Rebamipide, a gastro-protective and anti-inflammatory drug, promotes gastric ulcer healing following eradication therapy for Helicobacter pylori in a Japanese population: a randomized, double-blind, placebo-controlled trial.

Author(s): Terano A, Arakawa T, Sugiyama T, Suzuki H, Joh T, Yoshikawa T, Higuchi K, Haruma K, Murakami K, Kobayashi K, Rebamipide Clinical Study Group

Affiliation(s): Department of Gastroenterology, Dokkyo University School of Medicine, Tochigi, Japan.

Publication date & source: 2007-08, J Gastroenterol., 42(8):690-3. Epub 2007 Aug 24.

Publication type: Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't

BACKGROUND: One week of Helicobacter pylori eradication therapy is insufficient for healing of gastric ulcers. We examined the efficacy of rebamipide in gastric ulcer healing following 1 week of eradication therapy in a randomized, double-blind, placebo-controlled trial. METHODS: Patients with H. pylori-positive gastric ulcer were enrolled and received 1 week of eradication therapy, followed by 100 mg of rebamipide or placebo for 7 weeks. The primary end point was the gastric ulcer healing rate. RESULTS: Of the 309 patients entered in the trial, 301 completed H. pylori eradication therapy; 154 patients took rebamipide, and 147 took placebo. The healing rate in the rebamipide group was higher than that in the placebo group in the per-protocol analysis-80.0% (104/130) versus 66.1% (82/124) [95% confidence interval (CI), 3.1-24.7; P = 0.013)-and in a full analysis-70.1% (108/154) versus 60.5% (89/147) (95% CI, -1.1 to 20.3; P = 0.080). CONCLUSIONS: Compared with placebo, rebamipide significantly promoted gastric ulcer healing following 1 week of eradication therapy.