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

Background: Ranitidine bismuth citrate (RBC) in co-prescription with c larithromycin for 2 weeks has been shown to be effective for the eradi cation of Helicobacter pylori. Moreover, several studies have reported good a pylori eradication rates with RBC plus two antibiotics for 1 w eek. Aim: To compare the a pylori eradication rates and safety of two different RBC co-prescription regimens. Methods: Patients undergoing e ndoscopy for upper gastrointestinal symptoms were randomized to open t reatment with either RBC 400 mg b.d. plus clarithromycin 250 mg b.d. a nd tinidazole 500 mg b.d. for 1 week (RbcCT) or RBC 400 mg b.d. plus c larithromycin 500 mg b.d. (RbcC) for 2 weeks. a pylori infection was d etected by CLO-test on antral biopsy and confirmed by histology on ant ral and corpus biopsies and by C-13-urea breath test (UBT), A further UBT was performed at least 4 weeks after the end of treatment to asses s the H. pylori eradication. a. pylori eradication was calculated for an intention-to-treat (ITT) population (all a pylori-positive patients who received at least one treatment dose) and for an all-patients-tre ated (APT) population (patients of the ITT population assessed for a p ylori at least 4 weeks after the end of treatment). Results: Two hundr ed and ninety-five patients (142 males, 153 females, mean age 48 years ) were recruited to the study. Of these, 239 had a pylori infection co nfirmed by all three tests required by the protocol. The two treatment groups were similar with respect to all the demographic data. a pylor i, 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 betw een the two treatments, irrespective of the population analysis (P = 0 .001). Adverse events occurred in 7% of patients on RbcCT and in 13% o n RbcC. No serious adverse events were reported. Conclusions: The 1-we ek treatment with RBC plus clarithromycin and tinidazole yielded highe r eradication rates than the 2-week treatment with RBC plus clarithomy cin. Both treatments were well tolerated.