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Resistance Exercise and Supraphysiologic Androgen Therapy in Eugonadal Men With HIV-Related Weight Loss
A Randomized Controlled Trial
Alison Strawford, PhD;
Theresa Barbieri;
Marta Van Loan, PhD;
Elizabeth Parks, PhD;
Don Catlin, MD;
Norman Barton, MD, PhD;
Richard Neese, PhD;
Mark Christiansen, MD;
Janet King, RD, PhD;
Marc K. Hellerstein, MD, PhD
JAMA. 1999;281:1282-1290.
Context Repletion of lean body mass (LBM) that patients lose in human immunodeficiency virus (HIV) infection has proved difficult. In healthy, HIV-seronegative men, synergy between progressive resistance exercise (PRE) and very high-dose testosterone therapy has been reported for gains in LBM and muscle strength.
Objective To determine whether a moderately supraphysiologic androgen regimen, including an anabolic steroid, would improve LBM and strength gains of PRE in HIV-infected men with prior weight loss and whether protease inhibitor antiretroviral therapy prevents lean tissue anabolism.
Design Double-blind, randomized, placebo-controlled trial; post hoc analysis for effect of HIV-protease inhibitor therapy conducted from January to October 1997.
Setting Referral center in San Francisco, Calif.
Patients Volunteer sample of 24 eugonadal men with HIV-associated weight loss (mean, 9% body weight loss), recruited from an AIDS clinic and by referral and by advertisement.
Intervention For 8 weeks, all subjects received supervised PRE with physiologic intramuscular testosterone replacement (100 mg/wk) to suppress endogenous testosterone production. Randomization was between an anabolic steroid, oxandrolone, 20 mg/d, and placebo.
Main Outcome Measures Lean body mass, nitrogen balance (10-day metabolic ward measurements), body weight, muscle strength, and androgen status.
Results Twenty-two subjects completed the study (11 per group). Both groups showed significant nitrogen retention and increases in LBM, weight, and strength. The mean (SD) gains were significantly greater in the oxandrolone group than in the placebo group (5.6 [2.1] vs 3.8 [1.8] g of nitrogen per day [P=.05]; 6.9 [1.7] vs 3.8 [2.9] kg of LBM [P=.005];greater strength gains for various upper and lower body muscle groups by maximum weight lifted [P=.02-.05] and dynamometry [P=.01-.05]). The mean (SD) high-density lipoprotein cholesterol level declined 0.25 (0.14) mmol/L (9.8 [5.4] mg/dL) significantly in the oxandrolone group (P<.001 compared with placebo). Results were similar whether or not patients were taking protease inhibitors. One subject in the oxandrolone group discontinued the study because of elevated liver function test results.
Conclusions A moderately supraphysiologic androgen regimen that included an anabolic steroid, oxandrolone, substantially increased the lean tissue accrual and strength gains from PRE, compared with physiologic testosterone replacement alone, in eugonadal men with HIV-associated weight loss. Protease inhibitors did not prevent lean tissue anabolism.
Author Affiliations: Department of Nutritional Sciences, University of California, Berkeley (Drs Strawford, Parks, Neese, Christiansen, and Hellerstein); Division of Endocrinology and Metabolism, Department of Medicine, San Francisco General Hospital, University of California, San Francisco (Drs Hellerstein and Christiansen); Western Human Nutrition Research Center, United States Department of Agriculture, Presidio of San Francisco (Ms Barbieri and Drs Van Loan and King); Human Nutrition Unit, London School of Hygiene and Tropical Medicine, London, England (Dr Strawford); Biotechnology General Corporation, Iselin, NJ (Dr Barton); and Department of Molecular and Medical Pharmacology, University of California, Los Angeles (Dr Catlin).
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