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

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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 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. (J Pediatr 2000;136:35-40)

Section snippets

METHODS

We undertook a double-blind, placebo-controlled study in which cisapride or placebo was given for 12 weeks to children with constipation. The study was performed at the Hospital Infantil de Mexico “Federico Gomez” from 1992 to 1994. Informed consent was obtained from all the parents, and the study was approved by the Committee of Clinical Investigation. The following definitions were used: (1) constipation, fewer than 3 bowel movements per week5, 15, 16; (2) chronic constipation, constipation

RESULTS

A total of 55 consecutive patients were considered for enrollment in the study. Eight had a normal frequency of BMs after the initial 2-week observation period. Of the remaining 47, 7 were found to have anismus during initial manometry and were therefore excluded. The remaining 40 patients were then enrolled in phase I. Of those, 4 were excluded after randomization. Two patients did not follow the study instructions and never took the study medication (excluded after the visit in week 4, both

DISCUSSION

This randomized study demonstrates that cisapride is effective in the treatment of children with constipation. The response rate was significantly different in the 2 groups: the odds ratio for response to cisapride was significantly higher, and patients treated with cisapride responded more rapidly than patients responding to placebo. Also, the cisapride group experienced a significant increase in the number of SBMs per day, as well as a significant decrease in the number of fecal soiling

Acknowledgements

We thank Dr Alan Leichtner for his critical review of the manuscript and helpful suggestions and Dr Ramón Alcántara for his support during the performance of the study.

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    Supported in part by a grant from Janssen Pharmaceutics, Mexico City.

    ☆☆

    Reprint requests: Samuel Nurko, MD, Pediatric Gastroenterology, Children’s Hospital, 300, Longwood Ave, Boston, MA 02115.

    0022-3476/2000/$12.00 + 0  9/21/101644

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