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Cisapride for the treatment of constipation in children: A double-blind study
S Nurko1, J A Garcia-Aranda, L B Worona
1Department of Gastroenterology and Nutrition Hospital Infantil De Mexico "Federico Gomez," Mexico City, Mexico.
Insights
Cisapride significantly improved constipation symptoms in children, including bowel movements and encopresis, compared to placebo. This study demonstrates cisapride
Area of Science:
- Pediatric Gastroenterology
- Clinical Pharmacology
Background:
- Constipation is a common pediatric gastrointestinal disorder.
- Effective treatment options for pediatric constipation are crucial.
Purpose of the Study:
- To evaluate the efficacy of cisapride in treating constipation in children.
- To compare cisapride's effectiveness against a placebo.
Main Methods:
- A 12-week, double-blind, placebo-controlled study.
- Children with chronic constipation were randomized to receive cisapride or placebo.
- Outcomes included bowel movement frequency, encopresis, laxative use, and transit time.
Main Results:
- Cisapride treatment resulted in a 76% success rate versus 37% for placebo (P <.03).
- Significant improvements were observed in spontaneous bowel movements, fecal soiling, encopresis, laxative use, and gastrointestinal transit time with cisapride.
- While placebo showed some improvement in soiling and laxative use, cisapride demonstrated superior overall efficacy.
Conclusions:
- Cisapride is an effective treatment for pediatric constipation.
- The study supports the use of cisapride for improving multiple constipation-related symptoms in children.
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.
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