Cisapride for the treatment of constipation in children : A double-blind study

Abstract

Objective: To determine whether cisapride is effective in the treatment of children with constipation. Study design: Double-blind, placebo-controlled study in which children with chronic constipation were randomly assigned to treatment with cisapride or placebo for 12 weeks.Results: Forty children were enrolled, and 36 completed the therapy. Treatment successes occurred in 15 of 17 (76%) subjects in the cisapride group and 8 of 19 (37%) subjects in the placebo group (P < .03). The odds ratio for response after cisapride administration was 8.2 times higher (95% CI 1.S to 49.4). During cisapride therapy, there was a significant improvement in number of spontaneous bowel movements per week (from 0.9 ± 0.1 to 4.1 ± 1.1), and there was a significant decrease in number of fecal soiling episodes per day (1.8 ± 0.5 to 0.08 ± 0.4), percent with encopresis (82% vs 23%), number of laxative doses per week (from 10.5 ± 2.6 to 0.8 ± 0.6), percent using laxatives (77% to 24%), and total gastrointestinal transit time (from 115.0 ± g.7 hours to 77.0 ± 11.1 hours). With placebo, there were no significant changes in the number of spontaneous bowel movements (from 1.0 ± 0.8 to 2.2 ± 0.6), percent with encopresis (74% vs 47%), or total gastrointestinal transit time (from 112.5 ± 4.9 hours to 95.4 ± 9.8 hours); but there was a significant decrease in number of fecal soiling episodes per day (from 1.3 ± 0.4 to 0.4 ± 0.2) and number of laxative doses used per week (from 11.5 ± 2.9 to 2.05 ± 0.7). The final number of spontaneous bowel movements, fecal soiling episodes, laxatives used, or percent patients with encopresis was not different when patients receiving cisapride were compared with those receiving placebo.Conclusion: Cisapride was effective in the treatment of children with constipation.