Meta-analysis of randomized controlled trials on the benefits and risks of using cisapride for the treatment of gastroesophageal reflux in children.

Abstract

Gastroesophageal reflux is a common problem in infancy. Cisapride is a commonly used therapy for gastroesophageal reflux in children. In view of recent concern regarding adverse effects this study aims to evaluate the benefits and risks of cisapride for the treatment of gastroesophageal reflux in children. A meta-analysis of randomized controlled trials of cisapride using a random-effects model. Ten trials involving 415 children were identified. There was no evidence of a significant reduction in vomiting severity with cisapride as measured by a clinical score (five trials, standardized weighted mean difference -0.18; 95% confidence interval (CI) -0.51 to 0.15). Twenty-four-hour esophageal pH monitoring data showed the mean reflux index was significantly lower in the children treated with cisapride compared with controls (five trials, weighted mean difference -6.24; 95% CI -8.81 to -3.67). With cisapride treatment, there was no reduction in the mean number of reflux episodes lasting greater than 5 min (three trials, weighted mean difference -0.72; 95% CI -1.92 to 0.47) or in the number of children with esophagitis at final follow up compared with baseline (two trials, relative risk 0.80; 95% CI 0.40 to 1.61). There was no significant difference in reported side-effects or adverse events (six trials, relative risk 1.16; 95% CI 0.95 to 1.41). No clinically important benefits of cisapride in children with gastroesophageal reflux have been demonstrated. Nor was there any evidence of adverse or harmful events.