Five-day regimens containing ranitidine bismuth citrate plus high-dose clarithromycin and either amoxycillin or tinidazole for Helicobacter pylori infection

Background: Ranitidine bismuth citrate (RBC)-based triple therapies for a p eriod of 7 days have proved to be an effective treatment for Helicobacter p ylori. Aim: To investigate the eradication efficacy, safety profile and patient co mpliance of two RBC-based triple therapies given for 5 days. Methods: Eighty H. pylori-positive patients with dyspeptic symptoms, referr ed to us for gastroscopy, were consecutively enrolled in this prospective, randomized, open-label study. These patients were randomly assigned to rece ive a 5-day course of RBC 400 mg b.d. plus clarithromycin 500 mg b.d. and e ither tinidazole 500 mg b.d. (RBCCT group) or amoxycillin 1 g b.d. (RBCCA g roup). The H. pylori status was assessed by means of histology and rapid ur ease test at entry, and by C-13-urea breath test 8 weeks after the completi on of treatment. Results: All enrolled patients completed the study. Thirty-seven of 40 pati ents treated with RBCCT (both PP and ITT analysis: 93%; 95% CI: 80-98%) and 35 of 40 in the RBCCA group (both PP and ITT analysis: 88%; 95% CI: 73-96% ) returned H. pylori-negative. Slight or mild side-effects occurred in 4/40 patients (10%) in the RBCCT group and in 5/40 (12%) in the RBCCA group. Conclusion: This is the first study demonstrating the efficacy of RBC-based triple therapies given for only 5 days. RBC regimens containing high-dose clarithromycin and either amoxycillin or tinidazole prove to be well tolera ted, safe and preserve good eradication rates even when administered for a shorter than conventional duration.