High Helicobacter pylori eradication rates have consistently been reported with 2-week dual therapy regimens of ranitidine bismuth citrate plus clarithromycin. Ranitidine bismuth citrate with two antibiotics may provide an alternative 1-week eradication regimen.Methods:
This double-blind, randomized, parallel group, international, multicentre study compared ranitidine bismuth citrate 400 mg b.d. and clarithromycin 500 mg b.d. for 2 weeks (RC) with ranitidine bismuth citrate 400 mg b.d., clarithromycin 500 mg b.d. and metronidazole 400 mg b.d. for 1 week (RCM) for eradication of H. pylori in 350 patients with dyspepsia.Results:
Treatment with RC and RCM eradicated H. pylori (established by the combination of two negative results from two discrete 13C-UBTs at nominal weeks 4 and 12) from 89% (95% CI: 84-94) and 92% (95% CI: 88-97) of the observed population, and from 78% (95% CI: 72-84) and 80% (95% CI: 75-86) of the intention-to-treat population. When established only by one negative 13C-UBT result at least 28 days after the end of treatment, the respective intention-to-treat rates were 85% (95% CI; 79-90) and 88% (95% CI: 83-93). Both regimens were well-tolerated, only 6% of patients given RC and 4% given RCM discontinued treatment. Median plasma bismuth concentrations at the end of the second week of study were low, at 3.5 and 0.4 ng/mL, respectively.Conclusions:
Ranitidine bismuth citrate triple therapy for 1 week (RCM) and dual therapy for 2 weeks (RC) were equally effective for the eradication of H. pylori infection.