Once-daily therapy for H. pylori infection: a randomized comparison of four regimens.

Abstract

We sought to determine the efficacy and tolerability of novel, once-daily therapies in the treatment of Helicobacter pylori infection. One hundred sixty subjects with H. pylori infection documented by endoscopic biopsy or serology plus 13C-urea breath test were randomly assigned to omeprazole 80 mg q.d. and metronidazole extended-release formulation 750 mg q.d. for 10 days (OM); OM plus amoxicillin 1.5 g q.d. for 10 days (OMAm); OM plus azithromycin 500 mg q.d. for 7 days (OMAz); or OM plus clarithromycin 1 g q.d. for 10 days (OMCI). A repeat breath test was done 6 wk after the completion of therapy. Subjects were considered compliant if they took > or = 80% of each study medication as prescribed. Intent-to-treat eradication rates were OM = 8% (95% confidence interval [CI], 2-20%), OMAm = 35% (95% CI, 21-52%), OMAz = 65% (95% CI, 48-79%), and OMCI = 78% (95% CI, 62-89%). Lack of compliance was seen in 5% of subjects given OM, 8% given OMAm, 3% given OMAz, and 15% given OMCI. This pilot study demonstrated that once-daily triple therapy with high-dose omeprazole, metronidazole extended-release formulation, and clarithromycin achieved an eradication rate approaching 80%. Further study may permit development of optimal once-daily dosing and enhance eradication rates.