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.


METHODS
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.


CONCLUSIONS
Cisapride was effective in the treatment of children with constipation.
Nurko
S
S
Department of Gastroenterology and Nutrition Hospital Infantil De Mexico "Federico Gomez," Mexico City, Mexico.
Garcia-Aranda
J A
JA
Worona
L B
LB
Zlochisty
O
O
D000293:Adolescent; D000704:Analysis of Variance; D002400:Cathartics / Q000627:therapeutic use; D016009:Chi-Square Distribution; D002648:Child; D002675:Child, Preschool; D002908:Chronic Disease; D020117:Cisapride / Q000627:therapeutic use*; D003248:Constipation / Q000188:drug therapy*; D003672:Defecation / Q000187:drug effects; D004311:Double-Blind Method; D004688:Encopresis / Q000517:prevention & control; D005242:Fecal Incontinence / Q000517:prevention & control; D005260:Female; D005765:Gastrointestinal Agents / Q000627:therapeutic use*; D005769:Gastrointestinal Motility / Q000187:drug effects; D005772:Gastrointestinal Transit / Q000187:drug effects; D006801:Humans; D016015:Logistic Models; D008297:Male; D016017:Odds Ratio; D010919:Placebos; D016016:Proportional Hazards Models; D016896:Treatment Outcome
D002400:Cathartics; D005765:Gastrointestinal Agents; D010919:Placebos; D020117:Cisapride