Simethicone in the treatment of infant colic: a randomized, placebo-controlled, multicenter trial.

ABSTRACT

OBJECTIVE: To determine the efficacy of simethicone in the treatment of infant colic. DESIGN: Randomized, double blind, placebo-controlled. SETTING: Three general pediatric practices in distinct geographic regions. PATIENTS Eighty-three infants between 2 and 8 weeks of age with infant colic. INTERVENTIONS: Treatment with simethicone and placebo in double blind crossover fashion. RESULTS: A total of 166 treatment periods, ranging from 3 to 10 days, were evaluated in the 83 infants. Compared to baseline, improvement in symptoms was reported for 54% of the treatment periods, worsening was reported for 22%, and, for 24%, there was no change. The likelihood of the treatment period being rated as showing improvement, worsening, or no change was the same whether the infant was receiving placebo or simethicone. Twenty-eight percent of he infants responded only to simethicone, 37% only to placebo, and 20% responded to both. No statistically significant differences were noted among these three groups of responders. No difference could be shown even when infants with "gas-related symptoms" (by parental report) were separated out as a group. CONCLUSION: Although both produced perceived improvements in symptoms, simethicone is no more effective than placebo in the treatment of infantile colic.