Comparison of ranitidine bismuth citrate plus clarithromycin with omeprazole plus clarithromycin for the eradication of Helicobacter pylori

Background: Many dual and triple therapy treatment regimens have been propo sed for the eradication of Helicobacter pylori. However, assessing the rela tive efficacy of these regimens is complicated by differences in study desi gn, and few well-controlled comparative studies have been reported. Methods: This multicentre, randomized, double-blind study involved 530 duod enal ulcer patients, of whom 520 had confirmed H. pylori infection. Patient s received 14 days b.d, dual therapy of either ranitidine bismuth citrate ( RBC) 400 mg or omeprazole 20 mg, both with clarithromycin 500 mg to eradica te H. pylori, followed by a further 14 days of treatment with RBC 400 mg b. d, or omeprazole 20 mg o.d, to facilitate ulcer healing. H, pylori eradicat ion and ulcer healing were assessed at least 26 days after the end of treat ment. Adverse events were recorded throughout the study. Results: H. pylori was eradicated in 90% of patients who received RBC with clarithromycin and in 66% of patients who received omeprazole with clarithr omycin (per protocol; P < 0.001), intention-to-treat eradication rates were 77% and 60%, respectively (P < 0.001). Ulcer healing rates were 97% in the RBC treatment group and 95% in the omeprazole treatment group. Only 3% and 1% of patients in the RBC and omeprazole treatment groups, respectively, w ere withdrawn due to adverse events. Conclusions: RBC with clarithromycin is a simple and highly effective dual therapy regimen for the eradication of H. pylori, and is significantly more effective than omeprazole with clarithromycin, Both treatment regimens are well tolerated and effectively heal duodenal ulcers.