I M Halabi1. 1. Department of Pediatrics, University of Jordan, Amman.
Abstract
BACKGROUND: This study was conducted to explore the use of cisapride in the treatment of chronic idiopathic constipation in children. METHODS:Seventy-nine children were screened. Seventy-three of them met the selection criteria that included clinical, laboratory, radiologic, and histopathologic investigations. These patients entered a week-long phase I of disimpaction using lactulose. Four of them were noncompliant and thus were excluded from the next phase. In phase II sixty-nine patients were assigned to two treatment groups: 0.3 mg/kg cisapride four times a day versus matching placebo for 8 weeks in a double-blind study. The two groups that completed phase II were similar in age and duration of symptoms, confirmed by statistical analysis. Stool frequency was assessed weekly, beginning at the end of the disimpaction phase and continuing for 9 weeks. Total gastrointestinal transit time was measured twice, on completion of phase I and 9 weeks later. Transit time is the time required for a carmine marker taken orally after overnight fast to appear in the stool. RESULTS: There was a significant difference between stool frequency per week before and after cisapride treatment, stool frequency per week at the end of phase II with cisapride versus placebo, and total gastrointestinal transit time before and after treatment with cisapride (p < 0.05 for all values). No such difference was demonstrated when comparing stool frequency per week or total gastrointestinal transit time before and after placebo (p > 0.05 for both). CONCLUSIONS:Cisapride may have a role in the management of chronic idiopathic constipation in children.
RCT Entities:
BACKGROUND: This study was conducted to explore the use of cisapride in the treatment of chronic idiopathic constipation in children. METHODS: Seventy-nine children were screened. Seventy-three of them met the selection criteria that included clinical, laboratory, radiologic, and histopathologic investigations. These patients entered a week-long phase I of disimpaction using lactulose. Four of them were noncompliant and thus were excluded from the next phase. In phase II sixty-nine patients were assigned to two treatment groups: 0.3 mg/kg cisapride four times a day versus matching placebo for 8 weeks in a double-blind study. The two groups that completed phase II were similar in age and duration of symptoms, confirmed by statistical analysis. Stool frequency was assessed weekly, beginning at the end of the disimpaction phase and continuing for 9 weeks. Total gastrointestinal transit time was measured twice, on completion of phase I and 9 weeks later. Transit time is the time required for a carmine marker taken orally after overnight fast to appear in the stool. RESULTS: There was a significant difference between stool frequency per week before and after cisapride treatment, stool frequency per week at the end of phase II with cisapride versus placebo, and total gastrointestinal transit time before and after treatment with cisapride (p < 0.05 for all values). No such difference was demonstrated when comparing stool frequency per week or total gastrointestinal transit time before and after placebo (p > 0.05 for both). CONCLUSIONS:Cisapride may have a role in the management of chronic idiopathic constipation in children.