Healing effects of rebamipide and omeprazole in Helicobacter pylori-positive gastric ulcer patients after eradication therapy: a randomized double-blind, multinational, multi-institutional comparative study

Abstract

BACKGROUND AND AIMS: A recent placebo-controlled trial showed that rebamipide, which is a mucosal-protective antiulcer agent, promoted gastric ulcer healing without affecting the Helicobacter pylori status. We conducted a randomized, double-blind trial to compare the healing effects of rebamipide and the proton-pump inhibitor omeprazole in H. pylori-positive gastric ulcers after H. pylori eradication therapy.

METHODS: After completion of 1 week of eradication therapy, 132 patients with H. pylori-positive gastric ulcer were enrolled in 5 Chinese and 4 Korean institutions. Patients were randomly assigned to take either 20 mg of omeprazole (n = 63) or 300 mg of rebamipide (n = 65) daily for 7 weeks. Healing was defined as complete recovery and S1 and S2 stage ulcer according to the Sakita-Miwa classification.

RESULTS: Healing rates at 12 weeks were 81.5% (53/65) and 82.5% (52/63) in the rebamipide and omeprazole groups, respectively. There was no significant difference in treatment efficacy, as evidenced by gastric ulcer healing rates (absolute difference -1.0%; 95% confidence interval -10.7 to 8.7; p = 0.88). The H. pylori eradication rate and ulcer healing rate did not differ between the groups, the latter regardless of eradication outcome.

CONCLUSIONS: Rebamipide is as effective as omeprazole in treating of H. pylori-positive gastric ulcer after eradication therapy.