A Double‐Blind Randomized Study of Cisapride in the Treatment of Nonulcer Dyspepsia

• Published in: Canadian journal of gastroenterology 1997, Vol.11 (2), p.127-134
• Main Authors: Champion, MC, MacCannell, KL, Thomson, ABR, Tanton, R, Eberhard, S, Sullivan, SN, Archambault, A, For The Canadian Cisapride Nud Study Group
• Format: Article
• Language: English
• ISSN: 2291-2789; 0835-7900; 2291-2797
• DOI: 10.1155/1997/314839

Cisapride is a substituted benzamide with gastrointestinal prokinetic effects presumed to be due to the enhancement of the physiological release of acetylcholine at the myenteric plexus. In a multicentre study, 189 patients with nonulcer dyspepsia (NUD) received single‐blind placebo treatment for two weeks. A total of 123 patients with no or minimal response to placebo and epigastric pain of at least moderate severity and frequency were randomly assigned to one of three parallel double‐blind treatments for six weeks: cisapride 10 mg tid, cisapride 20 mg tid or placebo. The severity and frequency of individual symptoms (epigastric pain, heartburn, nausea, vomiting, anorexia, postprandial discomfort, regurgitation, lower abdominal pain, bloating and constipation) were assessed on a four‐ and five‐point categorical scale, respectively, by the investigator at three on‐treatment visits and by patients in a daily diary. Analysis of investigator and patient assessments for differences in symptom severity x frequency composite scores among the three treatment groups showed no statistically significant differences for individual symptoms or symptom clusters. As assessed by the investigator, and compared with baseline, cisapride 20 mg tid significantly (P