A recent randomized controlled trial confirmed the value of this approach by showing significant improvement in distress scores of infants whose mothers followed a low-allergen diet (excluding dairy, soy, wheat, eggs, peanuts, tree nuts, and fish) for 7 days.5 This well-designed study included 107 patients (a relatively large sample in the published research about colic), and showed an absolute risk reduction of 37% (NNT=3) for those mothers following the challenge.
A small RCT (43 patients) suggested efficacy in the substitution of a whey hydrolysate formula in place of cow’s milkbased formula for infants with colic (casein hydrolysate formula has been more widely studied), but there continues to be controversy regarding the preferred protein hydrolysate formula (whey vs casein) in the treatment of colic.3
Several medications have been tested in RCTs; only dicyclomine has shown an effect in a few small RCTs.3,4 However, there have been reports of apnea and other serious, although infrequent, adverse effects. For that reason, the manufacturer has contraindicated the use of this medication in infants aged <6 months.
A small (n=68) study of an herbal tea showed reduced symptoms (RR=0.57 favoring the active tea), although the mean volume of tea consumption (32 mL/kg/d) is a nutritional concern in this age group.6 No adverse events were noted, but the small sample size limits the ability to detect any but the most common events.
Recommendations from others
The American Gastroenterological Association recommends a hypoallergenic, protein hydrolysate formula for formula fed infants or a maternal low-allergen diet as an initial strategy for infant struggling with colic symptoms if the clinician is considering a diagnosis of (cow’s milk) allergy.7
The American Academy of Family Physicians on their familydoctor.org web site makes no specific formula or diet adjustment recommendations.8 The web site does list some techniques (eg, massage or warm compress of abdomen, swing or car rides) not supported by the available evidence. The National Library of Medicine and the National Institutes of Health web site Medline Plus presents similar information.9 The American Academy of Pediatrics does not address the topic on its public web site.