Aims : 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. Methods : 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. Results : 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. Conclusions : 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.

SUMMARYAim: 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. Methods: 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 13 C-urea breath tests at 4 and 12 weeks, and was evaluated using a 2 · 2 factorial design with proton pump inhibitor and antibiotic as factors.Results: 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. Conclusions: 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.

Background: Esomeprazole is the first proton pump inhibitor to be developed as an optical isomer for the treatment of acid‐related diseases. Methods: 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. Results: 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. Conclusions: 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.

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