Background: Cyproheptadine has been used therapeutically as an appetite stimulant in various chronic illnesses. However, no clinical data are available on the therapeutic effect of cyproheptadine in malnourished children without underlying pathological conditions. Objective: Investigate the short-term effect of cyproheptadine on weight gain in malnourished children who appear otherwise normal on physical examination. Methods: Seventy malnourished children who were otherwise normal on physical examination were recruited to participate in a randomized, double-blind, placebo-controlled trial. Thirty-seven children were randomized to a treatment regimen of cyproheptadine (0.1 mg/kg/dose, three times/day for eight weeks), and 33 children were randomized to receive placebo over a period of eight weeks. Subjects were evaluated at a baseline visit and at four visits at two-week intervals. Parameters assessed included baseline demographics, anthropometrics (weight, height, skin-fold thickness, waist and hip circumferences, and fat composition by bioelectric impedance analysis), adverse events, and pill counts. Data were analyzed by Student’s t-test and Chi-square test; a p- value < 0.05 was considered significant. Results: No significant differences were observed in baseline demographic characteristics and anthropometric parameters between the groups. The cyproheptadine-treated group showed a significantly greater weight gain over the baseline compared with the control group. The absolute weight gain was significantly higher in the cyproheptadine-treated group than in the control group at the end of study. No significant difference was observed in the change in the body fat percentage between the groups. No serious adverse events were reported. Adverse events included mild sedation, nausea, diarrhea, abdominal pain, and headache. No significant differences in the frequency of adverse events were observed between the groups. Conclusions: Cyproheptadine treatment was well tolerated and resulted in significant weight gain in malnourished children, without increasing the body fat percentage.
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