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Simethicone in the treatment of infant colic: a randomized, placebo-controlled, multicenter trial
T J Metcalf1, T G Irons, L D Sher
1Willow Creek Pediatrics, Salt Lake City, UT.
Insights
Simethicone offers no significant benefit over placebo for treating infant colic. This randomized controlled trial found similar perceived symptom improvements for both simethicone and placebo treatments in infants.
Area of Science:
- Pediatrics
- Gastroenterology
- Pharmacology
Background:
- Infant colic is a common condition affecting newborns.
- Current treatments for infant colic lack consistent efficacy.
- Simethicone is frequently used to alleviate gas-related discomfort in infants.
Purpose of the Study:
- To evaluate the effectiveness of simethicone in treating infant colic.
- To compare simethicone's efficacy against a placebo in a randomized, double-blind, crossover study.
Main Methods:
- A randomized, double-blind, placebo-controlled crossover trial was conducted.
- Eighty-three infants aged 2-8 weeks with colic received either simethicone or placebo.
- Symptom changes were assessed over 3-10 day treatment periods.
Main Results:
- No statistically significant difference in symptom improvement was observed between simethicone and placebo.
- Perceived improvements were reported in 54% of treatment periods, with similar rates for both interventions.
- Individual infant responses showed no significant difference between simethicone and placebo responders.
Conclusions:
- Simethicone is not more effective than placebo for treating infantile colic.
- Perceived symptom improvements were observed with both simethicone and placebo.
- Further research may be needed to identify effective colic treatments.
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.
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