Study design (if review, criteria of inclusion for studies)
12-week, randomized, double-blind, controlled trial
Participants
18 subjects with documented CF (sweat or genetics positive), minimum age of 5 years, and ideal body weight for height <100% were entered, and 16 completed the study.
Interventions
cyproheptadine hydrochloride (CH) vs. placebo
Outcome measures
Subjects were seen at baseline and every 4 weeks. Measures included baseline demographics, Shwachman score, anthropometrics (weight, height, body mass index, skin folds, and body composition by bioelectric impedance analysis), spirometry, caloric intake, days of oral (PO) and intravenous (IV) antibiotics, and a symptom and satisfaction survey.
Main results
Subjects in the CH group showed significant increases in weight (mean 3.45 kg vs. 1.1 kg in the placebo group), height, BMI percentiles, ideal body weight/height, weight for age z-scores, and fat and fat-free mass. There were no changes or differences in PO or IV antibiotic use or spirometric changes. No significant side effects except transient mild sedation occurred in the CH group. Patient acceptance was good.
Authors' conclusions
In conclusion, CH appears to be an effective appetite stimulant with minimal side effects in children and adults with CF.