Evaluation of Cyproheptadine Hydrochloride Effects on Weight Gain in Underweight Children with Anorexia; A Randomized Clinical Trial

Background: Cyproheptadine hydrochloride is an antihistaminic drug. Appetite stimulation is one of its secondary effects that can be of advantage in some diseases. In this study we investigated the effect of Cyproheptadine hydrochloride on weight gain in underweight children with anorexia at age group 2 to10 years old. Materials and Methods: In this randomized clinical trial, we selected 2-10 year-old underweight children with anorexia who referred to Ayatollah Mousavi Hospital in Zanjan (Iran), during 2015. One hundred and thirty-six children were allocated at random in two groups. The Cyproheptadine - treated children group were given the drug orally; 0.1 mg/kg/dose three times per day for 8 weeks, while patients in placebo group received placebo with the same dose. After two months, weight gain was compared with the previous values in both groups. Results: In this study, 86 patients (63.2%) were female. The average increase in weight in the cyproheptadine - treated group was significantly higher than in the placebo group (1.08 ± 0.67 kg and 0.22 ± 0.46 kg, respectively) (p=0.005). The average increase height in the Cyproheptadine -treated group was significantly higher than in the placebo group (1.60 ± 0.97 cm, and 0.86 ± 0.85 cm, respectively) (p=0.005). According to the parents of both groups, anorexia in the Cyproheptadine -treated group improved in 100%, and in the placebo group in 52.7%. This difference was statistically significant (p=0.005). No any side effects of Cyproheptadine hydrochloride were observed. Conclusion: According to the finding of our study, there were no serious side effects of Cyproheptadine hydrochloride. Therefore considering the acceptable safety of Cyproheptadine hydrochloride for inducing growth in underweight children, we propose its administration with the aforementioned dose.