One-Week Triple Therapy With Ranitidine Bismuth Citrate, Clarithromycin and MetronidazoleVersusTwo-Week Dual Therapy With Ranitidine Bismuth Citrate and Clarithromycin forHelicobacter pyloriInfection: A Randomized, Clinical Trial


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Abstract

Objective:The aim of this study was to compare the efficacy and side effects of 1-wk triple therapy with ranitidine bismuth citrate (RBC) 400 mgb.i.d., clarithromycin 500 mgb.i.d., and metronidazole 500 mgb.i.d., to 2-wk dual therapy with RBC 400 mgb.i.d.and clarithromycin 500 mgb.i.d.forH. pyloriinfection in a randomized, clinical trial.Methods:Patients (18–80 yr) with a culture provenH. pyloriinfection were randomized to one of these regimens. Side effects were scored on a semiquantitative scale. Endoscopy was performed ≥4 wk after treatment. Antral biopsy samples were taken for hematoxylin-eosin stain (HE), rapid urease test, and culture and corpus samples for culture and HE. Two weeks after the endoscopy, a 13C-urea breath test was performed. Eradication failure was defined as detection ofH. pyloriby culture or by at least two other tests.Results:A total of 104 patients, 54 men, age 54 ± 14 yr, (36 duodenal ulcer, 16 gastric ulcer, and 52 functional dyspepsia) were included. Gender, age, and diagnosis were comparable in both groups. Fourteen of 52 patients in both triple and dual therapy, respectively, had significant side effects, but all patients completed the course. Eradication results were 49 of 52 (94%; 95% CI: 84–99%) and 50 of 52 (96%; 95% CI: 87–100%) on intention to treat analysis and 44 of 46 (96%; 95% CI: 85–99%) and 48 of 49 (98%; 95% CI: 89–100%) on per protocol analysis for triple and dual therapy respectively.Conclusion:Both regimens are very effective and well tolerated in the treatment ofH. pyloriinfection. The triple regimen has the advantage of being shorter.

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