The authors of “Colicky baby? Here’s a surprising remedy” (PURLs, J Fam Pract. 2011;60:34-36) suggest that probiotics are a remedy for infantile colic. The study was funded by producers of probiotics, but the rigorous study design is deemed to make bias unlikely, leading the authors to recommend a change in practice. We very much hope this will be a big step forward, but feel the need to air our concerns: namely, that probiotics (cost: about $40 per month) may substitute for parental love (cost: $0 per lifetime). It’s a huge marketing opportunity, as 10% to 25% of infants have infantile colic.1 We are not fully convinced of the benefits.
To start with, the term “infantile colic” suggests an abdominal cause, although this “cause” is not mentioned in published criteria.2 It has been suggested that infantile colic may simply lie at the upper end of a normal distribution.3
Related to the treatment, no adverse events were reported, nor any differences between the placebo and probiotics groups in frequency of stools or incidence of regurgitation or constipation.
Then why did the babies cry less? The answer seems obvious: because they have less pain. But why do babies have less pain from having an enhanced intestinal flora vs a natural one, while having no change in gastrointestinal functions? Has nature gone astray? Could there have been factors that made mothers feel the difference between the treatment and the placebo groups, such as side effects that were not reported and that may have enhanced the placebo effect? (Notably, one study found a substantial placebo effect on colic.4) Babies are extremely emotionally symbiotic with their mothers, and thereby very prone to “suggestivity” coming from the mother (or father).
We certainly do not mean to suggest that colic is related to poor parenting skills. We do, however, see a need for more investigations before turning the prescription of probiotics for infantile colic into a clinical guideline.
Jean-Luc Mommaerts, MD, MSc
Dirk Devroey, MD, PhD
Brussels, Belgium
References
1. Roberts DM, Ostapchuk M, O’Brien JG. Infantile colic. Am Fam Physician. 2004;70:735-740.
2. Hyman PE, Milla PJ, Benninga MA, et al. Childhood functional gastrointestinal disorders: neonate/toddler. Gastroenterology. 2006;130:1519-1526.
3. Savino F, Cordisco L, Tarasco V, et al. Lactobacillus reuteri DSM 17938 in infantile colic: a randomized, double-blind, placebo-controlled trial. Pediatrics. 2010;126:e526-e533.
4. Metcalf TJ, Irons TG, Sher LD, et al. Simethicone in the treatment of infant colic: a randomized, placebo-controlled multicenter trial. Pediatrics. 1994;94:29-34.
The authors respond:
Thank you for your letter and comments. We wholeheartedly agree that nothing can replace a parent’s love and patience in dealing with colic.
The study was randomized, which decreases the risks of bias that you describe. You correctly point out that placebo was also an effective treatment for colic, although not as effective as the intervention. Nevertheless, we think that this was a welldone study offering a new treatment for colic that many physicians may not have previously considered.
Thomas Koonce, MD, MPH
Anne Mounsey, MD
Chapel Hill, NC
Kate Rowland, MD
Chicago