Comparison of the Effects of Low-Dose Versus Standard-Dose Cyproheptadine on BMI Increase in Children and Assessment of its Adverse Drug Reactions: A Randomized Clinical Trial

INTRODUCTION/OBJECTIVE: Childhood underweight and low body mass index are major public health concerns. There is no definitive evidence on the dosage adjustment of Cyproheptadine as an appetite stimulant. This study aimed to evaluate the effect of Cyproheptadine on Body Mass Index (BMI) in underweight children and assess its associated adverse effects. METHODS: This randomized double-blinded clinical trial study was conducted on thin children aged 2 to 10 years. The study was conducted on three groups of 92 children receiving low-dose Cyproheptadine, standard-dose Cyproheptadine, or placebo. Children were assessed monthly for 4 months for changes in anthropometric indices and treatment-related side effects. Data were analyzed using SPSS version 23 Results: Mean BMI showed significant between-group differences at three and four months (p = 0.001 and p < 0.001, respectively). Drowsiness occurred significantly more often in the standard- dose group than in the low-dose group at all visits (p < 0.001). No significant differences between groups in terms of irritability (p > 0.05). Mood swings were consistently more frequent in both Cyproheptadine groups than in the placebo group (p = 0.03). DISCUSSION: These results are consistent with prior evidence supporting Cyproheptadine's role in promoting weight gain and add important insight into dose-related safety. However, the short follow-up period limits conclusions about long-term outcomes. CONCLUSIONS: Low-dose cyproheptadine is an effective and safer therapeutic option for increasing BMI in children, offering efficacy comparable to the standard dose with fewer adverse effects. These results also highlight the necessity of long-term monitoring to ensure sustained efficacy and safety.