Six months of omeprazole 20 mg daily, 20 mg every other day or 40 mg at weekends in duodenal ulcer patients: A multicenter, prospective, comparative study

We performed an open, prospective, randomized, three-cell, 6-month clinical trial on the prevention of duodenal ulcer (DU) relapse, comparing three ome-prazole schedules, i.e. 20 mg daily, 20 mg every other day (e.o.d.) and 40 mg on Saturdays and Sundays (S/S). Diagnosis of either healed or relapsed DU was on an endoscopic basis. Follow-up visits were performed at 3-monthly intervals with endoscopy at the baseline, after 6 months and at every symp tomatic relapse. Statistics: χ² test with standardized deviates, Yates’ corrected χ² test and analysis of variance (one-way). One hundred and fifteen patients were randomized to receive omeprazole 20 mg/day, 123 omeprazole 20 mg e.o.d. and 115 40 mg S/S. Twenty-eight dropped out (11, 8 and 9, respectively). Demonstrated ulcer relapse rates were 5.7% with omeprazole 20 mg/day, 18.1% with 20 mg e.o.d. and 17.6% with 40 mgS/S (p = 0.0124, ‘per-protocol’ analysis). No clinically significant adverse effects were recorded. In conclu sion, of the three schedules studied, omeprazole 20 mg/day proved the most effective maintenance treatment for healed DU. © 1995 S. Karger AG, Basel.