The efficacy of cisapride vs. placebo and diet in patients with chronic constipation.

The effects of cisapride (10 mg three times daily) on the stool evacuation characteristics, laxative consumption (symptom diary) and motility pattern (rectoanal manometry) were assessed in patients with chronic idiopathic constipation who fulfilled Rome II criteria. After a 14-day basal period on a diet rich in fiber (phase I), patients were treated with placebo (n = 20) or cisapride (n = 19) (phase II). Anorectal manometry was performed at the end of each phase. The study was controlled, randomized and double blind. Side effects related to the use of cisapride were noted and found to be mild. Cisapride and placebo increased stool frequency from 4 (1-11) to 7 (14-12) (p < 0.001) and from 4 (2-10) to 6 (2-11) (p < 0.05) per week, respectively. Straining was decreased from 69.0% to 39.7% in the cisapride (p < 0.0001) group, and from 79% to 35% (p < 0.0001) in the placebo group. Both cisapride and placebo decreased the feeling of incomplete evacuation from 91.7% to 37.5% (p < 0.0001) and from 82.7% to 39.2% (p < 0.0001), respectively. Cisapride reduced the need of laxatives and showed a tendency to normalize stool consistency but did not influence any other symptom or bowel motility parameter.