Cyproheptadine for the treatment of functional abdominal pain in childhood: a double-blinded randomized placebo-controlled trial

Abstract

Aim: The management of functional abdominal pain (FAP) in children and adolescents is challenging for health care professionals, and there are only limited or inconclusive studies of pharmacologic or behavioral therapy in childhood FAP. The objective of this randomized placebo-controlled clinical trial was to determine the potential efficacy and safety of cyproheptadine in the treatment of pediatric FAP.

Methods: Between January 2006 and March 2007, 29 clinically referred children and adolescents with FAP (aged 4.5 to 12 years) completed a 2-week, double-blinded randomized placebo-controlled trial of cyprohetadine. Primary outcome measure was the self-reported change of frequency and duration of abdominal pain by using a 6-point scale, and the parents' impression or assessment of the children's improvement.

Results: By week 1 and 2 of the intervention, the intensity and frequency of abdominal pain among the patients treated with cyproheptadine, were rated as complete resolved and very much improved or improved for 3 (20%), 10 (66.6%), respectively. However, in the placebo-receiver children, these scales had no change in 7 (50%), rated as improved or very much improved in 5 (35.7%), and become worse in 2 (14.3%). The patients' self-reported and the parents' impression in the cyproheptadine group were significantly better than it in the placebo group (P=0.003).

Conclusion: Among children with functional abdominal pain, cyproheptadine is enough effective to improve the intensity and frequency of abdominal pain in a short-term period.