Cisapride in the control of symptoms in infants with gastroesophageal reflux: A randomized, double-blind, placebo-controlled trial

Objective: To evaluate the efficacy of cisapride in the treatment of uncomp licated gastroesophageal reflux in children younger than 36 months of age. Study design: A total of 95 patients satisfied the entry criteria and were randomly assigned to double-blind treatment with either cisapride (n = 50), 0.2 mg/kg 4 times daily, or placebo (n = 45) for 2 weeks. At the end of th e 2- week treatment period, symptom diary and parental evaluation with repe at 24-hour pH study were performed. Results: Sixty-eight patients completed the trial (38 in the cisapride grou p and 30 in the placebo group). There were no significant differences in th e symptoms of crying, vomiting, or gagging; the overall symptom intensity s core; or parental global evaluations. There was a significant difference (P < .03) in the percent time pH <4, the number of reflux episodes lasting mo re than 5 minutes, and the duration of the longest episode. No significant difference was demonstrated for the number of episodes with pH <4 or the re flux score. Conclusions: Cisapride was no better than placebo for relief of symptoms in children with uncomplicated gastroesophageal reflux. A beneficial effect w as demonstrated in the cisapride group in relation to the measured paramete rs for esophageal acid exposure time.