Ten-day triple therapy with ranitidine bismuth citrate, amoxicillin, and clarithromycin in eradicating Helicobacter pylori

OBJECTIVE: Fourteen-day therapy with ranitidine bismuth citrate, amoxicillin, and clarithromycin has been shown to have a high Helicobacter pylori eradication rate (> 90%) in U.S. trials. The aim of this study was to determine the H. pylori eradication rate of a ranitidine bismuth citrate-based triple regimen of shorter duration (10 days), which has been shown to be effective in Europe. METHODS: Dyspeptic patients who had a positive baseline C-13-urea breath test and either a positive antral rapid urease test or positive IgC serology were studied. Treatment consisted of ranitidine bismuth citrate 400 mg, clarithromycin 500 mg, and amoxicillin 1 g, all given b.i.d. for 10 days. Eradication was determined >4 wk after completion of therapy by the C-13-urea breath test (enrichment <2.4%). Results are expressed for intent-to-treat (all patients randomized even if they did not take the drug) and per-protocol (major protocol violators excluded) analyses. RESULTS: Seventy-seven patients with a mean age of 48 +/- 1.8 yr were studied. Forty-eight patients had eradication of H. pylori with this regimen (62%), 16 patients (21%) did not have eradication, and 13 patients (17%) did not return for breath testing. By intent-to-treat analysis the eradication rate was 62% (95% confidence intervals [CI], 51%, 73%) and by per-protocol analysis the eradication rate was 75% (95% CI, 63%, 85%). CONCLUSIONS: Ten-day, twice-daily therapy with ranitidine bismuth citrate, amoxicillin, and clarithromycin has an eradication rate that ranges from 62-75%. Fourteen-day therapy may be preferable because of higher eradication rates. (C) 1999 by Am. Cell. of Gastroenterology.