Effects of rebamipide on aspirin-induced gastric damage

Objective To determine whether rebamipide can reduce or prevent gastric mucosal lesions induced by aspirin. Design Randomized double-blind cross-over study. Methods A single dose of 1.5 g oral aspirin (3 x 0.5 g tablets) was administered to 20 healthy male volunteers on three occasions at 2-week intervals. The 20 volunteers were randomized into two groups: one receiving placebo (P-R group; n = 12) and the other oral rebamipide 100 mg, three times daily for 7 days (R-P group; n = 8). Each group then crossed over to the alternative treatment for a second treatment period. There were no significant differences between the two groups at baseline for the total number of gastric mucosal lesions and for the number of lesions at each site in the stomach 1 and 3 h after aspirin challenge. Results Cross-over analysis of the total number of lesions 3 h after aspirin administration revealed a nearly significant (P= 0.058) difference in treatment effect. A significant difference in treatment effect in the antrum region was observed (P=0.015). Both differences were due to improvement during rebamipide treatment. Analysis of reported adverse effects showed no statistically significant difference between the two groups. Conclusion Rebamipide is effective in reducing gastric mucosal lesions in healthy volunteers following a single challenge with aspirin.