Tj. Metcalf et al., SIMETHICONE IN THE TREATMENT OF INFANT COLIC - A RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER TRIAL, Pediatrics, 94(1), 1994, pp. 29-34
Objective. To determine the efficacy of simethicone in the treatment o
f infant colic. Design. Randomized, double blind, placebo-controlled.
Setting. Three general pediatric practices in distinct geographic regi
ons. 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 peri
ods, ranging from 3 to 10 days, were evaluated in the 83 infants. Comp
ared 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 h
e 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) w
ere separated out as a group. Conclusion. Although both produced perce
ived improvements in symptoms, simethicone is no more effective than p
lacebo in the treatment of infantile colic.