Ranitidine bismuth citrate (RBC) based triple therapy for 7 days is more effective than RBC plus clarithromycin for 14 days in dyspeptic patients with Helicobacter pylori infection

Abstract

Ranitidine bismuth citrate (RBC) in co-prescription with clarithromycin for 2 weeks has been shown to be effective for the eradication of Helicobacter pylori. Moreover, several studies have reported good H. pylori eradication rates with RBC plus two antibiotics for 1 week. To compare the H. pylori eradication rates and safety of two different RBC co-prescription regimens. Patients undergoing endoscopy for upper gastrointestinal symptoms were randomized to open treatment with either RBC 400 mg b.d. plus clarithromycin 250 mg b.d. and tinidazole 500 mg b.d. for 1 week (RbcCT) or RBC 400 mg b.d. plus clarithromycin 500 mg b.d. (RbcC) for 2 weeks. H. pylori infection was detected by CLO-test on antral biopsy and confirmed by histology on antral and corpus biopsies and by ¹³C-urea breath test (UBT). A further UBT was performed at least 4 weeks after the end of treatment to assess the H. pylori eradication. H. pylori eradication was calculated for an intention-to-treat (ITT) population (all H. pylori-positive patients who received at least one treatment dose) and for an all-patients-treated (APT) population (patients of the ITT population assessed for H. pylori at least 4 weeks after the end of treatment). Two hundred and ninety-five patients (142 males, 153 females, mean age 48 years) were recruited to the study. Of these, 239 had H. pylori infection confirmed by all three tests required by the protocol. The two treatment groups were similar with respect to all the demographic data. H. pylori ITT eradication rates were 85% (104/123) for RbcCT and 67% (78/116) for RbcC. APT eradication rates were 92% (104/113) for RbcCT and 76% (78/103) for RbcC. A significant statistical difference was found between the two treatments, irrespective of the population analysis (P = 0.001). Adverse events occurred in 7% of patients on RbcCT and in 13% on RbcC. No serious adverse events were reported. The 1-week treatment with RBC plus clarithromycin and tinidazole yielded higher eradication rates than the 2-week treatment with RBC plus clarithomycin. Both treatments were well tolerated.