Low-versus high-dose azithromycin triple therapy for Helicobacter pylori infection

Background: We report a clinical trial which evaluated the effectiveness of triple therapy containing low- and high-dose azithromycin to treat Helicob acter pylori infection. Methods: From March 1997 to March 1998, patients infected with H. pylori we re assigned to receive either: Treatment 1: ranitidine bismuth citrate (RBC ) (400 mg b.d,) and amoxycillin (1 g b.d.) for 10 days with azithromycin 50 0 mg o.m, for 3 days; or Treatment 2: RBC and amoxycillin for 10 days with azithromycin Ig o.m, for 3 days. H, pylori eradication was established by a urea breath test at least 4 weeks after therapy. Side-effects and complian ce were assessed using a diary. Results: Sixty-eight patients were enrolled, Fifty-seven per cent of patien ts were treated for active peptic ulcer disease or a history of peptic ulce r disease. Treatment 1 cured H, pylori in 44% and 44% by per protocol and i ntention-to-treat analysis, respectively. The corresponding eradication rat es for Treatment 2 were 79% and 75%, Two patients taking Treatment 2 droppe d out of the study because of side-effects. Conclusions: With RBC and amoxycillin for 10 days, azithromycin at a dose o f 1 g/day for 3 days was significantly better at curing H. pylori infection than azithromycin 500 mg/day for 3 days.