton pump inhibitor or RBC) and differences between pooled cure rates were calculated. Forty-seven studies were identified: seven using RBC, 39 using proton pump inhibitor, one using both. RBC-C-I was somewhat superior to RBC-C-A, although this difference only reached statistical significance in intention-to-treat analysis. Overall, proton pump inhibitor-C-I and proton pump inhibitor-C-A were equally effective, but in nitroimidazole-susceptible strains, proton pump inhibitor-C-I performed better, in nitroimidazole-resistant strains, proton pump inhibitor-C-A performed better. No serious side-effects were reported and pooled drop-out rates were equal. In general, proton pump inhibitor-C-I and proton pump inhibitor-C-A are equally effective and therefore other factors such as local prevalence of resistant strains, cost of therapy and options for second-line treatment should determine which regimen should be preferred. When using RBC, the RBC-C-I combination is somewhat superior to RBC-C-A.",2002.0,0,0
383,11328258,"Control of intragastric pH with omeprazole 20 mg, omeprazole 40 mg and lansoprazole 30 mg.",P O Katz; S Xue; D O Castell,"Single daily doses of proton pump inhibitors, omeprazole and lansoprazole provide effective acid suppression and equal healing and symptom relief in patients with GERD. Despite this, controversy exists as to the efficacy of available proton pump inhibitors in the control of gastric acidity. To assess the efficacy of omeprazole 20 mg vs. lansoprazole 30 mg and omeprazole 40 mg vs. lansoprazole 30 mg in intragastric pH control. Study I: 12 Helicobacter pylori-negative volunteers (mean age 33 years) were treated with omeprazole 20 mg and lansoprazole 30 mg in random order before breakfast for 7 days. Study II: 24 subjects (mean age 36 years) were similarly treated with omeprazole 40 mg and lansoprazole 30 mg for 7 days after a baseline pH study. One week washout was allowed between studies. Subjects had the same meal on each study day. On day seven, a 24-h intragastric pH study was performed. The percentage time for which gastric pH > 4 was analysed (Gastrosoft, Synectics Medical Inc.) and expressed as mean +/- s.d. (1) Omeprazole 20 mg and lansoprazole 30 mg showed no significant difference in the percentage time for which gastric pH > 4 in the daytime and night-time periods. (2) The percentage time for which pH > 4 with omeprazole 40 mg was significantly greater than lansoprazole 30 mg in both daytime (61 +/- 19% vs. 48 +/- 14%, P < 0.001), and night-time periods (34 +/- 21% vs. 26 +/- 14%, P < 0.05). (3) A large inter-subject variation existed in both studies. (4) In 10 subjects who participated in both studies, omeprazole 40 mg showed a significantly higher percentage time for which pH > 4 in the daytime (69 +/- 18% vs. 51 +/- 15%, P=0.015) than omeprazole 20 mg. These pH data support the therapeutic equivalency of FDA approved doses of omeprazole and lansoprazole.",2002.0,0,0
384,11333287,Barrett's esophagus: major issues uncertain and unsolved.,M Miller,,2001.0,0,0
385,11336154,Update in the pharmacological management of peptic ulcer haemorrhage.,A K Kubba; N M Selby; C J Hawkey,"The management of peptic ulcer haemorrhage still poses questions and controversies and this applies to the pharmacological mode. This review suggests that high-dose acid suppression is beneficial in reducing rebleeding and surgery rates. The choice of acid suppressant is far from conclusive, but emerging evidence suggests that proton pump inhibitors may be more effective than H2-antagonists. The only other drug which may be useful in selected patients is octreotide, but its universal use cannot be recommended.",2001.0,0,0
386,11336566,COX-2 inhibitors vs. NSAIDs in gastrointestinal damage and prevention.,A Ballinger; G Smith,"Non-steroidal anti-inflammatory drugs (NSAIDs) inhibit production of protective gastric mucosal prostaglandins and also have a direct topical irritant effect. In some patients this results in dyspepsia and development of gastroduodenal erosions and ulceration. The risk of ulcer complications, such as bleeding, perforation and death is increased approximately 4-fold in NSAID users. Patients at high risk of ulcer complications include the elderly, those taking anticoagulants, steroids and aspirin, those with a previous history of peptic ulceration and patients with concomitant serious medical problems. The interaction of NSAIDs with Helicobacter pylori (the major cause of peptic ulceration in non-NSAID users) is controversial and some studies suggest that H. pylori infection may even protect against NSAID-induced ulceration. Selective inhibitors of the inducible cyclooxygenase-2 (COX-2) enzyme spare COX-1 in the gastric mucosa and, hence, do not inhibit production of mucosal prostaglandins. COX-2-selective inhibitors are associated with a significant reduction in gastroduodenal damage compared with traditional NSAIDs. Proton pump inhibitors (PPI) are probably the best agents for healing and prevention of NSAID-induced ulcers. Preliminary studies suggest that COX-2 selective inhibitors, like traditional NSAIDs, may prevent lower gastrointestinal cancer. Further studies are needed but they may be useful in individuals at high risk of certain types of lower gastrointestinal malignancy with increased gastrointestinal tolerability and safety.",2002.0,0,0
387,11336584,Helicobacter pylori infection--current treatment practice.,H H Xia; B C Yu Wong; N J Talley; S K Lam,"Helicobacter pylori infection, which is present in 30 - 60% of the population in developed countries and in more than 60% in developing countries, is established to be a major cause of gastritis, peptic ulcer disease and gastric cancer. Eradication therapy has been incorporated into clinical practice over the past 15 years. Treatment regimens include a 2 week bismuth-based triple therapy (a bismuth compound plus metronidazole, tetracycline or amoxycillin), a 1 week proton-pump inhibitor (PPI)-based triple therapy and a 1 week ranitidine bismuth citrate (RBC)-based triple therapy (a PPI or RBC plus any two of the three antibiotics, metronidazole, amoxycillin and clarithromycin). These regimens achieve eradication rates of > 80%. H. pylori resistance to metronidazole and clarithromycin decreases the clinical efficacy of most regimens, despite the high eradication rates for resistant strains achieved by the RBC-triple therapy in some recent trials. The dose of antibiotics (especially clarithromycin) and the duration of treatment may also influence the eradication rate. Doctors' beliefs impact on clinical practice and, thus, influence the clinical application of eradication therapy. Whereas peptic ulcer disease and primary gastric low-grade B-cell mucosa-associated lymphoid tissue lymphoma (MALToma) have become established as definite indications for eradication therapy, there remain controversies surrounding non-ulcer dyspepsia, gastro-oesophageal reflux disease, atrophic gastritis, intestinal metaplasia, use of non-steroidal anti-inflammatory drugs (NSAIDs) and H. pylori-related extradigestive diseases.",2002.0,0,0
388,11337218,The association between antiulcer medication and initiation of cobalamin replacement in older persons.,S L Mitchell; K Rockwood,"As chronic use of antiulcer medications might predispose older persons to cobalamin deficiency, we studied participants (> 65 years) in the clinical examination of the Canadian Study of Health and Aging to test the association between the use of an antiulcer medication (histamine-2 blocker or proton pump inhibitor) at baseline with initiation of cobalamin replacement during the 5 year follow-up period. Of 1054 eligible subjects, 125 (11.7%) were taking an antiulcer medication at baseline. At follow-up, 49 (4.6%) had started cobalamin replacement. Antiulcer medication use at baseline was significantly associated with the initiation of cobalamin therapy (odds ratio 2.56, 95% confidence interval 1.30-5.05), even after adjusting for age, gender and institutional residence (odds ratio 2.61, 95% confidence interval 1.31-5.23). There is an independent association between the use of antiulcer medication and initiation of cobalamin therapy. While the relationship is not unambiguously causal, this finding underscores the need for judicious prescribing of antiulcer medications for older persons.",2001.0,0,0
389,11343480,Long-term outcome of medical and surgical therapies for gastroesophageal reflux disease: follow-up of a randomized controlled trial.,S J Spechler; E Lee; D Ahnen; R K Goyal; I Hirano; F Ramirez; J P Raufman; R Sampliner; T Schnell; S Sontag; Z R Vlahcevic; R Young; W Williford,"Severe gastroesophageal reflux disease (GERD) is a lifelong problem that can be complicated by peptic esophageal stricture and adenocarcinoma of the esophagus. To determine the long-term outcome of medical and surgical therapies for GERD. Follow-up study conducted from October 1997 through October 1999 of a prospective randomized trial of medical and surgical antireflux treatments in patients with complicated GERD. Mean (median) duration of follow-up was 10.6 years (7.3 years) for medical patients and 9.1 years (6.3 years) for surgical patients. Two hundred thirty-nine (97%) of the original 247 study patients were found (79 were confirmed dead). Among the 160 survivors (157 men and 3 women; mean [SD] age, 67 [12] years), 129 (91 in the medical treatment group and 38 in the surgical treatment group) participated in the follow-up. Use of antireflux medication, Gastroesophageal Reflux Disease Activity Index (GRACI) scores, grade of esophagitis, frequency of treatment of esophageal stricture, frequency of subsequent antireflux operations, 36-item Short Form health survey (SF-36) scores, satisfaction with antireflux therapy, survival, and incidence of esophageal adenocarcinoma, compared between the medical antireflux therapy group and the fundoplication surgery group. Information on cause of death was obtained from autopsy results, hospital records, and death certificates. Eighty-three (92%) of 90 medical patients and 23 (62%) of 37 surgical patients reported that they used antireflux medications regularly (P<.001). During a 1-week period after discontinuation of medication, mean (SD) GRACI symptom scores were significantly lower in the surgical treatment group (82.6 [17.5] vs 96.7 [21.4] in the medical treatment group; P =.003). However, no significant differences between the groups were found in grade of esophagitis, frequency of treatment of esophageal stricture and subsequent antireflux operations, SF-36 standardized physical and mental component scale scores, and overall satisfaction with antireflux therapy. Survival during a period of 140 months was decreased significantly in the surgical vs the medical treatment group (relative risk of death in the medical group, 1.57; 95% confidence interval, 1.01-2.46; P =.047), largely because of excess deaths from heart disease. Patients with Barrett esophagus at baseline developed esophageal adenocarcinomas at an annual rate of 0.4%, whereas these cancers developed in patients without Barrett esophagus at an annual rate of only 0.07%. There was no significant difference between groups in incidence of esophageal cancer. This study suggests that antireflux surgery should not be advised with the expectation that patients with GERD will no longer need to take antisecretory medications or that the procedure will prevent esophageal cancer among those with GERD and Barrett esophagus.",2001.0,0,1
390,11346101,Gastro-oesophageal reflux disease: not so benign.,A E Duggan; M A Harvey,,2001.0,0,0
391,11346200,Low incidence of Helicobacter pylori infection in patients with duodenal ulcer and chronic liver disease.,W A Shahin; E Z Abdel-Baset; A K Nassar; M M Atta; S M Kabil; J A Murray,"Duodenal ulcer (DU) is a common problem in patients with chronic liver disease (CLD) and with inadequate response to H2 receptor antagonists. Omeprazole might be more effective. In DU-CLD patients, Helicobacter pylori prevalence is low. Nitric oxide is increased in gastric mucosa in cirrhosis. Oxygen-free radicals have a role in gastric inflammation and are abnormal in CLD. Nitrotyrosine is a marker of nitric oxide and oxygen-free radical toxic mucosal reaction. Sixty-nine patients were divided into 2 groups: control (26 patients with DU) and CLD groups (43 patients, DU-CLD). Omeprazole was given (40 mg/day) for 2 or 4 weeks. Symptoms and endoscopy findings were recorded before and after treatment. Antral biopsy specimens were stained for H. pylori and nitrotyrosine. Clinical features of DU are similar in patients with and without CLD. The main presentation was epigastric pain (70%) and bleeding (23%). Healing rate with omeprazole was higher in DU-CLD patients (90.7%) than in controls (80.8%). H. pylori was much lower in DU-CLD patients (51.2%) than controls (96.2%). Nitrotyrosine staining was negative in normal controls (0%) and positive in control-DU (100%), CLD-H. pylori positive (81%), and CLD-H. pylori negative (91%) cases. DU in patients with CLD is not different clinically from those without CLD. Omeprazole effectively and safely treats DU in CLD. Nitric oxide and free oxygen radicals may result in gastric mucosal changes in CLD similar to that caused by H. pylori.",2001.0,0,0
392,11351143,Comparison of pantoprazole 20 mg to ranitidine 150 mg b.i.d. in the treatment of mild gastroesophageal reflux disease.,S Kaspari; A Biedermann; J Mey,"Despite a high prevalence of mild gastroesophageal reflux disease (GERD), few studies investigated efficacy and safety of proton pump inhibitors in this indication. This randomized double-blind study compares pantoprazole to ranitidine in GERD 0 and I, i.e. reflux without esophagitis or with confined lesions only. Patients received either pantoprazole 20 mg o.a.d. or ranitidine 150 mg b.i.d. Outcome was assessed after 2 and 4 weeks. Primary criterion was relief of leading symptoms, i.e. heartburn, acid eructation and pain on swallowing, after 4 weeks of treatment. According to the per-protocol (PP) analysis, 69% (100/144) and 80% (115/144) of patients in the pantoprazole group were relieved of leading symptoms after 2 and 4 weeks, respectively. The rates in the ranitidine group were 47% (62/133) and 65% (86/133). Thus, superiority of pantoprazole could be proven. Quality-of-life parameters improved more in the pantoprazole group and patients' assessment of treatment was more favorable. Analysis for Helicobacter pylori status showed infection to lead to higher symptom relief rates. Both study medications were well tolerated. Pantoprazole 20 mg demonstrated superior efficacy with faster relief of reflux symptoms and similar tolerability compared to ranitidine 150 mg in the treatment of mild GERD.",2001.0,0,1
393,11356991,Reduction of acid exposure and regression of Barrett's esophagus.,R E Sampliner,"The goals of treatment of Barrett's esophagus (BE) include relieving reflux symptoms, healing inflammatory lesions, and preventing esophageal adenocarcinoma. Reduction of acid reflux is believed to prevent progression of BE. A critical question is whether or not regression of BE occurs in response to therapy with proton pump inhibitors. The natural history of BE is altered both by the use of medications (over-the-counter or prescribed) and by endoscopic surveillance with periodic biopsies. Regression occurs when the length and surface area of BE decreases, along with the emergence of islands of squamous epithelium in the BE segment. However, the extent of regression is difficult to assess because intestinal metaplasia may underlie the islands of squamous epithelial regrowth. Sampling by endoscopic biopsy is useful in ruling out progression of BE to dysplasia or adenocarcinoma; however, complete regression of the lesion cannot be definitively proven by this technique. To date, published clinical trials of proton pump inhibitor therapy in patients with BE provide evidence of increases in squamous islands in the BE segment, but do not provide convincing data in support of complete regression of BE. In a review of prospective studies of the treatment of BE with proton pump inhibitors (PPIs) (with or without surgery), only 3 of 123 patients had apparent complete reversal of BE. This article reviews the current understanding of regression in BE following treatment with PPIs.",2001.0,0,0
394,11356993,What is the optimal medical therapy for Barrett's esophagus?,K R DeVault,"The development of Barrett's esophagus (BE) in patients with gastroesophageal reflux disease (GERD) is troubling because of its known association with esophageal cancer. When evaluated clinically, patients with BE have the severest form of GERD and require aggressive therapy to control esophageal acid exposure. Both hypotension of the lower esophageal sphincter and the extent of esophageal acid exposure are major contributors to severe GERD and its complications. It is hypothesized that better control of acid will improve outcomes for BE patients. While it is clear that therapy (medical or surgical) for reflux rarely if ever results in total regression of BE, there are some limited data to support improvement in BE with control of reflux. Current medical choices include prokinetic agents, histamine type-2 receptor antagonists, and proton pump inhibitors. In the future, genetic markers may be used in identifying BE patients at the greatest risk for histologic progression, and chemoprevention with cyclooxygenase-2 inhibitors may be a therapeutic option. This paper will review the rationale for and results of medical antireflux therapy in patients with BE.",2001.0,0,0
395,11356994,Medical therapy versus antireflux surgery in Barrett's esophagus: what is the best therapeutic approach?,A Klaus; R A Hinder,"We conducted a review of the literature comparing medical treatment with antireflux surgery in patients with Barrett's esophagus (BE). In particular, we wanted to assess the efficacy of medical and surgical therapies in preventing the progression of Barrett's epithelium to dysplasia or adenocarcinoma of the esophagus. In general, few BE patients show complete regression of BE epithelium following medical or surgical therapy. The incidence of developing dysplasia or cancer following surgical therapy appears to be less than with medical therapy; however, there is an insufficient number of current, randomized controlled studies to confirm this. Surveillance of BE is required regardless of treatment. This review suggests that there may be a trend in support of surgery being somewhat better than medical therapy in the prevention of BE progression and adenocarcinoma. We suggest that patients with BE should be considered for antireflux surgery - in particular, certain subgroups of BE patients.",2001.0,0,0
396,11374675,"Helicobacter pylori-negative duodenal ulcers: prevalence, clinical characteristics, and prognosis--results from a randomized trial with 2-year follow-up.",P Bytzer; P S Teglbjaerg; Danish Ulcer Study Group,"The proportion of Helicobacter pylori-negative duodenal ulcer disease appears to be increasing. Data on clinical outcome and prognosis in this subgroup are lacking. Two hundred seventy-six duodenal ulcer patients randomized, irrespective of H. pylori status, to either eradication therapy or maintenance omeprazole (double-blind, double-dummy design) for 1 yr were studied. Patients were followed up for a total of 2 yr, with visits performed every 2 months the first year and every 6 months the following year. Endoscopies for assessment of ulcer relapse were done at 6 and 12 months or in the event of symptomatic relapse. H. pylori status was assessed by culture, immunohistochemistry, and urea breath test at entry, at 6, 12, and 24 months or at failure. The primary endpoint was discontinuation, irrespective of reason. Patients were considered H. pylori negative if all three tests were negative. Patients were considered H. pylori-positive if any of the three diagnostic tests were positive. Study staff were blinded to H. pylori results. Thirty-two (12%) patients were H. pylori negative at entry. There were no differences according to H. pylori status for a number of clinical and demographic characteristics. However, H. pylori-negative patients had a shorter history of ulcer symptoms and were more likely to be NSAID users (19% vs 1%, p < 0.001). Only 28% of the H. pylori-negative patients completed the study, as compared with 40% of H. pylori-positive patients (p = 0.0005). The main reasons for the poorer prognosis in H. pylori-negative patients were relapse of ulcer/ulcer not healed (35% vs 26%) and relapse of severe dyspepsia symptoms without ulcer relapse (16% vs 7%). H. pylori-negative patients randomized to eradication therapy left the study early compared with H. pylori-negative patients randomized to long-term omeprazole therapy. Outcome in omeprazole-treated patients did not differ according to H. pylori status (p = 0.3). Clinical characteristics in H. pylori-negative and positive duodenal ulcer patients differ little. Clinical outcome over 2 yr is significantly poorer in H. pylori-negative patients, especially if treated empirically with eradication therapy. These results suggest that H. pylori infection should be assessed in all duodenal ulcer patients before treatment is decided.",2001.0,0,0
397,11380322,Three-day lansoprazole quadruple therapy for Helicobacter pylori-positive duodenal ulcers: a randomized controlled study.,B C Wong; W H Wang; W M Wong; G K Lau; F M Fung; N N Kung; K M Chu; K C Lai; W H Hu; F L Hu; X G Liu; C K Chan; M F Yuen; W M Hui; S K Lam,"To compare the efficacy and tolerability of a 3-day quadruple therapy with a standard 7-day triple therapy in eradicating Helicobacter pylori infection and healing duodenal ulcers. Patients with H. pylori-positive duodenal ulcers were randomized to receive either lansoprazole 30 mg, clarithromycin 500 mg, and metronidazole 400 mg twice daily for 7 days (LCM-7) or lansoprazole 30 mg, clarithromycin 500 mg, metronidazole 400 mg, and bismuth subcitrate 240 mg twice daily for 3 days (LCMB-3). No pre- or post-treatment acid suppression was used. Follow-up endoscopy was performed at week 6. A total of 118 patients were recruited. Sixty patients in the LCM-7 group and 53 patients in the LCMB-3 group returned for endoscopy. Intention-to-treat eradication rates were 87% and 86% (P=0.94) and per protocol eradication rates were 87% and 94% (P=0.29) in the LCM-7 and LCMB-3 groups, respectively. Per protocol and intention-to-treat ulcer healing rates were 98% and 98% in LCM-7 and 100% and 91% in LCMB-3, respectively. There were no significant differences in efficacy in relation to the initial metronidazole and clarithromycin susceptibility. Significant reduction in the duration of side-effects was found in the LCMB-3 group. The 3-day quadruple therapy is highly effective, better tolerated and can be considered as a first-line therapy in duodenal ulcer management.",2002.0,0,0
398,11381356,Helicobacter pylori: diagnostics and management in peptic ulcer disease: a review.,R E Dicicco,"The management of peptic ulcer disease (PUD) has progressed markedly over the past century. Thanks to the discovery of Helicobacter pylori, our treatment focus has shifted from antacids and H2 antagonists to proton pump inhibitors and antimicrobial agents. Despite these advances, many treatment issues remain ambiguous. Some of the most controversial issues include management of the infection at a general practice level, particularly whom to treat, which regimens are most effective, and which diagnostic criteria (if any) should be used. This article will provide a brief description of available diagnostic modalities and summarize recent research findings on optimal testing techniques and treatment in primary care.",2002.0,0,0
399,11392163,[The effect of cigarette smoking and alcohol consumption on efficacy of Helicobacter pylori eradication].,Z Namiot; D B Namiot; A Kemona; M Gołebiewska; R Bucki,"None of the drug regimens used to treat H. pylori infection ensures 100% of efficacy. One may think therefore that among factors modifying H. pylori eradication there are also cigarette smoking and alcohol consumption. The aim of the study was to determine the influence of cigarette smoking and alcohol consumption on efficacy of H. pylori eradication. The study was conducted on 142 H. pylori positive peptic ulcer patients treated with either OAT-omeprazole (2 x 20 mg), amoxycillin (2 x 1000 mg), tinidazole (2 x 500 mg) (69 patients) or OAC-omeprazole (2 x 20 mg), amoxycillin (2 x 1000 mg), clarithromycin (2 x 250 mg) (73 patients). Detailed information on smoking and drinking habits was obtained from a questionnaire fulfilled by all subjects. Patients were defined as smokers if smoked 5 or more cigarettes per day and as drinkers if drank 25 g or more alcohol per week. To enter the study patients had to have confirmed H. pylori infection by two tests (CLO-test and histology). Eradication was considered successful if both tests gave negative results 4-6 weeks after the cessation of treatment. The efficacy of H. pylori eradication was similar in both groups (OAT--69.6%, OAC--78.1%). Patients who smoked cigarettes had lower rate of H. pylori eradication in OAC group (smokers 65.8%, non-smokers 91.4%, p < 0.01), while patients who drank alcohol had higher eradication rate in OAT group (drinkers 85.2%, non-drinkers 59.5%, p < 0.05). When two factors (smoking, drinking) were analyzed together, it was found that in drinkers treated with OAT, smoking did not change the efficacy of H. pylori eradication, while in non-drinkers decreased by two times (75.0% vs 38.9%, p < 0.02). In drinkers treated with OAC, smoking did not change the efficacy of H. pylori eradication (but this was likely related to the limited number of patients), while decreased it in non-drinkers from 90.0% to 65.2% (p < 0.05). When two groups were analyzed together (OAT + OAC), the lowest efficacy of H. pylori eradication exhibited smokers who do not drink (53.7%) followed by smokers who drink (75.8%), non-smokers who do not drink (83.3%) and non-smokers who drink (92.9%); in each case the efficacy of eradication was higher than in smokers who do not drink (p < 0.05, p < 0.01, p < 0.01, respectively). Both cigarette smoking and alcohol consumption can affect the efficacy of H. pylori eradication. Smoking and drinking habits should be taken into account, when the set of drugs for H. pylori eradication is chosen.",2001.0,0,0
400,11392580,Asthma and gastro-oesophageal reflux: can the response to anti-reflux therapy be predicted?,T Kiljander; E R Salomaa; E Hietanen; H Helenius; K Liippo; E O Terho,"The aim of the study was to investigate which features predict favourable response to omeprazole therapy in asthmatics with gastro-oesophageal reflux (GER). The study population consisted of 52 outpatient asthmatics with GER who had completed an intervention where they were randomized to receive omeprazole 40 mg once a day or placebo for 8 weeks. After a 2-week washout period the patients were crossed over. Asthma symptoms were found to be relieved > or = 20% in 18 (35%) patients who were thus regarded as responders. A logistic regression analysis was performed in order to identify which features separate the responders from the non-responders. More responders were found among the patients whose body mass index (BMI) was higher (P = 0.02) or whose distal esophageal reflux was more severe [total time (%) pH < 4 (P = 0.01) or time (%) pH < 4 in upright position (P = 0.04)]. Adding other predictors to the total time (%) pH < 4, which was the most significant predictor for response in multi-variate analysis, did not further increase the prediction for favourable outcome. It is concluded that severe distal oesophageal reflux and obesity predict amelioration in asthma symptoms after 8-week omeprazole treatment in asthmatics with GER. Adding more than one predictor does not seem to further increase prediction for favourable asthma response.",2002.0,0,0
401,11394727,A review of omeprazole use in the treatment of acid-related disorders in children.,A E Zimmermann; J K Walters; B G Katona; P E Souney; D Levine,"Acid peptic disease is a common problem, with a similar prevalence of gastroesophageal reflux disease (GERD) in adults and children. The presentation of GERD in infants and children varies from crying, irritability, or sleep disturbance to feeding difficulties, vomiting, or rumination. Helicobacter pylori (HP)-related diseases and gastric and duodenal ulcers are much more common in adults than in children, who are more likely to have gastritis or duodenitis. However, because HP infection is most likely acquired in childhood, treatment of children with endoscopically documented active HP disease may minimize the potential risk for peptic ulcer or gastric cancer in adulthood, although this is yet to be proved. Omeprazole has been shown to be effective in the treatment of acid-related diseases. This paper reviews the literature on the use and administration of omeprazole for the treatment of GERD, peptic ulcer disease, HP infection, and other acid-related conditions in children. Studies were identified through searches of MEDLINE and Science Citation Index for the period 1986 to November 2000, and from the reference lists of identified articles. The search terms used included omeprazole, proton pump inhibitor (PPI), children, pediatrics, routes of administration, GERD, HP infection, esophagitis, and administration. In addition, the manufacturer of omeprazole was asked for relevant unpublished information. Marketed and extemporaneous formulations of omeprazole have been administered to children aged 2 months to 18 years for the treatment of erosive esophagitis, gastric ulcer, duodenal ulcer, HP infection, and related conditions at dosages of 5 to 80 mg/d (0.2-3.5 mg/kg/d) for periods ranging from 14 days to 36 months with a low incidence of adverse effects. The initial dose most consistently reported to heal esophagitis and provide relief of symptoms of GERD appears to be 1 mg/kg per day. In uncontrolled clinical trials and case reports to date, omeprazole has been effective and well tolerated for the acute and chronic treatment of esophageal and peptic ulcer disease in children, particularly those who had failed to respond to previous treatment with histamine2-receptor antagonists. Should future long-term, controlled clinical trials in children demonstrate safety and efficacy, this PPI is likely to find a place in the armamentarium of pediatric pharmacotherapy.",2001.0,0,0
402,11394734,"Lansoprazole-based triple therapy versus ranitidine bismuth citrate-based dual therapy in the eradication of Helicobacter pylori in patients with duodenal ulcer: a multicenter, randomized, double-dummy study.",F Luzza; A Giglio; E Ciliberto; A Belmonte; C Cavaliere; N Saccà; C Frandina; R Fiocca; V Trimboli; F Pallone,"The optimal treatment regimen for eradication of Helicobacter pylori in patients with duodenal ulcer has yet to be determined. Based on a search of MEDLINE, no studies have been performed comparing a proton pump inhibitor-based triple therapy regimen with a ranitidine bismuth citrate (RBC)-based dual therapy regimen, both containing clarithromycin. This study was undertaken to compare the efficacy of lansoprazole (LAN)-based triple therapy with that of RBC-based dual therapy in H pylori-infected patients with duodenal ulcer. Patients were randomized to receive either 1 week of triple therapy with LAN 30 mg BID, clarithromycin 500 mg BID, and tinidazole 500 mg BID, followed by 3 weeks of LAN 30 mg BID, or 2 weeks of dual therapy with RBC 400 mg BID plus clarithromycin 500 mg BID, followed by 2 weeks of RBC 400 mg BID. Eradication of H pylori was defined as negative results on both the urease quick test and histologic examination > or =4 weeks after the end of treatment. Duodenal healing and recurrence rates were assessed endoscopically at 8 weeks and 6 months. A per-protocol (PP) analysis was conducted for each efficacy end point. Also conducted were an intent-to-treat (ITT) analysis in which patients with missing data were considered failures, and an observed analysis (OBS), which included patients with an evaluable result after treatment, regardless of compliance. One hundred eighty-five patients (126 men, 59 women; age range, 18-76 years; mean age, 43 years) were enrolled and randomized to treatment. In the LAN and RBC groups, respectively, H. pylori eradication rates were 92.6%, 93.1%, and 72.8% versus 78.6%, 77.9%, and 64.5% in the PP (P = 0.02), OBS (P = 0.01), and ITT analyses. The corresponding duodenal ulcer healing rates were 98.6%, 98.7%, and 83.7% versus 90.8%, 91.5%, and 81.7%; these differences were not statistically significant. Side effects were mild, occurring in 20.7% of LAN patients and 17.2% of RBC patients. Ulcer recurred in 2 RBC patients. No difference was observed between treatments in terms of the occurrence of gastritis or improvement of symptoms. Based on the results of the PP and OBS analyses, LAN-based triple therapy was superior to RBC-based dual therapy for the eradication of H. pylori in patients with duodenal ulcer.",2001.0,0,1
403,11395670,Pantoprazole versus lansoprazole in French patients with reflux esophagitis.,J L Dupas; P Houcke; R Samoyeau; French Collaborative Pantaprazole Study Group,"The aim of this study was to compare the efficacy of pantoprazole 40 mg and lansoprazole 30 mg given for 4 to 8 weeks on endoscopic healing and symptom relief in grade II-III reflux esophagitis patients (according to Savary-Miller classification). Four hundred and sixty one patients were included (pantoprazole n=226, lansoprazole n=235) in this prospective, randomized, multicenter double-blind study. Endoscopic control was performed at 4 weeks and at 8 weeks if esophagitis was not healed. In the intention-to-treat analysis, the healing rates at 4 weeks were 81 and 80% in the pantoprazole and lansoprazole groups, respectively (NS), 90 and 86% at 8 weeks (NS). In the per-protocol analysis, the healing rates at 4 weeks were 86% in the 2 groups and at 8 weeks 97% in the pantoprazole group and 93% in the lansoprazole group (NS). The heartburn relief rates at day 14 were 88% and 86% in the pantoprazole and lansoprazole groups, respectively. Only esophagitis grade at entry was shown to be a predictive factor for healing at 4 weeks (P<0.0001). This study showed that pantoprazole 40 mg once daily is as effective and well tolerated as lansoprazole 30 mg once daily in the treatment of grade II-III acute reflux esophagitis.",2001.0,1,1
404,11402494,Pantoprazole.,P Poole,"The pharmacology, pharmacokinetics, clinical efficacy, adverse effects, and dosage and administration of pantoprazole are reviewed. Pantoprazole is a gastric hydrogen-potassium adenosine triphosphatase (H+/K(+)-ATPase) inhibitor. It shares the same core structure as other currently available proton-pump inhibitors (PPIs). The FDA-labeled indication is the short-term treatment of erosive esophagitis. PPIs act by selectively inhibiting H+/K(+)-ATPase in the secretory canaliculus of the stimulated parietal cell. Understanding the pharmacodynamics of PPIs is more relevant than knowing their pharmacokinetics, since the duration of action depends on the rate of de novo proton-pump regeneration, not the duration of drug circulation in the body. Pantoprazole is well absorbed, undergoes little first-pass metabolism, and has an absolute bioavailability of approximately 77%. Pantoprazole has been evaluated in more than 100 clinical trials involving more than 11,000 patients. It is effective in treating erosive esophagitis and duodenal and gastric ulcers. It is also effective as adjunctive treatment with antimicrobials in patients infected with Helicobacter pylori. Pantoprazole has been shown to control acid production in Zollinger-Ellison syndrome. Pantoprazole is well tolerated. The most commonly reported adverse effects are headache, diarrhea, and abdominal pain. The recommended oral dosage for erosive esophagitis is 40 mg once a day for up to eight weeks. The recommended i.v. dose is 40 mg given over 15 minutes once a day in patients with gastroesophageal reflux disease who are unable to take oral medication. Pantoprazole appears to be as safe and effective as other PPIs in acid-related disorders.",2001.0,0,0
405,11403809,Helicobacter pylori and symptomatic relapse of gastro-oesophageal reflux disease: a randomised controlled trial.,W Schwizer; M Thumshirn; J Dent; I Guldenschuh; D Menne; G Cathomas; M Fried,"There is little information on the effects of Helicobacter pylori eradication in patients with a primary diagnosis of gastro-oesophageal reflux disease (GORD). Our aim was to investigate the effect of H pylori eradication in this group of patients. We did a double-blind, randomised, placebo-controlled study in 70 patients with GORD. We assigned individuals to three groups. All patients received lansoprazole 30 mg twice daily for 10 days, followed by 30 mg once daily for 8 weeks. Patients infected with H pylori received either antibiotics (clarithromycin 500 mg and amoxicillin 1000 mg twice daily) or placebo for the first 10 days. Controls were patients not infected with H pylori. Patients were followed up for 6 months at 2-week intervals for GORD symptoms. At the end of the study we repeated endoscopy and oesophageal and gastric 24 h-pH monitoring. 58 of 70 patients completed our study. At the end of the study 16 of these patients were H pylori-positive (14 placebo and two eradication failures), 13 were negative because of successful H pylori eradication, and 29 were controls. H pylori-positive patients relapsed earlier (54 days) than did those in whom H pylori was eradicated (100 days) (p=0.046). The H pylori-negative control group relapsed after the longest period (110 days). However, time to relapse was also affected by oesophagitis grade (no oesophagitis 127 days, grade III or IV oesophagitis 18 days). When results were corrected for the affect of oesophagitis grade, H pylori-positive patients relapsed earlier (p=0.086) than H pylori-eradiated patients and controls (p=0.001). H pylori infection positively affects the relapse rate of GORD. Eradication of H pylori could, therefore, help to prolong disease-free interval in patients with GORD.",2001.0,0,0
406,11408992,Proton-pump inhibitors for acute peptic ulcer bleeding.,B L Erstad,"To review the use of proton-pump inhibitors for acute peptic ulcer bleeding. Articles were obtained through computerized searches of MEDLINE (1966-September 2000). Additionally, several textbooks containing information on the diagnosis and management of acute peptic ulcer bleeding were reviewed. The bibliographies of retrieved publications and textbooks were reviewed for additional references. All randomized studies and pharmacoeconomic evaluations that used proton-pump inhibitor therapy for acute peptic ulcer bleeding were included. Randomized controlled trials and meta-analyses involving other therapies for treating peptic ulcer bleeding were also reviewed for possible inclusion. The primary outcomes extracted from the literature were persistent or recurrent bleeding, transfusion requirements, need for endoscopic intervention or surgery, length of stay, and mortality. Data from double-blind, placebo-controlled trials involving more than 1000 patients demonstrate that short-term, high-dose omeprazole therapy is effective for reducing bleeding and transfusion requirements in patients with acute peptic ulcer bleeding. The patients most likely to benefit from this therapy are hospitalized patients at high risk for rebleeding and patients in whom endoscopic evaluation must be delayed or is unavailable. Omeprazole (and likely other proton-pump inhibitors) is useful in reducing bleeding and transfusion requirements in patients with acute peptic ulcer bleeding, although better delineation of appropriate candidates is needed.",2001.0,0,1
407,11419818,"Management of heartburn in a large, randomized, community-based study: comparison of four therapeutic strategies.",C W Howden; J M Henning; B Huang; N Lukasik; J W Freston,"Our objective was to compare four management strategies for heartburn: therapy with an H2-receptor antagonist (ranitidine), therapy with a proton pump inhibitor (lansoprazole), crossover from ranitidine to lansoprazole (""step-up"" therapy), and crossover from lansoprazole to ranitidine (""step-down"" therapy). This was a controlled, double-blind, multicenter trial comprising 593 adults with heartburn, randomized to one of four groups for 20 wk. Subjects received either ranitidine 150 mg b.i.d. for 20 wk, or lansoprazole 30 mg once daily for 20 wk, or ranitidine 150 mg b.i.d. for 8 wk [corrected] followed by lansoprazole 30 mg once daily for 12 wk (""step-up""), or lansoprazole 30 mg once daily for 8 wk followed by ranitidine 150 mg b.i.d. for 12 wk (""step-down""). Outcome measures were based on self-reports in daily diaries of 24-h heartburn severity, measured by maximum daytime and nighttime severity, and percentage of 24-h heartburn-free days measured by absence of both daytime and nighttime heartburn. Median heartburn severity was significantly lower (p < 0.05) for lansoprazole (0.25) than the other groups (0.46 ranitidine, 0.44 ""step-up,"" 0.35 ""step-down""). The lansoprazole group had a significantly higher percentage of 24-h heartburn-free days (median 81.4%, p < 0.01) than other groups (66.6, 66.9, and 73.6%, respectively). In the ""step-up"" and ""step-down"" groups, heartburn was less severe, and percentages of 24-h heartburn-free days were higher during lansoprazole treatment regardless of treatment sequence. Proton pump inhibitor treatment provides more consistent heartburn relief than an H2-receptor antagonist, or ""step-up"" or ""step-down"" therapy.",2001.0,0,1
408,11419827,"Pantoprazole therapy in the long-term management of severe acid peptic disease: clinical efficacy, safety, serum gastrin, gastric histology, and endocrine cell studies.",K D Bardhan; P Cherian; A E Bishop; J M Polak; H Romanska; M J Perry; A Rowland; M Thompson; P Morris; A Schneider; R Fischer; W Ng; R Lühmann; B McCaldin,"Pantoprazole is the third proton pump inhibitor to become available. When this study was started, there were few data on its long-term use. Our aim was to investigate this aspect and, because powerful inhibitors of acid secretion can cause hypergastrinemia and, in experimental animals, enterochromaffin-like cell hyperplasia, we also monitored serum gastrin and endocrine cell histology. One hundred fifty patients refractory to H2-receptor antagonists, running an aggressive course or with complications, were entered into a 5-yr treatment program. We performed serial endoscopy, checked for adverse events, and laboratory values. We also monitored serum gastrin, gastric endocrine cell histology, and antral and corpus gastritis. This report presents results from up to 3 yr of treatment. Cumulative healing on 40-80 mg of pantoprazole was 82% at 4 wk and 92% by 12 wk. Most patients became asymptomatic within 4 wk. Remission on maintenance treatment with 40 mg (n = 111) was 85% at 12 months and 78% at 24 months. Treatment was safe; only four patients had adverse events definitely related to pantoprazole. Elevations in gastrin were modest and there were no significant changes in gastric endocrine cells. The number of enterochromaffin-like cells tended to decrease. Pantoprazole is effective, safe, and does not seem to be associated with large increases in serum gastrin or alterations in gastric endocrine cells.",2001.0,0,1
409,11419855,Surgery versus medical therapy for gastroesophageal reflux disease.,K R DeVault,,2001.0,0,0
410,11421865,Proton pump inhibitors versus H2-antagonists: a meta-analysis of their efficacy in treating bleeding peptic ulcer.,J P Gisbert; L González; X Calvet; M Roqué; R Gabriel; J M Pajares,"To evaluate whether proton pump inhibitors are more effective than H2-antagonists (H2-A) for the treatment of bleeding peptic ulcer. PubMed database until January 2000. Comparative randomized trials of proton pump inhibitors (omeprazole, lansoprazole, or pantoprazole) vs. H2-A (cimetidine, ranitidine or famotidine). Meta-analysis combining the odds ratios (OR) of the individual studies in a global OR (Peto method). OUTCOMES EVALUATED: Persistent or recurrent bleeding, need for surgery, or mortality. Eleven studies fulfilled the inclusion criteria and contained data for at least one of the planned comparisons. Persistent or recurrent bleeding was reported in 6.7% (95% CI: 4.9-8.6%) of the patients treated with proton pump inhibitors, and in 13.4% (95% CI: 10.8-16%) of those treated with H2-A (OR 0.4; 95% CI: 0.27-0.59) (chi2-homogeneity test, 18; P=0.09). Surgery was needed in 5.2% (95% CI: 3.4-6.9%) of the patients treated with proton pump inhibitors, and in 6.9% (95% CI: 4.9-8.9%) of the patients treated with H2-A (OR 0.7; 95% CI: 0.43-1.13). Respective percentages for mortality were 1.6% (95% CI: 0.9-2.9%) and 2.2% (95% CI: 1.3-3.7%) (OR 0.69; 95% CI: 0.31-1.57). SUB-ANALYSIS: Five studies evaluated the effect of both therapies given in bolus injections on persistent or recurrent bleeding rate, which was 6% (95% CI: 3.6-8.3%) and 8.1% (95% CI: 5.3-10.9%), respectively (OR, 0.57; 95% CI: 0.31-1.05). Persistent or recurrent bleeding in high risk patients (Forrest Ia, Ib and IIa) occurred in 13.2% (95% CI: 7.9-8%) of the patients treated with proton pump inhibitors and in 34.5% (27-42%) of those treated with H2-A (OR 0.28; 95% CI: 0.16-0.48). In patients not having endoscopic therapy, persistent or recurrent bleeding was reported, respectively, in 4.3% (95% CI: 2.7-6.7%) and in 12% (95% CI: 8.7-15%) (OR 0.24; 95% CI: 0.13-0.43). Less marked differences were observed in patients having adjunct endoscopic therapy: 10.3% (95% CI: 6.7-13.8%) and 15.2% (11.1-19.3%) (OR 0.59; 95% CI: 0.36-0.97). Moreover, the significance disappeared in this group when a single outlier study was excluded. Proton pump inhibitors are more effective than H2-A in preventing persistent or recurrent bleeding from peptic ulcer, although this advantage seems to be more evident in patients not having adjunct sclerosis therapy. This beneficial effect seems to be similar or even more marked in patients with Forrest Ia, Ib or IIa ulcers. However, proton pump inhibitors are not more effective than H2-A for reducing surgery or mortality rates. Nevertheless, the data are too scarce and heterogeneous to draw definitive conclusions, and further comparative trials are clearly warranted.",2001.0,1,1
411,11421866,"The new proton pump inhibitor esomeprazole is effective as a maintenance therapy in GERD patients with healed erosive oesophagitis: a 6-month, randomized, double-blind, placebo-controlled study of efficacy and safety.",N B Vakil; R Shaker; D A Johnson; T Kovacs; R D Baerg; C Hwang; D D'Amico; B Hamelin,"Esomeprazole, the S-isomer of omeprazole, is the first proton pump inhibitor to be developed as an optical isomer. In patients with erosive oesophagitis, esomeprazole has produced significantly greater healing rates and improved symptom resolution vs. omeprazole. This study assesses the efficacy of esomeprazole for preventing relapse in patients with healed oesophagitis. In this 6-month US multicentre randomized double-blind placebo-controlled trial, 375 Helicobacter pylori-negative patients with endoscopically healed oesophagitis received esomeprazole 40 mg, 20 mg, 10 mg, or placebo once daily. The primary efficacy end-point was maintenance of healing at 6 months. Secondary end-points assessed changes in symptoms, and long-term safety and tolerability. Significantly (P < 0.001) more patients remained healed with esomeprazole 40 mg (87.9%), 20 mg (78.7%), or 10 mg (54.2%), than with placebo (29.1%). Relapse, when it occurred, was later with esomeprazole. Sustained resolution of heartburn was observed in the 40 mg and 20 mg groups; there was a high correlation between absence of heartburn and maintenance of healing. Adverse effects were mild, infrequent and not significantly different between groups. Esomeprazole is effective and well-tolerated in the maintenance of healing of erosive oesophagitis. Esomeprazole 40 mg and 20 mg offer significant clinical benefit to patients.",2001.0,0,1
412,11421876,,,,,0,0
413,11421879,Cure of Helicobacter pylori infection in elderly patients: comparison of low versus high doses of clarithromycin in combination with amoxicillin and pantoprazole.,A Pilotto; M Franceschi; G Leandro; L Bozzola; M Rassu; G Soffiati; F Di Mario; G Valerio,"Advancing age may influence clarithromycin's pharmacokinetics. No studies have yet compared the effects of different dosages of clarithromycin in combination with a proton pump inhibitor and amoxicillin in elderly patients. To compare the efficacy and tolerability of clarithromycin 250 mg vs. clarithromycin 500 mg twice daily (b.d.) in combination with pantoprazole and amoxicillin in elderly patients. One hundred and fifty-four elderly patients with H. pylori-associated ulcer disease or chronic gastritis were consecutively randomized to receive pantoprazole 40 mg daily plus amoxicillin 1 g, and either clarithromycin 250 mg b.d. (PAC 250) or clarithromycin 500 mg b.d. (PAC 500). Two months after therapy, endoscopy and gastric biopsies were repeated. The cure rates of H. pylori infection in the PAC 250 and PAC 500 groups were, respectively, 83% and 79% (ITT analysis) and 94% and 88% (PP analysis) (P=N.S.). Significant decreases in chronic gastritis activity both in the body (P < 0.00001) and the antrum (P < 0.0001) of the stomach were found in H. pylori-cured patients, independently of clarithromycin dosage. Four patients in PAC 250 (5%) and seven in PAC 500 (9%) reported adverse events (P=N.S.). One patient in PAC 250 (25%) and three in PAC 500 (43%) discontinued the study because of these drug-related side-effects (P=N.S.). In elderly patients, 1-week triple therapy with a proton pump inhibitor, amoxicillin and clarithromycin is a highly effective and well tolerated anti-H. pylori treatment. With this combination, clarithromycin at the lower dose of 250 mg b.d. achieved excel- lent cure rates and minimized adverse events and costs.",2001.0,0,0
414,11421880,Is a one-week course of triple anti-Helicobacter pylori therapy sufficient to control active duodenal ulcer?,B Tepes; I Krizman; M Gorensek; M Gubina; I Orel,"Triple therapy currently forms the cornerstone of the treatment of patients with Helicobacter pylori-positive duodenal ulcer. To establish whether prolonged antisecretory therapy is necessary in patients with active duodenal ulcer. A total of 77 patients with H. pylori-positive duodenal ulcer were included in a prospective, controlled, double-blind study. All patients received a 7-day treatment with omeprazole 20 mg b.d., clarithromycin 500 mg b.d. and amoxicillin 1000 mg b.d. Patients in the omeprazole group underwent an additional 14-day therapy with omeprazole 20 mg; patients in placebo group received placebo. Endoscopy was performed upon inclusion in the study and after 3 and 8 weeks. Seventy-four patients were eligible for a per protocol analysis after 3 weeks, and 65 after 8 weeks. After 3 weeks, the healing rate was 89% in the omeprazole group and 81% in the placebo group (P=0.51). After 8 weeks, the ulcer healed in 97% of the patients in the total group (95% CI: 92.7-100%). H. pylori was eradicated in 88% of patients in the omeprazole group and in 91% in the placebo group (P=1.0). No statistically significant differences between the groups were found in ulcer-related symptoms or in ulcer healing. In patients with H. pylori-positive duodenal ulcer, a 7-day triple therapy alone is sufficient to control the disease.",2001.0,0,0
415,11421883,"Modified seven-day, quadruple therapy as a first line Helicobacter pylori treatment.",X Calvet; N Garcia; E Gené; R Campo; E Brullet; I Sanfeliu,"Cure rates of 7-day triple therapy seem to be decreasing. Quadruple therapies may be an alternative, although their complex administration makes patient acceptance difficult. To test the usefulness of a thrice a day, quadruple therapy to cure Helicobacter pylori infection. A total of 122 consecutive patients with peptic ulcer and Helicobacter pylori infection were treated with omeprazole 20 mg b.d., tetracycline chlorhydrate 500 mg t.d.s., metronidazole 500 mg t.d.s., and bismuth subcitrate 120 mg t.d.s. administered with meals for 7 days. Cure was tested by either endoscopy or breath test after 2 months, and by urea breath test 6 months after therapy. Seven patients were lost to follow-up. Of the remaining 115, 110 were cured at the first control, giving an intention-to-treat cure rate of 90.2% (95% CI: 83-95%) and a per protocol cure rate of 95.7% (95% CI: 90-98%). One hundred three patients returned for a 6-month breath test; all but one were cured. Side-effects were minimal or minor in 47 patients (40.8%) and moderate in four (3.4%). Compliance was good, 95% of patients taking more than 90% of the pills. Six (5%) patients stopped treatment after 1, 2, 4 (two patients) and 6 (two patients) days. Thrice a day quadruple therapy shows excellent cure rates, far above 90%, is well-tolerated and compliance is easy. Head-to-head comparison with triple therapies as first line Helicobacter pylori treatment seems warranted.",2001.0,0,0
416,11421884,What is the optimal length of proton pump inhibitor-based triple therapies for H. pylori? A cost-effectiveness analysis.,X Calvet; E Gené; T López; J P Gisbert,"Triple therapy with a proton pump inhibitor, clarithromycin and amoxicillin is widely used for H. pylori infection. The appropriate length of treatment remains controversial. To determine whether length of treatment has an impact on the cost-effectiveness of triple therapy. The study took the form of a cost-effectiveness analysis spanning 2 years. The perspective was societal and the setting, ambulatory care. Subjects were Helicobacter pylori-positive patients with a duodenal ulcer. The triple therapy trials spanned 7, 10 or 14 days and the main outcome measures were cost per patient and marginal cost for additional cured patient calculated for a low cost-of-care setting (Spain), for a high-cost setting (USA), and for two follow-up strategies: (i) systematic 13C-urea breath test after eradication; (ii) clinical follow-up, breath-test if symptoms recurred. Base-case analysis showed that for both the 13C-UBT and the clinical follow-up branches, lowest costs were obtained with 7-day schedules both in Spain and the USA. Sensitivity analysis showed that in Spain, 10-day therapies would have to increase 7-day cure rates by 10-12% to become cost-effective. In contrast, in the USA only a 3-5% increase was needed. The corresponding figures for 14-day therapy were 25-35% and 8-11%, respectively. Seven-day therapies seem the most cost-effective strategy. However, in high-cost areas the differences were less evident.",2001.0,0,1
417,11421886,Potential gastrointestinal effects of long-term acid suppression with proton pump inhibitors.,K Neal; R Logan,,2001.0,0,1
418,11422462,Helicobacter pylori and early duodenal ulcer status post-treatment: a review.,J M Meyer; N P Silliman; C A Dixon; N Y Siepman; J E Sugg; R J Hopkins,"Data submitted to the FDA were reviewed to analyze the relationship between Helicobacter pylori infection and the incidence of early duodenal ulcers, within 6 weeks, following treatment. Retrospective analyzes were performed on data from three H. pylori development programs submitted to the FDA: ranitidine-bismuth-citrate (RBC), lansoprazole (L) and omeprazole (O). Efficacy assessments for the RBC, L and O programs were made at end of a 4-week treatment period, 4-6 weeks following the end of a 14-day treatment period, and 4 weeks following the end of a 4-week treatment period, respectively. Overall, there was a 15%, 21% and 23% decrease in the number of patients in the RBC, L and O programs, respectively, with ulcers among H. pylori cleared/eradicated patients post-treatment compared with patients with persistent infection. Among patients who did not have cleared/eradicated H. pylori in the RBC and O programs, where antisecretory agents were continued beyond the antimicrobial treatment period, the number of ulcers was lower in the antisecretory plus antimicrobial subgroups compared with the antimicrobial alone subgroups (37% vs. 46% for RBC and 33% vs. 42% for O). Among patients with cleared/eradicated H. pylori, the number of patients with ulcers in the antimicrobial alone subgroups and antisecretory plus antimicrobial subgroups were similar within each program. Antimicrobials alone had significantly lower rates of ulcers among patients with cleared/eradicated H. pylori as compared with patients without clearance/eradication. The early incidence of duodenal ulcers is significantly decreased in patients with H. pylori clearance/eradication.",2001.0,0,0
419,11422471,Is eradication of Helicobacter pylori with colloidal bismuth subcitrate quadruple therapy safe?,R H Phillips; M W Whitehead; L A Doig; C E Sieniawska; H T Delves; R P Thompson; J J Powell,"When standard triple therapy fails to eradicate Helicobacter pylori, quadruple 'rescue' therapy is often used which, in Europe, generally comprises colloidal bismuth subcitrate (CBS) based triple therapy and a proton pump inhibitor. Since hypochlorhydria could greatly increase absorption of the toxic bismuth ion from CBS, we investigated the bismuth status of patients receiving anti-H. pylori quadruple therapy. In a prospective open label study 34 patients with nonulcer dyspepsia or peptic ulcer disease, who had failed to eradicate H. pylori with standard triple therapy, were subsequently treated with CBS, omeprazole, amoxycillin and metronidazole (BOAM). A further 35 patients received triple therapy for the eradication of H. pylori: CBS, amoxycillin and metronidazole (BAM) (n = 18); placebo bismuth, amoxycillin and metronidazole (AM) (n = 9); or omeprazole, amoxycillin and metronidazole (OAM) (n = 8). Whole blood bismuth levels were determined before and within 24 hours of completing treatment. Analysis of bismuth was by inductively coupled plasma mass spectrometry, and concentrations were compared between groups and with the Hillemand 'alarm level' for blood bismuth (50-100 microg/l). BOAM gave higher blood bismuth levels than BAM (difference in means 13.1, CI 6.0-20.2, p <.001); three (8.8%) patients taking BOAM had concentrations within the Hillemand alarm level at 54.2, 64.7 and 91.8 microg/l. OAM and AM did not alter baseline blood bismuth levels. Caution should be observed in prescribing CBS with gastric acid suppression, and alternative bismuth preparations should be considered.",2001.0,0,0
420,11423595,Quadruple therapy for symptomatic spontaneous duodenal ulcer disease.,M C Bateson,"To investigate Helicobacter pylori eradication in duodenal ulcer patients with a new regimen, lansoprazole 30 mg daily for one or four weeks plus twice daily tetracycline 500 mg, clarithromycin 250 mg, and metronidazole 400 mg. Spontaneous duodenal ulcer is regularly associated with H pylori, and permanent cure follows eradication of this bacterium. Numerous treatments have been proposed and none is ideal, possibly because of primary or acquired antibiotic resistance. Quadruple regimens with proton pump inhibitor therapy and three antibiotics offer promise as the most effective therapy. From November 1995 all patients with spontaneous duodenal ulcer were offered quadruple therapy. A month after completion a carbon 14 urea breath test (UBT) was performed. Sensitivity of H pylori to the antibiotics used was tested in 1992-3, 1996, and 1999. A total of 331 patients were treated; 313 attended for a UBT, of which 299 were negative (95.5%). Of those patients who had an endoscopy with positive urease test immediately before treatment, 95/101 (94.0%) on lansoprazole for one week and 116/121 (95.8%) on lansoprazole for four weeks had a negative UBT. H pylori antibiotic sensitivity did not change. This regimen produced some of the best results yet seen and may be generally recommended as first line therapy.",2001.0,0,0
421,11429668,Ranitidine bismuth citrate.,N Chiba; R H Hunt; A B Thomson,"Recognition of the relationship between Helicobacter pylori infection and the development of gastroduodenal disease has increased greatly in recent years. To avoid complications of H pylori infection, such as the development of recurrent duodenal and gastric ulcers, effective therapies are required for eradication of the infection. This article reviews ranitidine bismuth citrate (RBC), a novel complex of ranitidine, bismuth and citrate, which was developed specifically for the purpose of eradicating H pylori. Dual therapy with RBC in combination with clarithromycin for 14 days yields eradication rates of 76%. Triple therapy bid for one week with a proton pump inhibitor, clarithromycin and either amoxicillin or a nitroimidazole (tinidazole or metronidazole) is advocated as the treatment of choice for H pylori eradication. Analogous regimens with RBC in place of proton pump inhibitors show effective eradication rates in comparative studies and with pooled data. RBC, used alone or in combination with other antibiotics, appears to be a safe and effective drug for the treatment of H pylori infection. Bismuth levels do not appear to rise to toxic levels.",2001.0,0,0
422,11432296,Acid peptic disease in the elderly.,J D Linder; C M Wilcox,"GERD and peptic ulcer disease are important diseases in the elderly. GERD presents similarly in the elderly and the young, although elderly patients may have less severe symptoms yet more severe mucosal disease and a higher prevalence of BE. Although the prevalence of H. pylori is falling, the elderly remain at risk for peptic ulcer because of the widespread use of NSAIDS. The presentation of peptic ulcer disease in the elderly can be subtle and atypical when compared with younger patients, leading to a delay in diagnosis. Because of comorbidity in the aged, peptic ulcer disease and its complications result in increased morbidity and mortality rates.",2001.0,0,0
423,11434595,"The AMOR study: a randomized, double-blinded trial of omeprazole versus ranitidine together with amoxycillin and metronidazole for eradication of Helicobacter pylori.",C Ell; C Schoerner; W Solbach; M Stolte; M Vieth; W Ridl; W Moser; AMOR Study Group,"Besides antibiotics, additionally effective acid inhibition is necessary for the eradication of Helicobacter pylori. To assess the significance of acid suppression and, in particular, treatment with proton pump inhibitors (PPIs) compared with H2 receptor antagonists (H2 RAs). The primary target parameter for the study was H. pylori eradication. In addition, the ulcer healing rate, speed of pain reduction, score for gastritis in the antrum and gastric body, and rate of side effects were recorded. Randomized, double-blinded, multicentre study. A total of 456 patients between the ages of 18 and 80 years with H. pylori-positive duodenal ulcers were included in the study. Using a randomization list, patients were assigned either to a treatment group receiving omeprazole 40 mg once daily, amoxycillin 750 mg three times a day, and metronidazole 500 mg three times a day (OAM), or to a group receiving ranitidine 300 mg once daily, amoxycillin 750 mg three times a day, and metronidazole 500 mg three times a day (RAM). The treatment period was 7 days in both groups. Long-term acid-suppressant treatment was not given. The eradication rate was 87.1% (169/194, intention to treat [ITT]) in the OAM group and 77% (137/ 178, ITT) in the RAM group. The difference of 10.1% (95% CI 2.5-18%) is statistically significant (P= 0.0104). The ulcer healing rate was 93.3% in the OAM group (181/194, ITT) and 92.1% in the RAM group (164/178, ITT, NS). With regard to the speed and intensity of pain reduction, the OAM group was superior to the RAM group. In patients in whom H. pylori eradication was successful, the reduction in the antral and gastric body gastritis score was significantly greater than in patients without eradication. In the OAM group, 39.1% of the patients (n = 90) reported one or more side effects, compared with 44.7% (n = 101) in the RAM group (P= 1.5449, NS). Omeprazole (40 mg once daily in the morning) is significantly more effective than ranitidine (300 mg once daily in the morning) with respect to H. pylori eradication when used together with amoxycillin (750 mg three times a day) and metronidazole (500 mg three times a day) for a 7-day treatment period.",2002.0,0,1
424,11434608,Long-term management of gastro-eosophageal reflux disease with omeprazole or open antireflux surgery.,C J O'Boyle; D I Watson,,2002.0,0,0
425,11447983,Effect of intravenous omeprazole on recurrent bleeding after endoscopic treatment of bleeding peptic ulcers.,T J Savides; V Pratha,,2001.0,0,0
426,11448445,Pharyngeal pH measurements in patients with respiratory symptoms before and during proton pump inhibitor therapy.,T R Eubanks; P Omelanczuk; A Hillel; N Maronian; C E Pope; C A Pellegrini,"Pharyngeal pH monitoring is a diagnostic tool used to identify Gastroesophageal reflux disease (GERD) as an etiology of respiratory symptoms. We performed pharyngeal pH monitoring on 14 patients with respiratory symptoms thought to be induced by GERD. Symptoms and pH monitoring (esophageal and pharyngeal) were assessed prior to and 3 months after the initiation of double-dose proton pump inhibitor therapy. Symptoms included cough, hoarseness, and throat clearing. Ten patients had at least one episode of pharyngeal reflux (PR+) and 4 patients had no pharyngeal reflux (PR-). Pharyngeal reflux episodes in PR+ patients decreased from 3.5 to 0.9 (P <0.05) per day with 8 of 10 (80%) patients having elimination or reduction of such episodes. Eight of 9 PR+ patients (89%) with suppressed pharyngeal reflux on medical therapy had resolution of respiratory symptoms. Three of 4 PR- patients (75%) had persistent symptoms on medical therapy. Proton pump inhibitor therapy improves clinical symptoms and decreases pharyngeal reflux episodes in patients with respiratory symptoms related to GERD. Direct measurement of pharyngeal pH is helpful in the identification of patients likely to respond to antireflux therapy.",2001.0,0,0
427,11462887,Evaluation of an office-based urine test for detecting Helicobacter pylori: a Prospective Pilot Study.,D C Wu; C H Kuo; C Y Lu; Y C Su; F J Yu; Y C Lee; S R Lin; C S Liu; C M Jan; W M Wang,"To ascertain the reliability of a newly developed office-based urine test, the RAPIRUN test, used for detection of H. pylori infection. Urine specimens from 142 consecutive patients undergoing gastroendoscopy (77 men, 65 women; mean 52.0 years) were tested with RAPIRUN at the same time. The total reaction time for the urine test is 20 min. None of the patients had received any H. pylori eradicating treatment. The H. pylori status was evaluated based on 5 different tests: culture, histology, biopsy urease test, 13C-urea breath test, and the RAPIRUN test. A commercial office-based kit using an immunochromatographic technique was used to examine urine samples for H. pylori antibody. H. pylori status was defined as positive when the culture was positive or if 2 of the other 3 tests (histology, biopsy urease test, and 13C-urea breath test were positive. Of 93 patients with H. pylori infection, 88 were tested as positive by RAPIRUN (sensitivity 94.6%). Of 48 patients without infection, 43 were found to be negative by RAPIRUN (specificity 89.6%). One case with an invalid urine test was excluded. This urine test is a rapid, inexpensive, reliable and easy-to-use tool for the diagnosis of H. pylori infection in untreated patients. It can be used for mass screening of patients' H. pylori status, particularly in children, postgastrectomy patients, uncooperative patients, and patients undergoing bismuth or proton pump inhibitor treatment.",2002.0,0,0
428,11467624,Quality of life in patients with endoscopy-negative heartburn: reliability and sensitivity of disease-specific instruments.,N J Talley; S Fullerton; O Junghard; I Wiklund,"Endoscopy-negative gastroesophageal reflux disease (GERD) lacks objective markers of disease severity. Evaluation of therapies for GERD must therefore rely on subjective measures, including patient self-report questionnaires, to measure the clinical effectiveness of therapeutic interventions. We aimed to evaluate the previously validated Gastrointestinal Symptoms Rating Scale (GSRS) and the Quality of Life in Reflux and Dyspepsia (QOLRAD) questionnaires for reliability and responsiveness to change over time. Patients (n = 1143) with heartburn, but no esophagitis included in a randomized clinical trial assessing the effectiveness of active treatment with proton pump inhibitors over 4 wk were evaluated. The test-retest reliability of both questionnaires over time was good to excellent (GSRS 0.53-0.69; QOLRAD 0.65-0.76), as was the responsiveness estimated by standardized response means (GSRS reflux dimension, -1.43; QOLRAD 0.81-1.43) and effect sizes (GRSR reflux dimension, -1.74; QOLRAD 0.82-1.56). The relationship between improvement in the GSRS reflux dimension score and the amount of clinical benefit as estimated by the patients themselves (based on the Overall Treatment Evaluation) suggested a minimally clinical relevant change is 0.5 on the seven graded scales applied. The importance rating indicated that an important change in the GSRS reflux dimension and the QOLRAD dimensions is equivalent to 1.0, and a very important change to 1.5. The GSRS and QOLRAD are valid questionnaires that are reliable and sensitive to change. Both questionnaires should be suitable for use in clinical trials of therapeutic interventions for patients with heartburn.",2001.0,0,0
429,11471482,Cost-effectiveness of proton-pump inhibitors for maintenance therapy of erosive reflux esophagitis.,B B Dean; R M Siddique; B D Yamashita; A S Bhattacharjya; J J Ofman,"The relative cost-effectiveness of proton-pump inhibitors (PPIs) in the maintenance therapy of erosive reflux esophagitis was studied. Decision analysis was used to model the cost-effectiveness of PPIs on the basis of clinical trial results. Management decisions in the model were based on published U.S. guidelines and recommendations. Probability estimates were derived from a systematic review of the literature. The model's base-case scenario compared rabeprazole, lansoprazole, and omeprazole for the prevention of symptom recurrence over one year. Meta-analyzed estimates of efficacy were derived from trials by using a generalized logistic regression model with random effects. Medical costs for hospitalization, procedures, and office visits reflected 2000 Medicare payment; drug costs were based on 2000 average wholesale prices. Average costs per patient were comparable among the PPIs (rabeprazole, $1414; lansoprazole, $1671; and omeprazole, $1599). Rabeprazole prevented symptom recurrence in 86% of rabeprazole recipients, versus 68% for lansoprazole and 81% for omeprazole, and yielded the lowest average cost-effectiveness ratio (rabeprazole, $1637 per recurrence prevented; lansoprazole, $2439; and omeprazole, $1968). The model was robust to changes in key variables. When evaluated by decision analysis over a wide range of assumptions, rabeprazole was comparable to other PPIs in terms of cost and offered improved effectiveness for maintenance therapy of erosive reflux esophagitis.",2002.0,0,1
430,11471851,A randomized comparison of triple therapy Helicobacter pylori eradication regimens in children with peptic ulcers.,P L Shcherbakov; V A Filin; I A Volkov; P A Tatarinov; Y B Belousov,"An open, randomized trial was performed to compare the efficacy of three Helicobacter pylori eradication regimens in children with peptic ulcer disease. A total of 106 children (5 - 15 years) were treated for 1 week with metronidazole, 30 - 40 mg/kg per day depending on age, amoxycillin, 750 mg/day, and one of three anti-secretory agents: proprietary omeprazole, 20 - 40 mg/day depending on age; generic omeprazole, 20 - 40 mg/day; or ranitidine, 150 mg twice daily. The H. pylori eradication rate was significantly higher in patients receiving proprietary omeprazole (88.9%) than in those receiving generic omeprazole (80.0%) or ranitidine (74.3%), and this was associated with a trend towards faster ulcer healing. It is concluded that triple therapy consisting of an anti-secretory agent and two antimicrobials produces effective eradication of H. pylori and ulcer healing in children with peptic ulcer disease, and that proprietary omeprazole is more effective than both ranitidine and the generic formulation used in this study.",2002.0,0,0
431,11474311,"Relapse prevention in reflux oesophagitis with regard to Helicobacter pylori status: a double-blind, randomized, multicentre trial to compare the efficacy of pantoprazole versus ranitidine.",R J Adamek; J Behrendt; C Wenzel,"To compare prospectively the effectiveness of 1 year's treatment with pantoprazole versus ranitidine in order to prevent relapse after initial cure of reflux oesophagitis. For the first time the influence of the initial Helicobacter pylori status on therapeutic results was also taken into account. In order to cure reflux oesophagitis, 396 patients with Savary/Miller stage II or III reflux oesophagitis were treated with pantoprazole 40 mg once daily for 8 weeks. Those who were H. pylori positive (n = 140) were also given 1 week of eradication treatment with clarithromycin 2 x 250 mg daily, metronidazole 2 x 400 mg daily, and a further 40 mg pantoprazole daily. The 303 patients who were endoscopically cured after the 8-week period were randomized and treated with either pantoprazole 20 mg (n = 199) or ranitidine 150 mg (n = 104) daily in double-blind fashion. The primary objective was to assess the time to endoscopically proven recurrence of reflux oesophagitis. In the intention-to-treat (ITT) population, 66.3% (118/178) of the pantoprazole group and 34.0% (32/94) of the ranitidine group showed neither endoscopic nor clinical symptoms of relapse after the 1-year treatment period (P < 0.0001) (per-protocol populations: 70.3% [109/155] in the pantoprazole group and 39.4% [28/71] in the ranitidine group). In the pantoprazole group, the relapse rate in initially H. pylori-positive patients who underwent eradication was 30.9% (17/55) and in H. pylori-negative patients 29% (29/100). Long-term treatment with 20 mg pantoprazole daily to prevent relapse of reflux oesophagitis in H. pylori-negative patients is significantly more effective than 150 mg ranitidine daily. The initial H. pylori eradication treatment does not influence the outcome of the long-term treatment.",2001.0,1,1
432,11475467,"Pharmacokinetic studies with esomeprazole, the (S)-isomer of omeprazole.",T Andersson; M Hassan-Alin; G Hasselgren; K Röhss; L Weidolf,"This article reviews the pharmacokinetics of esomeprazole, the (S)-isomer of the proton pump inhibitor (PPI) omeprazole. Esomeprazole is the first single isomer PPI developed for the treatment of patients with acid-related diseases. In vitro experiments in human liver microsomes demonstrated that the formation of the hydroxy and 5-O-desmethyl metabolites of esomeprazole is via cytochrome P450 (CYP) 2C19, whereas that of the sulphone metabolite is via CYP3A4. The formation rate of the hydroxy metabolite from esomeprazole is lower than for (R)-omeprazole, but that of the 2 other metabolites is higher, demonstrating stereoselective metabolism. The sum of the intrinsic clearances of all 3 metabo- lites for esomeprazole was one-third of that for (R)-omeprazole, suggesting lower clearance of esomeprazole in vivo. In vivo investigations demonstrated that esomeprazole is chirally stable after administration. Esomeprazole is 97% bound to plasma proteins. In normal (extensive) metabolisers with regard to CYP2C19, esomeprazole is metabolised more slowly than omeprazole, resulting in a higher area under the concentration-time curve (AUC) after administration of the same dose. This is more pronounced after repeated administration rather than after a single dose. In poor metabolisers, the AUC is lower for esomeprazole than for omeprazole, contributing to less overall interindividual variability for esomeprazole than for omeprazole. In general, esomeprazole and omeprazole are subject to the same metabolic transformations. Almost complete recoveries were reported and the ratio between urinary and faecal excretion is about 4:1 for both compounds. The dose-dependent increase in AUC of esomeprazole with repeated administration results from a combination of decreased first-pass elimination and decreased systemic clearance. Patients with gastro-oesophageal reflux disease exhibit a pharmacokinetic pattern similar to that in healthy individuals, whereas elderly individuals exhibited a slightly lower metabolism rate. Patients with a severe deficit in their liver function had a lower rate of metabolism, as would be expected, whereas those with mild to moderate liver disease did not exhibit any alteration in the pharmacokinetics. The pharmacokinetics of esomeprazole in individuals with impaired renal function is unlikely to differ from that in healthy individuals. A slight sex difference in the pharmacokinetics of esomeprazole was demonstrated in that the AUC and peak plasma drug concentration were slightly, but not statistically significantly, higher in females than in males.",2002.0,0,0
433,11480494,Safety and efficacy of long term esomeprazole therapy in patients with healed erosive oesophagitis.,P N Maton; N B Vakil; J G Levine; C Hwang; W Skammer; P Lundborg; Esomeprazole Study Investigators,"To evaluate the safety and tolerability of long term treatment with esomeprazole in patients with healed erosive oesophagitis, and to describe its efficacy in the maintenance of healing. US multicentre, noncomparative, nonblind study. 807 patients with endoscopically confirmed healed erosive oesophagitis. Patients received esomeprazole 40 mg once daily for up to 12 months. Adverse events and clinical laboratory tests were assessed over the study period. Endoscopy was performed at the final visit of the antecedent healing trials and at months 6 and 12 of the current safety trial; gastric biopsies were obtained at the initial visit of the healing trials and at the end of the safety trial. 80.9% of patients completed 6 months of treatment; 76.6% completed 12 months of treatment. There were no serious drug-related adverse events. Diarrhoea, abdominal pain, flatulence, and headache were the only treatment-related adverse events reported by >3% of patients. Mean changes in laboratory measures were generally small and not clinically meaningful. Plasma gastrin levels increased, as expected, and reached a plateau after 3 months. No changes in gastric histological scores were noted in the majority of patients. Evaluation of gastric biopsies revealed an overall decline in chronic inflammation and atrophy. Intestinal metaplasia findings remained essentially unchanged. Life table estimates of maintenance of healing were 93.7% [95% confidence interval (CI) 92.0 to 95.5%] at 6 months and 89.4% (95% CI 87.0 to 91.7%) at 12 months. Daily treatment with esomeprazole 40 mg for up to 1 year in patients with healed erosive oesophagitis was generally well tolerated and effective. No safety concerns arose.",2002.0,0,1
434,11488106,Criteria used by general practitioners in prescribing prokinetic or antisecretory drugs in patients with functional dyspepsia.,J Monés; M Guilera; M Artés; J S López; T Guerrero; O Fillat; CAVIDAD Group,"To analyze the clinical factors considered by general practitioners for the prescription of prokinetic or antisecretory drugs in patients with functional dyspepsia (FD), and to assess therapeutic outcomes and factors predicting effectiveness. Multicentric, prospective and observational study. 1,021 patients with FD were included. One hundred and thirty-two (132) were excluded from the analysis because they were taking ASA or NSAID. Patients were classified according to their predominant symptoms as reflux, ulcer, dysmotility or non-specific. At the physician discretion, treatment with alkali drugs was prescribed to 38 patients, prokinetic drugs to 574, antisecretory drugs to 123 and a combined therapy to 154. One month later, patient self-perception of symptomatic improvement was evaluated in patients treated with prokinetic drugs and antisecretory drugs. 85% of the patients reported symptomatic improvement after one month of treatment. Patients with non-specific FD had lower improvement rates regardless of the drug used (prokinetic or antisecretory) (77%) compared to all the other types (p = 0.03). Prescription of prokinetics was associated to female gender (OR: 0.43; 95% CI: 0.28-0.66) and early satiety (OR: 2.5; 95% CI: 1.6-4.1). A longer symptomatic evolution (OR 0.92: 95% CI: 0.88-0.97) was the only independent predictive factor of a poor response to prokinetic drugs. Among patients with FD attended by general practitioners, female gender and early satiety symptom were associated to the prescription of prokinetic drugs. Early symptomatic effectiveness rates for prokinetic or antisecretory drugs alike were high (85%). Patients with non-specific dyspepsia or long symptomatic evolution showed less favorable symptomatic response to prokinetic drugs.",2002.0,0,0
435,11488657,Review Article: is Helicobacter pylori relevant in the management of reflux disease?,J Dent,"Data on the interaction of reflux disease and Helicobacter pylori infection are limited in scope and rigour, controversial and difficult to interpret. Despite this, a framework of understanding is emerging, which is consistent with known effects on gastric acid secretion. In patients with moderate to severe H. pylori-induced corpus gastritis, eradication can increase substantially impaired gastric acid secretion sufficiently to precipitate reflux disease in people with pre-existing sub-clinical defective gastro-oesophageal competence. By contrast, reflux disease in duodenal ulcer patients probably benefits from eradication of H. pylori. There appears to be no significant impact on reflux disease from eradication in healthy subjects or individuals whose primary problem is reflux disease. Helicobacter pylori-infected reflux disease patients respond slightly better to proton pump inhibitors. These agents cause a topographic alteration of gastritis from antrum to corpus, the clinical significance of which is controversial. Many practitioners misjudge the risks and benefits of the effects of H. pylori eradication on reflux disease. Regardless of patient diagnosis, the balance is in favour of H. pylori eradication. For those in whom reflux oesophagitis development is a defined possibility, oesophagitis is mild, easily treated and most unlikely to be associated with any major risk for development of oesophageal adenocarcinoma.",2001.0,0,0
436,11495074,High-dose proton-pump inhibitors as a diagnostic test of gastro-oesophageal reflux disease in endoscopic-negative patients.,P Juul-Hansen; A Rydning; C D Jacobsen; T Hansen,"To evaluate a high dose of a proton-pump inhibitor as a diagnostic test in endoscopy-negative patients presenting with symptoms indicating gastro-oesophageal reflux disease. 64 patients were studied in a prospective, randomized, double-blind study, using a cross-over design. After a run-in period with the diary registration of basic GORD symptoms and recording of the consumption of antacid tablets, the patients were given either 60 mg of lansoprazole once daily or placebo in randomized order. Symptoms were recorded, as well as antacid tablets taken in order to relieve pain. GORD was determined by 24-h oesophageal pH monitoring. The test was considered positive when consumption of antacid tablets was reduced > or = 75% compared to pretreatment. In the GORD group, 29 (85%) tested positive during active treatment compared to 3 (9%) when on placebo. Corresponding figures for the non-GORD patients were 50% and 27%, giving a test sensitivity and specificity of 85% and 73%, respectively. During active treatment, VAS scores for acid regurgitation, heartburn and over all were significantly lowered in GORD patients, compared to heartburn only in the non-GORD group. 60 mg lansoprazole once daily for 5 days is an easy to use method for diagnosing GORD in endoscopy-negative patients. Using 24-h oesophageal pH monitoring as the reference method, the sensitivity was relatively high, while the specificity was lower. Further studies are needed to determine how a PPI could be used as a diagnostic test in GORD.",2002.0,0,1
437,11500608,Does short-term treatment with proton pump inhibitors cause rebound aggravation of symptoms?,P G Farup; P H Juul-Hansen; A Rydning,"Rebound acid hypersecretion might occur after treatment with proton pump inhibitors. This study looks for a rebound aggravation of symptoms after short-term treatment with lansoprazole. Sixty-two patients (19 men and 43 women; mean age, 54 years; range, 32-77 years) with heartburn and regurgitation and normal upper endoscopy findings were studied in a randomized, double-blind, placebo-controlled trial with a crossover design. There were two 5-day treatment periods with lansoprazole 60 mg once daily or placebo in random order, separated by a 9-day washout period. Reflux, total, and antacid scores were calculated for each of the treatment periods. Higher scores during the placebo period in the group given lansoprazole first than in the group given placebo first indicated a rebound aggravation of symptoms. The mean symptom scores during the placebo period in the groups given lansoprazole first and placebo first were as follows: reflux score, 21.5 and 17.6, respectively (not significant); total score, 11.2 and 10.3, respectively (not significant); and antacid score, 8.2 and 7.2, respectively (not significant). There is no indication of a rebound aggravation of symptoms 12 to 14 days after a 5-day treatment with lansoprazole 60 mg once daily in patients with reflux symptoms.",2001.0,0,0
438,11507354,No clinical benefit of adding cisapride to pantoprazole for treatment of gastro-oesophageal reflux disease.,C J van Rensburg; K D Bardhan,"Although a proton pump inhibitor (PPI) and a prokinetic drug are often combined for the medical treatment of gastro-oesophageal reflux disease (GORD), there are few well-conducted clinical studies on the efficacy and tolerability of this therapy. This study investigates whether pantoprazole plus cisapride leads to an additional benefit in comparison to pantoprazole alone. Randomized double-blind prospective multicentre study conducted in patients of 33 hospitals in Ireland, South Africa and the UK. A total of 350 intention-to-treat (ITT) patients aged 18 years or older with GORD of grade II and III were included in the study. The per-protocol (PP) population comprised 152 patients in the pantoprazole group and 136 in the pantoprazole plus cisapride group. Patients received either pantoprazole 40 mg once daily or pantoprazole 40 mg once daily plus cisapride 20 mg twice daily. Treatment outcome was assessed after 4 and 8 weeks. The primary criterion was endoscopically confirmed healing after 4 weeks. Additionally, relief of leading symptoms was studied. The prior null hypothesis was no difference in healing rates between both treatment groups. After 4 weeks of treatment 81% and 82%, and after 8 weeks 89% and 90%, of PP patients treated with pantoprazole or pantoprazole plus cisapride were healed, respectively. Thus, equivalence of the two treatment strategies could be proven. Additionally, improvement of symptom relief showed no significant difference between the two regimens. In contrast to disease grade at baseline, Helicobacter pylori status did not influence the healing rates in our study. Both study medications were tolerated well. Addition of cisapride to pantoprazole provides no further benefit in the treatment of GORD.",2001.0,0,0
439,11507356,"Famotidine versus omeprazole, in combination with amoxycillin and tinidazole, for eradication of Helicobacter pylori infection.",C C Hsu; J J Chen; T H Hu; S N Lu; C S Changchien,"Eradication regimens combining two antibiotics with a proton pump inhibitor have been studied intensively. In contrast, only a few studies have focused on the possible role of H2-receptor antagonists in eradication therapy. The mechanism involved in the synergy between antibiotics and proton pump inhibitors is still controversial. To compare the results of two triple-therapy regimens, different only in the antisecretory drugs used, in patients with Helicobacter pylori infection, and to assess the impact of primary resistance to metronidazole on treatment outcome. A total of 120 patients with peptic ulcer and non-ulcer dyspepsia were randomly assigned to a 2-week course of either: famotidine 40 mg twice a day, amoxycillin 1 g twice a day and tinidazole 500 mg twice a day (FAT group; n = 60); or omeprazole 20 mg twice a day, amoxycillin 1 g twice a day and tinidazole 500 mg twice a day (OAT group; n = 60). Upper endoscopy was performed prior to treatment and at least 4 weeks after completion of treatment and discontinuation of the antisecretory therapy. H. pylori status was assessed by a biopsy urease test, histology and culture. In the intention-to-treat analysis, eradication of H. pylori was achieved in 48 of the 60 patients (80%; 95% confidence interval: 70-90%) in the FAT group, compared to 50 of the 60 patients (83.3%; 95% confidence interval: 74-93%) in the OAT group. In the per protocol analysis, eradication therapy was achieved in 48 out of 53 patients (90.6%; 95% confidence interval: 83-98%) treated with FAT and 50 out of 57 patients (87.7%; 95% confidence interval: 79-96%) treated with OAT (not significant). The primary metronidazole resistance was present in 28.8% of strains. Overall, per protocol eradication rates in strains resistant and susceptible to metronidazole were 83.3% and 91.3% respectively (P > 0.05). Two-week courses of either high-dose famotidine or omeprazole, both combined with amoxycillin and tinidazole, are equally effective for eradication of H. pylori infection. In a 2-week triple therapy, metronidazole resistance has no significant impact on eradication rates.",2001.0,0,1
440,11509155,What is the best treatment for patients with severe gastroesophageal reflux disease (GERD)?,E Henley; L Chang,,2001.0,0,0
441,11510387,Dyspepsia in primary care--to prescribe or to investigate?,S Ghosh; M Kinnear,,2001.0,0,0
442,11510389,A randomised controlled trial of four management strategies for dyspepsia: relationships between symptom subgroups and strategy outcome.,N T Lewin van den Broek; M E Numans; E Buskens; T J Verheij; N J de Wit; A J Smout,"The first step in the management of uncomplicated dyspepsia in primary care often consists of prescribing empirical therapy, but in certain cases prompt endoscopy might be preferred. Any decision is usually based on the patient's symptoms and the presumed underlying pathology that causes these symptoms. To assess the relationship between symptom subgroups and the effect of management strategies on primary care patients with dyspepsia. Randomised controlled trial. All patients presenting successively with a new episode of dyspepsia between January 1995 and November 1997. The results of four management strategies in dyspeptic primary care patients were compared and the value of subgrouping within this trial was estimated. Patients were allocated to one of either (a) empirical treatment in which therapy was based on the presented symptoms, or empirical treatment with (b) omeprazole or (c) cisapride regardless of the presented symptoms, or (d) prompt endoscopy followed by the appropriate treatment. Patients were retrospectively classified into the subgroups for each strategy using baseline data. The yield of each strategy was measured by counting the number of strategy failures in the first year. Of the 349 included patients, 326 were analysed. No statistically significant difference could be demonstrated between the strategies or between the symptom subgroups. However, patients in the reflux-like subgroup showed a trend towards a better outcome in all empirical strategies. Ulcer-like dyspepsia seemed to benefit from omeprazole. The non-specific subgroup seemed to benefit from cisapride but also had the highest proportion of strategy failure. Prompt endoscopy did not appear especially useful in any subgroup. Although this study has relatively low power, we conclude that the use of symptom subgroups seems to be a sensible approach when choosing empirical therapy in dyspepsia. Patients with reflux-like symptoms seem to have the best prognosis in the first year in every strategy.",2001.0,0,1
443,11510629,"Drug interaction studies with esomeprazole, the (S)-isomer of omeprazole.",T Andersson; M Hassan-Alin; G Hasselgren; K Röhss,"Esomeprazole, the (S)-isomer of omeprazole, is the first proton pump inhibitor (PPI) developed as a single isomer for the treatment of patients with acid related diseases. Because of the extensive use of PPIs, the documentation of the potential for drug interactions with esomeprazole is of great importance. Altered absorption or metabolism are 2 of the major mechanisms for drug-drug interactions. Since intragastric pH will increase with esomeprazole treatment, it can be hypothesised that the absorption of drugs with pH-sensitive absorption (e.g. digoxin and ketoconazole) may be affected. Esomeprazole does not seem to have any potential to interact with drugs that are metabolised by cytochrome P450 (CYP) 1 A2, 2A6, 2C9, 2D6 or 2E1. In drug interaction studies with diazepam, phenytoin and (R)-warfarin, it was shown that esomeprazole has the potential to interact with CYP2C19. The slightly altered metabolism of cisapride was also suggested to be the result of inhibition of a minor metabolic pathway for cisapride mediated by CYP2C19. Esomeprazole did not interact with the CYP3A4 substrates clarithromycin (2 studies) or quinidine. Since the slightly increased area under the concentration-time curve (AUC) of cisapride could be explained as an inhibition of CYP2C19, the data on these 3 CYP3A4 substrates indicate that esomeprazole does not have the potential to inhibit this enzyme. The minor effects reported for diazepam, phenytoin, (R)-warfarin, and cisapride are unlikely to be of clinical relevance. Clarithromycin interacts with the metabolism of esomeprazole resulting in a doubling of the AUC of esomeprazole. The increased plasma concentrations of esomeprazole are unlikely to have any safety implications. It can be concluded that the potential for drug-drug interactions with esomeprazole is low, and similar to that reported for omeprazole.",2002.0,0,0
444,11513166,Barrett's-related esophageal adenocarcinoma: is chemoprevention a potential option?,M B Fennerty; G Triadafilopoulos,"Review the rationale behind secondary prevention of Barrett's related esophageal adenocarcinoma and critically appraise the emerging literature regarding prevention of neoplasia in Barrett's esophagus with antisecretory and/or cyclo-oxygenase inhibition therapy. The existing English language literature regarding secondary cancer prevention in patients with Barrett's esophagus is reviewed and its potential clinical implications discussed. There is biologic plausibility to pursue ""chemoprevention"" trials with antisecretory and/or cyclo-oxygenase inhibition therapy in patients with Barrett's esophagus. Chemoprevention trials using potent antisecretory therapy coupled with cyclo-oxygenase 2 inhibition are warranted and may provide a means of decreasing the occurrence of cancer and cancer-related mortality in this disease.",2001.0,0,0
445,11519776,"Healing and relapse rates in gastroesophageal reflux disease treated with the newer proton-pump inhibitors lansoprazole, rabeprazole, and pantoprazole compared with omeprazole, ranitidine, and placebo: evidence from randomized clinical trials.",J J Caro; M Salas; A Ward,"The older proton pump inhibitor (PPI) omeprazole and the newer PPIs lansoprazole, rabeprazole, and pantoprazole are approved for the acute and maintenance treatment of gastroesophageal reflux disease (GERD). On the basis of the results of randomized clinical trials, this study sought to estimate healing and relapse rates in acute and maintenance treatment of GERD with the newer PPIs compared with omeprazole, the histamine2-receptor antagonist ranitidine (the most frequent non-PPI comparator in studies of PPIs), and placebo. A search of MEDLINE was conducted to identify randomized, controlled clinical trials that included a PPI in > or =1 treatment arm and assessed the healing of erosive esophagitis endoscopically. The primary outcome for studies of acute therapy was healing rate, and the primary outcome for studies of maintenance therapy was relapse rate. Fifty-three studies were identified, of which 38 involved acute therapy (12 excluded) and 15 maintenance therapy. None of the studies of pantoprazole met the inclusion criteria for maintenance therapy. The 8-week overall healing rate ratios in the comparison of newer PPIs with omeprazole 20 mg/d were as follows: lansoprazole 30 mg/d, 1.02 (95% CI, 0.98-1.06): rabeprazole 20 mg/d, 0.93 (95% CI, 0.87-1.00); and pantoprazole 40 mg/d, 0.98 (95% CI, 0.90-1.07). In the comparison of any PPI with ranitidine 300 mg/d, the ratios were as follows: lansoprazole, 1.62 (95% CI, 1.46-1.76); rabeprazole, 1.36 (95% CI, 1.20-1.54); pantoprazole, 1.60 (95% CI, 1.33-1.96); and omeprazole, 1.58 (95% CI, 1.41-1.78). Relapse rates over 1 year of treatment were similar between lansoprazole and rabeprazole. Compared with ranitidine, there were statistically significant differences in the rates of resolution of heartburn symptoms (P < 0.002), ulcer healing (P < 0.05), and relapse (P < 0.01). Similar results were seen in the comparison of PPIs with placebo in terms of rates of resolution of heartburn symptoms (P < 0.01), ulcer healing (P < 0.001), and relapse (P < 0.006). In this study, the newer PPIs were of similar efficacy to omeprazole in terms of heartburn control, healing rates, and relapse rates. All the PPIs were superior to ranitidine and placebo in healing erosive esophagitis and decreasing relapse rates.",2002.0,1,1
446,11549822,Helicobacter pylori: a debated factor in gastroesophageal reflux disease.,P Sharma,"The prevalence of Helicobacter pylori infection is steadily decreasing in developing countries, and this has been paralleled by an increasing incidence of gastroesophageal reflux disease (GERD) and adenocarcinomas of the esophagus and of the esophagogastric junction. The prevalence of H. pylori infection, which is on the decline in Europe and in the United States, is probably related to improvements in sanitary conditions and socioeconomic status. These epidemiological data do not support a role for H. pylori in the pathogenesis of GERD, but at the same time suggest a negative association with the rising incidence in esophageal diseases. While H. pylori infection clearly does not cause GERD, it may protect certain susceptible individuals from the development of GERD and its complications. There are conflicting reports that GERD can develop after H. pylori eradication and that proton pump inhibitors are less effective in suppressing intragastric acidity in H. pylori negative patients--reasons not to eradicate H. pylori in GERD patients. On the contrary, other data suggest an increase in the development of atrophic gastritis in GERD patients (H. pylori positive) on long-term proton pump inhibitor therapy - a reason to eradicate H. pylori. Preexisting lower esophageal sphincter dysfunction, susceptibility to GERD, unmasking of latent GERD, and patterns and severity of gastritis may be important factors contributing to the development of GERD rather than just the presence or absence of infection with H. pylori.",2001.0,0,0
447,11552904,Decreasing oesophageal acid exposure in patients with GERD: a comparison of rabeprazole and omeprazole.,J P Galmiche; F Zerbib; P Ducrottè; J Fournet; P Rampal; N Avasthy; T J Humphries,"Rabeprazole has been shown to be more potent and faster than other proton pump inhibitors in in vitro studies and highly effective in decreasing oesophageal acid exposure in patients with gastro-oesophageal reflux disease (GERD). This study was a multicentre, double-blind, placebo-controlled, randomized, parallel-group comparison of three active treatment regimens utilizing two different proton pump inhibitors, or placebo, administered over 7 days in patients with GERD. Eighty-two patients with symptomatic GERD were given placebo, rabeprazole 10 mg b.d., rabeprazole 20 mg o.m., or omeprazole 20 mg o.m. for 7 days. Twenty-four hour oesophageal pH monitoring was performed at baseline and repeated at the conclusion of the treatment period. At the end of study, the percentage time (mean +/- s.d.) with pH < 4 over a 24-h period was significantly decreased by the three active regimens but without significant difference between them (9.27 +/- 4.77; 2.53 +/- 4.27; 2.02 +/- 1.71 and 2.91 +/- 4.06 for placebo, rabeprazole 10 mg b.d., rabeprazole 20 mg o.m. and omeprazole 20 mg o.m., respectively). Acid exposure was normalized in 90% of patients treated with rabeprazole 10 mg b.d., 95% treated with rabeprazole 20 mg o.m., 78% treated with omeprazole 20 mg o.m., and only 9.5% of patients treated with placebo. Both rabeprazole and omeprazole were well-tolerated. Although rabeprazole 20 mg o.m. showed greater activity numerically, this study demonstrates that rabeprazole 10 mg b.d. and 20 mg o.m. are equivalent to omeprazole 20 mg o.m. in decreasing oesophageal acid exposure.",2001.0,0,1
448,11552905,Bedtime H2 blockers improve nocturnal gastric acid control in GERD patients on proton pump inhibitors.,S Xue; P O Katz; P Banerjee; R Tutuian; D O Castell,"Proton pump inhibitors taken twice daily before meals (proton pump inhibitor b.d. AC) effectively controls daytime gastric pH; however, nocturnal gastric acid breakthrough (NAB) occurs in more than 75% of patients. Adding an H2-blocker at bedtime decreases NAB in normal subjects. The efficacy of this regimen has not been evaluated in GERD patients. The aim of this study was to assess the effects of proton pump inhibitor b.d., both with and without bedtime H2-blocker on intragastric pH and the occurrence of NAB in GERD patients. Prolonged ambulatory pH studies in GERD patients were reviewed. Group A: 60 patients (mean age 53 years, male 30) taking either omeprazole 20 mg or lansoprazole 30 mg b.d. Group B: 45 patients (mean age 49 years, male 23) on proton pump inhibitor b.d. (omeprazole 20 mg or lansoprazole 30 mg) plus an H2-blocker at bedtime (ranitidine 300 mg, famotidine 40 mg or nizatidine 300 mg). Eleven patients were evaluated during treatment with both regimens (group C). The percentage time of nocturnal and daytime intragastric pH > 4 and per cent of patients with gastric NAB were analysed. In the patients with NAB, its duration and associated oesophageal acid exposure also were analysed. Median percentage time intragastric pH > 4 overnight was 51% in group A, compared to 96% in group B (P < 0.0001). Median percentage daytime pH > 4 was 73% in group A and 79.8% in group B (P=0.14). Median percentage time intragastric pH >p 4 overnight increased from 54.6% without H2RA to 96.5% after adding bedtime H2RA (P=0.0013) in group C patients. NAB occurred in 82% patients in group A and 40% in group B (P < 0.0001). The mean duration of oesophageal acid exposure during NAB was significantly shorter in group B (18 +/- 6 min) than in group A (42 +/- 9 min, P=0.04). Adding a bedtime H2-blocker to the treatment enhanced nocturnal gastric pH control and decreased NAB compared to the proton pump inhibitor b.d. regimen. A bedtime H2-blocker also decreased oesophageal acid exposure during NAB. Adding a bedtime H2-blocker to a proton pump inhibitor b.d. regimen should be considered in patients who require continued nocturnal gastric acid control whilst taking proton pump inhibitor b.d.",2001.0,0,0
449,11552908,"Influence of pantoprazole on oesophageal motility, and bile and acid reflux in patients with oesophagitis.",P Netzer; A Gut; R Brundler; C Gaia; F Halter; W Inauen,"Reflux of duodeno-gastric juice into the oesophagus appears to be involved in the pathogenesis of both reflux oesophagitis and oesophageal adenocarcinoma. Although proton pump inhibitors have been shown to decrease acid reflux and heal oesophagitis, their effect on biliary reflux and motility is less clear. To investigate whether pantoprazole also reduces bile reflux and whether this is paralleled by a change in oesophageal motility. Combined 24-h measurements of intraoesophageal bilirubin concentration, pH and pressure were performed in 18 symptomatic patients with endoscopically proven reflux oesophagitis before and on day 28 of treatment with pantoprazole, 40 mg/day, under standardized conditions. A reflux symptom score was determined initially and every 2 weeks thereafter. After 56 days on medication, a control endoscopy was performed. The symptom score and the acid and bile reflux improved significantly, whereas the motility parameters did not change during the study period. Helicobacter pylori-positive patients had a significantly higher bile reflux time (32.1 +/- 4.3%) than H. pylori-negative patients (16.3 +/- 3.1%) (P=0.009). The endoscopic healing rate was 89%. The cough symptoms disappeared in three of four patients. The proton pump inhibitor pantoprazole decreases both acid and bile reflux. The decrease of bile reflux cannot be explained by increased oesophageal clearance as oesophageal motility did not improve with therapy. Interestingly, H. pylori infection of the stomach was associated with higher levels of oesophageal bile reflux.",2001.0,0,0
450,11552911,Lansoprazole in children: pharmacokinetics and efficacy in reflux oesophagitis.,C Faure; L Michaud; E K Shaghaghi; M Popon; M Laurence; J F Mougenot; R Hankard; J Navarro; E Jacoz-Aigrain,"Data on the proton pump inhibitor lansoprazole in paediatric patients are limited. To investigate the pharmacokinetics, optimal dosage and efficacy of lansoprazole in paediatric patients. A 24-h gastric pH recording and a pharmacokinetic study were performed after 7 days of lansoprazole, 17 mg/m2, in 23 patients with reflux oesophagitis (median age, 3.5 years). Response was defined as pH > 3 for > 65% of the recording. The dosage was doubled in non-responders. Patients with no response on day 14 were excluded. Responders underwent endoscopy after 4 weeks on the response-inducing dosage; abnormal findings led to a repeat endoscopy after four additional weeks. Nine patients responded to 17 mg/m2 and six to 30.3 mg/m2. On day 7, time with pH > 3 was significantly correlated with the area under the plasma concentration-time curve (P=0.003). The area under the plasma concentration-time curve was significantly greater in the nine responders to 17 mg/m2 than in the 14 other patients. Pharmacokinetic parameters were similar in responders and non-responders to the higher dose. After 4 weeks, oesophagitis was healed in 80% of responders. Adverse events occurred in three patients and required treatment discontinuation in one. Lansoprazole is effective and safe in children. The optimal starting dosage is 30 mg/m2 or 1.4 mg/kg.",2001.0,0,0
451,11552922,Efficacy of triple therapy with rabeprazole for Helicobacter pylori infection and CYP2C19 genetic polymorphism.,K Hokari; T Sugiyama; M Kato; M Saito; T Miyagishima; M Kudo; K Nishikawa; J Ishizuka; Y Komatsu; T Mizushima; H Kagaya; S Hige; H Takeda; M Asaka,"Rabeprazole is a new, potent, proton pump inhibitor. The metabolism of rabeprazole is less dependent on CYP2C19 genetic polymorphism. A total of 102 Helicobacter pylori-positive patients with gastric ulcer were randomly allocated to three groups: rabeprazole 10 mg (RAC10), rabeprazole 20 mg (RAC20) or rabeprazole 40 mg (RAC40) plus amoxicillin 750 mg and clarithromycin 200 mg twice daily for 7 days. CYP2C19 genotype was determined by the polymerase chain reaction-restriction fragment length polymorphism method. All-patients-treated-based eradication rates in patients treated with RAC10, RAC20 and RAC40 were 83%, 77% and 90%, respectively, and per protocol-based eradication rates were 83%, 80% and 90%, respectively. The eradication rates in the three groups were not significantly different. There was also no significant difference between the all-patients-treated-based eradication rate in CYP2C19 extensive metabolizers and that in poor metabolizers (86% vs. 77%). Adverse events were 12% in extensive metabolizers and 23% in poor metabolizers, and the difference in these incidence rates was also not statistically significant. Triple therapy with 10 mg of rabeprazole combined with amoxicillin/clarithromycin is effective for Japanese patients with H. pylori infection, and the H. pylori eradication rate is not affected by CYP2C19 genetic polymorphism.",2001.0,0,0
452,11552923,Intragastric distribution of Helicobacter pylori during short-term omeprazole therapy: study using Carnoy's fixation and immunohistochemistry for detection of bacteria.,S Ishihara; T Okuyama; N Ishimura; M Ono; T Hashimoto; H Kazumori; T Kaji; H Sato; H Fujishiro; K Adachi; R Fukuda; Y Kinoshita,"There is controversy about the effect of acid-suppressive therapy on Helicobacter pylori density and the severity of histological gastritis in the corpus. To evaluate the precise distribution of H. pylori, both on the surface mucus cells and in the surface mucus gel layer, by using Carnoy's fixation and immunostaining for the detection of bacteria. A total of 19 peptic ulcer patients with H. pylori infection were studied. All patients received a 6-week course of treatment with omeprazole (20 mg/day). Before and after the therapy, H. pylori density in Carnoy-fixed tissue sections was examined immunohistochemically. The effect of omeprazole therapy on the severity of gastritis was also evaluated. H. pylori density and the grade of gastritis significantly decreased in the antrum after omeprazole therapy. In the corpus, however, there were no significant changes in H. pylori density or the severity of gastritis after omeprazole therapy. Carnoy's fixation and immunostaining was found to be useful for the detection of H. pylori in the surface mucus gel layer as well as on the surface mucus cells in biopsy tissue sections. By using this method, H. pylori density decreased in the antrum, but remained unchanged in the corpus after a 6-week course of omeprazole therapy.",2001.0,0,0
453,11559644,The cost of long term therapy for gastro-oesophageal reflux disease: a randomised trial comparing omeprazole and open antireflux surgery.,H E Myrvold; L Lundell; P Miettinen; S A Pedersen; B Liedman; J Hatlebakk; R Julkunen; K Levander; M Lamm; C Mattson; J Carlsson; N O Ståhlhammar; Nordic GORD Study Group,"To comprehensively assess the relative merits of medical and surgical therapy for gastro-oesophageal reflux disease (GORD), health economic aspects have to be incorporated. We have studied the direct and indirect costs of medical and surgical therapy within the framework of a prospective randomised multicentre trial. After initial treatment of reflux oesophagitis with omeprazole to control symptoms and to heal oesophagitis, 154 patients were randomised to continue treatment with omeprazole (20 or 40 mg daily) and 144 patients to have an open antireflux operation (ARS). In case of GORD relapse, patients allocated to omeprazole were offered ARS and those initially operated on had either a reoperation or were treated with omeprazole. The costs were assessed over five years from randomisation. Differences in cumulative direct medical costs per patient between the two therapeutic strategies diminished with time. However, five year direct medical costs per patient when given omeprazole were still significantly lower than for those having ARS in Denmark, Norway, and Sweden (differences were DKK 8703 (US$1475), NOK 32 992 (US$ 5155), and SEK 13 036 (US$ 1946), respectively). However, in Finland the reverse was true (the difference in favour of ARS amounted to FMK 7354 (US$ 1599)). When indirect costs (loss of production due to GORD related sick leave) were also included, the cost of surgical treatment increased substantially and exceeded the cost of medical treatment in all countries. The total costs of medical therapy for chronic GORD were lower than those of open ARS when prospectively assessed over a five year period, although significant differences in cost estimates were revealed between countries.",2001.0,0,0
454,11563995,"Pharmacokinetics and pharmacodynamics of esomeprazole, the S-isomer of omeprazole.",T Andersson; K Röhss; E Bredberg; M Hassan-Alin,"Esomeprazole, the S-isomer of omeprazole, is the first proton pump inhibitor developed as a single isomer for the treatment of acid-related diseases. To examine the pharmacokinetics and pharmacodynamics of esomeprazole. In a crossover study, 12 healthy males received 5, 10 or 20 mg of esomeprazole, or 20 mg of omeprazole, once daily over 5 days. The pharmacokinetics and effects on pentagastrin-stimulated peak acid output of esomeprazole and omeprazole were studied on days 1 and 5. The area under the curve (AUC) of both esomeprazole and omeprazole increased from day 1 to day 5. The correlation between acid inhibition and AUC for esomeprazole could be well described with a sigmoid Emax model. The mean inhibition values of the pentagastrin-stimulated peak acid output on day 1 for 5, 10 and 20 mg of esomeprazole were 15%, 29% and 46%, respectively; the corresponding day 5 values were 28%, 62% and 90%. The mean inhibition values of the pentagastrin-stimulated peak acid output for omeprazole were 35% (day 1) to 79% (day 5). The pharmacokinetics of esomeprazole are time and dose dependent. There was a good correlation between AUC and effect for esomeprazole. These data suggest an increased acid inhibitory effect of esomeprazole compared to omeprazole.",2002.0,0,0
455,11563998,Comparable clinical efficacy and tolerability of 20 mg pantoprazole and 20 mg omeprazole in patients with grade I reflux oesophagitis.,K D Bardhan; C Van Rensburg,"Several clinical trials have shown that pantoprazole (40 mg) and omeprazole (40 or 20 mg) have similar efficacy and safety in the treatment of grade II-IV reflux oesophagitis (Savary-Miller classification). To compare the efficacy and safety of once-daily doses of pantoprazole (20 mg) and omeprazole (20 mg) with respect to symptom relief and healing of patients with grade I reflux oesophagitis. Patients with endoscopically established grade I reflux oesophagitis (non-confluent, patchy red lesions with/without white fibrin coating) were enrolled into this randomized, open, parallel-group, multicentre study. A total of 328 patients (n=166 in the pantoprazole group, n=162 in the omeprazole group) were recruited in 23 centres. Patients received 4 weeks of treatment. If the reflux oesophagitis was not completely healed, the treatment was extended to 8 weeks. After 2 and 4 weeks of treatment with either pantoprazole or omeprazole, the rate of symptom relief was similar (70% vs. 79% and 77% vs. 84%, respectively). High healing rates were observed after 4 and 8 weeks (pantoprazole: 84% and 90%, respectively; omeprazole: 89% and 95%, respectively). Both treatments were well tolerated. The most frequently reported adverse events on pantoprazole and omeprazole, respectively, were nausea (8% vs. 7%), diarrhoea (5% vs. 6%) and headache (6% vs. 3%). After 4 and 8 weeks of treatment with pantoprazole (20 mg) or omeprazole (20 mg), patients with mild gastro-oesophageal reflux disease (grade I) showed comparably high rates of symptom relief and healing. Both treatments were safe and well tolerated.",2002.0,1,1
456,11566458,Omeprazole as adjuvant therapy to endoscopic combination injection sclerotherapy for treating bleeding peptic ulcer.,G Javid; I Masoodi; S A Zargar; B A Khan; G N Yatoo; A H Shah; G M Gulzar; J S Sodhi,"Therapeutic endoscopy has provided a new means of treating bleeding peptic ulcers. Additional medical therapy may enhance the therapeutic benefit. Hemostasis is highly pH dependent and is severely impaired at low pH. Proton pump inhibitors, by achieving a significantly higher inhibition of gastric acidity, may improve the therapeutic outcomes after endoscopic treatment of ulcers. We enrolled 166 patients with hemorrhage from duodenal, gastric, or stomal ulcers and signs of recent hemorrhage, as confirmed by endoscopy. Twenty-six patients had ulcers with an arterial spurt, 41 patients had active ooze, 37 had a visible vessel, and 62 patients had an adherent clot. All patients received endoscopic injection sclerotherapy using 1:10,000 adrenaline and 1% polidocanol and were randomly assigned to receive omeprazole (40 mg orally) every 12 hours for 5 days or an identical-looking placebo. The outcome measures used were recurrent bleeding, surgery, blood transfusion, and hospital stay. Six (7%) of 82 patients in the omeprazole group had recurrent bleeding, as compared with 18 (21%) in the placebo group (P = 0.02). Two patients in the omeprazole group and 7 patients in the placebo group needed surgery to control their bleeding (P = 0.17). One patient in the omeprazole group and 2 patients in the placebo group died (P = 0.98). Twenty-nine patients (35%) in the omeprazole group and 61 patients (73%) in the placebo group received blood transfusions (P <0.001). The average hospital stay was 4.6 +/- 1.1 days in the omeprazole group and 6.0 +/- 0.7 days in the placebo group (P <0.001). The addition of oral omeprazole to combination injection sclerotherapy decreases the rate of recurrent bleeding, reduces the need for surgery and transfusion, and shortens the hospital stay for patients with stigmata of recent hemorrhage.",2002.0,0,1
457,11573100,"Bismuth-based quadruple therapy with bismuth subcitrate, metronidazole, tetracycline and omeprazole in the eradication of Helicobacter pylori.",R Lahaie; A Farley; C Dallaire; A Archambault; C A Fallone; T Ponich; R Hunt; M Oravec; P Whitsitt; S V Van Zanten; N Marcon; R Bailey; A Dumont; B Nguyen; S Desrochers; J Spénard,"A previous study showed that 14 days of qid bismuth-based triple therapy with tetracycline 500 mg, metronidazole 250 mg and colloidal bismuth subcitrate 120 mg resulted in excellent Helicobacter pylori eradication rates (89.5%). The present study looked at a shorter treatment period by adding omeprazole and by reducing the dose of tetracycline. One hundred sixty-one patients with H pylori confirmed by histology and (13)carbon urea breath test were included in the study. They were treated for seven days with bismuth subcitrate 120 mg plus metronidazole 250 mg plus tetracycline 250 mg qid plus omeprazole 20 mg bid (OBMT). Patients were 18 to 75 years of age and had dyspepsia with or without a history of peptic ulcer. Patients with irritable bowel syndrome, active ulcer or previous attempt at eradication, or those who had used antibiotics or antiulcer drugs in the previous 30 days were excluded. Eradication was determined by two (13)carbon urea breath tests done one and three months, respectively, after treatment. Strains with minimal inhibitory concentrations of 8 microg/mL or higher were considered to be resistant to metronidazole. The overall per protocol eradication rate was 84%-89.5% in metronidazole-sensitive and 70.8% in metronidazole-resistant strains. Modified intent-to-treat analysis resulted in a 80% eradication rate--82.5% in metronidazole-sensitive and 66.7% in metronidazole-resistant strains. Only one patient discontinued treatment because of adverse events. The OBMT regimen used in this study is safe and effective against metronidazole-sensitive H pylori strains.",2002.0,0,0
458,11583061,Pharmacoeconomic issues of the treatment of gastroesophageal reflux disease.,M Storr; A Meining; H D Allescher,"Gastroesophageal reflux disease (GERD) is one of the most common diagnoses in a gastroenterologist's practice. Gastroesophageal reflux (GER) describes the retrograde movement of gastric contents through the lower oesophageal sphincter (LES) to the oesophagus. GER can occur physiologically and may be accompanied by symptoms. The introduction of endoscopes and ambulatory devices for continuous monitoring of oesophageal pH (24 h pH monitoring) has led to great improvement in the ability to diagnose reflux disease and reflux-associated complications. The development of pathological reflux and GERD can be attributed to many factors. Pathophysiology of GERD includes transient lower oesophageal sphincter relaxations (TLESRs), incompetent LES because of a decreased lower oesophageal sphincter pressure (LESP) and deficient or delayed oesophageal acid clearance. Uncomplicated GERD may be treated by modification of lifestyle and eating habits in an early stage of GERD. The various agents currently used for treatment of GERD include mucoprotective substances, antacids, H2-blockers, prokinetics and proton pump inhibitors (PPIs). Although these drugs are effective, they do not necessarily influence the underlying causes of the disease by improving the oesophageal clearance, increasing the LESP or reducing the frequency of TLESRs. The following article gives an overview regarding current concepts of the pathophysiology and pharmacological treatment of GERD stressing on pharmacoeconomic issues of the treatment and discusses the advantages and disadvantages for step-up and step-down therapy.",2001.0,0,0
459,11586996,[Changes in ultra rapid urease test and histopathological examination for Helicobacter pylori by antisecretory drugs].,L E Ferreira; G S Meirelles; R R Vieira; M A Bragagnolo Júnior; J M Chebli; A F de Souza,"One of the major problems when evaluating dyspeptic patients at public hospitals is the large interval between the consultation and the endoscopy, leading to the prescription of antisecretory drugs, what can be responsible for false results on examinations. To evaluate changes in ultrarapid urease test and histopathological examination for Helicobacter pylori by antisecretory drugs. In a prospective double-blind study, 50 patients with dyspeptic complaints and endoscopic diagnosis of peptic ulcer, erosive gastritis, esophagitis or duodenitis with a positive urease test, were randomized to a 7-day course of treatment with either omeprazole 20 mg or ranitidine 300 mg a day. Before and after treatment, two biopsy specimens each were obtained from the antrum and corpus and an ultrarapid urease test and a histopathological examination for Helicobacter pylori were performed. There were no significant changes in the results of ultrarapid urease test and histopathological examination for Helicobacter pylori after treatment with ranitidine. With omeprazole, we observed a decrease in positive results in ultrarapid urease test and histopathological examination for Helicobacter pylori in the antrum, but not in the corpus. Omeprazole, used for 7 days can lead to negative results in ultrarapid urease test and histopathological examination for Helicobacter pylori in the antrum, and should not be employed in patients before the endoscopy is performed.",2002.0,0,0
460,11588454,"Intravenous omeprazole in critically ill patients: a randomized, crossover study comparing 40 with 80 mg plus 8 mg/hour on intragastric pH.",P F Laterre; Y Horsmans,"To compare intravenous omeprazole 40-mg single dose with 8 mg/hr after an 80-mg bolus injection on 24-hr intragastric pH in intensive care unit (ICU) ventilated patients. Prospective, randomized crossover study. A 42-bed medicosurgical ICU in a university hospital Medicosurgical ventilated patients at risk of gastrointestinal bleeding. After baseline determination of intragastric pH, patients were randomly allocated to have a 40-mg iv omeprazole bolus injection (arm I) or 80 mg bolus, followed by 8 mg/hr continuous infusion for 24 hrs (arm II). After a 24-hr washout period, the opposite regimen was given in a crossover design. Intragastric pH was determined at regular intervals during the treatment period. In ten patients completing the protocol, the intragastric pH was similar for the two regimens for the first 12 hrs. The area under the pH curve was 5.51 +/- 0.48 for arm I compared with 6.02 +/- 0.33 for arm II (NS). Time to reach a pH of 4 or 6 was not significantly different for the two regimens. Time spent with a pH greater than 4 and 6 for the first 12 hrs was 10.11 +/- 1.14 and 8.31 +/- 1.16 hrs vs. 10.11 +/- 0.75 and 7.43 +/- 1.19 hrs for arm I and arm II, respectively (NS). When the first 24 hrs are considered, the area under the pH curve was 5.17 +/- 0.49 for arm I vs. 6.36 +/- 0.25 for arm II (p <.05). Time spent with a pH greater than 4 and 6 was 17.2 +/- 2.4 hrs and 12.63 +/- 2.22 vs. 23 +/- 0.41 and 19.48 +/- 1.63 in arm I and arm II, respectively (p <.05 and.01). An intragastric pH above 6 for all determinations was only observed in arm II. In critically ill patients, intravenous omeprazole 40 mg single dose is as effective as 8 mg/hr after an 80-mg bolus injection on mean intragastric pH, time spent with a pH greater than 4 and 6, but only for the first 12 hrs. If an intragastric pH greater than 6 has to be maintained for 24 hrs in all patients, an 80-mg bolus followed by 8 mg/hr iv omeprazole is to be given. Our data suggest that in several critically ill patients, a single 40-mg iv omeprazole bolus injection may be able to achieve stress ulcer prophylaxis and that 40 mg twice daily should be compared with 8 mg/hr after an 80-mg bolus injection in bleeding ulcers.",2001.0,0,0
461,11588538,"Medical, surgical, and endoscopic treatment of gastroesophageal reflux disease and Barrett's esophagus.",D O Castell,"Over the past decade, medical and surgical approaches to the patient with gastroesophageal reflux disease (GERD) have improved dramatically. Proton pump inhibitors have become the dominant medical therapy because of their high efficacy and safety. Laparoscopic surgical approaches have improved concomitantly with the advances in medical therapy, resulting in the perception that either continuous medical therapy or surgery are appropriate options for long-term maintenance of this chronic disorder. Recent approval of new endoscopic treatments for GERD has generated considerable interest, but acceptance of these techniques should be limited by the small number of patients studied to date, the lack of placebo controls, and the short duration of follow-up.",2002.0,0,0
462,11588545,Clinical and demographic predictors of Barrett's esophagus among patients with gastroesophageal reflux disease: a multivariable analysis in veterans.,M A Eloubeidi; D Provenzale,"The subgroup of patients with gastroesophageal reflux disease (GERD) that should undergo endoscopy to rule out Barrett's esophagus (BE) has not been well defined. To examine demographic and clinical variables predictive of BE before endoscopy. A validated GERD questionnaire was administered to 107 patients with biopsy-proven BE and to 104 patients with GERD but no BE shown by endoscopy. Frequent symptoms were defined as symptoms that occurred at least once or more each week. Severity of symptoms was rated on a scale from 1 to 4 (mild to very severe). Univariate analysis and multivariable logistic regression were performed to determine whether demographic characteristics and the duration, severity, and frequency of GERD symptoms were associated with the identification of BE. Eighty-five percent of the GERD patients and 82% of the BE patients completed the questionnaire. There was no difference between the groups in terms of race, gender, or proton pump inhibitor use. The BE patients were older (median age, 64 vs. 57 years, p = 0.04). In multivariable logistic regression, an age of more than 40 years ( p = 0.008), the presence of heartburn or acid regurgitation ( p = 0.03), and heartburn more than once a week ( p = 0.007) were all independent predictors of the presence of BE. Interestingly, patients with BE were less likely to report severe GERD symptoms ( p = 0.0008) and nocturnal symptoms ( p = 0.03). Duration of symptoms, race, alcohol, and smoking history were not associated with BE. Upper endoscopy should be performed in GERD patients more than 40 years of age who report heartburn once or more per week. The severity of symptoms and the presence of nocturnal symptoms are not reliable indicators of the presence of BE.",2002.0,0,0
463,11589723,Serum chromogranin A as a screening test for gastric enterochromaffin-like cell hyperplasia during acid-suppressive therapy.,S Sanduleanu; A De Bruïne; M Stridsberg; D Jonkers; I Biemond; W Hameeteman; G Lundqvist; R W Stockbrügger,"Serum chromogranin A (CgA), a marker of neuroendocrine neoplasia, increases during profound gastric acid inhibition, possibly reflecting the trophic effect of gastrin on the enterochromaffin-like (ECL) cells. This study investigated the clinical value of serum CgA as a screening test for gastric fundic enterochromaffin-like (ECL) cell hyperplasia during acid-suppressive therapy. A consecutive series of 230 dyspeptic patients referred for upper gastrointestinal endoscopy was investigated in a cross-sectional design. They were 154 patients on continuous medium-term (6 weeks to one year) or long-term (longer than one year) acid inhibition with either proton pump inhibitors (PPIs, n = 117) or histamine2-receptor antagonists (H2RAs, n = 37) for gastro-oesophageal reflux disease, and 76 nontreated subjects, with normal endoscopic findings (control group). Fasting blood samples were analysed for gastrin and CgA. Gastric biopsy specimens (oxyntic mucosa) were examined for histological evaluation of gastritis (Sydney classification) and of ECL cell hyperplasia (Solcia classification). Serum CgA levels correlated positively with serum gastrin, following a quadratic function (r = 0.78, P < 0.0001). Elevated serum CgA values during long-term acid inhibition correlated with the presence and severity of fundic ECL cell hyperplasia. Multivariate analysis identified hypergastrinaemia (P < 0.0001), duration of acid inhibition (P < 0.0001), H. pylori infection (P = 0.008), ECL cell hyperplasia (P = 0.012), and body gland atrophy (P = 0.043) as independent predictors of elevated serum CgA. In subjects on long-term acid inhibition (n = 123), serum CgA was equally sensitive but more specific than serum gastrin for the detection of ECL cell hyperplasia (sensitivity, 91.3% for both; specificity, 73% vs. 43%, P < 0.0001). During long-term gastric acid inhibition, serum CgA levels reflect the presence and severity of fundic ECL cell hyperplasia. Serum CgA is therefore a useful screening test for gastric ECL cell proliferative changes within this context.",2002.0,0,0
464,11596835,Cost effectiveness in Canada of a multidrug prepackaged regimen (Hp-PAC)+ for Helicobacter pylori eradication.,K Agro; G Blackhouse; R Goeree; A R Willan; J Q Huang; R H Hunt; B J O'Brien,"To assess the cost effectiveness of a multidrug prepackaged regimen for Helicobacter pylori, the Hp-PAC (lansoprazole 30mg, clarithromycin 500 mg, amoxicillin 1 g, all twice daily), relative to alternative pharmacological strategies in the management of confirmed duodenal ulcer over a 1-year period from 2 perspectives: (i) a strict healthcare payer perspective (Ontario Ministry of Health) excluding the patient copayment; and (ii) a healthcare payer perspective including the patient copayment. A decision-analytical model was developed to estimate expected per patient costs [1998 Canadian dollars ($ Can)], weeks without ulcer and symptomatic ulcer recurrences for the Hp-PAC compared with: proton pump inhibitor (PPI)-clarithromycin-amoxicillin (PPI-CA), PPI-clarithromycin-metronidazole (PPI-CM), PPI-amoxicillin-metronidazole (PPI-AM) and ranitidine-bismuthmetronidazole-tetracycline (RAN-BMT). All PPI-based regimens had higher expected costs but better outcomes relative to RAN-BMT. From a strict healthcare payer perspective, PPI-CM ($Can 209) yielded lower expected costs than PPI-CA ($Can 221) and slightly lower costs than Hp-PAC ($Can 211). However, these 3 regimens all shared identical outcomes (51.2 weeks without ulcer). When the current Ontario, Canada, $Can 2 patient copayment was added to the dispensing fee, Hp-PAC yielded lower costs ($Can 214) than PPI-CM ($Can 216). From a strict healthcare payer perspective, Hp-PAC is weakly dominated by PPI-CM with an incremental cost effectiveness (relative to RAN-BMT) of $Can 5.77 per ulcer week averted. When the patient copayment is added to this perspective, Hp-PAC weakly dominates PPI-CM ($Can 5 per ulcer week averted). Regardless of perspective, Hp-PAC and PPI-CM differed by only $Can 2 per patient over 1 year and the expected time without ulcer was 51.2 weeks for both. More data on the clinical and statistical differences in H. pylori eradication with Hp-PAC and PPI-CM would be useful. This analysis does not in clude the possible advantage of Hp-PAC in terms of compliance and antibacterial resistance.",2001.0,0,1
465,11599627,Efficacy of a nitroimidazole containing tripletherapy regime in Singapore.,K L Ling; W Luman; B Ho; H S Ng,"There has been a gradual increase in the proportion of Singapore patients with metronidazole resistant strains of Helicobacter pylori. We studied the efficacy of a nitroimidazole containing regime in eradicating H. pylori. Consecutive treatment naive patients with peptic ulcer disease and culture proven H. pylori were recruited. From each patient, two antral biopsies were taken for rapid urease test and two for histology. Two biopsies each from the gastric antrum and corpus were taken for H. pylori culture. Antibiotic sensitivity to amoxycillin, metronidazole, clarithromycin and tetracycline were tested using the disc diffusion method. Patients were treated with lansoprazole 30 mg bd, tinidazole 500 mg bd and clarithromycin 500 mg bd for seven days. Successful eradication was defined as either negative urea breath tests 4 and 12 weeks after treatment, or negative histology and culture at least four weeks after the end of treatment. A total of 64 patients were culture positive (51 males, 13 females). Forty-two patients had duodenal ulcers (DU), 17 gastric ulcers (GU), and 5 DU and GU. Metronidazole resistance was detected in 16 patients (25%). Three of the 16 patients (19%) had a mixed population of resistant and sensitive strains of H. pylori. None of the H. pylori isolates were resistant to amoxycillin, tetracycline or clarithromycin. Overall, eradication was achieved in 51/64 patients (80%). Eradication rate was 88% (42/48) among those with metronidazole sensitive strains, and 56% (9/16) among those with metronidazole resistant strains (p < 0.02). A high proportion of our patients with metronidazole resistant strains of H. pylori failed eradication therapy when a nitroimidazole containing regime was used. It may not be appropriate to use a nitroimidazole containing without prior knowledge of the antibiotic sensitivity pattern of the H. pylori isolate.",2001.0,0,0
466,11600458,Intravenous omeprazole after endoscopic treatment of bleeding peptic ulcers.,K R Palmer,,2002.0,0,0
467,11674925,,,,,0,0
468,11676331,Randomized trial of a quadruple-drug regimen and a triple-drug regimen for eradication of Helicobacter pylori: long-term follow-up study.,D Kumar; V Ahuja; A Dhar; M P Sharma,"In developing countries, H. pylori eradication rates are suboptimal. A quadruple-drug regimen may improve on the eradication rate achieved with triple-drug regimen. 64 consecutive patients with active duodenal ulcer associated with H. pylori infection were randomized to receive either a one-week triple-drug regimen (lansoprazole, clarithromycin, secnidazole) or a one-week quadruple-drug regimen (lansoprazole, amoxycillin, colloidal bismuth subcitrate, secnidazole). H. pylori eradication and ulcer healing were assessed 4 weeks after completion of therapy. Patients were followed up at 24 weeks and 52 weeks for H. pylori recurrence. Both the regimens eradicated H. pylori in 75% (95% CI 0.6-0.9) of patients. The ulcer-healing rate with the triple-drug regimen was 97% (95% CI 0.91-1.0) and 91% (95% CI 0.91-1.0) with the quadruple-drug regimen. No ulcer or H. pylori recurrence occurred in patients eradicated with the triple-drug regimen, whereas 8.3% of patients eradicated with the quadruple-drug regimen had ulcer as well as H. pylori recurrence during the 52-week follow up. Triple-drug regimen achieves similar eradication rates as quadruple-drug regimen in H. pylori infection.",2002.0,0,0
469,11677204,Helicobacter pylori eradication does not exacerbate reflux symptoms in gastroesophageal reflux disease.,P Moayyedi; C Bardhan; L Young; M F Dixon; L Brown; A T Axon,"Observational studies have suggested that Helicobacter pylori may protect against gastrointestinal reflux disease (GERD), but these results could be due to bias or confounding factors. We addressed this in a prospective, double blind, randomized, controlled trial. H. pylori-positive patients with at least a 1-year history of heartburn with a normal endoscopy or grade A esophagitis were recruited. Patients were randomized to 20 mg omeprazole, 250 mg clarithromycin, and 500 mg tinidazole twice a day for 1 week or 20 mg omeprazole twice a day and identical placebos. A second concurrently recruited control group of H. pylori-negative patients were given open label 20 mg omeprazole twice a day for 1 week. All patients received 20 mg omeprazole twice a day for the following 3 weeks and 20 mg omeprazole once daily for a further 4 weeks. Omeprazole was discontinued at 8 weeks and patients were followed up for a further 10 months. A relapse was defined as moderate or severe reflux symptoms. H. pylori eradication was determined by 13C-urea breath test. The H. pylori-positive cases were randomized to antibiotics (n = 93) or placebo (n = 97). Relapse of GERD occurred in 83% of each of the antibiotic, placebo, and H. pylori-negative groups during the 12-month study period. Life tables revealed no statistical difference between the 2 H. pylori-positive groups (log rank test, P = 0.84) or between the 3 groups (log rank test, P = 0.94) in the time to first relapse. Two patients in each group developed grade B esophagitis at 12 months. H. pylori eradication therapy does not seem to influence relapse rates in GERD patients.",2002.0,0,0
470,11683686,Systematic review of proton pump inhibitors for the acute treatment of reflux oesophagitis.,S J Edwards; T Lind; L Lundell,"Esomeprazole is a new proton pump inhibitor, which has been compared to omeprazole for the treatment of reflux oesophagitis in clinical trials. To compare the effectiveness of esomeprazole with the recommended dose of proton pump inhibitors in the healing of reflux oesophagitis, using omeprazole as a common comparator. Systematic review of randomized controlled trials. Extraction and re-analysis of data to provide 'intention-to-treat' results. Meta-analysis using a Fixed Effects model. A meta-analysis of healing rates of esomeprazole 40 mg compared to omeprazole 20 mg gave the following results: at 4 weeks (relative risk 1.14; 95% CI: 1.10, 1.18) and 8 weeks (RR 1.08; 95%CI: 1.05, 1.10). Other proton pump inhibitors compared to omeprazole 20 mg are as follows: lansoprazole 30 mg at 4 weeks (RR 1.02; 95%CI: 0.97, 1.08) and 8 weeks (RR 1.01; 95%CI: 0.97, 1.06); pantoprazole 40 mg at 4 weeks (RR 0.99; 95%CI: 0.91, 1.07) and 8 weeks (RR 0.98; 95%CI: 0.93, 1.04); rabeprazole 20 mg at 4 weeks (RR 1.00; 95%CI: 0.87, 1.14) and 8 weeks (RR 0.98; 95%CI: 0.91, 1.05). Esomeprazole has demonstrated higher healing rates than omeprazole at 4 and 8 weeks. Other proton pump inhibitors (lansoprazole, pantoprazole and rabeprazole) have not shown higher healing rates when compared with omeprazole.",2002.0,0,1
471,11683696,Long-term lansoprazole treatment for gastro-oesophageal reflux disease: clinical efficacy and influence on gastric mucosa.,K Geboes; W Dekker; C J Mulder; K Nusteling; Dutch Study Group,"Long-term acid suppression is believed to accelerate atrophic gastritis in Helicobacter pylori-positive patients. The influence of long-term therapy with lansoprazole has not been examined. To study the clinical and endoscopic efficacy and histological evolution of gastric mucosa during 5 years of maintenance treatment with lansoprazole, 30 mg. Seventy-eight patients with endoscopically proven oesophagitis were followed for 5 years. Biopsies taken at the start of the study, during follow-up and after 5 years were available for 73 patients. The total endoscopic relapse rate was 14.1%. At the start of the study, 34 patients were Helicobacter pylori negative and 39 were Helicobacter pylori positive (two atrophy, 25 antral gastritis, 12 pangastritis). At 5 years, no histological changes had occurred in Helicobacter pylori-negative patients. In the Helicobacter pylori-positive group, 20 patients developed pangastritis, six had normal histology and one had antral gastritis. Ten of the 12 patients with pangastritis had reduced antral activity. There was no increase in intestinal metaplasia, but there was a tendency towards regression of atrophy in the antrum and towards increased atrophy in the body of the stomach. Maintenance treatment with lansoprazole, 30 mg, is efficacious. The development of glandular atrophy and intestinal metaplasia was not accelerated in Helicobacter pylori-positive patients. Helicobacter pylori eradication must be considered only because of the higher cancer risk associated with chronic Helicobacter pylori-related gastritis.",2002.0,0,1
472,11683929,A pilot study to determine the effectiveness of garlic oil capsules in the treatment of dyspeptic patients with Helicobacter pylori.,C A McNulty; M P Wilson; W Havinga; B Johnston; E A O'Gara; D J Maslin,"Resistance of Helicobacter pylori to clarithromycin and metronidazole is now found worldwide. Steam-distilled garlic oil has in vitro activity against H. pylori and may be a useful alternative treatment strategy. In this pilot study dyspeptic patients with positive serology for H. pylori confirmed by 13C urea breath test (UBT), at 0 and 2 weeks, were enrolled. Treatment consisted of one 4 mg garlic oil capsule with a meal four times per day for 14 days. H. pylori eradication was defined as a negative UBT at both follow-up appointments. Suppression was defined as a 50% fall in 13C excess between baseline and follow-up 1. Five patients completed the study. There was no evidence of either eradication or suppression of H. pylori or symptom improvement whilst taking garlic oil. These negative results show that, within the gastric milieu, garlic oil at this dose does not inhibit H. pylori. A higher dose administered for a longer time-period may be effective. Antibiotics are usually combined with a proton-pump inhibitor or bismuth salt, as the only antibiotic with any in vivo activity against H. pylori in monotherapy is clarithromycin. A proton pump inhibitor raises gastric pH and, by increasing bacterial division, may increase the in vivo activity of garlic oil. This may be worth pursuing in a future trial.",2002.0,0,0
473,11683930,"A multicenter, double-blind study on triple therapy with lansoprazole, amoxicillin and clarithromycin for eradication of Helicobacter pylori in Japanese peptic ulcer patients.",M Asaka; T Sugiyama; M Kato; K Satoh; H Kuwayama; Y Fukuda; T Fujioka; T Takemoto; K Kimura; T Shimoyama; K Shimizu; S Kobayashi,"Two triple therapies with lansoprazole (LPZ)/amoxicillin (AMPC)/clarithromycin (CAM) for eradication of Helicobacter pylori were studied in multicenter, double-blind fashion to evaluate the eradication rate of H. pylori and safety of eradiation treatment in Japanese patients with H. pylori-positive active gastric ulcers or duodenal ulcers. Patients were randomly chosen for the control treatment of LPZ 30 mg twice a day (b.i.d.; Group A-LPZ-only) or the test treatments of LPZ 30 mg plus AMPC 750 mg and CAM 200 mg b.i.d. (Group B-LAC200) and LPZ 30 mg, AMPC 750 mg and CAM 400 mg b.i.d. (Group C-LAC400). All eradication treatments lasted for a period of 7 days. Successful eradication was assessed by culture and gastric histology 1 month after completion of the ulcer treatment. The eradication rates of H. pylori in the full analysis set were 0% in Group A-LPZ-only, 87.5% in Group B-LAC200 and 89.2% in Group C-LAC400 for gastric ulcer and, 4.4% in Group A-LPZ-only, 91.1% in Group B-LAC200 and 83.7% in Group C-LAC400 for duodenal ulcer. The eradication rates of Group B-LAC200 and Group C-LAC400 were 89.2% (95% CI: 84.8-93.7%) and 86.4% (95%CI: 81.5-91.3%) in total in the full analysis set, 89% (95% CI: 84.3-93.7%) and 85.3% (95%CI: 80.1-90.5%) in the per protocol set. The eradication rates in Groups B-LAC200 and group C-LAC400 were statistically significantly higher than the rate in Group A-LPZ-only for both gastric ulcer and duodenal ulcer patients (p <.0001 for both). A satisfactorily high H. pylori eradication rate was obtained in Japanese ulcer patients with the triple therapy regimen consisting of LPZ 30 mg, AMPC 750 mg, and CAM 200 mg b.i.d.",2002.0,0,0
474,11692055,Helicobacter pylori eradication therapy is more effective in peptic ulcer than in non-ulcer dyspepsia.,J P Gisbert; S Marcos; J L Gisbert; J M Pajares,"To evaluate whether eradication therapy is more effective in peptic ulcer disease (PUD) than in non-ulcer dyspepsia (NUD). We retrospectively studied 481 patients with NUD (183 patients) or PUD (298 patients) infected with Helicobacter pylori included in several prospective clinical trials. Three eradication regimens were given: (1) proton pump inhibitor (PPI) plus clarithromycin, plus either amoxycillin or metronidazole for 7 days (297 patients); (2) ranitidine bismuth citrate (RBC) plus clarithromycin plus amoxycillin for 7 days (79 patients); and (3) RBC plus clarithromycin plus amoxycillin plus metronidazole for 5 days (105 patients). H. pylori eradication was defined as a negative 13C-urea breath test 4 weeks after completing treatment. H. pylori eradication rates were 82% (95% CI 78-87%) with PPI plus two antibiotics for 7 days, 85% (95% CI 75-91%) with RBC plus two antibiotics for 7 days, and 91% (95% CI 86-97%) with RBC plus three antibiotics for 5 days (P < 0.05 compared with the first regimen). Overall, the H. pylori eradication rate in patients with NUD was 78% (95% CI 71-84%), while in patients with PUD it was 89% (95% CI 86-93%) (P < 0.001). Both the combination of PPI plus two antibiotics for 7 days and the combination of RBC plus three antibiotics for 5 days were more effective in PUD than in NUD patients. However, RBC plus clarithromycin plus amoxycillin for 7 days was equally effective in both diseases. RBC plus two antibiotics for 7 days achieved better results than the same therapy with PPI only in NUD patients (84% v. 59%, P < 0.01), but both regimens were similar when prescribed in PUD patients (86% v. 88%). In the multivariate analysis, the type of therapy, the diagnosis (NUD v. PUD), and the product variable of therapy (with RBC plus 2 antibiotics for 7 days) and diagnosis (interaction variable) were the only variables that influenced H. pylori eradication. The odds ratio (OR) for the effect of RBC versus PPI plus two antibiotics for 7 days in patients with NUD was 4 (95% CI 1.7-9.7; P < 0.01), whereas in patients with PUD no statistical significance was achieved (OR 0.79; 95% CI 0.2-3.9). Overall, H. pylori eradication therapy is more effective in PUD than in NUD patients. This advantage of eradication therapies in PUD patients seems to be observed with 7-day PPI-based triple regimens, and with 5-day RBC-based quadruple therapy, while the 7-day RBC-based triple regimen seems to be equally effective in both diseases.",2002.0,0,0
475,11693321,Quantitative assessment of gastric corpus atrophy in subjects using omeprazole: a randomized follow-up study.,N C van Grieken; G A Meijer; M M Weiss; E Bloemena; J Lindeman; J P Baak; S G Meuwissen; E J Kuipers,"Atrophy of the gastric mucosa most frequently results from chronic Helicobacter pylori infection and is a risk factor for the development of gastric cancer. Profound acid suppression has been suggested to accelerate the onset of gastric mucosal atrophy. The aim of the present study was to evaluate the effects of H. pylori eradication and acid inhibition by omeprazole on gastric atrophy by means of quantitative analysis of tissue morphology. Corpus biopsy specimens were obtained during endoscopy in 71 gastroesophageal reflux disease (GERD) patients at baseline and after 3 and 12 months. A total of 48 subjects were H. pylori positive and 23 were H. pylori negative. All subjects received omeprazole 40 mg once daily after the first endoscopy for 12 months. After randomization, 27 of the 48 H. pylori-positive patients also received eradication therapy. In hematoxylin and eosin-stained slides the volume percentages of glands (VPGL), volume percentages of stroma (VPS), and volume percentages of infiltrate (VPI) were measured in the glandular zone of the mucosa. The results were evaluated by computerized morphometric analysis. In the eradication group, the mean VPGL increased from 63.0% to 67.7% and 71.5% after 3 and 12 months (p < 0.001), respectively. The mean VPS and VPI decreased from 33.1% and 4.0% to 29.3% and 3.0% and to 26.4% and 2.1% (p < 0.001 and p = 0.04), respectively. Patients with the lowest VPGL at baseline showed the largest increases of VPGL after eradication treatment as compared to patients with high a VPGL at baseline. In the H. pylori-persistent group the VPI showed a significant increase (p = 0.01), and in the H. pylori-negative group VPGL increased significantly from 71.9% to 75.2% (p = 0.03) after 12 months. Eradication of H. pylori leads to restitution of the volume percentage of glandular epithelium to normal levels, even during treatment with proton pump inhibitors. Whether this effect can also be seen in patients with marked atrophy needs further investigation.",2002.0,0,0
476,11695354,"Symptom relief in gastroesophageal reflux disease: a randomized, controlled comparison of pantoprazole and nizatidine in a mixed patient population with erosive esophagitis or endoscopy-negative reflux disease.",D Armstrong; P Paré; D Pericak; M Pyzyk; Canadian Pantoprazole GERD Study Group,"Gastroesophageal reflux disease (GERD) in primary care practice presents symptomatically, and resources to distinguish promptly between erosive esophagitis and endoscopy-negative reflux disease (ENRD) are limited. It is therefore important to determine the roles of proton pump inhibitors and histamine-2-receptor antagonists for first-line symptom-based therapy in patients with erosive esophagitis and ENRD. The aim of this study was to compare pantoprazole 40 mg once daily versus nizatidine 150 mg b.i.d. in a mixed GERD patient population with ENRD or erosive esophagitis (Savary-Miller grades 1-3). A 4-wk randomized, double-blind, parallel-group, multicenter study conducted in Canada. Eligible patients had experienced GERD symptoms > or = 4 times weekly for > 6 months. Patients were randomized to pantoprazole 40 mg once daily or nizatidine 150 mg b.i.d.. Endoscopy was performed before randomization and after 4 wk of therapy. Of 220 patients randomized to therapy, 208 were available for a modified intent-to-treat analysis. Erosive esophagitis was present in 125 patients; 35 patients were Helicobacter pylori positive. There was complete symptom relief after 7 days of therapy in 14% of patients on nizatidine and in 40% of those on pantoprazole (p < 0.0001), and after 28 days of treatment in 36% and 63% of patients, respectively (p < 0.0001). After 28 days of treatment, adequate heartburn control was reported by 58% of the nizatidine group and in 88% of the pantoprazole (p < 0.0001); erosive esophagitis healing rates were 44% for nizatidine and 79% for pantoprazole (p < 0.001). Rescue antacid was needed by a greater number of patients using nizatidine than of those using pantoprazole (p < 0.001). H. pylori infection was associated with an increased probability of erosive esophagitis healing. Pantoprazole once daily was superior to nizatidine b.i.d. in producing complete heartburn relief in a mixed population of GERD patients and in achieving erosion healing. The proportions of patients with complete symptom relief were greater with pantoprazole after 7 days of therapy than with nizatidine after 28 days. The present study data suggest that pantoprazole is a highly effective first-line therapy for the management of gastroesophageal reflux disease in a primary care practice setting.",2002.0,1,1
477,11721321,[Diagnosis and treatment of Helicobacter pylori infection. Its relationship with gastrointestinal ulcer and antimicrobial resistance].,P Antelo; M Almuzara; A Avagnina; J Topor; C Barberis; T Barcia; G Araujo; C Vay; A Famiglietti,"Reliable data regarding the efficacy of different schemes of triple therapy for the eradication of Helicobacter pylori in our country, are not available. Patients with Helicobacter pylori infection and non-ulcer dyspepsia or active peptic ulcer disease were randomized in three different groups for therapy with, omeprazole 20 mg, clarithromycin 500 mg and amoxicillin 1000 mg, twice daily for one week (OCA 1, 40 patients) and the same treatment but for two weeks in a second group (OCA 2, 40 patients). The third group received omeprazole 20 mg, clarithromycin 500 mg and metronidazole 500 mg twice daily during one week (OCM, 40 patients). The primary efficacy end point was the eradication of Helicobacter pylori as confirmed by negative urea breath test, 4 weeks after the completion of treatment. Of 120 patients enrolled in the study, 113 met the entry criteria. Of them, 103 completed the treatment. When analyzed by intention to treat, after 4 weeks of finishing the treatment, Helicobacter pylori was eradicated in 92.3% of patients in OCA 1, 89.7% in OCA 2, and 82.8% in OCM. There was no significant difference between the three groups, regarding the eradication efficacy. Side effects were observed more frequently in OCA 2 and OCM groups. Primary resistance to amoxicillin and clarithromycin was not demonstrated, while 20% of cultured strains were resistant to metronidazole. In patients with peptic ulcer disease or non-ulcer dysplasia, triple therapy with omeprazole and two antibiotics is highly effective in the eradication of Helicobacter pylori. One week of OCA therapy is as effective as two weeks of OCA or one week of OCM, with less side effects.",2002.0,0,0
478,11721754,"Comparing lansoprazole and omeprazole in onset of heartburn relief: results of a randomized, controlled trial in erosive esophagitis patients.",J E Richter; P J Kahrilas; S J Sontag; T O Kovacs; B Huang; J L Pencyla,"This randomized, double-blind, multicenter study was conducted to confirm a previous finding that lansoprazole relieves heartburn faster than omeprazole in patients with erosive esophagitis. A total of 3510 patients with erosive esophagitis and at least one episode of moderate to very severe daytime and/or nighttime heartburn during the 3 days immediately before the screening visit were randomized to lansoprazole 30 mg once daily or omeprazole 20 mg once daily for 8 wk. Patients recorded the presence and severity of daytime and nighttime heartburn in daily diaries. On treatment days 1-4, patients were telephoned to confirm the completion of their daily diary. The primary efficacy parameters were the percentage of heartburn-free days and heartburn-free nights, as well as the average severity of daytime and nighttime heartburn. During treatment day I and all evaluation time points including the entire 8-wk treatment period, significantly (p < 0.05) higher percentages of patients treated with lansoprazole than those treated with omeprazole did not experience a single episode of heartburn. Onset of heartburn relief was more rapid in lansoprazole-treated versus omeprazole-treated patients: on day 1, 33% versus 25% of lansoprazole- versus omeprazole-treated patients were heartburn-free. The percentages of heartburn-free days and heartburn-free nights were also significantly (p < 0.01) greater for patients treated with lansoprazole at all evaluation time points. Heartburn severity was significantly less among those treated with lansoprazole compared with omeprazole. Both treatments were safe and well tolerated. Over 8 wk, lansoprazole 30 mg once daily relieved heartburn symptoms faster and more effectively than omeprazole 20 mg once daily in patients with erosive esophagitis.",2002.0,0,0
479,11726849,Pseudomembranous esophagitis.,A K Nayyar; C Royston; D N Slater; K D Bardhan,"Little is known of pseudomembranous esophagitis, a condition of striking endoscopic appearance. Presented here is a description of its nature and outcome. Information on all patients with upper GI disease seen in our unit are held in a computerized database that includes presentation, diagnosis (including pseudomembranous esophagitis), treatment, and outcome. Forty-eight patients (mean age 70 years) with pseudomembranous esophagitis were seen over 15 years; 42 were in-patients with various illnesses. At endoscopy, a thin, concentric membrane and/or thick slough covered the distal half and occasionally the entire esophagus. This layer, yellow or blackened, could be peeled away to reveal underlying friable esophageal submucosa. The membrane was composed of fibrinous exudate and inflammatory cells; there was no basement membrane, hence the term pseudomembrane. Patients were treated with histamine H2 receptor antagonists or proton pump inhibitors for about 3 months and followed by endoscopy or clinical observation. All became asymptomatic; the pseudomembrane had disappeared in 32 who underwent follow-up endoscopy. It recurred in 3 of 38 being followed (mean 3.2 years), again associated with another illness requiring hospitalization. The long-term outcome was poor, determined by age and general condition and independent of pseudomembranous esophagitis. Seven patients died within 3 months and 17 during follow-up (mean 42 months, range 5-140 months). Pseudomembranous esophagitis is an unusual condition of unknown cause, probably under-reported and associated with systemic illness. It heals rapidly and recurrence is uncommon.",2002.0,0,0
480,11742194,One week of treatment with esomeprazole-based triple therapy eradicates Helicobacter pylori and heals patients with duodenal ulcer disease.,Z Tulassay; A Kryszewski; P Dite; D Kleczkowski; J Rudzinski; Z Bartuzi; G Hasselgren; A Larkö; M Wrangstadh,"Proton pump inhibitor (PPI) monotherapy is commonly continued for 3 weeks after Helicobacter pylori eradication with PPI-based triple therapy regimens to ensure duodenal ulcer (DU) healing. This randomized, double-blind, multicentre study evaluated whether only 1 week of triple therapy with the new PPI esomeprazole was sufficient to ensure high rates of ulcer healing and H. pylori eradication. A total of 446 H. pylori-positive patients with active DU received twice daily treatment with esomeprazole 20 mg (n = 222) or omeprazole 20 mg (n = 224) in combination with amoxicillin 1 g and clarithromycin 500 mg for 1 week (EAC and OAC, respectively). Patients in the OAC group then received 3 weeks' monotherapy with omeprazole 20 mg once daily; those treated with EAC received placebo. Ulcer healing was assessed by endoscopy on completion of therapy and H. pylori status was assessed by (13)C-urea breath testing and histology 4-6 weeks later. Ulcer healing rates (95% CI) for intention-to-treat and per-protocol populations were: EAC + placebo 91% (87-95%) and 94% (90-97%); OAC + omeprazole 92% (88-95%) and 96% (92-98%). Corresponding H. pylori eradication rates were: EAC + placebo 86% (81-90%) and 89% (84-93%); OAC + omeprazole 88% (83-92%) and 90% (85-93%). Both eradication regimens were well tolerated, and patient compliance was high. A 1-week regimen of esomeprazole-based triple therapy is sufficient for DU healing and H. pylori eradication in patients with DU disease.",2002.0,0,0
481,11761013,Comparison of diagnostic methods for Helicobacter pylori infection in patients with upper gastrointestinal bleeding.,P Griñó; S Pascual; J Such; J A Casellas; M Niveiro; M Andreu; J Sáez; E Griñó; J M Palazón; F Carnicer; M Pérez-Mateo,"Accuracy of the most frequently used tests for diagnosing Helicobacter pylori infection in patients with upper gastrointestinal bleeding of peptic origin is determined. Seventy-eight patients with endoscopically-proven upper gastrointestinal bleeding of peptic origin were included. The presence of H. pylori was considered when observed from the histology or, if negative, when serology and breath test were both positive. Accuracy of the rapid urease test was estimated in accordance with results obtained with other diagnostic methods. Lesions causing gastrointestinal bleeding were 56 duodenal ulcers, 13 gastric ulcers, 7 pyloric channel ulcers, 13 acute lesions of the gastric mucosa and 16 erosive duodenitis. H. pylori infection was present in 68 patients (87.2%). Forty-four patients had received non-steroidal anti-inflammatory drugs. The sensitivity/specificity (%) of the diagnostic methods was 48.5/100 for the rapid urease test, 91/77.8 for the breath test, 89.5/80 for serology and 86.3/100 for histology. The prior consumption of proton-pump inhibitors and antibiotics induced false-negative results in the rapid urease test and breath test, with no effect on serology and histology. The prevalence of H. pylori infection in patients with upper gastrointestinal bleeding from peptic lesions is high. Sensitivity of the rapid urease test for diagnosing H. pylori is low in this setting. Cases with negative rapid urease test need the combination of two or more additional tests if diagnosis is to be achieved. Cases with positive rapid urease test do not need further investigation for diagnosis.",2002.0,0,0
482,11761026,Regular-dose versus high-dose omeprazole in peptic ulcer bleeding: a prospective randomized double-blind study.,M Udd; P Miettinen; A Palmu; M Heikkinen; E Janatuinen; P Pasanen; R Tarvainen; M V Kairaluoma; M Lohman; H Mustonen; R Julkunen,"It has been suggested that profound acid inhibition along with endoscopic therapy might prevent rebleeding and reduce mortality in patients with peptic ulcer bleeding. The aim of the study was to test the possible equivalence of a high dose and the regular dose of omeprazole in peptic ulcer bleeding. We performed a prospective randomized double-blind study involving 142 patients with acute peptic ulcer bleeding (Forrest classification I-II: spurting or oozing bleeding, non-bleeding visible vessel, clot and black base). One-hundred-and-two (71.8%) patients received endoscopic treatment (adrenaline injection and/or heater probe) in pre-entry. Patients were randomly assigned to receive the regular dose of omeprazole intravenously (20 mg once a day for 3 days, i.e. 60 mg/72 h) or a high dose of omeprazole (80 mg bolus + 8 mg/h for 3 days, i.e. 652 mg/72 h). Rebleeding, surgery and death were the outcome measures. Six (8.2%) of the 73 patients receiving the regular dose of omeprazole and 8 (11.6%) of the 69 patients receiving the high dose of omeprazole rebled (P = 0.002 for equivalence, equivalence limit 0.15). Three (4.1%) of the former patients and 5 (7.2%) of the latter group underwent surgery. Four (5.5%) patients in the regular-dose and 2 (2.9%) in the high-dose group died within 30 days. Under the defined tolerance limits, the regular dose of omeprazole is as successful as a high dose in preventing peptic ulcer rebleeding.",2002.0,0,0
483,11764536,Helicobacter pylori and nonsteroidal anti-inflammatory drugs.,F K Chan,"The complex interaction between H. pylori and NSAIDs implies that it is over simplistic to conclude that their relationship is independent, synergistic, or antagonistic without considering the influence of other factors. Factors such as previous exposure to NSAIDs, a history of ulcer complication, concurrent use of acid-suppressant therapy, and the difference between NSAIDs and low-dose aspirin all affect the outcome. Several recommendations can be made with regard to the indications of H. pylori eradication for patients requiring NSAIDs. First, patients taking NSAIDs who have ulcers or previous ulcer disease should be tested for the bacterium, and it should be eradicated if present because it is impossible to determine whether the ulcers are caused by H. pylori or NSAIDs or both. Antiulcer drugs should be prescribed to prevent ulcer recurrence for patients who continue to require NSAIDs. Although the efficacy of omeprazole is enhanced by H. pylori infection, it is not justified to leave a pathogen in the stomach in exchange for a modest therapeutic gain. Second, for patients who take low-dose aspirin, eradication of H. pylori substantially reduces the risk of ulcer bleeding. It is advisable that patients taking low-dose aspirin who are at risk of ulcer bleeding should be tested for H. pylori and treated for it if the infection is found. Third, for patients who are about to start NSAIDs, screen-and-treat H. pylori has the potential of reducing the ulcer risk at an affordable incremental cost. It might be argued that any interaction between H. pylori and NSAIDs would become irrelevant in the era of COX-2-selective NSAIDs. Even among patients who are receiving a COX-2-selective NSAID, however, a large-scale study showed that the ulcer risk is significantly higher in H. pylori-positive patients than in uninfected patients. This finding suggests that the relative importance of H. pylori in ulcer development might increase with a reduced toxicity of COX-2-selective NSAIDs. With an increasing use of low-dose aspirin for cardiovascular prophylaxis, the problem of aspirin-related ulcer disease is expected to rise. Given the significant role of H. pylori in the latter condition, screen-and-treat H. pylori might be a useful strategy for the prevention of ulcer complications in high-risk patients receiving low-dose aspirin in the future.",2002.0,0,0
484,11772142,Rabeprazole: an update of its use in acid-related disorders.,C I Carswell; K L Goa,"Rabeprazole is an inhibitor of the gastric proton pump. It causes dose-dependent inhibition of acid secretion. In 8-week studies, among patients with gastro-oesophageal reflux disease (GORD), rabeprazole 20 mg/day or 10mg twice daily was as effective as omeprazole and superior to ranitidine in the healing of GORD. Symptom relief with rabeprazole was superior to that provided by placebo and ranitidine and similar to omeprazole. In long-term trials rabeprazole 10 mg/day was similar to omeprazole 20 mg/day in a 2-year study and superior to placebo in 1-year studies, in both the maintenance of healing and prevention of symptoms in patients with healed GORD. In nonerosive GORD, 4-week studies have shown rabeprazole to be more effective than placebo in relieving heartburn and various other gastrointestinal symptoms. Data among patients with Barrett's oesophagus suggest rabeprazole 20 mg/day may be more effective than placebo in maintaining healing of associated oesophagitis after 1 year of treatment. One-week triple Helicobacter pylori eradication therapy with rabeprazole plus clarithromycin and amoxicillin achieved eradication rates of > or =85%. Rabeprazole is as effective as omeprazole and lansoprazole when included as part of a triple-therapy regimen for the eradication of H. pylori. Eradication rates of >90% were achieved when rabeprazole 20 to 40 mg/day was included as part of a quadruple eradication regimen. As monotherapy for peptic ulcer healing and symptom relief, 4- to 8-week studies have shown rabeprazole 10 to 40 mg/day to be superior to placebo and ranitidine and have similar efficacy to omeprazole. Preliminary 1-year data among 16 patients with Zollinger-Ellison syndrome suggest rabeprazole 60 to 120 mg/day can resolve and prevent the recurrence of symptoms and endoscopic lesions associated with this condition. In clinical trials of up to 2 years' duration the tolerability of rabeprazole is similar to that of placebo, ranitidine and omeprazole. Common adverse events assigned to rabeprazole have been diarrhoea, headache, rhinitis, nausea, pharyngitis and abdominal pain. Histological changes and increases in serum gastrin levels were unremarkable and typical of proton pump inhibitors. No dosage adjustment is necessary in renal and mild to moderate hepatic impairment. Rabeprazole is a well tolerated proton pump inhibitor. It has proven efficacy in healing, symptom relief and prevention of relapse of peptic ulcers and GORD and can form part of effective H. pylori eradication regimens. It is an important alternative to H(2) antagonists and an additional treatment option to other proton pump inhibitors in the management of acid-related disorders.",2002.0,0,0
485,11772247,Helicobacter pylori: strategies for treatment.,F Gomollón; B Sicilia,"Helicobacter pylori (Hp) is a Gram-negative bacteria able to live in the human stomach, a very surprising fact considering the acid environment of gastric mucosa. Identified by Marshall and Warren in 1982 [1,2], this bacterium seems aetiologically related to many gastric diseases, previously known as 'acid related diseases'. Compelling evidence demonstrates that Hp is the most important aetiological agent of gastritis [3], the principal causal factor in peptic ulcer [4], contributes to the genesis of gastric cancer [5] and has a critical role in the development of many mucosa-associated lymphoid tissue (MALT) lymphomas [6]. Although experimental data have recently provided hard evidence to support the role of Hp in the genesis of gastritis, ulcer and carcinoma [7], a critical argument for Hp generating peptic ulcer disease has been, in fact, the change in the natural history of peptic ulcer that follows the cure of the infection.",2002.0,0,0
486,11772270,A novel therapeutic approach for Helicobacter pylori infection: the bismuth-based triple therapy monocapsule.,W A de Boer,"Helicobacter pylori infection causes peptic ulcer disease and must be regarded as a serious infectious disease. Over the past two decades treatment of the infection has been a controversial issue. Treatment is purely empirical and based on combinations of two, three or four existing drugs. Antimicrobial resistance is important and an observed increase in the prevalence of resistance may change the relative importance of certain antibiotics. Bismuth-based triple therapy with bismuth, tetracycline and metronidazole is a well investigated, cheap and FDA approved regimen to cure the infection. Adding a proton pump inhibitor (PPI) increases efficacy. A novel monocapsule (""Helicide"") that contains bismuth, tetracycline and metronidazole simplifies the regimen. This new and patient-friendly drug has been investigated in clinical studies and is expected to be released in North America in 2002.",2002.0,0,0
487,11773669,Clinical efficacy of proton pump inhibitor therapy in neurologically impaired children with gastroesophageal reflux: prospective study.,K M Cheung; P W Tse; C H Ko; Y C Chan; C Y Leung; K H Chan,"To study the effects of proton pump inhibitors in reducing vomiting, gastrointestinal bleeding, and chest infections in institutionalised neurologically impaired children with gastroesophageal reflux. Prospective study. A regional hospital, Hong Kong. Neurologically impaired children with refractory gastroesophageal reflux. Episodes of vomiting, gastrointestinal bleeding, and pneumonia in the baseline and proton pump inhibitor treatment periods. Nine children received proton pump inhibitor therapy for a median duration of 81 days. Mean reflux index was 9.3% (standard deviation, 5%). Dosage of omeprazole used was 1.0-2.3 mg/kg/d. Vomiting was reduced significantly with proton pump inhibitor treatment (median vomiting index [baseline]=0.4, median vomiting index [proton pump inhibitors]=0.2; P<0.05). No significant decrease in gastrointestinal bleeding or chest infection was observed. Proton pump inhibitors significantly reduced vomiting episodes in neurologically impaired children with gastroesophageal reflux.",2002.0,0,0
488,11777288,Omeprazole versus ranitidine in the medical treatment of acute upper gastrointestinal bleeding: assessment by early repeat endoscopy.,P Fasseas; B Leybishkis; G Rocca,"The purpose of this study was to assess the effects of acid suppression in patients with upper gastrointestinal bleeding using early repeat endoscopy. Ninety-two patients with the diagnosis of acute upper gastrointestinal bleeding (endoscopically verified), entered a single-blind, randomised study comparing two treatment groups: omeprazole (40 mg orally daily) to ranitidine (50 mg intravenously four times daily). The lesions considered were gastric ulcers, duodenal ulcers and erosive gastritis. All patients were candidates for medical treatment. The parameters assessed included: 1) stabilisation of the lesion by repeat endoscopy at 7.0 +/- 3.0 days, 2) bleeding recurrence, 3) duration of stay in the intermediate medical care unit. For erosive gastritis only parameters 2 and 3 were considered. The study was limited to the hospitalisation period. Endoscopic stabilisation rate at 7.0 +/- 3.0 days for duodenal lesions was higher in the omeprazole group (71% vs 37%, p=0.03), but there was no significant difference for gastric lesions (50% vs 54%, NS). The overall bleeding recurrence rate (0% vs 17%, p=0.013) and the duration of stay (3.9 vs 6.4 days, p<0.01) were significantly lower in the omeprazole group. Our study suggests that omeprazole is more effective than ranitidine in the pharmacological treatment of acute upper gastrointestinal bleeding.",2002.0,0,0
489,11802013,Gastroesophageal reflux and obstructive sleep apnea.,B A Senior; M Khan; C Schwimmer; L Rosenthal; M Benninger,"To determine the extent to which gastroesophageal reflux (GER)-initiated laryngeal chemoreflexes contribute to obstructive sleep apnea (OSA). Prospective, nonrandomized clinical trial of an antireflux treatment protocol as a means of reducing the severity of OSA. Population consisted of 10 males aged 20 to 64 years with confirmed OSA (by overnight polysomnography) and GER (by ambulatory pH probe monitoring). Patients were treated with omeprazole and standard antireflux protocol for 30 days and pre- and posttreatment polysomnography variables were compared. Mean apnea index declined 31% (45-31, P = .04); mean respiratory disturbance index declined 25% (62-46, P = .06). Three patients (30%) are ""treatment responders"" as defined by traditional OSA treatment definitions. These results suggest a potential relationship between OSA and GER, the treatment of which may be an effective adjunctive in those with both disorders. Treatment of GER may significantly impact OSA in select individuals.",2002.0,0,0
490,11802014,"Evaluation of omeprazole in the treatment of reflux laryngitis: a prospective, placebo-controlled, randomized, double-blind study.",J P Noordzij; A Khidr; B A Evans; E Desper; R K Mittal; J F Reibel; P A Levine,"Proton-pump inhibitors are often recommended in the treatment of laryngitis secondary to gastric reflux. Despite prospective treatment studies reporting high efficacy, only one previous report has been placebo-controlled and blinded. The objective of this study was to determine the efficacy of omeprazole in treating proven reflux laryngitis. Prospective, placebo-controlled, randomized, double-blind clinical trial. Fifty-three patients with one or more reflux laryngitis symptoms were recruited to undergo 24-hour dual-channel pH probe testing. Thirty patients with more than four episodes of laryngopharyngeal reflux were enrolled. By random assignment, 15 patients received 40 mg omeprazole twice a day and the other 15 received placebo for a period of 2 months. Symptoms (hoarseness, throat pain, lump in throat sensation, throat clearing, cough, excessive phlegm, dysphagia, odynophagia, and heartburn) and endoscopic laryngeal signs (erythema, edema, and mucus accumulation) were recorded initially, at 1 month, and 2 months. In general, most symptom scores improved over time for both the omeprazole and placebo groups. Hoarseness, when patients begin with low hoarseness symptom scores, and throat clearing improved significantly more in patients on omeprazole than in those on placebo during the 2-month study. Throat pain, lump in throat sensation, excessive phlegm, difficulty swallowing, pain with swallowing, and heartburn showed improvement in both treatment arms, signifying the possibility of a placebo effect. Endoscopic laryngeal signs did not change significantly over the course of the study for either treatment group. A placebo effect appears to exist in the treatment of reflux laryngitis. However, hoarseness, when initially scored low, and throat clearing resulting from reflux laryngitis are effectively treated by omeprazole.",2002.0,0,0
491,11802510,"Amoxycillin, clarithromycin and either sucralfate or pantoprazole for eradication of Helicobacter pylori in duodenal ulcer (a randomized controlled trial).",A Vcev; A Vceva; S Kurbel; B Takac; D Stimac; A Ivandić; R Ostojić; A Barbir; D Hovat; S Mihaljević,"Sucralfate enhances the anti-Helicobacter pylori activity of antimicrobials and has an inhibitory effect on H. pylori. To evaluate the efficacy and safety of one-week sucralfate-based eradication therapy for H. pylori infection in patients with duodenal ulcers, compared with treatment based on pantoprazole, in a randomized controlled multicenter study. One hundred and twenty patients with active duodenal ulcers and H. pylori infection were treated with amoxycillin 1 g b.d. plus clarithromycin 500 mg b.d. for the first 7 days. Patients were randomly assigned to receive either sucralfate 1 g t.d.s. for 4 weeks (SAC group; n = 60) or pantoprazole (PAC group; n = 60) 40 mg b.d. for the first 7 days and 40 mg o.d. for the next 3 weeks. The patient's H. pylori status was determined by a urease test and histological investigation before the treatment, and again 4 weeks after cessation of all medication. One hundred and eleven patients completed the study. H. pylori infection was eradicated in 76.4% (42/55) of patients in the SAC group (ITT analysis: 70%, 95% CI: 58-80%) vs. 85.7% (48/56) of patients in the PAC group (ITT analysis: 80%, 95% CI: 70-89) (N.S.). All ulcers had healed. There were no significant differences between the two regimens regarding the occurrence of adverse effects. Our study shows that one-week triple therapy with amoxycillin, clarithromycin and either pantoprazole or sucralfate are effective regimens to cure H. pylori infection in patients with duodenal ulcer.",2002.0,0,0
492,11802748,Clinical outcome and influencing factors of a new short-term quadruple therapy for Helicobacter pylori eradication: a randomized controlled trial (MACLOR study).,Gerhard Treiber; Joachim Wittig; Susanne Ammon; Siegfried Walker; Leen-Jan van Doorn; Ulrich Klotz,"Short-term therapies for eradicating Helicobacter pylori in selected patients might offer advantages in terms of costs, compliance, and adverse effects in contrast to standard 1-week triple therapy. To determine eradication success and influencing factors in a new short-term quadruple therapy, a total of 243 patients positive for H pylori were randomly assigned to 1 of 3 regimens according to age, smoking status, and diagnosis: a 5-day treatment with 3 antibiotics (amoxicillin, 1 g twice daily [bid]; clarithromycin, 250 mg bid; and metronidazole, 400 mg bid) and lansoprazole (30 mg bid [L5; reference treatment]) or ranitidine hydrochloride (300 mg bid [R5]), or the same 3-day antibiotic-lansoprazole combination (L3) with a 2-day pretreatment with lansoprazole. A total of 234 patients completed the study. On an intention-to-treat basis, overall eradication of H pylori was confirmed in 86.4%: 89.2% in the L5 group vs 81.2% in the L3 group vs 88.8% in the R5 group; differences were not significant. Multiple logistic regression analysis showed that younger age (<55 years; P =.03), history of peptic ulcer disease (P =.04), smoking (P =.03), metronidazole resistance (P =.003), low ranitidine trough serum concentrations (P =.005), cytotoxin-associated gene A-negative strains in peptic ulcer disease (P =.04), and outer inflammatory protein A-positive strains (P =.02) were associated with eradication failure. This new quadruple H pylori eradication regimen is efficacious, safe, well tolerated, and cost saving, and may be a treatment option for patients older than 55 years with no history of peptic ulcer disease. Furthermore, strains that are sensitive to all antibiotics, cytotoxin-associated gene A-positive, and outer inflammatory protein A-negative could be suitable for short-term quadruple therapy. Patients with an unfavorable combination of characteristics should be treated for a minimum of 7 days.",2002.0,0,1
493,11802750,"Ulcer prevention in long-term users of nonsteroidal anti-inflammatory drugs: results of a double-blind, randomized, multicenter, active- and placebo-controlled study of misoprostol vs lansoprazole.",David Y Graham; Naurang M Agrawal; Donald R Campbell; Marian M Haber; Cyndy Collis; Nancy L Lukasik; Bidan Huang; NSAID-Associated Gastric Ulcer Prevention Study Group,"Studies that report prevention of ulcer recurrence among long-term users of nonsteroidal anti-inflammatory drugs (NSAIDs) that do not stratify for Helicobacter pylori status may not be generalizable to the large population of individuals without H pylori. This was a prospective, double-blind, multicenter, active- and placebo-controlled study among 537 patients without H pylori who were long-term users of NSAIDs and who had a history of endoscopically documented gastric ulcer. Patients were randomized to receive placebo, 200 microg of misoprostol 4 times a day, or 15 or 30 mg of lansoprazole once daily for 12 weeks. Ulcer status was determined by endoscopy at 4, 8, and 12 weeks. Patients receiving lansoprazole (15 or 30 mg) remained free from gastric ulcer longer than those who received placebo (P<.001) but for a shorter time than those who received misoprostol. By week 12, the percentages of gastric ulcer-free patients were as follows: placebo, 51% (95% confidence interval [CI], 41.1%-61.3%); misoprostol, 93% (95% CI, 87.2%-97.9%); 15-mg lansoprazole, 80% (95% CI, 72.5%-87.3%); and 30-mg lansoprazole, 82% (95% CI, 75.0%-89.6%). A significantly higher proportion of patients in the misoprostol group reported treatment-related adverse events and early withdrawal from the study. When the impact of withdrawals on ulcer development was considered (as failures), therapy was successful for 69% for each of the active treatment groups and 35% for the placebo group. Proton pump inhibitors such as lansoprazole are superior to placebo for the prevention of NSAID-induced gastric ulcers but not superior to misoprostol, 800 microg/d. When the poor compliance and potential adverse effects associated with misoprostol are considered, proton pump inhibitors and full-dose misoprostol are clinically equivalent.",2002.0,1,1
494,11808967,"Reliability, validity, and responsiveness of severity of dyspepsia assessment (SODA) in a randomized clinical trial of a COX-2-specific inhibitor and traditional NSAID therapy.",Linda Rabeneck; Kimberly Wristers; Jay L Goldstein; Glenn Eisen; Seema D Dedhiya; Thomas A Burke,"We aimed to assess the Severity of Dyspepsia Assessment (SODA) scales as measures of change in dyspepsia-related health in a blinded, randomized, controlled trial in arthritis patients treated with nonsteroidal anti-inflammatory drugs. Three thousand nine hundred seven arthritis patients completed SODA at baseline and weeks 4, 13, 26, and 52 and/or at early termination. Using baseline and 4-wk data, reliability was evaluated with Cronbach's a and the intraclass correlation coefficient (ICC). Dyspepsia adverse events were defined based on a combined set of World Health Organization Adverse Reaction Terminology terms. The ability of SODA to measure change in dyspepsia-related health was evaluated by comparing SODA change scores by dyspepsia adverse event severity level and withdrawal status. Responsiveness was further evaluated by the area under the curve (AUC) from receiver operating characteristic curves using withdrawal due to dyspepsia as the criterion. The SODA scales--Pain Intensity (alpha = 0.93), Non Pain Symptoms (alpha = 0.82), and Satisfaction (alpha = 0.89)--demonstrated excellent internal consistency reliability using baseline data. Reproducibility was fair to good: Pain Intensity ICC = 0.49, Non Pain Symptoms ICC = 0.61, and Satisfaction ICC = 0.45. SODA change scores (4-wk score - baseline score) increased, or worsened, with increasing dyspepsia severity and differentiated between adjacent levels of dyspepsia severity for eight of nine adjacent comparisons (p < 0.05). SODA change scores also differentiated between those who did and did not withdraw (p < 0.001). Responsiveness was highest with the Pain Intensity scale (AUC = 0.78), followed by the Non Pain Symptoms (AUC = 0.74) and Satisfaction (AUC = 0.75) scales. SODA is a reliable, valid instrument for use as a measure of dyspepsia tolerability in future clinical trials involving cyclo-oxygenase-2-specific and/or traditional nonsteroidal anti-inflammatory drugs.",2002.0,0,0
495,11809180,Eradication of Helicobacter pylori and risk of peptic ulcers in patients starting long-term treatment with non-steroidal anti-inflammatory drugs: a randomised trial.,Francis K L Chan; K F To; Justin C Y Wu; M Y Yung; W K Leung; Timothy Kwok; Y Hui; Henry L Y Chan; Cynthia S Y Chan; Elsie Hui; Jean Woo; Joseph J Y Sung,"Whether Helicobacter pylori increases the risk of ulcers in patients taking non-steroidal anti-inflammatory drugs (NSAIDs) is controversial. We hypothesised that eradication of H pylori infection would reduce the risk of ulcers for patients starting long-term NSAID treatment. Patients were enrolled if they were NSAID naïve, had a positive urea breath test, had dyspepsia or an ulcer history, and required long-term NSAID treatment. They were randomly assigned omeprazole triple therapy (eradication group) or omeprazole with placebo antibiotics (placebo group) for 1 week. All patients were given diclofenac slow release 100 mg daily for 6 months from randomisation. Endoscopy was done at 6 months or if severe dyspepsia or gastrointestinal bleeding occurred. The primary endpoint was the probability of ulcers within 6 months. Analyses were by intention to treat. Of 210 arthritis patients screened, 128 (61%) were positive for H pylori. 102 patients were enrolled, and 100 were included in the intention-to-treat analysis. H pylori was eradicated in 90% of the eradication group and 6% of the placebo group. Five of 51 eradication-group patients and 15 of 49 placebo-group patients had ulcers. The 6-month probability of ulcers was 12.1% (95% CI 3.1-21.1) in the eradication group and 34.4% (21.1-47.7) in the placebo group (p=0.0085). The corresponding 6-month probabilities of complicated ulcers were 4.2% (1.3-9.7) and 27.1% (14.7-39.5; p=0.0026). Screening and treatment for H pylori infection significantly reduces the risk of ulcers for patients starting long-term NSAID treatment.",2002.0,0,0
496,11819780,Treatment of Helicobacter pylori.,A Harris,,2002.0,0,0
497,11819830,Barrett's metaplasia: clinical implications.,S Ishaq; J A Jankowski,"The incidence of Barrett's metaplasia (BM) as well as Barrett's adenocarcinoma (BA) has been increasing in western populations. The prognosis of BA is worse because individuals present at a late stage. Attempts have been made to intervene at early stage using surveillance programmes, although proof of efficacy of endoscopic surveillance is lacking, particularly outside the specialist centres. The management of BM needs to be evidence-based as there is a lack clarity about how best to treat this condition. The role of proton pump inhibitors and antireflux surgery to control reflux symptoms is justified. Whether adequate control of gastroesophageal reflux early in the disease alters the natural history of Barrett's change once it has developed, and/or prevents it in patients with gastroesophageal reflux disease but with no Barrett's change, remains unanswered. There is much to be learned about BM. Thus there is great need for carefully designed large randomised controlled trials to address these issues in order to determine how best to manage patients with BM.",2002.0,0,0
498,11822005,Ulcer and gastritis.,J C Y Wu; J J Y Sung,"The literature on peptic ulcer and gastritis in 2000 again focused on the topics of Helicobacter pylori, nonsteroidal anti-inflammatory drugs (NSAIDs), and gastric cancer. New diagnostic tests for H. pylori infection have been evaluated, and rescue therapies for failed H. pylori eradication have been tested. The causal relationship between H. pylori infection and nonulcer dyspepsia, gastric cancer, gastroesophageal reflux disease, and NSAID-related ulcers remained heated topics of debate. In 2000, landmark clinical trials and meta-analyses were published addressing these issues. The role of endoscopy in managing nonulcer dyspepsia was better defined. The role of H. pylori eradication in NSAID/aspirin users was reexamined in high-risk patients. Clinical benefit was finally confirmed for specific inhibitors of cyclooxygenase-2 (COX-2). The millennium year turned out to be a very important one in the advancement of knowledge in this field.",2002.0,0,0
499,11825309,"Lansoprazole: pharmacokinetics, pharmacodynamics and clinical uses.",D A Gremse,"Lansoprazole (Prevacid, TAP Pharmaceuticals, Inc.) is a substituted benzimidazole that inhibits gastric acid secretion. This agent is approved for the short-term treatment of erosive reflux oesophagitis, active gastric ulcer, active duodenal ulcer and the treatment of non-steroidal anti-inflammatory drug (NSAID)-induced gastric and duodenal ulcers. It is also approved for the long-term treatment of healed reflux oesophagitis, healed duodenal ulcer, the treatment of hypersecretory conditions such as Zollinger-Ellison syndrome and the eradication of Helicobacter pylori as a component of triple therapy with lansoprazole, clarithromycin and amoxicillin, or dual therapy with lansoprazole and amoxicillin. Its mechanism of action is to selectively inhibit the membrane enzyme H+/K+ ATPase in gastric parietal cells. In clinical trials, lansoprazole is more effective than placebo or histamine (H2)-receptor antagonists in the treatment of reflux oesophagitis. Lansoprazole administered at a dose of 30 mg daily produced faster relief of symptoms and superior healing rates in patients with gastric or duodenal ulcers or reflux oesophagitis than H2-receptor antagonists. A daily dose of 30 mg lansoprazole reduced epigastric pain faster than omeprazole 20 mg daily in patients with peptic ulcer disease but healing rates at 4 and 8 weeks were similar with both agents at these dosages. Lansoprazole was more effective than H2-receptor antagonists in patients with Zollinger-Ellison syndrome and produced similar treatment outcome to omeprazole. Lansoprazole in combination with clarithromycin and amoxicillin produced similar rates of eradication of H. pylori. In clinical trials, lansoprazole is well-tolerated and has a low frequency of side effects similar to that of H2-receptor antagonists or omeprazole.",2002.0,0,0
500,11866257,"Brazilian consensus on gastroesophageal reflux disease: proposals for assessment, classification, and management.",JoaquimPradoP Moraes-Filho; Ivan Cecconello; Joaquim Gama-Rodrigues; LuizdePaula Castro; Maria Aparecida Henry; Ulisses G Meneghelli; Eamonn Quigley; Brazilian Consensus Group,"The Brazilian Consensus on Gastroesophageal Reflux Disease considers gastroesophageal reflux disease to be a chronic disorder related to the retrograde flow of gastroduodenal contents into the esophagus and/or adjacent organs, resulting in a variable spectrum of symptoms, with or without tissue damage. Considering the limitations of classifications currently in use, a new classification is proposed that combines three criteria-clinical, endoscopic, and pH-metric-providing a comprehensive and more complete characterization of the disease. The diagnosis begins with the presence of heartburn, acid regurgitation, and alarm manifestations (dysphagia, odynophagia, weight loss, GI bleeding, nausea and/or vomiting, and family history of cancer). Also, atypical esophageal, pulmonary, otorhinolaryngological, and oral symptoms may occur. Endoscopy is the first approach, particularly in patients over 40 yr of age and in those with alarm symptoms. Other exams are considered in particular cases, such as contrast radiological examination, scyntigraphy, manometry, and prolonged pH measurement. The clinical treatment encompasses behavioral modifications in lifestyle and pharmacological measures. Proton pump inhibitors in manufacturers' recommended doses are indicated, with doubling of the dose in more severe cases of esophagitis. The minimum time of administration is 6 wk. Patients who do not respond to medical treatment, including those with atypical manifestations, should be considered for surgical treatment. Of the complications of gastroesophageal reflux disease, Barrett's esophagus presents a potential development of adenocarcinoma; biopsies should be performed, independent of Barrett's esophagus extent or location. In this regard the designation ""short Barrett's"" is not important in terms of management and prognosis.",2002.0,0,0
501,11868007,Epinephrine versus epinephrine plus fibrin glue injection in peptic ulcer bleeding: a prospective randomized trial.,Paul Pescatore; Philippe Jornod; Jan Borovicka; Drahoslava Pantoflickova; Walter Suter; Christa Meyenberger; André Louis Blum; Gian Dorta,"Peptic ulcer bleeding remains a disease with considerable morbidity and mortality. Epinephrine is the most widely used endoscopic injection agent, but bleeding recurs in 20% of high-risk cases. Fibrin glue might be an ideal injection agent, based on its physiologic properties, despite its demanding injection technique and high cost. The aim of this study was to determine whether the injection of fibrin glue in combination with epinephrine improves outcome for patients at high risk of recurrent bleeding. Patients were prospectively randomized to injection of epinephrine alone (n = 70) or epinephrine plus fibrin glue (n = 65). Endoscopy was repeated daily until the ulcer base was clean. All patients were treated with high-dose omeprazole. Initial hemostasis was 100% in both groups. There was no significant overall difference in rates of recurrent bleeding (24.3% and 21.5%, respectively, for epinephrine and epinephrine plus fibrin). When patients were stratified according to Forrest criteria, no significant difference could be found, although there was a trend toward less recurrent bleeding after fibrin injection of actively bleeding ulcers. There was no significant difference in the proportions of patients who required surgery (10% and 6%, respectively, for epinephrine and epinephrine plus fibrin). Mortality was the same (3%) in each group. Adding fibrin glue to epinephrine for injection treatment of bleeding peptic ulcers does not improve outcome. Fibrin glue might be of some value in selected cases.",2002.0,0,0
502,11874994,Long-term effect of H2RA therapy on nocturnal gastric acid breakthrough.,William K Fackler; Tina M Ours; Michael F Vaezi; Joel E Richter,"Adding histamine 2 receptor antagonists (H2RAs) to proton pump inhibitor (PPI) therapy is a common practice to block nocturnal acid breakthrough (NAB). Controversy exists over its efficacy because of H2RA intolerance. No prospective study has addressed this issue. Twenty-three healthy volunteers and 20 gastroesophageal reflux disease (GERD) patients were studied. Ambulatory pH monitoring was performed with one electrode in the gastric fundus and the other 5 cm above the lower esophageal sphincter. Baseline pH testing was performed and repeated after 2 weeks on PPI twice daily before meals (omeprazole 20 mg). All subjects then received 28 days of PPI plus H2RA Qhs (ranitidine 300 mg) with repeat pH testing on days 1, 7, and 28. Eighteen controls and 16 GERD patients completed all 5 studies. Compared with baseline, all 4 medication regimens decreased supine % time pH < 4 (P = 0.001). The administration of PPI + 1 day of H2RA was the only therapy that significantly decreased % time gastric pH < 4 for the supine period compared with PPI twice daily alone (P < 0.001). There was no difference in % time supine gastric pH < 4 between 2 weeks of PPI twice daily alone and either 1 week or 1 month of PPI + bedtime H2RA. The combination of H2RA and PPI therapy reduced NAB only with the introduction of therapy. Because of H2RA tolerance, there is no difference in acid suppression between PPI twice daily and PPI twice daily + H2RA after 1 week of combination therapy.",2002.0,0,0
503,11876697,"Onset of symptom relief with rabeprazole: a community-based, open-label assessment of patients with erosive oesophagitis.",M Robinson; S Fitzgerald; R Hegedus; A Murthy; L Jokubaitis; FAST Trial Investigators,"In numerous clinical trials, proton pump inhibitors have demonstrated potent acid suppression and healing of erosive oesophagitis, as well as successful symptom relief for the entire spectrum of gastro-oesophageal reflux disease. The 'Future of Acid Suppression Therapy' (FAST) trial evaluated, in actual clinical practice, the timing of symptom relief, changes in symptom severity, health-related quality of life and safety in endoscopically confirmed erosive gastro-oesophageal reflux disease treated with rabeprazole. This open-label, multicentre study enrolled 2579 patients to receive rabeprazole treatment using 20 mg once daily for 8 weeks. Between two clinical visits (at enrollment and week 8), patients used an interactive voice response system to rate gastro-oesophageal reflux disease symptoms. Subgroup analyses of efficacy were conducted for gender, age, Hetzel-Dent grade, presence of Barrett's oesophagus and for patients reporting previously ineffective symptom relief with omeprazole or lansoprazole. On day 1, rabeprazole significantly decreased daytime and night-time heartburn severity, regurgitation and belching. Complete relief of daytime and night-time heartburn was achieved in 64.0% and 69.2% of symptomatic patients, respectively, on day 1, and in 81.1% and 85.7% of patients, respectively, on day 7. Patients with moderate or severe heartburn symptoms at baseline achieved an even greater degree of satisfactory symptom relief (none or mild) from day 1 onwards. The median time to satisfactory heartburn relief was 2 days. Subgroup analyses showed no consistent differences in efficacy compared to the overall population treated. Health-related quality of life in patients was significantly lower than that of the US general population and improved significantly after 8 weeks of rabeprazole therapy. Rabeprazole was well tolerated, with headache as the most common adverse event, reported by less than 2% of the study population. In this large, open-label trial, rabeprazole rapidly and effectively relieved gastro-oesophageal reflux disease symptoms in most patients with erosive oesophagitis. Substantial symptom relief was noted on day 1; improvement continued over the first week and at week 4. By week 8, the health-related quality of life had also improved vs. baseline.",2002.0,0,1
504,11876701,"A randomized, double-blind, comparative study of standard-dose rabeprazole and high-dose omeprazole in gastro-oesophageal reflux disease.",G Holtmann; P Bytzer; M Metz; V Loeffler; A L Blum,"Rabeprazole has a faster onset of antisecretory action than omeprazole, and it is of interest to determine whether this translates into faster symptom relief in patients with gastro-oesophageal reflux disease. To assess the relief from heartburn after 3 days of treatment with standard-dose rabeprazole or high-dose omeprazole (primary end-point). Secondary end-points included the decrease in score for other symptoms of gastro-oesophageal reflux disease, healing rates and quantification of antacid use. Patients with endoscopically confirmed erosive oesophagitis were randomized to receive 4 weeks of double-blind treatment with rabeprazole (20 mg) or omeprazole (40 mg). Patients who were not healed after 4 weeks received a further 4 weeks of treatment. Two hundred and seventy-four patients were screened, 251 patients were randomized and 230 patients completed the trial. The numbers of patients with relief from heartburn on day 4 were similar in the two groups (84% for rabeprazole; 95% confidence interval, 76-90%; 83% for omeprazole; 95% confidence interval, 75-89%). There were no significant differences between the treatments in the relief from other gastro-oesophageal reflux disease symptoms or in healing rates. The number of reports of severe heartburn during the first 3 days was higher in the omeprazole group (daytime heartburn: 4.7% for rabeprazole vs. 10.3% for omeprazole, P=0.005; night-time heartburn: 4.7% for rabeprazole vs. 9.8% for omeprazole, P=0.01; statistical comparisons defined post hoc). Standard-dose rabeprazole was as effective as high-dose omeprazole in relieving symptoms by day 4 of treatment and in healing oesophageal lesions, but had a faster onset of action in patients with severe heartburn. This suggests that the improved pharmacological properties of rabeprazole translate into a clinically relevant advantage.",2002.0,1,1
505,11876711,The cost-effectiveness of population Helicobacter pylori screening and treatment: a Markov model using economic data from a randomized controlled trial.,J Mason; A T R Axon; D Forman; S Duffett; M Drummond; W Crocombe; R Feltbower; S Mason; J Brown; P Moayyedi; Leeds HELP Study Group,"Economic models have suggested that population Helicobacter pylori screening and treatment may be a cost-effective method of reducing mortality from gastric cancer. These models are conservative as they do not consider that the programme may reduce health service peptic ulcer and other dyspepsia costs. We have evaluated the economic impact of population H. pylori screening and treatment over 2 years in a randomized controlled trial and have incorporated the results into an economic model exploring the impact of H. pylori eradication on peptic ulcer disease and gastric cancer. Subjects between the ages of 40 and 49 years were randomly invited to attend their local primary care centre. H. pylori status was evaluated by (13)C-urea breath test and infected individuals were randomized to receive omeprazole, 20 mg b.d., clarithromycin, 250 mg b.d., and tinidazole, 500 mg b.d., for 7 days or identical placebos. Economic data on health service costs for dyspepsia were obtained from a primary care note review for the 2 years following randomization. These data were incorporated into a Markov model comparing population H. pylori screening and treatment with no intervention. A total of 2329 of 8407 subjects were H. pylori positive: 1161 were randomized to receive eradication therapy and 1163 to receive placebo. The cost difference favoured the intervention group 2 years after randomization, but this did not reach statistical significance (11.42 ponds sterling per subject cost saving; 95% confidence interval, 30.04 ponds sterling to -7.19 pounds sterling; P=0.23). Analysis by gender suggested a statistically significant dyspepsia cost saving in men (27.17 ponds sterling per subject; 95% confidence interval, 50.01 pounds sterling to 4.32 pounds sterling; P=0.02), with no benefit in women (-4.46 per subject; 95% confidence interval, -33.85 pounds sterling to 24.93 pounds sterling). Modelling of these data suggested that population H. pylori screening and treatment for 1,000,000 45-year-olds would save over 6,000,000 pounds sterling and 1300 years of life. The programme would cost 14, 200 pounds sterling per life year saved if the health service dyspepsia cost savings were the lower limit of the 95% confidence intervals and H. pylori eradication had only a 10% efficacy in reducing mortality from distal gastric cancer and peptic ulcer disease. Modelling suggests that population H. pylori screening and treatment are likely to be cost-effective and could be the first cost-neutral screening programme. This provides a further mandate for clinical trials to evaluate the efficacy of population H. pylori screening and treatment in preventing mortality from gastric cancer and peptic ulcer disease.",2002.0,0,0
506,11886474,Increased primary resistance to recommended antibiotics negatively affects Helicobacter pylori eradication.,C Ecclissato; M A M Marchioretto; S Mendonça; A P O Godoy; R A Guersoni; M Deguer; H Piovesan; J G P Ferraz; J Pedrazzoli,"To evaluate the efficacy of two commonly employed treatments for Helicobacter pylori infection and the impact of bacterial resistance to antibiotics on eradication rate. Ninety-two consecutive H. pylori-positive patients with active peptic ulcer disease were randomly enrolled to receive a 7-day treatment with either lansoprazole 30 mg plus amoxicillin 1 g and clarithromycin 500 mg [all twice a day (b.i.d.), Group A, n = 46]; or bismuth subcitrate 125 mg four times a day (q.i.d.) plus tetracycline 500 mg q.i.d and furazolidone 200 mg b.i.d. (Group B, n = 46) H. pylori status was reassessed 30 days after completion of the therapy and bacterial resistance to the antibiotics was investigated using an in vitro assay. Five patients from each study group were lost to follow up. Both treatments resulted in similar H. pylori eradication rate: 66-60% (per protocol), 59-52% (intention-to-treat) in Groups A and B, respectively (non significant). However, eradication improved to 79% in the absence of H. pylori resistance to clarithromycin or amoxicillin. Primary resistance to clarithromycin or amoxicillin may underscore a potentially serious problem for the eradication of H. pylori infection. Testing for bacterial resistance may become necessary to improve therapeutic efficacy.",2002.0,0,0
507,11922549,Esomeprazole (40 mg) compared with lansoprazole (30 mg) in the treatment of erosive esophagitis.,Donald O Castell; Peter J Kahrilas; Joel E Richter; Nimish B Vakil; David A Johnson; Seth Zuckerman; Wendy Skammer; Jeffrey G Levine,"Esomeprazole, the S isomer of omeprazole, has been shown to have higher healing rates of erosive esophagitis than omeprazole. This study compared esomeprazole with lansoprazole for the healing of erosive esophagitis and resolution of heartburn. This United States multicenter, randomized, double blind, parallel group trial was performed in 5241 adult patients (intent-to-treat population) with endoscopically documented erosive esophagitis, which was graded by severity at baseline (Los Angeles classification). Patients received 40 mg of esomeprazole (n = 2624) or 30 mg of lansoprazole (n = 2617) once daily before breakfast for up to 8 wk. The primary efficacy endpoint was healing of erosive esophagitis at week 8. Secondary assessments included proportion of patients healed at week 4, resolution of investigator-recorded heartburn, time to first and time to sustained resolution of patient diary-recorded heartburn, and proportion of heartburn-free days and nights. Esomeprazole (40 mg) demonstrated significantly higher healing rates (92.6%, 95% CI = 91.5-93.6%) than lansoprazole (30 mg) (88.8%, 95% CI = 87.5-90.0%) at week 8 (p = 0.0001, life-table estimates, intent-to-treat analysis). A significant difference in healing rates favoring esomeprazole was also observed at week 4. The difference in healing rates between esomeprazole and lansoprazole increased as baseline severity of erosive esophagitis increased. Sustained resolution of heartburn occurred faster and in more patients treated with esomeprazole. Sustained resolution of nocturnal heartburn also occurred faster with esomeprazole. Both treatments were well tolerated. Esomeprazole (40 mg) is more effective than lansoprazole (30 mg) in healing erosive esophagitis and resolving heartburn. Healing rates are consistently high with esomeprazole, irrespective of baseline disease severity.",2002.0,0,0
508,11941946,Dual versus triple therapy in eradication of Helicobacter pylori.,B Ohlin; A Cederberg; T Kjellin; E Kullman; K Melén; C Staël von Holstein; M Thoring,"Duodenal ulcers should be treated by eradication of Helicobacter pylori. This study compared the efficacy of a proton pump inhibitor together with one or two antibiotics in eradication therapy. 177 patients who were H. pylori positive were randomized to receive 14 days of either: lansoprazole 30 mg bd and amoxicillin 1 g bd (LA), omeprazole 20 mg bd and amoxicillin 1 g bd (OA) or lansoprazole 30 mg bd, amoxicillin 1 g bd and clarithromycin 500 mg bd (LAC). The efficacy was assessed at four weeks and at six months after the end of treatment. Biopsies were taken for culture and bacterial sensitivity testing at inclusion and at four weeks after the end of treatment. 149 patients were evaluated for efficacy. The eradication rate was significantly higher in LAC (96%) compared to LA (51%) and OA (64%) treatments (P < 0.001). At baseline 17%, 21% and 19% of the patients in the LA, OA and LAC groups, respectively, were resistant to metronidazole and only one patient was resistant to clarithromycin. Post-treatment, four patients had acquired metronidazole resistance. LAC is more effective than LA and OA for eradication of H. pylori in duodenal ulcer disease.",2002.0,0,1
509,11941952,Efficacy of trimebutine therapy in patients with gastroesophageal reflux disease and irritable bowel syndrome.,J Kountouras; D Chatzopoulos; C Zavos; P Boura; J Venizelos; A Kalis,"GERD (gastroesophageal reflux disease) occurs in 25-51% of IBS (irritable bowel syndrome) patients. Trimebutine has been effective in some IBS patients by modulating colonic motility. Furthermore, it increases gastric emptying rates, and controls esophageal motility. The aim of this study was to investigate the efficacy of trimebutine therapy in GERD patients with IBS. Sixty-nine patients with GERD and IBS underwent upper gastrointestinal endoscopic, histologic and clinical evaluation prior to and 3 months post-treatment. H. pylori presence was determined by histology and CLOtest. Forty patients (Group A) were treated with omeprazole plus trimebutine for 3 months: in 32 H. pylori-positive patients (subgroup A1), a standard triple eradication regimen was introduced. Twenty-nine patients (Group B) were treated with omeprazole for 3 months: in 24 H. pylori-positive patients (subgroup B1), the same eradication therapy was employed. Specialized intestinal metaplasia of the gastroesophageal junction was observed in 20% and in 17.2% of the patients in Groups A and B, respectively. Eradication rates were similar in subgroups A1 (84%) and B1 (83%). In Group A there was a significant improvement in GERD (P = 0.003) and IBS symptoms (P < 0.0001) as well as esophagitis (P = 0.029), when compared with Group B. Trimebutine appears to be effective in patients with GERD and IBS.",2002.0,0,0
510,11966495,Hiatal hernia is the key factor determining the lansoprazole dosage required for effective intra-oesophageal acid suppression.,M Frazzoni; E De Micheli; A Grisendi; V Savarino,"Effective intra-oesophageal acid suppression can be achieved with lansoprazole. The daily dosage could be influenced by the presence of hiatal hernia. To assess the lansoprazole daily dosage required to normalize oesophageal acid exposure in patients with and without hiatal hernia. Fifty patients with complications or atypical manifestations of gastro-oesophageal reflux disease were given lansoprazole, 30 mg once daily. Three to four weeks after the start of treatment, patients underwent oesophageal pH monitoring while on therapy. If the results were still abnormal, the lansoprazole dosage was doubled and 24-h pH-metry was repeated 20-30 days thereafter. A 30-mg daily dosage of lansoprazole normalized oesophageal acid exposure in 70% of cases, whilst a 60-mg daily dosage was necessary in the remainder: the two groups differed only in the presence of hiatal hernia (28% vs. 100%, respectively; P=0.000). Effective intra-oesophageal acid suppression was obtained in all 25 patients without hiatal hernia with the 30-mg daily dosage of lansoprazole. Hiatal hernia is the key factor determining the lansoprazole dosage required for effective intra-oesophageal acid suppression in complicated and atypical gastro-oesophageal reflux disease. High efficacy of a 30-mg daily dosage of lansoprazole can be predicted in the absence of hiatal hernia.",2002.0,0,0
511,11978171,Combination drug therapy for gastroesophageal reflux disease.,L Brian Cross; Lori N Justice,"To evaluate the role of combination therapy with proton-pump inhibitors (PPIs) and histamine(2) receptor antagonists in gastroesophageal reflux disease (GERD). Clinical literature identified through MEDLINE (January 1966-August 2001). Key search terms included gastroesophageal reflux, benzimidazoles; omeprazole; lansoprazole; pantoprazole; rabeprazole; receptor antagonists, histamine(2); therapy, combination drug; therapy, combined modality; and combinations, drug. Approximately 80-90% of patients show healing of reflux esophagitis after 8 weeks of once-daily PPI therapy. Patients taking PPI therapy twice daily still have nocturnal acid breakthrough (periods of gastric pH <4 lasting for > or =60 min during the night) as much as 70% of the time. The clinical application of this finding has not been shown. One trial has shown that omeprazole in the morning plus ranitidine at bedtime is not as effective as omeprazole twice daily given before the morning and evening meals at controlling nocturnal acid breakthrough. Further, 1 small trial in healthy subjects without GERD showed that the addition of a 1-time dose of ranitidine at bedtime to a twice-daily regimen of omeprazole may decrease the occurrence of nocturnal acid breakthrough. However, the clinical significance of this finding is not clear. No studies in patients with GERD demonstrate that the addition of histamine(2) receptor antagonists to twice-daily PPI therapy provides any further benefit above that derived from PPIs alone. The parameter used to measure the efficacy of combination regimens for GERD thus far--nocturnal acid breakthrough--has not been proven to correlate with improvement of GERD symptoms in any controlled or prospective clinical trials. Further investigation is needed to determine optimal therapy in patients refractory to standard doses of PPIs.",2002.0,0,0
512,11982907,Detection of Helicobacter pylori-associated asymptomatic duodenal ulcer in a boy.,Toshiaki Shimizu; Yukiko Yarita; Ryuyo Suzuki; Yuichiro Yamashiro,,2002.0,0,0
513,11984146,Pharmacokinetic study of esomeprazole in patients with hepatic impairment.,Henrik Sjövall; Einar Björnsson; Johan Holmberg; Göran Hasselgren; Kerstin Röhss; Mohammed Hassan-Alin,"To evaluate the pharmacokinetics and safety of esomeprazole (Nexium), the S-isomer of omeprazole, after repeated oral dosing in patients with hepatic impairment. Single-centre, open-label one-way study. Twelve patients (aged 40-60 years) with mild to severe hepatic impairment received once-daily oral esomeprazole 40 mg for 5 days. Serial blood samples were drawn up to 24 h post-dose on day 5 to determine plasma levels of esomeprazole and its metabolites. Pharmacokinetic parameters were compared with an historical control group of 36 gastro-oesophageal reflux disease (GORD) patients (aged 29-58 years) with normal hepatic function. Esomeprazole was absorbed rapidly (mean maximum plasma concentration (Cmax) 6.1 micromol/l, mean time to Cmax (tmax) 1.9 h) and eliminated rapidly (mean plasma elimination half-life (t1/2) 2.1 h). Elimination of its pharmacologically inactive sulphone and hydroxy metabolites was more gradual. Patients with mild hepatic impairment had area under the plasma concentration-time curve during the dosage interval (AUCtau) and t1/2 values largely within the range of the control group. In patients with moderate hepatic impairment, t1/2 values were similar and AUCtau was slightly higher than in controls, whereas both parameters were increased in patients with severe hepatic impairment. The mean ratios of esomeprazole AUCtau, Cmax and t1/2 values in patients with and without hepatic impairment were 1.8, 1.3 and 1.3, respectively. The steady-state pharmacokinetics of esomeprazole were not altered substantially by mild or moderate hepatic impairment; however, plasma levels of esomeprazole were elevated in severe cases. Thus, dose adjustment appears unwarranted in mild or moderate hepatic impairment, but may be required in some severely impaired patients. Esomeprazole was tolerated well across the spectrum of hepatic impairment.",2002.0,0,0
514,12030956,Meta-analysis: the efficacy of intravenous H2-receptor antagonists in bleeding peptic ulcer.,J E Levine; G I Leontiadis; V K Sharma; C W Howden,"Although a previous meta-analysis found that intravenous H2-receptor antagonists were only weakly beneficial in bleeding gastric ulcer and of no benefit in bleeding duodenal ulcer, patients with ulcer bleeding continue to receive such treatment. To re-evaluate the efficacy of intravenous H2-receptor antagonists in ulcer re-bleeding, surgery and mortality by updating the previous meta-analysis. After two independent literature searches, randomized, placebo-controlled trials of intravenous H2-receptor antagonists in bleeding ulcer published between 1984 and 2000 were added to those from the initial meta-analysis. Pooled rates of re-bleeding, surgery and death were re-calculated, together with the relative risk reduction, absolute risk reduction, number needed to treat and Mantel-Haenszel odds ratio. Intravenous H2-receptor antagonists did not significantly reduce re-bleeding, surgery or death in bleeding duodenal ulcer. There were small but significant reductions in re-bleeding, surgery and death in bleeding gastric ulcer; the absolute risk reductions were 7.2%, 6.7% and 3.2%, respectively. Intravenous H2-receptor antagonists are of no value in bleeding duodenal ulcer, although they may be mildly beneficial in bleeding gastric ulcer. Because proton pump inhibitors have a greater inhibitory effect on gastric acid secretion than H2-receptor antagonists, they may be more effective in ulcer bleeding and should be further evaluated for that indication.",2002.0,0,0
515,12030957,Helicobacter pylori eradication does not worsen quality of life related to reflux symptoms: a prospective trial.,L Laine; V Dhir,"Concern has been raised that Helicobacter pylori therapy may lead to the development of gastro-oesophageal reflux disease. This prospective study was designed to assess reflux-related quality of life and the symptoms of gastro-oesophageal reflux disease in patients undergoing H. pylori therapy. Patients with a primary complaint of dyspepsia (upper abdominal pain or discomfort) and endoscopic biopsy positive for H. pylori received triple therapy for 2 weeks. A validated reflux-related quality of life questionnaire sensitive to change was given at baseline, 1 month and 6 months after therapy; symptoms were also recorded. A urea breath test was performed 1 month after the end of therapy; patients and investigators were blind to the results. H. pylori was eradicated in 48 of 61 patients. The mean scores in cured patients for each of the five domains were comparable at baseline and 6 months after therapy: differences were - 0.23 to 0.13 (P > 0.20) on a scale of 1-7. The proportion of cured patients with a large decrease in quality of life (10-17% in the five domains) was similar to the proportion with a large increase (15-21%). Heartburn was present at baseline in 22 cured patients; at 6 months, it persisted in 13 and resolved in nine, whilst nine patients developed new heartburn. A population of patients presenting with dyspepsia should have no overall increase or decrease in quality of life due to symptomatic gastro-oesophageal reflux disease in the 6 months after H. pylori therapy.",2002.0,0,0
516,12030959,"Duodenal ulcer healing with 1-week eradication triple therapy followed, or not, by anti-secretory treatment: a multicentre double-blind placebo-controlled trial.",R Colin; Hepylog Investigator Study Group,"In the management of Helicobacter pylori induced duodenal ulcer, it is still controversial whether anti-secretory treatment needs to be continued following a 1-week course of eradication therapy. 150 patients with H. pylori active duodenal ulcer (diameter > or = 5 mm) were included. After a 1-week eradication treatment combining omeprazole 20 mg b.d., amoxicillin 1000 mg b.d. and clarithromycin 500 mg b.d. (OAC), patients were randomized to omeprazole 20 mg or placebo for 3 additional weeks. The primary variable was ulcer healing assessed at 4 weeks. Eradication was verified 4 weeks after cessation of study drugs by 13C-urea breath test. Intention-to-treat analysis (ITT) included 131 patients with positive histopathology at inclusion. Healing rates were not statistically different, at 89% and 87%, respectively, in the OAC-omeprazole and OAC-placebo groups (95% CI: -8.7; 13.7). Numerically, healing rates in patients with successful eradication was higher [94/104 (90%)] than in patients with failed eradication [21/27 (78%)]. However, the difference was not statistically significant (P < 0.1). One-week OAC eradication triple therapy achieves excellent healing rates in patients with uncomplicated duodenal ulcer disease. Although the confidence interval of the difference in healing suggests little or no benefit of continued omeprazole treatment after 1 week, larger studies are needed to address this issue definitively.",2002.0,0,0
517,12031222,"[Management of dyspepsia, gastroduodenal ulcer and Helicobacter pylori infection in primary care].",E Gené; X Calvet; R Azagra; T López; M J Cubells,"To evaluate management of dyspepsia, gastroduodenal ulcer and Helicobacter pylori infection in the setting of family practice. An observational transversal study was performed. An anonymous questionnaire was send by mail between January and October 2000. Primary care. Physicians of 17 Primary Care centers. Sixty-four per cent of the physicians returned the answered questionnaire (107/165). Primary care doctors reported they had indicated eradication therapy at least once during last year in 94.3%; 89.7% usually indicate H. pylori eradication for duodenal ulcer and 70.1% for gastric ulcer. The main method for the study of dyspepsia was endoscopy associated with antral histology or rapid urease test for determination of H. pylori status. Omeprazole, clarithromycin and amoxicillin twice daily for seven days was the preferred eradication therapy (77.6%). Forty-five percent of physicians systematically tested patients to confirm cure of the infection; 36.4% tested patients only if symptoms relapsed. Breath test (72.7%) was the preferred method to confirm eradication. Physicians with postgraduate specialty in Family Care and Community Medicine (MFyC) demand less often gastroenterologist evaluation, indicate less frequently upper tract radiology, use more often C13 urea breath test for diagnosis and indicate more often eradication treatment for erosive duodenitis than unspecialised family doctors. Management of dyspepsia and H. pylori infection in Primary Care in our area is reasonably adapted to current consensus recommendations. Many differences in management were observed between MFyC and non-specialised primary care physicians.",2002.0,0,0
518,12032434,Eradication of Helicobacter pylori infection with proton pump inhibitor-based triple therapy. A randomised study.,F Palmas; R Pellicano; E Massimetti; M Berrutti; S Fagoonee; M Rizzetto,"Helicobacter pylori (H. pylori) infection plays an important role in the pathogenesis of duodenal ulcer (DU) disease. Low DU recurrences and reinfection rates were universally described, when treatment was effective. It has been suggested that short-term triple therapy, comprising a proton pump inhibitor plus 2 antibiotics (clarithromycin, amoxycillin or a nitroimidazole), should be used as first choice in treating H. pylori infection. Nevertheless, conflicting results have been reported on using these treatment regimens in different countries. Our aim was to compare cure rates of H. pylori infection, with a 1-week triple therapy versus 10 and 15 day triple schedules, in patients with DU. A total of 172 patients (91 males, mean age 56.2+/- 3.2 years) were randomly treated with a triple therapy including a standard dose of proton pump inhibitor, amoxicillin at a dose of 1 g twice daily and clarithromycin 500 mg twice a day. Sixty-six patients received a 1-week triple therapy (group I), 42 subjects were treated with a 10-day triple therapy (group II) and 64 others with a 14-day triple therapy (group III). H. pylori infection at entry and after eradication, at least 4 weeks after therapy had ended, were assessed by 13C urea breath test and histology on biopsies from the antrum and the corpus. At the end of the course of treatment, the overall H. pylori eradication rate was 68.2% (45/66) in group I, 76.2% (32/42) in group II and 71.9% (46/64) in group III, without any statistically significant difference between the 3 differing period regimens, although a trend for better results with the 10-day triple therapy was observed. Compliance was good and side effects infrequent and mild. None of the 3 periods of triple therapy achieved 80% eradication rate recommended by the Maastricht Consen-sus Conference. The 10-day triple therapy, although not significantly, provided a satisfactory treatment against H. pylori infection.",2002.0,0,0
519,12058660,Helicobacter pylori eradication for peptic ulceration: an observational study in a Scottish primary care setting.,E H Forrest; J F MacKenzie; R C Stuart; A J Morris,"Despite being established for the treatment of peptic ulcer (PU) disease, few studies have assessed the long-term effectiveness and economic benefits of Helicobacter pylori (Hp) eradication in primary care. Our aim was to investigate the effect of community based Hp eradication for patients with chronic peptic ulcer disease requiring maintenance acid suppression. The endpoints used were the patients dyspeptic symptoms and the requirement for the prescription of maintenance acid suppression therapy. The study area covered seven general practices in the Glasgow area. Patients with previously diagnosed peptic ulcer disease receiving prescribed acid suppression therapy were invited to a dyspepsia clinic. Hp status was assessed by Helisal rapid blood test (HRBT). Positive patients received Hp eradication therapy and were reviewed six weeks later. At six months a review of practice records was carried out, and two years after eradication a postal questionnaire was sent to participating patients. A total of 243 patients attended the initial clinic of which 81.9% were HRBT positive. 156 of 196 patients offered Hp eradication re-attended at six weeks. The per protocol eradication rate was 91.7%. After six months patients who had received eradication therapy were less likely to require maintenance acid suppression therapy compared with those to whom eradication was not given. Two years after treatment 76.5% of patients felt their symptoms were improved, but 42.2% were still receiving maintenance therapy. The estimated cost of treatment per month per patient had fallen from 20.23 Pounds to 9.39 Pounds after eradication. In conclusion we felt that community based Hp eradication for patients with chronic PU disease is effective, however it does not completely alleviate dyspepsia. Predictors of symptomatic response or of no longer requiring acid suppression therapy after two years were younger age of onset of PU disease and absence of pre-documented gastro-oesophageal reflux disease or hiatus hernia. Hp eradication improves patients symptoms, reduces the requirement for maintenance acid suppression and is cost-effective after two years follow-up in this targeted group.",2002.0,0,0
520,12060039,Mucosal ablation in Barrett's esophagus.,S J Walker; C R Selvasekar; N Birbeck,"Barrett's esophagus is a prevalent, premalignant condition affecting the gastroesophageal junction and distal esophagus. Ablation plus antireflux therapy has recently been advocated to prevent the development of adenocarcinoma or to treat those unfit or unwilling to undergo esophagectomy. The present article, based on a search of Medline/ISI databases and cross-referencing of relevant articles, reviews the literature on this subject. A number of techniques have been used to remove the affected mucosa, including laser, electrocoagulation, argon plasma coagulation and photodynamic therapy but, as yet, none has been shown to be superior. Depending on the method used, ablation results in complete removal of Barrett's esophagus in approximately one third of patients and a partial response in nearly two-thirds. The resultant squamous mucosa is apparently 'normal' but may regress. To promote and maintain regeneration, antireflux therapy must be sufficient to reduce repetitive injury to the esophageal mucosa. Whether ablation reduces the cancer risk or delays its occurrence is unknown, though recent data suggests benefit. Complications are infrequent and usually mild. Regular follow-up endoscopy and deep biopsies continue to be necessary. Careful data from much larger populations with long-term follow-up is required before ablation reaches the stage of broad clinical application.",2002.0,0,0
521,12060040,Ablation of Barrett's epithelium: the promise and the problems.,P Urosevic; G K Kiroff,The incidence of adenocarcinoma of the esophagus has increased dramatically over recent years. Because Barrett's epithelium is recognized as a risk factor for adenocarcinoma there is an interest in reversing this metaplasia. A number of endoscopic methods of destruction of esophageal columnar epithelium have been described. The purpose of this article is to review the currently available methods of managing Barrett's epithelium with particular reference to the role of ablative therapy in reducing the risk of adenocarcinoma.,2002.0,0,0
522,12060043,Efficacy and tolerability of pantoprazole versus ranitidine in the treatment of reflux esophagitis and the influence of Helicobacter pylori infection on healing rate.,U G Meneghelli; S Boaventura; J P P Moraes-Filho; O Leitão; A P Ferrari; J R Almeida; A F N Magalhães; L P Castro; M T Haddad; M Tolentino; J L Jorge; E Silva; I Maguilnik; R Fischer,"Patients with reflux esophagitis (grade II or III, Savary-Miller, intention-to-treat, n=256, age range 19-82 years) were randomly assigned to a double-blind, double-dummy treatment with either pantoprazole 40 mg once daily or ranitidine 150 mg twice daily. After 4 weeks, each patient was clinically and endoscopically assessed. Failure to heal required a further 4 weeks of treatment and a new evaluation thereafter. After 4 weeks, healing of lesions was confirmed in 63% (69 out of 109) of patients receiving pantoprazole and in 22% (25 out of 113) receiving ranitidine (P < 0.001, per protocol population). After 8 weeks, the cumulative healing rates were 88% and 46%, respectively (P < 0.001). Complete freedom from esophagitis-related symptoms (acid eructation, heartburn, pain while swallowing) was greater in the pantoprazole than in ranitidine group after 2 and 4 weeks (74% vs. 47%; 87% vs. 52%, respectively, P < 0.001). After 4 weeks, the healing rate was 76% in Helicobacter pylori (Hp)-positive vs. 45% in Hp-negative patients treated with pantoprazole (P < 0.01). The Hp status did not influence healing rates in patients treated with ranitidine. The most frequent adverse events in the pantoprazole group were diarrhea and somnolence (2-3% of patients), and in the ranitidine group, headache, diarrhea, dizziness, increase of liver enzymes and pruritus (2-4% of patients). In conclusion, pantoprazole was more effective than ranitidine in the healing rate and relief from reflux esophagitis-associated symptoms, and Hp infection was associated with higher healing rate during therapy with pantoprazole but not with ranitidine.",2002.0,0,1
523,12070410,Effect of pantoprazole versus other proton pump inhibitors on 24-hour intragastric pH and basal acid output in Zollinger-Ellison syndrome.,Akli Ramdani; Michel Mignon; Roland Samoyeau,"In this open prospective study, the efficacy of pantoprazole in reducing gastric acid secretion in Zollinger-Ellison syndrome patients was compared to that obtained previously with other proton pump inhibitors. Eleven male patients previously treated with omeprazole (n=7, mean dosage: 63 mg/day; range: 20-100 mg/day) or lansoprazole (n=4, mean dosage: 75 mg/day; range: 30-120 mg/day) were included. These patients underwent a 24-hour intragastric pH-metry, measurement of basal acid output and of serum gastrin first while receiving their usual therapy and second after 7 to 10 days of pantoprazole treatment at a mean dosage of 116 mg/day (range: 40-200 mg/day). Basal acid output was evaluated after each intragastric pH-metry, one hour before the next intake of proton pump inhibitor and a serum gastrin curve was determined according to 9 fixed time points. One patient dropped out before the second intragastric pH-metry due to an adverse event (varicella) unrelated to pantoprazole and was reinvestigated thereafter. The median 24-h intragastric pH with pantoprazole was not significantly different than that with the other proton pump inhibitors (5.3 versus 4.6, respectively; P=0.90). Neither the median basal acid output values nor the median serum gastrin levels were significantly different between pantoprazole and the other proton pump inhibitors. In these patients with the Zollinger-Ellison syndrome, pantoprazole was well tolerated and equally effective to the other proton pump inhibitors in terms of antisecretory potency.",2002.0,0,0
524,12071079,[Diagnosis of gastroesophageal reflux].,H D Allescher,"Around 10-20% of the population suffer from the hallmark symptoms of heartburn, regurgitation, sour burping and retrosternal pain. Based on their characteristic medical history alone, such patients can usually be presumed to have gastroesophageal reflux disease (GERD). In around 30-50% of them, the endoscopic examination will reveal the typical erosions and ulcerations in the esophagus. In addition to the clinical symptoms, endoscopy plays a central role in diagnosing GERD. An endoscopy is always indicated whenever these warnings symptoms are present. In patients with persistent reflux problems, endoscopy is indicated to diagnose erosive reflux esophagitis. This procedure should include a routine biopsy taken distal to the Z-line to enable histological detection of the metaplasia associated with Barrett's esophagus. Although the majority of patients exhibit the classical symptoms and respond to acid suppression therapy, endoscopy may not find erosions (non-erosive reflux disease NERD). In these cases, further diagnostic steps must be taken to verify the diagnosis of gastroesophageal reflux disease. There are patients, moreover, who exhibit unclear, uncharacteristic reflux symptoms, such as respiratory diseases with bronchial asthma, chronic bronchitis, chronic cough or ENT problems like posterior laryngitis and globus sensation (a lump in the throat). In these uncertain cases and in patients with NERD, 24-hour pH monitoring can verify and objectify and acid gastroesophageal reflux. An association can then be made between acid reflux and symptomatology. As an alternative, trial therapy with a proton pump inhibitor can help identify patients who have acid-related problems and symptoms. Other functional tests such as radiographic examination, manometry or scintigraphy are less well suited, if at all, for primary diagnostics of gastroesophageal reflux disease.",2002.0,0,0
525,12072599,,,,,0,1
526,12082341,Rabeprazole.,C A Desai; B D Samant,,2002.0,0,0
527,12085028,Recurrent bleeding from peptic ulcer associated with adherent clot: a randomized study comparing endoscopic treatment with medical therapy.,Brian L Bleau; Christopher J Gostout; Kenneth E Sherman; Michael J Shaw; William V Harford; Ray F Keate; Waldo P Bracy; David E Fleischer,"Endoscopic therapy reduces the recurrence of bleeding from actively bleeding peptic ulcers and those with visible vessels. However, the use of endoscopic therapy for ulcers with adherent clots remains controversial. The purpose of this study was to determine whether removal of clot from an ulcer and endoscopic therapy reduces the frequency of recurrent bleeding. Patients with acute upper GI bleeding from peptic ulcers with adherent clots and no active bleeding were enrolled in a multicenter study. At each center patients were stratified for age, use of nonsteroidal anti-inflammatory drugs, and ulcer location, and were randomized to endoscopic or medical management. Endoscopic therapy consisted of injection of the base of the adherent clot with a solution of epinephrine and mechanical removal of the clot. The base of the ulcer and any stigmata of bleeding were then coagulated until cavitation and adequate coagulation were obtained. Patients in both groups received standard medical therapy for peptic ulcer. Patients were evaluated for recurrence of bleeding for 1 month. Fifty-six patients were enrolled. Rates of recurrent bleeding were 34.3% (12/35) in the medical treatment arm versus 4.8% (1/21) in the endoscopic treatment arm (p < 0.02). In patients with GI bleeding caused by gastric or duodenal ulcers with an adherent clot found on endoscopy, endoscopic therapy with injection of the base of the clot, clot removal, and heat probe coagulation significantly reduces the rate of recurrent bleeding compared with medical therapy alone.",2002.0,0,0
528,12087138,Lansoprazole for the prevention of recurrences of ulcer complications from long-term low-dose aspirin use.,Kam Chuen Lai; Shiu Kum Lam; Kent Man Chu; Benjamin C Y Wong; Wai Mo Hui; Wayne H C Hu; George K K Lau; Wai Man Wong; Man Fung Yuen; Annie O O Chan; Ching Lung Lai; John Wong,"The role of gastric acid suppression in preventing the recurrence of ulcer complications after the eradication of Helicobacter pylori infection in patients taking long-term low-dose aspirin is uncertain. We enrolled 123 patients who had ulcer complications after using low-dose aspirin continuously for more than one month and who had H. pylori infection. After the ulcers had healed and the H. pylori infection was eradicated, the patients were randomly assigned to treatment with 30 mg of lansoprazole daily or placebo, in addition to 100 mg of aspirin daily, for 12 months. The primary end point was the recurrence of ulcer complications. During a median follow-up of 12 months, 9 of the 61 patients in the placebo group (14.8 percent), as compared with 1 of the 62 patients in the lansoprazole group (1.6 percent), had a recurrence of ulcer complications (adjusted hazard ratio, 9.6; 95 percent confidence interval, 1.2 to 76.1). Of these 10 patients, 4 had evidence of a recurrence of H. pylori infection and 2 had taken nonsteroidal antiinflammatory drugs before the onset of complications. Patients in the lansoprazole group were significantly less likely to have a recurrence of ulcer complications than patients in the placebo group (P=0.008). There was no significant difference in mortality between the two groups. In patients who had ulcer complications related to the long-term use of low-dose aspirin, treatment with lansoprazole in addition to the eradication of H. pylori infection significantly reduced the rate of recurrence of ulcer complications.",2002.0,0,0
529,12093317,Esomeprazole: a review of its use in the management of acid-related disorders.,Lesley J Scott; Christopher J Dunn; Gordon Mallarkey; Miriam Sharpe,"Esomeprazole (S-isomer of omeprazole), the first single optical isomer proton pump inhibitor, generally provides better acid control than current racemic proton pump inhibitors and has a favourable pharmacokinetic profile relative to omeprazole. In a large well designed 8-week trial in patients (n >5000) with erosive oesophagitis, esomeprazole recipients achieved significantly higher rates of endoscopically confirmed healed oesophagitis than those receiving lansoprazole. Respective healed oesophagitis rates with once-daily esomeprazole 40mg or lansoprazole 30mg were 92.6 and 88.8%. Overall, esomeprazole was also better than omeprazole, although these differences were not always statistically significance. Ninety-two to 94% of esomeprazole recipients (40mg once daily) achieved healed oesophagitis versus 84 to 90% of omeprazole recipients (20mg once daily). Esomeprazole was effective across all baseline grades of oesophagitis; notably, relative to lansoprazole, as baseline severity of disease increased, the difference in rates of healed oesophagitis also increased in favour of esomeprazole. Resolution of heartburn was also significantly better with esomeprazole 40mg than with these racemic proton pump inhibitors. Long-term (up to 12 months) therapy with esomeprazole effectively maintained healing in these patients. Once-daily esomeprazole 20 or 40mg for 4 weeks resolved symptoms in patients with symptomatic gastro-oesophageal reflux disease (GORD) without oesophagitis. Symptoms were effectively managed in the long-term with symptom-driven on-demand esomeprazole (20 or 40mg once daily). Eradicating Helicobacter pylori infection is considered pivotal to successfully managing duodenal ulcer disease. Seven days' treatment (twice-daily esomeprazole 20mg plus amoxicillin 1g and clarithromycin 500mg) eradicated H. pylori in >/=86% of patients (intention-to-treat), a rate that was similar to equivalent omeprazole-based regimens. Esomeprazole is generally well tolerated, both as monotherapy and in combination with antimicrobial agents, with a tolerability profile similar to that of other proton pump inhibitors. Few patients discontinued therapy because of treatment-emergent adverse events (<3% of patients), with very few (<1%) drug-related serious adverse events reported. Esomeprazole is an effective, well tolerated treatment for managing GORD and for eradicating H. pylori infection in patients with duodenal ulcer disease. In 8-week double-blind trials, esomeprazole healed oesophagitis and resolved symptoms in patients with endoscopically confirmed erosive oesophagitis and overall, provided better efficacy than omeprazole. Notably, in a large (n >5000 patients) double-blind trial, esomeprazole 40mg provided significantly better efficacy than lansoprazole in terms of healing rates and resolution of symptoms. Long-term therapy with esomeprazole maintained healed oesophagitis in these patients. Esomeprazole also proved beneficial in patients with symptomatic GORD without oesophagitis. Thus, esomeprazole has emerged as an option for first-line therapy in the management of acid-related disorders.",2002.0,0,0
530,12094846,Rabeprazole in nonerosive gastroesophageal reflux disease: a randomized placebo-controlled trial.,Philip Miner; William Orr; Joseph Filippone; Leonard Jokubaitis; Sheldon Sloan,"Clinical results to date suggest that antisecretory therapy may be less effective in providing symptom relief for patients with nonerosive gastroesophageal reflux disease (GERD) than for patients with erosive disease. This study was carried out to assess the efficacy and rapidity of once-daily rabeprazole (10 mg or 20 mg) in relieving symptoms in endoscopically negative patients with moderately severe GERD symptoms and to evaluate the safety of these doses over 4 wk. This placebo-controlled, double blind study enrolled 203 men and women with moderately severe symptoms of GERD. After a 2-wk, single-blind placebo run-in phase, patients were randomized to receive 10 mg or 20 mg of rabeprazole or placebo once daily for 4 wk. Rabeprazole rapidly and effectively relieved heartburn, with significant improvements on day 1 of dosing. It also improved most other GERD-related symptoms, including regurgitation, belching, bloating, early satiety, and nausea. Both rabeprazole doses were significantly superior to the placebo with respect to time to the first 24-h heartburn-free interval (2.5 and 4.5 days for 10 mg and 20 mg of rabeprazole, respectively, vs 21.5 days for the placebo) and first daytime or nighttime heartburn-free interval (1.5-3 days for rabeprazole groups vs 12.5-15 days for the placebo), as well as to percentage of time patients were heartburn-free and free of antacid use. Both rabeprazole doses were well tolerated. Based on these findings and prior studies, rabeprazole reliably relieves GI symptoms equally well in both nonerosive GERD and erosive GERD.",2002.0,0,0
531,12109663,Indications for Helicobacter pylori eradication therapy and first-line therapy regimen in Japan: recommendation by the Japanese Society for Helicobacter Research.,Kiichi Satoh,"In November 2000, eradication therapy for Helicobacter pylori infection was approved under the present Japanese system of health insurance. Before the approval, the Japanese guideline of ""Diagnosis and Treatment of H. pylori infection"" was made by the guideline committee of the Japanese Society for Helicobacter Research. Indications for H. pylori eradication therapy were classified into three groups: (A) recommended: gastric and duodenal ulcers; (B) recommended and managed at a specialized institution: low-grade gastric mucosa-associated lymphoid tissue lymphoma; (C) current studies of the significance of the therapy: following endoscopic mucosal resection of early gastric cancer and gastric surgery for gastric cancers, hyperplastic gastric polyp, atrophic gastritis, and nonulcer dyspepsia. The first-line therapy regimen recommended is 1 week of triple therapy with a proton pump inhibitor standard dose twice a day, amoxicillin 750 mg bid, and clarithromycin 200 or 400 mg bid. The reasons for preferring this regimen are to avoid extensive use of metronidazole, which is allowed for treatment of Trichomonas infection in Japan, and the low rate of emergence of clarithromycin-resistant H. pylori with amoxicillin co-therapy. For second-line therapy patients should be referred to specialists, who can examine the susceptibility of H. pylori isolates against antibiotics and have much experience with this therapy.",2003.0,0,0
532,12115096,,,,,0,0
533,12117874,Distribution and partial characterisation of IgG Fc binding protein in various mucin producing cells and body fluids.,K Kobayashi; H Ogata; M Morikawa; S Iijima; N Harada; T Yoshida; W R Brown; N Inoue; Y Hamada; H Ishii; M Watanabe; T Hibi,"Mucus released from goblet cells is important in intestinal mucosal defence, and mucin glycoproteins are thought to be major components of mucus. Recently, we identified and cloned another component of human colonic mucus, IgG Fc binding protein (Fc gamma BP). Fc gamma BP is immunologically distinct from known Fc gamma receptors and its structure contains repeated cysteine rich unit sequences resembling those present in mucins. In this work, we assessed the tissue distribution of Fc gamma BP, its binding activity in various body fluids, and its ability to inhibit complement mediated haemolysis. Immunohistochemical localisation of Fc gamma BP, using monoclonal antibodies against Fc gamma BP (K9 or K17) and labelled IgG, was conducted in various mucin producing tissues: colon, small intestine, stomach, gall bladder, cystic duct, choledochus, bronchus, submandibular gland, conjunctiva, and cervix uteri. The binding activity of Fc gamma BP in mucus extracted from colon, gastric juice, bile, nasal discharges, saliva, sputum, and tears was also examined by immunodotblot and immunoprecipitation using these monoclonal antibodies. Inhibition of complement mediated haemolysis by Fc gamma BP was investigated using sheep red blood cells (SRBC) and anti-SRBC IgG. The immunohistochemical study revealed that mucin secreting cells in the colon, small intestine, gall bladder, cystic duct, choledochus, bronchus, submandibular gland, and cervix uteri contained Fc gamma BP, and immunodotblot and immunoprecipitation analysis using IgG and monoclonal antibodies demonstrated that the fluids secreted by these cells were capable of binding IgG. Mucin producing cells of the conjunctiva did not express Fc gamma BP molecules or bind to IgG. The surface mucus cells in the stomach were variably positive for Fc gamma BP. Perhaps because of proteolytic degradation, Fc gamma BP in gut lavage fluid did not have IgG binding activity, although this activity was present in the mucus covering the colon. Fc gamma BP suppressed complement mediated haemolysis of SRBC. Fc gamma BP is widely expressed on mucosal surfaces and in external secretions. It is functionally intact in several fluids. These findings lend support to the concept that Fc gamma BP is an important component of mucosal immunological defences.",2002.0,0,0
534,12117882,Role of nitric oxide in gastric motor and sensory functions in healthy subjects.,S D Kuiken; M Vergeer; S H Heisterkamp; G N J Tytgat; G E E Boeckxstaens,"Impaired accommodation and hypersensitivity to distension of the proximal stomach are considered to be important factors in the pathogenesis of dyspeptic complaints. As fundus relaxing agents may be effective in the treatment of these symptoms, insight into the mediators involved in fundic accommodation and associated perceptual responses is important. Therefore, we studied the effect of nitric oxide (NO) synthase inhibition by N(G)-monomethyl-L-arginine (L-NMMA) on fundic tone, postprandial sensations, and gastric perception in healthy volunteers. Eighteen healthy volunteers participated in a double blind, placebo controlled, randomised study. They underwent a gastric barostat study to evaluate the effect of L-NMMA on meal and distension induced sensations and on fundic relaxation in response to oral meal intake, intraduodenal lipid, and glucagon administration. Compared with placebo, L-NMMA decreased fundic volume after oral meal intake (438 (55) v 304 (67) ml; n=8; p<0.05) and during intraduodenal lipid infusion (384 (37) v 257 (43) ml; n=10; p<0.05) but not after glucagon injection (570 (62) v 540 (52) ml; n=4; p=0.4). In addition, basal fundic volume was significantly reduced by L-NMMA. Scores for nausea and satiation were decreased by L-NMMA after oral meal intake but not during intraduodenal lipid infusion. Perception scores to gastric distension were not altered by L-NMMA. NO is involved in maintaining basal fundic tone and in meal induced fundic relaxation in humans, but not in visceral perception.",2002.0,0,0
535,12119060,Are proton pump inhibitors the first choice for acute treatment of gastric ulcers? A meta analysis of randomized clinical trials.,Maribel Salas; Alexandra Ward; Jaime Caro,"Gastric ulcers are a frequent problem in the United States. Proton pump inhibitors have been shown to increase healing rates and improve clinical symptoms. The objective of this study is to compare gastric ulcer healing rates for patients treated with a proton pump inhibitor (PPI) (omeprazole, rabeprazole, pantoprazole, or lansoprazole), an histamine 2- receptor antagonist (ranitidine) or placebo. A literature search was conducted to identify randomized, controlled clinical trials that included a PPI in at least one treatment arm and assessed the gastric ulcer healing rates endoscopically. The healing rates were estimated for each treatment at specific time points, and Rate Ratios (RR) and 95% confidence intervals (CI) were estimated for each trial. Sixteen trials met the inclusion criteria: four compared a PPI versus placebo, nine compared a PPI versus ranitidine (no trials of rabeprazole versus ranitidine met the inclusion criteria), and three compared a newer PPI (lansoprazole, pantoprazole or rabeprazole) versus omeprazole. In relation to ranitidine, the pooled RR of PPIs (lansoprazole, omeprazole and pantoprazole) was 1.33 (95% CI 1.24 to 1.42) at four weeks. In each trial, greater improvement in the studied clinical symptoms was found with the newer PPIs (rabeprazole, pantoprazole and lansoprazole) when compared to omeprazole. In this study treatment with PPIs resulted in higher healing rates than ranitidine or placebo. This evidence suggests that the first choice for gastric ulcer treatment for the greater relief of symptoms is one of the newer PPIs.",2002.0,0,0
536,12120281,Ethical perspectives on pharmacogenomic profiling in the drug development process.,Amalia M Issa,"Pharmacogenomics, which is a field that encompasses the study of genetic polymorphisms that underlie individual differences in drug response, is rapidly advancing. The potential for the widespread use of pharmacogenomics in the drug development process merits an examination of its fundamental impact on clinical-trial design and practice. This article provides a critical analysis of some of the issues that pertain to pharmacogenomics in the drug development process. In particular, four areas will be discussed: clinical-trial design; subject stratification; some new social risks; and economic concerns. Recommendations are offered for addressing the issues that are discussed and anticipating the regulatory needs for pharmacogenomics-based trials.",2002.0,0,0
537,12122962,Gastroesophageal reflux disease: new treatments.,Philip O Katz,"The primary therapeutic endpoint for patients with gastroesophageal reflux disease is complete relief of symptoms and improvement in quality of life. The withdrawal of cisapride has created a vacuum in the prokinetic market, with few promising drugs in the pipeline. Reflux inhibitors are being considered for clinical trials, but as of yet are unavailable. Proton pump inhibitors (PPIs) continue to be the backbone of therapy for acid suppression, providing excellent relief of symptoms and healing of erosive esophagitis. Isomeric technology with esomeprazole as the prototype represents an advance in PPI pharmacology. Antireflux surgery is now more patient-friendly, with shorter hospitalization and less major morbidity compared to open fundoplication, but surgery is at best equal to medical therapy when optimal doses of antisecretory therapy are used. Two endoscopic procedures were recently approved by the U.S. Food and Drug Administration for treatment of gastroesophageal reflux disease: radiofrequency energy delivery to the gastroesophageal junction, and transoral flexible endoscopic suturing. These techniques should be used selectively until we have more data and until results are compared to the safe and highly effective medical therapies.",2002.0,0,0
538,12126239,The natural course of gastroesophageal reflux disease in children.,M Ashorn; T Ruuska; R Karikoski; P Laippala,"The consequences of chronic gastroesophageal reflux disease (GERD) starting in childhood have not been widely studied. Our aim was to evaluate the usefulness of endoscopy in the primary diagnosis of GERD and to investigate the long-term course of this disease in children. Between 1989 and 1999, 136 children had been endoscoped because of persisting symptoms of GER. After exclusions (neurological impairment, infant GER), 96 subjects were included, and files from 76 were available for the final evaluation. Twenty-four hour pH-monitoring had been performed primarily on 67 children and at follow-up on 28, and endoscopy to 69 subjects and at follow-up to 33, respectively. Medical therapy as well as symptoms prior to the therapy were registered. Clinical outcome was assessed at the end of the follow-up period. Presenting symptoms were recurrent abdominal pain, heartburn, regurgitation and vomiting. Twenty-two patients had respiratory symptoms in addition to the gastrointestinal complaints. PH-recording was normal in 17/67 subjects, slightly pathological in 33 and severe reflux was diagnosed in 13 patients. Histologically, minimal changes associated with GER were diagnosed in 22 and mild esophagitis in 7. Thirty-six patients had been treated with prokinetic drugs. H2-blockers had been used in 24 children and proton-pump inhibitors in 4. After a mean follow-up period of 28 months, only 24% of patients had become symptom-free. Control endoscopy showed no progression of the esophageal inflammation in any of the subjects. Pathological reflux in children is associated with no or mild esophageal inflammation, which is unlikely to deteriorate. Therefore endoscopic control could be limited to cases with severe esophagitis.",2003.0,0,0
539,12126240,On-demand treatment in patients with oesophagitis and reflux symptoms: comparison of lansoprazole and omeprazole.,F Johnsson; B Moum; M Vilien; O Grove; M Simren; M Thoring,"There are few data on how patients on maintenance treatment of reflux oesophagitis take their medication. This study was designed to investigate the dosing patterns of patients on on-demand treatment and to compare lansoprazole with omeprazole in this regard. Patients with reflux oesophagitis, initially treated until absence of symptoms, took capsules of either lansoprazole (30 mg) or omeprazole (20 mg) for 6 months; they were instructed to take the medication only when reflux symptoms occurred. In order to document dosing patterns, the medication was dispensed in bottles supplied with a Medication Event Monitoring System recording date and time the bottles were opened. There were regular follow-up visits with assessment of symptoms. Three-hundred patients were eligible for analysis according to 'all patients treated'. A dosing pattern was found of an increased intake mornings and evenings and constant intervals between intakes. Although there was no correlation between oesophagitis grade or initial symptoms and the amount of medication consumed, the patients had significantly fewer reflux symptoms the more medication they consumed. There was no difference in the number of capsules consumed between the lansoprazole (0.73 capsules/day) and omeprazole groups (0.71 capsules/day). Nor was there any difference between the groups in reflux symptoms during the course of the study. Despite rigorous instructions to take medication on demand, the results suggest that it is patient habits more so than symptoms that determine the frequency and interval of medication intake. Symptoms are not therefore decisive for the amount of medication consumed.",2003.0,0,0
540,12132559,Esomeprazole: a clinical review.,Thomas J Johnson; Dennis D Hedge,"The pharmacology, pharmacodynamics, pharmacokinetics, clinical efficacy, and adverse effects of esomeprazole are reviewed. Esomeprazole, a proton-pump inhibitor (PPI), is the S-isomer of omeprazole. Esomeprazole has FDA-approved labeling for use in the treatment of symptomatic gastroesophageal reflux disease (GERD), including healing and maintenance of healing of erosive esophagitis and as part of a triple-drug regimen for Helicobocter pylori infection. Esomeprazole is structurally similar to other PPIs but is the first PPI to include only the active isomer, which may lead to improved pharmacokinetic and pharmacodynamic characteristics. Esomeprazole maintains intragastric pH at a higher level and above 4 for a longer period than other PPIs. Clinical studies have shown that esomeprazole is at least equivalent in safety and efficacy to other drugs in the class. Esomeprazole has demonstrated efficacy in the treatment of erosive esophagitis, the maintenance of healing of erosive esophagitis, and the treatment of signs and symptoms of GERD. Effective dosages are 20 or 40 mg orally every day or as needed. Esomeprazole magnesium 40 mg once daily in combination with amoxicillin and clarithromycin is effective in eradicating H. pylori infection. The potential for interacting with other drugs is limited and is similar to that of omeprazole. The most common adverse effects are headache, respiratory infection, and abdominal symptoms. Esomeprazole has pharmacokinetic properties that may make it more effective than omeprazole in some patients.",2003.0,0,0
541,12135019,Genotyping of Helicobacter pylori in paraffin-embedded gastric biopsy specimens: relation to histological parameters and effects on therapy.,Ger H A Scholte; Leen-Jan van Doorn; Annemieke Cats; Elisabeth Bloemena; Jan Lindeman; Wim G V Quint; Stefan G M Meuwissen; Ernst J Kuipers,"Colonization with Helicobacterpylori can lead to GI disease. Bacterial genotypes and host factors, such as acid production, can influence the progress of disease. We investigated H. pylori genotypes and histological parameters in the same paraffin-embedded gastric biopsy specimens. Paraffin-embedded antrum and corpus biopsy samples from 75 gastroesophageal reflux disease patients were histologically examined and tested for H. pylori vacA (s and m regions), cagA, and iceA genotypes. Patients were investigated at baseline (58 H. pylori positive and 17 H. pylori negative) and after treatment with omeprazole with or without additional antibiotic therapy. Genotyping at baseline was complete in 52 (90%) of the 58 H. pylori positive patients. Multiple genotypes were detected in eight (14%) of these. Genotypes were highly consistent between antrum and corpus biopsy specimens at baseline and in follow-up samples. Genotypes from paraffin sections matched those from corresponding cultured strains in 10 selected cases. In the antrum, the degree of inflammation was associated with vacA s1 and cagA+ genotypes, and the degree of neutrophil activity was associated with the cagA+ genotype. In the corpus, the degree of inflammation was significantly associated with vacA s1, cagA+, and iceA1 genotypes and the degree of atrophy was associated with vacA s1, m1, and cagA+ genotypes, whereas the degree of neutrophil activity was associated with vacA s1 and cagA+ genotypes. vacA s2 and cagA-strains appeared more resistant to antibiotic therapy, irrespective of resistance to clarithromycin. Our findings confirm the relevance of the H. pylori genotypes for the severity of gastric disease and the efficacy of antibiotic therapy.",2002.0,0,0
542,12135028,Comparison of oral omeprazole and endoscopic ethanol injection therapy for prevention of recurrent bleeding from peptic ulcers with nonbleeding visible vessels or fresh adherent clots.,Hye Kyung Jung; Hye-Young Son; Sung-Ae Jung; Sun Young Yi; Kwon Yoo; Doe-Young Kim; Il-Hwan Moon; Han Chu Lee,"Omeprazole is a potent inhibitor of gastric acid secretion. Recently it was reported that p.o. omeprazole therapy reduced the rebleeding rate in patients with nonbleeding visible vessels or adherent clots. The aim of this study was to ascertain whether p.o. administration of omeprazole can be an effective alternative to endoscopic injection therapy in peptic ulcers with stigmata of recent hemorrhage. A total of 101 patients who had peptic ulcer bleeding based on endoscopic findings of nonbleeding visible vessels or fresh adherent clots were randomly assigned to receive omeprazole (40 mg p.o. every 12 h) or endoscopic ethanol injection therapy. Rebleeding rates were 22.9% (11 of 48) in the omeprazole group and 20.8% (11 of 53) in the endoscopic injection therapy group. The rebleeding rates of clinical significance were 14.6% and 13.2%, respectively. There was no significance difference in the rebleeding rate, requirement for surgery, total units of blood transfused, or mortality between the two groups. Oral omeprazole administration is comparable to endoscopic ethanol injection therapy for prevention of rebleeding in patients with nonbleeding visible vessels or adherent clots.",2002.0,0,0
543,12135192,Development and validation of a scoring system predicting failure of endoscopic epinephrine injection therapy in Taiwanese patients with bleeding peptic ulcers.,Yi-Shin Huang; Hwai-Jeng Lin; Yi-Rern Fang; Kelly Wang; Full-Young Chang; Shou-Dong Lee,"Endoscopic epinephrine injection therapy (EIT) is always the first choice of treatment for bleeding peptic ulcers, although it fails in 15% to 30% of patients. The aim of this study was to develop a new scoring system to predict the failure in EIT, and to validate this scoring model prospectively. This study enrolled 125 patients who presented with the stigmata of hemorrhage of peptic ulcers and underwent EIT. Patients with coagulopathy were excluded from the study. Univariate analysis of the clinical and endoscopic parameters to predict failure in EIT was performed first. A multiple logistic regression was used to develop a scoring system. This scoring equation was further applied to 50 prospective patients with bleeding peptic ulcers to validate its predictive value. EIT failed to arrest bleeding in 32 (25.6%) patients. Shock, blood transfusion of at least 500 ml, active bleeding, and ulcer size were effective in predicting failure in EIT as calculated by univariate analysis, while multivariate analysis showed shock, active bleeding and ulcer size to be the independent predictors. The scoring equation, defined as -3.14 + 1.29 (shock) + 0.99 (active bleeding) + 0.13 (ulcer size in mm), had a sensitivity of 81.8% and a specificity of 76.9% in predicting failure of EIT in the prospective cohort of 50 bleeding patients. The presence of shock, active bleeding (spurting or oozing hemorrhage) and ulcer size are risk factors of failure of EIT in Taiwanese patients with bleeding peptic ulcers. The scoring system based on these three parameters can predict failure in EIT, while alternative treatment should be considered in case patients fail EIT.",2002.0,0,0
544,12139836,[Helicobacter pylori eradication in patients with peptic ulcer after two treatment failures: a prospective culture-guided study].,R Vicente; B Sicilia; S Gallego; M J Revillo; J Ducóns; F Gomollón,"To determine the effectiveness of a third, culture-guided, treatment of H. pylori infection after two unsuccessful attempts. Forty-two consecutive patients with a diagnosis of peptic ulcer were included in an open prospective and multicenter study. After two unsuccessful attempts at eradication (demonstrated by positive urea breath test), all patients underwent endoscopy and H. pylori infection was confirmed by urease test, histology and culture (Pylori-Agar, Bio Merieux, France). Antibiotic susceptibility to metronidazole, amoxicillin, tetracycline and clarithromycin was defined by E-test. Thirty-nine patients received a two-week quadruple culture-guided therapy defined by the protocol, which considered sensitivity data and previous allergies to antibiotics (one culture was contaminated, one patient refused treatment and one was allergic to tetracycline and amoxicillin and was resistant to metronidazole and clarithromycin). Compliance was monitored by pill counting and eradication was defined as a negative urea breath test six weeks after the end of treatment. Sensitivity data were obtained in 41 patients. Intention-to-treat analysis revealed that overall eradication was achieved in 60% (24/40). Eighteen strains (43.9%) were resistant to metronidazole, 21 (51.2%) were resistant to clarithromycin and 8 (19.5%) were resistant to both drugs. None of the strains were resistant to amoxicillin or tetracycline. We used mainly two kinds of quadruple therapy in the 39 patients. Despite good compliance with treatment based on omeprazole (20 mg/12 h), bismuth subcitrate (120 mg/6 h), tetracycline (500 mg/4 h) and clarithromycin (500 mg/ 12 h) (OBTC) eradication was achieved in only 9 of 19 patients (47.4%; CI: 24.4-71.1) (one patient failed to attend the urea breath test). Nineteen clarithromycin-resistant patients received amoxicillin (1,000 mg/12 h) instead of clarithromycin (OBTA) and this treatment was effective in 14 (73.7%; CI: 48.8-90.9). Eradication was achieved in one patient who was allergic to amoxicillin and resistant to clarithromycin and metronidazole and who received ciprofloxacin (500 mg/8 h) instead of clarithromycin (OBTCipro). No clinical factors associated with eradication failure were found. Despite the use of two-week, high-dose, quadruple and culture-guided combinations of drugs, a third treatment was frequently unsuccessful. The lowest eradication rate was obtained in patients with H. pylori strains sensitive to all antibiotics; therefore, we believe that other factors could influence eradication rates. New prospective and randomized studies are needed in this subgroup of patients to find effective treatments.",2003.0,0,0
545,12141885,On-demand and intermittent therapy for gastro-oesophageal reflux disease: economic considerations.,John M Inadomi,"Since gastro-oesophageal reflux disease (GORD) is a prevalent condition characterised by frequent relapses, long-term costs of management for this disease are high. Thus, strategies to decrease resource expenditures without impairing patient quality of life are desirable. On-demand therapy (one-dose when symptoms occur) and intermittent therapy (short course of medication when symptoms occur) are attractive since pharmaceutical expenditures may be decreased, and many patients self-employ this strategy. The purpose of this paper was to examine the economic implications of on-demand or intermittent therapy for GORD. A review of selected studies evaluating medication suitable for on-demand or intermittent administration was performed. A complete search for published studies on the cost effectiveness of on-demand or intermittent therapy for GORD was conducted, and the results discussed in detail. Antacids, alginates, topically active agents, histamine(2)-receptor antagonists, and proton pump inhibitors have all demonstrable efficacy compared with placebo when administered on-demand. Proton pump inhibitors constitute the most effective pharmacological means to treat GORD. Although step-up strategies initially using less potent medication may decrease resource use, cost-effectiveness analysis illustrates that on-demand or intermittent therapy with proton pump inhibitors may be reasonable options. Further work that defines quality of life and patient preferences associated with GORD may allow for proper allocation of resources for the management of this condition.",2002.0,0,0
546,12143188,Efficacy and tolerability of ranitidine bismuth citrate plus amoxycillin and clarithromycin as first- or second-line therapy to cure Helicobacter pylori infection.,Antonio Tursi; Giovanni Brandimarte; GianMarco Giorgetti; Maria Ester Modeo; Andrea Gigliobianco,"Ranitidine bismuth citrate has recently been introduced for the treatment of H. pylori infection and obtains good eradication rates; however, eradication failures still appear in a considerable proportion of cases. The aim of this study was to compare the efficacy and tolerability of ranitidine bismuth citrate plus amoxycillin and clarithromycin as first- or second-line therapy to cure H. pylori infection. We studied 423 consecutive H. pylori-positive patients. In 210 consecutive patients H. pylori infection was diagnosed for the first time (group A), while 213 consecutive patients were enrolled after failure of a first attempt to eradicate H. pylori (group B). All patients received ranitidine bismuth citrate 400 mg b.d. plus clarithromycin 500 mg b.d. and amoxycillin 1 g b.d. for seven days. H. pylori-status was evaluated by means of histology and rapid urease test at entry and by 13C-urea breath test in all patients one month after treatment. 410/423 patients completed the study (202/210 in group A and 208/213 in group B). Two patients of group A and 1 patient of group B were withdrawn from the study due to poor compliance, 6 group A patients and 4 group B patients were lost to follow-up. In group A, after the end of treatment, 181/202 patients were H. pylori-negative (per-protocol analysis: 89.60% [C.I. 95%: 82-95%]; on intention-to-treat analysis: 86.19% [C.I. 95%; 76-92%]), side-effects occurred in 29 patients (13.80%); they were severe in 2 patients and the patients were withdrawn from the study. In group B, after the end of treatment, 200/208 patients were H. pylori-negative (per-protocol analysis: 95.15% [C.I. 95%; 92-100%], on intention-to-treat analysis: 93.89% [C.I. 95%; 89-98%), side-effects occurred in 11 patients (5.13%); they were slight or mild and did not require discontinuation of the treatment. The results of group B were statistically better than group A, both in eradication rate (P < 0.01) as well as both side-effects provoked (P < 0.01). Ranitidine bismuth citrate-clarithromycin-amoxycillin is more effective when used as second-line therapy rather than when used as first-line therapy; second, ranitidine bismuth citrate-clarithromycin-amoxycillin shows lower and slighter side-effects when used as second-line therapy rather than when used as first-line therapy; finally, the excellent tolerability of ranitidine bismuth citrate + clarithromycin + amoxycillin influences positively the patients' compliance, both as first- and second-line therapy.",2003.0,0,0
547,12144575,One-week triple vs. quadruple therapy for Helicobacter pylori infection - a randomized trial.,X Calvet; J Ducons; J Guardiola; L Tito; V Andreu; F Bory; R Guirao; Group for Eradication Studies from Catalonia and Aragón (Gresca),"Seven-day triple therapy including omeprazole, clarithromycin and amoxicillin has become the treatment of choice for Helicobacter pylori infection. However, 7 days of classical quadruple therapy combining omeprazole, tetracycline, metronidazole and bismuth may be an alternative to triple therapy. To compare triple vs. quadruple therapy for H.pylori eradication. Three hundred and thirty-nine patients with peptic ulcer and H. pylori infection were included in the study. Patients were randomized to receive omeprazole, 20 mg, amoxicillin, 1 g, and clarithromycin, 500 mg, all b.d., or omeprazole, 20 mg b.d., tetracycline chloride, 500 mg, metronidazole, 500 mg, and bismuth subcitrate, 120 mg, all t.d.s. Cure was defined as a negative urea breath test at least 2 months after treatment. Per protocol and intention-to-treat cure rates were 86%[95% confidence interval (CI), 80-91%] and 77% (95% CI, 70-83%) for triple therapy, and 89% (95% CI, 82-93%) and 83% (95% CI, 76-88%) for quadruple therapy. No significant differences between the groups were found in the cure rates, compliance or side-effects. One-week triple and quadruple therapy show similar results when used as first-line eradication treatment.",2003.0,0,0
548,12144577,Furazolidone-based triple 'rescue therapy' vs. quadruple 'rescue therapy' for the eradication of Helicobacter pylori resistant to metronidazole.,V Isakov; I Domareva; L Koudryavtseva; I Maev; Z Ganskaya,"The optimal treatment of patients with Helicobacter pylori resistant to metronidazole has not been established. To compare the efficacy of quadruple and furazolidone-based triple therapy in the eradication of H. pylori resistant to metronidazole. Duodenal ulcer patients (n = 70) in whom initial eradication therapy failed and who harboured H. pylori strains resistant to metronidazole were randomized to receive one of the following 7-day regimens: colloidal bismuth subcitrate, 240 mg, tetracycline, 750 mg, and furazolidone, 200 mg, each given twice daily (BTF), or omeprazole, 20 mg b.d., colloidal bismuth subcitrate, 240 mg b.d., tetracycline, 500 mg q.d.s., and metronidazole, 500 mg b.d. (OBTM). H.pylori status was assessed by culture, histology and rapid urease test before treatment and 4-6 weeks after therapy. Susceptibility to metronidazole was assessed by the agar dilution method. H. pylori eradication rates with intention-to-treat/per protocol analyses were: BTF, 85.7%/90.9%; OBTM, 74.2%/89.6%. Duodenal ulcers were healed in nine of 10 (90%) patients in the BTF group and in all patients (12/12) (100%) in the OBTM group (P = N.S.). A significantly lower rate of adverse events was observed in the BTF group than in the OBTM group (31.4% vs. 60%, P = 0.03), but there was no difference in terms of discontinuation of treatment (2/35 vs. 6/35, P = N.S.). The 1-week BTF regimen was as effective as the OBTM regimen, and produced less adverse events. Thus, it may be used in patients in whom resistance of H. pylori to metronidazole is suspected.",2003.0,0,0
549,12144580,"Effects of rabeprazole, 20 mg, or esomeprazole, 20 mg, on 24-h intragastric pH and serum gastrin in healthy subjects.",S Warrington; K Baisley; M Boyce; B Tejura; A Morocutti; N Miller,"To compare the antisecretory effects of rabeprazole and esomeprazole in an open, randomized, two-way crossover, clinical pharmacology study. Twenty-four healthy subjects (14 men, 10 women; mean age 26.8 years) received rabeprazole 20 mg or esomeprazole 20 mg daily on days 1-5, with a 14-day 'wash-out'. Intragastric pH was recorded continuously, and serum gastrin measured, on days 0, 1 and 5. On day 0, mean intragastric pH AUC was significantly higher before the esomeprazole than before the rabeprazole treatment in four of the five time intervals analysed. On days 1 and 5, mean intragastric pH AUC was higher after rabeprazole than esomeprazole during 5-11, 14-24 and 0-24 h after dosing. Mean pH AUC in the first 5 h after dosing on day 5 was higher after esomeprazole than rabeprazole (P=0.012). On day 1, mean per cent times pH > 3 and > 4 were significantly greater after rabeprazole than esomeprazole during 0-14, 14-24 and 0-24 h. On day 5, mean serum gastrin AUC0-4 was higher (P = 0.017) after rabeprazole than esomeprazole (335 vs. 316 pg/mL.h). In this clinical pharmacology study, rabeprazole 20 mg daily was more effective than esomeprazole 20 mg daily in increasing intragastric pH and maintaining pH > 3 and > 4. On day 5, mean pH AUC was higher after esomeprazole than rabeprazole.",2003.0,0,0
550,12145570,Barrett's esophagus in patients with gastroesophageal reflux disease. Medical therapy or antireflux surgery?,A Klaus; G Mühlmann; W Kirchmayr; H Weiss; G J Wetscher,"Barrett's esophagus is the most serious form of gastroesophageal reflux disease. It may develop due to uncontrolled chronic duodenogastroesophageal reflux and represents a premalignant abnormality. The question of the development of Barrett's esophagus and the progression to adenocarcinoma of the esophagus is addressed by comparison of the data available in the literature. A retrospective review of the literature on the outcome of GERD patients after surgical and medical therapy, is made. Surgical therapy is able to eliminate reflux of gastric and duodenal contents and therefore seems to be superior over medical therapy in the prevention of Barrett's esophagus and its progression to invasive cancer. Surgery should be considered in all Barrett's patients especially in young patients, patients with large hiatal hernia, increasing drug doses or noncompliance to medical therapy.",2002.0,0,0
551,12145815,Management of ulcers with adherent clots.,Loren Laine,,2002.0,0,0
552,12150380,Validity and reliability of the reflux symptom index (RSI).,Peter C Belafsky; Gregory N Postma; James A Koufman,"Laryngopharyngeal reflux (LPR) is present in up to 50% of patients with voice disorders. Currently, there is no validated instrument that documents symptom severity in LPR. We developed the reflux symptom index (RSI), a self-administered nine-item outcomes instrument for LPR. The purpose of this investigation was to evaluate the psychometric properties of the RSI. For validity assessment, 25 patients with LPR were evaluated prospectively before and six months after b.i.d. treatment with proton pump inhibitors (PPI). Each patient completed the RSI as well as the 30-item voice handicap index (VHI). For reliability assessment, the study patients were given the RSI on two separate occasions before the initiation of treatment. Normative RSI data were derived from 25 age-matched and gender-matched controls taken from an existing database of asymptomatic individuals without any evidence of LPR. The mean RSI (+/- standard deviation) of patients with LPR improved from 21.2 (+/- 10.7) to 12.8 (+/- 10.0), and the mean VHI improved from 52.2 (+/- 24.7) to 41.5 (+/- 25.0) after 6 months of therapy (p = 0.001 and 0.065, respectively). Of the three VHI subscales (emotional, physical, functional), only the functional subscale improved significantly (p = 0.037). Patients who experienced a five point or better improvement in RSI were 11 times more likely to experience a five-point improvement in VHI (95% confidence interval = 1.7, 76.8). For reliability assessment, the first and second pretreatment RSIs were 19.9 (+/- 11.1) and 20.9 (+/- 9.6), respectively (correlation coefficient = 0.81, p < 0.001). The single-item correlation coefficients ranged from 0.41 to 0.91 (p < 0.05 for all items). The mean pretreatment RSI in patients with LPR was significantly higher than controls (21.2 versus 11.6; p < 0.001). The mean RSI of patients with LPR after 6 months of PPI therapy approached that of asymptomatic controls (p > 0.05). The RSI is easily administered, highly reproducible, and exhibits excellent construct and criterion-based validity.",2003.0,0,0
553,12150706,New strategies for the prevention and treatment of Helicobacter pylori infection.,Paolo Ruggiero; Samuele Peppoloni; Duccio Berti; Rino Rappuoli; Giuseppe Del Giudice,"Helicobacter pylori infects the stomach of > 50% of the human population worldwide, with higher prevalence in the developing countries. A strict correlation between H. pylori infection and gastroduodenal diseases has been demonstrated, including gastritis, peptic ulcer and gastric cancer. Current therapies against H. pylori consist of an antisecretory plus antibiotics. These therapies are effective in 80 - 90% of the cases; presently, no alternative therapies have been shown to give comparable or better results. There are two main reasons for therapy failure: poor compliance, which results in cure discontinuation, and antibiotic resistance. To overcome the drawbacks inherent to any antibiotic therapy, a prophylactic vaccine seems to be the most reasonable approach. Vaccines have been developed based on data obtained in animal models, a number of which are currently in Phase I clinical trials, in some cases giving encouraging data for safety and immunogenicity. In the absence of any immunological correlate of protection against H. pylori, it will be possible to evaluate the efficacy of these vaccines only in large Phase III clinical trials.",2003.0,0,0
554,12152963,Proton pump inhibitors: an update.,Bruce T Vanderhoff; Rundsarah M Tahboub,"Since their introduction in the late 1980s, proton pump inhibitors have demonstrated gastric acid suppression superior to that of histamine H2-receptor blockers. Proton pump inhibitors have enabled improved treatment of various acid-peptic disorders, including gastroesophageal reflux disease, peptic ulcer disease, and nonsteroidal antiinflammatory drug-induced gastropathy. Proton pump inhibitors have minimal side effects and few significant drug interactions, and they are generally considered safe for long-term treatment. The proton pump inhibitors omeprazole, lansoprazole, rabeprazole, and the recently approved esomeprazole appear to have similar efficacy.",2002.0,0,0
555,12163100,Impact of Helicobacter pylori and nonsteroidal anti-inflammatory drugs on gastric ulcerogenesis in experimental animals and in humans.,Teresa Pawlik; Peter C Konturek; Jan W Konturek; Stanislaw J Konturek; Tomasz Brzozowski; Marta Cześnikiewicz; Malgorzata Plonka; Władysław Bielanski; Hany Areny,"Helicobacter pylori (H. pylori) and nonsteroidal anti-inflammatory drugs (NSAID) are the most common pathogens in the gastroduodenal mucosa in animals and humans, but their relationship in ulcerogenesis has been little studied. According to some authors, H. pylori infection in humans does not act synergistically with NSAID on ulcer healing, therefore, there is no need to eradicate the germ. This notion is supported by the finding that the eradication of H. pylori does not affect NSAID-induced gastropathy treated with omeprazole and that H. pylori infection induces a strong cyclooxygenase-2 expression resulting in excessive biosynthesis of gastroprotective prostaglandins, which should in turn counteract NSAID-induced gastropathy and heal the existing ulcer. Other investigators claim that H. pylori infection acts synergistically with NSAID on ulcer development, therefore, H. pylori should be eradicated, particularly at the start of long-term NSAID therapy. Maastricht 2-2000 consensus also recommends eradication prior to NSAID treatment, but this eradication does not appear to accelerate ulcer healing or to prevent the recurrent ulcers in NSAID users. Our studies in almost 6,000 dyspeptic patients undergoing upper endoscopy and [(13)C]-urea breath test (UBT) revealed that about 70% of these patients are H. pylori (+) and about 30.6% of these develop gastroduodenal ulcers. Of these ulcers, over 70% were H. pylori (+) positive, 12% NSAID (+), 8% were both H. pylori (+) and NSAID (+), while 22% ulcers were H. pylori (-) and NSAID (-) or ""idiopathic"" ulcers. Basically, our results support Hawkey's concept and this also agrees with our findings in the rat model showing that: (1) there is no synergistic interaction between H. pylori infection and NSAID on gastric ulcer development, (2) H. pylori and NSAID are independent risk factors for peptic ulceration, and (3) NSAID therapy in H. pylori positive patients attenuates the ulcer development possibly due to direct inhibitory action of these drugs on H. pylori.",2003.0,0,0
556,12165818,Preoperative symptom evaluation and esophageal acid infusion predict response to laparoscopic Nissen fundoplication in gastroesophageal reflux patients who present with cough.,C J Allen; M Anvari,"Most patients with cough and gastroesophageal reflux disease (GERD) improve on medical treatment with proton pump inhibitors (PPI). Nonresponders may be considered for antireflux surgery, but the selection of patients is difficult. We have performed laparoscopic Nissen fundoplications (LNF) in 677 patients. Of these patients, 81% have undergone 6-month follow-up assessment with 24-h pH testing, esophageal manometry, symptom scores, and quality-of-life scores. LNF controlled heartburn in 93% and improved cough in 81%. Stepwise multiple regression showed that the preoperative cough score (r = 0.620, p <0.0001) and change in cough on and off PPI (r = 0.296, p = 0.0002) predicted improvement after surgery. A positive result on a randomized acid infusion test was associated with a greater improvement in cough after surgery (p = 0.0243). An acid infusion test and assessment of cough on and off PPI may be useful preoperative tools for the selection of patients with cough for LNF.",2002.0,0,0
557,12165819,Assessment of the afferent vagal nerve in patients with gastroesophageal reflux.,D Hong; M Kamath; S Wang; J Tabet; G Tougas; M Anvari,"The objective of this study was to assess the integrity of the vagal nerve afferent pathways in patients with gastroesophageal reflux disease (GERD). Seven GERD patients (4 males and 3 females, mean age 39 +/- 8 years) were studied. Twelve healthy volunteers (11 males and 1 female, mean age 32 +/- 8 years) were used as the control group. Cortical evoked potentials were measured. Electrical stimulation of the esophageal mucosa was performed through a custom-built device. Latencies and N2/P2 amplitude were measured. Reproducible cortical evoked potentials were obtained from all subjects. The stimulation threshold for GERD patients to electrical esophageal stimulation was 5.1 +/- 1.5 mA compared to 7.8 +/- 2.0 mA in healthy volunteers (p <0.05). There was no difference in peak latencies or N2/P2 amplitude between GERD patients and controls. GERD patients have a normal vagal nerve function, but they exhibit a decreased threshold for esophageal perception. The mechanism responsible for increased esophageal sensitivity observed in GERD patients is still undetermined and warrants further study.",2002.0,0,0
558,12170405,Jejunal feeding tubes via gastrostomy in children.,T Doede; S Faiss; F Schier,"The implantation of a jejunal feeding tube, via percutaneous endoscopic gastrostomy (PEG), is a possible method for the treatment of inadequate oral feeding in patients who are affected by gastroesophageal reflux. This study involves a retrospective analysis of all the patients up to 18 years of age, who were treated by means of jejunal feeding tubes at the Universitätsklinikum Benjamin Franklin, Berlin, between 15 September 1995 and 1 August 2000. In all, 76 patients received a PEG, and 12 of them were also given jejunal feeding tubes. One of these patients has experienced no complications. In the other 11 children, 52 changes of jejunal tube have been required. The most important reason for these changes was displacement of the tube into the gastrointestinal tract, resulting from technical problems with the connecting section. Jejunal feeding tubes in patients with gastrostomy are an alternative to fundoplication and drugs. However, a high rate of changes is to be expected.",2002.0,0,0
559,12171952,"Primary prevention of diclofenac associated ulcers and dyspepsia by omeprazole or triple therapy in Helicobacter pylori positive patients: a randomised, double blind, placebo controlled, clinical trial.",J Labenz; A L Blum; W W Bolten; B Dragosics; W Rösch; M Stolte; H R Koelz,"There is much controversy as to whether or not treatment of Helicobacter pylori reduces the occurrence of peptic ulcers during therapy with a non-steroidal anti-inflammatory drug (NSAID). To assess the efficacy of triple therapy or omeprazole on the occurrence of diclofenac associated ulcers in H pylori positive patients. This was a randomised, double blind, placebo controlled, multicentre trial in H pylori positive patients requiring NSAID therapy who had no past or current peptic ulcer. They received diclofenac 50 mg twice daily for five weeks in combination with one of the four randomly assigned treatments: anti-H pylori treatment for one week (omeprazole 20 mg+clarithromycin 500 mg+amoxicillin 1 g, all twice daily) followed by placebo for four weeks (OAC-P); anti-H pylori treatment for one week followed by antisecretory treatment with omeprazole 20 mg once daily for four weeks (OAC-O); omeprazole 20 mg once daily for five weeks (O-O); or placebo for five weeks (P-P). Patients were endoscoped before and after treatment. Data from 660 patients were included in an intention to treat analysis. The occurrence of peptic ulcers in the four treatment groups during the study period was: 1.2% for OAC-P, 1.2% for OAC-O, 0% for O-O, and 5.8% for P-P (p<0.05 between placebo and all active treatment groups). Patients who received active treatment developed therapy requiring dyspeptic symptoms less frequently than those who received placebo (p<0.05 between placebo and all active treatment groups). In H pylori infected patients, all three active therapies reduced the occurrence of NSAID associated peptic ulcer and dyspeptic symptoms requiring therapy.",2002.0,0,1
560,12171953,Relative contribution of mucosal injury and Helicobacter pylori in the development of gastroduodenal lesions in patients taking non-steroidal anti-inflammatory drugs.,C J Hawkey; J Naesdal; I Wilson; G Långström; A J Swannell; R A Peacock; N D Yeomans,"A past history of peptic ulceration increases the risk of an ulcer developing during non-steroidal anti-inflammatory drug (NSAID) use. Whether this is due to Helicobacter pylori infection or to reactivation of the original lesion is unclear. We used multivariate regression analyses of three large similar trials to identify factors that placed patients at high risk of ulcer development or relapse. We compared the efficacy of omeprazole 20 mg daily, misoprostol 200 micro g twice daily, and ranitidine 150 mg twice daily in preventing ulcers and erosions at different sites and in patients who were H pylori positive and negative. Patients with endoscopic lesions (which healed) initially were significantly more likely than those without to develop further erosions or ulcers during treatment (rate ratio 2.12, 1.07-4.17). Risk mounted further with ulcers versus erosions, particularly those that had been slow to heal. There was a highly significant tendency for the relapse lesion to replicate the site and type of the original lesion (mean odds ratios ranging from 3 to 14). Treatment failure was significantly less likely with omeprazole than with placebo, misoprostol, or ranitidine. This advantage was especially evident in H pylori positive patients receiving acid suppression (5.7% v 16.6% for gastric ulcer with omeprazole). Relapse of lesions in patients taking NSAIDs was highly site and type specific and not adversely affected by H pylori status. This strongly implies that local mucosal factors predispose to ulcer development in patients taking NSAIDs. Identification of the responsible mucosal changes would aid understanding and could promote better treatment.",2002.0,0,0
561,12171954,Influence of sex and Helicobacter pylori on development and healing of gastroduodenal lesions in non-steroidal anti-inflammatory drug users.,C J Hawkey; I Wilson; J Naesdal; G Långström; A J Swannell; N D Yeomans,"Factors predisposing to endoscopic ulcer formation or healing with non-steroidal anti-inflammatory drugs (NSAIDs) have not been well defined. We used multivariate analysis of data from three large similar trials to identify factors associated with endoscopic lesions and healing. We compared the effectiveness of omeprazole 20 mg and 40 mg daily, misoprostol 200 micro g four times daily, and ranitidine 150 mg twice daily in healing ulcers and erosions at different sites and in patients who were Helicobacter pylori positive and negative. Older age, past ulcer history, rheumatoid arthritis, and H pylori infection were significantly associated with ulcers. Duodenal ulcer was significantly more likely than gastric ulcer with a past ulcer history (odds ratio 1.59, 1.16-2.17), H pylori infection (1.4, 1.04-1.92), and male sex (2.35, 1.75-3.16) while female sex, older age (> or = 60 years: 1.39, 1.03-1.88), and higher NSAID dose (>1 defined daily dose: 1.57, 1.16-2.14) were associated with gastric ulceration. Sex differences were seen in both H pylori positive and negative patients. Gastric and duodenal ulcer healing was significantly faster with omeprazole 20 mg than with misoprostol 200 micro g four times daily or ranitidine 150 mg twice daily although misoprostol was more effective at healing erosions. Gastric ulcer healing was slower with large ulcers (0.37, 0.25-0.54 for >10 mm v 5-10 mm) or a past ulcer history (0.51, 0.34-0.76), and faster with H pylori infection (1.55, 1.06-2.29), especially with acid suppression (72% v 37% at four weeks with ranitidine). Among NSAID users, H pylori and male sex independently increase the likelihood of duodenal ulceration. H pylori infection does not affect duodenal ulcer healing and enhances gastric ulcer healing by ranitidine and possibly other acid suppressing treatments.",2002.0,0,0
562,12172406,Esomeprazole 40 mg and 20 mg is efficacious in the long-term management of patients with endoscopy-negative gastro-oesophageal reflux disease: a placebo-controlled trial of on-demand therapy for 6 months.,Nicholas J Talley; Thomas L Venables; Jonathan R B Green; David Armstrong; Kevin P J O'Kane; Mustafa Giaffer; Karna D Bardhan; Rolf G S Carlsson; Samuel Chen; Göran S Hasselgren,"On-demand therapy may offer an effective approach to the long-term management of gastro-oesophageal reflux disease (GORD) without oesophagitis. To examine the efficacy of the novel proton pump inhibitor esomeprazole as on-demand therapy in endoscopy-negative GORD. Endoscopy-negative GORD patients who achieved complete resolution of heartburn after short-term esomeprazole or omeprazole treatment (n = 721) were randomized to esomeprazole 20 mg (n = 282), 40 mg (n = 293) or placebo (n = 146) on demand (maximum one dose/day) for 6 months. The primary and secondary efficacy endpoints were time to study discontinuation due to (i) unwillingness to continue and (ii) inadequate control of heartburn, respectively. Both doses of esomeprazole were more effective than placebo. During the 6-month period, 42% of placebo recipients discontinued treatment due to unwillingness to continue, compared with 8% and 11% of esomeprazole 20 mg and 40 mg recipients, respectively. Overall, more patients treated with esomeprazole were free from gastrointestinal symptoms after 6 months of on-demand therapy. Esomeprazole 20 mg was superior to placebo for on-demand treatment of GORD; a higher dose did not confer additional clinical benefit. Over 90% of patients were willing to continue on-demand treatment with esomeprazole 20 mg over a 6-month period.",2002.0,0,0
563,12172417,One week regimen of esomeprazole based triple therapy is sufficient for duodenal ulcer healing and Helicobacter pylori eradication in patients with duodenal ulcer disease.,Yim Heng Boon; Charles Vu; Sunil Kaushik; Chia Siew Cheng; Tan Chi Chiu; Lim Chee Chian,,2002.0,0,0
564,12174375,Arterial chemotherapy of 5-fluorouracil and mitomycin C in the treatment of liver metastases of colorectal cancer.,Lian-Xin Liu; Wei-Hui Zhang; Hong-Chi Jiang; An-Long Zhu; Lin-Feng Wu; Shu-Yi Qi; Da-Xun Piao,"Regional chemotherapy using hepatic artery catheters is a good method of treating patients with colorectal cancer liver metastases. We investigated the survival of patients with liver metastases from colorectal cancer using 5-fluorouracil (5-FU) and mitomycin C Cthrough implantable hepatic arterial infusion port. Seventy-five patients with inoperable liver metastases from colorectal cancer were included between March, 1992 and November, 2001. We placed implantable hepatic arterial catheter (HAC) port by laparotomy. 5-FU, 1 000 mg/ m(2)/d continuous infusion for five days every four weeks, was delivered in the hepatic arterial catheter through the port. Mitomycin C, 30 mg/m(2)/d infusion in the first day every cycle through the port. Response to the treatment was evaluated by serial determinations of plasma CEA and imaging techniques consisting of computerized tomography and sonography of liver. Sixty-eight were performed hepatic artery chemotherapy and fifty-six were followed up among seventy-five HAC patients. Twenty-six patients(46.4 %) have responded and 4 complete remission were achieved. Eight patients (14.3 %) had stable liver metastases. Twenty-two patients (39.3 %) were progressed with increased tumor size and number. Twenty-nine patients(51.8%) had a decreased serum CEA level, while 10 patients (17.9 %) were stable and 17 patients (30.4 %) had an increased serum CEA level. There were no operative death in this series. Complications, which occurred in 18 patients (32.1 %), were as followed: hepatic artery thrombosis in 11, Upper gastric and intestinal bleeding in 3, liver abscess in 1, pocket infection in 1, cholangitis in 1, and hepatic artery pseudo-aneurysm in one patient. Combined infusion of 5-FU and mitomycin C by hepatic artery catheter port is an effective treatment for liver metastases from colorectal cancer. The high response and lower complication rates prove the adjuvant treatment of colorectal cancer with this treatment.",2002.0,0,0
565,12177723,Early relief of upper gastrointestinal dyspeptic symptoms: a survey of empirical therapy with pantoprazole in Canadian clinical practice.,David Armstrong; Farouk Kazim; Marcel Gervais; Myron Pyzyk,"Upper gastrointestinal symptoms attributable to gastroesophageal reflux disease or peptic ulcer are common, but the outcome of proton pump inhibitor therapy in clinical practice is not well documented. To assess the range of upper gastrointestinal acid-related symptoms in clinical practice and the rapidity of their response to pantoprazole (40 mg daily), after seven days of therapy. A total of 726 Canadian physicians (65.3% family physicians) recorded a working diagnosis and alarm features in eligible patients, who then recorded the severity of eight upper gastrointestinal symptoms in a daily symptom diary during the first week of therapy. Complete data were obtained from 2273 (37.3% male) of 3261 patients; physicians diagnosed reflux esophagitis alone (66.9%), peptic ulcer (9.7%), other upper gastrointestinal disorders (12.3%) and reflux esophagitis with another diagnosis (11.1%). Alarm features were common (29.6%), but a history of gastrointestinal blood loss was rare (less than 1%). Mean daytime heartburn scores decreased from 2.59 to 1.40, and epigastric pain scores decreased from 2.54 to 1.56 over the first week (P<0.00001); the proportions of patients who became symptom-free were 68.1% and 55.4%, respectively. Decreased mean symptom scores were also observed for acid regurgitation (2.21 to 1.35), bloating (2.47 to 1.57), nausea (2.03 to 1.36), slow digestion (2.51 to 1.56) and burping (2.56 to 1.69). The percentage of patients with severe or very severe symptoms decreased from 53.5% to 13.8% at day 7. The physician's initial diagnosis was not predictive of outcome. In a predominantly primary care population with upper gastrointestinal acid-related symptoms, proton pump inhibitor therapy produces prompt symptomatic relief in most patients. Potential alarm symptoms are common, and further research is required to determine the absolute risk of alarm symptoms and their implications for empirical therapy.",2002.0,0,0
566,12182742,Impact of Helicobacter pylori eradication on heartburn in patients with gastric or duodenal ulcer disease -- results from a randomized trial programme.,P Malfertheiner; J Dent; L Zeijlon; P Sipponen; S J O Veldhuyzen Van Zanten; C-F Burman; T Lind; M Wrangstadh; E BayerdOrffer; J Lonovics,"Helicobacter pylori infection has been proposed as a protective factor against the development of gastro-oesophageal reflux disease. To study heartburn and endoscopic findings before and after H. pylori eradication therapy in patients with peptic ulcer disease. In a multicentre trial programme, patients (n = 1497) were randomized to the omeprazole triple therapy group or to the control group, and were followed for 1-6 months after treatment. Patients in whom the infection was eradicated were compared with those in whom infection persisted. The severity of heartburn was measured at baseline and at each return visit. Endoscopy was performed 6 months after therapy in two of the five studies. In patients with duodenal ulcer, there was a significantly lower prevalence of heartburn after successful eradication of H. pylori relative to that after failed eradication (estimated odds ratio, 0.48). The reduction in the prevalence of heartburn in patients with gastric ulcer was independent of the post-treatment H. pylori status. In studies in which ulcer relapse was included in the model, this factor emerged as a significant factor for heartburn. The observed incidence of oesophagitis at the last visit was not influenced by H. pylori status. Eradication of H. pylori in patients with peptic ulcer disease was associated with a reduced prevalence of heartburn. Prevention of ulcer relapse could be the true cause of this reduction.",2003.0,0,1
567,12182745,"Efficacy of quadruple therapy with pantoprazole, bismuth, tetracycline and metronidazole as rescue treatment for Helicobacter pylori infection.",D Boixeda; F Bermejo; C Martín-De-Argila; A López-Sanromán; V Defarges; F Hernández-Ranz; J M Milicua; A García-Plaza,"To study the efficacy of a 7-day quadruple regimen combining pantoprazole, bismuth, tetracycline and metronidazole as rescue treatment for Helicobacter pylori infection after failure of standard triple therapy. A prospective study was made of 140 patients infected with H. pylori and diagnosed with peptic ulcer or non-ulcer dyspepsia in whom triple therapy with proton pump inhibitor, clarithromycin and amoxicillin had failed. The patients were treated with quadruple therapy including pantoprazole, 40 mg twice daily, colloidal bismuth subcitrate, 120 mg four times daily, tetracycline, 500 mg four times daily, and metronidazole, 500 mg three times daily, for 7 days. Two months after completion of therapy, a 13C-urea breath test was performed to confirm eradication. With quadruple therapy, the H. pylori eradication rates were 82% (95% confidence interval (CI), 75-88%) by 'intention-to-treat' and 85% (95% CI, 79-91%) by 'per protocol'. No major side-effects were observed. No differences in eradication success were observed in relation to underlying disease (peptic ulcer: 85% (95% CI, 76-91%) vs. non-ulcer dyspepsia: 83% (95% CI, 68-93%)) or smoking habits (smokers: 86% (95% CI, 75-93%) vs. non-smokers: 83% (95% CI, 71-91%)). Quadruple therapy with pantoprazole, bismuth, tetracycline and metronidazole for 7 days is an effective H. pylori eradication treatment for patients in whom standard triple therapy has failed.",2003.0,0,0
568,12184168,"[Evaluation of efficacy, safety and tolerability rabeprazole in treatment of acid-peptic diseases ].",José Alves de Freitas; Lúcia Maria Praciano Lima; José Luiz Ranieri; Júnior Cláudio Olivieri; Hélio José Fragoso; Décio Chinzon,"Rabeprazole, a substituted benzimidazole, represents a new generation of proton pump inhibitors that has recently been approved by the FDA and European Union for treatment of acid-related diseases. To assess the efficacy and tolerability of rabeprazole 20 mg in actual conditions of use in everyday clinical practice on subjects with diagnosis of erosive gastroesophageal reflux disease and/or gastric and/or duodenal ulcer. A total of 171 outpatients (55% men, 45% women) with a mean age of 42.5 years were enrolled in this trial. The majority of subjects (81.0%) were Caucasians. Patients with endoscopically confirmed erosive/ulcerative gastroesophageal reflux disease (Savary-Miller classification), duodenal ulcer and/or benign gastric ulcer were eligible to receive rabeprazole 20 mg once daily for 4 to 8 weeks, depending on the diagnosis and at investigators' discretion. Patients were requested to record their symptoms in a diary card in a daily basis. One hundred and sixty two patients completed the study in accordance with the protocol. Reflux esophagitis was diagnosed in 78 (48.1%) patients, duodenal ulcer in 39 (24.1%) and gastric ulcer in 24 (14.8%). Eleven (6.8%) patients presented reflux esophagitis associated with duodenal ulcer and 7 (4.3%) associated with gastric ulcer. Finally, 3 (1.9%) presented both gastric and duodenal ulcer. Fifty-three percentage of patients were free of symptoms on the first day of treatment and 89.5% after a week. The healing rate was 84.4% for patients with reflux esophagitis, 90.6% for duodenal ulcer and 90.9% for gastric ulcer. The adverse effects were minimal and transitory. Rabeprazole is highly effective and well tolerated in acute healing of reflux esophagitis and peptic ulcers. In addition, it provides fast symptoms relief.",2002.0,0,0
569,12185876,Posterior laryngitis: effects of treatment with omeprazole alone.,M Rodríguez-Téllez; H Galera-Ruiz; F Argüelles-Arias; I Carmona; F Muñoz-Borje; J M Herrerías,"To evaluate the effect of omeprazole treatment on the symptoms and lesions of patients with posterior laryngitis (PL). Twenty-one patients with a clinical and laryngoscopic diagnosis of PL were studied. Results for each laryngeal symptom (dysphonia, hoarseness, cough, foreign body sensation, and burning) and laryngoscopic finding (mucus stasis, erythema, oedema, hypertrophy, ulceration, and granulation) at baseline, 12 weeks after treatment with omeprazole, 20 mg twice daily, and 12 weeks after treatment discontinuation were compared. No changes in their hygienic-dietary or postural habits were recommended. A reduction in symptom severity and frequency was observed (p < 0.05), as well as in the severity of laryngoscopic findings (p < 0.05)--except for granulation--immediately after treatment discontinuation. A relapse of laryngoscopic findings was seen at 12 weeks after treatment discontinuation (p < 0.01). The trend towards symptom recurrence was not significant. Treatment with omeprazole alone modifies clinical manifestations and endoscopic findings in patients with PL. Controlled clinical trials with a high number of patients and longer-term follow-up are needed to define the best therapeutic regimen for these patients.",2002.0,0,0
570,12185929,GORD and Barrett's oesophagus: does oesophageal motility matter?,Manuel Rodríguez-Téllez,,2002.0,0,0
571,12187086,Treatment modalities and outcome of the renal victims of the Marmara earthquake.,Mehmet Sükrü Sever; Ekrem Erek; Raymond Vanholder; Mehmet Koc; Mahmut Yavuz; Hulya Ergin; Rumeyza Kazancioglu; Kamil Serdengecti; Gunay Okumus; Nurhan Ozdemir; Ralf Schindler; Norbert Lameire; Marmara Earthquake Study Group,"Treatment of renal problems during natural catastrophes is highly complicated both for medical and logistic reasons. The therapeutic interventions applied to and the outcome of 639 victims with acute renal problems during the catastrophic Marmara earthquake have been the subject of this study. Questionnaires regarding information about 63 clinical and laboratory variables were sent to 35 reference hospitals that treated the victims. Information considering therapeutic interventions and outcome obtained through these questionnaires was submitted to analysis. At least one form of renal replacement therapy was administered to 477 (74.6%) of the 639 victims. Of these, 437, 11, and 4 were treated solely by intermittent hemodialysis, continuous renal replacement therapy, and peritoneal dialysis, respectively; 25 victims needed more than one dialysis modality. In total, 5,137 hemodialysis sessions were performed. Also, 2,981, 2,837 and 2,594 units of blood, fresh frozen plasma, and human albumin were administered, respectively. Transfusion of these products was usually associated with higher rates of dialysis needs and mortality. Ninety-seven patients (15.2%) died. The mortality rate of dialyzed victims was higher as compared to nondialyzed ones (17.2 vs. 9.3%, p = 0.015). Massive amounts of dialysis treatment as well as blood and blood product transfusions can be necessary in the treatment of catastrophic earthquake victims with nephrological problems. Despite the potential risk of a high mortality, in the case of appropriate and energetic medical interventions, reasonable final outcomes can be achieved.",2003.0,0,0
572,12187761,[Prostaglandin derivatives--indication and critical points].,Tetsuo Arakawa; Kazuhide Higuchi; Yasuhiro Fujiwara; Toshio Watanabe; Kazunari Tominaga,"After discovery of H. pylori, management of peptic ulcer disease (PUD) is getting much easier. However, four thousands a year still died caused by this disease in Japan. Ten to twenty percent of the non-NSAIDs ulcer could be expected to remain after complete eradication of H. pylori; The number could be still 100,000-200,000 a year in Japan. Furthermore, NSAIDs ulcer would not decrease in number in the post-H. pylori era. Recurrence of ulcer is related to the quality of ulcer healing. Deficiency of prostaglandins(PG) in the mucosa is another main reason than H. pylori infection of poor quality of ulcer healing. Therefore, a PG analogue may be a most reasonable tool for treatment of H. pylori-negative PUD including NSAIDs ulcer, but is often poorly tolerated because of diarrhea and abdominal pain. The mucosal damage caused by NSAIDs is also gastric acid-dependent and so, an H2-receptor antagonist is to some extent effective although the efficacy is far behind of that with a PG-analogue. Recently, a proton-pump inhibitor has been reported to exert the same effect as a PG-analogue in healing of gastroduodenal mucosal damage caused by NSAIDs and the superior effect in preventing recurrence of the damage with better tolerance. This results suggest that strong acid inhibition is highly effective for such damage. Whether such strong acid inhibition causes disturbance of absorption of NSAIDs is not clear, which might result in poor antiinflammatory effect. Elderly patients often have tendency of constipation and less possibility of pregnancy. Therefore, a PG-analogue may be not only safe but also more favorable for such patients.",2002.0,0,0
573,12192254,Juvenile scleroderma.,Balu H Athreya,"Scleroderma is a relatively rare disorder in children. Among its subsets, localized scleroderma is more common in children than the systemic variety. No exciting new finding was reported in 2001 specifically applicable to childhood scleroderma. However, many new advances in our understanding of the growth factors, cytokines, and chemokines were reported. These studies should help us to understand the pathogenesis of early lesions of scleroderma, vascular changes, and fibrosis and perhaps lead us toward more rational therapy.",2003.0,0,0
574,12197909,Helicobacter pylori: the challenge in therapy.,Franco Bazzoli; Paolo Pozzato; Theodore Rokkas,"For the therapeutic management of Helicobacter pylori infection, the Maastricht 2-2000 Consensus Report have introduced the concept of the 'treatment package' that considers first- and second-line eradication therapies together. According to this consensus statement, the first-line therapy for H. pylori eradication is a combination of the proton pump inhibitors (PPI) or ranitidine bismuth citrate (RBC) and claritromycin plus either amoxicillin or metronidazole. The second-line treatment is suggested to be PPI-quadruple therapy for a minimum of 7 days. If bismuth compounds are not available, PPI-based triple therapy will have to be used as a second-line treatment only after susceptibility testing. Since no considerable progress has been made during the past year in treatment regimens, there is still a need for new compounds that are specific for H. pylori, which could constitute future therapies.",2002.0,0,0
575,12197911,Helicobacter pylori infection in geriatrics.,Alberto Pilotto; Nathalie Salles,"The prevalence of Helicobacter pylori infection increases with age worldwide. However, the percentage of H. pylori-positive elderly patients who are tested and treated for their infection remains very low. We now have data that demonstrate the benefit of curing H. pylori infection in elderly patients with H. pylori-associated peptic ulcer disease and severe chronic gastritis. Furthermore, the cure of H. pylori may prevent progression of intestinal metaplasia and gastric atrophy. Studies are needed to clarify the role of eradication for elderly patients who have nonulcer dyspepsia, gastroesophageal reflux disease and who use nonsteroidal anti-inflammatory drugs. H. pylori infection may be easily diagnosed by histological evaluation, rapid urease test or culture performed on gastric biopsies taken during endoscopy. However, the biopsy site must be carefully selected in elderly patients. For noninvasive monitoring of H. pylori infection after treatment, the 13C-urea breath test has significantly higher accuracy than serology in the elderly. The role of the H. pylori stool antigen test in old age still needs to be clarified. One-week PPI-based triple therapy regimens including clarithromycin, amoxycillin and/or nitroimidazoles are highly effective and well tolerated in elderly patients. Low doses of both PPIs and clarithromycin (in combination with standard doses of amoxycillin or nitroimidazoles) are sufficient. Antibiotic resistance and low compliance are the main factors related to treatment failure at any age.",2002.0,0,0
576,12200646,Short-term omeprazole treatment does not influence biochemical parameters of bone turnover in children.,I Kocsis; A Arató; H Bodánszky; L Szönyi; A Szabó; T Tulassay; B Vásárhelyi,"Gastric proton pump inhibitors are widely used in the treatment of dyspeptic problems and for the eradication of H. pylori infection. Data are not available on whether omeprazole, a representative of proton pump inhibitors, influences the function of osteoclastic H+-pump in children. We studied the impact of short-term omeprazole administration on the biochemical parameters of bone turnover in pediatric patients. Urinary calcium excretion, serum total alkaline phosphatase activity, collagen type 1 crosslinked C-telopeptide, and osteocalcin levels were determined in 34 children [20 girls (9 prepubertal) and 14 boys (6 prepubertal)] before and after 2 weeks of omeprazole treatment at a dose of 20 mg/day. The measured parameters were within the healthy reference range in each patient. None of them altered during the study in any age or in any gender. We conclude that omeprazole, at a dose of 20 mg/day, does not significantly influence the investigated biochemical parameters of osteoclast and osteoblast function in pediatric patients.",2003.0,0,0
577,12207836,Dietary antioxidants and DNA damage in patients on long-term acid-suppression therapy: a randomized controlled study.,K L M White; D M Chalmers; I G Martin; S M Everett; P M Neville; G Naylor; A E Sutcliffe; M F Dixon; P C Turner; C J Schorah,"Free radicals and reactive species produced in vivo can trigger cell damage and DNA modifications resulting in carcinogenesis. Dietary antioxidants trap these species limiting their damage. The present study evaluated the role of vitamins C and E in the prevention of potentially premalignant modifications to DNA in the human stomach by supplementing patients who, because of hypochlorhydria and possible depletion of gastric antioxidants, could be at increased risk of gastric cancer. Patients undergoing surveillance for Barrett's oesophagus (n 100), on long-term proton pump inhibitors were randomized into two groups: vitamin C (500 mg twice/d) and vitamin E (100 mg twice/d) for 12 weeks (the supplemented group) or placebo. Those attending for subsequent endoscopy had gastric juice, plasma and mucosal measurements of vitamin levels and markers of DNA damage. Seventy-two patients completed the study. Plasma ascorbic acid, total vitamin C and vitamin E were elevated in the supplemented group consistent with compliance. Gastric juice ascorbic acid and total vitamin C levels were raised significantly in the supplemented group (P=0.01) but supplementation had no effect on the mucosal level of this vitamin. However, gastric juice ascorbic acid and total vitamin C were within normal ranges in the unsupplemented group. Mucosal malondialdehyde, chemiluminescence and DNA damage levels in the comet assay were unaffected by vitamin supplementation. In conclusion, supplementation does not affect DNA damage in this group of patients. This is probably because long-term inhibition of the gastric proton pump alone does not affect gastric juice ascorbate and therefore does not increase the theoretical risk of gastric cancer because of antioxidant depletion.",2002.0,0,0
578,12220416,"Surgical therapy for Barrett's esophagus: prevention, protection and excision.",T R DeMeester,,2003.0,0,0
579,12220421,Photodynamic therapy for Barrett's esophagus: a review.,C J Kelty; S L Marcus; R Ackroyd,"Barrett's esophagus is the major risk factor for the development of esophageal adenocarcinoma, which is increasing in incidence faster than any other cancer in the Western world. Barrett's esophagus has previously been considered an irreversible lesion that required life-long surveillance to detect malignant transformation. However, endoscopic ablative techniques to destroy the abnormal mucosa and allow squamous regeneration have now been developed. Photodynamic therapy (PDT) is a non-thermal technique where the interaction of a photosensitizer in the tissues and light of a known wavelength results in tissue destruction. It appears to be an effective tool for ablating dysplasia and superficial cancers in Barrett's esophagus. The status of PDT for this disease is reviewed.",2003.0,0,0
580,12220426,Laparoscopic fundoplication in mentally normal children with gastroesophageal reflux disease.,K V Menon; M Booth; J Stratford; T C B Dehn,"Laparoscopic antireflux surgery has been performed in neurologically impaired and scoliotic children. We aimed to assess the effectiveness of laparoscopic fundoplication in mentally normal children with gastroesophageal reflux disease that failed to respond to medical therapy. Data were prospectively collected (symptoms, medical therapy, endoscopies' findings) on 12 children (nine boys, three girls) aged 9-15 years with gastroesophageal reflux disease. Pre- and postoperative ambulatory 24-h pH and DeMeester and Johnson scores were also recorded. Effectiveness of surgery was assessed by comparison of pre- and postoperative total acid exposure time, Visick grade, need for antireflux medication and symptom scores. In total, 11 children underwent a laparoscopic Nissen fundoplication and one underwent a Toupet procedure. Median length of stay was 2 (2-3) nights. The median preoperative pH acid exposure time (AET) was 4.7 (0.8-16.4) percent compared with postoperative AET of 0.4 (0-3) percent. Early postoperative dysphagia occurred in four out of 12 patients, requiring a total of six dilatations. Postoperative Visick scores were: grade I=7 and grade II=5. Laparoscopic fundoplication can be safely performed and is effective in children with GERD who have failed to respond to medical therapy.",2003.0,0,0
581,12230655,Gastro-oesophageal reflux in children.,Yadlapalli Kumar; Rajini Sarvananthan,,2002.0,0,0
582,12235064,Laparoscopic fundoplication is the treatment of choice for gastro-oesophageal reflux disease. Protagonist.,L Lundell,,2002.0,0,0
583,12235065,,,,,0,0
584,12244498,Risk assessment and prediction of rebleeding in bleeding gastroduodenal ulcer.,A Guglielmi; A Ruzzenente; M Sandri; R Kind; F Lombardo; L Rodella; F Catalano; G de Manzoni; C Cordiano,"The aims of this study were to identify risk factors for recurrence of hemorrhage in bleeding gastroduodenal ulcers after endoscopic injection therapy, and to develop a simple and relevant prognostic score which could be used to assess the early risk of recurrence and the residual risk of rebleeding. A prospective study was conducted from January 1995 to December 1998, in 738 patients who were admitted to our department for acute bleeding peptic ulcer and who underwent endoscopic examination. Ulcers with active bleeding or signs of recent bleeding were treated with injection therapy using epinephrine (1/10,000) and 1% polidocanol. Multivariate analysis revealed that liver cirrhosis, recent surgery, systolic blood pressure below 100 mmHg, hematemesis, Forrest classification, and ulcer size and site were significantly predictive variables for the recurrence of hemorrhage. Among these, Forrest classification was the most important. The overall accuracy of the predictive model was 71% (95% CI = 63 - 79%). The model showed a better sensitivity of 90% for early rebleeding (< 48 hours) than for late rebleeding (> or = 48 hours) where the sensitivity was 65 %. A prognostic score was obtained and patients were classified into four risk classes: very low (VL), low (L), high (H), and very high (VH). The rebleeding rates for the four classes were 0%, 7.9%, 31.8% and 67.9%, and the mortality rates were 5.9%, 8.6%, 13.9% and 35.7%, respectively. The residual risk of rebleeding after 48 hours was 0%, 3.3%, 10.4%, and 14.3% in the VL, L, H and VH classes, respectively. After 5 days the residual risk was under 4% in all classes. This study demonstrates that the proposed prognostic score, which is easily obtained after emergency endoscopy, is useful in clinical practice because it can identify patients with different levels of rebleeding risk. It can be helpful in patient management and decision making for discharge.",2003.0,0,0
585,12269842,"Gastroesophageal reflux in children: pathogenesis, prevalence, diagnosis, and role of proton pump inhibitors in treatment.",Benjamin D Gold; James W Freston,"A substantial percentage of infants, children and adolescents experience gastroesophageal reflux disease (GERD) and its accompanying symptoms, as well as disease complications. The diagnosis of GERD in children is made based upon the child's history, and data derived primarily from pH monitoring tests and endoscopy. In those children with confirmed reflux disease, the options for management parallel those recommended in adult patients, with the first step consisting of lifestyle changes. Surgical procedures may also be performed; however, these are rarely recommended prior to an adequate course of pharmacologic therapy, and appropriate case selection is important. Among the current pharmacotherapeutic options available in the US, the prokinetic agents and the acid-inhibitory agents (histamine-2 receptor antagonists, proton pump inhibitors) are the most widely used. The clinical utility of the prokinetic agents has been limited by the recent withdrawal of cisapride from the US marketplace and the potential for irreversible central nervous system complications with metoclopramide. Numerous clinical studies performed in adults, and several studies involving children, have demonstrated that the proton pump inhibitors are more effective than the histamine-2 receptor antagonists in the relief of GERD symptoms and healing of erosive esophagitis. In children, omeprazole and lansoprazole may be administered as the intact oral capsule, or in those who are unable or unwilling to swallow, the granule contents of the capsule may be mixed with soft foods (e.g. apple sauce) or fruit drinks/liquid dietary supplements prior to oral administration with no detrimental effects on pharmacokinetics, bioavailability, or pharmacodynamics. Studies performed with omeprazole and lansoprazole in children have shown pharmacokinetic parameters that closely resemble those observed in adults. In over a decade of use in adults, the proton pump inhibitor class of agents has been found to have a good safety profile. Studies involving children have also shown these agents to be well tolerated. In numerous drug-drug interaction studies performed with these two proton pump inhibitors, relatively few clinically significant interactions have been observed.",2003.0,0,0
586,12352293,"Short course of omeprazole: a better first diagnostic approach to noncardiac chest pain than endoscopy, manometry, or 24-hour esophageal pH monitoring.",William M Pandak; Shahwali Arezo; Sharon Everett; Robert Jesse; Gail DeCosta; Theresa Crofts; Chris Gennings; Michael Siuta; Alvin Zfass,"Noncardiac chest pain (NCCP) presents as a frequent diagnostic challenge, with patients tending to use a disproportionate level of health care resources. Gastroesophageal reflux disease (GERD) is the most frequent cause of NCCP. To test the efficacy of a potent acid-suppressing agent as a diagnostic test in the evaluation of NCCP and to compare it with three commonly used tests. Eighteen men and 24 women, aged 22 to 77 years, who presented with recurrent chest pain complaints of a noncardiac etiology, as determined by rest/stress perfusion imaging with technetium Tc99m sestamibi (MIBI), were enrolled in a prospective, double-blinded, placebo-controlled, crossover trial using high-dose omeprazole. Thirty-seven patients completed both arms of the trial. Findings were compared with those of endoscopy, manometry, and ambulatory 24-hour two-channel esophageal pH monitoring. All patients underwent initial diagnostic upper endoscopy, esophageal manometry, and 24-hour pH monitoring. Patients were then randomly assigned to either placebo or omeprazole (40 mg/d orally twice daily) for 14 days, washed out for 21 days, and then crossed over. Patient's symptoms were determined using a Visual Analogue Scale to measure the severity of chest pain before and after each period. Seventy-one percent of patients in the omeprazole arm reported improved chest pain, whereas only 18% in the placebo arm did. Abnormal results on manometry (20%), 24-hour pH monitoring (42%), or endoscopy with visual evidence of esophagitis (26%) were found less frequently. Combination of the three tests did not significantly increase their usefulness. In NCCP patients with GERD, as defined by positive results on a 24-hour pH test or presence of esophagitis on endoscopy, omeprazole treatment led to a response in 95% of patients, whereas 90% of GERD-positive patients treated with placebo did not respond. Of NCCP patients determined to be GERD negative, 39% responded to omeprazole. Omeprazole as a first diagnostic tool in the evaluation of MIBI-negative NCCP is sensitive and specific for determining the cause of NCCP. Endoscopy, manometry, and 24-hour pH monitoring were not only less sensitive in diagnosing NCCP, but they were significantly more expensive.",2002.0,0,0
587,12354485,Peptic-ulcer disease.,Francis K L Chan; W K Leung,"The discovery of Helicobacter pylori has greatly changed our approach to peptic ulcer disease. Bacterial, host, and environmental factors all have a role in peptic-ulcer disease. Although the prevalence of uncomplicated peptic ulcers is falling, hospital admissions for ulcer complications associated with non-steroidal anti-inflammatory drugs (NSAIDs) are rising. Evidence suggests that prescription of NSAIDs along with potent antiulcer agents and the use of highly selective cyclo-oxygenase-2 inhibitors reduce gastroduodenal ulceration. Whether these therapeutic advances will translate into clinical benefits remains to be seen. The interaction between H pylori and NSAIDs is one of the most controversial issues in peptic ulcer disease. With the fall in rates of H pylori infection, the proportion of ulcers not related to this organism and NSAIDs has risen, which will affect the management of peptic ulcer.",2002.0,0,0
588,12358234,Effect of H. pylori status on gastric ulcer healing in patients continuing nonsteroidal anti-inflammatory therapy and receiving treatment with lansoprazole or ranitidine.,Donald R Campbell; Marian M Haber; Eric Sheldon; Cyndy Collis; Nancy Lukasik; Bidan Huang; Jay L Goldstein,"The purpose of this research was to determine the impact of pretreatment Helicobacter pylori infection on gastric ulcer healing rates in patients receiving nonsteroidal anti-inflammatory drugs (NSAIDs) and antisecretory medications. This was a pooled, prospective analysis of two identical double blind, multicenter, parallel group studies. Six hundred ninety-two patients receiving NSAIDs and with endoscopy-documented gastric ulcers were enrolled from 90 North American sites in primary care and referral centers. Patients were randomized to receive ranitidine (150 mg b.i.d.) or lansoprazole (15 mg or 30 mg once daily) for 8 wk. Ulcer healing was assessed by endoscopy at 4 and 8 wk in an intent-to-treat population. H. pylori status was determined at baseline by histology. Across all three treatment groups, gastric ulcers were more likely to heal and heal faster if the individual was infected with H. pylori. Healing rates at 8 wk were statistically significantly greater among H. pylori positive patients (n = 181) than among negative patients (n = 497) (70% vs 61%, respectively; p < 0.05), especially among those with large ulcers (> 10 mm) and in younger patients (< 60 yr old). Simple healing rates (regardless of H. pylori status) were significantly better in the 15- and 30-mg lansoprazole groups than in the ranitidine group after 4 wk (46%, 54%, and 32%, respectively; p < or = 0.01) and 8 wk (66%, 74%, and 50%, respectively; p < 0.001). In patients receiving NSAIDs, gastric ulcer healing with an antisecretory agent is significantly enhanced in the presence of H. pylori infection.",2002.0,0,0
589,12360599,[Fromilid (clarithromycin) in eradication patients in patients with duodenal ulcer associated with Helicobacter pylori (comparison of two treatment variations)].,Iu V Vasil'ev; L A Zvenigorodskaia; E V Kolomiets; V Iu Firsanova,"Comparison of two treatment regimens of eradication treatment of duodenal ulcer (DU) associated with Helicobacter pylori based on fromilid (clarithromycin). 20 DU patients associated with HP were divided into two groups. 10 patients of group 1 received omeprazol, fromilid and metronidazol and 10 patients of group 2 were given omeprazol, fromilid and furasolidon for 7 days followed by 2-week omeprazol alone. The patients were examined clinically and endoscopically; HP were detected with a fast urease test and polymerase chain reaction before and after the treatment. Control examinations were performed 6 weeks after the medication. In group 1 duodenal healing was observed in all the 10 patients, HP eradication occurred in 9 of 10 patients by urease test and in 4 patients by PCR, in group 2 in 8 of 10, 10 of 10 and 10 of 10, respectively. Fromilid (clarithromycin) is effective in eradication treatment in combination with fromilid and metronidazol or furazolidon.",2002.0,0,0
590,12360630,Management of dyspepsia.,Shehan Abeygunasekera; Nicholas J Talley,Proper management of uninvestigated dyspepsia is a challenging task for any clinician. Efficient and cost-effective management of such patients requires careful history taking and awareness of the available options.,2003.0,0,0
591,12362215,Motion--Helicobacter pylori worsens GERD: arguments for the motion.,Colm A O'Morain; Asghar Qasim,"There are several reasons for eradicating Helicobacter pylori in patients with chronic gastroesophageal reflux disease (GERD). Perhaps the most compelling is the evidence that chronic acid suppression therapy can lead to the development of atrophic gastritis, a premalignant condition, in patients with H pylori infection. Epidemiological data that suggest that H pylori is less prevalent in GERD patients than in control subjects may be susceptible to publication bias, and confounding social and environmental factors may also be involved. Although it has been thought that eradication of the organism might lead to increased esophageal acid exposure, this has not been demonstrated in practice. Studies that appeared to show that GERD could be provoked by antimicrobial therapy of duodenal ulcers also have methodological weaknesses. Underlying GERD symptoms might be unmasked after withdrawal of acid-suppression therapy, for reasons that are unrelated to H pylori. In fact, eradication of the organism has been shown to decrease heartburn in patients with peptic ulcer disease. When H pylori is successfully eradicated in patients with GERD, relapse rates are not increased, and the disease-free interval seems to be prolonged. Eradication of the organism is a wise policy in patients who face long term acid-suppression therapy for GERD.",2003.0,0,0
592,12362216,Motion--Helicobacter pylori causes or worsens GERD: arguments against the motion.,Kenneth E L McColl,"Data from large epidemiological studies show that Helicobacter pylori is less prevalent in patients with gastroesophageal reflux disease (GERD) than in control subjects. The more virulent cagA-positive strains of the organism are also less commonly seen in patients with erosive esophagitis and in those with Barrett's esophagus than in those with less severe forms of GERD. Although the relationship between H pylori and gastric physiology is complex, the organism has little effect on acid secretion in most North American or Western European subjects, and has a net suppressive effect, especially in elderly subjects, in other parts of the world. Thus, the organism has a potential protective effect against GERD, which is exacerbated by gastric acidity. H pylori has no proven effect on other gastric factors that might provoke reflux, including delayed gastric emptying or inappropriate relaxation of the gastric fundus. Two well-designed interventional studies have found that eradication of H pylori either provoked GERD or had no effect. A third smaller study, which seemed to demonstrate that persistent infection was associated with GERD, was flawed, in that the two treatment groups were not comparable. The evidence thus does not support the idea that H pylori infection provokes or aggravates GERD.",2003.0,0,0
593,12362217,Motion--Laparoscopic Nissen fundoplication is more cost effective than oral PPI administration: arguments against the motion.,Amnon Sonnenberg,"Discussion of the cost effectiveness of medical and surgical treatments of gastroesophageal reflux disease (GERD) is plagued by a number of logical fallacies. Several of these defects in reasoning are reviewed. For example, it is inappropriate to compare the costs of therapies unless they are equally effective. The relative cost effectiveness of various treatment options is difficult to determine because monetary expenditures and gains in health status cannot easily be measured in commensurate units. Not everything can be translated into incremental cost effectiveness ratios. Two decision analyses from European investigators seemed to show that Nissen fundoplication was more cost effective than long term acid-suppression therapy, but they failed to consider the costs of surgical complications and failures. The most comprehensive decision analysis, employing a Markov chain model, found that the two treatment options were roughly equivalent, at least during the first seven years of follow-up. Decision analyses often do not reflect actual practice patterns and cannot provide solutions to problems that cannot be solved by appropriate medical reasoning. Moreover, results that are reported by specialized surgical centres probably cannot be duplicated by less experienced surgeons. The increasing incidence of esophageal adenocarcinoma has been erroneously attributed to the use of potent acid-suppressant medications, but the actual cause has been shown to be the decreased prevalence of Helicobacter pylori. There are no significant differences in the incidence of this tumour after medical or surgical therapy of GERD. It is unlikely, however, that arguments will convince proponents of one treatment or another to change their opinions.",2003.0,0,0
594,12362218,Etiology of dyspepsia: implications for empirical therapy.,Richard H Hunt; Carlo Fallone; Sander Veldhuyzen Van Zanten; Phil Sherman; Nigel Flook; Fiona Smaill; Alan B R Thomson; Canadian Helicobacter pylori Study Group,"Dyspepsia describes a symptom complex thought to arise in the upper gastrointestinal tract and includes, in addition to epigastric pain or discomfort, symptoms such as heartburn, acid regurgitation, excessive burping or belching, a feeling of slow digestion, early satiety, nausea and bloating. Based on the evidence that heartburn cannot be reliably distinguished from other dyspeptic symptoms, the Rome definition appears to be too narrow and restrictive. It is particularly ill suited to the management of uninvestigated dyspepsia at the level of primary care. In patients presenting with uninvestigated dyspepsia, a symptom benefit is associated with a 'test and treat' approach for Helicobacter pylori infection. A substantial proportion of those who do not benefit prove to have esophagitis on endoscopy. In those with functional dyspepsia, the benefits of H pylori eradication, if any, appear to be modest. Hence, a 'symptom and treat' acid-suppression trial with proton pump inhibitors, and a 'test and treat' strategy for H pylori are two acceptable empirical therapies for patients with univestigated dyspepsia.",2003.0,0,0
595,12366621,Detecting Helicobacter pylori infection in hospitalized frail older patients: the challenge.,Nathalie Salles-Montaudon; Sylvia Dertheil; Nathalie Broutet; Nathalie Gras; Lurdes Monteiro; Antoine De Mascarel; Francis Megraud; Jean-Paul Emeriau,"Helicobacter pylori infection has not been well studied in older people, especially in hospitalized, frail patients. The aim of our study was to evaluate the prevalence of the infection in this population using five H. pylori diagnostic tests. Prospective observational study. Geriatric acute care unit of the Department of Geriatrics (Hôpital Xavier Arnozan, Pessac, France). One hundred seven consecutively hospitalized patients with a diagnostic indication for upper gastrointestinal endoscopy. Geriatric assessment, information on drug intake, indication/results of gastric endoscopy, and results of H. pylori infection diagnostic tests (culture and histological analysis on biopsy specimens, serology, 13carbon-urea breath test (13C-UBT), detection of H. pylori stool antigens (HpSA)) were assessed for each included patient. Fifty-one patients (47.7%) were H. pylori positive with at least one test. 13C-UBT was more frequently positive than the other four tests, with a significant difference from culture, histological analysis, and HpSA (P <.05). Positive 13C-UBT results were significantly associated with H. pylori presence using histological analysis and neutrophil activity of the antrum and corpus. Antibiotic treatments significantly decreased the positivity rate of all of the tests performed, and severe corpus atrophy decreased the positivity rate of culture, histological analysis, and HpSA. Almost one-third of the H. pylori-positive patients would have remained undetected without performing the 13C-UBT. The low prevalence of H. pylori detection in these hospitalized, frail patients may be explained by the high frequency of current and previous antibiotic treatments.",2002.0,0,0
596,12374248,"Tolerability of once-weekly alendronate in patients with osteoporosis: a randomized, double-blind, placebo-controlled study.",Susan Greenspan; Ellen Field-Munves; Richard Tonino; Mary Smith; Richard Petruschke; Lixia Wang; John Yates; Anne E de Papp; Joanne Palmisano,"To compare the upper gastrointestinal (GI) tract tolerability of once-weekly oral alendronate, 70 mg, and placebo. This was a 12-week multicenter, randomized, double-blind, placebo-controlled study. The first patient initiated treatment on June 5, 2000, and the last patient completed treatment on March 1, 2001. The study enrolled 450 postmenopausal women and men with osteoporosis (224 took alendronate, 226 took placebo) who were ambulatory and community dwelling at 48 outpatient study centers in the United States. By design, approximately half of the patients were naive to bisphosphonates. The primary end point was upper GI tract tolerability based on the incidence of any upper GI tract adverse events. Secondary end points included the number of discontinuations due to drug-related upper GI tract adverse events and the change from baseline in bone resorption, assessed by the urinary N-telopeptide-creatinine ratio at 12 weeks. A subgroup analysis of the primary and secondary end points was performed on the patients stratified by prior bisphosphonate use. The safety and tolerability of the weekly alendronate and placebo regimens were captured as clinical and laboratory adverse events. A total of 11% of the alendronate patients and 13% of the placebo patients reported an upper GI tract adverse event. Discontinuations due to drug-related upper GI tract adverse events occurred in 3% of alendronate patients and 1% of placebo patients. The differences between the treatment groups for the primary and secondary end points were not significant. For the primary end point, the upper limit of the 95% confidence interval of the difference was well within the prespecified 14% comparability bound (-2.2%; 95% confidence interval, -8.3% to 3.9%). The overall incidence of upper GI tract adverse events was lower in the subgroup of patients with prior bisphosphonate exposure (8%) than in those who were bisphosphonate naive (16%). However, regardless of prior bisphosphonate exposure, the incidence of upper GI tract adverse events was similar between the alendronate and placebo patients. The urinary N-telopeptide-creatinine ratio showed a significant decrease in the alendronate patients (72% of baseline, P<.001) compared with a slight increase in the placebo patients (106% of baseline) at week 12. In this 3-month study, the incidence of upper GI tract adverse events in patients treated with once-weekly alendronate, 70 mg, was comparable to that with placebo.",2002.0,0,0
597,12378634,Azithromycin in a triple therapy for H.pylori eradication in active duodenal ulcer.,Vladimir T Ivashkin; Tatiana L Lapina; Oksana Yu Bondarenko; Olga A Sklanskaya; Petr Ya Grigoriev; Yuri V Vasiliev; Emilia P Yakovenko; Pavel V Gulyaev; Valeri I Fedchenko,"To assess and compare the efficacy and safety of two triple regimes: A) metronidazole, amoxicillin and omeprazole, which is still widely used in Russia, and B) azithromycin, amoxicillin and omeprazole in healing active duodenal ulcer and H.pylori eradication. 100 patients with active duodenal ulcer were included in the open, multicentre, randomized study with comparative groups. Patients were randomly assigned to one of the following one-week triple regimes: A) metronidazole 500 mg bid, amoxicillin 1 g bid and omeprazole 20 mg bid (OAM, n=50) and B) azithromycin 1 g od for the first 3 days (total dose 3 g), amoxicillin 1 g bid and omeprazole 20 mg bid (OAA, n=50). Omeprazole 20 mg od was given after the eradication course as a monotherapy for three weeks. The control endoscopy was performed 8 weeks after the entry. H.pylori infection was determined in the entry of the study and four weeks after the cessation of treatment by means of histology and CLO-test. 97 patients completed the study according to the protocol (1 patient of the OAM group did not come to the control endoscopy, 2 patients of the OAA group stopped the treatment because of mild allergic urticaria). Duodenal ulcers were healed in 48 patients of the OAM group (96 %; CI 90.5-100 %) and in 46 patients of the OAA group (92 %; CI 89.5-94.5 %) (p=ns). H.pylori infection was eradicated in 15 out of 50 patients with OAM (30 %; CI 17-43 %) and in 36 out of 50 patients treated with OAA (72 %; CI 59-85 %) (P<0.001)- ITT analysis. The triple therapy with omeprazole, amoxicillin and metronidazole failed to eradicate H.pylori in the majority of patients, which is an essential argument to withdraw this regimen out of the national recommendations. Macrolide with amoxicillin are preferable to achieve higher eradication rates. Azithromycin (1 g od for the first 3 days) can be considered as a successful component of the triple PPI-based regimen.",2003.0,0,0
598,12380700,Helicobacter pylori: when is treatment now indicated?,A Duggan,"The prevalence of Helicobacter pylori in Western societies has rapidly declined, as reflected by the consistent decline in peptic ulcer disease. Nevertheless, there remains a cohort of the elderly population with a high prevalence of H. pylori infection. While the benefits of H. pylori eradication for H. pylori-associated duodenal ulcer disease is beyond dispute, a number of contentious areas remains. The aim of the present paper is to review the benefits of H. pylori eradication in clinical situations that may confront the non-gastroenterologist.",2003.0,0,0
599,12381251,Randomised controlled trial of pantoprazole versus ranitidine for the treatment of uninvestigated heartburn in primary care.,Nicholas J Talley; Michael G Moore; Arn Sprogis; Peter Katelaris,"To investigate whether pantoprazole (20 mg/d) produces significantly greater symptom control than ranitidine (300 mg/d) in patients with gastro-oesophageal reflux disease (GORD). Multicentre, randomised, double-blind, parallel-group comparison. 76 general practices in north-west Sydney and Newcastle, New South Wales (Australia), from 19 January 1999 to 22 September 2000. 307 patients aged 18 years or over presenting with symptomatic GORD. Pantoprazole (20 mg once daily) or ranitidine (150 mg twice daily). Patient-assessed frequency and severity of heartburn using the Gastrointestinal Symptom Rating Scale (GSRS) and a patient heartburn diary. Pantoprazole was associated with significantly higher rates of complete control of GORD symptoms than ranitidine at four weeks (40% v 19%; P < 0.001), eight weeks (55% v 33%; P < 0.001), six months (71% v 56%; P = 0.007) and 12 months (77% v 59%; P = 0.001). Low-dose pantoprazole is an effective alternative to standard-dose ranitidine for initial and maintenance treatment of patients with symptomatic GORD.",2002.0,0,0
600,12390102,Eradication rates of clarithromycin-resistant Helicobacter pylori using either rabeprazole or lansoprazole plus amoxicillin and clarithromycin.,K Murakami; R Sato; T Okimoto; M Nasu; T Fujioka; M Kodama; J Kagawa; S Sato; H Abe; T Arita,"The resistance of Helicobacter pylori to clarithromycin has become one of the primary reasons for eradication failure. To compare the eradication rates of triple therapy using amoxicillin (A), clarithromycin (C) and rabeprazole (R) or lansoprazole (L) against clarithromycin-sensitive and clarithromycin-resistant strains. Two hundred and ninety-five patients were randomly divided into four groups and treated for 1 week: 147 cases were treated with RAC, i.e. 49 cases with R20C400 (10 mg R + 750 mg A + 200 mg C, twice daily), 48 cases with R40C400 (20 mg R + 750 mg A + 200 mg C, twice daily) and 50 cases with R40C800 (20 mg R + 750 mg A + 400 mg C, twice daily); 148 cases with treated with LAC (30 mg L + 750 mg A + 200 mg C, twice daily). According to intention-to-treat and per protocol analyses, the eradication rates were 88% and 91% with RAC and 78% and 81% with LAC; the eradication rates with R20C400, R40C400 and R40C800 were 94%, 81% and 86%, respectively, in the intention-to-treat analysis. In addition, the eradication rates for clarithromycin-sensitive strains with RAC and LAC were 98% and 89%, respectively, and for clarithromycin-resistant strains with RAC and LAC were 8.1% and 0%, respectively. The eradication rate was significantly higher with RAC than LAC. The eradication rate for clarithromycin-resistant strains was low in both groups, and an improved eradication rate could not be achieved by changing the dose of clarithromycin or proton pump inhibitor.",2003.0,0,1
601,12390212,Does Helicobacter pylori eradication affect symptoms in nonulcer dyspepsia: a 5-year follow-up study.,D McNamara; M Buckley; J Gilvarry; C O'Morain,"The role of Helicobacter pylori infection in nonulcer dyspepsia remains controversial. To date studies exploring the effect of H. pylori eradication on symptoms have reported conflicting results. Randomised control trials employing validated outcome measures have also been difficult to interpret because of several important issues such as the large placebo response seen in patients with nonulcer dyspepsia and both the natural variability in symptoms and symptom severity with time. The association of symptom improvement with resolution of gastritis has meant that the length of follow up employed in most studies has been insufficient. We report the findings of a randomised placebo controlled trial (n = 100), using a validated symptom questionnaire and 5 year follow up to determine the effect of H. pylori eradication on symptoms in nonulcer dyspepsia. In all 64 that were reviewed at 5 years there was a significant difference between patients who were H. pylori negative and those who remained positive with regard to complete symptom resolution, consumption of relevant medications and peptic ulcer disease development, in favour of active treatment. There was a trend for gradual symptom improvement over time irrespective of H. pylori status, which may reflect the natural history of this condition. For those who remained symptomatic at 5 years, there was no difference in symptom severity based on H. pylori status. The findings of this study support the use of H. pylori eradication in symptomatic patients with nonulcer dyspepsia both to induce symptom resolution and to prevent disease progression.",2002.0,0,0
602,12391910,[Differential diagnosis and therapy of acute pancreatitis].,S Haas; M V Singer,"Acute pancreatitis is classified in an interstitial edematous pancreatitis and a hemorrhagic necrotizing pancreatitis comprising 80% and 20% respectively of all cases. 80% of acute pancreatitis are attributed to biliary and alcoholic origin whereas in more than 10% no etiology can be established comprising the idiopathic forms of acute pancreatitis. Clinical symptoms are rather unspecific resulting in a large number of abdominal and extraabdominal diseases that have to be considered regarding the differential diagnosis. Diagnosis is based on clinical examination, laboratory findings and ultrasound. However it has to be taken into account that a lack of abdominal symptoms and unaltered amylase and lipase levels may be present in spite of overt pancreatitis. As severe pancreatitis is associated with a steep increase in mortality the early identification of severe pancreatitis is crucial. Several prognostic scores like the Ranson-, Glasgow- and APACHE-II score were developed to achieve a higher sensitivity detecting transition to severe pancreatitis. In addition new prognostic serum parameters are applicable. A prophylactic antibiotic therapy is recommended in patients with sterile necrosis whereas an infected necrosis requires organ preserving necrosectomy and retroperitoneal lavage which can be done surgically or referring to new concepts endoscopically. Apart from renal and respiratory failure, necrosis, pseudocysts and pancreatic abscess are the main complications. In the presence of detected stones in the common bile tract ERCP in combination with stone extraction and papillotomy reduces morbidity and mortality in patients with biliary pancreatitis. Laparoscopic cholecystectomy should be performed as soon as the patient has recovered and preferably during the same hospital admission.",2003.0,0,0
603,12395996,Short-term therapeutic trial of proton pump inhibitors in suspected extraesophageal reflux.,Walter Habermann; Karl Kiesler; Andreas Eherer; Gerhard Friedrich,"Pharyngoesophageal gastric acid reflux is thought to initiate chronic posterior laryngitis. The gold standard for measuring gastric reflux is dual-channel 24-hour pH monitoring. This is a time-consuming, inconvenient, expensive method that is not available in all areas. New therapeutic regimes that make use of proton pump inhibitors (PPIs) have proven to be therapeutically efficient for control of acid reflux. Twenty-four consecutive patients with chronic voice disorders and signs of posterior laryngitis were selected for therapy. Twenty-four hour pH monitoring was performed independently before the therapy. The trial therapy consisted of all patients receiving pantoprazole, 40 mg once daily for 6 weeks. Immediately following the therapy a statistically significant (p < 0.05) improvement was observed in all patients. This improvement was analyzed retrospectively by comparison with the results of 24-hour pH monitoring. In 71% of the patients the 24-hour pH-monitoring gave a positive result showing a high number of patients with extraesophageal reflux in our study group. Patients with positive results of pH-monitoring responded in a statistically significant manner (p < 0.05) to the pantoprazole therapy, whereas those patients without detected reflux did not. A 3-month follow-up of the patients with a positive result of the pH-monitoring confirmed the improvement. No patients reported adverse effects. A 6-week treatment with pantoprazole can be clinically justified. It helps to save time and reduce costs, allows for selection of reflux-negative patients for alternative therapy, and may prevent inadequate treatment of patients with false-negative pH monitoring. Twenty-four hour pH monitoring is still recommended for patients unresponsive to this trial therapy.",2003.0,0,0
604,12412610,Motion--Laparoscopic Nissen fundoplication is more cost effective than oral PPI administration: arguments for the motion.,Lee L Swanström,"Gastroesophageal reflux disease is a mechanical disorder of the foregut. While medications can only provide symptom relief, surgery can correct the pathophysiological abnormality of the lower esophageal sphincter. The costs of medical and surgical therapy are much greater than the costs of medication or hospitalization alone. In the case of medical therapy, one must consider the costs of serial monitoring and of failed treatment. The effectiveness of treatment also depends on patient-related factors, including weight, socioeconomic factors, smoking, alcohol use, dietary habits and the use of nonsteroidal anti-inflammatory drugs. Surgical results depend on the experience and skill of the surgeon, as well as the attributes of the institution in which the procedure is undertaken. Therefore, studies that come from specialized centres may not be applicable to the community. Data from the author's facility indicate that laparoscopic Nissen fundoplication is the most cost effective option when it is undertaken by experienced surgeons on otherwise healthy patients who have documented gastroesophageal reflux disease.",2003.0,0,0
605,12415039,Gastroesophageal reflux and cow milk allergy: is there a link?,Silvia Salvatore; Yvan Vandenplas,"Gastroesophageal reflux (GER) and cow milk allergy (CMA) occur frequently in infants younger than 1 year. In recent years, the relation between these 2 entities has been investigated and some important conclusions have been reached: in up to half of the cases of GER in infants younger than 1 year, there may be an association with CMA. In a high proportion of cases, GER is not only CMA associated but also CMA induced. The frequency of this association should induce pediatricians to screen for possible concomitant CMA in all infants who have GER and are younger than 1 year. With the exception of some patients with mild typical CMA manifestations (diarrhea, dermatitis, or rhinitis), the symptoms of GER associated with CMA are the same as those observed in primary GER. Immunologic tests and esophageal pH monitoring (with a typical pH pattern characterized by a progressive, slow decrease in esophageal pH between feedings) may be helpful if an association between GER and CMA is suspected, although the clinical response to an elimination diet and challenge is the only clue to the diagnosis. This article reviews the main features of GER and CMA, focusing on the aspects in common and the discrepancies between both conditions.",2003.0,0,0
606,12428065,The clinical importance of proton pump inhibitor pharmacokinetics.,B R Yacyshyn; A B R Thomson,"Achieving the optimal clinical response for patients with upper gastrointestinal peptic disease is important. This response depends on the pathology treated as well as on the choice of proton pump inhibitor. Here, we identify factors in specific disease therapy and proton pump inhibitor (PPI) pharmacokinetic and pharmacodynamic characteristics that help us achieve this goal. These include differences in PPI bioavailability and acid-suppressive effects. Available data indicate that PPIs appear to have similar potency on a milligram basis, and that omeprazole and lansoprazole are more frequently double dosed than pantoprazole. The lower propensity for double dosing with pantoprazole may also result in lower medication acquisition costs and a reduction in physician visits due to ineffective therapy with the standard dosing of these other agents.",2003.0,0,0
607,12430068,Reflux disease and Barrett's esophagus.,T Rösch,,2003.0,0,0
608,12430078,"""Floppy"" Nissen vs. Toupet laparoscopic fundoplication: quality of life assessment in a 5-year follow-up (part 2).",T Kamolz; F A Granderath; T Bammer; H Wykypiel; R Pointner,"Quality of life as an outcome variable has become an important measure in clinical research. This study is the second part of a prospective assessment of the quality of life outcome, in a 5-year follow-up of patients who underwent laparoscopic Nissen fundoplication or Toupet fundoplication. Data from a 1-year follow-up have been previously published (part I). Using the Gastrointestinal Quality of Life Index (GIQLI), the quality of life data of 169 consecutive patients who had undergone a laparoscopic Nissen fundoplication (LNF; n = 104) or a laparoscopic Toupet fundoplication (LTF; n = 65), were evaluated 3 years and 5 years postoperatively. Six patients out of the initial study group (n = 175), including three from each group, were excluded from the main analysis because they had undergone laparoscopic re-fundoplication during the 1-year follow-up. Data from patients with repeat surgery have been analysed separately. In addition to administering the GIQLI, we evaluated patient satisfaction with surgery, possible surgical side effects or recurrent disease-related symptoms, the use of antireflux medication, and also surgical interventions in relation to initial antireflux surgery. In those patients, who were willing (n = 111) we also performed esophageal manometry and 24-hour pH monitoring 5 years postoperatively. At 3 years and 5 years postoperatively, the analysis of quality of life data showed that the GIQLI score remained stable in comparison with the 1-year follow-up data, with mean scores of 121 +/- 8.7 points in the LNF-group and 119.8 +/- 9 points in the LTF-group, at 5 years after surgery. Laparoscopic re-fundoplication was necessary in four patients due to a ""slipping"" Nissen (LNF group n = 1) or recurrent symptoms (LTF group, n = 3). In two patients in the LTF group herniation of a trocar incision was found. No patient suffered from severe surgical side effects. Patient satisfaction with surgery was rated as ""excellent"" or ""good"" in 97.9 % of patients. There were no significant differences between the groups concerning these data. The results of esophageal manometry and 24-hour pH monitoring also remained stable and showed normal values in all but two patients (in the LTF group), who suffered from mild and infrequent symptoms of recurrent heartburn without endoscopic signs of esophagitis. The outcome in patients who underwent laparoscopic re-fundoplication is comparable to the outcomes for those with a successful primary intervention. Both Nissen and Toupet laparoscopic fundoplication can significantly improve patients' quality of life during the 5 years following surgical intervention. Quality of life scores for both surgical groups were almost equal and postoperative outcomes were comparable to values in healthy controls. Patient satisfaction with surgical treatment was very high, even though repeat laparoscopic surgery was necessary in some cases. Patients who had a repeat procedure experienced nearly identical outcomes.",2003.0,0,0
609,12436372,[Gastrointestinal side effects in the therapy of rheumatologic diseases].,U Schiemann; H Kellner,"Antirheumatic drugs may lead to a number of relevant gastrointestinal complications. Symptomatical treatments with glucocorticoids and non steroidal antirheumatic drugs (NSAD) are known to induce gastric or duodenal ulcers, above all under combination therapies. Side effects of DMARD's (methotrexate, leflunomide, hydroxy/chloroquine, sulfasalazine) include unspecifical gastrointestinal symptoms like nausea, vomiting and diarrhea as well as induction of ulcerative mucosal lesions (methotrexate) and occurrence of a hepatopathy. The latter may appear as an asymptomatical elevation of liver transaminases or cholestase parameters, but can also lead, in some cases of a monothera-py (hydroxy-/chloroqine, sulfasalazine) or combination therapy (methotrexate + leflunomide) to a fulminant hepatitis. TNF-alpha-inhibiting drugs (etanercept, infliximab) as a new generation of anti-inflammatory therapeutics don't have relevant gastrointestinal side effects according recently published data.",2003.0,0,0
610,12439119,Omeprazole triple therapy versus omeprazole quadruple therapy for healing duodenal ulcer and eradication of Helicobacter pylori infection: a 24-month follow-up study.,Gerassimos J Mantzaris; Kalliopi Petraki; Emmanuel Archavlis; Pericles Amberiadis; Panagiotis Christoforidis; Demetrius Kourtessas; Efterpi Chiotakakou; George Triantafyllou,"To evaluate the efficacy of omeprazole triple therapy versus omeprazole quadruple therapy for Helicobacter pylori infection. Prospective, randomized, single-centre, investigator-blind study. Departments of Gastroenterology and Histopathology, Evangelismos Hospital, Athens, Greece. One hundred and forty-nine consecutive patients with active duodenal ulcer were randomized to receive omeprazole (20 mg b.d.), amoxicillin (1 g b.d.) and clarithromycin (0.5 g b.d.) (OAC, n = 78), or omeprazole (20 mg b.d.), colloidal bismuth subcitrate (120 mg q.i.d.), metronidazole (0.5 g t.i.d.) and tetracycline hydrochloride (0.5 g q.i.d.) (OBMT, n = 71) for 10 days. Patients' symptoms were scored, and compliance and treatment-related side effects were assessed. Endoscopy was performed before treatment and at 10-12 weeks and 12 months after treatment. H. pylori infection and its successful eradication were sought by histology, immunohistochemistry and campylobacter-like organisms (CLO) tests on multiple biopsies taken from the gastric antrum, corpus and fundus. Patients were re-evaluated clinically and underwent a C-urea breath test (UBT) at 21-24 months. Those with dyspepsia and/or recrudescence of H. pylori were re-endoscoped. Patient groups were comparable for age, sex, smoking, occasional use of nonsteroidal anti-inflammatory drugs (NSAIDs), and current or past bleeding episodes. Six and seven patients in the OAC and OBMT treatment groups, respectively, were lost to follow-up. Eight patients were non-compliant. Two ulcers in the OAC group and one in the OBMT group did not heal. By intention-to-treat (ITT) and per-protocol (PP) analyses, ulcer healing rates were 86% (67/78) and 97% (67/69), respectively, for the OAC group, and 82% (58/71) and 98% (58/59), respectively, for the OBMT group. H. pylori eradication at 10-12 weeks after treatment was 78% (61/78) and 88% (61/69) for OAC, and 65% (46/71) and 78% (46/59) for OBMT, by ITT and PP analyses, respectively (P > 0.1). Side effects were more common with OBMT. Relapse rates of H. pylori were 3% and 2% for the first and second years, respectively. Four H. pylori-negative patients developed reflux symptoms, but only two developed erosive oesophagitis between 12 and 24 months. OAC and OBMT were equally effective in healing active duodenal ulcers and eradicating H. pylori, but OAC should be used as a first-line treatment because of its better tolerance.",2003.0,0,0
611,12452520,An open non-comparative clinical study for the evaluation of safety and efficacy of esomeprazole in patients of reflux oesophagitis in Indian population.,N H Dinakaran; J S Rajkumar; Nandkishor P Potdar; Anish Desai,"The proton pump inhibitors have consistently been shown to be far more effective than the others are in gastro-oesophageal reflux disease (GERD) as proton pump inhibitors (PPIs) block the final and rate-limiting step of parietal acid production. The primary objective of the study was to assess the efficacy and tolerability of esomeprazole 40 mg given once a day for 4 weeks in patients with reflux oesophagitis. An open, non-comparative study was done with 103 patients in 4 centres with endoscopic erosive oesophagitis. Symptoms of reflux oesophagitis such as heartburn/retrosternal pain and regurgitation recorded on a 4-point scale, dysphagia being marked as present or absent. Oesophagitis was graded as 5-point scale. There was a significant decrease in mean score of heartburn (60.8% and 86%), retrosternal pain (60.84% and 86.75%), mean score of regurgitation (65% and 90%) at second and fourth week respectively. Global assessment of overall symptoms by patients showed complete resolution of symptoms in 86.4% patients at week 4. At the end of treatment 93 out of 103 patients showed complete healing, 13.6% of total cases had side effects. Esomeprazole was found effective and safe in the treatment of GERD.",2003.0,0,1
612,12452757,Proton-pump inhibitors for stress ulcer prophylaxis in critically ill patients.,Rose Jung; Robert MacLaren,"To evaluate the use of proton-pump inhibitors (PPIs) for stress ulcer prophylaxis in critically ill adults. Computerized biomedical literature search of MEDLINE (1966-June 2002) was conducted using the MeSH headings proton-pump inhibitor, ulcer, critical care, and acid. References of selected articles were reviewed. A manual search of critical care, surgery, trauma, gastrointestinal, and pharmacy journals was conducted to identify relevant abstracts. Traditional medications used for stress ulcer prophylaxis include antacids, histamine(2) receptor antagonists (H(2)RAs), and sucralfate. Few studies have evaluated PPIs for stress ulcer prophylaxis. The majority of studies have demonstrated that enteral or intravenous administration of PPIs to critically ill patients elevates intragastric pH and consistently maintains pH > or =4.0. PPIs are safe and seem to be as efficacious as H(2)RAs or sucralfate for prevention of bleeding from stress-related mucosal damage (SRMD) and they may provide cost minimization. The small patient populations limit the results of comparative studies. Available data indicate that PPIs are safe and efficacious for elevating intragastric pH in critically ill patients. PPIs should be used only as an alternative to H(2)RAs or sucralfate since the superiority of PPIs over these agents for preventing SRMD-associated gastrointestinal bleeding has not been established. Additional comparative studies with adequate patient numbers and pharmacoeconomic analyses are needed before PPIs are considered the agents of choice for stress ulcer prophylaxis.",2003.0,0,0
613,12455204,"Tenatoprazole. Benatoprazole, TU 199.",,,2003.0,0,0
614,12465720,"Gastro-oesophageal reflux in obese subjects: influence of overweight, weight loss and chronic gastric balloon distension.",E M H Mathus-Vliegen; G N J Tygat,"Gastro-oesophageal reflux is an obesity-related health risk assumed to improve after weight loss. Prolonged intragastric balloon distension might oppose this. The purpose of the study was to investigate the prevalence of gastro-oesophageal reflux in untreated obese subjects and to study the consequences of weight loss with or without intragastric balloon treatment. Patients participating in a randomized double-blind, sham-controlled trial received balloon or sham treatment for the first 13 weeks. Thereafter, all subjects received a balloon for the remaining year. Twenty-four-hour pH recordings were made at the start, after 13 weeks of balloon or sham treatment, after 26 and 52 weeks of balloon treatment and 13 weeks after balloon removal. Group-wise, pH data of 42 untreated patients (BMI 43.4 kg/m2) were highly abnormal. On an individual level, 22 subjects (52%) had some evidence of reflux, 17 patients (40%) showed pathological total reflux times and 8 (19%) had combined total, upright and supine reflux with grade B reflux oesophagitis in only one patient. Albeit poorly, oesophageal acid exposure was related to body weight and visceral fat distribution. A reduction in acid reflux was observed in sham-treated weight-losing subjects, whereas in balloon-treated subjects supine reflux and duration of the longest reflux increased. In the second 13-week period, the initially improved pH values worsened by balloon placement in sham-treated subjects. Values in balloon-balloon-treated subjects stabilized. After 52 weeks, acid reflux levelled off at pretreatment values and further improved after balloon removal. At these times, decreased visceral fat masses correlated significantly with diminished oesophageal exposure to acid. Obesity predisposed to gastro-oesophageal reflux. Body weight loss and, strikingly, visceral fat loss resulted in improved reflux parameters. Adverse effects on acid reflux by gastric balloon distension wore off over time.",2003.0,0,0
615,12468950,Levofloxacin based regimens for the eradication of Helicobacter pylori.,Simona Di Caro; Maria Assunta Zocco; Filippo Cremonini; Marcello Candelli; Enrico C Nista; Francesco Bartolozzi; Alessandro Armuzzi; Giovanni Cammarota; Luca Santarelli; Antonio Gasbarrini,"A 7 day treatment scheme based on rabeprazole/levofloxacin/amoxycillin or tinidazole achieved an eradication rate over 90%. However, the combination of drugs and duration of treatment for the correct use of levofloxacin in the eradication of are still unclear. To compare the efficacy and tolerability of rabeprazole/levofloxacin based dual therapies given for 5, 7 or 10 days with rabeprazole/levofloxacin/amoxycillin triple therapy for 7 days. One hundred and sixty patients with infection documented by the C-urea breath test and histology were included in this prospective, open label study. Subjects were randomized in four groups: (1) levofloxacin (500 mg o.d.), amoxycillin (1 g b.d.) and rabeprazole (20 mg o.d.) for 7 days; (2) levofloxacin (500 mg o.d.) and rabeprazole (20 mg o.d.) for 5 days; (3) levofloxacin (500 mg o.d.) and rabeprazole (20 mg o.d.) for 7 days; and (4) levofloxacin (500 mg o.d.) and rabeprazole (20 mg o.d.) for 10 days. Six weeks after the end of therapy status was checked by using the C-urea breath test. All patients completed the therapeutic regimens. The eradication rate was not significantly modified by treatment duration in the dual therapy schemes (5 days: 20/40, 50%; 7 days: 28/40, 70%; 10 days: 26/40, 65%). The eradication rate of the 1 week levofloxacin based triple therapy was significantly higher than that observed using any dual therapies (36/40). No major adverse effects were observed. A rabeprazole/levofloxacin dual eradication regimen is simple and well tolerated but does not achieve an acceptable eradication rate when compared to a 1 week rabeprazole/levofloxacin/amoxycillin triple therapy. The eradication rate did not increase with a longer regimen.",2003.0,0,0
616,12471537,Long-term follow-up and factors predictive of recurrence in Barrett's esophagus treated by argon plasma coagulation and acid suppression.,M Kahaleh; J-L Van Laethem; N Nagy; M Cremer; J Devière,"In several series, argon plasma coagulation (APC) combined with acid suppression has led to short- or medium-term eradication of Barrett's esophagus. The present study was designed to assess the long-term outcome after this treatment. 39 patients with Barrett's esophagus, seven of them with low-grade dysplasia, underwent APC and received 40 mg omeprazole daily for eradication of the metaplastic epithelium. After the treatment period, patients were randomly assigned to receive 20 or 40 mg omeprazole daily for long-term acid suppression. Histological and endoscopic changes were evaluated annually. Univariate and multivariate analyses were used to test the following 10 variables as predictors of sustained reversal of Barrett's esophagus at the end of follow-up: age, gender, length of diseased segment, presence of hiatal hernia, circumferential nature of lesion, presence of low-grade dysplasia at initial biopsy, number of coagulation sessions, result of pH monitoring under protein pump inhibitor (PPI) treatment, omeprazole dosage, and initial response to therapy (after 1 month). The median follow-up period was 36 months (range 12 - 48). The endoscopic and histological relapse rates at 1, 12, and 24 months, and end of follow-up were, respectively, 30 % and 44 % (12/39 and 17/39), 57 % and 54 % (16/28 and 15/28), 60 % and 57 % (17/28 and 16/28), and 62 % for both rates (23/37). According to multivariate analysis, shorter length of diseased segment and normalization of pH with PPI treatment were the only independent predictors of sustained long-term re-epithelialization. Among the seven patients with low-grade dysplasia, four experienced relapse after 1 month, and during the long-term follow-up, one was lost to follow-up and all the others experienced relapse, but only one developed low-grade dysplasia again. Cancer was found in two cases after 12 and 18 months, respectively. Persistence of acid reflux and greater length of diseased segment are the major factors associated with a high relapse rate after successful initial reversal. APC for ablation of Barrett's esophagus cannot be recommended.",2003.0,0,0
617,12480858,Recent developments in gastroenterology.,Paul Moayyedi; Alex Ford,,2003.0,0,0
618,12481170,Esomeprazole: update and clinical review.,Danial E Baker,The U.S. Food and Drug Administration's Nonprescription Drugs Advisory Committee and Gastroenterological Drugs Advisory Committee recommended approval of omeprazole as an over-the-counter treatment of heartburn in patients who have at least two episodes of heartburn each week. The consumer studies that have been conducted indicate that the majority of patients understand the proposed labeling and could use the proposed label to determine if the omeprazole therapy was appropriate for them. Esomeprazole is an effective agent in the treatment of gastroesophageal reflux disease (GERD) and erosive esophagitis. Newer studies continue to support its efficacy and safety in the treatment of these conditions. Several of the most recent studies have included comparisons with other proton pump inhibitors. The results of these studies indicate that all the proton pump inhibitors are effective in treating GERD and erosive esophagitis and that some patients would benefit from esomeprazole therapy.,2003.0,0,0
619,12485118,The effects of nocturnal acid breakthrough on Helicobacter pylori eradication.,Jin Il Kim; Soo-Heon Park; Jae Kwang Kim; In Sik Chung; Kyu Won Chung; Hee Sik Sun,"The effects of nocturnal gastric acid breakthrough (NAB) on Helicobacter pylori eradication are still unknown in peptic ulcer patients. The purposes of this study were to compare the effect of lansoprazole 30 mg twice a day (bid) to lansoprazole 60 mg once a day (qd) on the prevalence of NAB, and to determine whether NAB affects the eradication of H. pylori in peptic ulcer patients. Experiments were carried out in 67 patients with H. pylori-positive peptic ulcers. They were randomized into two groups, one treated with a combination of lansoprazole 60 mg, clarithromycin 1.0 g, and amoxycillin 2.0 g once a day before breakfast (qd group), and the other, divided doses of the drugs were given before breakfast and dinner (bid group) for 2 weeks. NAB occurred in 31 patients, 55.2% in qd group, and 39.5% in bid group (p =.226). H. pylori eradication was achieved in 61.3% in NAB positive group and 83.3% in NAB negative group (p =.055). The mean duration of NAB for H. pylori eradication group was 99.3 +/- 22.7 min, and 293.2 +/- 49.8 min for H. pylori persistence group (p <.05). The median intragastric pH of the H. pylori eradication and persistence group was 5.7 +/- 0.2 and 4.2 +/- 0.4, respectively (p <.05). Neither the morning dose and the divided dose regimen of lansoprazole affected the intragastric acidity and occurrence of the NAB. NAB did not influence H. pylori eradication in peptic ulcer patients, but the duration of NAB and total intragastric median pH were found to influence the H. pylori eradication.",2003.0,0,0
620,12487624,Pantoprazole: an update of its pharmacological properties and therapeutic use in the management of acid-related disorders.,Susan M Cheer; Amitabh Prakash; Diana Faulds; Harriet M Lamb,"Pantoprazole (Protonix) is an irreversible proton pump inhibitor (PPI) that reduces gastric acid secretion. In combination with two antimicrobial agents (most commonly metronidazole, clarithromycin or amoxicillin) for 6-14 days, pantoprazole 40 mg twice daily produced Helicobacter pylori eradication rates of 71-93.8% (intent-to-treat [ITT] or modified ITT analysis) in patients without known antibacterial resistance. Pantoprazole-containing triple therapy was at least as effective as omeprazole- and similar in efficacy to lansoprazole-containing triple therapy in large trials. In the treatment of moderate to severe gastro-oesophageal reflux disease (GORD), oral pantoprazole 40 mg/day was as effective as other PPIs (omeprazole, omeprazole multiple unit pellet system, lansoprazole and esomeprazole) and significantly more effective than histamine H(2)-antagonists. Pantoprazole 20 mg/day provided effective mucosal healing in patients with GORD and mild oesophagitis. Intravenous pantoprazole 40 mg/day can be used in patients who are unable to take oral medication. Oral pantoprazole 20-40 mg/day for up to 24 months prevented relapse in most patients with healed GORD. According to preliminary data, oral pantoprazole 20 or 40 mg/day was effective at healing and preventing non-steroidal anti-inflammatory drug (NSAID)-related ulcers, and intravenous pantoprazole was at least as effective as intravenous ranitidine in preventing ulcer rebleeding after endoscopic haemostasis. Oral or intravenous pantoprazole up to 240 mg/day maintained target acid output levels in most patients with hypersecretory conditions, including Zollinger-Ellison syndrome. Oral and intravenous pantoprazole appear to be well tolerated in patients with acid-related disorders in short- and long-term trials. Tolerability with oral pantoprazole was similar to that with other PPIs or histamine H(2)-antagonists in short-term trials. Formal drug interaction studies have not revealed any clinically significant interactions between pantoprazole and other agents. In conclusion, pantoprazole is an effective agent in the management of acid-related disorders. As a component of triple therapy for H. pylori eradication and as monotherapy for the healing of oesophagitis and maintenance of GORD, pantoprazole has shown similar efficacy to other PPIs and greater efficacy than histamine H(2)-antagonists. Limited data suggest that it is also effective in Zollinger-Ellison syndrome and in preventing ulcer rebleeding. Pantoprazole is well tolerated with minimal potential for drug interactions. The availability of pantoprazole as both oral and intravenous formulations provides flexibility when the oral route of administration is not appropriate. Thus, pantoprazole is a valuable alternative to other PPIs in the treatment of acid-related disorders.",2003.0,0,0
621,12492176,Management of peptic ulcer disease not related to Helicobacter pylori or NSAIDs.,Carolyn Quan; Nicholas J Talley,"Helicobacter pylori (H. pylori) infection is widely accepted as the most important factor in the pathogenesis of duodenal ulcer. However, in parallel with more effective eradication of H. pylori, the prevalence of H. pylori is changing, and H. pylori-negative peptic ulcer disease appears to be increasing. When making a diagnosis of H. pylori-negative peptic ulcer disease, it is essential to avoid misclassification because of inaccurate diagnosis. In addition, secondary causes may need to be excluded with appropriate investigations. In the absence of H. pylori, nonsteroidal anti-inflammatory drug usage is the most common cause of peptic ulcer; surreptitious nonsteroidal anti-inflammatory drug usage is a cause of unexplained ulcer disease in up to 60% of patients. Hypersecretory syndromes such as Zollinger-Ellison syndrome, although rare, need to be excluded. Once all known etiological factors are excluded, there remains a group of patients with so-called ""idiopathic ulcers."" The interplay of etiological factors in the pathogenesis of idiopathic peptic ulcer disease is poorly defined but may include a genetic predisposition, altered acid secretion, rapid gastric emptying, defective mucosal defense mechanisms, psychological stress, and smoking. The management of idiopathic peptic ulcers is not defined; they appear to be more resistant to standard therapy, can be associated with more frequent complications, and those that relapse may require long-term maintenance therapy.",2003.0,0,0
622,12492181,Effect of Helicobacter pylori eradication on development of erosive esophagitis and gastroesophageal reflux disease symptoms: a post hoc analysis of eight double blind prospective studies.,Loren Laine; Jennifer Sugg,"The aim of this study was to assess the development of erosive esophagitis, the development of gastroesophageal reflux disease (GERD) symptoms in patients without prior symptomatic or endoscopic GERD, and the worsening of GERD symptoms in patients with prior symptomatic GERD in a post hoc analysis of eight double-blind prospective trials of Helicobacter pylori (H. pylori) therapy in 1165 patients. Patients with active or past duodenal ulcer and without baseline erosive esophagitis had end of study endoscopies 4-30 wk after completion of therapy. A total of 533 patients had heartburn and regurgitation scores assessed at baseline and 4 wk after end of therapy, and were divided into two groups: 1) no prior GERD symptoms (N = 127) and 2) prior GERD symptoms (N = 406). H. pylori was assessed at baseline and > or = 4 wk after therapy by rapid urease test, histology, and culture. Erosive esophagitis developed in 24 (4%) of 621 patients with cure versus 14 (3%) of 544 with persistent H. pylori (OR = 1.52, 95% CI = 0.78-2.97). In the longest study (28-30-wk follow-up), esophagitis developed in two (7%) of 28 patients with cure versus five (7%) of 76 with persistent infection. New GERD symptoms developed in 13 (14%) of 92 patients with cure versus seven (20%) of 35 with persistent infection (OR = 0.66,95% CI = 0.24-1.82). GERD worsened in 20 (7%) of 269 with cure vs 20 (15%) of 137 with persistent H. pylori (OR = 0.47, 95% CI = 0.24-0.91; p = 0.02). Our results do not support the hypothesis that H. pylori eradication in patients with duodenal ulcer disease leads to the development of erosive esophagitis, the development of new symptomatic GERD, or worsening of symptoms in patients with pre-existing GERD.",2003.0,0,0
623,12495317,What's new in general surgery: gastrointestinal conditions.,Barbara L Bass,,2003.0,0,0
624,12501151,"Occurrence of ventilator-associated pneumonia in mechanically ventilated pediatric intensive care patients during stress ulcer prophylaxis with sucralfate, ranitidine, and omeprazole.",Dincer Yildizdas; Hacer Yapicioglu; Hayri Levent Yilmaz,"The purpose of the study was to evaluate the effects of sucralfate, ranitidine, and omeprazole use on incidence of ventilatory-associated pneumonia (VAP) and mortality in ventilated pediatric critical care patients. This prospective study was conducted at the pediatric intensive care unit (PICU) between August 2000 and February 2002. A total of 160 patients who needed mechanical ventilation were randomized into 4 groups according to the computer-generated random number table: group (S), (n = 38) received sucralfate suspension 60 mg/kg/d in 4 doses via the nasogastric tube that was flushed with 10 mL of sterile water; group (R), (n = 42) received ranitidine 2 mg/kg/d intravenously in 4 doses; group (O), (n = 38) received omeprazole 1 mg/kg/d intravenously in 2 doses; and group (P), (n = 42) did not receive any medication for stress ulcer prophylaxis. Treatment was begun within 6 hours of PICU admission. Seventy patients (44%) developed VAP. VAP rate was 42% (16 of 38) in the sucralfate group, 48% (20 of 42) in the ranitidine group, 45% (17 of 38) in the omeprazole group, and 41% (17 of 42) in the nontreated group. Overall mortality rate was 22% (35 of 160); it was 21% (8 of 38) in the sucralfate group, 23% (10 of 42) in the ranitidine group, 21% (8 of 38) in the omeprazole group, and 21% (9 of 42) in the nontreated group. Our results did not show any difference in the incidence of VAP and mortality in mechanically ventilated PICU patients treated with ranitidine, omeprazole, or sucralfate, or nontreated subjects (P =.963, confidence interval [CI] = 0.958-0.968; P =.988, CI = 0.985-0.991, respectively). Nine patients (5.6%) had macroscopic bleeding. There was no statistically significant difference in macroscopic bleeding between groups. Our results did not show any difference in the incidence of VAP, macroscopic stress ulcer bleeding, and mortality in the mechanically ventilated PICU patients treated with ranitidine, omeprazole, or sucralfate, or nontreated subjects. None of the treatment regimens increased VAP compared with the nontreated group. Because there is insufficient data about stress ulcer prophylaxis and VAP in the pediatric age group, more studies with larger numbers of patients are needed.",2003.0,0,0
625,12501222,Celecoxib versus diclofenac and omeprazole in reducing the risk of recurrent ulcer bleeding in patients with arthritis.,Francis K L Chan; Lawrence C T Hung; Bing Y Suen; Justin C Y Wu; Kenneth C Lee; Vincent K S Leung; Aric J Hui; Ka F To; Wai K Leung; Vincent W S Wong; S C Sydney Chung; Joseph J Y Sung,"Current guidelines recommend that patients at risk for ulcer disease who require treatment for arthritis receive nonsteroidal antiinflammatory drugs (NSAIDs) that are selective for cyclooxygenase-2 or the combination of a nonselective NSAID with a proton-pump inhibitor. We assessed whether celecoxib would be similar to diclofenac plus omeprazole in reducing the risk of recurrent ulcer bleeding in patients at high risk for bleeding. We studied patients who used NSAIDs for arthritis and who presented with ulcer bleeding. After their ulcers had healed, we randomly assigned patients who were negative for Helicobacter pylori to receive either 200 mg of celecoxib twice daily plus daily placebo or 75 mg of diclofenac twice daily plus 20 mg of omeprazole daily for six months. The end point was recurrent ulcer bleeding. In the intention-to-treat analysis, which included 287 patients (144 receiving celecoxib and 143 receiving diclofenac plus omeprazole), recurrent ulcer bleeding occurred in 7 patients receiving celecoxib and 9 receiving diclofenac plus omeprazole. The probability of recurrent bleeding during the six-month period was 4.9 percent (95 percent confidence interval, 3.1 to 6.7) for patients who received celecoxib and 6.4 percent (95 percent confidence interval, 4.3 to 8.4) for patients who received diclofenac plus omeprazole (difference, -1.5 percentage points; 95 percent confidence interval for the difference, -6.8 to 3.8). Renal adverse events, including hypertension, peripheral edema, and renal failure, occurred in 24.3 percent of the patients receiving celecoxib and 30.8 percent of those receiving diclofenac plus omeprazole. Among patients with a recent history of ulcer bleeding, treatment with celecoxib was as effective as treatment with diclofenac plus omeprazole, with respect to the prevention of recurrent bleeding. Renal toxic effects are common in high-risk patients receiving celecoxib or diclofenac plus omeprazole.",2003.0,0,0
626,12513106,Lansoprazole: in the management of gastroesophageal reflux disease in children.,Lesley J Scott,"Lansoprazole, a proton pump inhibitor, inactivates the H(+)/K(+)-ATPase pump in parietal cells, thereby suppressing basal and stimulated gastric acid secretion and increasing intragastric pH. After 8-12 weeks' treatment with lansoprazole, all children (n = 27) with esophagitis at baseline were healed (confirmed by endoscopy) and 76% of 62 evaluable children experienced improvements in overall gastroesophageal reflux disease (GERD) symptoms. In this noncomparative trial, 66 children (aged 1-11 years) with GERD with or without esophagitis received oral lansoprazole 15 or 30 mg once daily dependent on their weight. The drug is generally well tolerated in children with GERD. In the largest study, the most common treatment-related adverse events occurring during therapy were constipation and headache.",2003.0,0,0
627,12516945,"Bismuth subcitrate/metronidazole/ tetracycline--Axcan Pharma. Bismuth triple therapy--Axcan Pharma, Helicide.",,,2003.0,0,0
628,12526942,Minimizing recurrent peptic ulcer hemorrhage after endoscopic hemostasis: the cost-effectiveness of competing strategies.,Brennan M R Spiegel; Joshua J Ofman; Karen Woods; Nimish B Vakil,"Controversy exists regarding the optimal strategy to minimize recurrent ulcer hemorrhage after successful endoscopic hemostasis. Our objective was to evaluate the cost-effectiveness of competing strategies for the posthemostasis management of patients with high risk ulcer stigmata. Through decision analysis, we calculated the cost-effectiveness of four strategies: 1) follow patients clinically after hemostasis and repeat endoscopy only in patients with evidence of rebleeding (usual care); 2) administer intravenous proton pump inhibitors (i.v. PPIs) after hemostasis and repeat endoscopy only in patients with clinical signs of rebleeding; 3) perform second look endoscopy at 24 h in all patients with successful endoscopic hemostasis; and 4) perform selective second look endoscopy at 24 h only in patients at high risk for rebleeding as identified by the prospectively validated Baylor Bleeding Score. Probability estimates were derived from a systematic review of the medical literature. Cost estimates were based on Medicare reimbursement. Effectiveness was defined as the proportion of patients with rebleeding, surgery, or death prevented. The selective second look endoscopy strategy was the most effective and least expensive of the four competing strategies, and therefore dominated the analysis. The i.v. PPI strategy required 50% fewer endoscopies than the competing strategies, and became the dominant strategy when the rebleed rate with i.v. PPIs fell below 9% and when the cost of i.v. PPIs fell below 10 dollars/day. Compared with the usual practice of ""watchful waiting,"" performing selective second look endoscopy in high risk patients may prevent more cases of rebleeding, surgery, or death at a lower overall cost. However, i.v. PPIs are likely to reduce the need for second look endoscopy and may be preferred overall if the rebleed rate and cost of i.v. PPIs remains low.",2003.0,0,0
629,12534405,"Effect of oral omeprazole in reducing re-bleeding in bleeding peptic ulcers: a prospective, double-blind, randomized, clinical trial.",M J Kaviani; M R Hashemi; A R Kazemifar; S Roozitalab; A-A Mostaghni; S Merat; M Alizadeh-Naini; H Yarmohammadi,"Endoscopic therapies and continuous intravenous omeprazole can decrease the morbidity and duration of hospital stay of patients with high-risk peptic ulcer. To evaluate the role of oral omeprazole in high-risk bleeders. After injection therapy of 160 patients with high-risk peptic ulcer, 80 received oral omeprazole and 80 received placebo, and all were followed up. One hundred and forty-nine patients (71 omeprazole and 78 placebo) completed the study. Eleven patients were excluded from the study. Thirty-seven (25%) patients had gastric ulcer and 112 (75%) had duodenal ulcer. Fifty-seven (38%) ulcers showed visible vessels, 80 (54%) showed oozing of blood and 12 (8%) showed a spurting artery. Only one patient died (placebo group). The mean hospital stays were 62.8 +/- 28.6 h and 75 +/- 39 h in the omeprazole and placebo groups, respectively (P = 0.032). The mean amounts of blood transfused were 1.13 +/- 1.36 and 1.68 +/- 1.68 bags in the omeprazole and placebo groups, respectively (P = 0.029). The re-bleeding rate was lower in the omeprazole group than in the placebo group (12 vs. 26, respectively; P = 0.022). Oral omeprazole is effective in decreasing the hospital stay, re-bleeding rate and the need for blood transfusion in high-risk ulcer bleeders treated with endoscopic injection therapy.",2003.0,0,0
630,12534409,Baclofen decreases acid and non-acid post-prandial gastro-oesophageal reflux measured by combined multichannel intraluminal impedance and pH.,M F Vela; R Tutuian; P O Katz; D O Castell,"Omeprazole controls acid but not non-acid reflux. The GABA B agonist baclofen decreases acid reflux through the inhibition of transient lower oesophageal sphincter relaxations (TLESRs) and should similarly decrease non-acid reflux. Using combined multichannel intraluminal impedance and pH (MII/pH), we compared acid and non-acid reflux after placebo and baclofen. Nine healthy volunteers and nine heartburn patients underwent two 2-h studies of combined MII/pH in right lateral decubitus after a refluxogenic meal in random order: on placebo and after baclofen 40 mg p.o. Tracings were analysed for acid and non-acid reflux episodes, re-reflux and symptoms in the heartburn patients. In normal subjects baclofen significantly reduced the median number of episodes of acid (7 vs. 1, P = 0.02), non-acid (2 vs. 0, P = 0.005), and all reflux combined (10 vs. 2, P = 0.006); re-reflux was not reduced (0 vs. 0, P = N.S.). In heartburn patients, baclofen significantly decreased the median number of episodes of acid (15 vs. 6, P = 0.004), non-acid (4 vs. 2, P = 0.003), re-reflux (2 vs. 0, P = 0.02), and all reflux combined (23 vs. 8, P = 0.004); it also reduced the median number of acid-related (9 vs. 1, P = 0.008) and non-acid-related (1 vs. 0, P = 0.04) symptoms. Baclofen reduces post-prandial acid and non-acid reflux and their associated symptoms. GABA B agonists may have a role in treating GERD.",2003.0,0,0
631,12534411,"Effect of different proton pump inhibitors, differences in CYP2C19 genotype and antibiotic resistance on the eradication rate of Helicobacter pylori infection by a 1-week regimen of proton pump inhibitor, amoxicillin and clarithromycin.",H Kawabata; Y Habu; H Tomioka; H Kutsumi; M Kobayashi; K Oyasu; T Hayakumo; S Mizuno; K Kiyota; M Nakajima; K Kimoto; H Inokuchi; K Kawai,"To investigate the effect of different proton pump inhibitors, S-mephenytoin 4'-hydroxylase (CYP2C19) genotype and antibiotic susceptibility on the eradication rate of Helicobacter pylori. One hundred and eighty-seven H. pylori-infected peptic ulcer patients were randomly treated with either rabeprazole (10 mg b.d.) or lansoprazole (30 mg b.d.) plus amoxicillin (750 mg b.d.) and clarithromycin (400 mg b.d.) for 1 week. The antibiotic susceptibility and CYP2C19 genotype (extensive or poor metabolizer) were investigated. The eradication rates in the rabeprazole-amoxicillin-clarithromycin (RAC) and lansoprazole-amoxicillin-clarithromycin (LAC) groups were 75% and 69%, respectively, on an intention-to-treat basis, and 80% and 75%, respectively, on a per protocol basis. The eradication rate for clarithromycin-resistant strains was significantly lower than that for clarithromycin-sensitive strains (24% vs. 86%, P < 0.05). For clarithromycin-sensitive strains in the LAC group, there was a tendency for a lower eradication rate in extensive than poor metabolizers. The eradication rate in extensive metabolizers in the RAC group tended to be higher than that in extensive metabolizers in the LAC group (89% vs. 78%, P = 0.079726). The success of the 1-week proton pump inhibitor-amoxicillin-clarithromycin regimen depends on the susceptibility of H. pylori to clarithromycin. Moreover, differences in CYP2C19 genotype influence the eradication rates of lansoprazole-based therapy, and the rabeprazole-based regimen has an advantage especially in extensive metabolizers.",2003.0,0,0
632,12544691,Impact of clarithromycin resistance and CYP2C19 genetic polymorphism on treatment efficacy of Helicobacter pylori infection with lansoprazole- or rabeprazole-based triple therapy in Japan.,Ikuya Miki; Nobuo Aoyama; Toshiyuki Sakai; Daisuke Shirasaka; Casmir Marwa Wambura; Shuji Maekawa; Kohei Kuroda; Takao Tamura; Tomoko Kita; Toshiyuki Sakaeda; Katsuhiko Okumura; Masato Kasuga,"Helicobacter pylori treatment failure is thought to be due mainly to polymorphic cytochrome P450 2C19 (CPY2C19) genetic polymorphism, associated with proton pump inhibitor metabolism, and antimicrobial susceptibility. This report has ascertained which was more important, CPY2C19 polymorphism or antimicrobial susceptibility, when using 1-week lansoprazole-based or rabeprazole-based triple therapy in Japan. An open, randomized, parallel group study. One hundred and forty-five subjects with H. pylori-positive gastritis or peptic ulcers were randomly assigned to receive 30 mg lansoprazole twice daily (LAC group), 10 mg rabeprazole twice daily (RAC20 group), or 20 mg rabeprazole twice daily (RAC40 group), with 1000 mg amoxicillin twice daily and 400 mg clarithromycin twice daily for 1 week. Antimicrobial resistance testing was performed by E-test. More than 4 weeks after completion of treatment, H. pylori status was assessed by 13C-urea breath test, histology, and culture. Cure rates expressed as intention-to-treat and per-protocol analyses, respectively, were 79.6 and 83.0% with LAC, 85.4 and 89.1% with RAC20, and 83.3 and 88.9% with RAC40. In the case of clarithromycin-sensitive strains, the cure rates were more than 97%, regardless of CPY2C19 polymorphism. However, treatment succeeded in only one out of 16 clarithromycin-resistant strains. The key to successful eradication of H. pylori, using lansoprazole or rabeprazole with clarithromycin and amoxicillin, is clarithromycin susceptibility, not CPY2C19 polymorphism.",2003.0,0,0
633,12560856,Motion--genetic testing is useful in the diagnosis of nonhereditary pancreatic conditions: arguments against the motion.,Jonathan A Cohn,"Mutations of two genes, the cystic fibrosis transmembrane conductance regulator gene (CFTR) and the pancreatic secretory trypsin inhibitor gene (PSTI), are associated with an increase in the risk of idiopathic chronic pancreatitis. Persons who have mutations of both CFTR alleles (one severely and one mildly affected) are especially susceptible to this disease. Because these compound heterozygotes have sufficient residual CFTR function, they do not develop cystic fibrosis lung disease. One PSTI mutation, N34S, independently increases the risk of pancreatitis. Thus, the risk of pancreatitis is greatest among individuals who are CFTR compound heterozygotes and who also have the PSTI mutation. Nonetheless, most people with CFTR and PSTI mutations do not develop pancreatitis. This fact indicates that environmental influences and gene-gene interactions also affect pancreatitis risk. Although CFTR and PSTI genetic testing can identify persons at an increased risk of pancreatitis, there are several reasons why the routine screening of individuals with nonhereditary pancreatitis is not recommended at this time: most disease-associated mutations are not detected by readily available techniques, genetic counselling guidelines do not exist, most patients with mutations do not develop pancreatitis and the results of testing do not affect the clinical management of pancreatitis.",2003.0,0,0
634,12561004,Reflux disease and Barrett's esophagus.,S Haag; G Holtmann,"Gastroesophageal reflux disease (GERD) is one of the most prevalent gastrointestinal disorders. The key feature of GERD is reflux of gastric contents into the esophagus. Medical treatment with proton-pump inhibitors (PPIs) is well established and is considered the standard treatment. Given the high prevalence of the condition and the excellent response to medical therapy, antireflux surgery is an option for patients with volume reflux that is not properly controlled by medical therapy. Adenocarcinoma is a rare but life-threatening complication of GERD. The only known precursor lesion for esophageal adenocarcinoma is Barrett's esophagus. In recent years, a clearer understanding of the development of Barrett's and of its progression toward invasive cancer has developed. Genetic factors almost certainly determine the individual risk. The length of the Barrett's esophagus segment and the size of a hiatal hernia are associated with the risk of developing high-grade dysplasia and esophageal adenocarcinoma.With regard to the clinical management of GERD patients with Barrett's, endoscopic surveillance at 3-year intervals is now considered appropriate in the absence of dysplasia. In patients with high-grade dyspepsia, the situation is more difficult. While a considerable proportion of these patients may already have invasive cancers, there is also the possibility that there is only focal dysplasia. For this reason, it is justifiable to carry out curative endoscopic resection. Mucosal ablation procedures may also be appropriate, but these still need to be properly investigated in clinical trials.",2003.0,0,0
635,12562316,Review of esomeprazole in the treatment of acid disorders.,David A Johnson,"Esomeprazole (Nexium, AstraZeneca) is the (S)-isomer of omeprazole and the first proton pump inhibitor to be developed as an optical isomer. Esomeprazole has an improved pharmacokinetic profile, resulting in increased systemic exposure and less interindividual variability compared with omeprazole, and more effective suppression of gastric acid production compared with other proton pump inhibitors. In several large, double-blind, randomised trials, significantly higher rates of endoscopically-confirmed healing of erosive oesophagitis and resolution of heartburn have been achieved in patients with gastro-oesophageal reflux disease receiving 8 weeks of esomeprazole 40 mg o.d. compared with those receiving omeprazole 20 mg o.d. or lansoprazole 30 mg o.d. In the maintenance of healed erosive oesophagitis, esomeprazole 10, 20 or 40 mg o.d. was significantly more effective than placebo in two 6-month, randomised, double-blind trials. Additionally, esomeprazole 20 mg o.d. was more effective than lansoprazole 15 mg in the maintenance of healed erosive oesophagitis in another 6-month, randomised, double-blind trial. Healing of oesophagitis was also effectively maintained by esomeprazole 40 mg o.d. in a 12-month non-comparative trial. Esomeprazole 20 or 40 mg o.d. effectively relieved heartburn in patients with gastro-oesophageal reflux disease without oesophagitis in two 4-week, placebo-controlled trials. Clinical trials have shown that triple therapy with esomeprazole 40 mg o.d. in combination with amoxicillin and clarithromycin produced Helicobacter pylori eradication rates similar to those obtained using triple therapy involving twice-daily dosing with other proton pump inhibitors. Esomeprazole is well-tolerated, with a spectrum and incidence of adverse events similar to those associated with omeprazole.",2003.0,0,0
636,12562445,Esomeprazole 20 mg and lansoprazole 15 mg in maintaining healed reflux oesophagitis: Metropole study results.,K Lauritsen; J Devière; M-A Bigard; E Bayerdörffer; G Mózsik; F Murray; S Kristjánsdóttir; V Savarino; K Vetvik; D De Freitas; V Orive; L Rodrigo; M Fried; J Morris; H Schneider; S Eklund; A Larkö; Metropole study results,"To compare the efficacy of esomeprazole, 20 mg once daily, vs. lansoprazole, 15 mg once daily, for the maintenance treatment of patients with healed reflux oesophagitis. During the initial open healing phase, 1391 patients with endoscopically verified reflux oesophagitis and a history of heartburn, with or without acid regurgitation, received esomeprazole 40 mg for 4-8 weeks. Patients who were healed (identified by endoscopy at 4 or 8 weeks) and symptom free were then randomized to receive 6 months of treatment with esomeprazole, 20 mg once daily, or lansoprazole, 15 mg once daily. Esomeprazole, 20 mg once daily, maintained a significantly higher proportion of patients in remission than lansoprazole, 15 mg once daily, over 6 months [83% (95% CI, 80-86%) of esomeprazole recipients compared with 74% (95% CI, 70-78%) of lansoprazole recipients; P < 0.0001; life table estimates]. When data were analysed according to baseline Los Angeles grade classification, esomeprazole, 20 mg once daily, achieved consistently higher remission rates across all grades of disease severity, whereas the efficacy of lansoprazole decreased to a greater extent with increasing severity of reflux oesophagitis. Esomeprazole, 20 mg once daily, is more effective than lansoprazole, 15 mg once daily, in maintaining remission in patients with healed reflux oesophagitis.",2003.0,0,0
637,12562446,"A randomized, double-blind trial of the efficacy and safety of 10 or 20 mg rabeprazole compared with 20 mg omeprazole in the maintenance of gastro-oesophageal reflux disease over 5 years.",B Thjodleifsson; G Rindi; R Fiocca; T J Humphries; A Morocutti; N Miller; K D Bardhan; European Rabeprazole Study Group,"Gastro-oesophageal reflux disease has a chronic course, and often requires long-term treatment. Proton pump inhibitors are the treatment of choice for both acute and maintenance treatment, but little is known from randomized controlled trials of their effects beyond 1 year. To compare the efficacy and safety of two doses of rabeprazole with 20 mg omeprazole in the maintenance treatment of erosive gastro-oesophageal reflux disease over 5 years. Two hundred and forty-three patients who had previously responded to acute treatment for erosive gastro-oesophageal reflux disease were prospectively randomized to receive 5 years of treatment with rabeprazole (10 or 20 mg daily) or omeprazole (20 mg daily). The primary outcome measure was endoscopically confirmed relapse of erosive gastro-oesophageal reflux disease. One hundred and twenty-three patients (51%) completed all 5 years of the study, with similar completion rates in the three groups. Relapses occurred in nine of 78 (11.5%), eight of 82 (9.8%) and 11 of 83 (13.3%) patients in the rabeprazole 20 mg, rabeprazole 10 mg and omeprazole 20 mg groups, respectively. Gastric biopsy showed no evidence of any harmful effects. All treatments were well tolerated. Rabeprazole 10 mg, rabeprazole 20 mg and omeprazole 20 mg all had similar efficacy in the maintenance treatment of gastro-oesophageal reflux disease. All three were safe and well tolerated during 5 years of treatment.",2003.0,0,0
638,12591037,"Endoscopic, deep mural implantation of Enteryx for the treatment of GERD: 6-month follow-up of a multicenter trial.",David A Johnson; Robert Ganz; James Aisenberg; Lawrence B Cohen; Jacques Deviere; T Raymond Foley; Gregory B Haber; Jeffrey H Peters; Glen A Lehman,"This prospective, multicenter, single-arm study evaluated the safety and efficacy of the endoscopic implantation of Enteryx, a biocompatible, non-biodegradable liquid polymer for the treatment of GERD. Eighty-five patients with heartburn symptoms responsive to proton pump inhibitor (PPI) use were enrolled. Inclusion requirements were HRQL score < or = 11 on PPI and > or = 20 off PPI, and 24-hour PH probe with > or = 5% total time at PH < or = 4. Patients with a hiatus hernia > 3 cm, grade 3 or 4 esophagitis, or esophageal motility disorder were excluded. Using a 4-mm needle tipped catheter during standard endoscopy, implants were made in 3-4 quadrants deep into the wall of the cardia. Use of PPI medications, pH-metry, manometry, GERD symptoms, and patient quality of life were assessed over a 6-month follow-up period. At 6 months, PPI use was eliminated in 74% and reduced by > 50% in 10% of patients. The median HRQL score improved from 24.0 pre-implant (baseline off PPIs) to 4.0 at 6 months (p < 0.001). Mean total esophageal acid exposure time was 9.5% pretherapy and 6.7% at 6 months (p < 0.001). Mean LES length increased from 2.0 cm at baseline to 3.0 cm posttherapy (p = 0.003). There were no clinically serious adverse events. Transient mild-to-moderate chest pain commonly occurred after implantation. The endoscopic implantation of Enteryx is a safe and effective therapy for eliminating or decreasing the need for PPI medications, improving GERD symptoms and patient quality of life, and decreasing esophageal acid exposure among patients suffering from GERD.",2003.0,0,0
639,12616111,Long-term results of a randomized prospective study comparing medical and surgical treatment of Barrett's esophagus.,Pascual Parrilla; Luisa F Martínez de Haro; Angeles Ortiz; Vicente Munitiz; Joaquín Molina; Juan Bermejo; Manuel Canteras,"To compare the results of medical treatment and antireflux surgery in patients with Barrett's esophagus (BE). The treatment of choice in BE is still controversial. Some clinical studies suggest that surgery could be more effective than medical treatment in preventing BE from progressing to dysplasia and adenocarcinoma. However, data from prospective comparative studies are necessary to answer this question. One hundred one patients were included in a randomized prospective study, 43 with medical treatment and 58 with antireflux surgery. All patients underwent clinical, endoscopic, and histologic assessment. Functional studies were performed in all the operated patients and in a subgroup of patients receiving medical treatment. The median follow-up was 5 years (range 1-18) in the medical treatment group and 6 years (range 1-18) in the surgical treatment group. Satisfactory clinical results (excellent to good) were achieved in 39 of the 43 patients (91%) undergoing medical treatment and in 53 of the 58 patients (91%) following antireflux surgery. The persistence of added inflammatory lesions was significantly higher in the medical treatment group. The metaplastic segment did not disappear in any case. Postoperative functional studies showed a significant decrease in the median percentage of total time with pH below 4, although 9 of the 58 patients (15%) showed pathologic rates of acid reflux. High-grade dysplasia appeared in 2 of the 43 patients (5%) in the medical treatment group and in 2 of the 58 patients (3%) in the surgical treatment group. In the latter, both patients presented with clinical and pH-metric recurrence. There was no case of malignancy after successful antireflux surgery. These results show that there are no differences between the two types of treatment with respect to preventing BE from progressing to dysplasia and adenocarcinoma. However, successful antireflux surgery proved to be more efficient than medical treatment in this sense, perhaps because it completely controls acid and biliopancreatic reflux to the esophagus.",2003.0,0,0
640,12620183,Gastroesophageal reflux disease.,Colin W Howden; William D Chey,"Heartburn on 2 or more days a week warrants medical attention, as patients are likely to suffer from gastroesophageal reflux disease (GERD). Chronic GERD can lead to the development of complications including erosive esophagitis, stricture formation, and Barrett's esophagus, which increases the risk of esophageal adenocarcinoma. A trial with a proton pump inhibitor (PPI) is the quickest and most cost-effective way to diagnose GERD, and is at least as sensitive as 24-hour intra-esophageal pH monitoring. As PPIs only bind to actively secreting proton pumps, they should be dosed 30 to 60 minutes before a meal. Despite these recommendations, a recent survey of over 1000 US primary care physicians found that 36% instructed their patients to take a PPI with or after a meal or did not specify the timing of dosing. The patients who will have the best response to surgical therapy for GERD are those who had clearly documented acid reflux with typical symptoms, and who have responded to PPI treatment. Unfortunately, the same survey found that most physicians recommend antireflux surgery for patients in whom medical therapy has failed.",2003.0,0,0
641,12622756,"Review article: Esomeprazole--enhanced bio-availability, specificity for the proton pump and inhibition of acid secretion.",P Lindberg; D Keeling; J Fryklund; T Andersson; P Lundborg; E Carlsson,"Esomeprazole, the S-isomer of omeprazole, is the first proton pump inhibitor available for clinical use as a single isomer. It demonstrates pharmacological and clinical benefits beyond those seen with the racemic omeprazole. Esomeprazole has higher and more consistent bio-availability than omeprazole, which results in a greater area under the plasma concentration-time curve. It is the area under the plasma concentration-time curve of omeprazole and esomeprazole that determines how much of each reaches the parietal cell, and thus the control of gastric acid secretion that is achieved. Esomeprazole, like other proton pump inhibitors, has a high specificity for the acidic environment of the parietal cell, where it is accumulated, activated and covalently inhibits the proton pump. Proton pumps elsewhere in the body do not achieve the level of acidity needed for accumulation and activation. Esomeprazole, 40 mg once daily, provides more effective control of gastric acid secretion than omeprazole, 20 or 40 mg once daily, and all other proton pump inhibitors given at their standard doses. This translates into greater clinical effect compared with omeprazole, 20 mg once daily, and lansoprazole, 30 mg once daily, in the management of reflux disease. Esomeprazole therapy is well tolerated, with a low adverse events profile, similar to that seen with omeprazole.",2003.0,0,0
642,12622764,"Randomized controlled study of rabeprazole, levofloxacin and rifabutin triple therapy vs. quadruple therapy as second-line treatment for Helicobacter pylori infection.",W M Wong; Q Gu; S K Lam; F M Y Fung; K C Lai; W H C Hu; Y K Yee; C K Chan; H H X Xia; M F Yuen; B C Y Wong,"To test the efficacy of rabeprazole, levofloxacin and rifabutin triple therapy vs. quadruple therapy for the second-line treatment of Helicobacter pylori infection. One hundred and nine patients who had failed previous H. pylori eradication were randomized to receive: (i) rabeprazole, 20 mg b.d., rifabutin, 300 mg once daily, and levofloxacin, 500 mg once daily, for 7 days (triple therapy); or (ii) rabeprazole, 20 mg b.d., metronidazole, 400 mg t.d.s., bismuth subcitrate, 120 mg q.d.s., and tetracycline, 500 mg q.d.s., for 7 days (quadruple therapy). Endoscopy and culture were performed before treatment. The clarithromycin (79% vs. 21%, P < 0.001) and metronidazole (89% vs. 40%, P < 0.001) resistance rates were significantly higher in patients with previous exposure than in those with no previous exposure. The intention-to-treat and per protocol eradication rates were 91%/91% for the triple therapy group and 91%/92% for the quadruple therapy group. For patients with double resistance to metronidazole and clarithromycin, the eradication rates were 85% (17/20) in the triple therapy group and 87% (13/15) in the quadruple therapy group. Compliance was greater than 95% for both regimens. Rabeprazole, levofloxacin and rifabutin-based triple therapy and quadruple therapy were equally effective as second-line treatments for H. pylori infection.",2003.0,0,0
643,12630044,Effect of anti-Helicobacter pylori IgG antibody titer following eradication of Helicobacter pylori infection.,Wasaburo Koizumi; Satoshi Tanabe; Hiroshi Imaizumi; Ken-ichi Hibi; Mitsuhiro Kida; Masahito Ohida; Isao Okayasu; Katsunori Saigenji,"We measured the levels of IgG antibody in patients treated for H. pylori infection using four commercially available ELISA (enzyme linked immunosorbent assay) kits. A total of 37 patients with peptic ulcers (21 patients had gastric ulcers and 16 patients had duodenal ulcers) were treated and monitored. These patients were treated for 14 days with either a dual therapy regime consisting of amoxicillin at 1,500 mg per day and omeprazole at 20 mg per day or a triple therapy regime consisting of the same medications as above plus metronidazole at 1,000 mg per day. Of these 37 patients, 24 patients (64.9%) had successful eradication of the H. pylori infection. The other 13 patients (35.5%) remained infected. Infection by H. pylori was confirmed prior to treatment using conventional microbiological (rapid urease test) and histological tests on biopsy specimens obtained by endoscopy. Four commercially available ELIZA kits (GAP-IgG, Hel-P, Helico-G and HM-CAP) were used to measure the serum levels of IgG antibody against H. pylori before treatment and at 3, 6 and 9 months after treatment. A significant decrease in the IgG titer was observed with the successful eradication of the H. pylori infection. In patients whom the H. pylori infection was not eradicated, the IgG titer remained the same throughout the testing period. All the kits showed a significant decrease in the IgG levels (approximately 50% at 3 months) with patients that were successfully treated. The HM-CAP kit had the lowest sensitivity at detection the decrease in antibody levels (approximately 42% decrease at 3 months). The GAP-IgG kit was able to detect whether or not H. pylori was eradicated in shortest time period (100% uniformity ratio at 3 months). The results of this study suggest that monitoring serum IgG levels after treatment may provide an early indicator of the efficacy of therapy in eradicating H. pylori infection. Additionally, the serum IgG level can provide evidence of infection in chronic gastritis patients even when the biopsy specimens are negative by microbiological and/or histological tests.",2003.0,0,0
644,12631654,Delivery of radiofrequency energy to the lower oesophageal sphincter and gastric cardia inhibits transient lower oesophageal sphincter relaxations and gastro-oesophageal reflux in patients with reflux disease.,W C E Tam; M N Schoeman; Q Zhang; J Dent; R Rigda; D Utley; R H Holloway,"Radiofrequency energy (RFe) treatment to the lower oesophageal sphincter (LOS) and gastric cardia is a new luminally delivered therapy proposed as an alternative treatment for gastro-oesophageal reflux disease (GORD). However, it is unclear how RFe achieves its antireflux effect. This study investigated the effects of RFe on mechanisms of spontaneous reflux in patients with GORD. Twenty patients with GORD underwent endoscopy, symptom evaluation, and combined postprandial oesophageal manometry and pH monitoring before and six months after RFe, and 24 hour ambulatory pH monitoring before and at six and 12 months after treatment. RFe reduced the rate of postprandial transient LOS relaxations from 6.8 (5.7-8.1) (median (interquartile range) per hour to 5.2 (4.2-5.8) per hour (p<0.01), and increased mean basal LOS pressure from 5.2 (SEM 0.3) mm Hg to 8.0 (SEM 0.4) mm Hg (p<0.01). The number of reflux events was reduced from 10 (2-15.3)/3 hours to 5 (3.5-8.5)/3 hours (p<0.05) and there was an associated significant reduction in acid exposure time from 5.4% (0.4-14.7) to 3.9% (0.4-6.6) (p<0.05). RFe significantly reduced ambulatory oesophageal acid exposure from 10.6% (7.8-13.0) to 6.8% (3.1-9.1) (p<0.01) at six months and 6.3% (4.7-10.9) (p<0.05) at 12 months. All patients required acid suppressant medication for symptom control before RFe. Six months after treatment, 15 patients (75%) were in symptomatic remission and 13 (65%) at 12 months. RFe has significant effects on LOS function that are associated with improvement in the antireflux barrier. Uncontrolled clinical data also suggest a beneficial effect in the control of reflux symptoms in these patients.",2003.0,0,0
645,12631678,Non-steroidal anti-inflammatory drugs: overall risks and management. Complementary roles for COX-2 inhibitors and proton pump inhibitors.,C J Hawkey; M J S Langman,"Non-steroidal anti-inflammatory drugs (NSAIDs) are well recognised as causing peptic ulceration and ulcer complications. However, several critical issues, including the amount of both gastrointestinal and non-gastrointestinal disease affected by NSAIDs, their interaction with ancillary risk factors, and how to optimise management in subgroups, remain poorly understood. In this article, strategies for subgroups that take account of non-specific gastrointestinal risks, minimisation of residual risk, and the importance of non-gastrointestinal toxicity are suggested, and areas for research identified.",2003.0,0,0
646,12641500,Low-dose or standard-dose proton pump inhibitors for maintenance therapy of gastro-oesophageal reflux disease: a cost-effectiveness analysis.,J H S You; A C M Lee; S C Y Wong; F K L Chan,"Studies on the use of low-dose proton pump inhibitor for the maintenance therapy of gastro-oesophageal reflux disease have shown that it might be comparable with standard-dose proton pump inhibitor treatment and superior to standard-dose histamine-2 receptor antagonist therapy. To compare the impact of standard-dose histamine-2 receptor antagonist, low-dose proton pump inhibitor and standard-dose proton pump inhibitor treatment for the maintenance therapy of gastro-oesophageal reflux disease on symptom control and health care resource utilization from the perspective of a public health organization in Hong Kong. A Markov model was designed to simulate, over 12 months, the economic and clinical outcomes of gastro-oesophageal reflux disease patients treated with standard-dose histamine-2 receptor antagonist, low-dose proton pump inhibitor and standard-dose proton pump inhibitor. The transition probabilities were derived from the literature. Resource utilization was retrieved from a group of gastro-oesophageal reflux disease patients in Hong Kong. Sensitivity analysis was conducted to examine the robustness of the model. The standard-dose proton pump inhibitor strategy was associated with the highest numbers of symptom-free patient-years (0.954 years) and quality-adjusted life-years gained (0.999 years), followed by low-dose proton pump inhibitor and standard-dose histamine-2 receptor antagonist. The direct medical cost per patient in the standard-dose proton pump inhibitor group (904 US dollars) was lower than those of the low-dose proton pump inhibitor and standard-dose histamine-2 receptor antagonist groups. The standard-dose proton pump inhibitor strategy appears to be the most effective and least costly for the maintenance management of patients with gastro-oesophageal reflux disease in Hong Kong.",2003.0,0,0
647,12641502,"Effect of treatment of Helicobacter pylori on the prevention of gastroduodenal ulcers in patients receiving long-term NSAIDs: a double-blind, placebo-controlled trial.",K C Lai; C S Lau; W Y Ip; B C Y Wong; W M Hui; W H C Hu; R W M Wong; S K Lam,"There is controversy as to whether Helicobacter pylori and non-steroidal anti-inflammatory drugs interact to cause peptic ulcers. To study whether the eradication of H. pylori in patients on long-term non-steroidal anti-inflammatory drug therapy prevents the development of ulcers. Patients infected with H. pylori whilst receiving long-term non-steroidal anti-inflammatory drug therapy, but with no ulcers at baseline endoscopy, were randomized to receive either triple antibiotic therapy (metronidazole 300 mg, clarithromycin 250 mg and amoxicillin 500 mg, given four times daily; n = 70) or placebo (n = 70) for 2 weeks. Non-steroidal anti-inflammatory drugs were continued throughout the study period. Endoscopy was repeated 12 weeks after the end of treatment. The development of ulcers was compared between the two groups. Endoscopy at 12 weeks revealed peptic ulcer development in five [7%; 95% confidence interval (CI), 2-16] of the patients who received triple therapy and in six (9%; 95% CI, 3-18) of those who received placebo (P = 1.00). No significant difference in the development of ulcers was found between patients with persistent H. pylori infection (7/80; 9%; 95% CI, 4-17) and those with the eradication of H. pylori (4/52; 8%; 95% CI, 2-19) (P = 1.00). The eradication of H. pylori in patients receiving long-term treatment with non-steroidal anti-inflammatory drugs did not prevent ulcer development. However, because the rate of ulcer development was low, a study with a larger sample size is required to confirm this finding.",2003.0,0,0
648,12641522,High eradication rates of Helicobacter pylori with a new sequential treatment.,A Zullo; D Vaira; N Vakil; C Hassan; L Gatta; C Ricci; V De Francesco; M Menegatti; A Tampieri; F Perna; V Rinaldi; F Perri; C Papadìa; F Fornari; S Pilati; L S Mete; A Merla; R Potì; G Marinone; A Savioli; S M A Campo; D Faleo; E Ierardi; M Miglioli; S Morini,"Eradication rates of Helicobacter pylori with standard triple therapy are disappointing, and studies from several countries confirm this poor performance. To assess the eradication rate of a new sequential treatment regimen compared with conventional triple therapy for the eradication of H. pylori infection. One thousand and forty-nine dyspeptic patients were studied prospectively. H. pylori-infected patients were randomized to receive 10-day sequential therapy [rabeprazole (40 mg daily) plus amoxicillin (1 g twice daily) for the first 5 days, followed by rabeprazole (20 mg), clarithromycin (500 mg) and tinidazole (500 mg) twice daily for the remaining 5 days] or standard 7-day therapy [corrected] [rabeprazole (20 mg), clarithromycin (500 mg) and amoxicillin (1 g) twice daily]. H. pylori status was assessed by histology, rapid urease test and 13C-urea breath test at baseline and 6 weeks or more after completion of treatment. Higher eradication rates were found with the sequential regimen compared to the standard regimen (intention-to-treat: 92% vs. 74%, P < 0.0001; per protocol: 95% vs. 77%, P < 0.0001). Higher eradication rates were also seen in patients with peptic ulcer disease and non-ulcer dyspepsia. In both treatments, compliance was similar (> 90%), as was the rate of side-effects, which were mild. This 10-day sequential treatment regimen achieves high eradication rates in peptic ulcer disease and non-ulcer dyspepsia.",2003.0,0,0
649,12650778,Nocturnal acid breakthrough in perspective: let's not throw out the baby with the bath water.,Donald O Castell,,2003.0,0,0
650,12650788,"Bismuth-based quadruple therapy using a single capsule of bismuth biskalcitrate, metronidazole, and tetracycline given with omeprazole versus omeprazole, amoxicillin, and clarithromycin for eradication of Helicobacter pylori in duodenal ulcer patients: a prospective, randomized, multicenter, North American trial.",Loren Laine; Richard Hunt; Hala El-Zimaity; Bich Nguyen; Michael Osato; Jean Spénard,"This multicenter, randomized, active-controlled trial assessed efficacy of bismuth-based quadruple therapy with omeprazole, bismuth biskalcitrate, metronidazole, and tetracycline (OBMT) using a single-triple capsule of BMT compared with triple therapy with omeprazole, amoxicillin, and clarithromycin (OAC) in treatment of patients with Helicobacter pylori infection and duodenal ulcers. Patients with active duodenal ulcer or diagnosed within the past 5 yr and with infection documented by (13)C-urea breath test plus histology or culture were randomly assigned to 10-day course of OBMT using a single-triple capsule containing bismuth biskalcitrate 140 mg, metronidazole 125 mg, and tetracycline 125 mg given as three capsules q.i.d. with omeprazole 20 mg b.i.d., or a 10-day course of OAC, omeprazole 20 mg plus amoxicillin 1 g plus clarithromycin 500 mg, all b.i.d. Eradication was confirmed by two negative urea breath tests at >1 month and >2 months after therapy. One hundred thirty-eight patients received OBMT and 137 OAC. Modified intent-to-treat eradication rates were 87.7% for OBMT and 83.2% for OAC (95% CI = -3.9%-12.8%; p = 0.29). OBMT eradicated 91.7% metronidazole-sensitive and 80.4% metronidazole-resistant strains (p = 0.06). OAC eradicated 92.1% clarithromycin sensitive and 21.4% clarithromycin-resistant strains (p < 0.001). Adverse events occurred in 58.5% of OBMT patients and 59.0% of OAC patients. OBMT regimen using the single-triple capsule is as efficacious and well-tolerated as the widely used OAC regimen for H. pylori eradication. This OBMT therapy largely overcomes H. pylori metronidazole resistance, present in 40% of patients in this study.",2003.0,0,0
651,12656697,Meal-stimulated gastric acid secretion and integrated gastric acidity in gastro-oesophageal reflux disease.,J D Gardner; S Sloan; P B Miner; M Robinson,"No current methods exist to determine meal-stimulated gastric acid secretion in humans under conditions that approximate those of daily living with the ingestion of breakfast, lunch and dinner. Gastric and oesophageal pH were measured in 26 healthy subjects and in 59 subjects with gastro-oesophageal reflux disease. Meal-stimulated gastric acid secretion was calculated from the buffer capacity of the meals determined in vitro and from the time required for the gastric pH to decrease to pH 2 in vivo following ingestion of the meal. There was a significant correlation between gastric secretion with each meal and the corresponding post-prandial integrated gastric acidity. There was also a significant correlation between meal-stimulated gastric secretion and integrated gastric acidity from 09.00 to 22.00 h in both subjects with gastro-oesophageal reflux disease and controls. In subjects with gastro-oesophageal reflux disease, gastric secretion and integrated gastric acidity from 09.00 to 22.00 h were significantly higher than those in controls. There was a significant correlation between oesophageal acidity and integrated gastric acidity from 09.00 to 22.00 h in subjects with gastro-oesophageal reflux disease. As post-prandial gastric acidity is increased in subjects with gastro-oesophageal reflux disease, it seems likely that increased gastric acidity is an important aetiological factor in this disease.",2003.0,0,0
652,12656698,Determination of the reduction in gastric acidity necessary to prevent pathological oesophageal reflux in patients with gastro-oesophageal reflux disease treated with a proton pump inhibitor.,J D Gardner; S Sloan; P B Miner; M Robinson,"In subjects with gastro-oesophageal reflux disease treated with a gastric antisecretory agent, the extent to which gastric acidity needs to be reduced to prevent pathological oesophageal acid exposure is not known. Gastric and oesophageal pH were measured in 26 healthy subjects and in 59 subjects with gastro-oesophageal reflux disease. In 27 of the subjects with gastro-oesophageal reflux disease, pH was also recorded on days 1, 2 and 8 of treatment with 20 mg omeprazole and 20 mg rabeprazole in a randomized, two-way, cross-over fashion. Receiver operating characteristic analysis was used to determine values for the integrated oesophageal acidity and time oesophageal pH<or=4 that gave optimal cut-off points for distinguishing between normal and pathological oesophageal reflux. Using these cut-off points, we found that the probability of no pathological oesophageal reflux (Y) could be best fitted by an exponential equation, Y = a(e-bX) + c, where a, b and c are constants and X is the value of the integrated gastric acidity. There was close agreement between the predicted and observed percentages of subjects with pathological oesophageal reflux during different days of treatment. In subjects with gastro-oesophageal reflux disease treated with a proton pump inhibitor, the value of the integrated gastric acidity can predict the likelihood of pathological oesophageal reflux.",2003.0,0,0
653,12656699,The effects of lansoprazole on erosive reflux oesophagitis are influenced by CYP2C19 polymorphism.,M Kawamura; S Ohara; T Koike; K Iijima; J Suzuki; S Kayaba; K Noguchi; S Hamada; M Noguchi; T Shimosegawa; Study Group of GERD,"The acid suppressive effect of lansoprazole is influenced by the P450 2C19 (CYP2C19) polymorphism. To investigate whether the CYP2C19 genotype is related to the healing of erosive reflux oesophagitis during treatment with lansoprazole. Eighty-eight Japanese patients with erosive reflux oesophagitis were treated with a daily oral dose of 30 mg lansoprazole for 8 weeks. The CYP2C19 genotype, Helicobacter pylori infection status and serum pepsinogen I/II ratio were assessed before treatment. At 4 and 8 weeks, the healing of erosive reflux oesophagitis was evaluated endoscopically. The healing rates were 57.1%, 69.2% and 72.7% at 4 weeks and 77.4%, 95.0% and 100% at 8 weeks in homozygous extensive metabolizers, heterozygous extensive metabolizers and poor metabolizers, respectively. At 8 weeks, the healing rate of erosive reflux oesophagitis was significantly lower in homozygous extensive metabolizers than in the other two groups (P < 0.05). The H. pylori status and serum pepsinogen I/II ratio had less influence than CYP2C19 polymorphism on the healing rate of erosive reflux oesophagitis. The therapeutic effect of lansoprazole on erosive reflux oesophagitis is influenced by the CYP2C19 genotype status. Therefore, a test of CYP2C19 genotype may be useful for the medical treatment of reflux oesophagitis with lansoprazole.",2003.0,1,1
654,12662375,'Rescue' therapy with rifabutin after multiple Helicobacter pylori treatment failures.,Javier P Gisbert; Xavier Calvet; Luis Bujanda; Santiago Marcos; José Luis Gisbert; José María Pajares,"Eradication therapy with proton pump inhibitor, clarithromycin and amoxicillin is extensively used, although it fails in a considerable number of cases. A 'rescue' therapy with a quadruple combination of omeprazole, bismuth, tetracycline and metronidazole (or ranitidine bismuth citrate with these same antibiotics) has been recommended, but it still fails in approximately 20% of cases. Our aim was to evaluate the efficacy and tolerability of a rifabutin-based regimen in patients with two consecutive H. pylori eradication failures.  Prospective multicenter study. Consecutive patients in whom a first eradication trial with omeprazole, clarithromycin and amoxicillin and a second trial with omeprazole, bismuth, tetracycline and metronidazole (three patients) or ranitidine bismuth citrate with these same antibiotics (11 patients) had failed were included. A third eradication regimen with rifabutin (150 mg bid), amoxicillin (1 g bid) and omeprazole (20 mg bid) was prescribed for 14 days. All drugs were administered together after breakfast and dinner. Compliance with therapy was determined from the interrogatory and the recovery of empty envelopes of medications. H. pylori eradication was defined as a negative 13C-urea breath test 8 weeks after completing therapy. Fourteen patients have been included. Mean age +/- SD was 42 +/- 11 years, 41% males, peptic ulcer (57%), functional dyspepsia (43%). All patients took all the medications and completed the study protocol. Per-protocol and intention-to-treat eradication was achieved in 11/14 patients (79%; 95% confidence interval = 49-95%). Adverse effects were reported in five patients (36%), and included: abdominal pain (three patients), nausea and vomiting (one patient), and oral candidiasis (one patient); no patient abandoned the treatment due to adverse effects. Rifabutin-based rescue therapy constitutes an encouraging strategy after multiple previous eradication failures with key antibiotics such as amoxicillin, clarithromycin, metronidazole and tetracycline.",2003.0,0,0
655,12662378,"Lafutidine, a novel histamine H2-receptor antagonist, vs lansoprazole in combination with amoxicillin and clarithromycin for eradication of Helicobacter pylori.",Hajime Isomoto; Kenichiro Inoue; Hisashi Furusu; Hitoshi Nishiyama; Saburo Shikuwa; Katsuhisa Omagari; Yohei Mizuta; Kunihiko Murase; Ikuo Murata; Shigeru Kohno,"In contrast to the growing amount of data concerning proton pump inhibitor-based triple therapy for Helicobacter pylori infection, it is still controversial whether proton pump inhibitor can be replaced by H2 receptor antagonist without compromising efficacy. Lafutidine is a novel potent H2 receptor antagonist with gastroprotective activities such as enhancement of gastric mucosal blood flow. 122 outpatients with positive cultures and subsequent successful cultivation of H. pylori for antimicrobial susceptibility tests were randomized to receive a 7-day course of either lafutidine (20 mg twice daily) or lansoprazole (30 mg twice daily), plus clarithromycin (200 mg twice daily) and amoxicillin (750 mg twice daily). Eradication was considered successful if the rapid urease test, culture, histology and [13]C-urea breath test were all negative at least 4 weeks after cessation of therapy. Cytochrome p450 2C19 genotype status using polymerase chain reaction-restriction fragment length polymorphism was also studied. On intention-to-treat basis, H. pylori cure was achieved in 52 of 61 (85.2%) patients and 49 of 61 (80.3%) patients for the lafutidine- and lansoprazole-based therapies, respectively. The predicted 95% confidential intervals for the 4.9% of the difference were -1.8-11.6%. Using per protocol analysis, the eradication rates were 88.2% (52/59) and 84.5% (49/58), respectively. The predicted 95% confidential intervals for the 3.7% of the difference were -2.6-10.0%. Adverse events were observed in five and six patients, from the lafutidine and lansoprazole groups, respectively, but they were generally mild. Genetic predisposition of cytochrome p450 2C19 had no significant influence on treatment outcome in both regimens. The lafutidine-clarithromycin-amoxicillin therapy yielded satisfactory results for eradicating H. pylori, which was comparable with those of the lansoprazole-based regimen with the same drug combination.",2003.0,0,0
656,12671413,Empiric esomeprazole in the treatment of laryngopharyngeal reflux.,John M DelGaudio; J Patrick Waring,"Objectives were to determine the efficacy of empiric treatment with esomeprazole for patients diagnosed with laryngopharyngeal reflux and to determine a treatment paradigm for this patient population. Prospective study. Patients were treated with a once-daily dose of 40 mg esomeprazole for 8 weeks. All patients completed a subjective symptom scale (rating laryngeal symptoms and esophageal symptoms) and scoring of flexible fiberoptic examination before treatment and at 4 and 8 weeks of treatment. Nonresponders (<50% reduction in symptom score) were recommended to undergo 24-hour dual-probe pH study while on a regimen of 40 mg esomeprazole once a day, to evaluate for the adequacy of acid suppression. Thirty patients completed the course of therapy. After 4 weeks of treatment, only 8 of 30 patients had significant improvement of their overall symptoms (8 of 30 improved on laryngeal score, and 11 of 18 improved on esophageal score). At 8 weeks of treatment, 19 of 30 patients had significant improvement on their overall symptoms (18 of 30 on laryngeal score, and 13 of 18 on their esophageal score). Five of seven nonresponders who agreed to be tested had positive findings on pH studies (on medication regimen) at 1 cm above the upper esophageal sphincter. Four of 10 nonresponders improved further after increasing their dosage to 40 mg twice a day. Laryngeal examination scores were statistically improved in responders after 8 weeks of treatment. Laryngopharyngeal reflux symptoms require at least 8 weeks of treatment for significant improvement in the majority of patients. Esophageal symptoms improve sooner. Nonresponders at a daily dose of 40 mg should be treated with a dosage of 40 mg twice daily, and pH study on medication reserved for nonresponders at this higher dose. Laryngeal examination scores showed mild but statistically significant improvement at 8 weeks of therapy in responders.",2003.0,0,0
657,12672327,Endoluminal therapies for gastro-oesophageal reflux disease.,Jean Paul Galmiche; Stanislas Bruley des Varannes,"Gastro-oesophageal reflux disease (GORD) is a common chronic disorder that has severe impact on quality of life and often requires continuous acid-suppression therapy. Proton-pump inhibitors (PPIs) are extremely effective but expensive, and do not restore the normal antireflux barrier at the gastro-oesophageal junction. Antireflux surgery, even with the laparoscopic approach, has not proven more cost-effective than maintenance therapy with PPIs. Postoperative morbidity is substantial, especially when procedures are done outside expert centres. In the past few years several endoscopic techniques have been developed to treat chronic GORD on an outpatient basis. These techniques include radiofrequency-energy delivery and endoscopic suturing, although other approaches are now under development. STARING POINT: Two prospective open-label studies have recently reported 1-year follow-up of GORD patients treated either by radiofrequency-energy delivery (G Triadafilopoulos and colleagues Gastrointest Endosc 2002; 55:149-56) or endoscopic suturing (Z Mahmood and colleagues Gut 2003; 52:34-39). In a US multicentre trial, Triadafilopoulos and colleagues delivered radiofrequency energy to the cardia and distal oesophagus in patients with chronic heartburn, regurgitation or both (the Stretta procedure). All patients were on continuous acid-suppression therapy, but none had severe oesophagitis or hiatus hernia of more than 2 cm. At 12 months, 94 patients available for follow-up showed significant improvement in GORD symptoms, quality of life, and oesophageal acid-exposure. The need for PPI therapy fell from 98% to 30% of patients. In the Mahmood study, 26 similar patients had endoscopic suturing in a single centre. After 1 year, symptoms and quality of life improved and the need for PPIs was reduced to 36% from 100%. In both studies, only minor complications occurred, none of which required specific therapeutic intervention. WHERE NEXT? An effective outpatient procedure to treat chronic GORD would represent a major step forward. However, further studies are needed before an endoscopic approach can be adopted, as none of the published trials are well-controlled studies. Longer follow-up is needed to ensure that relapses do not occur rapidly, complications do not occur more frequently with less skilled operators, or that endoscopic-induced changes do not complicate or compromise subsequent antireflux surgery. Comparative studies of the cost-effectiveness of endoscopic therapy should also include medical strategies such as intermittent or on-demand PPI therapy.",2003.0,0,0
658,12680476,Pharmacogenetics of the proton pump inhibitors: a systematic review.,Elaine Chong; Mary H H Ensom,"Cytochrome P450 (CYP) 2C19 mediates the major metabolic transformations of the proton pump inhibitors (PPIs) omeprazole, pantoprazole, lansoprazole, esomeprazole, and rabeprazole. Genetic polymorphism of CYP2C19 can lead to significant phenotypic variation in the activity of this isoenzyme and thus in the metabolism of PPIs. We systematically reviewed the pharmacogenetic studies of PPIs with respect to the effects of CYP2C19 polymorphism on the clinical outcomes of PPI therapy. We searched MEDLINE (January 1966-August 2002) and EMBASE (January 1988-August 2002) for English-language articles on the pharmacogenetics of PPIs; the search was supplemented by a bibliographic review of all relevant articles. Seventeen pertinent citations were identified, and the quality (level) of evidence for each was categorized according to the rating scale of the United States Preventive Services Task Force. We found that the relationship between CYP2C19 genetic polymorphism and clinical outcomes after PPI therapy has not yet been clearly delineated. Virtually all pharmacogenetic studies of PPIs have been performed in Japanese men; thus, the clinical relevance of CYP2C19 genetic polymorphism in non-Asian patients and women is unknown. Differences among dual- and triple-therapy drug regimens make it difficult to compare H. pylori eradication studies and assess their applicability to current practice patterns. Drug adherence, a pivotal factor in the success of eradication therapy, was addressed in only four trials. Future directions for research include performing more studies with larger sample sizes, particularly in non-Asian populations and women; measuring plasma PPI concentrations to directly correlate H. pylori infection and ulcer cure rates with plasma drug availability; expanding the study population to patients with gastroesophageal reflux disease; and exploring the influence of CYP3A4 in the success or failure of PPI therapy. Although CYP2C19 genotyping is currently only a research instrument, it may be a valuable clinical tool in select patients to ensure optimal PPI therapy.",2003.0,0,1
659,12684276,"Not the perfect study, but helpful wisdom for treating asthma patients with gastroesophageal reflux disease.",Joel E Richter,,2003.0,0,0
660,12689666,Evidence-based analysis: postoperative gastric bleeding: etiology and prevention.,Jade S Hiramoto; Jonathan P Terdiman; Jeffrey A Norton,"Although the incidence of stomach hemorrhage is declining, stress-related gastric bleeding remains an important source of morbidity and mortality in cancer patients undergoing major surgical procedures to remove tumor. Prevention of stress-related bleeding is desirable; however, the optimal use of drugs to prevent gastric bleeding is unclear. Prophylaxis is recommended for surgical patients who require prolonged mechanical ventilation or have a coaguloathy. Histamine-2 receptor antagonists and sucralfate will reduce the likelihood of clinically important gastric-bleeding. Sucralfate appears to be less effective than H-2 blockers, but it is associated with fewer side effects such as nosocomial pneumonia. Preliminary studies show that proton pump inhibitors are most effective, have few side effects, but are most expensive. Intravenous proton pump inhibitors may be the drugs of choice for stress ulcer prophylaxis (SUP) in high-risk patients.",2003.0,0,0
661,12694087,Reflux symptoms in general practice: diagnostic evaluation of the Carlsson-Dent gastro-oesophageal reflux disease questionnaire.,M E Numans; N J de Wit,"Amongst primary care patients with dyspeptic symptoms, those with reflux-like symptoms or gastro-oesophageal reflux disease are expected to benefit most from empirical proton pump inhibitor therapy. Recognition of this patient group, however, is difficult. The Carlsson-Dent gastro-oesophageal reflux disease questionnaire was developed to justify the selection of primary care patients for empirical proton pump inhibitor treatment. To evaluate the diagnostic test characteristics of the Carlsson-Dent questionnaire in a primary care population. A prospective, open-label, multi-centre diagnostic prevalence study was conducted amongst primary care adults with reflux symptoms. All patients completed the questionnaire and underwent gastroscopy. If no abnormalities were found, the patients were prescribed 2 weeks of treatment with omeprazole (20 mg daily). Receiver operating characteristic curve analysis was used to determine the overall discriminative value of the questionnaire. Diagnostic test characteristics of both the cut-off score (total diagnostic score) in the questionnaire and the physician's provisional classification were measured using oesophagitis and omeprazole treatment success as the reference tests. Of the 536 patients included, 515 underwent endoscopy. No abnormalities were found in 286 (55%). Omeprazole treatment success occurred more frequently in patients with a total diagnostic score of > 7 and oesophagitis II-IV in patients with a total diagnostic score of > 9. The diagnostic test characteristics of the questionnaire were comparable with those of the physician's provisional classification. The area under the receiver operating characteristic curve did not exceed 0.65. Kappa values for observer agreement with the gold standard were far below 0.4. The diagnostic performance of this version of the Carlsson-Dent questionnaire was poor. It equalled the physician's clinical judgement and therefore its value for clinical use is limited.",2003.0,0,0
662,12694089,Safety and efficacy of 7-day rabeprazole- and omeprazole-based triple therapy regimens for the eradication of Helicobacter pylori in patients with documented peptic ulcer disease.,C J Hawkey; J C Atherton; H C Treichel; B Thjodleifsson; M Ravic,"A double-blind, randomized study was designed to determine whether rabeprazole- and omeprazole-based triple therapy regimens are therapeutically equivalent in the eradication of Helicobacter pylori. Three hundred and forty-five patients with current or previously active peptic ulcer and a positive H. pylori urease test were randomly assigned to receive RCA, OCA, RCM or OCM twice daily for 7 days (R, rabeprazole 20 mg; O, omeprazole 20 mg; C, clarithromycin 500 mg; A, amoxicillin 1000 mg; M, metronidazole 400 mg). H. pylori eradication was documented by negative 13C-urea breath tests at 4 and 12 weeks, and was evaluated using a 2 x 2 factorial design with proton pump inhibitor and antibiotic as factors. Overall eradication rates (per protocol/intention-to-treat) were 87%/77% and 85%/75% with rabeprazole and omeprazole, respectively (not significant). However, a statistical interaction between proton pump inhibitor and antibiotic was identified. RCA produced a somewhat higher eradication rate than OCA (94% vs. 84%; difference, 9.8%; 95% confidence interval, - 0.7% to + 20.4%), whereas RCM produced a lower eradication rate than OCM (79% vs. 86%; difference, 8.1%; 95% confidence interval, - 21.4% to + 5.1%). Ulcer healing rates were > 90% with H. pylori eradication. Each regimen was well tolerated. Rabeprazole- and omeprazole-based triple therapy regimens are therapeutically equivalent in the eradication of H. pylori and well tolerated. The statistical interaction observed between the proton pump inhibitor and supplementary antibiotic may be due to chance.",2003.0,0,0
663,12698301,Outcome trials of COX-2 selective inhibitors: global safety evaluation does not promise benefits.,Jorge Gomez Cerezo; Rubin Lubomirov Hristov; Antonio J Carcas Sansuán; Juan J Vázquez Rodríguez,"Gastrointestinal toxicity is the most frequent adverse effect associated with nonsteroidal anti-inflammatory drug use. The most clinically relevant side effects of this toxicity are ulcer complications, including perforation, obstruction, or bleeding. Selective cyclooxygenase (COX-2) inhibitors (coxibs) have been proposed as a safer alternative to traditional, nonsteroidal anti-inflammatory drugs and they are currently widely used in clinical practice. The aim of this review was to analyze the available evidence and then critically evaluate the outcome trials supporting the use of coxibs in terms of their clinical gastrointestinal benefits and global safety. All published clinical trials on selective COX-2 inhibitors were identified by searching Medline, the World Wide Web (WWW), and abstracts in Congress proceedings. From these, we selected randomized trials that clinically evaluated relevant safety outcome measures. Papers only describing endoscopic evaluation were excluded. Our search yielded three outcome trials and two pooled safety analyses. The outcome studies supporting the gastrointestinal and global safety of coxibs were found to be biased in their design, analysis, and dissemination, and interpretation of a clinical benefit. Cost considerations would make the use of coxibs acceptable only in patients at high gastrointestinal risk. The association of the reduced gastroerosive potential of coxibs with improved meaningful outcomes is debatable. Bias in the design of the trials, selection of outcome measures, post-hoc changes in analysis and the variables used, as well as flaws in the publication and reporting of trial results cast serious doubts on the gastrointestinal and global safety profile of coxibs. In addition, their high cost and the lack of clear identification of patients that would benefit most from treatment means the effectiveness of these drugs is uncertain at the moment.",2003.0,0,0
664,12701009,Helicobacter pylori infection does not affect the early rebleeding rate in patients with peptic ulcer bleeding after successful endoscopic hemostasis: a prospective single-center trial.,D Schilling; A Demel; T Nüsse; E Weidmann; J F Riemann,"Eradication of Helicobacter pylori infection can reduce the rebleeding rate of peptic ulcer bleeding in the long term. There are few data on the influence of H. pylori on the rebleeding rate in the acute phase of bleeding however. We therefore prospectively investigated the influence of H. pylori infection on the early rebleeding rate in patients who had undergone successful endoscopic hemostasis treatment for peptic ulcer bleeding. Between January 1996 and November 2000 all patients with peptic ulcer bleeding were evaluated consecutively. The diagnosis of H. pylori infection was made at index endoscopy, using histology and the rapid urease test. Bleeding activity was assessed using the Forrest classification. After successful endoscopic hemostasis all patients received omeprazole 40 mg or pantoprazole 40 mg, intravenously, twice a day for 3 days. Rebleeding episodes were recorded over 21 days following primary hemostasis. 344 patients were enrolled into the study. The prevalence of H. pylori infection was 62.9 %. A total of 51 patients showed rebleeding (14.8 %), of whom 31 were H. pylori-positive (60 %). There was no statistically significant difference between the H. pylori-positive and -negative patients, however. The rebleeding rate did not differ between patients with H. pylori infection alone and patients also using nonsteroidal anti-inflammatory drugs. When stratifying patients according to activity of bleeding at index endoscopy, we were also unable to find any significant influence of H. pylori infection on the outcome of Forrest class I and IIa bleedings. Based on our data, it can be concluded that H. pylori infection does not affect the early rebleeding rate in patients with peptic ulcer bleeding after successful endoscopic hemostasis.",2003.0,0,0
665,12708935,A cost-effectiveness analysis of stress ulcer prophylaxis.,Kelly N Schupp; Linda M Schrand; Alan H Mutnick,"To evaluate the efficacy, safety, and cost of using cimetidine, famotidine, and lansoprazole for stress ulcer prophylaxis (SUP) at our institution and determine which agent was most cost-effective. An observational study of adults admitted to the medical, surgical, or cardiovascular intensive care unit was conducted to compare the cost and effectiveness of cimetidine, famotidine, and lansoprazole for SUP. Patients were identified for inclusion during three 2-week periods in 2000. Medical record reviews were conducted to gather data regarding the costs associated with the administration of SUP drugs and the treatment of any adverse events or therapeutic failures. Decision analysis was used to determine the average cost per patient for each treatment arm. A cost-effectiveness analysis was then conducted to determine which of the SUP agents was associated with the least cost without adversely affecting patient outcomes. A sensitivity analysis was applied to determine the robustness of the data. Eighty-eight patients were included in the analysis. Five of the patients started on cimetidine experienced therapeutic failure, whereas no patients receiving lansoprazole experienced therapeutic failure. For these reasons, and because lansoprazole is an oral agent, the average costs associated with lansoprazole use were lower than with the use of cimetidine. Lansoprazole was found to be the most cost-effective therapy. This study showed that lansoprazole is a cost-effective agent for the use of SUP at our institution. However, due to the higher cost of intravenous pantoprazole, the model demonstrates that, assuming equal effectiveness, intravenous pantoprazole would not be cost-effective when compared with cimetidine.",2003.0,0,0
666,12717871,Effects of antireflux treatment on bronchial hyper-responsiveness and lung function in asthmatic patients with gastroesophageal reflux disease.,Shan-Ping Jiang; Rui-Yun Liang; Zhi-Yong Zeng; Qi-Liang Liu; Yong-Kang Liang; Jian-Guo Li,"To investigate the effects of antireflux treatment on bronchial hyper-responsiveness and lung function in asthmatic patients with gastroesophageal reflux disease (GERD). Thirty asthmatic patients with GERD were randomly divided into two groups (group A and group B). Patients in group A (n=15) only received asthma medication including inhaled salbutamol 200 microg four times a day and budesonide 400 microg twice a day for 6 weeks. Patients in Group B (n=15) received the same medication as group A, and also antireflux therapy including oral omeprazole 20 mg once a day and domperidone 10 mg three times a day for 6 weeks. Pulmonary function tests and histamine bronchoprovocation test were performed before and after the study. There was no significant difference in the baseline values of pulmonary function and histamine PC(20-FEV1) between the two groups. At the end of the study, the mean values for VC, VC%, FVC, FVC%, FEV(1), FEV(1)%, PEF, PEF%, PC(20-FEV1) were all significantly improved in group B, compared with group A. Antireflux therapy may improve pulmonary function and inhibit bronchial hyper-responsiveness in asthmatic patients with GERD.",2003.0,0,0
667,12724630,Paradigm shift in the management of gastroesophageal reflux disease.,William O Richards; Hugh L Houston; Alfonso Torquati; Leena Khaitan; Michael D Holzman; Kenneth W Sharp,"To compare the short-term results of the radiofrequency treatment of the gastroesophageal junction known as the Stretta procedure versus laparoscopic fundoplication (LF) in patients with gastroesophageal reflux disease (GERD). The Stretta procedure has been shown to be safe, well tolerated, and highly effective in the treatment of GERD. All patients presenting to Vanderbilt University Medical Center for surgical evaluation of GERD between August 2000 and March 2002 were prospectively evaluated under an IRB-approved protocol. All patients underwent esophageal motility testing and endoscopy that documented GERD preoperatively, either by a positive 24-hour pH study or biopsy-proven esophagitis. Patients were offered the Stretta procedure if they had documented GERD and did not have a hiatal hernia larger than 2 cm, LES pressure less than 8 mmHg, or Barrett's esophagus. Patients with larger hiatal hernias, LES pressure less than 8 mmHg, or Barrett's were offered LF. All patients were studied pre- and postoperatively with validated GERD-specific quality-of-life questionnaires (QOLRAD) and short-form health surveys (SF-12). Current medication use and satisfaction with the procedure was also obtained. Results are reported as mean +/- SEM. Seventy-five patients (age 49 +/- 14 years, 44% male, 56% female) underwent LF and 65 patients (age 46 +/- 12 years, 42%, 58% female) underwent the Stretta procedure. Preoperative esophageal acid exposure time was higher in the LF group. Preoperative LES pressure was higher in the Stretta group. In the LF group, 41% had large hiatal hernias (>2 cm), 8 patients required Collis gastroplasty, 6 had Barrett's esophagus, and 10 had undergone previous fundoplication. At 6 months, the QOLRAD and SF-12 scores were significantly improved within both groups. There was an equal magnitude of improvement between pre- and postoperative QOLRAD and SF-12 scores between Stretta and LF patients. Fifty-eight percent of Stretta patients were off proton pump inhibitors, and an additional 31% had reduced their dose significantly; 97% of LF patients were off PPIs. Twenty-two Stretta patients returned for 24-hour pH testing at a mean of 7.2 +/- 0.5 months, and there was a significant reduction in esophageal acid exposure time. Both groups were highly satisfied with their procedure. The addition of a less invasive, endoscopic treatment for GERD to the surgical algorithm has allowed the authors to stratify the management of GERD patients to treatment with either Stretta or LF according to size of hiatal hernia, LES pressure, Barrett's esophagus, and significant pulmonary symptoms. Patients undergoing Stretta are highly satisfied and have improved GERD symptoms and quality of life comparable to LF. The Stretta procedure is an effective alternative to LF in well-selected patients.",2003.0,0,0
668,12737768,What is the best NSAID regimen for arthritis patients with bleeding ulcer?,Eric A Jackson,,2003.0,0,0
669,12738450,,,,,0,0
670,12738455,Elemental diet is an effective treatment for eosinophilic esophagitis in children and adolescents.,Jonathan E Markowitz; Jonathan M Spergel; Eduardo Ruchelli; Chris A Liacouras,"Eosinophilic esophagitis (EoE), a disorder characterized by eosinophilic infiltration of the esophageal mucosa, has been defined in large part through published case reports and series leading to ambiguity in both diagnostic and treatment options. Corticosteroids, cromolyn, and elemental diet have all been reported as successful treatments for EoE. In this study, we sought to accurately define a population of patients with EoE and then assess their response to elemental diet. A series of patients with chronic symptoms of gastroesophageal reflux disease and an isolated esophageal eosinophilia on esophagogastroduodenoscopy (EGD) were identified. Therapy with a proton pump inhibitor was instituted for 3 months, followed by repeat EGD when symptoms persisted. A 24-h pH probe study was performed, and those with significantly abnormal studies were excluded. The remaining patients were diagnosed with EoE and placed on an elemental diet for 1 month, followed by a repeat EGD. Of 346 patients with chronic gastroesophageal reflux disease symptoms and eosinophils on esophageal biopsy, 51 (14.7%) were ultimately diagnosed with EoE. There was significant improvement in vomiting, abdominal pain, and dysphagia after the elemental diet. The median number of esophageal eosinophils per high-powered field (HPF) decreased from 33.7 before the diet to 1.0 after the diet (p <0.01). The average time to clinical improvement was 8.5 days. Elemental diet resulted in striking improvement in both symptoms and histologic evidence of disease in children and adolescents with EoE, as identified by strict diagnostic criteria.",2003.0,0,0
671,12743433,Lansoprazole fast disintegrating tablet: a new formulation for an established proton pump inhibitor.,Fabio Baldi; Peter Malfertheiner,"Lansoprazole is a proton pump inhibitor (PPI) which is an effective and well-tolerated treatment option in the management of acid-related disorders. Lansoprazole fast disintegrating tablet (LFDT)--a new, patient-friendly and more convenient formulation of lansoprazole which can be taken with or without water--is the first PPI to be made available as an orally disintegrating tablet. It represents an innovative drug delivery system, comprising enteric-coated microgranules of lansoprazole compressed with an inactive, rapidly dispersing matrix to form a tablet. When the tablet is placed on the tongue and sucked gently it disintegrates rapidly in the mouth, releasing the enteric-coated microgranules which are swallowed with the patient's saliva without water. Alternatively, the tablet can be swallowed with a drink of water. Studies have shown that the bioavailability of LFDT is comparable to lansoprazole capsules, at both 15 and 30 mg doses; the indications and recommended dosages for LFDT are therefore identical to lansoprazole capsules. The new formulation may be of particular benefit to those with active life-styles who do not always have water available, patients who have difficulty in swallowing, and elderly patients.",2003.0,0,0
672,12743434,Comparable efficacy of pantoprazole and omeprazole in patients with moderate to severe reflux esophagitis. Results of a multinational study.,T Körner; K Schütze; R J M van Leendert; I Fumagalli; B Costa Neves; M Bohuschke; G Gatz,"To compare the efficacy and tolerability of pantoprazole 40 mg and omeprazole MUPS 40 mg in patients with moderate to severe gastroesophageal reflux disease (GERD). In this randomized, double-blind, parallel-group, multicenter study conducted in Austria, Germany, Portugal, Switzerland and The Netherlands, patients with endoscopically confirmed moderate to severe GERD (Savary/Miller esophagitis grade II/III) were enrolled. They received a once-daily dose of either 40 mg pantoprazole or 40 mg omeprazole MUPS. Healing was determined by endoscopy after 4 weeks of treatment. If patients were not healed, treatment was extended for another 4 weeks. An additional endoscopy was performed in these cases after 8 weeks of treatment. Healing was determined by endoscopy after 4 and 8 weeks. In addition, treatment effect on symptoms was evaluated by the investigator using a questionnaire assessing heartburn, reflux regurgitation and pain on swallowing at each visit, as well as by a self-administered questionnaire comprising further 24 gastrointestinal symptoms. Analyses were performed for the intention-to-treat (ITT) and the per-protocol (PP) population. In addition, patients with high compliance (HC: 90% </=110%) were considered in a separate group. Adverse events and the influence of the Helicobacter pylori status were investigated. A total of 669 outpatients were enrolled in the study, with 337 patients receiving pantoprazole and 332 omeprazole MUPS. The PP population consisted of 552 patients, 282 treated with pantoprazole and 270 with omeprazole MUPS. The healing rates in both treatment groups were shown to be equivalent and were higher in patients who adhered closely to the administration protocol (HC). According to ITT (ITT(HC)) analyses, healing rates were 65.3% (77.4%) in the pantoprazole and 66.3% (74.7%) in the omeprazole group after 4 weeks. Furthermore, patients infected with H. pylori had slightly but not significantly higher healing rates than those with a negative test result. The safety profile of both treatments was comparable. Pantoprazole 40 mg and omeprazole MUPS 40 mg were equivalent with respect to healing after 4 and 8 weeks of treatment in patients with reflux esophagitis grade II/III. Overall, HC patients had higher healing rates than the regular compliant patients. Both drugs were well tolerated and safe.",2003.0,0,0
673,12744297,Lansoprazole overutilization: methods for step-down therapy.,Cynthia J Pohland; Stephanie A Scavnicky; Steve S Lasky; Chester B Good,"To identify the documented indications for long-term therapy with lansoprazole 30 mg twice daily at the Veterans Affairs Pittsburgh Healthcare System, assess compliance with appropriate use criteria, evaluate patients eligible for step-down therapy, and recommend appropriate step-down therapy in order to improve patient care, decrease overprescribing, and reduce medication costs. Prospective intervention. The records of all patients with prescriptions for lansoprazole 30 mg twice daily as of June 2000 were reviewed. Patients were interviewed to assess medication compliance and symptom control and to provide education on lifestyle modifications. Interventions with the providers were completed to encourage step-down therapy in appropriate patients. Two hundred forty-eight patients with active prescriptions for twice-daily lansoprazole were reviewed. Of these patients, 66% (n = 163) did not have an indication compliant with the medical center's guidelines for use of lansoprazole 30 mg twice daily. Of these, 88% (n = 143) had no documented attempt at step-down therapy and 49% (n = 80) had no documented gastrointestinal workup. Interventions for step-down therapy were recommended for 48% (n = 120) of the 248 patients. Forty-six percent (n = 60) of recommendations were accepted, resulting in a cost savings of dollars 85000 per year. A high rate of clinician noncompliance with the guidelines for appropriate use of lansoprazole 30 mg twice daily was found. These prescribing patterns resulted in significant cost concerns. Our review and interventions led to step-down therapy for almost half of the patients receiving twice-daily lansoprazole. This review of patient records and intervention with primary care providers resulted in cost reduction and offered an opportunity to educate patients on beneficial lifestyle modifications.",2003.0,0,0
674,12749518,A pharmacoeconomic comparison of the efficacy and costs of pantoprazole and omeprazole for the treatment of peptic ulcer or gastroesophageal reflux disease in The Netherlands.,Ben A van Hout; Rogier M Klok; Jacobus R B J Brouwers; Maarten J Postma,"The focus of treatment of patients with peptic ulcer or gastroesuphageal reflux disease has changed during the last 15 years, with a shift from histamine2-receptor antagonists to proton-pump inhibitors (PPIs). From 1993 to 2000, expenditures for omeprazole (90% of total market share of PPIs) increased in The Netherlands from 68 million euros to 230 million euros. In 1999, expenditures for pantoprazole accounted for the majority of the rest of the market share for PPIs. The objective of this study was to compare the efficacy and costs of treatment with pantoprazole and omeprazole in The Netherlands. First, we reviewed clinical studies that compared the efficacy of different dosages of omeprazole and pantoprazole. Second, we analyzed data from a nationwide database of drug prescriptions to determine the dosages used in daily practice in 1999. The data were based on a representative sample of approximately 40% of the Dutch community pharmacies. Third, we modeled the outcome of potential substitution of pantoprazole for omeprazole and the corresponding scenarios for nationwide cost savings using the prescription information from the nationwide database. Potential savings within the Dutch health care system were estimated. The 1999 prescription data indicated that pantoprazole treatment cost a mean 1.59 euros/d, compared with 2.12 euros/d for omeprazole (1.00 euro = 1.0487 US dollars). The mean cost per defined daily dose of omeprazole was 1.65 euros, compared with 1.59 euros for pantoprazole. Following the summary of product characteristics, treatment with pantoprazole appeared to be less costly for all indications. The projected annual cost savings for substituting pantoprazole for omeprazole on 90% of treatment days were estimated at 40.8 million euros. However, these projected savings may be offset by the costs of switching and the costs of upward dose adjustments that some patients may require. Based on the available documentation about effectiveness and costs of omeprazole and pantoprazole, pantoprazole may provide a more favorable pharmacoeconomic profile than omeprazole. However, this is only true if the substitution of omeprazole by pantoprazole can be achieved without loss of efficacy or tolerability.",2003.0,0,0
675,12750918,Globus sensation and gastroesophageal reflux.,Julia M Chevalier; Edgar Brossard; Philippe Monnier,"Recent studies suggest that gastroesophageal reflux disease (GERD) may be a major cause of globus sensation. However, the incidence and severity of GERD in patients with globus sensation without reflux symptoms are unknown. In order to establish the relationship between globus sensation in the jugular fossa and GERD, 20 patients attending our ear, nose and throat (ENT) outpatient clinic with globus sensation were investigated with 24-h pH monitoring. A four-channel pH catheter was used with the pH electrodes spaced 5 cm apart in order to detect reflux along the whole length of the esophagus. Fifteen patients complained about globus sensation only; five patients complained additionally about classical reflux symptoms. Thirteen patients showed pathologic reflux measurements. Most of the patients had reflux limited to the distal one-third of the esophagus. Patients with pathologic pH measurements were treated with proton pump inhibitors. Ten out of 13 patients improved with treatment. This study suggests that globus may be associated with reflux, and acidity does not have to reach the pharynx to produce globus sensation.",2003.0,0,0
676,12751335,"After the hype, HOPE (and HPS): some lessons from the Women's Health Initiative trial, the Heart Outcomes Prevention Evaluation study and the Heart Prevention Study.",Paulo Andrade Lotufo,,2003.0,0,0
677,12752349,Helicobacter pylori eradication and gastric ulcer healing--comparison of three pantoprazole-based triple therapies.,P Malfertheiner; T Kirchner; M Kist; A Leodolter; U Peitz; S Strobel; M Bohuschke; G Gatz; BYK Advanced Gastric Ulcer Study Group,"To study the efficacy of three pantoprazole-based triple therapy regimens for the eradication of Helicobacter pylori infection and gastric ulcer healing. In an open, multi-centre, randomized study, 519 H. pylori-positive patients with active gastric ulcer were randomized to receive pantoprazole (40 mg) (P) and two of three antibiotics: clarithromycin (500 mg) (C), metronidazole (500 mg) (M) or amoxicillin (1000 mg) (A). Triple therapy (PAC, PCM, PAM) was administered twice daily for 7 days, followed by pantoprazole until the ulcer had healed. Antrum and corpus biopsies were taken to determine the pattern of gastritis, to assess the H. pylori status and to determine the strain susceptibility to antibiotics, and from the ulcer margins and base to exclude malignancy. Scores based on the Sydney system were used to categorize the gastritis phenotypically. The H. pylori eradication rates for the per protocol (intention-to-treat) analysis were 89% (67%) for PAC, 83% (68%) for PCM and 76% (60%) for PAM, with a significant difference between PAC and PAM. Healing rates after 4 weeks were 91% for PAM, 90% for PCM and 88% for PAC (per protocol analysis). The eradication rates were lower in patients in whom strains resistant to any antibiotic used in the triple therapies were detected. Successful eradication [odds ratio, 5.2 (3.3; 8.3)] and the ulcer size (< 15 mm) were significant predictors for healing after 4 weeks. The regimens showed a comparable safety profile and compliance. Pantoprazole-based triple therapies are effective in the eradication of H. pylori infection in gastric ulcer patients, as reported in previous similar sized studies in duodenal ulcer patients. Successful eradication and an ulcer size of < 15 mm are the best predictors of gastric ulcer healing after 4 weeks.",2003.0,0,0
678,12752726,Helicobacter pylori infection and perforated peptic ulcer prevalence of the infection and role of antimicrobial treatment.,Javier P Gisbert; José María Pajares,"Although the role of Helicobacter pylori infection on noncomplicated peptic ulcer disease has been definitively established, the precise relationship between the organism and complicated ulcer has hardly been studied. The mean prevalence of H. pylori infection in patients with perforated peptic ulcer is of only about 65-70%, which contrasts with the almost 90-100% figure reported in noncomplicated ulcer disease. However, H. pylori infection rates in various studies range markedly from 0% to 100%, suggesting that differences in variables as number and type of diagnostic methods used to diagnose H. pylori infection, or frequency of nonsteroidal anti-inflammatory drug intake, may be responsible for the low prevalence reported in some studies. Recurrent ulcer disease after peptic ulcer perforation mainly occurs in patients with H. pylori infection, which suggests that the microorganism plays an important role in this complication. All patients with perforated peptic ulcer should be treated by simple closure of the perforation and with therapy aimed at healing of the ulcer and eradicating the H. pylori infection, as disappearance of the organism prevents, or at least decreases, ulcer recurrence and ulcer perforation in patients with H. pylori-associated perforated ulcers after simple closure. Therefore, H. pylori eradicating treatment should be started during the immediate postoperative period. The patients with intractable recurrent symptoms of peptic ulcer despite adequate medical treatment, but without H. pylori infection (e.g. a patient using nonsteroidal anti-inflammatory drugs), is probably the only remaining indication for elective definitive surgical treatment of peptic ulcer disease.",2003.0,0,0
679,12755836,Meta-analysis: proton pump inhibitor or H2-receptor antagonist for Helicobacter pylori eradication.,D Y Graham; F Hammoud; H M T El-Zimaity; J G Kim; M S Osato; H B El-Serag,"To compare H2-receptor antagonists and proton pump inhibitors as adjuvants to triple therapy for Helicobacter pylori eradication. H. pylori-infected patients with peptic ulcer were randomized to receive either 300 mg nizatidine or 30 mg lansoprazole plus 1 g amoxicillin and 500 mg clarithromycin taken b.d. for 7 days. H. pylori eradication was assessed 4 weeks after therapy. Using meta-analytical techniques, we combined the results of this study with other randomized controlled comparisons of H2-receptor antagonists and proton pump inhibitors as adjuvants to triple therapy. One hundred and one patients were randomized. H. pylori eradication was 94% (47/50) [95% confidence interval (CI), 83-99%] (intention-to-treat) in the H2-receptor antagonist group vs. 86% (44/51) (95% CI, 74-94%) in the proton pump inhibitor group (P = 0.3). There has been a total of 12 similar studies (1415 patients). The overall efficacy was similar in intention-to-treat analysis: 78% (549/701) with H2-receptor antagonists vs. 81% (575/714) with proton pump inhibitors (odds ratio, 0.86; 95% CI, 0.66-1.12). A non-significant trend favouring H2-receptor antagonist (79% vs. 69%; odds ratio, 1.14; 95% CI, 0.76-1.71; P = 0.5) was seen in the comparison of clarithromycin-containing regimens. In contrast, in non-clarithromycin-containing trials, there was a slight, but significant, advantage with proton pump inhibitors (85% vs. 78%; odds ratio, 0.64; 95% CI, 0.45-0.92; P = 0.02). Overall, proton pump inhibitor and H2-receptor antagonist antisecretory agents appear to be similarly effective as adjuvants for H. pylori triple therapy. It is unlikely that the direct anti-H. pylori effect of proton pump inhibitors is responsible for their ability to enhance anti-H. pylori therapy.",2003.0,0,0
680,12755837,Meta-analysis: comparing the efficacy of proton pump inhibitors in short-term use.,R M Klok; M J Postma; B A van Hout; J R B J Brouwers,"Proton pump inhibitors have a prominent role in the management of acid-related diseases. Controlling expenses on proton pump inhibitors would yield great economic benefits for Dutch health care. To investigate whether clinical differences in proton pump inhibitors exist. We searched Medline, EMBASE and the Cochrane Library. We identified papers in English, German, French or Dutch in which two or more proton pump inhibitors were compared under the same clinical conditions in gastro-oesophageal reflux disease, peptic ulcer disease or Helicobacter pylori eradication. The pooled relative risks were calculated using the Mantel-Haenszel method. Two significant differences were found in the proton pump inhibitors compared. In gastro-oesophageal reflux disease, esomeprazole 40 mg was superior to omeprazole 20 mg (relative risk, 1.18; 95% confidence interval, 1.14-1.23). In peptic ulcer disease, pantoprazole 40 mg was superior to omeprazole 20 mg (relative risk, 1.07; 95% confidence interval, 1.02-1.13). In Helicobacter pylori eradication, no significant differences were found. Both significant differences found were in favour of the highest dose of proton pump inhibitor on a milligram basis. This indicates that the difference may be dose dependent and not proton pump inhibitor specific. Therefore, when prescribing proton pump inhibitors, arguments other than clinical efficacy, such as those related to pharmaco-economics, may be considered.",2003.0,0,0
681,12760710,"Seven-day proton pump inhibitor, amoxicillin and clarithromycin triple therapy. factors that influence Helicobacter pylori eradications success.",D Boixeda; C Martín De Argila; F Bermejo; A López Sanromán; F Hernández Ranz; A García Plaza,"To evaluate which factors influence eradication success with standard triple therapy for Helicobacter pylori. A prospective study was made of 891 patients infected by H. pylori and diagnosed with duodenal ulcer (n=422), gastric ulcer (n=221), or functional dyspepsia (n=248). Initially, an endoscopy with biopsies of antrum and body (haematoxylin-eosin stain), and a 13C-urea breath test were performed. All patients were treated for seven days with either omeprazole 20 mg twice daily in 442 patients (OCA) or pantoprazole 40 mg twice daily in 449 patients (PCA), associated to clarithromycin (500 mg twice a day) and amoxicillin (1 g twice a day). Two months after completing therapy urea breath test was repeated to confirm eradication. Mean age +/- SD was 51.6 +/- 15 years, 61% were male. Overall eradication rate was 73.7% (95% CI 69-77%) and 80.8% (77-84%) with OCA and PCA therapy, respectively, showing significant difference between treatment regimens (chi 2 =6.3; p= 0.01). As refers to underlying diseases, H. pylori eradication was achieved in 77.4% (74-80%) of peptic ulcers and 77% (71-82%) of functional dyspepsia (p=n.s.). With our two treatment regimens (OCA/PCA) eradication success was 74/81% in peptic ulcer (p=0.03), and 72/80% in functional dyspepsia (p=0.1). In the multivariate analysis, type of therapy was the only variable that correlated with eradication success (odds ratio 1.5; 95% CI: 1.1-2.1) (chi2 model: 6,4; p=0.01). Standard triple therapy containing a proton pump inhibitor, clarithromycin and amoxicillin for seven days achieves in our community a moderate eradication success; this result could improve by using pantoprazole instead of omeprazole. This therapy is equally effective in patients with peptic ulcer and functional dyspepsia.",2003.0,0,0
682,12760719,Validation of the 13c-urea breath test for the initial diagnosis of helicobacter pylori infection and to confirm eradication after treatment.,J P Gisbert; J Ducons; F Gomollón; J E Domínguez-Muñoz; F Borda; G Miño; I Jiménez; M A Vázquez; S Santolaria; S Gallego; J Iglesias; G Pastor; A Hervás; J M Pajares,"the breath test with 13C-urea (UBT) is a method widely used in Spain, but its diagnostic accuracy has not been evaluated in a clinical trial until now. Our objective was to validate the UBT (TAU-KIT) both as an initial diagnostic method for the detection of H. pylori infection and as a method to confirm eradication. a multi-centre study in 7 Spanish hospitals was performed. A group of dyspeptic patients who had not previously received eradication treatment was included, and a second group of patients with gastric ulcer or upper gastrointestinal bleeding due to peptic ulcer was also included (eradication of H. pylori was confirmed 6 to 8 weeks after treatment completion with omeprazole, clarithromycin and amoxycillin). In both groups an endoscopy was performed with biopsies for histology and rapid urease test. Patients were considered infected if both tests yielded positive results, and not infected when both tests were negative. The UBT 13C-urea (TAU-KIT, Isomed S.L., Madrid, Spain) was performed with citric acid and 100 mg of 13C-urea. The pathologist and persons responsible for endoscopy, urease test and UBT were all unaware of the results from the other diagnostic methods. in the pre-treatment group (36 patients) the prevalence of H. pylori was 72%, the area under the ROC curve for the diagnosis of infection with the UBT was 0.99, and the best cut-off point was 5 units, with the following results: sensitivity= 96% (95% CI = 81-99%), specificity= 100% (69-100%), positive predictive value (PPV) = 100% (87-100%), negative predictive value (NPV) = 92% (59-100%), likelihood ratio (LR) + = infinity, and LR- = 0.04. In the post-treatment group (85 patients) the prevalence of H. pylori was 16%, the area under the ROC curve was 0.99, and the best cut point was 4.6, with the following results: sensitivity= 100% (77-100%), specificity = 97% (90-99%), PPV = 88% (62-98%), NPV = 100% (95-100%), LR+ = 35, and LR- = 0. UBT provides excellent accuracy both for the initial diagnosis of H. pylori infection and to confirm eradication after treatment.",2003.0,0,0
683,12762431,Does eradication of Helicobacter pylori reduce hypergastrinaemia during long term therapy with proton pump inhibitors?,A K Gürbüz; A M Ozel; Y Yazgan; A Günay; T Polat,"To evaluate the effect of Helicobacter pylori (Hp) eradication therapy on blood gastrin levels in long-term PPI users, since proton pump inhibitors (PPIs) and Helicobacter pylori (Hp) are major causes of hypergastrinaemia. A prospective study. Twenty seven Hp (+) patients enrolled in the study. Twenty were given eradication treatment (ET group), and the rest were given symptomatic treatment (ST group). Those who remained Hp (+) after eradication therapy were also added into the ST group. Lansoprazol 30 mg/day was given to both groups for three months thereafter. Fasting and non-fasting blood gastrin levels (FGL and NFGL) were measured initially and one month and four months after treatment. At the end of fourth month, FGL was significantly higher than both initial and first month level (p < 0.01) in the ST group. NFGL in this group did not change significantly (p > 0.05) after eradication therapy. In the ET group, FGL was significantly higher in the fourth month than the first month (p < 0.001) and than the initial level (p < 0.05). NFGL was higher, but not statistically in the fourth month than in the first month (p > 0.05) and significantly lower than the initial level (p < 0.05) in this group. We suggest that testing for Hp positivity and treating it if detected would be an appropriate approach to avoid hypergastrinaemia, especially in candidate patients for long term PPI treatment.",2003.0,0,0
684,12763982,Empirical prescribing for dyspepsia: randomised controlled trial of test and treat versus omeprazole treatment.,Gianpiero Manes; Antonella Menchise; Claudio de Nucci; Antonio Balzano,"To compare the efficacy of a ""Helicobacter pylori test and treat"" strategy with that of an empirical trial of omeprazole in the non-endoscopic management by empirical prescribing of young patients with dyspepsia. Randomised controlled trial. Hospital gastroenterology unit. 219 patients under 45 years old presenting with dyspepsia without alarm symptoms. Patients received treatment with omeprazole 20 mg (group A) or with a urea breath test followed by an eradication treatment in case of H pylori infection or omeprazole alone in non-infected patients (group B). Lack of improvement or recurrence of symptoms prompted endoscopy. Improvement in symptoms assessed by a dyspepsia severity score every two months; use of medical resources (endoscopic workload and medical consultation); clinical outcome. 96/109 (88%) patients in group A and 61/110 (55%) in group B (P < 0.0001) had endoscopy: in 19 patients in group A and 32 in group B (20/67 infected and 12/43 non-infected) because of no improvement; in 77 further patients in group A and 29 in group B (7 infected and 22 non-infected) because of recurrence of symptoms during follow up. Endoscopy showed peptic ulcers only in group A; oesophagitis occurred significantly more often in group B than in group A. About 80% of examinations were normal in both groups, but nine duodenal scars occurred in group A. Eradication treatment allows resolution of symptoms in a large number of patients with dyspepsia and reduces the endoscopic workload. After a trial of omeprazole, symptoms recur in nearly every patient. Such treatment is also likely to mask an appreciable number of peptic ulcers and cases of oesophagitis.",2003.0,0,0
685,12767952,A randomized controlled trial of test-and-treat strategy for Helicobacter pylori: clinical outcomes and health care costs in a managed care population receiving long-term acid suppression therapy for physician-diagnosed peptic ulcer disease.,James E Allison; Leo B Hurley; Robert A Hiatt; Theodore R Levin; Lynn M Ackerson; Tracy A Lieu,"Guidelines recommend Helicobacter pylori (HP) testing and treatment for patients with a history of peptic ulcer disease (PUD), assuming that PUD has been documented and that successful HP eradication would eliminate the need for further therapy and medical utilization. An open-label, randomized controlled trial in a managed care setting evaluated the clinical outcome and costs of an HP test-and-treat (T & T) strategy in 650 patients receiving long-term acid suppression therapy for physician-diagnosed PUD. Patients were randomized to T & T for HP (n = 321) or to usual care (n = 329). Outcome measures included presence and severity of PUD symptoms, use of acid-reducing medication, and acid-peptic-related health care costs during 12-month follow-up. Only 17% of study participants had PUD confirmed by radiography or endoscopy; only 38% of the T & T group tested positive for HP. At 12 months, patients in the T & T group were less likely to report ulcerlike dyspepsia or use of acid-reducing medication; however, 75% of the T & T group used acid-reducing medication during the second half of the 12-month follow-up. In the 12 months after randomization, the T & T group had higher total acid-peptic-related costs than the usual care group. Most patients receiving long-term acid suppression therapy for physician-diagnosed PUD in community practice settings are likely to have HP-negative, uninvestigated dyspepsia. Routine testing and treating for HP will not reduce acid-peptic-related costs and have only a modest (though statistically significant) effect in reducing clinical symptoms and use of acid-reducing medications.",2003.0,0,0
686,12772004,"Validation of the GSFQ, a self-administered symptom frequency questionnaire for patients with gastroesophageal reflux disease.",Pierre Paré; François Meyer; David Armstrong; Myron Pyzyk; Dan Pericak; Ron Goeree,"Although the diagnosis of gastroesophageal reflux disease (GERD) is based primarily on symptoms experienced by a patient, relatively little attention has been paid to the development and validation of self-administered questionnaires specific to GERD symptoms. The present article presents the validation of the short, self-administered GERD Symptom Frequency Questionnaire (GSFQ). Patients with GERD participating in a randomized clinical trial comparing pantoprazole and nizatidine were asked to complete the GSFQ together with validated instruments for measurement of health-related quality of life (Medical Outcome Study Short Form 12) and gastrointestinal symptoms (Gastrointestinal Symptom Rating Scale). Completion of the GSFQ, Medical Outcome Study Short Form 12 and Gastrointestinal Symptom Rating Scale took place upon entry into the trial (baseline) and during the trial (days 7 and 28). Endoscopy was performed at baseline and after 28 days. Cronbach alpha was used to assess the internal consistency of the questionnaire. The test-retest reliability of the GSFQ was examined by the intraclass correlation coefficient among the 36 patients with stable GERD symptoms between day 7 and day 28. Construct validity was assessed by comparing the GSFQ with previously validated instruments. Known group validity was determined by comparing GSFQ scores across groups of patients known to differ clinically. Responsiveness to change was assessed by the Guyatt's statistic. Two hundred twenty-one patients formed the study baseline group. The analysis demonstrated that the GSFQ questionnaire had excellent psychometric properties shown by the high internal consistency (Cronbach alpha 0.84); that the test-retest reliability was satisfactory (intraclass correlation coefficient 0.64); that there was good evidence that the GSFQ indeed measured what it was intended to measure (validity); and that the GSFQ was highly responsive to change (Guyatt's statistic 1.48). The GSFQ is a short, self-administered, easy to use, GERD-specific questionnaire which should be considered as a useful assessment tool in the evaluation of patients with GERD and in the assessment of treatment outcomes.",2003.0,0,0
687,12772009,Motion--Cyclo-oxygenase-2 selective nonsteroidal anti-inflammatory drugs are as safe as placebo for the stomach: arguments against the motion.,Andreas Maetzel,"Cyclo-oxygenase (COX) exists in two isoforms, COX-1 and COX-2, that direct the synthesis of prostaglandins, prostacyclin and thromboxane. Traditional nonsteroidal anti-inflammatory drugs (NSAIDs) inhibit both isoenzymes, resulting in damage to the mucosa of the stomach and duodenum, but also in cardioprotection. Selective COX-2 inhibitors are less likely to damage the upper gastrointestinal tract, as has been shown by large, randomized, controlled trials. Specifically, the newer agents are superior to ibuprofen and naproxen in this regard, but celecoxib and diclofenac were not significantly different in patients who were not also taking low-dose acetylsalicylic acid. These studies did not include a placebo arm, however, and controlled comparisons of COX-2 inhibitors with placebo have not enlisted enough subjects to demonstrate conclusively that they are equally safe. Selectivity for the COX-2 isoform affords protection against upper gastrointestinal toxicity possibly at the expense of the cardioprotective effect of traditional NSAIDs. This might explain the higher rate of nonfatal myocardial infarction in patients who are given rofecoxib compared with naproxen. A traditional NSAID, combined with either misoprostol or a proton pump inhibitor, is still a suitable alternative to selective COX-2 inhibitors for the treatment of arthritis.",2003.0,0,0
688,12776003,Optimizing medical therapy for gastroesophageal reflux disease: state of the art.,Philip O Katz,"Potential interventions for gastroesophageal reflux disease include lifestyle modifications, antacids, mucosal protectants, prokinetic (promotility) agents, H2 receptor antagonists (H2RAs) and, the agents of choice in 2003, proton pump inhibitors (PPIs). This article reviews the current state of the art in use of these agents. Lifestyle changes, though sound in their intent and in many cases based on solid laboratory research, can today be considered only adjuncts to pharmacologic therapy. The mainstay of pharmacologic therapy in 2003 is antisecretory therapy. Both H2RAs and PPIs inhibit acid secretion and raise intragastric pH. H2RAs only block one receptor, have limited effect on acid reduction, and are relatively weak inhibitors of meal-stimulated acid secretion. PPIs provide superior control of intragastric pH over a 24-hour period compared with H2RAs and effect greater symptom relief and healing.",2003.0,0,0
689,12781886,"Gastroesophageal reflux, quality of life, and satisfaction in patients with achalasia treated with open cardiomyotomy and partial fundoplication.",Marta Ponce; Vicente Ortiz; Manuel Juan; Vicente Garrigues; Concepción Castellanos; Julio Ponce,"Cardiomyotomy, often associated with an antireflux technique, is effective in the management of achalasia, although gastroesophageal reflux (GER) may occur after the procedure. Patient-centered measures, ie, health-related quality of life (HRQoL) and satisfaction, should be included in the evaluation of the patients. A study was made of the incidence of GER (symptoms, upper endoscopy and 24-hour pH monitoring), HRQoL (Short Form-36 Health Survey), and satisfaction after open-access cardiomyotomy and 180-degree anterior fundoplication in 28 consecutive patients, with a minimum postoperative follow-up of 12 months. Mean age was 45 years (range 15 to 80) and 68% were female. In 8 subjects (all with heartburn) GER morbidity was present (4 with esophagitis and 4 with positive pH study), and 6 patients required proton pump inhibitors. Short Form-36 scores after surgery were similar to those found in the general population. Patient satisfaction was high and was more related to the absence of dysphagia than to the presence of GER symptoms. Gastroesophageal reflux is relatively frequent after cardiomyotomy and partial fundoplication, although the efficacy of proton pump inhibitor treatment minimizes its clinical significance.",2003.0,0,0
690,12786613,Review article: management of mild and severe gastro-oesophageal reflux disease.,G N J Tytgat,"Treatment of endosocopy-negative gastro-oesophageal reflux disease (s-GERD) should be directed towards rapid relief of symptoms and then maintenance of relief using minimum yet effective therapy. Responses to proton pump inhibitors are somewhat lower in s-GERD patients compared to GERD with overt erosive damage (e-GERD). The reasons for a lower response rate are not clear but may relate to the inclusion of patients who do not have reflux disease or patients with a lower oesophageal sensory threshold. Also poorly understood is the lower yield of complete heartburn relief when the number of associated dyspeptic symptoms is high. Some form of long-term therapy is needed in the majority of patients. 'On demand' proton pump inhibitor therapy to control reflux symptoms is a new and attractive option. Time to study discontinuation due to insufficient control of heartburn, or any other reason resulting in unwillingness to continue with on-demand therapy, is a pragmatic outcome that is well suited to definition of the efficacy of on-demand therapy. The goals of treatment of e-GERD should be to relieve symptoms and to heal lesions. Symptom severity and much less endoscopic abnormalities drives the therapeutic choices. When symptoms are mild or intermittent and when oesophagitis is of limited degree, standard dose proton pump inhibitor is usually instituted. Fewer and fewer clinicians would still opt for an H2-receptor antagonist. If there is moderate or severe oesophagitis or if symptoms are particularly troublesome, then the patient should start with standard-dose proton pump inhibitor therapy once a day, but not uncommonly a b.d. dosage maybe necessary. Once the dose of the acid suppressant that relieves symptoms is found, this dose should be maintained for a period of 3 months. After this time, an attempt should be made to reduce the dose. If symptoms recur, then the patients should go back to the full-dose proton pump inhibitor and a plan should be formulated for long-term treatment. The long-term treatment options vary between ongoing acid and suppressant therapy, with occasional attempts to reduce the dose, or to go for 'on demand' therapy and (rarely) includes consideration for surgery or endoscopic anti-reflux therapy.",2003.0,0,0
691,12786632,"One-week triple therapy with esomeprazole, clarithromycin and metronidazole provides effective eradication of Helicobacter pylori infection.",S Veldhuyzen Van Zanten; S Machado; J Lee,"To compare the eradication rates of treatment with esomeprazole, metronidazole and clarithromycin (EMC) vs. omeprazole, metronidazole and clarithromycin (OMC), given for 7 days. OMC treatment was followed by 3 weeks of treatment with 20 mg omeprazole alone; the EMC group received placebo. A randomized, double-blind, controlled study was conducted in 36 Canadian centres. Patients had a minimum 3-month history of dyspepsia, with or without a previous history of peptic ulcer disease, and were Helicobacter pylori positive by urea breath test. The eradication of H. pylori was determined by two negative breath tests performed at least 4 and 8 weeks following the completion of treatment. The intention-to-treat and per protocol populations consisted of 379 and 339 patients, respectively. The success rates of EMC/placebo were 76% (144/190) by intention-to-treat and 80% (138/172) by per protocol analysis; for OMC/omeprazole, the rates were 72% (137/189) and 75% (125/167), respectively. The difference between the two treatment groups was not significant. Treatment was well tolerated. A 7-day regimen of esomeprazole, metronidazole and clarithromycin is effective and well tolerated for the eradication of H. pylori infection.",2003.0,0,0
692,12786634,"Short- and long-term therapy for reflux oesophagitis in the elderly: a multi-centre, placebo-controlled study with pantoprazole.",A Pilotto; G Leandro; M Franceschi; Ageing and Acid-Related Disease Study Group,"No placebo-controlled clinical trials have yet been published on the efficacy of therapy in older subjects with oesophagitis. To evaluate the efficacy of pantoprazole in preventing the recurrence of oesophagitis in elderly subjects. One hundred and sixty-four patients aged 65 years and over with acute oesophagitis were treated openly with pantoprazole, 40 mg daily, for 8 weeks. Patients with documented healing of erosive oesophagitis were then treated with pantoprazole, 20 mg daily, for 6 months. Thereafter, cured patients were randomized to receive pantoprazole, 20 mg daily, or placebo for the following 6 months. Clinical evaluations were performed every 2 months, and endoscopy was repeated after 8 weeks and after 6 and 12 months and/or whenever symptoms suggested a relapse of oesophagitis. After 8 weeks, the healing rates of oesophagitis were 81.1% (75.1-87.1%) and 93.7% (89.7-97.7%) by intention-to-treat and per protocol analyses, respectively. After 6 months, the corresponding values were 82% (75.4-88.5%) and 92.4% (87.6-97.2%), respectively. After 12 months, the per protocol and intention-to-treat healing rates of oesophagitis were 95.1% (88.5-100%) and 79.6% (68.3-90.9%), respectively, in the treatment group vs. 32.7% (19.9-45.4%) and 30.4% (18.3-42.4%), respectively, in the placebo group (P = 0.0001). Heartburn, acid regurgitation and chest pain were significantly associated with the relapse of oesophagitis (P = 0.0001), whereas hiatus hernia, Helicobacter pylori infection, concomitant diseases and treatments were not. In the elderly, pantoprazole was highly effective in healing and reducing the relapse of oesophagitis; discontinuing active treatment after 6 months was associated with a significant increase in the relapse rate.",2003.0,0,0
693,12786635,A validated symptoms questionnaire (Chinese GERDQ) for the diagnosis of gastro-oesophageal reflux disease in the Chinese population.,W M Wong; K F Lam; K C Lai; W M Hui; W H C Hu; C L K Lam; N Y H Wong; H H X Xia; J Q Huang; A O O Chan; S K Lam; B C Y Wong,"To develop a validated gastro-oesophageal disease (GERD) symptom questionnaire for the Chinese population. One hundred Chinese patients with GERD and 101 healthy Chinese controls were presented with a 20-item GERD questionnaire in the Chinese language (Chinese GERDQ). Quality of life in GERD patients was assessed by SF-36. A standard dose of proton pump inhibitors for 4 weeks was prescribed to 35 patients with newly diagnosed GERD. The Chinese GERDQ was performed before, 4 weeks and 8 weeks after treatment. Concept, content, construct, discriminant validity and reliability of the questionnaire were assessed. Seven items were selected by logistic regression to account for most of the differences between controls and GERD patients with a good reproducibility and internal consistency. A cut-off score of equal or greater than 12 was determined to discriminate between controls and GERD patients with a sensitivity of 82% and a specificity of 84%. The Chinese GERDQ correlated negatively with five domains of the SF-36 and discriminated between GERD patients who reported symptomatic improvement during proton pump inhibitor treatment and symptoms deterioration upon withdrawal of proton pump inhibitor treatment. The Chinese GERDQ could be used in epidemiological studies to assess the frequency and severity of GERD in patient populations and in interventional studies of GERD.",2003.0,0,0
694,12794781,The cost effectiveness of rofecoxib and celecoxib in patients with osteoarthritis or rheumatoid arthritis.,Andreas Maetzel; Murray Krahn; Gary Naglie,"To evaluate the cost effectiveness of the cyclooxygenase 2 (COX-2) selective nonsteroidal antiinflammatory drug (NSAID) rofecoxib compared with naproxen and the COX-2 NSAID celecoxib compared with ibuprofen and diclofenac. Cost-effectiveness analysis based on a 5-year Markov model. Probability estimates were derived from detailed data of 2 randomized trials and a systematic search of the medical literature. Utility estimates were obtained from 60 randomly selected members of the general public. Cost estimates were obtained from Canadian provincial databases. Incremental cost-effectiveness ratios were calculated for patients at average risk of upper gastrointestinal (UGI) events and for high-risk patients with a prior history of a UGI event. Subjects were patients with osteoarthritis or rheumatoid arthritis (RA) where a decision has been made to treat with NSAIDs but who do not require low-dose aspirin. Main outcome measures were proportion of patients with clinical or complicated UGI events, quality-adjusted life expectancy, and life expectancy. Evaluation of rofecoxib versus naproxen in patients with RA at average risk resulted in costs per quality-adjusted life year (QALY) gained of $Can271,188. Celecoxib was dominated by diclofenac in average-risk patients. Both rofecoxib and celecoxib are cost-effective in high-risk patients. Analyses by age groups and assuming a threshold of Can$50,000 per QALY gained, suggest that rofecoxib or celecoxib would be cost-effective in patients aged over 76 and 81, respectively, without additional risk factors. Both rofecoxib and celecoxib are economically attractive in high risk and elderly patients. They are not economically attractive in patients at average risk. Coprescription of proton-pump inhibitors with COX-2 NSAIDs is not economically attractive for patients at high risk.",2003.0,0,0
695,12795454,Effect of pantoprazole on the course of reflux-associated laryngitis: a placebo-controlled double-blind crossover study.,A J Eherer; W Habermann; H F Hammer; K Kiesler; G Friedrich; G J Krejs,"The optimal management of patients with reflux-associated laryngitis is unclear. We performed a placebo-controlled crossover trial in patients with proven reflux disease and associated laryngitis to determine the effect of pantoprazole and to gain information on the natural course of the disease. Sixty-two consecutive non-smoking patients with hoarseness and proven laryngitis were examined. Scores with respect to the larynx and for subjective complaints were determined and 24-h pH-metry to assess acid reflux in the lower oesophagus and pharynx was performed. Patients with pathologic reflux were given the chance to enter a double-blinded randomized crossover trial with pantoprazole 40 mg b.i.d. and placebo for a duration of 3 months each, separated by a 2-week washout period. Twenty-four of 62 patients showed pathological reflux; 21 patients were included in the study and 14 concluded all parts of the study. Both pantoprazole and placebo resulted in a marked improvement in laryngitis scores (decrease of 8.0 +/- 1.4 versus 5.6 +/- 2.6; no significant difference between the 2 treatments) and symptoms after the first 3 months (decrease of oesophageal symptom score of 2.2 +/- 1.4 versus 5.4 +/- 2.8; decrease of laryngeal scores of 8.3 +/- 3.6 versus 10.3 +/- 3.9; also no significant difference between the 2 treatments). A second pH-metry 2 weeks thereafter proved the persistence of reflux in most of these patients. Switching to pantoprazole led to a further improvement of scores. In the group switched to placebo there was recurrence only in a minority of patients. The self-limited nature of reflux-associated laryngitis in non-smokers is largely underestimated. Laryngitis improves despite the persistence of reflux. Pantoprazole may be helpful especially in relieving acute symptoms, but the advantage of long-term treatment over placebo has been greatly overestimated.",2003.0,0,0
696,12795457,Do Japanese and Swedish peptic ulcer patients respond differently to Helicobacter pylori eradication therapies and what are their histological features?,P Unge; K Kimura; P Sipponen; P Ekström; K Satoh; M Hellblom; B Ohlin; A Stubberöd; K Kihira; T Yube; Y Yoshida,"As a consequence of gastric histological differences, Japanese and Swedish peptic ulcer (PU) patients may respond differently to Helicobacter pylori eradication therapies. The study was single-blind and compared four eradication therapies in Japanese and Swedish patients with healed gastric (GU) or duodenal (DU) ulcer. Swedish patients received either (a) omeprazole+clarithromycin (OC, where O = 20 mg, C = 500 mg) for 2 weeks, or triple therapy with (b) omeprazole + amoxicillin + clarithromycin (OAC-L where O = 20mg, A = 1 g, C = 250 mg); (c) OAC-H (where O = 20 mg, A-1 g, C-500 mg); or (d) omeprazole + metronidazole + clarithromycin (OMC, where O = 20 mg, M = 400 mg, C = 250 mg) for 1 week. Antibiotic doses were weight-adjusted downwards in Japanese patients. H. pylori was assessed using the urea breath test (UBT), histology and culture pre-entry, with UBT being repeated 4 and 8 weeks after stopping treatment. Histology and culture were repeated if the UBT was positive post-therapy. Recruitment included 120 patients from Japan (43 GU, 61 DU, 16 GU+DU) and 120 from Sweden (119 DU, 1 GU+DU). There were 26 exclusions from a FAS analysis due to H. pylori negativity (14), no drug administration (7) or no data after visit 1 (5). Eradication rates (FAS) from Japan were (a) 63%, (b) 93%, (c) 96% or (d) 96%, and for Sweden (a) 92%, (b) 86%, (c) 93% or (d) 96%. Dual therapy was less effective in patients with gastric atrophy associated with GU disease. Tolerability was good in all treatment groups, with no serious adverse events. Triple therapies were safe and effective for H. pylori eradication in Japanese and Swedish peptic ulcer patients. Dual therapy was significantly less effective in the Japanese patients, half of whom had a history of GU and more abnormal histology than in the Swedish patients, all of whom had DU.",2003.0,0,0
697,12797426,Overview of medical therapy for gastroesophageal disease.,Amarnath Ramakrishnan; Philip O Katz,"The last twenty years have seen an evolution of much improved strategies in the medical treatment of GERD. Current therapy is targeted at acid suppression, to deal with consequences of mucosal injury and afford resolution of symptoms. Given their modest efficacy, there is no longer much support for initial treatment with H2RAs. PPIs have been shown to provide the highest levels of symptom relief and esophageal healing, in addition to preventing relapse and complications. With this class of agents, the clinician is able to prescribe a drug that is as highly effective as surgery for the purpose intended, without worrying about long term sequelae of acid suppression. It appears that patients with extraesophageal GERD must be treated with higher doses of pharmacologic therapy, principally with the PPIs, for longer periods of time to achieve complete relief of symptoms when compared to patients with heartburn and erosive esophagitis. There is still no clear consensus as to whether aggressive acid suppression alters the natural history of Barrett's esophagus. Based on their initial success, it appears that the next generation of evolving medical therapies will continue to play an important role in the management of GERD. The outcome from medical therapy is the standard against which the results of the novel endoscopy anti-reflux treatments will be measured.",2003.0,0,0
698,12797427,An overview of the success and failure of surgical therapy: standards against which the outcome of endoscopic therapy is measured.,Nimish Vakil; Christino Canga,"Medical therapy for reflux disease has evolved from frequent antacid use to once daily proton pump inhibitor therapy. Despite the efficacy of these agents in healing erosive esophagitis, there are several short-comings with medical therapy including incomplete symptom relief, the need for continuous maintenance therapy, and cost. Endoscopic and laparoscopic treatments for reflux disease are appealing because they could reduce or eliminate the need for chronic maintenance therapy with medications. While there is evidence of high quality on the efficacy of medical therapy from randomized controlled trials, data on endoscopic procedures and surgery is more limited. This article summarizes the needed studies and the standards against which these procedures should be measured.",2003.0,0,0
699,12797437,"Gatekeeper Reflux Repair System: technique, pre-clinical, and clinical experience.",Paul Fockens,"The Gatekeeper Reflux Repair System is a new, promising endoscopic anti-reflux therapy. It has now been shown that it is possible to implant hydrogel prosthesis in the submucosa of the esophagus of humans. The pilot study in humans showed that it is a safe technique and no prostheses migrated into the mediastinum. With the help of endoscopic ultrasonography, each prosthesis was followed during the 6-month pilot study. After finishing this pilot study, new multi-center studies have been initiated with implantation of more prostheses to increase efficacy. One of the definite advantages over the other endoscopic treatments currently being developed is its reversibility. Regarding endoscopic anti-reflux therapy in general, it is important to stress that at this time no data are available in the literature about the comparison to medical therapy. At the same time long-term results are also unknown. For these reasons these endoscopic procedures must be considered experimental and they should be performed in a clinical research setting. Within a few years the role of the Gatekeeper Reflux Repair System will be better understood for those PPI-dependent GERD-patients who wish to stop their medication.",2003.0,0,0
700,12797438,"Endoscopic implantation of enteryx for the treatment of gastroesophageal reflux disease: technique, pre-clinical and clinical experience.",Hubert Louis; Jacques Devière,"The implantation of Enteryx polymer in the LES is a fast, minimally invasive procedure with anticipated low procedural risks and limited costs. Preliminary clinical data after 6 months of follow-up show good results in more than 80% of the patients, with objective improvement of acid reflux time. Enteryx is effective in the management of GERD, as evidenced by the ability of GERD patients with a history of use of PPIs and other GERD medications to eliminate or significantly reduce use of these medications. Mechanisms of action of Enteryx implantation suggest a change in distensibility of the LES, allowing a greater competency of the cardia. LES pressure and length might be increased after polymer implantation, and further studies are needed to study the effect of Enteryx on transient relaxations of the LES, which is the prevalent mechanism of reflux in patients with mild GERD. Challenges with this procedure include refining technique to deliver adequate volume in each patient and determining if the ring-shaped implant is needed. In addition to acid reflux, another indication for use of this treatment might be biliary reflux in gastrectomized patients; preliminary data suggest that Enteryx may reduce symptoms and improve bile reflux (J. Devière, unpublished observations, 2002). Further studies are needed to definitively establish the safety of the procedure. This is a major point because gastroenterologists are not dealing with ill patients but primarily with individuals who have a good quality of life while taking PPIs. The other area to investigate is the efficacy of the treatment through a sham-controlled study. Finally, this endoscopic technique will have to be evaluated in terms of cost-effectiveness against medical and surgical therapies.",2003.0,0,0
701,12800080,[Impact of 24-hour intraesophageal pH monitoring with 2 channels in the diagnosis of reflux-induced otolaryngologic disorders].,W J Issing; S Tauber; C Folwaczny; O Reichel,"Patients with gastroesophageal reflux disease (GERD) may suffer from a large variety of symptoms in the upper aerodigestive tract such as globus sensation, chronic cough, hoarseness and many others. Diagnosis and causal therapy may sometimes be difficult with gastroenterologic evaluation sometimes revealing no pathologic result. The objective of this study was to determine the impact of 24-hour intraesophageal pH monitoring with 2 channels (gastric and laryngeal) in the diagnosis of reflux-induced otolaryngologic disorders. This study included 22 patients presenting to the Department of Otolaryngology with symptoms like chronic cough (n = 3), globus sensation and dysphagia (n = 11), heartburn (n = 2), hoarseness and dysphonia (n = 2) or burning sensation of the tongue (n = 1). Three patients had a pathologic formation in the glottic area (leukoplakia, granuloma, polyp). All patients underwent a otolaryngological examination, a gastroenterological investigation and a 24-hour intraesophageal pH monitoring with 2 channels. All 22 patients showed laryngeal mucosal lesions (posterior laryngitis). The gastroenterological evaluation with esophagogastroduodenoscopy was normal in 4 cases. 13 patients showed a hiatal hernia, 4 patients were suffering from a reflux-esophagitis grade I and 2 patients from grade II. One patient had an erythema and 5 patients showed erosions of the gastric mucosa. Seven patients had more than one of the above mentioned diagnoses. Intraesophageal pH-monitoring with 2 channels over 24 hours revealed a gastroesophageal reflux of all 22 patients and a high reflux to the laryngeal level of 21 patients, probably causing laryngopharyngeal symptoms. Therapy of the patients consisted of medical antireflux treatment with proton pump inhibitor esomeprazol (Nexium, 40 mg, 1-0-0). Within 4 weeks 15 of 22 patients had no more laryngopharyngeal symptoms or at least a significant reduction. Patients with laryngopharyngeal symptoms such as hoarseness, globus sensation or dysphagia can suffer from GERD, even if typical symptoms such as heartburn or retrosternal pain do not exist and gastroesophageal intervention reveals a normal result. The best diagnostic instrument for the diagnosis of reflux-induced otolaryngologic disorders is a 24-hour intraesophageal pH-monitoring with 2 channels (measure-points at the distal esophagus and laryngeal level). Medical antireflux treatment should consist of proton pump inhibitors (e. g. Nexium) in a dose of 40 mg per day over at least 4 weeks.",2003.0,0,0
702,12800464,Etoricoxib in the treatment of chronic pain.,M R Duncan; H A Capell,"For the many patients who suffer chronic pain, we seek the most effective anti-inflammatory drug with the least side-effect profile and the greatest long-term safety. Etoricoxib, a selective COX2 inhibitor, has been shown to be as effective as non-selective non-steroidal anti-inflammatory drugs in the management of chronic pain in rheumatoid arthritis and osteoarthritis, for periods of up to one year. Data on etoricoxib efficacy in chronic low back pain is beginning to emerge. The side-effect profile of etoricoxib suggests it is well tolerated with similar adverse effects to non-selective NSAIDs. Larger studies are awaited, to see whether superior gastrointestinal tolerability can be proven. Further work will be required to show that etoricoxib is safe in patients with pre-existing cardiovascular or gastrointestinal comorbidity, and the potentially confounding role of aspirin still needs to be elucidated. However, etoricoxib shows promise as a new and effective COX2 inhibitor in clinical practice.",2003.0,0,0
703,12809850,Re: Laine and Sugg-Helicobacter pylori eradication on esophagitis and GERD.,R J L F Loffeld,,2003.0,0,0
704,12811310,Intra-oesophageal pH profiles and pharmacokinetics of pantoprazole and esomeprazole: a crossover study in patients with gastro-oesophageal reflux disease.,Bernd Simon; Peter Müller; Oliviu Pascu; Gudrun Gatz; Peter Sander; Reinhard Huber; Hermann Mascher,"To compare the effect of pantoprazole and esomeprazole on intra-oesophageal pH and investigate their pharmacokinetics in patients with symptomatic gastro-oesophageal reflux disease (GORD). Double-blind, randomized, two-period crossover study. Caucasian men with symptomatic GORD (n=48) were selected on the basis of clinical records of typical GORD symptoms, confirmed by a pathological reflux time (oesophageal pH<4 for > or =6% of the time). They received oral pantoprazole 40 mg once daily (od) or esomeprazole 40 mg od for seven days. Continuous 24 h oesophageal pH-metry was performed at baseline and day 7. Evaluations included: pre- and post-treatment differences in the percentage of time with pH<4.0 and <3.0 between baseline and day 7; area under the curve (AUC), Cmax, and T(1/2); point estimates and 90% confidence intervals (CI) on days 1 and 7, calculated for ratios of the AUC and Cmax. Both drugs decreased the mean total number of reflux episodes and reduced the percentage of reflux time within 24 h to <3%. No pathological reflux was detectable after repeated administration of either drug. The 90% CI were within the predefined range at all time points; thus, equivalence of pantoprazole and esomeprazole was concluded. For pantoprazole, Cmax and AUC were unchanged on day 7 vs day 1, confirming its high and constant bioavailability. For esomeprazole, Cmax and AUC were increased on day 7 vs day 1 by 80% and 50%, respectively, indicating low initial bioavailability. No clinically relevant side effects were seen for either drug. Pantoprazole and esomeprazole have equivalent effect on oesophageal pH, since no pathological reflux was detected after treatment with either drug. For esomeprazole, the Cmax and AUC increased after multiple dosing; for pantoprazole the pharmacokinetics were predictable and independent of the number of administered doses.",2003.0,0,0
705,12811323,Evidence-based practice: gastroesophageal reflux disease.,Delores Saddler,,2003.0,0,0
706,12816172,A randomized trial of an acid-peptic disease management program in a managed care environment.,Joshua J Ofman; Richard Segal; Wayne L Russell; Deborah J Cook; Meenu Sandhu; Susan K Maue; Edward H Lowenstein; Ray Pourfarzib; Erv Blanchette; Gray Ellrodt; Scott R Weingarten,"To study the effectiveness of a disease management program for patients with acid-related disorders. A cluster-randomized clinical trial of 406 patients comparing a disease management program with ""usual practice."" Enrolled patients included those presenting with new dyspepsia and chronic users of antisecretory drugs in 8 geographically separate physician offices associated with the Orlando Health Care Group. There were 35 providers in the intervention group and 48 in the control group. The disease management program included evidence-based practice guidelines implemented by using physician champions, academic detailing, and multidisciplinary teams. Processes of care, patient symptoms, quality of life, costs, and work days lost were measured 6 months after patient enrollment. Compared with usual practice, disease management was associated with improvements in Helicobacter pylori testing (61% vs 9%; P = .001), use of recommended H pylori treatment regimens (96% vs 10%; P = .001), and discontinuation rates of proton pump therapy after treatment (70% vs 36%; P = .04). There were few differences in patient quality of life or symptoms between the 2 study groups. Disease management resulted in fewer days of antisecretory therapy (71.7 vs 88.1 days; P = .02) but no difference in total costs. This disease management program for patients with acid-related disorders led to improved processes of care. The effectiveness of such a program in other settings requires further study.",2003.0,0,0
707,12818266,Effects of 6-12 months of esomeprazole treatment on the gastric mucosa.,Robert M Genta; Guido Rindi; Roberto Fiocca; David J Magner; Donald D'Amico; Douglas S Levine,"The aim of this study was to determine the effect of 6-12 months of treatment with esomeprazole on the histopathology of the gastric mucosa. Two identically designed, randomized, placebo-controlled trials of esomeprazole 40, 20, or 10 mg daily for up to 6 months, as well as a noncomparative, multicenter trial of esomeprazole 40 mg daily for up to 12 months, were conducted in 1326 patients with healed erosive esophagitis (1294 negative for Helicobacter pylori [H. pylori]). Gastric biopsy samples were obtained before treatment and on completion of (or discontinuation from) the trials. Samples were evaluated for the presence of H. pylori, characteristics of acute gastritis or atrophic gastritis, and enterochromaffin-like cell pathology. During treatment with esomeprazole, the number of patients with an improvement in gastric histological scores was typically greater than or equal to the number who worsened. Gastric histological scores worsened for each corporal or antral characteristic of gastritis in <6.2% of patients. Histological scores with esomeprazole and placebo were similar throughout the 6-month trials. Only one among 1326 patients treated with esomeprazole (H. pylori negative) had evidence of treatment-emergent atrophic gastritis. On final biopsy, 5-12% of patients had abnormal enterochromaffin-like cell scores (simple, linear, or micronodular hyperplasia). There were no instances of enterochromaffin-like cell dysplasia, carcinoids, or neoplasia. Patients with healed erosive esophagitis receiving esomeprazole for up to 12 months had minor fluctuations in gastric histological scores, similar to those experienced in untreated populations. Use of esomeprazole did not raise any safety concerns with respect to the development of atrophic gastritis, or cause clinically significant changes in enterochromaffin-like cells.",2003.0,0,0
708,12823154,,,,,0,0
709,12825570,Rofecoxib in rheumatoid arthritis: new indication. No better that other NSAIDS.,,"(1) For symptoms of rheumatoid arthritis (pain, joint stiffness), the reference treatment is a nonsteroidal antiinflammatory drug (NSAID) such as diclofenac or ibuprofen. Celecoxib, a coxib NSAID, has no proven advantages over these other NSAIDs. (2) Rofecoxib is the second coxib to be approved in this indication. The clinical evaluation file shows that the optimal daily dose is 25 mg. (3) A comparative trial in more than 8 000 patients, showed that rofecoxib was no more effective than 1 g/day of naproxen. There are no trials comparing rofecoxib with celecoxib, diclofenac or ibuprofen. (4) In clinical trials the overall frequencies of adverse effects and treatment withdrawals for adverse effects were the same for rofecoxib as for other NSAIDs. In one trial, rofecoxib caused fewer gastrointestinal disturbances, particularly serious ones, than naproxen. But rofecoxib caused more gastrointestinal disturbances than placebo. During postmarketing follow up in the United States, a number of deaths due to gastrointestinal complications on rofecoxib were reported. Rofecoxib carries the same renal risk as other NSAIDs. An excess risk of cardiovascular events cannot be ruled out. (5) In practice, the advent of rofecoxib in no way influences the choice of NSAID for symptomatic treatment of rheumatoid arthritis.",2003.0,0,0
710,12825865,Effect of short-term treatment with regular or high doses of omeprazole on the detection of Helicobacter pylori in bleeding peptic ulcer patients.,M Udd; P Miettinen; A Palmu; R Julkunen,"It is unknown whether short-term regular or high-dose omeprazole has any influence on the colonization of Helicobacter pylori in the stomach. We therefore studied the effect of 3-day treatment of 2 different doses of omeprazole. H. pylori-positive patients with peptic ulcer bleeding (n = 101) were randomized to receive either a regular dose (20 mg/day for 3 days) (n = 51) or a high dose of omeprazole (80 mg bolus + 8 mg/h infusion/day for 3 days) (n = 50). H. pylori status was assessed by histology and urease testing of gastric biopsies pre-entry and after 3-day therapy. With the high dose of omeprazole, tests for the diagnosis of H. pylori became negative significantly more often than with the regular dose (60% versus 27.5%, P=0.001 (any test), 67.6% versus 31.7%, P=0.003 (histology) and 82.2% versus 43.6%, P=0.001 (urease test)). Conversion of the H. pylori tests negative after 3-day treatment of omeprazole is dose-dependent. The diagnosis of H. pylori infection depends on the timing of biopsies in relation to the beginning of proton-pump inhibitor treatment. If samples to find H. pylori are not taken before the treatment, the presence of the bacteria may be overlooked.",2003.0,0,0
711,12831332,Pharmacotherapy of chronic cough in adults.,J Mark Madison; Richard S Irwin,"Chronic cough is a debilitating symptom for which patients commonly seek medical attention. Among adult non-smokers who are not taking an angiotensin-converting enzyme inhibitor and have a normal or near normal chest radiograph, postnasal drip syndrome caused by a variety of rhinosinus conditions, asthma and non-asthmatic eosinophilic bronchitis and gastro-oesophageal reflux disease singly or in combination, are the most common diagnoses underlying chronic cough. Pharmacotherapy for chronic cough can be either specific or non-specific. Specific therapy is preferable and the most effective as it is directed at the aetiologies and pathophysiological mechanisms responsible for cough. In contrast, non-specific therapy is used only in limited clinical settings, as it is directed at the symptom rather than underlying aetiologies and aims only to control, rather than eliminate cough.",2003.0,0,0
712,12831333,Pharmacotherapy for chronic gastro-oesophageal reflux disease and Barrett's oesophagus.,Peter Wurm; John de Caestecker,"Over the last two decades there have been major advances in the medical treatment of gastro-oesophageal reflux disease (GORD) and Barrett's oesophagus. Motility agents, H(2)-receptor antagonists and proton-pump inhibitors (PPI) have all been evaluated in short- and long-term studies. Symptomatic response needs to be differentiated from healing of oesophagitis and maintenance of remission. Clinical trials have convincingly demonstrated the superiority of PPIs to motility agents and H(2)-receptor antagonists for all clinical aspects of GORD. Barrett's oesophagus requires lifelong acid suppression. Treatment with standard doses of PPIs is often insufficient and higher doses are frequently required. Medical treatment does not appear to result in clinically significant regression of Barrett's oesophagus.",2003.0,0,0
713,12839378,Quadruple therapy for initial eradication of Helicobacter pylori in peptic ulcer: comparison with triple therapy.,C Ganesh Pai; C P Thomas; Asok Biswas; Sugandhi Rao; K Ramnarayan,"Quadruple therapy appears to be more effective than standard triple therapy in the management of patients with Helicobacter pylori infection who harbor drug-resistant organisms. No data are available on the relative efficacies of triple and quadruple drug regimens from India. Consecutive patients with peptic ulcer and H. pylori infection were randomized to receive lansoprazole 30 mg twice daily along with either amoxycillin (500 mg four times daily) and clarithromycin (500 mg twice a day) (Group A), or tri-potassium dicitrato bismuthate (120 mg four times daily), metronidazole (400 mg thrice daily) and tetracycline (500 mg 4 times daily) (Group B) for 10 days. Presence of H. pylori infection was looked for using an in-house urease test and histology before starting treatment, and 30 days after completion of treatment. Twenty-nine of 35 patients in Group A and 24 of 33 in Group B had eradication of infection (82.8% and 72.7% by intention-to-treat analysis, and 87.9% and 85.7% by per protocol analysis, respectively; p = ns). Side-effects occurred in 4 (12%) and 5 (18%) patients in Groups A and B, respectively (p = ns); discontinuation of drugs was required in two patients in group B. Quadruple therapy for initial treatment of H. pylori infection does not offer any advantage over standard triple therapy in Indian patients.",2003.0,0,0
714,12848630,Helicobacter pylori eradication and peptic ulcer healing: the impact of deleting the proton pump inhibitor and using a once-daily treatment.,T-U Wheeldon; T T H Hoang; D C Phung; A Björkman; M Granström; M Sörberg,"To compare cheaper and simpler once-daily regimens, with and without a proton pump inhibitor, with standard, twice-daily, triple therapy. A randomized, placebo-controlled, treatment trial in Vietnam allocated 296 Helicobacter pylori-infected patients with peptic ulcer of >or= 5 mm to one of three regimens: (i) twice-daily: lansoprazole 30 mg, clarithromycin 250 mg and tinidazole 500 mg; (ii) once-daily: lansoprazole 60 mg, clarithromycin 500 mg and tinidazole 1000 mg; (iii) once-daily: placebo, clarithromycin 500 mg and tinidazole 1000 mg. H. pylori status was assessed by culture and immunoblot, ulcer healing by endoscopy and side-effects by structured questionnaires. Per protocol eradication (N = 256) was higher with standard therapy (87%) than with once-daily therapy (72%), and both were better than once-daily therapy without proton pump inhibitor (39%). Per protocol ulcer healing after standard therapy (83%) was not significantly better than that after once-daily therapy (73%), but better than that after therapy without proton pump inhibitor (65%). Side-effects were reported at similar rates in all groups. Proton pump inhibitor was needed for optimal eradication and ulcer healing. Twice-daily administration showed improved success rates when compared with once-daily therapies. Peptic ulcer healing was achieved even in patients treated with antibiotics only, confirming the central role of H. pylori in the pathophysiology of peptic ulcer disease.",2003.0,0,0
715,12848632,Proton-pump inhibitor therapy for acetylsalicylic acid associated upper gastrointestinal symptoms: a randomized placebo-controlled trial.,R J F Laheij; L G M Van Rossum; J B M J Jansen; F W A Verheugt,"Patients using acetylsalicylic acid (aspirin) have an increased risk of upper gastrointestinal discomfort. The aim of this study was to assess whether gastric acid suppression improves upper gastrointestinal symptoms in patients using low-dose aspirin for cardiovascular disease. In a double-blind, placebo-controlled randomised trial, 150 patients using low-dose (80 mg) acetylsalicylic acid with upper gastrointestinal symptoms who had been admitted at the Coronary Care Unit of the University Medical Center Nijmegen were assigned to treatment with rabeprazole (20 mg once daily) or placebo for 4 weeks. Treatment success, defined as complete upper gastrointestinal symptom relief, could be evaluated in 143 patients. At 4 weeks after randomization, 34 of the 73 patients assigned to rabeprazole therapy (47%) as compared with 30 of the 70 patients given placebo (43%) reported complete upper gastrointestinal symptom relief (P = 0.54). Rabeprazole therapy did lead to a 52% improvement of heartburn symptoms [25% vs. 16%; odds ratio (OR) 0.48, 95% confidence interval (CI): 0.24-0.97]. Epigastric pain, regurgitation, bloating and nausea symptoms did not statistically change after treatment. Patients with a history of dyspepsia more often reported treatment success in comparison to those without (75% vs. 40%; OR 0.25, 95% CI: 0.09-0.70). Proton-pump inhibitor therapy significantly reduced heartburn, but not other acetylsalicylic acid associated symptoms.",2003.0,0,0
716,12848633,Is it possible to predict treatment response to a proton pump inhibitor in functional dyspepsia?,E Bolling-Sternevald; K Lauritsen; N J Talley; O Junghard; H Glise,"The efficacy of proton pump inhibitors in functional dyspepsia is modest and the prognostic factors are almost unknown. Data were pooled on patients (n = 826) with a diagnosis of functional dyspepsia from two placebo-controlled trials who were treated with omeprazole, 10 or 20 mg once daily, for 4 weeks. Self-administered questionnaires for the assessment of symptoms and health-related quality of life were completed before entry, and epigastric pain/discomfort was recorded on diary cards. Treatment success was defined as the complete absence of epigastric pain/discomfort on each of the last 3 days of week 4. Prognostic factors were identified by multiple logistic regression analysis. The most discriminating predictor of treatment success (P < 0.0001) was the number of days with epigastric pain/discomfort during the first week of treatment. Fewer days with symptoms during the first week led to higher response rates at 4 weeks. In addition, age > 40 years, bothersome heartburn, low scores for bloating, epigastric pain and diarrhoea, history of symptoms for < 3 months and low impairment of vitality at baseline were identified as positive predictors of outcome. Early response to treatment with a proton pump inhibitor, during the first week, seems to predict the outcome after 4 weeks in patients with functional dyspepsia.",2003.0,0,0
717,12850673,Evaluation and management of patients with recurrent peptic ulcer disease after acid-reducing operations: a systematic review.,Richard H Turnage; George Sarosi; Byron Cryer; Stuart Spechler; Walter Peterson; Mark Feldman,"This systematic review examines the evidence for commonly employed strategies of managing patients with recurrent ulcer disease after acid-reducing operations. Particular attention is given to recent evidence relating Helicobacter pylori (H. pylori ) and nonsteroidal anti-inflammatory drugs (NSAIDs) to ulcer recurrence after operative therapy. MEDLINE word searches of the literature from 1966 to 2001 identified 895 articles that cross-reference the terms ""peptic ulcer disease (PUD),"" ""surgery,"" and ""recurrence."" Articles were selected for systematic review of evidence relating incomplete vagotomy, NSAIDs, and H. pylori to postoperative ulcer recurrence and evidence supporting common medical and surgical strategies. The relationship between incomplete vagotomy and recurrent ulcer disease is suggested by randomized controlled trials and well-designed prospective case series. The evidence that NSAID use is an important pathogenic factor in recurrent ulcer disease includes the relationship between NSAIDs and primary PUD, the occurrence of NSAID-induced ulcers in patients taking proton pump inhibitors, and case series demonstrating virulent ulcer disease in patients taking aspirin despite prior acid-reducing operations. The relationship between H. pylori infection and postoperative ulcer recurrence remains uncertain despite multiple controlled trials and well-designed case series that have documented high rates of H. pylori infection in postoperative patients. The initial management of patients with recurrent ulcer disease after acid-reducing operations consists of a protein pump inhibitor or a histamine-2 receptor antagonist and antibiotics directed at H. pylori, if present. Evidence for this regimen includes prospective randomized trials demonstrating the efficacy of cimetidine in healing ulcers after acid-reducing operations and prospective, randomized studies documenting the efficacy of histamine-2 receptor antagonists and protein pump inhibitors in the management of patients with primary PUD. The critical role that H. pylori infection plays in primary PUD and the minimal risks associated with H. pylori eradication strongly support the initiation of antibiotic therapy when H. pylori is present. The principal indication for operative management of recurrent PUD is the occurrence of ulcer complications that cannot be managed by medical or endoscopic means. The operative management of patients with failed acid-reducing operations is based on ulcer recurrence rates and morbidity and mortality rates in randomized and nonrandomized prospective trials of patients with primary PUD and retrospective case series of patients undergoing remedial operative procedures after various failed acid-reducing operations.",2003.0,0,0
718,12853722,GERD 2003 -- a consensus on the way ahead.,Steven F Moss; David Armstrong; Rudi Arnold; Peter Ferenci; Kwong M Fock; Gerald Holtmann; Denis M McCarthy; Joaquim P Moraes-Filho; Ernst Mutschler; Raymond Playford; Stuart J Spechler; Vincenzo Stanghellini; Irvin M Modlin,"Gastroesophageal reflux disease (GERD) has in recent times become an important public health issue owing to the considerable health care resources utilized in its management, its deleterious effect on quality of life and the increasing prevalence of a relatively rare complication of reflux disease - esophageal adenocarcinoma. We review here the major current challenges in the field of reflux disease and its complications, and provide some approaches that may be useful in management. The issues to be faced include the very limited comprehension of the reasons behind the increasing prevalence of the disease, difficulties in correlating symptoms with objective data of pathological gastroesophageal reflux and the relatively unsophisticated tools we are employing to investigate the underlying pathophysiology. It is certain that the lack of well-defined and characterized methodologies to compare the effects of therapy require the development of more effective questionnaire-type analytic tools. In regard to treatment, there is little doubt that the widely prescribed proton pump inhibitors have dose-equivalent efficacy and are the most highly effective agents capable of suppressing acid, controlling many of the symptoms of GERD and healing erosions. Nevertheless, many patients continue to experience symptoms on withdrawal or at night. Pharmacological agents that can effectively increase lower esophageal sphincter pressure or promote motility are as yet unavailable. Although the introduction of laparoscopic techniques has resulted in a modest revival in surgical intervention using a variety of 'wrap-type' operations, the indications are few and the procedure is associated with a significant morbidity and even mortality especially if the expertise of the surgeon is an issue. Endoscopic techniques of regulating reflux are at this time experimental and not applicable to the general population. Intestinal metaplasia in the lower esophagus is probably very common. Whether and how to, first, screen for, and then, perform surveillance in Barrett's esophagus remains highly problematic and contentious.",2003.0,0,0
719,12854158,Density of Helicobacter pylori may affect the efficacy of eradication therapy and ulcer healing in patients with active duodenal ulcers.,Yung-Chih Lai; Teh-Hong Wang; Shih-Hung Huang; Sien-Sing Yang; Chi-Hwa Wu; Tzen-Kwan Chen; Chia-Long Lee,"To evaluate the association of pre-treatment Helicobacter pylori (H. pylori) density with bacterial eradication and ulcer healing rates in patients with active duodenal ulcer. One hundred and four consecutive duodenal ulcer outpatients with H. pylori infection ascertained by gastric histopathology and (13)C-urea breath test (UBT) were enrolled in this study. H. pylori density was graded histologically according to the Sydney system (normal, mild, moderate, and marked). In each patient, lansoprazole (30 mg b.i.d.), clarithromycin (500 mg b.i.d.) and amoxicillin (1 g b.i.d.) were used for 1 week, then 30 mg lansoprazole once daily was continued for an additional 3 weeks. Follow-up endoscopy was performed at 4 weeks after completion of the therapy, and UBT was done at 4 and 8 weeks after completion of the therapy. The H. pylori eradication rates were 88.9 %/100.0 %, 94.3 %/100.0 %, and 69.7 %/85.2 %; and the ulcer healing rates were 88.9 %/100.0 %, 94.3 %/100.0 %, and 63.6 %/77.8 % (intention-to-treat/per protocol analysis) in the mild, moderate, and marked H. pylori density groups, respectively. The association of pretreatment H. pylori density with the eradication rate and ulcer healing rate was both statistically significant (P=0.013/0.006 and 0.002/<0.001, respectively; using results of intention-to-treat/per protocol analysis). Intragastric bacterial load may affect both the outcome of eradication treatment and ulcer healing in patients with active duodenal ulcer disease.",2003.0,0,0
720,12858605,Noncardiac chest pain: evaluation and treatment.,Guy D Eslick; Ronnie Fass,"Noncardiac chest pain is a heterogeneous condition for which diagnosis and treatment are challenging. Research is needed to streamline evaluation to minimize unnecessary invasive testing and costs. Chest pain clinics to assess chest pain patients are popular in the United States and may be of value in reassuring patients and reducing presentation to hospital; however, recently this has been contended [111]. Options for the effective treatment of NCCP are dependent on the risk of an adverse outcome and the cost-effectiveness of the management algorithm that is followed. Most (64%) of those presenting to the emergency department with chest pain are classified as having NCCP [112,113]. GERD is probably the most important cause and application of a test of acid suppression with a high-dose PPI for 1 to 2 weeks seems to be a useful diagnostic tool. In those patients with GERD-related NCCP, short-term and potentially long-term therapy with a PPI (commonly higher than standard dose) is required to alleviate symptoms. Esophageal dysmotility is relatively uncommon in patients with NCCP and evaluation by esophageal manometry might be limited to rule out achalasia. Chest wall syndromes are common but probably often missed. Many patients with NCCP have psychologic or psychiatric abnormalities, as either the cause or an effect of the chest pain, but diagnosis here depends on techniques not applied easily in the acute situation. Pain modulators seem to offer significant improvement in chest pain symptoms for non-GERD-related NCCP. Finally, trials of management strategies to deal with this problem are required urgently, because the earlier discharge of patients with NCCP may exacerbate the problem. Fig. 2 provides a flow chart for diagnosis and treatment of NCCP.",2003.0,0,0
721,12858607,Functional dyspepsia: evaluation and treatment.,Magnus Simrén; Jan Tack,"Functional dyspepsia is one of the most common disorders seen in general practice and by gastroenterologists. New concepts regarding the pathophysiology and its role for the symptom pattern have emerged during the last few years. This is of importance for development of new treatment alternatives in the near future. At the moment, however, empirical treatment with acid-suppressive agents and prokinetics is the recommended therapeutic approach in the management of these patients, despite limited efficacy. Identification and treatment of H pylori infection has been recommended for uninvestigated dyspepsia, because it may cure underlying peptic ulcer disease, but is unlikely to provide symptomatic benefit to patients with functional dyspepsia. Refractory patients may respond to antidepressants or to psychologic treatments, but proof of efficacy is limited. New and more effective approaches are badly needed for functional dyspepsia.",2003.0,0,0
722,12858654,[Four different treatment protocols for Helicobacter pylori infection--a clinical pilot study].,Semra Cavaljuga; Srdan Gornjaković; Dubravka Potkonjak,"A pilot clinical trial specially designed to test four different treatment regimens of Helicobacter pylori infection was performed among hospitalized and outpatient based patients in Clinical Centre University of Sarajevo, Gastroenterohepatology Clinics. Another objective was to assess Helicobacter pylori total cradication rates, partial cradication rates and after treatment persistent Helicobacter pylori infection rates among patients with clinically proven peptic ulcer disease (PUS). All patients randomly assigned into four groups had endoscopically and Helicourcasa test (HUT Astra) proven peptic ulcers. Each group was treated with one of the following four triple regimens: ranitidine + amoxicillin + metronidazole (RAM); ranitidine + clarithromycin + metronidazole (RCM); omeprazole + amoxicillin + metronidazole (OAM) and omeprazole + clarithromycin + m etronidazole (OCM). All triple regimens were given twice-a-day for one week following either ranitidine or omeprazole for two weeks depending of basic regimens. The highest Helicobacter pylori eradication was produced with OCM regimens (91.7%). Using same regimens we found the lowest partial eradication rate of all regimens (8.3%) and no persistency of H. pylori after the treatment. The lowest total eradication rate was found using RCM regimens (67.7%), while there was no difference in the cure rate between OAM (76.9%) and RAM (77.3%) regimens. If it is applicable, recommended treatment regimen as a first choice for proven H. pylori infection is OCM.",2003.0,0,0
723,12859219,The impact of treatment for gastro-oesophageal reflux disease on health-related quality of life: a literature review.,Manishi Prasad; Anne M Rentz; Dennis A Revicki,"Gastro-oesophageal reflux disease (GORD) is common in the general population and is diagnosed based on patient-reported symptoms and clinical tests. Although clinical tests are available, significant percentages of patients report symptoms of heartburn and reflux despite negative endoscopies, and 24-hour pH tests are not often used by primary-care physicians in diagnosis. Consequently, patient-reported symptoms and health-related QOL (HR-QOL) are important in assessing treatment outcome. HR-QOL is significantly impaired in patients with GORD, and HR-QOL is associated with symptom severity and changes in GORD-related symptoms. The objective of this literature review is to examine the impact of pharmacological treatment on HR-QOL in patients with GORD. Generic and disease-specific HR-QOL measures have been used in clinical trials to evaluate the impact of GORD on patient functioning and well-being. The Psychological General Well-Being (PGWB) Index and the 36-Item Short-Form Health Survey (SF-36) have been used in several clinical trials of treatment for GORD and have consistently shown that HR-QOL improves with successful therapy. These trials have been conducted primarily with two pharmacological agents, omeprazole and ranitidine. On the Heartburn-specific Quality of Life questionnaire, patients treated with ranitidine reported better HR-QOL after treatment compared with placebo therapy. In two clinical trials where omeprazole and ranitidine were compared, patients treated with omeprazole reported significantly better HR-QOL (based on the PGWB Index) than those treated with ranitidine; however, 2 other trials did not detect significant differences between the treatments. Results from clinical trials using disease-specific measures (Gastrointestinal Quality of Life Index [GIQLI] and Heartburn-specific Quality of Life questionnaire) demonstrate similar findings, supporting the association between treatment-related symptom resolution and improvements in HR-QOL. The GIQLI was used in a trial comparing pantoprazole and ranitidine, where results favoured pantoprazole therapy. Several studies have demonstrated that resolution of GORD symptoms is associated with improvement in HR-QOL. Although there is evidence that treatment for GORD does improve symptoms and HR-QOL outcomes, further research is needed to more completely understand the value of medical therapy for GORD.",2003.0,0,0
724,12860586,"Approach to treatment of dyspepsia in primary care: a randomized trial comparing ""test-and-treat"" with prompt endoscopy.",Nicolaas L A Arents; Jacob C Thijs; Anton A van Zwet; Marco Oudkerk Pool; Jan-Mark Gotz; Ger T van de Werf; Klaas Reenders; Wim J Sluiter; Jan H Kleibeuker,"The value of the ""test-and-treat"" strategy in the approach to dyspepsia has been evaluated only in a few secondary care studies. Most patients with dyspepsia, however, are treated by their primary care physician. This study evaluated the test-and-treat strategy in primary care. Patients consulting their general practitioners for dyspepsia were randomized to either direct open-access endoscopy with Helicobacter pylori testing or a test-and-treat strategy by H pylori serology. In the 12-month follow-up period, any additional treatment or referral for investigations was left at the discretion of the general practitioner. At the end of the study, data were collected concerning the number of endoscopies, changes in symptom severity and quality of life, patient satisfaction, and the use of medical resources. Two hundred seventy patients were enrolled (129 who received endoscopy and 141 in the test-and-treat group). The prevalence of H pylori infection was 38.3% and 37.2% in the test-and-treat and endoscopy groups, respectively. In the test-and-treat group, 46 patients (33%) were referred for endoscopy during follow-up. Improvement in symptom severity, quality of life, and patient satisfaction was comparable in both groups. Patients in the test-and-treat group paid more dyspepsia-related visits to their general practitioner (P =.005). Patients in the endoscopy group were more often prescribed proton pump inhibitors (P =.007), whereas patients in the test-and-treat group were more often prescribed prokinetic drugs (P =.005). The test-and-treat strategy proved to be as effective and safe as prompt endoscopy. Only a minority of patients were referred for endoscopy after the test-and-treat approach.",2003.0,0,0
725,12869082,Economic analysis of celecoxib versus diclofenac plus omeprazole for the treatment of arthritis in patients at risk of ulcer disease.,K K C Lee; J H S You; J T S Ho; B Y Suen; M Y Yung; W H Lau; V W Y Lee; J Y Sung; F K L Chan,"To evaluate the economic impact of celecoxib therapy vs. diclofenac plus omeprazole therapy for the treatment of arthritis in Chinese patients with a high risk of bleeding, from the perspective of a public health organization in Hong Kong. The medical records of 287 Chinese arthritic patients with a history of bleeding ulcers who had previously participated in a randomised study of celecoxib 200 mg twice daily and extended-release diclofenac 75 mg twice daily plus 20 mg of omeprazole daily for 6 months were reviewed. Compared to the diclofenac plus omeprazole group, the average total direct cost per patient in the celecoxib group showed a significant reduction of 11%, from HK 10,915 (range HK dollars 10,915-57,899) to HK dollars 9714 (range HK dollars 9714-89,770) (P<0.0001) (1 US dollars=7.8 HK dollars). The median direct medical cost for routine management in the celecoxib group was significantly lower (11%) than that for the diclofenac plus omeprazole group [HK dollars 10,915 (range 10,915-28,048) vs. HK dollars 9714 (range HK dollars 6946-26,179) (P<0.0001)]. In patients who experienced recurrent bleeding, the celecoxib group showed a significantly higher median cost of management of recurrent bleeding than the diclofenac plus omeprazole group [HK dollars 8466 (range 572-29,851) vs. HK dollars 23,210 (range HK dollars 12,318-65,823)] (P=0.036). Celecoxib therapy appears to cost less compared with diclofenac plus omeprazole for treatment of arthritis in Chinese patients with a high risk of bleeding.",2003.0,0,0
726,12869883,"Pantoprazole rapidly improves health-related quality of life in patients with heartburn: a prospective, randomized, double blind comparative study with nizatidine.",Pierre Paré; David Armstrong; Dan Pericak; Myron Pyzyk,"Health-related quality of life (HRQoL) is impaired in untreated patients with gastroesophageal reflux disease (GERD). In the absence of an objective marker such as erosions, assessment of treatment efficacy can be based on symptoms and HRQoL. To evaluate changes in HRQoL during treatment with pantoprazole or nizatidine in patients with GERD. This was a prospective, randomized, double blind Canadian multicenter study. Patients with GERD, characterized by heartburn that had occurred 4 or more times per week for at least 6 months, were treated for 28 days with either pantoprazole 40 mg once daily or nizatidine 150 mg twice daily. HRQoL assessment was performed before endoscopy (baseline) and on days 7 and 28 after treatment. HRQoL was assessed using 4 domains of the SF-36, the SF-12 summary scales and the gastrointestinal system rating scale (GSRS). A total of 208 patients (n = 106 pantoprazole treatment group, n = 102 nizatidine treatment group) was available for intention-to-treat analysis. Baseline HRQoL scores were comparable between the 2 treatment groups. After 7 days, treatment with pantoprazole led to a statistically significant greater improvement in HRQoL in 2 SF-36 domains: bodily pain (pantoprazole versus nizatidine, P = 0.0088) and vitality (pantoprazole versus nizatidine, P = 0.0137), and in the GSRS reflux score (pantoprazole versus nizatidine, P = 0.0078). After 28 days of treatment, the changes in scores relative to baseline were still greater with pantoprazole than with nizatidine. The improvement in the 4 SF-36 domains and the GSRS reflux score achieved by pantoprazole after 7 days were also significantly greater than those achieved by nizatidine after 28 days. HRQoL improves more rapidly and to a greater degree following treatment with pantoprazole than nizatidine. Control of heartburn strongly predicts HRQoL improvement during the acute treatment of GERD. Our data support the approach to use pantoprazole instead of nizatidine as the initial therapy for patients with heartburn in a primary care practice setting.",2003.0,0,0
727,12869885,"13C-urea breath test, referral patterns, and results in children.",Yaron Niv; Galia Abuksis; Rivka Koren,"The family is the core unit for Helicobacter pylori (Hp) infection. In most instances, Hp colonization occurs in early childhood, and correlates with socioeconomic parameters. Helicobacter pylori infection is highly prevalent in many countries, and may cause chronic gastritis and peptic ulcer in adults and in children. Gastritis induced by Hp may be associated with recurrent abdominal pain in children, and eradication of the bacterium may improve the clinical symptoms. AIM The primary aim of this study is to characterize the group of pediatric patients according to the referral patterns and results of 13C-urea breath test (13C -UBT) in our laboratory. The secondary aim is to investigate the result of different treatment combinations for Hp eradication. The 13C-UBT was performed with 75 mg urea labeled with 13C in 200 mL orange juice. Breath samples were collected at 0 and 30 minutes, and the results expressed as the change in the 13C/12C ratio at T30' minus T0' The cutoff for Hp eradication was 3.5. The physicians who ordered the test completed a questionnaire covering demographic data (age, gender, and origin), indication for the test was use of a proton pump inhibitor (PPI), and type of combination eradication therapy. The study sample consisted of 1655 children, aged 1 to 18 years, 992 (59.9%) boys and 663 (40.1%) girls, from all parts of the country. The 13C-UBT was positive in 763 (46.1%). The prevalence of positive results was directly correlated with age. History of peptic disease was the main indication for the test, in 1346 (81.4%) cases. Details on eradication therapy were available for 435 children of whom 42.5% had a positive 13C-UBT, indicating a successful eradication rate of 57.5%. Compared with Israeli and American-European origin, children of Asian-African origin had a higher rate of referrals for reason of validation of successful Hp eradication, greater long-term PPI use, and a higher rate of 13C-UBT positivity. No significant difference was demonstrated between the triple therapy regimens used. 13C-UBT may be performed in children of all age groups. The main indication is a history of peptic ulcer disease. The prevalence of Hp infection increased with age and the only factor associated with increased Hp infection was Asian-African origin. The most frequent eradication therapy used in children is a combination of omeprazole, amoxicillin, and clarithromycin.",2003.0,0,0
728,12872094,Endoscopic ablation of Barrett's related neoplasia: what is the evidence supporting its use?,M Brian Fennerty,,2003.0,0,0
729,12883788,[Treatment strategies for gastroesophageal reflux disease].,B Neuhauser; H Bonatti; R A Hinder,"Gastroesophageal reflux disease (GERD) is a very common disorder. Therapeutic options include lifestyle modifications, medical therapy, laparoscopic antireflux surgery, and three more recent options-injection therapy to the lower esophageal sphincter, endoscopic sewing procedures, and radio frequency ablation therapy. Medical therapy is effective in most patients but not always successful with advanced disease. Up to 70% of subjects do not have adequate nocturnal control of gastric acid secretion with 20 mg of omeprazole given twice per day. Patients who do not tolerate medical therapy, who respond inadequately, or who want to avoid life-long drug therapy are candidates for alternate treatments. Studies on endoscopic procedures such as polymethylmethacrylate (PMMA) injection, the Stretta procedure,and endoscopic suturing techniques all suffer from having small study groups for each procedure,unknown durability, short follow-up, and the absence of randomized, controlled procedures. Limitations on endoscopic techniques are esophageal motility disorders, severe esophagitis, and larger hiatal hernias. Laparoscopic antireflux surgery remains a well-established, durable alternative to long-term medical therapy. It has the benefits of convenience, safety, minimal complications, improved quality of life, and low cost. Alternative methods will have to earn their place against this gold standard.",2003.0,0,0
730,12889553,Low frequency of upper gastrointestinal complications in a cohort of high-risk patients taking low-dose aspirin or NSAIDS and omeprazole.,A Lanas; L Rodrigo; J L Márquez; E Bajador; F Pérez-Roldan; J Cabrol; E Quintero; M Montoro; F Gomollón; S Santolaria; S Lorente; M Cucala; J Nuevo; EMPHASYS Study Group,"There is very little information available on the incidence of complications and on the best prevention therapy in high-risk patients taking non-steroidal anti-inflammatory drugs (NSAIDs) and/or aspirin. Randomized-controlled trials in such patients are rare for ethical reasons. We studied the incidence of gastrointestinal complications in high-risk patients taking long-term low-dose aspirin or non-aspirin-NSAIDs combined with omeprazole in a real-life clinical setting. This was a multicentre, prospective and observational study including 247 consecutive high-risk patients who had a clinical indication for long-term treatment with either low-dose aspirin or non-aspirin NSAIDs and omeprazole therapy. The occurrence of gastrointestinal complications was measured. In addition to a recent history of peptic ulcer bleeding, all patients had at least 1 other risk factor and 112 (45.3%) had 3 or more risk factors; 78.9% were taking low-dose aspirin and the remainder non-aspirin NSAIDs. Mean follow-up was 14.6 +/- 10.38 months. Three patients taking low-dose aspirin developed upper gastrointestinal bleeding (1.2%; 95% CI 0.3-3.5; 1.0 event/100 patients/year). This was similar to the rate observed in studies involving non-high-risk patients taking low-dose aspirin and higher than that observed in patients not taking low-dose aspirin. Two additional patients developed a lower gastrointestinal bleeding event (0.81% (0.04%-3.12%); 0.67 events/100 patients/year), which was within the range expected in NSAID users. The use of omeprazole in the high-risk patient taking low-dose aspirin or NSAIDs seems to be a safe therapeutic approach in this population and is associated with a low frequency of upper gastrointestinal complications.",2003.0,0,0
731,12893394,The effects of cognitive impairment on mortality among hospitalized patients with heart failure.,Giuseppe Zuccalà; Claudio Pedone; Matteo Cesari; Graziano Onder; Marco Pahor; Emanuele Marzetti; Maria R Lo Monaco; Alberto Cocchi; Pierugo Carbonin; Roberto Bernabei,"Cognitive impairment is a common, potentially reversible condition among older patients with heart failure. Because cerebral metabolic abnormalities have been associated with reduced survival in younger patients with advanced heart failure, we assessed the effect of cognitive impairment on the survival of older patients with heart failure. The association between cognitive dysfunction and in-hospital mortality was assessed in 1113 patients (mean [+/- SD] age, 78 +/- 9 years) who had been admitted for heart failure to 81 hospitals throughout Italy. One-year mortality was assessed in 968 patients with heart failure (age, 76 +/- 10 years) participating in the same study. Cognitive impairment was defined as a Hodkinson Abbreviated Mental Test score <7. In-hospital death occurred in 65 (18%) of the 357 participants with cognitive impairment and in 26 (3%) of the 756 patients with normal cognition (P <0.0001). Out-of-hospital mortality was 27% (51/191) among patients with cognitive impairment and 15% (115/777) among other participants (P <0.0001). In multivariate Cox regression models, decreasing levels of cognitive functioning were associated with increasing in-hospital mortality; cognitive impairment was associated with an almost fivefold increase in mortality (relative risk = 4.9; 95% confidence interval: 2.9 to 8.3) after adjusting for several potential confounders. Cognitive impairment is an independent prognostic marker in older patients with heart failure. Assessment of cognitive functioning, even by simple screening tests, should be part of the routine assessment of elderly patients with heart failure.",2003.0,0,0
732,12895187,Assessment of non-steroidal anti-inflammatory drug (NSAID) damage in the human gastrointestinal tract.,Martin W James; Christopher J Hawkey,"Aspirin is widely prescribed and confers considerable benefit to patients by reducing cardiovascular and cerebrovascular morbidity and mortality. Nonsteroidal anti-inflammatory drugs (NSAIDs) are effective analgesics, antipyretics and reduce the inflammatory component in conditions such as rheumatoid arthritis. However, both agents are associated with an increased risk of gastrointestinal symptoms and the potentially serious consequences of gastroduodenal ulceration, bleeding and perforation. The introduction of highly selective cyclo-oxygenase (COX)-2 inhibitors or the coprescription gastroprotective agents with nonselective NSAIDs have offered strategies to reduce the incidence of such events. This review article analyzes the quantitative techniques that can be employed by clinical pharmacologists and the clinical studies performed to assess NSAID damage in the gastrointestinal tract.",2003.0,0,0
733,12904140,Treatment and prevention of aspirin-induced gastroduodenal ulcers and gastrointestinal bleeding.,Angel Lanas; Angel Ferrández,"Aspirin use is associated with gastroduodenal mucosal damage and increased risk of upper gastrointestinal (GI) bleeding. Many aspirin users should receive prophylactic treatment since they often have several risk factors for upper GI complications. The best therapeutic approach for reducing GI toxicity in low-dose aspirin users is still ill-defined as only a few studies have focused on this problem. Omeprazole appears to be very effective in reducing both acute gastroduodenal mucosal damage and upper GI bleeding in the high-risk patient taking low-dose aspirin, but data with other anti-ulcer agents are lacking (misoprostol) or inconsistent (ranitidine) at present. The role of Helicobacter pylori is controversial in NSAID users, but there is now wide agreement that H. pylori infection increases mucosal damage and the risk of upper GI bleeding in low-dose aspirin users.",2003.0,0,0
734,12906006,"Digestive Disease Week 2003. 17-22 May 2003, Orlando, Fl, USA.",Sue Gotham,,2003.0,0,0
735,12907352,"Re: Johnson et al. endoscopic, deep mural implantation of enteryx for the treatment of GERD: 6-month follow-up of a multicenter trial.",Maurits J Wiersema,,2003.0,0,0
736,12916657,The pathogenesis of Barrett's esophagus.,Rebecca C Fitzgerald; Michael J G Farthing,"Significant progress has been made in clinicians' understanding of the molecular pathogenesis of BE, and the laboratory findings are beginning to lead to hypothesis-driven clinical studies; however, the following questions remain unanswered: (1) how can clinicians identify the persons most at risk for the development of esophageal adenocarcinoma, (2) what are the environmental gene interactions in esophageal carcinogenesis, and (3) can clinicians prevent the development of esophageal adenocarcinoma in the population at risk? As esophageal adenocarcinoma starts to reach epidemic proportions, further research in these areas is urgently required. With the advent of the genomic era and an explosion in studies in BE, significant progress can be made.",2003.0,0,0
737,12925153,"Effects of rebamipide, a gastro-protective drug on the Helicobacter pylori status and inflammation in the gastric mucosa of patients with gastric ulcer: a randomized double-blind placebo-controlled multicentre trial.",T Fujioka; T Arakawa; T Shimoyama; T Yoshikawa; M Itoh; M Asaka; H Ishii; H Kuwayama; R Sato; S Kawai; T Takemoto; K Kobayashi,"To investigate the effects of rebamipide on the Helicobacter pylori eradication rate with amoxicillin and omeprazole. The trial also examined its histological effects on gastro-mucosal inflammation after eradication. Two hundred and six H. pylori-positive patients with active gastric ulcer underwent 8-week based therapy (OA) consisting of 2-week amoxicillin with omeprazole and subsequent 6-week omeprazole. They randomly received either rebamipide (OA-R) or placebo (OA-P) for 16 weeks: combined with the OA based therapy, and subsequently for another 8 weeks. Besides eradication rate, inflammatory findings of gastric mucosa after eradication were evaluated histologically. Per Protocol Set analysis showed no significant difference in eradication rate between OA-R (64.6%; 95% confidence interval, 54.3-75.0%) and OA-P (67.9%; 95% CI, 57.6-78.3%). Histological findings in the gastric mucosa of the ulcer region, however, indicated a significant improvement (P = 0.017) in inflammation scores in OA-R (1.84 +/- 0.41) compared with that in OA-P (2.02 +/- 0.39) after 16-weeks of treatment. This suppressive effect on inflammation was observed even in the OA-R patients unsuccessfully eradicated. Rebamipide demonstrated a suppressive effect on the persistent and possibly chronic inflammation in the gastric mucosa of the ulcer region after eradication, but the drug did not improve the eradication rate.",2003.0,0,0
738,12943489,Recurrent duodenal ulcer haemorrhage: a pharmacoeconomic comparison of various management strategies.,Uday Chand Ghoshal; Rakesh Aggarwal; Chalamalasetty Sreenivasa Baba,"Duodenal ulcer (DU) bleeding has a 7 - 13% mortality rate and bleeding often recurs. Prevention of recurrence is, therefore, an important goal. Eradication of Helicobacter pylori or maintenance treatment with a proton pump inhibitor (PPI) may reduce recurrent DU bleeding. Economic comparison of these options is sparse. After the control of index bleeding with endotherapy and drugs, three strategies were evaluated: empirical treatment for possible H. pylori infection followed by a PPI for 2 months; test for H. pylori, eradication if positive, maintenance PPI if negative; maintenance PPI alone. Probability and direct cost data were obtained from a Medline search and Indian hospitals, respectively. Cost-minimisation, cost-utility, one- and two-way sensitivity analyses and threshold values were evaluated. Treatment of H. pylori, particularly empirical, was the preferred strategy and dominated maintenance treatment with PPI. The test-and-treat strategy was better than the empirical treatment strategy only when the probabilities of H. pylori eradication, ulcer healing following eradication and of frequency of H. pylori infection in bleeding DU were less than 58, 73 and 58%, respectively. Eradication of H. pylori is preferred in preventing recurrent bleeding from DU.",2003.0,0,0
739,12946553,,,,,0,0
740,12949712,"Improvement of gastroesophageal reflux symptoms after radiofrequency energy: a randomized, sham-controlled trial.",Douglas A Corley; Philip Katz; John M Wo; Andreas Stefan; Marco Patti; Richard Rothstein; Steven Edmundowicz; Michael Kline; Rodney Mason; M Michael Wolfe,"Gastroesophageal reflux disease is a prevalent disorder that often requires long-term medical therapy or surgery. The United States Food and Drug Administration recently cleared new endoluminal gastroesophageal reflux disease treatments; however, no controlled trials exist. We randomly assigned 64 gastroesophageal reflux disease patients to radiofrequency energy delivery to the gastroesophageal junction (35 patients) or to a sham procedure (29 patients). Principal outcomes were reflux symptoms and quality of life. Secondary outcomes were medication use and esophageal acid exposure. After 6 months, interested sham patients crossed over to active treatment. At 6 months, active treatment significantly and substantially improved patients' heartburn symptoms and quality of life. More active vs. sham patients were without daily heartburn symptoms (n = 19 [61%] vs. n = 7 [33%]; P = 0.05), and more had a >50% improvement in their gastroesophageal reflux disease quality of life score (n = 19 [61%] vs. n = 6 [30%]; P = 0.03). Symptom improvements persisted at 12 months after treatment. At 6 months, there were no differences in daily medication use after a medication withdrawal protocol (n = 17 [55%] vs. n = 14 [61%]; P = 0.67) or in esophageal acid exposure times. There were no perforations or deaths. Radiofrequency energy delivery significantly improved gastroesophageal reflux disease symptoms and quality of life compared with a sham procedure, but it did not decrease esophageal acid exposure or medication use at 6 months. This procedure represents a new option for selected symptomatic gastroesophageal reflux disease patients who are intolerant of, or desire an alternative to, traditional medical therapies.",2003.0,0,0
741,12949740,Radiofrequency energy treatment of GERD.,Peter J Kahrilas,,2003.0,0,0
742,12950427,Triple vs quadruple therapy for treating Helicobacter pylori infection: an updated meta-analysis.,E Gené; X Calvet; R Azagra; J P Gisbert,,2003.0,0,0
743,12953341,Omeprazole disposition in children following single-dose administration.,Gregory L Kearns; Tommy Andersson; Laura P James; Andrea Gaedigk; Rebecca A Kraynak; Susan M Abdel-Rahman; Krishnaswami Ramabadran; John N van den Anker,"Omeprazole is frequently used to treat gastroesophageal reflux in infants and children despite the lack of age-specific pharmacokinetic and dosing information in the approved product labeling. To address this challenge, the authors examined the potential influence of development and cytochrome P450 2C19 (CYP2C19) genotype on omeprazole disposition by conducting two pharmacokinetic (PK) studies in children and adolescents (ages 2-16 years) after a single oral 10- or 20-mg dose of the drug. Plasma omeprazole concentrations were determined by HPLC-MS from seven plasma samples obtained over a 6-hour postdose period. Pharmacokinetic parameters were determined by noncompartmental methods. Subjects were genotyped for CYP2C19 by PCR-RFLP. Data were available from 37 patients (19 female), 10 of whom were < or = 5 years of age. No drug-associated adverse events were observed. The numbers of functional CYP2C19 alleles per subject in the cohort were 2 (n = 25), 1 (n = 11), and 0 (n = 1). Pharmacokinetic parameters (mean +/- SD, range) were as follows: tmax (2.1 +/- 1.2, 1-6 h), Cmax (331.1 +/- 333.6, 20.8-885.8 ng/mL), AUC0-->infinity (809.5 +/- 893.8, 236.9-1330.9 ng/mL.h), t1/2 (0.98 +/- 0.22, 0.7-1.4 h), and CL/F (1.8 +/- 1.4, 0.3-5.8 L/h/kg). Comparison of mean AUC0-->infinity values normalized for dose (i.e., per 1 mg/kg) between subjects with one versus two functional CYP2C19 alleles revealed no statistically significant difference. In addition, the CL/F and apparent elimination rate constant (lambda z) for omeprazole were not significantly different for subjects with one versus two functional CYP2C19 alleles. No association between age and CL/F, t1/2, or lambda z was observed. The range of t1/2 values for omeprazole was similar to those reported in adults (1-1.5 h). (1) in children ages 2 to 16 years receiving 10 or 20 mg of omeprazole as a single oral dose, the PK are quite comparable to values reported for adults, and (2) in pediatric patients who are CYP2C19 extensive metabolizers, there was no association between genotype and the pharmacokinetics of omeprazole.",2003.0,0,0
744,12956102,Comparison of four-day and seven-day pantoprazole-based quadruple therapy as a routine treatment for Helicobacter pylori infection.,S Y de Boer; P C v d Meeberg; H Siem; W A de Boer,"H. pylori eradication is usually performed with three or four drugs for at least seven days. Recently four reports have shown a cure rate of approximately 90% using a four-day quadruple therapy. The objectives of this prospective study were: 1) to evaluate the efficacy of pantoprazole-based quadruple therapy, and 2) to compare the efficacy and tolerability of four-day with seven-day quadruple therapy. The study was performed in a single centre. The first 56 consecutive patients with nonulcer dyspepsia or peptic ulcer disease and proven H. pylori infection received seven days of quadruple therapy (pantoprazole, bismuth, tetracycline and metronidazole). At least six weeks after treatment, endoscopy was repeated with six biopsies of the antrum and corpus for histology, urease test and culture. The next 59 consecutive patients followed the same protocol but received four-day quadruple therapy. Using an intention-to-treat analysis, the cure rate in the seven-day treatment group was 54/56 (96.4%, 95% confidence interval (CI) 87.7-99.6%). In the per protocol analysis the cure rate was 53/55 (96.3%, 95% CI 87.5-99.6%). Primary metronidazole resistance was observed in seven patients. All were cured. Using an intention-to-treat analysis, the cure rate in the four-day treatment group was 51/59 (86.4%, 95% CI 75.0-94.0%). In the per protocol analysis the cure rate was 50/58 (86.2%, 95% CI 74.6-93.8%). Primary metronidazole resistance was observed in seven patients, four of whom were cured. In three out of eight patients in whom four-day treatment failed, secondary metronidazole resistance was induced. Both treatment regimens were well tolerated. The difference between cure rates of both regimens did not reach statistical significance (p=0.0585). Routine use of both four-day and seven-day pantoprazole-based quadruple anti-H. pylori treatment is effective and well tolerated. The results of both regimens reach the required eradication standard, but results with the seven-day regimen were slightly but not significantly better. Seven-day treatment may be superior, especially in case of metronidazole resistance, and should be preferred.",2003.0,0,0
745,12965978,The effect of endoscopic therapy in patients receiving omeprazole for bleeding ulcers with nonbleeding visible vessels or adherent clots: a randomized comparison.,Joseph J Y Sung; Francis K L Chan; James Y W Lau; Man-Yee Yung; Wai-Keung Leung; Justin C Y Wu; Enders K W Ng; S C Sydney Chung,"The optimal treatment of ulcers with nonbleeding visible vessels and adherent clots is unclear. To compare intravenous omeprazole infusion plus endoscopic therapy with intravenous omeprazole infusion alone for prevention of recurrent bleeding from ulcers with nonbleeding visible vessels or adherent clots. Single-blind randomized study with blinded evaluation of study end points. An endoscopy center in a university hospital in Hong Kong. 156 persons with upper gastrointestinal bleeding and ulcers showing nonbleeding visible vessels or adherent clots. Combination of endoscopic therapy and omeprazole infusion versus sham endoscopic therapy and omeprazole infusion. Recurrent ulcer bleeding before discharge and within 30 days. 78 patients were recruited in each group. Ulcer bleeding recurred before discharge in seven patients who received intravenous omeprazole alone (9%) and no patients who received combined therapy (difference, 9 percentage points [95% CI, 1.7 to 17.6 percentage points]; P = 0.01). The probability of recurrent bleeding within 30 days was 11.6% (9 patients) in the omeprazole-alone group and 1.1% (1 patient) in the combined therapy group (difference, 10.5 percentage points [CI, 1.7 to 19.8 percentage points]; P = 0.009). Patients in the combined therapy group required less transfusion (difference in median units of blood transfused, 1 unit [CI, 0 to 2 units]; P = 0.02). One patient in the combined therapy group had surgery for ulcer perforation. Four patients receiving omeprazole alone (5.1%) and two patients receiving combined therapy (2.6%) died within 30 days. The combination of endoscopic therapy and omeprazole infusion is superior to omeprazole infusion alone for preventing recurrent bleeding from ulcers with nonbleeding visible vessels and adherent clots.",2003.0,0,0
746,12966628,[As-needed treatment with gastric acid inhibitors in gastroesophageal reflux disease].,A C Poen; M H Otten,"Although proton pump inhibitors and H2-receptor antagonists are usually prescribed for continuous use by patients with gastro-oesophageal reflux disease, at least 50% of such patients do not take their medication daily and some take it only sporadically. On-demand treatment with proton pump inhibitors or H2-receptor antagonists is safe and cost-effective. Indications are: (a) incidental reflux episodes of short duration, (b) periodic reflux lasting several weeks or months, (c) chronic reflux not requiring continuous treatment. On-demand treatment is unsuitable for patients with reflux disease who either require daily medication or in whom the maximal dosage is insufficient. There are three types of on-demand treatment. Type 1: use of medication only in case of incidental symptoms. Type 2: continuous medication for 2-4 weeks when symptoms appear. Type 3: continuous use because of chronic symptoms, but the interval between doses is determined by the patient on the basis of his symptoms. All antacids can in principle be used for on-demand treatment; for type 3 treatment, antacids with a rapid onset of action are preferred. A favourable response to the two weeks of initial therapy is a good predictor for successful on-demand treatment.",2003.0,0,0
747,12967538,Omeprazole and placebo have same long-term effect on dyspepsia.,Mark Lepsch; Scott M Strayer,,2003.0,0,0
748,12969082,Direct comparative trials of the efficacy of proton pump inhibitors in the management of gastro-oesophageal reflux disease and peptic ulcer disease.,N Vakil; M B Fennerty,"Five proton pump inhibitors are now available for use in North America. Claims of differences in the clinical efficacy of different strengths and/or agents have been made. To identify any consistent evidence of differences in outcomes between agents or doses within this class of drugs. A search of the medical literature was performed in two electronic databases, and randomized controlled trials of higher quality were included in the assessment. Thirty-two trials met our criteria. No convincing data were found to indicate that low doses of proton pump inhibitors are as effective as standard doses of proton pump inhibitors in the healing of erosive oesophagitis or in the relief of symptoms of gastro-oesophageal reflux disease; however, they may be as effective as maintenance therapy for gastro-oesophageal reflux disease and peptic ulcer disease. Differences were found between the standard doses of proton pump inhibitors with regard to the onset of symptom relief in gastro-oesophageal reflux disease (lansoprazole was faster than omeprazole, and esomeprazole was faster than both lansoprazole and omeprazole) and the healing of oesophagitis (esomeprazole was superior to both omeprazole and lansoprazole). Despite these differences, there are as yet insufficient data to establish the superiority of any one agent over all others across all disease states treated with these agents.",2003.0,0,0
749,12969084,Esomeprazole administered through a nasogastric tube provides bioavailability similar to oral dosing.,M B Sostek; Y Chen; W Skammer; H Winter; J Zhao; T Andersson,"To determine if nasogastric tube administration of the enteric-coated pellets from an opened esomeprazole capsule provides bioavailability similar to oral dosing with the intact capsule. A randomized, single-centre, open-label, two-period crossover pharmacokinetic study consisting of two 5-day dosing periods separated by a 7- to 14-day washout period was conducted. Healthy subjects between the ages of 18 and 50 years received esomeprazole 40 mg once daily either orally as an intact capsule, or as a suspension of the enteric-coated pellets from an opened capsule in water through a nasogastric tube. In 47 evaluable subjects, the 90% confidence intervals were 0.87-1.08 and 0.93-1.25 for the geometric mean of the ratio of nasogastric tube administration relative to administration of the intact capsule for the area under the plasma concentration-time curve and for maximum plasma concentration, respectively, on day 1, demonstrating bioequivalence. Oral and nasogastric administration also demonstrated similar bioavailabilities on day 5. Esomeprazole was well tolerated regardless of the mode of administration. Nasogastric tube administration of the enteric-coated pellets from an opened esomeprazole 40 mg capsule provides bioavailability similar to oral dosing. Administration of the contents of an opened esomeprazole 40 mg capsule in water through a nasogastric tube is a practical alternative for patients with feeding tubes who require effective gastric acid suppression, but cannot swallow an oral preparation.",2003.0,0,0
750,12969085,Once-daily pantoprazole 40 mg and esomeprazole 40 mg have equivalent overall efficacy in relieving GERD-related symptoms.,T Scholten; G Gatz; U Hole,"To compare the efficacy of pantoprazole and esomeprazole for the treatment of gastro-oesophageal reflux disease- (GERD-) related symptoms. In this multicentre, randomized, double-blind study 217 patients [intention-to-treat (ITT) population] diagnosed with endoscopically proven GERD grade B/C received pantoprazole (40 mg once daily (o.d.), n = 112] or esomeprazole (40 mg o.d/, n = 105) for 4 weeks. Patients recorded GERD-related symptoms (daytime and night-time) using diaries (daily), and/or by telephone interviews (every third day) and completed the Gastrointestinal Symptom Rating Scale (GSRS) questionnaire. The area under the time curve (AUC) for the sum score of GERD-related symptoms (symptom load of each patient during the treatment) and the time to reach adequate relief from GERD-related symptoms were calculated. Patients reported first adequate relief from daytime GERD-related symptoms after a mean of 3.7 (pantoprazole) and 5.9 days (esomeprazole) (P = 0.034); the values for the night-time were 1.7 and 3.5 days, respectively (P = 0.012, ITT). The AUCs for the single symptoms and the sum scores were comparable. Treatment with pantoprazole resulted in significantly faster first-time relief from daytime and night-time GERD-related symptoms than esomeprazole. Pantoprazole and esomeprazole were similar with respect to reduction of load of GERD-related symptoms.",2003.0,0,0
751,12969091,Sequential treatment for Helicobacter pylori eradication in duodenal ulcer patients: improving the cost of pharmacotherapy.,C Hassan; V De Francesco; A Zullo; G Scaccianoce; D Piglionica; E Ierardi; C Panella; S Morini,"Several studies have shown that Helicobacter pylori eradication rates with standard 7-day triple therapy are unsatisfactory. A novel 10-day sequential treatment regimen recently achieved a significantly higher eradication rate. To improve the pharmacotherapeutic cost, we evaluated whether an acceptable eradication rate could be achieved in peptic ulcer patients by halving the dose of clarithromycin. In a prospective, open-label study, 152 duodenal ulcer patients with H. pylori infection, assessed by rapid urease test and histology, were enrolled. Patients were randomized to receive either a 10-day sequential treatment comprising rabeprazole 20 mg b.d. plus amoxicillin 1 g b.d. for the first 5 days, followed by rabeprazole 20 mg b.d., clarithromycin 500 mg b.d. and tinidazole 500 mg b.d. for the remaining 5 days (high-dose therapy), or a similar schedule with the clarithromycin doses halved to 250 mg b.d. (low-dose therapy). No further antisecretory drugs were offered. Four to six weeks after therapy, H. pylori eradication and ulcer healing rates were assessed by endoscopy. Similar H. pylori eradication rates were observed following high- and low-dose regimens for both per protocol (97.3% vs. 95.9%; P = N.S.) and intention-to-treat (94.7% vs. 92.2%; P = N.S.) analyses. No major side-effects were reported. At repeat endoscopy, peptic ulcer healing was observed in 93% and 93% of patients following high- and low-dose therapy, respectively. The cheaper low-dose sequential regimen may be suggested for H. pylori eradication in duodenal ulcer patients, even without continued proton pump inhibitor therapy after eradication treatment.",2003.0,0,0
752,12969092,Meta-analysis: comparative efficacy of different proton-pump inhibitors in triple therapy for Helicobacter pylori eradication.,M Vergara; M Vallve; J P Gisbert; X Calvet,"It is not known whether certain proton-pump inhibitors are more efficacious than others when used in triple therapy for Helicobacter pylori eradication. To compare the efficacy of different proton-pump inhibitors in triple therapy by performing a meta-analysis. A MEDLINE search was performed. Abstracts of the European Helicobacter pylori Study Group and the American Gastroenterological Association congresses from 1996 to 2002 were also examined. Randomized studies with at least two branches of triple therapy that differed only in terms of type of proton-pump inhibitor were included in a meta-analysis using Review Manager 4.1. Fourteen studies were included. Intention-to-treat cure rates were similar for omeprazole and lansoprazole: 74.7% vs. 76%, odds ratio (OR) 0.91 [95% confidence interval (CI) 0.69-1.21] in a total of 1085 patients; for omeprazole and rabeprazole: 77.9% vs. 81.2%, OR 0.81 (95% CI 0.58-1.15) in a total of 825 patients; for omeprazole and esomeprazole: 87.7% vs. 89%, OR 0.89 (95% CI 0.58-1.35) in 833 patients; and for lansoprazole and rabeprazole: 81% vs. 85.7%, OR 0.77 (95% CI 0.48-1.22) in 550 patients. The efficacy of various proton-pump inhibitors seems to be similar when used for H. pylori eradication in standard triple therapy.",2003.0,0,0
753,12970129,,,,,0,0
754,12970637,Double-blind placebo-controlled trial of omeprazole in irritable infants with gastroesophageal reflux.,David John Moore; Billy Siang-Kuo Tao; David Robin Lines; Craig Hirte; Margaret Lila Heddle; Geoffrey Paul Davidson,"To assess the efficacy of omeprazole in treating irritable infants with gastroesophageal reflux and/or esophagitis. Irritable infants (n=30) 3 to 12 months of age met the entry criteria of esophageal acid exposure >5% (n=22) and/or abnormal esophageal histology (n=15). They completed a 4-week, randomized, double-blind, placebo-controlled crossover trial of omeprazole. Cry/fuss diary (minutes/24 hours) and a visual analogue scale of infant irritability as judged by parental impression were obtained at baseline and the end of each 2-week treatment period. The reflux index fell significantly during omeprazole treatment compared with placebo (-8.9%+/-5.6%, -1.9%+/-2.0%, P<.001). Cry/fuss time decreased from baseline (267+/-119), regardless of treatment sequence (period 1, 203+/-99, P<.04; period 2, 188+/-121, P<.008). Visual analogue score decreased from baseline to period 2 (6.8+/-1.6, 4.8+/-2.9, P=.008). There was no significant difference for both outcome measures while taking either omeprazole or placebo. Compared with placebo, omeprazole significantly reduced esophageal acid exposure but not irritability. Irritability improved with time, regardless of treatment.",2003.0,0,0
755,12973372,Pantoprazole: a new proton pump inhibitor in the management of upper gastrointestinal disease.,K D Bardhan,"Pantoprazole, the third proton pump inhibitor (PPI) to become available, has been extensively investigated. Pantoprazole inhibits acid more powerfully than histamine H(2) receptor antagonists (H(2)RAs) and omperazole 20 mg and raises median 24-h gastric pH from about 1.5 to 3-4 in healthy volunteers and in duodenal ulcer patients to above 5. Results from studies have confirmed that pantoprazole is superior to H(2)RAs in speed of healing and symptom relief in patients with peptic ulcer. In patients with duodenal ulcer pantoprazole was as effective as omperazole 20 mg and in patients with gastric ulcer pantoprazole was statistically superior to omeprazole 20 mg after 4 weeks. In triple combination therapy of peptic ulcer disease, the mean eradication rate of Helicobacter pylori in data pooled from 32 pantoprazole-based studies was 86% and compliance with treatment was about 90%. Results pooled from 5 large clinical trials of gastroesophageal reflux disease showed healing rates significantly superior to those achieved with H(2)RAs and similar to those of other PPIs at 4 and 8 weeks. Symptom relief was more rapid with pantoprazole and maintenance treatment kept the majority of patients in remission; relapse rates at 1 year were 25-28% on 20 mg daily and 6-22% on 40 mg daily. Maintenance treatment with pantoprazole 40 mg has been shown to keep most patients with aggressive or refractory ulcer and reflux disease in remission for up to 3 years. Pantoprazole was also effective in the management of patients with Zollinger-Ellison syndrome. In volunteers given aspirin, pantoprazole 40 mg proved significantly superior to ranitidine and placebo in preventing the development of mucosal damage and was significantly better than placebo in preventing gastric ulcer and duodenal ulcer in arthritic patients on nonsteroidal antiinflammatory drugs. Clinical trials, postmarketing surveillance and long-term studies have confirmed that pantoprazole is effective and safe for the short- and long-term management of peptic ulcer and reflux disease, with side effects similar in incidence and type to those of H(2)RAs.",2003.0,0,0
756,1345192,"Mechanisms of NSAID-induced ulcerogenesis: structural properties of drugs, focus on the microvascular factors, and novel approaches for gastro-intestinal protection.",K D Rainsford,"The multifactorial ulcer-producing actions of non-steroidal anti-inflammatory drugs (NSAIDs) are briefly reviewed and the main actions highlighted as the focus for potential strategies for reducing the ulcerogenic effects of these drugs. While some clinical benefits are evident from long-term clinical studies from application of PG analogues (misoprostol) and H+/K(+)-ATP-ase inhibitors (omeprazole) these are, ultimately, expensive approaches. Chemical structural properties of the NSAIDs underlying differences in their ulcerogenicity are analyzed with the objective of establishing the reasons for the low ulcerogenicity of some of these drugs (e.g. azapropazone). These studies serve as a basis for developing less gastrotoxic drugs in the future. In the studies we have undertaken analysis of the benefits of micronutrients and of modulating eicosanoid metabolism have been considered. The results of some clinical trials with micronutrients have proven encouraging. These and other approaches and pitfalls reported give further encouragement to explore the mechanisms of the protective effects of these latter agents and serve as a basis for future developments.",1992.0,0,0
757,14499765,Therapy for gastroesophageal reflux disease: more is not necessarily better.,David C Metz,,2003.0,0,0
758,14499767,"Endoscopic implantation of enteryx for treatment of GERD: 12-month results of a prospective, multicenter trial.",David A Johnson; Robert Ganz; James Aisenberg; Lawrence B Cohen; Jacques Devière; T Raymond Foley; Gregory B Haber; Jeffrey H Peters; Glen A Lehman,"This study aimed to assess the efficacy and safety of endoscopically implanting a nonresorbable biocompatible polymer (Enteryx) in the distal esophagus and proximal gastric cardia for the treatment of gastroesophageal reflux disease (GERD). In a prospective, multicenter, international trial, 85 well-controlled GERD patients who were receiving chronic proton pump inhibitor (PPI) therapy underwent Enteryx implantation under fluoroscopic visualization, without general anesthesia. After the procedure, patients were discharged within approximately 2-4 h. Patients were judged to be treatment responders if after implantation they reduced PPI dosage by >/=50%. Follow-up evaluations were conducted at 1, 3, 6, and 12 months and included medication usage, symptoms, quality of life, endoscopy, pH monitoring, manometry, and documentation of adverse events. At 12 months, 80.3% (95% CI = 69.9%-88.3%) of 81 evaluable patients were treatment responders. Of the responders, 87.7% completely discontinued PPIs, and 12.3% reduced PPI dosage by >/=50%. Treatment response was more likely in patients with residual implant volume of >/=5 mL (p = 0.027). Other patient and treatment variables were not predictive. Both GERD heartburn and regurgitation symptom scores significantly improved at 12 months compared with baseline (p < 0.001). There were significant reductions in median supine, upright, and total percent time of esophageal exposure to pH <4. Endoscopically assessed esophagitis grades were unchanged. No serious adverse events were encountered. Transient retrosternal chest pain was experienced by 91.8% of patients. This pain was seldom severe and was typically successfully managed with prescription pain medication. Enteryx implantation allows most patients to discontinue PPI therapy, improves their symptoms, and reduces esophageal acid exposure. The effects of implantation are long-lasting, and morbidity is transient and minimal. The procedure requires basic endoscopic skills and seems to provide a useful option in the effective clinical management of GERD.",2003.0,0,0
759,14499769,Step-down from multiple- to single-dose proton pump inhibitors (PPIs): a prospective study of patients with heartburn or acid regurgitation completely relieved with PPIs.,John M Inadomi; Lisa McIntyre; Latoya Bernard; A Mark Fendrick,"Management costs for gastroesophageal reflux disease are high because of the expensive medications used for maintenance therapy. Previous studies have illustrated the success of step-down from proton pump inhibitors (PPIs) to less-expensive therapy once symptoms have abated. This study was conducted to determine whether patients requiring greater than single-dose PPI for initial symptom resolution could be stepped-down to single-dose PPI and whether this intervention decreased costs or adversely affected quality of life. Consecutive patients in whom greater than single-dose PPI had completely alleviated reflux-type symptoms (heartburn or acid regurgitation) were recruited through the use of pharmacy records of PPI prescriptions. Eligible subjects completed baseline demographic information and quality-of-life surveys and were stepped-down to single-dose PPI (lansoprazole 30 mg or omeprazole 20 mg daily). Follow-up continued for 6 months or until subjects reported recurrence of reflux-type symptoms, at which point PPIs were reinstituted at the dose that had originally alleviated the subjects' symptoms. The primary outcome was the proportion of subjects in whom step-down was successful, defined as no recurrence of reflux-type symptoms on single-dose PPI. A total of 117 subjects enrolled in the study; all were followed to the primary endpoint. 79.5% did not report recurrent symptoms of heartburn or acid regurgitation during the 6 months after step-down to single-dose PPI. Logistic regression revealed that longer duration of PPI use before study enrollment was associated with greater likelihood of symptom recurrence with step-down. Although quality of life was not significantly altered, dyspepsia (excluding reflux-type symptoms) increased. Overall costs of management were reduced. The majority of patients rendered asymptomatic on greater than single-dose PPI might be subsequently stepped-down to single-dose therapy without recurrence of reflux-type symptoms. This intervention can decrease management costs without adversely affecting quality of life.",2003.0,0,1
760,14502118,"Endoscopic therapy for GERD--baking, sewing, or stuffing: an evidence-based perspective.",David A Johnson,"The concept of using endoscopic therapy for the treatment of symptomatic gastroesophageal reflux disease (GERD) is a relatively recent development. Currently, three basic techniques are approved for use in the United States. To date, clinical trials have examined either a thermal approach, endoscopic suturing, or injection intervention in the area of the lower esophageal sphincter. However, the trials for each type of endoscopically directed therapy have varied in methodologic design and data analysis. It is important to recognize these differences when attempting to compare the efficacy and outcomes for each endoscopic therapy. Additionally, the risk/benefit profile must be carefully evaluated for each of these interventions before considering it a viable treatment strategy.",2003.0,0,0
761,14529149,Current consensus on the diagnosis and treatment of H. pylori-associated gastroduodenal disease.,Hidekazu Suzuki; Tatsuhiro Masaoka; Sachiko Nomura; Yoshinori Hoshino; Kumiko Kurabayashi; Yuriko Minegishi; Masayuki Suzuki; Hiromasa Ishii,"Helicobacter pylori (H. pylori) is a spiral shaped bacterium that resides in the stomach mucosa. Isolation of H. pylori from the stomach mucosa changed the erstwhile widely held belief that the stomach contains no bacteria and is actually sterile. Once H. pylori is safely ensconced in the mucus, it is able to neutralize the acid in the stomach by elaborating an enzyme called urease. Urease converts urea, of which there is an abundant supply in the stomach (derived from saliva and the gastric juice), into bicarbonate and ammonia, which are strong bases. These bases form a cloud of acid-neutralizing chemicals in the vicinity of the organisms, protecting them from the acid in the stomach. This urea hydrolysis reaction is utilized for the diagnosis of H. pylori infection in the urea breath test (UBT) and the rapid urease test (RUT). In Japan, both invasive tests, such as bacterial culture, histopathology and RUT, and non-invasive tests such as UBT and serology are conducted for the diagnosis of H. pylori infection. For confirming the results of eradication therapy, UBT is considered to be the most sensitive and specific. In order to treat H. pylori infection, a new one-week triple therapy regimen (lansoprazole or omeprazole + amoxicillin + clarithromycin) has been approved for use in patients with peptic ulcer disease in Japan. As for H. pylori eradication in the case of other diseases in which the bacterium has been implicated (e.g., chronic atrophic gastritis, gastric MALT lymphoma, gastric cancer, non-ulcer dyspepsia, chronic urticaria, idiopathic thrombocytopenic purpura (ITP)), further basic and clinical investigation is required.",2003.0,0,0
762,14532918,"[Omeprazole, amoxicillin and clarithromycin in the treatment of helicobacterpylori, in 7 and 10-day regimens].",Wilson Rodríguez; Arturo Pareja Cruz; Luis Yushimito; Alberto Ramírez Ramos; Robert H Gilman; José Watanabe Yamamoto; Carlos Rodríguez Ulloa; Daniel Mendoza Requena; José Guerra Valencia; Julio Leey Casella; Erick Chinga Alayo; Billie Velapatiño; Teresa Valencia,"The most accepted treatment for infection by Helicobacter pylori is the proton pump inhibitor based therapy with two antibiotics. However, there is no consensus regarding the duration. The purpose here was to compare eradication percentages in the omeprazole+amoxicillin+clarithromycin regimen administered during 7 days versus 10 days and confront the results with a previous 14-day* experience in Peru. Patients from the Central Military Hospital and Peruvian-Japanese Hospital evidencing chronic upper gastrointestinal tract symptoms were recruited. We excluded patients with peptic ulcer. Biopsies were taken for diagnosis, for urease and PCR tests, culture and coloring with silver. Omeprazole+clarithromycin+amoxicillin was used during 7 days versus 10 days. Control endoscopy was performed one month after treatment had been completed and molecular biology techniques were used to differentiate recurrences from new infections. Susceptibility to clarithromycin was assessed. 36 patients were included in each group. Eradication was the same in both groups: 86.1% (31/36). In several patients in whom the bacteria persisted, the same initial nucleus was found. In a previous study* using this same regimen during 14 days, a 93% eradication was obtained. 91.18% of our samples were susceptible to clarithromycin. In Peru, the omeprazole+clarithromycin+amoxicillin combination gives results higher than 80% in the eradication of infection by Helicobacter pylori. The 7 and 10 days regimens eradicated the bacteria in 86% of our patients.",2003.0,0,0
763,14561022,Overuse of acid suppressive therapy in hospitalised patients with pulmonary diseases.,A Niklasson; A Bajor; L Bergendal; M Simrén; H Strid; E Björnsson,"Overuse of acid suppressive therapy (AST) has been reported in hospitalised patients, but the use in specific patient categories is unexplored. We assessed the use of and indication for AST and upper endoscopic investigations in hospitalised patients on a pulmonary ward compared with patients on other wards. 301 patients were enrolled in the study. 162 were hospitalised on a pulmonary ward with a control group consisting of 139 from both a surgical and general internal medicine ward. Adequate indications for AST were those strongly supported by medical literature. Among the 301 patients enrolled, 132 (44%) used AST. 78 (59%) had no adequate indication for AST. On the pulmonary ward 79 (49%) patients used AST, compared to only 10 (20%) on the internal medicine ward (P < 0.05). On the pulmonary ward 68% of the patients had no adequate indication for AST, which was more common than inappropriate use of ASTon the control wards (P < 0.05). The most common inadequate indication for AST was peptic ulcer prophylaxis during corticoidsteroid therapy. In hospitalised patients a significant overuse of AST was observed, particularly among pulmonary patients. More adequate use of AST can contribute to substantial savings for the health-care system.",2003.0,0,0
764,14562363,Gastroesophageal reflux disease at the turn of millennium.,Lee-Guan Lim; Khek-Yu Ho,"Gastroesophageal reflux disease (GERD) has been an area of active research in the Asia-Pacific region in the recent years. This article outlines some of the interesting research findings. It comprises three parts. The first part dealt with recent data on the changing epidemiology of GERD in Asia. The second part summarized published studies on the relationship between GERD and Helicobacter pylori, relevant to the Asia-Pacific region. The last part discussed some of the recent advances in the treatment of GERD.",2003.0,0,0
765,14572558,Belching: dyspepsia or gastroesophageal reflux disease?,Mona Lin; George Triadafilopoulos,"Eructation (belching) is a common symptom seen in clinical practice. Because either belching or heartburn may result from transient lower esophageal sphincter relaxations, it has been proposed that belching may be a manifestation of gastroesophageal reflux disease (GERD). In this retrospective study we evaluated the prevalence of belching in dyspepsia and GERD and the relation of belching to acid reflux events documented by pH monitoring. We examined the prevalence, frequency, and severity of belching and other GERD symptoms by use of standardized questionnaires in 180 GERD patients (group A) and 78 dyspeptic controls (group B) referred for evaluation at our institution. GERD was defined as either endoscopic esophagitis (or Barrett's esophagus) or positive DeMeester score (>14.2) on pH monitoring or both. Dyspeptic patients had normal endoscopy and pH studies. We also analyzed the relationship of belching to acid reflux events during the 24-h period of pH studies. Of 180 GERD patients, 132 (70%) reported belching during pH monitoring, versus 63 of 78 dyspeptic patients (80%) (p = ns). Similarly, 163 of 180 GERD patients (90%) reported heartburn versus 64 of 78 of dyspeptic patients (82%) (p = ns). Review of symptom questionnaires revealed no significant difference in belching severity between groups. However, heartburn and acid regurgitation were significantly more severe among GERD patients. There was a significantly higher correlation of both heartburn and belching with acid events in patients with GERD compared with patients with dyspepsia. In addition, although both belching and heartburn were significantly improved in patients with GERD, belching scores remained unchanged after proton pump inhibitor (PPI) therapy in patients with dyspepsia. Belching is as common and as severe in patients with dyspepsia as it is in patients with GERD. Belching and heartburn in GERD patients are more likely correlated with episodes of pathological acid reflux. Because belching cannot be clinically used as a discriminatory symptom, ambulatory pH monitoring should be considered to elucidate the relationship of belching to acid reflux in patients with dyspepsia or GERD.",2003.0,0,0
766,14572560,Eradication of Helicobacter pylori improves the healing rate and reduces the relapse rate of nonbleeding ulcers in patients with bleeding peptic ulcer.,Perttu E T Arkkila; Kari Seppälä; Timo U Kosunen; Reijo Haapiainen; Eero Kivilaakso; Pentti Sipponen; Judit Mäkinen; Hannu Nuutinen; Hilpi Rautelin; Martti A Färkkilä,"A causal relationship between Helicobacter pylori (H. pylori) and peptic ulcer complications remains obscure. The aim of this study was to determine the importance of H. pylori and other risk factors for healing rate, ulcer recurrence, and rebleeding in patients with bleeding peptic ulcer. A total of 223 patients with H. pylori positive bleeding peptic ulcer were randomly allocated to three treatment groups: 1) quadruple therapy (QT) (88 patients); 2) dual therapy (DT) (88 patients); and 3) omeprazole and placebo therapy (OPl) (47 patients). Endoscopic assessment was performed initially and at 8 and 52 wk. Ulcer healing and eradication rates were assessed; endpoints were ulcer relapse and ulcer rebleeding during 52 wk. Results after 8 and 52 wk were available for 211 and 179 patients, respectively. Eradication rate was 100% (95% CI = 96-100%) in the QT, 84% (95% CI = 74-91%) in the DT, and 4% (95% CI = 1-15%) in the OPl group. Ulcer healing rate was 95% (95% CI = 91-98%) in H. pylori negative and 8% (95% CI = 70-91%) in H. pylori positive patients. Ulcer relapses occurred in 2% (95% CI = 0.5-6%) of H. pylori negative and in 38% (95% CI = 24-54%) of H. pylori positive patients, and rebleeding occurred in five patients (three H. pylori positive and two negative). Eradication of H. pylori infection enhances healing of bleeding peptic ulcers after endoscopic therapy. H. pylori infection is an important independent risk factor for relapsing of nonbleeding ulcers in patients with bleeding peptic ulcer.",2003.0,0,0
767,14572567,,,,,0,0
768,14603076,An overview of proton pump inhibitors.,Gabriella Der,"Proton pump inhibitors are the standard of treatment for acid-related disorders. These disorders include gastroesophageal reflux disease and its complications (i.e., erosive esophagitis and Barrett's esophagus), peptic ulcer disease, Zollinger-Ellison syndrome, and idiopathic hypersecretion. Proton pump inhibitors are also successfully used for the treatment of Helicobacter pylori infection and upper gastrointestinal bleeding. There are currently five proton pump inhibitors approved by the Food and Drug Administration and available in the United States. These are omeprazole (Prilosec), lansoprazole (Prevacid), rabeprazole (Aciphex), pantoprazole (Protonix), and esomeprazole (Nexium). This review discusses the history of proton pump inhibitors and compares and evaluates the pharmacology including mechanism of action, pharmacokinetics, pharmacodynamics, administration, dosage, and drug interactions. Information regarding therapeutic indications, clinical efficacy, short- and long-term side effects, and cost is also presented. A case presentation offers an analysis of the use of proton pump inhibitors in individualized patient care.",2003.0,0,0
769,14603078,Gastroesophageal reflux disease: clinical manifestations.,Jennifer L Williams,"Gastroesophageal reflux disease (GERD) is generally a lifelong illness that affects many people, but its significance is often underestimated. Chronic abnormal gastric reflux results in erosive esophagitis in up to 60% of patients with GERD. Esophageal stricture, Barrett's esophagus, and esophageal adenocarcinoma are the most serious complications of GERD. Although heartburn and acid regurgitation are the most common complaints, extraesophageal symptoms such as noncardiac chest pain, laryngitis, coughing, and wheezing can be manifestations of GERD. Unfortunately, the severity of symptoms is not a reliable indicator of the severity of erosive esophagitis. Endoscopy is the preferred method to diagnose and grade erosive esophagitis, and various classification systems are used to grade disease severity. The Los Angeles Classification is a valid and widely accepted system to evaluate the severity of erosive esophagitis. The immediate goals of treatment are to provide effective symptomatic relief and to achieve healing in patients with esophageal damage. The treatment regimen often begins by prescribing a therapy to reduce gastric acid secretion. A proton pump inhibitor is the preferred agent for many patients. Because GERD is a chronic, relapsing disease, long-term maintenance therapy is usually necessary to relieve symptoms, prevent complications, and improve the quality of life in patients with GERD.",2003.0,0,0
770,14603582,Gastroprotection by coxibs: what do the Celecoxib Long-Term Arthritis Safety Study and the Vioxx Gastrointestinal Outcomes Research Trial tell us?,Jaime A Oviedo; M Michael Wolfe,Current evidence suggests that PPIs might be effective in maintaining patients in remission during continued NSAID use and that the combination of omeprazole plus diclofenac is as effective as treatment with celecoxib in preventing recurrent bleeding. Larger outcome studies comparing the combination of a PPI with other nonselective NSAIDs and a selective COX-2 inhibitor (and the combination of a selective COX-2 inhibitor with a PPI or misoprostol) are required to determine whether or not any regimen will further decrease or eliminate the risk of ulcer complications in high-risk individuals.,2003.0,0,0
771,14606102,Effect of a single oral dose of rabeprazole on nocturnal acid breakthrough and nocturnal alkaline amplitude.,Jin-Yan Luo; Chun-Yan Niu; Xue-Qin Wang; You-Ling Zhu; Jun Gong,"To study the effect of rabeprazole (RAB) on nocturnal acid breakthrough (NAB) and nocturnal alkaline amplitude (NAKA) and to compare it with omeprazole (OME) and pantoprazole (PAN). By an open comparative study, forty patients with active peptic ulcer were randomly assigned to receive one of the three PPIs (proton pump inhibitor) with a single oral dose. They were divided into RAB group (10 mg), OME group (20 mg) and PAN group (40 mg). Twenty healthy volunteers were enrolled to the control group (without taking any drug). Intragastric pH monitoring was then performed 1 hour before and 24 hours after the dose was given. No clinically undesirable signs and symptoms possibly attributed to the administration of RAB or OME and PAN were recognizable throughout the study period. All subjects completed the study according to the protocol. All data were processed by a computer using the Student t test or t' test followed by an analysis of covariance. P<0.05 was considered to have statistical significance. The intragastric pH of NAB was significantly higher in RAB group (1.84+/-0.55) than in either OME group (1.15+/-0.31) or PAN group (1.10+/-0.30) (both P<0.01). RAB produced a longer sustaining time (4.65+/-1.22 h) on NAKA than OME (3.22+/-1.89 h) (P<0.05), PAN (3.15+/-1.92 h) (P<0.05), and the sustaining time of NAKA in RAB group was longer than that in the healthy control group (P<0.01) too. In addition, RAB produced a much higher pH on NAKA (6.41+/-0.45) in comparison with PAN (6.01+/-0.92) (P<0.05). A single oral dose of 10 mg RAB may increase the pH of NAB and shorten the sustaining time of NAB, and it may increase the pH of NAKA as well as prolong the sustaining time of NAKA.",2003.0,0,0
772,14613451,,,,,0,0
773,14615670,Extraesophageal manifestations of GERD.,John Napierkowski; Roy K H Wong,"The association between gastroesophageal reflux disease (GERD) and extraesophageal disease is often referred to as extraesophageal reflux (EER). This article reviews EER, discussing epidemiology, pathogenesis, diagnosis, and treatment with a focus on the most studied and convincing EER disorders-asthma, cough, and laryngitis. Although EER comprises a heterogeneous group of disorders, some general characterizations can be made, as follows. First, although GERD's association with extraesophageal diseases is well-established, definitive evidence of causation has been more elusive, rendering epidemiological data scarce. Secondly, regarding the pathogenesis of EER, 2 basic models have been proposed: direct injury to extraesophageal tissue by acid and pepsin exposure or injury mediated through an esophageal reflex mechanism. Third, because heartburn and regurgitation are often absent in patients with EER, GERD may not be suspected. Even when GERD is suspected, the diagnosis may be difficult to confirm. Although endoscopy and barium esophagram remain important tools for detecting esophageal complications, they may fail to establish the presence of GERD. Even when GERD is diagnosed by endoscopy or barium esophagram, causation between GERD and extraesophageal symptoms cannot be determined. Esophageal pH is the most sensitive tool for detecting GERD, and it plays an important role in EER. However, even pH testing cannot establish GERD's causative relationship to extraesophageal symptoms. In this regard, effective treatment of GERD resulting in significant improvement or remission of the extraesophageal symptoms provides the best evidence for GERD's pathogenic role. Finally, EER generally requires more prolonged and aggressive antisecretory therapy than typical GERD requires.",2003.0,0,0
774,14615672,Management of gastroesophageal reflux disease.,Radu Tutuian; Donald O Castell,"Gastroesophageal reflux disease (GERD) is a chronic condition requiring long-term treatment. Simple lifestyle modifications are the first methods employed by patients and, because of their low cost and simplicity, should be continued even when more potent therapies are initiated. Potent acid-suppressive therapy is currently the most important and successful medical therapy. Whereas healing of the esophageal mucosa is achieved with a single dose of any proton pump inhibitor (PPI) in more than 80% of cases, symptoms are more difficult to control. Patients with persistent symptoms on therapy should be tested (preferably with combined multichannel intraluminal impedance and pH) for association of symptoms with acid, nonacid, or no GER. Long-term follow-up studies indicate that PPIs are efficacious, tolerable, and safe medication. So far, promotility agents have shown limited efficacy, and their side-effect profile outweighs their benefits. Antireflux surgery in carefully selected patients (ie, young, typical GERD symptoms, abnormal pH study, and good response to PPI) is as effective as PPI therapy and should be offered to these patients as an alternative to medication. Still, patients should be informed about the risks of antireflux surgery (ie, risk of postoperative dysphagia; decreased ability to belch, possibly leading to bloating; increased flatulence). Endoscopic antireflux procedures are recommended only in selected patients and given the relative short experience with these techniques, patients treated with endoscopic procedures should be enrolled in a rigorous follow-up program.",2003.0,0,0
775,7497561,A comparison of intravenous ranitidine and omeprazole on gastric volume and pH in women undergoing emergency caesarean section.,A Tripathi; M Somwanshi; B Singh; P Bajaj,"We have compared the effect of intravenously administered omeprazole and ranitidine on gastric contents in a double-blind study in 80 consecutive women undergoing emergency Caesarean section. When the decision to perform emergency Caesarean section was made, patients were randomly assigned to receive either ranitidine 50 mg or omeprazole 40 mg intravenously. The volume and pH of the gastric contents were measured immediately after tracheal intubation and again before extubation. The gastric pH was found to be higher after omeprazole than after ranitidine immediately after intubation (5.89 +/- 1.46 and 5.21 +/- 1.36 respectively) (P < 0.05) and before extubation (5.97 +/- 1.38 and 5.32 +/- 1.24 respectively) (P < 0.05). However, the gastric volumes were comparable in both the groups. The number of patients with gastric volume > 25 ml and pH < 2.5 were 3 (7.5%) in the ranitidine group and 1 (2.5%) in the omeprazole group after intubation and none in either of the groups before extubation. We conclude that omeprazole 40 mg iv administered at the time of the decision to operate, results in higher gastric pH than ranitidine in obstetric patients undergoing emergency Caesarean section.",1995.0,0,0
776,7502551,Omeprazole/amoxicillin versus triple therapy for Helicobacter pylori in duodenal ulcer disease: two-year follow-up of a prospective randomized study.,J Labenz; M Stolte; U Peitz; B Tillenburg; H Köhl; T Becker; G Börsch,"The present study was designed to compare the efficacy and tolerability of triple therapy and dual therapy for Helicobacter pylori in duodenal ulcer patients and to evaluate the long-term clinical course of ulcer disease. Forty duodenal ulcer patients with proven H. pylori infection were enrolled into the study and randomly treated with either triple therapy consisting of bismuth subsalicylate, metronidazole and tetracycline plus ranitidine or with dual therapy comprising omeprazole and amoxicillin. Patients were investigated clinically and endoscopically including assessment of H. pylori infection by means or rapid urease test, culture, histology and urea breath testing 4 weeks after cessation of eradication therapy, in 1-year intervals and when dyspeptic symptoms recurred. One patient of each group was lost during follow-up. H. pylori infection was cured by triple therapy in 84.2% and by dual therapy in 78.9% (p = 1.00). During follow-up, all patients with cure of H. pylori infection (n = 31) remained in stable remission with respect to duodenal ulcer disease, while 6 out of 7 patients persistently infected with H. pylori developed an ulcer relapse (p < 0.001). One patient with cured infection had had an episode of dyspeptic symptoms requiring pharmacotherapy and in another 3 patients mild refluxesophagitis without necessity of medical treatment had been detected on the occasion of a scheduled endoscopy. In the short-term, cure of the infection resulted in a marked reduction of the degree of antral gastritis and in a loss of activity in all but one patient.(ABSTRACT TRUNCATED AT 250 WORDS)",1995.0,0,0
777,7519630,Use of PCR with feces for detection of Helicobacter pylori infections in patients.,A A van Zwet; J C Thijs; A M Kooistra-Smid; J Schirm; J A Snijder,"PCR was performed for the detection of Helicobacter pylori in feces from 24 patients with proven infections. Several precautions were taken to overcome possible inhibition of PCR with feces. In the first 12 patients, feces were examined shortly after endoscopy. In another group of 12 patients, who were treated during 2 weeks with omeprazole (40 mg each day) to increase gastric pH, feces were examined as well. H. pylori target DNA could not be detected in the stools of any of the 24 infected patients. It was concluded that there was no substantial shedding of H. pylori in feces from either group of patients.",1994.0,0,0
778,7527761,"Lansoprazole. A reappraisal of its pharmacodynamic and pharmacokinetic properties, and its therapeutic efficacy in acid-related disorders.",C M Spencer; D Faulds,"Lansoprazole is a benzimidazole derivative that effectively decreases gastric acid secretion, regardless of the primary stimulus, via inhibition of gastric H+,K(+)-adenosine triphosphatase (ATPase). It provides effective symptom relief and healing of peptic ulcer and reflux oesophagitis after 4 to 8 weeks of therapy and appears to prevent recurrence of lesions when administered as maintenance therapy. When administered at therapeutic dosages, lansoprazole produced higher healing rates than ranitidine or famotidine in patients with duodenal and gastric ulcers. Lansoprazole heals duodenal ulcers more rapidly than ranitidine or famotidine. Relief of ulcer symptoms in lansoprazole recipients is at least equivalent to, and tends to be more rapid than, that in patients receiving histamine H2-receptor antagonists. In comparisons with omeprazole 20 mg/day, lansoprazole 30 mg/day produced duodenal ulcer healing more rapidly and reduced ulcer pain to a greater extent at 2 weeks, but overall healing rates were similar after 4 weeks of therapy. At therapeutic dosages, lansoprazole produces superior healing and symptom relief of reflux oesophagitis in comparison with ranitidine, and it tends to relieve heartburn more effectively than omeprazole, although both agents produce equivalent healing. Healing of peptic ulcers or reflux oesophagitis refractory to histamine H2-receptor antagonists occurs after 8 weeks in the majority of patients treated with lansoprazole, and lansoprazole and omeprazole demonstrate similar efficacy in patients with refractory peptic ulcers. In patients with Zollinger-Ellison syndrome, lansoprazole effectively controls mean basal gastric acid output. Lansoprazole is generally well tolerated in clinical trials. The incidence of adverse effects is similar to that of omeprazole, ranitidine and famotidine in comparative studies. Combination therapy with lansoprazole and antibacterial agents such as amoxicillin, tinidazole, roxithromycin and/or metronidazole appears to eradicate Helicobacter pylori in 22 to 80% of patients with this organism. Limited data also suggest that lansoprazole may have superior activity against H. pylori in comparison with omeprazole, although the clinical relevance of this preliminary finding requires further confirmation. Thus, lansoprazole may be considered as alternative to existing antisecretory agents available for the treatment of acid-related disorders, particularly because it may provide more rapid healing and relief of symptoms.",1994.0,0,0
779,7552644,Critical issues in the management of gastroesophageal reflux disease.,J W Freston; J R Malagelada; H Petersen; R F McCloy,"To discuss some of the critical issues in the management of gastroesophageal reflux disease (GERD). GERD is a chronic relapsing disease characterized by pathological exposure of the distal esophagus to gastric acid. Diagnosis of the condition can often be made on the basis of symptomatology alone. Endoscopy can help in assessing the degree of esophageal damage, influencing the choice of therapy, and should be performed at least once during a symptomatic patient's lifetime to exclude a diagnosis of Barrett's esophagus. However, endoscopy is mandatory at diagnosis if alarm symptoms are present. Treatment should aim to provide the lowest degree of acid suppression needed for the control of symptoms. Proton pump inhibitors (PPIs) represent the most cost-effective treatment option for the short- and long-term management of GERD. Compared with standard- and high-dose H2-receptor antagonists, PPIs result in superior and faster healing and symptom relief across all grades of esophagitis and are more effective at maintaining patients in symptomatic and endoscopic remission. Treatment with PPIs has also been shown to reduce the rate of recurrent stricture after initial dilatation. PPIs are generally well tolerated, and to date there have been no reports of gastric dysplasia resulting from their long-term use. Anti-reflux surgery should be reserved for patients who are unresponsive to continuous PPI therapy or perhaps for young patients. It will be several years before the impact of laparoscopic fundoplication as a cost-beneficial therapy for GERD can be assessed. The superior clinical efficacy of PPIs when compared with any other drug regimen for GERD make them the treatment of choice for the short- and long-term management of this troublesome condition.",1995.0,0,0
780,7555936,Omeprazole versus ranitidine as adjunct therapy to endoscopic injection in actively bleeding ulcers: a prospective and randomized study.,C Villanueva; J Balanzó; X Torras; S Sáinz; G Soriano; D González; F Vilardell,"Although high rates of initial hemostasis can be achieved with endoscopic injection therapy in actively bleeding ulcers, the incidence of rebleeding is not negligible. Optimal conditions for clotting may require achieving deep and sustained acid inhibition to avoid the deleterious effect of acid and pepsin secretions on the hemostatic process. The aim of this study was to assess whether omeprazole could improve the efficacy of ranitidine as an adjunct treatment in endoscopic injection therapy to avoid rebleeding. Eighty-six patients with active arterial bleeding from a peptic ulcer disclosed at emergency endoscopy were included in this prospective trial. All patients received injections of 1:10,000 adrenaline. Subsequently, they were randomized to receive either intravenous omeprazole (n = 45), with an initial dose of 80 mg followed by 40 mg every eight hours for four days and thereafter with oral administration; or ranitidine (n = 41), 50 mg every six hours for 12 to 24 hours and thereafter with oral administration. The two groups were well matched in terms of clinical and endoscopic data. There were no statistically significant differences between the groups with regard to: further bleeding (29% in both groups), need for emergency surgery (20% in the omeprazole group vs. 22% in the ranitidine group), transfusion requirements (2.4 +/- 2.2 vs. 2.2 +/- 2.1 units), length of hospital stay (14.1 +/- 13.9 vs. 15.3 +/- 15.4 days), or mortality (7% vs. 2%). Our results suggest that omeprazole does not improve the efficacy of ranitidine after endoscopic injection therapy in patients with an active arterial bleeding ulcer.",1995.0,0,0
781,7555939,What should be done when initial endoscopic therapy for bleeding peptic ulcer fails?,P Swain,,1995.0,0,0
782,7560828,The effect of the Gulf War on upper-gastrointestinal bleeding.,R Ganam; A Sternberg; D Koskas; Y Wagner; Z Fireman,"Upper-gastrointestinal bleeding may be related to tension or fear, which are commonly aggravating factors in digestive diseases. A survey was made of patients living in and around Hadera (located in Israel's central coastal region) during the Gulf War (January 18 through February 28, 1991) who suffered from upper-gastrointestinal bleeding; they were compared with patients seen during 1990 and 1992-1993 at the same time of the year. We found no appreciable difference in the rate of upper-gastrointestinal bleeding during the analogous periods covered in the survey.",1995.0,0,0
783,7563582,Lansoprazole--a new proton pump inhibitor.,W Ahmed; A Ali; H Qureshi; S J Zuberi; Z U Shamsi,,1995.0,0,0
784,7564870,[Treatment of acute peptic gastroduodenal ulcer: omeprazole is superior to ranitidine especially in the early phase of ulcer healing. A prospective controlled randomized serial endoscopy study].,J Hotz; W Kark; K Plein; F Wiedbrauck; A Guthke; O Otten,"Omeprazole (OM) has been shown to be superior to H2-Blockers in terms of complete healing rates of gastric (GU) and duodenal ulcers (DU). We investigated in more detail the kinetics of ulcer healing under OM (20 mg mane) compared with ranitidine (RAN 300 mg nocte) in GU (n = 28) and DU (n = 27) by multiple series endoscopy. After endoscopic diagnosis (day 0) patients were allocated to either OM or RAN in a random order. Endoscopic controls were undertaken at day (d) 3, 7, 14, 21, 28, 42 up to complete ulcer healing. The seize of ulcer areas was assessed by independent endocopists estimating the longest and shortest diameter D acc. to the formula A = pi x D1 x D2:4. In GU and DU cumulating healing rates were sign, higher under OM. In GU and DU, the most striking differences in the absolute and percentual reduction of ulcer seize in favour of OM vs RAN were observed mainly during the first week. At d3 under OM the reduction in DU-area was 43% and at d7 75% compared to a distinctly lower rate under RAN with the corresponding figures of 9% and 61% resp. In GU the mean reduction in area was for IM at d3 41%, at d7 82% in contrast to RAN at d3 of 34% and d7 of 49%. The faster healing during the first week was accompanied by sign more rapid reduction in day-and-night-painscore during OM vs RAN.(ABSTRACT TRUNCATED AT 250 WORDS)",1995.0,0,1
785,7565948,A comparison of five maintenance therapies for reflux esophagitis.,S Vigneri; R Termini; G Leandro; S Badalamenti; M Pantalena; V Savarino; F Di Mario; G Battaglia; G S Mela; A Pilotto,"Patients with reflux esophagitis have a high rate of relapse within one year after therapy is discontinued. We enrolled 175 adults with endoscopy-confirmed reflux esophagitis in a prospective study comparing five maintenance therapies. All the patients were initially treated with omeprazole (40 mg orally once a day) for four to eight weeks, and healing was confirmed by endoscopy. Participants were then stratified according to their initial grade of esophagitis and randomly assigned to 12 months of treatment with one of the following: cisapride (10 mg three times a day), ranitidine (150 mg three times a day), omeprazole (20 mg per day), ranitidine plus cisapride (10 mg three times a day), or omeprazole plus cisapride. Endoscopy was repeated after 6 and 12 months of treatment; the endoscopists were blinded to the treatment assignments. Remission was defined as the absence of esophageal lesions on scheduled or unscheduled follow-up endoscopy. In an intention-to-treat analysis, the numbers of patients in continued remission at 12 months were 19 of 35 (54 percent) in the cisapride group, 17 of 35 (49 percent) in the ranitidine group, 28 of 35 (80 percent) in the omeprazole group, 23 of 35 (66 percent) in the ranitidine-plus-cisapride group, and 31 of 35 (89 percent) in the omeprazole-plus-cisapride group. Omeprazole was significantly more effective than cisapride (P = 0.02) or ranitidine (P = 0.003), and combination therapy with omeprazole plus cisapride was significantly more effective than cisapride alone (P = 0.003), ranitidine alone (P < 0.001), or ranitidine plus cisapride (P = 0.03). Ranitidine plus cisapride was significantly better than ranitidine alone (P = 0.05). For maintenance treatment of reflux esophagitis, omeprazole alone or in combination with cisapride is more effective than ranitidine alone or cisapride alone, and the combination of omeprazole and cisapride is more effective than ranitidine plus cisapride.",1995.0,0,1
786,7569755,Pantoprazole and ranitidine in the treatment of acute duodenal ulcer. A multicentre study.,W Schepp; M Classen,"Pantoprazole is a new substituted benzimidazole that inhibits the parietal cell H+,K(+)-adenosine triphosphatase. Pantoprazole (40 mg) was compared with ranitidine (300 mg) in the treatment of acute duodenal ulcer. Two hundred and sixty-six patients with endoscopically diagnosed duodenal ulcers entered this multicentre, double-blind study. The primary efficacy variable was complete ulcer healing at 2 weeks; treatment then continued for a further 2 weeks if ulcers were unhealed. After 2 weeks 112 of 164 (68%) patients in the pantoprazole group had healed ulcers, compared with 36 of 81 (44%) taking ranitidine (p < 0.001). After 4 weeks the cumulative healing rates were 96% and 85% (p < 0.01). Improvement in ulcer pain was also significantly better with pantoprazole than with ranitidine (81% versus 62% with no pain at 2 weeks, p < 0.01). Pantoprazole is clinically superior to ranitidine in the treatment of acute duodenal ulcer, in terms of both healing and symptom relief.",1995.0,1,1
787,7572902,The effects of short-term lansoprazole therapy on Helicobacter pylori infection and antral gastritis in duodenal ulcer patients.,N C Jhala; M M McFarland; S A Brightman; B Morale; W Rubin; B F Atkinson,"Lansoprazole is a new potent proton pump inhibitor that exhibits activity against Helicobacter pylori in vitro. This study endeavored to determine the effects of 4 wk of lansoprazole therapy upon H. pylori infection and antral gastritis in duodenal ulcer patients and to determine the relationship of the gastritis with Helicobacter infection and with ulcer activity. Satisfactory antral biopsies were obtained from 119 duodenal ulcer patients before and after 4 wk of therapy with lansoprazole, ranitidine, or placebo. Sections were scored blindly for degree of active and chronic inflammation and extent of H. pylori infection. Four weeks of lansoprazole (30 mg daily) or ranitidine (300 mg daily) therapy produced a significant decrease in H. pylori infection. The reduction of H. pylori infection, but not ulcer healing per se, correlated with the decrease in active and chronic antral inflammation. Reduction of H. pylori infection, however, did not improve the good ulcer-healing rates already achieved at 4 wk by potent acid inhibition. Lansoprazole exhibits activity against H. pylori in vivo. Short-term improvement in antral gastritis is affected by reduction of H. pylori infection but not by ulcer healing.",1995.0,0,0
788,7601011,Pharmacological management of gastro-oesophageal reflux disease.,E C Klinkenberg-Knol; H P Festen; S G Meuwissen,"Gastro-oesophageal reflux disease (GORD) ranges from episodic symptomatic reflux without oesophagitis to severe oesophageal mucosal damage, such as Barrett's metaplasia or peptic stricture. The multifactorial pathogenesis of GORD prevents medical cure of the disease. GORD is a chronic disease with a high tendency to relapse, requiring a long term treatment strategy in practically all patients. Complete healing of all mucosal lesions is not necessarily the aim of treatment in all patients. In milder forms of reflux disease, symptom relief is the most important goal. Many patients with mild GORD do well on symptomatic self-care with antacids and/or alginate. In addition, lifestyle changes should be advised to all patients: these improve symptoms and enhance the efficacy of therapy. In the acute treatment of GORD the prokinetic drug cisapride has been shown to be effective in relieving symptoms and healing grade I to II oesophagitis. Cisapride decreases symptomatic and endoscopic relapse in patients with mild GORD. Histamine H2-receptor antagonists are effective in relieving reflux symptoms in about 50% of patients, but with regard to healing, H2-antagonists appear to be mainly effective in grades I and II and not in higher grades of oesophagitis. Maintenance treatment with H2-antagonists is mainly symptomatically effective in patients with mild GORD. Proton pump inhibitors (PPIs) provide significantly higher healing rates of reflux oesophagitis than H2-antagonists, even in the more severe cases of oesophagitis and Barrett's ulcers. PPIs are also effective in patients with oesophagitis refractory to treatment with H2-antagonists. PPIs have become the drugs of first choice in healing of all patients with more severe forms of reflux oesophagitis, and increasingly also for patients with milder forms of oesophagitis, certainly those who fail to respond to other drugs. In maintenance treatment of GORD, PPIs are the most effective drugs, offering the possibility of keeping nearly all patients in remission with adjusted doses. Current patient data of up to 5 years indicate the safety of this strategy for this period, but the exact consequences of strong acid inhibition over a longer period still have to be clarified. At present, all but a few patients with GORD can be managed adequately by medical therapy.",1995.0,0,0
789,7605147,The rationale for continuous maintenance treatment of reflux esophagitis.,C W Howden; D O Castell; S Cohen; J W Freston; R C Orlando; M Robinson,"Reflux esophagitis is a chronic process associated with frequent episodes of relapse in many patients. In addition, the disease may be progressive in at least some patients. Erosion of the esophageal mucosa precedes the development of some of the complications of the condition. There is accumulating evidence that continuous treatment of patients with erosive esophagitis effectively maintains symptomatic remission and absence of esophageal erosions. Whether such treatment will prevent the development of complications has not yet been demonstrated. We investigated a number of questions concerning the natural history and complications of erosive esophagitis and the need for maintenance treatment for patients with severe manifestations of disease as well as the impact of continuous maintenance treatment on the natural history of reflux esophagitis and its complications.",1995.0,0,0
790,7605854,Lansoprazole versus ranitidine for the treatment of reflux oesophagitis. UK Lansoprazole Clinical Research Group.,K D Bardhan; C J Hawkey; R G Long; A G Morgan; K G Wormsley; I K Moules; D Brocklebank,"Lansoprazole is a H+.K(+)-ATPase (proton pump) inhibitor with an anti-secretory action and is therefore potentially useful in the treatment of gastro-oesophageal reflux. This study was conducted to determine the efficacy and short-term safety of lansoprazole at doses of 30 mg or 60 mg once daily, compared with ranitidine 150 mg twice daily, in the treatment of patients with reflux oesophagitis. This was a double-blind, stratified, randomized, comparative, parallel group study conducted in five centres in the UK. A total of 229 patients (155 men) aged 18-79 years with endoscopically-confirmed oesophagitis were randomized to receive lansoprazole 30 mg p.o. daily, lansoprazole 60 mg p.o. daily, or ranitidine 150 mg p.o. b.d. Efficacy was assessed by endoscopic examination at 4 weeks and 8 weeks, together with symptom relief and antacid usage. Lansoprazole 30 mg and 60 mg were superior at 4 and 8 weeks (P < 0.01) to ranitidine in healing reflux oesophagitis: respective healing rates being 84%, 72% and 39% after 4 weeks and 92%, 91% and 53% after 8 weeks. Relief of heartburn with lansoprazole 30 mg and 60 mg was superior to that achieved with ranitidine at both week 4 (P < 0.01) and week 8 (P < 0.02). Sixty-four patients experienced a total of 85 adverse events, one-third of which were considered drug-related. The incidence and severity were similar in the three groups. Lansoprazole 30 mg and 60 mg once daily are more effective than ranitidine 150 mg twice daily in the short-term treatment of reflux oesophagitis.",1995.0,1,1
791,7614102,Double-blind comparison of pantoprazole and omeprazole for the treatment of acute duodenal ulcer.,J A Beker; G Bianchi Porro; M A Bigard; G Delle Fave; G Devis; H Gouerou; C Maier,"To compare the healing rates of acute duodenal ulcer in patients receiving pantoprazole 40 mg or omeprazole 20 mg once daily and to assess drug tolerance. Randomized, double-blind study evaluating patients with healed duodenal ulcer on endoscopy after 2 weeks of treatment and patients unhealed at 2 and after 4 weeks of treatment. Hospital or private gastroenterology practice outpatients. Men or women, aged at least 18 years, with one or two duodenal ulcers. Patients with ulcer complications or with other significant acid-related disease were excluded. A total of 270 patients entered the study, of whom 255 were included in the per-protocol analysis. The primary measure of efficacy was the healing rates of duodenal ulcers. Complete healing of ulcers was observed in 88 (71%) of the 124 patients in the pantoprazole group and in 85 (65%) of the 131 patients in the omeprazole group after 2 weeks of treatment. The cumulative healing rates after 4 weeks were 118 (95%) out of 124 and 117 (89%) out of 131 patients, respectively. There was no significant difference between treatment groups with respect to either healing rates or freedom from ulcer pain at 2 weeks. Both treatments were well tolerated: only 10 and 11 patients in the pantoprazole and omeprazole groups, respectively, reported adverse events. Diarrhoea was reported by two patients in each group. Pantoprazole 40 mg daily and omeprazole 20 mg daily are equally effective in inducing ulcer healing.",1995.0,1,1
792,7614110,"Omeprazole and H2-receptor antagonists in the acute treatment of duodenal ulcer, gastric ulcer and reflux oesophagitis: a meta-analysis.",S Eriksson; G Långström; L Rikner; R Carlsson; J Naesdal,"This paper is a meta-analysis of 30 published, double-blind clinical trials comparing omeprazole with ranitidine or cimetidine for the treatment of duodenal ulcer, gastric ulcer and reflux oesophagitis. These studies compare the recommended doses of omeprazole with those for ranitidine and cimetidine, and the confidence intervals for the therapeutic gain show that the findings are highly reliable. The difference in healing rates favoured omeprazole over ranitidine in patients with duodenal ulcer after 2 weeks of treatment (15.2 percentage units; P < 0.001), and after 4 weeks of treatment in patients with gastric ulcer (9.9 percentage units; P = 0.005), or reflux oesophagitis (23 percentage units; P < 0.001). Similarly, omeprazole gave a 20.6 percentage units higher average healing rate than cimetidine in patients with duodenal ulcer after 2 weeks of treatment (P < 0.0001). Significantly more patients treated with omeprazole were free of symptoms at their first follow-up visit than patients treated with ranitidine or cimetidine.",1995.0,0,0
793,7639232,"Comparison of once daily doses of lansoprazole (15, 30, and 60 mg) and placebo in patients with gastric ulcer.",D L Avner; R Movva; K J Nelson; M McFarland; W Berry; W Erfling,"A multicenter, double-blind study was conducted in 268 patients to compare the safety and efficacy of 15, 30, and 60 mg of lansoprazole and placebo in the treatment of gastric ulcer. The study included an 8-wk treatment period to assess healing and a 6-month posttreatment period to evaluate ulcer recurrence. Endoscopies were performed, GI symptoms and antacid use were assessed, and safety evaluations were conducted, including serum gastrin and biopsies of the lesions and the greater curvature of the stomach. At week 4, healing rates were significantly higher with lansoprazole 15 and 30 mg (64.6 and 58.1%, respectively) compared with placebo (37.5%). By week 8, healing rates were 76.7% with placebo, 92.2% with 15 mg of lansoprazole, 96.8% with 30 mg, and 93.2% with 60 mg of lansoprazole (p < 0.05). The drug was well tolerated, with no significant differences from placebo in the incidence of adverse events. Fasting serum gastrin increased in all lansoprazole groups, reaching a plateau by week 2 and returning to baseline levels by month 1 posttreatment. No significant increase in Grimelius-positive cells or inflammation was evident. All but two patients had normal gastric morphology evaluated by Solcia classification. Lansoprazole, 15, 30, and 60 mg, administered once daily before eating, healed gastric ulcers to an approximately equal degree, and all were significantly better than placebo.",1995.0,0,1
794,7647898,Omeprazole-amoxycillin therapy for eradication of Helicobacter pylori in duodenal ulcer bleeding: preliminary results of a pilot study.,D Jaspersen; T Körner; W Schorr; M Brennenstuhl; C H Hammar,"Thirty-five patients with duodenal ulcer bleeding and Helicobacter pylori-colonization were assigned to receive 2 x 20 mg omeprazole and 3 x 750 mg amoxycillin daily for 2 weeks. Eradication was defined as no evidence of H. pylori infection by urease test and by histology 4 weeks after completion of therapy. Two patients were lost to follow up. All ulcers healed completely (100% ulcer healing rate). Twenty-nine out of the 33 patients were H. pylori-negative (87.9% eradication rate). Three patients complained of typical side effects of amoxycillin (9.1% side effect rate). The patients were prospectively followed for 12 months. After ulcer healing, no maintenance therapy was given. One of the 29 patients in whom H. pylori eradication had been successful suffered a second ulcer hemorrhage with H. pylori reinfection (3.4% relapse rate of ulcer bleeding), and this was managed endoscopically. Recurrent ulcer hemorrhage occurred in 2 out of 4 H. pylori-resistant patients. At the end of the follow-up period, of the patients in whom H. pylori eradication had been initially successful, only the patient with re-bleeding remained reinfected. The 4 H. pylori-resistant patients showed persistent H. pylori colonization. In conclusion, omeprazole plus amoxycillin is a safe and effective treatment for eradicating H. pylori; this treatment reduces the relapse rate of duodenal ulcer bleeding.",1995.0,0,0
795,7648115,Laparoscopic Nissen fundoplication is a satisfactory alternative to long-term omeprazole therapy.,M Anvari; C Allen; A Borm,"A total of 168 patients with proven gastro-oesophageal reflux disease (GORD) receiving long-term medical therapy underwent laparoscopic Nissen fundoplication. The operation was converted to open fundoplication in four patients. All patients reported complete (92.3 per cent) or partial (7.7 per cent) relief of reflux symptoms 1 month after surgery. There were no associated deaths and the perioperative complication rate was 8.9 per cent. The mean(s.e.m.) length of operating time was 69.9(2.4) min and mean(s.e.m.) hospital stay 2.7(0.1) days. Symptom score assessment, 24-h oesophageal pH recording and lower oesophageal sphincter pressure showed significant (P < 0.0001) improvement 6 months after surgery in 85 evaluable patients. Before operation 37.5 per cent of the patients were considered symptomatically controlled on omeprazole and had excellent symptom control after surgery. This initial experience suggests that laparoscopic Nissen fundoplication is a safe and effective treatment for patients with GORD requiring long-term medication.",1995.0,0,0
796,7648229,Treatment of Helicobacter pylori infections.,J C Thijs; E J Kuipers; A A van Zwet; A S Pena; J de Graaff,"The available literature on the relationship between several diseases and Helicobacter pylori (H. pylori) is reviewed. Duodenal ulcer, gastric ulcer, complicated peptic ulcer, abdominal symptoms and gastroduodenal mucosal damage during the use of non-steroid anti-inflammatory drugs (NSAIDs), non-ulcer dyspepsia (NUD) and gastric malignancy are discussed. The case for and against eradication is critically discussed. Eradication of H. pylori should be pursued in all patients with peptic ulcer disease, whether they are using NSAIDs or not. Eradication of H. pylori in the treatment of NUD should be considered experimental. Treatment aimed at the eradication of H. pylori should be considered in all patients with low-grade malignant mucosa-associated lymphoid tissue (MALT) lymphoma and in all patients with Ménétrier's disease. Finally, this treatment should be considered in a subset of H. pylori-infected patients who possibly are at an increased risk of gastric cancer: patients with a strong family history of gastric carcinoma and patients in need of long-term treatment with a proton-pump inhibitor. In view of the importance of patient compliance, the risk of side-effects and the possibility of inducing metronidazole resistance when treatment with a metronidazole-containing regimen is used, treatment aimed at the eradication of H. pylori should be carefully implemented and monitored.",1995.0,0,0
797,7653963,Peptic ulcer--a new look.,J Y Kang,"This review covers major advances in peptic ulcer disease over the last 25 years. Flexible endoscopy enables accurate diagnosis of peptic ulcer to be made and its introduction made possible the large number of controlled clinical trials on the use of various agents in peptic ulcer treatment. The histamine H-2 receptor antagonists, which reduce gastric acid output, were the first major group of potent ulcer healing drugs introduced. Subsequently, other ulcer healing agents with different modes of action, e.g. colloidal bismuth, sucralfate, prostaglandin analogues, omeprazole were also shown to be effective. The identification of Helicobacter pylori ten years ago was another major advance in peptic ulcer disease. This bacterium is now thought to be the most important cause of peptic ulcer disease and its eradication cures the disease. There are still unanswered questions regarding varying sequelae of Helicobacter pylori infection, the effect of the infection on gastric acid and gastrin secretion while a convenient and effective treatment regime remains to be developed. Non-steroidal anti-inflammatory drugs are now thought to be the second most important cause of peptic ulcer disease and a major risk factor for ulcer complications and mortality. While misoprostol and histamine H-2 antagonists can prevent peptic ulcer associated with these substances, indications for prophylaxis have not yet been defined. If Helicobacter pylori infection could be controlled through improved socio-economic standards and possible development of a vaccine, and if anti-inflammatory drugs devoid of gastric side effects can be developed, peptic ulcer may become a less important health problem in the future.",1995.0,0,0
798,7654116,Empiric therapy for gastroesophageal reflux disease.,N E Schindlbeck; A G Klauser; W A Voderholzer; S A Müller-Lissner,"In the absence of highly specific symptoms and without esophageal erosions, long-term pH monitoring is necessary for diagnosing gastroesophageal reflux disease. This method, however, is not generally available. To determine whether gastroesophageal reflux disease can be diagnosed empirically by acid suppression in patients with normal results of endoscopy. We studied 33 consecutive outpatients with pathologic findings on pH monitoring who had symptoms compatible with gastroesophageal reflux disease and normal results of esophagogastroduodenoscopy, particularly a normal appearance of the esophageal mucosa. The severity of symptoms was graded on a visual analog scale from 1 to 10 by the patient. The patients were treated for at least 7 days with either ranitidine, 150 mg twice daily (patients 1 through 10), omeprazole, 40 mg/d (patients 11 through 21), or omeprazole, 40 mg twice daily (patients 22 through 33). A reassessment of symptoms and second pH monitoring were performed during the last day of treatment. Omeprazole, 40 mg/d, significantly reduced the severity of symptoms from 7.1 (range, 4 to 9) to 3.7 (0 to 8) and the reflux measure mean acidity from 0.98 mmol/L (0.21 to 76 mmol/L) to 0.02 mmol/L (0 to 0.47 mmol/L). Omeprazole, 40 mg twice daily, significantly reduced the severity of symptoms from 6.8 (3 to 10) to 0.6 (0 to 2) and the mean acidity from 0.38 mmol/L (0.13 to 8.5 mmol/L) to 0.01 mmol/L (0 to 0.14 mmol/L). Both doses of omeprazole were superior to ranitidine, 150 mg twice daily. When a 75% reduction of symptoms was defined as positive, the ""omeprazole test"" with 40 mg twice daily had a sensitivity of 83.3%, whereas the sensitivity with 40 mg/d was only 27.2%. In practice, the diagnosis of gastroesophageal reflux disease can be ruled out if symptoms do not improve with a limited course of high-dose proton pump inhibitors.",1995.0,0,1
799,7654889,Prognostic factors for relapse and maintenance treatment with cisapride in gastro-oesophageal reflux disease.,G N Tytgat; A L Blum; M Verlinden,"To perform a further Cox proportional hazards logistic regression analysis of data from two large-scale placebo-controlled trials with cisapride as maintenance treatment in reflux disease. Analysis of each of the two databases, allowing the model to operate freely, led to the identification of a number of unexpected putative predictors of outcome in the 6 to 12 months following initial healing of oesophagitis with an H2-receptor antagonist or omeprazole. This allowed us to delineate more accurately the patient population that is likely to respond to long-term continuous treatment with low or standard dose cisapride. The analysis revealed that symptom severity may be more useful than endoscopic severity in predicting relapse or in guiding therapy. Reflux oesophagitis outcome is particularly poor in the presence of treatment-recalcitrant symptoms or severe mucosal damage. Analysis showed cisapride to be effective in the maintenance treatment of patients with non-refractory symptoms, irrespective of the initial severity of oesophagitis, the healing agent used, or a history of previous endoscopic relapses.",1995.0,0,0
800,7654890,Treatment and prevention of relapse of mild oesophagitis with omeprazole and cisapride: comparison of two strategies.,J M Kimmig,"Oesophagitis is usually a chronic condition. Healing with omeprazole is often followed by early relapse. Combination treatment and subsequent maintenance treatment with the prokinetic cisapride may be of benefit in relapse prevention. Patients with endoscopically proven oesophagitis, grade I (n = 120) or grade II (n = 105), were randomized in an open fashion to receive 8 weeks of healing treatment with omeprazole 20 mg daily (OM) followed by 12 months of follow-up without maintenance treatment, or 8 weeks of combined treatment of omeprazole 20 mg daily plus cisapride 5 mg t.d.s. (OMCIS) followed by 12 months of maintenance treatment with cisapride 5 mg t.d.s. (CIS). Only the patients healed after acute treatment were included in the 12-month follow-up study for evaluation of endoscopic relapse. In the group of patients with oesophagitis grade I (n = 58 receiving OM, n = 62 receiving OMCIS), healing rates were comparable for both acute treatment regimens. In the group of patients with grade II (n = 54 receiving OM, n = 51 receiving OMCIS), the healing rates were slightly but not significantly in favour of OMCIS after 4 and 8 weeks of treatment. During the 12 months of follow-up, CIS maintenance treatment was associated with a significant reduction of relapse. In the group of patients with initial grade I oesophagitis, the relapse rates after 3 months were 20% in the OMCIS group receiving CIS maintenance treatment, compared to 48% in the group healed on OM without further maintenance treatment (P = 0.04). After 6 months, these relapse rates were 31% and 85% respectively (P < 0.001), and after 12 months 40% and 96% (P < 0.001). In the group of patients with initial grade II oesophagitis, they were, respectively, 20% vs. 39% after 3 months (P = 0.056), 41% vs. 78% after 6 months (P < 0.001) and 52% vs. 95% after 12 months (P < 0.001). The results of this open study indicate that continued treatment with cisapride 5 mg t.d.s. (after initial healing with omeprazole 20 mg daily plus cisapride 5 mg t.d.s.) is beneficial in the long-term management of grade I and II oesophagitis: this treatment approach significantly reduces the high relapse rate observed after stopping healing treatment with omeprazole.",1995.0,0,1
801,7654895,A double-blind study of pantoprazole and omeprazole in the treatment of reflux oesophagitis: a multicentre trial.,J Mössner; A H Hölscher; R Herz; A Schneider,"Pantoprazole is a new substituted benzimidazole which is a potent inhibitor of gastric acid secretion by its action upon H+,K(+)-ATPase. To compare pantoprazole 40 mg with omeprazole 20 mg as once daily dosing in the treatment of reflux oesophagitis (grades II and III). This double-blind, randomized, multicentre study included 286 patients. Patients were reendoscoped after 4 weeks, and continued to receive a further 4 weeks of treatment if they were not healed at this time. After 4 weeks of treatment, complete healing occurred in 126/170 (74%) patients in the pantoprazole group and in 67/86 (78%) patients in the omeprazole group (per-protocol analysis). At 8 weeks, the corresponding healing rates were 153/170 (90%) and 81/86 (94%). The differences between the treatment groups were not significant (P = 0.57 and 0.34). Improvement in the principal symptoms of reflux oesophagitis was also very similar between the treatment groups, with 59% and 69% at 2 weeks, and 83% and 86% at 4 weeks, respectively, being free from any individual symptom. Both treatments were well tolerated. This study has shown pantoprazole and omeprazole to be similarly effective and well tolerated in the treatment of mild to moderate reflux oesophagitis.",1995.0,0,1
802,7657041,"Six months of omeprazole 20 mg daily, 20 mg every other day or 40 mg at weekends in duodenal ulcer patients: a multicenter, prospective, comparative study. Interdisciplinary Group for Ulcer Study.",,"We performed an open, prospective, randomized, three-cell, 6-month clinical trial on the prevention of duodenal ulcer (DU) relapse, comparing three omeprazole schedules, i.e. 20 mg daily, 20 mg every other day (e.o.d.) and 40 mg on Saturdays and Sundays (S/S). Diagnosis of either healed or relapsed DU was on an endoscopic basis. Follow-up visits were performed at 3-monthly intervals with endoscopy at the baseline, after 6 months and at every symptomatic relapse. chi 2 test with standardized deviates, Yates' corrected chi 2 test and analysis of variance (one-way). One hundred and fifteen patients were randomized to receive omeprazole 20 mg/day, 123 omeprazole 20 mg e.o.d. and 115 40 mg S/S. Twenty-eight dropped out (11, 8 and 9, respectively). Demonstrated ulcer relapse rates were 5.7% with omeprazole 20 mg/day, 18.1% with 20 mg e.o.d. and 17.6% with 40 mg S/S (p = 0.0124, 'per-protocol' analysis). No clinically significant adverse effects were recorded. In conclusion, of the three schedules studied, omeprazole 20 mg/day proved the most effective maintenance treatment for healed DU.",1995.0,0,0
803,7657042,Two-year follow-up of duodenal ulcer patients treated with omeprazole and amoxicillin.,S Miehlke; E Bayerdörffer; N Lehn; G A Mannes; A Sommer; W Höchter; J Weingart; R Hatz; G Ruckdeschel; P Dirschedl,"The present study evaluated the time in remission during a 2-year follow-up after eradication of Helicobacter pylori (HP) in patients with an HP-associated duodenal ulcer (DU). HP was eradicated by combined treatment with high-dose omeprazole (2 x 40 mg) and amoxicillin (2 x 1,000 mg; n = 27) administered for 10 days (OME + AMX); alternatively, patients were treated with omeprazole monotherapy (OME) using the same dosage (n = 25). During the 2-year follow-up period endoscopy including histological examination was performed after 1 and 2 years or whenever symptoms compatible with ulcer relapse occurred. HP eradication was achieved in 82% of the OME + AMX group, but in 0% of the OME group. The cumulative DU relapse rates were 0% after 1 year and 7% after 2 years in 22 patients who became HP-negative. Both HP-negative patients who relapsed in the 2nd year of follow-up were HP-positive again at the time of relapse. Of the 5 patients who were not eradicated after OME + AMX therapy, 2 relapsed within the 1st year (40%) and another 2 within the 2nd year (80%). In the OME group the cumulative relapse rates within 1 and 2 years of follow-up were 52 and 76%, respectively. The results further confirm that eradication of HP with combined OME + AMX treatment leads to a distinct decrease in DU relapse rates and thus may cure DU disease. Long-term eradication with combined OME + AMX treatment is possible, and the rate of reinfection with HP is low (4.5%/year).",1995.0,0,0
804,7661154,90% cure: which anti-Helicobacter therapy can achieve this treatment goal?,W A de Boer; G N Tytgat,,1995.0,0,0
805,7661159,Treatment of Helicobacter pylori infection with omeprazole-amoxicillin combination therapy versus ranitidine/sodium bicarbonate-amoxicillin.,M T al-Assi; R A Cole; T J Karttunen; H el-Zimaity; R M Genta; D Y Graham,"Simpler, effective therapies to treat Helicobacter pylori infection are greatly needed. Omeprazole co-therapy apparently enhances effectiveness of some antimicrobials. Our objective in this study was to determine whether the apparent additional benefit provided by omeprazole to amoxicillin therapy could be equaled by a high dose of ranitidine plus sodium bicarbonate. In a prospective randomized trial, we tested 1 g amoxicillin b.i.d. with either omeprazole 20 mg b.i.d., or high dose ranitidine (900 and 1800 mg) plus sodium bicarbonate tablets 650 t.i.d. (with meals) for 14 day. Fifty-two patients with documented H. pylori infection and peptic ulcer completed therapy. The cure rate with omeprazole and amoxicillin was poor (46%), with the 95% confidence interval (CI) = 25-67%. Ranitidine plus sodium bicarbonate was also poor (39% cure) with the 95% CI = 21.5-59% (p > 0.57). Average compliance was more than 92% for all three groups. Side effects were experienced in only two patients (stomatitis and mild diarrhea). Neither the omeprazole nor ranitidine plus bicarbonate plus amoxicillin therapies used here can be recommended for treatment of H. pylori infection.",1995.0,0,0
806,7661161,"Effect of triple therapy or amoxycillin plus omeprazole or amoxycillin plus tinidazole plus omeprazole on duodenal ulcer healing, eradication of Helicobacter pylori, and prevention of ulcer relapse over a 1-year follow-up period: a prospective, randomized, controlled study.",M Saberi-Firoozi; S Massarrat; S Zare; M Fattahi; A Javan; H Etaati; N Dehbashi,"Triple therapy and amoxycillin plus omeprazole are the two most widely recommended regimens for the eradication of Helicobacter pylori. However, no controlled studies with a large number of cases are available for the reliable comparison of these two regimens. The aim of this controlled, randomized, prospective study was to compare the effect of these two regimens and a further regimen for metronidazole-resistant patients on duodenal ulcer healing, H. pylori eradication, and prevention of ulcer relapse. Patients (n = 144) with proven duodenal ulcer (DU) were randomized to one of the three following regimens: group A, omeprazole (2 x 40 mg) plus amoxycillin (4 x 500 mg) for 2 wk; group B, triple therapy: bismuth nitrate (4 x 375 mg) plus metronidazole (4 x 250 mg) and tetracycline (4 x 500 mg) daily for 2 wk and ranitidine (150 mg) for the first week and bismuth nitrate (4 x 375 mg) alone for a further 2 wk; group C, omeprazole (20 mg) plus amoxycillin (4 x 500 mg) and tinidazole (2 x 500 mg) for 2 wk. A total of 46 patients in group A, 39 in group B, and 43 in group C completed the study. One patient in group A and three in group B did not tolerate the regimens and dropped out of the study. Control endoscopy was performed 8 wk after the start of treatment and when symptoms appeared (up to 1 yr after the start of treatment). In subjects who completed the study, both the healing rate of DU in group B (97% compared with 74 and 73% in A and C, respectively, p < 0.02) and the H. pylori eradication rate in group B (85 compared with 35%, p < 0.0001 in A and 58%, p < 0.02, in C) were significantly higher than in groups A and C. The symptomatic ulcer relapse during the 1-yr follow-up in patients with initially healed ulcers was similar in all groups (18, 16, and 19% in A, B, and C, respectively). The predictor of healing using logistic regression analysis was night pain (p < 0.05). The predictor of H. pylori eradication was sex (p < 0.05). The 2-wk triple therapy plus an additional 2-wk treatment with the bismuth derivative (without a prolonged administration of acid suppressing drugs) seems to be an effective and economic treatment not only for the eradication of H. pylori but also for the healing of acute DU. The higher incidence of side effects found after triple therapy compared with the other two regimens was tolerated by the patients.",1995.0,0,0
807,7661162,"Triple therapy with sucralfate, tetracycline, and metronidazole for Helicobacter pylori-associated duodenal ulcers.",J J Sung; V K Leung; S C Chung; T K Ling; R Suen; A F Cheng; A K Li,"Triple therapy with bismuth, metronidazole, and tetracycline or amoxicillin is effective for the treatment of Helicobacter pylori, but side effects are common. Sucralfate inhibits H. pylori hemagglutinin, protease, and lipase and thus might affect colonization of the bacterium in the stomach. We compared the efficacy and side effects of triple therapy with sucralfate versus triple therapy with bismuth plus omeprazole in the treatment of H. pylori-associated duodenal ulcer (DU). One hundred and fifty DU patients were recruited in this study; 71 cases were randomized to receive bismuth 120 mg q.i.d., metronidazole 400 mg q.i.d., and tetracycline 500 mg q.i.d. (BMT) for 1 wk, and 79 cases were randomized to receive sucralfate 1 g q.i.d., metronidazole 400 mg q.i.d., and tetracycline 500 mg q.i.d. (SMT) for 1 wk. For the ulcer treatment, BMT patients were also given omeprazole 20 mg daily for 4 wk, and SMT patients received sucralfate for 4 wk from day of randomization. Fifty-three patients in the BMT group and 60 in the SMT group finished the treatment and follow-up at 8 wk. H. pylori was eradicated in 49 out of 53 (92%) patients in the BMT group and in 45 out of 60 (75%) patients in the SMT group (p = 0.0057). Forty-nine (92%) patients who received omeprazole and BMT and 53 (88%) patients who received SMT had healed DU at 8 wk (p = 0.34). Side effects related to medication were reported in 38 (71.7%) patients in the BMT group and in 42 (70%) patients in the SMT group. On an intention-to-treat basis, there was no difference in ulcer healing between the BMT group (93.1%) and the SMT group (89.7%). H. pylori eradication was achieved in 84.4 and 66.2% in the BMT and SMT groups, respectively (p = 0.018). Therapy of sucralfate, tetracycline, and metronidazole for 1 wk has a satisfactory but lower success rate in eradication of H. pylori when compared with the conventional triple therapy plus omeprazole. Side effects of this therapy are no fewer than the conventional triple therapy.",1995.0,0,0
808,7672677,Intragastric acidity as a predictor of the success of Helicobacter pylori eradication: a study in peptic ulcer patients with omeprazole and amoxicillin.,J Labenz; M Stolte; A L Blum; I Jorias; F Leverkus; M Sollböhmer; J Bertrams; G Börsch,"Omeprazole plus amoxicillin cures Helicobacter pylori infection. The hypothesis was tested that low acidity is a predictor of outcome. Fifty patients with relapsing or complicated, or both H pylori positive duodenal (n = 25) or gastric ulcer (n = 25) were randomly treated with either omeprazole 20 mg twice daily plus amoxicillin 1 g twice daily or with omeprazole 40 mg twice daily plus amoxicillin 1 g twice daily over two weeks. After one week of combined treatment, a 24 hour gastric pH measurement was performed in all patients. H pylori cure rate was 67%. Patients who later turned out to be cured had higher pH values during night time and after meals (p < 0.05). In an explorative analysis drug compliance, smoking, location of the ulcer (duodenum versus stomach), age, and grade of body gastritis were additional predictors of the outcome. Smoking (p = 0.006), compliance (p = 0.037), duodenal ulcer disease (p = 0.065), and young age (p = 0.021) were related to high acidity. In conclusion, the success of eradication treatment with omeprazole and amoxicillin in ulcer patients infected with H pylori depends on intragastric pH. Drug compliance, smoking habits, location of ulcer, age, and activity of body gastritis are other predictors and in part related to intragastric acidity.",1995.0,0,0
809,7697690,The efficacy of two doses of omeprazole for short- and long-term peptic ulcer treatment in the elderly.,A Pilotto; F Di Mario; G Battaglia; S Vigneri; G Leandro; M Franceschi; M De Boni; A Grasso; F Vianello; R Naccarato,"This study evaluated the efficacy, safety, and most suitable dose of omeprazole in short-term acute treatment (4 weeks) and maintenance treatment (6 months) of patients older than 60 years of age with endoscopically diagnosed gastric ulcer (GU) or duodenal ulcer (DU). This randomized, prospective study included 156 patients (67 GU and 89 DU; mean age, 74.8 and 72.3 years, respectively) who were randomized in the acute phase into two treatment groups: omeprazole 20 mg/d or 40 mg/d as a single morning dose for 4 weeks. The 6-month follow-up phase included 101 patients who were randomized to receive omeprazole 20 mg/d or 20 mg every other day. After 4 weeks of treatment, 94.0% of GU patients and 95.5% of DU patients showed complete ulcer scarring with no statistical differences between doses. At the end of the 6-month follow-up, 4.5% of GU patients and 8.8% of DU patients relapsed, with no statistical differences between groups. No clinically significant adverse events were recorded. In conclusion, omeprazole is a highly effective, well-tolerated, and safe drug for the short- and long-term treatment of GU and DU in the elderly. The dose of 20 mg/d for the acute phase and 20 mg on alternate days for maintenance therapy appears most appropriate for elderly patients with ulcers.",1994.0,0,0
810,7697902,Prevention of nonsteroidal anti-inflammatory drug-induced gastroduodenal ulcers: role of mucosal protective and gastric antisecretory drugs.,E Z Dajani; N M Agrawal,"One of the most serious side effects of nonsteroidal anti-inflammatory drugs (NSAIDs) is upper gastrointestinal mucosal damage that may result in erosions, ulcerations and other serious complications. NSAIDs reduce endogenous prostaglandins, and this reduction is relevant to their pharmacology and toxicity. The stomach and to some extent the duodenum are the major organs involved in the mucosal toxicity of NSAIDs. With the availability of the synthetic prostaglandin misoprostol, it has become possible to prevent NSAID-induced gastroduodenal ulcers without compromising the beneficial antirheumatic and analgesic effects of NSAID therapy. In fact, misoprostol is the only drug with established long-term efficacy in preventing NSAID-induced gastroduodenal ulcers in rheumatic patients. The purpose of this communication is to critically review the efficacy of gastric antisecretory drugs, mucosal protective drugs and misoprostol when used for the prevention of NSAID-induced ulcers, considering only data from well-controlled, randomized, double-blind clinical studies. The histamine H2-receptor antagonist ranitidine has been shown to be effective in preventing NSAID-induced duodenal ulcers, but has no efficacy in preventing NSAID-induced gastric ulcers. In a direct comparative trial with ranitidine, misoprostol (200 micrograms qid) was significantly more effective than ranitidine (150 mg bid) in preventing gastric ulcers in chronic NSAID users. The inactivity of ranitidine in preventing gastric ulcers indicates that the pathogenesis of NSAID-induced gastric ulcers is not related to gastric acid. Limited but conflicting data exist with omeprazole. The mucosal-coating drug sucralfate has not been found effective in preventing NSAID ulcers. In fact, in a direct comparative trial, misoprostol (200 micrograms qid) was significantly more effective than sucralfate (1 g qid) in preventing gastric ulcers in patients receiving chronic NSAID therapy. No meaningful data exist with organic bismuth salts, a group of drugs which has mucosal coating and protective properties. From this brief overview, we conclude: (1) mucosal-coating compounds have no therapeutic role in preventing NSAID-induced ulceration; (2) gastric antisecretory drugs are not effective in preventing NSAID-induced gastric ulcers, and (3) misoprostol is the only antiulcer drug proven to be effective for preventing NSAID-induced gastric and duodenal ulcers in patients receiving chronic NSAID. Misoprostol represents a major therapeutic advance for the management of NSAID-induced mucosal injury.",1995.0,0,0
811,7698617,Eradication of Helicobacter pylori reduces the possibility of rebleeding in peptic ulcer disease.,T Rokkas; A Karameris; A Mavrogeorgis; E Rallis; N Giannikos,"A close relationship has been found between Helicobacter pylori and peptic ulcer disease. Furthermore, eradication of H. pylori is associated with low recurrence rates. The aim of the present study was to examine whether eradication of H. pylori has any impact on the complications of ulcers, such as bleeding. Thirty-one patients hospitalized for duodenal ulcer bleeding, undergoing conservative treatment and with a previous history of bleeding, comprised the group studied. All patients had emergency endoscopy, and tests for H. pylori proved to be positive in all. After discharge, patients were given omeprazole 20 mg daily for 4 weeks for ulcer healing, which was achieved in all patients (100%). After this, patients were randomized to receive either omeprazole 20 mg t.i.d. alone (group O, n = 15) or the combination of omeprazole 20 mg t.i.d. + amoxicillin 500 mg q.i.d. (group O + A, n = 16) for 2 weeks. Endoscopy was performed 4 weeks after treatment ended to check for eradication of H. pylori and again when rebleeding or symptomatic relapse occurred. Groups O and O + A were similar in age, sex, smoking habits, and NSAID use. The follow-up period was 12 months for both groups. Eradication was achieved in 2 of 15 (13.3%) patients in group O and in 13 of 16 (81.3%) patients in group O + A (p < .001). Five patients rebled during follow-up. All of them belonged to group O and were patients in whom eradication had failed. In contrast, none of group O + A had rebleeding (p = 0.18).(ABSTRACT TRUNCATED AT 250 WORDS)",1995.0,0,0
812,7698624,Helicobacter pylori eradication reduces the rate of rebleeding in ulcer hemorrhage.,D Jaspersen; T Koerner; W Schorr; M Brennenstuhl; C Raschka; C H Hammar,"To evaluate whether eradication with omeprazole and amoxicillin results in a reduction of ulcer recurrence and rebleeding in patients with Helicobacter pylori-associated duodenal ulcer hemorrhage, patients with upper gastrointestinal hemorrhage from duodenal ulcers with stigmata of recent hemorrhage, a drop in hemoglobin level of more than 2 g/dL, and documented H. pylori infection (by rapid urease test and histologic findings) were randomly assigned to receive omeprazole, 40 mg every day, and amoxicillin, 1 g twice a day, (Group A) or omeprazole alone, 40 mg every day, (Group B) for 2 weeks. No maintenance antiulcer therapy was given. Patients underwent a second endoscopy 4 weeks after completion of therapy and were followed for 1 year. Endoscopy was performed again at the end of 1 year. All patients showed ulcer healing 4 weeks after completion of therapy. H. pylori eradication rates were 83% (Group A) and 5% (Group B) (p < .001). Ulcer recurrences were significantly lower in Group A (3/29 or 10%) than in Group B (9/22 or 41%; p < .05). Comparison of Group A patients with eradication and Group B patients without eradication also revealed a significant difference in rates of ulcer relapse (1/24 or 4% versus 9/21 or 43%; p < .01). Rebleeding occurred significantly less often in the dual therapy group than in the omeprazole group (0/29 versus 6/22 or 27%; p < .01). Eradication of H. pylori significantly reduces the rates of ulcer recurrence and rebleeding in patients with duodenal ulcer bleeding. Dual therapy with omeprazole and amoxicillin should be considered in all H. pylori-positive patients with hemorrhage from duodenal ulcers.",1995.0,0,0
813,7698632,The long-term management of patients with bleeding ulcers: Helicobacter pylori eradication instead of maintenance antisecretory therapy.,L Laine,,1995.0,0,0
814,7698828,"Peptic ulcer disease in children. Diagnosis, treatment, and the implication of Helicobacter pylori.",P M Sherman,"Peptic ulcers are a relatively infrequent occurrence in children. Ulcers in the stomach and duodenum are typically secondary to systemic illnesses or drugs in young children; secondary ulcers do not recur. In contrast, duodenal ulcers in older children and adolescents have a relapsing course that is increasingly recognized to be related to coexisting, chronic, active antral gastritis and Helicobacter pylori infection. Antihelicobacter therapy not only heals duodenal ulcers, but it alters the natural history by reducing the frequency of ulcer recurrences. Not all primary duodenal or gastric ulcers in the pediatric population, however, are related to H. pylori; their cause remains unknown. Treatment for these patients requires either antacids, H2 blockers, proton pump inhibitors, or ulcer coating agents for 6-8 weeks along with long-term maintenance therapy.",1994.0,0,0
815,7712301,Efficacy of omeprazole combined with antibiotics for Helicobacter pylori eradication and duodenal ulcer recurrence.,M Lazzaroni; G Maconi; S Bargiggia; M Minguzzi; G Bianchi Porro,"To establish the efficacy of omeprazole combined with two antibiotics for Helicobacter pylori eradication and duodenal ulcer relapse. Thirty-seven patients with endoscopically proven duodenal ulcer and H. pylori infection. Treatment consisted of 20 mg omeprazole daily for 4 weeks with the addition, during the second and third weeks, of amoxycillin (1 g three times daily) and metronidazole (1 g daily) (group A) or placebo (group B). Endoscopy and biopsy to assess ulcer recurrence and H. pylori status were performed at entry to the study, after 4 weeks of therapy, and 1 and 6 months after treatment. Duodenal ulcers healed in all patients. H. pylori infection was eradicated in 15 (79%) out of 19 patients in group A and one (6%) out of 16 patients in group B (P < 0.01). One patient in each of the groups was lost to follow-up after 6 weeks. During the 6 month follow-up period, duodenal ulcers recurred in three of the 16 patients with H. pylori eradication, compared with 16 of the 19 patients with persistent H. pylori infection (19 versus 84%; P < 0.01). The combination of omeprazole with amoxycillin and metronidazole is effective in H. pylori eradication. This triple therapy, which eradicates H. pylori, also significantly reduced duodenal ulcer relapse.",1995.0,0,0
816,7729633,Double-blind trial of omeprazole and amoxicillin to cure Helicobacter pylori infection in patients with duodenal ulcers.,E Bayerdörffer; S Miehlke; G A Mannes; A Sommer; W Höchter; J Weingart; W Heldwein; H Klann; T Simon; W Schmitt,"Anti-Helicobacter pylori treatment with combinations of omeprazole and amoxicillin is a promising treatment option. The aim of this study was to investigate whether a daily omeprazole dose of 120 mg combined with amoxicillin would cure H. pylori infection at a rate comparable with that achieved with ""triple therapy."" In a double-blind, randomized, controlled, and multicenter trial in Germany, 270 patients with an H. pylori-associated duodenal ulcer were treated with 40 mg omeprazole three times a day and 750 mg amoxicillin three times a day for the first 14 days (n = 139) followed by 20 mg omeprazole once daily until day 42 or with omeprazole plus 750 mg amoxicillin placebo three times a day for the same time period (n = 131). Cure rates of H. pylori infection were 91% in the omeprazole plus amoxicillin group, 0% in the omeprazole plus placebo group, and 89% and 0%, respectively, performing an intention-to-treat analysis. Cure of H. pylori infection in patients pretreated with omeprazole was only 58% compared with 95% in patients who were not. The cumulative 12-month relapse rates were 11.3% and 44% in the treatment groups and 1.6% in H. pylori-negative and 49% in H. pylori-positive patients. The combination of 120 mg omeprazole daily and 2.25 g amoxicillin daily with its H. pylori cure rate of around 90% is one of the best tolerated and most effective treatment regimens.",1995.0,0,0
817,7732329,Meta-analysis of the effect of placebo on the outcome of medically treated reflux esophagitis.,F Pace; G Maconi; P Molteni; M Minguzzi; G Bianchi Porro,"To ascertain the placebo-induced effect in the treatment of reflux esophagitis, we reviewed all the English-language literature concerning the results of placebo-controlled trials of erosive/ulcerative esophagitis from 1976 to 1990. Twenty-two studies fulfilled our meta-analytic criteria. After 4 to 8 weeks of treatment, active drugs (cimetidine, ranitidine, nizatidine, omeprazole, metoclopramide, sucralfate) were significantly more effective than placebo in the healing of esophagitis, with a pooled rate difference (PRD) of 0.22 in favor of the active drug, an odds ratio (OR) of 2.57 (confidence interval (CI) = 2.0-3.3). Pooled mean healing rate (+/- SD) with the active drug was 47.3 +/- 24.0%, as compared with 26.8 +/- 18.0% obtained with placebo after 4 to 8 weeks of treatment. With regard to symptomatic response, complete disappearance of symptoms was observed in an average of 31.6% active-treated patients and in 11.8% of placebo-treated patients, respectively. The PRD was 0.20, and the OR 2.25 (CI = 1.65-3.06). The incidence of side effects was not statistically different for the two treatment groups. Placebo is a relatively inactive drug in the short-term treatment of erosive ulcerative reflux and does not appear to change the natural history of the disease.",1995.0,0,0
818,7732331,Pantoprazole is superior to ranitidine in the treatment of acute gastric ulcer.,J Hotz; K Plein; H Schönekäs; K Rose,"Pantoprazole is a newly developed gastric H+/K(+)-adenosine triphosphatase inhibitor with a potent and long-acting inhibitory effect on gastric acid secretion. In a double-blind multicenter study with 28 centers in Germany, pantoprazole (40 mg before breakfast) was compared with ranitidine (300 mg at bedtime) with regard to healing rates, time until healing, symptom relief, and tolerability. A total of 248 outpatients with benign gastric ulcer were included. The healing rates after 2, 4, and 8 weeks were 37%, 87%, and 97%, respectively, in the pantoprazole and 19%, 58%, and 80% in the ranitidine group. The differences between the two groups were significant at 2 weeks (p < 0.01), 4 weeks (p < 0.001), and 8 weeks (p < 0.001; Cochran/Mantel-Haenszel method). Ulcer healing proceeded significantly faster with pantoprazole (p < 0.001; Uleman's U-test). Both treatments were well tolerated. Pantoprazole appears to be superior to ranitidine in gastric ulcer healing.",1995.0,0,1
819,7733075,Impact of colloidal bismuth subnitrate in the eradication rates of Helicobacter pylori infection-associated duodenal ulcer using a short treatment regimen with omeprazole and clarithromycin: a randomized study.,M Forné; J M Viver; J C Espinós; I Coll; F Tresserra; J Garau,"Recent trials have shown that duodenal ulcers treated by H2-blockers heal faster if Helicobacter pylori is eradicated concurrently. To evaluate the efficacy of a short treatment regimen in H. pylori eradication and ulcer healing and to assess the impact of colloidal bismuth subnitrate (CBS) in H. pylori eradication rate. Sixty-one patients with H. pylori-associated duodenal ulcer were randomized in two short treatment groups. Group A patients (31) were given omeprazole 20 mg b.i.d. x 8 days. Clarithromycin (500 mg, b.i.d.) and CBS (120 mg, q.i.d.) were added 24 h after starting omeprazole and were given for 7 days. Group B patients (30) were treated as group A patients but without CBS. Endoscopies were performed at entry and 4 wk after the end of treatment. Presence of H. pylori was assessed at each endoscopy by urease test, and biopsy specimens were examined for histological evidence of gastritis and by Gram stain and culture for H. pylori infection. No patient received follow-up treatment. H. pylori eradication rates were achieved in 25/31 (80.6%) group A patients and in 15/30 (50%) in group B patients (p = 0.012). Duodenal ulcer healing was documented in 30/31 (96.8%) patients in group A and in 25/30 (83%) patients in group B. The addition of CBS to the double therapy with omeprazole and clarithromycin substantially improves the eradication rate of H. pylori. Short therapy with omeprazole 20 mg/b.i.d., clarithromycin 500 mg/b.i.d., and CBS 120 mg/q.i.d. is a safe, well tolerated combination that achieves a 80.6% eradication rate of H. pylori and duodenal ulcer healing rates as good as those achieved by omeprazole 20 mg/d when given for 4 wk.",1995.0,0,0
820,7737552,Omeprazole 10 mg or 20 mg once daily in the prevention of recurrence of reflux oesophagitis. Solo Investigator Group.,C M Bate; S N Booth; J P Crowe; R A Mountford; P W Keeling; B Hepworth-Jones; M D Taylor; P D Richardson,"This study determined the optimal maintenance dose of omeprazole in reflux oesophagitis. One hundred and ninety three patients rendered asymptomatic and healed after four or eight weeks omeprazole were randomised double blind to 10 mg omeprazole once daily (n = 60 evaluable), 20 mg omeprazole once daily (n = 68), or placebo (n = 62) for one year or until symptomatic relapse. Each omeprazole regimen was superior to placebo in preventing both symptomatic relapse (life table analysis, p < 0.001) and endoscopically verified relapse (p < 0.001). At 12 months, the life table endoscopic remission rates (proportions of patients without grade > or = 2 oesophagitis) were: 50% (95% confidence intervals 34 to 66%) with 10 mg omeprazole once daily, 74% (62 to 86%) with 20 mg omeprazole once daily, and 14% (2 to 26%) with placebo. At 12 months, the life table symptomatic remission rates (proportions of patients asymptomatic or with mild symptoms) were: 77% (64 to 89%) with 10 mg omeprazole once daily, 83% (73 to 93%) with 20 mg omeprazole once daily, and 34% (16 to 52%) with placebo. Both 10 mg and 20 mg omeprazole once daily were effective in prolonging the remission of reflux oesophagitis: 10 mg may be appropriate to start longterm treatment, though the existence of a dose response relation means that 20 mg once daily may be effective in patients for whom 10 mg once daily is suboptimal.",1995.0,0,1
821,7750667,"Influence of lansoprazole on intragastric 24-hour pH, meal-stimulated gastric acid secretion, and concentrations of gastrointestinal hormones and enzymes in serum and gastric juice in healthy volunteers.",G Brunner; M Hell; K J Hengels; U Hennig; W Fuchs,"Twelve healthy volunteers (6 females, 6 males) between 26 and 36 years of age were enroled in this double-blind, randomized, placebo-controlled, three-way cross-over study. The objective was to determine the influence of lansoprazole (Agopton, Takeda Pharma GmbH, Aachen), a novel proton pump inhibitor, in doses of 30 and 60 mg, on the intragastric pH, on meal-stimulated gastric acid secretion and on the concentration of gastrointestinal hormones and enzymes in serum and gastric juice. Active drug or placebo had to be taken as single daily morning doses on an empty stomach for 7 days. Each wash-out period between drug application periods was 2 weeks long. Lansoprazole induced a dose-related increase in intragastric pH as well as a relevant reduction of basal acid output, meal-stimulated acid output and meal-stimulated secretion volume. 60 mg lansoprazole was significantly superior to 30 mg in increasing intragastric pH. The basal secretion volume in volunteers on 30 and 60 mg lansoprazole were lower than in volunteers on placebo. Serum gastrin and serum pepsinogen concentrations increased in a dose-dependent manner. Pepsin output and pepsin activity in gastric juice were slightly decreased in volunteers on 30 mg lansoprazole and markedly suppressed in volunteers on 60 mg lansoprazole 2 h after meal stimulation. Intrinsic factor concentration increased in volunteers on lansoprazole with a clear dose relationship. The evaluation of laboratory data and reported nonserious adverse events proved the relative safety of this new antiulcer agent.",1995.0,0,0
822,7750682,[Lansoprazole versus ranitidine in the prevention of early recurrences of digestive hemorrhages from gastroduodenal ulcers. Randomized double-blind multicenter study].,P Michel; C Duhamel; B Bazin; J L Raoul; B Person; M A Bigard; J L Legoux; V Sallerin; R Colin,"Strong inhibition of acid secretion could be able to decrease gastric and duodenal ulcer early rebleeding. OBJECTIVE--The aim of this double blind randomized trial was to compare early rebleeding rates of 2 groups of patients treated with ranitidine (600 mg/day) or lansoprazole (60 mg/day) per os for 6 consecutive days. METHODS--Seventy five patients with a high risk of rebleeding (clinical and endoscopical criteria) were included in this trial. These ulcers were Ia (n = 10), Ib (n = 20), IIa (n = 13), IIb (n = 32) in Forrest classification. RESULTS--Nineteen out of 75 patients rebled (25.3%): 11 out of 37 (30%) and 8 out of 38 (21%) in the ranitidine and lansoprazole groups respectively. Rates of rebleeding were 10%, 12.5%, 36% and 29% respectively in the ulcers grade Ia (previously treated with endoscopic sclerosis), Ib, IIa and IIb in the Forest classification. CONCLUSION--The rates of rebleeding were not statistically different in the 2 groups of treatment. The high rebleeding rates observed with Forrest IIa and IIb and duodenal ulcers support the need of haemostatic endoscopic therapy associated to antisecretory treatment in such patients.",1994.0,0,1
823,7753750,Severe gastroesophageal reflux disease. Medical and surgical options for long-term care.,J B Marshall,"Severe gastroesophageal reflux disease is usually a chronic problem with periods of relapse, but effective medical and surgical therapies are available. Two recently introduced agents, omeprazole (Prilosec) and cisapride (Propulsid), represent advances in medical therapy; the safety of long-term, continuous omeprazole therapy is under investigation. Used by surgeons with sufficient experience, the new laparoscopic approach offers potential advantages over conventional anti-reflux surgery in suitable candidates. The decision of whether to recommend long-term medical therapy or surgery must be individualized. Medical therapy may be the best choice in elderly patients and poor surgical candidates, in patients whose symptoms are well controlled with omeprazole and who accept its benefit-risk profile, and when a highly experienced anti-reflux surgeon is not available. Surgery may be appropriate (assuming a skilled surgeon is available) in patients who are young, have trouble taking medication, need multiple agents to control symptoms, and need continuous omeprazole therapy but are unwilling to accept the theoretical risk of gastric carcinoid tumors that accompanies it.",1995.0,0,0
824,7766739,,,,,0,1
825,7766740,A comparison of lansoprazole and ranitidine in the treatment of erosive oesophagitis. Multicentre Investigational Group.,M Robinson; B Sahba; D Avner; N Jhala; P A Greski-Rose; D E Jennings,"Lansoprazole is a new proton pump inhibitor which produces prolonged decrease of gastric acidity. The aim of this study was to compare lansoprazole to a standard dose of ranitidine in the treatment of patients with reflux oesophagitis. Two hundred and forty-seven patients with erosive oesophagitis were randomly assigned to 8 weeks of treatment with either 30 mg lansoprazole once daily or 150 mg ranitidine twice daily. Two hundred and forty-two patients were included in the analysis. Lansoprazole (30 mg) daily, healed oesophagitis in 92.1% of patients after 8 weeks of treatment. This was significantly superior to 150 mg ranitidine b.d.s. which healed oesophagitis in 69.9% of patients (P < 0.001). Relief of reflux symptoms was superior with lansoprazole to that with ranitidine. Both lansoprazole and ranitidine were well tolerated with no serious drug-related adverse events noted. Lansoprazole, 30 mg once daily, is highly effective and safe in the short-term treatment of erosive oesophagitis.",1995.0,0,1
826,7768408,The reasons for ineffectiveness of H2-receptor antagonists in gastroesophageal reflux disease.,V Savarino; G S Mela; G Celle,,1995.0,0,0
827,7769186,Peptic ulcer patterns in Arctic Norway.,B O Eriksen; O K Garpestad; H Søndenå; P G Burhol,"While there are four times as many duodenal as gastric ulcers in Europe and the United States, previous studies have shown gastric ulcers to be more common in the Arctic regions of Norway. To investigate a possible change in the duodenal-to-gastric ulcer ratio, the incidence rate of first-time peptic ulcer in a well defined population in Northern Norway was studied by registration of all examinations of the upper digestive tract from 1983 to 1984. In this population, 5.3% were examined by endoscopy (52.5%) or a barium meal (47.5%). The incidence rates of duodenal and gastric ulcers were 1.4 and 0.8 per 1,000 per year, resulting in a duodenal-to-gastric ulcer ratio of 1.7:1. Although this ratio is higher than in a previous study (1.1:1), the pattern of peptic ulcer disease in northern Norway is still different from that in the rest of Europe.",1995.0,0,0
828,7770708,"Lansoprazole versus omeprazole in active duodenal ulcer. A double-blind, randomized, comparative study.",P Ekström; L Carling; P Unge; O Anker-Hansen; S Sjöstedt; H Sellström,"Lansoprazole is a new substituted benzimidazole that inhibits the H+,K(+)-adenosine triphosphatase in the parietal cell and, like the first developed proton pump inhibitor omeprazole, gives a strong inhibition of gastric acid output. In this double-blind randomized comparative study patients with active duodenal ulcers were treated with either 30 mg lansoprazole or 20 mg omeprazole in the morning. All demographic data in the two treatment groups were comparable. A total of 279 patients entered the study. There was no difference in healing rates between the groups either after 2 weeks (86.2% for lansoprazole and 82.1% for omeprazole) or after 4 weeks (97.1% and 96.2%). No patient ceased treatment owing to side effects. Both lansoprazole and omeprazole generate very high healing rates and good symptom relief in active duodenal ulcer. Side effects are few and mild.",1995.0,1,1
829,7774757,"Effects of pancreatic digestive enzymes, sodium bicarbonate, and a proton pump inhibitor on steatorrhoea caused by pancreatic diseases.",T Nakamura; K Takebe; K Kudoh; M Ishii; K Imamura; H Kikuchi; F Kasai; Y Tandoh; N Yamada; Y Arai,"Forty-five patients with pancreatic steatorrhoea (27 with calcified pancreatitis, 13 with non-calcified pancreatitis, two with pancreaticoduodenectomy, one with total pancreatectomy, and two with pancreatic cancer) were divided into four groups and given the following medication for 2 to 4 weeks: 4 to 6 g/day of sodium bicarbonate (group I); 9 g/day of high-lipase pancreatin (lipase, 56,600 U/g, Fédération Internationale Pharmaceutique (FIP); group II); 12 to 24 tablets or 9.0 g of commercial pancreatic enzyme preparations (group III); or 50 mg of omeprazole (group IV). Faecal fat excretion was evaluated before and after drug administration. Faecal fat excretion was reduced by 2.9 g (range, 1.7 to 5.0 g) in group I; 8.8 g (range, 2.9 to 39.9 g) in group II; 10.8 g (range, 2.3 to 21.8 g) in group III; and 4.3 g (range, 3.6 to 5.6 g) in group IV. The pancreatic digestive enzyme preparation was more effective than sodium bicarbonate and agents that raise the pH of the upper small intestine (such as proton-pump inhibitors) in reducing faecal fat excretion. The results indicate that all of the preparations used are effective against mild pancreatic steatorrhoea. If the condition is more advanced, however, a massive dosage of pancreatic digestive enzyme and possibly the combined use of an agent to raise the pH of the upper small intestine are likely to be effective.",1995.0,0,0
830,7795283,Twelve-month omeprazole vs ranitidine in the treatment of Helicobacter pylori positive patients with healed duodenal ulcer.,F Catalano; A Liberti; G Branciforte; R Catanzaro; A M Bucceri; A Blasi,"We evaluated the results of a 12-month treatment using different regimens of omeprazole at the dose of 20 mg daily (three day week-end treatments and every other day) and of 150 mg nocte of ranitidine on Helicobacter pylori status and on preventing duodenal ulcer relapses in 140 Helicobacter pylori positive patients with healed duodenal ulcer. Only every-other-day omeprazole suppresses Helicobacter pylori after 3 month therapy (p < 0.001), after 6 months (p < 0.001) and 12 months (p < 0.05). After 3 months (T1) no significant effectiveness was found in the prevention of ulcer relapses by omeprazole and ranitidine. After 6 months (T2) a significant reduction of relapses (p < 0.05) was recorded when comparing every- other-day omeprazole to the weekend regimen. After 12 months every-other-day omeprazole treatment significantly reduced the relapses compared with the week-end therapy (p = 0.05) and with ranitidine (p < 0.05).",1995.0,0,1
831,7797824,Comparative trial of pantoprazole and ranitidine in the treatment of reflux esophagitis. Results of a German multicenter study.,H Koop; W Schepp; H G Dammann; A Schneider; R Lühmann; M Classen,"In 249 patients with acute symptomatic reflux esophagitis grade II and III (Savary-Miller classification), we compared the efficacy and safety of pantoprazole, a newly developed proton pump inhibitor given at a once-daily dose of 40 mg, with a standard dose of the H2 receptor antagonist ranitidine (150 mg b.i.d.) in a randomized, double-blind, multicenter study. Complete healing was achieved after 4 and 8 weeks of therapy (protocol-correct) in 69 and 82% (pantoprazole) and 57 and 67% (ranitidine), respectively (p = 0.054 at 4 weeks and p < 0.01 at 8 weeks). The predominant symptoms of gastroesophageal reflux, i.e., heartburn and acid eructation, were more effectively reduced in pantoprazole- than in ranitidine-treated patients. The frequency of adverse events was low and did not differ between the two treatment groups. We conclude that pantoprazole is superior to ranitidine in the acute treatment of reflux esophagitis.",1995.0,1,1
832,7800005,Antibacterial treatment of gastric ulcers associated with Helicobacter pylori.,J J Sung; S C Chung; T K Ling; M Y Yung; V K Leung; E K Ng; M K Li; A F Cheng; A K Li,"There is a strong association between infection with Helicobacter pylori and gastric ulcers that are unrelated to the use of nonsteroidal antiinflammatory medications. We studied the efficacy of antibacterial therapy without medication to suppress gastric acid for the treatment of patients with H. pylori infection and gastric ulcers unrelated to the use of nonsteroidal agents. Patients with gastric ulcers seen on endoscopy and with H. pylori infection confirmed by smear or culture were randomly assigned to receive either a one-week course of antibacterial agents (120 mg of bismuth subcitrate, 500 mg of tetracycline, and 400 mg of metronidazole, each given orally four times a day) or a four-week course of omeprazole (20 mg orally per day). Follow-up endoscopies were performed after five and nine weeks. The patients and their physicians were aware of the treatment assignments, but the endoscopists were not. A total of 100 patients were randomly assigned to treatment, and 85 completed the trial. At five weeks, H. pylori had been eradicated in 41 of the 45 patients in the antibacterial-treatment group (91.1 percent; 95 percent confidence interval, 82.9 to 99.3) and in 5 of the 40 in the omeprazole group (12.5 percent; 95 percent confidence interval, 2.3 to 22.7; P < 0.001). The gastric ulcers were healed in 38 of the patients treated with antibacterial drugs (84.4 percent; 95 percent confidence interval, 73.9 to 95.0) and in 29 of those treated with omeprazole (72.5 percent; 95 percent confidence interval, 58.6 to 86.4; P = 0.28). At nine weeks, ulcer healing was confirmed in 43 of the patients receiving antibacterial therapy and in 37 of those receiving omeprazole (P = 1.0). The mean (+/- SD) duration of pain during the first week of treatment was 1.9 +/- 2.6 days in the omeprazole group, as compared with 3.6 +/- 3.0 days in the antibacterial-treatment group (P = 0.004). One year after treatment, recurrent gastric ulcers were detected in 1 of 22 patients (4.5 percent) in the antibacterial-treatment group and in 12 of 23 (52.2 percent) in the omeprazole group (P = 0.001). H. pylori was detected in the 1 patient with a recurrent ulcer who had received antibacterial treatment and in 10 of the 12 patients with recurrent ulcers who had received omeprazole. In patients with H. pylori infection and gastric ulcers unrelated to the use of nonsteroidal antiinflammatory drugs, one week of antibacterial therapy without acid suppression heals the ulcers as well as omeprazole and reduces the rate of their recurrence.",1995.0,0,0
833,7809344,Effect of short-term cognitive psychotherapy on recurrence of duodenal ulcer: a prospective randomized trial.,I Wilhelmsen; T T Haug; H Ursin; A Berstad,"The aim of this prospective, randomized trial was to assess whether short-term cognitive psychotherapy (10 sessions during 4 months) could reduce the 1-year recurrence rate of duodenal ulcer. One group received psychotherapy; one group was a control group. One hundred patients, aged 17 to 64 years, with duodenal ulcer were selected from March 1989 to May 1991. The main outcome measure was relapse of duodenal ulcer, which was verified by endoscopy. When psychotherapy started after cessation of antiulcer medication, the relapse-free time was significantly shorter in the therapy group than in the controls. When the protocol was modified so that psychotherapy and antiulcer medication were given concomitantly, there was no significant difference in recurrence rate between the groups at 1-year follow-up (84% in the therapy group and 92% in the control group). Symptoms of upper abdominal discomfort/pain, measured every second month, decreased significantly in the therapy group compared to the control group. Psychotherapy led to less neuroticism (Eysenck Personality Questionnaire) and less trait anxiety (Spielberger Trait Anxiety Scale) compared to controls at 4 months. At the 12-month follow-up, most of this gain was lost, but the psychotherapy group had lower scores on ""concern about disapproval"" on the Sociotropy-Autonomy Scale than the control group. There is no beneficial effect of short-term cognitive psychotherapy on the 1-year recurrence rate of duodenal ulcer.",1994.0,0,0
834,7819903,Eradication of Helicobacter pylori should be pivotal in managing peptic ulceration. Eradication largely prevents relapse.,C J Hawkey,,1994.0,0,0
835,7819904,Eradication of Helicobacter pylori should be pivotal in managing peptic ulceration. Helicobacter pylori is not the causative agent.,C O Record,,1994.0,0,0
836,7839093,Intravenous omeprazole/amoxicillin and omeprazole pretreatment in Helicobacter pylori-positive acute peptide ulcer bleeding. A pilot study.,R J Adamek; M Freitag; W Opferkuch; G H Rühl; M Wegener,"The aims of this study were to evaluate a Helicobacter pylori eradication schedule for H. pylori-positive gastroduodenal ulcer bleeding, which could be commenced intravenously after endoscopic diagnosis, and to assess the effect of omeprazole pretreatment on bacterial eradication. In a prospective study 20 consecutive patients with H. pylori-positive acute peptide ulcer bleeding, who were managed conservatively including endoscopic injection therapy, were treated with a 2-week regimen consisting of either 40 mg omeprazole three times daily (with the exception of the loading dose of 80 mg) and 2 g amoxicillin three times daily intravenously for 3 days and 20 mg omeprazole twice daily and 1 g amoxicillin twice daily orally for 11 days (n = 10) or only with 40 mg omeprazole three times daily (with the exception of the loading dose of 80 mg) intravenously for 3 days and 20 mg omeprazole twice daily and 1 g amoxicillin twice daily orally for 11 days (n = 10). Subsequently, both groups received 20 mg omeprazole twice daily orally for 4 weeks. H. pylori eradication, defined as negative bacterial findings in urease test, culture and histology, or 13C-urea breath test at least 4 weeks after cessation of omeprazole medication, was achieved in 100% (10/10) of patients in the first group but only in 30% (3/10) of patients in the second group (p < 0.01). Ulcer healing was endoscopically confirmed in all but one patient in the second group. For the first time a promising concept for H. pylori eradication in H. pylori-positive ulcer bleeding is available by using a combined intravenous and oral omeprazole/amoxicillin therapy, which can be started intravenously immediately after an emergency upper GI endoscopy. In addition, these data imply that omeprazole pretreatment may not be wise when H. pylori eradication is attempted.",1994.0,0,0
837,7839956,Helicobacter pylori and peptic ulcer disease.,J P Cello,"Since William Beaumont's classic description of gastric physiology in 1847, the focus of clinical practice and basic research concerning gastric and duodenal ulcers has centered on the secretion of acid and pepsin. In addition to these well-known factors (largely determined by heredity, age, and oral intake), the search for other agents that alter the mucosal barrier has identified a bacillus, Helicobacter pylori, as a significant agent in the development of chronic gastritis and benign gastric and duodenal ulcers. This review explores the scientific evidence for an important causal role of H. pylori in the development of peptic ulcers on the basis of pathologic, pathophysiologic, and pharmacologic data.",1995.0,0,0
838,7851000,NSAID-induced peptic ulcer disease: a critical review of pathogenesis and management.,J M Scheiman,"Nonsteroidal anti-inflammatory drugs (NSAIDs) initiate gastroduodenal ulceration and promote complications such as bleeding and perforation. Age greater than 60 years, a prior history of ulcer disease, and concomitant corticosteroid use are important risk factors for ulcer development. NSAIDs interfere with mucosal defense via direct toxic effects in addition to cyclooxygenase inhibition and subsequent depletion of endogenous prostaglandins. While all NSAIDs are ulcerogenic, drugs which avoid topical injury and do not inhibit mucosal prostaglandins appear to have lesser risk of toxicity. Although NSAID injury requires luminal acid, prophylactic use of H2 receptor antagonists has been disappointing, preventing duodenal injury only. Greater acid suppression with proton pump inhibition appears promising. Prostaglandins are effective for prevention of NSAID-induced gastroduodenal injury, but are not well tolerated. Recent evidence suggests NSAID ulcers heal rapidly with proton pump inhibitors compared to H2 receptor antagonists in those patients who require continued NSAID therapy.",1994.0,0,0
839,7851056,Pharmacokinetic optimisation of the treatment of peptic ulcer in patients with renal failure.,U Gladziwa; U Koltz,"The pathogenesis of peptic ulceration is not yet clear. It could be due to an imbalance between acid secretion and mucosal defensive and/or protective mechanisms, but the association between Helicobacter pylori and peptic ulceration has questioned this hypothesis. Therefore, drugs inhibiting acid secretion and/or eradicating H. pylori are of major interest. Peptic ulcer disease is often associated with renal failure. For the selection of the proper dosage of these agents their pharmacokinetic properties and alterations in pharmacokinetics in various disease states, including renal failure, should be known. As histamine H2-receptor antagonists and pirenzepine are mainly eliminated by the renal route their elimination is dependent on creatinine clearance. Consequently, their elimination will be impaired in patients with renal insufficiency, which makes dosage reduction mandatory in these patients. No dosage supplementation is necessary after any type of dialysis because the drugs are removed in insignificant amounts by the various blood purification procedures. Misoprostol and proton pump inhibitors, such as omeprazole, lansoprazole and pantoprazole, are primarily eliminated by nonrenal routes. Therefore no dosage adjustments are necessary in patients with renal insufficiency. Bismuth salts, sucralfate and antacids should be avoided in patients with renal failure because of the accumulation of their cations and the associated risk of toxic reactions. For most agents more long term experience from comparative and double-blinded studies is needed to define better their clinical efficacy and tolerability in patients with renal failure.",1994.0,0,0
840,7860516,"Gastro-oesophageal reflux disease pathophysiology, diagnosis and management.",V Jayanthi; V R Shankar,,1994.0,0,0
841,7863247,Histologic patterns of omeprazole and nizatidine-healed duodenal ulcers:accuracy of endoscopic diagnosis.,A Russo; S Lanzafame; A Magnano; N Giannone; S Cosentino,"The mechanisms underlying duodenal ulcer (DU) recurrence after endoscopically confirmed healing are unclear. We sought to examine histologic differences in healing induced by omeprazole and nizatidine. This also entailed assessing interobserver variation in endoscopic diagnosis and the correlation between endoscopic and histomorphologic healing. We treated 31 DU patients for 4 weeks with either omeprazole (20 mg daily a.m.) or nizatidine (300 mg twice daily). The healing rates of both groups showed no significant differences (86.7% versus 81.2%; p = 0.5). Good mucosal repair rates did not differ significantly (38.5% versus 69.2% respectively; p = 0.5). Endoscopists' agreement over scar type was 0.80, with the chance of agreement 0.70 (k = 0.34 +/- -0.08). The correlation between macroscopic and histologic appearance of scars was fair, but fully significant (r = 0.48; p < 0.05). We conclude that the study was too small to detect significant differences in healing patterns between the two drugs. The wide variation in endoscopic diagnosis suggests that mucosal repair is best assessed by histologic examination of biopsy samples.",1994.0,0,1
842,7865492,The effect of eradication of Helicobacter pylori upon the duodenal ulcer recurrence--a 24 month follow-up study.,N Y Kim; H S Oh; M H Jung; S H Wee; J H Choi; K H Lee,"To evaluate the effect of eradication of Helicobacter pylori(H.pylori) in the patients with duodenal ulcer(Du) upon the DU recurrence. This study was performed for 190 patients with DU. Four different methods-microscopy of Gram stained mucosal smear, specific culture, biopsy urease test, histology of H &E staining-were taken for identifying colonization of H. pylori before treatment, and for finding the eradication of H. pylori 4 weeks after completion of therapy in each treatment group (cometidine, omeprazole, colloidal bismuth subcitrate(CBS), CBS and metronidazole double therapy, CBS, metronidazole and amoxicillin triple therapy). To detect DU recurrence, the gastroscopy was performed at 6, 12, 18, and 24 months after therapy. The eradication rate of the cimetidine group the omeprazole group, and the CBS group were 0%, 7.7%, 0%, respectively, and that of the double therapy group and the triple therapy group were 44.4% and 89.3%, respectively. Seventy three patients who were followed up for 2 years were categorized into two groups according to the eradication of H. pylori. The recurrence rate was 3.2% both in 1 year and 2 years later in the former group-one consisting of 31 patients with H. pylori eradicated, while the recurrence rate was 57.1% in 1 year and 78.6% in 2 years later, in the latter group-the other of 42 patients with H. pylori not eradicated. The eradication of H. pylori in patients with DU reduces the recurrence of DU.",1994.0,0,0
843,7865640,Scintigraphic assessment of the intragastric distribution and gastric emptying of an encapsulated drug: the effect of feeding and of a proton pump inhibitor.,J C Atherton; N Washington; M A Bracewell; L J Sutton; J L Greaves; A C Perkins; C J Hawkey; R C Spiller,"Local delivery of therapeutic agents to the stomach may be a useful strategy in the treatment of Helicobacter pylori infection. We aimed to see whether the intragastric distribution and gastric retention of a therapeutic agent could be improved, either by giving omeprazole or by dosing after a meal. Twelve healthy volunteers took part in this double-blind placebo-controlled crossover study comparing the effects of omeprazole 20 mg twice daily for 5 days with placebo, and the fasted with the fed state, on the gastric emptying and intragastric distribution of a soluble scintigrapic marker contained in a drug capsule. Dosing after food profoundly prolonged gastric residence of the drug label, prolonging mean time to 50% emptying (T50) from 0.5 +/- 0.1 h in the fasted state to 2.0 +/- 0.2 h when given after food. Food also improved intragastric distribution by increasing delivery to the body and fundus. Omeprazole enhanced the effect of food, prolonging T50 to 2.9 +/- 0.3 h, but had no effect in fasted subjects. Dosing after food markedly improves the aspects of local drug delivery to the stomach investigated in this study, and omeprazole enhances this effect. Post-prandial dosing may, therefore, be useful for improving delivery of some anti-Helicobacter agents.",1994.0,0,0
844,7865641,Amoxycillin capsules with omeprazole for the eradication of Helicobacter pylori. Assessment of the importance of antibiotic dose timing in relation to meals.,J C Atherton; N Hudson; G E Kirk; C K Hawkey; R C Spiller,"Giving antibiotics after meals prolongs their gastric residence time and improves their intragastric distribution. We aimed to see whether this would result in improved eradication of Helicobacter pylori. Eighty patients with H. pylori infection were treated with 40 mg omeprazole in the morning for 28 days and amoxycillin 500 mg q.d.s. for days 15-28. Amoxycillin dosing was randomised to either 1 h before or 10 min after food. Good compliance was pre-defined as missing less than four doses of amoxycillin or two of omeprazole. Amoxycillin dosing after meals was shown not to affect H. pylori eradication rate either when results were analysed on an intention-to-treat basis [amoxycillin before meals successful in 63% (25/40), after in 65% 26/40)] or for good compliers only [before meals 81% (17/21), after 71% (20/28)]. This excludes, with 95% confidence, a benefit of greater than 18% from dosing before, or 23% from dosing after meals. Good compliance, however, was shown to be important, with H. pylori eradication in 76% (37/49) of good compliers compared with 48% (11/23) of others completing the protocol (P < 0.05). The timing of antibiotic administration in relation to meals is not important in the treatment of H. pylori infection with this regimen of amoxycillin capsules and omeprazole. Good compliance, is however, an important determinant of treatment success.",1994.0,0,0
845,7865647,Long term treatment with omeprazole 20 mg three days a week or 10 mg daily in the prevention of duodenal ulcer relapse.,G Bianchi Porro; R Corinaldesi; M Lazzaroni; L Barbara; L Capurso; P Paoluzi; A Mangiameli; F Sabbatini; M Franceschi; E Bolling,"The aim of this study was to compare omeprazole 10 mg o.m. (daily) with omeprazole 20 mg o.m. on Friday to Sunday inclusive (weekend) in the prevention of duodenal ulcer relapse over a 6-month period. After an open healing phase (4 to 8 weeks) with omeprazole 20 mg o.m., 81 patients entered the follow-up phase. Forty-two were randomized in a double-blind double-dummy technique, to omeprazole 10 mg o.m., and 39 to omeprazole 20 mg at weekends. At 3 and 6 months or on symptomatic relapse the patients underwent endoscopy with gastric biopsies (quantitative assessment of argyrophilic and gastrin cells), symptom evaluation, and laboratory screening with fasting serum gastrin. Five patients in the 10 mg group and four in the weekend group were lost to follow-up. The estimated relapse rates over six months in the two groups receiving 10 mg daily or 20 mg at weekends were 19% and 31%, respectively (95% CI of percentage difference: -33% to 8%: intention-to-treat analysis, P = N.S.). During the follow-up phase, symptoms tended to be milder in the omeprazole 10 mg daily group compared to the weekend group. Gastrin levels increased significantly during the healing phase but then stayed almost constant in the omeprazole 10 mg group, and significantly decreased with weekend treatment. The median number of argyrophilic cells showed a slight but statistically significant increase in the omeprazole 10 mg daily group, but did not change in the weekend group. Both the healing and long-term therapies were well tolerated. Our data do not show a clear difference between the two treatment regimens, but there was a tendency towards a lower recurrence rate with omeprazole 10 mg daily compared with 20 mg weekend therapy.",1994.0,0,0
846,7865648,,,,,0,1
847,7866820,One-week low-dose triple therapy for the eradication of Helicobacter pylori infection.,J Labenz; M Stolte; G H Rühl; T Becker; B Tillenburg; M Sollböhmer; G Börsch,"To evaluate the efficacy and safety of two 1-week low-dose triple therapy regimens for the treatment of Helicobacter pylori infection. Eighty patients with H. pylori infection and peptic ulcer disease (n = 64) or functional dyspepsia (n = 16), with similar demographic and clinical characteristics, were treated for 1 week with either omeprazole 20 mg once in the morning and clarithromycin 250 mg and metronidazole 400 mg twice daily (OCM; n = 40) or with omeprazole 20 mg once in the morning and clarithromycin 250 mg and tetracycline 500 mg twice daily (OCT; n = 40). H. pylori infection was assessed by urease test, culture and histology performed before and 4 (or more) weeks after cessation of the eradication therapy. H. pylori infection was treated successfully in 38 out of 40 patients by OCM and in 26 out of 40 patients by OCT (95 versus 65%, respectively; P = 0.0015). The OCM regimen was well tolerated in all patients except for one who complained of epigastric pain. Three patients on the OCT regimen reported side effects (abdominal pain, diarrhoea, pruritus), two of whom discontinued the study medication after 1 day. The 1-week low-dose triple therapy comprising omeprazole, clarithromycin and metronidazole was highly effective in eradicating H. pylori and was well tolerated. The replacement of metronidazole by tetracycline resulted in a significant decrease in the eradication rate.",1995.0,0,0
848,7871380,Effects of omeprazole and eradication of Helicobacter pylori on gastric and duodenal mucosal enzyme activities and DNA in duodenal ulcer patients.,K Vetvik; E Schrumpf; P Mowinckel; S Aase; K J Andersen,"Duodenal and gastric content of mucosal enzymes in duodenal ulcer (DU) patients differs from that of controls. The purpose of this study has been to examine the effect of omeprazole and eradication of Helicobacter pylori on mucosal enzymes in DU patients. The enzyme activities of seven gastric and duodenal mucosal marker enzymes from the brush border, lysosomes, and mitochondria have been studied. In study I the measurements were made in 29 patients with an active DU before and after 14 days of omeprazole treatment. In study II 22 duodenal ulcer patients were given bismuth subnitrate, oxytetracycline, and metronidazole (triple therapy) for 2 weeks to eradicate H. pylori. Biopsy specimens were taken from the duodenum and the stomach for enzyme measurements and histologic assessment. In study II additional specimens were obtained from the prepyloric region for urease tests and culture of H. pylori. The ulcer healing rates were more than 90% after both omeprazole and triple therapy. H. pylori was eradicated in 86% after triple therapy. The activities of the brush-border enzymes lactase, neutral-alpha-glucosidase, alkaline phosphatase, leucyl-beta-naphthylamidase, and gamma-glutamyltransferase (gamma-GT) increased significantly in the duodenal bulb and the descending duodenum during treatment with omeprazole. No changes in duodenal enzyme activity were detected after triple therapy, whereas a significant fall in gamma-GT and acid phosphatase activities was seen in the stomach. The mucosal DNA in the gastric antrum decreased both after treatment with omeprazole and after triple therapy. A similar decrease in mucosal DNA of the gastric antrum was demonstrated after both omeprazole and triple therapy with bismuth subnitrate, oxytetracycline, and metronidazole. Omeprazole also affects the content of duodenal mucosal enzymes, whereas triple therapy particularly affects the gastric mucosal enzyme activity.",1994.0,0,0
849,7884169,Triple therapy eradicated H. pylori equally in patients pretreated with omeprazole or ranitidine. A 12-month follow-up.,A Archimandritis; V Balatsos; V Delis; A Mentis; K Kastanas; N Scandalis,"The aim of this study was twofold: first, to investigate the effectiveness of a standard triple therapy (tripotassium dicitrato bismuthate, 125 mg q.i.d., tetracycline hydrochloride 500 mg q.i.d., and metronidazole 500 mg t.i.d.) in eradicating Helicobacter pylori in patients with duodenal ulcer successfully healed with omeprazole or ranitidine; second, to examine the influence of the eradication on duodenal ulcer recurrence rate after 12 months. Two hundred forty-five consecutive H. pylori-positive patients with healed duodenal ulcer either with omeprazole (20 mg/day, 126 patients) or with ranitidine (150 mg b.i.d., 119 patients) given at random, began triple therapy for 15 days. H. pylori eradication was looked for 4-5 weeks later by culture of biopsy material, hematoxylin-eosin stain, and rapid urease test. H. pylori-eradicated patients were followed up for 12 months. Endoscopy was carried out at the end of the follow-up or whenever symptoms appeared. Five patients (2.0%) withdrew because of triple-therapy-related side effects. The eradication rate was 92% (220 of 240 patients); no difference was found between those healed with omeprazole (93%, 114 of 123 patients) or ranitidine (91%, 106 of 117 patients). Of 220 successfully treated patients, 132 completed the 12-month follow-up. The duodenal ulcer recurrence rate was 4% (5 of 132 patients); 3% (2 of 70) in the omeprazole group and 5% (3 of 62) in the ranitidine group healed. All the recurrences were asymptomatic. H. pylori recurrence rate was 11% (14 of 132 patients); no difference was found between patients healed with omeprazole (10%, 7 of 70 patients) or with ranitidine (11%, 7 of 62 patients). All the recurrent duodenal ulcers occurred in H. pylori-positive patients (36%, 5 of 14 patients). Standard triple therapy after duodenal ulcer healing with omeprazole or ranitidine eradicates H. pylori in comparable high rates. Side effects were mild and dropouts were only 2%. Ulcer recurrence rate 12 months after eradication was low and comparable between those healed with omeprazole or ranitidine.",1995.0,0,0
850,7884170,"Comparison of serum anti-gliadin, anti-endomysium, and anti-jejunum antibodies in adult celiac sprue.",C Sategna-Guidetti; S Grosso; M Bruno; S B Grosso,"We compared the diagnostic accuracy of a new immunological marker of celiac sprue (CS), the antijejunum antibody (JAB), with that of antigliadin (AGA) and antiendomysium (EmA) antibodies. One hundred untreated adults with biopsy-proven CS, 52 healthy controls, and 57 patients with inflammatory bowel disease, lymphoma of the small bowel, Whipple's disease, and irritable bowel syndrome were investigated. Only JAB and EmA were detected at a similar titer in all patients with untreated CS but in no controls (100% sensitivity and specificity). Sensitivity of AGA was, respectively, 55% for IgA and 78% for Ig class, with a 100 and 82% specificity. The differences in frequencies between both EmA and JAB with IgA and IgG AGA were highly significant. We conclude that JAB and EmA provide a reliable noninvasive screening test for clinically significant gluten-sensitive enteropathy. The lower cost of IgA-JAB is a major advantage, owing to the different availability of the lower third of the esophagus and jejunum from primates. The sensitivity and specificity of the two tests are almost identical, but we find interpreting EmA easier than JAB especially when the titer is low.",1995.0,1,1
851,7884660,"Pharmacokinetic properties of a novel gastric proton pump inhibitor, (+/-)-2-[(4-methoxy-6,7,8,9-tetrahydro-5H-cyclohepta[b]pyridin-9- yl)sulfinyl]-1H-benzimidazole sodium salt, in healthy subjects.",T Uematsu; M Nakano; K Kosuge; A Nagai; A Sato; M Nakashima,"The pharmacokinetics and safety of TY-11345 [(+/-)-2-[(4-methoxy-6,7,8,9-tetrahydro-5H-cyclohepta[b]pyridin-9- yl)sulfinyl]-1H-benzimidazole sodium salt], a novel gastric proton pump inhibitor, were studied in healthy male volunteers after single (20, 40, and 80 mg) and repeated oral doses (60 mg, once daily for 7 days) as enteric-coated tablet. At the single doses of 20 and 40 mg, intragastric pH was continuously monitored in each of two subjects. No abnormal findings definitely attributable to the test drug were observed throughout the study. In the single-dose study, the maximum plasma concentration (Cmax) and area under the plasma concentration-time curve of TY-11345 increased in a dose-proportional manner. The time to reach Cmax was about 3 h after dosing and plasma concentrations declined thereafter with a half-life of about 1 h irrespective of dose. The effect of food intake on the pharmacokinetic parameters of TY-11345, which was evaluated at the dose of 40 mg in a cross-over design, was not significant. TY-11345 was not detected in urine unchanged, while a main metabolite and its conjugate were identified in urine as 32-38% of the dose. An intragastric pH value over 4 was obtained about 3 h after the administration of 40 mg and maintained for more than 5 h, despite the fall of plasma concentration. This effect was less obvious at a dose of 20 mg. In the multiple-dose study, the pharmacokinetics exhibited no substantial difference between the first and last doses.(ABSTRACT TRUNCATED AT 250 WORDS)",1994.0,0,0
852,7886394,Omeprazole plus amoxicillin for cure of Helicobacter pylori infection. Factors influencing the treatment success.,J Labenz; F Leverkus; G Börsch,"Omeprazole plus amoxicillin may cure Helicobacter pylori infection. However, the published results vary rather widely, and the factors influencing the treatment success remain unclear. Four hundred and twenty-three H. pylori-positive patients were treated with 1- or 2-week regimens comprising 40 mg or 80 mg omeprazole and amoxicillin in 11 prospective protocols. A complete set of data was available for 405 patients (ulcer disease, n = 383; dyspepsia, n = 22) and was submitted to uni- and multi-variate statistical analyses to elucidate the factors affecting the cure rates of the infection; 18 patients were lost to follow-up. The overall proportion of H. pylori cure was 76%. Insufficient compliance (p < 0.001), a short duration of treatment (p < 0.001), smoking (p = 0.003), and omeprazole pretreatment (p = 0.041) were the significant independent factors predicting treatment failure, whereas advanced age (p = 0.002), high scores of grade and of activity of gastritis (p = 0.035 and p = 0.019, respectively), and gastric ulcer disease (p = 0.058) were independent factors predicting treatment success. Several patient- and therapy-related factors diminish or increase the rate of H. pylori cure obtained by omeprazole/amoxicillin. These should be considered in future studies comparing different treatment regimens for curing H. pylori infection and also when designing treatment regimens applicable for routine clinical practice.",1994.0,0,0
853,7895926,High-dose omeprazole plus amoxicillin or clarithromycin cures Helicobacter pylori infection in duodenal ulcer disease.,J Labenz; M Stolte; C Domian; J Bertrams; G Börsch,"Treatment with omeprazole plus amoxicillin or clarithromycin resulted in encouraging Helicobacter pylori cure rates in pilot and controlled studies. The present prospective, randomized study was designed to compared the efficacy and safety of amoxicillin and clarithromycin as constituents of omeprazole-enhanced antibiotic therapy of H. pylori infection. Fifty patients with active duodenal ulcer disease and histologically and/or culturally confirmed H. pylori colonization of the gastric mucosa were treated with omeprazole (day 1-14: 40 mg twice daily, day 15-42: 20 mg once in the morning). The patients were randomly assigned to receive either amoxicillin (1 g twice daily; group I: n = 25) or clarithromycin (500 mg twice daily; group II: n = 25) during the first 2 weeks of treatment. The patients of group I and II had comparable demographic and clinical characteristics. One patient of group I was lost to follow-up. H. pylori infection was cured in 87.5% of group I and 84.0% of group II (p = 1.00). All ulcers had healed after 6 weeks of omeprazole treatment. Pain relief occurred within the first day of treatment in the majority of patients of both groups (p = 0.89). Minor side effects were recorded in 6 patients of group I and in 4 patients of group II (25 vs. 16%; p = 0.50). In 1 female patient amoxicillin had to be withdrawn after 3 days because of nausea and emesis. In conclusion, 2 weeks of treatment with omeprazole plus amoxicillin or clarithromycin are highly and equally effective regimens to cure H. pylori infection in patients with duodenal ulcer disease.",1995.0,0,0
854,7895928,Effect of intravenous infusion of omeprazole and ranitidine on twenty-four-hour intragastric pH in patients with a history of duodenal ulcer.,S Kiilerich; T Rannem; L Elsborg,"The effect on intragastric pH of two different dose regimens of continuous intravenous infusion of omeprazole (4 or 8 mg/h after a bolus of 80 mg), and ranitidine (0.25 mg/kg/h after a bolus of 50 mg) was studied in 10 patients with duodenal ulcer disease in symptomatic remission. The pH was monitored over 24-hour periods during fasting in a cross-over, randomised design including a baseline period. With the high omeprazole dose it was possible to maintain a pH > or = 4 in all patients but 1 and 6 of the patients also maintained a pH > or = 6. The lower dose of omeprazole seemed to be somewhat less effective. Continuous infusion of ranitidine was as efficient as the higher omeprazole infusion although with a tendency to decreased pH levels towards the end of the 24-hour period. Thus, in order to obtain consistently high pH levels of 4-6 over a prolonged period a continuous infusion of omeprazole, an 80-mg bolus plus a continuous infusion of 8 mg/h seem to be needed.",1995.0,0,0
855,7898228,Effect of acid suppression on efficacy of treatment for Helicobacter pylori infection.,W de Boer; W Driessen; A Jansz; G Tytgat,"Eradication of Helicobacter pylori from the stomach by triple therapy with bismuth, tetracycline, and metronidazole cures peptic ulcer disease. We investigated whether concomitant acid inhibition with omeprazole would improve the results of triple therapy. 108 consecutive patients with peptic-ulcer disease and biopsy-proven H pylori infection were randomised to 7 days of triple therapy with or without omeprazole 20 mg twice daily. Patients in the omeprazole-treated group were pretreated with 3 days of omeprazole. Eradication of H pylori was assessed by 10 endoscopic biopsies for urease test, histology, and culture 4-6 weeks after treatment. 53 of 54 (98.1%) patients treated with omeprazole were cured compared with 45 of 54 (83.3%) of those not treated (p = 0.02), a difference in efficacy of 14.8% (95% Cl 4.2-25.4%). Most side effects were mild and did not interfere with compliance; 105 patients (97.2%) finished treatment. Gastro-intestinal side effects were significantly fewer in the omeprazole group. We conclude that the addition of omeprazole to triple therapy improves efficacy, lessens side effects, and is sufficiently efficacious to obviate the need for a diagnostic test of cure in compliant patients.",1995.0,0,0
856,7906759,Duodenal ulcer healing by eradication of Helicobacter pylori without anti-acid treatment: randomised controlled trial.,S W Hosking; T K Ling; S C Chung; M Y Yung; A F Cheng; J J Sung; A K Li,"Randomised trials have shown that duodenal ulcers treated by H2 blockers heal faster if Helicobacter pylori is eradicated concurrently. It remains unknown whether eradication of H pylori without suppression of acid-secretion, is sufficient to allow healing. 153 patients with H pylori infection and duodenal ulcer were randomised to receive either a 1-week course of bismuth subcitrate, tetracycline, and metronidazole (76), or omeprazole for 4 weeks with the same three-drug regimen for the first week (77). Endoscopy and antral biopsies were done at entry and 4 weeks after treatment. 132 patients were suitable for analysis. Duodenal ulcers healed in 60 (92%; 95% CI 86-100%) patients taking bismuth, tetracycline, and metronidazole compared with 63 (95%; 88-100%) taking omeprazole in addition to the three other drugs. H pylori was eradicated in 61 (94%; 88-100%) who received only three drugs compared with 66 (98%; 96-100%) who received omeprazole as well. Symptoms were reduced more effectively during the first week in patients who received omeprazole (p = 0.003). We conclude that a 1-week regimen of bismuth, tetracycline, and metronidazole for patients with H pylori and duodenal ulcer eradicates the organism and heals the ulcer in most patients. Concurrent administration of omeprazole reduces ulcer pain more rapidly but has no effect on ulcer healing.",1994.0,0,0
857,7911400,Treatment of gastroesophageal (acid) reflux with lansoprazole: an overview.,G Dobrilla; F Di Fede,"Despite the fact that reflux esophagitis is a multifactorial disease, inhibition of gastric acid secretion is the mainstay of medical treatment, both for moderate and severe cases. Antisecretory agents lower the acidity of the refluxate, thus decreasing its aggressive effect, which favors the mucosal healing process. The greater the acid inhibition, the greater will be the mucosal repair. This is the reason for a therapeutic gain for H2-receptor antagonists over anticholinergics and antacids, and for proton pump inhibitors over H2-receptor antagonists. The most recently developed proton pump inhibitor, lansoprazole, at doses of 15, 30, or 60 mg/day for 4 and 8 weeks of treatment, has proven to be significantly more effective than placebo (one multicenter study involving 292 patients) or ranitidine (three multicenter studies involving 653 patients) in terms of mucosal healing and symptom relief. In two comparative trials with omeprazole 20 mg vs lansoprazole 30 mg (in a total of 349 evaluable patients) healing rates were found to be similar, but in one trial the relief of heartburn proved to be significantly more pronounced in patients receiving lansoprazole who also used fewer antacids. The frequency of adverse events was comparable in the two treatment groups. Reflux esophagitis is a chronic condition and after stopping antisecretory treatment, including lansoprazole, most patients relapse in terms of symptoms and endoscopical lesions, which suggests the need for long-term treatment. However, a strategy for long-term control of reflux esophagitis remains to be defined (lower daily dose, alternate-day standard dose, or concomitant prokinetic drugs?). The safety of proton pump inhibitors given for prolonged periods also needs to be more thoroughly evaluated.",1993.0,0,0
858,7913348,"Omeprazole versus ranitidine plus somatostatin in the treatment of severe gastroduodenal bleeding: a prospective, randomized, controlled trial.",O Goletti; F Sidoti; P V Lippolis; F De Negri; E Cavina,"In a randomized, controlled clinical trial omeprazole was compared with ranitidine plus somatostatin in the treatment of severe acute gastrointestinal bleeding due to peptic pathology. Intravenous infusion of the drugs was administered until clinical stabilization or surgical operation. The two regimens were equally effective in controlling bleeding. The need for blood transfusion and surgical operation together with the mortality rate did not differ significantly between groups. No toxic effects were observed as a result of the infusion of omeprazole. In this study the infusion of omeprazole alone showed an efficacy comparable to the association of ranitidine and somatostatin in the treatment of severe acute peptic bleeding.",1994.0,0,0
859,7913635,Review article: drug therapy for reflux oesophagitis.,W A de Boer; G N Tytgat,"Gastro-oesophageal reflux disease is a common disorder and symptoms can be mild to severe. Management of the disease should be individualized. Life-style changes are important for all patients. Drug therapy is often necessary but only very few patients with severe disease need surgical treatment. The purpose of this article is to focus on drug therapy and to review the clinical trials of all the drugs used for gastro-oesophageal reflux disease. Thereafter, judged solely on the data derived from these trials, a practical approach to the management of gastro-oesophageal reflux disease is suggested.",1994.0,0,0
860,7921146,Causal role of Helicobacter pylori in peptic ulcer relapse.,M Asaka; T Ohtaki; M Kato; M Kudo; T Kimura; T Meguro; S Horita; K Inoue,"Helicobacter pylori has been shown to infect the gastric mucous layer of almost all patients with duodenal ulcer disease, as well as that of most patients with gastric ulcer disease. Recent studies have suggested that the eradication of H. pylori affects the natural history of duodenal ulcer disease such that the rate of relapse decreases markedly. We evaluated the relationship between H. pylori infection and peptic ulcer relapse in a Japanese population following a prospective study. Seven of 18 (38.9%) gastric ulcer patients positive for H. pylori relapsed by the end of 1 year, whereas only 1 of 9 (11.1%) gastric ulcer patients without H. pylori developed ulcer relapse (P < 0.05). Relapse rates of duodenal ulcer patients negative for H. pylori were significantly lower than those positive for H. pylori within 1 year (0% vs 66.7%; P < 0.01). The effects of anti-H. pylori drugs on the eradication of H. pylori were examined in 50 patients with peptic ulcers. Eradication rates with a proton pump inhibitor (PPI) alone (omeprazole 20 mg) showed the lowest values (4 of 13; 30.8%). The rates were: 44.4% for amoxicillin alone (4 of 9); 70% for triple therapy consisting of amoxicillin, metronidazole, and bismuth subnitrate (14 of 20); and 87.5% for concomitant therapy of the PPI plus amoxicillin (7 of 8). Reinfection rates of H. pylori within 1 year after eradication of this organism were distinctly higher in the PPI alone group (80%) than in other groups (18.2%-32.4%).(ABSTRACT TRUNCATED AT 250 WORDS)",1994.0,0,0
861,7942668,Omeprazole 40 mg o.m. combined with amoxycillin alone or with amoxycillin and metronidazole in the eradication of Helicobacter pylori.,K L Goh; S C Peh; N Parasakthi; N W Wong; K K Tan; Y L Lo,"Our objectives were to determine the effect of dual therapy with omeprazole and amoxicillin and of triple therapy with omeprazole, amoxicillin, and metronidazole in the eradication of Helicobacter pylori (HP) and to study the long-term results of eradication in these patients. A prospective, randomized, controlled trial was performed. Patients who were recruited had unequivocal evidence of HP infection based on culture, histology, rapid urease test, and Gram's stain of a tissue smear. Eradication was defined as the absence of bacteria in all tests performed on both corpus and antral biopsies. The infection was eradicated in 15 of 19 (78.9%) patients randomized to receive dual therapy and in 19 of 22 (86.4%) patients who received triple therapy. We followed the course of 30 patients in whom HP had been eradicated for a prolonged term (up to 12 months). All remained clear of HP. Twenty-five of 28 patients (89.3%) with duodenal ulcers in whom HP was successfully eradicated remained healed at 12 months. Fewer side effects were reported among patients who received the dual therapy. Combination therapy with omeprazole and amoxicillin with or without metronidazole is effective in the eradication of HP. In particular, the dual therapy regimen with amoxicillin is not only effective but is also well tolerated by patients.",1994.0,0,0
862,7942680,Effect of up to 3 years of high-dose lansoprazole on Barrett's esophagus.,R E Sampliner,"Barrett's esophagus is a metaplastic condition resulting from gastroesophageal reflux disease. Previous medical and surgical therapies have failed to predictably eradicate Barrett's. The objective of this study was to assess the impact of long-term, high-dose lansoprazole, a proton pump inhibitor, on Barrett's esophagus. Patients with Barrett's esophagus at least 3 cm long and with specialized columnar epithelium were treated with 60 mg of lansoprazole each morning. Every 6 months, patients had standardized symptomatic, laboratory, and endoscopic assessment. The length of Barrett's esophagus was measured, photo-documented, and biopsied. Twenty-seven patients with Barrett's esophagus have been treated an average of 2.9 yr. Symptoms improved (70%, 19 patients), and erosive esophagitis healed (100%, 13 patients), but there was no significant reduction in the length of Barrett's epithelium (mean length at baseline 5.7 cm, final visit 5.3 cm). However, by the final visit, 20 of 26 patients (77%) had squamous islands: two unchanged in size, six with increased surface area, and 12 newly developed on therapy. Initially, mean fasting gastrin levels rose significantly but then plateaued after 1 month of therapy. Of 10 patients with gastrin levels for 18 months or longer, only one had a level > or = 400 pg/ml. Lansoprazole 60 mg for up to 3 yr was safe and effective in controlling symptoms and esophagitis. The impact on the extent of Barrett's esophagus over this time interval was manifested by the extension and development of squamous islands.",1994.0,0,0
863,7942755,Pharmacodynamics of famotidine in gastric ulcer.,V Savarino; G S Mela; P Zentilin; S Vigneri; G Celle,,1994.0,0,0
864,7951847,Serum gastrin levels following administration of omeprazole alone or in combination with pirenzepine.,A Iwasaki; K Miyazawa; Y Kawamura; Y Sakai; Y Tashiro; K Ito; Y Arakawa; Y Matsuo,"Serum gastrin levels in 44 peptic ulcer patients (26 gastric ulcer patients and 18 duodenal ulcer patients) were determined after they had been treated with omeprazole (OPZ) (20 mg/day) alone or in combination with pirenzepine (PZP) (100 mg/day). Serum gastrin levels were measured before, as well as 2, 4, and 6 weeks after administration, and the changes were compared. The levels were significantly elevated (twofold) at 2 weeks of treatment in both the OPZ and OPZ plus PZP groups. In patients taking OPZ alone, the levels rose up to 6 weeks, while in those taking OPZ plus PZP the levels decreased at 4 and 6 weeks. At 4 weeks, serum gastrin levels in the OPZ plus PZP group were lower (although not significantly) than those in patients taking OPZ alone. In gastric ulcer patients, serum gastrin levels in the OPZ group were significantly elevated, while in the OPZ plus PZP group, these levels were only slightly, but not significantly elevated. There was no significant difference between the two gastric ulcer groups at any time. In duodenal ulcer patients, serum gastrin levels increased significantly at 2 weeks of treatment in both groups. At 4 weeks and thereafter, the serum gastrin levels remained significantly high in patients taking OPZ alone, while they decreased at both 4 and 6 weeks in patients taking OPZ plus PZP. Thus, serum gastrin levels in duodenal ulcer patients were markedly decreased by the addition of PZP.(ABSTRACT TRUNCATED AT 250 WORDS)",1994.0,0,0
865,7960688,"A multicenter, double-blind, randomized controlled study of omeprazole versus ranitidine in the treatment of duodenal ulcer in Israel.",N Arber; Y Avni; R Eliakim; A Swissa; E Melzer; D Rachmilewitz; F Konikoff,"A multicenter, double-blind, randomized, controlled study of 203 Israeli patients with endoscopically proven duodenal ulcer is described. The study compares the efficacy (i.e., ulcer healing and relief of symptoms) and safety of 20 mg omeprazole once daily in the morning, with those of 300 mg ranitidine once daily at night. The omeprazole group had significantly higher cumulative healing rates than the ranitidine group both at day 15 (71% vs. 55%, P < 0.03) and day 29 (94% vs. 86%, P < 0.05). The efficacy was unaffected by known risk factors such as smoking. The omeprazole group had significantly fewer days with pain than the ranitidine group (median 1 vs. 3.5 days) (P < 0.03). There were no differences in ulcer size, symptoms or healing rates between Ashkenazi and Sephardic patients who were born in Israel, or who had immigrated to Israel. In summary, the present study confirms the efficacy and safety of omeprazole in the treatment of duodenal ulcer. Omeprazole provides more rapid relief of the symptoms and heals a greater proportion of duodenal ulcers, within 2-4 weeks, than ranitidine.",1994.0,1,1
866,7986962,Review article: Helicobacter pylori eradication--understandable caution but no excuse for inertia.,J G Penston,"The long-term management of patients with peptic ulcer disease is unsatisfactory, as judged by the persistently high levels of haemorrhage, perforation and death from this condition in Western countries. Although ulcer recurrence and complications can be prevented, many patients with peptic ulcer disease fail to receive the benefits of modern therapeutic regimens. In recent years, eradication of Helicobactor pylori has been promoted as a 'cure' for peptic ulcer disease and, while such claims are premature, there can be little doubt that this treatment--when successful--dramatically improves the medium-term prognosis of ulcer patients. However, in general, clinicians have given this promising therapeutic advance a lukewarm welcome. The aim of this detailed review of the literature is to remove the uncertainty and confusion surrounding many aspects of eradication therapy. Estimates are provided of the eradication rates after either triple therapy or the combination of omeprazole plus amoxycillin, and the sources of variation in published studies are discussed. Problems associated with eradication therapy, including side effects, compliance and re-infection, are addressed in order to ascertain the extent and clinical significance of each factor. In addition, studies reporting the outcome of patients with peptic ulcer disease after eradication are assessed with reference to both ulcer recurrence and complications. The result of the review is to dissipate much of the scepticism concerning eradication therapy. However, whilst acknowledging the efficacy of eradication therapy, its limitations have also to be recognized. By itself, it does not provide the complete answer to peptic ulcer disease. For some ulcer patients, eradication therapy is the preferred option; for others, prophylactic therapy with H2-receptor antagonists is more suitable. Guidelines are proposed for the selection of patients for each alternative therapy. The crucial point is that patients with peptic ulcer--excluding the small proportion with a mild form of the disease--require positive, long-term management consisting of either continuous prophylaxis with H2-receptor antagonists or the eradication of Helicobacter pylori.",1994.0,0,0
867,7990246,Hypertension in the elderly. Implications and generalizability of randomized trials.,C D Mulrow; J A Cornell; C R Herrera; A Kadri; L Farnett; C Aguilar,"To estimate morbidity and mortality benefits of drug therapy for hypertensive elderly subjects, compare these benefits with effects in younger subjects, and provide a framework for generalizing results derived from trials to actual patients. A literature search using MEDLINE from 1966 to 1993, references from reviews and trial articles, and experts. Randomized trials lasting at least 1 year that evaluated effects of drug treatment on morbidity and mortality outcomes in hypertensive persons. Four independent reviewers appraised protocol characteristics and quality of selected trials. There were 13 trials involving 16,564 elderly persons (age 60 years and older). The prevalence of cardiovascular risk factors, cardiovascular disease, and competing comorbid diseases was lower among trial participants than the general population of hypertensive elderly persons. When the six large high-quality trials were combined, trial results showed 43 subjects (95% confidence interval [CI], 31 to 69) and 61 subjects (95% CI, 39 to 141) needed to be treated for 5 years to prevent one cerebrovascular event and one coronary heart disease event, respectively. Including the other seven trials did not change the results significantly. Only 18 subjects (95% CI, 14 to 25) needed to be treated to prevent one cardiovascular event (cerebrovascular or cardiac). Twelve trials in primarily younger and middle-aged adults involved approximately 33,000 persons. For all outcomes except cardiac mortality, two to four times as many of the younger subjects as the older subjects needed to be treated for 5 years to prevent morbid and mortal events. No significant effect on cardiac mortality was seen among younger subjects, while 78 older subjects (95% CI, 50 to 180) needed to be treated to prevent a fatal cardiac event. Randomized trials demonstrate that treating healthy older persons with hypertension is highly efficacious. Five-year morbidity and mortality benefits derived from trials are greater for older than younger subjects. Extrapolating benefits from trials to individual patients is difficult, but should take into account multiple issues including the patient's risk factors, preexisting cardiovascular disease, and competing comorbid illnesses.",1994.0,0,0
868,8007082,NIH Consensus Conference. Helicobacter pylori in peptic ulcer disease. NIH Consensus Development Panel on Helicobacter pylori in Peptic Ulcer Disease.,,,1994.0,0,0
869,8016006,Omeprazole in the treatment of asthmatics with nocturnal symptoms and gastro-oesophageal reflux: a placebo-controlled cross-over study.,G A Ford; P S Oliver; J S Prior; R J Butland; S P Wilkinson,"Eleven adult patients with nocturnal asthma, and gastro-oesophageal reflux documented by endoscopy or ambulatory oesophageal pH monitoring completed a double-blind cross-over study (4 week treatment, one week run-in and cross-over periods) comparing the effects of omeprazole 20 mg daily and placebo on asthma control assessed by symptoms, peak expiratory flow rate and bronchodilator usage. Omeprazole treatment did not improve asthma symptoms during the day or night, or peak expiratory flow rate readings. There was no difference in bronchodilator inhaler usage during omeprazole therapy. Treatment of gastro-oesophageal reflux with omeprazole in patients with nocturnal asthma and gastro-oesophageal reflux does not improve asthma symptoms or peak expiratory flow rate. This suggests that gastro-oesophageal reflux does not exacerbate bronchoconstriction in nocturnal asthma.",1994.0,0,0
870,8017361,Bismuth-free triple therapy for eradicating Helicobacter pylori and reducing the gastric ulcer recurrence rate.,M Karita; M G Morshed; K Ouchi; K Okita,"The goals of this study were to assess the effectiveness of a new triple therapy consisting of amoxicillin and metronidazole with plaunotol in the eradication of Helicobacter pylori infection in humans, and to determine whether this treatment regimen reduces the rate of recurrence of gastric ulcer in patients infected with H. pylori, without instituting maintenance therapy with H2-receptor antagonists. Thirty patients with active gastric ulcer who were infected with H. pylori were first treated with omeprazole until scarring occurred. Patients then received plaunotol for 4 wk, with amoxicillin and metronidazole for 7 days. This triple therapy resulted in the safe eradication of H. pylori in 26 (86.7%) of 30 patients, with no recurrence of ulcer seen during a 12-month follow-up period in patients who tested negative for the presence of H. pylori. In addition, histological inflammatory changes improved in these patients. Of the four patients with persistent H. pylori infection, in three (75%), ulcers recurred. This new triple therapy was very effective in eradicating H. pylori in infected patients and in reducing the rate of recurrence of gastric ulcer in these patients.",1994.0,0,0
871,8017742,Long-term treatment with omeprazole for refractory reflux esophagitis: efficacy and safety.,E C Klinkenberg-Knol; H P Festen; J B Jansen; C B Lamers; F Nelis; P Snel; A Lückers; C P Dekkers; N Havu; S G Meuwissen,"To evaluate the long-term efficacy and safety of omeprazole in patients with gastroesophageal reflux disease resistant to treatment with histamine-2 (H2)-receptor antagonists. Cohort analytic study with a mean follow-up of 48 months (range, 36 to 64 months). Patients receiving ambulatory care from referral centers. 91 patients with gastroesophageal reflux disease resistant to treatment with an H2-receptor antagonist but subsequently responsive to 40 mg of omeprazole daily. Open maintenance therapy consisting of 20 mg of omeprazole daily in 86 patients and 40 mg daily in 5 patients. Endoscopy to assess healing; side effects, laboratory values, fasting serum gastrin level, and gastric corpus biopsies to assess safety. Esophagitis recurred in 47% of the patients receiving 20 mg of omeprazole daily, but all rehealed after the dose was doubled. Seven of 40 patients (18%) had a second relapse after a mean follow-up time of 24 months (range, 9 to 36 months) that was successfully treated with a further 20-mg dose increment for a mean period of 36 months (range, 6 to 39 months). Median gastrin levels increased initially from 60 ng/L before study entry to 162 ng/L (P < 0.01) with treatment and reached a plateau during maintenance treatment. Very high gastrin levels (> 500 ng/L) were observed in a subgroup (11%) of patients. The incidence of micronodular hyperplasia increased from 2.5% of the patients at first biopsy to 20% at the last biopsy (P = 0.001), with a corresponding progression of gastritis to subatrophic or atrophic gastritis from less than 1% to 25% (P < 0.001), which was more pronounced in patients with very high serum gastrin levels. Maintenance therapy with omeprazole was effective for at least 5 years in patients with gastroesophageal reflux disease resistant to treatment with H2-receptor antagonists. Treatment was accompanied by a persistent increase in serum gastrin levels and an increase of micronodular argyrophil cell hyperplasia and subatrophic or atrophic gastritis.",1994.0,0,1
872,8020815,Effect of omeprazole and sucralfate on prepyloric gastric ulcer. A double blind comparative trial and one year follow up.,H T Sørensen; H H Rasmussen; I Balslev; S Boesby; J Boné; A Kruse; S N Rasmussen,"This study compared healing rates, relief of symptoms, frequency of adverse events, and proportion of patients in remission after one year follow up in 104 patients with active prepyloric ulcer during treatment with 40 mg omeprazole once daily or 2 g sucralfate twice daily, using a randomised double blind controlled trial. Healing rates after two, four, and six weeks were (omeprazole/sucralfate) 49%/23%; 83%/59%; 90%/70% respectively. After two weeks, omeprazole was more efficient than sucralfate in relief of daytime and nocturnal epigastric pain, nausea, and heartburn. The proportion of patients in remission after one year follow up was significantly higher in the omeprazole group (p < 0.01). Of the healed patients ulcers recurred in 36% in the omeprazole group and in 46% in the sucralfate group. It is concluded that the ulcer healing rate was higher and symptom relief was more pronounced in the omeprazole group compared with the sucralfate group, and that more patients were still in remission after a one year follow up period.",1994.0,0,0
873,8023719,Comparison of omeprazole and histamine H2-receptor antagonists in the treatment of elderly and young patients with reflux oesophagitis.,O F James; K S Parry-Billings,"Retrospective analyses of two multicentre clinical trials were carried out to examine the association of age with endoscopically verified reflux oesophagitis lesions and symptoms before and after 4 or, if necessary, 8 weeks randomized double-blind treatment with omeprazole (20 mg o.m.) or histamine H2-receptor antagonists (H2RA) (cimetidine 400 mg q.d.s. or ranitidine 150 mg b.d.). Of the elderly patients (> or = 65 years) 79 received omeprazole, 39 cimetidine and 36 ranitidine; of the young patients (< 65 years) 200 received omeprazole, 94 cimetidine and 102 ranitidine. The objective of treatment was to heal the oesophagus and to relieve the patient's symptoms. On completion of the studies the proportion of elderly omeprazole-treated patients (68%) healed and symptom-free was nearly three times that of elderly H2RA-treated patients (23%, p < 0.001). In the young patient group the proportion of omeprazole-treated patients (57%) both healed and symptom-free was nearly twice that of H2RA-treated patients (29%, p < 0.001). The advantage of omeprazole over H2RA, in terms of endoscopic healing and symptom relief, is at least as great in elderly patients as in younger patients.",1994.0,0,1
874,8038354,Rapid healing of gastric ulcers with lansoprazole.,K D Bardhan; J Ahlberg; W S Hislop; C Lindholmer; R G Long; A G Morgan; S Sjostedt; P M Smith; R Stig; K G Wormsley,"Lansoprazole is a new proton pump inhibitor which powerfully decreases acid secretion. We compared the efficacy and short-term safety of lansoprazole against ranitidine in the healing of gastric ulcer. This was a parallel group, comparative multicentre, prospectively randomized, double-blind study which included 250 patients with gastric ulcer, 219 of whom had follow-up endoscopic data. Both lansoprazole 30 mg and 60 mg daily produced significantly more rapid healing of gastric ulcer than ranitidine 300 mg nightly with healing rates after 4 weeks of 78% (P < 0.05), 84% (P < 0.01) and 61%, respectively. After 8 weeks, the corresponding healing rates were 99%, 97% and 91% (P = 0.08). Symptom relief was similar for all treatment groups, but fewer antacids were used by patients receiving lansoprazole. Sixty-nine patients experienced 91 adverse events; the incidence, pattern and severity was similar across all three treatment groups. Lansoprazole 30 mg and 60 mg once daily had similar efficacy. Both were superior to ranitidine 300 mg nocte in healing gastric ulcer. The short-term safety profile of lansoprazole was similar to ranitidine. These data indicate that lansoprazole should be used at a dose of 30 mg once daily for the treatment of gastric ulcers.",1994.0,0,1
875,8038358,Short report: omeprazole-tetracycline combinations are inadequate as therapy for Helicobacter pylori infection.,M T al-Assi; R M Genta; D Y Graham,"Current triple antimicrobial therapies cure Helicobacter pylori infection in 60-90% of cases but are cumbersome. Addition of omeprazole to amoxycillin has been shown to enhance effectiveness when compared to amoxycillin alone. We studied omeprazole 20 mg t.d.s. plus tetracycline 500 mg q.d.s. for 14 days (OMP/TCN) and omeprazole 40 mg in the morning plus tetracycline 500 mg q.d.s. along with bismuth subsalicylate tablets 2 q.d.s. (OMP/TCN/BSS) for 14 days. Forty-four patients (19 OMP/TCN, 25 OMP/TCN/BSS) with H. pylori peptic ulcer disease were studied. H. pylori status was evaluated at least 4 weeks after ending antimicrobial therapy. In the OMP/TCN group cure of H. pylori infection was achieved in 5/19 (26%). Adding bismuth to the regimen improved the results; 4 weeks after ending therapy cure of H. pylori infection was achieved in 12/25 (48%). Neither regimen can be recommended for routine cure of H. pylori infection. Although one cannot predict which antimicrobial therapies will be enhanced by the addition of omeprazole, these data suggest that future studies should evaluate drugs whose effectiveness is compromised by low pH.",1994.0,0,0
876,8047821,Effects of eradication of Helicobacter pylori on gastritis in duodenal ulcer patients.,E Solcia; L Villani; R Fiocca; O Luinetti; R Boldorini; E Trespi; M Perego; C Alvisi; M Lazzaroni; G Bianchi Porro,"The incidence and mean score of Helicobacter pylori-related, active antroduodenitis, lesions of superficial antral epithelium and duodenal gastric-type metaplasia were higher in endoscopic biopsies from a large series of patients with duodenal ulcer, when compared with asymptomatic patients or patients with non-ulcer dyspepsia. In 65 out of 73 patients with duodenal ulcer who could be followed up, H. pylori was eradicated using a combination of amoxycillin, 3 g daily, metronidazole, 1 g daily, and omeprazole, 20 mg daily. Rapid and permanent (6-month follow-up) abolition of both gastroduodenitis activity and lesions of the gastric surface epithelium was observed in these 65 patients. There was also a progressive decrease in total immune-inflammatory cells but without a substantial change in duodenal gastric-type metaplasia. Similar, but transient and quantitatively less prominent, improvements were observed in the antroduodenal mucosa, which had been temporarily cleared of H. pylori by treatment with omeprazole alone. Conversely, increased gastritis activity, epithelial lesions and immune-inflammatory cell scores were found in the short term in the corpus mucosa, which was not cleared of H. pylori after omeprazole treatment. It is concluded that, of the various H. pylori-related mucosal changes, antroduodenitis activity and antral epithelial lesions most closely reflect the severity of mucosal damage and are probably the most important factors in duodenal ulcerogenesis. Their complete and rapid suppression after bacterial eradication may be a key factor in preventing ulcer relapse.",1994.0,0,0
877,8047822,Prevention of duodenal ulcer relapse by long-term treatment with omeprazole.,H P Festen,"Duodenal ulcer is a chronic disease with a high risk of relapse--if left untreated, the relapse rate is 50-80% per year (1). However, the relapse rate can be effectively reduced by inhibition of gastric acid secretion. Although many patients can be managed with episodic therapy, controlled either by the patient or doctor, continuous maintenance treatment is often necessary for patients with severe forms of the disease and those at risk of complications (2). Maintenance therapy with single night-time doses of an H2-receptor antagonist reduces relapse rates from approximately 75% to 25% per year (3). As omeprazole is more effective than the H2-receptor antagonists in the acute treatment of duodenal ulcer, healing virtually all patients within 4 weeks (4), it may also be more effective in the maintenance treatment of duodenal ulcer disease. To date, three studies have reported the effect of omeprazole on relapse rates of duodenal ulcer. A Danish multicentre study involved 195 patients, who were treated with omeprazole, either 10 mg once daily, or 20 mg once daily on Friday, Saturday and Sunday (weekend therapy), or with placebo (5). After 6 months, the remission rates were 67% and 70%, respectively, for those patients receiving omeprazole--significantly higher than in those receiving placebo (17% after 6 months). An Italian multicentre study of 81 patients found that omeprazole, both 10 mg once daily, and 20 mg once daily at weekends (Friday, Saturday and Sunday), was equally effective in preventing relapse. The proportions of patients in remission were 81% and 70%, respectively, after 6 months (6).(ABSTRACT TRUNCATED AT 250 WORDS)",1994.0,0,0
878,8047827,Efficacy of omeprazole in lower grades of gastro-oesophageal reflux disease.,T Havelund; L S Laursen; K Lauritsen,"Grade I oesophagitis is usually considered to be a less severe form of gastro-oesophageal reflux disease (GORD). However, with regard to symptom severity, patients without macroscopic mucosal lesions have been shown not to differ from those with more severe oesophagitis. A number of controlled trials on the efficacy of omeprazole in GORD have included patients with lower grades of the disease. The results show that the differences in efficacy between omeprazole and H2-receptor antagonists, which have been established for the treatment of erosive and ulcerative oesophagitis, also extend to patients with grade I oesophagitis (erythema and friability). In these studies, omeprazole provided more rapid symptom resolution and histological improvement than ranitidine. In one double-blind comparative trial, complete endoscopic normalization of the oesophageal mucosa was observed in 90% of patients with grade I oesophagitis within 4 weeks of treatment with omeprazole, 40 mg once daily, compared with 55% of those treated with ranitidine, 150 mg twice daily; at 8 weeks the mucosa in all patients in the omeprazole group had completely healed at endoscopy, while oesophagitis was still present in 21% of the patients receiving ranitidine. A separate 6-month, placebo-controlled maintenance study was performed in patients who had completed a short-term study and who had total relief from the major symptoms of GORD and complete healing of endoscopic oesophagitis. All patients given placebo had an endoscopic recurrence (i.e. endoscopic grade I or more) and this was associated with the return of symptoms in 75% of cases.(ABSTRACT TRUNCATED AT 250 WORDS)",1994.0,0,0
879,8047829,Long-term treatment of gastro-oesophageal reflux disease with omeprazole.,L Lundell,"Reflux oesophagitis is a chronic disorder with frequent relapses on cessation of initial successful treatment. In patients with reflux oesophagitis, treatment with the acid pump inhibitor, omeprazole, has repeatedly been demonstrated to prevent the recurrence of symptoms and of erosive and/or ulcerative lesions in the oesophagus. Comparative trials have shown that an average of 82% of oesophagitis patients were maintained in endoscopic and symptomatic remission over a period of 12 months when treated with omeprazole, 20 mg once daily. This compares with only 36% of patients in remission when given 'full-dose' H2-receptor antagonist therapy (ranitidine, 300 mg daily). It is interesting to note that, in a recent trial, 62% of reflux oesophagitis patients were in remission after 12 months of treatment with omeprazole, 10 mg once daily, compared with the corresponding figure of 72% among those on 20 mg once daily. In patients poorly responsive to control of oesophagitis with H2-receptor antagonists, omeprazole at a dose of at least 20 mg daily is required to achieve symptom resolution and endoscopic healing--and remission can be maintained for years with continued omeprazole treatment. Omeprazole has been shown to have a good long-term safety profile, as evaluated in these trials.",1994.0,0,0
880,8047830,Appropriate acid suppression for optimal healing of duodenal ulcer and gastro-oesophageal reflux disease.,C W Howden; D W Burget; R H Hunt,"Comparisons of the effectiveness of treatments for healing duodenal ulcer are essential to determine optimal management strategies for both economic analysis and quality-of-life evaluation. Differences are usually made on the basis of the proportion of ulcers healed at varying time intervals. It has been shown by meta-analysis that healing of duodenal ulcers with antisecretory drugs is directly correlated to the degree of acid suppression. More recently, sophisticated meta-analysis of 24-hour intragastric acidity data and clinical trials of antisecretory drugs has demonstrated that the optimal degree and duration of gastric acid suppression for healing duodenal ulcer can be achieved by an aggregate time above pH 3 of 18-20 hours/day. These conditions predict 100% ulcer healing at 4 weeks. Antisecretory drug regimens that approach these criteria should achieve faster healing than other agents, with a concomitant acceleration of symptom resolution. Regression analysis was performed on the healing-time curves for each drug class to determine the rate of ulcer healing per week. The mean proportion of ulcers healed, irrespective of treatment duration, was highest for omeprazole, which also provided a significantly faster rate of duodenal ulcer healing than all other drug classes (p < 0.001). It has recently been shown that healing of erosive oesophagitis with antisecretory drugs is directly correlated with both the duration of acid suppression over the 24-hour period (p < 0.05) and the elevation of intra-oesophageal pH above 4. Furthermore, oesophageal acid exposure time can be normalized by maintaining the intra-oesophageal pH above 4 for at least 96% of the 24-hour period.(ABSTRACT TRUNCATED AT 250 WORDS)",1994.0,0,0
881,8047832,Long-term consequences with regard to clinical outcome and cost-effectiveness of episodic treatment with omeprazole or ranitidine for healing of duodenal ulcer.,A Walan; S Eriksson,"The clinical outcome and cost-effectiveness of episodic treatment of duodenal ulcer with omeprazole and ranitidine were evaluated over a 5-year period. The analysis was based on data from published clinical trials comparing healing rates obtained with omeprazole and with ranitidine, as well as on data from the literature on ulcer recurrence and other clinical events. Patients with an active duodenal ulcer were treated until healed or for a maximum of 24 weeks. Maintenance therapy was instituted in patients with ulcers that were very slow to heal and in patients with frequent relapses after cessation of treatment. Patients who experienced frequent relapses while receiving maintenance therapy, and those whose ulcer had not healed after 24 weeks of continuous treatment, were defined as candidates for surgery. A statistical model was set up and a random number generator used to generate a sequence of clinical events, month by month, over a 5-year period for each patient in a large cohort. Episodic treatment with omeprazole was shown to be more effective in avoiding maintenance treatment and surgery when compared with episodic treatment with ranitidine. Patients who received episodic treatment with omeprazole also spent more time in remission from disease. Using current Swedish cost data, it was found that episodic treatment with omeprazole was more cost-effective than episodic treatment with ranitidine.",1994.0,0,1
882,8053433,"Double-blind comparison of lansoprazole, ranitidine, and placebo in the treatment of acute duodenal ulcer. Lansoprazole Study Group.",F Lanza; J Goff; C Scowcroft; D Jennings; P Greski-Rose,"To study in a double-blind controlled manner the effects of lansoprazole 15 mg or 30 mg daily compared with ranitidine 300 mg once daily and placebo in the relieving of symptoms and healing of acute duodenal ulceration. Two hundred eighty patients with duodenal ulcer entered in to the study from 30 centers. They were randomized in a double-blind manner into four groups with 80 patients entered into each active treatment group and 40 patients into the placebo group. Endoscopy was performed at 2- and 4-wk intervals to assess healing. Symptom relief was recorded, serum gastrin levels were measured, and gastric mucosal biopsies were obtained to evaluate for the presence of acute and chronic inflammation, the presence of neoplasia, and the extent of gastric endocrine growth at the time of endoscopy. After 4 wk of treatment using per protocol analysis, 19 of 40 (47.5%) patients receiving placebo had healed compared with 55 of 78 (70.5%) receiving ranitidine (p < 0.05 vs. placebo), 61 of 76 (80.3%) receiving lansoprazole 30 mg (p < 0.05 vs. placebo), and 72 of 78 (92.3%) receiving lansoprazole 15 mg (p < 0.05 vs. placebo and ranitidine). In patients with evaluable data, lansoprazole 30 mg and ranitidine produced greater relief of night-time symptoms and lansoprazole 15 mg produced greater relief of both day- and night-time symptoms than did placebo after 4 wk of treatment. Ranitidine increased fasting serum gastrin levels (22%; p < 0.05 vs. placebo), whereas both lansoprazole regimens produced more marked rises in serum gastrin (54% and 60%; p < 0.05 vs. placebo and ranitidine). Lansoprazole 15 mg and 30 mg also increased the density of antral G-cells (105.8% and 128.80%; p < 0.05 vs. baseline) and greater curvature Grimelius-positive cells (20.33% and 28.8%; p < 0.05 vs. baseline); there were no increases in the density of antral EC- or D-cells, and there was no alteration of gastric endocrine growth as judged by the Solcia classification. Both ranitidine and lansoprazole were associated with decreased antral Helicobacter pylori density accompanied, in the lansoprazole groups, by decreased antral inflammation scores. All antisecretory regimens were associated with increased inflammatory scores in the greater curvature. In acute duodenal ulceration, treatment with lansoprazole 15 and 30 mg produced 4-wk healing rates and symptom relief superior to those produced by placebo and the 15-mg dose similar to those produced by placebo. The 15-mg dose of lansoprazole was also superior to ranitidine in healing duodenal ulcer after 4 wk of therapy.",1994.0,1,1
883,8060802,Clinical review of lansoprazole.,S P Lockhart,"Lansoprazole is an inhibitor of gastric H+,K(+)-ATPase, commonly referred to as the 'proton pump'. The pharmacodynamic effect of proton pump inhibition is to reduce gastric acid secretion. Long experience with H2 antagonists and more recently proton pump inhibitors has demonstrated the value of reducing gastric acid secretion in conditions where acid plays a key role in the pathogenesis of gastrointestinal inflammation and ulceration. The pharmacokinetics, pharmacodynamics and clinical safety of lansoprazole are discussed elsewhere in this supplement, and so this review will focus upon the European and American experience of the efficacy of lansoprazole in the treatment of peptic ulceration and gastro-oesophageal reflux.",1994.0,0,0
884,8065190,Current diagnosis and treatment of gastroesophageal reflux disease.,K R DeVault; D O Castell,"To review recent advances in the diagnosis and treatment of gastroesophageal reflux disease (GERD). Original English language reports were obtained through a Medline search of the National Library of Medicine up to and including 1993. The reference lists of all original reports and review articles were searched to locate any further material. In the evaluation of therapeutic efficacy, randomized studies were preferentially considered; greatest priority was given to double-blind, placebo-controlled trials. Abstracts, nonrandomized trials, and non-English language publications were considered only when other data were unavailable. Information obtained from histories and physical examinations suggests that GERD occurs in many patients. Evaluation of mucosal injury with use of either endoscopy or air contrast barium radiography is an important early step in the diagnosis of GERD. Endoscopy obtains tissue for histologic study, especially in Barrett's esophagus. Prolonged esophageal pH monitoring is the most useful determinant of the presence and amount of reflux of acid. Patients with GERD should be counseled on lifestyle modification and the use of antacids and antirefluxants. Histamine type 2 receptor antagonists provide symptomatic relief in 32 to 82% of patients with GERD and resolution of verified esophagitis in 0 to 82%. Responses with omeprazole therapy are higher; symptomatic responses were noted in 62 to 94% of patients, and healing of esophagitis occurred in 71 to 96%. Promotility agents and surgical therapy have a role in selected patients. GERD is a chronic disorder that often necessitates individualized lifelong therapy. Many questions remain to be answered about the cost-effectiveness of both diagnostic tests and therapy for GERD.",1994.0,0,0
885,8079104,A pharmacodynamic study of two omeprazole regimens suitable for long-term treatment of duodenal ulcer.,S Vigneri; V Savarino; G S Mela; R Termini; F Di Mario; M Pantalena; P Zentilin; F Muratore; A Scialabba; S Badalamenti,"The experience with long-term treatment of peptic ulcer with omeprazole is still scant, but the possibility cannot be excluded that its better pharmacodynamic effect on gastric acidity also has a positive result in the relapse rate. Moreover, this drug acts via a mechanism other than receptorial binding, and therefore its efficacy should not dissipate with time. This study was carried out to assess the pharmacodynamic properties and the possible changes with time of two dose regimens of omeprazole that could be suitable for long-term treatment in duodenal ulcer. Twenty patients with endoscopically proven duodenal ulcer were studied by means of 24-h gastric pH-metry both in basal conditions and on the 5th day of acute treatment with 40 mg omeprazole in the morning. All the ulcers healed after 4 weeks, and thereafter 10 patients were randomized to receive orally 20 mg omeprazole daily at 0800 h in single-blind fashion (group A) and 10 to receive 20 mg omeprazole every other day (group B) for up to 6 months. At the end of the 1st, 3rd, and 6th month of these maintenance treatments 24-h gastric pH-metry was repeated to assess the antisecretory effect of each regimen over time. In group-B patients the test was performed on 2 consecutive days (without and with medication) at each time interval. The fasting gastrin values were also determined. The patients underwent esophagogastroduodenoscopy every 2 months. Three patients in group B were lost to follow-up for various reasons, and only seven remained eligible for final analysis. The two long-term regimens of omeprazole were able to increase significantly pH values (p < 0.02-0.001) and the times spent at and above pH 3.0 (p < 0.001) over 24 h compared with basal conditions. In group A the 24-h pH value obtained in the 6th month was higher (p < 0.02) than that in the 3rd month of maintenance treatment. In group B the pharmacologic effect tended to decrease on the day without medication compared with the day with medication, but the difference between them was significantly (p < 0.05) only at the 6-month interval. There was no significant difference between the gastrin levels of the two groups in the long-term treatment. No ulcer relapse was detected at any long-term endoscopic control in the two groups of patients. The two omeprazole regimens we tested are effective in reducing gastric acidity, and their pharmacodynamic action does not decrease with time. They are therefore suitable for maintenance treatment in acid-related disorders.",1994.0,0,0
886,8136088,Risk-benefit assessment of omeprazole in the treatment of gastrointestinal disorders.,W Creutzfeldt,"For the treatment of duodenal and gastric ulcer and reflux oesophagitis, especially erosive oesophagitis, omeprazole has an advantage over histamine H2-receptor antagonists because it heals significantly more patients significantly faster. Adverse effects have been observed during short term treatment with the same frequency as during treatment with H2-antagonists. Also, maintenance treatment with omeprazole of reflux oesophagitis is significantly superior to H2-antagonist therapy. During long term treatment for up to 8 years no further drug-related adverse effects have been observed. Moderate hypergastrinaemia occurs in some patients, especially if an omeprazole dosage of 40 mg/day is needed. A slight increase of the agyrophil (endocrine) cell volume density and an extension of micronodular hyperplasia in the oxyntic mucosa after several years of omeprazole treatment seem to be related to the severity of the corpus gastritis and not to drug-induced hypergastrinaemia, because similar changes have been observed in equal frequency in patients not receiving anti-secretory drugs. Theoretical arguments against long term treatment with potent acid-suppressing drugs, such as the possible consequences of gastric bacterial overgrowth or hypergastrinaemia, are not supported by clinical observations and epidemiological data and are, therefore, speculative.",1994.0,0,1
887,8161665,Use of omeprazole in Zollinger-Ellison syndrome: a prospective nine-year study of efficacy and safety.,D C Metz; D B Strader; M Orbuch; P D Koviack; K M Feigenbaum; R T Jensen,"H+, K(+)-ATPase inhibitors such as omeprazole are the antisecretory agents of choice for the management of gastric acid hypersecretory states, including the Zollinger-Ellison syndrome. However, long-term follow-up data on the overall efficacy and safety of these agents in large numbers of patients are lacking. In the current study we examined the long-term efficacy and safety of omeprazole in 116 patients with Zollinger-Ellison syndrome treated with oral omeprazole at a single centre for up to 114 months (mean +/- S.E.M. = 38 +/- 3 months). The initial omeprazole maintenance dose was established according to the acute upward dose titration method in 89/116 patients (77%). Gastric acid output was effectively controlled using 60 mg of omeprazole once daily in 41/89 patients (46%) and 22/89 patients (25%) required twice daily omeprazole therapy. The mean ranitidine equivalent dose for patients who required 60 mg omeprazole once daily (2.5 +/- 0.2 g/day) was significantly lower than the mean ranitidine equivalent dose for patients who required more than 60 mg omeprazole once daily (4.3 +/- 0.3 g/day). Long-term omeprazole maintenance therapy was discontinued in 36/116 patients (31%) but in no cases was discontinuation due either to drug-induced side-effects or uncontrolled gastric acid output. Fasting serum gastrin levels were significantly elevated above pre-treatment levels at only one time point during follow-up and were likely due to tumour growth rather than a drug effect. The final long-term omeprazole maintenance doses were lower than the initial doses but correlated closely with the pre-omeprazole basal acid output (r = 0.41, P < 0.001) and ranitidine equivalent dose requirements (r = 0.49, P < 0.001). We conclude that omeprazole effectively and safely controls gastric acid hypersecretion in all patients with Zollinger-Ellison syndrome for up to nine years without evidence by tachyphylaxis.",1993.0,0,0
888,8166150,Omeprazole for the treatment of posterior laryngitis.,P L Kamel; D Hanson; P J Kahrilas,"To determine whether the patients with refractory posterior laryngitis respond to treatment with omeprazole. Sixteen consecutive patients with persistent posterior laryngitis despite prior therapy with H2 blockers were recruited from outpatient university otolaryngology and gastroenterology practices. Patients received 6 to 24 weeks of omeprazole 40 mg qhs, which was increased to 40 mg twice a day for 6 weeks in four patients with continuing symptoms. Laryngoscopy, esophagoscopy, and esophageal/laryngeal symptom questionnaire were completed at entry to the study. Laryngoscopy and the questionnaire were repeated at the conclusion of the study. A follow-up questionnaire was completed at 6 weeks. Laryngoscopy scores improved from 4.44 to 1.94 (nonblinded otolaryngologist) and 4.31 to 1.88 (blinded otolaryngologist) (P < 0.05). Laryngeal and esophageal symptom indices improved from 13.94 and 9.00 to 3.00 and 0.38, respectively (P < 0.05). Symptom indices increased to 7.00 and 7.33, respectively, after the discontinuation of therapy (P < 0.05 compared with the conclusion of the study). One patient intolerant of omeprazole underwent fundoplication and was asymptomatic 6 weeks after surgery. Only 3 patients had esophagitis at entry. The signs and symptoms of posterior laryngitis improve with the administration of omeprazole and symptoms recur after discontinuation of therapy, suggesting that reflux is the underlying etiology. Patients with refractory symptoms, but intolerant of omeprazole, may benefit from antireflux surgery. Laryngoscopic findings of posterior laryngitis are often subtle, and many patients with posterior laryngitis do not have esophagitis.",1994.0,0,0
889,8174980,"Effect of omeprazole on intragastric bacterial counts, nitrates, nitrites, and N-nitroso compounds.",E Verdu; F Viani; D Armstrong; R Fraser; H H Siegrist; B Pignatelli; J P Idström; C Cederberg; A L Blum; M Fried,"Previous studies have suggested that profound inhibition of gastric acid secretion may increase exposure to potentially carcinogenic N-nitroso compounds. The aim of this study was to find out if the proton pump inhibitor omeprazole (20 mg daily) is associated with increased concentrations of potentially carcinogenic N-nitroso compounds in gastric juice. The volume of gastric contents, number of bacteria, and concentrations of nitrates, nitrites, and N-nitroso compounds was determined in gastric aspirates obtained after an overnight fast in 14 healthy volunteers (7M:7F) after one week of treatment with placebo, and one and two weeks' treatment with omeprazole. Median bacterial concentrations were 1.0 x 10(4) (range 5.0 x 10(3)-5.0 x 10(6)) colony forming units (CFU)/ml after one weeks' treatment with placebo and increased significantly to 4.0 x 10(5) (0-3.3 x 10(7)) CFU/ml after two weeks' treatment with omeprazole (p < 0.05). A similar increase was seen in the concentration of nitrate reducing bacteria. There was no difference in the volume of gastric aspirates after treatment with omeprazole when compared with placebo (65 (29-155) ml v 42 (19-194) ml). The concentration of N-nitroso compounds was 0.13 (0-1.0) mumol/l after two weeks of omeprazole, which was not significantly different from that seen with placebo (0.15 (0-0.61) mumol/l). There was also no increase in the concentrations of nitrates or nitrites. It is concluded that omeprazole (20 mg once daily) for two weeks in healthy volunteers is associated with gastric bacterial proliferation but does not increase concentrations of N-nitroso compounds.",1994.0,0,0
890,8180295,A review of treatment of duodenal and gastric ulcers--pantoprazole vs. omeprazole.,W Schepp; M Rehner; L Witzel,"The efficacy and safety of pantoprazole in the treatment of duodenal and gastric ulcers has been compared with that of the first proton pump inhibitor omeprazole in two (previously reported) clinical studies. Pantoprazole (40 mg/day) administered orally was an effective and well-tolerated treatment for both indications. Pantoprazole was as effective as omeprazole (20 mg/day) and had a similar safety profile. For gastric ulcers, the healing rate with pantoprazole was superior to that with omeprazole at 4 weeks.",1994.0,0,0
891,8180296,Long-term therapy with pantoprazole in patients with peptic ulceration resistant to extended high-dose ranitidine treatment.,G Brunner; U Harke,"Patients (106) with peptic ulceration of the oesophagus, stomach and duodenum, unresponsive to 3 or more months of high-dose treatment with ranitidine, were initially given pantoprazole (40-80 mg, p.o.) daily. In 96.7% of the patients ulcers healed within 2 to 8 weeks, and in 2.3% of patients the ulcers healed within 12 weeks. In just one patient with severe oesophagitis, the lesion took more than 6 months to heal. After ulcer healing, patients (98 to date) were treated with pantoprazole (40 mg/day) as long-term maintenance therapy. Eighty-eight of the 98 patients have been taking pantoprazole for 6 months to 3 years. During maintenance therapy, peptic disease was kept in remission in most patients with 40 mg pantoprazole. Twelve patients with oesophagitis and two patients with gastric ulcers needed higher doses (80-120 mg) to control the disease. One female patient developed peripheral oedema which disappeared quickly after stopping treatment. No further drug-related adverse effects were observed. Seven patients withdrew from the study and two patients died, all for non-drug-related reasons. Routine laboratory tests remained without significant changes in all patients. Mean (+/- S.E.M.) serum gastrin levels were already elevated during the initial high-dose ranitidine treatment (128 +/- 23 pg/ml). Within one year of the start of the pantoprazole treatment, serum gastrin levels rose to 3 times normal values (189 +/- 32 pg/ml). Thereafter, no further increases in serum gastrin were observed for up to 2.5 years. Enterochromaffin-like (ECL) cell density increased very slightly from 0.19% to 0.24% within one year.(ABSTRACT TRUNCATED AT 250 WORDS)",1994.0,0,0
892,8186337,Short report: treatment of gastric ulcer with lansoprazole or ranitidine: a multicentre clinical trial.,P Michel; M Lemaire; R Colin; G Bommelaer; J C Rambaud; J L Dupas; M A Bigard; J C Verwaerd,"We studied the effectiveness of lansoprazole and ranitidine in promoting gastric ulcer healing in a multicentre double-blind trial, by comparing the proportion of healed ulcers after 4 and 8 weeks of treatment. One hundred and fifty-eight patients were randomly given either ranitidine (150 mg each morning and at bedtime) or lansoprazole (30 mg each morning and placebo at bedtime). One hundred and twenty-eight patients completed the trial (62 taking lansoprazole, 66 taking ranitidine). Fifty-one (80%) of those treated with lansoprazole and forty-two (62%) of those treated with ranitidine had healed ulcers at 4 weeks (P < 0.05). Sixty-one (98%) patients who received lansoprazole and 57 (86%) who received ranitidine had healed ulcers at 8 weeks (P < 0.05). The observed differences were not significant in the intention-to-treat analysis. No serious adverse event was reported with lansoprazole.",1994.0,0,1
893,8186350,Comparison of pantoprazole and ranitidine in the treatment of acute duodenal ulcer. Pantoprazole-Duodenal Ulcer-Study Group.,G Judmaier; H R Koelz,"Pantoprazole is a new substituted benzimidazole that blocks the H+/K(+)-ATPase in the gastric mucosa and thus inhibits acid secretion. Efficacy and tolerability of pantoprazole (40 mg at breakfast) and ranitidine (300 mg at bedtime) in the treatment of uncomplicated acute duodenal ulcer were compared in a double-blind randomized multicentre trial. Of 202 outpatients who entered the study, 185 terminated the treatment without violation of the protocol. After 2 weeks of treatment, healing rates (protocol correct) with pantoprazole and ranitidine were 81 and 53%, respectively (P < 0.001), the corresponding results after 4 weeks were 97 and 83% (P < 0.01). Pantoprazole was more effective with respect to symptom relief. Both treatments were well tolerated. Pantoprazole 40 mg at breakfast is superior to ranitidine 300 mg at bedtime in the short-term treatment of acute, uncomplicated duodenal ulcer.",1994.0,1,1
894,8194953,Omeprazole treatment of chronic duodenal ulceration.,Z A Kassir; Z A Thamer,"Omeprazole, a substituted benzimidazole, is an acid pump inhibitor, introduced for treatment of chronic duodenal ulceration. In a study of 116 patients with endoscopically documented chronic duodenal ulcers, omeprazole affected healing in 77 (66.3%) patients after two weeks and 106 (91.4%) patients after four weeks, with symptoms relief in 102 (88%) patients within the first week of treatment. There was significantly higher healing rate in females (p < 0.05) and diffuse ulceration rather than single ulcers (p < 0.05). In meta-analysis comparing omeprazole to other antiulcer drugs reported in this country, there was a significant higher healing rate (p < 0.01) and symptom relief (p < 0.01) in favour of omeprazole. It proved to be effective and safe for the short term treatment of chronic duodenal ulceration.",1994.0,0,0
895,8200123,Cytoprotection with misoprostol: use in the treatment and prevention of ulcers.,A Ballinger,"Prostaglandins protect the gastric mucosa by decreasing gastric acid secretion, increasing mucus and bicarbonate production and maintaining mucosal blood flow. Non-steroidal anti-inflammatory drugs (NSAIDs) cause gastroduodenal damage and this is due, at least in part, to inhibition of mucosal prostaglandin production. Misoprostol is a synthetic analogue of prostaglandin E1 which has been used in the healing of ulcers and prevention of peptic ulcers in patients taking NSAIDs. Misoprostol is of equal efficacy to H2 antagonists in the healing of ordinary peptic ulcers (not associated with NSAIDs). Misoprostol is superior to placebo in healing NSAID ulcers during continued NSAID treatment but there have been no comparative trials with other ulcer-healing drugs. Misoprostol, H2 antagonists and sucralfate are of similar efficacy in prevention of NSAID-associated duodenal ulcers but misoprostol is more effective in prevention of gastric ulcers. Misoprostol has not been compared to omeprazole in this situation.",1994.0,0,0
896,8200548,Omeprazole v ranitidine for prevention of relapse in reflux oesophagitis. A controlled double blind trial of their efficacy and safety.,J Dent; N D Yeomans; M Mackinnon; W Reed; F M Narielvala; D J Hetzel; E Solcia; D J Shearman,"The aim of this study was to compare recurrence rates of reflux oesophagitis (after endoscopic healing with omeprazole) over a 12 month period of randomised, double blind, maintenance treatment with either daily omeprazole (20 mg every morning; n = 53), weekend omeprazole (20 mg on three consecutive days a week, n = 55) or daily ranitidine (150 mg twice daily, n = 51). Patients were assessed for relapse by endoscopy (with gastric biopsy) at six and 12 months, or in the event of symptomatic recurrence, and serum gastrin was monitored. At 12 months, the estimated proportions of patients in remission (actuarial life table method) were 89% when receiving daily omeprazole compared with 32% when receiving weekend omeprazole (difference 57%, p < 0.001, 95% confidence intervals: 42% to 71%) and 25% when receiving daily ranitidine (difference 64%, p < 0.001, 95% confidence intervals: 50% to 78%). Median gastrin concentrations increased slightly during the healing phase, but remained within the normal range and did not change during maintenance treatment. No significant pathological findings were noted, and no adverse events were attributable to the study treatments. In conclusion, for patients who respond favourably to acute treatment with omeprazole 20 mg every morning, the drug is a safe and highly effective maintenance treatment for preventing relapse of reflux oesophagitis and its associated symptoms over 12 months. By contrast, weekend omeprazole and daily ranitidine were ineffective.",1994.0,0,1
897,8205592,Treatment of patients with Zollinger-Ellison syndrome.,M Mignon; D Pospai; S Forestier; J Vatier; T Vallot,"In the treatment of Zollinger-Ellison syndrome patients with severe disease and acid hypersecretion, proton pump inhibitors are the drugs of choice. Data have now been accumulated on lansoprazole treatment of 41 patients (21 treated at the National Institutes of Health [NIH], Bethesda, Maryland, USA, and 20 treated at the Bichat-Claude Bernard Hospital, Paris, France). Short-term studies of the inhibitory action of lansoprazole on acid secretion have been carried out in both institutions. Our group first performed a dose-response analysis of the efficacy of lansoprazole in reducing basal acid output (BAO) in four patients with severe Zollinger-Ellison syndrome (mean BAO 52 +/- 9 [SD] mmol H+/h) who had previously been treated with a mean omeprazole dosage of 75 mg/day. The maximum acid inhibitory effect was obtained with lansoprazole 60-90 mg/day. The 40-hour duration of action of lansoprazole appears equivalent to that of omeprazole. In a second study at the Bichat-Claude Bernard Hospital, nine Zollinger-Ellison syndrome patients underwent 24-hour intragastric pH monitoring while receiving lansoprazole (mean dosage 80 mg/day, range 30-165 mg/day) or omeprazole (mean dosage 75 mg/day, range 20-180 mg/day). The acid inhibitory activity of the two drugs was comparable. Those patients are currently receiving long-term maintenance treatment with lansoprazole, and satisfactory clinical and biological secretory control has been achieved. The long-term safety and efficacy of lansoprazole administration were studied in the 21 patients followed at the NIH. In those patients the initial maintenance dose was determined using acid inhibition studies; in all patients lansoprazole controlled gastric acid hypersecretion and peptic symptoms in both the short and long term. The mean initial maintenance dose was 60 mg QID, except for two patients who required 60 mg BID. During long-term treatment (mean duration 31 months, range 1-43 months), six patients required a dosage increase within the first year, while the lansoprazole dose could be reduced in six others. The safety profile of lansoprazole has been excellent. Comparable results have been noted in nine Zollinger-Ellison syndrome patients during an ongoing evaluation in our institution. These studies indicate that lansoprazole is an efficacious, well-tolerated antisecretory agent in patients with Zollinger-Ellison syndrome.",1993.0,0,0
898,8205595,Lansoprazole and Helicobacter pylori infection.,F Pallone; F Luzza; G Delle Fave; B Annibale; A Marcheggiano; L Biancone; A Torsoli; L Capurso,"Helicobacter pylori-associated gastritis is present in virtually all patients with duodenal ulcer (DU). Eradication of H pylori is associated with a highly significant decline in the recurrence rates of DU, indicating that treatments aimed at eradicating H pylori are mandatory in these patients. The novel proton pump inhibitor lansoprazole exhibits a potent antiulcer effect and, in vitro, a direct antibacterial effect against H pylori. Conflicting data have been reported on the question of whether lansoprazole is bactericidal against H pylori in vivo when administered alone. The aim of this double-blind trial was to address this issue further by comparing the effects of two different 4-week regimens (lansoprazole alone or in combination with amoxicillin) on H pylori infection in patients with DU. Patients were assessed before and after the 4-week treatment and 3 months after stopping the study medication. The ulcer healing rates at 4 weeks were similar for the two treatments while there was a trend for higher recurrence rates at 4 months in patients receiving lansoprazole alone. The frequency of high-grade H pylori infection was significantly lower in the lansoprazole and amoxicillin group both at 4 weeks (84% clearing) and 4 months. After 4 weeks of treatment there were no patients with residual H pylori-positive active antral gastritis in the lansoprazole and amoxicillin group compared with 25% in the lansoprazole alone group. Neither treatment significantly affected the IgG antibody response to H pylori either at the circulatory or the mucosal level. In contrast, the mucosal H pylori-specific IgA response was significantly enhanced after 4 weeks and more markedly after treatment with lansoprazole.(ABSTRACT TRUNCATED AT 250 WORDS)",1993.0,0,0
899,8270292,Alternate-day therapy with omeprazole for duodenal ulcer.,P Dhawan; D N Amarapurkar; R H Kalro,"Maximal acid suppression produced by a single dose of 20 mg omeprazole has been reported to persist for over 24 hours, with acid secretion returning to normal after 2 days. (i) To study the effect of single oral dose of 20 mg omeprazole on maximal acid output (MAO) and peak acid output (PAO) in duodenal ulcer patients and healthy volunteers. (ii) To compare the efficacy of omeprazole 20 mg daily versus 20 mg on alternate days in the treatment of duodenal ulcer. Open randomized comparative trial. MAO and PAO were estimated in five duodenal ulcer patients and five healthy volunteers before, and 24 hours and 48 hours after, a single 20 mg oral dose of omeprazole. Fifty eight consecutive uncomplicated duodenal ulcer patients were randomized to receive omeprazole 20 mg either daily (n = 30) or on alternate days (n = 28) for four weeks. The two groups were matched for age, sex, duration of ulcer symptoms, smoking, NSAID use, and ulcer size at entry. Symptom scores using a pre-defined scoring system and endoscopic ulcer healing rates were evaluated at 2 and 4 weeks. MAO and PAO showed significant reduction in both duodenal ulcer patients and healthy controls 24 hours after 20 mg omeprazole. Reduction at 48 hours was significant in duodenal ulcer patients but not in controls. Endoscopic healing rates of duodenal ulcer at 2 and 4 weeks were 80% and 93.3% respectively in the daily treatment group and 71.4% and 85.7% respectively in the alternate-day treatment group. These differences were not statistically significant. 20 mg omeprazole on alternate days is as effective as 20 mg daily (i) in suppressing MAO and PAO and (ii) in the treatment of duodenal ulcer.",1993.0,0,0
900,8276209,Do continuous infusions of omeprazole and ranitidine retain their effect with prolonged dosing?,H S Merki; C H Wilder-Smith,"Prolonged infusions of H2-antagonists are commonly used in intensive care units, although little is known about their antisecretory efficacy beyond the initial 24 hours of dosing. The aim of this study was to assess the antisecretory effects of infusions of ranitidine and omeprazole for a period of 72 hours. Twelve healthy volunteers received individually titrated 72-hour intravenous infusions of omeprazole, ranitidine, or placebo in a double-blind, crossover study. Gastric pH and dosing requirements were compared. The median percentage of time with pH > 4 (interquartile range) was 93% (88%-95%) on day 1 and 96% (94%-99%) on day 3 with omeprazole and 67% (56%-78%) and 43% (31%-51%), respectively, with ranitidine (both P < 0.001 vs. omeprazole). The mean doses (+/- SD) required on days 1 and 3 for omeprazole were 235.8 +/- 44 mg and 134.0 +/- 37 mg (P < 0.0001), and ranitidine doses were 502.5 +/- 76 mg and 541.8 +/- 25 mg, respectively (P = 0.05). Omeprazole infusions consistently maintained gastric pH above 4 over a period of 72 hours with progressively lower doses. Significant tolerance to the antisecretory effect of ranitidine infusion developed in 72 hours, which was not overcome despite individually titrated doses of more than 500 mg/24 hours. Consequently, application of pharmacodynamic results of single-day H2-blocker and proton-pump inhibitor studies to prolonged infusion trials for stress ulcer-related bleeding is inappropriate.",1994.0,0,0
901,8280818,Does 40 mg omeprazole daily offer additional benefit over 20 mg daily in patients requiring more than 4 weeks of treatment for symptomatic reflux oesophagitis?,C M Bate; S N Booth; J P Crowe; B Hepworth-Jones; M D Taylor; P D Richardson,"This study was designed to establish whether 40 mg omeprazole once daily exhibits sufficient additional efficacy over that of 20 mg omeprazole once daily in patients with symptomatic reflux oesophagitis requiring more than an initial 4-week course of 20 mg omeprazole once daily (o.m.) to warrant routine use of the higher dose. Three hundred and thirteen patients were randomized to receive either 20 mg omeprazole (4 weeks) then 20 mg (second 4 weeks if not both healed and symptom-free after 4 weeks), or 20 mg omeprazole (4 weeks) then 40 mg omeprazole o.m. (second 4 weeks). One hundred and twenty-seven patients were healed and symptom-free after 4 weeks and left the study at that point. Taking the second treatment period in isolation, the healing rate (64% vs. 45%, P < 0.02) and relief of heartburn (72% vs. 60%, P < 0.002) were greater among patients receiving 40 mg omeprazole o.m., demonstrating the existence of a dose-response relationship for omeprazole. However, on completion, there were no significant differences between the patients randomized to the 20/20 mg (healed 65%, asymptomatic 69%) or the 20/40 mg (healed 74%, asymptomatic 74%: both not significant differences compared with 20/20 mg) regimens. The magnitude of the difference in efficacy between 20 and 40 mg omeprazole in symptomatic reflux oesophagitis is insufficient to warrant the routine use of 40 mg in patients requiring more than 4 weeks' treatment with 20 mg omeprazole o.m.; continued treatment with 20 mg omeprazole for 4-8 weeks is the preferred option.",1993.0,0,1
902,8285777,Omeprazole and high dose ranitidine in the treatment of refractory reflux oesophagitis.,S Cucchiara; R Minella; C Iervolino; M T Franco; A Campanozzi; M Franceschi; F D'Armiento; S Auricchio,"Thirty two consecutive patients (age range 6 months-13.4 years) with severe reflux oesophagitis were randomised to a therapeutic trial for eight weeks during which they received either standard doses of omeprazole (40 mg/day/1.73 m2 surface area) or high doses of ranitidine (20 mg/kg/day). Twenty five patients completed the trial (12 on omeprazole, 13 on ranitidine). At entry and at the end of the trial patients underwent symptomatic score assessment, endoscopic and histological evaluation of the oesophagus, and simultaneous oesophageal and gastric pH measurement; results are given as median (range). Both therapeutic regimens were effective in decreasing clinical score (omeprazole before 24.0 (15-33), after 9.0 (0-18); ranitidine before 19.5 (12-33), after 9.0 (6-12)), in improving the histological degree of oesophagitis (omeprazole before 8.0 (6-10), after 2.0 (0-60); ranitidine before 8.0 (8-10), after 2.0 (2-6), and in reducing oesophageal acid exposure, measured as minutes of reflux at 24 hour pH monitoring (omeprazole before 129.4 (84-217), after 44.6 (0.16-128); ranitidine before 207.3 (66-306), after 58.4 (32-128)) as well as intragastric acidity, measured as median intragastric pH (omeprazole before 2.1 (1.0-3.0), after 5.1 (2.2-7.4); ranitidine before 1.9 (1.6-4), after 3.4 (2.3-5.3)). Serum gastrin concentration was > 150 ng/l in four patients on omeprazole and in three patients on ranitidine. It is concluded that in children with refractory reflux oesophagitis high doses of ranitidine are comparable with omeprazole for the healing of oesophagitis and relief of symptoms; both drugs resulted in efficacious reduction of intragastric acidity and intra-oesophageal acid exposure.",1993.0,0,1
903,8304303,One-year follow-up of duodenal ulcers after 1-wk triple therapy for Helicobacter pylori.,J J Sung; S C Chung; T K Ling; M Y Yung; A F Cheng; S W Hosking; A K Li,"to study the ulcer recurrence rate of Helicobacter pylori-positive duodenal ulcers at 1 yr after eradication of the bacteria by triple therapy. Patients with H. pylori-positive duodenal ulcers were randomized to receive either triple therapy for 1 wk plus omeprazole for 4 wk (Triple+OMP) (n = 78), or omeprazole alone (OMP) for 4 wk (N = 77). Patients were followed up every 3 months for symptom enquiry. At 1 yr, all asymptomatic patients were invited to attend for gastroscopy. At 8 wk, 16 patients in the OMP group and four in the Triple+OMP group had an ulcer. During the 1-yr period, 12 patients in the OMP group and no patient in the Triple+OMP group developed symptomatic ulcers. At follow-up endoscopy at 1 yr, another 10 ulcers were detected in the OMP group and two in the Triple+OMP group. Fifteen patients in the OMP group and 13 in the Triple+OMP group were lost to follow-up. In total, ulcers were detected in 39 of 61 (64%) assessable patients in the OMP group, and in six of 65 (9%) assessable patients in the Triple+OMP group after 1 yr (chi 2 test: p < 0.001). Of the patients whose H. pylori were successfully eradicated by Triple+OMP at 8 wk, 90% remained H. pylori negative at 1 yr. Triple therapy for 1 wk eradicates H. pylori infection and significantly reduces duodenal ulcer relapses.",1994.0,0,0
904,8307443,Evidence for the essential role of Helicobacter pylori in gastric ulcer disease.,J Labenz; G Börsch,"Helicobacter pylori (H pylori) eradication heals chronic active type B gastritis and dramatically changes the natural history of duodenal ulcer disease. There are few data concerning the role of anti-H pylori treatment in gastric ulcer disease. A total of 83 patients presenting with H pylori positive active gastric ulcer disease were treated with omeprazole and antibiotics (amoxicillin, ciprofloxacin, roxithromycin) in seven different clinical protocols, each of which included the attempt to eradicate H pylori infection and to evaluate the post-therapeutic course of ulcer disease. The overall proportion of H pylori eradication was 67.9% (53 of 78 patients available for follow up). Best results were obtained with two week treatment regimens comprising omeprazole 20 mg twice daily and amoxicillin 500 mg four times a day or 1000 mg twice daily (eradication > 80%). Eradication of H pylori speeds up ulcer healing, with a six week healing rate of 84.9% compared with 60% in patients with persistent H pylori infection (p = 0.0148). In a subgroup of 11 patients with refractory ulcers, H pylori eradication (n = 10) was associated with ulcer healing on continued acid suppression in nine cases. One male patient with chronic antral ulcer did not respond to treatment within the next six months (H pylori and ulcer persistence), and in one female patient a resistant body ulcer was identified as gastric lymphoma. Fifty patients with healed ulcers were followed up for one year. Patients with (n = 32) and without (n = 18) bacterial eradication had similar demographic and clinical characteristics. H pylori eradication was associated with a statistically significant reduction of ulcer recurrences (3.1 v 55.6%, p<0.001). This study concludes that H pylori eradication considerably changes the natural history of H pylori associated gastric ulcer disease. In addition, H pylori eradication speeds up ulcers healing and is associated with healing of previously refractory ulcers. Thus, treatment aimed at bacterial eradication should be considered in all patients with gastric ulcers severe enough to contemplate further treatment options.",1994.0,0,0
905,8307444,Duodenal bacterial overgrowth during treatment in outpatients with omeprazole.,M Fried; H Siegrist; R Frei; F Froehlich; P Duroux; J Thorens; A Blum; J Bille; J J Gonvers; K Gyr,"The extent of duodenal bacterial overgrowth during the pronounced inhibition of acid secretion that occurs with omeprazole treatment is unknown. The bacterial content of duodenal juice of patients treated with omeprazole was therefore examined in a controlled prospective study. Duodenal juice was obtained under sterile conditions during diagnostic upper endoscopy. Aspirates were plated quantitatively for anaerobic and aerobic organisms. Twenty five outpatients with peptic ulcer disease were investigated after a 5.7 (0.5) weeks (mean (SEM)) treatment course with 20 mg (nine patients) or 40 mg (16 patients). The control group consisted of 15 outpatients referred for diagnostic endoscopy without prior antisecretory treatment. No patient in the control group had duodenal bacterial overgrowth. In the omeprazole group bacterial overgrowth (> or = 10(5) cfu/ml) was found in 14 (56%) patients (p = 0.0003). The number of bacteria (log10) in duodenal juice in patients treated with omeprazole was distinctly higher (median 5.7; range < 2-8.7) when compared with the control group (median < 2; range < 2-5.0; p = 0.0004). As well as orally derived bacteria, faecal type bacteria were found in seven of 14 and anaerobic bacteria in three of 14 patients. Bacterial overgrowth was similar with the two doses of omeprazole. These results indicate that duodenal bacterial overgrowth of both oral and faecal type bacteria occurs often in ambulatory patients treated with omeprazole. Further studies are needed to determine the clinical significance of these findings, particularly in high risk groups during long term treatment with omeprazole.",1994.0,0,0
906,8527612,Review article: the continuing development of proton pump inhibitors with particular reference to pantoprazole.,R Huber; B Kohl; G Sachs; J Senn-Bilfinger; W A Simon; E Sturm,"Inhibition of the gastric proton pump is gaining acceptance as the treatment of choice for severe gastrooesophageal reflux disease, and for treatment of duodenal and gastric ulceration. Three of these drugs are now available (omeprazole, lansoprazole and pantoprazole) and more are being developed. Proton pump inhibitors share the same core structure, but differ in terms of substituents on this core. The substitutions are able to modify some important chemical properties of the compounds. For example, pantoprazole is significantly more acid-stable than omeprazole or lansoprazole. E3810 is significantly less stable than the other compounds. We present an explantation for this finding that depends on the relative pK values for the pyridine and benzimidazole nitrogens, especially the former. Pantoprazole formulated in an enteric-coated tablet displays high bioavailability and linear pharmacokinetics whether on single or multiple dose regimens. Although all three proton pump inhibitors provide a similar chemical conversion to sulphenamides, which are highly reactive cysteine reagents, these reagents derivatize different cysteines in the extracytoplasmic or membrane domain of the pump and inhibit the pump at different rates. Whereas the differences in chemical reactivity can be explained by the solution chemistry of the compounds, selective derivatization of different cysteines on the protein argues for an involvement of pump structure in response to the presence of the proton pump inhibitor on its luminal surface. This suggests that the proton pump inhibitors, which were originally designed to take advantage of only the highly acidic space generated in the parietal cell by the production of the sulphenamide, are made even more selective by the protein they target. Pantoprazole is metabolized by a combination of phase I and phase II metabolism, and has also been shown to have a very low potential for drug interaction. Studies of acid secretion in man have shown this compound to be an effective and long lasting inhibitor of acid secretion. The pharmacodynamics explain the cumulative effect of repeated doses and maximal acid secretory capacity with a once daily dosage.",1995.0,0,1
907,8527617,Comparison of pantoprazole versus omeprazole in the treatment of acute duodenal ulceration--a multicentre study.,M Rehner; H G Rohner; W Schepp,"In this randomized, double-blind, multicentre study, the proton pump inhibitors pantoprazole and omeprazole were compared in patients with active duodenal ulcers. Two hundred and seventy-six protocol-correct patients received either pantoprazole 40 mg (n = 185) or omeprazole 20 mg (n = 91), once daily for 2 or 4 weeks, depending on the progress of ulcer healing. Rates of complete ulcer healing after 2 weeks were 71% in patients given pantoprazole and 74% in patients given omeprazole. After 4 weeks the figures were 96% and 91%, respectively. These differences were not significant. There was no significant difference in ulcer pain prior to treatment, and 85% of the pantoprazole group and 86% on omeprazole were pain-free after 2 weeks (not significant). The time until complete pain relief with pantoprazole or omeprazole, based on data from diary cards, was not significantly different (P > 0.05, Uleman's U-test). Both treatments were equally well tolerated. Changes in routine laboratory parameters were minimal in both groups. Pantoprazole was shown to be a highly-effective and well-tolerated treatment for acute duodenal ulcer. Pantoprazole 40 mg and omeprazole 20 mg were equally effective with respect to ulcer healing and pain relief, and have similar adverse event profiles.",1995.0,0,1
908,8527618,"Eradication of Helicobacter pylori and prevention of recurrence of duodenal ulcer: a randomized, double-blind, multi-centre trial of omeprazole with or without clarithromycin.",R P Logan; K D Bardhan; L R Celestin; A Theodossi; K R Palmer; P I Reed; J H Baron; J J Misiewicz,"Antimicrobial treatment for Helicobacter pylori eradication is currently recommended for all patients with duodenal ulcer disease, but consensus on the best treatment is lacking. Patients with active duodenal ulcer and H. pylori were enrolled in a double-blind, randomized, placebo-controlled multi-centre study. Patients received omeprazole 40 mg daily for 28 days and either clarithromycin 500 mg t.d.s. or placebo t.d.s. for the first 14 days. Patients underwent endoscopy before starting treatment, at 2 weeks, immediately after stopping treatment if unhealed at 2 weeks, and at 1, 6 and 12 months after the end of treatment, or at the recurrence of symptoms. Eradication of H. pylori, duodenal ulcer healing and ulcer recurrence were measured. One-hundred and fifty-four patients were recruited and randomized to omeprazole plus clarithromycin (n = 74) or to omeprazole plus placebo (n = 80). One month after treatment, H. pylori was eradicated in 57 of 69 (83%; 95% CI: 72-91%) patients receiving omeprazole plus clarithromycin, compared with 1 of 75 (1%; 95% CI: 0-7%) receiving omeprazole alone (P < 0.001). In patients receiving omeprazole plus clarithromycin the ulcer healed at 2 weeks in 83% (95% CI: 71-91%) and at 4 weeks in 100% (95% CI: 95-100%), compared with 77% (95% CI: 66-86%) and 97% (95% CI: 91-100%) in those given omeprazole plus placebo (N.S.). Ulcers recurred at 12 months in 6% (95% CI: 1-16%) of patients given omeprazole plus clarithromycin, compared with 76% (95% CI: 63-86%) of patients given omeprazole plus placebo (P < 0.001). The incidence of side-effects was similar in both treatment groups (38% with clarithromycin dual therapy and 29% with omeprazole plus placebo; P = 0.304). Ninety per cent of patients took at least 90% of their prescribed medication. Omeprazole plus clarithromycin dual therapy eradicated H. pylori in 83% of patients with duodenal ulcer and significantly decreased 12-month recurrence from 76% to 6%.",1995.0,0,0
909,8536850,The effect of intrathecal opioid-receptor agonists on visceral noxious stimulation in rabbits.,F M Borgbjerg; C Frigast; J B Madsen; L F Mikkelsen,"Conflicting results have been published concerning the effects of different opioid-receptor agonists against visceral noxious stimulation. The introduction of colorectal distention facilitates research in this field. The aim of this study was to examine intrathecally administered opioid agonists against colorectal distention in conscious rabbits. Rabbits were equipped with a subcutaneous intrathecal injection system. Colorectal distention was induced by inflation of a balloon inserted into the descending colon. The test parameter was the pressure eliciting a characteristic visceromotor response. Examinations were performed before and after administration of the following drugs: morphine, U50488H, [D-Pen2, D-Pen5]enkephalin (DPDPE), naloxone, MR2266, naltrindole, saline, and acidified saline. The visceromotor response to colorectal distention was inhibited in a dose-dependent fashion by intrathecal opioids acting as agonists at all three types of opioid receptors. Morphine was antagonized more effectively by intrathecal than intramuscular naloxone. U50488H and DPDPE were equally antagonized by the specific antagonists MR2266 and naltrindole. Electrical thresholds in the lumbar region were increased, although they remained unaltered in the cervical region after administration of all three agonists. Intrathecal administration of different opioid agonists produces a dose-dependent spinal effect. The rank order of potencies in this model is DPDPE > U50488H > morphine > saline = 0.",1996.0,0,1
910,8540510,"Short- and long-term omeprazole for the treatment and prevention of duodenal ulcer, and effect on Helicobacter pylori.",L Marzio; G Biasco; F Cifani; C DeFanis; M Falcucci; G Ferrini; L Grossi; G Iannetti; G Larcinese; R Lattanzio,"This study analyzes the effect of short- and long-term omeprazole (OM) on duodenal ulcer healing, recurrence, and H. pylori status. Patients affected by active duodenal ulcer were randomly allocated to treatment with OM 20 mg or 40 mg once daily for 4 wk. Subsequently, patients with healed duodenal ulcer were randomly assigned to one of the following three groups: OM 20 mg once daily for 12 months, OM 20 mg alternate days for 12 months, and no treatment. Endoscopy was performed at entry, at 4 wk, and after 4, 8, and 12 months. Two biopsy specimens from antrum, body, and fundus were taken for histology and search for H. pylori. One hundred and eighty patients with active duodenal ulcer were admitted. Ninety-one were treated with OM 20 mg once daily and 89 with OM 40 mg for 4 wk. The results at 4 wk show 92.8% patients healed with OM 20 mg and 95.1% at 40 mg (NS). In the second part of the study, 96 of the patients who healed at 4 wk (45 with OM 20 mg, and 51 with OM 40 mg) entered the long-term study. Thirty-six patients received OM 20 mg daily for 12 months, 35 OM 20 mg on alternate days for 12 months, and 25 patients no treatment. The results show a healing rate of 100%, 100%, and 95% with OM 20 mg daily, of 97%, 95%, and 93% with OM 20 mg on alternate days, and of 81%, 50%, and 40% (p < 0.01) with no treatment at 4, 8, and 12 months, respectively. H. pylori that was found in 97% of patients at entry, at 4 wk was found in 92.8% of patients treated with OM 20 mg and in 97.5% of patients treated with OM 40 mg (NS). In one-third of the patients, H. pylori disappeared from the antrum but was found in the fundus. A 30% reduction in the presence of H. pylori was seen in the group treated with 20 mg daily for 12 months. We conclude that both continuous and alternate-day long-term OM treatment at 20 mg are similarly efficacious in the prevention of duodenal ulcer recurrence. Healing active duodenal ulcers with 20 or 40 mg does not influence subsequent treatment. Long-term OM at 20 mg daily for 12 months suppresses H. pylori temporarily in one-third of the patients. In these patients however, H. pylori reactivates after the end of treatment.",1995.0,0,0
911,8545694,Laparoscopic fundoplication in the treatment of severe gastroesophageal reflux disease: preliminary results of a prospective trial.,J G Tucker; B J Ramshaw; C L Newman; M S Sims; E M Mason; T D Duncan; G W Lucas,"To determine the technical feasibility and success of laparoscopic fundoplication in the treatment of severe gastroesophageal reflux disease (GERD), 18 consecutive adult patients were enrolled in a prospective study. All patients had received unsuccessful conservative treatment, were refractory to medical management, or had recurrence of symptoms of esophagitis after omeprazole therapy. All patients had severe acid reflux on 24-hour esophageal pH monitoring, endoscopic evidence of previous or ongoing esophagitis, and a defective lower esophageal sphincter on manometry. Complete (Nissen) fundoplication was done in 11 and partial (Toupet) fundoplication in 7 patients; the mean operative time was 183 minutes (range, 120 to 357 minutes). Feedings were initiated on the first postoperative day, and the average length of stay was 2.6 days (range, 1 to 6). There were no deaths or conversions to laparotomy. Postoperative morbidity consisted of transient bloating in three patients and dysphagia requiring dilatation in four patients. Return to work or normal activity averaged 19 days (range, 3 to 28), and 17 patients (94%) reported good to excellent results, with a median follow-up of 7 months. Laparoscopic fundoplication is technically feasible and offers a sound surgical alternative to patients with refractory GERD, but longitudinal follow-up is required to confirm long-term results.",1996.0,0,0
912,8561153,Cure of Helicobacter pylori infection: role of duration of treatment with omeprazole and amoxicillin.,R J Adamek; W Opferkuch; B Pfaffenbach; M Wegener,"To date, some studies have suggested that short-term therapy may be a promising therapeutic concept for the eradication of Helicobacter pylori. The primary objective of the present study was to elucidate the role of the duration of treatment in the cure of H. pylori infection. Forty consecutive patients with H. pylori-positive peptic ulcer disease were randomly allocated to four study groups. The groups were treated with a 14-day course of 20 mg omeprazole b.i.d. orally combined with 2 g amoxicillin t.i.d. intravenously for 1 day (n = 10; six women, age range 40-84 yr), for 3 days (n = 10; five women, age range 29-74 yr), for 5 days (n = 10; five women, age range 21-82 yr), for 7 days (n = 10); five women, age 42-82 yr), respectively. Initially, a standardized clinical evaluation of symptoms and and upper GI tract endoscopy were performed for assessment of H. pylori infection of the gastric mucosa (biopsy urease test, specific culture, and histology). At least 4 wk after cessation of omeprazole medication, H. pylori eradication was evaluated either as described or with the help of the 13C-urea breath test. H. pylori eradication, defined as negative bacterial findings in urease test, culture, and histology or 13C-urea breath test at least 4 wk after discontinuation of omeprazole therapy, was achieved in one of 10 patients (10%) in the one-day group, none of 10 patients (0%) in the 3- and 5-day groups and six of 10 patients (60%) in the 7-day group. We conclude that short-term therapies with the proton pump inhibitor omeprazole and the antibiotic amoxicillin must be considered completely ineffective if performed as a short-term therapy for up to 5 days. A therapy duration of 7 days seems to mark a turning point in antibiotic effectiveness, with a rapid increase in eradication rates.",1996.0,0,0
913,8566592,,,,,0,0
914,8574714,Efficacy and optimum dose of omeprazole in a new 1-week triple therapy regimen to eradicate Helicobacter pylori.,P Moayyedi; P Sahay; D S Tompkins; A T Axon,"To assess the efficacy of a 1-week course of omeprazole, clarithromycin and tinidazole for the eradication of Helicobacter pylori and the optimum dose of omeprazole required. The study was divided into two sequential phases. The first phase was an open, two-centre study. The second phase was a single-blind, single-centre study. Patients found to be infected with H. pylori at endoscopy were enrolled in the study. In phase 1, patients were prescribed 20 mg omeprazole, 250 mg clarithromycin and 500 mg tinidazole twice daily for 1 week. In phase 2, all patients were prescribed 250 mg clarithromycin and 500 mg tinidazole twice daily for 1 week. In addition, patients were randomly assigned to receive 20 mg omeprazole twice daily (group A), 20 mg omeprazole daily (group B) or no omeprazole (group C). Eradication was assessed in all patients by 13C-urea breath testing 4 weeks after the completion of therapy. In phase 1, H. pylori eradication was achieved in 132 (88%) of 150 evaluable patients. In phase 2, eradication was achieved in 44 (88%) of 50 individuals in group A, 47 (88.7%) of 53 in group B and 30 (63.8%) of 47 in group C. In the omeprazole groups, 22 patients harboured metronidazole-resistant strains of H. pylori and all were cured by the omeprazole regimen. One patient harboured a strain of H. pylori that was resistant to clarithromycin alone but which was successfully eradicated. Treatment failed in two out of three patients harbouring H. pylori strains resistant to both clarithromycin and tinidazole. One week of omeprazole, clarithromycin and tinidazole is effective in eradicating H. pylori. There is no advantage in increasing the dose of omeprazole from once to twice daily. This regimen is effective in patients with 5-nitroimidazole-resistant strains of H. pylori.",1995.0,0,0
915,8578163,Lansoprazole capsules and amoxicillin oral suspension in the treatment of peptic ulcer disease.,J G Hatlebakk; L B Nesje; T Hausken; C J Bang; A Berstad,"Lansoprazole is a potent antisecretory drug also possessing anti-Helicobacter pylori activity in vitro. It is a candidate drug for combination regimens with antibiotics for treating H. pylori infections. In a semiblind study, 65 patients with duodenal and/or gastric ulcer and pathologic 14C urea breath test results were treated with either 60 mg lansoprazole every morning only for 14 days or combined with 500 mg amoxicillin oral suspension four times daily between meals, given for 11 days. Endoscopy and breath test were repeated after 6 weeks and 6 months. Patients with unhealed ulcers were withdrawn. Eradication of H. pylori infection was attained in 46% of patients receiving lansoprazole and amoxicillin but in no patient receiving lansoprazole alone. Ulcers healed significantly more often in those who were H. pylori-negative (18 of 19 (95%)) than in those who were H. pylori-positive (20 of 41 (49%)). Adverse events, particularly stomatitis/sore throat and diarrhea, occurred significantly more often when amoxicillin was combined with lansoprazole. Lansoprazole eradicated H. pylori infection only when combined with amoxicillin. Eradication rates in this study are hardly acceptable, and further studies are necessary to define optimal doses and duration of treatment. Using amoxicillin as an oral suspension may not be of any substantial benefit and may cause stomatitis and sore throat.",1995.0,0,0
916,8578181,Omeprazole in the long-term treatment of gastro-oesophageal reflux disease. A double-blind randomized dose-finding study.,L S Laursen; T Havelund; S Bondesen; J Hansen; G Sanchez; E Sebelin; C Fenger; K Lauritsen,"Omeprazole is effective in the treatment of reflux oesophagitis, and it is important to determine the lower dose limit with still appropriate clinical efficacy. Patients with endoscopic oesophagitis grade 1-4 (N = 220) were randomized to double-blind treatment with 20 mg or 40 mg omeprazole daily for 4-8 weeks. Those healed after this initial treatment phase were re-randomized to double-blind treatment with 20 mg omeprazole daily (n = 67), 10 mg omeprazole daily (n = 68), or placebo (n = 33) for 6 months. Remission was defined as the absence of any endoscopic sign of oesophagitis. Healing rates were increased with 40 mg omeprazole, the therapeutic gain compared with the 20-mg dose being 15% after 4 and 8 weeks. The proportion of patients in remission after 6 months was 59% with 20 mg omeprazole, 35% with 10 mg omeprazole, and 0% with placebo. Maintenance treatment with 10 mg omeprazole can prevent recurrence of oesophagitis in about one-third of patients with all grades of oesophagitis, and 20 mg omeprazole in about twice as many.",1995.0,0,1
917,8578185,Non-bleeding visible vessel treatment: perendoscopic injection therapy versus omeprazole infusion.,C Grosso; A Rossi; P Gambitta; M Bini; G Zanasi; Z Pirone; R Arcidiacono,"The non-bleeding visible vessel in a peptic ulcer is the highest risk factor for a bleeding recurrence among not actively bleeding lesions. Perendoscopic injection of sclerosing compounds is usually used as prophylaxis against rebleeding. Forty-two patients with visible vessels in a peptic ulcer at an emergency endoscopic procedure have been studied: 21 patients underwent prophylactic perendoscopic hemostasis, and 21 patients were infused with omeprazole intravenously. Eight patients (19%), four in each group, had early rebleedings (within 48 h after the enrollment). There was no significant difference between the two types of treatment. At the endoscopic control after 48 h there were significantly more lesions with higher risk of rebleeding (Forrest IIa and IIb) in the group treated with perendoscopic hemostasis. Our data suggest that omeprazole infusion is a valid alternative to injection treatment of non-bleeding visible vessels.",1995.0,0,0
918,8578213,Helicobacter pylori eradication: a critical appraisal and current concerns.,R H Hunt,"Helicobacter pylori is now well recognized as a critical factor in the majority of patients with peptic ulcer disease and successful treatment of the infection results in cure of the disease. However, treatment of this infection has proved difficult, involving a combination of drugs, and has usually involved complex treatment regimens. Triple therapy involving a bismuth compound in combination with metronidazole and tetracycline or amoxicillin have been most widely used and achieve successful cure of the infection in about 90% of cases when the tetracycline combination is used. More recently, the use of the proton-pump inhibitors in combination with amoxicillin have been widely advocated to combine effective symptom relief with high ulcer healing rates and an opportunity to cure the disease. However, all these treatments have some disadvantages due to unpredictability, adverse events, complex regimens making compliance difficult, or cost. This article reviews the results of current treatments for the eradication of H. pylori infection and identifies opportunities for the development of optimal approaches to the cure of this infection.",1995.0,0,0
919,8578217,Sucralfate in Helicobacter pylori eradication strategies.,S K Lam; W H Hu; C K Ching,"Sucralfate monotherapy has been shown to suppress but not eradicate Helicobacter pylori. The combination of sucralfate with antibiotic(s) has been evaluated recently in the treatment of H. pylori-positive duodenal ulcer. The aim of this article is to review the efficacy of sucralfate-containing duotherapy and triple therapy in duodenal ulcer healing and H. pylori eradication rates. Reports on duotherapy and triple therapy including sucralfate as the mediating agent were analysed to assess the duodenal ulcer healing and H. pylori eradication rates. One study on duotherapy with sucralfate and amoxycillin achieved an ulcer healing rate of 86% and H. pylori eradication rate of 40%, which compared favourably with sucralfate monotherapy that resulted in duodenal ulcer healing and H. pylori eradication rates of 65% and 0% respectively. A total of six studies have examined triple therapy using sucralfate with two antibiotics. The duodenal ulcer healing rates were generally over 90% and the H. pylori eradication rates about 80% (range 59% to 100%). In one comparative study, the 4-week duodenal ulcer healing and H. pylori eradication rates of sucralfate-containing triple therapy were not distinguishable from those of omeprazole-containing triple therapy. It is concluded that sucralfate is an effective mediating agent for the eradication of H. pylori in patients with duodenal ulcer.",1995.0,0,0
920,8578219,Helicobacter pylori and peptic ulcer.,M G Korman; G N Tytgat,"Helicobacter pylori is an important pathogen causing both gastric and duodenal ulcer. The causal relationship is based on the strong association of peptic ulcer with H. pylori-induced gastritis, the improved rate of healing with H. pylori suppression, and markedly low recurrence rates for ulcer after H. pylori eradication. The ideal regimen for H. pylori eradication should be simple, inexpensive, free of side effects, and effective in at least 90% of patients. Triple therapy involving bismuth, metronidazole and tetracycline or amoxicillin results in the best and most consistent eradication data, but there is a significant incidence of side effects and problems with compliance. Acid suppression with ranitidine or omeprazole combined with antibiotics is effective but expensive with variable results in clinical trials. Sucralfate may also reduce H. pylori density and enhance the action of antibiotics used in eradication regimens. Studies reported in this Journal suggest that sucralfate can be successfully substituted for bismuth in triple therapy regimens with documented efficacy and few side effects. Considerable progress in developing newer regimens to eradicate H. pylori has been made. However, the development of an ideal drug or regimen remains a challenge.",1995.0,0,0
921,8578233,Helicobacter pylori eradication: unravelling the facts.,J S Dixon,"Recommendations for the choice, doses or duration of eradication therapy are still lacking. The purpose of this review was therefore to assess what conclusions could be drawn about eradication therapy, subsequent reinfection with Helicobacter pylori and ulcer recurrence. Data were extracted from published papers and abstracts and entered into a dedicated database for appropriate subset analyses. Despite problems of patient compliance and metronidazole resistance, triple therapy with either a bismuth salt or an antisecretory agent plus two antibiotics appears to provide the most effective eradication of H. pylori (< 80%). Dual therapies such as omeprazole plus amoxycillin are less effective (mean 59%, range 0-92%). Reinfection rates over one year vary between countries from 3% in Australia and the USA to 35% in Ireland. Reports of ulcer recurrence during the first year after successful eradication range from 0 to 27%. There are insufficient data for particular doses and durations of eradication therapy from well designed controlled studies.",1995.0,0,0
922,8580267,Helicobacter pylori eradication in a clinical setting: success rates and the effect on the quality of life in peptic ulcer.,T G Reilly; R C Ayres; V Poxon; R P Walt,"Helicobacter pylori eradication for peptic ulcer has been widely taken up. Evidence for the efficacy of different regimens is often derived from small series in clinical trials but there is little reporting of everyday practice with unselected patients. Freedom from ulcer relapse has been demonstrated, but not whether this equates with clinical success. We report on a series of 706 patients with H. pylori infection who, between January 1991 and April 1995, received eradication therapy followed by assessment of H. pylori status. Two-hundred and seven of these patients were followed-up by postal questionnaire, validated by parallel questionnaires to their general practitioners, covering clinical outcome measures. The overall eradication rate was 81.7%, and a 1-week course of omeprazole plus two antibiotics was significantly better than a 2-week course of standard triple therapy (85.0% vs. 78.0%, P < 0.05). Amongst 21 first-time failures, a 7-day course of a clarithromycin-containing triple therapy succeeded in 18. The questionnaire replies indicate that, following successful H. pylori eradication, ulcer patients are less likely to consult with ulcer symptoms (P < 0.0005), take medication (P < 0.0005), require further prescription (P < 0.0005), or lose work-time because of their ulcer (P < 0.005). They are more likely to have a subjective sense of ulcer cure (P < 0.0005). In addition to clear cost savings, social benefits are now demonstrated when H. pylori is eradicated. A well-tolerated 1 week regimen is genuinely effective in everyday practice.",1995.0,0,0
923,8580271,"Addition of metronidazole to omeprazole/amoxycillin dual therapy increases the rate of Helicobacter pylori eradication: a double-blind, randomized trial.",G D Bell; C M Bate; A T Axon; G Tildesley; G D Kerr; J R Green; C E Emmas; M D Taylor,"To compare the efficacy, safety and tolerability of an omeprazole/amoxycillin (OA) dual therapy Helicobacter pylori eradication regimen with an omeprazole/amoxycillin/metronidazole (OAM) triple therapy regimen. In this double-blind trial, conducted in 19 hospitals, 119 patients with symptomatic duodenal ulcer disease were randomized to receive either 14 days treatment with omeprazole 40 mg daily, amoxycillin 500 mg t.d.s. and placebo followed by a further 14 days' treatment with omeprazole 20 mg daily (n = 59) or 14 days treatment with omeprazole 40 mg daily, amoxycillin 500 mg t.d.s., and metronidazole 400 mg t.d.s., followed by a further 14 days' treatment with omeprazole 20 mg daily (n = 60). H. pylori status was assessed by 13C-urea breath test at entry and at 4 weeks post-treatment. H. pylori infection was eradicated in 46% of the OA treated patients and in 92% of the OAM treated patients, a mean difference of 46% (P < 0.0001, 95% CI for the difference: +30 to +62). In only one patient was the duodenal ulcer not endoscopically healed after 4 weeks of treatment (OA 100%; OAM 98% healed). There were no significant differences in speed of symptom relief or improvement in symptoms between the two groups. Both regimens were well tolerated, with 96% of patients completing the course, and only one patient withdrawing due to an adverse event. The only side-effect with a significantly higher incidence in the OAM group was diarrhoea, which occurred in 36% of patients compared to 16% of patients in the OA group (P < 0.05). A regimen consisting of omeprazole 40 mg daily, amoxycillin 500 mg t.d.s. and metronidazole 400 mg t.d.s. for 14 days gives an appreciably higher H. pylori eradication rate than omeprazole and amoxycillin alone, with acceptable tolerability.",1995.0,0,0
924,8580272,"A comparison of three doses of lansoprazole (15, 30 and 60 mg) and placebo in the treatment of duodenal ulcer. The Lansoprazole Study Group.",D L Avner; E R Dorsch; D E Jennings; P A Greski-Rose,"Lansoprazole is a new proton pump inhibitor for the treatment of peptic ulcer disease. A double-blind, multicentre study was undertaken in 296 patients with endoscopically proven duodenal ulcer to compare the efficacy and safety of lansoprazole 15, 30 or 60 mg with placebo. Ulcer healing was documented by endoscopy at 2 and 4 weeks; patients whose ulcers healed after 4 weeks were followed for up to 6 months post-treatment. Four-week healing rates of 89.4%, 91.7% and 89.9% were obtained with lansoprazole 15, 30 and 60 mg, respectively, compared with 46.1% on placebo (P < 0.001). All three doses of lansoprazole produced rapid symptom relief, although patients taking 60 mg lansoprazole required fewer antacids than did those taking 15 mg. At 6 months, the percentages of patients healed were 45.3%, 40.0% and 38.4% in the lansoprazole 15, 30 and 60 mg dosage groups, respectively, and 25.3% for the placebo group. No significant adverse events were documented during the period of this trial. Lansoprazole is an effective and safe treatment for duodenal ulcer and the 15 mg dose is as effective as 30 or 60 mg.",1995.0,0,1
925,8580280,Patterns of 24-hour oesophageal acid exposure after acute withdrawal of acid suppression.,W C Orr; M H Mellow; M R Grossman,"To measure 24-h ambulatory oesophageal pH data in patients with gastro-oesophageal reflux disease prior to, during and after acute treatment with comparable doses of omeprazole and ranitidine. The subjects were 20 adults with at least 8% acid contact time. Ten subjects were treated for 1 week with omeprazole 20 mg q.d.s. and 10 subjects with ranitidine 300 mg t.d.s. All subjects were examined at the end of 1 week of therapy and subsequent to cessation of treatment (1 day for ranitidine and 3 days for omeprazole). Both drugs produced a statistically significant (P < 0.05) decrease in acid contact time with acute treatment. Omeprazole produced a significantly greater decrease in acid contact time when compared to ranitidine. Subsequent to treatment cessation, the total acid contact time for omeprazole remained significantly less than the baseline level, while ranitidine returned to levels which were not significantly different from the baseline. These data provide no evidence for a 'reflux rebound' subsequent to the cessation of acute acid secretory suppression.",1995.0,0,0
926,8583073,Effect of parenteral omeprazole and ranitidine on gastric pH and the outcome of bleeding peptic ulcer.,A Lanas; A Artal; J M Blás; M T Arroyo; J Lopez-Zaborras; R Sáinz,"The pharmacotherapy of bleeding peptic ulcer is directed at attempting to keep the gastric pH above the proteolytic range for pepsin. In this randomized, prospective, open clinical trial we have compared the effects and outcome of omeprazole versus ranitidine in patients with bleeding peptic ulcer. Of 219 consecutive patients with upper gastrointestinal bleeding, 51 (23.2%) had an ulcer with endoscopic predictors of rebleeding at the time of diagnosis. These 51 patients were selected at random to receive either omeprazole (80 mg bolus and 40 mg/12 h i.v.) or ranitidine (50 mg/4 h i.v.). No endoscopic therapy was performed at the time of diagnosis. Twenty of these patients with duodenal ulcer (n = 10 omeprazole, n = 10 ranitidine) underwent 24-h gastric pH monitoring. Both groups were homogeneous in all clinical and endoscopic parameters. No differences in blood transfusion units, time of hospitalization, the lowest hematocrit measured, and mortality rates were observed between the groups. However, omeprazole reduced the number of rebleeding episodes (p = 0.1) and the need for surgery (3.8% vs. 22.7%; p = 0.05). Omeprazole also reduced the amount of time the gastric pH was < 6 (15.3 +/- 5.9% vs. 61.8 +/- 5.6%, p < 0.0001). We conclude that parenteral omeprazole is much more effective than ranitidine in keeping the gastric pH above the proteolytic range for pepsin in bleeders and that this might explain a better outcome in a subset of patients with bleeding peptic ulcers treated with parenteral omeprazole.",1995.0,0,0
927,8585108,Pharmacokinetic interaction between lansoprazole and theophylline.,G R Granneman; M D Karol; C S Locke; J H Cavanaugh,"The pharmacokinetic interaction potential of the new proton-pump inhibitor lansoprazole and theophylline was assessed in a double-blind, two-period (13-day duration per period), multiple-dose crossover study in 14 healthy male volunteers. Lansoprazole 60 mg or placebo once daily was coadministered with anhydrous theophylline 200 mg four times daily. Plasma theophylline concentrations were quantitated via high-performance liquid chromatography. Lansoprazole did not appear to affect substantially the absorption profile or clearance of theophylline. Theophylline area under the plasma concentration-versus-time curve over the 6-h dosing interval decreased slightly (13%) but statistically significantly during lansoprazole coadministration. As the magnitude of this effect was small, this interaction is likely to be clinically insignificant.",1995.0,0,1
928,8590162,Meta-analysis of randomized clinical trials comparing lansoprazole with ranitidine or famotidine in the treatment of acute duodenal ulcer.,T Poynard; M Lemaire; H Agostini,"The aim was to compare the clinical efficacy of lansoprazole with the efficacies of ranitidine and famotidine in order to rank this drug in the hierarchy of duodenal ulcer treatments. All randomized clinical trials in which lansoprazole was used to treat patients with duodenal ulceration were reviewed. The meta-analysis included a quality assessment for each trial. The main criterion chosen for the meta-analysis was the endoscopic healing rate at 4 weeks; other criteria were the healing rate at 2 weeks and the absence of pain at 2 and 4 weeks. Statistical methods used were the Der Simonian and Laird method and the method of Peto et al. A sensitivity analysis was performed according to the H2 blocker type (famotidine or ranitidine). Odds ratios against histamine-receptor blockers were used to compare lansoprazole indirectly with omeprazole and other drugs. Five double-blind trials were identified including 848 patients. The mean 4-week healing rate in patients treated with lansoprazole was 85%, which was significantly higher than the healing rate in patients treated with H2-receptor blockers (75%). This difference of 10% was significant (P < 0.01) according to the Der Simonian method, and the corresponding odds ratio of 2.27 (95% confidence interval 1.5-3.2) was significant according to the Peto method (P < 0.01). There was also a significant difference in favour of lansoprazole for 2-week healing rates (mean difference 20%, P < 0.01) and for the percentage of patients without pain at 2 weeks (mean difference 8%; P < 0.02). Indirect comparisons of 4-week healing rates showed no difference between 30 mg lansoprazole and 20 mg omeprazole and confirmed that both drugs had a greater efficacy than ranitidine, famotidine, nizitidine, cimetidine or sucralfate. This meta-analysis showed that 30 mg lansoprazole was more effective in producing healing at 2 and 4 weeks than ranitidine or famotidine. Lansoprazole also led to a greater reduction in the percentage of patients free of pain at 2 weeks. The efficacy of lansoprazole was not different from that of omeprazole.",1995.0,0,0
929,8594244,Consensus conference. Medical treatment of peptic ulcer disease. Practice guidelines. Practice Parameters Committee of the American College of Gastroenterology.,A H Soll,"To integrate the realization that peptic ulcer most commonly reflects infection with Helicobacter pylori or use of aspirin and other nonsteroidal anti-inflammatory drugs (NSAIDs) into a disease management approach. Guidelines were outlined by the author and presented for review to the American College of Gastroenterology (ACG) Practice Parameters Committee, selected by the president of the ACG, and a panel of experts in peptic ulcer, selected by the committee. These guidelines were formulated following extensive review of the literature obtained by MEDLINE search and presented for detailed review and revision to unpublicized committee meetings on three occasions and to experts by mail. These recommendations are an official statement of the ACG and have been approved by the American Gastroenterological Association and the American Society for Gastroenterological Endoscopy. Firm recommendations are discriminated from reasonable suppositions pending definitive data. Since cure of H. pylori infection decreases recurrence rates and facilitates healing, antibiotic therapy is indicated for all H. pylori-infected ulcer patients. No optimal, simple antibiotic regimen has yet emerged. Simultaneous conventional ulcer therapy is recommended to facilitate symptom relief and healing. For refractory ulcers, only maximal acid inhibition offers advantage over continued conventional therapy; cure of H. pylori infection is likely to facilitate healing of refractory ulcers. Only with complicated or refractory ulcers should conventional maintenance therapy be continued, at least until successful H. pylori eradication is confirmed. A search for NSAID use is indicated for all ulcer patients. For NSAID-associated ulcers these drugs should be discontinued if possible and H. pylori, if present, should be cured.",1996.0,0,0
930,8598839,Atrophic gastritis and Helicobacter pylori infection in patients with reflux esophagitis treated with omeprazole or fundoplication.,E J Kuipers; L Lundell; E C Klinkenberg-Knol; N Havu; H P Festen; B Liedman; C B Lamers; J B Jansen; J Dalenback; P Snel; G F Nelis; S G Meuwissen,"Helicobacter pylori infection plays an important part in the development of atrophic gastritis and intestinal metaplasia, conditions that predispose patients gastric cancer. Profound suppression of gastric acid is associated with increased severity of gastritis caused by H. pylori, but it is not known whether acid suppression increases the risk of atrophic gastritis. We studied patients from two separate cohorts who were being treated for reflux esophagitis: 72 patients treated with fundoplication in Sweden and 105 treated with omeprazole (20 to 40 mg once daily) in the Netherlands. In both cohorts, the patients were followed for an average of five years (range, three to eight). After fundoplication, the patients did not receive acid-suppressive therapy. The presence of H. pylori was assessed at the first visit by histologic evaluation in the fundoplication group and by histologic and serologic evaluation in the omeprazole group. The patients were not treated for H. pylori infection. Before treatment and during follow-up, the patients underwent repeated gastroscopy, with biopsy sampling for histologic evaluation. Among the patients treated with fundoplication, atrophic gastritis did not develop in any of the 31 who were infected with H. pylori at base line or the 41 who were not infected; 1 patient infected with H. pylori had atrophic gastritis before treatment that persisted after treatment. Among the patients treated with omeprazole, none of whom had atrophic gastritis at base line, atrophic gastritis developed in 18 of the 59 infected with H. pylori(P<0.001) and 2 of the 46 who were not infected (P=0.62). Patients with reflux esophagitis and H. pylori infection who are treated with omeprazole are at increased risk of atrophic gastritis.",1996.0,0,0
931,8601113,Omeprazole as a risk factor for campylobacter gastroenteritis: case-control study.,K R Neal; H M Scott; R C Slack; R F Logan,,1996.0,0,1
932,8602022,Proton-pump inhibitors or H2-receptor antagonists for Helicobacter pylori eradication-a meta-analysis.,G Holtmann; P Layer; H Goebell,,1996.0,0,0
933,8607487,Cost-effectiveness of treatment regimens for the eradication of Helicobacter pylori in duodenal ulcer.,N Vakil; M B Fennerty,"Eradication of Helicobacter pylori with antimicrobials was recommended by a recent NIH consensus panel for all infected patients with peptic ulcer disease. The precise regimen that should be used for eradication of the infection remains uncertain because of the variety of regimens described, variable results with the regimens, and difficulties in predicting drug compliance outside clinical trials. A decision analysis tree was developed with three regimens that are widely used regimens for the eradication of H. pylori: 1) 2-wk triple drug therapy (metronidazole, bismuth, tetracycline with H2 receptor antagonist), 2) 2-wk omeprazole and amoxicillin, and 3) 2-wk omeprazole and clarithromycin. Traditional H2 receptor antagonist therapy was used for comparison. A 2-yr time period was chosen for study to allow sufficient time for relapse and to evaluate its effect on the treatment strategy. Probabilities for eradication, compliance, and metronidazole resistance were determined from published data, and assumptions were tested by sensitivity analysis. Standard 2-wk triple drug therapy was the least expensive strategy ($720), and conventional H2 receptor antagonist therapy was the most expensive ($1791). Costs with 2-wk therapy with omeprazole and clarithromycin ($768) were lower than with omeprazole and amoxicillin ($1028). Treatment to eradicate H. pylori in infected patients with duodenal ulcer is a less expensive strategy than traditional therapy with H2 receptor antagonists. Triple drug therapy is the optimal regimen in areas where metronidazole resistance rates are < 36% and compliance is > 53%. Omeprazole and amoxicillin is not cost-effective unless eradication rates are greater than 74%. Dual drug therapy with omeprazole and clarithromycin is effective in regions where metronidazole resistance is high or where it is anticipated that there would be poor compliance with the more complicated triple drug therapy regimen.",1996.0,0,0
934,8607489,"Triple therapy with azithromycin, omeprazole, and amoxicillin is highly effective in the eradication of Helicobacter pylori: a controlled trial versus omeprazole plus amoxicillin.",G Bertoni; R Sassatelli; E Nigrisoli; P Tansini; G Bianchi; G Della Casa; A Bagni; G Bedogni,"Azithromycin is a new-generation, acid-stable macrolide antibiotic that achieves remarkably high concentrations in gastric tissue, persisting above the MIC90 for Helicobacter pylori over a 5-day period after a single 500-mg oral dose. We evaluated a new metronidazole-free triple therapy with omeprazole 20 mg b.i.d. plus amoxicillin 1 g b.i.d. (both for 14 days) and azithromycin 500 mg mane (for the first 3 days only) (group I) versus double therapy with omeprazole 20 mg b.i.d. plus amoxicillin 1 g t.i.d., both for 14 days (group II). H. pylori status was determined by urease test and histology before and 6 wk after completion of therapy. Ninety-two patients with peptic ulcer disease or nonulcer dyspepsia completed the study. H. pylori infection was eradicated in 44 (91.6%) of 48 patients randomized to receive triple therapy versus 26 (59.1%) of 44 who received double therapy (p < 0.001). Smoking, but not omeprazole pretreatment, proved to be a risk factor for treatment failure only in the double-therapy group (p = 0.05). All ulcers healed by the time of the 8-wk endoscopic control. Side effects, usually minor, were recorded in 12.5% and 9.1% of patients, respectively (NS), but therapy had to be discontinued in one patient in group I and in three in group II (NS). Two-week triple therapy with omeprazole, amoxicillin, and (for the first 3 days) low-dose azithromycin is highly effective in eradicating H. pylori. This regimen is safe and well-tolerated, and we recommend that it be used as first-line treatment, as an alternative to less-effective omeprazole-amoxicillin double therapy. Moreover, azithromycin appears to be a new, promising antibiotic for future innovative anti-H. pylori combinations.",1996.0,0,0
935,8608760,Helicobacter pylori eradication: the best long-term prophylaxis for ulcer bleeding recurrence?,D Jaspersen,"Peptic ulcer is the most common cause of acute intestinal hemorrhage. Helicobacter pylori is now accepted as being a pathogenetic agent in chronic active gastritis, and is strongly associated with ulcer disease. Eradication of H. pylori reduces significantly the rate of ulcer recurrence. Preliminary data demonstrate that rebleeding did not occur in patients with complicated ulcers whose H. pylori infection had been eradicated. That this should be the case follows logically from the fact that, if ulcer relapses are eliminated, the associated hemorrhage must also be eliminated. Recent publications on this topic are discussed in this review article.",1995.0,0,0
936,8608881,Helicobacter pylori augments the pH-increasing effect of omeprazole in patients with duodenal ulcer.,J Labenz; B Tillenburg; U Peitz; J P Idström; E F Verdú; M Stolte; G Börsch; A L Blum,"Omeprazole is less effective in healthy subjects than in patients with duodenal ulcers. The aim of this study was to determine whether Helicobacter pylori augments the pH-increasing effect of omeprazole in patients with duodenal ulcers. In 16 patients with duodenal ulcers, baseline intragastric acidity was measured before and 4-6 weeks after the cure of H. pylori infection. In 17 patients with duodenal ulcers, 24-hour pH metry was performed during treatment with 20 mg omeprazole once daily before as well as after eradication of H. pylori. Intragastric acidity was measured using a glass electrode placed 5 cm below the cardia. H. pylori infection was assessed by [13C] urea breath test, culture, histology, and rapid urease test. H. pylori eradication resulted in marked decrease of the pH-increasing effect of omeprazole (24-hour median gastric pH, 5.5 vs. 3.0; P<0.002) that was most pronounced during nighttime (median gastric pH, 6.4 vs. 2.1; P=0.001). On the other hand, baseline intragastric pH remained unchanged after eradication (median gastric pH, 1.0 vs. 1.1; P=0.5). In patients with duodenal ulcers treated with omeprazole, intragastric pH depends significantly on the presence or absence of H. pylori, whereas baseline pH remained unchanged after H. pylori eradication.",1996.0,0,1
937,8610725,Asthma and gastroesophageal reflux: acid suppressive therapy improves asthma outcome.,S M Harding; J E Richter; M R Guzzo; C A Schan; R W Alexander; L A Bradley,"To determine (1) the appropriate omeprazole (Prilosec) dose required for adequate acid suppression in asthmatics with gastroesophageal reflux, (2) whether aggressive acid suppressive therapy of gastroesophageal reflux improves asthma outcome in asthmatics with gastroesophageal reflux, (3) the time course of asthma improvement, and (4) demographic, esophageal, or pulmonary predictors of a positive asthma response to antireflux therapy. Thirty nonsmoking adult asthmatics with gastroesophageal reflux (asthma defined by American Thoracic Society criteria and reflux defined by symptoms and abnormal 24-hour esophageal pH testing) were recruited from the outpatient clinics of a 900-bed university hospital. Patients underwent baseline studies including a demographic questionnaire, esophageal manometry, dual-probe 24-hour esophageal pH test, barium esophogram, and pulmonary spirometry. During the 4-week pretherapy phase, patients recorded reflux and asthma symptom scores and peak expiratory flow rates (PEFs) upon awakening, 1 hour after dinner, and at bedtime. Patients began 20 mg/d omeprazole, and the dose was titrated until acid suppression was documented by 24-hour pH test. Patients remained on this acid suppressive dose for 3 months. Responders were identified by a priori definitions: asthma symptom reduction by >20% and/or PEF increase by >20%. Asthma symptom scores, PEF's baseline and posttherapy pulmonary spirometry were analyzed. Twenty-two (73%) patients were asthma symptom and /or PEF responders: 20 (67%) were asthma symptom responders, and 6 (20%) were PEF responders. Responders reduced their asthma symptoms by 57% (P<0.001), improved their morning and night PEFs by 8% and 9% (both P <0.005), and had improvement in forced expiratory volume at 1 second (P <0.02), mean forced expiratory flow during the middle half (25% to 75%) of the forced vital capacity (P <0.04), and peak expiratory flow (P <0.01) with acid suppressive therapy. Mean acid suppressive dose of omeprazole was 27 mg/d (+/-2.2) with 27% (8) patients requiring more than 20 mg/d. The presence of regurgitation or excessive proximal esophageal reflux predicted asthma response with 100% sensitivity, 100% negative predictive value, specificity of 44% and a positive predictive value of 79%. Acid suppressive therapy with omeprazole improves asthma symptoms and/or PEFs by >20% and improves pulmonary function in 73% of asthmatics with gastroesophageal reflux after 3 months of acid suppressive therapy. Many asthmatics (27%) required >20 mg/d of omeprazole to suppress acid. The presence of regurgitation and/or excessive proximal esophageal reflux predicts a positive asthma outcome.",1996.0,0,0
938,8610914,"Effective maintenance treatment of reflux esophagitis with low-dose lansoprazole. A randomized, double-blind, placebo-controlled trial.",M Robinson; F Lanza; D Avner; M Haber,"To compare the efficacy of two doses of lansoprazole with that of placebo in preventing recurrence of erosive esophagitis in a 12-month period. Randomized, double-blind, parallel, placebo-controlled trial. 25 U.S. medical centers. 173 patients with documented healing of erosive esophagitis after 8 weeks of acid-suppressing therapy. Lansoprazole, 15 mg or 30 mg, or placebo once daily for as long as 12 months. Endoscopy and symptom evaluation after 1, 2, 3, 6, 9, and 12 months of treatment. Endoscopy was also done whenever symptoms suggested erosive changes. Lansoprazole was significantly superior to placebo in maintaining healing and preventing recurrence of symptoms. By month 1, 45% of placebo recipients remained healed compared with more than 90% of patients in either lansoprazole group. By month 12, only 24% of placebo recipients remained healed compared with 79% of patients receiving 15 mg of lansoprazole and 90% of patients receiving 30 mg of lansoprazole. During the same period, 35% of placebo recipients remained asymptomatic compared with 72% of recipients of 15 mg of lansoprazole and 67% of recipients of 30 mg of lansoprazole. The 15-mg and 30-mg lansoprazole doses did not differ significantly in maintaining healing and controlling symptoms. Follow-up after recurrence of erosion indicated that during the 12 months, 35% of placebo recipients and 2% of lansoprazole recipients had three or more recurrences. Lansoprazole effectively maintains healing of erosive esophagitis. The 15-mg and 30-mg lansoprazole doses did not differ significantly for use as maintenance treatment.",1996.0,0,1
939,8615506,"A comparison of lansoprazole, omeprazole, and ranitidine for reducing preoperative gastric secretion in adult patients undergoing elective surgery.",K Nishina; K Mikawa; N Maekawa; Y Takao; M Shiga; H Obara,"Acid aspiration syndrome of induction of anesthesia is a life-threatening complication whose severity is affected by both pH and volume of the aspirated gastric juice. We compared the effects of two proton pump inhibitors (PPIs), lansoprazole and omeprazole, and an H2 blocker, ranitidine, on gastric secretion in a prospective, randomized, double-blind fashion in 200 adult patients of ASA physical status I undergoing elective surgery. The patients were divided into eight groups (n = 25 each) according to their premedication. The patients received lansoprazole-lansoprazole (Group L-L), lansoprazole-placebo (Group L-P), placebo-lansoprazole (Group P-L), omeprazole-omeprazole (Group O-O), omeprazole-placebo (Group O-P), placebo-omeprazole (Group P-O), placebo-ranitidine (Group P-R), or placebo-placebo (Group P-P), as the first and second medications. The dose of the study drug was 30 mg for lansoprazole, 150 mg for ranitidine, and 80 mg for omeprazole. The first medication was administered orally at 9:00 PM on the night before surgery and the second at 5:30 AM in the morning on the day of the surgery. Each patient fasted overnight and took the drug with 20 mL of water. After tracheal intubation, gastric fluid was aspirated via an orogastric tube and the volume and pH of the aspirate were measured. The pH of the aspirated gastric fluid was higher in Groups P-R, L-L, P-L, O-O, and O-P than in Group P-P (P < 0.05). The volume of the gastric contents was similar in Groups P-0 and P-P, and the other groups had smaller gastric volume than Group P-P (P < 0.05). Gastric fluid from patients in Group P-R was the least acidic (pH 6.1 +/- 1.2) and had the least volume (0.09 +/- 0.06 mL/kg). Group L-L was comparable with Group P-R in both pH and volume, whereas Groups P-L and O-O were similar to Group P-R only in volume. The proportion of patients at risk according to the traditional criteria (pH < 2.5 and volume 0.4 mL/kg) was significantly lower in Groups L-L (0%), P-L (4%), O-O (4%), and P-R (0%) than in Group P-P (48%) (P < 0.05). We concluded that two consecutive doses of lansoprazole or a morning dose of ranitidine seemed to be the most effective preanesthetic medication for reducing gastric acidity and volume.",1996.0,0,0
940,8629205,A cost-effective approach to the patient with peptic ulcer bleeding.,G C Jiranek; R A Kozarek,"The average hospital cost to manage patients hospitalized at Virginia Mason Hospital who bleed from a peptic ulcer is approximately $5000 per patient in our series of 30 patients. Because there are 150,000 admissions per year in the United States for peptic ulcer bleeding, the total hospital cost can be estimated to be $750 million. The actual cost may be higher because our 30 patients had minimal complications and were discharged on average in less than 4 days. The majority of hospital cost is incurred by the intensive care unit or the hospital nursing floor. There is a close to linear relation between the length of stay and the total hospital cost. Upper gastrointestinal endoscopy is a major advance in the treatment of peptic ulcer bleeding. It can provide significant cost savings by identifying some patients with bleeding peptic ulcers who have clean bases on endoscopy who are then eligible for prompt discharge from the hospital. In addition, endoscopic thermal therapy (with multipolar electrocautery or heater probe) and injection therapy cost less than $50 in incremental cost and can reduce further bleeding by 43%, reduce the need for urgent surgery by 63%, and reduce the mortality rate by 60%. Some patients still require urgent surgical intervention, which is substantially more costly than endoscopic hemostasis but is highly effective. Preliminary studies show promise in predicting further bleeding, with clinical scoring systems such as the Baylor Bleeding Score and with the use of Doppler ultrasonography. Better prediction of further bleeding should guide the choice of durable hemostasis early in the hospitalization. Additional studies should clarify the role of NSAID avoidance and H. pylori eradication in the long-term prevention of recurrent peptic ulcer bleeding.",1996.0,0,1
941,8633565,,,,,0,0
942,8645075,The role of a defective lower esophageal sphincter in the clinical outcome of treatment for gastroesophageal reflux disease.,M Costantini; G Zaninotto; M Anselmino; C Boccù; L Nicoletti; E Ancona,"To evaluate the clinical role of a defective lower esophageal sphincter in the long-term outcome of medical and surgical treatment for gastroesophageal reflux disease. Nonrandomized control study (median follow-up, 33 months). Referred care. Fifty-five patients with gastroesophageal reflux disease were prospectively evaluated using a symptom questionnaire, upper endoscopy, esophageal manometry, and 24-hour pH monitoring. Patients were classified into three groups: (1) those with a manometrically defective lower esophageal sphincter, treated surgically; (2) those with a manometrically defective lower esophageal sphincter, treated medically; and (3) those with a manometrically normal lower esophageal sphincter, treated medically. Nissen antireflux procedure and medical therapy with H2-blockers and/or omeprazole. Symptomatic improvement after treatment and need for continuous medication. After therapy, symptoms improved significantly in all three groups (P < .05), but least in the patients who declined surgery. Among patients with a defective lower esophageal sphincter, medical therapy could be discontinued in 13 of 14 patients who had surgery compared with one of 14 who declined surgery. Of the 27 patients with a normal lower esophageal sphincter who were treated medically, medical therapy could be discontinued in 12. In patients with gastroesophageal reflux disease who have a defective lower esophageal sphincter, surgery can ensure durable symptom control. Patients with a defective sphincter who decline surgery are destined for lifelong therapy, whereas in approximately half of those with a normal sphincter, medical therapy can eventually be discontinued.",1996.0,0,0
943,8661818,Medical treatment of metastasizing carcinoid tumors.,R Arnold,"Long-acting somatostatin analogs, such as octreotide, comprise the therapeutic modality of choice for the symptomatic relief of flush and diarrhea in patients with carcinoid syndrome. The sequelae of gastric acid hypersecretion in patients with gastrin-producing duodenal carcinoids (gastrinoma) are perfectly controlled by proton pump inhibitors. Antiproliferative medical strategies to control the growth of metastatic carcinoid tumors include long-acting somatostatin analogs, interferon alpha, and the combination of the two. However, the success rate is less than 50%, and it is questionable whether true tumor regression can be expected. Controlled prospective studies are mandatory to address the question whether interferon or somatostatin analogs or the combination of the two should be used as first-line medical strategies and if hepatic artery embolization in patients with liver metastases should be performed before beginning medical therapy. Chemotherapy, including etoposide and cisplatin, has been shown to be effective only for purely differentiated neuroendocrine carcinomas and not for slowly growing carcinoids.",1996.0,0,0
944,8672831,Comparative role of omeprazole in the treatment of gastroesophageal reflux disease.,V A Skoutakis; R H Joe; D S Hara,"To review gastroesophageal reflux disease (GERD) and its treatment, with emphasis on the use and place of omeprazole, a proton pump inhibitor. A compilation prepared by the National Library of Medicine's Interactive Retrieval Services (Medlars II) for the period 1987 to 1994 was used as the data source. Focus was placed on human comparative clinical studies with well-accepted measures of esophageal healing (endoscopy) and symptom resolution. Safety data were compiled from the clinical trials literature and large postmarketing data studies. Pharmacoeconomic studies selected were judged to meet the criteria of good design, presence of sensitivity testing, and statement of perspective. Data were obtained from double-blind, controlled clinical studies. Other data were extracted from pertinent literature of good design and significant results. Overall, the clinical trials of omeprazole for the treatment of patients with erosive GERD demonstrate that omeprazole provides superior therapy in terms of esophageal healing symptom resolution and patient compliance when compared with histamine2-receptor antagonists (H2RAs) and antacids. In addition, studies also indicate that omeprazole is the most effective agent for the treatment of patients with GERD refractory to other treatments. Dosage adjustment is not necessary in patients with impaired renal or hepatic function or in the elderly. Finally, although the acquisition drug cost for daily treatment of patients with GERD is highest with the use of omeprazole, pharmacoeconomic studies indicate that treatment is more cost-effective with the use of omeprazole than with H2RA or antacid treatment alone or combined with nonpharmacologic approaches. Based on efficacy, safety, and cost-effectiveness, omeprazole is the drug of choice for the treatment of patients with endoscopically confirmed erosive GERD.",1995.0,0,0
945,8677931,Omeprazole coupled with two antibiotics for Helicobacter pylori eradication and prevention of ulcer recurrence.,G Bianchi Porro; M Lazzaroni; S Bargiggia; G Maconi; E Trespi; M Perego; C Alvisi; L Villani; O Luinetti; R Fiocca; M Franceschi; B Cesana; E Solcia,"Numerous therapeutic trials aimed at eradicating Helicobacter pylori (HP) from the gastric mucosa and preventing ulcer recurrence have been carried out; however, an optimal treatment has not yet been established with carefully controlled randomized studies. The aim of our study was to evaluate the efficacy of an association of omeprazole (OM) coupled with two antibiotics in the eradication of HP and prevention of duodenal ulcer (DU) recurrence. One hundred and eighty three patients with active DU were randomized under double-blind conditions to receive either OM 20 mg for 4 wk plus amoxycillin 3 g daily and metronidazole 1 g daily during the 2nd and 3rd wk (91 patients, group A) or OM 20 mg for 4 wk plus matching placebo (92 patients, group B). Endoscopy was performed before and at the end of the 4-wk treatment as well as 2, 6, and 12 months later. Biopsies were taken from the duodenum, antrum, and gastric body at each endoscopic examination for HP histological detection and for evaluation of inflammatory changes according to the Sydney system. After 4 wk, 84/86 patients (98%) of group A and 80/86 (93%) of group B were healed of their ulcers. The percentage of eradication was 90% in group A and 1% in group B. During a 12-month follow-up, DU relapsed in 4/63 (6%, including two of three reinfected cases) HP-eradicated group A patients, 4/8 (50%) HP-noneradicated group A patients, and 52/65 (80%) persistently HP-positive group B patients. Rapid, complete, and persistent suppression of gastroduodenitis activity and gastric surface epithelium lesions was observed in most HP-eradicated group A patients, whereas a transient decrease of bacterial colonization and inflammatory scores in the antrum and a transient worsening of corpus gastritis were found in group B patients. The combined therapy with amoxycillin, metronidazole, and omeprazole is highly effective in both HP eradication and prevention of duodenal ulcer recurrence.",1996.0,0,0
946,8678002,Low H. pylori reinfection rate after triple therapy in Chilean duodenal ulcer patients.,G Figueroa; R Acuña; M Troncoso; D P Portell; M S Toledo; V Albornoz; J Vigneaux,"We studied prospectively in a single-blind controlled manner the efficacy of 4-wk triple-antibiotic therapy, with amoxicillin (500 mg p.o., t.i.d.), metronidazole (250 mg p.o., t.i.d.), and bismuth subsalicylate tablets (524 mg p.o., q.i.d.), plus omeprazole (20 mg p.o., q.d.) and compared it with omeprazole (id) in the treatment of duodenal ulcer (DU) patients colonized with Helicobacter pylori. One hundred DU patients were entered prospectively over a 12-month period. Fifty-seven of them received triple therapy plus omeprazole and 43 received omeprazole alone. Clinical, endoscopic, and bacteriological evaluations were performed on admission and at 28 days, 4, 8, and 12 months after treatment. After 4-wk treatment (day 28), the ulcer healing rate was high, but there was no significant difference between rates in the triple therapy and omeprazole groups (99% vs. 91%). In contrast, the long-term DU recurrence rate after 12-month follow-up was significantly lower (p > 0.01) for triple therapy (3/57, 5%), compared with omeprazole (34/43, 79%). The difference (higher relapse rate for omeprazole-treated patients) was significant (p < 0.001) by the second evaluation, 4 months after treatment. The eradication rate of H. pylori was also significantly higher among DU patients treated with triple therapy (p < 0.001) during all prospective evaluations, grand mean, 82% (range 82-87%), compared with the omeprazole-treated group, in which there were no cases in which H. pylori was eradicated. Follow-up revealed that 2/47 H. pylori-eradicated patients became reinfected after 1 yr, giving a reinfection rate of 4.2 patient/yr. Four-week triple-antibiotic therapy plus omeprazole constitutes an adequate alternative for treatment of Chilean DU patients.",1996.0,0,0
947,8680534,Effects of pirenzepine on omeprazole-induced hypergastrinemia and acid suppression in peptic ulcer patients.,A Tari; M Hamada; T Kamiyasu; Y Fukino; M Sumii; K Haruma; K Sumii; M Inoue; G Kajiyama,"Omeprazole effectively suppresses acid secretion, resulting in the long-term elevation of intragastric pH and serum gastrin level. Pirenzepine has been reported to inhibit gastrin secretion. This study was carried out to examine the effects of additional pirenzepine treatment on the hypergastrinemia and gastric acid suppression induced by omeprazole. Concentrations of serum gastrin and plasma somatostatin were measured in 28 peptic ulcer patients before treatment, after omeprazole treatment (20 mg/day) for 2 weeks, and after omeprazole and pirenzepine (100 mg/day) treatment for 2 weeks. The acid inhibitory effect of pirenzepine treatment in addition to omeprazole was evaluated by 24-h intragastric pH measurement in six healthy volunteers. Serum gastrin level was increased significantly, to 2.4-fold the pretreatment level, by omeprazole treatment. Additional treatment with pirenzepine suppressed serum gastrin level to 0.6-fold the omeprazole-treatment level. The serum somatostatin level was not altered significantly either by omeprazole treatment or by omeprazole and pirenzepine treatment. In healthy volunteers whose pH 3 holding time on 24-h intragastric pH monitoring was 70% by omeprazole treatment, omeprazole and pirenzepine treatment markedly increased the pH 3 holding time, to 89%. These findings suggest that pirenzepine is useful in reducing the undesirable effects of omeprazole-induced hypergastrinemia, i.e., the excessive trophic effect of omeprazole on the acid-secreting part of the stomach and the overstimulation of acid secretion. The additional pirenzepine treatment is also effective in suppressing acid secretion.",1996.0,0,0
948,8689142,Current management of gastroesophageal reflux disease.,K R DeVault,"Gastroesophageal reflux disease (GERD) is a chronic condition that is very common, and may result in considerable morbidity as well as mortality (from complications). I present data on the therapy of patients with GERD and offer a practical approach to their management. The goals of management of GERD are relief of symptoms, healing of esophagitis, prevention of complications, and maintenance of remission. Simple lifestyle changes may control GERD in up to 20% of patients. Promotility therapy addresses the pathophysiology of this disorder, but the best results are only 50 to 60% control using cisapride, whereas the older agents (metoclopramide and bethanechol) are limited by side effects. Acid suppression using histamine receptor antagonists controls GERD in 50 to 60% of patients, whereas proton pump inhibitors offer the most effective control (80-100%). A surgical approach (especially using newer laparoscopic techniques) will provide effective therapy of GERD in a high percentage of patients, but further careful comparisons are needed to define the long-term efficacy and cost issues associated with both surgical and chronic medical therapy of GERD. Despite this lack of long-term data, we know that GERD is a chronic, often lifelong illness, and maintenance therapy should be offered to most patients. This therapy may include aggressive medical therapy (up to and including chronic proton pump inhibitor therapy) or antireflux surgery in selected patients.",1996.0,0,0
949,8690200,"Effect of omeprazole on the distribution of metronidazole, amoxicillin, and clarithromycin in human gastric juice.",A F Goddard; M J Jessa; D A Barrett; P N Shaw; J P Idström; C Cederberg; R C Spiller,"The mechanism by which antimicrobial therapy against Helicobacter pylori is enhanced by acid suppression is unknown. The aim of this study was to investigate the effect of omeprazole on gastric juice, plasma, and saliva concentrations of metronidazole, amoxicillin, and clarithromycin. Single doses of antibiotic were administered intravenously to 24 healthy men (each antibiotic to 8 subjects) while taking placebo or omeprazole. Antibiotic concentrations were measured in gastric juice, plasma, and saliva. The pharmacokinetic parameters gastric clearance and gastric transfer fraction were calculated for each antibiotic. In the omeprazole group compared with the placebo group, mean maximum antibiotic gastric juice concentrations (in milligram per liter) of metronidazole decreased from 33.6 to 8.3 (P = 0.0001), whereas those of clarithromycin were unchanged, and those of amoxicillin increased from 0.13 to 0.68 (P = 0.02). Omeprazole increased salivary concentrations of metronidazole (P = 0.02) but had no effect on clarithromycin concentrations (no amoxicillin was detectable in saliva). Omeprazole decreases the intragastric concentrations of metronidazole by reducing acid secretion and increases intragastric concentrations of amoxicillin partly by reducing gastric juice volume. Novel pharmacokinetic parameters have been described that provide an insight into the mechanisms underlying drug transfer across the blood-stomach barrier.",1996.0,0,0
950,8690219,Pharmacology of the gastric mucosa: a rational approach to Helicobacter polytherapy.,J R Lambert,,1996.0,0,0
951,8701375,Efficacy of ciprofloxacin in the eradication of Helicobacter pylori.,D Dresner; W Coyle; R Nemec; R Peterson; T Duntemann; J M Lawson,"In small preliminary trials, ciprofloxacin has failed to eradicate Helicobacter pylori. Since fluoroquinolones have a marked reduction in bactericidal activity at acidic pH, we altered the gastric pH using omeprazole and investigated the efficacy of ciprofloxacin in eradicating H pylori. Forty-four consecutive patients infected with H pylori were prospectively studied in a randomized, double-blind, controlled trial comparing ciprofloxacin with a placebo for 2 weeks. Both treatment groups received bismuth and omeprazole. In 36 patients, follow-up endoscopy was done 4 weeks after the cessation of all study drugs. The H pylori infection cleared in 13 of 17 patients (76%) in the ciprofloxacin group versus 5 of 19 (26%) in the placebo group. Concurrent administration of omeprazole with ciprofloxacin resulted in increased bactericidal activity against H pylori. Ciprofloxacin when combined with omeprazole and bismuth is efficacious for eradication of H pylori.",1996.0,0,0
952,8707107,Relation between oesophageal acid exposure and healing of oesophagitis with omeprazole in patients with severe reflux oesophagitis.,R H Holloway; J Dent; F Narielvala; A M Mackinnon,"Reducing oesophageal acid exposure by suppressing acid secretion with omeprazole is highly effective in healing reflux oesophagitis. Some patients with severe oesophagitis, fail to heal and whether this results from inadequate acid suppression or other factors is unclear. The aim of this study, was to investigate the relation between oesophageal acid exposure and healing in patients with severe reflux oesophagitis treated with omeprazole. Sixty one patients with grade 3 or 4 ulcerative oesophagitis were treated for eight weeks with omeprazole 20 mg every morning. Those patients unhealed at eight weeks were treated with 40 mg every morning for a further eight weeks. Endoscopy and 24 hour oesophageal pH monitoring were performed before treatment and at the end of each treatment phase while receiving treatment. Thirty per cent of patients failed to heal with the 20 mg dose. Unhealed patients had greater total 24 hour oesophageal acid exposure before treatment, and while receiving treatment also had greater acid exposure and a smaller reduction in acid exposure than did patients who healed. Forty seven per cent of the unhealed patients also failed to heal with the 40 mg dose. These patients had similar levels of acid exposure before treatment to those who healed, but had greater acid exposure while receiving treatment, particularly at night when supine. Patients with severe ulcerative oesophagitis who are refractory to omeprazole have greater oesophageal acid exposure while receiving treatment than responding patients. This is due to a reduced responsiveness to acid suppression, and is likely to be an important factor underlying the failure of the oesophagitis to heal.",1996.0,0,0
953,8722392,Effects of permanent eradication or transient clearance of Helicobacter pylori on histology of gastric mucosa using omeprazole with or without antibiotics.,E Solcia; R Fiocca; L Villani; J Carlsson; A Rudbäck; L Zeijlon,"Changes in Helicobacter pylori-associated gastritis of the antrum and corpus were investigated in a large number of patients treated with omeprazole, with or without the addition of amoxycillin. To investigate the role of H. pylori-associated gastritis in ulcerogenesis and its interplay with omeprazole, biopsies were taken and evaluated according to the Sydney system. Successful eradication of H. pylori (assessed histologically 4 weeks after the end of therapy) led to prompt and persistent suppression of gastritis activity, slow, partial regression of mononuclear inflammation and an ulcer recurrence rate of only 14% during the 6 months' follow-up. In patients treated with omeprazole and placebo, or where eradication treatment with omeprazole and amoxycillin had failed, transient clearance of H. pylori from the antral (but not oxyntic) mucosa was seen. In both of these groups of patients transient regression in the antrum, and worsening in the corpus, of gastritis activity and mononuclear inflammation were evident, coupled with ulcer recurrence rates of 72 and 46%, respectively. It was concluded that H. pylori colonization and gastritis activity play a crucial role in ulcerogenesis, that acid inhibition treatment improves antral H. pylori gastritis and worsens the oxyntic mucosal gastritis, and that this can be prevented by eradication of the H. pylori infection.",1996.0,0,0
954,8722408,Suppression of Helicobacter pylori colonization with omeprazole.,Y Fukuda,"The efficacy of omeprazole, 20 mg once daily, in suppressing Helicobacter pylori colonization was studied in 33 patients with peptic ulcers. Omeprazole treatment produced a significant fall in the number of H. pylori colony-forming units in the antrum. This finding, together with the results of a meta-analysis of clinical trials of H. pylori eradication therapy, suggests that combinations of omeprazole and antibiotics may be useful as eradication therapy in patients with peptic ulcer disease and H. pylori infection.",1996.0,0,0
955,8730245,Treatment of Helicobacter pylori infection with low or high dose omeprazole combined with amoxycillin and the effect of early retreatment.,R W van der Hulst; J F Weel; S B Verheul; J J Keller; F J ten Kate; A van der Ende; E A Rauws; J Dankert; G N Tytgat,"Cure rates of H. pylori infection, using dual therapy with omeprazole and amoxycillin, vary considerably and the efficacy of retreatment with this regimen in the case of initial failure is controversial. Therefore, we conducted a large prospective double-blind randomized trial, studying the efficacy of low vs. high dose omeprazole in dual therapy and of early retreatment with the same regimens. One hundred and sixty-eight consecutive H. pylori-positive patients, suffering from either peptic ulcer disease or functional dyspepsia, were enrolled. Group I (n = 84) received omeprazole 20 mg b.d. plus amoxycillin 750 mg t.d.s., for 2 weeks. Group II (n = 84) received omeprazole 40 mg t.d.s. plus amoxicillin 750 mg t.d.s., for 2 weeks. The H. pylori eradication rate was 60.2% in group I and 64.3% in group II (P = 0.59). Cure of H. pylori infection was significantly better in patients with peptic ulcer disease, compared to non-ulcer dyspeptics (P = 0.016). Retreatment, given in 54 patients, was successful in 21.4% patients in group I and in 28% patients in group II (P = 0.58). High dose of omeprazole has no advantage compared to low dose in terms of eradication efficacy. Early retreatment with the same regimen offers limited improvement in cure rate. Presence of peptic ulcer disease influences cure rates significantly.",1996.0,0,0
956,8730253,Comparison of two lansoprazole-antibiotic combinations (amoxycillin or classical triple therapy) for treatment of H. pylori infection in duodenal ulcer patients.,F Parente; G Maconi; S Bargiggia; E Colombo; G Bianchi Porro,"To compare the eradicating capacity of two different antibiotic-lansoprazole combinations (amoxycillin vs. standard triple therapy) with that of lansoprazole alone in Helicobacter pylori-positive duodenal ulcer patients. Ninety-six out-patients with H. pylori-positive duodenal ulcer were randomly assigned to receive one of the following three antiulcer regimens: (1) lansoprazole 30 mg b.d. for 4 weeks plus amoxycillin 1 g t.d.s. during the last 2 weeks; or (2) lansoprazole 30 mg once daily for 4 weeks plus classical triple therapy (tripotassium dicitratobismuthate 240 mg b.d., amoxycillin 1 g t.d.s. and tinidazole 500 mg b.d.) for the last 2 weeks; or (3) lansoprazole 30 mg once daily for 4 weeks. Endoscopy was repeated at the end of treatment and 1 month later. A rapid urease test and histology were used to determine H. pylori status. Duodenal ulcer healing rates at 4 weeks were 96% after both lansoprazole with amoxycillin, and lansoprazole with triple therapy, and 97% after lansoprazole alone. Eradication of H. pylori was significantly better with lansoprazole with triple therapy than with either lansoprazole with amoxycillin or lansoprazole alone (90% vs. 55% vs. 3%, respectively). Classical triple therapy combined with lansoprazole is significantly more effective than the lansoprazole with amoxycillin combination for the eradication of H. pylori in duodenal ulcer patients pre-treated with lansoprazole.",1996.0,0,0
957,8733992,Cost of acid peptic disorders in a managed-care organization.,R Segal; W L Russell; R Ben-Joseph; B Mansheim,"The purpose of this study was to determine the cost of managing ambulatory patients with symptoms of acid peptic disorders in a managed-care organization under actual clinical conditions. Study data were collected in a large independent practice association model health maintenance organization in Gainesville, Florida, from prescription records maintained in a computerized database and from patient medical records. Patients had to be started on a histamine2-receptor antagonist (H2RA) or the proton pump inhibitor omeprazole between 1992 and 1994. A total of 113 patients qualified for inclusion in the study; 57 received H2RAs, 27 received omeprazole, and 29 received combination therapy. The costs of procedures, physician visits, and drug therapy were considered in the economic evaluation. Costs were evaluated using two methods: the capitation total cost (CTC) and the fee-for-service total cost (FSTC). The mean CTC and FSTC for managing a patient with acid peptic symptoms for 6 months were $382 +/- 356 (range, $14 to $1820) and $456 +/- 368 (range, $52 to $1925), respectively. Drug costs represented 52% of the total FSTC and 62% of the total CTC. Drug costs were followed by the costs for encounters with primary care physicians, endoscopy, referral to specialists, and upper gastrointestinal (UGI) tract procedures. Documented outcomes were available for 85 patients. Compared with patients receiving H2RAs (n = 41), patients receiving omeprazole (n = 18) had significantly lower FSTCs ($317 +/- 219 compared with $423 +/- 307, respectively); diagnostic testing costs (for endoscopy, $0 compared with $44 +/- 119, respectively; for UGI procedures, $22 +/- 42 compared with $55 +/- 54, respectively); physician encounter costs ($66 +/- 40 compared with $86 +/- 38, respectively); and referral to specialist costs ($0 compared with $18 +/- 60, respectively). Patients receiving omeprazole also had more positive clinical outcomes than patients receiving H2RAs (78% compared with 49%, respectively), resulting in a more favorable cost of producing a successful outcome compared with patients receiving an H2RA. The cost of success was $407 for patients treated with omeprazole compared with $869 for patients treated with H2RAs. The findings of this analysis conducted under actual clinical conditions support findings of randomized clinical trials showing the cost-effectiveness of proton pump inhibitors.",1996.0,0,1
958,8759655,Persistent acid secretion during omeprazole therapy: a study of gastric acid profiles in patients demonstrating failure of omeprazole therapy.,L P Leite; B T Johnston; R J Just; D O Castell,"To identify patients with gastroesophageal reflux disease (GERD) who, despite omeprazole 20 mg b.i.d., demonstrate continued abnormal gastric acid secretion. Eighty-eight patients with GERD completed ambulatory gastric and esophageal pH monitoring for persistent symptoms on omeprazole 20 mg b.i.d.. Seventeen (19%) demonstrated abnormal gastric acid secretion (percentage time gastric pH < 4 > 50%). The 17 omeprazole failures (OF) were compared with: 1) 19 randomly selected patients with GERD (also studied on omeprazole 20 mg b.i.d. and 2) 19 normal volunteers studied on both placebo and omeprazole 20 mg b.i.d.. Total time intragastric pH < 4, 24-hr gastric pH frequency distribution, and 15-min median pH values for the 6-h period after the evening omeprazole dose were compared. Both the 24-hr frequency distribution for gastric pH and the 15-min median gastric pH profile for patients with GERD and volunteers on omeprazole 20 mg b.i.d. were almost identical. By contrast, gastric pH studies from the OF group receiving omeprazole 20 mg b.i.d. most closely resembled those of the normal subjects receiving placebo, with respect to these variables. Gastric pH monitoring in seven of the 17 OF patients while on omeprazole 80 mg/day demonstrated a significant decrease in the median percentage time gastric pH remained below 4 (32.8% on 80 mg/day vs 74.3% on 40 mg/day; p < 0.02). There are individuals whose intragastric acidity persists despite conventional doses of omeprazole. Although the underlying mechanism remains unclear, the majority (six of seven) (87%) demonstrated improved gastric acid control when placed on high dose omeprazole, indicating that this is often a dose-dependent phenomenon.",1996.0,0,0
959,8759659,Antimicrobial therapy for Helicobacter pylori infection versus long-term maintenance antisecretion treatment in the prevention of recurrent hemorrhage from peptic ulcer: prospective nonrandomized trial on 125 patients.,C Santander; R G Grávalos; A Gómez-Cedenilla; J Cantero; J M Pajares,"Our objective was to assess the effectiveness of therapy for Helicobacter pylori (HP) on the prevention of recurrent bleeding in patients with recent upper gastrointestinal hemorrhage from peptic ulcers. We performed a prospective follow-up study without randomization on 125 consecutive patients (83 males and 42 females) who had presented with their first major episode of upper gastrointestinal hemorrhage from peptic ulcer (22 gastric and 103 duodenal ulcers). All 125 patients were HP-positive. During the acute phase of bleeding, all patients were treated with standard supportive measures. After the acute bleeding phase, patients were allocated to two treatment groups: 1) antimicrobial therapy-84 patients received one of the following three regimens: 1) amoxicillin 500 mg t.i.d. for 10 days + omeprazole 20 mg b.i.d. for 30 days; 2) clarythromycin 500 mg t.i.d. for 12 days + omeprazole 20 mg b.i.d. for 30 days; or 3) amoxicillin 500 mg t.i.d. for 10 days + metronidazole 500 mg t.i.d. for 10 days + colloidal bismuth subcitrate 240 mg b.i.d. for 30 days. For long-term antisecretion maintenance treatment, 41 patients were allocated to either omeprazole 20 mg once a day or ranitidine 150 mg once a day, for 1 yr. During the follow-up period, peptic ulcers recurred in six patients in the antibiotic group (7.14%) and 13 patients in the maintenance group (31.7%) (p < 0.001). The fraction of patients without recurrent bleeding was greater in the antibiotic group than in the maintenance group. Two patients in the antibiotic group (2.3%) and five in the maintenance group (12.1%) had recurrent hemorrhages (p < 0.1). Cure of HP infection reduces the recurrence of peptic ulcer and of rebleeding from ulcer disease more effectively than does long-term maintenance therapy.",1996.0,0,0
960,8771431,How to achieve a near 100% cure rate for H. pylori infection in peptic ulcer patients. A personal viewpoint.,W A de Boer,"Infection with Helicobacter pylori is the main etiological factor in duodenal and gastric ulcer disease, and eradication of the organism cures peptic ulcer disease. Cure of the infection therefore has become the ultimate treatment goal in ulcer patients. Only therapies that achieve a > 90% cure rate should be used in clinical practice and, as in any other disease, the therapy with the highest cure rates should be used. Bismuth-based triple therapy is considered the gold standard; it has been used successfully in many studies, usually with good tolerability on the part of patients. Many physicians have been hesitant to prescribe this therapy. The regimen is complex, and it is thought to have many side effects. Several groups have shown that concomitant therapy with a proton pump inhibitor increases efficacy and lessens side effects. Moreover, it has become clear that the duration of treatment can be decreased to just 7 days. With this adjustment it now seems sensible to use this short 7-day quadruple therapy, which at present has superior cure rates when compared with any other anti-Helicobacter therapy. This article is a plea for the use of this regimen and gives practical advice about how to employ therapy in general practice. Suggestions are made about how to motivate a patient to comply with the therapy prescribed. If these suggestions are followed, good compliance seems possible, and a near 100% cure rate will be within reach.",1996.0,0,0
961,8771432,Brush cytology: a reliable method to detect Helicobacter pylori.,M Dalla Libera; P Pazzi; G Carli; E Contato; I Piva; R Scagliarini; A Merighi; N Ricci; S Gullini,"This study was conducted to verify the reliability of brush cytology in detecting Helicobacter pylori in an unselected group of patients with duodenal ulcer (DU) and nonulcer dyspepsia (NUD). Endoscopy was performed on 416 consecutive patients: group A, 94 with active DU; group B, 176 patients with DU after omeprazole (n = 78), ranitidine (n = 43), or triple anti-H. pylori therapy (n = 55); and group C, 146 patients with NUD. During endoscopy, the gastric mucosa was brushed and two biopsy samples from the antrum and body were obtained for histology. In 65 patients, culture of the brush-collected materials also was performed as was that from of biopsy samples. The overall frequency of H. pylori presence detected by brush cytology was significantly higher compared with that of histology (p < 0.001), particularly in group A (p < 0.05), group C (p < 0.05), and in patients with DU after omeprazole treatment (p < 0.01), but not in patients with DU after ranitidine or anti-H. pylori treatment. The overall frequency of H. pylori-positive cultures from the brush-collected material was higher compared with cultures from the biopsy samples (38.5% vs. 24.6%), particularly in the NUD group (32.6% vs. 16.3%). Brush cytology is more sensitive than histology, besides being faster and cheaper, for the assessment of H. pylori infection, particularly when the density of the bacteria is low.",1996.0,0,0
962,8774516,Effect of omeprazole in the treatment of refractory acid-related diseases in childhood: endoscopic healing and twenty-four-hour intragastric acidity.,S Kato; K Ebina; K Fujii; H Chiba; H Nakagawa,"To determine the clinical efficacy of once-daily treatment with omeprazole in refractory acid-related diseases in children. Endoscopic healing and 24-hour intragastric pH values were assessed in 13 patients with refractory reflux esophagitis (n = 5), refractory and/or giant duodenal ulcer (n = 6), or giant gastric ulcer (n = 2). The mean dose of omeprazole was 0.6 mg/kg per day (range, 0.3 to 0.7 mg/kg per day). Pharmacokinetic studies of omeprazole were performed in seven patients. The cumulative healing rates at 2, 4, 6, and 8 weeks of treatment were 46%, 85%, 92%, and 92%, respectively. Esophagitis in one patient did not heal despite increases in doses of up to 1.6 mg/kg per day (40 mg/day). The mean intragastric pH of omeprazole-treated patients was 5.2 (range, 3.0 to 6.6) and mean hydrogenion activity was 1.78 mmol/L (range, 0.01 to 10.42 mmol/L). There was wide interindividual variation in the reduction of gastric acid production. Mean intragastric H+ activity in omeprazole-treated patients was significantly lower than that of control subjects (p < 0.005) and that of patients treated with histamine type 2(H2)-receptor antagonists (p < 0.05). Mean intragastric H+ activity was not significantly correlated to the area under the concentration-time curve of omeprazole. No severe adverse effects were reported during treatment or at follow-up. Omeprazole has a potent antisecretory effect and is a suitable alternative for short-term treatment of refractory acid-related diseases; a relatively low dose (0.6 mg/kg per day) appears to be optimal in most patients. Unhealed esophagitis at 8 weeks of treatment was considered to be refractory to omeprazole.",1996.0,0,0
963,8780593,How do you spell relief in reflux esophagitis? PPI!,M B Fennerty,,1996.0,0,0
964,8781634,Prolonged treatment with omeprazole does not improve the eradication rate of Helicobacter pylori infection--a short report [corrected].,K L Goh; N Parasakthi; S C Peh; P E Anderson; K K Tan,"Omeprazole has been shown to have a suppressive effect on Helicobacter pylori. The aim of this study was to determine if prolonged treatment with omeprazole would result in a higher eradication rate than short course treatment. Twenty patients with endoscopy proven duodenal ulcers and unequivocal evidence of Helicobacter pylori (HP) infection based on culture, histology, urease test and Gram's stain of a fresh tissue smear were treated with omeprazole 40 mg om for 2-4 weeks. Following ulcer healing, patients received either maintenance omeprazole 20 mg om or placebo for up to one year. All 20 patients had healed ulcers following a 2-4 week course of omeprazole 40 mg om.. All were negative for HP at the end of treatment. Thirteen patients received short course therapy with omeprazole only, followed by placebo. On follow-up endoscopy at 3 months, only one of 13 (7.7%) had eradicated the bacteria. Seven patients received maintenance treatment with omeprazole 20mg om for one year. Following completion of treatment, patients were followed up at 1, 3 and 6 months. Only one of 7 (14.3%) patients had eradicated the infection on long term follow-up. The eradication rates of HP with both short and long course omeprazole monotherapy were low.",1995.0,0,0
965,8781686,Lansoprazole and omeprazole in the treatment of acid peptic disorders.,R A Blum,"The pharmacology, pharmacokinetics, efficacy, safety, and dosage and administration of lansoprazole and omeprazole are reviewed. Lansoprazole and omeprazole are proton-pump inhibitors (PPIs). These agents bind covalently to hydrogen/potassium-exchanging adenosine triphosphatase in gastric parietal cells, rendering the molecule nonfunctional and inhibiting the secretion of gastric acid. The bioavailability of lansoprazole is 85%; that of omeprazole is 54%. Although lansoprazole and omeprazole have a plasma half-life of less than 2 hours, the duration of action is more than 24 hours. Clinical trials have shown lansoprazole and omeprazole to be effective in the treatment of duodenal ulcers, gastric ulcers, peptic ulcer disease involving Helicobacter pylori infection, recurrent ulcers, ulcers induced by nonsteroidal anti-inflammatory drugs, reflux esophagitis, Barrett esophagus, and Zollinger-Ellison syndrome. In many cases, these PPIs were more effective than histamine H2-receptor antagonists or worked when the latter failed. Lansoprazole and omeprazole have similar adverse-effect profiles and are well tolerated in both long- and short-term therapy. The dosage and duration of therapy vary with the condition being treated or the individual patient. Dosage adjustments should be considered only in the case of lansoprazole in patients with severe liver disease. Lansoprazole and omeprazole are highly specific in blocking a critical step in gastric acid production and have been found to be safe and effective in the treatment of many acid peptic disorders.",1996.0,0,0
966,8781903,Cure of gastric ulcer disease after cure of Helicobacter pylori infection--German Gastric Ulcer Study.,E Bayerdörffer; S Miehlke; N Lehn; G A Mannes; W Höchter; J Weingart; H Klann; A Sommer; W Heldwein; R Hatz; T Simon; K H Bolle; E Bästlein; A Meining; G Ruckdeschel; M Stolte,"Helicobacter pylori infection is associated with gastric ulcer disease in about 75% of cases. The aim of this study was to determine whether H. pylori eradication reduces gastric ulcer relapse rates. The study was randomized, controlled, multicentric and investigator blinded, and was conducted at three university hospitals, two teaching hospitals, and by six practising gastroenterologists. During a period of 1 year 152 patients with gastric ulcers were randomly assigned to one of two treatment regimens: omeprazole 20 mg daily in the morning for 8 weeks (74 patients), or bismuth subsalicylate 600 mg three times daily for 8 weeks combined with 500 mg amoxicillin twice daily and 1000 mg tinidazole twice daily for the first 10 days (triple therapy) (78 patients). Follow-up examinations were performed 6, 12 and 18 months after treatment and whenever ulcer symptoms occurred. Of the 152 randomized patients five were excluded because of gastric cancer, 10 missed follow-up examinations and seven receiving triple therapy terminated treatment because of side effects. Of the remaining 130 patients, five of 69 (7.2%) in the omeprazole and six of 61 (9.8%) in the triple group were H. pylori negative. After 8 weeks' therapy, the gastric ulcer was healed in 85.9% (omeprazole) and in 81.8% triple) in H. pylori-positive patients, and in 80% (omeprazole) and 16.7% (triple) in H. pylori-negatives. H. pylori was eradicated in 8.1% of the patients who received omeprazole monotherapy and in 78.2% receiving triple therapy, and in 8.1% and 69.4% in an intention-to-treat analysis. The subsequent relapse rates during a follow-up period of 12 months were 50% in the omeprazole group and 4% in the triple group. Gastric ulcer relapse was observed in 49% of patients who were H. pylori positive and in 2% who were H. pylori negative after treatment. The data show that the presence of H. pylori is an important predictor of gastric ulcer relapse and that eradication of H. pylori may heal gastric ulcer disease.",1996.0,0,0
967,8784314,Quality of life scale for gastroesophageal reflux disease.,V Velanovich; S R Vallance; J R Gusz; F V Tapia; M A Harkabus,"Treatment of uncomplicated gastroesophageal reflux disease (GERD) is primarily to improve the symptoms of the patient. However, measurement of symptomatic outcome is difficult because it is as the patient perceives it to be and not ""objective."" This creates a need to develop a simple and understandable instrument to measure symptomatic outcome. All patients referred for evaluation of GERD were eligible for this prospective study. During the initial visit, patients were asked to complete the Gastroesophageal Reflux Data Sheet. This ten-item questionnaire included an overall assessment of satisfaction; the best possible score was 0, and the worst was 45. The evaluation included history, physical examination, and additional studies, including upper gastrointestinal series, esophagogastroduodenoscopy, esophageal manometry, and 24-hour esophageal pH monitoring as indicated. Initial treatment was medical with histamine2-blockers, omeprazole, cisapride, or both. If a patient was dissatisfied with medical treatment and had both a hypotensive lower esophageal sphincter and abnormal results of the 24-hour pH monitoring, then operative treatment with either laparoscopic or open Nissen or Toupet fundoplication was offered. After approximately three months of medical treatment or one month after operative treatment, patients were asked to complete the questionnaire again. Data were analyzed using nonparametric tests and linear regression analysis. A total of 72 patients were assessed, and 100 percent of them completed the questionnaire. Patients who were satisfied with their condition had a median health-related quality of life (HRQL) score of five, and those who were dissatisfied had a median score of 26 (p < 0.000001). Patients who ultimately chose surgical therapy had a median preoperative score of 28, compared with 15 for patients who chose to continue medical therapy (p = 0.0001). The change in HRQL score from before treatment to after treatment for surgical patients was 27 compared with 11 for medically treated patients (p < 0.002). Items 1 through 6 of the questionnaire were individually sensitive to the effects of treatment. However, there was no correlation between HRQL and the composite pH score or with the lower esophageal sphincter pressure. This HRQL score has advantages over standard health status instruments for GERD including simplicity for patients (and therefore a high compliance rate), ease of understanding for physicians, and sensitivity to the effects of treatment. In addition, it may help determine, early in the course of treatment, patients who may ultimately require surgical therapy, thereby avoiding prolonged, but futile, medical therapy.",1996.0,0,0
968,8786770,Atrophic gastritis and Helicobacter pylori in reflux esophagitis.,A H Repucci,,1996.0,0,0
969,8789310,,,,,0,0
970,8791950,Comparison of two low-dose one-week triple therapy regimens with and without metronidazole for cure of H. pylori infection.,B H Jaup; A Norrby,"One-week triple therapy consisting of omeprazole 20 mg b.d., clarithromycin 250 mg b.d. and tinidazole 500 mg b.d. is an effective therapy for H. pylori infection with a cure rate of 93%. We therefore compared two similar 1-week regimens consisting of a lansoprazole, clarithromycin and either metronidazole or tetracycline in a prospective study. Two cohorts, each of 60 patients suffering from H. pylori infection associated with peptic ulcer disease or ulcer-like dyspepsia, were treated for 1 week with either lansoprazole 30 mg b.d., clarithromycin 250 mg b.d. and either metronidazole 400 mg b.d. (cohort A, n = 60) or tetracycline 300 mg b.d. (cohort B, n = 60). Four weeks after treatment, cure of H. pylori infection was evaluated by endoscopy using rapid urease testing together with histology. In cohort A, 55 patients out of 60 showed cure of H. pylori infection (92%); the treatment was well tolerated, but three patients suffered from side-effects. In cohort B, which was free of metronidazole, 50 out of 60 patients showed cure of H. pylori infection (83%); two patients reported side-effects. The differences between the two cohorts were not statistically significant. Triple therapy for 1 week with lansoprazole as the antisecretory agent seems to be as effective as is reported for omeprazole-based regimens.",1996.0,0,0
971,8791951,"A seven-day Helicobacter pylori treatment regimen using clarithromycin, omeprazole and tripotassium dicitrato bismuthate.",M J Weldon; A Broadbent; S Chambers; R Mistry; L Ranganath; S R Gould,"To evaluate clarithromycin 500 mg t.d.s., tripotassium dicitrato bismuthate 240 mg b.d. and omeprazole 20 mg b.d. for 7 days as a Helicobacter pylori treatment regimen. The H. pylori status of dyspeptic patients undergoing endoscopy was assessed by histology, culture and rapid urease testing of biopsies and by 13C-urea breath test. Fifty patients who were H. pylori-positive were treated with the above treatment regimen for 7 days. Those patients with active duodenal ulcers present at endoscopy were given omeprazole 20 mg nocte for a further 21 days. Not less than 28 days after completing treatment, all tests were repeated to reassess H. pylori status. Bacterial sensitivity of H. pylori cultures was determined and patients recorded any side-effects. On an intention-to-treat basis, H. pylori infection was cured in 90% (95% CI: 78-96%) of patients. Taste disturbance was experienced by 35% patients. Compliance was excellent, with 96% patients taking more than 95% of tablets. Metronidazole resistance was 41% but all cultures were sensitive to clarithromycin. This 7-day treatment achieved a high level of cure of H. pylori infection with relatively minor side-effects. It may have a role to play, particularly where there is a high level of metronidazole resistance.",1996.0,0,0
972,8791952,Low-dose omeprazole plus clarithromycin and either tinidazole or amoxycillin for Helicobacter pylori infection.,A Tursi; G Cammarota; M Montalto; A Papa; G Veneto; L Cuoco; F Trua; G Branca; G Fedeli; G Gasbarrini,"The aim of our study was to compare two 1-week, low-dose triple therapies for Helicobacter pylori eradication. One hundred consecutive patients, suffering from dyspeptic symptoms with H. pylori infection, were randomly allocated to 7 days of treatment with omeprazole 20 mg o.m. plus clarithromycin 250 mg b.d. and either tinidazole 500 mg b.d. (group A: n = 50, 19 with peptic ulcer) or amoxycillin 1000 mg b.d. (group B: n = 50, 20 with peptic ulcer). H. pylori-status was evaluated by means of histology, culture and urease test, at entry and 8 weeks after treatment. Three patients did not complete the treatment. H. pylori eradication was obtained in 35 patients from group A (73%) (95% CI, 55-82%) and in 40 patients from group B (82%) (95% CI, 66-90%). On intention-to-treat analysis, the rates of eradication were similar. Side-effects occurred in seven patients from group A (14.58%) and in four patients from group B (8.33%), but none discontinued therapy because of side-effects. Both triple 1-week, low-dose omeprazole therapies gave good eradication rates with infrequent side-effects.",1996.0,0,0
973,8791955,Dose-response of omeprazole combined with amoxycillin on duodenal ulcer healing and eradication of Helicobacter pylori.,W Pommerien; V Schultze; B Braden; B Lembcke; M Wrangstadh; W Londong,"Combination therapy using omeprazole and amoxycillin can cure Helicobacter pylori infection, but data are controversial concerning the efficacy of this regimen. The present study investigated varying doses of omeprazole combined with a standard amoxycillin dose on duodenal ulcer healing and eradication of H. pylori, in order to find an optimal dose regimen. H. pylori-positive out-patients (n = 231) with duodenal ulcers were treated randomly and double-blind with either omeprazole 20, 40 or 80 mg b.d. plus amoxycillin 1 g b.d. for 14 days. Patients with an unhealed ulcer after this therapy took omeprazole 20 mg o.m. for another month. After 2 weeks, ulcer healing rates in the three treatment groups were not statistically different (85, 82 and 93%, respectively). Treatment with omeprazole 80 mg b.d. was significantly better in curing H. pylori infection (eradication rate 69%) than treatment with omeprazole 20 and 40 mg b.d. (47 and 53%). Combination of either omeprazole 20 or 40 mg b.d. plus amoxycillin 1 g b.d., is not sufficiently effective to be recommended as an anti-H. pylori therapy. Omeprazole 80 mg b.d. combined with amoxycillin is more efficient and well tolerated, but better treatment options now exist to cure H. pylori infection.",1996.0,0,0
974,8791964,Twenty-four-hour intragastric pH profiles and pharmacokinetics following single and repeated oral administration of the proton pump inhibitor pantoprazole in comparison to omeprazole.,M Hartmann; U Theiss; R Huber; R Lühmann; H Bliesath; W Wurst; P W Lücker,"Pantoprazole is a proton pump inhibitor characterized by a low potential to interact with the cytochrome P450 enzyme system in man. Its effect on intragastric pH following single and repeated oral intake was investigated in comparison to omeprazole by continuous intragastric pH-metry at doses recommended for treatment of peptic ulcer disease. Sixteen healthy male subjects underwent two dosing periods. From day 1 to day 7, they were given once daily by mouth 40 mg pantoprazole in one period and 20 mg omeprazole in the other period, according to a double-blind randomized crossover design. Twenty-four-hour intragastric pH was recorded and frequent blood samples for pharmacokinetic analysis were taken on day 1 and day 7. A placebo pH profile was obtained prior to each treatment period. Pantoprazole was significantly more effective than omeprazole with regard to increase in 24-h and daytime pH, following both single (median 24-h pH: 1.45 vs. 1.3, P < 0.05; median daytime pH: 1.6 vs. 1.3, P < 0.01) and repeated (median 24-h pH: 3.15 vs. 2.05, P < 0.01; median daytime pH: 3.8 vs. 2.65, P < 0.05) oral intake. As compared to the first dose, repeated administration of both drugs markedly increased the effect on intragastric pH. With pantoprazole, steady-state serum concentrations were obtained after the first dose, but not with omeprazole. Both drugs were well tolerated without relevant changes in vital signs of clinical laboratory parameters. Pantoprazole 40 mg is significantly more effective than omeprazole 20 mg in raising intragastric pH.",1996.0,0,0
975,8791965,The effects of omeprazole 20 and 40 mg twice daily on intragastric acidity in duodenal ulcer patients.,V Savarino; G S Mela; P Zentilin; M R Mele; S Vigneri; C Mansi; G Celle,"The combination of omeprazole with amoxycillin or clarithromycin is used as treatment against Helicobacter pylori. It seems likely that the antibacterial activity of the antibiotic may be improved by increasing gastric pH towards neutrality, and a twice daily regimen of omeprazole is probably needed. To assess the effects of twice daily administration of omeprazole 20 and 40 mg. Twelve duodenal ulcer patients in remission were randomized to receive in single-blind fashion either placebo, omeprazole 20 mg or omeprazole 40 mg twice daily (08.00 and 20.00 h). On the sixth day of dosing they underwent 24-h gastric pH-metry. Omeprazole 20 and 40 mg b.d. produced marked decreases (P < 0.001) of 24-h gastric acidity (pH 5.4 +/- 0.9 and pH 5.7 +/- 0.6, respectively, vs. a basal pH of 1.4 +/- 0.2) and kept gastric pH at levels higher than 3.0 for almost 24 h. Gastric pH was kept above 5.0 for about 18 h and above 6.0 for about 10 h, while the time spent above 7.0 did not exceed 3 h. There were no significant differences between the two omeprazole dosages at any pH threshold. Omeprazole 20 mg b.d. is sufficient to render the gastric milieu as anacidic as possible in duodenal patients.",1996.0,0,1
976,8791967,A trial of lansoprazole in refractory gastric ulcer.,C J van Rensburg; J A Louw; A H Girdwood; A E Simjee; I N Marks,"The proton-pump inhibitor, lansoprazole, a more potent gastric acid inhibitor with a longer action than H2-receptor antagonists, should heal refractory gastric ulcers more effectively. Lansoprazole's efficacy in healing refractory gastric ulcer(s) (i.e. after 6 weeks of treatment with H2-receptor antagonists, antacids or sucralfate at recommended dosages, and/or a relapse within 1 year of documented gastric ulcer), was compared by a two-dose regimen in a four-centre, randomized, parallel group study. One hundred and eighteen patients (59 per group) with an endoscopically confirmed gastric ulcer > or = 3 mm, received lansoprazole 30 or 60 mg daily. We assessed efficacy endoscopically at 4 and 8 weeks, and again after documented healing during a maintenance phase of lansoprazole 30 mg/day at 2 and 4 months. Demographic and anthropometric data were comparable. Healing rates at 4 weeks were 63% (30 mg) vs. 66% (60 mg) (95% CI, -14 to 21%) and cumulatively at 8 weeks, 83% (30 mg) vs. 81% (60 mg) (95% CI, -12 to 16%). Two and 4 months after documented healing, 86% and 78% of intention-to-treat patients remained in remission. Lansoprazole 30 or 60 mg/day appear equally effective in healing refractory gastric ulcers, while maintenance therapy of 30 mg/day effectively prevented an ulcer relapse.",1996.0,0,0
977,8791969,Efficacy and tolerability of pantoprazole 40 mg versus 80 mg in patients with reflux oesophagitis.,C J van Rensburg; P J Honiball; H D Grundling; J H van Zyl; S K Spies; F P Eloff; A E Simjee; I Segal; J F Botha; A K Cariem; I N Marks; I Theron; T D Bethke,"Pantoprazole is a substituted benzimidazole which is a potent inhibitor of gastric acid secretion by its action upon H+, K+-ATPase. Pantoprazole 40 mg and 80 mg were compared in a randomized double-blind study in 192 out-patients with stage II or III (Savary-Miller classification) reflux oesophagitis. Patients received either pantoprazole 40 mg (n = 97) or pantoprazole 80 mg (n = 95), once daily before breakfast for 4 weeks. Treatment was extended for a further 4 weeks if the oesophagitis had not healed. After 4 weeks complete healing of the reflux oesophagitis was seen in 78% of protocol-correct patients given pantoprazole 40 mg daily (n = 86), and in 72% in the 80 mg (n = 87) group. The cumulative healing rates after 8 weeks were 95 and 94%, respectively (P > 0.05, Cochran-Mantel-Haenszel), and time until healing of oesophagitis comparable in both groups. Differences between doses were also not significant in an intention-to-treat analysis. Both dosing schedules were well tolerated and the patients experienced remarkable symptom relief. No adverse event or changes in laboratory values of clinical significance could definitely be ascribed to the trial medication. The 40 mg pantoprazole dosage is comparable to 80 mg in reflux oesophagitis, both in efficacy and tolerability.",1996.0,0,0
978,8792686,,,,,0,0
979,8792693,Efficacy and safety of lansoprazole in the treatment of erosive reflux esophagitis. The Lansoprazole Group.,D O Castell; J E Richter; M Robinson; S J Sontag; M M Haber,"This study was designed to compare lansoprazole 30 mg, lansoprazole 15 mg, omeprazole 20 mg, and placebo in the treatment of erosive reflux esophagitis. In a double-blind, multicenter study, 1284 patients with endoscopically diagnosed erosive reflux esophagitis were randomized to received lansoprazole 30 mg (n = 422), lansoprazole 15 mg (n = 218), omeprazole 20 mg (n = 431), or placebo (n = 213) once daily for 8 wk. At 2, 4, 6, and 8 wk, healing was evaluated endoscopically. Patients kept daily diaries of symptoms. Healing rates at 2, 4, 6, and 8 wk were 65.3%, 83.3%, 89.4%, and 90.0%, respectively, for lansoprazole 30 mg; 56.3%, 74.6%, 80.3%, and 78.8% for lansoprazole 15 mg; 60.9%, 82.0%, 89.7%, and 90.7% for omeprazole 20 mg; and 23.9%, 32.8%, 36.6%, and 40.0% for placebo (all active treatments higher than placebo, p < 0.001). Healing rates with lansoprazole 30 mg were significantly higher than with lansoprazole 15 mg at all time points (p < 0.05). Healing rates with omeprazole 20 mg were significantly higher than with lansoprazole 15 mg at 4, 6, and 8 wk and were similar to those with lansoprazole 30 mg. Based on patient diaries, lansoprazole 30 mg produced better symptomatic relief than lansoprazole 15 mg or omeprazole 20 mg, primarily early in the treatment course. Both lansoprazole 30 mg and omeprazole 20 mg were more effective than lansoprazole 15 mg in esophageal mucosal healing. Compared with omeprazole 20 mg, lansoprazole 30 mg was as safe, was similarly effective with respect to esophageal healing, and provided superior symptomatic relief, primarily early in treatment. Lansoprazole 30 mg provided greater symptomatic relief than lansoprazole 15 mg.",1996.0,1,1
980,8792694,Lansoprazole prevents recurrence of erosive reflux esophagitis previously resistant to H2-RA therapy. The Lansoprazole Maintenance Study Group.,S J Sontag; D G Kogut; R Fleischmann; D R Campbell; J Richter; M Haber,"This randomized, double-blind study was designed to determine whether the proton pump inhibitor lansoprazole could prevent relapse among patients with healed erosive reflux esophagitis that had been resistant to healing with at least 3 months of H2-receptor antagonist therapy. By the end of the year, 13% of placebo patients remained healed compared with 67% of lansoprazole 15 mg and 55% of lansoprazole 30 mg patients (p < 0.001 for time to first relapse). All placebo patients were symptomatic by the end of the study whereas only one-third of the lansoprazole patients was symptomatic at the end of the 12-month study period. The two lansoprazole doses were comparably effective in maintaining healing and in symptom control and were well tolerated. Fasting serum gastrin values increased significantly to about 1.5-2 times the baseline values over the first 2 months of lansoprazole treatment; no further increase was noted. Erosive relapse can be prevented in most patients for up to 1 yr with lansoprazole 15 mg or 30 mg once daily.",1996.0,0,1
981,8792695,Omeprazole versus ranitidine or ranitidine/metoclopramide in poorly responsive symptomatic gastroesophageal reflux disease.,J E Richter; S M Sabesin; D G Kogut; R M Kerr; L D Wruble; M J Collen,"To evaluate complete symptom resolution, mucosal healing, and tolerability of omeprazole, ranitidine, or ranitidine/metoclopramide in patients with poorly responsive, symptomatic gastroesophageal reflux disease (GERD). Adults with persistent symptomatic GERD after ranitidine treatment were stratified by esophagitis grade and randomized to omeprazole 20 mg once daily, ranitidine HCI 150 mg twice daily, or ranitidine HCI 150 mg twice daily plus metoclopramide HCI 10 mg four times daily. Endoscopies were conducted at baseline and at wk 4 and 8. Patients assessed overall symptom improvement at wk 4 and 8 and evaluated daytime and nighttime heartburn, dysphagia, and acid regurgitation daily. After 1 wk, 13% of patients receiving omeprazole (N = 100) had complete resolution of all GERD symptoms versus 1% and 3% of patients receiving ranitidine (N = 97) or ranitidine/metoclopramide (N = 93), respectively (p < 0.001). More patients receiving omeprazole had complete symptom resolution at wk 4 (33%) and at the end of the study (64%; both p < 0.001) than patients receiving ranitidine (8% and 28%, respectively) or ranitidine/metoclopramide (7% and 29%, respectively). Regardless of baseline esophagitis grade, more patients receiving omeprazole had complete symptom resolution. At wk 8, more than 91% of patients with grade 0 or 1 esophagitis at baseline were still healed irrespective of treatment. At wk 8, 80% of patients with esophagitis grade 2 or higher at entry were healed with omeprazole (p < 0.001 vs ranitidine [40%] and ranitidine/metoclopramide [46%]). Thirty-four percent of patients reported an adverse event. Significantly more patients receiving combination treatment reported an adverse event than patients treated with single agents. In patients with persistent GERD symptoms after ranitidine, omeprazole (20 mg daily for up to 8 wk) provides faster and more complete resolution of common GERD symptoms than continued ranitidine (300 mg daily) alone or in combination with metoclopramide (40 mg daily). Omeprazole provides significantly higher rates of endoscopic healing than ranitidine alone or with metoclopramide. Omeprazole and ranitidine are generally well tolerated. The addition of metoclopramide to ranitidine significantly increases adverse events.",1996.0,0,1
982,8792697,4-day lansoprazole quadruple therapy: a highly effective cure for Helicobacter pylori infection.,W A de Boer; R J van Etten; R W Schade; M E Ouwehand; P M Schneeberger; G N Tytgat,"We have advocated quadruple therapy as the optimal therapy for cure of Helicobacter pylori infection. In this study, we investigated the efficacy and tolerability of 4-day therapy with lansoprazole, bismuth, tetracycline, and metronidazole. In a prospective open study, 51 consecutive patients, most of them with chronic peptic ulcer disease and biopsy proven H. pylori infection, received 4-day lansoprazole quadruple therapy after 3 days of lansoprazole pretreatment. Repeat endoscopy was performed 6 wk later, with antral and corpus biopsies for rapid urease test, histology, and culture. A patient was considered cured if three methodologies had negative results. By intention-to-treat, 48 of 51 patients (94%) (95% CI 84%-99%) were cured; per protocol, 48 of 49 (98%) (95% CI 89%-100%) were cured. In 14 patients, the bacterial isolates were tested for metronidazole susceptibility: 12/12 with a sensitive strain were cured, as were 2/2 with a resistant strain. The regimen was well tolerated. Most side effects were mild, and none caused treatment to be stopped prematurely. Four-day lansoprazole quadruple therapy achieves a very high cure rate in an unselected population of mainly ulcer patients. Furthermore, the regimen is short, can be used in patients allergic to penicillin, and is well tolerated, with no dropouts due to side effects. Presently, this regimen should be used only in patients with a metronidazole-sensitive pre-treatment bacterial isolate. When empiric treatment is used, 7-day quadruple therapy remains the therapy of choice, because it has well-documented efficacy against metronidazole-resistant strains. Further studies are needed to define the optimal treatment duration for quadruple therapy in patients with metronidazole-resistant strains.",1996.0,0,0
983,8804374,Management of upper gastrointestinal bleeding in the patient with chronic liver disease.,R Jutabha; D M Jensen,"This article reviews the management of severe upper gastrointestinal bleeding in the patient with chronic liver diseases. The initial assessment, diagnostic work-up, and treatment options for variceal and nonvariceal bleeding are discussed. The role of diagnostic and therapeutic endoscopy for esophagogastric varices is reviewed with special emphasis on new endoscopic techniques including variceal band ligation and cyanoacrylate injection. Various pharmacologic, surgical, and radiologic treatment options for variceal bleeding also are discussed. In addition, nonvariceal causes of severe upper gastrointestinal bleeding are reviewed including peptic ulcer diseases, Mallory-Weiss tear, portal hypertensive gastropathy, and gastric antral vascular ectasia.",1996.0,0,0
984,8804868,Helicobacter pylori eradication with short-term therapy leads to duodenal ulcer healing without the need for continued acid suppression therapy.,K L Goh; P Navaratnam; S C Peh; N W Wong; S Y Chuah; N A Rahman; Y L Lo,"To determine whether duodenal ulcers continue to heal following successful Helicobacter pylori eradication with short-term eradication therapy without further acid suppression therapy. Patients with endoscopically proven duodenal ulcers who were H. pylori positive were randomized to receive omeprazole 40 mg each morning and clarithromycin 500 mg three times daily or famotidine 40 mg twice daily and clarithromycin 500 mg three times daily for 2 weeks. No acid-suppressing agents nor ulcerhealing drugs such as bismuth compounds or sucralfate were prescribed after that. Patients were re-examined endoscopically at week 2 at the end of treatment, and at week 6, 4 weeks after the completion of treatment. Thirty of 44 (68.2%) patients from both treatment arms, in whom the bacteria were subsequently noted to have been eradicated, had healed ulcers at week 2; at Week 6, 42 of 44 (95.5%) were noted to have healed ulcers without further acid-suppressing or ulcer-healing treatment. Although a short-term acid-suppressing treatment is insufficient to heal ulcers, where an important putative factor such as H. pylori is eliminated, the ulcer healing process continues without further need for acid-suppressing or ulcer-healing agents.",1996.0,0,1
985,8804873,Refractory duodenal ulcer healing and relapse: comparison of omeprazole with Helicobacter pylori eradication.,E Avsar; C Kalayci; N Tözün; R Lawrence; S Kiziltas; O Gültekin; N B Ulusoy,"To investigate differences between omeprazole and Helicobacter pylori eradication in patients with duodenal ulcers refractory to H2-receptor antagonists and to compare the recurrence rates after the two treatments. Forty-five patients with endoscopically proven duodenal ulcers refractory to H2-receptor antagonists and H. pylori infection were randomly assigned to 8 weeks of treatment with omeprazole 40 mg/day or 4 weeks of treatment with colloidal bismuth subcitrate 480 mg/day plus metronidazole 750 mg/day and tetracycline 1000 mg/day from day 1 to day 14. Patients were evaluated endoscopically and clinically at the end of treatment. Patients with healed ulcers were followed up for 1 year after cessation of the treatment. Endoscopy was performed at 3 and 12 months. Ulcer healing occurred in 100% (21/21) of patients on triple therapy and 70.5% (12/17) of those treated with omeprazole alone (P = 0.0123). The relapse rate at the 3rd month was 11.7% (2/17) in the triple therapy group and 60% (6/10) in the omeprazole group (P = 0.0248). Of the patients followed to study endpoint (relapse or endoscopy at 12 months) three of 12 (25%) receiving triple therapy, compared to six of eight (75%) receiving omeprazole, relapsed (P = 0.0648). These results show that triple therapy is more effective than omeprazole in the treatment of refractory duodenal ulcers and reduces the rate of ulcer relapse.",1996.0,0,0
986,8805734,Gastroesophageal reflux disease.,P J Kahrilas,"To review the management of gastroesophageal reflux disease (GERD) in adults with esophageal complications (esophagitis, stricture, adenocarcinoma, or Barrett metaplasia) or extraesophageal complications (otolaryngological manifestations and asthma). Peer-reviewed publications located via MEDLINE or cross-citation. Emphasis was placed on new developments in diagnosis and therapeutics. Thus, fewer than 10% of identified citations are discussed. Controlled therapeutic trials were emphasized. The validity of pathophysiological observations and uncontrolled trials were critiqued by the author. Esophagitis is typically a chronic, recurring disorder treated with long-term antisecretory therapy, titrated to disease severity. Laparoscopic [correction of Laparascopic] antireflux surgery is an alternative strategy, but neither long-term efficacy data nor an appropriate controlled trial comparing it with proton pump inhibitor therapy exists. The main risk of esophagitis is adenocarcinoma arising from Barrett metaplasia, the incidence of which is increasing. Strong evidence suggests that both reflux-induced asthma and otolaryngological complications (subglottic stenosis, laryngitis, pharyngitis, or cancer) can occur without esophagitis. While the otolaryngological manifestations usually respond to antisecretory medications, reflux-induced asthma responds convincingly only to antireflux surgery. Although esophagitis and GERD symptoms predictably respond to antisecretory medicines, the risk of adenocarcinoma from Barrett metaplasia dictates that if heartburn is refractory to treatment, chronic (>5 years), or accompanied by dysphagia, odynophagia, or bleeding, it should be evaluated by endoscopy. Thereafter, patients with Barrett metaplasia require surveillance endoscopy to control the cancer risk. Reflux-induced asthma remains a vexing problem in the absence of either medical therapy or proven efficacy of a reliable mechanism of prospectively identifying affected patients.",1996.0,0,0
987,8821611,,,,,0,0
988,8823578,Update on the pathophysiology and management of gastro-oesophageal reflux disease: the role of prokinetic therapy.,G N Tytgat; J Janssens; J C Reynolds; M Wienbeck,,1996.0,0,0
989,8824650,Only four days of quadruple therapy can effectively cure Helicobacter pylori infection.,W A De Boer; W M Driessen; G N Tytgat,"To determine whether 4 days of quadruple therapy using bismuth, tetracycline and metronidazole combined with omeprazole is effective treatment for Helicobacter pylori infection. Non-ulcer dyspepsia, as well as chronic peptic ulcer patients with biopsy-proven H. pylori infection received 4 days of quadruple therapy. They were pretreated with 3 days of omeprazole. At least 5-6 weeks later, endoscopy was repeated with 10 biopsies for urease test, histology and culture to establish cure of infection. None of the 54 patients included was lost to follow-up but two had a 14C-urea breath test instead of endoscopy. Side-effects did not interfere with compliance. Forty-nine out of 54 patients (91%; 95% CI: 80-97%) were cured. Metronidazole susceptibility data were available from 43 pre-treatment isolates. Of these 38/40 (95%) with a metronidazole-sensitive strain, and one of three with a metronidazole-resistant strain were cured. Four days of quadruple therapy after omeprazole pre-treatment is a feasible, well tolerated, and effective treatment for H. pylori infection, especially in those carrying a metronidazole-sensitive strain. It seems that in quadruple therapy, cure rate and treatment duration have a non-linear relation. Our results need confirmation, but for patients suffering from side-effects with the 7-day regimen stopping treatment after 4 days is justified.",1995.0,0,0
990,8824655,Pantoprazole and omeprazole in the treatment of reflux oesophagitis: a European multicentre study.,R Corinaldesi; M Valentini; J Belaïche; R Colin; H Geldof; C Maier,"Pantoprazole is a new substituted benzimidazole which inhibits gastric H+,K(+)-ATPase. In this double-blind, multicentre study, pantoprazole 40 mg once daily was compared with omeprazole 20 mg once daily in the treatment of grade II and III (Savary-Miller) reflux oesophagitis. Endoscopy was repeated after 4 weeks of treatment, and also after 8 weeks in patients unhealed at 4 weeks. The primary efficacy variable was ulcer healing; after 4 weeks, 81/103 (78.6%) patients in the pantoprazole group and 83/105 (79.0%) patients in the omeprazole group had healed completely. After 8 weeks, the cumulative healing rates were 94.2% and 91.4% in the pantoprazole and omeprazole groups, respectively (P > 0.05 at 4 weeks and 8 weeks). Both groups experienced rapid relief of the key symptoms: heartburn, acid regurgitation and pain on swallowing. The time course of relief of the individual symptoms was similar in both groups after 2 and 4 weeks (P > 0.05). Both treatments were well tolerated, with only three patients withdrawing owing to adverse events. Pantoprazole has been shown to be as effective as omeprazole in the treatment of reflux oesophagitis.",1995.0,1,1
991,8824658,Morning or evening dosage of omeprazole for gastro-oesophageal reflux disease?,J Hendel; L Hendel; S Aggestrup,"When routinely checking patients receiving omeprazole treatment for gastro-oesophageal reflux, we have been finding patients with surprisingly low nocturnal gastric pH. The aim of this study was to evaluate the impact of timing of the 40 mg omeprazole once daily regimen. We evaluated the difference in effect of 40 mg omeprazole, given as a morning or evening dose, in 17 patients with gastro-oesophageal reflux disease. Gastric and oesophageal pH was recorded by portable 24-h two-channel pH-metry in a cross-over design of 14 days of morning and 14 days of evening administration. In five patients pathological reflux was abolished by both regimens, four only during morning dosage, and three only during evening dosage. In the remaining five patients abolition of pathological reflux was not achieved. The therapeutic outcome and patient preference for morning or evening administration were closely related to the individual oesophageal pH curves. Patients with reflux induced by physical activity had a clear preference for morning dosage, patients with nocturnal reflux showed a clear preference for evening dosage. Gastric pH profiles showed a high inter-individual variation; paired statistics, however, revealed a significant impact of dosage timing on the gastric pH profile. After morning dosage the work-day part (the first 7 h) of the gastric pH profile is 0.72 +/- 0.91 (mean difference of pairs +/- s.d.) higher than after evening dosage (P < 0.01). After evening dosage the gastric pH during the supine period is 0.64 +/- 0.83 (mean difference of pairs +/- s.d.) higher than after morning dosage (P = 0.02). The timing of a 40 mg omeprazole dosage regimen has a clinically significant impact on the 24-h pH profile, and that--by relating to the patient 24-hour oesophageal pH-metry in combination with the patient symptomatology--the timing of this dosage is highly important for therapeutic efficacy.",1995.0,0,0
992,8826575,Corticosteroids and ulcers: is there an association?,P G Pecora; B Kaplan,"The literature presented supports a small but highly probable association between corticosteroids and ulcers. The following characteristics appear to be exhibited by patients who are at high risk for developing corticosteroid-induced ulcers: corticosteroids coadministered with NSAIDs, a total dosage greater than 1000 mg of prednisone equivalent, a duration of therapy longer than 30 days, and a history of PUD. Further prospective research examining the association of corticosteroids and PUD in conjunction with other contributing factors is needed. The role of prophylactic therapy to prevent corticosteroid-induced ulcers is not well established. Even though a small study in liver transplant recipients, who are already at increased risk for GI ulceration, has suggested beneficial effects with prophylactic regimens, generalization of these results to all corticosteroid-treated patients would be inappropriate. Large prospective trials to determine the most efficacious prophylactic regimen (e.g., histamine2-receptor antagonists, proton pump inhibitors, cytoprotective agents [misoprostol]) for corticosteroid-induced ulcerations are not currently available. We suggest that most prophylaxis currently performed is unnecessary. In high-risk patients, however, prophylaxis appears to be prudent until further information is available.",1996.0,0,0
993,8835890,"Candida overgrowth after treatment of duodenal ulcer. A comparison of cimetidine, famotidine, and omeprazole.",M K Goenka; R Kochhar; A Chakrabarti; A Kumar; O Gupta; P Talwar; S K Mehta,"Acid-reducing drugs can cause increased growth of microbes, including fungus, because of high gastric pH. Our purpose was to evaluate the occurrence of mycotic infection in patients with duodenal ulcer on anti-ulcer therapy and to compare the effects of cimetidine, famotidine, and omeprazole. Eighty patients with duodenal ulcer (62 males and 18 female patients, 16-65 years old) were evaluated for mycotic infection before and after 6 weeks of therapy (cimetidine, 20 patients; famotidine, 40 patients; omeprazole, 20 patients). Mycotic infection was diagnosed by endoscopic biopsy from the ulcer edge subjected to smear, culture, and histopathology and by endoscopic brush samples and gastric aspirate. On the basis of these studies, patients were categorized as having no fungal growth, saprophytic growth, or significant fungal growth. Thirty-five (43.8%) patients had evidence of fungus before ulcer therapy, and 16 of the 35 (20%) had significant fungal growth. The fungal isolation rate was higher in older patients (> and = 45 years of age) and in those with an ulcer size > and = 2 cm. While there was no significant increase in the total number of patients with evidence of fungus after therapy (n = 36), there was a significant increase in those with significant growth (n = 27, p < 0.05) compared with pretreatment status. We found that posttreatment gastric pH of > and = 4 was associated with a higher fungal positivity rate (59.4%) than pH values < 4 (32.4%, p < 0.05). However, neither the type of drug used nor the response in terms of ulcer healing correlated with the presence of fungus. Regardless of the type of drug used, acid-reducing therapy is associated with increased significant fungal growth.",1996.0,0,0
994,8839554,"Misoprostol and omeprazole in the prevention of chemotherapy-induced acute gastroduodenal mucosal injury. A randomized, placebo-controlled pilot study.",S Sartori; L Trevisani; I Nielsen; D Tassinari; V Abbasciano,"Chemotherapy (CT) may induce acute mucosal injury to the stomach and duodenum, but its prevention has been scarcely investigated. One hundred and eighty-two cancer patients with normal stomach and duodenum or having fewer than 3 erosions, selected to be treated with cyclophosphamide, methotrexate, and 5-fluorouracil (CMF) (77 breast carcinoma patients) or 5-fluorouracil (5-FU) (105 colon carcinoma patients), were randomly assigned to prophylactic treatment with misoprostol, 400 micrograms twice a day; omeprazole, 20 mg once a day; or placebo, 1 tablet twice a day. Seven days after the end of the second source of CT, all patients underwent control esophagogastroduodenoscopy. Endoscopic findings were quantified on the basis of an arbitrary score: 0 = normal; 1 = less than 3 erosions; 2 = 3-15 erosions; 3 = more than 15 erosions or ulcer; 4 = giant ulcer (greatest dimension of more than 2 cm) or multiple ulcers with cumulative greatest dimension exceeding 2 cm. Mean score increased significantly in the placebo and misoprostol groups, either after CMF (P < 0.001 and P < 0.05, respectively) or after 5-FU (P < 0.001 for both), whereas it did not in the omeprazole group. Gastric and duodenal ulcers were significantly less frequent in patients receiving omeprazole than in those receiving placebo (P < 0.05 after both CMF and 5-FU). No significant difference was observed between placebo and misoprostol. Omeprazole was significantly more effective than placebo and misoprostol in reducing the frequency and degree of the endoscopic worsening, either after CMF or after 5-FU (P < 0.05 for both CT regimens). Epigastric pain and/or heartburn were significantly less frequent in patients receiving omeprazole than in those receiving placebo (P < 0.01) or misoprostol (P < 0.001). The strong and prolonged inhibition of gastric acid production induced by omeprazole seems to be effective in preventing chemotherapy-induced gastroduodenal mucosal injury. Further trials are necessary to verify whether such a prevention of endoscopically observed injury can translate into prevention of clinically significant injury.",2000.0,0,0
995,8840615,Helicobacter pylori eradication--evaluation of triple therapy containing omeprazole.,M K Goenka; K Das; K Vaiphei; R Nijhawan; R Kocbhar,"There is a need to develop alternative regimen(s) for treating Helicobacter pylori infection because of problems of drug compliance, side-effects and resistance with the conventional regimen consisting of bismuth, metronidazole and an antibiotic. To compare prospectively the efficacy of conventional triple therapy (bismuth subcitrate 120 mg QID, amoxycillin 500 mg QID and metronidazole 400 mg TID for 2 weeks with one containing omeprazole (20 mg OD), bismuth subcitrate and amoxycillin (regimen B). Sixty two consecutive patients with H pylori infection associated with antral gastritis and/or duodenal ulcer were randomized to two treatment groups and re- evaluated after completion of 2 weeks of therapy and then after a further 4 weeks for eradication of H pylori, ulcer healing and drug side-effects. Regimen B resulted in higher H pylori eradication rate as compared to regimen A (76.7% vs 63.3%, better ulcer healing rate (90.9%, vs 70.6%), lesser side-effects (10.0% vs 36.7%) and better drug compliance (100% vs 93.3%). The difference between the two regimens was significant (p < 0.05) only in respect to side-effects. For H pylori eradication, omeprazole, bismuth and amoxycillin combination for 2 weeks is as effective as the conventional therapy and is better tolerated.",1996.0,0,0
996,8843275,The impact of omeprazole and laparoscopy upon hiatal hernia and reflux esophagitis.,D McKenzie; T Grayson; H C Polk,,2001.0,0,1
997,8847032,Optimal dose of omeprazole in combination with amoxicillin in eradicating H. pylori and preventing relapses in duodenal ulcer patients.,T Rokkas; A Mavrogeorgis; C Liatsos; E Rallis; N Kalogeropoulos,"Triple therapy schemes, based on bismuth salts, eradicate H.pylori in a high percentage of duodenal ulcer (DU) patients. However, a simple and effective regime with a low complication rate is desirable. Previous studies have shown that the combination of Omeprazole (O) with an antibiotic (most commonly Amoxycillin [A]) is effective, but the optimal dose of O in this combination is not well defined. The aim of this study therefore was to address this subject. The following four groups of patients were studied: group I (20mg O daily + 500mg A qid, n=18), group II (20mg O bid + 500mg A qid, n=17), group III (20mg O tid + 500mg A qid, n=18), group IV (20mg O qid + 500mg A qid, n=20). Patients were treated for two weeks with the above combinations. Endoscopy was performed four weeks after stopping treatment to check for H. pylori eradication and then one year later or when symptoms suggesting relapse occurred. Eradication rates were as follows; group I 6/18 (33.3%), group II 10/17 (58.8%), group III 15/18 (83.3%), group IV 17/20 (85%). The highest eradication rate was achieved in group IV which was significantly higher (P<0.001) than in all the other groups except for group III. After treatment, there was a total of 48 H. pylori (-) and 25 H. pylori (+) patients in the four groups of patients studied. Relapse occurred in 20/25 (80%) of the H. pylori (+) patients and in only 2/48 (4.16%) of the H. pylori (-) patients (P<0.001). a) The combination of Omeprazole and Amoxycillin is effective in eradicating H. pylori. It seems that in this combination 60 or 80mg of Omeprazole is equally effective in achieving high percentages of eradication. Eradication of H. pylori with this regime prevents duodenal ulcer recurrence.",1995.0,0,0
998,8850302,"Kinetic studies of Helicobacter pylori urease inhibition by a novel proton pump inhibitor, rabeprazole.",J B Park; L Imamura; K Kobashi,"Urease is an important virulence factor of pathogenicity of gastric Helicobacter pylori. The inhibition of H. pylori urease by the novel proton pump inhibitor, rabeprazole, was investigated kinetically. It was found to act as an irreversible noncompetitive inhibitor of the enzyme. The inhibitory potency of rabeprazole was dependent on the pH of reaction mixture and its Ki values were 0.14 microM (pH 5.0), 0.34 microM (pH 7.0) and 6.10 microM (pH 8.5). Progressive inactivation of urease by rabeprazole initially proceeded according to pseudo-first-order kinetics with respect to the remaining enzymatic activity at pH 7.0 and 37 degrees C, with a second-order rate constant of 0.0017 microM-1 s-1. When the inactivation half-life was plotted versus the reciprocal of the rabeprazole concentration, a straight line was obtained with a slope of -3.12. From an Arrhenius-plot of the temperature-dependence of the inactivation (over the range of 5-37 degrees C), an activation energy of 13.2 kcal/mol was calculated. Recovery of activity was incomplete for H. pylori urease inhibited by rabeprazole, suggesting that the rabeprazole-urease complex is very stable.",1996.0,0,1
999,8851451,Pathogenesis and treatment of acid peptic disorders: comparison of proton pump inhibitors with other antiulcer agents.,S W Sanders,"Acid peptic disorders, including gastric ulcers, duodenal ulcers, and gastroesophageal reflux disease, are commonly occurring conditions with high direct and indirect costs. The pathogenesis of these disorders involves an imbalance between acid secretion and gastric mucosal defenses. Pharmacologic treatment of acid peptic disorders has focused on correcting this imbalance by either improving mucosal defenses with drugs such as sucralfate, bismuth, and prostaglandin analogs, neutralizing acid with antacids, or decreasing acid secretion with histamine2 (H2)-receptor antagonists, or, more recently, proton pump inhibitors. Proton pump inhibitors are more potent inhibitors of acid secretion than H2-receptor antagonists. In clinical comparisons, proton pump inhibitors were shown to be more effective in the treatment of acid peptic disorders than H2-receptor antagonists. Helicobacter pylori infection is a factor in 85% to 100% of duodenal ulcers and 70% to 90% of gastric ulcers; eradicating this organism results in a considerable decrease in the recurrence of ulcers. Current management of peptic ulcer disease includes the use of combination antisecretory and antibiotic therapy for acute treatment of H pylori-associated disease. Patient self-medication with over-the-counter products, including H2-receptor antagonists, may have an impact on the potential for reducing the recurrence of peptic ulcer disease in patients with H pylori infection. Patients with recurrent disease should be informed of the need to seek medical treatment through aggressive education at the point of sale for over-the-counter drugs.",1996.0,0,0
1000,8853263,How to treat Helicobacter pylori infection--should treatment strategies be based on testing bacterial susceptibility? A personal viewpoint.,W A de Boer; G N Tytgat,"Peptic ulcer disease is an infectious disease. Only antibiotic regimens that achieve a 90% cure should be used to treat this infection. Antimicrobial susceptibility is the main determinant in the success of therapy; cure rates are usually lower in resistant strains. As in any other infectious disease it is essential in treatment studies to stratify results according to pretreatment bacterial susceptibility. Cure-rates have to be reported separately for sensitive and resistant strains. It must be realized that a study achieving a high cure rate with a certain regimen can either have included few patients with resistant strains or, alternatively, the regimen tested can have a high efficacy in resistant strains. This issue is fundamental and only if that information is available, do we know whether or not we can reproduce the results reported in that particular study in a different population. We have reviewed all Helicobacter studies that tested pretreatment bacterial susceptibility. The results achieved with dual therapy, bismuth triple therapy, proton pump inhibitor triple therapy and quadruple therapy in sensitive and resistant strains are discussed. Based on these data, treatment recommendations are made for empirical treatment in areas with low resistance rates and those with high resistance rates. If treatment is individualized and based on the antibiogram then easier, shorter and cheaper regimens seem possible.",1996.0,0,0
1001,8853753,Long-term treatment with lansoprazole of patients with duodenal ulcer and basal acid output of more than 15 mmol/h.,B I Hirschowitz; J Mohnen; S Shaw,"About 10% of patients with duodenal ulcers have marked gastric acid hypersecretion with basal acid output (BAO) of more than 15 mmol/h, which is in the range found in Zollinger-Ellison syndrome. We report long-term, up to 4 years, prospective treatment using lansoprazole in nine male patients with duodenal ulcers and a BAO of more than 15 mmol/h whose results are compared with those in 10 male Zollinger-Ellison syndrome patients with intact stomachs reported in detail in an accompanying paper. All 19 subjects, except one Zollinger-Ellison syndrome patient who had gastric and oesophageal ulcers, had a history of duodenal ulcers; 22% of those with gastric acid hypersecretion had oesophagitis compared with 60% of those with Zollinger-Ellison syndrome. Each subject had the dose of lansoprazole adjusted to give a BAO of less than 5 mmol/h. At 3-month intervals to 1 year, and then at 6-monthly intervals, basal and pentagastrin stimulated secretions were studied, in addition to gastroscopy with biopsy for gastric mucosal morphology. Basal and maximal acid and pepsin secretions were not different between gastric acid hypersecretion and Zollinger-Ellison syndrome patients before treatment. During treatment, BAO was reduced by over 90% to less than 2 mmol/h, while peak acid output was reduced by 70% in those with gastric acid hypersecretion and 90% in Zollinger-Ellison syndrome patients. Four gastric acid hypersecretion patients had relapses during treatment, three times in one patient and twice in another patient, but all responded to continued treatment with lansoprazole. Of the seven ulcer-related relapses in the gastric acid hypersecretion patients, four occurred with a BAO of less than 2 mmol/h and three with a BAO of 7.1-7.3 mmol/h; five of the seven relapses occurred in the absence of Helicobacter pylori. Lansoprazole remained effective at an average dose of approximately 70 mg/day, without causing any side-effects. Lansoprazole is apparently safe and effective for treating hypersecretion, whether due to hypergastrinaemia (Zollinger-Ellison syndrome) or not (non-Zollinger-Ellison syndrome hypersecretors).",1996.0,0,0
1002,8853754,,,,,0,0
1003,8853756,Lansoprazole versus ranitidine in the maintenance treatment of reflux oesophagitis.,A L Gough; R G Long; B T Cooper; C S Fosters; A D Garrett; C H Langworthy,"To assess the relative efficacies of lansoprazole 15 mg once daily, lansoprazole 30 mg once daily and ranitidine 300 mg b.d. in the maintenance treatment of reflux oesophagitis for 12 months. Multicentre, out-patient, double-blind, parallel group, prospectively randomized clinical trial. Patients with grade 0, asymptomatic oesophagitis after 8 weeks of treatment with lansoprazole 30 mg once daily were randomized to receive lansoprazole 30 mg once daily (L30) (n = 75), lansoprazole 15 mg once daily (L15) (n = 86) or ranitidine 300 mg b.d. (R600) (n = 74) for 12 months. Endoscopy was repeated at 6 and 12 months, and symptomatic assessment was made every 3 months. Efficacy was primarily assessed by the time to endoscopically confirmed relapse (oesophagitis grade > or = 1) and the proportion of patients who relapsed during the 12-month study period. Severity of symptoms were secondary efficacy measures. For all patients randomized with at least one post-baseline endoscopy (intent-to-treat principle) both lansoprazole 15 mg (P < 0.001) and lansoprazole 30 mg (P < 0.001) were significantly superior to ranitidine 600 mg with respect to time to endoscopic relapse. There was no difference between the lansoprazole groups (P = 0.11). There was evidence of relapse in 27 of 86 (31.4%), 15 of 75 (20.0%) and 50 of 74 (67.6%) of the patients treated with lansoprazole 15 mg and 30 mg and ranitidine 600 mg, respectively. Patients receiving treatment with either lansoprazole dosages experienced significantly less severe heartburn and regurgitation than those patients treated with ranitidine. There were no differences between the treatment groups with respect to the severity or incidence of adverse events. No clinically significant laboratory changes were observed in any of the treatment groups. Serum gastrin levels were elevated in all treatment groups, and most markedly in those patients receiving lansoprazole, but there was no significant difference between the treatments. Morphological and immunohistochemical examination of the gastric biopsies revealed no clinically relevant changes from baseline in any of the treatment groups. Both lansoprazole 15 mg and lansoprazole 30 mg once daily are significantly more effective than high-dose ranitidine in maintaining reflux oesophagitis in remission.",1996.0,0,1
1004,8853757,Effect of short- and long-term treatment with omeprazole on the absorption and serum levels of cobalamin.,B E Schenk; H P Festen; E J Kuipers; E C Klinkenberg-Knol; S G Meuwissen,"To evaluate absorption of protein-bound and unbound cyanocobalamin before and during treatment with omeprazole, and cobalamin levels in patients on long-term treatment with omeprazole. In eight former duodenal ulcer patients absorption of unbound and protein-bound cobalamin was determined by measuring 24-h urinary excretion of unbound 58Co-cyancobalamin or protein-bound 57Co-cyanocobalamin during a modified Schilling test. Tests were performed before and during treatment with 20 mg and 40 mg omeprazole daily for 9 days. Serum cobalamin levels were assessed in 25 patients with gastro-oesophageal reflux disease (GERD) before and during long-term maintenance therapy with omeprazole. Mean treatment duration was 56 months (range 36-81 months). Urinary excretion of unbound cobalamin was unchanged with both dosages of omeprazole. Excretion of 57Co-cyanocobalamin, however, decreased significantly during treatment with both 20 mg omeprazole (mean +/- S.E.M.: 1.31 +/- 0.20 vs. 0.54 +/- 0.17%; P < 0.02) and 40 mg omeprazole (1.25 +/- 0.26 vs. 0.29 +/- 0.06%; P < 0.02). Mean serum cobalamin levels (+/- S.E.M.) before and during therapy with omeprazole in GERD patients were 298 +/- 27 and 261 +/- 16 pg/mL (normal range 180-900 pg/mL), respectively (P = N.S.). Absorption of protein-bound, but not unbound, cyanocobalamin is decreased when measured by a modified Schilling test during treatment with omeprazole. However, no change in serum cobalamin levels was observed in patients with GERD after treatment with omeprazole for up to 7 years.",1996.0,0,0
1005,8853758,Reflux symptom relief with omeprazole in patients without unequivocal oesophagitis.,C M Bate; S M Griffin; P W Keeling; A T Axon; M W Dronfield; R W Chapman; D O'Donoghue; J Calam; J Crowe; R A Mountfords; D A Watts; M D Taylor; P D Richardson,"As many as 50% of patients with reflux symptoms have no endoscopic evidence of oesophagitis. This multicentre study was designed to assess symptom relief after omeprazole 20 mg once daily in patients with symptoms typical of gastro-oesophageal reflux disease but without endoscopic evidence of oesophagitis. Patients (n = 209) were randomized in a double-blind study to receive either omeprazole 20 mg once daily (n = 98) or placebo (n = 111) for 4 weeks. Symptoms were assessed at clinic visits and using daily diary cards, with patient-completed questionnaires providing additional data on symptoms and on psychological disturbance. On completion, symptom relief favoured omeprazole: 57% of patients on omeprazole were free of heartburn (vs. 19% on placebo), 75% were free of regurgitation (47%) and 43% were completely asymptomatic (14%), each with P < 0.0001. Fewer patients in the omeprazole group required alginate/antacid relief medication (P < 0.05). Symptom relief (time to first heartburn-free day) was more rapid with omeprazole (2 vs. 5 days on placebo; P < 0.01). A greater reduction in anxiety occurred in the omeprazole group (P < 0.05). Omeprazole 20 mg once daily is effective in providing relief of the symptoms typical of gastro-oesophageal reflux disease in patients with essentially normal oesophageal mucosa.",1996.0,0,0
1006,8853759,Altered bowel function and duodenal bacterial overgrowth in patients treated with omeprazole.,S J Lewis; S Franco; G Young; S J O'Keefe,"The dramatic inhibitory effect of proton pump inhibitors on acid secretion has raised concern about possible side-effects, such as small bowel bacterial overgrowth, which may result in further gut dysfunction. The aim of this study was to assess the effect of proton pump inhibitors on duodenal bacteriology, carbohydrate absorption and bowel habit. Small bowel bacterial overgrowth and xylose absorption were measured by culture of aspirated duodenal fluid and a combined 1 g 14C-D-xylose absorption-metabolism test in 20 patients with peptic ulcer disease. Tests were repeated after 4 weeks of treatment with omeprazole 20 mg daily. Intestinal transit was assessed by recording interdefecatory intervals and stool form. All patients showed an increase in duodenal bacterial counts following treatment, geometric mean counts increasing from 330 to 95000 CFU/mL. The geometric mean of the difference was 290 CFU/mL (95% CI, 110-720 CFU/mL; P < 0.0001). No changes were noted in the xylose absorption or metabolism tests. Mean interdefecatory intervals decreased by 32% from 31.7 to 21.6 h, the mean difference being 10.1 h (95% CI, 1.6-18.5 h: P = 0.01). The mean stool form index increased from 2.95 to 4.70, mean difference 1.75 (95% CI, 1.10-2.40: P < 0.0001), with four patients reporting diarrhoea. The results indicate that conventional treatment for duodenal ulcers with a proton pump inhibitor significantly increases bacterial colonization of the duodenum and the speed of intestinal transit.",1996.0,0,1
1007,8853767,"One-week triple therapy with omeprazole, amoxycillin and clarithromycin for treatment of Helicobacter pylori infection.",M M Yousfi; H M el-Zimaity; R M Genta; D Y Graham,"Multi-drug regimens are generally required to reliably cure H. pylori infection. We previously demonstrated that a 2-week three-times-a-day regimen of amoxycillin and clarithromycin was effective against H. pylori infection. To evaluate the efficacy and side-effects of a 1-week twice-daily dosing schedule for the treatment of H. pylori infection. We studied the efficacy of 1-week of therapy with 20 mg of omeprazole, 1 g of amoxycillin and 250 mg of clarithromycin, all twice daily H. pylori status was determined at entry and 4 or more weeks after completing antimicrobial therapy using histology (Genta stain) and culture. Thirty-one patients with documented peptic ulcer disease and H. pylori infection were treated. The H. pylori infection was cured in 24 (77%, 95% CI = 58-90%) (intention-to-treat). In a per protocol analysis the cure rate was 23 of 29 patients (79%, 95% CI = 60-92%). One patient took only 43% of the study drugs and another withdrew following development of an anaphylactic reaction to study medication. Mild side-effects were reported by 16% including diarrhoea, headache and altered taste. Compliance averaged 95%. Pretreatment clarithromycin resistance averaged 5% and had not been acquired by any strains post-therapy. This combination of omeprazole, amoxycillin and low-dose clarithromycin resulted in a relatively low cure rate even in patients with clarithromycin-sensitive isolates. Large comparative studies will be needed to define the optimal duration, dose and dosing interval if this combination of drugs is to become competitive.",1996.0,0,0
1008,8853770,Symptomatic and endoscopic duodenal ulcer relapse rates 12 months following Helicobacter pylori eradication treatment with omeprazole and amoxycillin with or without metronidazole.,G D Bell; C M Bate; A T Axon; G Tildesley; J L Martin; M D Taylor; P D Richardson,"To determine the effect of Helicobacter pylori eradication with omeprazole and amoxycillin, with or without metronidazole, on the 12-month course of duodenal ulcer disease. In a randomized; double-blind study, conducted in 19 hospitals, 105 H. pylori positive duodenal ulcer patients were healed and symptom-free following either omeprazole dual therapy (omeprazole 40 mg o.m.+amoxycillin 500 mg t.d.s., OA, eradication rate 46%, n = 52) or omeprazole triple therapy (omeprazole 40 mg o.m.+amoxycillin 500 mg t.d.s.+metronidazole 400 mg t.d.s., OAM, eradication rate 92%, n = 53) for 2 weeks, followed by 2 weeks of omeprazole 20 mg o.m. and a 12-month untreated follow-up period, after which time all patients were endoscoped. Endoscopic and symptomatic relapse rates, and effect on H. pylori status measured using 13C-urea breath test, were determined. During the 12-month untreated follow-up period, the life-table endoscopic relapse rates were 12% (95% CI: 2-22%) and 2% (95% CI: 0-6%) for OA and OAM patients, respectively. By 12 months, life-table symptomatic relapse rates were 22% (95% CI: 13-37%) and 19% (95% CI: 8-30%) for OA and OAM, respectively. In the 12 months untreated follow-up period, 2/69 (3%, 95% CI: 0-7%) patients rendered H. pylori negative had an endoscopic relapse at the end of the 12-month follow-up period, compared with 5/31 (16%, 95% CI: 3-29%) patients remaining H. pylori positive (P = 0.03 between H. pylori positive and negative groups). Twelve of 69 (17%, 95% CI: 8-26%) patients rendered H. pylori negative relapsed symptomatically, compared with 9/31 (29%, 95% CI: 13-45%) patients remaining H. pylori positive (P = N.S. between groups). There was a significant improvement in epigastric pain (P = 0.0001), nausea and vomiting (P < 0.05) between entry to the study and 1, 6 and 12 months post-treatment for both treatment groups. OAM eradicates H. pylori in significantly more patients than OA, but successful H. pylori eradication with either OAM or OA predisposes to low endoscopic and symptomatic relapse rates for duodenal ulcer patients when followed up for 12 months.",1996.0,0,0
1009,8853771,Long-term follow-up after cure of Helicobacter pylori infection with 4 days of quadruple therapy.,J Y Lai; W A De Boer; W M Driessen; L M Geuskens,"We have shown that 4 days of quadruple therapy after omeprazole pre-treatment is an effective therapy for curing H. pylori infection. In this study we investigated whether this regimen would maintain the high cure rate during long-term follow-up. Some recent studies have reported high recurrence rates after apparent cure. Apparently not all methods to test for cure have sufficient sensitivity to pick up small numbers of residual bacteria. This study also served to investigate whether our methods to test for cure 5-6 weeks post-treatment were reliable. All patients from a previous study were invited to return for a 14C-urea breath test and serology. A representative group of 37 patients (76%) returned for a urea breath test and serology. The mean follow-up was 14.7 months (range 11.4-23.6 months). None of the 37 patients had a positive urea breath test results. IgG antibody titres fell steadily in all patients, showing a mean decrease of 83% at the end of the follow-up. None of the patients showed an increase in titre. Reinfection was therefore 0% (0 of 37). Four days of quadruple therapy seems to be an effective therapy for the eradication of H. pylori as evidenced after long-term follow-up. Our biopsy methodology is reliable in identifying treatment failures 5-6 weeks post-treatment.",1996.0,0,0
1010,8857137,A randomized blinded comparison of omeprazole and ranitidine in the treatment of chronic esophageal stricture secondary to acid peptic esophagitis.,S E Silvis; M Farahmand; J A Johnson; H J Ansel; S B Ho,"Esophageal strictures due to gastroesophageal reflux disease are often resistant to medical therapy and require repeated dilation procedures. Our aim was to compare the efficacy of therapy with omeprazole (20 mg/day) to ranitidine (150 mg twice daily) in the treatment of chronic esophageal strictures. Thirty-three patients with chronic esophageal stricture disease (mean length of prior treatment, 50.9 months) were entered into a randomized blinded trial. The majority (88%) of the patients had received multiple prior esophageal dilations (mean, 7.9 per patient). Endoscopy and barium esophagograms were performed initially and at the end of 10 months. Symptoms were considered every 2 months and dilations performed as needed. The patient groups were equivalent. One patient in each group was subsequently lost to follow-up. No significant differences were seen in symptom improvement or need of dilation. At the final endoscopy, 8 of 17 (47%) patients receiving ranitidine had residual erosions or ulceration, compared with 1 of 14 (7%) patients receiving omeprazole (p >0.2). All patients receiving ranitidine had persistent strictures, whereas 8 of 14 (57.1%) patients receiving omeprazole had radiographic and endoscopic resolution of their strictures (p <0.004). These data further emphasize the need for vigorously treating esophagitis in patients with acid peptic strictures.",1996.0,0,0
1011,8858742,Prevention of peptic ulcer and dyspeptic symptoms with omeprazole in patients receiving continuous non-steroidal anti-inflammatory drug therapy. A Nordic multicentre study.,P Ekström; L Carling; S Wetterhus; P E Wingren; O Anker-Hansen; G Lundegårdh; E Thorhallsson; P Unge,"Non-steroidal anti-inflammatory drugs (NSAIDs) are known to cause gastroduodenal lesions and dyspeptic symptoms. Patients with a history of dyspepsia or uncomplicated peptic ulcer disease and with a need for continuous NSAID treatment were randomized to receive either 20 mg omeprazole once daily or placebo. Gastroduodenal ulcers, erosions, and dyspeptic symptoms were evaluated after 1 and 3 months. During a 3-month study period 4.7% (4 of 85) of omeprazole-treated patients developed peptic ulcer, compared with 16.7% (15 of 90) of patients treated with placebo. This prophylactic effect of omeprazole was sustained independently of previous peptic ulcer history or Helicobacter pylori status. Development of dyspeptic symptoms requiring active treatment, either alone or in combination with ulcer(s) or erosions, occurred in 15.3% (15 of 85) of patients treated with omeprazole and 35.6% of those who received placebo. Omeprazole, 20 mg once daily, provides effective prophylactic therapy in patients at risk of developing NSAID-associated peptic ulcers or dyspeptic symptoms.",1996.0,0,0
1012,8865446,A review on treatment of bleeding peptic ulcer: a collaborative task of gastroenterologist and surgeon.,J J Kolkman; S G Meuwissen,"The majority of patients presenting with acute upper gastrointestinal haemorrhage bleed from peptic diseases erosive gastritis and duodenal or gastric ulcers. Early gastroscopy is essential in order to reach a diagnosis, assess the prognosis, and institute appropriate therapy. In a meta-analysis it was shown that H2-antagonists significantly reduced mortality. However, two large, prospective and placebo-controlled studies with famotidine and omeprazole failed to show reduction of rebleeding or death. The value of endoscopic haemostatic therapy in patients with high-risk peptic ulcers (active bleeding and non-bleeding visible vessel) has been firmly established with 75% decrease in rebleeding and operation rate, and a 40% reduction in mortality. Risk factors for an adverse outcome are: elderly patients, concomitant diseases and large ulcers in the posterior duodenal bulb or on the lesser curvature. The mortality for emergency surgery in upper GI bleeding is still 10-50%. The mortality of elective operations is less than 2%. Some studies have reduced mortality by avoiding emergency surgery through early elective surgery in high-risk patients.",1996.0,0,0
1013,8868099,Advances in the use of somatostatins in the management of endocrine tumors.,A Chaudhry; L Kvols,"With the introduction of long-acting somatostatin analogues, several advances have been made in the management of endocrine tumors. Octreotide was first used for the management of acromegaly and later used for metastatic gastroenteropancreatic tumors. Somatostatin receptor imaging has recently been introduced not only for the localization of somatostatin receptor-positive tumors but also for selection of optimal therapy. In addition to inhibitory effects on exocrine and endocrine secretion, octreotide has also been suggested to have antiproliferative effects manifested mainly by stabilization of disease and not tumor regression.",1996.0,0,0
1014,8877348,The use of omeprazole for resistant oesophagitis in children.,P B Martin; S M Imong; J Krischer; H R Noblett; B K Sandhu,"Following failure of conventional therapy for reflux oesophagitis, 15 children were treated with omeprazole 20 mg daily for a period of up to three months initially. Treatment resulted in a marked symptomatic improvement as measured by incidence of pain, vomiting, dysphagia and haematemesis. Four children failed treatment and required fundoplication. No complications from the use of omeprazole were recorded and some children have continued long-term treatment.",1996.0,0,0
1015,8881802,,,,,0,1
1016,8881809,Bacterial overgrowth during treatment with omeprazole compared with cimetidine: a prospective randomised double blind study.,J Thorens; F Froehlich; W Schwizer; E Saraga; J Bille; K Gyr; P Duroux; M Nicolet; B Pignatelli; A L Blum; J J Gonvers; M Fried,"Gastric and duodenal bacterial overgrowth frequently occurs in conditions where diminished acid secretion is present. Omeprazole inhibits acid secretion more effectively than cimetidine and might therefore more frequently cause bacterial overgrowth. This controlled prospective study compared the incidence of gastric and duodenal bacterial overgrowth in patients treated with omeprazole or cimetidine. 47 outpatients with peptic disease were randomly assigned to a four week treatment regimen with omeprazole 20 mg or cimetidine 800 mg daily. Gastric and duodenal juice were obtained during upper gastrointestinal endoscopy and plated for anaerobic and aerobic organisms. Bacterial overgrowth (> or = 10(5) cfu/ml) was present in 53% of the patients receiving omeprazole and in 17% receiving cimetidine (p < 0.05). The mean (SEM) number of gastric and duodenal bacterial counts was 6.0 (0.2) and 5.0 (0.2) respectively in the omeprazole group and 4.0 (0.2) and 4.0 (0.1) in the cimetidine group (p < 0.001 and < 0.01; respectively). Faecal type bacteria were found in 30% of the patients with bacterial overgrowth. Basal gastric pH was higher in patients treated with omeprazole compared with cimetidine (4.2 (0.5) versus 2.0 (0.2); p < 0.001) and in patients with bacterial overgrowth compared with those without bacterial overgrowth (5.1 (0.6) versus 2.0 (0.1); p < 0.0001). The nitrate, nitrite, and nitrosamine values in gastric juice did not increase after treatment with either cimetidine or omeprazole. Serum concentrations of vitamin B12, beta carotene, and albumin were similar before and after treatment with both drugs. These results show that the incidence of gastric and duodenal bacterial overgrowth is considerably higher in patients treated with omeprazole compared with cimetidine. This can be explained by more pronounced inhibition of gastric acid secretion. No patient developed signs of malabsorption or an increase of N-nitroso compounds. The clinical significance of these findings needs to be assessed in studies with long-term treatment with omeprazole, in particular in patients belonging to high risk groups such as HIV infected and intensive care units patients.",1996.0,0,0
1017,8882382,Pantoprazole. A review of its pharmacological properties and therapeutic use in acid-related disorders.,A Fitton; L Wiseman,"Pantoprazole is an irreversible proton pump inhibitor which, at the therapeutic dose of 40mg, effectively reduces gastric acid secretion. In controlled clinical trials, pantoprazole (40mg once daily) has proved superior to ranitidine (300mg once daily or 150mg twice daily) and equivalent to omeprazole (20mg once daily) in the short term (< or = 8 weeks) treatment of acute peptic ulcer and reflux oesophagitis. Gastric and duodenal ulcer healing proceeded significantly faster with pantoprazole than with ranitidine, and at similar rates with pantoprazole and omeprazole. The time course of gastric ulcer pain relief was similar with pantoprazole, ranitidine and omeprazole, whereas duodenal ulcer pain was alleviated more rapidly with pantoprazole than ranitidine. Pantoprazole (40mg once daily) showed superior efficacy to famotidine (40mg once daily) in ulcer healing and pain relief after 2 weeks in patients with duodenal ulcer in a large multicentre nonblinded study. In mild to moderate acute reflux oesophagitis, significantly greater healing was obtained with pantoprazole than with ranitidine and famotidine, whereas similar healing rates were seen with pantoprazole and omeprazole. Pantoprazole showed a significant advantage over ranitidine in relieving symptoms of heartburn and acid regurgitation. Reflux symptoms were similarly alleviated by pantoprazole and omeprazole. Preliminary results indicate that triple therapy with pantoprazole, clarithromycin and either metronidazole or tinidazole is effective in the treatment of Helicobacter pylori-associated disease; however, these findings require confirmation in large well-controlled studies. Pantoprazole appears to be well tolerated during short term oral administration, with diarrhoea (1.5%), headache (1.3%), dizziness (0.7%), pruritus (0.5%) and skin rash (0.4%) representing the most frequent adverse events. The drug has lower affinity than omeprazole or lansoprazole for hepatic cytochrome P450 and shows no clinically relevant pharmacokinetic or pharmacodynamic interactions at therapeutic doses with a wide range of drug substrates for this isoenzyme system. In conclusion, pantoprazole is superior to ranitidine and as effective as omeprazole in the short term treatment of peptic ulcer and reflux oesophagitis, has shown efficacy when combined with antibacterial agents in H. pylori eradication, is apparently well tolerated and offers the potential advantage of minimal risk of drug interaction.",1996.0,0,0
1018,8884304,One-week low-dose triple therapy vs. two-week medium-dose double therapy for H.pylori infection.,A Tursi; G Cammarota; A Papa; M Montalto; G Veneto; G Capelli; L Cuoco; G Branca; G Fedeli; G Gasbarrini,"Our study is to compare a short-term low-dose triple therapy with a long-term medium-dose double therapy for H.pylori eradication. One hundred and ten consecutive patients, suffering from dyspeptic symptoms, with H.pylori infection, were randomly allocated to one of the following 2 groups with different therapeutic regimens: A) omeprazole 20 mg/day for 7 days, tinidazole 500 mg bid for 7 days, clarithromycin 250 mg bid for 7 days (55 pts, 20 with peptic ulcer); B) omeprazole 20 mg bid for 14 days, amoxycillin 1000 mg bid for 14 days (55 pts, 28 with peptic ulcer). The ""H.pylori status"" was evaluated by means of histology, culture and urease test, at entry and 8 weeks after treatment. Two group A and one group B pts didn't complete the treatment. The H.pylori eradication was obtained in 38 pts of group A (71.69%) (C.I.95%: 55.19176-80.86293), in 31 of group B (58.49%) (C.I.95%: 42.32777-69.7017); on Intention-to-Treat analysis, the rate of eradication gave similar results. Side effects occurred in 9 pts of group A (16.98%), in 8 of group B (14.81%). Short-term low-dose triple therapy with omeprazole/tinidazole/clarithromycin has a better cost/benefit ratio than long-term dual therapy with omeprazole/amoxycillin in the H.pylori eradication, but it causes more side-effects.",1996.0,0,0
1019,8898433,Pooled analysis of anti-Helicobacter pylori treatment regimens.,P Unge; A Berstad,"The human pathogen Helicobacter pylori and its association with peptic ulcer has dramatically changed the therapeutic approach to patients with this disease. Successful treatment of the infection has consistently been shown to prevent ulcer recurrence. Published data on therapeutic options are sometimes confusing since only few studies have similar design, drug combinations, dosage, dosing, formulation, patient material, and size. A formal meta-analysis is therefore of limited value. Data on anti-H. pylori therapies from a large number of publications are pooled into a few groups based on the combination of drugs, regardless of dosage, duration, etc., of the therapy. A mean success rate is calculated for all studies with subanalysis with regard to study design, size, doses and duration. Triple combinations are needed to achieve a success rate of more than 80%. Bismuth/tetracycline based triple therapy gives 82% success rate (range 43-100%) compared to 85% and 87% success rate (range 72-100% and 43-100%) achieved with omeprazole/clarithromycin based triples respectively. Omeprazole/clarithromycin based triple regimens are the most effective anti-H. pylori therapeutic strategies, slightly superior to bismuth triple regimens.",1996.0,0,1
1020,8899084,Rapid symptom relief in reflux oesophagitis: a comparison of lansoprazole and omeprazole.,A S Mee; J L Rowley,"Lansoprazole, a substituted benzimidazole, is a proton pump inhibitor which is highly effective in the control of 24-h intragastric acidity. The aim of this multicentre, randomized, double-blind study was to compare lansoprazole 30 mg once daily and omeprazole 20 mg once daily in the symptom relief and healing of patients with reflux oesophagitis. Six hundred and four patients with endoscopically proven oesophagitis and a recent history of heartburn were randomly assigned to receive lansoprazole 30 mg or omeprazole 20 mg daily for 4-8 weeks. Daily assessment of symptoms was made by the patient using a 100-mm Visual Analogue Scale. Clinical symptoms were evaluated at weeks 0, 1, 4 and 8. Endoscopic assessment of healing, defined by normalization of the oesophageal mucosal appearance, was made at weeks 4 and 8. Two hundred and eighty-two patients in the lansoprazole group and 283 patients in the omeprazole group were eligible for inclusion in the per protocol analysis. At 3 days, there was a significant improvement in daytime symptoms of heartburn for patients in the lansoprazole group compared with the omeprazole group (P = 0.05). A similar but non-significant trend was seen at 7 days (P = 0.18). Clinical assessment at 7 days demonstrated significant improvement in daytime epigastric pain in the lansoprazole group compared with the omeprazole group (P = 0.03), with a similar but non-significant trend in night-time epigastric pain (P = 0.07). Healing rates of oesophagitis at 4 and 8 weeks were 70 and 87%, respectively, with lansoprazole, and 63 and 82%, respectively, with omeprazole. Logistic regression analysis of the cumulative healing rates, which included baseline factors affecting outcome, resulted in an odds ratio of 1.46 (95% CI = 0.87-2.45), suggesting a higher chance of being healed with lansoprazole treatment compared with omeprazole treatment. A total of 615 adverse events were reported by 308 (51%) patients during the study period. The majority of events were mild in nature and the incidence was similar in both treatment groups. The most frequently reported events were headache, diarrhoea and nausea. Lansoprazole provides greater symptom relief compared with omeprazole during the first week of treatment. Both treatments were effective in healing oesophagitis.",1996.0,1,1
1021,8899093,Effects of lansoprazole plus amoxycillin on the cure of Helicobacter pylori infection in Japanese peptic ulcer patients.,M Kato; M Asaka; M Kudo; M Sukegawa; M Katagiri; T Koshiyama; H Kagaya; K Nishikawa; K Hokari; H Takeda; T Sugiyama,"The effect of lansoprazole plus amoxycillin on curing Helicobacter pylori infection and peptic ulcer recurrence was evaluated. The study group was composed of 68 patients with gastric ulcers and 51 with duodenal ulcers, all were H. pylori-positive. The participants were assigned at random to the lansoprazole alone group (lansoprazole 30 mg o.m. for 6 or 8 weeks) or the lansoprazole plus amoxycillin group (lansoprazole alone regimen plus amoxycillin at 500 mg q.d.s. concomitantly for the first 2 weeks). Healed patients were not given maintenance treatment with acid secretion inhibitors. The cure rate for H. pylori infection and the ulcer recurrence rate after 1 year were investigated. The cure rate for H. pylori infection was 4.2% in patients receiving lansoprazole alone and 38.5% in patients receiving lansoprazole plus amoxycillin (P < 0.01) for gastric ulcers, and 0% in patients receiving lansoprazole alone and 61.9% in patients receiving lansoprazole plus amoxycillin (P < 0.001) for duodenal ulcers. The recurrence rate was 42.3% in patients receiving lansoprazole alone and 28.6% in patients receiving lansoprazole plus amoxycillin for gastric ulcers, and 66.7% for patients receiving lansoprazole alone and 11.1% for patients receiving lansoprazole plus amoxycillin (P < 0.001) for duodenal ulcers. None of the patients with gastric or duodenal ulcers cured of H. pylori infection had a recurrence. Concomitant use of lansoprazole and amoxycillin increased the curative effects on H. pylori infection. However, the cure rates with this regimen remained inadequate.",1996.0,0,0
1022,8899094,Omeprazole versus ranitidine: short-term triple-therapy in patients with Helicobacter pylori-positive duodenal ulcers.,A Spadaccini; C De Fanis; G Sciampa; V Masciulli; U Pantaleone; M Di Virgilio; C Magnarini; G Pizzicannella,"To compare the results of two short triple-therapy regimens, different only in the antisecretory drugs used, in patients with active duodenal ulcer and Helicobacter pylori infection. All patients received a combination of clarithromycin 250 mg b.d. and tinidazole 500 mg b.d. for 1 week, in addition to an antisecretory drug: omeprazole 20 mg (50 patients) or ranitidine 300 mg (50 patients) twice daily for 1 week, followed by a single daily dose for a further 3 weeks. Upper gastrointestinal endoscopy, with rapid urease test and histological examination of antral and corpus biopsies, was performed prior to the treatment and at least 2 months after the discontinuation of the antisecretory therapy. Duodenal ulcer healing was documented in all patients at the endoscopic examination after therapy. H. pylori eradication was achieved in 46 of 50 patients (92%, 95% CI = 85-99%) in the omeprazole group and in 43 of 50 patients (86%, 95% CI = 76-96%) in the ranitidine group: the difference is not significant. Omeprazole or ranitidine, in combination with clarithromycin and tinidazole, are equally effective in the eradication of H. pylori infection and healing of duodenal ulcers.",1996.0,0,0
1023,8900901,"Screening for latent gluten sensitivity: questions many, but answers few.",M N Marsh,,1996.0,0,0
1024,8902348,Early detection and management of esophageal cancer.,C Margulies; R Kim; J C Reynolds,,1996.0,0,0
1025,8917326,Gastroesophageal reflux disease. The long and the short of therapeutic options.,W M Brady; C P Ogorek,"Gastroesophageal reflux disease (GERD) is a common and treatable condition. Initial therapy includes lifestyle modifications, avoidance of certain medications, and use of antacids, alginic acid preparations, and over-the-counter histamine2 (H2) receptor antagonists. Escalation of therapy for acute disease relies primarily on H2 receptor antagonists given in conventional dosages. Although H2 receptor antagonists remain the cornerstone of therapy, sucralfate and promotility agents, especially cisapride, may offer alternatives. Most cases of GERD that are resistant to these therapies can be reliably healed with proton pump inhibitors (PPIs). Patients whose GERD is healed with one of the aforementioned agents often relapse unless they receive further therapy. For patients with mild disease, H2 receptor antagonists, cisapride, or a combination of the two may prevent recurrent symptoms. In severe disease, PPIs are the agents of first choice, but concerns about the safety of long-term use must be considered. In selected patients, surgery offers an option for long-term control of GERD. With present surgical techniques, symptom relief can be obtained with little risk of complications.",1996.0,0,0
1026,8931401,Diagnosis and treatment of esophageal diseases associated with HIV infection. Practice Parameters Committee of the American College of Gastroenterology.,D T Dieterich; C M Wilcox,,1996.0,0,0
1027,8931413,Therapeutic options after failed Helicobacter pylori eradication therapy.,R W van der Hulst; J F Weel; A van der Ende; F J ten Kate; J Dankert; G N Tytgat,"Many of the currently used Helicobacter pylori eradication regimens fail to cure 5-20% of the patients. Those patients will remain at risk of developing a potentially fatal complication of peptic ulcer disease. Therefore, a new attempt to cure H. pylori infection after initial failure of therapy is indicated. We studied the efficacy of three retreatment regimens after initial failure of omeprazole-amoxicillin dual therapy. Fifty-three patients whose treatment failed were randomly assigned to receive retreatment with the same regimen of omeprazole 20 mg b.i.d. (group I) or omeprazole 40 mg t.i.d. (group II) plus amoxicillin 750 mg t.i.d. for 14 days. Forty patients in whom the omeprazole-amoxicillin retreatment failed were assigned to receive omeprazole 20 mg b.i.d., amoxicillin 750 mg t.i.d., and metronidazole 500 mg t.i.d. for 14 days (group III) or omeprazole 20 mg b.i.d. plus clarithromycin 500 mg t.i.d. for 14 days (group IV). H. pylori infection was assessed by culture and histology of gastric biopsies before and 4-6 wk after cessation of therapy. Susceptibility of H. pylori to amoxicillin, clarithromycin, and metronidazole was determined by the E test. In groups I (n = 28) and II (n = 25), cure of H. pylori infection was achieved in 21% and 28% of patients, respectively (not significant). In groups III (n = 20) and IV (n = 20), H. pylori infection was cured in 75% and 70%, respectively. Retreatment with an identical omeprazole-amoxicillin dual regimen is of limited benefit, a result that is independent of the omeprazole dose. In contrast, a third H. pylori eradication attempt with omeprazole-clarithromycin dual therapy or omeprazole-amoxicillin-metronidazole triple therapy provides reasonable cure rates after failure of omeprazole-amoxicillin dual therapy.",1996.0,0,0
1028,8942297,,,,,0,0
1029,8942536,Edgar J. Poth Memorial Lecture. Is Helicobacter pylori a myth or the missing link?,W H Schwesinger,,1996.0,0,0
1030,8944373,"Lansoprazole 30 mg versus omeprazole 40 mg in the treatment of reflux oesophagitis grade II, III and IVa (a Dutch multicentre trial). Dutch Study Group.",C J Mulder; W Dekker; M Gerretsen,"To compare the efficacy and safety of lansoprazole 30 mg daily (LAN30) and omeprazole 40 mg daily (OME40) in the treatment of moderate (Savary-Miller grade II) as well as severe reflux oesophagitis (grade III/IVa). A double-blind, randomized, multicentre study, involving 211 patients at 29 Dutch hospitals. Healing was assessed by endoscopy, performed on admission, after 4 weeks and after 8 weeks if the patient was not healed after 4 weeks. Symptom relief was determined by symptom assessments at the same time points. Safety was evaluated by determining the incidence of adverse events. There was no significant difference in intention-to-treat (ITT) healing rates after 4 weeks (LAN30 87.5%, OME40 80.6%; 95% CI (-4.0; +17.8)) and in the ITT overall healing (LAN30 96.1%, OME40 93.1%; 95% CI (-4.2; +10.2)) rates between the LAN30 and the OME40 group. Relief of reflux-related symptoms at 4 weeks as well as 8 weeks did not differ significantly between the treatment groups. No difference in the incidence of adverse events was observed between the groups. Treatment of patients with reflux oesophagitis grade II, III or IVa with LAN30 was as effective as with OME40 with respect to healing as well as symptom relief.",1996.0,1,1
1031,8946978,"Comparison of once-daily doses of omeprazole (40 and 20 mg) and placebo in the treatment of benign gastric ulcer: a multicenter, randomized, double-blind study.",J E Valenzuela; D G Kogut; A J McCullough; J R Colón Pagán; U Shah; J Whipple; L R Gilde; T J Simon,"The purpose of this multicenter, randomized, double-blind study, conducted in 520 patients, was to compare the efficacy and safety of omeprazole (40 and 20 mg once daily) with placebo in the treatment of benign gastric ulcer. Treatment with omeprazole or placebo lasted 4 wk; those whose ulcers remained unhealed continued the same treatment regimen for an additional 4 wk. The effects of therapy were determined by endoscopy and assessment of GI symptoms. Safety and tolerability were evaluated through reported adverse events, physical examinations, and laboratory tests. At weeks 4 and 8, the proportion of patients with healed ulcers was significantly greater in the omeprazole 40- and 20-mg groups than in the placebo group (p < 0.01). At week 8, the healing rate was significantly greater in the 40-mg group than in the 20-mg group (82.7 vs 74.8%, p < 0.05). In patients with large ulcers (>1 cm), the 40-mg regimen was associated with a significantly higher healing rate (78.9%) than both the 20-mg regimen (61.4%) and placebo (34.6%) at week 8 (p < 0.05 vs omeprazole 20 mg; p < 0.01 vs placebo). Healing rates in patients with small ulcers were similar for the 40- and 20-mg groups. Omeprazole was well tolerated, with no significant differences versus placebo in the overall incidence of clinical or laboratory adverse events. Omeprazole 40 and 20 mg, administered once daily, healed a significantly greater proportion of patients than did placebo. The 40-mg regimen offered significant advantages over the 20-mg regimen in patients with large ulcers.",1996.0,0,0
1032,8948611,Paroxysmal laryngospasm secondary to gastroesophageal reflux.,C J Loughlin; J A Koufman,"Over a 2-year period (1992 to 1994), 12 consecutive adult patients with paroxysmal laryngospasm were prospectively studied. All had had other symptoms of gastroesophageal reflux (GER); however, only 4 (33%) experienced symptoms of heartburn. Each patient underwent fiberoptic laryngeal examination, barium swallow/esophagography, and ambulatory, 24-hour, double-probe pH monitoring (pH-metry). Eleven (92%) of the 12 patients had evidence of GER on examination, and 10 (83%) had abnormal pH-metry, including 3 who demonstrated pharyngeal reflux while having normal total acid exposure times in the esophageal probe. All the patients responded to antireflux treatment, using dietary and lifestyle modifications and omeprazole, with complete cessation of the laryngospastic episodes. This study documents the role of GER in the etiology of paroxysmal laryngospasm, it highlights the advantages of double-probe pH-metry in diagnosing this extraesophageal manifestation of GER, and it demonstrates that antireflux therapy with omeprazole is effective in controlling GER-induced laryngospasm.",1996.0,0,0
1033,8958363,,,,,0,0
1034,8959519,Significant increase in eradication rates of Helicobacter pylori infection with two consecutive dual therapies (omeprazole and amoxycillin or omeprazole and clarithromycin). A randomized study in 450 Spanish patients.,J A Moreno; J M Pajares; C Santander; P Carpintero; C Hermida; S Lara; R García Grávalos,"Helicobacter pylori infection is associated with peptic ulcer disease and chronic gastritis, and eradication of the microorganism markedly reduces the recurrence of peptic ulcer. However, a major problem is the choice of a treatment that is effective, has high eradication rate, and is well tolerated by patients. We evaluated the eradication of H. pylori infection in patients with chronic gastritis (CG), duodenal ulcer (DU), and gastric ulcer (GU) after two dual therapies (omeprazole with either amoxycillin or clarithromycin). Of 450 patients initially included in the study, 207 had CG, 187 DU and 56 GU, and all presented with H. pylori infection. Diagnosis was made from endoscope examination, biopsy samples, rapid urease test and 13C-urea breath test (UBT). H. pylori infection was considered to be present when two of the tests had positive results. All patients were randomized to one of two regimens: (A) omeprazole (20 mg b.i.d.) plus amoxycillin (750 mg t.i.d.) or (B) omeprazole (40 mg b.i.d.) plus clarithromycin (500 mg t.i.d.). The duration of each of the regimens was 2 weeks. Fifty-eight patients who showed H. pylori infection after the first treatment (27 with CG, 24 with DU, and 7 with GU) were allocated to a second therapy. H. pylori eradication was assessed by UBT, 6 weeks after the end of the therapies; positive values were those higher than 5 delta units. A second consecutive dual therapy of omeprazole plus an antibiotic (amoxycillin or clarithromycin) not used in the first therapy improved on the eradication rates obtained with the first regimen. The overall eradication rates were also higher, but no significant differences were found between amoxycillin and clarithromycin. The best results were obtained in those patients with GU.",1996.0,0,0
1035,8959522,Ecabet sodium eradicates Helicobacter pylori infection in gastric ulcer patients.,T Shimoyama; Y Fukuda; S Fukuda; A Munakata; Y Yoshida; T Shimoyama,"Ecabet sodium (ecabet), a new agent that has protective effects on the gastric mucosa has anti-Helicobacter pylori effects, binding with urease to inhibit H. pylori activity, and causing the bacterial to become non-viable. Ecabet monotherapy eradicates H. pylori infection in Japanese monkeys. We investigated a new regimen that included ecabet to eradicate H. pylori infection in gastric ulcer patients. Fifty-five H. pylori-positive patients with gastric ulcer were randomly assigned to one of two groups: group 1 received dual therapy with lansoprazole (30 mg o.d.) for 8 weeks plus clarithromycin (200 mg b.i.d.) or amoxicillin (250 mg q.i.d.) for 2 weeks. Group 2 received triple therapy with lansoprazole (30 mg o.d.) and ecabet sodium (1.0 g b.i.d.) for 8 weeks plus clarithromycin (200 mg b.i.d.) or amoxicillin (250 mg q.i.d.) for 2 weeks. Four weeks after the treatment was withdrawn, H. pylori status was evaluated by histological examination, rapid urease test, and culture. The eradication rate was 26% (7 out of 27 patients) in group 1 and 79% (22 out of 28 patients) in group 2. All patients completed the treatment. The addition of ecabet to the regimen increased the eradication rate of H. pylori infection, and there were no associated major side effects.",1996.0,0,0
1036,8968456,Lansoprazole: a proton pump inhibitor.,W R Garnett,"To summarize the published data on lansoprazole, a proton pump inhibitor approved by the Food and Drug Administration for use in the treatment of duodenal ulcer, erosive esophagitis, and pathologic hypersecretory conditions (e.g., Zollinger-Ellison syndrome). Published data on lansoprazole identified by MEDLINE searches (1985-1996), as well as other pertinent literature. Clinical efficacy trials discussed were limited to multicenter, double-blind, parallel group, prospective studies, where possible. Lansoprazole inhibits gastric acid secretion via inhibition of gastric hydrogen/potassium adenosine triphosphatase (H+,K(+)-ATPase), an enzyme of the gastric parietal cell membrane that forms part of the proton pump that performs the final step in the acid secretory process. Lansoprazole binds covalently to parietal cell H+,K(+)-ATPase, rendering it nonfunctional and inhibiting the secretion of gastric acid. In clinical trials, lansoprazole has been shown to be more effective than placebo and standard doses of histamine (H)2-receptor antagonists and as effective as standard doses of omeprazole for the treatment of peptic ulcer disease, gastroesophageal reflux, Zollinger-Ellison syndrome, and nonsteroidal antiinflammatory drug-induced lesions. Lansoprazole is safe and effective for the treatment of acid-related disorders. It is more effective than the H2-receptor antagonists and comparable to omeprazole for these indications. The choice between lansoprazole and omeprazole is likely to be institution-specific and pharmacoeconomic.",1996.0,0,0
1037,8971285,Prescribing patterns for dyspepsia in primary care: a prospective study of selected general practitioners.,K Bodger; M J Daly; R V Heatley,"To define prescribing patterns for symptomatic dyspeptic patients in a cross-section of general practitioners in Leeds, United Kingdom. Nine general practitioners from a range of practices took part in a prospective observational study of prescribing patterns for dyspepsia. All consultations with symptomatic dyspeptic patients were recorded over a 4-month period. Symptoms were recorded as ulcer-like, reflux-like, or nonspecific, and details of recent therapy, previous investigations and any prescription issued were noted. 257 consecutive consultations were recorded (new patients 23%, consulted before but not investigated 33%, previously investigated 44%). 93% of consultations resulted in a prescription (antacids 24%, prokinetic/motility agent 8%, H2-receptor antagonist 36%, proton pump inhibitor 24%, Helicobacter pylori eradication therapy 8%). 42.5% of new patients received an acid-suppressing drug as first-line therapy, of which only 32% had tried over-the-counter remedies. Symptom-type (ulcer-like, reflux-like or nonspecific) significantly influenced choice of empiric therapy (P < 0.001), though prescribing was still variable. Although around 60% of patients with previously negative investigations or only minor disease received acid-suppressing drugs, such patients were six times more likely to receive 'less potent' treatments (no prescription, antacid or motility agent) than those with known acid-peptic disease (odds ratio 6.23, P < 0.01). Only 30% of patients with previously documented peptic ulcer received H. pylori eradication therapy, yet patients with a wide range of other diagnoses received this form of treatment. Management guidelines may help to promote a more consistent and selective use of newer treatments, and promote more cost-effective patient care.",1996.0,0,0
1038,8971300,Helicobacter pylori eradication using one-week low-dose lansoprazole plus amoxycillin and either clarithromycin or azithromycin.,G Cammarota; A Tursi; A Papa; M Montalto; G Veneto; L Cuoco; G Fedeli; G Gasbarrini,"To evaluate and compare two 1-week low-dose triple therapies based on lansoprazole, amoxycillin and a macrolide in eradicating Helicobacter pylori. Seventy consecutive patients, suffering from dyspeptic symptoms with H. pylori infection, were randomly allocated to one of two treatment groups: (A) (LAC; n = 35) lansoprazole 30 mg once daily, amoxycillin 1000 mg b.d., clarithromycin 250 mg b.d., all for 7 days; and (B) (LAA; n = 35) lansoprazole 30 mg once daily and amoxycillin 1000 mg b.d., both for 7 days, plus azithromycin 500 mg once daily for only 3 days. The H. pylori status was evaluated by means of histology and rapid urease test at entry and 8 weeks after treatment. Three patients did not complete the treatment: one in the LAC group was withdrawn owing to severe side-effects; two patients in the LAA group stopped the treatment prematurely. H. pylori eradication was obtained in 28 of 34 (82%; 95% CI = 66-93%) patients in the LAC group and in 20 of 33 (61%; 95% CI = 42-77%) patients in the LAA group. The difference is significant (P < 0.029). On intention-to-treat analysis, the rates of eradication were (28 of 35 patients, 80% in the LAC group and 20 of 35 patients, 57% in the LAA group. Side-effects occurred in nine (26%) and six (18%) patients in the LAC and LAA groups, respectively. Low-dose lansoprazole plus amoxycillin and clarithromycin is more effective than low-dose lansoprazole plus amoxycillin and azithromycin, but it gave a greater incidence of side-effects.",1996.0,0,0
1039,8973995,Lack of pharmacokinetic interaction after administration of lansoprazole or omeprazole with prednisone.,J H Cavanaugh; M D Karol,"In a recently reported case, administration of omeprazole, a ""proton pump"" inhibitor, was temporally associated with the clinical relapse of pemphigus in a 44-year-old woman whose condition had been stabilized with a fixed dose of prednisone, suggesting the possibility of a drug interaction. This placebo-controlled, randomized, double-blind, three-period crossover study was conducted to evaluate and compare the pharmacokinetics of prednisolone after a single dose of prednisone given during multi-dose administration of lansoprazole or omeprazole. Lansoprazole (30 mg), omeprazole (40 mg), or placebo was administered once daily under fasted conditions for 7 days to healthy male volunteers. On the seventh day, a single dose of prednisone (40 mg) was administered concomitantly with the study medication, and plasma prednisolone concentrations were measured by high-performance liquid chromatography for 24 hours thereafter. Two weeks separated the first doses of each study period. Eighteen volunteers entered the study; pharmacokinetic data were evaluable for 15 participants. Safety data were evaluable for 16 participants in the lansoprazole/prednisone group; 17 in the omeprazole/ prednisone group; and 17 in the placebo/prednisone group. The pharmacokinetic parameters for prednisolone, including the maximum observed plasma concentration (Cmax), time to maximum plasma concentration (tmax), terminal-phase half-life (t1/2), and area under the concentration-time curve, were comparable for the three regimens. Adverse events (AEs) rated as possibly or probably drug related were reported by 50%, 24%, and 47% for subjects in the lansoprazole, omeprazole, and placebo treatment groups, respectively. Headache was the most common drug-related AE. No serious AEs were reported, and no subject withdrew from the study because of an AE. Concomitant administration of lansoprazole or omeprazole does not affect the absorption, biotransformation, or disposition of a single dose of prednisone. All three treatment regimens were well tolerated.",1996.0,0,1
1040,8978346,"Studies on the interrelation between Zollinger-Ellison syndrome, Helicobacter pylori, and proton pump inhibitor therapy.",H C Weber; D J Venzon; R T Jensen; D C Metz,"The interrelation between Helicobacter pylori infection and proton pump inhibitor therapy in patients with Zollinger-Ellison syndrome is unknown. The aim of this study was to evaluate the influence of these factors on parameters of Zollinger-Ellison syndrome. Prevalence of H. pylori was determined by biopsy and antibody testing in 84 patients. The influence of H. pylori status on clinical and laboratory parameters of Zollinger-Ellison syndrome was evaluated. Seroconversion after surgery was assessed retrospectively in infected patients. The prevalence of H. pylori exposure was 23% (10% with active infection). Acid output was higher in H. pylori-negative patients, but other clinical and biochemical parameters did not differ. Parameters were also similar for patients determined to be H. pylori positive by histology or antibody testing alone. Seroconversion rates did not differ between those rendered or not rendered disease free despite a significant reduction in acid output. H. pylori infection is not a risk factor for peptic ulceration in patients with Zollinger-Ellison syndrome. The prevalence is lower than in the general population and much lower than for patients with idiopathic peptic ulcer disease. Long-term omeprazole therapy in H. pylori-positive patients with Zollinger-Ellison syndrome may-lead to a reduction in parietal cell mass.",1997.0,0,0
1041,8979780,Randomised controlled trial of ranitidine versus omeprazole in combination with antibiotics for eradication of Helicobacter pylori.,T C Tham; J S Collins; C Molloy; J M Sloan; K B Bamford; R G Watson,"This study compared high dose ranitidine versus low dose omeprazole with antibiotics for the eradication of H pylori. 80 patients (mean age 48 years, range 18-75) who had H pylori infection were randomised in an investigator-blind manner to either a two-week regime of omeprazole 20 mg daily, amoxycillin 500 mg tid and metronidazole 400 mg tid (OAM), or ranitidine 600 mg bd, amoxycillin 500 mg tid and metronidazole 400 mg tid (RAM), or omeprazole 20 mg daily and clarithromycin 500 mg tid (OC), or omeprazole 20 mg daily and placebo (OP). H pylori was eradicated in 6 of 19 patients in the OAM group (32%); 8 of 18 in the RAM group (44%), 4 of 15 in the OC group (27%); none of 18 in the OP group (0%). [< P0.005 for OAM, RAM, OC vs OP; P = N.S. between OAM, RAM, OC]. Overall metronidazole resistance was unexpectedly high at 58%. Eradication rates in metronidazole sensitive patients were 71% (5/7) and 100% (3/3) for OAM and RAM respectively. In conclusion, H pylori eradication rates using high dose ranitidine plus amoxycillin and metronidazole may be similar to that of low dose omeprazole in combination with the same antibiotics for omeprazole with clarithromycin. Overall eradication rates were low due to a high incidence of metronidazole resistance but were higher in metronidazole-sensitive patients. Even high dose ranitidine with two antibiotics achieves a relatively low eradication rate. These metronidazole-based regimens cannot be recommended in areas with a high incidence of metronidazole resistance.",1996.0,0,0
1042,8980932,Reinfection and duodenal ulcer relapse in south-east Asian patients following successful Helicobacter pylori eradication: results of a 2-year follow-up.,K L Goh; P Navaratnam; S C Peh,"To determine the reinfection rate of Helicobacter pylori and duodenal ulcer relapse rate in a group of patients followed up long term. Prospective study. Patients were followed up endoscopically at 3, 6, 12 and 24 months after successful H. pylori eradication and duodenal ulcer healing. H. pylori status was determined by culture, rapid urease test, Gram's stain of a fresh tissue smear and histological examination of antral biopsies and rapid urease test and histological examination of corpus biopsies. Duodenal ulcer healing, H. pylori reinfection. Thirty-eight patients with duodenal ulcer disease (35 active, 3 healed) had successfully eradicated H. pylori following treatment with omeprazole/amoxycillin (n = 11), omeprazole/amoxycillin/metronidazole (n = 16) and colloidal bismuth subcitrate/ amoxycillin/metronidazole (n = 11). All patients with active duodenal ulcer had healed ulcers at the end of therapy. Thirty-five of 38 patients were seen according to schedule up to 2 years; two patients were seen up to 12 months and one up to 6 months only. Reinfection with H. pylori was not recorded in any of our patients. Shallow duodenal ulcers were noted in three patients at 1-year follow-up, two of whom admitted to taking non-steroidal anti-inflammatory drugs (NSAIDs); H. pylori status was negative in all three. Subsequent follow-up revealed spontaneous healing of the ulcers in all three patients. At 2 years, one patient whose H. pylori status was negative had recurrence of duodenal ulcer. All of the three patients who defaulted subsequent to follow-up were negative for H. pylori and had healed ulcers on follow-up endoscopy at 6 and 12 months. Reinfection rate with H. pylori was zero in a group of South-East Asian patients who had successfully eradicated the infection. Duodenal ulcer relapse was also low (2.9%) in this group of patients at 2 years.",1996.0,0,0
1043,8991862,Effects of dextran sulphate sodium on intestinal epithelial cells and intestinal lymphocytes.,J Ni; S F Chen; D Hollander,"The effects of dextran sulphate sodium (DSS) on mouse intestinal epithelial cells and intraepithelial lymphocytes were analysed to investigate the mechanism by which DSS induces colitis and tumours in mice. Cytotoxicity of DSS towards intestinal epithelial cells and intestinal intraepithelial lymphocyte hybridomas or fresh intestinal intraepithelial lymphocytes seems to have concentration, time, and cell type dependency with increasing concentrations and time causing increased cytotoxicity. Integrin alpha 4 expression was marginally down regulated by 0.5% of DSS, while alpha M290 expression was up regulated. DSS inhibits the binding of 9.1 gamma delta cells to both extracellular matrix (ECM) and epithelial cells. Conversely at high concentrations it increases binding to all ECM except poly-L-lysine. Various cytokines including TGF beta, interleukin 2, and tumour necrosis factor alpha as well as prostaglandin alter the expression of the integrin alpha 4 and M290 subunits at the cell surface, and also alter the adhesion of 9.1 gamma delta cells to epithelial monolayers. The expression of a large number of cell adhesion molecules expressed on intraepithelial lymphocytes is affected by a combination of the abundant gut cytokine TGF beta and DSS, suggesting that DSS induced colitis may ultimately arise from a combination of gut cytokine and DSS. DSS also triggers intraepithelial lymphocyte aggregation on all ECM coated plate tested. These data suggest that the potential roles of DSS induced colitis may be: (a) direct cytotoxicity; (b) interference with the normal interaction between intestinal lymphocytes, epithelial cells, and ECMs; (c) aberrant modulation of the expression of the integrin beta 7 receptors, other cell receptors, and their functions.",1996.0,0,0
1044,8995934,Natural course of gastroesophageal reflux disease: 17-22 year follow-up of 60 patients.,J Isolauri; M Luostarinen; E Isolauri; P Reinikainen; M Viljakka; O Keyriläinen,"To elucidate the long-term course of conservatively managed gastroesophageal reflux disease without H2-antagonists or omeprazole.  Clinical trial, uncontrolled. Gastroenterological outpatient department of a teaching hospital. Sixty of 87 patients consecutively referred for severe gastroesophageal reflux symptoms and with objectively proven pathological reflux. Esophagoscopy, esophagography, cinecardiography of cardiac region, standard reflux test, and confirmatory Bernstein-Baker test. Follow-up included a standardized interview, esophagoscopy with biopsy, and 24-h pH monitoring. At follow-up 17-22 yr after referral, symptoms were less than at the time of referral in 36 of the 50 nonoperated patients (six now symptom-free), were unchanged in five, and were worse in nine patients. Medication for reflux symptoms was no longer used by 34 of the nonoperated patients. The prevalence of erosive esophagitis fell from 40% at referral to 27% at follow-up endoscopy; 42% of the studied patients had pathological 24-h pH, and the endoscopies revealed six new cases of Barrett's metaplasia. Of the 41 nonoperated patients examined with both endoscopy and 24-h pH, 27 (66%) had erosive esophagitis and/or pathological pH values. Of the 10 operated patients, all had fewer symptoms at follow-up than they had at referral (nine were symptom-free). The prevalence of erosive esophagitis fell from 60% at referral to 10% at follow-up. One of the 10 patients had pathological 24-h pH at follow-up. Neither the presence of esophagitis or hiatal hernia nor the severity of symptoms at the time of referral predicted the course of the disease of the conservatively treated patients. The severity of the symptoms declines in the long term, but pathological reflux persists in most of the conservatively treated patients. Thus, the reflux itself is not self-limiting, and therapy should be designed with this in mind.",1997.0,0,0
1045,8995971,Omeprazole and Barrett's regression: is asymptomatic good enough?,K J Krueger; J A DiPalma,,1997.0,0,0
1046,8996045,Pharmacoeconomic comparison of treatments for the eradication of Helicobacter pylori.,J L Taylor; M Zagari; K Murphy; J W Freston,"Patients with Helicobacter pylori-induced duodenal ulcer should have their infection eradicated. The optimal choice of antibiotic therapy, however, is less clear. To evaluate costs and outcomes of treatment with 8 antibiotic regimens with documented activity against H pylori vs maintenance therapy with histamine2-receptor antagonists (H2RA). A meta-analysis for 119 studies enrolling 6416 patients to determine aggregate eradication rates. The complexity of each regimen was used to determine the anticipated compliance rate and actual effectiveness. A decision analytic model with Monte Carlo simulation determined annual costs and health outcomes. Average annual total costs of testing for H pylori infection and antibiotic treatment ranged from $223 to $410 and prevented ulcer recurrence in 70% to 86% of patients. The H2RA maintenance therapy cost $425 and prevented recurrence in 72% of patients. The lowest costs and recurrence rates were achieved by 3 regimens: standard triple therapy (a combination of bismuth subsalicylate, metronidazole, and tetracycline hydrochloride) for 14 days ($223, with 18% recurrence); a combination of clarithromycin, metronidazole, and a proton pump inhibitor for 7 days ($235, with 15% recurrence); and standard triple therapy with a proton pump inhibitor for 7 days ($236, with 14% recurrence). Treatment with any regimen resulted in lower costs compared with H2RA maintenance therapy. Three antibiotic regimens had consistently lower costs and better outcomes: standard triple therapy for 14 days, metronidazole, clarithromycin, and a proton pump inhibitor for 7 days, and standard triple therapy plus a proton pump inhibitor for 7 days.",1997.0,0,1
1047,9003618,Molecular typing of Helicobacter pylori isolates from a multicenter U.S. clinical trial by ureC restriction fragment length polymorphism.,V D Shortridge; G G Stone; R K Flamm; J Beyer; J Versalovic; D W Graham; S K Tanaka,The molecular typing of 81 pretreatment Helicobacter pylori isolates and the comparison of 18 pretreatment-posttreatment pairs is described by restriction fragment length polymorphism (RFLP) of the ureC gene. The results of our study show the extreme genomic diversity of H. pylori and indicate that infection by H. pylori in the United States does not appear to be limited to a small number of RFLP types.,1997.0,0,0
1048,9009677,Evaluation of the efficacy and tolerability of four different therapeutic regimens for the Helicobacter pylori eradication.,A Tursi; G Cammarota; M Montalto; A Papa; L Cuoco; G M Veneto; O Cannizzaro; G Fedeli; G Gasbarrini,"The aim of our study is to evaluate the efficacy and tolerability of four different therapeutic regimens for Helicobacter pylori eradication. One-hundred and thirty-two consecutive patients suffering from either peptic ulcer or non-ulcer dyspepsia, with Helicobacter pylori infection, were allocated to one of the following 4 groups with different therapeutic regimens: A) omeprazole 20 mg bid for 14 days/amoxycillin 1000 mg bid for 14 days/tinidazole 500 mg bid for 14 days (30 patients, 13 with peptic ulcer); B) omeprazole 20 mg bid for 14 days/amoxycillin 1000 mg bid for 14 days (41 patients, 23 with peptic ulcer); C) omeprazole 20 mg bid for 14 days/azithromycin 500 mg/day for 3 days for 2 consecutive weeks (25 patients, 12 with peptic ulcer); D) omeprazole 20 mg/day for 7 days/clarithromycin 250 mg bid for 7 days/tinidazole 500 mg bid for 7 days/ (36 patients, 14 with peptic ulcer). The Helicobacter pylori status was evaluated by means of histology, culture and urease test, at entry and 8 weeks after treatment. 2 group A, B and D patients, 1 D patient didn't complete the treatment. In evaluable patients, the Helicobacter pylori eradication was obtained in 24 patients of group A (85.71%), in 24 of group B (58.98%), in 11 of group C (45.83%) and in 24 of group D (70.58%). On intention-to-treat analysis, Helicobacter pylori eradication was 80% in group A, 56.09% in group B, 44% in group D and 66.67% in group D. Sideeffects occurred in 6 patients of group A (20.68%), in 5 of group B (12.5%), in 3 group D (8.82%) and none of group C. In conclusion, triple therapy with omeprazole/clarithro-mycin/tinidazole is better for cost/benefit ratio; omeprazole/amoxycillin/tinidazole is more effective than others regimens in the Helicobacter pylori eradication, but causes more side effects; double therapy with omeprazole/azithromycin is the most tolerable and the least efficacy for Helicobacter pylori eradication.",1996.0,0,0
1049,9012279,Contemporary medical therapy for gastroesophageal reflux disease.,R Fass; L J Hixson; M L Ciccolo; P Gordon; G Hunter; W Rappaport,"Gastroesophageal reflux disease is a chronic disorder that requires long-term therapy in most patients. The appropriate medical therapy should be individualized to the severity of symptoms, the degree of esophagitis and the presence of other acid-reflux complications. Lifestyle changes should form the basis of any therapeutic approach. In patients with mild to moderate disease, initial therapy with histamine H2-receptor antagonists in conventional dosages is suggested. Prokinetic agents are potentially useful in patients with impaired esophageal or gastric motor function, but their efficacy as single agents does not appear to surpass that of standard doses of H2 blockers. Sucralfate, a cytoprotective agent, is an additional therapeutic option. For patients with more severe disease, omeprazole and lansoprazole provide unequaled healing rates and accelerated symptom relief. In most patients, maintenance therapy is vital. Surgery is indicated in patients whose disease is refractory to medical therapy and in those who develop complications not amenable to medical therapy.",1997.0,0,0
1050,9026477,Marked increase in gastric acid secretory capacity after omeprazole treatment.,H L Waldum; J S Arnestad; E Brenna; I Eide; U Syversen; A K Sandvik,"In contrast with the histamine2 (H2) blockers, proton pump inhibitors have not been shown to give rebound hypersecretion of acid. Taking into consideration the hyperplasia of the enterochromaffin-like (ECL) cell provoked by hypergastrinaemia secondary to profound acid inhibition and the central role of histamine from ECL cells in the regulation of acid secretion, the lack of any rebound acid hypersecretion after treatment with proton pump inhibitors has been questioned. To reassess the effect of treatment with omeprazole on post-treatment acid secretion. Basal and pentagastrin stimulated acid secretion were determined in nine patients with reflux oesophagitis before and 14 days after termination of a 90 day treatment period with the proton pump inhibitor omeprazole (40 mg daily). Basal gastrin release were determined before and during omeprazole treatment. Furthermore, biopsy samples from the oxyntic mucosa were taken before and at the end of the treatment period for chemical (histamine and chromogranin A (CgA)) evaluation of the ECL cell mass. A substantial increase in meal stimulated gastrin release during omeprazole treatment resulted in an increased ECL cell mass. Furthermore, CgA in serum increased during omeprazole treatment suggesting that serum CgA may be used as a test to evaluate ECL cell hyperplasia. A significant increase in basal and a marked (50%) and significant increase in pentagastrin stimulated acid secretion were found after treatment with omeprazole. Increased acid secretion after a conventional treatment period with a proton pump inhibitor is probably due to ECL cell hyperplasia and may have negative consequences for acid related diseases.",1996.0,0,0
1051,9031379,Scleroderma and pregnancy.,V D Steen,"Pregnancy in systemic sclerosis may be uneventful, with both good maternal and fetal outcomes. Because scleroderma is a multisystem disease and complications do occur, however, careful antenatal evaluations, discussion of potential problems, and participation in a high-risk obstetric monitoring program is very important to optimize the best outcome. Because women with diffuse scleroderma are at greater risk for developing serious cardiopulmonary and renal problems early in the disease, they should be encouraged to delay pregnancy until the disease stabilizes. All patients who become pregnant during this high-risk time should be monitored extremely carefully. Although there are some suggestions that there are increases in infertility and miscarriages before disease onset, recent studies show that these issues probably do not have major impact for women with established scleroderma who plan to become pregnant. The high risk of premature and small infants may be minimized with specialized obstetric and neonatal care, however. Renal crisis in scleroderma is the only truly unique aspect of these pregnant, which, unlike blood pressure elevation in nonscleroderma pregnancies, must be treated aggressively with ACE inhibitors. Other pregnancy problems may not be unique to scleroderma, but because it is a chronic illness, any complication carries higher risks for both mother and child. Careful planning, close monitoring, and aggressive management should allow women with scleroderma to have a high likelihood of a successful pregnancy.",1997.0,0,0
1052,9031898,"Short-term low-dose triple therapy with azithromycin, metronidazole and lansoprazole appears highly effective for the eradication of Helicobacter pylori.",M Caselli; L Trevisani; A Tursi; S Sartori; M Ruina; I Luzzi; P Gaudenzi; V Alvisi; G Gasbarrini,"Although the OCN (omeprazole, clarithromycin and nitroimidazoles) short-term low-dose regimens are regarded as 'the standard' in the treatment of Helicobacter pylori infection, azithromycin is a new-generation, acid-stable macrolide which may prove particularly useful for a new short-term low-dose triple therapy regimen. To further improve OCN eradication treatments by reducing both the number of pills and the total cost. A new short-term low-dose triple therapy (LAM) using lansoprazole 30 mg once a day for 1 week, azithromycin 500 mg once a day for 3 days, and metronidazole 250 mg twice a day for the same 3 days, was administrated to 60 patients presenting with H. pylori-positive gastritis with or without peptic ulcer, and compared with the classic 'Bazzoli regimen' (OCT: omeprazole, clarithromycin, tinidazole) in 60 matched patients. H. pylori infection before and after therapy was evaluated by a rapid urease test, conventional histology and toluidine-stained semi-thin sections. Three biopsies from the corpus and three from the antrum were taken during endoscopical examination before and 7-8 weeks after discontinuation of the treatment. Patient compliance, drug tolerance and drug costs were also taken into consideration. H. pylori infection was eradicated 7-8 weeks after treatment in 56 of the 60 patients in the LAM group (93.3%), and in 52 of the 57 patients in the OCT group who completed the treatment (91.2%), with no statistical difference. When gastric or duodenal ulceration was present, ulcer healing was observed in all cases. The new proposed short-term low-dose triple therapy (LAM) appears to be as effective as the OCT for the eradication of H. pylori infection. The new treatment, however, seems to have advantages in terms of drug tolerance, patient compliance and therapy cost.",1997.0,0,0
1053,9037444,"Omeprazole, amoxicillin and bismuth for peptic ulcer healing and Helicobacter pylori eradication.",G Treiber; S Walker; U Klotz,"A controlled, randomized study was performed in patients with active peptic ulcer disease and positive Helicobacter pylori (Hp) status to assess the clinical efficacy (endoscopic healing and eradication of Hp) of different combined treatments. In the first part of the study a treatment with omeprazole (CAS 73590-58-6) (40 mg once daily) alone (group A) or in combination with tripotassium dicitrato bismuthate (TDB; 240 mg bid, group B) for 4 weeks was evaluated in 20 and 13 patients, respectively. As expected healing rates were high and comparable (75 vs. 85%), however, Hp-eradication was zero in both groups. In the subsequent second part of the trial group A (n = 19) received omeprazole (20 mg bid) for 2 weeks + amoxicillin (CAS 26787-78-0) tablets (1 g bid only 2nd week). Accumulated healing rate increased to 95% but Hp-eradication was 37%. From group B only 8 patients participated in a second 4-week course of monotherapy with TDB. Whereas healing occurred in all individuals, Hp-eradication was still low (12.5%). In addition plasma levels (omeprazole, Bi) and urinary excretion (Bi) were monitored to test whether drug interaction and/or noncompliance of the patients could help to explain the clinical findings. Systemic availability of Bi was increased by the coadministration of omeprazole and plasma levels of omeprazole were in general higher in Hp-positive patients if compared to those of Hp-negative patients. The following conclusions could be drawn from the 4 parts of the study: Treatment of peptic ulcer disease with omeprazole either alone or in combination with TDB is effective for ulcer healing but not for eradicating Hp. Omeprazole seems to decrease the Hp-eradicating potential of Bi probably due to a drug interaction. A second treatment course with TDB is apparently not of much benefit. One week pretreatment with omeprazole does not affect healing but might attenuate Hp-eradication rate of subsequent combined treatment with amoxicillin. One week coadministration of amoxicillin is not sufficient. The magnitude of omeprazole's plasma levels has no effect on Hp-eradication rates. As the numbers of patients in this study was relatively small these conclusions need to be confirmed by larger trials.",1997.0,0,0
1054,9040198,"Acute upper gastrointestinal bleeding in the Amsterdam area: incidence, diagnosis, and clinical outcome.",E M Vreeburg; P Snel; J W de Bruijne; J F Bartelsman; E A Rauws; G N Tytgat,"In the United States of America and the United Kingdom several epidemiological upper gastrointestinal bleeding (UGIB) surveys have been done. However, information about the current epidemiology of acute UGIB in continental Western Europe is sparse. From July of 1993 to July of 1994, 951 patients with acute UGIB were prospectively included in 12 hospitals in the Amsterdam area. Data were collected prospectively with a standard questionnaire and included demographic as well as specific data relating to UGIB. The overall incidence was 45 per 100,000 persons/yr. Patients had an advanced age (median, 71 yr), and shock was found in 63%. Coexisting illnesses were present in 85%. Twenty percent had a history of previous ulcer disease, of whom 33% used acid suppressive therapy. Endoscopy was performed within 24 h in 78%, and in 42% a gastroduodenal ulcer was found. In 24%, no diagnosis could be made at the initial endoscopy, in these patients endoscopy was done significantly later than in those in whom a diagnosis was readily made. Rebleeding occurred in 16.4%, and 7% had surgery. Mortality rate was 13.9%, which was considered in one-third to be directly related to the bleeding. The incidence and diagnostic profile of UGIB is similar to other large European studies, but different from those for the United States. Bleeding could perhaps have been prevented in the patients with a history of previous ulcer disease. The 24-h endoscopy service was not as fast, accurate, and widespread as we assumed. Mortality seems to be more related to advanced age, shock, and coexisting illnesses.",1997.0,0,0
1055,9040200,,,,,0,0
1056,9041231,Gastric mucosa during treatment with lansoprazole: Helicobacter pylori is a risk factor for argyrophil cell hyperplasia.,R Eissele; G Brunner; B Simon; E Solcia; R Arnold,"The mechanisms causing progression of fundic gastritis and changes in argyrophil cell morphology in patients undergoing long-term treatment with proton pump inhibitors are unknown. The hypothesis of this study was that Helicobacter pylori is a risk factor for both gastritis and argyrophil cell hyperplasia. Forty-two patients with peptic disorders resistant to H2-blockers were treated with 30-90 mg lansoprazole daily for up to 5 years. Serum gastrin levels, antral gastrin cells, fundic argyrophil cells, parameters of gastritis, and H. pylori infection were evaluated regularly. In nonantrectomized patients, serum gastrin levels increased from a median of 76 pg/mL to 163 pg/mL within 3 months. Antral gastrin cell density increased from 175 to 267 cells/mm2 (P < 0.001), and fundic argyrophil cell density increased from 83 to 149 cells/mm2 (P < 0.001). Chronic inflammation, activity, and atrophy of the oxyntic mucosa worsened exclusively in patients with H. pylori infection. Linear and/or micronodular argyrophil cell hyperplasia was diagnosed in 2.6% of patients before lansoprazole and in 29.2% after 5 years treatment. These changes were significantly related to serum gastrin levels, H. pylori infection, chronic inflammation, and atrophy of the oxyntic mucosa. H. pylori represents an important factor for the progression of fundic gastritis and the development of argyrophil cell hyperplasia during long-term treatment with lansoprazole.",1997.0,0,1
1057,9041253,Complement activation after ischemia-reperfusion in human liver allografts: incidence and pathophysiological relevance.,J Y Scoazec; G Borghi-Scoazec; F Durand; J Bernuau; B N Pham; J Belghiti; G Feldmann; C Degott,"Little is known about the occurrence and possible consequences of local complement activation in human liver transplantation. The aim of this study was to search for signs of complement activation in human liver allografts and evaluate their relationship to cell injury and leukocyte sequestration. In 33 postreperfusion biopsy specimens, 9 preoperative specimens, and 10 intraoperative specimens, the cytolytic membrane attack complex of complement was localized, expression of complement inhibitors was evaluated, and intragraft accumulation of leukocytes and platelets was quantitated. In control samples and preoperative biopsy specimens, the membrane attack complex was detected only in extracellular deposits, associated with its soluble inhibitors clusterin and vitronectin. Comparable observations were performed in 14 postoperative specimens. In the remaining 19 postoperative specimens, membrane attack complex decorated a variable proportion of hepatocytes. The extent of membrane attack complex deposition correlated with the increase in postoperative aspartate aminotransferase levels in serum (P = 0.002) and the decrease in postoperative factor V levels in serum (P = 0.002). It also correlated with the number of leukocytes and platelets accumulating within the graft (P < or = 0.001). Local complement activation is frequent during human liver transplantation and probably contributes to cell injury and leukocyte sequestration in the allograft.",1997.0,0,1
1058,9042987,Lansoprazole heals erosive reflux oesophagitis in patients with Barrett's oesophagus.,S J Sontag; T G Schnell; G Chejfec; C Kurucar; J Karpf; G Levine,"Barrett's oesophagus is thought to be a complication of severe gastro-oesophageal reflux. To determine whether the proton pump inhibitor, lansoprazole, is effective in healing erosive reflux oesophagitis in patients with Barrett's oesophagus. An 8-week, randomized, double-blind study was conducted using patients with both erosive reflux oesophagitis and Barrett's oesophagus. Erosive reflux oesophagitis was defined as grades 2-4 oesophagitis; Barrett's oesophagus, as specialized columnar epithelium obtained by biopsy from the tubular oesophagus; and healing, as a return to grade 0 or 1 oesophageal mucosa (complete re-epithelialization). One-hundred and five (105) patients from one centre were randomized to receive either lansoprazole 30 mg daily or ranitidine 150 mg twice daily. Unhealed or symptomatic lansoprazole patients at week 4 were randomized to receive the same 30 mg dose daily or an increased dose of 60 mg daily. Endoscopy was performed at baseline and at weeks 2, 4, 6 and 8. The treatment groups were similar in regards to baseline characteristics, erosive reflux oesophagitis grades and length of Barrett's oesophagus. At each 2-week interval, lansoprazole patients had significantly greater healing rates and less day and night heartburn and regurgitation than ranitidine patients. There were no significant differences between treatment groups in antacid use, quality of life parameters, or rate of reported adverse events. Median values for fasting serum gastrin levels remained within the normal range for both groups. In patients with both Barrett's oesophagus and erosive reflux oesophagitis, lansoprazole is significantly more effective than ranitidine in relieving reflux symptoms and healing erosive reflux oesophagitis.",1997.0,0,0
1059,9055715,Randomised double blind controlled study of recurrence of gastric ulcer after treatment for eradication of Helicobacter pylori infection.,A T Axon; C A O'Moráin; K D Bardhan; J P Crowe; A D Beattie; R P Thompson; P M Smith; F D Hollanders; J H Baron; D A Lynch; M F Dixon; D S Tompkins; H Birrell; K R Gillon,"To determine whether eradication of Helicobacter pylori infection reduces recurrence of benign gastric ulceration. Randomised, double blind, controlled study. Patients were randomised in a 1:2 ratio to either omeprazole 40 mg once daily for eight weeks or the same treatment plus amoxycillin 750 mg twice daily for weeks 7 and 8. A 12 month untreated follow up ensued. Teaching and district general hospitals between 1991 and 1994. 107 patients with benign gastric ulcer associated with H pylori. Endoscopically confirmed relapse with gastric ulcer (analysed with life table methods), H pylori eradication, and healing of gastric ulcers (Mantel-Haenszel test). 172 patients were enrolled. Malignancy was diagnosed in 19; 24 were not infected with H pylori; four withdrew because of adverse events; and 18 failed to attend for start of treatment, leaving 107 patients eligible for analysis (35 omeprazole alone; 72 omeprazole plus amoxycillin). In the omeprazole/amoxycillin group 93% (67/72; 95% confidence interval 84% to 98%) of gastric ulcers healed and 83% (29/35; 66% to 94%) in the omeprazole group (P = 0.103). Eradication of H pylori was 58% (42/72; 46% to 70%) and 6% (2/35; 1% to 19%) (P < 0.001) and relapse after treatment was 22% (16/72) and 49% (17/35) (life table analysis, P < 0.001), in the two groups, respectively. The recurrence rates were 7% (3/44) after successful H pylori eradication and 48% (30/63) in those who continued to be infected (P < 0.001). Eradication of H pylori reduces relapse with gastric ulcer over one year. Eradication rates achieved with this regimen, however, are too low for it to be recommended for routine use.",1997.0,0,0
1060,9058634,Twenty-four-hour monitoring of intragastric acidity: comparison between lansoprazole 30mg and pantoprazole 40mg.,C Florent; S Forestier,"To date, there is no published study, comparing the effects of lansoprazole and pantoprazole on gastric acid secretion inhibition. The aim of this study, was to compare the effects of these two drugs on 24-h intragastric pH-metry. Twelve healthy volunteers were included in an open, randomized, crossover study. Each subject received lansoprazole 30mg during 7 days followed, after a 14-day wash-out period, by pantoprazole 40 mg for 7 days or vice versa. Intragastric 24-h pH monitoring was performed before the treatment, and then after the first and seventh intake in each treatment period. The decrease in gastric acidity on daytime, night-time and total 24-h periods during both treatments was significantly different from the base value. Significant differences in acid inhibition were found between lansoprazole 30mg and pantoprazole 40 mg during daytime and 24 h after the first intake. After repeated dose regimens, a significant difference was detected between treatment periods but only for pH above 4. After the first dose, the median pH value with lansoprazole was also significantly greater than for pantoprazole. Pantoprazole activity increased significantly from first to seventh intake, in contrast to lansoprazole. Lansoprazole 30 mg was significantly more potent than pantoprazole 40 mg on 24-h pH profiles on the first and seventh days. The antisecretory effect of lansoprazole was maximum after the first intake whereas pantoprazole activity increased significantly between the first and last intake.",1997.0,0,0
1061,9060586,Long-term comparison of antireflux surgery versus conservative therapy for reflux esophagitis.,J Isolauri; M Luostarinen; M Viljakka; E Isolauri; O Keyriläinen; A L Karvonen,"The purpose of the study was to evaluate the long-term symptomatic and endoscopic outcome in gastroesophageal reflux disease with erosive esophagitis, comparing conservative with operative management. The study comprised 105 of 120 patients consecutively referred for severe reflux symptoms to the gastroenterologic outpatient department of a teaching hospital, where erosive esophagitis was confirmed endoscopically. If conservative management (modified lifestyle and medication) failed to relieve symptoms and heal the esophagitis, antireflux surgery (Nissen fundoplication) was undertaken. Follow-up (median, 10.9 years) evaluation of all patients included comprehensive, standardized interviews; self-scoring of symptoms at the time of referral and currently; and observations at endoscopy. Nissen fundoplication was performed on 37 of the 105 patients. At follow-up of these 37 patients, (31) 84% had no or only occasional mild heartburn, (33) 89% were free from erosive esophagitis, and (2) 5% were taking H2 antagonists or omeprazole. The corresponding figures in the 68 patients with only conservative treatment were (36) 53%, (31) 45%, and (14) 21%. The mean change in symptom score between referral time and follow-up was 5.7 in the surgically treated group and 1.7 in the nonsurgically treated group. Fifteen new cases of Barrett's metaplasia were found at follow-up. In gastroesophageal reflux disease with erosive esophagitis, surgical treatment gave results subjectively and objectively superior to those from conservative management.",1997.0,0,0
1062,9068463,Lansoprazole heals erosive reflux esophagitis resistant to histamine H2-receptor antagonist therapy.,S J Sontag; D G Kogut; R Fleischmann; D R Campbell; J Richter; M Robinson; M McFarland; S Sabesin; G A Lehman; D Castell,"We conducted a randomized, double-blind, multicenter clinical trial to determine whether lansoprazole was superior to continued therapy with histamine H2-receptor antagonist therapy in healing erosive reflux esophagitis. Investigators from nine medical centers enrolled 159 patients with endoscopically documented esophageal erosions and/or ulcers that had failed to heal with 12 or more wk of at least standard dosages of histamine H2-receptor antagonist therapy. Patients received ranitidine 150 mg b.i.d. for 8 wk or lansoprazole 30 mg for 4 wk followed by either lansoprazole 30 mg or lansoprazole 60 mg for another 4 wk of treatment. Patients underwent endoscopy at screening and at weeks 2, 4, and 8. At 2, 4, and 8 wk of therapy, healing rates were significantly higher in the lansoprazole group compared with the ranitidine group (p < 0.001). By 8 wk, 84% of the lansoprazole group were healed as opposed to only 32% of the ranitidine group. Lansoprazole was superior to ranitidine in providing relief of upper abdominal burning and daytime heartburn (p < 0.001) and reducing the need for antacids (p < 0.001). Lansoprazole patients had less interference with sleep and less day time drowsiness than ranitidine patients (p = 0.05). The percentages of patients with adverse events were similar in both groups. Fasting serum gastrin levels at weeks 4 and 8 were significantly higher in the lansoprazole group compared with the ranitidine group. Eight weeks of lansoprazole therapy is safe, superior to continued ranitidine therapy, and effective in healing more than 80% of patients with erosive reflux esophagitis previously resistant to histamine H2-receptor antagonist therapy.",1997.0,1,1
1063,9068464,Anti-Helicobacter pylori treatment in bleeding ulcers: randomized controlled trial comparing 2-day versus 7-day bismuth quadruple therapy.,N N Kung; J J Sung; N W Yuen; P W Ng; K C Wong; E C Chung; B H Lim; C H Choi; T H Li; H C Ma; S P Kwok,"One-week bismuth triple therapy has been established to be highly effective in curing H. pylori infection, but patient compliance has been the major factor of success in therapy. For patients hospitalized for ulcer bleeding, an effective regimen that can completed before discharge will ensure full compliance. To compare 2-day versus 1-wk bismuth triple therapy plus omeprazole in curing H. pylori infection and bleeding peptic ulcers. 100 patients with non-actively bleeding duodenal (DU) or gastric ulcers (GU) and confirmed H. pylori infection were randomized to receive either bismuth subcitrate 120 mg, tetracycline 500 mg, and metronidazole 400 mg four times daily for 1 wk (OBTM-7) or bismuth subcitrate 240 mg, tetracycline 500 mg, and metronidazole 400 mg four times daily for 2 days (OBTM-2). Both groups of patients also received omeprazole 20 mg twice daily for the first week. In the OBTM-2 group, the anti-Helicobacter therapy was finished during hospitalization. Endoscopy was repeated 5 wk after randomization to monitor ulcer healing and determine H. pylori status. Side effects related to the anti-Helicobacter therapy was graded as follows: A, mild discomfort, which did not affect daily activity; B, moderate discomfort affecting daily activity; and C, severe discomfort and patients discontinued therapy. Forty-six patients in the OBTM-2 group and 50 in the OBTM-7 group returned for follow-up endoscopy. With an intention-to-treat analysis, ulcer healing was achieved in 44 of 46 patients (95.7%) in the OBTM-2 group versus 49 of 50 (98%) in the OBTM-7 group, p = 0.61. H. pylori eradication was successful in 35 of 46 patients (76.1%) in the OBTM-2 and in all 50 patients (100%) in the OBTM-7 group, p = 0.00024. There was no difference in the severity of side effects experienced by the patients in the OBTM-2 group than in the OBTM-7 group (19 vs 32%, p = 0.16). None of the patients had rebled during the period of follow-up. Despite similar efficacy in ulcer healing, the 2-day quadruple therapy is less effective than the 1-wk regimen in curing H. pylori infection.",1997.0,0,0
1064,9075454,Antimicrobial management of Helicobacter pylori-associated gastrointestinal tract disease.,D R Guay; S J Gilberstadt,"Since the identification of Helicobacter pylori in 1983, this pathogen has become the dominant focus of investigation in a variety of gastrointestinal tract disorders, including peptic ulcer disease, nonulcer dyspepsia, and gastric carcinoma. During the past 7 years, the efficacy of a variety of antimicrobial single, dual, and triple therapy regimens--including the use of acid-suppressive agents, such as proton pump inhibitors, and histamine2-receptor antagonists--in the eradication of H pylori have been investigated. Newer treatment approaches, such as dual therapy (proton pump inhibitor + 1 antimicrobial agent) and 7-day regimens have shown a high degree of success and have the potential to improve compliance. However, the optimal regimen, in terms of cost, efficacy, and tolerability, and optimal length of treatment still remains to be determined.",1997.0,0,0
1065,9085323,Lansoprazole: a comprehensive review.,A E Zimmermann; B G Katona,"Lansoprazole is the second member of the substituted benzimidazole class of antisecretory agents approved for use in the United States. These drugs decrease parietal cell acid secretion by inhibiting H+, K(+)-adenosine triphosphatase, the final step in the secretion of acid. Lansoprazole has been studied extensively for the short-term treatment of duodenal and gastric ulcers, reflux esophagitis, and Helicobacter pylori-positive peptic ulcer disease; long-term treatment of Zollinger-Ellison syndrome; and maintenance treatment of erosive esophagitis. A dosage of 30 mg/day produced higher healing rates and equivalent or faster relief of ulcer symptoms than ranitidine or famotidine in patients with duodenal or gastric ulcers and reflux esophagitis. Compared with omeprazole 20 mg/day, that dosage provided faster epigastric pain relief in these patients after 1 week, although healing rates for the two agents were equivalent at 4 and 8 weeks. In patients with peptic ulcer refractory to 8-week therapy with histamine2-receptor antagonists, healing rates were not significantly different between lansoprazole and omeprazole. In patients with Zollinger-Ellison syndrome, lansoprazole was superior to histamine2-receptor antagonists and was similar in efficacy, safety, and duration of action to omeprazole. Combinations of lansoprazole or omeprazole with one or two antibiotics produced equivalent eradication of H. pylori. In clinical trials, lansoprazole was well tolerated, with frequency of adverse effects similar to that reported with ranitidine, famotidine, and omeprazole.",1997.0,0,0
1066,9088577,Eradication of Helicobacter pylori: an objective assessment of current therapies.,J G Penston; K E McColl,"The purpose of the present review was to determine objectively the optimal treatment for the eradication of H. pylori amongst the currently used regimens. A comprehensive literature search provided a data-base relating to the following treatments: dual therapy with an anti-secretory drug plus either amoxycillin or clarithromycin; standard triple therapy, with or without additional anti-secretory drugs; proton pump inhibitor triple therapy; and H2-receptor antagonist triple therapy. Emphasis was placed on intention-to-treat analyses of eradication rates using all of the available evidence. The criteria used to select the optimal treatment were efficacy (eradication rates), frequency of side-effects, simplicity of the regimen (number of tablets per day and duration of treatment) and cost. The analysis showed that proton pump inhibitor triple therapy (that is, a proton pump inhibitor plus any two of amoxycillin, clarithromycin or a nitroimidazole) was the preferred treatment for the eradication of H. pylori. In particular, the 1-week, low-dose regimen with omeprazole plus clarithromycin plus tinidazole produced the highest eradication rates (> 90%) with the lowest frequency of side-effects and at only modest cost.",1997.0,0,1
1067,9091801,A comparison of omeprazole and placebo for bleeding peptic ulcer.,M S Khuroo; G N Yattoo; G Javid; B A Khan; A A Shah; G M Gulzar; J S Sodi,"The role of medical treatment for patients with bleeding peptic ulcers is uncertain. We conducted a double-blind, placebo-controlled trial in 220 patients with duodenal, gastric, or stomal ulcers and signs of recent bleeding, as confirmed by endoscopy. In 26 patients the ulcers showed arterial spurting, in 34 there was active oozing, in 35 there were nonbleeding, visible vessels, and in 125 there were adherent clots. The patients were randomly assigned to receive omeprazole (40 mg given orally every 12 hours for five days) or placebo. The outcome measures studied were further bleeding, surgery, and death. Twelve of the 110 patients treated with omeprazole (10.9 percent) had continued bleeding or further bleeding, as compared with 40 of the 110 patients who received placebo (36.4 percent) (P<0.001). Eight patients in the omeprazole group and 26 in the placebo group required surgery to control their bleeding (P<0.001). Two patients in the omeprazole group and six in the placebo group died. Thirty-two patients in the omeprazole group (29.1 percent) and 78 in the placebo group (70.9 percent) received transfusions (P<0.001). A subgroup analysis showed that omeprazole was associated with significant reductions in recurrent bleeding and surgery in patients with nonbleeding, visible vessels or adherent clots, but not in those with arterial spurting or oozing. In patients with bleeding peptic ulcers and signs of recent bleeding, treatment with omeprazole decreases the rate of further bleeding and the need for surgery.",1997.0,0,0
1068,9097989,Choice of long-term strategy for the management of patients with severe esophagitis: a cost-utility analysis.,G R Heudebert; R Marks; C M Wilcox; R M Centor,"Omeprazole has shown remarkable efficacy and safety in the treatment of patients with gastroesophageal reflux disease (GERD); similarly, laparoscopic techniques have allowed less morbidity in patients undergoing fundoplication procedures. Concerns about the long-term cost and safety of both strategies have prompted a debate of their role in long-term management of patients with severe erosive esophagitis. A cost-utility analysis was performed to compare two strategies: laparoscopic Nissen fundoplication (LNF) vs. omeprazole. A two-stage Markov model was used to obtain cost and efficacy estimates; all estimates were discounted at 3% per year. The time horizon was 5 years. Sensitivity analyses were performed on all relevant variables. Both strategies were similarly effective (4.33 quality-adjusted life years per patient), with omeprazole less expensive than LNF ($6053 vs. $9482 per patient). At 10 years, LNF and omeprazole costs were similar. Efficacy estimates were extremely sensitive to changes in quality of life associated with postoperative symptoms and long-term use of medication. Medical therapy is the preferred treatment strategy for most patients with severe erosive esophagitis. Individuals with a long life expectancy are good candidates for LNF if postoperative morbidity is low and GERD symptoms remain abated for many years.",1997.0,0,0
1069,9101000,Extent and variation of omeprazole prescribing in an elderly population of Ontario.,J E McBride; J L Pater; J L Dorland; Y M Lam,"To determine the extent of omeprazole prescribing in the senior population of Ontario over a 1-year period; the variation in omeprazole prescribing for this population according to age group, gender, and geographic region: and the extent of inappropriate prescribing of omeprazole for this population. Retrospective drug utilization review of prescription drug insurance claims. The Ontario Drug Benefit (ODB) program claims database. The following outcomes were measured: the proportion of seniors in Ontario who received a prescription for omeprazole from April 1, 1992 to March 31, 1993: effects of age group, gender, and geographic region of residence on omeprazole prescribing; and the extent of inappropriate omeprazole prescribing according to the ODB criteria for use. Prescribing of omeprazole was defined as inappropriate if a first-line antiulcer drug (i.e., histamine2-receptor antagonist) was not prescribed within 1-6 months of the first prescription claim for omeprazole. A total of 29,936 seniors in Ontario received omeprazole from April 1, 1992 to March 31, 1993 (2.53 recipients per 100 eligible population). The age-gender group most frequently prescribed omeprazole was women 65-74 years, followed by women and men 75 years or older, and then men 65-74 years. Omeprazole prescribing varied widely among the 48 provincial counties (range of 1.66 recipients per 100 eligible population to 4.52 recipients per 100 population, p < 0.001). There was no evidence of a clustering effect in omeprazole prescribing at the county level. Prescribing of omeprazole was considered to be inappropriate for 80.5% of recipients. This study demonstrated the ineffectiveness of the ODB limited-use program in controlling omeprazole prescribing. Further study should be done to examine determinants of variation in prescribing by geographic region.",1997.0,0,0
1070,9128233,Laparoscopic treatment of gastroesophageal reflux disease.,H C Alexander; R S Hendler; N E Seymour; G T Shires,"Laparoscopic fundoplication is technically feasible in treating gastroesophageal reflux disease (GERD). Although medication is the primary treatment for GERD, not all patients respond completely or are able to adhere to a medical regimen. In the present series, 59 patients were laparoscopically treated for GERD at three centers using a standardized technique. All patients had been medically treated prior to referral, although 84 per cent had heartburn and 2 per cent had laryngitis despite 20 to 40 mg/day of omeprazole. Fifteen per cent of patients were intolerant of or would no longer take omeprazole. Patients were evaluated by esophageal manometry (in 100%) and 24-hour pH studies (in 66%). Seventy-six per cent of patients had lower-esophageal sphincter pressure <15 mm Hg. Five patients had low esophageal body peristaltic pressures (<35 mm Hg). These patients underwent Toupet partial fundoplication, whereas 54 patients underwent Nissen fundoplication. Mean operative time was 158 +/- 7 minutes, and three patients (5%) were converted to an open procedure. Operative complications were minor and occurred in 13 per cent. In 45 patients evaluated 1 year after surgery, heartburn had resolved in 98 per cent. Thirty-nine of 56 patients (70%) had mild early (<1 month postoperatively) dysphagia, and 9 (19%) had severe early dysphagia, which improved in 7 after nonoperative dilatation. Two of these had continued mild dysphagia. Two patients had severe dysphagia and were laparoscopically converted from Nissen to Toupet fundoplications, which resulted in marked improvement. Early gas bloat symptoms occurred in 45 per cent and dropped to 5 per cent at 1 year. Laparoscopic treatment of GERD is safe and effective in preventing reflux symptoms. Although mild dysphagia occurs after the procedure, this is transient in most patients. Patients with severe dysphagia can be treated with nonoperative dilatation or laparoscopic partial fundoplication and maintain the antireflux characteristics of the wrap.",2001.0,0,0
1071,9128302,Efficacy of omeprazole one year after cure of Helicobacter pylori infection in duodenal ulcer patients.,J Labenz; B Tillenburg; U Peitz; G Börsch; J P Idström; E Verdú; M Stolte; A L Blum,"We have previously shown that, in duodenal ulcer patients, pH control by omeprazole is less pronounced after cure of Helicobacter pylori infection. The present study was designed to test the hypothesis that this response to omeprazole persists 1 yr after cure of H. pylori infection. In 12 duodenal ulcer patients, intragastric acidity was measured with a glass electrode during treatment with omeprazole (20 mg) once daily before, and 4-6 wk and 1 yr after, cure of H. pylori infection. H. pylori infection was assessed by [13C]urea breath test, culture, histology (Warthin Starry stain), and rapid urease test. Cure of H. pylori infection resulted in a lowered pH during omeprazole treatment. This effect persisted after 1 yr. Median 24-h gastric pH before H. pylori treatment was 5.6; 4-6 wk after cure of the infection it was 2.9 (p = 0.003), and 1 yr after cure of the infection it remained unchanged (pH = 2.5; p = 0.5). Accordingly, twice as much time was spent above pH 3 and pH 4 before H. pylori treatment than 1 or 12 months after cure (percent of time > or = pH 3: 82.7 vs. 49.7 vs. 43.1; percent of time > or = pH 4: 72.7 vs. 38.3 vs. 26.4). In duodenal ulcer patients, cure of H. pylori infection resulted in a marked rapid and persistent decrease of the pH increasing effect of omeprazole. Therefore, H. pylori is a determinant of the pH achieved in response to omeprazole treatment in duodenal ulcer patients.",1997.0,0,1
1072,9128303,Normalization of esophageal pH with high-dose proton pump inhibitor therapy does not result in regression of Barrett's esophagus.,P Sharma; R E Sampliner; E Camargo,"The importance of esophageal acid control in the management of Barrett's esophagus is controversial. The objective of this study was to assess the impact of esophageal acid control on the symptoms of reflux disease, healing of erosive esophagitis, change in length of Barrett's epithelium, and the appearance of squamous islands. Thirteen of 27 patients on 60 mg lansoprazole underwent ambulatory 24 h esophageal pH monitoring while on therapy. Symptoms were recorded, and the length of Barrett's epithelium was measured, photographed, and biopsied every 6 months over an average of 5.7 yr. Eight of 13 patients had a normal 24 h pH (group I, mean pH < 4, 0.8%), five patients had abnormal results (group II, mean pH < 4, 10.6%). Symptoms improved in all patients, and there was complete healing of erosive esophagitis in all patients. An increase in the number of squamous islands was noted in 62.5% of patients in group I and in 80% of patients in group II. The mean length of Barrett's epithelium at baseline and study completion in group I was 5.6 and 5.0 cm, respectively (mean decrease, 0.6 cm), and for group II was 4.2 and 4.2 cm, respectively (mean decrease, 0 cm). There was no significant difference in the change in length between the two groups (p = 0.494). Although symptoms improved, erosive esophagitis healed, and squamous islands increased, there was no significant decrease in the length of Barrett's esophagus. Control of esophageal pH alone is not sufficient for the reversal of Barrett's esophagus.",1997.0,0,0
1073,9128316,Triple therapy with ranitidine or lansoprazole in the treatment of Helicobacter pylori-associated duodenal ulcer.,M Lazzaroni; S Bargiggia; G Bianchi Porro,"The aim of this study was to verify the efficacy--in the cure of duodenal ulcer associated H. pylori infection--of ranitidine 300 mg taken late in the evening or lansoprazole 30 mg taken before breakfast, coupled with clarithromycin and metronidazole. Eighty patients with endoscopically proven active duodenal ulcer were randomized to take ranitidine or lansoprazole for 4-8 wk, together with clarithromycin 250 mg b.i.d. and metronidazole 500 mg b.id. for the first 2 wk. Endoscopic controls, as well as histological and urease tests for H. pylori, were performed at entry and after 4 and 8 wk. According to intent-to-treat analysis, ulcers were healed after 4 wk in 36/40 patients (90%) with ranitidine and in 38/40 (95%) with lansoprazole. After 8 wk, the healing percentage with ranitidine and lansoprazole was 97% (39/40) and 95% (38/40), respectively. H. pylori was eradicated in 85% of the patients taking ranitidine and in 90% of those taking lanzoprazole. Side effects were reported in 25% of the patients in both groups. Our results confirm that the combination of ranitidine, clarithromycin, and metronidazole can be considered an alternative to proton pump inhibitors in terms of clinical efficacy and economy.",1997.0,0,1
1074,9136821,"Prevalence and clinical spectrum of gastroesophageal reflux: a population-based study in Olmsted County, Minnesota.",G R Locke; N J Talley; S L Fett; A R Zinsmeister; L J Melton,"Gastroesophageal reflux is considered a common condition, but detailed population-based data on reflux in the United States are lacking. The aim of this study was to determine the prevalence and clinical spectrum of gastroesophageal reflux in Olmsted County, Minnesota. A reliable and valid self-report questionnaire was mailed to an age- and sex-stratified random sample of 2200 Olmsted County residents aged 25-74 years. The prevalence per 100 of heartburn and/or acid regurgitation experienced at least weekly was 19.8 (95% confidence interval [95% CI], 17.7-21.9). Heartburn and acid regurgitation were associated with noncardiac chest pain (odds ratio [OR], 4.2; 95% CI, 2.9-6.0), dysphagia (OR, 4.7; 95% CI, 2.9-7.4), dyspepsia (OR, 3.1; 95% CI, 1.9-5.0), and globus sensation (OR, 1.9; 95% CI, 1.0-3.6) but not with asthma, hoarseness, bronchitis, or a history of pneumonia. Among subjects with reflux symptoms, 1.0% reported an episode of hematemesis and 1.3% had a past esophageal dilatation. Symptoms of reflux are common among white men and women who are 25-74 years of age. Heartburn and acid regurgitation are significantly associated with chest pain, dysphagia, dyspepsia, and globus sensation. The percentage of patients reporting complications is low, but the absolute number is probably considerable given the high prevalence of the condition in the community.",2001.0,1,1
1075,9140153,Effect of omeprazole on the outcome of endoscopically treated bleeding peptic ulcers. Randomized double-blind placebo-controlled multicentre study.,O B Schaffalitzky de Muckadell; T Havelund; H Harling; S Boesby; P Snel; E M Vreeburg; S Eriksson; P Fernström; G Hasselgren,"Haemostasis is highly pH-dependent and severely impaired at low pH. However, there is no clear evidence that acid-suppressing drugs have beneficial effects in peptic ulcer haemorrhage. Endoscopic haemostatic treatment provides important reduction in morbidity and may be more efficient when a neutral intragastric pH is maintained. We conducted a double-blind, placebo-controlled multicentre study of intravenous infusion of omeprazole (80 mg as bolus, followed by 8 mg/h) or placebo for 72 h. All patients received 20 mg omeprazole orally from day 3 until follow-up on day 21. Only patients with ulcer haemorrhage, endoscoped within 12 h after admission, and with a history or signs of circulatory failure and spurting bleeding, oozing bleeding, visible vessel, or clot, were included. Endoscopic intervention was aimed at when spurting bleeding, oozing bleeding, or a visible vessel was observed. The primary efficacy measure was the worst ranking on an overall outcome scale (5 = death, 4 = surgery, 3 = additional endoscopic treatment, 2 = more than 3 units of blood, and 1 = no more than 3 units of blood transfused). Base-line prognostic factors of treatment success by day 3 and of other binary outcomes were considered in a logistic regression model. Two hundred and seventy-four patients were randomly assigned to omeprazole (134 patients) or placebo (140 patients). The number of patients included in the 'intention-to-treat' analysis was 130 in the omeprazole group and 135 in the placebo group. The primary variable, the overall outcome at 72 h, showed a difference (P = 0.004) between the two treatments in favour of omeprazole. Treatment success by 72 h defined as no death, no operation, or no additional endoscopic treatment was 91.0% in the omeprazole group and 79.7% in the placebo group (therapeutic gain, 11.3 percentage units; 95% confidence interval, 2.3 to 20.4 percentage units). Significant differences in favour of omeprazole were also found for secondary variables such as number of blood transfusions, duration and degree of bleeding, and the need for surgery and additional endoscopic treatments on day 3 and day 21. However, the numbers of deaths by day 3, 21, or 35 were very similar. We found a beneficial effect of intravenous omeprazole in severe ulcer haemorrhage, with a reduction in the number of operations, in endoscopic treatments, and in the duration and severity of bleeding.",1997.0,0,0
1076,9140154,Continuous intravenous infusion of omeprazole in elderly patients with peptic ulcer bleeding. Results of a placebo-controlled multicenter study.,G Hasselgren; T Lind; L Lundell; E Aadland; P Efskind; A Falk; A Hyltander; C Söderlund; S Eriksson; P Fernström,"Does profound acid inhibition by continuous infusion of omeprazole for 72 h reduce further bleeding in elderly patients with peptic ulcer bleeding (PUB)? Three hundred and thirty-three patients > or = 60 years old with PUB were randomized to omeprazole (80 mg + mg/h) or placebo as continuous infusion for 72 h. From day 4 to 21 all patients received 20 mg omeprazole orally once daily. When evaluated on day 3, the primary variable 'overall outcome' (based on an ordinal ranking scale; see Study variables) (P = 0.017) and the secondary variables, surgery (P = 0.003), degree (P = 0.004) and duration of bleeding (P = 0.003) all favored the omeprazole group. Blood transfusions, need for endoscopic treatment, and mortality were not statistically different. On follow-up, by day 21, the mortality in the group initially receiving intravenous omeprazole was 6.9%, while the intravenous placebo group showed an extremely low mortality, 0.6%. Three days' infusion of omeprazole improved overall outcome and reduced need for intervention in PUB patients.",1997.0,0,0
1077,9140165,Does profound acid inhibition improve haemostasis in peptic ulcer bleeding?,A Berstad,,1997.0,0,0
1078,9146768,"Immediate repeat course of amoxycillin, metronidazole and omeprazole to eradicate Helicobacter pylori.",M Ström; M Sörberg; K A Jönsson,"To investigate a repeat treatment regimen with the same antibiotic combination of amoxycillin and metronidazole in patients with continuing Helicobacter pylori infection. Eighty-two patients with severe peptic ulcer disease and concurrent Helicobacter pylori infection were treated with a two week regimen of omeprazole (40 mg once daily), amoxycillin (750 mg t.d.s.) and metronidazole (400 mg t.d.s.). Upper gastrointestinal tract endoscopy was performed before, and approximately 2 months after, completion of antibiotic therapy. Biopsies were taken for rapid urease testing and the histological demonstration of H. pylori infection. Patients with persistent H. pylori infection at follow-up endoscopy were re-treated with a second and identical antibiotic treatment course. A subsequent endoscopic examination with accompanying biopsies was performed at least 6 weeks after the second treatment course and after a further 6, 18 and 30 months. Eradication of H. pylori was achieved in 69 patients (84%, 95% CI: 75-90%) after the first treatment. Four patients (4/82 = 5%) were withdrawn from the study because of side-effects. All of the remaining nine patients had their H. pylori infection eradicated after the second treatment course (95% CI: 70-100%). Seventy-eight patients had a follow-up examination after a median 30 months of the initial eradication of H. pylori, and all but one remained free of infection and none had an ulcer relapse. This study demonstrates that patients with persistent H. pylori infection after completing a primary course of omeprazole (40 mg once daily), amoxycillin (750 mg t.d.s.) and metronidazole (400 mg t.d.s.) will probably respond to a repeat course of treatment with the same antibiotic combination.",1997.0,0,0
1079,9146769,Randomized study comparing omeprazole plus amoxycillin versus omeprazole plus clarithromycin for eradication of Helicobacter pylori.,G Spinzi; A Bortoli; E Colombo; E Lesinigo; R Venturelli; V Terruzzi; G Imperiali; G Minoli,"Dual therapy with omeprazole plus amoxycillin or with omeprazole plus clarithromycin has been proposed for eradication of Helicobacter pylori. The main problem is the great variability in the rate of eradication. A group of 287 consecutive patients with active peptic ulcers and H. pylori infections were admitted to a prospective, randomized, multicentre study, to be given omeprazole 20 mg b.d. plus either amoxycillin 1 g b.d. or clarithromycin 500 mg t.d.s. for 2 weeks. Cure was defined as the absence of H. pylori infection, 4-6 weeks after completing anti-microbial therapy, assessed by urease activity and histology of antral and body gastric biopsies. The bacteria were eradicated in 68/143 patients (48%) treated with amoxycillin and omeprazole and 70/144 patients (49%) treated with clarithromycin and omeprazole (intention-to-treat analysis). The ulcers were healed in 118/127 patients (93%) treated with amoxycillin and in 115/123 (94%) of those treated with clarithromycin. Undesirable effects were rare with both treatments. Combined treatment with omeprazole plus either amoxycillin or clarithromycin produced a high percentage of short-term healing of ulcers and was well tolerated, but is not useful as first-line anti-Helicobacter pylori treatment.",1997.0,0,0
1080,9146770,An increasing dose of omeprazole combined with amoxycillin cures Helicobacter pylori infection more effectively.,S Miehlke; G A Mannes; N Lehn; C Hele; M Stolte; E Bayerdörffer,"The combination of omeprazole and amoxycillin has demonstrated effectiveness with very few side-effects in the treatment of H. pylori infection, however cure rates have varied widely. The present study addresses the question as to the extent to which the cure rate of H. pylori infection depends on the size of the daily omeprazole dose, and investigates other patient-related factors that influence treatment success. In a randomized, controlled and investigator-blinded trial, 163 hospitalized patients with H. pylori-associated gastritis were treated with 20 mg omeprazole once daily in the morning, 20 mg omeprazole b.d., 40 mg omeprazole b.d. or 60 mg omeprazole b.d. for 14 days. In addition, all patients received 1000 mg amoxycillin b.d. on days 5-14. Endoscopic and histological examinations were performed prior to treatment, at the end of treatment and 4 weeks after completion of treatment. H. pylori infection was cured in 18 of 40 (45%, 95% CI: 29-62%), in 22 of 39 (56.4%, 95% CI: 40-72%), in 25 of 38 (65.8%, 95% CI: 49-80%), and in 33 of 40 (82.5%, 95% CI: 67-93%) patients, respectively, (P < 0.001). Side-effects leading to discontinuation of treatment occurred in only 1.2%. The daily dose of omeprazole is an important factor for the success of dual therapy comprising omeprazole and amoxycillin in curing H. pylori infection. Cure of H. pylori infection correlates positively and significantly with the size of the daily omeprazole dose. The combination of high-dose omeprazole and amoxycillin is an effective and well-tolerated regimen for the treatment of H. pylori-associated diseases.",1997.0,0,0
1081,9146775,In single doses ranitidine effervescent is more effective than lansoprazole in decreasing gastric acidity.,J S Arnestad; P M Kleveland; H L Waldum,"A rapid and reproducible decrease of gastric acidity is preferable in patients with penetrating/perforating peptic ulcers and in on-demand treatment of some patients with dyspepsia. The present study was done to compare the effect of single doses of ranitidine effervescent with that of the proton pump inhibitor lansoprazole. Twelve healthy young volunteers were studied by 11-h intragastric continuous pH recording after the intake of ranitidine 150 or 300 mg effervescent tablets or lansoprazole 30 mg capsules. Trial medications were taken with 200 mL water, and the subjects remained fasting apart from 250 mL fluid at 4 h. Ranitidine effervescent, both 150 and 300 mg, induced a rapid and persisting increase in gastric pH in most of the subjects, whereas a single dose of lansoprazole 30 mg did not affect intragastric pH in five of the twelve subjects. The histamine H2-blocker ranitidine given as an effervescent formulation is superior to the proton pump inhibitor lansoprazole in inducing a rapid decrease of gastric acidity.",1997.0,0,0
1082,9146776,Lansoprazole versus omeprazole: influence on meal-stimulated gastric acid secretion.,H G Dammann; W Fuchs; G Richter; F Burkhardt; N Wolf; T A Walter,"To investigate, by means of meal-stimulated acid secretion, the extent to which differences in plasma half-life, bioavailability and the recommended therapeutic dose can influence the antisecretory potency of lansoprazole and omeprazole. In this double-blind, placebo-controlled, crossover study, 10 healthy male volunteers received 15 mg or 30 mg lansoprazole, 20 mg or 40 mg omeprazole or placebo for 5 days, in a randomized order. Meal-stimulated acid secretion was determined by means of a homogenized test meal and intragastric titration. On day 1, meal-stimulated acid secretion was decreased by 35% and 45% after administration of 15 mg or 30 mg lansoprazole, and by 16% and 42% after 20 mg or 40 mg omeprazole. After 3 and 5 days of dosing the decreases were 53% and 48% with 15 mg lansoprazole, 82% and 82% with 30 mg lansoprazole, 43% and 39% with 20 mg omeprazole, and 76% and 83% with 40 mg omeprazole. At all measuring points during the 5-day dosing periods, lansoprazole 15 mg and 30 mg proved superior to 20 mg omeprazole in inhibiting meal-stimulated gastric acid secretion, but the differences were only statistically significant for the lansoprazole 30 mg dose, 30 mg lansoprazole and 40 mg omeprazole proved equipotent. On day 1 only 30 mg lansoprazole was significantly better than placebo. This study demonstrated the following order of antisecretory potency: 30 mg lansoprazole = 40 mg omeprazole > 15 mg lansoprazole approximately 20 mg omeprazole.",1997.0,0,0
1083,9146777,Lansoprazole 15 and 30 mg daily in maintaining healing and symptom relief in patients with reflux oesophagitis.,J G Hatlebakk; A Berstad,"In patients with reflux oesophagitis, endoscopic healing and symptom relief are considered important treatment goals in long-term care. To compare the effect of lansoprazole 15 and 30 mg daily on maintaining endoscopic healing and symptom relief in patients with moderate reflux oesophagitis. In a single-centre, double-blind randomized clinical trial, 103 patients with grade 1 or 2 reflux oesophagitis who were endoscopically healed and asymptomatic after lansoprazole 30 mg daily for 12 weeks, were randomized to maintenance therapy with either lansoprazole 15 mg or 30 mg o.m. Endoscopy was repeated after 3, 6 and 12 months, and symptom relief assessed after 3, 6, 9 and 12 months. Relapse of oesophagitis or symptoms were considered end-points. After 12 months, 14/50 patients (28%) receiving lansoprazole 15 mg daily had suffered an endoscopic relapse compared to 8/53 patients (15%) treated with lansoprazole 30 mg daily. A life table analysis showed no statistically significant difference between the two groups (P = 0.086). Significantly more patients were kept in complete symptomatic remission in the 30 mg group (P < 0.01). In the 15 mg group, 23/50 (46%) had suffered either an endoscopic or symptomatic relapse on completion of the study, compared to 12/53 (23%) in the 30 mg group. A life table analysis showed this difference to be statistically significant (P = 0.010). Lansoprazole 15 and 30 mg daily were equally well tolerated. No statistically significant differences were found in endoscopic relapse rate or occurrence of adverse events, while lansoprazole 30 mg proved superior to 15 mg in maintaining patients in symptomatic relief and combined endoscopic and symptomatic remission.",1997.0,0,0
1084,9146778,Daily omeprazole surpasses intermittent dosing in preventing relapse of oesophagitis: a US multi-centre double-blind study.,S J Sontag; M Robinson; W Roufail; B I Hirschowitz; S M Sabesin; W C Wu; J Behar; W L Peterson; K R Kranz; A Tarnawski; Y Dayal; R Berman; T J Simon,"Relapse of erosive oesophagitis occurs in almost all patients if treatment is stopped after initial healing. To assess the potential of different therapeutic regimens of omeprazole to prevent relapse of erosive reflux oesophagitis after initial healing with omeprazole. Patients whose active erosive reflux oesophagitis (grade > or = 2) had healed (grade 0 or 1) after 4-8 weeks of open-label omeprazole 40 mg daily (phase I) were eligible to join a multi-centre, 6-month double-blind, placebo-controlled maintenance study (phase II), which included endoscopy, symptom assessments, serum gastrin measurements, and gastric fundic biopsies. During phase I, endoscopy was performed at weeks 0, 4, and 8. At the end of phase I, 429 of 472 patients (91%) were healed, and there were significant reductions in heartburn, dysphagia and acid regurgitation. Of the 429 patients who healed, 406 joined phase II and were randomized to one of three groups: 20 mg omeprazole daily (n = 138), 20 mg omeprazole for 3 consecutive days each week (n = 137), or placebo (n = 131). During phase II, endoscopy was performed at months 1, 3, and 6 or at symptomatic relapse. The percentages of patients still in endoscopic remission at 6 months were 11% for placebo, 34% for omeprazole 3-days-a-week, and 70% for omeprazole daily. Both omeprazole regimens were superior to placebo in preventing recurrence of symptoms (P < 0.001); however, omeprazole 20 mg daily was superior to omeprazole 20 mg 3-days-a-week (P < 0.001). Compared to baseline, omeprazole therapy resulted in no significant differences among treatment groups in the distribution of gastric endocrine cells. These results show that after healing of erosive oesophagitis with 4-8 weeks of omeprazole, relapse of oesophagitis and recurrence of reflux symptoms can be prevented in 70% of patients with a maintenance regimen of 20 mg daily, but that intermittent dosing comprising 3 consecutive days each week significantly compromises efficacy.",1997.0,0,0
1085,9149186,Does pretreatment with omeprazole decrease the chance of eradication of Helicobacter pylori in peptic ulcer patients?,B Annibale; G D'Ambra; I Luzzi; A Marcheggiano; C Iannoni; M Paoletti; M C Anania; M Marignani; G Delle Fave,"It has been reported that pretreatment with omeprazole could decrease the efficacy of Helicobacter pylori eradication. Our aim was to compare the efficacy, safety, and tolerability of the eradicating regimen, omeprazole/amoxicillin/metronidazole. The two antibiotics were scheduled either during the first or during the last 2 wk of omeprazole administration. In this prospective controlled study conducted in a single center, 78 symptomatic peptic ulcer patients were treated for 4 wk with omeprazole 40 mg o.m.; the patients were randomly assigned to receive amoxicillin 1 g t.i.d. postprandially and metronidazole 250 mg t.i.d. postprandially, either during the first 2 wk (group A, n = 40) or the last 2 wk of therapy with omeprazole (group B, n = 38). H. pylori status was assessed by culture, histology, urease test, and IgG antibodies. Each patient's course was followed for 1 yr. H. pylori infection was cured in 97.4% of group A (95% CI: 0.84-0.99) and in 89% of group B (95% CI: 0.73-0.96, p = 0.28). Healing was achieved in 80% of the patients in group A (95% CI: 0.63-0.90) and in 75.7% of patients in group B (95% CI: 0.60-0.90, p = 0.60) At 12-month follow-up, 72 patients were evaluated: 37/38 (97%) of patients in group A and 33/33 (100%) in group B were confirmed as cured of the infection (NS). Peptic ulcer healing rate reached 100% in the two groups. Furthermore, between the two groups, there were no significant differences in symptom relief or improvement. Both regimens were well tolerated, and no patient had to be withdrawn from therapy because of an adverse event. Minor side-effects appeared to be similar in the two groups (40% vs. 38%). This randomized study clearly indicates that omeprazole pretreatment does not significantly reduce the efficacy of eradicating therapy for H. pylori in peptic ulcer patients.",1997.0,0,0
1086,9155573,Efficacy of primed infusions with high dose ranitidine and omeprazole to maintain high intragastric pH in patients with peptic ulcer bleeding: a prospective randomised controlled study.,J Labenz; U Peitz; C Leusing; B Tillenburg; A L Blum; G Börsch,"In healthy subjects, continuous infusions of high dose ranitidine and omeprazole produce high intragastric pH values. To test the hypothesis that both drugs also maintain high intragastric pH values in patients with bleeding ulcers. In two parallel studies, 20 patients with bleeding duodenal ulcers and 20 patients with bleeding gastric ulcers were randomly assigned to receive either ranitidine (0.25 mg/kg/hour after a bolus of 50 mg) or omeprazole (8 mg/hour after a bolus of 80 mg) for 24 hours. Intragastric pH was continuously recorded with a glass electrode placed 5 cm below the cardia. Both drugs rapidly raised the intragastric pH above 6. During the second 12 hour period, however, the percentage of time spent below a pH of 6 was 0.15% with omeprazole and 20.1% with ranitidine (p = 0.0015) in patients with duodenal ulcer; in patients with gastric ulcer it was 0.1% with omeprazole and 46.1% with ranitidine (p = 0.002). Primed infusions of omeprazole after a bolus produced consistently high intragastric pH values in patients with bleeding peptic ulcers, whereas primed infusions with ranitidine were less effective during the second half of a 24 hour treatment course. This loss of effectiveness may be due to tolerance.",1997.0,0,0
1087,9165314,An objective end point for dilation improves outcome of peptic esophageal strictures: a prospective randomized trial.,Z A Saeed; F C Ramirez; K S Hepps; R A Cole; F E Schneider; P S Ferro; D Y Graham,"The usual end point for defining success of dilation is subjective (relief of dysphagia). In most patents thus managed strictures recur. We asked whether an objective end point would improve outcome. After dilation to 15 mm, patients were randomized into subjective and objective groups. In subjective group patients, end point for dilation was alleviation of dysphagia; in objective group patients, passing the 12 mm barium pill test. Objective group patients who failed underwent redilation until they passed the pill or failed three times. During Part 1 of the study, patients received ranitidine, during Part 2 they received omeprazole. In part 1, dysphagia was alleviated in 7 of 8 subjective group patients. Only 2 of 10 objective group patients passed the pill test and no additional patients passed after 3 sessions, although most had no dysphagia. In Part 2, 19 subjective groups and 15 objective group patients were studied. End point was not achieved in 3 objective group patients. Over long-term follow-up, objective group patients had less recurrent dysphagia (p = 0.02) and required fewer redilation sessions (p < 0.05). Overall, the pill test correlated with the presence or absence of dysphagia (P < 0.001). Predictive value of passing the pill 1 week after dilation for the absence of dysphagia was 100%, but of failing the pill test and the presence of dysphagia was only 18%. Achieving an objective end point reduces stricture recurrence and the need for subsequent dilation. Initial subjective improvement does not predict long-term success.",1997.0,0,0
1088,9175200,Incidence of antireflux surgery in Finland 1988-1993. Influence of proton-pump inhibitors and laparoscopic technique.,M Viljakka; M Luostarinen; J Isolauri,"The advent of proton-pump inhibitors, and subsequently of the laparoscopic technique, can be assumed to have influenced the use of antireflux surgery in gastro-oesophageal reflux disease. Data on antireflux operations carried out in Finland in 1988-93 were obtained from national statistics, and the number of operations performed laparoscopically in 1993 was ascertained by a questionnaire to all relevant units. The rates per 100,000 population in the catchment areas were calculated. Antireflux surgery almost always implied fundoplication. During 1993, 784 fundoplications and 43 other antireflux procedures were performed in Finland (total population around 5 million). The fundoplication rate per 100,000 population rose from 8.8 to 15.4 between 1988 and 1993. The increase was minimal (8.1-8.2) in 1990-91 when the first proton-pump inhibitor, omeprazole, was introduced, but remarkably greater (12.8-15.4) in 1992-93, when the laparoscopic technique became popular. Differences in fundoplication rates were six to tenfold between health service districts and even larger between hospitals. The numbers of antireflux operations in Finland were almost static when proton-pump inhibitors were introduced, but rapidly increased after the advent of the laparoscopic technique. Remarkable discrepancies were found in the incidence of fundoplication between different areas and hospitals.",1997.0,0,0
1089,9177975,A critical appraisal of current management practices for infant regurgitation--recommendations of a working party.,Y Vandenplas; D Belli; P Benhamou; S Cadranel; J P Cezard; S Cucchiara; C Dupont; C Faure; F Gottrand; E Hassall; H Heymans; C M Kneepkens; B Sandhu,"Regurgitation is a common manifestation in infants below the age of 1 year and a frequent reason of counselling of general practitioners and paediatricians. Current management starts with postural and dietary measures, followed by antacids and prokinetics. Recent issues such as an increased risk of sudden infant death in the prone sleeping position and persistent occult gastro-oesophageal reflux in a subset of infants receiving milk thickeners or thickened ""anti-regurgitation formula"" challenge the established approach. Therefore, the clinical practices for management of infant regurgitation have been critically evaluated with respect to their efficacy, safety and practical implications. The updated recommendations reached by the working party on the management of infant regurgitation contain five phases: (1 A) parental reassurance; (1 B) milk-thickening agents; (2) prokinetics; (3) positional therapy as an adjuvant therapy; (4 A) H2-blockers; (4 B) proton pump inhibitors; (5) surgery.",1997.0,0,0
1090,9178669,Speed of healing and symptom relief in grade II to IV gastroesophageal reflux disease: a meta-analysis.,N Chiba; C J De Gara; J M Wilkinson; R H Hunt,"Esophagitis healing proportions are often incorrectly called the healing rate. The aim of this study was to compare different drug classes by expressing the speed of healing and symptom relief through a new approach. A fully recursive literature search to July 1996 identified 43 articles on gastroesophageal reflux disease (GERD) (7635 patients) meeting strict inclusion criteria: single- or double-blind randomized studies in adults with endoscopically proven erosive or ulcerative esophagitis. For each drug class, linear regression analysis estimated the average percentage of patients who were healed and heartburn free per week. Mean overall healing proportion irrespective of drug dose or treatment duration (< or =12 weeks) was highest with proton pump inhibitors (PPIs; 83.6% +/- 11.4%) vs. H2-receptor antagonists (H2RAs; 51.9% +/- 17.1%), sucralfate (39.2% +/- 22.4%), or placebo (28.2% +/- 15.6%). Correcting for patients without baseline heartburn, the mean heartburn-free proportion was highest with PPIs (77.4% +/- 10.4%) vs. H2RAs (47.6% +/- 15.5%). PPIs showed a significantly faster healing rate (11.7%/wk) vs. H2RAs (5.9%/wk) and placebo (2.9%/wk). PPIs provided faster, more complete heartburn relief (11.5%/wk) vs. H2RAs (6.4%/wk). More complete esophagitis healing and heartburn relief is observed with PPIs vs. H2RAs and occurs nearly twice as fast. This semiquantitative expression of speed of healing and symptom relief permits comparisons for future economic evaluation and quality-of-life assessments.",1997.0,0,1
1091,9178717,Eradication of high-grade dysplasia using 5-ALA and acid suppression: a (photo)dynamic duo.,S J Heller; J Van Dam,,1997.0,0,0
1092,9187828,Nonpulmonary medical complications in the intermediate and long-term survivor.,J R Maurer; S Tewari,"This article deals with the nonpulmonary, non-infectious complications in intermediate and long-term survivors of lung transplantation. Although they are an infrequent cause of mortality, these disorders can cause significant morbidity in this population. Diseases associated with the gamut of medications used post-transplant are specifically discussed, as are diseases caused by the direct immunosuppressive action of some of these drugs. General care of transplant patients also entails attention to their underlying diseases, and to routine medical considerations common to all patients.",1997.0,0,0
1093,9187886,Efficacy of a pectin-based anti-reflux agent on acid reflux and recurrence of symptoms and oesophagitis in gastro-oesophageal reflux disease.,T Havelund; C Aalykke; L Rasmussen,"Gastro-oesophageal reflux disease may be treated with a drug forming a floating neutral raft in the stomach. The pectin-based raft-forming anti-reflux agent Aflurax (Idoflux) was examined, first regarding reduction of oesophageal acid exposure, and next as to its efficacy as maintenance treatment in patients with healed oesophagitis. Double-blind, placebo-controlled randomized clinical trials. Open access endoscopy unit. Fourteen patients with erosive oesophagitis had measurement of acid exposure. Eighty-eight patients with healed erosive/ulcerative oesophagitis and relief of heartburn after pre-treatment with omeprazole received maintenance treatment. Crossover 12-h oesophageal pH monitoring during Aflurax/placebo treatment. Maintenance treatment for up to 6 months with two tablets of Aflurax 1200 mg or placebo four times daily. Percentage time pH less than 4 in 6 plus 6 h (upright + supine). Time to recurrence of moderate or severe heartburn (life table analysis). The median (interquartile range) acid exposure times in the upright position were: 3.1% (1.6-13.0%) on Aflurax versus 6.7% (2.5-14.9%) on placebo (P = 0.10). In the supine position no difference was found (Aflurax 13.7%, placebo 13.2%). The time to recurrence of heartburn with Aflurax treatment was prolonged significantly; after 6 months the life table estimates were 48% of patients in remission on Aflurax versus 8% on placebo (P = 0.01). Following treatment, erosive oesophagitis was found in 17/34 on Aflurax versus 28/38 on placebo (P < 0.05). Aflurax significantly delays recurrence of moderate or severe heartburn and erosive oesophagitis, when used as maintenance treatment. The acid exposure was not significantly reduced with pH monitoring.",1997.0,0,0
1094,9190140,Effects of long-term treatment with lansoprazole and omeprazole on serum gastrin and the fundic mucosa.,M T Arroyo Villarino; A Lanas Arbeloa; F Esteva Díaz; J Ortego Fernández de Retana; R Sainz Samitier,"To compare the effects of long-term lansoprazole and omeprazole treatment (6 months) on serum gastrin levels. Forty duodenal ulcer patients without previous treatment with proton pump inhibitors were randomized to receive either 20 mg/day or omeprazole or 30 mg/day of lansoprazole. Serum gastrin levels were determined on entry and every 2 months. On finalizing the study antral and fundic biopsies were obtained for immunohistochemical analysis of the enterochromaffin-like cell population. Before starting the treatment fasting serum gastrin was similar in both groups (108.7 +/- 60.9 pg/mL omeprazole; 102.7 +/- 56.9 pg/mL lansoprazole). The treatment with either omeprazole or lansoprazole increased serum gastrin levels, but the increase was mild, maximal at 2 months and similar between omeprazole and lansoprazole (113.44 +/- 114.9 pg/mL omeprazole vs 166.1 +/- 117.9 pg/mL lansoprazole; p > 0.05). When serum gastrin levels were individually analyzed by patient, most were below 200 pg/mL and only 3 patients (1 omeprazole/2 lansoprazole) had levels near 500 pg/mL which were not correlated with enterochromaffin-like cell hyperplasia. Long-term treatment with either omeprazole or lansoprazole is safe, at least during 6 months, and results in mild hypergastrinemia. No differences between these two drugs were observed.",1997.0,0,1
1095,9200281,Peptic ulcer perforation before and after the introduction of H2-receptor blockers and proton pump inhibitors.,M Hermansson; C Staël von Holstein; T Zilling,"The aim of this retrospective study was to compare patients treated for perforated peptic ulcer before and after the introduction of the H2-receptor antagonists and proton pump inhibitors (PPI) with regard to their medical history, clinical features, methods of diagnosis and treatment, complications, and mortality. During the study period 1974 to 1992 we found a significant reduction in the incidence of peptic ulcer perforation (P < 0.001). Patients admitted during the later period of the study were older and more seriously ill. The incidence of perforation among men decreased, but that among women was stable, thus changing the sex ratio towards a female preponderance at the end of the study period. After the introduction of PPI the relative number of gastric perforations decreased compared with the number of perforations in the duodenum. A relatively higher proportion of patients with gastric perforations was taking acetylsalicylic acid or non-steroid, anti-inflammatory drugs at the time of admission compared with patients with duodenal perforation. Simple suture of the perforation was the operative procedure used in 80% of the patients. Even though patients were increasingly older and more ill, neither the mortality nor the rate of postoperative complications changed during the study period.",1997.0,0,1
1096,9203934,"Double blind cross-over placebo controlled study of omeprazole in the treatment of patients with reflux symptoms and physiological levels of acid reflux--the ""sensitive oesophagus"".",R G Watson; T C Tham; B T Johnston; N I McDougall,"At least 10-15% of patients with reflux symptoms have a normal endoscopy and physiological levels of acid reflux on pH monitoring. Such patients with 50% or more of symptoms associated with acid reflux episodes have ""a positive symptom index"" (SI), and it has been proposed that this defines the ""sensitive oesophagus"". To test the response to omeprazole 20 mg twice daily for four weeks of patients with normal levels of acid reflux using a randomised, placebo controlled, double blind, cross-over design. Eighteen patients with normal levels of reflux, 12 of whom had a positive SI. Response was measured by symptomatic assessment and the SF-36 quality of life (QOL) questionnaire. Patients with a positive SI showed the following improvements on omeprazole compared with placebo: decrease in symptom frequency (p < 0.01), severity (p < 0.01) and consumption of antacids (p < 0.01). In the group with a negative SI only one patient clearly improved. The QOL parameters for bodily pain (65.6 v 53.4, p = 0.03) and vitality (60.6 v 48.8, p = 0.049) were significantly better on omeprazole than placebo for the group overall. Omeprazole improves symptoms in 11 of 18 patients with normal endoscopy and pH monitoring, particularly those with a positive SI. This supports the theory that such patients have an oesophagus which is ""sensitive"" to acid reflux and are part of the GORD spectrum.",1997.0,0,0
1097,9204594,Another therapeutic schedule in eradication of Helicobacter pylori.,A Vcev; D Vuković; A Ivandić; A Vceva; B Dmitrović; D Kovacić; M Volaric; D Paulini; N Mićunović; D Horvat; S Mihaljević,"In this study, the efficacy and tolerability of two different therapeutic schedules in eradicating Helicobacter pylori and healing duodenal ulcer were evaluated. The study included 60 patients with duodenal ulcer and Helicobacter pylori infection. They were randomly allocated to either of two groups: group 1 (N = 30) received omeprazole 20 mg for 28 days, amoxicillin 3 x 500 mg for 7 days and metronidazole 3 x 500 mg for 5 days, and group 2 (N = 30) received omeprazole 20 mg for 28 days, ACA (amoxicillin 500 mg plus clavulanic acid 125 mg) 3 x 625 mg for 7 days and metronidazole 3 x 500 mg for 5 days. Endoscopic examination, bioptic urease test and histologic examination were performed before, and 30 and 90 days after the treatment. Endoscopic examination was also performed one month after the beginning of the treatment, when healing of duodenal ulcer was observed in 90% (27/30) of the group 1 patients and in 93.3% (28/30) of the group 2 patients. The Helicobacter pylori eradication achieved in group 1 and 2 was 76.7% (23/30) and 83.3% (25/30), respectively. Side effects were present in 20% (6/30) of the group 1 patients and in 23.3% (7/30) of the group 2 patients. Side effects were mild and did not require interruption of the treatment. A higher rate of eradication was achieved in group 2 than in group 1, but the difference was not statistically significant.",1997.0,0,0
1098,9209204,Prevention of recurrences of erosive reflux esophagitis: a cost-effectiveness analysis of maintenance proton pump inhibition.,R A Harris; M Kuppermann; J E Richter,"To determine the cost-effectiveness of three management strategies for healed erosive reflux esophagitis: maintenance therapy with a proton pump inhibitor (PPI) from the outset; no maintenance therapy unless a patient's symptoms recur once over a year; and no maintenance therapy unless a patient's symptoms recur twice over a year. Decision analysis using data from randomized trials of lansoprazole, case series, and expert opinion. For patients with grade 4 esophagitis, maintenance from the outset is the most efficient approach. For all other patients, providing maintenance PPI after a patient experiences two recurrences is the least costly but least effective approach. The other two approaches prevent more recurrences: waiting to initiate maintenance therapy until symptoms recur once requires an additional $73 for each recurrence prevented whereas maintenance PPI from the outset requires an additional $819 for each recurrence prevented. Maintenance therapy from the outset is cost effective if symptoms of esophagitis cause a 22% or greater decrement in quality of life (using $50,000 per quality-adjusted life year gained as a cost-effectiveness definition). However, withholding maintenance until the time of a first recurrence is cost effective if symptoms cause a 2% or greater decrement in quality of life. For grades 2 and 3 esophagitis, providing maintenance therapy after a patient experiences a further recurrence is a preferred option that appears cost-effective across a wide array of assumptions. Maintenance therapy from the outset, however, appears cost-effective only for those patients who report a significant decline in quality of life associated with esophagitis or for those patients with baseline grade 4 esophagitis.",1997.0,0,1
1099,9218071,Maintenance therapy with cisapride after healing of erosive oesophagitis: a double-blind placebo-controlled trial.,N I McDougall; R G Watson; J S Collins; R J McFarland; A H Love,"There are few data on the role of prokinetic agents as maintenance therapy in moderately severe reflux oesophagitis despite the high relapse rate of this condition after healing. To determine whether cisapride is more effective than placebo as maintenance therapy after healing of moderate erosive oesophagitis in two respects: first, in preventing symptomatic relapse and preserving quality of life; and, second, in improving oesophageal motor function. Forty-two patients whose grade II-III oesophagitis had been healed with omeprazole were randomized to receive either cisapride 20 mg nocte or placebo for 6 months. Oesophageal pH monitoring and manometry were performed before starting maintenance therapy and after 4 weeks, and symptomatic status and quality of life were assessed at weeks 0, 4, 13 and 26. After 4 weeks of maintenance therapy, lower oesophageal sphincter pressure improved in the cisapride group (16.4-21.9 mmHg, P = 0.01) but not in the placebo group (25.5-22.7 mmHg, P = 0.2). Oesophageal pH monitoring showed no significant changes in either group. Sixteen (76%) cisapride patients and 12 (57%) placebo patients withdrew within 4 weeks owing to symptomatic relapse (P = 0.2). After 26 weeks, 21 (100%) cisapride and 17 (81%) placebo patients had relapsed (log-rank analysis of survival time P = 0.07). Quality of life parameters deteriorated in both treatment groups to a similar degree. Maintenance therapy with cisapride 20 mg nocte improves the lower oesophageal sphincter pressure in patients whose oesophagitis has been healed with omeprazole. However, cisapride is no better than placebo in preventing symptomatic relapse or deterioration in quality of life.",1997.0,0,0
1100,9218075,Doubling the omeprazole dose (40 mg b.d. vs. 20 mg b.d.) in dual therapy with amoxycillin increases the cure rate of Helicobacter pylori infection in duodenal ulcer patients.,J Labenz; J A Beker; C P Dekker; A Farley; H U Klör; A Jönsson,"Several studies have shown that dual therapy with omeprazole and amoxycillin may cure Helicobacter pylori infection. However, the optimum dose of omeprazole has still to be established. An international, randomized, double-blind multicentre trial was conducted in patients with duodenal ulcers to compare the H. pylori cure rates obtained by dual therapy consisting of either omeprazole 20 mg b.d. plus amoxycillin 750 mg b.d. or omeprazole 40 mg b.d. plus amoxycillin 750 mg b.d. for 2 weeks. Dual therapy was followed by omeprazole 20 mg once daily for 2 weeks. Before entering the trial and 4 weeks after cessation of treatment H. pylori infection was assessed by histology and a 13C-urea breath test. 381 patients were randomized into the study, of whom 345 were evaluable for the all-patients-treated analysis of efficacy and 378 were valid for the evaluation of safety. Histology results showed that H. pylori infection was cured in 64 out 174 patients treated with omeprazole 20 mg b.d. plus amoxycillin and in 102 out of 171 patients treated with omeprazole 40 mg b.d. plus amoxycillin (37% vs. 60%; P < 0.001). Both treatment regimens were well tolerated, with adverse events reported by 29 (15.2%) and 35 patients (18.7%), respectively. This study has shown that dual therapy with amoxycillin 750 mg b.d. and omeprazole 40 mg b.d. is superior to dual therapy with amoxycillin and omeprazole 20 mg b.d. in patients with H. pylori-positive duodenal ulcers. Thus, a true dose-response relationship exists between omeprazole and treatment success. However, a combination of omeprazole with two of amoxycillin, clarithromycin and nitroimidazole is a preferable alternative for routine clinical use.",1997.0,0,0
1101,9218078,Low cure rate of Helicobacter pylori infection with omeprazole and furazolidone dual therapy for one week.,A A Van Zwet; J C Thijs; E J van der Wouden; A Kooy,"Furazolidone is an inexpensive antibiotic that has considerable anti-Helicobacter pylori activity in vitro. Twenty-three patients with culture-proven H. pylori infection were treated for one week with a dual therapy containing omeprazole and furazolidone. Eradication succeeded in 10 of the first 20 evaluable patients (50%; 95% CI: 27.2-72.8%). This percentage was regarded as too low, and the study was terminated. Side-effects were mild. With the possible increase in resistance to metronidazole and clarithromycin world-wide, furazolidone may be useful alternative in the treatment of H. pylori infection. Dual therapy for one week, however, is not sufficient.",1997.0,0,0
1102,9219786,"Eradication of H. pylori in a developing country: comparison of lansoprazole versus omeprazole with norfloxacin, in a dual-therapy study.",V K Gupta; A Dhar; S Srinivasan; A Rattan; M P Sharma,"Lansoprazole, a newer benzimidazole, is more potent than omeprazole in its anti-Helicobacter pylori effect in vitro. The present study was aimed at assessing its efficacy in a developing country. Fifty patients were randomized to receive either lansoprazole or omeprazole, with norfloxacin for 2 wk; the ulcer healing rates, H. pylori eradication rates, and recurrence rates were compared over a 6-month period. Both lansoprazole and omeprazole were equally effective in inducing healing of ulcer (96.1 vs 95.5%, p > 0.05) and eradicating H. pylori (76.9 vs 63.9%, p > 0.05), with very low recurrence rates over a 6-month follow-up period. Either lansoprazole or omeprazole combined with norfloxacin is effective in eradicating H. pylori in a high percentage of cases of duodenal ulcer, with little difference between the two proton pump inhibitors.",1997.0,0,1
1103,9222709,Pantoprazole-based dual and triple therapy for the eradication of Helicobacter pylori infection: a randomized controlled trial.,P Svoboda; I Kantorová; J Ochmann; J Doubek; L Kozumplík; J Marsová,"The eradication of Helicobacter pylori (Hp) infection in duodenal ulcer and dyspepsia has been achieved using various therapy regimens. The efficacy of protein pump inhibitor pantoprazole as part of these regimens has not been widely studied. During a prospective randomized trial, 250 Hp positive patients with either duodenal ulcer, erosive bulbitis, or gastritis and dyspepsia were treated using 14 days of therapy 1) pantoprazole 40 mg daily and clarithromycin 500 mg b.i.d. (PC), 2) pantoprazole 40 mg daily and clarithromycin 500 mg b.i.d. plus amoxicillin 1 g b.i.d. (PCA), or 3) bismuth subcitrate 120 mg t.i.d., roxithromycin 150 mg b.i.d., metronidazole 250 mg b.i.d. plus ranitidin 300 mg (BRMR). Hp status was assessed on 3 tests at the inclusion (2-specimen rapid urease test, 2-specimen histology, serology) and 2 tests (2-specimen rapid urease test, 2-specimen histology) 4 weeks after the end of the treatment. The entry criteria was fulfilled in 250 patients, of whom 13 missed the control endoscopy. The treatment had to be discontinued for adverse effects in 8 (10%) BRMR patients, and 1 (1%) PCA patients. Compliance was 100% in the PC group. All ulcers were healed at the end of the study with one exception in the BRMR group. The best eradication rate of Hp was shown by the PCA group with 94.8% (n = 73/77) followed by the PC group with 82.5% (n = 66/80) and finally the BRMR with 67.6% (n = 48/71)-PCA:BRMR - p < 0.001; PC:BRMR-p < 0.001; PCA:PC-p < 0.05. This study showed that triple therapy using PPI pantoprazole combined with antibiotics clarithromycin and amoxicillin was very effective in the eradication of Hp and treatment of duodenal ulcer with rare side effects. The dual pantoprazole and clarithromycin therapy had the highest rate of patient compliance, but is less effective than triple therapy. The combination of ranitidin with bismuth based triple therapy had the highest number of adverse events and the lowest rate of Hp eradication and therefore, should not be recommended.",1997.0,0,1
1104,9222732,"Eradication of Helicobacter pylori in peptic ulcer disease with amoxycillin, 2.0 g, and omeprazole, 80 or 120 mg: a prospective randomized trial.",R Fleischmann; R Demharter; J Barnert; K Füger; M Wienbeck; R Busch,"The appropriate dose of proton pump inhibitors needed for eradicating Helicobacter pylori by dual therapy is still controversial. The study was conducted as a single-blind, single-centre trial. Fifty-four patients with active duodenal ulcers were treated with amoxycillin tablets, 750 mg three times daily, and omeprazole, either 40 mg twice daily (group 1) or 40 mg three times daily (group 2), for 14 days in a prospective randomized trial. H. pylori eradication was assessed 10 weeks after starting treatment. Biopsies were taken for rapid urease tests and histological analysis and 13C-urea breath tests were ordered. In both groups ulcer healing was complete in 96.3% of patients after 10 weeks. Ten weeks after starting treatment, Helicobacter pylori was eradicated in 76.9% of the patients in group 1 and 74.1% of those in group 2, as shown by rapid urease tests and histological analysis. In the subgroup of fully compliant patients (n = 49) the eradication rates were 80% and 79.2%, respectively. Hyperacidity significantly reduced the eradication rates. Patients showing successful H. pylori eradication were significantly older (59 +/- 14.0 years vs. 49 +/- 15.6 years; P = 0.025). Eradication rates were lower in smokers than in non-smokers (36.4% vs. 83.9%; P = 0.006). It is concluded that higher omeprazole doses should be reserved for younger patients and smokers; in others they are not needed.",1997.0,0,0
1105,9230536,A critical appraisal of current management practices for infant regurgitation.,Y Vandenplas,"Regurgitation is a common manifestation in infants below the age of one year and a frequent reason of counseling of general practitioners and paediatricians. Current management starts with postural and dietary measures, followed by antacids and prokinetics. Recent issues such as an increased risk of sudden infant death in the prone sleeping position and persistent occult gastro-oesophageal reflux in a subset of infants receiving milk thickeners or thickened ""anti-regurgitation formula"" challenge the established approach. Therefore, the clinical practices for management of infant regurgitation have been critically evaluated with respect to their efficacy, safety and practical implications. The updated recommendations on the management of infant regurgitation contain 5 phases: (1A) parental reassurance; (1B) milk-thickening agents; (2) prokinetics; (3) positional therapy as an adjuvant therapy; (4A) H2-blockers; (4B) proton pump inhibitors; (5) surgery.",1997.0,0,0
1106,9236492,Graded exercise testing and chronic fatigue syndrome.,D L Elliot; L Goldberg; M O Loveless,,1997.0,0,0
1107,9246699,Maintenance treatment for gastro-oesophageal reflux disease. A placebo-controlled evaluation of 10 milligrams omeprazole once daily in general practice.,T L Venables; R D Newland; A C Patel; J Hole; M B Copeman; M L Turbitt,"Gastro-oesophageal reflux disease (GORD) is a frequent cause for consultation in general practice and is a chronically relapsing disease. This general practice study was a 6-month randomized, double-blind parallel-group placebo-controlled assessment of the efficacy and safety of continuous treatment with 10 mg omeprazole every morning after initial symptom control in 495 patients with GORD but without erosive oesophagitis. On the basis of life-table estimates for cumulative relapse rates, patients in the placebo group (52%) were almost twice as likely as those in the omeprazole group (27%) to discontinue therapy before 24 weeks because of inadequate relief of heartburn or for other reasons including adverse events (all-patients-treated analysis, log rank test, P = 0.0001). This study has shown that 10 mg omeprazole once daily is an effective and well-tolerated treatment strategy in general practice for the long-term management of symptoms of GORD in patients without erosive oesophagitis.",1997.0,0,1
1108,9248117,Lansoprazole versus omeprazole in the treatment of reflux esophagitis.,A Vcev; D Stimac; A Vceva; M Rubinić; A Ivandić; N Ivanis; D Horvat; M Volarić; I Karner,"To evaluate the therapeutic potential of the newly developed proton pump inhibitor lansoprazole in patients with reflux esophagitis (grade I and II according to Savary Müller criteria), the authors performed a single blind, randomized clinical trial comparing 20 mg omeprazole and 30 mg lansoprazole, involving 60 patients at two clinical hospitals. The treatment period was or 8 weeks, and main efficacy variables were healing of endoscopic changes and relief of reflux symptoms. No significant difference in terms of healing and relief of reflux symptoms was found either after 4 or after 8 weeks of treatment. In conclusion, 30 mg lansoprazole daily was found to be safe and effective therapy comparable to omeprazole in the short-term treatment for reflux esophagitis (grade I and II).",1997.0,0,0
1109,9260785,Guilty as charged: bugs and drugs in gastric ulcer.,S J Sontag,"Gastric ulcer disease remains a cause of hemorrhage, perforation, outlet obstruction, and death. Recent advances in the understanding of peptic ulcer disease indicate that infection with Helicobacter pylori and ingestion of nonsteroidal anti-inflammatory drugs (NSAIDs) are the cause of almost all gastric and duodenal ulcers. Our therapy, therefore, is in a state of transition: the old acid-suppressive temporary therapy that allows frequent ulcer recurrences and complications is being replaced by curative therapies. The old therapy, by reducing gastric acid secretion or enhancing gastric mucosal defenses, inhibited the cofactors needed for ulcer development. Acid suppression relieved symptoms and healed ulcers, while defense enhancers, such as prostaglandin analogs healed and prevented acute NSAID-induced gastric ulcers. These benefits were maintained, however, only as long as acid-reducing agents or mucosal defense enhancers were continued. On the other hand, curative therapies (such as eradicating H. pylori infection and/or stopping the use of NSAIDs) eliminate the causes of ulcer. Curative combination regimens consisting of antibiotics, ranitidine bismuth citrate, bismuth, and proton pump inhibitors have been approved by the Food and Drug Administration. These new regimens can cure benign gastric ulcer. Unfortunately, we cannot always determine which gastric ulcers are benign, and concern about gastric cancer remains. All gastric ulcers therefore still require biopsy and histological examination. With new treatment regimens, the time may be rapidly approaching when ulcer disease will be ""history.""",1997.0,0,0
1110,9260787,Accuracy of invasive and noninvasive tests to diagnose Helicobacter pylori infection after antibiotic treatment.,A Rollán; R Giancaspero; M Arrese; C Figueroa; V Vollrath; M Schultz; I Duarte; P Vial,"To compare the diagnostic accuracy of the most widely available tests for diagnosis of Helicobacter pylori infection after antibiotic treatment. A total of 59 H. pylori-positive, duodenal ulcer patients (mean age, 40.7 +/- 11.7 yr; 40 male and 19 female) were treated for 2 wk with either amoxicillin-metronidazole (n = 36) or omeprazole-amoxicillin-tinidazole (n = 23), and after 4 wk, were tested for H. pylori infection by [14C]urea breath test (UBT), serum IgG antibody level, and multiple antral biopsies for rapid urease testing, histology, Warthin-Starry stain, and polymerase chain reaction to detect H. pylori DNA. Infection status was established by a concordance of test results. H. pylori was eradicated in 47 patients (80%). UBT and rapid urease testing had the best sensitivity and specificity, although not statistically different to Warthin-Starry stain and polymerase chain reaction. Serology and histology had little diagnostic value in this setting due to high proportion of false-positive results. Noninvasive UBT is as accurate in predicting H. pylori status after antibiotic treatment as rapid urease testing and Warthin-Starry stain. Especially for duodenal ulcer patients, UBT could be considered the gold standard to confirm eradication of H. pylori.",1997.0,0,0
1111,9265894,Pathological case of the month. Helicobacter pylori gastritis.,A K Shetty; H Correa; J Udall; E Schmidt-Sommerfeld,,2001.0,0,0
1112,9270961,"Gastric acid, acid-suppressing drugs, and bacterial gastroenteritis: how much of a risk?",L A Garcia Rodríguez; A Ruigómez,"Recent studies have reported an association between acid-suppressing drugs (histamine H2 receptor antagonists and proton pump inhibitors) and development of infectious gastroenteritis. We conducted a case-control study nested in a cohort of more than 170,000 ever-users of acid-suppressing drugs to examine the association between acid-suppressing drugs and bacterial gastroenteritis, using data from the General Practice Research Database in the United Kingdom. We identified 374 confirmed cases of bacterial gastroenteritis and 2,000 randomly sampled controls from the study cohort. There was little increased risk of bacterial gastroenteritis among users of acid-suppressing drugs [relative risk (RR) = 1.1; 95% confidence interval (CI) = 0.8-1.4]. Omeprazole ""single users"" had an RR of 1.6 (95% CI = 1.0-2.4), but this effect was not observed among those using only omeprazole during the last year (RR = 1.1; 95% CI = 0.7-1.9). We did not find any dose or treatment duration response. These data do not support a major role for acid reduction in the development of bacterial gastroenteritis.",1997.0,0,1
1113,9272389,Influence of a proton pump inhibitor-based therapy on Helicobacter pylori strain selection.,S L Hazell; H M Mitchell; G Hanna; G Daskalopoulos,The influence of the proton pump inhibitor lansoprazole on strain diversity in Helicobacter pylori infected patients was investigated. Multiple isolates of Helicobacter pylori obtained pre- and post-therapy from gastric antral and body biopsies in 22 patients were compared using the random amplified polymorphic DNA-polymerase chain reaction (RAPD-PCR) for analysis. Post-therapy strains exhibiting novel RAPD-profiles were found in 5 of 22 patients (4 of 11 patients treated with lansoprazole alone and 1 of 11 patients treated with lansoprazole plus amoxicillin). Proton pump inhibition may affect the microecology of the stomach by influencing the colonisation patterns of specific strains.,1997.0,0,0
1114,9274464,Current European concepts in the management of Helicobacter pylori infection. The Maastricht Consensus Report. European Helicobacter Pylori Study Group.,,"There is considerable confusion over the management of Helicobacter pylori infection, particularly among primary care physicians, and numerous European countries lack national guidelines in this rapidly growing area of medicine. The European Helicobacter Pylori Study Group therefore organised a meeting in Maastricht of H pylori experts, primary care physicians and representatives of National Societies of Gastroenterology from Europe to establish consensus guidelines on the management of H pylori at the primary care and specialist levels, and to consider general health care issues associated with the infection. As in previous guidelines, eradication therapy was recommended in all H pylori positive patients with peptic ulcer disease. Additionally, at the primary care level in dyspeptic patients < 45 years old and with no alarm symptoms, diagnosis is recommended by non-invasive means (13C urea breath test, serology) and if H pylori positive the patient should be treated. Moreover, at the specialist level the indications for eradication of H pylori were also broadened to include H pylori positive patients with functional dyspepsia in whom no other possible causes of symptoms are identified by the specialist (after a full investigation including endoscopy, ultrasound and other necessary investigations), patients with low grade gastric mucosa associated lymphoid tissue (MALT) lymphoma (managed in specialised centres) and those with gastritis with severe macro- or microscopic abnormalities. There was consensus that treatment regimens should be simple, well tolerated and achieve an eradication rate of over 80% on an intention to treat basis. It was strongly recommended, therefore, that eradication treatment should be with proton pump inhibitor based triple therapy for seven days, using a proton pump inhibitor and two of the following: clarithromycin, a nitroimidazole (metronidazole or tinidazole) and amoxycillin.",1997.0,0,0
1115,9274470,Does treatment of Helicobacter pylori with antibiotics alone heal duodenal ulcer? A randomised double blind placebo controlled study.,S K Lam; C K Ching; K C Lai; B C Wong; C L Lai; C K Chan; L Ong,"Treatment of Helicobacter pylori infection prevents duodenal ulcer relapse. It has not been established if treatment of the infection heals duodenal ulcer. To test the hypothesis that treatment of the infection was associated with healing of duodenal ulcer. A randomised, double blind placebo controlled trial was performed to study the efficacy of an antibiotic only regimen consisting of 300 mg metronidazole, 500 mg amoxycillin, and 250 mg clarithromycin, each given four times daily for two weeks, in the healing of duodenal ulcer as assessed by endoscopy. Symptoms were controlled with acetaminophen and antacids. Of 100 consecutive patients with endoscopically established duodenal ulcer, 97 with positive rapid urease test on antral biopsy specimens were admitted into the study and 81 completed the trial. Of these, 40 were randomised to receive antibiotics and 41 to receive placebo. Treatment with antibiotics resulted in 92.5% (95% confidence interval (95% CI) 84.3-100) healing at four weeks and 100% at eight and 12 weeks; the corresponding healing rates for placebo treatment were respectively, 36.6%, 61%, and 63.4% (95% CIs 21.8-51.3, 46.0-75.9, and 48.7-78.2 respectively). The differences between the two treatment groups were significant at p < 0.001 at each time point and by life table analysis. Clearance of H pylori as assessed by urease test on antral biopsy specimens at four weeks and eradication of the organism as determined by 13C-urea breath test at eight weeks were achieved in 85% and 62.5% of patients respectively. Duodenal ulcer healed at four weeks in 87.2% and 86.2% (95% CIs 76.7-97.7 and 73.7-98.8) of patients in whom H pylori clearance or eradication, was achieved, versus 42.9% and 51.9% (95% CIs 27.9-57.8 and 38.3-65.5; p < 0.001 and < 0.003 respectively) in whom these processes failed. Stepwise discriminant analysis on 32 clinical, personal, and endoscopic characteristics as well as H pylori clearance and eradication identified H pylori clearance as the most discriminative variable for the healing of duodenal ulcer at four weeks, followed by ulcer depth and eradication of the organism. Treatment with an antibiotic only regimen was effective for the healing of duodenal ulcer, and clearance as well as eradication of H pylori contributed significantly to the healing. The results constituted the strongest evidence to date that H pylori infection was aetiologically related to duodenal ulceration, and support the concept of treating duodenal ulcer associated with H pylori as an infection and relieving its symptoms with acid reducing agents such as antacids.",1997.0,0,0
1116,9279507,Lansoprazole. An update of its pharmacological properties and clinical efficacy in the management of acid-related disorders.,H D Langtry; M I Wilde,"Lansoprazole is a proton pump inhibitor that reduces gastric acid secretion. It has proved effective in combination regimens for the eradication of Helicobacter pylori and as monotherapy to heal and relieve symptoms of gastric or duodenal ulcers and gastro-oesophageal reflux. After initial healing, it may be used to prevent recurrence of oesophageal erosions or peptic ulcers in patients in whom H. pylori is not the major cause of ulceration and to reduce basal acid output in patients with Zollinger-Ellison syndrome. Usual dosages are 15 to 60 mg/day, although dosages of < or = 180 mg/day have been used in patients with hypersecretory states. In patients with duodenal or gastric ulcer, short term lansoprazole monotherapy was similar to omeprazole and superior to histamine H2 receptor antagonists in achieving healing rates > 90%. Lansoprazole was as effective a component of H. pylori eradication regimens as omeprazole, tripotassium dicitrato bismuthate (colloidal bismuth subcitrate) or ranitidine. Lansoprazole was superior to ranitidine in symptom relief and healing of gastro-oesophageal reflux disease and tended to relieve symptoms more rapidly than omeprazole, although initial healing was similar. As maintenance treatment, lansoprazole was similar to omeprazole and superior to ranitidine in relieving symptoms and preventing relapse. Lansoprazole was also superior to ranitidine in healing and relieving symptoms of oesophageal erosions associated with Barrett's oesophagus; healing was maintained for a mean of 2.9 years in > or = 70% of patients. Lansoprazole was also superior to ranitidine in prophylaxis of redilatation of oesophageal strictures. After > or = 4 years of use in patients with Zollinger-Ellison syndrome, lansoprazole 60 to 180 mg/day effectively controlled basal acid output. Dosages may be reduced in some patients once healing and symptom relief has been achieved. Preliminary studies of lansoprazole in patients at risk of aspiration pneumonia or stress ulcers show promise. Although studies show lansoprazole is potentially effective in treating gastrointestinal bleeding, future studies should assess patients' H. pylori status. Lansoprazole has been well tolerated in clinical trials, with headache, diarrhoea, dizziness and nausea appearing to be the most common adverse effects. Tolerability of lansoprazole does not deteriorate with age and the drug is well tolerated in long term use (< or = 4 years) in patients with Zollinger-Ellison syndrome or reflux disease. Thus, lansoprazole is an important alternative to omeprazole and H2 receptor antagonists in acid-related disorders. In addition to its efficacy in healing or maintenance treatment, it may provide more effective symptom relief than other comparator agents.",1997.0,0,0
1117,9282967,Lifetime costs of surgical versus medical treatment of severe gastro-oesophageal reflux disease in Finland.,M Viljakka; J Nevalainen; J Isolauri,"Gastro-oesophageal reflux disease (GERD) can be effectively treated pharmacologically or surgically. As GERD is often a chronic condition, we compared the long-term costs of medical and surgical management. The medical regimens were ranitidine (150 or 300 mg/day), omeprazole (20 or 40 mg/day), and lansoprazole (30 mg/day), with costs calculated for total life expectancy after diagnosis and for one-third of that time. Costs for open or laparoscopic surgery (Nissen fundoplication) included pre- and post-operative investigations, sick leave, and calculated financial loss due to fatal outcome. Costs were lowest with ranitidine, 150 mg/day, for one-third of the patient's lifetime and highest with lifelong omeprazole, 40 mg/daily. The cost of open or laparoscopic operation was less than that of lifelong daily treatment with proton pump inhibitors or ranitidine, 300 mg daily. In Finland, antireflux surgery for GERD is cheaper than lifetime treatment with proton pump inhibitors.",1997.0,0,0
1118,9283991,Efficacy of lansoprazole against peptic ulcers induced by non-steroidal anti-inflammatory drugs: endoscopic evaluation of ulcer healing.,Y Matsukawa; Y Tomita; S Nishinarita; T Horie; K Kato; Y Arakawa; K Ko; H Shimada; M Nakano; Y Kitami; H Kurosaka,"Beyond the obvious step of limiting use of non-steroidal anti-inflammatory drugs (NSAIDs), the treatment of ulcers induced by NSAIDs remains controversial. We evaluated the efficacy of the proton-pump inhibitor lansoprazole on NSAID-induced ulcers. Ulcers were endoscopically diagnosed in 47 NSAID users. These patients received 30 mg/day lansoprazole, orally, for 6 or 8 weeks (6 weeks for duodenal ulcers and 8 weeks for other ulcers). Ulcer healing was assessed using an established classification system. The presence of immunoglobulin G antibody against Helicobacter pylori was also evaluated. The antibody was present in the sera of 51% of patients (24/47). Most of the ulcers reached scarring stages S1 (healing) or S2 (good healing), and the S2 healing rate was 35%. Two H. pylori seropositive patients did not reach these stages; their ulcers were improved by H. pylori eradication therapy, followed, in one case, by medication with misoprostol. Lansoprazole seemed to be useful for most patients with NSAID-induced ulcers, but a few needed additional treatments.",1997.0,0,0
1119,9284848,Enantioselective hydroxylation of omeprazole catalyzed by CYP2C19 in Swedish white subjects.,G Tybring; Y Böttiger; J Widén; L Bertilsson,"Stereoselective disposition of omeprazole and its formed 5-hydroxy metabolite were studied in five poor metabolizers and five extensive metabolizers of S-mephenytoin. After a single oral dose of omeprazole (20 mg), the plasma concentrations of the separate enantiomers of the parent drug and the 5-hydroxy metabolite were determined for 10 hours after drug intake. In poor metabolizers, the area under the plasma concentration versus time curve [AUC(0-8)] of (+)-omeprazole was larger and that of the 5-hydroxy metabolite of this enantiomer was smaller than the AUC(0-8) values in extensive metabolizers (p < 0.001). The mean AUC(0-8) of the (-)-enantiomer of omeprazole was also higher in poor metabolizers than in extensive metabolizers, but only 3.1-fold compared with 7.5-fold for (+)-omeprazole. The rate of formation of the hydroxy metabolite from (-)-omeprazole was low and not significantly different in poor and extensive metabolizers. These results show that (+)-omeprazole is to a major extent hydroxylated by CYP2C19. Also (-)-omeprazole may partly be metabolized by this enzyme but is mainly metabolized by another enzyme, presumably CYP3A4, to the achiral sulfone metabolite. The plasma concentration ratio of omeprazole to 5-hydroxyomeprazole obtained 3 hours after the drug intake has been used to distinguish between extensive and poor metabolizer phenotypes. With use of the ratio between the (+)-enantiomers of the parent drug and the metabolite, a better discrimination between phenotypes was obtained. The ratio between the (-)-enantiomers also separated the phenotypes but was less discriminatory. For the future, measurement of total concentrations will suffice for phenotyping.",1997.0,0,1
1120,9287260,Helicobacter pylori eradication--comparison of three drug regimens and symptomatic assessment in duodenitis and antral gastritis.,W C Tan; J Hogan; S K Purkayastha; M Lombard; N Krasner,"Helicobacter pylori (Hp) eradication in peptic ulcer disease is associated with a greatly reduced recurrence rate. The optimal drug regimen for HP eradication remains uncertain. It is also unclear if eradication of Hp in duodenitis and antral gastritis improves symptoms. The aims of this study were to compare the efficacy of three drug regimens in the eradication of Hp and to assess if Hp eradication improved symptoms in patients with duodenitis and antral gastritis. Patients (n = 79) found to have duodenal ulcer, duodenitis and/or antral gastritis with a positive urease test (CLO) at endoscopy were allocated to one of the three regimens: A. omeprazole 20 mg b.d. and clarithromycin 500 mg t.d.s. for two weeks (n = 27), B. De-Nol 240 mg b.d. for four weeks, metronidazole 400 mg t.d.s. and amoxicillin 500 mg t.d.s. for one week (n = 26), and C. omeprazole 20 mg b.d. and amoxicillin 500 mg t.d.s. for two weeks (n = 26). In conclusion, traditional 'triple' therapy with bismuth and two antibiotics achieved the highest Hp eradication rate and was best tolerated. Recolonisation with Hp was uncommon after eradication. Dyspeptic symptoms improved with Hp eradication in duodenitis and antral gastritis.",1997.0,0,0
1121,9287403,Prophylaxis of acute gastroduodenal bleeding after renal transplantation.,I Skála; O Marecková; S Vítko; I Matl; J Lácha,"Severe gastroduodenal bleeding after renal transplantation is effectively prevented by H2 receptor blockers. New drugs for prophylaxis include proton pump inhibitors. The aim of the present study was to compare the effects of prophylaxis with the H2 blocker ranitidine and with the proton pump inhibitor omeprazole. One hundred seventy-seven consecutive patients were included in a controlled, prospective, randomized study after cadaveric renal transplantation. In one case, ranitidine failed to prevent exsanguination due to duodenal peptic ulcer bleeding. No bleeding was noted in the omeprazole group. There were no significant differences between the groups in hospitalization time, development of renal function, amount of cyclosporin A, prednisone, azathioprine, or methylprednisoline ingested, or laboratory biochemical parameters. We conclude that prophylaxis of severe gastroduodenal bleeding after renal transplantation with omeprazole is effective. Omeprazole is certainly as good as ranitidine; its advantages are a prolonged effect and a simple dosage, independent of graft function development.",1997.0,0,0
1122,9301991,PCR-RFLP typing of ureC from Helicobacter pylori isolated from gastric biopsies during a European multi-country clinical trial.,G G Stone; D Shortridge; R K Flamm; J Beyer; A T Ghoneim; S K Tanaka,"A multi-country clinical trial was conducted in ten European countries to determine the efficacy of clarithromycin-omeprazole dual therapy for treating Helicobacter pylori infection in peptic ulcers. Gastric biopsies were cultured for H. pylori before and after treatment. PCR-RFLP was used to determine the genetic heterogeneity of 100 H. pylori isolates from pretreatment and posttreatment biopsies. An 820 bp amplified fragment of the ureC gene was digested with the restriction enzymes Sau3A and Hhal. Fourteen different Sau3A patterns and 15 different Hhal patterns were identified among the pretreatment isolates. In combination, 42 different RFLP types were identified. Comparison of isolates before treatment with those after treatment showed that five of ten patients on clarithromycin-omeprazole dual therapy had the same RFLP type and that all 12 patients on omeprazole therapy alone had the same RFLP type. All isolates were susceptible to clarithromycin prior to treatment, while seven of ten patients on clarithromycin-omeprazole therapy had H. pylori that was resistant to clarithromycin after therapy and 11 of 12 patients on omeprazole therapy had isolates susceptible to clarithromycin after treatment. In addition to PCR-RFLP typing, the presence of the cytotoxin-associated gene (cagA) and the vacuolating gene (vacA) was determined; 79% of the isolates were cagA-positive and all were vacA-positive. The results of this study indicate that infection of H. pylori in Europe is not restricted to a few RFLP types.",1997.0,0,0
1123,9305472,Review article: current practice and future perspectives in the management of gastro-oesophageal reflux disease.,R Lambert,"Gastro-oesophageal reflux disease (GERD) is primarily due to incompetence of the lower oesophageal sphincter (LOS) and crural diaphragm, with transient LOS relaxation frequently accounting for daytime reflux. In the absence of drugs that adequately correct the motility defects of GERD, treatment is directed towards decreasing gastric acidity. Oesophageal healing is related to control of 24-h intragastric acidity, the degree of acid suppression and duration of treatment. H2-receptor antagonists are generally less effective in GERD than in peptic ulcer disease. While providing symptomatic relief in non-erosive GERD, they are often ineffective in healing erosive oesophagitis. Proton pump inhibitors provide more rapid and complete healing and symptom resolution. They are superior to H2-receptor antagonists in the long-term management of erosive oesophagitis and in reducing recurrence of oesophageal stricture following mechanical dilatation. In Barrett's oesophagus, high-dose proton pump inhibitors in combination with laser/photodynamic ablation therapy can produce metaplastic regression, although this does not preclude future emergence of adenocarcinoma. Surgical morbidity and mortality rates in GERD generally remain higher than those associated with long-term pharmacotherapy. However, direct comparisons between laparascopic anti-reflux surgery and proton pump inhibitor maintenance therapy remain to be performed. Although there is no evidence that H. pylori infection worsens the severity of oesophagitis or that H. pylori is carcinogenic in the metaplastic oesophageal mucosa. It has been suggested that H. pylori-positive patients requiring long-term proton pump inhibitor therapy receive bacterial eradication therapy to reduce the risk of developing atrophic gastritis.",1997.0,0,0
1124,9305480,Age-dependent eradication of Helicobacter pylori with dual therapy.,G Treiber; S Ammon; U Klotz,"Combined treatment using an acid-inhibiting drug with antibiotics can cure Helicobacter pylori infection. However, eradication rates are highly variable, especially if a proton pump inhibitor is used with amoxycillin. Therefore it is important to define factors/predictors of the clinical outcome. In a single-blind study, 60 H. pylori-positive patients prospectively matched for diagnosis (erosive gastritis, duodenal and gastric ulcer), age (above and below 50 years) and smoking habits were randomly treated (each group n = 20) for 2 weeks with amoxycillin (1 mg b.d.) and either omeprazole (20 mg b.d.), lansoprazole (30 mg b.d.) or ranitidine (300 mg b.d.). Intragastric pH and plasma levels of the administered drugs were monitored over a dosing interval of 12 h. The overall eradication rates were 45% (intention-to-treat, ITT, 27/60) or 47% (per protocol 27/58); they did not differ (ITT) between omeprazole (50%), lansoprazole (40%) and ranitidine (45%). Median pH and time at which intragastric pH was above 4 was slightly lower for ranitidine (4.0 +/- 1.7; 51 +/- 25%) than for omeprazole (5.4 +/- 1.1: 77 +/- 25%; P < 0.05) or lansoprazole (4.4 +/- 1.6: 68 +/- 32%). Plasma concentrations of amoxycillin were comparable in all three treatment groups. Post-treatment H. pylori status was not dependent on those levels, or the drug-induced extent or duration of increased intragastric pH. However, H. pylori-eradicated patients were significantly (P < 0.05) older (56 +/- 13 years) than patients still H. pylori-positive (47 +/- 14 years). In addition, in patients older than 50 years (n = 33), eradication was higher (P < 0.01) than in patients (n = 25) below 50 years (65 vs. 24%). Eradication rate was highest (75-83%) in subgroups of patients (> 50 years and history of peptic ulcer or smokers). Neither activity/grade of peptic ulcer or erosive gastritis nor initial diagnosis were predictors for clinical outcome. The age of patients must be regarded as a major determinant of H. pylori eradication rate and may represent an important factor contributing to the highly variable clinical results.",1997.0,0,0
1125,9305485,Twenty-four-hour intragastric acidity and plasma gastrin during 3-month treatment with omeprazole in healthy subjects.,J C Delchier; R Benamouzig; L Stanescu; A Ropert; T Vallot; V Wirquin; F Roudot; D Lamarque; B Hamelin,"Prolonged treatment with omeprazole 20 or 40 mg/day is sometimes required, especially for severe oesophagitis. However, information about long-term effects on intragastric acidity and plasma gastrin response with such drug regimens is scarce. Sixteen healthy subjects (11 men, 5 women, mean age 29 years) randomly received either 20 or 40 mg of omeprazole once daily (at 08.00 h) for 3 months. Gastric pH was recorded every 6 s for 24 h from noon to noon under standardized conditions, and blood samples were collected hourly in order to determine the 24-h plasma gastrin response on day 0 (pre-entry), day 7, day 28 and day 90. From day 0 to day 7, 24-h median pH increased from 1.7 to 4.6 and mean percentage of time at pH < 4 decreased from 89% to 35% with omeprazole 20 mg. Respective values with omeprazole 40 mg were 1.9 to 4.3, and 89% to 34%. Inhibition of gastric acidity remained unchanged during the 3 months of treatment. Despite similar effects on the basis of 24-h analysis, the decrease in daytime acidity was slightly higher with omeprazole 40 mg than with omeprazole 20 mg. Twenty-four-hour integrated plasma gastrin significantly increased with both drug regimens between day 0 and day 7 (P < 0.01), and between day 7 and day 28 (P < 0.01) with omeprazole 40 mg; there was no significant increase between day 28 and day 90 with either of the drug regimens. Omeprazole 20 and 40 mg/day provides long-term stable acid suppression with a progressive increase in gastrin response, stabilizing after 2 months of treatment.",1997.0,0,0
1126,9305487,Treating the symptoms of gastro-oesophageal reflux disease: a double-blind comparison of omeprazole and cisapride.,J P Galmiche; P Barthelemy; B Hamelin,"Few studies have specifically addressed the management of the symptoms of gastro-oesophageal reflux disease, and there are no comparative data in this respect for acid pump inhibitors and prokinetic agents. Following endoscopy 424 patients presenting with heartburn as the predominant symptom of gastro-oesophageal reflux disease were randomized to treatment with omeprazole 20 or 10 mg once daily, or cisapride 10 mg four times daily, in a double-blind, double-dummy, parallel group, multicentre study. Symptoms and quality of life were assessed at 4 weeks. Patients still experiencing heartburn continued therapy for a further 4 weeks and the assessments were repeated. At 4 weeks, heartburn was resolved in 65% (95% CI: 57-73%), 56% (48-64%) and 41% (32%-49%) of patients treated, respectively, with omeprazole 20 mg and 10 mg once daily, and cisapride. Both omeprazole doses were significantly more effective than cisapride (P < 0.01). The same order of efficacy was observed regardless of the presence of erosive oesophagitis. Regurgitation and epigastric pain also improved to a greater degree with omeprazole than with cisapride. Quality of life was improved in all treatment groups, and the improvement in the reflux dimension of the Gastrointestinal Symptom Rating Scale (GSRS) score was significantly different between groups (P = 0.002). Omeprazole 20 or 10 mg once daily is significantly more effective than cisapride in the resolution of heartburn, regardless of the presence of erosive oesophagitis, and this is accompanied by an improvement in patient quality of life.",1997.0,0,1
1127,9305491,Gastric corpus IL-8 concentration and neutrophil infiltration in duodenal ulcer patients.,N Uemura; Y Oomoto; T Mukai; S Okamoto; S Yamaguchi; H Mashiba; K Taniyama; N Sasaki; K Sumii; K Haruma; G Kajiyama,"The purpose of the present study was to examine the association between interleukin-8 (IL-8) in the gastric body due to Helicobacter pylori infection and histological gastritis, as well as elucidating the effect of acid secretion inhibitors on H. pylori associated body gastritis in duodenal ulcer patients. Twenty H. pylori-negative patients, 20 H. pylori-positive patients with chronic gastritis without peptic ulceration, and 20 H. pylori-positive duodenal ulcer patients (DU) were studied. Four biopsy samples were taken, each from the greater curvature of the antrum and body of the stomach. Biopsies were histologically investigated by ELISA to determine the density of H. pylori, the degree of neutrophil infiltration and the IL-8 concentration in the mucosa. In the gastric mucosa of H. pylori-negative subjects, no IL-8 and hardly any neutrophil infiltration were observed. In contrast, enhanced IL-8 production and increased neutrophil infiltration were present in those infected with H. pylori. In H. pylori-positive patients, a significant correlation was observed between the IL-8 concentration and the degree of neutrophil infiltration, but no correlation was found in the body mucosa of those with DU. Twelve of 20 DU patients demonstrated hardly any neutrophil infiltration, despite the increased mucosal IL-8 content in the body. The administration of omeprazole in DU patients markedly increased mucosal neutrophil infiltration even though it did not cause any significant change in the H. pylori density and IL-8 concentration in the body. Although the effect of omeprazole was transient, a significant increase in neutrophil infiltration continued in comparison with the status before omeprazole administration in those subsequently undergoing maintenance treatment with H2-blockers. In H. pylori-positive chronic gastritis, IL-8 concentration is enhanced in the mucosa of the body, and is associated with increased neutrophil infiltration. However, in DU patients, despite increases in body IL-8 concentration, neutrophil infiltration is reduced and the gastritis may be localized in the antrum.",1997.0,0,0
1128,9317066,Gastroesophageal reflux disease in intellectually disabled individuals: leads for diagnosis and the effect of omeprazole therapy.,C J Bohmer; M C Niezen-de Boer; E C Klinkenberg-Knol; H A Tuynman; J H Voskuil; W L Devillé; S G Meuwissen,"The therapeutic approach to gastroesophageal reflux disease (GERD) in intellectually disabled individuals has not been studied extensively. So far, only low response rates to medical and surgical therapy of GERD have been reported. However, the efficacy of proton pump inhibitors, to date the most effective medical therapy for GERD, has never been evaluated in this population. Our purpose, therefore, was to study the effect of omeprazole on healing and symptom relief in the intellectually disabled. The treatment scheme was as follows: omeprazole 40 mg was given once daily (o.d.) as a healing dose for 3 months, and omeprazole 20 mg o.d. was given as a maintenance dose for another 3 months, to intellectually disabled subjects with endoscopically proven esophagitis, grades I-IV, according to Savary-Miller classification. After 3 and 6 months, the result of this treatment was evaluated by symptom scoring and/or endoscopy. In case of relapse, the dose was increased. At the first endoscopy, 40 of 107 patients (37%) had grade I, 36 (34%) grade II, 18 (17%) grade III, and 13 (12%) grade IV esophagitis. In 92 of 104 patients (88%), the treatment scheme was effective in healing the esophagitis and keeping patients in remission, independent of the severity of esophagitis. In 11 of 104 (11%) patients, a symptomatic relapse was observed after the dose was decreased to 20 mg o.d. However, all of these patients became symptom free again after the dose was increased to 40 mg o.d., and all were healed endoscopically at the end of the study. One (1%) patient needed omeprazole 60 mg o.d. for healing, but in this patient, no relapse was seen while on a maintenance dose of omeprazole 40 mg o.d. Marked improvement of persistent vomiting, hematemesis, regurgitation, food refusal, iron deficiency anemia, and depressive symptoms was seen at the end of the study. This study indicates that omeprazole is highly effective for all grades of esophagitis in the intellectually disabled. The dose needed to maintain them in remission can be titrated according to the reflux symptoms.",1997.0,0,0
1129,9317068,Bismuth subsalicylate instead of metronidazole with lansoprazole and clarithromycin for Helicobacter pylori infection: a randomized trial.,W D Chey; L Fisher; G H Elta; J L Barnett; T Nostrant; J DelValle; W L Hasler; J M Scheiman,"We evaluated the efficacy of lansoprazole, clarithromycin, and metronidazole (LCM) administered twice daily for 7 days. Because there is growing concern about the development of metronidazole-resistant H. pylori (HP) strains, we also tested a novel regimen consisting of lansoprazole, clarithromycin, and bismuth subsalicylate (LCB). Patients with active HP infection and peptic ulcer, a history of peptic ulcer, or nonulcer dyspepsia were randomized to either lansoprazole 30 mg b.i.d., clarithromycin 500 mg b.i.d., and metronidazole 500 mg b.i.d. or lansoprazole 30 mg b.i.d., clarithromycin 500 mg b.i.d., and bismuth subsalicylate 524 mg b.i.d. (LCB) for 7 days. Compliance and side effects were recorded by using a diary. ""Per protocol"" eradication with LCM was achieved in 41 of 47 (87%). By using ""intention to treat"" analysis, LCM eradicated HP infection in 43 of 53 patients (81%). By using ""per protocol"" analysis, LCB eradicated HP infection in 40 of 47 patients (85%). On an ""intention to treat"" basis, LCB led to HP eradication in 42 of 52 (81%). The most common significant side effects observed with LCM were altered taste (39%) and abdominal pain (19%). With LCB, the most common significant side effects were altered taste (23%) and dark stools (23%). LCB for 7 days was as effective in eradicating HP infection as a 7-day course of LCM. Further studies evaluating the role of bismuth compounds in proton-pump inhibitor based triple therapy are warranted. Such therapy may have particular importance in areas where high metronidazole resistance is a concern.",1997.0,0,0
1130,9324183,"Identification, diagnosis, and treatment of acid-related diseases in the elderly: implications for long-term care.",W R Garnett; S M Garabedian-Ruffalo,"Acid-related disorders such as peptic ulcer disease and gastroesophageal reflux disease occur frequently in the elderly and are associated with a high frequency of morbidity and mortality. The proton pump inhibitors lansoprazole and omeprazole produce faster rates of healing and greater symptomatic relief in patients with acid-related disorders than histamine2-receptor antagonists, are well tolerated, and are associated with few adverse events. Compared with omeprazole, which interacts with diazepam, warfarin, and phenytoin, lansoprazole produces only a minor increase in theophylline clearance. Proton pump inhibitors in combination with antibiotic therapy can eradicate Helicobacter pylori, the main risk factor in the recurrence of peptic ulcer disease, obviating the need for maintenance therapy. Long-term acid suppression with proton pump inhibitors may be necessary to prevent the recurrence of gastroesophageal reflux disease. The safety and efficacy profile of these agents makes them ideal for the treatment of acid-related diseases in elderly patients.",1997.0,0,0
1131,9339962,Current guidelines on stress ulcer prophylaxis.,M Tryba; D Cook,"Acute uppergastrointestinal bleeding in intensive care unit (ICU) patients may occur due to peptic ulcer disease, adverse drug effects, gastric tube lesions, acute renal failure, liver failure or stress-induced gastric mucosal lesions. Gastric acid hypersecretion can be observed in patients with head trauma or neurosurgical procedures. Gastric mucosal ischaemia due to hypotension and shock is the most important risk factor for stress ulcer bleeding. Preventive strategies aim to reduce gastric acidity (histamine H2 receptor antagonists, antacids), strengthen mucosal defensive mechanisms (sucralfate, antacids, pirenzepine) and normalise gastric mucosal microcirculation (sucralfate, pirenzepine). However, the most important prophylactic measure is an optimised resuscitation and ICU regime aiming to improve oxygenation and microcirculation. All drugs approved for stress ulcer prophylaxis in Europe (H2 antagonists, antacids, pirenzepine, sucralfate) have been shown to be effective in prospective controlled randomised trials. However, due to insufficient clinical data, prostaglandins and omeprazole cannot be recommended for this use. Stress ulcer prophylaxis is indicated only in patients at risk, and not in every ICU patient. The selection of drugs today depends not only on efficacy but also on possible adverse effects and on costs. In this regard, the most cost-effective drug is sucralfate. The clinical relevance of nosocomial pneumonia due to gastric bacterial overgrowth has decreased during the past decade due to several changes in the management of critically ill patients.",1997.0,0,0
1132,9343318,Parietal cell protrusions in gastric ulcer disease.,S Krishnamurthy; Y Dayal,"Oxyntic mucosal biopsy specimens from patients receiving omeprazole therapy have been described as frequently showing characteristic tonguelike protrusions of parietal cell cytoplasm (PCP) into the gland lumen. Although protrusion of parietal cell cytoplasm is believed to be associated with omeprazole therapy and has been implicated in the histogenesis of fundic gland polyps, we have observed it in a wide variety of different conditions unrelated to peptic ulcer disease or omeprazole therapy. To establish the incidence of PCP and analyze its relationship to gastritis, gland dilatation, cystic change, and fundic gland polyps, we studied 400 gastric mucosal biopsy specimens from gastric ulcer patients who were not receiving omeprazole therapy and who did not receive any medications for at least 2 weeks. Severity of each of these changes was graded on a scale of I to III. PCP was observed in oxyntic mucosal biopsy specimens from 60 (15%) patients and was associated with varying grades of chronic superficial or interstitial gastritis in 25 (Helicobacter pylori was identified in 12). Although chronic atrophic gastritis, cystic change, or fundic gland polyps were not identified in any of the cases with PCP, gland dilatation was present in 25 of 60 (42%) biopsy specimens. No consistent linear correlation was observed between increasing grades of PCP and gastritis or gland dilatation. Our findings of PCP in 15% of gastric ulcer patients who were off all medications for 2 weeks indicate that PCP is not always related to omeprazole usage. It appears to be a change encountered in a wide variety of diverse settings and, therefore, should not be used to monitor omeprazole therapy. In gastric ulcer patients, there is no linear correlation between PCP and gland dilatation or severity of gastritis. The lack of association of PCP with such cardinal features of fundic gland polyps as gland dilatation and cystic change suggests that PCP per se has little if any role in the development of such polyps. The exact clinical and functional significance of PCP remain to be established and merits further investigation.",1997.0,0,0
1133,9351030,Cure with omeprazole plus amoxicillin versus long-term ranitidine therapy in Helicobacter pylori-associated peptic ulcer bleeding.,J F Riemann; D Schilling; P Schauwecker; G Wehlen; D Dorlars; B Kohler; M Maier,"Long-term prophylaxis with ranitidine reduces the risk of recurrent bleeding in patients with a history of bleeding peptic ulcers. To date, no randomized study has been performed to compare cure of Helicobacter pylori infection versus H2 blocker prophylaxis in patients with bleeding peptic ulcer. In a prospective randomized study, 95 consecutive patients with H. pylori-associated peptic ulcer bleeding were randomized to either ranitidine prophylaxis (150 mg at night) for 2 years or to H. pylori-eradication with omeprazole 60 mg twice daily plus amoxicillin 750 mg three times daily for 10 days. (Intention-to-treat analysis). Forty-eight patients were enrolled in the ranitidine group; 47 in the omeprazole-plus-amoxicillin group. Mean follow-up was 576 days (77 to 730). Ulcer recurrence rate was 31.3% in the ranitidine group (group 1) versus 6.37% in the eradication group (group 2; p = 0.0018). More patients had recurrent bleeding in group 1 (8.3%) than in group 2 (4.2%) but we were not able to show a statistically significant difference with respect to recurrent bleeding between groups (p = 0.29). Definite cure of H. pylori infection was achieved in 89.3%. Cure of H. pylori infection reduces recurrence of peptic ulcer and therefore rebleeding more effectively than does long-term maintenance therapy with an H2 blocker.",1997.0,0,0
1134,9354197,A prospective follow-up study of 5669 users of lansoprazole in daily practice.,H Leufkens; A Claessens; E Heerdink; J van Eijk; C B Lamers,"Immediately after the introduction of the proton pump inhibitor lansoprazole, a 2-year follow-up study was started to evaluate patterns of use, safety and effectiveness of this drug in naturally occurring groups of patients in the Netherlands. Medical data were recorded by participating physicians while medication listing were provided by pharmacists. The study was designed according to the Safety Assessment of Marketed Medicines guidelines. The only inclusion criterion was the use of lansoprazole prior to entry into the study. A total of 5669 lansoprazole users was included by 374 general practitioners and 117 specialists. Lansoprazole was mostly prescribed in patients with reflux oesophagitis (55.1%), 'gastritis' (26.8%) and duodenal ulcers (11.4%), sometimes as part of a Helicobacter pylori eradication therapy (8.5%). For their complaints most patients (91.1%) had previously used acid-related drugs. Improvement or disappearance of complaints was achieved in 88.9% and 90.5% of patients after 4 and 8 weeks of treatment, respectively. Diarrhoea (4.1%), headache (2.9%) and nausea (2.6%) were the most frequently reported adverse events. The patterns of use of lansoprazole in daily practice deviated from the recommendations in the information leaflet. Nevertheless, lansoprazole was found to be safe in this naturally occurring group of users. Effectiveness appeared to be comparable to results found in clinical trials of the registered indications for lansoprazole.",1997.0,0,1
1135,9354201,Two omeprazole-based Helicobacter pylori eradication regimens for the treatment of duodenal ulcer disease in general practice.,M R Cottrill; C McKinnon; I Mason; S A Chesters; G Slatcher; M B Copeman; M L Turbitt,"Helicobacter pylori is the main acquired factor in the pathogenesis of duodenal ulcer disease. This multicentre study conducted in 32 general practice centres in the UK and Ireland was a double-blind, placebo-controlled, randomized, parallel-group comparison of triple therapy (n = 98: omeprazole 40 mg once daily and amoxycillin 1 g b.d. for 2 weeks, and metronidazole 400 mg t.d.s. for the first week) and dual therapy (n = 85: omeprazole 40 mg once daily and amoxycillin 1 g b.d. for 2 weeks, with placebo during the first week) for the eradication of H. pylori in patients with symptomatic duodenal ulcer disease. Patients who were successfully treated entered a follow-up phase for 12 months to assess symptomatic relapse and use of health-care resources. Eradication of H. pylori based on a second 13C-urea breath test was successful in 95% (95% confidence interval (CI) = 90-100%) of patients receiving omeprazole triple therapy and 53% (95% CI = 41-65%) of those receiving omeprazole dual therapy (P < 0.0001 between groups, all data available analysis). The all-patients-treated analysis gave eradication rates of 80 and 44% for omeprazole triple therapy and omeprazole dual therapy, respectively. Symptomatic relapse occurred in 16% (18/116) of the H. pylori-negative patients who entered the 12-month follow-up period, and there were significant reductions in the number of consultations, investigations and prescriptions relating to upper gastrointestinal symptoms compared with the 12 months prior to the eradication therapies (all P < 0.0001). The two treatment strategies were comparable in terms of the number of adverse events reported. Omeprazole triple therapy provides a highly effective treatment for the eradication of H. pylori infection in patients in general practice, with an adverse event profile similar to that seen with omeprazole dual therapy. The successful eradication of H. pylori with these omeprazole regimens results in a significant decrease in the use of health-care resources in the 12 months following treatment.",1997.0,0,0
1136,9354203,"Twice a day quadruple therapy (bismuth subsalicylate, tetracycline, metronidazole plus lansoprazole) for treatment of Helicobacter pylori infection.",D Y Graham; J Hoffman; H M el-Zimaity; D P Graham; M Osato,"Quadruple therapy (bismuth, metronidazole and tetracycline (BMT) + proton pump inhibitor) is touted as being > 95% effective, regardless of metronidazole resistance. We tested a 10-day b.d. quadruple therapy for treatment of H. pylori infection. Anti-H. pylori therapy consisted of lansoprazole 15 mg b.d. plus tetracycline 500 mg b.d., metronidazole 500 mg b.d., and swallowable Pepto-Bismol caplets (2 b.d.) for 10 days. H. pylori status was evaluated by culture and histology before and 4 or more weeks after therapy. The cure rate for intention-to-treat was 70%. Treatment success was calculated overall and separately in relation to antimicrobial resistance patterns. The cure rate among the metronidazole-sensitive isolates was 89.7% (26 of 29) vs. 41.2% (7 of 17) of the metronidazole-resistant isolates (P < 0.005). Moderate (n = 1) or severe (n = 3) side-effects were experienced in four patients with only one withdrawing because of side-effects. Twice a day quadruple therapy is effective for metronidazole-sensitive strains but its usefulness is markedly reduced by the presence of pre-treatment metronidazole resistance. Twice a day quadruple therapy can be recommended in locations where background metronidazole resistance is uncommon. Possibly, 14-day therapy or a higher dosage of metronidazole provide better results with metronidazole-resistant H. pylori.",1997.0,0,0
1137,9354205,Short-course therapy with amoxycillin-clarithromycin triple therapy for 10 days (ACT-10) eradicates Helicobacter pylori and heals duodenal ulcer. ACT-10 Study Group.,H Wurzer; L Rodrigo; D Stamler; A Archambault; T Rokkas; N Skandalis; R Fedorak; F Bazzoli; E Hentschel; P Mora; A Archimandritis; F Megraud,"Whilst the role of Helicobacter pylori eradication in managing duodenal ulcers has been established, consensus regarding the ideal regimen has not been achieved. Patients with H. pylori-positive active duodenal ulcer were randomly assigned to receive triple therapy with amoxycillin 1000 mg b.d. + clarithromycin 500 mg b.d. + omeprazole 20 mg daily for 10 days (ACT-10) or dual therapy with clarithromycin 500 mg t.d.s. + omeprazole 40 mg daily for 14 days (Dual). No additional acid suppression was provided following eradication therapy. Endoscopy, with biopsy for culture and histology, as well as 13C-urea breath testing (13C-UBT) were performed pre-treatment to assess H. pylori infection. H. pylori eradication was established at 4-6 weeks follow-up with culture (2 antral, 1 corpus biopsies), histology (2 antral biopsies), and 13C-UBT. Ulcer healing by endoscopy and change in clinical symptoms were also assessed at 4-6 weeks. Two hundred and sixty-seven (267) patients were randomized to ACT-10 (n = 137) or Dual therapy (n = 130). By per-protocol and intention-to-treat analyses, H. pylori eradication at 4-6 weeks follow-up was 91% (115/127) and 88% (120/136), respectively, for ACT-10 patients and 59% (68/115) and 55% (72/130), respectively, for Dual therapy patients (P < 0.001 for both analyses). Ulcer healing was high in both treatment groups: ACT-10, 93% (118/127) and 90% (122/136), respectively; and Dual therapy, 91% (104/114) and 85% (111/130), respectively. Pre-treatment resistance to clarithromycin was low (4%, 8/214) as compared to metronidazole resistance which was over 40%. Emergence of resistance to clarithromycin was observed in 2% of patients receiving ACT-10 and in 25% of those receiving Dual therapy. ACT-10 and Dual therapy patients experienced similar rates of drug-related adverse events (33% vs. 32%, respectively) and discontinuation from therapy due to an adverse event (1.5% vs. 5%, respectively). More than 90% of patients were compliant with each prescribed medication. In patients with active duodenal ulcer, a 10-day course of amoxycillin-clarithromycin-based triple therapy without additional acid suppression is highly effective in eradicating H. pylori and healing duodenal ulcer.",1997.0,0,0
1138,9354207,Treatment of reflux oesophagitis of moderate and severe grade with ranitidine or pantoprazole--comparison of 24-hour intragastric and oesophageal pH.,U Armbrecht; A Abucar; W Hameeteman; A Schneider; R W Stockbrügger,"Proton pump inhibiting drugs strongly decrease gastric acid secretion and have proven more effective in the treatment of reflux oesophagitis than H2-receptor antagonists. In a double-blind randomized trial, 24 patients with oesophagitis grade II (n = 15) and III (n = 9) were treated for 4 weeks with either ranitidine 150 mg b.d. (n = 13) or pantoprazole 40 mg o.m. (n = 11). Before the trial and on the last day of medication, 24-h intragastric pH and oesophageal pH profiles were performed. Healing was assessed by endoscopy. Pantoprazole increased median gastric pH from 1.7 to 3.9. Virtually no change in gastric pH was seen in the ranitidine group. Pantoprazole reduced the fraction time of pH < 4 in the oesophagus from 21% to 3% (P = 0.0005), and the median number of refluxes from 206 to 56 (P = 0.022). Oesophageal acid exposure was not decreased by ranitidine. Healing of the oesophagitis was seen in 6/11 cases after pantoprazole and in 3/13 cases after ranitidine (N.S.) In patients with oesophagitis of moderate and severe grade, pantoprazole 40 mg o.m. decreases intragastric acidity and gastro-oesophageal acid reflux more effectively than ranitidine 150 mg b.d.",1997.0,0,1
1139,9354209,Effects of oral rabeprazole on oesophageal and gastric pH in patients with gastro-oesophageal reflux disease.,M Robinson; P N Maton; S Rodriguez; B Greenwood; T J Humphries,"This study examined the dose-response effects of the new proton-pump inhibitor rabeprazole on oesophageal and gastric pH in patients with gastro-oesophageal reflux disease. This study had a single-centre, double-blind, randomized, two-way crossover design. Twenty patients were treated for two 7-day periods separated by a 7-10-day washout period. Patients were randomly assigned to receive either 20 mg of rabeprazole once daily during the first treatment period and 40 mg once daily during the second treatment period, or 40 mg during the first treatment period and 20 mg during the second treatment period. The primary efficacy variable was oesophageal acid exposure determined by 24-hour ambulatory pH monitoring. Acid-reflux time was defined as the percentage of time over 24 h that oesophageal pH was < 4. A dosage was considered effective if reflux time was reduced to < 6%, a number which has been our internal laboratory reference. Both rabeprazole 20 mg and 40 mg, given once daily, normalized reflux time, with decreases of 79% and 92% in acid exposure by day 7. Both dosages also decreased the mean total number of reflux episodes and the number of episodes lasting > 5 min, with no significant differences between dosages for any reflux parameter. Mean gastric pH increased with 20 mg from 1.86 at baseline to 3.71 on day 1 and 4.17 on day 7. Rabeprazole 40 mg once daily increased gastric pH from 2.01 to 4.37 on day 1, and to 4.65 on day 7. Safety analyses revealed no significant acute side-effects for either dosage. Pathological oesophageal acid exposure was normalized with both 20 mg and 40 mg dosages of rabeprazole, and the effects of these two doses did not differ. Rabeprazole was well-tolerated in this short-term study.",1997.0,0,1
1140,9356879,Can optimal acid suppression prevent rebleeding in peptic ulcer patients with a non-bleeding visible vessel: a preliminary report of a randomized comparative study.,H J Lin; W C Lo; C L Perng; K Wang; F Y Lee,"The hypothesis that profound acid suppression might prevent clot lysis and thus benefit patients with a non-bleeding visible vessel has not been confirmed. Omeprazole can suppress gastric acid remarkably and may be beneficial for patients with peptic ulcer bleeding. Fifty-two patients with a non-bleeding visible vessel at the ulcer base were enrolled and randomized into four groups (N = 13 in each group). In the cimetidine group, the patients received cimetidine 300 mg i.v. bolus followed by 300 mg i.v. every 6 hr during hospitalization. In the heater probe thermocoagulation + cimetidine group, the patients received heater probe thermocoagulation and cimetidine 300 mg i.v. bolus followed by 300 mg i.v. every 6 h during hospitalization. In the omeprazole q.d. group, the patients received omeprazole 40 mg i.v. bolus followed by 40 mg i.v. daily for two days. In the omeprazole q 12 h group, the patients received omeprazole 40 mg i.v. bolus followed by 40 mg i.v. every 12 h for two days. A 24 hr intragastric pH was recorded for every case. The mean 24 hr intragastric pH were higher in the omeprazole q.d. (mean 5.8) and the omeprazole q 12 h groups (mean 6.4) than in the cimetidine (mean 4.3) and the heater probe thermocoagulation + cimetidine groups (mean 4.9) (p < 0.05). Rebleeding occurred in 5, 2, 2 and 2 patients in the cimetidine, heater probe thermocoagulation + cimetidine, omeprazole q.d., and omeprazole q 12 h groups, respectively (p > 0.05). Volume of blood transfusion and number of days in hospital were not statistically different among the four groups. Omeprazole can remarkably suppress gastric acid when it is compared to that of the H2 receptor blocker. Patients with a non-bleeding visible vessel using omeprazole do not exhibit a decrease in the rebleeding rate as compared with those patients using cimetidine.",1997.0,0,0
1141,9360828,Advances in the diagnosis and treatment of gastroesophageal reflux disease.,M A Marcon,"Pathophysiology and treatment of gastroesophageal reflux (GER) in children have often been extrapolated from studies in adult patients. Fortunately, many groups are now addressing GER specifically in relation to children. Abnormalities in gastrointestinal motility are described in gastroesophageal reflux GER, and there are several new studies looking at this issue in infantile GER. An international working group has put together recommendations for management of infantile GER. The results of a large pediatric study using omeprazole and a review of the use of the prokinetic cisapride in pediatrics are summarized. Several papers review recent experiences with laparoscopic fundoplication. New diagnostic modalities used to investigate GER in infants and children are discussed. These studies aid in both our understanding of possible pathogenesis of GER as well as treatment of the young patient with GER.",1997.0,0,0
1142,9361167,"Omeprazole 10 milligrams once daily, omeprazole 20 milligrams once daily, or ranitidine 150 milligrams twice daily, evaluated as initial therapy for the relief of symptoms of gastro-oesophageal reflux disease in general practice.",T L Venables; R D Newland; A C Patel; J Hole; C Wilcock; M L Turbitt,"The efficacy of omeprazole, 20 mg once daily, in the treatment of reflux oesophagitis and the therapeutic advantages over the histamine H2 receptor antagonists are well documented. This study assessed 20 mg omeprazole daily (OM20), 10 mg omeprazole daily (OM10), and 150 mg ranitidine (RAN) twice daily for symptom relief in gastro-oesophageal reflux disease (GORD). Patients (n = 994) presenting with heartburn to their general practitioner underwent endoscopy to exclude peptic ulcer disease and were randomized into a UK, multicentre, parallel-group, double-blind comparison of the three treatments for 4 weeks. Symptoms were assessed at clinic visits after 2 and 4 weeks. Symptom relief after 4 weeks was achieved by 61% (OM20), 49% (OM10), and 40% (RAN) patients (OM20 versus OM10, P < 0.0167; OM20 versus RAN, P < 0.0001; OM10 versus RAN, P < 0.01). Among the patients (32%) with erosive reflux oesophagitis, symptom relief was achieved in 79% (OM20), 48% (OM10), and 33% (RAN) (OM20 versus OM10, P < 0.0001; OM20 versus RAN, P < 0.0001; OM1O versus RAN, NS). Omeprazole, 20 mg, is the most effective initial therapy for relief of GORD symptoms.",1997.0,0,1
1143,9361168,Heartburn without oesophagitis: efficacy of omeprazole therapy and features determining therapeutic response.,T Lind; T Havelund; R Carlsson; O Anker-Hansen; H Glise; H Hernqvist; O Junghard; K Lauritsen; L Lundell; S A Pedersen; A Stubberöd,"Data are limited on the value of effective antisecretory therapy in the relief of heartburn in patients without oesophagitis. Patients with heartburn, without endoscopic signs of oesophagitis, were randomized to double-blind treatment with omeprazole, 20 or 10 mg once daily, or placebo, for 4 weeks (n = 509). Pre-treatment oesophageal acid exposure was assessed using 24-h intra-oesophageal pH monitoring. Heartburn was assessed at 2 and 4 weeks. At 4 weeks the proportion of patients with complete absence of heartburn was 46% (95% confidence interval, 39-53%) with 20 mg omeprazole, 31% (25-38%) with 10 mg omeprazole, and 13% (7-20%) with placebo. Satisfaction with therapy was reported by 66%, 57%, and 31% of the patients, respectively. Omeprazole, 20 and 10 mg once daily, provides rapid relief of heartburn in patients without endoscopic oesophagitis.",1997.0,0,0
1144,9362172,Treatment versus management of gastroesophageal reflux disease.,P J Kahrilas,,1997.0,0,0
1145,9362179,Omeprazole as a diagnostic tool in gastroesophageal reflux disease.,B E Schenk; E J Kuipers; E C Klinkenberg-Knol; H P Festen; E H Jansen; H A Tuynman; M Schrijver; L A Dieleman; S G Meuwissen,"To determine the diagnostic value of empirical treatment with omeprazole in the diagnosis of gastroesophageal reflux disease (GERD). Patients with symptoms suggestive of GERD underwent upper gastrointestinal endoscopy and 24-h esophageal pH monitoring. Patients with reflux esophagitis grade 0 or 1 were included in the study and were randomized to double-blind treatment with either 40 mg omeprazole or placebo o.m. The effect of treatment was evaluated after 1 and 2 wk with a symptom questionnaire with a four-grade Likert scale, and symptomatic response outcome was compared with the results of 24-h pH-metry. Ninety-eight patients were included; however, 13 were excluded from the final analysis because of protocol violation. Of the remaining 85 patients, 54 had no signs of esophagitis at endoscopy, and 31 had esophagitis grade 1. The pH registration showed pathological gastroesophageal reflux in 47 patients (55%). Forty-one patients were randomized to treatment with omeprazole and 44 to placebo. There was a significant correlation between the pH registration result and response to omeprazole (p = 0.04, chi2), but not to placebo (p = 0.16). With pH-metry as the gold standard, the omeprazole test had positive and negative predictive values of 68% and 63%, respectively, for the diagnosis of GERD. When the omeprazole test was used as the gold standard, the positive and negative predictive values of pH monitoring were 68 % and 63 %, respectively. Similar sensitivity was found when the pH-metry was compared with presence of esophagitis. Determination of the symptomatic response to 40 mg of omeprazole for 14 days is a simple and inexpensive tool for the diagnosis of GERD, with a sensitivity and specificity comparable to 24-h pH monitoring.",1997.0,0,1
1146,9362183,Immediate eradication of Helicobacter pylori in patients with previously documented peptic ulcer disease: clinical and economic effects.,A M Fendrick; J T McCort; M E Chernew; R A Hirth; C Patel; B S Bloom,"The clinical and economic benefits of Helicobacter pylori eradication for patients with newly diagnosed peptic ulcer disease are widely accepted. The objective of this study was to estimate the cost-effectiveness of H. pylori eradication in the large cohort of asymptomatic patients receiving maintenance antisecretory therapy for a previously documented peptic ulcer disease. A decision analytic model estimated the clinical and economic effects of two management strategies for asymptomatic patients receiving maintenance antisecretory therapy for a previously documented peptic ulcer: strategy 1-immediate H. pylori eradication therapy and cessation of maintenance therapy, and strategy 2-continued-maintenance antisecretory therapy, with H. pylori eradication therapy reserved for the first symptom recurrence. At 1 yr, the model estimated that immediate H. pylori eradication therapy (strategy 1) led to 22% fewer months with ulcers (28.7 vs. 36.8 ulcer months/100 patient years), 10% fewer months with ulcer symptoms (21.0 vs. 23.1 symptom months/100 patient years), and 24% lower per-patient expenditures ($587 vs. $767/patient year) than maintenance antisecretory therapy and symptom-based H. pylori eradication (strategy 2). Immediate H. pylori eradication, however, resulted in 14% more months with upper gastrointestinal symptoms from all causes (37.9 vs. 33.2 symptom months/100 patient years) than strategy 2, because maintenance antisecretory therapy was effective in treating symptoms due to causes other than peptic ulcer disease. Ulcer-related outcomes of asymptomatic patients receiving maintenance antisecretory agents for peptic ulcer disease can be improved with immediate H. pylori eradication at reduced cost. Therefore, H. pylori eradication should be aggressively pursued in all patients-symptomatic or not-with previously documented peptic ulcers, who are receiving maintenance antisecretory therapy.",1997.0,0,1
1147,9362185,Omeprazole plus clarithromycin and either tinidazole or tetracycline for Helicobacter pylori infection: a randomized prospective study.,A Zullo; V Rinaldi; F Pugliano; F Diana; A F Attili,"Helicobacter pylori has begun to show resistance to imidazoles and could result in the low efficacy of short-term triple therapy. The aim of this study was to assess whether administration of tetracycline instead of tinidazole in short-term low-dose triple therapy could increase the H. pylori eradication rate. In a prospective study, 113 patients with peptic ulcer (n = 36) or non-ulcer dyspepsia (n = 77) were randomized to receive 1-wk treatment, composed of omeprazole 20 mg b.i.d., clarithromycin 250 mg b.i.d., and either tinidazole 500 mg b.i.d. (n = 57) or tetracycline 500 mg b.i.d. (n = 56), upon detection of H. pylori infection at endoscopy. H. pylori eradication, defined as a negative bacterial finding in a rapid urease test and upon histologic assessment at least 4 wk after cessation of therapy, was achieved in 86% (49 of 57; 95% confidence interval = 76.9-95) of patients in the first group and in 71.4% (40 of 56; 95% confidence interval = 59.6-83.3) in the second group (p = not significant). Side effects occurred in 28% of patients from the tinidazole-based group and in 12.5% from the tetracycline group (p = not significant). Two patients in the tinidazole group discontinued therapy at 5 and 6 days because of side effects. The administration of tetracycline instead of tinidazole in short-term triple therapy yielded disappointing results in H. pylori eradication.",1997.0,0,0
1148,9377618,Lansoprazole compared with histamine2-receptor antagonists in healing gastric ulcers: a meta-analysis.,S R Tunis; I A Sheinhait; C H Schmid; D J Bishop; S D Ross,"To compare the gastric ulcer healing rates of lansoprazole with histamine2-receptor antagonists (H2RAs) (ranitidine, famotidine, cimetidine, and roxatidine), a meta-analysis was performed using data from five published and eight unpublished randomized controlled trials. Analyses were performed using (1) both evaluable patients (n = 1527) and all randomized patients (n = 1655) (assuming that patients lost to follow-up were treatment failures); (2) all studies and a subset of studies that received high methodologic quality scores; and (3) fixed-effects, random-effects, and Bayesian statistical models. In all cases, lansoprazole was associated with a significantly higher rate of endoscopic healing at both 4 and 8 weeks compared with the H2RAs. When the most conservative Bayesian statistical model and intent-to-treat analysis were used, lansoprazole was associated with a 33% higher healing rate at 4 weeks (risk ratio = 1.33; 95% confidence interval [CI] = 1.19 to 1.49) and a 12% higher healing rate at 8 weeks (risk ratio = 1.12; 95% CI = 1.06 to 1.19) than were the H2RA agents. Similar results were obtained when the meta-analysis was performed on evaluable rather than all randomized patients and using the three different analytical techniques noted above. Slightly lower, though still highly significant, improvement in ulcer healing rates was obtained when the meta-analysis was performed using a subset of six studies that received high methodologic quality scores. These results support the conclusion that lansoprazole heals ulcers more quickly than do the H2RAs and also achieves higher overall rates of healing. The eradication of Helicobacter pylori associated with gastric ulcers was not assessed in individual studies.",1997.0,0,1
1149,9379150,Omeprazole maintenance therapy for GERD.,S M Parks,,1998.0,0,0
1150,9382084,Pantoprazole versus omeprazole in one-week low-dose triple therapy for curve of H. pylori infection.,R J Adamek; C Szymanski; B Pfaffenbach,,1997.0,1,1
1151,9385479,High eradication rate of Helicobacter pylori using a four-drug regimen in patients previously treated unsuccessfully.,M Tzivras; V Balatsos; S Souyioultzis; M Tsirantonaki; N Skandalis; A Archimandritis,"The objective of this study was to assess the efficacy of a new regimen in eradicating Helicobacter pylori (Hp) in patients with duodenal ulcer (DU) who were previously treated unsuccessfully with standard triple therapy (tripotassium dicitratobismuthate [TDB] 120 mg QID, metronidazole 500 mg TID, and tetracycline 500 mg QID) or proton-pump inhibitor (PPI) dual therapy (omeprazole 20 mg BID and amoxicillin 500 mg QID). The study included 133 consecutive patients aged 17 to 83 years with endoscopically diagnosed DU (diameter > or = 5 mm) in whom standard triple therapy or PPI dual therapy had failed to eradicate Hp. A rapid urease (CLO) test was performed on four biopsy specimens at study entry and at least 1 month after the end of treatment to confirm Hp colonization and eradication, respectively. Patients were considered to be Hp positive if any CLO test was positive within 2 hours, and Hp was considered to be eradicated if all CLO tests were still negative after 24 hours. In 31 randomly selected patients, Hp eradication was confirmed histologically as well. Patients were given omeprazole 60 mg/d (20 mg in the morning and 40 mg in the evening) plus amoxicillin 500 mg QID for 10 days and subsequently were given metronidazole 500 mg TID for 10 days plus TDB 120 mg QID for 6 weeks. One hundred and twenty-four patients were followed up; five (4%) withdrew because of side effects (protracted diarrhea, stomatitis, skin rashes). Per-protocol analysis showed Hp eradication in 113 of 119 patients (95%) and ulcer healing in 118 of 119 (99%). Intent-to-treat analysis showed an Hp eradication rate of 85% (113 of 133 patients) and an ulcer healing rate of 89% (118 of 133 patients). In per-therapy analysis, the Hp eradication rate was 91% (113 of 124 patients), and the ulcer healing rate was 95% (118 of 124 patients). Side effects were observed in 39 of 119 patients (33%) and were generally mild. The four-drug regimen used in this study, when given to patients previously treated unsuccessfully with standard triple therapy or PPI dual therapy, was highly effective in eradicating Hp and healing DUs and had no major side effects.",1998.0,0,0
1152,9385855,,,,,0,0
1153,9398875,"Double-blind, multicenter evaluation of lansoprazole and amoxicillin dual therapy for the cure of Helicobacter pylori infection.",W Harford; F Lanza; A Arora; D Graham; M Haber; A Weissfeld; P Rose; N Siepman,"Treatment with amoxicillin plus omeprazole results in disappointing cure rates of Helicobacter pylori infection. The minimal inhibitory concentration of lansoprazole for H. pylori in vitro is lower than that for omeprazole, prompting interest in treatment with amoxicillin plus lansoprazole. H. pylori-infected patients with endoscopically documented duodenal ulcer either currently or within the past year were randomized to 14 days of (1) lansoprazole, 30 mg bid, plus amoxicillin, 1 gm tid; (2) lansoprazole, 30 mg tid, plus amoxicillin, 1 gm tid; (3) lansoprazole, 30 mg tid alone; or (4) amoxicillin, 1 gm tid alone. Endoscopy was done at enrollment and at 4 to 6 weeks after completion of treatment or for recurrent symptoms. H. pylori status was assessed by culture and histology. Ulcer prevalence was evaluated at follow-up endoscopy. Two hundred sixty-two patients met enrollment criteria and were treated. By per-protocol analysis, H. pylori infection was cured in 57% of those treated with lansoprazole twice daily plus amoxicillin and in 67% of those treated with lansoprazole three times daily plus amoxicillin, compared with 0% treated with lansoprazole alone or amoxicillin alone (p < .001 for dual therapy versus either monotherapy). Amoxicillin resistance was not observed. At follow-up endoscopy, ulcer prevalence was 17% in patients treated with lansoprazole twice daily plus amoxicillin, 23% in those treated with lansoprazole three times daily plus amoxicillin, 33% in those treated with lansoprazole alone, and 35% in those treated with amoxicillin alone (p = .024; lansoprazole twice daily plus amoxicillin versus amoxicillin alone). Treatment with amoxicillin plus lansoprazole, 30 mg tid, led to cure of H. pylori infection in 67% of patients with active or recently healed duodenal ulcer.",1997.0,0,0
1154,9398878,"Duodenal ulcer healing after 7-day treatment: a pilot study with lansoprazole, amoxicillin, and clarithromycin.",B K Jaup,,1997.0,0,0
1155,9398891,Quadruple therapy: the golden bullet or a drug too far?,P Moayyedi,,1997.0,0,0
1156,9398893,"Double-blind, multicenter, placebo-controlled evaluation of clarithromycin and omeprazole for Helicobacter pylori-associated duodenal ulcer.",C O'Morain; A Dettmer; A Rambow; E von Fritsch; A G Fraser,"Eradication of Helicobacter pylori leads to faster ulcer healing and a significant decrease in ulcer recurrence. Clarithromycin is the most effective monotherapy for eradicating H. pylori from the gastric mucosa, and omeprazole frequently is used for the treatment of duodenal ulcer disease, prompting the interest to investigate rigorously the combination of clarithromycin and omeprazole for eradicating H. pylori. The aim of this double-blind, randomized, multicenter (n = 30), multinational (n = 10) study was to compare clarithromycin and omeprazole with omeprazole monotherapy for the eradication of H. pylori from the gastric mucosa, endoscopic healing, and reduction of symptoms and ulcer recurrence in patients with active duodenal ulcer. Patients with active duodenal ulcer associated with H. pylori infection were randomized to receive omeprazole, 40 mg every morning for 14 days, with either clarithromycin, 500 mg, or placebo three times daily, which was followed by omeprazole, 20 mg every morning for 14 days. Patients underwent endoscopy before enrolling in the study, immediately after finishing treatment, and at 4- to 6-week and 6-month follow-up evaluations or at the recurrence of symptoms. Two hundred and eight patients with active duodenal ulcer associated with confirmed H. pylori infection were randomized to treatment with either clarithromycin and omeprazole (n = 102) or omeprazole and placebo (n = 106). Four to six weeks after treatment was completed, H. pylori was eradicated in 74% (95% confidence interval, 63.0%-82.4%) of patients receiving clarithromycin and omeprazole, compared with 1% (0.0%-6.2%) of patients receiving omeprazole monotherapy (p < .001). Clarithromycin resistance developed in eight patients treated with clarithromycin and omeprazole and in none given omeprazole and placebo. Ulcers, which were healed following treatment in more than 95% of study patients, recurred by the 6-month follow-up visit in 10% (5%-19%) of dual therapy recipients, compared with 50% (39%-61%) of those who took omeprazole alone (p < .001). Clarithromycin and omeprazole dual therapy is simple and well-tolerated and leads to consistently high eradication rates for patients with duodenal ulcer associated with H. pylori infection.",1997.0,0,0
1157,9398894,Eradication of Helicobacter pylori using one-week triple therapies combining omeprazole with two antimicrobials: the MACH I Study.,T Lind; S Veldhuyzen van Zanten; P Unge; R Spiller; E Bayerdörffer; C O'Morain; K D Bardhan; M Bradette; N Chiba; M Wrangstadh; C Cederberg; J P Idström,"Eradication of Helicobacter pylori provides potential cure in the majority of patients with peptic ulcer disease, and eradication rates of more than 90% have been reported, using omeprazole in combination with two antimicrobials. The choice of antimicrobials, dose regimen and duration of treatment have varied between studies, however, and an optimal treatment still has to be established. We conducted an international, randomized, double-blind, placebo-controlled study involving more than 100 patients in each of six treatment groups in 43 hospital gastrointestinal units in Canada, Germany, Ireland, Sweden, and the United Kingdom. Patients (n = 787) with proved duodenal ulcer disease were randomized to treatment twice daily for 1 week with omeprazole, 20 mg (O), plus either placebo (P) or combinations of two of the following antimicrobials: amoxicillin, 1 gm (A), clarithromycin, 250 or 500 mg (C250, C500), or metronidazole, 400 mg (M). Eradication of H. pylori was evaluated by 13C-UBT, performed before and 4 weeks after treatment cessation. The eradication rates for the all-patients-treated analysis were 96%, OAC500; 95%, OMC250; 90%, OMC500; 84%, OAC250; 79%, OAM; and 1%, OP. OAC500 and OMC250 achieved eradication rates with lower 95% confidence interval limits exceeding 90%. All regimens were well-tolerated, 96% of patients complied with their dose regimen, and 2.3% of the patients discontinued treatment owing to adverse events. Omeprazole triple therapies given twice daily for 1 week produce high eradication rates, are well-tolerated, and are associated with high patient compliance. The two most effective therapies were those combining omeprazole, 20 mg, with either amoxicillin, 1 gm, plus clarithromycin, 500 mg, or metronidazole, 400 mg, plus clarithromycin, 250 mg, all given twice daily.",1997.0,0,0
1158,9398895,"Effectiveness of quadruple therapy using lansoprazole, instead of omeprazole, in curing Helicobacter pylori infection.",W A de Boer; R J van Etten; J Y Lai; P M Schneeberger; B A van de Wouw; W M Driessen,"Omeprazole enhances the efficacy of bismuth-based triple therapy. It is unknown whether the same is true for other proton pump inhibitors. Lansoprazole has superior anti-Helicobacter activity in vitro and possibly also in vivo; therefore we investigated quadruple therapy with lansoprazole. In two studies performed in separate hospitals, a total of 67 Helicobacter pylori-positive patients were treated with 7-day quadruple therapy (lansoprazole, colloidal bismuth subcitrate, tetracycline, and metronidazole) after 3 days of lansoprazole pretreatment. Testing for cure was done by endoscopy in study 1 and by breath test in study 2. Cure rates per protocol were 31 of 31 (100%) in study 1 and 30 of 32 (94%) in study 2. Intention-to-treat cure rates were 31 of 35 (89%) in study 1 and 30 of 32 (94%) in study 2. Cured overall were 32 of 34 with a metronidazole sensitive strain and 3 of 3 with a metronidazole-resistant strain. Data on side effects were collected from 51 patients. Twelve (21%) had no side effects, 27 (53%) had mild side effects, 10 (20%) had moderate side effects, but only 2 (4%) had severe side effects. Side effects, never were the reason that a patient stopped taking the medication. The results with lansoprazole-quadruple therapy are comparable to the historic control group treated with omeprazole-quadruple therapy. The cure rare is very high, and although mild to moderate side effects occurred in many patients, everybody finished the treatment regime.",1997.0,0,1
1159,9399390,The effect of cisapride in maintaining symptomatic remission in patients with gastro-oesophageal reflux disease.,J G Hatlebakk; F Johnsson; M Vilien; L Carling; S Wetterhus; T Thøgersen,"Successful treatment of gastro-oesophageal reflux disease (GORD) has traditionally been assessed as healing of reflux oesophagitis, which may not be relevant in patients with moderate disease. In these patients symptom relief and patient satisfaction with therapy are of fundamental importance. Cisapride has well-documented prokinetic effects and may be well suited for long-term therapy of GORD, but its effectiveness in purely symptomatic treatment is unknown. We therefore compared two dosage regimens of cisapride with placebo over a period of 6 months in patients with evidence of gastrooesophageal reflux, initially treated with antisecretory medication, with regard to maintaining symptom relief and satisfaction with treatment. Five hundred and thirty-five patients with reflux oesophagitis grade 1 (n = 293) or 2 (n = 124) or with no reflux oesophagitis but pathologic 24-h pH-metry (n = 118) achieved satisfactory symptom relief with an H2-receptor antagonist or proton pump inhibitor within 4-8 weeks. In a double-blind randomized, parallel-group study, they were then treated with cisapride, 20 mg at night or 20 mg twice daily, or placebo and followed up for a maximum period of 6 months. Relapse was defined as dissatisfaction with therapy or an average consumption of more than two antacid tablets a day. Median time to relapse was 63 days for cisapride, 20 mg twice daily; 59 days for cisapride, 20 mg at night; and 49 days for placebo. Time to relapse was not significantly different (P = 0.09). Presence and grade of oesophagitis at base line, type of therapy before randomization, and pattern of non-reflux symptoms at base line did not influence these findings significantly. The study indicates that cisapride is of limited value in maintenance therapy of GORD in patients in whom symptom relief has been accomplished with potent antisecretory medication. This 'step-down' approach to therapy seems disadvantageous in the long-term therapy of GORD.",1997.0,0,0
1160,9399741,"Unresolved issues in gastroesophageal reflux-related ear, nose, and throat problems.",J E Richter; D M Hicks,,1997.0,0,0
1161,9399748,Proton pump inhibitors or histamine-2 receptor antagonists for the prevention of recurrences of erosive reflux esophagitis: a cost-effectiveness analysis.,R A Harris; M Kuppermann; J E Richter,"Erosive esophagitis is a recurring condition for which many patients require preventive therapy. If maintenance therapy must be provided, the most cost-effective treatment strategy should be established. We evaluated the costs and benefits associated with three treatment strategies: 1) maintenance therapy with a proton pump inhibitor (PPI) strategy, 2) maintenance therapy with a high-dose histamine-2 receptor antagonist (H2RA) strategy, and 3) maintenance therapy with a standard-dose H2RA. If patients experience a symptomatic recurrence on the H2RA strategies, they then receive PPI maintenance. We used a cost-effectiveness model with a 1-yr time frame; data were obtained from randomized trials of lansoprazole and ranitidine, from case series, and expert opinion. In most situations, the high-dose H2RA strategy is the most costly, yet it is less effective than the PPI strategy. Among the remaining two options, the PPI strategy is more costly and more effective than the standard-dose H2RA strategy, requiring an additional $52-688 per recurrence prevented, depending on drug acquisition costs. The greater the degree to which esophagitis decreases quality of life, the more cost effective is the PPI strategy. For example, with a $50,000 per quality-adjusted life year cost-effectiveness threshold and a market-weighted average of drug costs, the PPI strategy appears cost effective for those patients who report that symptoms of esophagitis cause greater than a 9% decrement in quality of life. The high-dose H2RA strategy is not preferred in terms of either costs or benefits. The PPI strategy appears cost effective relative to the standard-dose H2RA strategy in the following situations: when patients are significantly bothered by esophagitis and in institutional settings where the difference in drug costs between PPIs and H2RAs is small.",1997.0,0,1
1162,9399755,Randomized comparison of ranitidine bismuth citrate-based triple therapies for Helicobacter pylori.,L Laine; R Estrada; M Trujillo; S Emami,"In an attempt to increase the efficacy and simplicity of FDA-approved regimens for Helicobacter pylori, we studied (1) addition of an inexpensive antibiotic (amoxicillin) to twice-daily ranitidine bismuth citrate (RBC)-clarithromycin dual therapy, and (2) substitution of RBC for bismuth subsalicylate + H2-receptor antagonist in bismuth-based triple therapy. Subjects with previously untreated Helicobacter pylori infection documented by 13C-urea breath test plus either endoscopic biopsy or serology were randomly assigned to a 2-wk course of (1) RBC 400 mg b.i.d., amoxicillin 1 g b.i.d., and clarithromycin 500 mg b.i.d. (RAC), or (2) RBC 400 mg b.i.d., metronidazole 250 mg t.i.d., and tetracycline 500 mg t.i.d. (RMT). Repeat breath test was performed 4 wk after the completion of therapy. Intent-to-treat and per-protocol cure rates for RAC were 46 of 50 patients (92%) and 45 of 47 patients (96%); for RMT they were 40 of 50 patients (80%) and 37 of 42 patients (88%). Study drugs were stopped due to side effects in three patients (6%) taking RAC and six patients (12%) taking RMT. Twice-daily RBC-based triple therapy with clarithromycin and amoxicillin produces Helicobacter pylori eradication rates over 90%, which is comparable to rates seen with proton pump inhibitor-based triple therapies. RBC also may be substituted for bismuth subsalicylate and an + H2-receptor antagonist in standard bismuth-based triple therapy.",1997.0,0,0
1163,9399786,Acid control and regression of Barrett's esophagus: is the glass half full or half empty?,D O Castell; P O Katz,,1997.0,0,0
1164,9402342,Helicobacter pylori infection in Chile.,G Figueroa; R Acuña; M Troncoso; D P Portell; M S Toledo; J Valenzuela,"This article summarizes studies designed to evaluate the role of Helicobacter pylori infection in Chile, described in 21 reports from nine centers in various Chilean regions published between 1985 and 1995. According to their data, H. pylori infection is quite frequent among patients with a variety of gastric conditions, including adults (43%-92%) and children (6%-100%). Levels of specific IgG antibodies to H. pylori are also elevated among patients with duodenal ulcers (100%) and gastritis (86%) as well as asymptomatic adults (75%). Combination therapy with three (but not two) drugs has been proved effective, with clinical improvement, ulcer cure, and H. pylori eradication occurring in well-controlled studies. Available evidence suggests that antibiotic resistance is not a major problem in treatment. The H. pylori reinfection rate is low (4.2% per year), suggesting that combination therapy with three drugs constitutes a cost-effective alternative for treating colonized symptomatic patients. Concurrent preliminary studies revealed that antibodies to VacA but not CagA proteins correlate with disease severity in Chilean patients. It can be concluded that local research assists local administrators of health resources to implement adequate policies to prevent, control, and treat H. pylori-related pathologies.",1997.0,0,0
1165,9421117,Clarithromycin dual therapy regimens for eradication of Helicobacter pylori: a review.,G A Pipkin; J S Dixon; R Williamson; J R Wood,"Peptic ulcer disease can be cured by eradication of Helicobacter pylori during treatment to heal the ulcer. Dual therapy regimens were among the first to be granted approval for use. Reports of dual therapies including clarithromycin as the sole antibiotic are reviewed. Reports were identified from literature up to May 1997. Information reviewed included patient population, medical diagnosis, trial design, eradication regimens, and H. pylori eradication rates. The great diversity between studies limits formal meta-analysis but a measure of relative efficacy has been obtained by comparison of eradication rates derived by clearly defined methods and by pooling data. Seventy-five reports of trials with 104 dual therapy treatment arms were reviewed. H. pylori eradication rates reported with ranitidine bismuth citrate plus clarithromycin range from 70-96% with a pooled observed rate of 85%. With omeprazole plus clarithromycin, reported eradication rates range from 27-90% with the pooled reported rate being 66%. Few data are available with either lansoprazole or ranitidine hydrochloride plus clarithromycin. High H. pylori eradication rates derived by consistent and clearly defined methods have been seen with ranitidine bismuth citrate plus clarithromycin. Lower and more variable rates are reported with clarithromycin and either a proton pump inhibitor or a histamine H2-receptor antagonist.",1998.0,0,0
1166,9421124,One week triple therapy for Helicobacter pylori: does high-dose clarithromycin confer additional benefit?,H J O'Connor; J Loane; H Bindel; A S Bhutta; K Cunnane,"Clarithromycin, a new acid stable macrolide antibiotic with proven efficacy against Helicobacter pylori, has been widely incorporated into eradication regimens but its optimal dosage schedule remains controversial. The standard dose of clarithromycin is 250 mg twice daily. In a prospective study designed to evaluate the helicobactericidal efficacy, patient acceptability, and ulcer healing efficacy of a triple therapy regimen incorporating high dose clarithromycin, 100 consecutive patients with H. pylori-positive peptic ulcer received omeprazole 20 mg twice daily in combination with metronidazole 400 mg twice daily and clarithromycin 500 mg twice daily for seven days. H. pylori status was assessed before and at least 4 weeks after therapy by rapid urease test and histology. Adverse events and compliance were assessed by direct questioning. Only two patients failed to attend for repeat endoscopy, leaving 98 evaluable patients. Of these, 94 were H. pylori-negative after therapy, giving an intention-to-treat eradication rate of 94% (95% confidence interval, 89%-99%). The ulcer healing rate was 92% (86%-98%), and ulcer healing was significantly associated with H. pylori eradication (p < 0.01). Adverse events were reported by 33% of patients of which nausea was the commonest (14%). Noncompliance with therapy was significantly associated with H. pylori treatment failure (p < 0.001). Seven day triple therapy incorporating high dose clarithromycin effectively eradicates H. pylori and heals ulcers, but it is disadvantaged by a relatively high rate of adverse events. In view of these findings and the fact that no direct comparison to date has shown increased efficacy from high dose clarithromycin, we would recommend continued use of low dose clarithromycin when combined with omeprazole and a nitroimidazole.",1998.0,0,0
1167,9425843,Lansoprazole potentiates vecuronium paralysis.,S M Ahmed; C Panja; R M Khan; S Bano,"The effect of lansoprazole, a newer second generation proton pump inhibitor, on vecuronium induced muscle paralysis was evaluated. Fifty adult patients comprising grade I (normal healthy patient) and grade II (patient with a mild systemic disease) as classified by the American Society of Anesthesiologists were randomly allocated into two different groups each consisting of 25 patients. Group I (control) did not receive lansoprazole and group II (study) received 30 mg lansoprazole in the night before operation. There was no statistically significant difference (p > 0.05) in the time required for complete paralysis between group I (215.7 +/- 15.19 seconds) and group II (197.5 +/- 14.13 seconds). However, the duration of paralysis was significantly different (p < 0.05) between group I (32.7 +/- 8.7 minutes) and group II (43.9 +/- 9.3 minutes). It was concluded that there is a potential for interactions and one should carefully and closely monitor the patients to prevent prolonged paralysis in patients receiving lansoprazole, as a pre-anaesthetic medication.",1998.0,0,1
1168,9432316,Time of Helicobacter pylori eradication assessment following treatment.,G A Neil; L J Suchower; P D Ronca; M L Skoglund,"The most appropriate time to assess accurately Helicobacter pylori eradication following treatment has been debated, with recommendations ranging from 1 to 3 months. The purpose of this study was to validate the assessment of H. pylori eradication 1 month following treatment. Three randomized, double-blind, active-controlled clinical trials were conducted in patients with endoscopically verified, active duodenal ulcers and H. pylori infection. Patients were treated with various treatment regimens of omeprazole plus amoxicillin. Ulcer healing, H. pylori eradication, and ulcer relapse were examined. Patients underwent repeat endoscopy and biopsy at 1 and 6 months following treatment (or sooner if symptoms returned) to determine the recurrence of ulcers and H. pylori status. To determine the accuracy of measuring H. pylori eradication at 1 month posttreatment, we compared the H. pylori status at 1 month and 6 months following treatment. In a combination of treatment groups and studies, a total of 384 evaluable patients represented data at both time points and were included in the analysis. Of those eradicated at 1 month posttreatment, 94% (141 of 150) remained eradicated at 6 months posttreatment. The proportion of patients with H. pylori eradicated at 1 month posttreatment did not differ significantly from that at 6 months posttreatment for each study. The overall efficiency of the two tests (agreement between tests) was 93% (359 of 384). Agreement between the 1-month and 6-month posttreatment H. pylori assessment was apparent, regardless of the treatment used. H. pylori eradication measured 1 month following cessation of treatment accurately reflects successful treatment of the infection.",1998.0,0,0
1169,9432318,Effects of smoking on cure of Helicobacter pylori infection and duodenal ulcer recurrence in patients treated with clarithromycin and omeprazole.,K D Bardhan; D Y Graham; R H Hunt; C A O'Morain,"Smoking may affect adversely the cure rate for Helicobacter pylori infection in patients treated with amoxicillin and omeprazole. Therapy with clarithromycin and omeprazole was tested for its effectiveness in the treatment of H. pylori infection in smokers and nonsmokers. Patients with verified duodenal ulcer and H. pylori infection received clarithromycin 500 mg tid, in combination with omeprazole 40 mg/ day, for 2 weeks, followed by omeprazole (20 or 40 mg daily) for 2 additional weeks according to a randomized, double-blind, multicenter design. Patients were analyzed by their smoking status for the cure of H. pylori infection, ulcer healing, and prevention of duodenal ulcer recurrence. After treatment with clarithromycin and omeprazole, H. pylori infection was cured in 71% of the smokers and in 77% of the nonsmokers (evaluated 4-6 weeks after treatment). Overall ulcer healing was 95%, and overall ulcer recurrence was 19%. For H. pylori-negative patients, ulcer recurrence was 12% in both smokers and nonsmokers. None of these values was significantly different when smokers were compared to nonsmokers. Therapy with clarithromycin and omeprazole is effective for cure of H. pylori infection in smokers and nonsmokers. Smoking has no effect on duodenal ulcer healing or duodenal ulcer recurrence for patients treated with this regimen.",1998.0,0,0
1170,9432335,Omeprazole-based dual and triple therapy for the treatment of Helicobacter pylori infection in peptic ulcer disease: a randomized trial.,O Pieramico; M V Zanetti; M Innerhofer; P Malfertheiner,"It was our goal to evaluate the efficacy and safety and patient compliance with omeprazole-based dual and triple therapy for eradication of Helicobacter pylori in peptic ulcer disease. One hundred seventy-five consecutive patients with H. pylori infection and associated active peptic ulcer were included. H. pylori infection was assessed by rapid urease test and histological analysis. Patients were randomized among three treatments: group 1 (56 patients): omeprazole, 20 mg bid, and amoxicillin, 1 gm bid, for 2 weeks; group 2 (61 patients): omeprazole, 20 mg bid, plus amoxicillin, 1 gm bid, and metronidazole, 500 mg bid, for 1 week; and group 3 (58 patients): omeprazole, 20 mg bid, plus amoxicillin, 1 gm bid, and clarithromycin, 500 mg bid, for 1 week. Ulcer healing and cure of infection were evaluated at 4 to 6 weeks after cessation of therapy. Eradication rate was calculated per-protocol and by an intention-to-treat analysis. At posttreatment endoscopy, duodenal ulcer was healed in 98.3% of patients. Eleven patients (6%) were lost to follow-up. H. pylori infection was treated successfully in 55% (95% confidence interval [CI] = 41%-69%) of patients of group 1; 86% (95% CI = 77%-95%) of group 2 (p < .001 vs. group 1); and 93% (95% CI = 85%-100%) of group 3 (p < .001 vs. group 1). On intention-to-treat analysis, eradication was 52%, 80%, and 86% in groups 1, 2, and 3, respectively. A good compliance was observed in more than 90% of patients of all groups. Side effects were reported by 7% of patients in group 1, 9% in group 2, and 11% in group 3. None of the patients stopped therapy because of side effects. Dual-therapy omeprazole-amoxicillin for 2 weeks is associated with significantly lower eradication rate than is 1-week omeprazole-based triple therapies. Triple therapy is well-tolerated and produces side effects similar to those of dual therapy. The highest cure rate of H. pylori infection was achieved with triple therapy of omeprazole, amoxicillin, and clarithromycin for 1 week.",1998.0,0,0
1171,9432342,Sucralfate as an alternative to bismuth in quadruple therapy for Helicobacter pylori eradication.,M G Korman; T D Bolin; J L Engelman; S Pianko,"There are persuasive arguments for treating all patients with Helicobacter pylori-associated peptic ulcer disease. However, the choice of therapeutic regimen remains problematical. Bismuth triple therapy produces greater than 80% cure of H. pylori infection, whereas omeprazole and bismuth quadruple therapy has produced cure rates in excess of 90%. Colloidal bismuth is not available in many countries, hence limiting the use of bismuth-based therapeutic regimens. We substituted widely available sucralfate for bismuth in a quadruple-therapy regimen. We studied 223 consecutive patients with gastritis or peptic ulcer disease in whom H. pyori infection was confirmed by CLOtest (Delta West Ltd., Bentley, WA, Australia) or histological assessment. Successful therapy was validated by the 14C urea breath test 4 to 6 weeks after therapy. Omeprazole, 20 mg was given twice daily for 10 days. After 3 days of omeprazole sucralfate (1 gm qid), tetracycline (500 mg qid) and metronidazole (400 mg tid) were added for 7 days. Therapy was successful in 194 of 223 patients (87%). Compliance was excellent, with only two patients being unable to tolerate therapy. Side effects were minimal and included nausea, vomiting, headache, and vaginal moniliasis. At 6 months' follow-up, 10 of 210 patients (5%) who were previously documented as ""cured"" had a positive breath test. The wide availability of sucralfate in many countries makes it a possible alternative to bismuth for use in proton pump quadruple-therapy regimens, achieving a reasonable cure rate for H. pylori infection.",1998.0,0,0
1172,9432343,Relationship between the efficacy of amoxicillin and intragastric pH for the treatment of Helicobacter pylori infection.,P M Kleveland; H L Waldum; E Brenna; S Aase; J A Maeland,"Proton pump inhibitors are reported to enhance the efficacy of antibiotics in the treatment of Helicobacter pylori infection. An elevated intragastric pH is considered to be an important factor for this increased antimicrobial efficacy. The aim of this study was to assess the effect of different doses of lansoprazole on 24-hour intragastric pH and to correlate the effect of amoxicillin on the cure rate for H. pylori infection with the intragastric pH obtained during lansoprazole treatment. Thirty-six duodenal ulcer patients who tested positively for H. pylori as assessed by a rapid urease test, culture, and histological evaluation were allocated randomly to dual treatment with amoxicillin, 3 gm/day, and lansoprazole in different doses ranging between 30 and 180 mg/day for 2 weeks. A 24-hour intragastric pH measurement was taken in all patients on the fifth day of treatment. H. pylori status was determined by culture and histological workup 6 weeks after cessation of the amoxicillin-lansoprazole medication. The H. pylori infection was treated successfully in 19 of 32 patients who completed the dual therapy (per protocol, 59.4%). The median intragastric pH in patients who were treated successfully was 4.4 (95% confidence interval [CI] = 3.7-4.7), as compared to 4.0 (95% CI = 3.5-4.5) in patients who were not treated successfully (p = .47, Wilcoxon's rank sum test). The median percentage of time that the intragastric pH exceeded 4 was not different in the two groups (p = .77). Administration of lansoprazole in doses exceeding 30 mg induced only a moderate additional increase in intragastric pH. Profound inhibition of gastric acid secretion seems not to be necessary to improve the effect of amoxicillin on the cure rate for H. pylori infection in patients with duodenal ulcers.",1998.0,0,0
1173,9437379,A prospective randomized comparative trial showing that omeprazole prevents rebleeding in patients with bleeding peptic ulcer after successful endoscopic therapy.,H J Lin; W C Lo; F Y Lee; C L Perng; G Y Tseng,"A blood clot in a peptic ulcer is unstable in a low pH environment. The use of omeprazole may prevent rebleeding by elevating intragastric pH in patients with bleeding peptic ulcer after hemostasis has been achieved. To assess the influence of using omeprazole and cimetidine on 24-hour intragastric pH and to determine their ability to prevent rebleeding after having achieved initial hemostasis in patients with active bleeding or nonbleeding visible vessels. One hundred patients with bleeding peptic ulcers who had obtained initial hemostasis were enrolled in this randomized comparative trial. In the cimetidine group (n = 50), a 300-mg intravenous bolus of cimetidine was given, followed by a 1200-mg continuous infusion daily for 3 days. Thereafter, 400 mg of cimetidine was given orally twice daily for 2 months. In the omeprazole group (n = 50), a 40-mg intravenous bolus of omeprazole was given, followed by 160 mg of continuous infusion daily for 3 days. Thereafter, 20 mg of omeprazole was given orally once daily for 2 months. A pH meter was inserted in each patient's fundus under fluoroscopic guidance after the intravenous bolus of cimetidine or omeprazole had been administered. The stigmata of recent hemorrhage before endoscopic therapy in the omeprazole and cimetidine groups were, respectively, spurting (9 vs 12), oozing (4 vs 9), and nonbleeding visible vessel (37 vs 29) (P > .05). The duration of intragastric pH higher than 6.0 was longer in the omeprazole group (mean [+/- SD], 84.4% +/- 22.9%) than that of the cimetidine group (mean [+/- SD], 53.5% +/- 32.3%) (P < .001). Rebleeding occurred in 2 patients (4%) in the omeprazole group and in 12 patients (24%) in the cimetidine group by day 14 after enrollment (P = .004). There was a tendency for patients in the omeprazole group to require less blood transfusion (median, 0 mL; range, 0-2500 mL) than those in the cimetidine group (median, 0 mL; range, 0-5000 mL) (P = .08). The hospital stay and number of operations and mortality rate were similar between both groups. The use of omeprazole is more effective than cimetidine in increasing intragastric pH and reducing rebleeding episodes in patients with bleeding peptic ulcers after successful endoscopic therapy. This suggests that omeprazole should be used routinely after successful endoscopic therapy.",1998.0,0,0
1174,9445108,Treatment of Barrett's esophagus by endoscopic laser ablation and antireflux surgery.,J A Salo; J T Salminen; T A Kiviluoto; A T Nemlander; O J Rämö; M A Färkkilä; E O Kivilaakso; S P Mattila,"The regeneration of intestinal metaplasia by squamous epithelium in 17 patients with Barrett's esophagus after endoscopic laser ablation in a reflux-free environment after successful antireflux surgery was prospectively examined. All patients had antireflux surgery, and healing of reflux was verified at postoperative endoscopy and 24-hour esophageal pH monitoring. Thereafter, in 11 patients, the whole Barrett's epithelium was ablated using endoscopic Nd-YAG laser energy in 1 to 8 sessions (mean, 4). The needed energy was 965 to 11,173 joules (mean 4709), or about 1000 joules per centimeter of Barrett's esophagus. Six patients had no laser ablation but were treated by antireflux surgery and served as a control group. In all laser-treated patients, the regenerated epithelium was histologically of squamous type in the tubular esophagus, but two patients still had intestinal metaplasia in the gastric cardia. In controls, the length of Barrett's esophagus and intestinal metaplasia remained unchanged. The length of follow-up was 26 months after the last laser session and 21 months in the control group. The regenerated esophageal epithelium arising after laser ablation in reflux-free environment surgery is of squamous type. This treatment may have a role in preventing the development of esophageal adenocarcinoma arising in Barrett's esophagus.",1998.0,0,0
1175,9445119,Incidence of infectious complications associated with the use of histamine2-receptor antagonists in critically ill trauma patients.,G E O'Keefe; L M Gentilello; R V Maier,"To determine the impact of histamine2 (H2)-receptor antagonist use on the occurrence of infectious complications in severely injured patients. Some previous studies suggest an increased risk of nosocomial pneumonia associated with the use of H2-receptor blockade in critically ill patients, but other investigations suggest an immune-enhancing effect of H2-receptor antagonists. The purpose of this study was to determine whether H2-receptor antagonist use affects the overall incidence of infectious complications. Patients enrolled in a randomized trial comparing ranitidine with sucralfate for gastritis prophylaxis were examined for all infectious complications during their hospitalization. Data on the occurrence of pneumonia were prospectively collected, and other infectious complications were retrospectively obtained from the medical record. The relative risk of infectious complications associated with ranitidine use and total infectious complications were analyzed. Of 98 patients included, the charts of 96 were available for review. Sucralfate was given to 47, and 49 received ranitidine. Demographic factors were similar between the groups. Ranitidine use was associated with a 1.5-fold increased risk of developing any infectious complication (37 of 47 vs. 26 of 47; 95% confidence interval, 1.04 to 2.28). Infectious complications totaled 128 in the ranitidine-treated group and 50 in the sucralfate-treated group (p = 0.0014). These differences remained after excluding catheter-related infections (p = 0.0042) and secondary bacteremia (p = 0.0046). Ranitidine use in severely injured patients is associated with a statistically significant increase in overall infectious complications when compared with sucralfate. These results indicate that ranitidine should be avoided where possible in the prophylaxis of stress gastritis.",1998.0,0,0
1176,9448162,Should we abandon metronidazole containing Helicobacter pylori treatment regimens? The clinical relevance of metronidazole resistance.,M B Fennerty,,1998.0,0,0
1177,9448170,Randomized clinical trial comparing two one-week triple-therapy regimens for the eradication of Helicobacter pylori infection and duodenal ulcer healing.,M Forné; J M Viver; M Esteve; F Fernández-Bañares; J Lite; J C Espinós; S Quintana; A Salas; J Garau,"One-week triple therapy has been shown to be effective in Helicobacter pylori eradication and duodenal ulcer healing. However, the optimal therapeutic combination has not yet been identified. Bismuth-containing regimens have the advantage of requiring only one antibiotic. It has been suggested that high doses of omeprazole improve the bactericidal efficacy of antimicrobial regimens against H. pylori. We evaluated the efficacy of two 1-wk triple-therapy regimens for H. pylori eradication and duodenal ulcer healing. On an intention-to-treat basis, 182 patients with H. pylori-associated duodenal ulcer were randomized. Group OCB patients (n = 91) were given omeprazole 40 mg b.i.d., clarithromycin 500 mg b.i.d., and colloidal bismuth subcitrate 120 mg q.i.d. for 7 days. Group OCA patients (n = 91) were treated with omeprazole and clarithromycin at the same doses plus amoxicillin 1 g b.i.d., also for 7 days. Endoscopies were performed at entry and at 4 wk after the end of treatment. The presence of H. pylori was assessed by urease test, histology, Gram stain, and culture. No patient received follow-up treatment. H. pylori eradication rates achieved in the OCB and OCA groups were similar whether by intention-to-treat (82.4% vs 88.9% ;p = 0.21) or per protocol analysis (83.3% vs 89.9%; p = 0.19). Duodenal ulcer healing rates also were the same for OCB and OCA in intention-to treat (91.2% vs 91.1%) and per protocol analysis (92.2% vs 92.1%), respectively (p = 0.98). High rates of H. pylori eradication and duodenal ulcer healing were obtained with both short-treatment regimens, which were safe and well-tolerated. Colloidal bismuth subcitrate seems to be a good alternative to amoxicillin in the triple-therapy combination with omeprazole and clarithromycin. The omeprazole dose does not seem to play a major role in H. pylori eradication in these therapeutic combinations.",1998.0,0,0
1178,9448198,"The ambulatory pH study is normal, but the patient is not--the importance of the symptoms index.",P Katz,,1998.0,0,0
1179,9459044,Pharmacokinetics and pharmacodynamics during treatment with the omeprazole 20 mg enteric-coated tablet and 20 mg capsule in asymptomatic duodenal ulcer patients.,A B Thomson; P Kirdeikis; R Lastiwka; K Röhss; P Sinclair; B Olofsson,"This study compared the 24 h intragastric pH profile and bioavailability at repeated dosing conditions of the omeprazole 20 mg enteric-coated tablet versus the 20 mg capsule. Forty duodenal ulcer patients in asymptomatic remission completed this randomized open two-way crossover study. Omeprazole 20 mg tablets or capsules were administered for seven days in each period. A 24 h pH recording was performed before the start of treatment and on day 7 of each treatment period. Plasma concentrations of omeprazole were determined 24 h after the dose. The treatment periods were separated by two to four weeks. The difference in percentage of time with pH of at least 3 was less than 16% in favour of the tablet (not significant). The estimated mean area under the plasma concentration-time curve as well as the maximum plasma concentration (Cmax) for omeprazole were 18% and 41% higher, respectively, for the tablet versus the capsule, with the latter percentage being statistically significant. The time to reach Cmax (tmax) with the tablet was, on average, about 0.5 h longer than to reach the tmax of the capsule. This study indicates that the enteric-coated tablet formulation of omeprazole is biodynamically equivalent to the capsule regarding their effects on intragastric pH during repeated dosing.",1998.0,0,0
1180,9462204,One week triple therapy for Helicobacter pylori: a multicentre comparative study. Lansoprazole Helicobacter Study Group.,J J Misiewicz; A W Harris; K D Bardhan; S Levi; C O'Morain; B T Cooper; G D Kerr; M F Dixon; H Langworthy; D Piper,"Eradication of Helicobacter pylori cures and prevents the relapse of duodenal ulceration and also results in histological resolution of chronic active gastritis. To compare four treatment regimens lasting seven days of a proton pump inhibitor and two antibiotics in the eradication of H pylori. Men or women with H pylori positive duodenal ulceration or gastritis, or both. A single blind, prospectively randomised, parallel group, comparative, multicentre study. After a positive CLO test, patients underwent histology, H pylori culture, and a 13C urea breath test to confirm H pylori status. Treatment with one of four regimens: LAC, LAM, LCM, or OAM, where L is 30 mg of lansoprazole twice daily, A is 1 g of amoxycillin twice daily, M is 400 mg of metronidazole twice daily, C is 250 mg of clarithromycin twice daily, and O is 20 mg of omeprazole twice daily, was assigned randomly. A follow up breath test was done at least 28 days after completing treatment. H pylori eradication (intention to treat) was 104/121 (86.0%) with LAC, 87/131 (66.4%) with LAM, 103/118 (87.3%) with LCM, and 94/126 (74.6%) with OAM. There was a significant difference (p < 0.001) in the proportion of patients in whom eradication was successful between LAC and LCM when compared with LAM, but no significant difference (p = 0.15) between LAM and OAM. Metronidazole resistance before treatment was identified as a significant prognostic factor with regard to eradication of H pylori. The regimens which contained metronidazole were significantly less effective than those without metronidazole in the presence of pretreatment resistant H pylori. There was no difference among the treatment groups with regard to the incidence and severity of adverse events reported. All four treatment regimens were safe and effective in eradicating H pylori in the patient population studied. LAC was the most efficacious treatment in patients with pretreatment metronidazole resistant H pylori, and was significantly better than LAM and OAM in this group of patients.",1998.0,0,1
1181,9465453,Proton-pump inhibitors for gastric acid-related disease.,T G Franko; J E Richter,"Proton-pump inhibitors are the most effective drugs introduced to date for suppressing gastric acid production. Although they are used to treat the same conditions as histamine type-2 receptor antagonists, they differ from the latter drugs in how they inhibit acid production, and in how they should be given. Initial concerns over potential ill effects of hypergastrinemia due to long-term acid suppression with proton-pump inhibitors have been unfounded.",1998.0,0,0
1182,9468251,A placebo-controlled dose-ranging study of lansoprazole in the management of reflux esophagitis.,D L Earnest; E Dorsch; J Jones; D E Jennings; P A Greski-Rose,"We compared the efficacy of three different doses of the proton pump inhibitor lansoprazole in the management of reflux esophagitis. Two hundred ninety-two patients with endoscopically confirmed reflux esophagitis were enrolled in a double-blind, multicenter study and were randomized to lansoprazole 15, 30, or 60 mg or placebo administered once daily for 8 wk. Healing rates after 4 wk of lansoprazole 15, 30, and 60 mg/d were 67.6%, 81.3%, and 80.6%, respectively. These were all significantly superior (p < 0.001) to placebo, which produced endoscopic healing in only 32.8% of the patients after 4 wk. The 4-wk healing rates with lansoprazole 30 or 60 mg were significantly higher than that with lansoprazole 15 mg (p < 0.05), confirming a dose-response effect. Cumulative healing rates after 8 wk of treatment were 52.5% with placebo and 90.0%, 95.4%, and 94.4% with lansoprazole 15, 30, and 60 mg, respectively (p < 0.001 for all doses of lansoprazole vs placebo). Lansoprazole was also significantly superior to placebo in relieving symptoms in patients with reflux esophagitis. Lansoprazole was well tolerated, and no serious treatment-related adverse events were encountered. Up to 3 months after discontinuation of treatment, all lansoprazole-treated groups had more patients free of endoscopic evidence of esophagitis than the group treated with placebo. Lansoprazole was safe and effective for the treatment of reflux esophagitis in this trial. This study indicates that the optimum daily dose of lansoprazole for reflux esophagitis is 30 mg.",1998.0,0,1
1183,9471024,"One-week therapy with omeprazole, clarithromycin and metronidazole or ornidazole, followed by 3 weeks' treatment with omeprazole, eradicates Helicobacter pylori equally and heals duodenal ulcer.",M Tzivras; A Archimandritis; V Balatsos; V Delis; S Souyioultzis; N Skandalis; E Kanellopoulou; Z Manika; P Davaris,"To estimate and compare the efficacy of 'triple' 1-week regimens--omeprazole, clarithromycin and a nitroimidazole (metronidazole or ornidazole)--followed by omeprazole, for an additional 3 weeks, on Helicobacter pylori eradication and duodenal ulcer (DU) healing, in a country with a high resistance rate of H. pylori to metronidazole. Open, prospective, two-centre study. Patients older than 18 years with active duodenal ulcer (DU), diagnosed by endoscopy and found to be infected with H. pylori (modified Giemsa stain and CLO test, Delta West, Australia), were included in the study. Three triple-drug regimens, given for 7 days, were used. (1) omeprazole (Om) 20 mg once a day, plus clarithromycin (Cl) 250 mg twice daily, plus ornidazole (Or) 500 mg twice daily (O1COr); (2) Om 20 mg twice daily, plus Cl 250 mg twice daily, plus Or 500 mg twice daily (OCOr); and (3) Om 20 mg twice daily, plus Cl 250 mg twice daily, plus metronidazole (M) 500 mg twice daily (OCM). Two hundred and three consecutive H. pylori-positive patients were included in the study, randomly assigned as follows: 50 patients (group A1: 32 men, 18 women, age 23-77 years) on O1COr; 47 patients (group A2: 29 men, 18 women, age 27-77 years) on OCOr; and 106 (group B: 71 men, 35 women, age 18-83 years) on OCM. Ulcer healing and H. pylori eradication were assessed endoscopically, 8-9 weeks after the start of treatment. H. pylori was considered eradicated if both histology and rapid urease test (six biopsies, antrum-body) were negative. Eleven patients were lost to follow-up; 192 patients were analysed. Group A1: 48; group A2: 44; group B: 100. 'Per-protocol' analysis: H. pylori eradication, 90-93% (P = 0.901); ulcer healing, 90-98% (P = 0.300). 'Intention to treat' analysis: H. pylori eradication, 85-88% (P = 0.887); ulcer healing, 86-91% (P = 0.657). Compliance was excellent, no serious side effects were observed and no patients withdrew due to side effects. No differences were observed in the H. pylori eradication and the healing rate among the groups. It seems that twice daily omeprazole is no better than single daily dosage and that ornidazole is as effective as metronidazole. In addition, in the studied population which is believed to have a high prevalence of metronidazole resistance, all the regimens used were effective.",1998.0,0,0
1184,9489902,One-week omeprazole treatment in the diagnosis of gastro-oesophageal reflux disease.,F Johnsson; L Weywadt; J H Solhaug; H Hernqvist; L Bengtsson,"Symptoms of gastro-oesophageal reflux are common, and currently available methods for diagnosing reflux disease are expensive and uncomfortable for the patient. The diagnostic value of a treatment test with omeprazole is unclear. Patients with dyspepsia including heartburn admitted for upper gastrointestinal endoscopy were studied in a prospective, randomized, double-blind Scandinavian multicentre study. Before entry 188 patients were enrolled, and 160 were randomized to 1-week treatment with 20 mg omeprazole twice daily or placebo. Gastro-oesophageal reflux disease (GERD) was defined as reflux oesophagitis Savary-Miller grades II-III at endoscopy or pH < 4 exceeding 4% of the total time at 24-h oesophageal pH-monitoring and was found in 135 patients. The treatment test was considered positive when the patient's symptoms improved during the treatment week compared with the pretreatment day. The sensitivity in diagnosing reflux disease was 71-81% with omeprazole as a diagnostic test, compared with 36-47% for placebo during treatment days 3-7. The specificity was similar for the two treatment arms during the first days of the study. During the end of the week a larger proportion of the patients with normal endoscopy and pH test responded to omeprazole treatment, giving omeprazole lower specificity than placebo. The investigators' overall evaluation of whether the patient was a responder to the test had a sensitivity of 75% and a specificity of 55% in the omeprazole-treated patients. The corresponding figures in the placebo group were 17% and 92%, respectively. One week of omeprazole treatment is a simple diagnostic test with a fairly high sensitivity. The specificity is poor owing to the placebo effect and to the lack of a gold standard in diagnosing reflux disease.",1998.0,0,0
1185,9489907,Prevention of gastric ulcer recurrence with tetraprenylacetone.,Y Nagasawa; M Tatsuta; H Iishi; S Ishiguro,"The role of cytoprotective agents in the treatment of ulcers remains unclear. In the present study we investigated the effect of tetraprenylacetone (TAP), a cytoprotective agent, on healing and recurrence of gastric ulcers infected with Helicobacter pylori and on the mucosal microvascular architecture of healed gastric ulcers. Ninety-five gastric ulcer patients with H. pylori infection were studied. Gastric ulcer patients with H. pylori infection received 20 mg omeprazole (44 patients) or 20 mg omeprazole and 150 mg TAP (46 patients) in random fashion. Ulcer healing was assessed with endoscopy 12 weeks after the start of treatment. The patients with healed ulcer were followed up for another 12 months without further therapy. During endoscopic examination at week 12, biopsy specimens were obtained from healed gastric ulcers, and the gastric mucosal microvascular architecture of the biopsy specimens was observed by means of the alkaline phosphatase staining method. The rate of ulcer healing at week 12 was similar in patients treated with omeprazole with and without TAP. However, at or within 12 months of the start of follow-up observation, ulcers recurred significantly less frequently in patients treated with both omeprazole and TAP than in those treated with omeprazole alone. Alkaline phosphatase staining methods showed that the mucosal microvascular architecture improved significantly more frequently in healed gastric ulcers that had been treated with both omeprazole and TAP than in those treated with omeprazole alone. Treatment with TAP plus omeprazole significantly decreases ulcer recurrence through TAP's improved mucosal restoration.",1998.0,0,0
1186,9489908,"Double-blind trial of omeprazole and amoxicillin in the cure of Helicobacter pylori infection in gastric ulcer patients. The Ulcer Study Group, Germany.",A Meining; W Höchter; J Weingart; A Sommer; H Klann; T Simon; F Huber; K H Bolle; R Hatz; G Fischer; N Lehn; M Stolte; E Bayerdörffer,"Our aim was to investigate the efficacy of omeprazole and amoxicillin in curing Helicobacter pylori infection in gastric ulcer patients. In a double-blind trial 185 H. pylori-positive gastric ulcer patients were prospectively randomized to receive 40 mg omeprazole twice daily and either 750 mg amoxicillin three times daily or 750 mg amoxicillin placebo three times daily on days 1-14, followed by 20 mg omeprazole daily on days 15-56. Twenty-seven patients were excluded because of lack of compliance or missed follow-up examinations; one patient receiving amoxicillin discontinued treatment owing to side effects. On an intention-to-treat basis, omeprazole/amoxicillin led to cure of H. pylori infection in 67.1% (47 of 70) of patients not using non-steroidal anti-inflammatory drugs (NSAIDs)/aspirin (ASA) and in 46.7% (14 of 30) of those taking NSAIDs/ASA (P < 0.05). With the omeprazole/placebo regimen, H. pylori infection was cured in 8.8% (no NSAIDs), and 0% (NSAIDs). The use of NSAIDs/ASA may limit the efficacy of omeprazole/amoxicillin in curing H. pylori infection in gastric ulcer patients.",1998.0,0,0
1187,9494148,A comparison of omeprazole with ranitidine for ulcers associated with nonsteroidal antiinflammatory drugs. Acid Suppression Trial: Ranitidine versus Omeprazole for NSAID-associated Ulcer Treatment (ASTRONAUT) Study Group.,N D Yeomans; Z Tulassay; L Juhász; I Rácz; J M Howard; C J van Rensburg; A J Swannell; C J Hawkey,"Suppressing acid secretion is thought o reduce the risk of ulcers associated with regular use of nonsteroidal antiinflammatory drugs (NSAIDs), but the best means of accomplishing this is uncertain. We studied 541 patients who required continuous treatment with NSAIDs and who had ulcers or more than 10 erosions in either the stomach or duodenum. Patients were randomly assigned to double-blind treatment with omeprazole, 20 mg or 40 mg orally per day, or ranitidine, 150 mg orally twice a day, for four or eight weeks, depending on when treatment was successful (defined as the resolution of ulcer and the presence of fewer than five erosions in the stomach, and fewer than five erosions in the duodenum, and not more than mild dyspepsia). We randomly assigned 432 patients in whom treatment was successful to maintenance treatment with either 20 mg of omeprazole per day or 150 mg of ranitidine twice a day for six months. At eight weeks, treatment was successful in 80 percent (140 of 174) of the patients in the group given 20 mg of omeprazole per day, 79 percent (148 of 187) of those given 40 mg of omeprazole per day, and 63 percent (110 of 174) of those given ranitidine (P<0.001 for the comparison with 20 mg of omeprazole and P=0.001 for the comparison with 40 mg of omeprazole). The rates of healing of all types of lesions were higher with omeprazole than with ranitidine. During maintenance therapy, the estimated proportion of patients in remission at the end of six months was 72 percent in the omeprazole group and 59 percent in the ranitidine group. The rates of adverse events were similar between groups during both phases. Both medications were well tolerated. In patients with regular use of NSAIDs, omeprazole healed and prevented ulcers more effectively than did ranitidine.",1998.0,1,1
1188,9494149,Omeprazole compared with misoprostol for ulcers associated with nonsteroidal antiinflammatory drugs. Omeprazole versus Misoprostol for NSAID-induced Ulcer Management (OMNIUM) Study Group.,C J Hawkey; J A Karrasch; L Szczepañski; D G Walker; A Barkun; A J Swannell; N D Yeomans,"Misoprostol is effective for ulcers associated with the use of nonsteroidal antiinflammatory drugs (NSAIDs) but is often poorly tolerated because of diarrhea and abdominal pain. We compared the efficacy of omeprazole and misoprostol in healing and preventing ulcers associated with NSAIDs. In a double-blind study, we randomly assigned 935 patients who required continuous NSAID therapy and who had ulcers or more than 10 erosions in the stomach or duodenum (or both) to receive 20 mg or 40 mg of omeprazole orally in the morning or 200 microg of misoprostol orally four times daily. Patients were treated for four weeks or, in the absence of healing, eight weeks. Treatment success was defined as the absence of ulcers and the presence of fewer than five erosions at each site and not more than mild dyspepsia. We then randomly reassigned 732 patients in whom treatment was successful to maintenance therapy with 20 mg of omeprazole daily, 200 microg of misoprostol twice daily, or placebo for six months. At eight weeks, treatment was successful in 76 percent of the patients given 20 mg of omeprazole (233 of 308), 75 percent of those given 40 mg of omeprazole (237 of 315), and 71 percent of those given misoprostol (212 of 298). The rates of gastric-ulcer healing were significantly higher with 20 mg of omeprazole (but not 40 mg of omeprazole) than with misoprostol. Healing rates among patients with duodenal ulcers were higher with either dose of omeprazole than with misoprostol, whereas healing rates among patients with erosions alone were higher with misoprostol. More patients remained in remission during maintenance treatment with omeprazole (61 percent) than with misoprostol (48 percent, P=0.001) and with either drug than with placebo (27 percent, P<0.001). There were more adverse events during the healing phase in the misoprostol group than in the groups given 20 mg and 40 mg of omeprazole (59 percent, 48 percent, and 46 percent, respectively). The overall rates of successful treatment of ulcers, erosions, and symptoms associated with NSAIDs were similar for the two doses of omeprazole and misoprostol. Maintenance therapy with omeprazole was associated with a lower rate of relapse than misoprostol. Omeprazole was better tolerated than misoprostol.",1998.0,1,1
1189,9494671,Helicobacter pylori infection--current status in Singapore.,K M Fock,"Helicobacter pylori infection is a common infection in Singapore affecting about 31% of the population. The seroprevalence of H. pylori infection increases with age from 3% in children below 5 years to 71% in adults above 65 years. Amongst the races, Chinese and Indians had similar rates of seropositivity (34.3% and 33.6%) while in Malays it was significantly lower (13.7%; P < 0.05). H. pylori infection is associated with peptic ulcer disease (both duodenal and gastric ulcer) as well as gastric cancer [adenocarcinoma, early gastric cancer and mucosa-associated lymphoma of T cell type (MALT) lymphoma]. Its role in non-ulcer dyspepsia is controversial. H. pylori was found in 31% of non-ulcer dyspepsia patients in Singapore compared with 28% in normal healthy controls. Gastric emptying test using indigestible solids shows that gastroparesis per se, H. pylori in the presence of gastroparesis (but not H. pylori alone) are related to dyspeptic symptom. H. pylori plays a synergistic role with non-steroidal anti-inflammatory drugs (NSAIDs) in causing bleeding in gastric ulcer but not in duodenal ulcer. Invasive and non-invasive methods are available for diagnosis of H. pylori and should be used to establish the aetiology of gastro-duodenal disease. Currently two groups of therapeutic regimes with eradication rates of 90% are available: bismuth containing regimes and proton-pump inhibitors based regimes. Triple therapy for one week (using three drugs effective against H. pylori) is currently the treatment of choice.",1998.0,0,0
1190,9496401,Lack of pharmacokinetic interaction between mexiletine and omeprazole.,M Kusumoto; K Ueno; K Tanaka; K Takeda; K Mashimo; T Kameda; Y Fujimura; M Shibakawa,"To investigate the effect of omeprazole on the pharmacokinetics of mexiletine. Nine healthy male Japanese volunteers participated in a crossover study. On day 1, the subjects received mexiletine 200 mg. On days 2-7, they received omeprazole 40 mg, and on day 8 they received mexiletine 200 mg and omeprazole 40 mg concomitantly. Serum concentrations of mexiletine were determined just before drug administration and at 1, 2, 3, 4, 6, 8, 12, and 24 hours on day 1 and day 8. No differences in mexiletine concentrations were observed between the two phases of the study. The mean AUCs after administration of mexiletine alone and in combination with omeprazole 40 mg/d were 6.26 and 6.20 ng.h/L, respectively. These findings suggest that omeprazole does not affect mexiletine metabolism.",1998.0,0,0
1191,9496950,AGA technical review: evaluation of dyspepsia. American Gastroenterological Association.,N J Talley; M D Silverstein; L Agréus; O Nyrén; A Sonnenberg; G Holtmann,,1998.0,0,0
1192,9497217,Does Helicobacter pylori eradication depend on the period of amoxicillin treatment? A retrospective study.,H Tanimura; S Kawano; M Kubo; T Abe; M Goto; J Tanabe; A Asai; T Ito,"In this study, the effect of different periods of amoxicillin (AMPC) treatment on the eradication rate of Helicobacter pylori in 173 patients with peptic ulcers (gastric ulcer, 109; duodenal ulcer, 64) was investigated. AMPC (1.5 g/day) was administered for 2, 4, or 6 weeks with omeprazole (20mg/day) and plaunotol (240mg/day), a mucoprotective drug, for 8 weeks. The H. pylori eradication rate was 46.7% for 2 weeks' treatment, 83.4% for 4 weeks' treatment, and 100% for 6 weeks' treatment. The eradication rate had a good correlation with the period of AMPC treatment. The healing rates of peptic ulcer at 4 and 8 weeks were 93.3% and 100%, respectively, in the 2-week group, 98.0% and 99.3% in the 4-week group, and 85.7% and 100% in the 6-week group. The recurrence rate of gastric and duodenal ulcers was 3.5% and 0% respectively, in the patients in whom H. pylori was eradicated and 30.0% and 40%, respectively, in the patients in whom H. pylori was not eradicated for 12 months after the H. pylori eradication treatment. Adverse effects of this regimen were observed in 5 (2.9%) of the 173 patients. Diarrhea was observed in 3 patients and eruption in 2. These adverse effects disappeared within a few days after only AMPC was withdrawn. Therefore, these may be caused by AMPC. The eradication rate of H. pylori depends on the period of AMPC treatment. This regiment, AMPC (1.5g/day) + omeprazole (20mg/day) + plaunotol (240mg/day), is safe and well tolerated for eradication of H. pylori.",1998.0,0,0
1193,9505878,Cost effectiveness of treatment for gastro-oesophageal reflux disease in clinical practice: a clinical database analysis.,A Eggleston; A Wigerinck; S Huijghebaert; D Dubois; A Haycox,"Previous evaluation of the cost effectiveness of antireflux medication used in gastro-oesophageal reflux disease (GORD) have been based on results obtained in controlled clinical trials. Unfortunately such an approach does not necessarily identify the therapeutic option which provides the greatest benefit from available resources in real life situations. To make an informed choice requires a recognition that the costs and benefits of therapy in practice may differ from those identified in trials. To evaluate, based on a retrospective prescription database analysis, the cost effectiveness of alternative treatment options for patients with uncomplicated GORD. The analysis assesses health service resource use during the first six months of treatment in three groups of patients initially prescribed cisapride (CIS), ranitidine (RAN), or omeprazole (OME). The MediPlus UK database was used to identify all health care resources consumed by patients in the three treatment groups during their first six months of treatment. Patients with more complicated GORD, as indicated by initial referral to a specialist or outpatient hospital visit (< 13%), were excluded from the analysis. The average cost per patient for the initial six months of treatment for CIS, RAN, and OME based therapies was 136 Pounds, 177 Pounds, 189 Pounds per patient, respectively. A major element underlying this cost variation was the acquisition cost and quantity of antireflux medication required by patients. The average number of one month equivalent prescriptions consumed during this six month period was 1.85 (CIS), 2.57 (RAN), and 2.96 (OME) with associated costs of 49 Pounds (CIS), 67 Pounds (RAN), and 105 Pounds (OME). Antacid and alginate/antacid use was higher in the CIS and RAN groups (about 1.0 antacid prescription per patient versus 0.4 for OME), but their contribution to the total cost per patient was less than 2%. The number of general practitioner consultations over the six month period for each treatment group was 2.4 (CIS), 2.9 (RAN), and 2.6 (OME) with associated costs of 60.31 Pounds (CIS), 73.06 Pounds (RAN), and 65.52 Pounds (OME). The average number of non-drug interventions (referrals, outpatient visits, endoscopies, barium meals, or x rays) was 0.34 in the RAN group compared with less than 0.2 in the CIS and OME groups. The costs associated with such interventions were 23.80 Pounds (RAN), 9.60 Pounds (CIS), and 11.10 Pounds (OME) per patient. The data indicate that the ""step up"" approach, starting with a prokinetic or H2 receptor antagonist, represents the most cost effective initial therapeutic strategy for a primary care physician to adopt when faced with a patient with first diagnosis of uncomplicated GORD.",1998.0,0,0
1194,9506245,Rabeprazole.,A Prakash; D Faulds,"Rabeprazole is a proton pump inhibitor with antisecretory properties. In vitro animal experiments have indicated that the inhibition of the proton pump by rabeprazole is partially reversible. Rabeprazole has 2- to 10-fold greater antisecretory activity than omeprazole in vitro. However, it dissociates more readily from H+,K(+)-ATPase than omeprazole, resulting in a shorter duration of action. In comparative clinical trials rabeprazole was significantly more effective than placebo, famotidine or ranitidine and as effective as omeprazole in the treatment of patients with erosive or ulcerative gastro-oesophageal reflux disease or gastric or duodenal ulcers. Healing rates with rabeprazole were independent of Helicobacter pylori status. Rabeprazole in combination with either clarithromycin and metronidazole or clarithromycin and amoxicillin or amoxicillin and metronidazole or clarithromycin for 7 days produced eradication of H. pylori in 100, 95, 90 and 63% of patients. The tolerability profile of rabeprazole 20mg once daily was similar to that of famotidine 20mg twice daily, ranitidine 150mg 4 times daily or omeprazole 20mg once daily in comparative trials. The adverse events reported with once daily administration of rabeprazole 20mg include malaise, nausea, diarrhoea, headache, dizziness and skin eruptions in 0.7 to 2.2% of patients.",1998.0,0,0
1195,9517646,A four-day low dose triple therapy regimen for the treatment of Helicobacter pylori infection.,L Trevisani; S Sartori; M Caselli; M Ruina; G Verdianelli; V Abbasciano,"The current guidelines recommend 1-wk triple therapy regimens for eradicating H. pylori infection. Until now, shorter regimens have scarcely been investigated. Azithromycin is a new generation macrolide antibiotic with unusual and favorable pharmacokinetics, and seems to be a very promising agent for innovative anti-H. pylori regimens. We assessed the efficacy and tolerability of a new 4-day low dose triple therapy in comparison with a well established 1-wk triple therapy in the treatment of Helicobacter pylori infection. One hundred-sixty consecutive patients with biopsy-proven H. pylori infection were randomized to receive lansoprazole 30 mg b.i.d. on days 1-4, azithromycin 500 mg u.i.d. on days 2-4, and tinidazole 2000 mg u.i.d. on day 3 (LAT group), or 7 days of triple therapy of omeprazole 20 mg u.i.d., clarithromycin 250 mg b.i.d., and tinidazole 500 mg b.i.d. (OCT group). Patients with gastric or duodenal active ulcer received proton pump inhibitors for an additional 4 wk. H. pylori eradication was defined as negative of both rapid urease test and histology on biopsies taken from the gastric body and antrum at least 1 month after the end of treatment. Seven patients in the LAT group and four in the OCT group were lost to follow-up. No significant difference in either efficacy or tolerability was observed between the two regimens. Active ulcers healed in 97.8% of cases with LAT and in 100% of cases with OCT. The eradication rate was 80.8% in the LAT group and 85.5% in the OCT group, considering the per-protocol results, and 73.3% and 81.2%, respectively, considering the intention-to-treat results. Side effects occurred in one LAzT patient and in two OCT patients; they were mild and did not interfere with compliance. The new proposed ultrashort triple therapy, including lansoprazole, low dose azithromycin for 3 days, and a single dose of tinidazole, appears to be a very effective anti-H. pylori regimen, a simpler, cheaper, well-tolerated, and equally effective alternative to 1-wk triple therapy.",1998.0,0,0
1196,9519012,PPIs vs H2RAs for erosive reflux esophagitis.,V J King,,1998.0,0,0
1197,9526173,Lansoprazole elevates the ratio of serum pepsinogen I v.s. pepsinogen II.,Y Matsukawa; S Nishinarita; M Kaneko; M Takei; M Murakami; T Horie; F Kawamura; Y Arakawa; H Kuwayama; H Kurosaka,"In order to investigate the mechanism by which proton pump inhibitor increases serum pepsinogen levels, we evaluated the effects of ulcer location and IgG antibody against Helicobacter pylori on lansoprazole-induced elevations. Patients with endoscopically proven peptic ulcer received lansoprazole 30 mg/day for 6 or 8 weeks; pepsinogen I and II levels, along with antibody to H. pylori, were measured in fasting blood samples. We found that whether or not antibody to H. pylori was present, pepsinogen I and II levels and the I/II ratio rose significantly in lansoprazole-treated patients. Patients with stomach-body ulcers showed smaller increases in both pepsinogens than did those with ulcers in the gastric angle/antrum or in the duodenum. In conclusion, lansoprazole increases serum levels of both pepsinogens I and II, although a larger increase in pepsinogen I elevates the pepsinogen I/II ratio. The relatively small increases seen in patients with stomach-body ulcers suggest atrophic changes in the gastric mucosa in patients with stomach-body ulcer.",1998.0,0,0
1198,9536937,Eradicating Helicobacter pylori reduces hypergastrinaemia during long-term omeprazole treatment.,A el-Nujumi; C Williams; J E Ardill; K Oien; K E McColl,"Both proton pump inhibitor drug treatment and Helicobacter pylori infection cause hypergastrinaemia in man. To determine whether eradicating H pylori is a means of reducing hypergastrinaemia during subsequent proton pump inhibitor treatment. Patients with H pylori were randomised to treatment with either anti-H pylori or symptomatic treatment. One month later, all received four weeks treatment with omeprazole 40 mg/day for one month followed by 20 mg/day for six months. Serum gastrin concentrations were measured before and following each treatment. In the patients randomised to anti-H pylori treatment, eradication of the infection lowered median fasting gastrin by 48% and meal stimulated gastrin by 46%. When gastrin concentrations one month following anti-H pylori/symptomatic treatment were used as baseline, omeprazole treatment produced a similar percentage increase in serum gastrin in the H pylori infected and H pylori eradicated patients. Consequently, in the patients in which H pylori was not eradicated, median fasting gastrin concentration was 38 ng/l (range 26-86) at initial presentation and increased to 64 ng/l (range 29-271) after seven months omeprazole, representing a median increase of 68% (p < 0.005). In contrast, in the patients randomised to H pylori eradication, median fasting gastrin at initial presentation was 54 ng/l (range 17-226) and was unchanged after seven months omeprazole at 38 ng/l (range 17-95). Eradicating H pylori is a means of reducing the rise in gastrin during subsequent long term omeprazole treatment. In view of the potential deleterious effects of hypergastrinaemia it may be appropriate to render patients H pylori negative prior to commencing long-term proton pump inhibitor treatment.",1998.0,0,0
1199,9540877,Accuracy of CLOtest after Helicobacter pylori therapy.,L Laine; L Suchower; E Johnson; P Ronca; G Neil,"The accuracy of rapid urease testing after Helicobacter pylori therapy has not been widely studied and might be diminished because of decreased numbers of organisms. We assessed CLOtest results after therapy in two randomized, double-blind trials. A total of 233 patients (in two separate studies) with true-positive baseline CLOtests (by histology or culture) received 2 weeks of omeprazole/amoxicillin, omeprazole, or amoxicillin. In study 1, patients received an additional 2 weeks of omeprazole therapy (20 mg/day) or placebo; no additional therapy was given in study 2. Endoscopy was repeated 4 weeks after completion of therapy in both studies. A diagnosis of cure required at least two negative endoscopic biopsy tests (histology, culture, CLOtest) and no positive tests. After therapy, 178 patients (76%) remained positive for H. pylori by histology and/or culture for both studies combined. Post-therapy CLOtest sensitivity was 86% and specificity was 95%. Sensitivity was poorer in patients after dual therapy than after monotherapy in both study 1 (68% vs. 89%; p = 0.03) and study 2 (75% vs. 94%; p = 0.03). CLOtest sensitivity after therapy was lower than expected in our large group of patients with baseline true-positive CLOtests. In addition, sensitivity was lower after the use of more effective therapy (i.e., dual therapy as compared with monotherapy). Although most patients with unsuccessful treatment will be identified with the CLOtest alone, a negative result should not be taken as diagnostic of eradication.",1998.0,0,0
1200,9546088,Gastroesophageal reflux disease during pregnancy.,P O Katz; D O Castell,"Pregnant patients with symptomatic GERD should be managed aggressively with lifestyle modification and dietary changes. Antacids and antacids/alginic acids combination or sucralfate should be considered first-line medical therapy. If symptoms are not adequately relieved or complications develop, treatment with cimetidine or ranitidine should be considered; these H2 receptor antagonists are preferred during pregnancy. Nizatidine cannot be recommended. Proton-pump inhibitors should be used with caution because little human experience is available. Despite this caveat, both proton-pump inhibitors are likely to be safe during pregnancy.",1998.0,0,0
1201,9548613,"Lansoprazole, amoxicillin, and clarithromycin triple therapy in vagotomized patients with dyspeptic complaints. A randomized, double-blind, placebo-controlled, clinical study without pretreatment diagnostic upper endoscopy.",R O Lindsetmo; R Johnsen; A Revhaug,"The Maastricht Consensus Report advises that, in Helicobacter pylori-positive patients after surgery for peptic ulcer disease, H. pylori should be eradicated. The aim of the present study was to investigate the symptomatic response of H. pylori eradication in previously vagotomized peptic ulcer patients with persistent dyspeptic complaints. The study was performed as a randomized, double-blind, placebo-controlled study. Pretreatment diagnostic upper endoscopy was omitted. All the results were submitted to intention-to-treat and efficacy analyses. We could not find any differences between the two groups with regard to intensity or frequency of upper abdominal pain, nausea, heartburn, or other abdominal symptoms during the 12-month follow-up. The triple therapy eradication rate was 88% at both 3- and 12-month controls. Vagotomized peptic ulcer patients with persistent dyspeptic complaints should undergo a diagnostic upper endoscopy to detect ulcer recurrence before H. pylori eradication treatment is considered.",1998.0,0,0
1202,9563921,Predictive factors for rebleeding in patients with peptic ulcer bleeding after multipolar electrocoagulation: a retrospective analysis.,H J Lin; G Y Tseng; W C Lo; F Y Lee; C L Perng; F Y Chang; S D Lee,"The role of endoscopic therapy for peptic ulcer bleeding is well-documented. Nevertheless, rebleeding occurs in 10% to 30% of patients, and such patients are at high risk for death without early retreatment or definitive surgery. The aim of our study was to predict which patients would rebleed within 1 month after successful multipolar electrocoagulation of 100 patients with active peptic ulcer bleeding (spurting, oozing, or nonbleeding visible vessel). We had achieved initial hemostasis in 97 patients and carried out univariate and multivariate analyses to predict which patients would rebleed. Rebleeding occurred within 1 month in 17 (17.5%) patients. we correlated 20 clinical and endoscopic factors with rebleeding episodes. With univariate analysis, blood transfusion of 500 ml or more at entry (p < 0.0001) and use of cimetidine (p = 0.01) were statistically significant for rebleeding. With multivariate analysis, use of omeprazole was an independent factor for preventing rebleeding (odds ratio, 7.68; 95% confidence interval, 1.642-35.929). We suggest that omeprazole may help to prevent rebleeding in patients who have had hemostasis with multipolar electrocoagulation.",1998.0,0,0
1203,9570169,Treatment of Helicobacter pylori infection.,J A Salcedo; F Al-Kawas,"Since acceptance of the association between Helicobacter pylori and peptic ulcer disease, eradication of H. pylori has become the standard of care in the treatment of peptic ulcer disease. Unfortunately, eradication therapy is no easy task, especially when one is faced with a myriad of drug combinations with varying degrees of efficacy and tolerability. The following is a review of the literature regarding the drugs and drug combinations used to eradicate H. pylori and their effectiveness both as single agents and in combination.",1998.0,0,0
1204,9570170,"Cost savings in duodenal ulcer therapy through Helicobacter pylori eradication compared with conventional therapies: results of a randomized, double-blind, multicenter trial. Gastrointestinal Utilization Trial Study Group.",A Sonnenberg; J S Schwartz; A F Cutler; N Vakil; B S Bloom,"We hypothesized that treatment of duodenal ulcer disease with antibiotic therapy directed toward Helicobacter pylori infection is more cost-effective than therapy with antisecretory agents. A randomized, double-blind, multicenter clinical trial of adult patients with active duodenal ulcer and H. pylori infection was conducted. Patients were randomized to receive 500 mg of clarithromycin 3 times a day plus 40 mg of omeprazole daily for 14 days followed by 20 mg of omeprazole daily for an additional 14 days (group 1), 20 mg of omeprazole daily for 28 days (group 2), or 150 mg of ranitidine hydrochloride twice a day for 28 days (group 3). The use of ulcer-related health care resources was documented during monthly interviews for 1 year after the initial therapy. Clinical success was evaluated 4 to 6 weeks and 1 year after the end of therapy. Of the 819 patients enrolled, 727 completed the study. Group 1 included 243 patients; group 2, 248 patients; and group 3, 236 patients. Patients in group 1 used fewer ulcer-related health care resources during the 1 year after therapy compared with groups 2 and 3 (comparisons are given as group 1 vs group 2 and group 1 vs group 3, respectively): the number of endoscopies performed, 28 vs 76 (P<.001) and vs 71 (P<.001); patients receiving drugs to treat an ulcer, 118 vs 180 (P<.001) and vs 168 (P<.001); clinic visits, 83 vs 135 (P=.05) and vs 161 (P<.001); hospitalizations, 0 vs 5 (P=.045) and vs 6 (P=.02); and length of hospital stay, 0 vs 24 days (P=.04) and vs 37 (P=.04). When ulcer-related costs were defined as the outcome variable in a multivariate linear regression analysis, therapy was determined to have a significant influence on costs (group 1 vs group 2, P<.001; group 1 vs group 3, P=.008). Clinical success rates at the end of the study and cure of H. pylori infection were significantly greater in group 1 compared with groups 2 and 3 (P<.001). Therapy with clarithromycin plus omeprazole provided savings of $1.94 and $2.96 (compared with therapy with omeprazole and with ranitidine hydrochloride, respectively) per dollar spent within the first year after therapy. This incremental cost-benefit translates to savings of $547 or $835 per patient in group 1 (compared with patients in group 2 or group 3, respectively) during the first year after therapy. Combination therapy with clarithromycin and omeprazole resulted in significantly fewer uses of ulcer-related health care resources than conventional antisecretory therapy during a 1-year follow-up and significant savings in associated costs during the same period. Patients who received clarithromycin plus omeprazole also showed a significantly improved clinical outcome compared with patients who received only omeprazole or ranitidine.",1998.0,0,0
1205,9570259,Changes in Helicobacter pylori-induced gastritis in the antrum and corpus during 12 months of treatment with omeprazole and lansoprazole in patients with gastro-oesophageal reflux disease.,M Stolte; A Meining; J M Schmitz; T Alexandridis; E Seifert,"Several studies have shown that treatment with omeprazole leads to aggravation of Helicobacter pylori gastritis in the corpus. Whether this also applies to lansoprazole, and whether, in comparison with omeprazole, there are differences in therapy-induced gastritis parameter changes remains unclear. In 111 patients infected with H. pylori and with gastro-oesophageal reflux disease we investigated the gastritis parameters in antral and corpus mucosa before and after 2, 6 and 12 months of treatment with 15 or 30 mg lansoprazole or 20 mg omeprazole/day. In all groups the different treatments had a similar effect: in both regions of the stomach, suppression or partial elimination of H. pylori was seen. However, improvement in the inflammation was observed only in the antrum, while in the corpus most gastritis parameters worsened significantly. There was no increase in intestinal metaplasia or atrophy. In common with omeprazole, lansoprazole aggravates the gastritis parameters in the corpus but improves them in the antrum. Treatment with proton pump inhibitors does not result in any increase in the incidence of atrophy/intestinal metaplasia. However, as gastritis predominating in the corpus seems to be associated with an elevated carcinogenic risk, consideration should be given to prophylactic H. pylori eradication therapy before initiating proton pump inhibitor treatment.",1998.0,0,1
1206,9570262,Lansoprazole triple therapy for Helicobacter pylori--is 5 days enough?,H J O'Connor; R McLoughlin; S Kelly; J Laundon; K Cunnane,"Seven-day proton pump inhibitor triple therapy is currently the treatment of choice for Helicobacter pylori infection. It is unclear whether triple therapy for less than 7 days might preserve efficacy while at the same time improving patient acceptability and compliance. To evaluate the Helicobactericidal efficacy, ulcer healing capacity and patient acceptability of a 5-day lansoprazole-based triple therapy regimen. Sixty-nine consecutive patients with H. pylori-positive peptic ulcer received lansoprazole 30 mg twice daily in combination with metronidazole 400 mg twice daily and clarithromycin 250 mg twice daily for 5 days. Ulcer healing medication was not continued after the 5-day regimen. H. pylori status was assessed before and at least 4 weeks after therapy by rapid urease test and histology. Adverse events and compliance were assessed by direct questioning. All 69 patients attended for repeat endoscopy and 63 were H. pylori-negative after therapy giving a cure rate of 91%, (95%, Cl: 85-98%). Of the 59 patients with active ulcers, 58 were healed at repeat endoscopy giving an ulcer healing rate of 98% (95% Cl: 92-100%). All patients fully complied with therapy and mild adverse events, mainly gastrointestinal, were reported by 11 patients (16%). Five-day lansoprazole triple therapy is an effective regimen for H. pylori infection which combines a high cure rate and ulcer healing efficacy with the advantages of excellent patient acceptability and compliance.",1998.0,0,0
1207,9570263,Bismuth-containing single-antibiotic 1-week triple therapy for Helicobacter pylori eradication.,B B Scott,"Although bismuth was both the first drug shown to alter the natural history of peptic ulcer disease and also a constituent of the first very effective eradication regimens, it has been excluded from the newer regimens, despite its safety and low cost, in favour of two antibiotics. To asses a novel 1-week regimen consisting of bismuth, clarithromycin and a proton pump inhibitor in routine clinical practice. One hundred and three consecutive patients with peptic ulcer disease and antral biopsies containing Helicobacter pylori were given a 7-day course of treatment with bismuth (tripotassium dicitrato bismuthate chelate) 120 mg q.d.s., clarithromycin 500 mg t.d.s. and lansoprazole 30 mg o.d. Completeness of eradication was assessed by a l3C-urea breath test, in all except three patients, at least 4 months later. Of the 100 patients who were assessed in this open treatment study 84 (84%; 95% CI: 77-91%) had a negative breath test. Minor side-effects were reported by 14% and more troublesome side-effects (nausea, vomiting, diarrhoea, hallucinations, nasty taste and body pains) were reported by 10%. A 1-week course of triple therapy including bismuth, clarithromycin and a proton pump inhibitor is effective in routine clinical practice and is well tolerated.",1998.0,0,0
1208,9576452,"Triple versus dual therapy for eradicating Helicobacter pylori and preventing ulcer recurrence: a randomized, double-blind, multicenter study of lansoprazole, clarithromycin, and/or amoxicillin in different dosing regimens.",H Schwartz; R Krause; B Sahba; M Haber; A Weissfeld; P Rose; N Siepman; J Freston,"The efficacy and safety of dual and triple therapies with a proton pump inhibitor and antibiotic(s) for therapy of Helicobacter pylori-associated duodenal ulcer disease have been compared using results from independent studies using different methods and regimens, making interpretation difficult. In a large, double-blind, multicenter study conducted in the United States, we compared a triple therapy regimen with four dual therapy and one monotherapy regimens in the eradication of H. pylori and the prevention of ulcer recurrence. Patients with active duodenal ulcer disease or history of duodenal ulcer disease within the past year and H. pylori infection were randomized to receive one of six 14-day treatment regimens: lansoprazole 30 mg, clarithromycin 500 mg, and amoxicillin 1 gm b.i.d.; lansoprazole 30 mg b.id. and either clarithromycin 500 mg b.i.d. or t.i.d.; lansoprazole 30 mg b.i.d. or t.i.d. with amoxicillin 1 gm t.i.d.; or lansoprazole 30 mg t.i.d. alone. No additional acid suppression therapy followed eradication therapy. Primary efficacy endpoints were eradication of H. pylori and ulcer recurrence. Of 396 patients enrolled in the study, 352 met the entry criteria for duodenal ulcer status and H. pylori positivity. At 4-6 wk after the end of therapy, H. pylori was eradicated from 94% (44 of 47) of patients receiving lansoprazole, clarithromycin, and amoxicillin triple therapy, 77% (39 of 51) of those receiving lansoprazole t.i.d./amoxicillin t.i.d., 75% (36 of 48) of those receiving lansoprazole b.i.d./clarithromycin t.i.d., 57% (28 of 49) of those receiving lansoprazole b.i.d./clarithromycin b.i.d., 53% (26 of 49) of those receiving lansoprazole b.i.d./amoxicillin t.i.d., and 2% (1 of 53) of those receiving lansoprazole monotherapy (p < or = 0.05, triple therapy vs each dual therapy and each dual therapy vs monotherapy). Of those patients who were documented as free of ulcer at 4-6 wk after treatment, ulcers recurred within 6 months in 7% of patients receiving triple therapy, as compared with 13-23% of patients receiving dual therapy, and 69% of patients receiving lansoprazole monotherapy. Patients who were H. pylori negative at 4-6 wk after treatment were less likely to have an ulcer recurrence than were patients who were H. pylori positive (11% [10 of 95] vs 47% [20 of 43], respectively, across treatment groups). For triple therapy and dual therapy, a similar proportion of patients reported a drug-related adverse event (23% vs 17-33%, respectively). In patients with active or a recent history of duodenal ulcer, a 14-day course of lansoprazole-based triple therapy without additional acid suppression therapy is highly effective in the eradication of H. pylori and in preventing ulcer recurrence. Among the dual therapies, higher eradication rates occurred when lansoprazole (with amoxicillin) or clarithromycin (with lansoprazole) was administered t.i.d. vs b.i.d., but the rates were still significantly lower than with lansoprazole triple therapy with all three drugs administered b.i.d.",1998.0,0,0
1209,9578184,"Pharmacokinetics and effect on caffeine metabolism of the proton pump inhibitors, omeprazole, lansoprazole, and pantoprazole.",T Andersson; J Holmberg; K Röhss; A Walan,"To study the pharmacokinetics of three proton pump inhibitors, omeprazole, lansoprazole, and pantoprazole, as well as any potential influence on CYP1A2 activity (measured by means of rate of caffeine metabolism) of these compounds at single dose and repeated dose administration. Fourteen healthy males, classified as 12 extensive metabolizers (EMs) and two poor metabolizers (PMs) according to the urinary S/R mephenytoin ratio, completed this open, randomized, three-way cross-over study. In each of the three 7-day treatment periods either omeprazole (20 mg), lansoprazole (30 mg) or pantoprazole (40 mg) in therapeutically recommended doses was administered once daily, and the pharmacokinetics of the proton pump inhibitors as well as the rate of caffeine metabolism was measured on days 1 and 7. In the EMs there was an increase in AUC from day 1 to day 7 for omeprazole. In the PMs the AUC of both omeprazole and lansoprazole was unchanged during repeated dosing, while for pantoprazole there was a tendency to a slight decrease. The AUC at steady state was for all three proton pump inhibitors 5 fold higher in PMs compared with EMs, indicating that the same proportion of the dose, irrespective of compound, is metabolized by CYP2C19. No induction of CYP1A2 was evident for any of the compounds in either EMs or PMs. The approximately 5 fold difference in AUC between EMs and PMs indicates that approximately 80% of the dose for all three proton pump inhibitors is metabolized by the polymorphically expressed CYP2C19. None of the three proton pump inhibitors, administered in therapeutically recommended doses, is an inducer of CYP1A2--neither in PMs nor in EMs.",1998.0,0,0
1210,9581986,Gastro-oesophageal reflux disease in primary care: an international study of different treatment strategies with omeprazole. International GORD Study Group.,R Carlsson; J Dent; R Watts; S Riley; R Sheikh; J Hatlebakk; K Haug; G de Groot; A van Oudvorst; A Dalväg; O Junghard; I Wiklund,"To assess the efficacy of omeprazole in patients presenting with troublesome reflux symptoms. Randomized, double-blind, parallel-group, placebo-controlled comparison. Primary care. Patients were recruited using a symptom-based questionnaire for diagnosis of gastro-oesophageal reflux disease. After endoscopy, patients without endoscopic oesophagitis were randomized to omeprazole 20 mg (Ome20), omeprazole 10 mg (Ome10) or placebo once daily for 4 weeks (n = 261) and those with oesophagitis (except circumferential/ulcerative) were randomized to receive either Ome20 or Ome10 once daily for 4 weeks (n = 277). Patients not symptom-free at 4 weeks received open treatment with Ome20 once daily for a further 4 weeks. Those symptom-free at 4-8 weeks were followed up for 6 months off treatment, to see whether their symptoms recurred. Complete upper GI symptom relief during week 4 on Ome20 or Ome10 in patients with or without endoscopic oesophagitis. Forty one percent of all patients on Ome20 and 35% on Ome10 reported complete relief from upper GI symptoms during week 4, whilst 73% of the patients on Ome20 and 62% on Ome10 obtained sufficient control. Complete relief during week 4 was reported by 19% of endoscopy-negative patients on placebo, and sufficient control by 35%. Endoscopic healing at 4 weeks occurred in 76% of oesophagitis patients on Ome20 and in 56% on Ome10. After 6 months off treatment, 90% of patients with oesophagitis and 75% of endoscopy-negative patients reported symptomatic relapse. Both 10 mg and 20 mg of omeprazole gave effective relief of symptoms, although 20 mg gave superior healing in patients with oesophagitis. After cessation of treatment, symptomatic relapse was rapid and frequent in both endoscopy-positive and endoscopy-negative patients.",1998.0,0,0
1211,9584552,Use of the Short Form-36 to detect the influence of upper gastrointestinal disease on self-reported health status.,J W Mant; C Jenkinson; M F Murphy; K Clipsham; P Marshall; M P Vessey,"Patient-centred outcome measures such as the Short Form-36 (SF-36) have been developed to assess the impact of ill health and medical interventions on self-reported health status. The objective of the study was to assess the impact of gastrointestinal disease upon health status as measured by the SF-36 physical and mental health component scores (PCS and MCS) and to assess whether these component scores might be an appropriate outcome measure for use in clinical research in gastroenterology. The subjects were 364 patients aged between 18 and 64 years who had been prescribed proton pump inhibitors (PPIs) by general practitioners in Oxfordshire. The general practices participating identified patients who had been prescribed PPIs. The data were abstracted from the general practice medical records of these patients concerning gastrointestinal diagnoses and other prescribed medications. The patients were sent the SF-36 questionnaire by post and the PCS and MCS scores were derived, which were adjusted for age and sex and compared with the scores of the general population of the Oxford region. Co-morbidity was assessed by the extent to which non-gastric medications were also used. The commonest diagnoses were oesophagitis/gastro-oesophageal reflux and indigestion. People with these diagnoses had significantly lower health status than the general population. Differences persisted when the results were controlled for the possible effects of co-morbidity. It was concluded that the SF-36 is sensitive to the impact of gastrointestinal disease on health status.",1998.0,0,1
1212,9585678,One-week proton pump inhibitor-based triple therapy eradicates residual Helicobacter pylori after failed dual therapy.,B S Sheu; J J Wu; H B Yang; A H Huang; X Z Lin,"The purposes of this study were to assess the efficacy of a 1-week proton pump inhibitor (PPI)-based triple therapy after failure of dual therapy in Helicobacter pylori eradication, and to compare the effectiveness of clarithromycin and metronidazole in this regimen. Between January 1996 and March 1997, 67 patients with persistent H. pylori infection after a 2-week course of dual therapy (amoxicillin plus omeprazole) were enrolled. They were randomly assigned to receive amoxicillin (1000 mg twice daily) and omeprazole (20 mg twice daily) plus either metronidazole (500 mg twice daily) or clarithromycin (250 mg twice daily). Endoscopy was performed in each patient to assess the status of H. pylori using the rapid urease test (CLOtest) and the histologic findings before dual therapy, after dual therapy, and after triple therapy. H. pylori isolates were tested for antibiotic resistance when triple therapy failed. The 1-week triple therapy was well tolerated in both groups with no adverse effects severe enough to cause withdrawal from the trial. Residual H. pylori was eradicated in 94% (33/35) of patients in the clarithromycin group and 84% (27/32) in the metronidazole group; the difference was not statistically significant. All seven patients in whom triple therapy failed were infected with metronidazole-resistant isolates and two also had clarithromycin-resistant isolates. This 1-week triple therapy is safe and effective in eradicating residual H. pylori after dual therapy failure. Failure of the rescue regimen is related to antimicrobial agent resistance. Because of the high metronidazole resistance rate in Taiwan, clarithromycin appears to be more promising than metronidazole for the control of H. pylori.",1998.0,0,0
1213,9598290,Recent findings in asthma likely to impact patient care.,M S Dykewicz; D K Ledford,"The management of asthma is becoming increasingly complex as more pharmacologic agents become available and we gain increased understanding of the pathogenetic processes of asthma and the risks for potentially irreversible airway remodeling that might be increased by suboptimal management and interactions with concomitant disease states such as gastroesophageal reflux. Although physicians now have greater responsibility to make use of this increasing knowledge to provide more effective management for their asthma patients, they also have a greater opportunity to increase the overall quality of life of patients under their care.",1998.0,0,0
1214,9603748,Varying efficacy of Helicobacter pylori eradication regimens: cost effectiveness study using a decision analysis model.,A E Duggan; K Tolley; C J Hawkey; R F Logan,"To determine how small differences in the efficacy and cost of two antibiotic regimens to eradicate Helicobacter pylori can affect the overall cost effectiveness of H pylori eradication in duodenal ulcer disease. A decision analysis to examine the cost effectiveness of eight H pylori eradication strategies for duodenal ulcer disease with and without 13C-urea breath testing to confirm eradication. Cumulative direct treatment costs per 100 patients with duodenal ulcer disease who were positive for H pylori. In model 1 the strategy of omeprazole, clarithromycin, and metronidazole alone was the most cost effective of the four strategies assessed. The addition of the 13C-urea breath test and a second course of omeprazole, clarithromycin, and metronidazole achieved the highest eradication rate (97%) but was the most expensive (62.63 pounds per patient). The cost of each additional effective eradication was 589.00 pounds (incremental cost per case) when compared with the cost of treating once only with omeprazole, clarithromycin, and metronidazole; equivalent to the cost of a patient receiving ranitidine for duodenal ulcer relapse for more than 15 years. Eradication strategies of omeprazole, amoxycillin, and metronidazole were less cost effective than omeprazole, clarithromycin, and metronidazole alone. In model 2 the addition of the 13C-urea breath test after treatment, and maintenance treatment, increased the cost of all the strategies and reduced the cost advantage of omeprazole, clarithromycin, and metronidazole alone. Small differences in efficacy can influence the comparative cost effectiveness of strategies for eradicating H pylori. Of the strategies tested the most cost effective (omeprazole, clarithromycin, and metronidazole alone) was neither the least expensive (omeprazole, amoxycillin, and metronidazole alone) nor the most effective (omeprazole, clarithromycin, and metronidazole with further treatment for patients found positive for H pylori on 13C-urea breath testing). Cost effectiveness should be an important part of choosing an eradication strategy for H pylori.",1998.0,0,0
1215,9604426,Helicobacter biology--discovery.,M J Buckley; C A O'Morain,"The presence of gastric spirochaetal organisms was first documented over a century ago. Though repeatedly reported in the medical literature, it was felt that these spiral bacteria were merely contaminants and the reports were generally ignored by the medical community. On 22 October 1982, at a meeting of the Royal Australian College of Physicians, successful culture of these 'Campylobacterlike organisms' from gastric biopsy specimens was reported for the first time. Moreover, it was shown that their presence was associated with gastritis and, possibly, with peptic ulceration. The subsequent discovery of the pivotal role of Helicobacter pylori in a wide range of conditions has revolutionised our understanding of gastroduodenal diseases. Improvements in diagnostic and therapeutic options, combined with the gradual acceptance of the aetiological role of an infective agent in peptic disease, have led to a remarkable change in the management of gastroduodenal conditions in the past decade.",1998.0,0,0
1216,9605259,Processing-independent analysis in the diagnosis of gastrinomas.,N R Jørgensen; J F Rehfeld; L Bardram; L Hilsted,"This study evaluates whether a new analytic principle, processing-independent analysis (PIA), offers better specificity and sensitivity than the conventional gastrin radioimmunoassay in the diagnosis of gastrinomas. Plasma concentrations of alpha-amidated gastrins and the total progastrin product were measured with radioimmunoassay and with PIA, respectively, in 512 samples taken for gastrin measurement and in a selected group of gastrinoma patients (n=10). Among the 512 patients were 9 with gastrinomas. In plasma from these patients the median degree of amidation (ratio of alpha-amidated gastrins to total progastrin product) was 75% (range, 25-98%), whereas in the other groups the medians varied from 41% to 86%. In the second group of gastrinoma patients all had a degree of amidation of less than 50%. In screening for gastrinomas PIA offered no diagnostic advantages in comparison with conventional gastrin radioimmunoassay. However, in selected patients who in spite of normal or slightly increased concentrations of amidated gastrins were still suspected of having gastrinoma, additional measurement of the total progastrin product showed incomplete processing of progastrin and thus proved helpful in establishing the diagnosis.",1998.0,0,0
1217,9606235,Proarrhythmia associated with cisapride in children.,S L Hill; J K Evangelista; A M Pizzi; M Mobassaleh; D R Fulton; C I Berul,"Cisapride is a prokinetic agent that facilitates gastrointestinal motility and is widely used for the treatment of gastroesophageal reflux disease (GERD) in adults and children. However, reports of ventricular proarrhythmia have been noted in patients taking cisapride, particularly in conjunction with other drugs that may inhibit hepatic metabolism of cisapride via the cytochrome P450 3A4 system. We designed a prospective, blinded study to evaluate the effect of cisapride on ventricular repolarization in children with GERD. We analyzed the electrocardiograms (ECGs) from 35 children (age 0.4 to 18 years, mean 5.2 years) including measurement of the resting QT interval (QTc), JT interval (JTc), as well as QT and JT interlead dispersion markers. Data from these patients were compared with ECGs from a control group of 1000 normal children. Eleven (31%) of 35 patients receiving cisapride had a prolonged QTc (> or = 450 ms). The JTc was prolonged > or = 360 ms in 16 of 35 patients (46%). The mean QTc in the cisapride group was 428 +/- 35 ms and mean JTc was 336 +/- 35 ms. An increased QT or JT dispersion (> 70 ms) was seen in only 3 of 35 children. Of the 11 children with QTc prolongation, 2 had documented torsades de pointes ventricular tachycardia. Both patients were taking cisapride concomitantly with a macrolide antibiotic. All other patients were treated with either cisapride alone or in conjunction with other GERD agents, such as ranitidine or omeprazole. Cisapride may cause prolongation of ventricular repolarization in children. There does not appear to be increased heterogeneity of repolarization or delayed depolarization in this small sample. The proarrhythmia may be exacerbated by medications that inhibit cytochrome P450 3A4 hepatic metabolism, overdosage, or mechanisms that result in decreased serum clearance. ECG intervals should be monitored in children maintained on cisapride, particularly when used in combination with other known QT-prolonging medications.",1998.0,0,0
1218,9609447,A comparison of omeprazole and placebo for bleeding peptic ulcer.,L R Felder; J S Barkin,,1998.0,0,0
1219,9631311,Miconazole gel increases the cure rate of Helicobacter pylori infection when added to lansoprazole and amoxicillin in a randomized trial.,K Ikezawa; H Kashimura; H Mahmudul; A Nakahara; A Yanaka; Y Matsuzaki; H Mutoh; N Tanaka,"Miconazole is an antimycotic agent with bacteriocidal activity against Helicobacter pylori in vitro. Its role in the clinical eradication of H. pylori has not been studied. The objective of this study was to investigate the efficacy and side effect profile of miconazole for the treatment of H. pylori. We studied 65 patients with gastritis or peptic ulcer disease in whom H. pylori infection was confirmed by a rapid urease test and microbiologic assessment. In vitro miconazole sensitivity was assessed for the H. pylori strains isolated from the enrolled patients. All patients were randomized to receive either dual therapy consisting of lansoprazole 30 mg daily and amoxicillin 500 mg three times a day for 14 days (LA, n = 33) or triple therapy using the LA regimen plus miconazole gel 100 mg three times a day for 14 days (LAM, n = 32). At least 8 weeks after the treatment, successful therapy was validated by the histological and microbiologic assessment. Adverse effects and drug adherence were monitored by direct questioning. The minimum inhibitory concentrations of miconazole ranged from 3.13 to 6.25 mg/L. H. pylori was eradicated in 16 of 33 patients (48%, 95% CI = 31% to 67%) after LA therapy, and 24 of 32 patients (75%, 95% CI = 59% to 91%) after LAM therapy (p < .03). There was no significant difference in the occurrence of adverse events between the two groups. The addition of miconazole gel to the LA regimen significantly improved the cure rate of H. pylori without an increase in adverse effects.",1998.0,0,0
1220,9638315,"[The action of the proton pump inhibitor pantoprazol against acetylsalicylic acid-induced gastroduodenopathy in comparison to ranitidine. An endoscopic controlled, double blind comparison].",P Müller; B Simon,"In a randomised double-blind parallel study the gastroduodenal tolerability of 300 mg acetylsalicilic acid daily (ASA, CAS 50-78-2) has been evaluated in the presence of placebo (n = 8), 40 mg pantoprazole (CAS 102625-70-7) daily (8 a.m.) (n = 16) and 300 mg ranitidine (CAS 66357-35-5) daily (8 a.m.) (n = 16) in healthy volunteers using upper GI-endoscopy. The treatment period lasted 14 days, endoscopic controls were performed at entry and repeated at day 14. At entry, the mean endoscopic score averaged 1.0 +/- 0.0 (+/- SEM) in the ASA/placebo, in the ASA/pantoprazole and the ASA/ranitidine group. In the placebo experiments 300 mg ASA daily induced marked gastroduodenal lesions at day 14 (lesion score of 6.8 +/- 1.4 (+/- SEM). Concomitant administration of 40 mg pantoprazole daily offered significant protection against 300 mg ASS daily on day 14 (2.1 +/- 0.6) (+/- SEM) (p < 0.05) vs ASA/placebo. 300 mg ASA plus 300 mg ranitidine daily reduced the damaging score to 4.9 +/- 1.2 (+/- SEM) (n.s. vs ASA/ placebo). Our data suggest that coadministration of 40 mg pantoprazole daily reduces significantly gastroduodenal lesions evoked by 300 mg ASA daily.",1998.0,0,0
1221,9640487,Ranitidine bismuth citrate in the treatment of Helicobacter pylori infection and duodenal ulcer.,T G Vondracek,"To review the clinical pharmacology of ranitidine bismuth citrate in the treatment of Helicobacter pylori (HP) infection and duodenal ulcer. A MEDLINE search of the English-language literature from 1992 to January 1997 was conducting using the key terms Tritec, ranitidine, and bismuth. References of articles pertaining to treatment of duodenal ulcer or HP were extensively searched for relevant sources. All articles pertaining to ranitidine bismuth citrate were considered for inclusion, with emphasis placed on randomized, double-blind trials. Priority was placed on data pertaining to regimens that are currently approved by the Food and Drug Administration for the treatment of duodenal ulcer in conjunction with HP. Each tablet of ranitidine bismuth citrate 400 mg contains 162 mg of ranitidine base, 128 mg of trivalent bismuth, and 110 mg of citrate. It uses the acid-suppressive actions of ranitidine and the antimicrobial and mucosal protective effects of bismuth to eradicate HP. Ranitidine bismuth citrate in conjunction with clarithromycin represents one of four treatment regimens currently approved in the US for duodenal ulcer associated with HP infection. In four double-blind, randomized trials, this agent has achieved HP eradication rates of 73-94% and duodenal ulcer healing rates of 73-89%. It is given twice daily for 28 days, and is associated with very low rates of adverse effects. Relative to some therapeutic alternatives, ranitidine bismuth citrate plus clarithromycin may be simpler to take and have less adverse effects, but may be more expensive. Compared with omeprazole plus clarithromycin, it is less expensive, may have lower ulcer healing rates, but may be more effective in eradicating HP. The role of ranitidine bismuth citrate will continue to evolve as more patients are treated, and other regimens continue to be tested for duodenal ulcer healing and HP eradication.",1998.0,0,0
1222,9647020,Eradication of Helicobacter pylori reduces the rate of duodenal ulcer rebleeding: a long-term follow-up study.,G Macri; S Milani; E Surrenti; M T Passaleva; G Salvadori; C Surrenti,"The long-term efficacy of Helicobacter pylori eradication to reduce the rate of recurrence of peptic ulcer bleeding is still uncertain. We evaluated the rate of duodenal ulcer rebleeding for 48 months after H. pylori eradication. Thirty-two male patients with H. pylori infection and duodenal ulcer bleeding were treated with omeprazole (40 mg/day for 4 wk), colloidal bismuth (480 mg/day for 2 wk), amoxicillin (2 g/day for 1 wk), and metronidazole (750 mg/day for 1 wk), and followed up for 48 months. Endoscopy and tests for H. pylori infection were repeated every year. Ulcer healed in all patients, but H. pylori infection persisted or recurred in 11 patients. Within 48 months, rebleeding occurred in nine (81.8%) of these patients, whereas the 21 patients who were persistently negative for H. pylori infection remained asymptomatic without rebleeding (0/ 21 = 0%, p < 0.002) during the whole follow-up. Eradication of H. pylori can reduce the rate of duodenal ulcer rebleeding for at least 4 yr, thus potentially modifying the natural history of the disease.",1998.0,0,0
1223,9647022,"Two-day quadruple therapy for cure of Helicobacter pylori infection: a comparative, randomized trial.",X Calvet; N García; R Campo; E Brullet; R Comet; M Navarro,"We sought to compare a 2-day quadruple therapy with a 14-day triple therapy in the treatment of Helicobacter pylori infection. Eighty-one consecutive patients with an endoscopically diagnosed peptic ulcer and demonstrated infection by H. pylori were included in the study. Patients were randomized to receive omeprazole 40 mg b.i.d., amoxicillin 2.5 g once daily, metronidazole 500 mg t.i.d., and bismuth subcitrate 360 mg t.i.d. for 2 days, followed by omeprazole 20 mg once daily for 6 additional days (Group 1) or a 14-day course of omeprazole 20 mg b.i.d., amoxicillin 1 g t.i.d., and metronidazole 500 mg t.i.d. (Group 2). Eradication was evaluated by antral biopsy and rapid urease test at 2 months after therapy and by C13-urea breath test after a year. Two patients were lost to follow-up at 2 months. Intention-to-treat analysis showed that H. pylori infection was cured in 29 of 42 patients (69%; 95% CI: 53-82%) in Group 1 versus 36 of 39 (92%; 95% CI: 78-98%) of patients in Group 2 (p = 0.009). Per-protocol analysis showed a cure rate of 71% (95% CI: 55-84%) (29/41 patients) and 95% (95% CI: 81-99%) (36/38 patients), respectively (p = 0.007). Fifty-five of 65 cured patients returned 1 year after treatment (26 in Group 1, 29 in Group 2). All but one in Group 2 remained cured. There were no significant differences in compliance (88% in Group 1 versus 92% in Group 2) or in the presence of side effects (27%; 95% CI: 15-43% versus 41%; 95% CI: 26-58%; ns). Two-day quadruple therapy is significantly less effective than 2-wk triple treatment.",1998.0,0,0
1224,9648957,No effects of high-dose omeprazole in patients with severe airway hyperresponsiveness and (a)symptomatic gastro-oesophageal reflux.,M J Boeree; F T Peters; D S Postma; J H Kleibeuker,"Acid gastro-oesophageal reflux may aggravate respiratory symptoms in patients with asthma and chronic obstructive pulmonary disease (COPD) by increasing airway hyperresponsiveness through vagally-mediated pathways. We wanted to determine whether elimination of acid reflux could improve symptoms in such patients. In a randomized, double-blind, placebo-controlled study, 36 allergic and nonallergic subjects (17 males and 19 females, mean age 52 yrs), with airway obstruction and severe airway hyperresponsiveness despite maintenance treatment with an inhaled corticosteroid and with increased acid gastro-oesophageal reflux, were treated either with omeprazole, 40 mg b.i.d., or placebo for 3 months. Primary endpoints were: airway hyperresponsiveness, as determined by the provocative concentration of methacholine producing a 20% fall in forced expiratory volume in one second (PC20); and airway obstruction. Secondary endpoints were: peak expiratory flow variability; reversibility to inhaled ipratropium bromide as a parameter of vagal activity; asthma symptoms scores; and medication used. Reflux was measured by 24 h ambulatory intraoesophageal pH measurement. Omeprazole, 40 mg b.i.d., for 3 months had no beneficial effect on any of the pulmonary parameters, despite its profound effect on acid reflux and improvement of reflux symptoms scores, compared to placebo. The results of this study do not support a role for intensive antireflux therapy to improve pulmonary symptoms and function in patients with asthma and chronic obstructive pulmonary disease, who have severe airway hyperresponsiveness despite maintenance treatment with inhaled corticosteroids.",1998.0,0,0
1225,9649457,The clinical and economic value of a short course of omeprazole in patients with noncardiac chest pain.,R Fass; M B Fennerty; J J Ofman; I M Gralnek; C Johnson; E Camargo; R E Sampliner,"Evaluation of new patients with noncardiac chest pain (NCCP) may require a variety of costly tests. The aim of this study was to evaluate the efficacy of the omeprazole test (OT) in diagnosing gastroesophageal reflux (GERD) in patients with NCCP and estimate the potential cost savings of this strategy compared with conventional diagnostic evaluations. Thirty-nine patients referred by cardiologists were enrolled. Baseline symptoms were recorded, and the patients were randomized to either placebo or omeprazole (40 mg AM and 20 mg PM) groups for 7 days. Patients were crossed over to the other arm after a washout period and repeat baseline symptom assessment. All patients underwent 24-hour esophageal pH monitoring and upper endoscopy before randomization. Thirty-seven patients (94.9%) completed the study. Twenty-three (62.2%) were classified as GERD positive and 14 as GERD negative. Eighteen (78%) GERD-positive patients and 2 (14%) GERD-negative patients had a positive OT (P < 0.01), yielding a sensitivity of 78.3% (95% confidence interval, 61.4-95.1) and specificity of 85.7% (95% confidence interval, 67.4-100). Economic analysis showed that the OT saves $573 per average patient evaluated and results in a 59% reduction in the number of diagnostic procedures. The OT is sensitive and specific for diagnosing GERD in patients with NCCP. This strategy results in significant cost savings and decreased use of diagnostic tests.",1998.0,0,0
1226,9659153,Assessment of symptomatic response as predictor of Helicobacter pylori status following eradication therapy in patients with ulcer.,K E McColl; A el-Nujumi; L S Murray; E M el-Omar; A Dickson; A W Kelman; T E Hilditch,"Helicobacter pylori eradication therapy is routinely used for treating patients with peptic ulcer disease. To assess the value of symptomatic response to H pylori eradication therapy as a marker of post-treatment H pylori status. One hundred and nine dyspeptic patients with active duodenal or gastric ulceration association with H pylori infection had their symptoms measured by a validated questionnaire before and three months following H pylori eradication therapy. The symptomatic response was compared with post-treatment H pylori status as determined by the 14C urea breath test. An eradication rate of 84% was achieved. Of the 92 patients eradicated of H pylori, 47% experienced complete or near complete resolution of dyspepsia. Of the 17 patients in whom the infection was not eradicated, only one (6%) experienced resolution of dyspepsia. Resolution of dyspepsia was therefore a powerful predictor of eradication of H pylori with a predictive value of 98%. In contrast, persistence of dyspepsia was a weak predictor of persisting infection with a predictive value of only 25%. Excluding patients with endoscopic evidence of coexisting oesophagitis and/or retrosternal discomfort or reflux at initial presentation did not increase the predictive value of persisting dyspepsia for persisting infection. Complete resolution of dyspeptic symptoms is a powerful predictor of eradication of H pylori infection in ulcer patients. Persistence of symptoms is a weak predictor of persisting infection and patients with persisting dyspepsia must have their H pylori status rechecked to guide future management.",1998.0,0,0
1227,9663722,Comparison of omeprazole and lansoprazole in short-term triple therapy for Helicobacter pylori infection.,G C Spinzi; L Bierti; A Bortoli; E Colombo; A M Fertitta; G L Lanzi; R Venturelli; G Minoli,"Effective anti-Helicobacter pylori therapies with few side-effects are needed. To study the effectiveness of short-term triple therapy with amoxycillin, clarithromycin and either omeprazole or lansoprazole for eradication and healing of peptic ulcers. Patients with gastric or duodenal ulcers received amoxycillin (1 g b.d.), clarithromycin (500 mg b.d.) and lansoprazole (30 mg b.d.) (LAC) or omeprazole (20 mg b.d.) (OAC) for 7 days. Endoscopic examinations were performed before treatment and at least 4 weeks after completion of therapy. H. pylori status was confirmed by rapid urease test and histological examination (Giemsa stain) from gastric biopsies taken from both the antrum and the body. A total of 356 patients were randomized in this single-blind study. On a per protocol basis, H. pylori was eradicated in 134 of 170 patients (79%) in the lansoprazole group and in 105 of 146 (72%) in the omeprazole group (P = 0.189); and in intention-to-treat analysis 72% and 62%, respectively (P = 0.043). Healing of the ulcers was obtained in 166 of 186 (98%), and in 139 of 146 patients (95%), respectively (P = 0.357). Side-effects occurred in two patients in the LAC group and in six in the OAC group B (four stopped therapy). This study has shown that the two regimens are highly effective in healing duodenal ulcers and are well tolerated. Neither treatment achieves the ideal cure rate for H. pylori. Lansoprazole does not appear to have a significant advantage over omeprazole either in ulcer healing or in H. pylori eradication.",1998.0,0,0
1228,9663726,"Prospective evaluation of a new anti-ulcer agent, ecabet sodium, for the treatment of Helicobacter pylori infection.",T Ohkusa; I Takashimizu; K Fujiki; A Araki; K Ariake; K Shimoi; K Honda; Y Enomoto; T Sakurazawa; T Horiuchi; S Suzuki; K Ishii; T Ishikura,"A new anti-ulcer agent, ecabet sodium, is active against Helicobacter pylori. To assess the efficacy of ecabet sodium for the eradication of H. pylori in patients with gastroduodenal diseases. In a prospective, randomized and controlled study, patients infected with H. pylori were assigned to one of the following two groups: group LA, who received lansoprazole 30 mg o.d. + amoxycillin 500 mg q.d.s. after meals for 2 weeks, and group LAE, who received lansoprazole 30 mg o.d. + amoxycillin 500 mg q.d.s. + ecabet sodium 1000 mg b.d. after meals for 2 weeks. H. pylori status was determined before and at least 4 weeks after the therapy by rapid urease test, histology and a urea breath test. Of 101 patients (mean age 53 years, range 17-77 years, M/F: 68/33) enrolled in the study, 97 patients completed the protocol. Four patients were withdrawn because of diarrhoea (three from group LA) and skin rash (one from group LAE). The eradication of H. pylori was achieved in 28/48 (58%) patients in group LA and 38/49 (78%) patients in group LAE. The rate of eradication of H. pylori produced by the LAE treatment was significantly higher than that produced by the LA treatment. Side-effects appeared in two patients (malaise 1, skin rash 1) in group LAE and in seven patients (diarrhoea 6, dizziness 1) in group LA. These side effects disappeared spontaneously with cessation of the treatment. Ecabet sodium in combination with lansoprazole and amoxycillin increased the rate of eradication of H. pylori. Ecabet sodium appeared to reduce the incidence of diarrhoea as a side-effect of the dual LA therapy.",1998.0,0,0
1229,9663727,Omeprazole 20 or 40 mg daily for healing gastroduodenal ulcers in patients receiving non-steroidal anti-inflammatory drugs.,G Massimo Claar; S Monaco; C Del Veccho Blanco; L Capurso; M Fusillo; B Annibale,"Non-steroidal anti-inflammatory drugs (NSAIDs) are strongly associated with gastroduodenal ulcers, and the management of patients with NSAID-associated ulcers represents a common clinical dilemma. To assess NSAID-associated ulcer healing during treatment with either standard (20 mg) or high dosage (40 mg) omeprazole. One hundred and sixty-nine patients chronically ingesting diclofenac, ketoprofen, indomethacin or naproxen for osteoarthritis or rheumatoid arthritis, who had abdominal pain and an endoscopically proven gastroduodenal ulcer, were evaluated in a randomized, double-blind, dose regimen trial with omeprazole 20 mg o.m. (n = 81) or omeprazole 40 mg o.m. (n = 88). Ulcer healing was assessed endoscopically at 4 and 8 weeks in the case of unhealed ulcers. Patients continued their usual daily dose of anti-inflammatory medication throughout the study period. One hundred and fifty-six patients completed the study (77 patients taking 20 mg omeprazole and 79 patients taking 40 mg omeprazole); 12 patients were lost during follow-up and one patient reported an adverse event. Cumulative ulcer intention-to-treat healing rates at 8 weeks were 88% (95% confidence interval (CI) = 79-95%) for the 20 mg omeprazole group and 96.2% (95% CI = 89-99%) for the 40 mg group, and 97.1% (95% CI = 90-100%) for the 20 mg omeprazole group and 98.6% (95% CI = 93-100%) for the 40 mg group by per protocol analysis. There were no statistically significant differences between the two groups. Symptom relief did not differ significantly between the two treatment groups. Both standard and high doses of omeprazole are equally safe and effective regimens for the treatment of NSAID-induced gastroduodenal ulcers when anti-inflammatory treatment is not discontinued.",1998.0,0,0
1230,9663834,One-year prophylactic efficacy and safety of pantoprazole in controlling gastro-oesophageal reflux symptoms in patients with healed reflux oesophagitis.,J Mössner; H Koop; H Porst; H Wübbolding; A Schneider; C Maier,"Pantoprazole is a benzimidazole derivative which selectively inhibits the proton pump H+. K+-ATPase necessary for the final step in gastric acid secretion. To investigate the tolerability and the prophylactic effect of pantoprazole 40 mg once daily on relapse in patients whose reflux oesophagitis had been healed. The safety of pantoprazole 40 mg once daily was assessed in an open 1-year trial on 222 patients whose reflux oesophagitis had been healed with omeprazole or pantoprazole. Relapse was defined as endoscopically-confirmed reflux oesophagitis (at least Grade I), with endoscopies being performed for patients experiencing 3 consecutive days of disease-specific symptoms. Kaplan-Meier survival analysis at 6 and 12 months gave estimated treatment failure rates of 2% and 6% from confirmed relapses (per-protocol), and of 9% and 30% for a worst-case group (all withdrawals counted as failures). The only population shift in laboratory variables was a doubling of the median serum gastrin level over the first 6 months; thereafter it stabilized. Fifty-four (24%) patients experienced adverse events; 15 of these withdrew. Serious adverse events were reported for 12 patients. Pantoprazole appears to be highly effective and to have a good safety profile for long-term prophylaxis of reflux oesophagitis.",1998.0,0,1
1231,9663835,Prognostic factors for relapse of reflux oesophagitis and symptoms during 12 months of therapy with lansoprazole.,J G Hatlebakk; A Berstad,"Symptom relief and endoscopic healing are both important treatment goals in patients with reflux oesophagitis. Knowledge of predictive factors for treatment success could facilitate choice of treatment in individual patients. To assess the value of clinical data and data from baseline ancillary investigations in predicting the outcome of maintenance therapy with a proton pump inhibitor. After healing and symptom relief had been obtained on open therapy with lansoprazole 30 mg daily, 103 patients with reflux oesophagitis grade 1 or 2 were randomized to maintenance therapy with lansoprazole 15 or 30 mg daily, and time until recurrence of symptoms and/or endoscopic changes was recorded. The predictive value of the following variables was assessed by Cox regression analysis: dose of lansoprazole, symptom severity, grade of reflux oesophagitis. Helicobacter pylori infection status, lower oesophageal sphincter resting tone, percentage of 24 h with an oesophageal pH of <4.0, and median 24 h intragastric pH before start of treatment. Dose of lansoprazole (P = 0.01) and symptom severity (P < 0.05) both significantly predicted time to relapse. Grade of reflux oesophagitis had only a borderline predictive value (P = 0.09), while H. pylori infection status and data from manometry and intraoesophageal 24-hour pH-metry did not predict relapse. Symptom severity before starting therapy is a significant predictive factor for treatment success during potent antisecretory therapy with lansoprazole, more so than endoscopic grade of reflux oesophagitis. In a group of patients with uncomplicated reflux oesophagitis being considered for maintenance therapy with lansoprazole, ancillary investigations with endoscopy, manometry and 24-hour pH-metry gave very limited prognostic information. H. pylori infected patients relapsed as early as patients who were not infected.",1998.0,0,0
1232,9663840,Ranitidine bismuth citrate with clarithromycin versus omeprazole with amoxycillin in the cure of Helicobacter pylori infection.,J J Kolkman; T G Tan; M Oudkerk Pool; W A Van Kleef; A A Geraedts; R J Timmerman; L F Crobach; J J Nicolai; A A Wolff; J Van Der Laan,"To compare the efficacy of ranitidine bismuth citrate plus clarithromycin (RBC-C) vs. omeprazole plus amoxycillin (OME-AMO) in the cure of Helicobacter pylori infection. In this double-blind, multicentre, parallel-group study 122 H. pylori-positive patients with active duodenal ulcer or gastritis, with confirmed history of duodenal ulcer, were randomized to treatment with ranitidine bismuth citrate 400 mg b.d. plus clarithromycin 500 mg b.d. or omeprazole 20 mg b.d. plus amoxycillin 1000 mg b.d. for 14 days, followed by 14 days of ranitidine bismuth citrate 400 mg b.d. or omeprazole 20 mg once daily, respectively, to facilitate ulcer healing. Endoscopy was carried out at the start of the study and 28 days after the end of treatment. At each endoscopy four biopsies were obtained from the antrum and four biopsies from the corpus, for rapid urease test, histology and culture. H. pylori infection was defined as a positive urease test, confirmed by histology or culture. Cure of H. pylori infection was defined as negative urease test, histology or culture from both sites. Per-protocol, all-patients-treated and intention-to-treat cure rates (95% confidence interval) were, respectively, 90% (81-89%), 90% (82-89%) and 84% (74-93%) for ranitidine bismuth citrate plus clarithromycin, and 39% (27-54%), 44% (31-57%) and 41% (29-53%) for omeprazole plus amoxycillin, P < 0.00001. Both regimens were well tolerated. Eight patients were lost to follow-up, for lack of efficacy (one patient), adverse events (three patients) or refusal of second endoscopy (four patients). Ranitidine bismuth citrate 400 mg b.d. with clarithromycin 500 mg b.d. is superior to omeprazole 20 mg b.d. with amoxycillin 1000 mg b.d. Ranitidine bismuth citrate with clarithromycin is the first dual therapy with high cure rates and good tolerance, and is easy to take. It may therefore prove a suitable first-line treatment in H. pylori infection.",1998.0,0,0
1233,9663841,"Susceptibility of Helicobacter pylori isolates to metronidazole, clarithromycin and amoxycillin in vitro and in clinical treatment in Japan.",H Miyaji; T Azuma; S Ito; H Suto; Y Ito; Y Yamazaki; F Sato; M Hirai; M Kuriyama; T Kato; Y Kohli,"Primary and acquired resistance to antibiotics is an important factor in determining the reason for treatment failure in Helicobacter pylori infection. We examined the relationship between the susceptibility of H. pylori isolates and the efficacy of chemotherapy. The minimal inhibitory concentrations (MICs) of metronidazole (MNZ), clarithromycin (CLAR) and amoxycillin (AMOX) of 320 H. pylori pre-treatment isolates were determined by the agar dilution method. In 290 patients with peptic ulcers. H. pylori infection was treated by dual or triple combination therapies for 2 weeks: one proton pump inhibitor (30 mg/day lansoprazole or 20 mg/day omeprazole) and one or two antibiotics (500 mg AMOX, 200 mg CLAR or 250 mg MNZ twice a day). MICs were also determined after the treatment failure. Among the drugs tested, for MNZ and CLAR, 8.1% and 9.1% of the isolates, respectively, were resistant, while no isolate was resistant to AMOX. After unsuccessful treatment using MNZ and CLAR, 66.7% and 70.61% of the isolates changed from sensitive to resistant, respectively. All isolates were sensitive to AMOX after treatment failure. The failure of the H. pylori treatment results in the induction of resistance to CLAR and/or MNZ. Regimens with a high cure rate should be used in order to prevent the generation of acquired resistance to antibiotics.",1998.0,0,0
1234,9672330,Omeprazole improves peak expiratory flow rate and quality of life in asthmatics with gastroesophageal reflux.,T R Levin; R M Sperling; K R McQuaid,"The aim of this study was to determine if omeprazole improves pulmonary function and quality of life in asthmatics with gastroesophageal reflux. This was a double blind, randomized, placebo-controlled cross-over trial. After a 4-wk lead-in period, nine patients with documented asthma and gastroesophageal reflux, were prescribed either omeprazole 20 mg, daily or placebo for 8 wk and then crossed over to the alternate treatment. Outcome measurements included: forced expiratory volume at 1 s (FEV1), peak expiratory flow rate (PEFR), and responses on the Asthma Quality of Life Questionnaire, a validated disease specific measure of functional status. After omeprazole treatment, compared with placebo, patients had higher mean morning and evening PEFR, mean absolute difference (95% CI): morning: 37.8 L/min. (10.9-64.6), evening: 31.2 (3.2-59.2). Omeprazole treatment led to higher mean overall scores on the Asthma Quality of Life Questionnaire, and on the subdomains of activity limitation, symptoms, and emotions (p = 0.039, 0.049, 0.024, 0.040). A trend toward higher FEV1 (mean: 15.6% difference) with omeprazole failed to reach statistical significance (p > 0.2). After taking omeprazole for 8 wk, asthmatics with GER have better PEFR and quality of life than after placebo.",1998.0,0,0
1235,9672334,The impact of Helicobacter pylori eradication on peptic ulcer healing.,G Treiber; J R Lambert,"Current literature was reviewed analyzing the outcome of peptic ulcer healing in relation to the results of the posttherapeutic Helicobacter pylori (HP) status. Literature was reviewed along with an analysis of 60 studies, comprising a total of 4329 patients. Successful Helicobacter pylori eradication was found to induce a better response in peptic ulcer healing, regardless of diagnosis: gastric ulcer 88% vs 73% (odds ratio [OR] 2.7, p < 0.01), duodenal ulcer 95% vs 76% (OR 5.6, p < 0.0001), and peptic ulcer 95% vs 76% (OR 6.6, p < 0.0001), for patients having their HP infection successfully cured versus those remaining HP-positive, respectively (Fisher's exact test). For all evaluated time points (< or = 6, 7-8, and 10-12 wk after beginning treatment), HP-negative patients had higher healing rates than HP-positive patients (95% vs 82%, 94% vs 69%, and 96% vs 78% with corresponding OR of 4.2, 6.5, and 7.4, all p < 0.0001, Fisher's exact test). The use of concomitant acid suppression therapy during initial HP eradication provided a benefit on peptic ulcer healing only for patients with persistent HP infection (improved healing rates of 78% vs 67%; otherwise rates were 94-96%). Likewise, prolonged acid inhibition in HP treatment failures after the initial HP treatment phase resulted in 7-20% improved healing rates, whereas patients becoming HP-negative did not profit. Successful HP eradication therapy accelerates peptic ulcer healing even without concomitant acid suppression.",1998.0,0,0
1236,9674479,Does medical antireflux therapy improve asthma in asthmatics with gastroesophageal reflux?: a critical review of the literature.,S K Field; L R Sutherland,"Identify and critically review the peer-reviewed, English-language studies of the effects of medical antireflux therapy in asthmatics with gastroesophageal reflux (GER). Using the 1966 to 1996 MEDLINE database, asthma was combined with GER to identify all studies of the effects of medical antireflux therapy on asthma control. The articles' bibliographies were also reviewed. Studies were graded according to Sackett's criteria and grouped by levels of evidence. A total of 242 citations were found; 171 were published in English. Twelve studies of the effects of medical antireflux therapy on asthma control, with a total of 326 treated patients, were identified. Eight studies were placebo-controlled, three were open studies, and one used an untreated control. Eight studies treated 20 or fewer patients. Reflux symptoms either did not improve or the effects of antireflux therapy on them were not reported in four studies. The combined data from the controlled medical antireflux studies showed that: (1) asthma symptoms improved in 69% of the subjects; (2) asthma medication use was reduced in 62% of the subjects; (3) evening peak expiratory flow (PEF), but not PEF at other times, improved in 26% of the subjects; and (4) spirometry did not improve in any of the placebo-controlled antireflux studies. Analysis of the combined data suggests that medical antireflux therapy improves asthma symptoms, may reduce asthma medication use, but has minimal or no effect on lung function.",1998.0,0,0
1237,9678814,Two-week course of pantoprazole combined with 1 week of amoxycillin and clarithromycin is effective in Helicobacter pylori eradication and duodenal ulcer healing.,J A Louw; C J van Rensburg; D Hanslo; H D Grundlings; A H Girdwood; I N Marks,"Experience with proton pump inhibitor-based triple therapy is predominantly with omeprazole-containing regimens. To investigate the efficacy of a pantoprazole-based regimen, with either a 1 or 2-week course of antibiotic co-therapy, in eradicating H. pylori, healing duodenal ulcers and to assess the antibiotic sensitivity profiles of isolated H. pylori strains. A single-blind, multicentre, parallel group comparison of patients with endoscopically proven, H. pylori associated, active duodenal ulceration. All patients received pantoprazole, 40 mg b.d. for 2 weeks. Patients were randomized to receive either 1 or 2 weeks of therapy with amoxycillin, 1 g b.d. and clarithromycin 500 mg b.d. Patients were endoscoped at entry, at 14 days and a minimum of 4 weeks after cessation of all therapy. H. pylori status was determined by urease reaction, histological assessment and culture from antral and body biopsies. Antibiotic sensitivity was determined using the agar dilution technique. Sixty-seven patients were randomized. One week co-therapy (n=33): eradication efficacy, ITT= 79% (95% CI: 61-91%); ulcer healing efficacy (at 6-week visit)=88% (95% CI: 72-97%). Two-week co-therapy (n=34): eradication efficacy, ITT=91% (95% CI: 76-98%: ulcer healing efficacy= 88% (95% CI: 73-97%). Both regimens were well tolerated and no primary antibiotic resistance was noted. Pantoprazole-based triple therapy, with either 1 or 2 weeks of co-therapy with amoxycillin and clarithromycin, is effective in eradicating H. pylori and healing duodenal ulceration.",1998.0,0,0
1238,9678815,"Lansoprazole and secnidazole with clarithromycin, amoxycillin or pefloxacin in the eradication of Helicobacter pylori in a developing country.",V Ahuja; A Dhar; C Bal; M P Sharma,"A number of triple drug regimens using proton pump inhibitors and two antibiotics have been evaluated in the West and reported to achieve Helicobacter pylori eradication rates of over 90%. In developing countries however, these combinations have neither been well evaluated, nor the optimum treatment for H. pylori infection well defined. To compare the combination of a proton pump inhibitor with a nitroimidazole and another antibiotic in eradicating H. pylori infection and healing duodenal ulcer. Sixty consecutive patients with active duodenal ulcer who were positive for H. pylori (by rapid urease test and 14C-urea breath test) were randomized into three treatments groups: (1) LAS (n=21): lansoprazole 30 mg o.m., amoxycillin 500 mg q.d.s. and secnidazole 2 g on alternate days for 2 weeks; (2) LCS (n=18): lansoprazole 30 mg o.m., clarithromycin 500 mg b.d. and secnidazole 2 g on alternate days for 1 week; (3) LPS (n=21): lansoprazole 30 mg o.m., pefloxacin 400 mg o.m. and secnidazole 2 g on alternate days for 2 weeks. Urease and breath tests were performed at 0, 6 and 12 weeks to check for H. pylori eradication. Intention-to-treat eradication rates were as follows: LAS 86%, LCS 83%, LPS 71%; the overall ulcer healing rate was 90% at 6 weeks. High H. pylori eradication rates were achieved using the amoxycillin- and clarithromycin-based therapies. Fewer side-effects, better compliance and low cost favoured the amoxycillin-based therapy.",1998.0,0,0
1239,9678816,Addition of bismuth subnitrate to omeprazole plus amoxycillin improves eradication of Helicobacter pylori.,A F Carvalho; L A Fiorelli; V N Jorge; C M Da Silva; G De Nucci; J G Ferraz; J Pedrazzoli,"To evaluate whether the addition of bismuth subnitrate to a dual oral therapy regimen with omeprazole plus amoxycillin could improve Helicobacter pylori eradication. Fifty consecutive Helicobacter pylori-positive patients were randomly enrolled to receive either (A) bismuth subnitrate (300 mg q.d.s.), omeprazole (20 mg b.d.) and amoxycillin (500 mg q.d.s.), or (B) omeprazole (20 mg b.d.) and amoxycillin (500 mg q.d.s.). Both groups (n=25 each) received the medication for 14 days. H. pylori status was reassessed 30 days after completion of the therapy in order to evaluate eradication rates. Six patients were lost to follow-up and therefore excluded from the study (three patients from each group). One patient from Group B withdrew from the study because of side-effects. The addition of bismuth subnitrate to omeprazole and amoxycillin significantly improved its efficacy in eradicating H. pylori, with 72% (18/25) eradication in Group A and 52% (13/25) in Group B (P=0.027). The addition of bismuth subnitrate to dual oral therapy was also capable of improving the healing of peptic ulcers when compared with dual oral therapy alone (100%, 8/8 vs. 58%, 4/7; P=0.021). Our results demonstrate that the addition of bismuth subnitrate to dual oral therapy enhances H. pylori eradication, and improves healing of peptic ulcers.",1998.0,0,0
1240,9678819,Screening for Helicobacter pylori in young dyspeptic patients referred for investigation--endoscopy for those who test negative.,N P Breslin; J Lee; M Buckley; C O'Morain,"Studies in young dyspeptic patients have suggested that screening strategies based on non-invasive H. pylori testing can reduce endoscopy workload by 25-40%. Such strategies usually propose that only H. pylori-positive individuals should undergo endoscopy. This approach may fail to diagnose idiopathic ulcers, ulcers in patients whose screening test is falsely negative and reflux disease. To investigate a hypothetical screening strategy in which endoscopy is initially performed only in H. pylori-negative dyspeptics. Seventy-two consecutive patients under 45 years of age undergoing investigation for 'ulcer-like' dyspepsia had invasive and non-invasive determination of H. pylori status. Individuals found to be H. pylori-positive at endoscopy received 1 week of proton pump inhibitor-based triple therapy. H. pylori-negative individuals received therapy tailored to their diagnosis. Endoscopy was repeated in the positive group to confirm successful eradication. Results were analysed according to our strategy, i.e. serologically-positive patients would have received eradication therapy without endoscopy, but patients found to be negative would have been referred for endoscopy. According to the serology test there were 39 positive and 33 negative results. Symptoms failed to resolve during follow-up in nine of the serological positives despite successful eradication. There were also five false positives who were deemed likely treatment failures. Thus according to our strategy, these 14 serologically-positive patients would ultimately have required an endoscopy and the other 25 serologically-positive patients would have avoided an endoscopy, resulting in a 35% reduction in endoscopy usage in this population. In the serologically-negative group there were three cases of peptic ulcer disease where the test was falsely negative, but they were detected by the strategy. No cases of gastric malignancy were detected at endoscopy. Thus our strategy would have reduced initial endoscopy referrals by 35% in this selected population. A strategy of empirical H. pylori eradication therapy can safely reduce the requirement for endoscopy in young dyspeptic patients without sinister symptoms.",1998.0,0,0
1241,9683093,Sample size calculation in economic evaluations.,M J Al; B A van Hout; B C Michel; F F Rutten,"A simulation method is presented for sample size calculation in economic evaluations. As input the method requires: the expected difference and variance of costs and effects, their correlation, the significance level (alpha) and the power of the testing method and the maximum acceptable ratio of incremental effectiveness to incremental costs. The method is illustrated with data from two trials. The first compares primary coronary angioplasty with streptokinase in the treatment of acute myocardial infarction, in the second trial, lansoprazole is compared with omeprazole in the treatment of reflux oesophagitis. These case studies show how the various parameters influence the sample size. Given the large number of parameters that have to be specified in advance, the lack of knowledge about costs and their standard deviation, and the difficulty of specifying the maximum acceptable ratio of incremental effectiveness to incremental costs, the conclusion of the study is that from a technical point of view it is possible to perform a sample size calculation for an economic evaluation, but one should wonder how useful it is.",2000.0,0,0
1242,9684126,Omeprazole in patients with mild or moderate reflux esophagitis induces lower relapse rates than ranitidine during maintenance treatment.,B Annibale; M Franceschi; M Fusillo; M Beni; B Cesana; G Delle Fave,"Patients with reflux esophagitis have rapid relapses after treatment withdrawal. This study was designed to investigate the relapse rate of symptomatic esophagitis during maintenance treatment with omeprazole versus ranitidine after the induction of acute healing with omeprazole. Patients with endoscopically verified acute erosive or ulcerative esophagitis (grade 2 or 3) were initially treated with 20 mg of omeprazole daily for 4, 8, or 12 weeks. After healing, the patients were randomized to maintenance treatment with omeprazole (20 mg every morning) or ranitidine (150 mg twice daily). A control endoscopy was performed at the end of the healing phase and after 6 months of maintenance treatment or symptomatic relapse. Of 231 initially treated patients, 223 were healed (no erosive esophagitis) and entered the maintenance study. The estimated proportions of patients in remission after 6 months of maintenance treatment with 20 mg of omeprazole once per day (n = 102) and 150 mg of ranitidine twice per day (n = 103) were 89.2% and 75.7%, respectively. The single daily dose of omeprazole worked significantly better than the doses of ranitidine (p < 0.001). The omeprazole group, in comparison to the ranitidine group, had a significantly higher number of patients without symptoms (37.8% vs 54.7%) and a lesser percentage of moderate symptoms (9.45% vs 19.8%). Maintenance treatment with omeprazole (20 mg once daily) is superior to ranitidine (150 mg twice daily) in keeping patients with mild to moderate erosive reflux esophagitis in remission over a 6-month period.",1998.0,0,1
1243,9689428,Efficacy of tetracycline and metronidazole alone or with ranitidine on the healing of duodenal ulcer and eradication of Helicobacter pylori. A randomized controlled multicenter study. Tetra-Metro-Ran Study Group.,S Massarrat; P Ihm; H K Koch,"In almost all eradication regimens, which contain antibiotics and bismuth derivatives, the administration of acid suppressing drugs for 4-6 weeks is recommended for healing of duodenal ulcer. The aim of this multicenter double blind study is to elucidate the effect of two classic antibiotics tetracycline (CAS 60-54-8) and metronidazole (CAS 443-48-1) alone or combined with ranitidine (CAS 66357-35-5) on the healing of duodenal ulcer and eradication of Helicobacter Pylori. Patients with duodenal ulcer were randomized to two treatment groups: group A received either ranitidine 4 x 150 mg or tetracycline 4 x 500 mg or metronidazole 3 x 250 mg for 2 weeks. Group B received 4 x placebo + tetracycline and metronidazole as in group A for 2 weeks. A final endoscopy was performed after 8 weeks. Four biopsy specimens were obtained from the antrum (two) and corpus (two) for both urease test and hematoxylin stain for detection of H. pylori. Out of 201 patients entering the study 156 completed the study (78 in A and 78 in B). The healing rate of duodenal ulcer was 98.7% in group A and 97.5 in group B. The eradication rate was only 33.3% in group B but 64% in group A (p < 0.001), when additionally ranitidine was given. The present study shows that treatment with the two antibiotics tetracycline and metronidazole alone results in a very low H. pylori eradication, but almost complete healing of duodenal ulcer after 8 weeks. Prolonged administration of antisecretory drugs in eradication regimens containing two antibiotics is not necessary for duodenal ulcer healing. However, the addition of H2-receptor antagonists or proton pump inhibitors to antibiotics increases the eradication rate.",1998.0,0,0
1244,9690720,Dose-response relationship of lansoprazole to gastric acid antisecretory effects.,R A Blum; R H Hunt; S L Kidd; H Shi; D E Jennings; P A Greski-Rose,"Proton pump inhibitors have been found to be effective in numerous studies in patients with peptic ulcer disease, particularly associated with Helicobacter pylori and gastro-oesophogeal reflux disorders. Optimal healing rates of antisecretory therapy for peptic acid disease is dependent upon the degree and duration of acid suppression and the length of treatment. To evaluate the extent and duration of gastric acid suppression of several lansoprazole regimens, administered for 5 consecutive days in 32 healthy adult male subjects. Intragastric 24-h pH monitoring was performed in 32 healthy subjects in a randomized, double-blind, four-way crossover study. Sixteen subjects (Group 1) received lansoprazole 30 mg o.d. (once daily), 15 mg b.d. (twice daily), 30 mg b.d. and 30 mg t.d.s. (three times a day) for 5 days; and 16 subjects (Group 2) received lansoprazole 30 mg o.d., 60 mg o.d., 60 mg b.d. and 60 mg t.d.s. for 5 days. Mean 24-h intragastric pH values for lansoprazole 30 mg o.d., 15 mg b.d., 30 mg b.d. and 30 mg t.d.s. were 4.47, 4.57, 5.07 and 5.63, respectively. Multiple-dose regimens of lansoprazole 30 mg b.d. and t.d.s. produced greater acid suppression compared to lansoprazole 30 mg o.d. and 15 mg b.d. There was no significant difference in acid suppression between lansoprazole 30 mg o.d. and 15 mg b.d. Mean 24-h intragastric pH values for lansoprazole 30 mg o.d., 60 mg o.d., 60 mg b.d. and 60 mg t.d.s. were 4.13, 4.45, 5.19 and 5.13, respectively. Multiple-dose regimens of lansoprazole 60 mg b.d. and t.d.s. produced significantly greater acid suppression compared to lansoprazole 30 mg o.d. and 60 mg o.d. There was no significant difference in acid suppression between lansoprazole 30 mg o.d. and 60 mg o.d. Lansoprazole 30 mg t.d.s., 60 mg b.d. and 60 mg t.d.s. produced significantly greater percentage time above pH 3, 4, 5 and 6 than did lansoprazole 30 mg o.d. Post-regimen serum gastrin values increased by 50-130% from pre-study mean values but remained within normal range and returned to pre-study values 7-14 days post-dosing. Multiple-dose regimens of lansoprazole (> or =30 mg b.d. for 5 days) produce significantly increased intragastric pH and significantly longer duration of increased intragastric pH than does lansoprazole 30 mg administered once daily.",1998.0,0,0
1245,9690725,Omeprazole and sucralfate in the treatment of NSAID-induced gastric and duodenal ulcer.,G Bianchi Porro; M Lazzaroni; G Manzionna; M Petrillo,"To establish the healing efficacy of two drugs, omeprazole and sucralfate, when given to patients who had developed gastric or duodenal ulcer while undergoing chronic treatment with non-steroidal anti-inflammatory drugs (NSAIDs). Ninety-eight patients with arthritis or arthrosis and NSAID-related gastric or duodenal ulcer were admitted to the endoscopic, single-blind study. They were randomized to receive either omeprazole 20 mg o.m. or sucralfate 2 g b.d. for 4-8 weeks. The patients continued to receive the same NSAID during the trial. Upper gastrointestinal endoscopy was performed at entry and after 4 or 8 weeks. Eighty-eight patients completed the 4-week study, but only 81 were available for final analysis at 8 weeks. Omeprazole was significantly superior to sucralfate in inducing gastric ulcer healing after both 4 (87 vs. 52%, P = 0.007) and 8 weeks (100 vs. 82%, P = 0.04). No statistically significant difference in duodenal ulcer healing rates emerged between the two groups either at 4 (79 vs. 55%) or 8 weeks (95 vs. 73%). The healing rates in patients with combined gastric and duodenal ulcer were 67 vs. 33% after 4 weeks and 6 7 vs. 6 7% after 8 weeks of treatment. The percentages of asymptomatic patients were similar in the two treatment groups both at 4 (70 vs. 73%) and 8 weeks (70 vs. 75%). H. pylori infection did not influence healing rates, but significantly more H. pylori-positive patients healed with omeprazole. The results of this study show that omeprazole is superior to sucralfate in healing NSAID-induced gastroduodenal ulcer in patients who continue to take anti-inflammatory drugs. The good results observed were unrelated to H. pylori status.",1998.0,0,0
1246,9690729,"US double-blind, controlled trials of omeprazole and amoxycillin for treatment of Helicobacter pylori.",L Laine; E Johnson; L Suchower; P Ronca; C Hwang; G Neil,"Widely variable Helicobacter pylori eradication rates have been reported with omeprazole/amoxycillin dual therapy. We present the first US double-blind, controlled trials of this dual therapy. Three separate studies were performed: Studies 1 and 2 included patients with an active duodenal ulcer and Study 3 included patients with a documented history of duodenal ulcer. H. pylori eradication regimens in all studies were omeprazole plus amoxycillin vs. omeprazole vs. amoxycillin for 2 weeks. Doses in Study 1 were omeprazole 40 mg b.d. and amoxycillin 500 mg t.d.s., and in Studies 2 and 3 they were omeprazole 20 mg b.d. and amoxycillin 1 g t.d.s. Endoscopic biopsy tests were used for H. pylori diagnosis, and testing for H. pylori eradication was done at least 4 weeks after the completion of therapy. Amoxycillin sensitivities were performed in Study 2. Intention-to-treat (ITT) and per protocol (PP) analyses showed that eradication rates with omeprazole/amoxycillin [ITT: 39%, 40%, 46% (n = 72, 62, 48); PP: 50%, 46%, 54% (n = 54, 52, 37)] were significantly greater than monotherapy with either omeprazole (ITT: 0-4%); PP: 0-5%) or amoxycillin (ITT: 2-5%; PP: 0-11%). No patients taking the dual therapy discontinued therapy due to adverse events. Amoxycillin resistance was not seen at baseline (n = 76) or after amoxycillin therapy (n = 56). Omeprazole/amoxycillin dual therapy is well tolerated but the eradication rate which can be expected in the USA is at best about 50%.",1998.0,0,0
1247,9692687,Primary gastroduodenal prophylaxis with omeprazole for non-steroidal anti-inflammatory drug users.,D Cullen; K D Bardhan; M Eisner; D G Kogut; R A Peacock; J M Thomson; C J Hawkey,"To investigate the efficacy of omeprazole 20 mg o.m. as primary prophylaxis against non-steroidal anti-inflammatory drug (NSAID)-associated ulcer disease or dyspeptic symptoms. A parallel group study compared patients randomized to receive omeprazole 20 mg o.m. or placebo as co-therapy with on-going NSAID treatment, over 6 months, in 19 specialist centres in Ireland, Hungary, France, the UK and the USA. One hundred and sixty-nine patients taking NSAIDs regularly, chronically and above defined minimum doses entered the trial. The main outcome measure was the development of gastric or duodenal ulcers detected endoscopically, the development of multiple erosions in the stomach or duodenum, or the onset of moderate or severe dyspeptic symptoms. The estimated probability of remaining free of these end-points for 6 months for patients taking omeprazole was 0.78 compared to 0.53 for placebo (P = 0.004). Fourteen patients receiving placebo (16.5%) developed 15 ulcers, comprising nine gastric and six duodenal ulcers, compared to three patients (3.6%) receiving omeprazole (all gastric ulcers). Logistic regression analysis showed that older patients were less likely, whilst those with rheumatoid arthritis were more likely, to remain free of NSAID-associated problems. Omeprazole is an effective agent for gastroduodenal prophylaxis in patients taking NSAIDs. Its main effect is to reduce the rate of development of gastric and duodenal ulcers.",1998.0,0,0
1248,9692699,Omeprazole is more effective than cimetidine in the prevention of recurrence of GERD-associated heartburn and the occurrence of underlying oesophagitis.,C M Bate; J R Green; A T Axon; G Tildesley; F E Murrays; S M Owen; C Emmas; M D Taylor,"There is documentation of the long-term use of omeprazole 10 mg o.d. in patients with reflux oesophagitis but not in the large number of gastrooesophageal reflux disease (GERD) patients without oesophagitis. There is also a paucity of data on the long-term use of cimetidine in GERD patients. One hundred and fifty-six patients (100 male) who previously had symptomatic non-ulcerative oesophagitis (81%) or symptoms without oesophagitis (19%), were recruited. All patients were in symptomatic remission following 4 weeks of omeprazole 20 mg o.d. or cimetidine 400 mg q.d.s. and, if required, a further 4 weeks of omeprazole 20 mg o.d. Patients were randomized to receive, double-blind, either omeprazole 10 mg o.m. (n = 77) or cimetidine 800 mg nocte (n = 79) for 24 weeks. A greater proportion of patients receiving omeprazole, compared with cimetidine, were in symptomatic remission after 12 (69 vs. 27%) and 24 weeks (60 vs. 24%) (each P < 0.0001). The median time to symptomatic relapse was longer for patients receiving omeprazole (169 vs. 15 days) (P = 0.0001). Of patients leaving the study in symptomatic remission, a greater proportion receiving omeprazole, compared with cimetidine, was free of oesophagitis (84 vs. 53%) (P < 0.05). Omeprazole 10 mg o.m. is more effective than cimetidine 800 mg nocte in the prevention of recurrence of GERD-associated heartburn and the occurrence of underlying oesophagitis.",1998.0,0,1
1249,9692700,"A comparison of omeprazole, lansoprazole and pantoprazole in the maintenance treatment of severe reflux oesophagitis.",D Jaspersen; K L Diehl; H Schoeppner; P Geyer; E Martens,"Proton pump inhibitors are effective for the healing of oesophagitis. Standard doses of omeprazole, lansoprazole or pantoprazole are sufficient for healing in mild to moderate cases of oesophagitis. To compare the efficacy of double the standard doses of omeprazole, lansoprazole or pantoprazole for maintenance treatment of severe oesophagitis complicated by a stricture. Thirty-six patients with reflux oesophagitis and stricture confirmed by endoscopy were included in a prospective study comparing three maintenance therapies. In all cases weekly dilatation of the stenosis was performed and patients were treated with omeprazole 20 mg b.d. until healing of oesophagitis and dysphagia relief were achieved. Thirty participants responded to therapy and were then randomly assigned to 4 weeks of maintenance treatment with omeprazole (20 mg b.d.; n = 10), lansoprazole (30 mg b.d.; n = 10) or pantoprazole (40 mg b.d.; n = 10). Subsequently, endoscopies were performed-the endoscopists were blinded to the therapy assignment. The endpoints were defined as the absence of oesophagitis, oesophageal stricture and complaints. After 4 weeks of treatment, the number of patients remaining in remission (no oesophagitis or stricture and no symptoms) was nine out of 10 (90%) in the omeprazole group, two out of 10 (20%) in the lansoprazole group (P < 0.01) and three out of 10 (30%) in the pantoprazole group (P < 0.01). In our study omeprazole was superior to either lansoprazole or pantoprazole in the maintenance treatment of complicated gastro-oesophageal reflux disease.",1998.0,1,1
1250,9692702,Ranitidine bismuth citrate versus omeprazole triple therapy for the eradication of Helicobacter pylori and healing of duodenal ulcer.,F Catalano; R Catanzaro; C Bentivegna; A Brogna; G Condorelli; R Cipolla,"To compare the efficacy and safety of triple therapy with omeprazole plus amoxycillin and clarithromycin vs. ranitidine bismuth citrate plus amoxycillin and clarithromycin in the treatment of Helicobacter pylori-associated duodenal ulcers. Eighty-one patients with duodenal ulcers were randomized to the following treatments: 39 cases with amoxycillin 1 g b.d. and clarithromycin 500 mg b.d. for 1 week plus omeprazole 20 mg b.d. for 2 weeks (omeprazole + amoxycillin + clarithromycin (OAC)), and 42 cases to the same regimen of amoxycillin and clarithromycin for 7 days plus ranitidine bismuth citrate 400 mg b.d. for 2 weeks (ranitidine bismuth citrate + amoxycillin + clarithromycin (RbAC)). Upper gastrointestinal endoscopy was performed together with a rapid urease test and histological examination of antral and corpus biopsy samples prior to treatment and 4 weeks after the end of therapy. Thirty-four patients in the OAC group and 38 in the RbAC group completed the treatment and 4-week follow-up. H. pylori was eradicated in 30 of 34 patients (88%) in the OAC group and in 32 of 38 patients (84%) in the RbAC group according to a per-protocol analysis (P = N.S.). Thirty-three (97%) patients treated with OAC and 36 (95%) treated with RbAC presented healed duodenal ulcers at 4 weeks (P = N.S.). On an intention-to-treat basis there was no difference in H. pylori eradication between the OAC (77%) and RbAC groups (76%); duodenal ulcer healing was achieved in 85 and 86% of patients in the OAC and RbAC groups, respectively (P = N.S.). The OAC and RbAC triple therapy regimens proved equally effective in both H. pylori eradication and in duodenal ulcer healing.",1998.0,0,0
1251,9692704,Randomized comparison of 1-hour topical method vs. amoxycillin plus omeprazole for eradication of Helicobacter pylori in duodenal ulcer patients.,K Przytulski; J Regula; A Dziurkowska-Marek; M Kohut; E Hennig; T Marek; J Ostrowski; A Nowak; E Butruk,"A novel 1-h topical method eradicated Helicobacter pylori in 96% of dyspeptic patients. The eradication rate of amoxycillin/omeprazole therapy varies from 0 to 93%. To compare both methods in patients with endoscopically proven duodenal ulcer. Eighty patients (59 males, 21 females; median age 43 years) were randomized into two therapeutic groups. The first group (group A) was treated with a 6-week course of ranitidine 300 mg/day, then omeprazole 20 mg b.d. with pronase 36000 units/day for 2 days, followed by 1-h topical therapy with a solution of bismuth, metronidazole, amoxycillin and pronase. The second group (group B) consisted of patients treated with omeprazole 20 mg b.d. and amoxycillin 2 g/day for 2 weeks, followed by a 4-week course of ranitidine 300 mg/day. Eradication of H. pylori was assessed by urease test, histology, a polymerase chain reaction and a 13C-urea breath test, all of which were performed 4 weeks after discontinuation of the antibacterial treatment. Eradication rates in groups A and B were 2.5% and 35% in an intention-to-treat analysis, respectively. Side-effects were encountered in 40.5% and 12.5% of subjects in groups A and B, respectively. Treatment tolerance was rated as poor by 54% of patients in group A and 2.5% of patients in group B. Both treatment regimens, the 1-h topical method and amoxycillin with omeprazole, have low eradication rates in patients with duodenal ulcer. In addition, the topical treatment is characterized by a high rate of side-effects and poor tolerance. Based on the results of our study, neither method can be recommended for eradication of H. pylori in patients with duodenal ulcer.",1998.0,0,0
1252,9693202,,,,,0,0
1253,9699931,Effect of omeprazole in patients with chest pain and normal coronary anatomy: initial experience.,J Chambers; R Cooke; A Anggiansah; W Owen,"Gastroesophageal reflux is frequently found in patients with chest pain despite normal coronary anatomy, but little data on the effect of specific medication exist. After performing 24 h ambulatory pH monitoring and the Bernstein test on 23 patients with normal coronary anatomy, we gave omeprazole, 40 mg nocte, for six weeks to these and to a control group of ten patients with coronary disease. Pain episodes per fortnight fell from 16.2 to 12.0 (P=0.02) in the patients with normal anatomy and from 19.6 to 17.1 (nonsignificant) in the patients with coronary disease. Improvement occurred in seven (30%) of the patients with normal coronary anatomy compared with one (10%) of those with coronary disease, while complete resolution occurred in four (17%) and none, respectively. Improvement or complete resolution were not predicted by the results of 24 h pH monitoring, although there was a trend towards the prediction of efficacy by the Bernstein test. Omeprazole shows promise as a treatment for patients with chest pain despite normal coronary anatomy and larger placebo-controlled trials should now be undertaken.",1998.0,0,0
1254,9701099,A comparison of 10 and 14 days of lansoprazole triple therapy for eradication of Helicobacter pylori.,M B Fennerty; T O Kovacs; R Krause; M Haber; A Weissfeld; N Siepman; P Rose,"Data from large, multicenter, US studies determining the efficacy of triple therapy for the eradication of Helicobacter pylori are lacking, especially for a treatment duration of less than 14 days. Patients with H pylori infection and active duodenal ulcer disease or a history of duodenal ulcer disease within the past year were randomized to receive 30 mg of lansoprazole, 1 g of amoxicillin, and 500 mg of clarithromycin twice daily for 10 or 14 days. The primary efficacy end point was the eradication of H pylori as confirmed by negative histological and culture results at 4 to 6 weeks after the completion of treatment. Of 284 patients enrolled in the study from 46 US sites, 236 met the entry criteria. At 4 to 6 weeks after the end of therapy, H pylori was eradicated in 85% (96/ 113) of the patients receiving 14-day triple therapy and in 84% (103/123) of those receiving 10-day triple therapy by per-protocol analysis (95% confidence interval for treatment group differences, -10.5 to 8.1; P>.05). There was also no significant difference between the 14- and 10-day treatment groups when analyzed by an intent-to-treat analysis of H pylori eradication. A similar proportion of patients in each treatment group reported an adverse event related to therapy (34% [46/136] vs 38% [56/148], respectively). In patients with an active or a recent history of duodenal ulcer, lansoprazole-based triple therapy for 10 or 14 days is highly effective in the eradication of H pylori. The duration of therapy may be reduced from 14 to 10 days without a significant effect on regimen efficacy.",1998.0,0,0
1255,9701523,"Hypergastrinaemia during long-term omeprazole therapy: influences of vagal nerve function, gastric emptying and Helicobacter pylori infection.",B E Schenk; E J Kuipers; E C Klinkenberg-Knol; E Bloemena; G F Nelis; H P Festen; E H Jansen; I Biemond; C B Lamers; S G Meuwissen,"elucidate the mechanisms that lead to severe hypergastrinaemia during long-term omeprazole therapy for gastro-oesophageal reflux disease (GERD). A total of 26 GERD patients were studied during omeprazole maintenance therapy. Twelve patients with severe hypergastrinaemia (gastrin > 400 ng/L) were compared with 14 control patients (gastrin < 300 ng/L). Helicobacter pylori serology and a laboratory screen were obtained in all patients. Gastric emptying was scored by the evidence of food remnants upon endoscopy 12 h after a standardized meal. Gastric antrum and corpus biopsies were analysed for histological parameters, as well as somatostatin and gastrin concentrations. All patients underwent a meal-stimulated gastrin test and the hypergastrinaemia patients also underwent a vagal nerve integrity assessment by pancreatic polypeptide testing (PPT). Severe hypergastrinaemia patients had a longer duration of treatment (80 vs. 55 months; P = 0.047) and were characterized by a higher prevalence of H. pylori infection (9/12 vs. 2/14, P = 0.004), corpus mucosal inflammation and atrophic gastritis (P < 0.04). This was reflected in lower serum pepsinogen A concentrations (mean +/- S.E.M. 53.6 +/- 17.9 vs. 137 +/- 16.0 mg/L, P = 0.03), pepsinogen A/C ratio (1.8 +/- 0.3 vs. 4.1 +/- 0.6, P = 0.005) and mucosal somatostatin concentrations (2.75 +/- 0.60 vs. 4.48 +/- 1.08 mg/g protein, P = 0.038). Two patients in the hypergastrinaemia group had signs of delayed gastric emptying, but none in the normogastrinaemia group did (P = N.S.). In addition, both groups had a normal meal-stimulated gastrin response. Severe hypergastrinaemia during omeprazole maintenance therapy for GERD is associated with the duration of therapy and H. pylori infection, but not with abnormalities of gastric emptying or vagal nerve integrity.",1998.0,0,0
1256,9701524,,,,,0,1
1257,9701525,Helicobacter pylori eradication as a surrogate marker for the reduction of duodenal ulcer recurrence.,G A Neil; L J Suchower; E Johnson; P D Ronca; M L Skoglund,"An abundance of data exists documenting the association of H. pylori eradication with the reduction in duodenal ulcer recurrence. To evaluate the validity of using H. pylori eradication as a surrogate marker for the reduction in duodenal ulcer recurrence using rigorously controlled studies. Three controlled clinical trials were conducted in patients with uncomplicated, active duodenal ulcers. Patients were treated with various combinations of omeprazole and amoxycillin. Ulcer healing and H. pylori eradication were assessed. For patients whose duodenal ulcer healed, duodenal ulcer recurrence was determined over a 6-month period in patients with H. pylori eradication and those remaining positive for H. pylori at least 4 weeks after treatment. To support the data obtained from these clinical trials, a search of the medical literature was conducted to identify additional human clinical trials in which duodenal ulcer recurrence rates were measured and categorized by H. pylori status at least 1 month post-treatment. In 11 controlled trials, the overall 6-18-month duodenal ulcer recurrence rate was 54% among patients remaining positive for H. pylori at least 4 weeks after treatment compared to 6% among patients with H. pylori eradication following treatment. This finding was corroborated by the uncontrolled trials, in which the duodenal ulcer recurrence rate was 64% among patients found to be H. pylori-positive and 6% for patients found to be H. pylori-negative at least 4 weeks after treatment. A time course of duodenal ulcer recurrence rates using pooled data from both controlled and uncontrolled studies demonstrated that duodenal ulcer recurrence rates for H. pylori-negative patients persisted for up to 4 years following treatment. Duodenal ulcer recurrence rates for H. pylori-positive patients increased for the first year, then levelled off. A comparison of the duodenal ulcer recurrence rates for different treatment regimens revealed that eradication regimens based on omeprazole plus antibiotics and bismuth plus antibiotics exhibited similar duodenal ulcer recurrence rates for H. pylori-positive and -negative patients. Regardless of treatment regimens, H. pylori eradication produced a consistent and significant reduction in duodenal ulcer recurrence. Therefore H. pylori eradication, 4 weeks post-therapy, can be used as a surrogate marker for reduced duodenal ulcer recurrence in investigational clinical trials.",1998.0,0,0
1258,9701531,An ascending single-dose safety and tolerance study of an oral formulation of rabeprazole (E3810).,E A Lew; R C Barbuti; T O Kovacs; B Sytnic; T J Humphries; J H Walsh,"Proton pump inhibitors such as omeprazole produce a long-lasting inhibition of gastric acid secretion associated with significant increases in plasma gastrin. Rabeprazole (E3810) is a new substituted benzimidazole H+,K+ ATPase inhibitor. It acts as an irreversible, non-competitive inhibitor of the H+,K+ ATPase and preliminary studies demonstrate that rabeprazole produces a potent and long-lasting inhibition of gastric acid secretion and a low level of hypergastrinaemia. This randomized, double-blind, placebo-controlled study was performed to further examine the effects of different single doses of rabeprazole on gastric acid secretion and serum gastrin. In this study, four groups of 10 healthy, non-smoking Helicobacter pylori-negative men (mean age 22.5 +/- 3.9 years) received single oral doses of 10, 20, 30 and 40 mg of rabeprazole. Two of the 10 volunteers in each group received placebo as part of the double-blind study design. All volunteers who entered into the study had a normal gastric acid secretory capacity as evaluated by pentagastrin challenge. Prior to administration of the first dose of test drug, volunteers underwent an inpatient 24-h measurement of baseline intragastric pH. One week later, volunteers received the test drug and again underwent an inpatient 24-h measurement of intragastric pH. During both periods, plasma samples were collected at specified intervals over 48 h and were sent for analysis of rabeprazole and gastrin levels. Administration of rabeprazole resulted in a dose-dependent increase in the duration and extent of intragastric pH elevation. The response among all volunteers receiving drug was significantly different from placebo, with greater acid inhibition occurring in the 30 and 40 mg groups. In addition, there was also a dose-related increase in plasma gastrin. The pharmacokinetics of rabeprazole were similar to those of other proton pump inhibitors with a t1/2 of between 0.7 and 1.0 h. There were no clinically significant effects on patient laboratory tests or serious adverse events. The results of this study suggest that rabeprazole is as potent as omeprazole and lansoprazole in inhibiting gastric acid secretion.",1998.0,0,0
1259,9707047,Noninvasive diagnosis of gastroesophageal inflammation using dipyridamole thallium-201 tomography.,B T De Gregorio; M B Fennerty; R A Wilson,"Esophagitis, a complication of GERD, and gastric erosions are common findings in dyspeptic patients. Unfortunately, these findings cannot be predicted based on symptoms alone and require endoscopy for an accurate diagnosis. Noninvasive diagnosis of other gastrointestinal pathology by radiopharmaceuticals (GA 67, Tc 99m pertechnetate) has previously been studied. We hypothesized that endoscopically documented esophagitis and/or gastric erosions could also be detected by using dipyridamole thallium-201 imaging and, if they were of sufficient accuracy, could serve as a useful, noninvasive screening test for esophagitis and/or gastric erosions. A pilot study was undertaken in 12 patients undergoing endoscopy for symptoms of GERD or dyspepsia. Esophagitis was defined as the presence of either erosions or ulceration and gastric erosions were defined as discrete mucosal breaks measuring > or = 1 mm. Dipyridamole thallium-201 imaging was performed the following day on all 12 patients. A standard dose of dipyridamole (0.56 mg/kg) was infused over 4 min, followed by a 3-mCi dose of thallium-201. Initial stress tomographic images and reinjection (1 mCi) resting tomographic images 3-4 h later were obtained using a gamma camera. Tomographic images were read blinded to the endoscopy results. Thallium-201 uptake was graded on a 0-3+ scale using the liver uptake as the internal comparative standard (2+ = uptake equal to the liver). Abnormal thallium uptake was defined as > or = 2+ in the area of the esophagus or stomach. Seven women and five men (mean age 41 yr, range 25-60 yr) were studied. Eight patients were taking histamine-2 receptor antagonists and none were on proton pump inhibitors, or promotility agents. All five patients with endoscopic esophagitis had a positive thallium-201 tomographic image. Seven patients had no evidence of esophagitis, and three had positive thallium-201 tomograms. Dipyridamole thallium-201 imaging sensitivity, specificity, and positive and negative predictive values for esophagitis were 100%, 57%, 63%, and 100%, respectively. All three patients with gastric erosions had positive thallium-201 tomograms. Six of nine patients without gastric erosions had positive tomograms. The sensitivity, specificity, and positive and negative predictive values of DT 201 gastric erosions were 100%, 33%, 33%, and 100%, respectively. Dipyridamole thallium-201 tomographic imaging has good sensitivity (100%) in detecting esophagogastric mucosal erosions, but its poor specificity (33-57%) results in an unacceptable accuracy as a screening test. Additionally, the cost of radiopharmaceuticals requires that sensitivity and specificity be at least equal to that of endoscopy for this test to be clinically valuable as a screening test. However, a noninvasive test for these diseases is inherently appealing, and further research in this area seems to be warranted.",1998.0,0,0
1260,9709081,Acid peptic diseases in the era of Helicobacter pylori.,P S Schoenfeld,"The treatment of peptic ulcers has been revolutionized by the discovery that Helicobacter pylori (H. pylori) bacteria is a causative agent for ulcer formation. However, when patients present with dyspepsia or epigastric discomfort, more than 80% of patients will not have ulcer disease and empiric treatment of H. pylori is not recommended for these patients. Eradication of H. pylori has not been demonstrated to improve the symptoms of non-ulcer dyspepsia compared with non-ulcer dyspepsia patients treated with placebo. Therefore, we recommend that patients should first be evaluated for peptic ulcers with endoscopy or upper gastrointestinal series before the diagnosis and treatment of H. pylori. Generally, the treatment of H. pylori should be limited to patients with peptic ulcers, mucosal-associated lymphoid tissue lymphomas, and gastric cancers. Most diagnostic tests for H. pylori, including quantitative IgG antibody, urea breath tests, rapid urease tests (CLO), tests of gastric mucosal biopsies, and staining of gastric mucosal biopsies, have equivalent diagnostic characteristics. Therefore, the choice of diagnostic test for H. pylori should be based on cost, ease of use, and lack of complications. Multiple antibiotic regimens are available for the treatment of H. pylori. Triple antibiotic therapy is the least expensive but has the highest rate of side effects and the least compliance. Combining a proton pump inhibitor with clarithromycin and another antibiotic will eradicate H. pylori with fewer side effects and better compliance but this is the most expensive antibiotic regimen.",1998.0,0,0
1261,9716248,"Effect of omeprazole treatment on plasma concentrations of the gastric peptides, xenin, gastrin and somatostatin, and of pepsinogen.",B Stoschus; G Hamscher; S Ikonomou; G Partoulas; C Eberle; T Sauerbruch; G E Feurle,"The peptide xenin 25 is a gastric mucosal constituent like gastrin, somatostatin and pepsinogen. Gastrin and pepsinogen plasma concentrations increase when the secretion of gastric acid is reduced by proton pump inhibitors. In the present investigation, treatment with omeprazole led to an increase in fasting and postprandial plasma concentrations of xenin, gastrin and pepsinogens A and C (P < 0.05, in each instance), whereas somatostatin plasma levels remained unchanged. Because subcutaneous injection of pentagastrin did not raise xenin plasma concentrations, a direct effect of gastrin on xenin production seems unlikely. This study indicates that xenin plasma concentrations are regulated by intragastric pH, as are those of gastrin and pepsinogen.",1998.0,0,1
1262,9721418,Omeprazole or misoprostol. Which works best for NSAID-induced ulcers?,M Gautam; C P Por; M F Evans,,1998.0,0,0
1263,9726384,"One-week use of ranitidine bismuth citrate, amoxycillin and clarithromycin for the treatment of Helicobacter pylori-related duodenal ulcer.",J J Sung; W K Leung; T K Ling; M Y Yung; F K Chan; Y T Lee; A F Cheng; S C Chung,"Proton pump inhibitors have been widely used in combination with amoxycillin, clarithromycin or metronidazole for the treatment of Helicobacter pylori infection. To study the effects of 1-week ranitidine bismuth citrate (RBC)-based triple therapy in the treatment of H. pylori-related duodenal ulcers. Patients with duodenal ulcers and H. pylori infection were prospectively randomized to receive either RBC with amoxycillin and clarithromycin for 1 week (RAC), or omeprazole with amoxycillin and clarithromycin for 1 week (OAC). No additional ulcer healing drug was used after the 1-week medication. Patients were assessed for H. pylori eradication, ulcer healing and side-effects after receiving the therapies. One hundred consecutive patients were recruited to this study, with 50 patients randomized to each treatment group. In the intention-to-treat analysis, duodenal ulcers were completely healed in 45 (90%) patients in the RAC group and 43 (89.6%) in the OAC group (P = 1.0). H. pylori eradication was confirmed in 47 (94%) in the RAC group and 42 (87.5%) in the OAC group (P = 0.31). There was no significant difference in the severity of side-effects experienced by the two treatment groups. One-week RBC-based triple therapy is an effective treatment for H. pylori-related duodenal ulcers. The therapeutic effects are comparable to a 1-week course of proton pump inhibitor-based triple therapy.",1998.0,0,1
1264,9726385,Short-term low-dose pantoprazole-based triple therapy for cure of Helicobacter pylori infection in duodenal ulcer patients.,P Pazzi; R Scagliarini; S Gamberini; V Matarese; C Rizzo; S Gullini,"The eradication of Helicobacter pylori infection has been achieved using various therapy regimens, but the efficacy of the proton-pump inhibitor pantoprazole as part of these regimens has not yet been widely tested. To evaluate the efficacy and tolerability of a 1-week low-dose pantoprazole-based triple therapy in patients with H. pylori-positive duodenal ulcer. In an open single-centre prospective study, 71 patients with endoscopically proven active duodenal ulcer and H. pylori infection received pantoprazole 40 mg o.m. for 4 weeks, and during the first week a combination antimicrobial treatment comprising tinidazole 500 mg b.d. plus clarithromycin 250 mg b.d. H. pylori eradication was defined as concordant negative histology and rapid urease test performed at endoscopy 4-6 weeks after the end of treatment, confirmed 4 weeks later by 13C-urea breath test. Sixty-six patients (93%) completed the trial and five patients were lost to follow-up. H. pylori infection was cured in 61 out of the 66 patients who completed the trial (per-protocol analysis: 92.4%, 95% CI: 83.2-97.5%; intention-to-treat analysis: 85.9%, 95% CI: 75.7-93.0%). At final endoscopy, 65 out of 66 patients had healed ulcer (98.5%). Mild adverse events occurred in six patients (9.1%). One-week low-dose pantoprazole-based triple therapy is a simple, effective and well-tolerated regimen for ulcer healing and H. pylori eradication in patients with duodenal ulcer.",1998.0,0,0
1265,9726386,Changes in Helicobacter pylori-induced gastritis in the antrum and corpus during and after 12 months of treatment with ranitidine and lansoprazole in patients with duodenal ulcer disease.,A Meining; G Kiel; M Stolte,"Several studies have shown that acid-suppressing treatment leads to aggravation of Helicobacter pylori gastritis in the corpus. It remains unclear whether this augmentation of the inflammation reverts to baseline after termination of treatment. In 114 H. pylori-infected duodenal ulcer patients we investigated the gastritis parameters in antral and corpus mucosa before treatment, after 6 and 12 months of therapy, and 6 months after termination of treatment with 15 mg lansoprazole or 150 mg ranitidine/day. Lansoprazole and ranitidine led to a significant aggravation of gastritis in the corpus after 6 and 12 months of treatment. However, while there was no change in gastritis in the antrum with ranitidine, treatment with lansoprazole led to partial elimination of H. pylori with improvement of the inflammation in this part of the stomach. Following termination of therapy, the observed changes reverted to baseline. No increase in intestinal metaplasia and/or atrophy in the antrum or corpus was observed. Both substances are associated with an aggravation of H. pylori gastritis in the corpus. However, only lansoprazole leads to a partial elimination of H. pylori with improvement of the inflammation in the antrum. The changes provoked by acid-suppressing treatment revert to baseline after termination of therapy.",1998.0,0,0
1266,9726387,Incidence of duodenal ulcer healing after 1 week of proton pump inhibitor triple therapy for eradication of Helicobacter pylori. The Lansoprazole Helicobacter Study Group.,A W Harris; J J Misiewicz; K D Bardhan; S Levi; C O'Morain; B T Cooper; G D Kerr; M F Dixon; H Langworthy; D Piper,"A number of clinical studies have assessed the efficacy of short-term twice-daily Helicobacter pylori eradication regimens but few have investigated the proportion of patients in whom duodenal ulcer disease was healed with these regimens. To compare the safety and efficacy of four 1-week H. pylori eradication regimens in the healing of H. pylori associated duodenal ulcer disease. Following endoscopic confirmation of duodenal ulcer disease and a positive CLO test, patients underwent a 13C-urea breath test to confirm H. pylori status. Treatment with one of four regimens: LAC, LAM, LCM or OAM, where L is lansoprazole 30 mg b.d., A is amoxycillin 1 g b.d., M is metronidazole 400 mg b.d., C is clarithromycin 250 mg b.d., and O is omeprazole 20 mg b.d., was assigned randomly to those patients who were H. pylori positive, with 62 (LAC), 64 (LAM), 61 (LCM) and 75 (OAM) patients in each treatment group. Follow-up breath tests and endoscopies were performed at least 28 days after the end of treatment. Duodenal ulcer disease was healed 28 days after treatment in 53/62 (85.5%) patients who were treated with LAC, 52/64 (81.3%) of patients treated with LAM, 49/61 (80.3%) of patients treated with LCM and 60/75 (80.0%) of patients treated with OAM (intention-to-treat analysis, n = 262, assumed unhealed if no follow-up endoscopy was performed). All the treatments were of similar efficacy (P = 0.85, chi-squared test) with regard to the healing of duodenal ulcer disease. The four 1-week treatment regimens were equally effective in healing H. pylori associated duodenal ulcer disease.",1998.0,1,1
1267,9726393,Comparison of rabeprazole 20 mg vs. omeprazole 20 mg in the treatment of active gastric ulcer--a European multicentre study. The European Rabeprazole Study Group.,C P Dekkers; J A Beker; B Thjodleifsson; A Gabryelewicz; N E Bell; T J Humphries,"Rabeprazole sodium is the newest member of a class of substituted benzimidazole molecules known as proton pump inhibitors. Other proton pump inhibitors have been shown to be effective in healing active, benign gastric ulcers. In this randomized, double-blind, multicentre study, conducted at 25 European sites, rabeprazole and omeprazole were compared in patients with active gastric ulcers. Two hundred and twenty-seven patients with active benign gastric ulcer were randomized to receive either rabeprazole 20 mg (n = 113) or omeprazole 20 mg (n = 114) once daily for 3 or 6 weeks, with healing monitored by endoscopy. After 3 weeks, complete healing (ITT analysis) was documented in 58% of patients given rabeprazole and 61% in patients given omeprazole (N.S.). After 6 weeks the healing rates were identical in both groups at 91%. Rabeprazole-treated patients had numerically greater symptom relief at all 12 points of comparison. The differences significantly favoured rabeprazole at week 3 for daytime pain improvement (P = 0.023) and at week 6 for pain frequency (P = 0.006) and complete resolution of night pain (P = 0.022). Both drugs were well-tolerated over the 6-week treatment course. Mean changes from baseline to end-point in fasting serum gastrin were comparable. No significant differences in laboratory parameters were seen. In this study, rabeprazole produced healing rates comparable to omeprazole at weeks 3 and 6, but provided more consistent and occasionally significantly superior symptom improvement. Both treatments were well-tolerated.",1998.0,1,1
1268,9731988,Performance of a rapid whole blood test for Helicobacter pylori in primary care: a German multicenter study.,A Hackelsberger; V Schultze; U Peitz; T Günther; M Nilius; U Diete; M Schumacher; A Roessner; P Malfertheiner,"Serological rapid whole-blood tests for the detection of H. pylori are presently being promoted for use in primary care. We conducted a multi-center study to investigate the diagnostic accuracy of the Boehringer Mannheim Helicobacter pylori test (BM test), which is identical with the Cortecs Helisal test. A previous diagnosis of H. pylori, a history of peptic ulcer diseases, or proton-pump inhibitor, bismuth or antibiotic use during the preceding month were exclusion criteria. The BM test was performed prior to endoscopy by 7 primary care physicians, 5 practicing gastroenterologists, or a single physician in the university hospital outpatient service. During endoscopy, antral and corpus biopsies were obtained for histology and rapid urease testing (RUT). H. pylori positivity was defined by histology and/or RUT as reference methods. H. pylori IgG-ELISA was performed additionally. Of the 203 patients included, 151 were H. pylori-positive by reference methods (74.4%). The overall accuracy of the BM test was 77.3%. Eight BM tests were indeterminate, and in the other 195 patients the test performed as follows: sensitivity 80.3%, specificity 81.3%, positive predictive value 92.9%, negative predictive value 57.4%. Using IgG-ELISA as reference, the BM test performance was similar. It also did not differ substantially among the three groups of physicians involved. We found the performance of the BM test to be insufficiently accurate, as both over- and underdiagnosis of H. pylori infection were not infrequent. This test needs to be improved before its use in primary care can be recommended.",1998.0,0,0
1269,9731991,Efficacy of lansoprazole in eradicating Helicobacter pylori: a meta-analysis.,F Bazzoli; P Pozzato; M Zagari; S Fossi; L Ricciardiello; G Nicolini; D Berretti; L De Luca,"The combination of lansoprazole with antibiotics either as double or triple therapy has demonstrated an H. pylori eradication rate of between 80 and 90%. With the aim of providing a complete revision of the results of these clinical studies and a quantification of the efficacy of lansoprazole in eradicating H. pylori and healing peptic ulcers, we have undertaken a meta-analysis of all the controlled studies published in the literature. This meta-analysis reviewed all randomized, controlled clinical trials published as full text articles in English between 1993 and 1996 that reported the efficacy of lansoprazole treatment as monotherapy or in combination with antibiotics in the treatment of peptic ulcer and in eradicating H. pylori. Articles were identified from the literature, which included both manual and computerized research (MEDLINE) and references provided by articles in this area. In order to compare the efficacy of triple therapy comprising lansoprazole vs. another PPI, data from abstracts (n = 5) were used, as no full text articles were located. This systematic review of the literature documents that lansoprazole has a high degree of efficacy in eradicating H. pylori, above all when used within treatment schemes including amoxicillin or clarithromycin, and metronidazole or tinidazole. This efficacy is comparable to that of other PPIs. Triple therapy allows the eradication of H. pylori in more than 85% of cases in patients with peptic ulcer. In addition, there is a substantial comparability of the efficacy of lansoprazole and omeprazole when they are used together with other anti-infective agents. Thus, lansoprazole appears to offer an option in the eradication of H. pylori.",1998.0,1,1
1270,9731992,Lansoprazole quadruple therapy is effective in curing Helicobacter pylori infection.,M G Korman; T D Bolin; F B Nicholson; J L Engelman,"Quadruple therapy using omeprazole combined with classic bismuth triple therapy has been advocated as optimal therapy for the cure of Helicobacter pylori (H. pylori) infection. We investigated the efficacy of substituting lansoprazole for omeprazole in proton pump quadruple therapy. In a prospective open study, 219 consecutive patients, with either peptic ulcer disease or biopsy-proven H. pylori-associated gastritis, received seven days of lansoprazole, bismuth, tetracycline and metronidazole after three days of lansoprazole pretreatment. Cure of infection was judged by 14C urea breath test at six weeks after completion of therapy. On an intention to treat basis, 198 of the 219 patients (90%) were confirmed to be cured of H. pylori infection. Compliance was excellent and minimal side effects reported. Lansoprazole-based quadruple therapy achieves a very high cure rate in an unselected population of either peptic ulcer patients or those with H. pylori-associated gastritis. Recommended regimens should achieve at least 90% cure of infection. Lansoprazole quadruple therapy is effective and compares favorably with other H. pylori treatment regimens.",1998.0,0,0
1271,9731993,Cure of H. pylori infection using a 7-day triple therapy combining pantoprazole with two antibiotics.,R J Adamek; B Pfaffenbach; C Szymanski,"Acid pump inhibitors combined with antimicrobials cure gastritis and peptic ulcer disease but a standard therapy has not yet been established. We therefore investigated a triple therapy with pantoprazole. The aim of this open-label monocenter trial, involving 30 intention-to-treat patients with peptic ulcer disease or functional dyspepsia, was to assess the H. pylori cure rate after a 7-day triple therapy with pantoprazole (40 mg bid) plus metronidazole (500 mg bid) and amoxicillin (1 g bid). The H. pylori status was assessed by rapid urease test, histological examination and culture at the initial examination and by histological examination and culture at the study end 4 weeks after ending all therapy. At the end of the trial H. pylori was eradicated in 21 of 27 per protocol patients (78%; 95% CI 58-91%) and in 21 of 30 patients included in the trial (70%; 95% CI 51-85%). In 15 of 16 per protocol patients with metronidazole-sensitive strain (94%; 95% CI 70-100%) the infection was cured, but in contrast eradication was accomplished in only one of 3 patients with a metronidazole-resistant H. pylori strain. Post-treatment resistance to metronidazole was observed in 6 cases, although 4 of them had had H. pylori strains sensitive to metronidazole at the initial visit. The gastritis had clearly been improved, and the activity of gastritis had completely disappeared 4 weeks after treatment. Seven adverse events were observed in 7 patients, the intensity of which was moderate in 6 cases. This short-term triple therapy with pantoprazole, amoxicillin and metronidazole provides an effective regimen especially in patients with metronidazole-sensitive strain.",1998.0,0,0
1272,9732938,,,,,0,0
1273,9732953,Omeprazole for bleeding PUD: do we finally have evidence for effective medical therapy?,P J Pedersen; D J Bjorkman,,1998.0,0,0
1274,9739959,Antisecretory therapy for bleeding peptic ulcer.,W L Peterson; D J Cook,,2001.0,0,0
1275,9744696,Somatostatin in the prevention of recurrent bleeding after endoscopic haemostasis of peptic ulcer haemorrhage: a preliminary report.,F Coraggio; G Rotondano; R Marmo; M G Balzanelli; A Catalano; F Clemente; F Moccia; P C Parola,"Although endoscopic injection therapy provides excellent initial haemostasis in actively bleeding ulcers, the incidence of recurrent haemorrhage is not negligible. The aim of this study was to compare somatostatin, omeprazole and ranitidine in preventing further haemorrhage after endoscopic injection haemostasis. Seventy-three patients with major stigmata of ulcer haemorrhage at endoscopy were treated with epinephrine injection and randomly assigned to receive either omeprazole (n = 24) or ranitidine (n = 24) or somatostatin (n = 25). The three groups were similar in all background variables including mean age, clinical and endoscopic features, severity of bleeding and timing of the haemostatic procedure. All patients underwent a second endoscopic look at 48 h. Failures of treatment or retreatment underwent emergency surgery. There were no statistically significant differences between the groups in terms of initial haemostasis, need for emergency surgery, transfusion requirements, length of hospital stay or mortality. Early recurrent haemorrhage was 5/22 (22.7%) in the ranitidine group, 5/23 (21.7%) in the omeprazole group and 2/23 (8.7%) in the somatostatin group. No major side-effect was noted with drug therapy. The preliminary results suggest that somatostatin might be more effective than ranitidine and omeprazole in the prevention of recurrent haemorrhage following endoscopic injection therapy of bleeding peptic ulcers.",1998.0,0,0
1276,9755995,,,,,0,1
1277,9755997,"The effects of omeprazole, a proton pump inhibitor, on early gastric stagnation after a pylorus-preserving pancreaticoduodenectomy: results of a randomized study.",N Toyota; T Takada; H Yasuda; H Amano; M Yoshida; T Isaka; H Hijikata; K Takada,"To determine the effects of Omeprazole, a proton pump inhibitor (PPI), on gastric stasis following a pylorus-preserving pancreatico-duodenectomy (PPPD) by means of a randomized trial of PPPD patients. Forty-two PPPD patients were randomly divided into two groups: Group 1 (n=24) received a PPI through a jejunal tube after PPPD, whereas Group 2 (n=18), serving as controls, received a saline solution through a jejunal tube and no medication after a PPPD. The daily volume and total acidity of the gastric juice, aspirated via nasogastric tube, were measured each day for 7 days following PPPD. In Group 1 the mean daily aspirated volume of gastric juice was 160.2 ml, and the mean maximum volume was 222.8 ml on the first postoperative day. In Group 2, six patients were withdrawn from this study for therapy on the third or fourth postoperative day due to gastric bleeding and/or a large amount of excreted gastric juice (in excess of 2,000 ml). The mean daily aspirated volume of gastric juice in the remaining Group 2 patients was 787.4 ml, and the mean maximum volume was 1,039 ml on the third postoperative day. Gastric secretion was significantly lower in Group 1 (p<0.05). Further, the total acidity of the gastric juice was significantly lower in Group 1 than in Group 2 for each of the 7 postoperative days (p<0.05). These results indicate that postoperative administration of a PPI significantly suppresses the volume and acidity of the gastric juice after PPPD.",1998.0,0,0
1278,9759744,Randomised controlled trial of Helicobacter pylori eradication in patients on non-steroidal anti-inflammatory drugs: HELP NSAIDs study. Helicobacter Eradication for Lesion Prevention.,C J Hawkey; Z Tulassay; L Szczepanski; C J van Rensburg; A Filipowicz-Sosnowska; A Lanas; C M Wason; R A Peacock; K R Gillon,"The effect of Helicobacter pylori in patients receiving non-steroidal anti-inflammatory drugs (NSAIDs) is unclear. We investigated the effects of H. pylori eradication in patients with current or previous peptic ulceration, dyspepsia, or both who continued to use NSAIDs. 285 patients were randomly assigned omeprazole 20 mg, amoxycillin 1000 mg, and clarithromycin 500 mg, twice daily (n=142, H. pylori eradication treatment), or omeprazole with placebo antibiotics (n=143, controls) for 1 week. All patients received omeprazole 20 mg once daily for 3 weeks until endoscopy, and, if the ulcer was not healed, 40 mg once daily until repeat endoscopy at 8 weeks. Ulcer-free patients with mild dyspepsia continued NSAIDs but not antiulcer treatment. We investigated ulcers with endoscopy at 1, 3, and 6 months and with carbon-13-labelled urea breath test at 3 months. The estimated probability of being ulcer-free at 6 months was 0.56 (95% CI 0.47-0.65) on eradication treatment and 0.53 (0.44-0.62) on on control treatment (p=0.80). Time to treatment failure did not differ between groups for ulcers or dyspepsia alone, per-protocol analysis, or final H. pylori status. 66% (58-74) of the eradication group compared with 14% (8-20) of the control group had a final negative H. pylori result (p<0.001). Fewer baseline gastric ulcers healed among eradication-treatment patients than among controls (72 vs 100% at 8 weeks, p=0.006). H. pylori eradication in long-term users of NSAIDs with past or current peptic ulcer or troublesome dyspepsia led to impaired healing of gastric ulcers and did not affect the rate of peptic ulcers or dyspepsia over 6 months.",1998.0,0,0
1279,9768524,Review article: one-week clarithromycin triple therapy regimens for eradication of Helicobacter pylori.,G A Pipkin; R Williamson; J R Wood,"One-week triple therapies have been endorsed as the treatment regimens of choice for eradication of Helicobacter pylori infection. Those that include clarithromycin appear to be the most effective. To review reports of triple therapies that include clarithromycin. Reports were identified from the literature to May 1998. The variation between study designs prevents a formal meta-analysis. A measure of the relative efficacies of regimens has, however, been gained by comparison and by pooling of intention-to-treat eradication rates. One hundred and ninety-two studies were identified which included 264 treatment arms of a 1-week triple therapy composed of clarithromycin with amoxycillin or a nitroimidazole (metronidazole or tinidazole), and either ranitidine bismuth citrate or a proton pump inhibitor (omeprazole, lansoprazole or pantoprazole). From reports of these studies, an intention-to-treat H. pylori eradication rate could be determined from 210 treatment arms of 151 studies. There is little to choose between the efficacies of 1-week clarithromycin-based triple therapy eradication regimens. However, those comprising clarithromycin, a nitroimidazole and either ranitidine bismuth citrate or a high dose of omeprazole are, in general, the most effective. Against antibiotic-resistant strains of H. pylori, regimens including ranitidine bismuth citrate may be more effective than those including a proton pump inhibitor.",1998.0,0,0
1280,9768529,Pantoprazole 20 mg is effective for relief of symptoms and healing of lesions in mild reflux oesophagitis.,A Dettmer; R Vogt; F Sielaff; R Lühmann; A Schneider; R Fischer,"To investigate the efficacy of a low dose of pantoprazole, a gastric proton pump inhibitor, for the relief of symptoms and healing of lesions in mild gastro-oesophageal reflux disease (GERD), and to compare it with the efficacy of ranitidine. Patients with endoscopically established GERD (Stage I, Savary-Miller classification) were enrolled into a randomized, double-blind, parallel-group and multicentre study (intention-to-treat n = 209, age range 19-82 years). They were treated once daily with oral pantoprazole 20 mg or ranitidine 300 mg, for up to 8 weeks. End-point parameters included relief of symptoms (heartburn, acid regurgitation, pain on swallowing) and the healing of GERD lesions. Relief from symptoms was assessed after 2 and 4 weeks, and endoscopically confirmed healing of lesions after 4 and 8 weeks. The proportion of patients reporting complete relief from symptoms after 2 weeks was greater in the pantoprazole than in the ranitidine group (69 vs. 48%, P < 0.01), with further improvements seen in the pantoprazole group after 4 weeks (80 vs. 65%, P < 0.05, Cochran-Mantel/Haenszel test). Healing of lesions was confirmed in 70/87 (80%) patients after 4 weeks (pantoprazole group), as compared with 55/86 (64%) patients (ranitidine group) (P < 0.05, per protocol population); after 8 weeks the respective results were 78/87 (90%) and 63/86 (73%) patients (P < 0.01). Both study medications were well tolerated. Low-dose pantoprazole (20 mg) is clinically superior to ranitidine (300 mg) in providing fast relief from symptoms and healing of lesions in patients with mild GERD.",1998.0,1,1
1281,9768530,H2-antagonist maintenance therapy versus Helicobacter pylori eradication in patients with chronic duodenal ulcer disease: a prospective study.,A T Prach; M Malek; M Tavakoli; D Hopwood; B W Senior; F E Murray,"Few outcome studies directly compare Helicobacter pylori eradication therapy with maintenance H2-antagonist therapy in duodenal ulcer disease. To examine prospectively the efficacy of H. pylori eradication therapy with ranitidine maintenance therapy over 1 year in patients with confirmed chronic duodenal ulcer. One hundred and nineteen patients with active H. pylori infection were randomized to receive ranitidine, 150 mg/day initially (58 patients), or omeprazole, 40 mg/day, amoxycillin 2 g/day and metronidazole 1.2 g/day for 14 days, or omeprazole 40 mg/day and clarithromycin 1.5 g/day, for 14 days (if penicillin-allergic). Symptoms were assessed using the Gastrointestinal System Rating Scale (GSRS) and SF36 quality of life index. 13C urea breath testing confirmed overall treatment success in 100% of patients (58/58) per protocol and 95.1% (58/61) on an intention-to-treat basis. At 4 and 12 months there were no differences in any GSRS symptoms between treatment groups. SF36 analysis showed a perceived health improvement at 4 and 12 months in patients who received H. pylori eradication. However, despite successful H. pylori eradication, one-fifth of patients still required antisecretory therapy. Following successful H. pylori eradication, chronic duodenal ulcer patients were at least as well symptomatically as when taking maintenance ranitidine. They perceived that their health had improved, but a subgroup was still acid-suppression dependent.",1998.0,0,0
1282,9768531,"Helicobacter pylori eradication and ulcer healing with daily lansoprazole, plus 1 or 2 weeks co-therapy with amoxycillin and clarithromycin.",J A Louw; C J Van Rensburg; S Moola; D Kotze; I N Marks,"Proton pump inhibitor based combination therapy is one standard strategy for Helicobacter pylori eradication. To compare the eradication and duodenal ulcer healing efficacy of two 2-week, single dose, lansoprazole based combination therapies. Healthy adult patients with endoscopically confirmed, H. pylori associated duodenal ulcer disease (3 mm > ulcer < 20 mm) were eligible for the study. All patients received a 14 day course of lansoprazole 30 mg o.m., and were randomized to receive either 7 or 14 days of amoxycillin 1 g b.d. and clarithromycin 500 mg b.d. Patients were endoscoped at entry and 14-17 days later. Symptomatic, unhealed patients received a further 14 days of therapy with lansoprazole 30 mg o.m. Eradication was confirmed a minimum of 28 days after cessation of all therapy by urease reaction and histological assessment of gastric body and antral biopsies (three biopsies each site). Sixty-two patients were randomized to a treatment arm, of which 58 could be included in an intention-to-treat and key-point-available analysis. H. pylori eradication rates were identical, at 93% (95% CI: 73-98% (1 week), 78-99% (2 week)). In the combined group, all but 13 ulcers were healed at 2 weeks; six required further therapy because of symptoms, while six of the seven asymptomatic patients went on to heal. An eradication regimen, based on a 2-week course of single dose lansoprazole with 1 week of antibiotic co-therapy, is effective in eradicating H. pylori, while the 2 weeks of acid suppression is usually effective in duodenal ulcer healing.",1998.0,0,0
1283,9768532,Low rate of emergence of clarithromycin-resistant Helicobacter pylori with amoxycillin co-therapy.,L Laine; L Suchower; J Frantz; A Connors; G Neil,"Patients with persistent Helicobacter pylori infection following treatment with clarithromycin or omeprazole plus clarithromycin often develop clarithromycin resistance. To assess pre- and post-treatment antibiotic resistance in three double-blind trials of triple therapy with omeprazole, amoxycillin and clarithromycin. Patients with H. pylori and duodenal ulcer (studies 1 and 2) or history of duodenal ulcer (study 3) were randomly assigned to 10 day courses of omeprazole 20 mg b.d., amoxycillin 1 g b.d. and clarithromycin 500 mg b.d. (OAC) or placebo, amoxycillin 1 g b.d. and clarithromycin 500 mg b.d. (AC). Endoscopy was performed at baseline and 4 weeks after completion of therapy in studies 1 and 2, and at 4-6 weeks after therapy in study 3. At baseline, H. pylori was diagnosed by CLO test with confirmation by histology, or by culture. Eradication was defined as no positive biopsy test and > or = 2 negative tests. Susceptibility testing was performed using the Etest. In the 91 patients with pre-treatment susceptible isolates who had persistent infection after AC, 10 developed resistance, eight had intermediate susceptibility and 73 continued to have clarithromycin-susceptible H. pylori isolates. In the 10 patients with pre-treatment susceptible isolates who had persistent infection after OAC, three developed clarithromycin resistance and seven still had susceptible isolates. Use of amoxycillin co-therapy results in a low rate of clarithromycin resistance developing in patients with persistent H. pylori infection following therapy with a clarithromycin-containing regimen.",1998.0,0,0
1284,9772054,Safety and efficacy of rabeprazole in combination with four antibiotic regimens for the eradication of Helicobacter pylori in patients with chronic gastritis with or without peptic ulceration.,W A Stack; A Knifton; D Thirlwell; A Cockayne; D Jenkins; C J Hawkey; J C Atherton,"Rabeprazole is a new fast acting proton pump inhibitor that has recently been proven to be effective in the treatment of peptic ulceration and reflux esophagitis. The aim of this study was to evaluate rabeprazole in combination with antibiotics for the eradication of Helicobacter pylori (H. pylori) in patients with chronic active gastritis with or without peptic ulcer disease. Seventy-five H. pylori-infected patients were randomized in a double-blind fashion to receive a 7-day treatment regimen consisting of: RAC, RAM, RCM, or RC (R=rabeprazole 20 mg b.d., A=amoxycillin 1 g b.d., C=clarithromycin 500 mg b.d., M=metronidazole 400 mg b.d.). Randomized patients were H. pylori-positive by gastric biopsy urease test, histology and 13C urea breath test (13C-UBT). H. pylori eradication was assessed by 13C-UBT, 4 and 8 wk after finishing treatment. Endoscopy with histology and culture for antibiotic sensitivity testing was performed pretreatment and if treatment failed. On an intention-to-treat analysis, treatment success was: RCM 100%, RAC 95%, RAM 90%, and RC 63%. The most common side effects were loose stools, headache, and taste disturbance, but there were no serious adverse events related to the study medication. The two patients failing RAM treatment had metronidazole-resistant strains before and after treatment. None of the pretreatment H. pylori isolates from six patients failing RC were clarithromycin resistant, but three of five successfully cultured posttreatment had developed clarithromycin resistance. Rabeprazole-based triple therapy with two antibiotics for 1 wk is safe and effective in eradicating H. pylori. Dual therapy with clarithromycin is less successful, and the majority of treatment failures develop clarithromycin resistance.",1998.0,0,1
1285,9772056,Cure of Helicobacter pylori infection and healing of duodenal ulcer: comparison of pantoprazole-based one-week modified triple therapy versus two-week dual therapy. The International Pantoprazole HP Study Group.,R J Adamek; T D Bethke,"Eradication of Helicobacter pylori (H. pylori) is recommended as the first-line therapeutic concept for reliable long-term prevention of duodenal ulcer (DU) relapse. Current treatment regimens vary in efficacy, complexity, and compliance. To assess the efficacy of pantoprazole in H. pylori eradication in parallel groups of patients using two eradication regimens. Patients, (18-85 yr old; intention-to-treat, n=286) with proven DU, positive rapid urease test (biopsy), and 13C-urea breath test (UBT) were included in a prospective, randomized, multicenter study. Modified triple therapy consisted of 40 mg pantoprazole b.i.d., 500 mg clarithromycin t.i.d., and 500 mg metronidazole t.i.d. for 7 days (PCM therapy); dual therapy consisted of 40 mg pantoprazole b.i.d. and 500 mg clarithromycin t.id. for 14 days (PC therapy). In both groups 40 mg pantoprazole o.d. was given until day 28 when healing of DU was evaluated endoscopically; H. pylori status was assessed by UBT on day 56. H. pylori eradication rate was 95% in PCM versus 60% in PC therapy groups (perprotocol population, p < 0.001), and 82% in PCM versus 50% in PC therapy in the intention-to-treat patient population (p < 0.001). The DU healing rate was 98% in the PCM and 95% in the PC therapy groups (per-protocol population). Both regimens were similarly well tolerated. Adverse events in both regimens included taste disturbance, diarrhea, and increased serum concentration of liver enzymes, at an incidence of < 10%. Compared to 2-wk PC therapy (pantoprazole and clarithromycin), the 1-wk PCM therapy (pantoprazole, clarithromycin, and metronidazole) is a significantly superior and highly promising strategy for eradication of H. pylori.",1998.0,0,0
1286,9777309,Proton pump inhibitors. Pharmacology and rationale for use in gastrointestinal disorders.,P Richardson; C J Hawkey; W A Stack,"Proton pump inhibitors (PPIs) are drugs which irreversibly inhibit proton pump (H+/K+ ATPase) function and are the most potent gastric acid-suppressing agents in clinical use. There is now a substantial body of evidence showing improved efficacy of PPIs over the histamine H2 receptor antagonists and other drugs in acid-related disorders. Omeprazole 20 mg/day, lansoprazole 30 mg/day, pantoprazole 40 mg/day or rabeprazole 20 mg/day for 2 to 4 weeks are more effective than standard doses of H2-receptor antagonists in healing duodenal and gastric ulcers. Patients with gastric ulcers should receive standard doses of PPIs as for duodenal ulcers but for a longer time period (4 to 8 weeks). There is no conclusive evidence to support the use of a particular PPI over another for either duodenal or gastric ulcer healing. For Helicobacter pylori-positive duodenal ulceration, a combination of a PPI and 2 antibacterials will eradicate H. pylori in over 90% of cases and significantly reduce ulcer recurrence. Patients with H. pylori-positive gastric ulcers should be managed similarly. PPIs also have efficacy advantages over ranitidine and misoprostol and are better tolerated than misoprostol in patients taking nonsteroidal anti-inflammatory drugs (NSAIDs). In endoscopically proven gastro-oesophageal reflux disease, standard daily doses of the PPIs are more effective than H2-receptor antagonists for healing, and patients should receive a 4 to 8 week course of treatment. For severe reflux, with ulceration and/or stricture formation, a higher dose regimen (omeprazole 40 mg, lansoprazole 60 mg, pantoprazole 80 mg or rabeprazole 40 mg daily) appears to yield better healing rates. There is little evidence that PPIs lead to resolution of Barrett's oesophagus or a reduction of subsequent adenocarcinoma development, but PPIs are indicated in healing of any associated ulceration. In Zollinger-Ellison syndrome, PPIs have become the treatment of choice for the management of gastric acid hypersecretion.",1998.0,0,0
1287,9777317,"Omeprazole. A review of its use in Helicobacter pylori infection, gastro-oesophageal reflux disease and peptic ulcers induced by nonsteroidal anti-inflammatory drugs.",H D Langtry; M I Wilde,"Omeprazole is a well studied proton pump inhibitor that reduces gastric acid secretion. This review examines its use in Helicobacter pylori infection, gastro-oesophageal reflux disease (GORD) with or without oesophagitis and gastrointestinal damage caused by nonsteroidal anti-inflammatory drugs (NSAIDs). Optimal omeprazole regimens for anti-H. pylori therapy are those that administer the drug at a dosage of 40 mg/day (in 1 or 2 divided doses) for 7, 10 or 14 days in combination with 2 antibacterial agents. As a component of 3-drug regimens in direct comparative studies, omeprazole was at least as effective as lansoprazole, pantoprazole, bismuth compounds and ranitidine. However, a meta-analysis suggests that triple therapies with omeprazole are more effective than comparable regimens containing ranitidine, lansoprazole or bismuth. Omeprazole also appears to be successful in triple therapy regimens used in children with H. pylori infection. In patients with acute GORD with oesophagitis, omeprazole is at least as effective as lansoprazole or pantoprazole in promoting healing, and superior to ranitidine, cimetidine or cisapride in oesophagitis healing and symptom relief. Omeprazole was similar to lansoprazole and superior to ranitidine in preventing oesophagitis relapse in patients with all grades of oesophagitis, but may be superior to lansoprazole or pantoprazole in patients with more severe disease. More patients with symptomatic GORD without oesophagitis experienced symptom relief after short term treatment with omeprazole than with ranitidine, cisapride or placebo, and symptoms were more readily prevented by omeprazole than by cimetidine or placebo. Omeprazole was effective in healing and relieving symptoms of reflux oesophagitis in children with oesophagitis refractory to histamine H2 receptor antagonists. Omeprazole is superior to placebo in preventing NSAID-induced gastrointestinal damage in patients who must continue to take NSAIDs. It is also similar to misoprostol and superior to ranitidine in its ability to heal NSAID-induced peptic ulcers and erosions, and superior to misoprostol, ranitidine or placebo in its ability to prevent relapse. In long and short term studies, omeprazole was well tolerated, with diarrhoea, headache, dizziness, flatulence, abdominal pain and constipation being the most commonly reported adverse events. Usual omeprazole dosages, alone or combined with other agents, are 10 to 40 mg/day for adults and 10 to 20 mg/day for children. Omeprazole is a well studied and well tolerated agent effective in adults or children as a component in regimens aimed at eradicating H. pylori infections or as monotherapy in the treatment and prophylaxis of GORD with or without oesophagitis or NSAID-induced gastrointestinal damage.",1998.0,0,1
1288,9779373,"What's new in pathology, pathophysiology and management of benign esophageal disorders?",S J Walker; J P Byrne,,1998.0,0,0
1289,9795409,"Dual versus triple therapy: comparison of five antibiotic regimens for eradication of Helicobacter pylori in a prospective, randomized study.",F W Kirstein; H J Epple; C Bojarski; L Victor; M Fromm; E O Riecken; J D Schulzke,"We compared the efficacy of three dual and two triple therapies for eradication of Helicobacter pylori (HP), and evaluated the influence of smoking and omeprazole pretreatment on HP eradication. 220 patients with proven HP infection (histology and 13C-urea breath test [UBT]) were randomly allocated to one of the following regimes: BMT (bismuth subsalicylate 600 mg t. i. d. for 28 days, metronidazole 400 mg t. i. d. and tetracycline 500 mg q. i. d. for ten days). OA (omeprazole 40 mg o. d. and amoxicillin 750 mq q. i. d. for 14 days), OC (omeprazole 40 mg o. d. and clarithromycin 500 mg b. i. d. for 14 days), OT (omeprazole 40 mg o. d. and tetracycline 500 mg q. i. d. for 14 days), OMC (omeprazole 40 mg o. d., metroinidazole 400 mg t. i. d. and clarithromycin 250 mg b. i. d. for seven days). Eradication was defined as negative UBT six weeks after completion of the therapy. In an ""all-patients-treated"" (""per-protocol"") analysis, the eradication rates were: BMT, 91% (93%); OA, 84% (90%); OC, 74% (74%); OT, 24% (24%); and OMC, 90% (93%). Smoking impaired the success of OA and OT (p < 0.05), but the efficacy of the triple regimens was not affected. Omeprazole pretreatment did not influence eradication rates. Thus, highest eradication rates were achieved with the two triple therapies tested. However, OA, given at a daily antibiotic dose of 3 g amoxicillin for 14 d, was also highly effective. After failure of triple therapy, OA was successful in seven of ten patients (70%). The efficacy of OC was lower than that of the triple therapies (p < 0.05). In conclusion, metronidazole- and clarithromycin-based triple therapies are highly effective first line therapies. OA, given at a dose of 3 g per day over 14 days, should be considered as a possible second line therapy, e.g. in retherapy after failed triple therapy.",1998.0,0,0
1290,9798803,Lansoprazole and omeprazole in the prevention of relapse of reflux oesophagitis: a long-term comparative study.,L Carling; C K Axelsson; H Forssell; A Stubberöd; K Kraglund; O Bonnevie; P Ekström,"Proton pump inhibitors are superior to H2-receptor antagonists in the prevention of relapse of oesophagitis, but few data directly compare the relative efficacies of lansoprazole and omeprazole in preventing oesophagitis relapse over a prolonged period. Patients with healed Grade II, III or IV oesophagitis were treated with lansoprazole 30 mg o.d. or omeprazole 20 mg o.d. for 48 weeks. Endoscopy and symptom assessment were performed after 12. 24 and 48 weeks of treatment and an additional symptom assessment 36 weeks after starting treatment. Intention-to-treat analysis included 248 patients (lansoprazole n = 126, omeprazole n = 122). Comparison of time to endoscopic and/or symptomatic relapse revealed no difference between the treatments. There was no significant difference between treatments with respect to the proportion of patients in whom endoscopic and/or symptomatic relapse was reported (lansoprazole 12/126 (9.5%), omeprazole 11/122 (9.0%)). No difference between the treatments in either the number or severity of adverse events was reported. Continuous treatment with either lansoprazole 30 mg or omeprazole 20 mg is effective in preventing the relapse of oesophagitis over a 48-week period in a majority of patients. Both treatments exhibit a similar side-effect profile.",1998.0,1,1
1291,9798805,,,,,0,0
1292,9802340,The effect of long-term acid suppression on gastric mucosal histology.,P L Fitzgibbons; P A Jamidar,,1998.0,0,1
1293,9802443,Gastrointestinal manometry studies in children.,A Kaul; C D Rudolph,"Children with gastrointestinal motility disorders present with diverse symptoms, and obtaining a detailed history is often impossible. As in adults, evaluation of a suspected motility disorder begins with exclusion of mechanical obstruction or primary inflammatory disorders. Subsequently, coordination of peristaltic function is evaluated in those segments of the gastrointestinal tract that are suspected to be abnormal based on the clinical history. Evaluation of gastrointestinal motility in children is particularly challenging because of frequent lack of patient cooperation and difficulties in adapting the equipment to patient size. This review discusses the indications and approach to the evaluation of motility of each region of the gastrointestinal tract in infants and children.",1998.0,0,0
1294,9811290,Omeprazole: therapy of choice in intellectually disabled children.,C J Böhmer; R C Niezen-de Boer; E C Klinkenberg-Knol; S G Meuwissen,"To study extensively the therapeutic approach of gastroesophageal reflux disease in intellectually disabled children. We studied the effect of omeprazole sodium on healing and symptom relief in 52 institutionalized intellectually disabled children (male-female, 21:31; mean age, 15.4 years; range, 4-19 years). Endoscopically proven esophagitis (grades I-IV, Savary-Miller classification) was treated with omeprazole sodium, 40 mg/d (20 mg/d for children weighing <20 kg) as healing dose for 3 months, and 20 mg/d (10 mg/d for children weighing <20 kg) as maintenance dose for another 3 months. After 3 and 6 months, results of treatment were evaluated using symptom scoring and/or endoscopy. For patients with relapse, the dose was increased. At first endoscopy, 19 patients (36%) of 52 showed grade I esophagitis; 20 (38%), grade II; 6 (12%), grade III; and 7 (13%), grade IV. In 44 (86%) of 51 patients, treatment was effective in healing esophagitis and keeping patients in remission, independent of the severity of esophagitis. In 7 patients (14%), a symptomatic relapse was observed after decreasing the dose. However, these patients became symptom free again after increasing the dose and showed healing on endoscopy at the end of the study. One child did not finish the study for reasons not related to therapy. Marked improvement of persistent vomiting, regurgitation, food refusal, iron deficiency anemia, and signs of depression was seen at the end. Omeprazole is highly effective for all grades of esophagitis in intellectually disabled children, without adverse effects. The dose needed to maintain the remission can be titrated according to the reflux symptoms. One disadvantage of medical therapy is that it is open ended, in contrast to operation, but surgery in this population has high mortality and complication rates.",1998.0,0,0
1295,9813387,"Comparison of omeprazole, metronidazole and clarithromycin with omeprazole/amoxicillin dual-therapy for the cure of Helicobacter pylori infection.",S Miehlke; A Meining; N Lehn; W Höchter; J Weingart; T Simon; W Krämer; H Klann; K Bolle; A Sommer; M Stolte; E Bayerdörffer,"In this randomized, multicenter trial, we evaluated the effectiveness and side effect profile of a modified omeprazole-based triple therapy to cure Helicobacter pylori infection. The control group consisted of patients treated with standard dual therapy comprising omeprazole and amoxicillin. One hundred and fifty-seven H. pylori infected patients with duodenal ulcers were randomly assigned to receive either a combination of omeprazole 10 mg, clarithromycin 250 mg and metronidazole 400 mg (OCM) given three times daily for 10 days (n = 81), or a combination of omeprazole 20 mg and amoxicillin 1 g (OA) given twice daily for 14 days (n = 76). Prior to treatment and after 2 and 6 weeks, gastric biopsies from the antrum and corpus were obtained for histology and H. pylori culture. H. pylori infection was cured in 97.4% after OCM and in 65.8% after OA in the per-protocol analysis (p < 0.001) (intention-to-treat analysis: 93.4% and 63.2%, respectively). H. pylori was successfully cultured in 122 patients (77%). The overall rate of metronidazole resistance was 19.7% (24/122), no primary resistance to clarithromycin or amoxicillin was found. In the OCM group, all patients infected with metronidazole-sensitive H. pylori strains (n = 51) and those infected with strains of unknown susceptibility to metronidazole (n = 14) were cured (100%), while 77% (10/13) of those harboring metronidazole-resistant strains were cured of the infection (p = 0.36). Side effects leading to premature termination of treatment occurred in 2.5% of the patients in the OCM group and in 1.4% of the OA group. We conclude that combined treatment with omeprazole, clarithromycin and a higher dose of metronidazole is highly effective in curing H. pylori infection, and that this regimen remains very effective in the presence of metronidazole-resistant strains.",2000.0,0,0
1296,9820370,A guideline for the treatment and prevention of NSAID-induced ulcers. Members of the Ad Hoc Committee on Practice Parameters of the American College of Gastroenterology.,F L Lanza,,1998.0,0,0
1297,9820380,Evaluation of the PyloriTek test for detection of Helicobacter pylori infection in cases with and without eradication therapy.,H Murata; S Kawano; S Tsuji; M Tsujii; H Sawaoka; H Iijima; N Kawai; M Hori,"The accuracy of the PyloriTek test (a 1-h rapid urease test) used after eradication therapy of Helicobacter pylori (H. pylori) has not been well clarified. This study was done to evaluate the accuracy of the PyloriTek test results for cases with and without eradication therapy, using culture and histology as gold standard methods, and to establish the suitable timing of the PyloriTek test after eradication treatment. One hundred sixty-three patients undergoing upper endoscopy were randomly selected; 100 patients had not received eradication therapy and 63 had. Three biopsy specimens each were obtained from the gastric antrum and the body for examination by PyloriTek, culture, and histology. The absence of H. pylori was established with negative results from both culture and histology. In cases without eradication therapy, PyloriTek, correctly identified 66 of 67 H. pylori-positive cases and 30 of 33 H. pylori-negative cases, yielding 98.5% sensitivity and 90.9% specificity. In cases with eradication therapy, PyloriTek gave correct diagnoses in 10 of 17 H. pylori-positive cases and in 45 of 46 H. pylori-negative cases, for 58.8% sensitivity and 97.8% specificity. However, when PyloriTek was used more than 4 months after the end of eradication therapy, both the sensitivity and the specificity increased to 100%. Considering time and cost, the use of PyloriTek alone may be satisfactory for detecting H. pylori infection in cases without eradication therapy. When patients are examined more than 4 months after intervention, the use of PyloriTek alone may be sufficient for correctly diagnosing H. pylori infections.",1998.0,0,0
1298,9820381,"Twice-daily, 10-day triple therapy with omeprazole, amoxicillin, and clarithromycin for Helicobacter pylori eradication in duodenal ulcer disease: results of three multicenter, double-blind, United States trials.",L Laine; L Suchower; J Frantz; A Connors; G Neil,"We assessed the safety and efficacy of 10-day twice-daily triple therapy for Helicobacter pylori (H. pylori) in three double-blind, controlled trials in patients with duodenal ulcer disease. H. pylori-infected patients with one or more duodenal ulcer(s) at endoscopy (studies 1, 2) or with a documented duodenal ulcer history and no duodenal ulcer or erosions at endoscopy (study 3) were randomly assigned to 10-day courses of omeprazole 20 mg b.i.d. plus amoxicillin 1 g b.i.d. plus clarithromycin 500 mg b.i.d. (OAC) or placebo plus amoxicillin 1 g b.i.d. plus clarithromycin 500 mg b.i.d. (AC). In studies 1 and 2, patients received an additional 18 days of omeprazole 20 mg q.d. (OAC group) or placebo (AC group). Endoscopy was repeated 4 wk after therapy in studies 1 and 2 and 4-6 wk after therapy in study 3. At baseline, H. pylori was diagnosed by CLOtest plus histology, or by culture. Eradication was defined as no positive biopsy test and two or more negative tests. Patients were defined as compliant if they took 75% or more of each study drug and missed < or = 3 consecutive days of the 10-day therapy. Intent-to-treat populations of the three studies combined were 241 patients for OAC and 266 for AC. Of all OAC patients combined, 2% stopped study medications due to adverse events, and 93% were compliant. Per-protocol cure rates were 78% to 90% (all studies combined, 84%) for OAC vs 33% to 45% (combined, 39%) for AC (p < 0.001, OAC vs AC); intent-to-treat eradication rates were 69% to 83% (combined, 75%) for OAC vs 32% to 37% (combined, 35%) for AC; (p < 0.001, OAC vs AC). Rigorously designed studies indicate that 10 days of twice-daily triple therapy with omeprazole, amoxicillin, and clarithromycin achieves per-protocol eradication rates of approximately 80% to 90% in the U.S.",1998.0,0,0
1299,9824338,Effect of omeprazole 20 mg twice daily on duodenogastric and gastro-oesophageal bile reflux in Barrett's oesophagus.,R E Marshall; A Anggiansah; D K Manifold; W A Owen; W J Owen,"Both acid and duodenal contents are thought to be responsible for the mucosal damage in Barrett's oesophagus, a condition often treated medically. However, little is known about the effect of omeprazole on duodenogastric reflux (DGR) and duodenogastro-oesophageal reflux (DGOR). To study the effect of omeprazole 20 mg twice daily on DGR and DGOR, using the technique of ambulatory bilirubin monitoring. Twenty three patients with Barrett's oesophagus underwent manometry followed by 24 hour oesophageal and gastric pH monitoring. In conjunction with pH monitoring, 11 patients (group 1) underwent oesophageal bilirubin monitoring and 12 patients (group 2) underwent gastric bilirubin monitoring, both before and during treatment with omeprazole 20 mg twice daily. In both groups there was a significant reduction in oesophageal acid (pH<4) reflux (p<0.005) and a significant increase in the time gastric pH was above 4 (p<0.005). In group 1, median total oesophageal bilirubin exposure was significantly reduced from 28.9% to 2.4% (p<0.005). In group 2, median total gastric bilirubin exposure was significantly reduced from 24.9% to 7.2% (p<0.005). Treatment of Barrett's oesophagus with omeprazole 20 mg twice daily results in a notable reduction in the exposure of the oesophagus to both acid and duodenal contents. In addition, delivery of duodenal contents to the upper gastric body is reduced.",1998.0,0,0
1300,9824598,Omeprazole in the treatment of ulcers induced by NSAIDs.,M J Langman,,1998.0,0,0
1301,9825880,Proton-pump inhibitors in acid-related diseases.,R R Berardi; L S Welage,,1998.0,0,0
1302,9829354,The usefulness of a structured questionnaire in the assessment of symptomatic gastroesophageal reflux disease.,R Carlsson; J Dent; E Bolling-Sternevald; F Johnsson; O Junghard; K Lauritsen; S Riley; L Lundell,"The diagnosis of gastroesophageal reflux disease (GERD) rests primarily on recognition of symptom patterns that are classical for reflux disease, but little attention has been paid to the use of a formal questionnaire for identifying such symptom patterns. A self-administered questionnaire was developed which has seven items that focus on the nature of the symptoms and the precipitating, exacerbating, and relieving factors. The diagnostic validity of the questionnaire was tested against endoscopy and 24-h pH monitoring. A further evaluation was undertaken in patients with symptoms suggestive of GERD and in patients with non-ulcer dyspepsia, to identify factors that might predict symptom relief during treatment with omeprazole. When endoscopic esophageal mucosal breaks and 24-h pH data were used as criteria for the diagnosis of GERD, the questionnaire had a sensitivity of 92% but a very low specificity of 19%. Symptom relief during treatment with omeprazole was predicted by the presence of heartburn, described as 'a burning feeling rising from the stomach or lower chest up towards the neck' (P = 0.004), and 'relief from antacids' (P = 0.02). In non-ulcer dyspepsia a positive response to omeprazole was confined to the subgroup of patients who identified their main discomfort as heartburn as described above. The present questionnaire using descriptive language usefully identified heartburn in patients presenting with upper abdominal symptoms, and this symptom predicted symptom resolution during treatment with omeprazole.",1998.0,0,0
1303,9831269,Speed of onset of oesophageal acid reduction with different proton-pump inhibitors in patients with reflux oesophagitis.,M Newton; W R Burnham; M A Kamm,"Proton-pump inhibitors are the most effective drug treatment for gastro-oesophageal reflux disease. With the increasing trend toward 'on demand' therapy, it is important to determine how quickly oesophageal acid reflux is reduced, and whether this differs between the available compounds. A 2 x 2 double-blind crossover study. Eight patients with Savary-Miller grade II oesophagitis underwent 24 h pre-treatment oesophageal pH monitoring. Each patient was randomly allocated to receive daily omeprazole 20 mg and lansoprazole 30 mg for 2 days, in two separate double-blind periods, with a washout period of 14 days. Two further oesophageal pH recordings were obtained during the second 48 h period of treatment with each drug. Five patients completed the study and their results are presented. Lansoprazole significantly reduced the percentage of total reflux time (P = 0.04) and percentage upright reflux time (P=0.04) on the second day of treatment compared to the pre-treatment, while this was not achieved with omeprazole. There was a significant difference in the reduction of the total reflux time (P= 0.011), upright reflux time (P=0.021) and total reflux episodes (P < 0.001) on day 2 of treatment when comparing lansoprazole with omeprazole. All patients on lansoprazole had a decrease in symptoms of heartburn and regurgitation, with complete resolution in four patients. Three patients had a decrease in these symptoms with omeprazole, including complete resolution in two. This study was limited by the small number of patients who underwent this demanding investigation. However, lansoprazole appears to have a more rapid onset of reduction of acid gastro-oesophageal reflux than omeprazole over a 48 h period.",1998.0,0,0
1304,9831406,Continuous and more effective duodenal ulcer healing under therapy with bismuth and two antibiotics than with dual therapy comprising omeprazole and amoxicillin.,M Kashifard; R Malekzadeh; F Siavoshi; J Mikaeli; S Massarrat,"To determine the speed of the healing process of duodenal ulcers during eradication regimens with and without a high-dose anti-secretory drug. An outpatient department of a university hospital as a community-based and referral centre. A total of 101 patients with proven duodenal ulcer and a positive urease test were randomized into two groups: one group received the classic triple therapy (bismuth subnitrate 3 x 375 mg for 4 weeks + tetracycline 3 x 500 mg + metronidazole 3 x 250 mg daily, both for 2 weeks ), the other group received dual therapy comprising amoxicillin 2 x 1000 mg + omeprazole 2 x 20 mg daily, both for 2 weeks. All patients underwent a control endoscopy 2 and 6 weeks after the beginning of treatment. Eradication was assumed if a urease test and culture were negative in all specimens taken from antral and corpus mucosa. In total, 93 patients completed all 6 weeks of the study (45 patients in the triple therapy group and 48 patients in the dual therapy group). The disappearance of ulcer pain was faster in the group under the regimen including omeprazole (dual therapy) than in the group with triple therapy (2.4+/-2.7 days versus 4.5+/-3.5 days; P< 0.01). The two-week healing rate was significantly higher in the patients treated with dual therapy than in the group treated with triple therapy (77% versus 33.3%; P< 0.01); however, 12 out of 37 patients with a healed ulcer in the dual therapy group had an ulcer relapse at 6 weeks (six became symptomatic). Only in one of these 12 patients was Helicobacter pylori eradicated. Fifteen of the 45 patients with triple therapy had healed ulcers at 2 weeks, and of these 14 remained healed at 6 weeks (H. pylori was eradicated in eight patients). The six-week healing rate with dual therapy was the same as with classic triple therapy (64.6% versus 77.6%); the eradication rate was lower in the former group than in the latter (30.4% versus 51.1% respectively; P=0.056). A high dose of a proton pump inhibitor (PPI) combined with amoxicillin results in rapid ulcer healing and pain disappearance, but is associated with early ulcer relapse due to lack of eradication of H. pylori. Its addition to regimens with bismuth and antibiotics is not necessary to achieve ulcer healing.",1998.0,0,1
1305,9834259,Ranitidine controls nocturnal gastric acid breakthrough on omeprazole: a controlled study in normal subjects.,P L Peghini; P O Katz; D O Castell,"Proton pump inhibitors administered twice daily do not provide complete nocturnal acid suppression. Acid breakthrough, or decrease in intragastric pH to <4 for an hour or longer, occurs in three quarters of normal subjects and patients at night. We compared the effect of a third dose of omeprazole at bedtime with that of a dose of ranitidine at bedtime on residual nocturnal acid secretion in patients receiving omeprazole twice daily. Twelve volunteers underwent overnight intragastric pH monitoring after 7 days of treatment with omeprazole, 20 mg twice daily, followed by different treatment supplements at bedtime: placebo; additional omeprazole, 20 mg; ranitidine, 150 mg; and ranitidine, 300 mg. Additional omeprazole at bedtime reduced the percentage of time with intragastric pH of <4 from 48% to 31% (P < 0.005) compared with omeprazole twice daily with placebo at bedtime. Ranitidine at bedtime reduced this parameter more, 5% with 150 mg and 6% with 300 mg (P <0.01 vs. omeprazole twice daily plus bedtime). Results for percentage of time with intragastric pH <3 were similar. Eleven subjects had acid breakthrough with placebo at bedtime; 7 with omeprazole at bedtime (P = NS); 4 with ranitidine, 150 mg at bedtime; and 3 with ranitidine, 300 mg at bedtime (P < 0. 05, ranitidine vs. placebo). Bedtime ranitidine is more effective than bedtime omeprazole on residual nocturnal acid secretion in patients receiving omeprazole twice daily. This finding suggests that fasting breakthrough nocturnal acid secretion in patients receiving omeprazole twice daily is most likely histamine related.",1998.0,0,0
1306,9840304,Outcome of open antireflux surgery as assessed in a Nordic multicentre prospective clinical trial. Nordic GORD-Study Group.,L Lundell; J Dalenbäck; J Hattlebakk; E Janatuinen; K Levander; P Miettinen; H E Myrvold; S A Pedersen; K Thor; O Junghard; A Andersson,"To evaluate the outcome of antireflux surgery in various hospitals in Scandinavian countries. Partly randomised controlled study, and partly open study. Hospitals throughout Norway, Sweden, Denmark and Finland. 310 patients with chronic reflux disease and oesophagitis who were initially entered into a randomised controlled study of omeprazole and antireflux surgery. Total fundic wrap, partial fundoplication, or omeprazole. Control of symptoms at one year. 154 patients who had their symptoms of reflux completely controlled with omeprazole were initially randomised to have an open operation but 10 refused, leaving 144 for analysis. 34 patients who had only a partial response were also offered operation; 120/178 (68%) had a total fundic wrap, and 53 (30%) partial fundoplication. 6 patients had postoperative complications that required reoperation and 123 made a completely uneventful recovery. Reflux was controlled in most patients, and only 10 (6%) required further treatment with omeprazole. The outcome in those patients who only responded partially to omeprazole was similar to that in patients who had a complete response. The outcome of antireflux surgery throughout Norway, Sweden, Denmark, and Finland is good.",2000.0,0,0
1307,9841603,"Disappearance of hyperplastic polyps in the stomach after eradication of Helicobacter pylori. A randomized, clinical trial.",T Ohkusa; I Takashimizu; K Fujiki; S Suzuki; K Shimoi; T Horiuchi; T Sakurazawa; K Ariake; K Ishii; J Kumagai; T Tanizawa,"Helicobacter pylori infection is common in patients with hyperplastic gastric polyps. To study the effect of eradication of H. pylori on the clinical course of patients with hyperplastic gastric polyps. Single-blind, randomized, controlled trial. University-based gastroenterology outpatient clinic. 35 patients with H. pylori infection and hyperplastic gastric polyps at least 3 mm in diameter. Patients were randomly assigned to a treatment group (n = 17), which received a proton-pump inhibitor (omeprazole or lansoprazole), amoxicillin, and either clarithromycin or ecabet sodium, or to a control group (n = 18), which received no treatment. Patients underwent endoscopy before enrollment and 12 to 15 months after the end of treatment. Serum gastrin levels and titers of IgG to H. pylori were measured. In the treatment group, the polyps had disappeared by 3 to 15 months (average, 7.1 +/- 1.2 months) after the end of treatment in 12 of all 17 patients (71%) and in 12 of the 15 patients (80%) in whom H. pylori was eradicated. However, 12 to 15 months after the start of the study, no change in polyps or H. pylori status was seen in any controls (P < 0.001). Histologic findings of inflammation and activity, serum gastrin levels, and titers of IgG to H. pylori showed significant regression in the treatment group compared with the control group (P < 0.01). Most hyperplastic polyps disappeared after eradication of H. pylori. Thus, eradication should be attempted before endoscopic removal is done in patients with hyperplastic gastric polyps and H. pylori infection.",1998.0,0,0
1308,9844069,Safety and efficacy of one-week triple therapy for eradicating Helicobacter pylori in children.,S Kato; H Ritsuno; K Ohnuma; K Iinuma; T Sugiyama; M Asaka,"Proton pump inhibitor-based eradication therapy of Helicobacter pylori has been widely studied in adults, but there have been only a few reports about this therapy in children. The purpose of this study was to investigate the safety and efficacy of 1-week triple therapy for eradication of H. pylori and ulcer healing in children. We prospectively studied 15 patients aged 2-17 years (5 with gastric ulcers, 8 with duodenal ulcers, and 2 with nodular gastritis alone). Three patients had H2 blocker-resistant duodenal ulcers. Patients received 0.75 mg/kg of lansoprazole b.i.d., 25 mg/kg of amoxicillin b.i.d., and 10 mg/kg of clarithromycin b.i.d. for 7 days. No additional therapy (including antisecretory drugs) was administered to any patients following eradication therapy. Patients underwent endoscopy to obtain antral biopsies (culture, urease test and histology) and to evaluate the mucosal status, and underwent a 13C-urea breath test before and 4-8 weeks after the completion of a 1-week course of therapy. All patients received the full drug regimen. Endoscopy showed complete healing of ulcers in 12 of 13 patients with peptic ulcer disease (92%). H. pylori was eradicated in 13 of 15 patients (87%). Diarrhea and/or an altered taste sensation occurred in 5 patients (33%). There were no hematological or biochemical abnormalities related to therapy. The 1-week triple therapy was safe and effective for eradicating H. pylori. The present study showed that ulcer healing in juveniles is closely associated with eradication of H. pylori, and that no additional therapy is required when H. pylori is eradicated. A shorter course of eradication therapy than 2 weeks may be suitable for children with H. pylori infection.",1998.0,0,0
1309,9845397,A placebo-controlled trial to assess the effects of 8 days of dosing with rabeprazole versus omeprazole on 24-h intragastric acidity and plasma gastrin concentrations in young healthy male subjects.,M P Williams; J Sercombe; M I Hamilton; R E Pounder,"Rabeprazole (LY307640, E3810) is a new, potent, proton pump inhibitor. A single daily 20 mg dose significantly decreases 24-h intragastric acidity. There are no data currently available directly comparing the effect of rabeprazole on 24-h acidity with established proton pump inhibitors. To compare the effects of rabeprazole 20 mg o.m. and omeprazole 20 mg o.m. on 24-h intragastric acidity and plasma gastrin concentration in a randomized, double-blind, placebo-controlled trial, in healthy H. pylori-negative subjects. Twenty-four healthy male volunteers, negative for H. pylori infection by serology and 13C-urea breath test, were studied on the 1st and 8th day of dosing with either placebo, rabeprazole 20 mg or omeprazole 20 mg, once each morning, in a crossover fashion. On days 1 and 8, hourly intragastric acidity was measured by gastric aspiration for 24 h from 08.00 hours. On day 8, plasma gastrin concentrations were also measured hourly from 08.00 to 24.00 hours, then every 2 h thereafter. A single dose of both rabeprazole and omeprazole significantly decreased 24-h intragastric acidity compared with placebo. The 24-h acidity on day 1 was significantly decreased for rabeprazole compared with omeprazole (331 vs. 640 mmol.h/L, P < 0.001), resulting in a significantly higher median 24-h intragastric pH and longer times at which intragastric pH was > 3 and > 4. On day 8 of dosing, the decrease in 24-h intragastric acidity was greater with rabeprazole than with omeprazole, but the difference was not statistically significant (160 vs. 218 mmol.h/L, P = 0.1). However, 24-h plasma gastrin concentration (1687 vs. 1085 pmol.h/L. P < 0.01) and percentage time that intragastric pH was > 3 (69 vs. 59%, P = 0.008) and > 4 (60 vs. 51%, P = 0.03) were significantly greater. Rabeprazole 20 mg once daily has a significantly faster onset of antisecretory activity than omeprazole 20 mg once daily. After 8 days the differences in intragastric pH > 3 and > 4 holding times persisted, but there was no significant difference in 24-h acidity.",1998.0,0,1
1310,9846909,Helicobacter pylori infection in children.,Y Vandenplas; U Blecker,"Helicobacter pylori colonizes the human stomach, especially during childhood. However, a variety of H. pylori strains exists, with major differences in virulence characteristics which probably account for different clinical symptoms, and the majority of infected subjects remains asymptomatic. Helicobacter pylori infection is correlated with socioeconomic conditions and hygienic circumstances, resulting in an extremely high prevalence in children in developing countries. Commercial screening tests are not capable of separating the more virulent strains (type I with vacuolating toxin VacA and CagA protein) from the less virulent strains (type II, VacA and CagA negative). Type I strains, but not type II, are associated with an increased risk for duodenal ulcer and gastric cancer. Therefore, future screening tests and vaccinations should focus on the type I strains.",1998.0,0,0
1311,9853554,Effects of trimebutine maleate on gastric motility in patients with gastric ulcer.,T Kamiya; T Nagao; T Andou; N Misu; Y Kobayashi; M Hirako; M Hara; T Fujinami,"The effects of trimebutine maleate (TM), a prokinetic drug, on gastrointestinal motility in patients with gastric ulcer were investigated. Twenty patients with active gastric ulcers were allocated to two groups; 10 patients received a proton pump inhibitor alone (PPI group), given orally, and 10 patients received oral TM in combination with a PPI (PPI + TM group), each for a period of 8 weeks. Electrogastrography (EGG) and gastric emptying were measured before and after the treatment period. During the active ulcer stage, tachygastria (more than 0.06 Hz) or bradygastria (less than 0.04 Hz) in the EGG frequency were observed in 9 patients either before or after meals. During the healed ulcer stage, tachygastria or bradygastria was observed in 4 of 10 patients in the PPI group, while in the PPI + TM group, 1 patient had tachygastria and none had bradygastria. Postprandial dip (PD) was observed in 3 of the 20 patients during the active stage, while after treatment, PD was observed in 3 patients in the PPI group and in 6 patients in the PPI + TM group, respectively. Gastric emptying in the PPI group did not show any change between before and after treatment, while that in the PPI + TM group improved significantly after treatment. These results suggest that TM may have an ameliorative effect on abnormal gastric motility in patients with gastric ulcer.",1998.0,0,0
1312,9855082,"Eradication of Helicobacter pylori by a 1-week course of famotidine, amoxicillin and clarithromycin.",M Gschwantler; B Dragosics; H Wurzer; G Brandstätter; W Weiss,"The combination of a proton pump inhibitor (PPI) such as omeprazole with amoxicillin and clarithromycin constitutes one of the most effective treatments for the eradication of Helicobacter pylori. Nevertheless, the mechanisms of interaction between these drugs remain unclear. It has been shown that minimal inhibitory concentration values of both antibiotics are considerably lower at neutral pH levels than in an acid environment. Further, omeprazole possesses bacteriostatic activity. To evaluate the significance of these mechanisms we replaced omeprazole with famotidine, a drug which only suppresses acid production, but has no intrinsic antimicrobial activity. We evaluated the efficacy of a 1-week course of famotidine 80 mg b.i.d., amoxicillin 1000 mg b.i.d. and clarithromycin 500 mg b.i.d. in a pilot study (20 patients), and then confirmed our results in a larger replication study (87 patients). A total of 107 patients with H. pylori-associated duodenal ulcer (n = 54), gastric ulcer (n = 14) or non-ulcer dyspepsia (n = 39) were included. Endoscopy was performed at baseline and 4-6 weeks after discontinuation of treatment. H. pylori status was assessed by the urease test and histology. H. pylori was successfully eradicated in 94 of 104 patients who completed the study (90.4%; CI 95%, 83.0-95.3%). By intention-to-treat analysis, the eradication rate was 87.9% (CI 95%, 80.1-93.4%). Ulcer healing was observed in 98.1% of duodenal ulcers and 92.9% of gastric ulcers (based on per-protocol analysis). Mild side effects that did not require termination of treatment were reported by seven patients (6.7%). A 1-week course of famotidine, amoxicillin and clarithromycin is a highly effective, simple and safe eradication regimen. Our data indicate that acid suppression is the crucial mechanism by which the activity of amoxicillin and clarithromycin against H. pylori is enhanced, whereas additional antimicrobial activity or other specific effects of PPIs seem to be less important.",1998.0,0,0
1313,9855086,Optimization of acid suppression for patients with peptic ulcer bleeding: an intragastric pH-metry study with omeprazole.,G Hasselgren; M Keelan; P Kirdeikis; J Lee; K Röhss; P Sinclair; A B Thomson,"To study whether an intravenous infusion dose of omeprazole (80 mg + 8 mg/h) during 24 h can be subsequently reduced with maintained effect. Second, to study the effect of oral omeprazole 20 mg given once or twice daily up to day 10, after cessation of a 3-day intravenous infusion (80 mg + 8 mg/h). Prospective, randomized, partly blinded study. Twelve Helicobacter pylori(+) patients and 12 H. pylori(-) subjects were included. In part I the patients received omeprazole, 80 mg + 8 mg/h, during 24 h followed by 8, 4 or 2 mg/h. In part II the subjects received 80 mg + 8 mg/h during 3 days followed by 20 mg omeprazole orally, once or twice daily until day 10. Intragastric pH was measured. All H. pylori(+) patients showed a rapid increase of intragastric pH with a mean intragastric pH of 6.7 during the second half of the first day. After the subsequent dose reduction, the mean pH decreased to 6.1-6.2. Patients continuing on 8 mg/h showed the best results. Likewise, all H. pylori(-) subjects showed a rapid and sustained reduction of intragastric acidity during the infusion. Subsequent dose reduction to 20 mg once daily led to a stable fraction of time with pH > 3 of 72%. Omeprazole given as a continuous infusion of 80 mg + 8 mg/h for 72 h followed by omeprazole 20 mg once daily raised the intragastric pH to and above levels alleged to allow haemostasis in patients with peptic ulcer bleeding and subsequent healing of the ulcer.",1998.0,0,0
1314,9858292,Can the C-14 urea breath test replace follow-up endoscopic biopsies in patients treated for Helicobacter pylori infection?,V Ahuja; C S Bal; M P Sharma,"The C-14 urea breath test (UBT) is the most specific noninvasive test to detect Helicobacter pylori, with reported sensitivity and specificity rates of 90% and 95%, respectively. This test has not been evaluated for eradication after a therapeutic trial. The goal of this study was to assess the accuracy of C-14 UBT in the diagnosis and eradication of H. pylori infection in patients with duodenal ulcer who were treated with a triple drug regimen. Sixty patients with active duodenal ulcers who tested positive for the rapid urease test had a C-14 UBT at 0 weeks (at enrollment) and at 6 and 12 weeks using 5 microCi (185 KBq) of C-14 urea. A single breath sample was collected at 15 minutes for UBT. H. pylori was eradicated using lansoprazole and two antibiotics. Receiver operator characteristic curves showed that, using a value of 400 counts per minute (cpm), UBT had a sensitivity rate of 91%, specificity rate of 93%, positive predictive value of 77%, and a negative predictive value of 97% in the prediction of H. pylori eradication. The mean + 3 SD of H. pylori-negative patients was 380.1 cpm; at this cutoff value, the sensitivity and specificity rates were 91.3% and 92.8%, respectively. The C-14 UBT was an accurate, rapid, and easily administered test to diagnose initial H. pylori infection and to monitor its eradication, thereby obviating the need for repeated endoscopic biopsies.",1998.0,0,0
1315,9860416,The utility of endoscopy in the management of patients with gastroesophageal reflux symptoms.,P K Blustein; P L Beck; J B Meddings; G M Van Rosendaal; R J Bailey; E Lalor; A B Thomson; M J Verhoef; L R Sutherland,"The utility of endoscopy in the management of patients with symptoms of gastroesophageal reflux disease (GERD) is unclear. The purpose of this prospective study was to assess the impact of endoscopy on the subsequent management of patients with uncomplicated reflux symptoms. A total of 742 patients underwent endoscopy for symptoms of GERD. Endoscopists recorded the therapy before endoscopy, the findings of endoscopy, and the treatment recommendations after endoscopy. There was no difference in pre-endoscopy therapy or grade of esophagitis in subjects undergoing endoscopy for failed therapy versus GERD symptoms alone. After endoscopy, the most common strategy for patients taking omeprazole was to maintain or increase the dose. For those taking an H2 blocker before endoscopy, the most common outcome was to switch the patient to omeprazole, independent of the grade of esophagitis. Most patients undergoing endoscopy for symptoms of GERD were switched to omeprazole regardless of the endoscopic findings. No esophageal cancer was identified and the incidence of Barrett's esophagus was low. It appears that endoscopy itself did not change the management of patients receiving H2-blocker therapy. A trial of a proton pump inhibitor before endoscopy should be considered.",1998.0,0,0
1316,9861876,An office approach to the diagnosis of chronic cough.,W R Lawler,"Chronic cough is a common problem in patients who visit family physicians. The three most common causes of chronic cough in those who are referred to pulmonary specialists are postnasal drip, asthma and gastroesophageal reflux. The initial treatment of patients with cough is often empiric and may involve a trial of decongestants, bronchodilators or histamine H2 antagonists, as monotherapy or in combination. If a therapeutic trial is not successful, sequential diagnostic testing including chest radiograph, purified protein derivative test for tuberculosis, computed tomography of the sinuses, methacholine challenge test or barium swallow may be indicated. By using a standard protocol for diagnosis and treatment, 90 percent of patients with chronic cough can be managed successfully in the family physician's office. However, in some cases it may take three to five months to determine a diagnosis and effective treatment. For the minority of patients in whom this diagnostic approach is unsuccessful, consultation with a pulmonary specialist is appropriate.",1998.0,0,0
1317,9862836,Transabdominal bowel sonography for the detection of intestinal complications in Crohn's disease.,C Gasche; G Moser; K Turetschek; E Schober; P Moeschl; G Oberhuber,"The course of Crohn's disease is characterised by the occurrence of intestinal complications such as strictures, intra-abdominal fistulas, or abscesses. Standard diagnostic procedures may fail to show these complications, in particular fistulas. To test the value of transabdominal bowel sonography (T) for the detection of intestinal complications in Crohn's disease. T was prospectively performed in 213 patients with Crohn's disease in a university based inflammatory bowel disease referral centre. Thirty three underwent resective bowel surgery and were included in this study. The accuracy of T to detect strictures, intra-abdominal fistulas, or abscesses was compared with surgical and pathological findings. T was able to identify strictures in 22/22 patients and to exclude it in 10/11 patients (100% sensitivity, 91% specificity). Fistulas were correctly identified in 20/23 patients and excluded in 9/10 patients (87% sensitivity, 90% specificity). Intra-abdominal abscesses were correctly detected in 9/9 patients and excluded in 22/24 patients (100% sensitivity, 92% specificity). In experienced hands T is an accurate method for the detection of intestinal complications in Crohn's disease. T is thus recommended as a primary investigative method for evaluation of severe Crohn's disease.",2000.0,0,1
1318,9862942,Lack of effect of treating Helicobacter pylori infection in patients with nonulcer dyspepsia. Omeprazole plus Clarithromycin and Amoxicillin Effect One Year after Treatment (OCAY) Study Group.,A L Blum; N J Talley; C O'Moráin; S V van Zanten; J Labenz; M Stolte; J A Louw; A Stubberöd; A Theodórs; M Sundin; E Bolling-Sternevald; O Junghard,"It is uncertain whether treatment of Helicobacter pylori infection relieves symptoms in patients with nonulcer, or functional, dyspepsia. We conducted a double-blind, multicenter trial of patients with H. pylori infection and dyspeptic symptoms (moderate-to-very-severe pain and discomfort centered in the upper abdomen). Patients were excluded if they had a history of peptic ulcer disease or gastroesophageal reflux disease and had abnormal findings on upper endoscopy. Patients were randomly assigned to seven days of treatment with 20 mg of omeprazole twice daily, 1000 mg of amoxicillin twice daily, and 500 mg of clarithromycin twice daily or with omeprazole alone and then followed up for one year. Treatment success was defined as the absence of dyspeptic symptoms or the presence of minimal symptoms on any of the 7 days preceding the 12-month visit. Twenty of the 348 patients were excluded after randomization because they were not infected with H. pylori, were not treated, or had no data available. For the remaining 328 patients (164 in each group), treatment was successful for 27.4 percent of those assigned to receive omeprazole and antibiotics and 20.7 percent of those assigned to receive omeprazole alone (P=0.17; absolute difference between groups, 6.7 percent; 95 percent confidence interval, -2.6 to 16.0). After 12 months, gastritis had healed in 75.0 percent of the patients in the group given omeprazole and antibiotics and in 3.0 percent of the patients in the omeprazole group (P<0.001); the respective rates of H. pylori eradication were 79 percent and 2 percent. In the group given omeprazole and antibiotics, the rate of treatment success among patients with persistent H. pylori infection was similar to that among patients in whom the infection was eradicated (26 percent vs. 31 percent). There were no significant differences between the groups in the quality of life after treatment. In patients with nonulcer dyspepsia, the eradication of H. pylori infection is not likely to relieve symptoms.",1998.0,0,0
1319,9872028,One-week low-dose triple therapy is effective in treating Helicobacter pylori-infected patients with bleeding peptic ulcers.,C L Lee; T C Tu; C H Wu; T K Chen; C C Chan; S H Huang; S C Lee,"Proton pump inhibitor (PPI)-based triple therapy, which combines a PPI and two antibiotics, is highly effective in eradicating Helicobacter pylori infection in peptic ulcer patients, even if given for only 1 week. However, the application of this regimen in patients with bleeding ulcers has not been adequately investigated. We studied the effectiveness of triple therapy in treating 122 patients with proven H. pylori infection, and bleeding stigmata on endoscopy; 97 had duodenal ulcer (DU), 15 had gastric ulcer (GU), and 10 had both types of ulcers. A regimen of omeprazole (20 mg), metronidazole (500 mg), and clarithromycin (250 mg) twice daily was administered for 1 week as soon as the patient could eat normally after bleeding, followed by omeprazole (20 mg) daily for 3 additional weeks. Follow-up endoscopy and 13C-urea breath tests (UBTs) were performed at least 4 weeks after triple therapy. A total of 104 patients completed the study, 83 with DU, 12 with GU, and nine with both. The overall ulcer healing rate was 97.1% and the eradication rate was 91.3%. Patients with and without H. pylori eradication did not differ significantly in terms of age, gender, UBT titer, units of blood transfused, or interval between endoscopy and the beginning of triple therapy. We conclude that 1-week low-dose PPI-based triple therapy is effective in eradicating H. pylori infection in patients with bleeding peptic ulcers. When followed by 3 weeks of additional PPI treatment, a satisfactory ulcer healing rate can also be achieved.",1999.0,0,0
1320,9882027,Does eradication of Helicobacter pylori impair healing of nonsteroidal anti-inflammatory drug associated bleeding peptic ulcers? A prospective randomized study.,F K Chan; J J Sung; R Suen; Y T Lee; J C Wu; W K Leung; H L Chan; A C Lai; J Y Lau; E K Ng; S C Chung,"Despite the widely accepted view that Helicobacter pylori is the most important cause of peptic ulcer disease, recent studies have suggested that the microbe protects against nonsteroidal anti-inflammatory drug (NSAID)-associated gastroduodenal lesions and promotes ulcer healing. We investigated the effects of H. pylori eradication on the healing of NSAID-associated bleeding peptic ulcers. Chronic NSAID users presenting with peptic ulcer haemorrhage underwent endoscopy to secure haemostasis and to document H. pylori infection by rapid urease test and culture. They were prospectively randomized to receive either omeprazole (20 mg once daily) for 8 weeks or a 1-week course of triple therapy (bismuth subcitrate 120 mg, tetracycline 500 mg, metronidazole 400 mg, all given four times daily) plus omeprazole (20 mg once daily) for 8 weeks. Endoscopy was repeated after 8 weeks. Final H. pylori status was determined by a 13C-urea breath test that was performed at least 4 weeks after discontinuation of omeprazole. 195 H. pylori-infected NSAID users, complicated by bleeding ulcers, were randomized to receive omeprazole alone (102) or triple therapy plus omeprazole (93). 174 patients returned for second endoscopy at 8 weeks (91 in the omeprazole group, 83 in the triple therapy group). Urea breath test was negative in 14% in the omeprazole group vs. 92% in the triple therapy group (P < 0.001). Complete ulcer healing was achieved in 88 (97%) patients in the omeprazole group and 77 (93%) in the triple therapy group (P=0. 31). On intention-to-treat analysis, ulcers were healed in 86% of the omeprazole group and 83% of the triple therapy group (P=0.50). There was no significant difference in the healing rates of gastric or duodenal ulcers between the two groups. Eradication of H. pylori did not impair the healing of NSAID-associated bleeding peptic ulcers.",1999.0,0,0
1321,9882031,Gastro-oesophageal reflux associated with nocturnal gastric acid breakthrough on proton pump inhibitors.,P O Katz; C Anderson; R Khoury; D O Castell,"Nocturnal gastric acid breakthrough, defined as intragastric pH < 4 for more than 1 h in the overnight period, is observed in up to 70% of normal subjects on proton pump inhibitors taken twice daily. The frequency of this breakthrough in patients with gastro-oesophageal reflux and accompanying oesophageal reflux during this period has not been studied. To examine the frequency of nocturnal break-through and accompanying oesophageal acid exposure in patients with gastro-oesophageal reflux treated with proton pump inhibitors twice daily. Prolonged ambulatory pH records from 76 patients on twice daily proton pump inhibitors between January 1991 and July 1997 were analysed for the presence of nocturnal gastric acid breakthrough and accompanying oesophageal pH < 4. Studies from 31 normal subjects on twice daily proton pump inhibitors constituted the control group. Nocturnal gastric acid breakthrough was seen in 70% of 61 patients with gastro-oesophageal reflux, 80% of 15 patients with Barrett's oesophagus and 67% of normal controls (P=N.S.). Oesophageal acid exposure was seen in 33% of gastro-oesophageal reflux patients, 50% of Barrett's oesophagus patients and 8% of normal controls (P < 0.03). No difference was found between patients taking omeprazole or lansoprazole. Nocturnal acid breakthrough is frequently seen on proton pump inhibitors twice daily and is often accompanied by oesophageal reflux. This has important implications for medical therapy in patients with severe gastro-oesophageal reflux and Barrett's oesophagus.",1999.0,0,0
1322,9882032,Nocturnal gastric acidity and acid breakthrough on different regimens of omeprazole 40 mg daily.,J G Hatlebakk; P O Katz; B Kuo; D O Castell,"On chronic intake of omeprazole, most healthy volunteers and patients still have nocturnal acid breakthrough (NAB), defined as night-time periods with gastric pH < 4.0 lasting for longer than 1 h. Gastro-oesophageal reflux during NAB may be particularly injurious to the oesophageal mucosa, contributing to the chronic lesions complicating the condition. To compare the effect of three different dosing regimens of omeprazole 40 mg daily with regard to suppressing nocturnal gastric acidity and avoiding NAB. Eighteen healthy volunteers were given three different regimens of omeprazole for 7 days each in randomized order: 40 mg before breakfast (qAM), 40 mg before dinner (qPM) and 20 mg before breakfast and dinner (b.d.). On day 7, 24-h intragastric and intraoesophageal pH-metry was performed. Tracings were analysed for the period from 22.00 h until 06.00 h with regard to the percentage of time at which gastric pH was below 4.0, 3.0 and 2.0, and also the occurrence and duration of NAB. Nocturnal acid breakthrough was significantly more common on qAM than on qPM and b.d. (P < 0.05) dosing. The percentage of time gastric pH was less than 4.0 overnight was significantly lower on qPM (median 31.3) and b.d. (median 20.5) than on qAM (median 66.3) dosing (P=0.01 and P < 0.02, respectively). A pH threshold of 3 and 4 showed the same differences, as did median 24-h gastric pH. Daytime acidity was not significantly different. In healthy volunteers, dinner time or split dosing of omeprazole 40 mg daily is significantly more effective than dosing before breakfast in preventing NAB and controlling gastric acidity. These regimens should be preferred in patients in whom suppression of nocturnal gastric acidity is desirable.",1999.0,0,0
1323,9882033,Comparison of 24-h control of gastric acidity by three different dosages of pantoprazole in patients with duodenal ulcer.,V Savarino; G S Mela; P Zentilin; G Bisso; M Pivari; S Vigneri; R Termini; S Fiorucci; P Usai; A Malesci; G Celle,"It is now clear that the extent to which gastric acid secretion must be suppressed varies with the clinical condition being treated. To assess the 24-h control of gastric acidity and the individual response variability of three different doses of pantoprazole. Sixty-four duodenal ulcer patients were recruited for this prospective, randomized, multicentre, double-blind, parallel-group study. They were subdivided into three well-matched groups treated with 20 mg o.m., 40 mg o.m. and 40 mg b.d. of pantoprazole, respectively. Endoscopy and intragastric pH monitoring were performed in each patient before and after 14 days of treatment. Fifty-five patients were eligible for final analysis (17 treated with 20 mg o.m., 18 with 40 mg o.m. and 20 with 40 mg b.d. pantoprazole). The ulcer crater healed in 94, 88 and 95% of cases, respectively. The three dosages of pantoprazole produced significant increases in gastric pH compared to basal levels (P < 0.0001). There was also a clear dose-dependent pharmacodynamic effect, which augmented on moving from the lowest dosage of 20 mg o.m. pantoprazole to the highest dosage of 40 mg b.d. (P < 0.01-0.001). The inter-individual response variability within the three treatment groups was more marked with the dose of 20 mg than with the two higher doses of pantoprazole. All three doses of pantoprazole we tested are highly effective in decreasing gastric acidity and there is a clear dose-dependent pharmacodynamic effect on moving from the lowest to the highest dosage. The greatest inter individual variation in the degree of acid inhibition was seen with pantoprazole 20 mg o.m., while the majority of patients responded adequately to the two higher doses of the drug.",1999.0,0,0
1324,9882037,Evaluation of a new ultrashort triple therapy for Helicobacter pylori disease.,L Trevisani; S Sartori; F Galvani; M Ruina; M Caselli; G Verdianelli; V Abbasciano,"1-week proton pump inhibitor-based triple therapies are considered the most effective and convenient drug combinations for curing Helicobacter pylori infection. Short therapies, lasting less than 1 week have been investigated rarely. To assess the efficacy and tolerability of a 3-day lansoprazole triple therapy after 1 day of lansoprazole pre-treatment. Seventy H. pylori-positive (rapid urease test and histology) patients received LAzT3 regimen (lanzoprazole 30 mg b.d. and azithromycin 500 mg o.m. for 3 days; tinidazole 2000 mg o.m. on day 1 and 1000 mg o.m. on days 2-3) after 1 day of lansoprazole pretreatment. Patients with active ulcer received lansoprazole 30 mg o.m. for an additional 4 weeks. Follow-up gastroscopy was carried out 4-6 weeks after completion of therapy. Eradication was defined as negative histology and rapid urease test. Four patients failed to attend the follow-up endoscopy. One patient complained of minor side-effects. H. pylori was eradicated in 57 of 66 patients suitable for evaluation, with a per-protocol cure rate of 86.3% (95%CI: 76-94%), and an intention-to-treat cure rate of 81.4% (95%CI: 70-90%). This new ultrashort triple therapy including lansoprazole, azithromycin and tinidazole seems to be effective in eradicating H. pylori. It is safe and well-tolerated, and may be taken into consideration as a valid alternative to the better known and widely used 1-week proton pump inhibitor-based triple therapies.",1999.0,0,0
1325,9892788,Health-related quality of life outcomes of omeprazole versus ranitidine in poorly responsive symptomatic gastroesophageal reflux disease.,D A Revicki; S Sorensen; P N Maton; R C Orlando,"This study evaluated changes in health-related quality of life (HRQL) outcomes of once-daily omeprazole compared with ranitidine for the short-term treatment of patients with poorly responsive symptomatic gastroesophageal reflux disease (GERD). A double-blind, randomized clinical trial, compared omeprazole versus ranitidine for the treatment of poorly responsive GERD. Eligible patients had a history of predominant heartburn symptoms with symptomatic heartburn after 6 weeks of ranitidine treatment. Patients were randomized to omeprazole 20 mg once daily (n = 156) or ranitidine 150 mg twice daily (n = 161) and followed for 8 weeks. Assessments were completed at baseline and after 8 weeks with physician-rated symptoms: Gastrointestinal Symptom Rating Scale (GSRS); Psychological General Well-Being (PGWB) Index; Sleep Scale; Impact on Daily Activities Scale, and Overall Treatment Effect. Primary HRQL endpoints were the GSRS reflux scale and PGWB total score. No differences between the 2 treatment groups were observed in baseline demographic, clinical or HRQL measures. After 8 weeks, omeprazole-treated patients had greater improvement in GSRS reflux scale scores (p<0.0001) and PGWB total scores (p = 0. 019) compared with ranitidine-treated patients. Significant between group differences favoring omeprazole were also observed in GSRS total scores (p<0.0001), abdominal pain scale scores (p = 0.003), and indigestion scale scores (p = 0.003), Impact on Daily Activities (p = 0.001), PGWB positive well-being (p = 0.015), anxiety (p = 0. 030), and general health scale scores (p = 0.010). Patient ratings of overall treatment effect demonstrated the significantly (p<0. 0001) greater benefits of omeprazole (mean = 5.26) compared with ranitidine treatment (mean = 3.83). Omeprazole treatment significantly reduced persistent reflux-related symptoms and normalized psychological well-being compared with ranitidine in poorly responsive symptomatic patients with GERD.",2000.0,0,0
1326,9892879,"Double-blind comparison [correction of Double-blind, placebo-controlled comparison] of rabeprazole 20 mg vs. omeprazole 20 mg in the treatment of erosive or ulcerative gastro-oesophageal reflux disease. The European Rabeprazole Study Group.",C P Dekkers; J A Beker; B Thjodleifsson; A Gabryelewicz; N E Bell; T J Humphries,"Rabeprazole sodium is the most recent member of a class of substituted benzimidazole molecules known as proton pump inhibitors. Other proton pump inhibitors have been shown to be effective in healing oesophagitis. In this randomised, double-blind, multicentre study, conducted at 27 European sites, the efficacy and safety of rabeprazole and omeprazole were compared in patients with erosive or ulcerative gastro-oesophageal reflux disease (GERD).100 patients received rabeprazole 20 mg, and 102 patients omeprazole 20 mg once daily for 4 or 8 weeks, with healing monitored by endoscopy. Overall GERD healing rates observed and evaluated at weeks 4 and 8 were equivalent. Four-week healing rates for rabeprazole and omeprazole were 81%-81% and 92%-94% for 8-week healing. Rabeprazole-treated patients had similar relief of the frequency and intensity of heartburn to those treated with omeprazole. Both drugs were well tolerated over the 8-week treatment period. Mean changes in fasting serum gastrin were comparable. No significant differences in laboratory parameters were seen. Biopsies for argyrophil ECL cell histology at the end-point revealed a similar distributions of hyperplasia grades to those at baseline in both groups. Biopsies of body and antral mucosa for other parameters were similar between treatments for Helicobacter pylori colonization, presence or degree of inflammation, atrophy or intestinal metaplasia at the end-point. In this study, GERD healing rates following rabeprazole 20 mg once daily were equivalent to those obtained with omeprazole 20 mg once daily. Both treatments resulted in a comparable relief of the frequency and intensity of heartburn associated with this disease, and both were well tolerated.",1999.0,0,1
1327,9892880,Evaluation of omeprazole as a cost-effective diagnostic test for gastro-oesophageal reflux disease.,C M Bate; S A Riley; R W Chapman; A T Durnin; M D Taylor,"There is a need for a simple, therapeutic test that is of diagnostic value and can also provide rapid symptom relief in patients who present with classic, mild symptoms suggestive of gastro-oesophageal reflux disease (GERD), when the diagnosis is based on symptom assessment alone. To assess the diagnostic value of a therapeutic trial of omeprazole 40 mg in a dyspeptic population. A total of 90 patients with symptoms suggestive of GERD entered the study. Patients underwent endoscopy and ambulatory oesophageal pH monitoring for 18-24 h. Patients then received omeprazole 40 mg o.m. for 2 weeks. There was a significant correlation between the diagnoses obtained from a trial of omeprazole and the diagnoses obtained from pH monitoring (P < 0. 05). There was no significant correlation between the diagnoses obtained from endoscopy and those obtained from pH monitoring. Both omeprazole and endoscopy were compared to pH monitoring as the 'gold standard' for the diagnosis of GERD and the cost per correct diagnosis with omeprazole was pound47 (95% CI: pound40- pound59) compared to pound480 (95% CI: pound396- pound608) with endoscopy. There was a complete absence of acid-related symptoms in the majority (59%) of patients after 3 days of omeprazole 40 mg therapy and, after 2 weeks, 82% of patients had experienced an improvement in overall symptoms ( 1 grade). We conclude that omeprazole can be used as a clinically effective tool in the initial management of GERD and that it is of diagnostic value in patients who present with typical symptoms, such as heartburn, when the diagnosis is based on symptom assessment alone.",1999.0,0,0
1328,9916663,Correlation of ambulatory 24-hour esophageal pH monitoring results with symptom improvement in patients with noncardiac chest pain due to gastroesophageal reflux disease.,R Fass; M B Fennerty; C Johnson; L Camargo; R E Sampliner,"Gastroesophageal reflux disease (GERD) accounts for up to 60% of patients with noncardiac chest pain (NCCP). Twenty-four-hour esophageal pH monitoring has been considered the most sensitive test for identifying acid reflux as the probable cause for chest pain. It is unclear if there is a correlation between the degree of esophageal acid exposure as determined by 24-hour esophageal pH monitoring and symptom improvement during a short course of high-dose omeprazole (the omeprazole test) in patients with NCCP due to GERD. Twenty-three patients with GERD-related NCCP were studied. All patients were referred by a cardiologist and evaluated by upper endoscopy and 24-hour esophageal pH monitoring. Diagnosis of GERD was defined by one or both tests being abnormal. Subsequently, patients underwent baseline symptom intensity assessment during 1 week off therapy followed by 1 week on therapy with high-dose omeprazole (40 mg A.M. and 20 mg P.M.). There was a statistically significant correlation between the esophageal acid exposure by 24-hour esophageal pH monitoring and the change in symptom intensity score after treatment. However, there was no significant correlation between the pH values and symptom intensity score during baseline or during the omeprazole test. In patients with GERD-related NCCP undergoing the omeprazole test, 24-hour esophageal pH monitoring has a therapeutic predictive value in addition to its diagnostic merit. Patients with greater esophageal acid exposure appear to have a greater response to antireflux treatment.",1999.0,0,0
1329,9926265,The Second Canadian Gastroesophageal Reflux Disease Consensus: moving forward to new concepts.,A B Thomson; N Chiba; D Armstrong; G Tougas; R H Hunt,"Gastroesophageal reflux disease (GERD) is a disease with serious consequences that may result in significant impairment in quality of life and disease morbidity. Across all grades of severity of symptoms and severity of underlying esophageal disease, proton pump inhibitors (PPIs) provide therapeutic gains over prokinetics (PKs) or H2 receptor antagonists (H2RAs). The potential cost effectiveness of using medications with higher acquisition costs that may lower health care costs overall is often disregarded when conducting cost comparisons with medications having lower 'up-front' costs. Limiting therapy to less effective agents condemns many patients to protracted suffering, repeated physician visits and needless reinvestigation of symptoms that could have been resolved by appropriate initial therapy. Based on current data, use of any classification of symptom severity as a basis for selecting one class of therapeutic agents over another for first line therapy (i.e. PKs, H2RAs for 'mild' GERD, versus a PPI for 'severe' disease) is unwarranted.",1999.0,0,0
1330,9930385,Comparison of the effect of lansoprazole and omeprazole on intragastric acidity and gastroesophageal reflux in patients with gastroesophageal reflux disease.,I Janczewska; M Sagar; S Sjöstedt; B Hammarlund; M Iwarzon; R Seensalu,"Lansoprazole (LAN) and omeprazole (OME) heal esophagitis effectively and to similar extents, but LAN has a faster effect on the relief of symptoms of gastroesophageal reflux. However, no strict comparison of the two proton pump inhibitors' effect on acid reflux and gastric acidity has been published. The aim of this study was to compare the effects of LAN and OME on gastroesophageal reflux with simultaneous measurements of gastric acidity in patients with established gastroesophageal reflux disease (GERD) and esophagitis. Fourteen patients with endoscopically verified erosive esophagitis and with a pretreatment esophageal 24-h pH measurement showing acid reflux to the esophagus participated in the study. This was a double-blind, randomized study with crossover design. Before (day 0) and on the last day (day 5) of each treatment period with encapsulated 30 mg LAN or 20 mg OME daily, 24-h intraesophageal and intragastric acidity were measured with antimony electrodes connected to an ambulatory pH recording system. Ten of 14 patients completed the study. There were no differences in intragastric or intraesophageal acidity or the number of reflux episodes on day 0 between the two treatments. Both LAN and OME treatments increased the median and nocturnal intragastric pH and decreased the 24-h area under the time curve for intragastric acidity significantly and to about the same extent (79% and 69% acid inhibition by LAN and OME, respectively) (NS). However, the percentage of time with pH below 4 in the esophagus was significantly less during LAN treatment (1.92% +/- 2.29; mean +/- standard deviation) than during OME treatment (4.76% +/- 2.88%) on day 5 (P = 0.002). There were also significantly fewer reflux episodes >5 min during treatment with LAN (1.00 +/- 1.33) than with OME (2.90 +/- 2.42) at the end of the treatment period (P = 0.031). In this study lansoprazole and omeprazole had a comparable effect on gastric acidity in patients with established GERD with esophagitis. However, 30 mg lansoprazole daily reduced the acidity in the oesophagus and the number of refluxes more effectively than 20 mg omeprazole daily. This might indicate that proton pump inhibitors affect the esophageal clearance and/or influence the lower esophageal sphincter differently.",1999.0,0,1
1331,9930386,Treatment with proton pump inhibitors induces tolerance to histamine-2 receptor antagonists in Helicobacter pylori-negative patients.,G Qvigstad; J S Arnestad; E Brenna; H L Waldum,"Treatment with H2 receptor antagonists (H2RAs) and proton pump inhibitors (PPIs) induces hypergastrinemia and causes rebound hypersecretion of gastric acid after treatment, and during treatment with H2RAs tolerance develops. In the present study we investigated whether a treatment period with a PPI induced tolerance to an H2RA. Thirteen patients with esophagitis were given omeprazole for 90 days. Twenty-four-hour pH monitorings without and with ranitidine were performed before and after treatment with omeprazole. Blood samples and biopsy specimens from the oxyntic mucosa were analyzed for gastrin, histamine, and chromogranin A. An increase in mucosal histamine and a reduction in the effect of ranitidine on gastric pH was found 14 days after discontinuing omeprazole compared with before treatment in Helicobacter pylori-negative but not in H. pylori-positive patients. Treatment with omeprazole reduces the effect of ranitidine in H. pylori-negative patients. This is caused by an increase in histamine released by the enterochromaffin-like cell secondarily to hypergastrinemia, corresponding to the tolerance towards H2RAs seen in patients with Zollinger-Ellison syndrome.",1999.0,0,0
1332,9930389,"Classification of dyspepsia. Identification of independent symptom components in 7270 consecutive, unselected dyspepsia patients from general practice.",V Meineche-Schmidt; E Christensen,"Several attempts to classify dyspepsia into subgroups have been proposed as a basis for empirical treatment and research. However, subgrouping has proved difficult due to overlap of symptoms between subgroups, and the response to empirical therapy is difficult to predict. We aimed to study whether natural symptom combinations occur in patients seeing general practitioners because of dyspepsia and whether symptom presentation could predict the effect of proton pump inhibitor treatment. The symptom presentation of 7270 consecutive, unselected patients with dyspepsia in general practice was studied by using principal-components analysis. The relation to the effect of omeprazole was studied in a subsample (n=471) with predominantly reflux-like or ulcer-like dyspepsia being included in a controlled clinical trial of omeprazole versus placebo. Four principal components (factors), explaining 36% of the total variance, were found. They describe four independent dimensions in the symptoms of dyspepsia that can be interpreted meaningfully as representing A) acid-related disease of the upper gastrointestinal tract, B) irritable bowel disorder, C) dysmotility of the stomach/duodenum, and D) dysmotility of the esophagus. In the subsample the response to proton pump inhibition therapy was associated with high component-A scores, low component-B scores, and low component-C scores. A pocket chart was devised to obtain the component scores easily in new patients. The analysis identified four characteristic, biologically meaningful dyspepsia components that express independent dimensions in the symptoms of patients with dyspepsia. The symptom scores corresponding to the four components may improve symptom-based diagnosis and thereby empirical therapy. In particular, the association between component scores and the effect of omeprazole suggests that classifying dyspepsia on the basis of these components may focus empirical omeprazole therapy even more.",1999.0,0,0
1333,9934729,Cholecystectomy and the risk of colon cancer.,I Todoroki; G D Friedman; M L Slattery; J D Potter; W Samowitz,"The relationship between cholecystectomy and the occurrence of subsequent colon cancer has been controversial. Using data collected as part of an incident case-control study of colon cancer conducted in northern California, Minnesota, and Utah, we evaluated this association. Participants were between 30 and 79 yr of age and had a first primary colon cancer diagnosed between October 1, 1991 and September 30, 1994. Analyses were adjusted for age, gender, family history of colorectal cancer, body mass index, dietary energy and fiber intake, use of aspirin or nonsteroidal antiinflammatory drugs, and long-term leisure-time vigorous physical activity. A weak positive association between cholecystectomy and proximal colon cancer (odds ratio [OR] and 95% confidence interval [CI] 1.3 [1.0-1.6]) was observed. This was counterbalanced by a weak, nonsignificant negative association (OR 0.8, 95% CI 0.6-1.1) with distal colon cancer leading to no overall association (OR 1.0, 95% CI 0.9-1.2). The association between colon cancer and cholecystectomy did not differ by gender or race, but it did differ by study area, with most of the increased association being attributed to the Minnesota population. The elevated risk of proximal colon cancer increased after cholecystectomy but disappeared after 14 years. Our results suggest that cholecystectomy or the underlying gallstone disease that prompts it may be related weakly to the risk of subsequent proximal colon cancer. However, the association may differ by geographic area of the country, and may be artifactual at least in part.",1999.0,0,1