Efficacy and tolerability of three regimens for Helicobacter pylori eradication -: A multicentre, double-blind, randomised clinical trial

Objective: Helicobacter pylori plays a pivotal role in gastroduodenal disease. Ranitidine bismuth citrate (RBC)-based triple therapies for a period of 7 days have proven to be an effective treatment for H. pylori. The aim of this study was to compare the eradication efficacy and tolerability profile of a 7-day course of RBC plus clarithromycin and amoxicillin, RBC plus clarithromycin, and omeprazole plus clarithromycin and amoxicillin. Design: Prospective, randomised, double-blind, multicentre study. Methods: A total of 154 H. pylori-positive patients with dyspeptic symptoms were randomised to RBC 400mg twice daily (bid) plus clarithromycin 500mg bid and amoxicillin Ig bid (RBCCA group, n = 53); RBC 400mg bid plus clarithromycin 500mg bid (RBCC group, n = 52); or omeprazole 20mg bid plus clarithromycin 500mg bid and amoxicillin Ig bid (OCA group, n = 49) administered for 7 days. H. pylori infection was initially detected on an antral biopsy by the rapid urease test and confirmed by C-13-urea breath test. H. pylori status was assessed by C-13-urea breath test at least 28 days after the end of treatment. Results: There were no statistically significant differences in eradication rates per intention-to-treat (ITT) analysis (n = 149) and per protocol (PP) analysis (n = 135) among the three regimens. Eradication rates per ITT were 82.6% [95% confidence interval (CI), 69.2 to 92%] for RBCCA; 82% (95% CI, 68.7 to 91.9%) for RBCC; and 72.3% (95% CI, 57.7 to 85.6%) for OCA. The corresponding figures for the PP analysis were 85.1% (95% CI, 71.1 to 93.1%), 83% (95% CI, 68.7 to 91.9%), and 73.2% (95% CI, 56.8 to 85.2%), respectively. All regimens were well tolerated. Adverse events occurred in 59 (38%) of the 154 patients and included minor gastrointestinal symptoms and neurological complaints (anxiety, insomnia and headache). Conclusions: The results of this study suggest that the best approach to eradicate H. pylori may be the combination of ranitidine bismuth citrate with clarithromycin either with or without amoxicillin.