Randomized comparison of differing periods of twice-a-day triple therapy for the eradication of Helicobacter pylori

Background: We assessed the efficacy, compliance, and tolerability of the twice-a-day triple therapy, amoxycillin, omeprazole, and clarithromycin, for Helicobacter pylori and studied the effect of treatment duration (7, 10 or 14 days) on these factors. Methods: One-hundred and fifty subjects with H. pylori infection documented by C-13-urea breath test were randomly assigned to a 7, 10 or 14-day course of amoxycillin 1 g b.d., omeprazole 20 mg b.d. and clarithromycin 500 mg b.d. Subjects returned at the end of therapy for pill count and assessment of side-effects. Subjects returned for a repeat C-13-urea breath test 4 weeks after the end of therapy. Results: Poor compliance (< 80% of medications taken) was seen in 0 subjects at 7 days, 6% at 10 days, and 10% at 14 days (P = 0.03 by chi(2) test for trend; difference for 7 vs. 14 days = 10%; 95% CI, -2 % to 18 %; P = 0.056). Intention-to-treat eradication rates were 86% at 7 days, 90% at 10 days and 92% at 14 days. Per-protocol eradication rates were 86% at 7 days, 91% at 10 days, and 95% at 14 days (P = 0.11; difference for 7 vs. 14 days = 9%;95% CI, -2% to 21%; P = 0.17). Conclusions: One week of twice-a-day amoxycillin, omeprazole and clarithromycin is well tolerated and provides a good rate of H. pylori eradication. Increasing the duration of therapy decreases compliance but has the potential to modestly improve efficacy if the patient takes the full complement of medication.