Cyproheptadine Use in Children With Functional Gastrointestinal Disorders

Objective: The objective of this study was to evaluate clinical improvement and safety with use of cyproheptadine in functional gastrointestinal disorders ( FGIDs) in children. Methods: Retrospectively evaluating the efficacy and safety of the use for indications including Rome III- defined FGIDs: functional abdominal pain, functional dyspepsia, irritable bowel syndrome ( IBS), abdominal migraine, cyclic vomiting syndrome. Response categories were as follows: no improvement group/ partial improvement group; requiring intervention, or complete improvement group ( CIG); warranting discontinuation; ongoing use; or parental unwillingness to stop medication. Results: Among 307 patients, 151 included; 58% girls, ages 1 to 18 years ( median 9); 110 ( 72.8%) reported complete symptom improvement; 41 ( 27.2%) reported no or partial improvement. Mean initial and final doses in the CIG were 4.85 mg/ day ( 0.14mg kg(-1) day(-1)) and 5.34 mg/ day ( 0.14mg kg(-1) day(-1)), respectively. A total of 102/151 ( 68%) reported no adverse effects. Adverse effects shown were as sleepiness in 19/ 151 ( 13%) and weight gain in 15/ 151 ( 10%). Cyproheptadine was effective in improving symptoms of functional abdominal pain, functional dyspepsia, in a relatively larger number of patients. Patients in smaller numbers had significant improvement 13/ 18 ( 72%) abdominal migraine, 10/ 10 ( 100%) IBS, and 6/ 8 ( 75%) cyclic vomiting syndrome. This is the first time report of improvement in IBS. Other pharmacodynamics had been as follows: the lower the body weight, the higher are the odds of no to partial improvement; patients in no improvement group/ partial improvement group experience more adverse effects as compared to the CIG; the single best predictor of clinical improvement was body mass index. A 1 unit increase in body mass index with cyproheptadine use increased the odds of clinical improvement by 1.5- fold ( P = 0.01). Conclusions: Cyproheptadine effectively improves symptoms of Rome IIIdefined FGIDs and has a good safety profile when used for these indications.