Study design (if review, criteria of inclusion for studies)
double-blind, placebo-controlled trial in two centers
Participants
Twenty-five patients with cystic fibrosis between 5 and 18 years
Interventions
Patients were randomized into two groups, to receive either cyproheptadine 4 mg three times per day for 12 weeks or placebo.
Outcome measures
Average weight gain, Body mass index (BMI), pulmonary function
Main results
Average weight gain was 0.67 kg in the placebo group and 1.61 kg in the cyproheptadine group (p = 0.036). Body mass index (BMI) decreased 0.07 kg/m(2); in the placebo group and increased 0.46 kg/m(2); in the intervention group (p = 0.027). The change in BMI for age (z score) was -0.19 in the placebo group and +0.20 in the cyproheptadine group (p = 0.003). BMI z score decreased 0.19 in the placebo group and increased 0.2 in the cyproheptadine group (p = 0.003). Changes in pulmonary function were not statistically different.
Authors' conclusions
Use of cyproheptadine in cystic fibrosis patients was well tolerated, showing a significant weight gain and a significant increase in BMI after 12 weeks. A clinically relevant effect size for weight/age (z score) and body mass index for age (z score) was found. Such findings suggest that the prescription of cyproheptadine can be an alternative approach for patients who need nutritional support for a short period of time.