Growth hormone improves clinical status in prepubertal children with cystic fibrosis: results of a randomized controlled trial.
OBJECTIVE
We conducted a 1-year randomized controlled trial to test the hypothesis that growth hormone (GH) improves the clinical status of children with cystic fibrosis.


METHODS
Nineteen prepubertal children were randomized to control (NonTX, n = 9) or to daily injections of GH (0.3 mg/kg/wk) (GHTX, n = 10) for 1 year. Every 3 months height, weight, and lean tissue mass were measured. Caloric intake, resting energy expenditure, pulmonary function, and respiratory muscle strength were measured every 6 months, as were total number of hospitalizations and courses of outpatient intravenous antibiotics.


RESULTS
The GHTX group had significantly greater height, height velocity (NonTX = 3.8 +/- 1.4 cm/y, GHTX = 8.1 +/- 2.4 cm/y; P =.002), weight, weight velocity (NonTX = 2.1 +/- 0.9 kg/y, GHTX = 4.5 +/- 1.1 kg/y; P =.004), and change in lean tissue mass (NonTX = 2.1 +/- 1.6 kg, GHTX = 4.7 +/- 1.7 kg; P =.01) analyzed by the Student t test. The GHTX group had significant improvement in delta forced vital capacity compared with the year before study, and respiratory muscle strength improved. The number of hospitalizations and outpatient intravenous antibiotic courses significantly decreased in the GHTX group but did not change in the NonTX group. No subject had development of cystic fibrosis-related diabetes.


CONCLUSIONS
Results of the first randomized controlled trial of GH treatment in cystic fibrosis indicate that GH improves growth and clinical status.
Hardin
D S
DS
Pediatric Endocrinology, University of Texas-Southwestern Medical School, Dallas TX 75390-9063, USA.
Ellis
K J
KJ
Dyson
M
M
Rice
J
J
McConnell
R
R
Seilheimer
D K
DK
D001823:Body Composition; D001827:Body Height; D001835:Body Weight; D002648:Child; D003550:Cystic Fibrosis / Q000188:drug therapy* / Q000503:physiopathology; D005260:Female; D019382:Human Growth Hormone / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D011446:Prospective Studies; D012129:Respiratory Function Tests
D019382:Human Growth Hormone