Clinical Question: What interventions are effective in the treatment of infant colic?

Setting: Various (meta-analysis)

Study Design: Systematic review

Synopsis: The authors 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) on the treatment of infant colic that were published in the English language. Only trials using the official definition of colic (i.e., unexplained paroxysmal bouts of fussing and crying lasting longer than three hours per day, for more than three days per week, for more than three weeks) were included. Trials were assessed individually for adequacy of allocation concealment and blinding of persons assessing outcomes.

From an original yield of 53 articles, nine were considered to have adequate case definitions, 12 to have adequate double-blinding, and only five to have both. All were considered to have adequate randomization. Of the RCTs that evaluated pharmaceutical interventions, three studied simethicone, three studied dicyclomine, and one studied scopolamine. None of the three simethicone trials found any significant benefit over placebo. Dicyclomine performed significantly better than placebo in all three trials (number needed to treat [NNT] = three). However, severe adverse effects have been attributed to use of dicyclomine (e.g., apnea, seizures, coma), especially in infants younger than seven weeks. Thus, the manufacturer has contraindicated its use in infants younger than six months. The one trial of scopolamine found no benefit compared with placebo but had 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 percent or more (NNT = six), compared with a usual diet. In bottle-fed infants, soy (NNT = two) and hypoallergenic formula (NNT = six) 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 (i.e., with a Snugli) nor the use of a car ride simulator (i.e., SleepTight) significantly reduced symptoms. Interestingly, advising parents to “reduce stimulation” reduced symptoms (NNT = two).

Two naturopathic interventions were evaluated. One RCT that compared herbal tea (containing chamomile, vervain, licorice, fennel, and balmmint) with placebo tea given to the infant at the onset of colic episodes, with a maximum dosage of 150 mL up to three times per day, showed a significant reduction in the number of infants meeting the criteria for colic (NNT = three). One RCT that evaluated the use of sucrose found a significant benefit that lasted less than 30 minutes, compared with placebo.

Bottom Line: Interventions with some evidence of effectiveness for infant colic include hypoallergenic diets and formula, soy formula, decreased infant stimulation, herbal tea, and dicyclomine. Reports of severe adverse effects of dicyclomine in infants younger than seven weeks caused a black box warning for use in infants younger than six months. The following interventions essentially are equal to or worse than placebo treatment: simethicone, scopolamine, lactase enzyme, fiber-enriched formula, increased carrying, car ride simulators, and sucrose. (Level of Evidence: 1a–)