Colic is the bane of many sleep-deprived parents of newborns — but even though some crying, colicky babies may respond to alternative medicine remedies their use has little or no support from clinical trials, according to a recent systematic review. However, there may be some promising herbal remedies for colic.
According to Rachel Perry, MPhil, MA, of Peninsula Medical School in Exeter, England, and her co-authors, the published literature did reveal some “encouraging results” for the following:
While a majority of the 15 randomized clinical trials included in the review showed results favorable to complementary or alternative medicine (CAM), most of the studies had one or more major flaws — and few of the interventions had support from independent replication, Perry and colleagues wrote in the journal Pediatrics.
Here are the details in a report from MedPage Today:
“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 trials,” Perry and co-authors concluded. “Additional replications are needed before firm conclusions can be drawn.”
Infantile colic, characterized by excessive and inconsolable crying during the first four months of life, is among the common conditions affecting infants and often proves difficult to treat.
Given that parents have few medically-recommended options among conventional treatments, use of CAM colic remedies could be quite high, the authors wrote in the introduction to their review.
Stressed-out parents can turn to a variety of sources of information to soothe colic — but the authors emphasized that most of these sources are unregulated (e.g., Web sites) and make claims that have no empirical support.
To address the lack of evidence, Perry and colleagues performed a systematic literature review to assess the quantity and quality of evidence supporting CAM for infantile colic in five literature databases through February 2010.
Their analysis included only completed randomized clinical trials whose endpoints included improvement in subjective measures of colic, in parental quality of life, and in physiologic parameters, as well as a reduced need for medication or other treatment and assessment of adverse events.
Investigation of 1,764 potentially relevant titles produced 15 randomized clinical trials of CAM modalities, encompassing a total of 944 infants. The reviewed studies were published from 1991 to 2008, with sample sizes ranging from eight to 175, including infants ages 0 to 16 weeks. Eight of the 15 trials were judged to have good-quality methodology.
The 15 trials comprised a variety of interventions: manipulation, herbal, glucose and sucrose preparations, probiotics, massage, and reflexology. One study evaluated four interventions versus a control group.
The review included three studies of herbal supplements — herbal tea, fennel extract, and Colimil (an herbal compound containing fennel, lemon balm, and chamomile) — and all three showed a significant improvement in colic symptoms (P<0.05 to P<0.005).
Among five studies of supplements, three evaluated sucrose or glucose, and all three yielded positive results for the intervention versus control (P<0.01). Although not discounting the results, the authors cited methodologic and statistical flaws in the three studies.
Studies of the remaining interventions generally yielded positive results in favor of the interventions versus controls, Perry and co-authors noted.
But the authors found these results suspect because of substantive flaws — including questionable aspects that related to recruitment, proper use of statistical methods, inclusion of post-hoc results, and omission of key details related to the methodology.
In discussing the paucity of high-quality evidence they found, the authors acknowledged that lack of knowledge about the mechanisms of infantile colic constitute a major obstacle to effective treatment.
“Its pathophysiology is unclear,” Perry and colleagues wrote. “Food allergies, formula intolerance, immaturity of gastrointestinal tract, excessive gas formation, or intestinal cramping have all been suggested as possible etiologies.”
“Arguably, any rational treatment should be directed at the mechanisms of the disease itself,” they added.