Little to no evidence exists to support herbal and alternative medicine remedies for infantile coli (IC), a common often difficult to treat condition characterized by excessive and inconsolable crying during the first four months of life, according to researchers from the United Kingdom.

Rachel Perry, MPhil, MA, BA, of the department of complementary medicine at the Peninsula Medical School of the Universities of Exeter and Plymouth in the United Kingdom, and colleagues evaluated 15 randomized clinical trials to evaluate whether complementary and alternative medicines (CAM) recommended for infantile colic actually soothed babies. Results were published in Pediatrics.

“Given that IC can be particularly stressful for new parents and because there are few recommended conventional treatments, CAM use may be high in this population and therefore needs additional investigation to evaluate the effectiveness of these approaches and treatments,” the researchers wrote.

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Although they found “encouraging results “ for several therapies, including fennel extract; an herbal tea mixture that contained chamomile, vervain, licorice, fennel and balm mint; and sugar solutions, the researchers noted that most of the studies had one or more major flaws and few of the results had been independently replicated.

“The notion that any form of CAM is effective for IC is not supported from the evidence from the included randomized clinical trials,” the researchers wrote.

The 15 trials encompassed a total of 944 infants and were selected from a total of 1,764 titles based on endpoints that met inclusion criteria that subjectively measured improvements in colic, parental quality of life and physiologic parameters, and reductions in the need for other medication.

Samples sizes in the individualized studies, which were published between 1991 and 2008, ranged from 8 to 175 and included infants aged 0 to 16 weeks. The studies evaluated a variety of different intervention strategies including: manipulation, herbal, glucose and sucrose preparations, probiotics, massage, and reflexology.

Among the favorable findings, the researchers noted that one study — a review of three different herbal supplements, including herbal tea, fennel extract and Colimil — found that infants administered the herbal supplements experienced significant improvements in colic symptoms (P<0.05 to P<0.005) compared with a control group.

Furthermore, findings from three studies that evaluated sucrose and glucose formulations yielded positive results for the intervention vs. control groups (P<0.01).

However, the researchers noted that, “the majority of the included trials in this review eschewed safety issues by not mentioning adverse effects and not providing reasons for subjects dropping out.” Other concerns included problems with statistical methods and the inclusion of post-hoc results.

Effective treatments for IC are limited because little is known about what causes the disorder, according to the researchers  food allergies, formula intolerance, immaturity of the gastrointestinal tract, excessive gas formation and intestinal cramping have all been suggested.

“Arguably, any rational treatment should be directed at the mechanisms of the disease itself,” the researchers wrote.

Researchers who design future trials investigating CAM for IC should strive to comply with the Consolidated Standards of Reporting Trials guidelines, good trial design and more stringent reporting procedures, they suggested.