Cisapride for the treatment of constipation in children: A double-blind study☆,☆☆,★
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.
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Reprint requests: Samuel Nurko, MD, Pediatric Gastroenterology, Children’s Hospital, 300, Longwood Ave, Boston, MA 02115.
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0022-3476/2000/$12.00 + 0 9/21/101644