IngentaConnect Randomized comparison of differing periods of twice-a-day triple ...

Authors: Laine, L.¹; Estrada, R.¹; Trujillo, M.¹; Fukanaga, K.¹; Neil, G.¹

Source: Alimentary Pharmacology & Therapeutics, Volume 10, Number 6, 1 October 1996 , pp. 1029-1033(5)

Abstract:

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 chi2 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.

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