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.

Infant Colic—What works

“…The interventions included: probiotics/synbiotics (N = 7), maternal dietary interventions (N = 1), preparations containing fennel (N = 3), or other nonprescription remedies (N = 6). Of the 17 studies selected, 12 were randomised controlled trials (15–18,20,41–47) and the remaining 5 were randomised crossover trials (48–52). The randomised crossover trials examined the effects of over the counter remedies including sucrose, glucose, lactase, peppermint, and simethicone.…”

“…The Alves et al (49) and Savino et al (17) studies used simethicone as the control intervention, whereas the Metcalf et al (51) study aimed to determine the effect of simethicone on infant colic. The Metcalf et al (51) study found no significant difference when simethicone was compared with a placebo. Interestingly, the Alves et al study (49) showed no differences in the infant's response to the active treatment (peppermint) when compared with simethicone as the control, demonstrating that the treatment and placebo had similar effect.…”

“…Consideration of the role of the placebo effect is important, because 5 of the studies examined in our review demonstrated little or no more effect than the placebo they were compared with (19,48,49,51,55). The placebo effect has been widely investigated, and it has been recognised as neurobiological (56,57), meaning that the expectation of a treatment or placebo being effective creates a biological effect.…”

Inanspruchnahme medizinischer und paramedizinischer Versorgung bei Säuglingen mit exzessivem Schreien: Querschnittsanalyse und Eltern-Survey

“…Obwohl Wirkstoffe wie Simeticon im Vergleich zu Placebo keine signifikanten Unterschiede in der Wirkung zeigen, werden sie verordnet [24]. Die Studienlage zeigt am ehesten bei Einsatz von probiotischen Ergänzungsmitteln wie z.…”

Treatments for Infant Colic

“…No medication has definitively proved beneficial in treating infant colic. Two randomised placebo-controlled trials have shown that simethicone is not more effective than placebo (5,6). In spite of the lack of positive results, simethicone is still widely used by physicians.…”