Growth hormone versus placebo treatment for one year in growth hormone deficient adults: increase in exercise capacity and normalization of body composition

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Abstract
OBJECTIVE Studies with GH substitution in GH‐deficient (GHD) adults lasting more than 6 months have so far been uncontrolled. End‐points such as physical fitness and body composition may be subject to a considerable placebo effect which weakens the validity of open studies. We therefore tested GH (2 IU/m2 per day) versus placebo treatment for 12 months. DESIGN Twenty‐nine patients (mean age 45.5±2.0 years) with adult‐onset GHD were studied in a double‐blind, parallel design. Measurements of body composition by means of conventional anthropometry, bioelectrical impedance (BIA), CT scan and DEXA scan, exercise capacity, and isometric muscle strength were performed at baseline and after 12 months treatment. For body composition measurements a control group of 39 healthy, age and sex‐matched subjects was included. RESULTS Sum of skinfolds (SKF) at 4 sites decreased significantly after GH treatment. Total body fat (TBF) as assessed by DEXA and BIA was elevated at baseline but normalized after GH. TBF assessed by SKF revealed significantly higher levels compared to DEXA and BIA, although all estimates intercorrelated closely. Visceral and subcutaneous abdominal fat decreased by 25 and 17%, respectively after GH (Pvs 58 : 42 (12 months); GH: 66 : 34 (baseline) vs 72 : 28 (12 months) (P=0.002); normal subjects: 67 : 33 (Pvs 51.6±8.2 (12 months); GH: 64.9±13.3 (baseline) vs 73.5±13.6 (12 months) (Pvs 156±8 (normal subjects (P2 seems too high in many adult patients.

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