A double-blind, randomized, placebo-controlled trial of cisapride in Saudi Arabs with functional dyspepsia.

BACKGROUND

Trials on functional dyspepsia (FD) have been performed mostly in Western populations. We evaluated the effect of cisapride in Saudi Arabs with FD.

METHODS

In a double-blind, randomized, placebo-controlled 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 heartburn, postprandial bloating, epigastric pain, early satiety, epigastric burning, and nausea. The global response to treatment was excellent or good in 86.7% and 26.7% of the cisapride and placebo groups, respectively. Treatment was judged more effective than the previous therapy in 86.4% and 33.3% of those receiving cisapride and placebo, respectively. There were no adverse drug effects.

CONCLUSIONS

Cisapride is an effective and well-tolerated treatment for FD in Saudi Arabs. Pharmacogenetic factors are unlikely to play any role in its effects.