title: A randomized, double-blind, placebo-controlled trial of cyproheptadine for appetite stimulation in cystic fibrosis.
abstract: OBJECTIVE
  To determine whether the administration of cyproheptadine was able to induce weight gain in patients with cystic fibrosis.
  
  
  METHODS
  We performed a double-blind, placebo-controlled trial in two centers in Brazil. Twenty-five patients with cystic fibrosis between 5 and 18 years completed the study. Patients were randomized into two groups, to receive either cyproheptadine 4 mg three times per day for 12 weeks or placebo. All data were collected at the beginning and at the end of the study period and included weight, height and spirometry.
  
  
  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.
  
  
  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.
authors.affiliation: Hospital São Lucas, Pontifícia Universidade Católica do Rio Grande do Sul, Porto Alegre, RS, Brazil. mepifanio@hotmail.com
authors.forename: Matias
authors.initials: M
authors.lastname: Epifanio
authors.forename: Paulo C
authors.initials: PC
authors.lastname: Marostica
authors.forename: Rita
authors.initials: R
authors.lastname: Mattiello
authors.forename: Larissa
authors.initials: L
authors.lastname: Feix
authors.forename: Regina
authors.initials: R
authors.lastname: Nejedlo
authors.forename: Gilberto B
authors.initials: GB
authors.lastname: Fischer
authors.forename: Renato T
authors.initials: RT
authors.lastname: Stein
mesh_terms: D000293:Adolescent; D019167:Appetite Stimulants / Q000627:therapeutic use*; D015992:Body Mass Index; D002648:Child; D002675:Child, Preschool; D003533:Cyproheptadine / Q000627:therapeutic use*; D003550:Cystic Fibrosis / Q000150:complications*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D013147:Spirometry; D015430:Weight Gain / Q000187:drug effects*
chemical_list: D019167:Appetite Stimulants; D003533:Cyproheptadine