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 ¹³C-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 ¹³C-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 χ² 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.