A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED TRIAL OF CISAPRIDE IN SAUDI ARABS WITH FUNCTIONAL DYSPEPSIA

Background: Trials on functional dyspepsia (FD) have been performed mo stly in Western populations. We evaluated the effect of cisapride in S audi Arabs with FD. Methods: In a double-blind, randomized, placebo-co ntrolled trial patients were treated with cisapride three times daily or matching placebo and assessed at 2 and 4 weeks. Results: Cisapride (n = 44) was significantly superior to placebo (n = 45) in improving h eartburn, postprandial bloating, epigastric pain, early satiety, epiga stric burning, and nausea. The global response to treatment was excell ent or good in 86.7% and 26.7% of the cisapride and placebo groups, re spectively. Treatment was judged more effective than the previous ther apy in 86.4% and 33.3% of those receiving cisapride and placebo, respe ctively. There were no adverse drug effects. Conclusions: Cisapride is an effective and well-tolerated treatment for FD in Saudi Arabs. Phar macogenetic factors are unlikely to play any role in its effects.