The Australian Multicenter Trial of Growth Hormone (GH) Treatment in GH-Deficient Adults

GH treatment in adults with GH deficiency has numerous beneficial effects, but most studies have been small. We report the results of an Australian multicenter, randomized, double-blind, placebo-controlled trial of the effects of recombinant human GH treatment in adults with GH deficiency. GH deficiency was defined as a peak serum GH of <5 mU/liter in response to insulin-induced hypoglycemia. Patients were randomly assigned to receive either GH (0.125 U/kg per week for 1 month and 0.25 U/kg per week for 5 months) or placebo. After 6 months, all patients received GH. The primary end points were biochemical responses, body composition, quality of life, and safety. One hundred sixty-six patients (72 females and 91 males) with a mean age of 40± 1 yr (±sem; range 17–67 yr) were recruited. Serum insulin-like growth factor-I (IGF-I) increased from a standard deviation score of −2.64 ± 0.27 (range −8.8 to +3.82; n = 78) to +1.08 ± 2.87 (range −7.21 to +6.42) at 6 months in the GH/GH group; 38% of the whole group ...