Cisapride in Functional Dyspepsia: A Double-Blind, Placebo-Controlled Randomized Trial in General Practice Patients

Abstract

This trial included patients from general practice with endoscopy-negative chronic dyspepsia and epigastric pain or discomfort. Eleven eligible patients with sufficiently severe dyspeptic symptoms after a 2-week placebo run-in period were entered into a 4-week, parallel group, double-blind randomized comparison of 10 mg cisapride three times daily and matched placebo, and were subsequently evaluable. Symptoms were comparable in the two treatment groups at the start of double-blind treatment. The cisapride group had a significantly greater reduction in the frequency of daytime epigastric pain/discomfort and the frequency and severity of nocturnal pain/discomfort after 2 weeks. After 2 weeks, all six cisapride recipients were free of nocturnal pain, compared with only one of five placebo recipients. After 4 weeks of double-blind therapy, improvements in the placebo group had reduced between-treatment differences, with five of six cisapride recipients and three of five placebo recipients being free of nocturnal pain. Cisapride was well tolerated.