Background: Complementary and alternative medicines often are advocated for infantile colic, yet there has been no synthesis of the evidence to inform current practice about their use.
Objective: To critically evaluate all randomized clinical trials of nutritional supplements and other complementary and alternative medicines as a treatment for infantile colic.
Methods: Five electronic databases were searched from their inception to February 2010 to identify all relevant randomized clinical trials of complementary and alternative medicines and supplements for infantile colic. Reference lists of retrieved articles were hand searched. Data were extracted by two independent reviewers, and methodological quality was assessed using the Jadad score and key aspects of the Cochrane risk of bias.
Results: Fifteen randomized clinical trials met the inclusion criteria and were included. Thirteen studies were placebo controlled. Eight were of good methodological quality. Eleven trials indicated a significant result in favor of complementary and alternative medicines. However, none of these randomized clinical trials were without flaws. Independent replications were missing for most modalities.
Conclusions: Some encouraging results exist for fennel extract, mixed herbal tea, and sugar solutions, although it has to be stressed that all trials have major limitations. Thus, the notion that any form of complementary and alternative medicine is effective for infantile colic currently is not supported from the evidence from the included randomized clinical trials. Additional replications are needed before firm conclusions can be drawn.