Abstract

A 6-month, open, randomized study was performed to evaluate different dosage regimens for maintenance therapy with omeprazole in patients refractory to treatment with standard histamine 2 (H 2)-blockers. One hundred two patients with gastric and/or duodenal ulcers, unhealed after 8 weeks of full-dose H 2-antagonist treatment but healed after a further 4 to 8 weeks of omeprazole 20–40 mg/d, were randomized into four treatment groups: omeprazole 20 mg once daily (group A), omeprazole 20 mg every other day (group B), omeprazole 20 mg twice weekly (group C), and ranitidine 150 mg at bedtime (control). Endoscopic and clinical examinations were performed at 3 and 6 months and at every symptomatic relapse. Eleven patients dropped out for reasons of noncompliance. Relapses were detected in 14.8% of 27 cases in group A, 19.4% of 31 cases in group B, 42.9% of 21 cases in group C, and 66.7% of 12 controls. The better outcomes in groups A and B, as compared with group C and the control group were statistically significant. These findings confirm the efficacy of omeprazole in maintenance therapy for refractory ulcers and suggest that drug administration should be daily or every other day, as twice-weekly dosages are less effective.

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