JOURNAL ARTICLE
MULTICENTER STUDY
RANDOMIZED CONTROLLED TRIAL

Recombinant human growth hormone in patients with HIV-associated wasting. A randomized, placebo-controlled trial. Serostim Study Group

M Schambelan, K Mulligan, C Grunfeld, E S Daar, A LaMarca, D P Kotler, J Wang, S A Bozzette, J B Breitmeyer
Annals of Internal Medicine 1996 December 1, 125 (11): 873-82
8967667

BACKGROUND: Body wasting, particularly loss of body cell mass, is an increasingly prevalent acquired immunodeficiency syndrome (AIDS)-defining condition and is an independent risk factor for death in patients infected with the human immunodeficiency virus (HIV). Treatment with growth hormone for 7 days resulted in weight gain and nitrogen retention, but the long-term effects of this treatment in patients with HIV-associated wasting are not known.

OBJECTIVE: To evaluate the long-term effect of treatment with growth hormone on weight, body composition, functional performance, and quality of life in patients with HIV-associated wasting.

DESIGN: Randomized, double-blind, placebo-controlled, multicenter trial.

SETTING: Outpatient university and community-based patient care facilities.

PATIENTS: 178 HIV-infected patients with documented unintentional weight loss of at least 10% or weight less than 90% of the lower limit of ideal body weight.

INTERVENTION: Patients were randomly assigned to receive either recombinant human growth hormone, 0.1 mg/kg of body weight per day (average dosage, 6 mg/d) (n = 90) or placebo (n = 88) for 12 weeks.

MEASUREMENTS: Weight; body fat, lean body mass, and bone mineral content (measured by dual-energy x-ray absorptiometry); total body water (by deuterium oxide dilution); extracellular water (by sodium bromide dilution); work output (by treadmill exercise); quality of life; and safety of treatment.

RESULTS: Treatment with growth hormone resulted in a sustained and statistically significant increase in weight (mean increase +/- SD, 1.6 +/- 3.7 kg [P < 0.001]) and lean body mass (3.0 +/- 3.0 kg [P < 0.001]), accompanied by a decrease in body fat (-1.7 +/- 1.7 kg [P < 0.001]). In contrast, in patients receiving placebo, weight (increase, 0.1 +/- 3.1 kg), lean body mass (decrease, 0.1 +/- 2.0 kg), and body fat (decrease, 0.3 +/- 2.2 kg) did not change significantly from baseline. Differences between groups at week 12 were statistically significant (P = 0.011 for body weight and P < 0.001 for lean body mass and body fat). A greater increase in treadmill work output was noted in the group receiving growth hormone (increase, 99 +/- 293 kg. m/min) compared with the group receiving placebo (increase, 20 +/- 233 kg.m/min)(P = 0.039). Health status (quality of life) scores did not differ between groups at baseline or after treatment. Days of disability and use of medical resources were the same for both groups. Treatment was was well tolerated; no significant differences were seen between groups in clinical events, progression of AIDS, CD4+ or CD8+ cell counts, or viral burden.

CONCLUSION: Treatment with growth hormone increases body weight, lean body mass, and treadmill work output and appears to be a safe and potentially effective therapy in patients with HIV-associated wasting.

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