CLINICAL QUESTION: What interventions are effective in the treatment of infantile colic?
STUDY DESIGN: Systematic review
SETTING: Various (meta-analysis)
SYNOPSIS: Numerous interventions are recommended for the treatment of colic, although few have been rigorously evaluated for their effectiveness. The authors of this meta-analysis performed a careful search of multiple databases, including Medline, the Cochrane Clinical Trials Registry, bibliographies of relevant reviews, and the Medical Editors Trial Amnesty for randomized controlled trials (RCTs) published in the English language. Only trials using the official definition of colic—unexplained paroxysmal bouts of fussing and crying lasting longer than 3 hours a day, for more than 3 days a week, for more than 3 weeks of duration—were included. Trials were individually assessed for adequacy of allocation concealment and blinding of individuals assessing outcomes.
From an original yield of 53 articles, 9 were considered to have adequate case definitions, 12 to have adequate double-blinding, and only 5 to have both. All were considered to have adequate randomization.
Of the RCTs evaluating pharmaceutical interventions, 3 studied simethicone, 3 dicyclomine, and 1 scopolamine. None of the simethicone trials found any significant benefit over placebo. Dicyclomine performed significantly better than placebo in all 3 trials (number needed to treat [NNT]=3). However, severe adverse effects have been attributed to dicyclomine use (apnea, seizures, and coma), especially in infants aged <7 weeks. Thus, the manufacturer has contraindicated its use in infants aged <6 months. The only trial of scopolamine found no benefit compared with placebo, but a higher incidence of adverse effects.
Nine different trials evaluated various dietary interventions. In breastfeeding women, a maternal hypoallergenic diet free of milk, egg, wheat, and nut products reduced colic symptoms by 25% or more (NNT=6) compared with a usual diet. In bottle-fed infants, both soy (NNT=2) and hypoallergenic formula (NNT=6) were more effective than regular formula. Treatment with lactase enzymes and fiber-enriched formula was no more effective than placebo.
With regard to behavioral intervention, neither carrying the infant more often (ie, with a Snugli) nor the use of a car-ride simulator (SleepTight) reduced symptoms significantly. Interestingly, advising parents to “reduce stimulation” reduced symptoms (NNT=2).
Two naturopathic interventions were evaluated. One RCT comparing herbal tea (containing chamomile, vervain, licorice, fennel, and balmmint) with placebo tea given at the onset of colic episodes, with a maximum dose of 150 mL up to 3 times per day, found a significant reduction in the number of infants meeting the criteria for colic (NNT=3). One RCT evaluating sucrose found a significant benefit compared with placebo that lasted less than 30 minutes.