Please use this identifier to cite or link to this item: http://hdl.handle.net/2440/7618
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Type: Journal article
Title: Cisapride in the control of symptoms in infants with gastroesophageal reflux: A randomized, double-blind, placebo-controlled trial
Author: Cohen, R.
O'Loughlin, E.
Davidson, G.
Moore, D.
Lawrence, D.
Citation: Journal of Pediatrics, 1999; 134(3):287-292
Publisher: MOSBY-ELSEVIER
Issue Date: 1999
ISSN: 0022-3476
1097-6833
Statement of
Responsibility: 
Cohen, Ralph C. ; O’Loughlin, Edward V. ; Davidson, Geoffrey P. ; Moore, D.J. ; Lawrence, Diana M.
Abstract: <h4>Objective</h4>To evaluate the efficacy of cisapride in the treatment of uncomplicated gastroesophageal reflux in children younger than 36 months of age.<h4>Study design</h4>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 the 2-week treatment period, symptom diary and parental evaluation with repeat 24-hour pH study were performed.<h4>Results</h4>Sixty-eight patients completed the trial (38 in the cisapride group and 30 in the placebo group). There were no significant differences in the symptoms of crying, vomiting, or gagging; the overall symptom intensity score; or parental global evaluations. There was a significant difference (P <.03) in the percent time pH <4, the number of reflux episodes lasting more 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 reflux score.<h4>Conclusions</h4>Cisapride was no better than placebo for relief of symptoms in children with uncomplicated gastroesophageal reflux. A beneficial effect was demonstrated in the cisapride group in relation to the measured parameters for esophageal acid exposure time.
Keywords: Esophagus; Humans; Gastroesophageal Reflux; Cisapride; Gastrointestinal Agents; Placebos; Treatment Failure; Administration, Oral; Chi-Square Distribution; Statistics, Nonparametric; Double-Blind Method; Hydrogen-Ion Concentration; Infant; Australia; Female; Male
RMID: 0030005475
DOI: 10.1016/S0022-3476(99)70451-8
Appears in Collections:Paediatrics publications

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