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

Scand J Gastroenterol. 1995 Jun;30(6):531-4. doi: 10.3109/00365529509089785.

Abstract

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.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Aged
  • Anti-Ulcer Agents / administration & dosage
  • Anti-Ulcer Agents / therapeutic use*
  • Cisapride
  • Double-Blind Method
  • Drug Administration Schedule
  • Dyspepsia / diagnosis
  • Dyspepsia / drug therapy*
  • Dyspepsia / physiopathology
  • Female
  • Humans
  • Male
  • Middle Aged
  • Piperidines / administration & dosage
  • Piperidines / therapeutic use*
  • Saudi Arabia
  • Treatment Outcome

Substances

  • Anti-Ulcer Agents
  • Piperidines
  • Cisapride