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

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 13 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 1.3 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 10.3 +/- 2.6 to 0.8 +/- 0.6), percent using laxatives (77% to 24%), and total gastrointestinal transit time (from 115.0 +/- 3.7 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.

Treatment of intractable constipation in children: experience with cisapride.

To establish whether cisapride is beneficial in children with intractable constipation, an open trial was performed. Chronically constipated children who had failed at least 12 weeks of medical therapy received cisapride at a dose of 0.2 mg/kg/dose TID for 12 weeks. Children with pelvic floor dyssynergia were excluded. Patients were followed prospectively for at least 12 months. Thirty children were initially enrolled, and 27 (14 boys, 13 girls) completed the study. At the end of 12 weeks of cisapride treatment, there was a significant increase in the number of bowel movements per week (1.43 +/- 0.52 to 6.48 +/- 4.16; p < 0.05) and significant decreases in the number of accidents per day (2.86 +/- 2.71 to 0.52 +/- 1.23; p < 0.05) and doses of laxatives used per week (14.33 +/- 5.84 to 3.37 +/- 7.10; p < 0.05). Encopresis disappeared in 65.2% of cases (p < 0.0001) and improved in 26%. Sixty-nine percent of the patients stopped using laxatives (p < 0.001). After 12 weeks 18 patients (66.6%) were asymptomatic, seven (25.9%) showed some improvement in bowel movement frequency and number of accidents, and two (7.4%) showed no improvement. The cisapride was well tolerated. After long-term follow-up (20 +/- 9.8 months), 37% of patients had recovered (asymptomatic and off laxatives and cisapride) and 29.6% were still asymptomatic but were using laxatives or cisapride. There were no differences in baseline characteristics between recovered and nonrecovered patients. We conclude that cisapride is effective in the treatment of some children with intractable constipation without pelvic floor dyssynergia.