A preliminary study of growth hormone therapy for Crohn's disease.
BACKGROUND
Crohn's disease is a chronic inflammatory disorder of the bowel. In a preliminary study, we evaluated whether the administration of growth hormone (somatropin) as well as a high-protein diet would ameliorate the symptoms of the disease.


METHODS
We randomly assigned 37 adults with moderate-to-severe active Crohn's disease to four months of self-administered injections of growth hormone (loading dose, 5 mg per day subcutaneously for one week, followed by a maintenance dose of 1.5 mg per day) or placebo. We instructed all patients to increase their protein intake to at least 2 g per kilogram of body weight per day. Patients continued to be treated by their usual physicians and to receive other medications for Crohn's disease. The primary end point was the change in scores on the Crohn's Disease Activity Index from base line to month 4. Scores can range from 0 to 600, with higher scores indicating more disease activity.


RESULTS
At base line, the mean (+/-SD) score on the Crohn's Disease Activity Index was somewhat higher among the 19 patients in the growth hormone group than among the 18 patients in the placebo group (287+/-134 vs. 213+/-120, P=0.09). Three patients in the placebo group withdrew before their first follow-up visit and were not included in the data analysis. At four months, the Crohn's Disease Activity Index score had decreased by a mean of 143+/-144 points in the growth hormone group, as compared with a decrease of 19+/-63 points in the placebo group (P=0.004). Side effects in the growth hormone group included edema (in 10 patients) and headache (in 5) and usually resolved within the first month of treatment.


CONCLUSIONS
Our preliminary study suggests that growth hormone may be a beneficial treatment for patients with Crohn's disease.
Slonim
A E
AE
Department of Pediatrics, North Shore University Hospital and New York University School of Medicine, Manhasset 11030, USA. slonim@nshs.edu
Bulone
L
L
Damore
M B
MB
Goldberg
T
T
Wingertzahn
M A
MA
McKinley
M J
MJ
D000328:Adult; D003131:Combined Modality Therapy; D003424:Crohn Disease / Q000145:classification / Q000178:diet therapy / Q000188:drug therapy*; D004044:Dietary Proteins / Q000008:administration & dosage; D004311:Double-Blind Method; D005260:Female; D019382:Human Growth Hormone / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D007279:Injections, Subcutaneous; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects
D004044:Dietary Proteins; D019382:Human Growth Hormone