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 Helicobacter pylori infection. Methods: From March 1997 to March 1998, patients infected with H. pylori were 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 500 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 compliance were assessed using a diary. Results: Sixty-eight patients were enrolled, Fifty-seven per cent of patients were treated for active peptic ulcer disease or a history of peptic ulcer disease. Treatment 1 cured H, pylori in 44% and 44% by per protocol and intention-to-treat analysis, respectively. The corresponding eradication rates for Treatment 2 were 79% and 75%, Two patients taking Treatment 2 dropped out of the study because of side-effects. Conclusions: With RBC and amoxycillin for 10 days, azithromycin at a dose of 1 g/day for 3 days was significantly better at curing H. pylori infection than azithromycin 500 mg/day for 3 days.