A randomized trial comparing seven-day ranitidine bismuth citrate and clarithromycin dual therapy to seven-day omeprazole, clarithromycin and amoxicillin triple therapy for the eradication of Helicobacter pylori.

Abstract

OBJECTIVE:

To assess Helicobacter pylori eradication after one week dual ranitidine bismuth citrate-clarithromycin (RBC-C) or triple omeprazole, clarithromycin and amoxicillin (OCA) therapy.

METHODS:

In this multicentre Canadian trial, H pylori-positive patients with functional dyspepsia or inactive peptic ulcer disease were randomized to open-label treatment with RBC-C (ranitidine bismuth citrate 400 mg plus clarithromycin 500 mg) or OCA (omezaprole 20 mg, clarithromycin 500 mg and amoxicillin 1000 mg), given twice a day for seven days. Treatment allocation was randomly assigned. H pylori infection was confirmed by positive 13C-urea breath test (13C-UBT). H pylori status was reassessed by UBT at least four and 12 weeks after treatment (negative: d13CO2 below 3.5 per mil). Intention-to-treat (ITT) eradication rates were determined for all patients with confirmed H pylori infection. Per protocol (PP) rate was determined for all patients treated with at least two evaluable follow-up visits.

RESULTS:

Three hundred five patients were included in the ITT and 222 in the PP analysis. The ITT eradication rates were 66% for RBC-C and 78% for OCA. The PP success rates were 84% for RBC-C and 96% for OCA. The difference for both ITT 12% (95% CI 2 to 22) and PP 12% (95% CI 4 to 19) were statistically significant, P=0.030 and P=0.007, respectively. Treatment was generally well tolerated.

CONCLUSION:

The eradication rate for the seven-day dual RBC-C regimen was lower than that for OCA.

• Authors: Sander Veldhuyzen van Zanten, Naoki Chiba, Alan Barkun, Carlo Fallone, Alain Farley, Alan Cockeram, Chrystian Dallaire, Lorinda Simms, Barbara Nicholls
• Journal: Canadian journal of gastroenterology = Journal canadien de gastroenterologie (Can J Gastroenterol) Vol. 17 Issue 9 Pg. 533-8 (Sep 2003) ISSN: 0835-7900 [Print] Canada
• PMID: 14532926 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Anti-Bacterial Agents
• Anti-Ulcer Agents
• ranitidine bismuth citrate
• Amoxicillin
• Ranitidine
• Urea
• Clarithromycin
• Omeprazole
• Bismuth

Topics

• Amoxicillin (therapeutic use)
• Anti-Bacterial Agents (therapeutic use)
• Anti-Ulcer Agents (therapeutic use)
• Bismuth (therapeutic use)
• Breath Tests
• Clarithromycin (therapeutic use)
• Drug Administration Schedule
• Drug Therapy, Combination
• Female
• Helicobacter Infections (diagnosis, drug therapy)
• Helicobacter pylori
• Humans
• Male
• Middle Aged
• Omeprazole (therapeutic use)
• Patient Satisfaction
• Ranitidine (analogs & derivatives, therapeutic use)
• Time Factors
• Urea (analysis)