To compare oxandrolone (OX) or strength training with nutrition alone (NA) for AIDS wasting.
Fifty patients with AIDS; 47 completing the study.
Randomization to (1) NA with placebo pills, (2) nutrition with 10 mg of OX administered orally twice a day, or (3) nutrition with progressive resistance training (PRT) for 12 weeks.
Midthigh cross-sectional muscle area (CSMA), physical functioning (PF), costs, and cost-effectiveness in dollars/quality-adjusted life-years ($/QALYs).
The OX and PRT subjects had increases in CSMA (7.0% ± 2.5%, P = 0.01; 5.0% ± 2.0%, P = 0.04, respectively), although these increases did not differ significantly from the NA arm (NA: 1.0% ± 1.0%; OX vs. NA: P = 0.09; PRT vs. NA: P = 0.26). Only PRT caused significant improvements in PF (mean ± SE: 10.4 ± 3.8 points on a 100-point scale) and 7 measures of strength (P values: 0.04 to <0.001). There were no overall differences between groups in PF change. Among patients with impaired baseline PF, however, OX was significantly less effective than NA and PRT was significantly better than NA. All treatments led to increases in protein intake and performance; NA and PRT also increased caloric intake. The institutional costs per subject in this trial were $983 for NA, $3772 for OX, and $3189 for PRT. At a community-based level of intensity, the institutional costs per QALY were $45,000 (range: $42,000-$64,000) for NA, $147,000 (range: $147,000-$163,000) for OX, and $31,000 (range: $21,000-$44,000) for PRT.
OX and PRT induce similar improvements in body composition, but PRT improves quality of life more than nutrition or OX, particularly among patients with impaired PF. PRT was the most cost-effective intervention, and OX was the least cost-effective intervention.
From the *Nutrition Infection Unit, Department of Community Health, Tufts University, Boston, MA; †Department of Medicine, Tufts-New England Medical Center, Boston, MA; ‡Institute for Clinical Research and Health Policy Studies and Department of Medicine, Tufts-New England Medical Center, Boston, MA; §Lipid Metabolism Laboratory, Jean Mayer United States Department of Agriculture (USDA) Human Nutrition Center on Aging at Tufts University, Boston MA; ∥Departments of Epidemiology and Biostatistics, Harvard School of Public Health, Boston, MA; ¶Department of Medicine, Stamford Hospital, Stamford, CT; #Nutrition, Sarcopenia, and Exercise Physiology Laboratory, Jean Mayer USDA Human Nutrition Center on Aging at Tufts University, Boston MA; and **Schneider Institute for Health Policy, Heller School, Brandeis University, Waltham MA.
Received for publication June 15, 2004; Accepted November 23, 2004.
Supported by the NIDDK (R01-DK51011), the Tufts-New England Medical Center General Clinical Research Center (M01-RR00054), the Boston Obesity/Nutrition Research Center (P30-DK46200), and the Lifespan/Tufts/Brown Center for AIDS Research (P30-AI42853).
BTG Pharmaceuticals (Iselin, NJ) supplied OX and placebo pills, and Mead Johnson Nutritionals (Evansville, IN) provided canned oral supplements.
Reprints: Abby Shevitz, Jaharis 263, TUSM, 150 Harrison Ave, Boston, MA 02111 (e-mail: firstname.lastname@example.org).