New Study in Patients with AIDS Wasting Shows Superiority of Exercise over Oxandrolone Use in Improving Strength, with Lower Risk of Adverse Effects and at a Lower Cost

Although the widespread availability of HAART has improved the well being of many patients living with HIV infection, AIDS-related wasting still occurs in people with AIDS, even in developed countries. Which interventions will best improve the quality as well as the quantity of muscle and increase dietary intake and strength in this patient population remain open to debate.

The aim of the present study was to compare the anabolic steroid oxandrolone (OX) or strength training with nutrition alone (NA) for the treatment of AIDS wasting.

Fifty patients were randomized to receive one of the following (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.

The main outcome measures were mid-thigh cross-sectional muscle area (CSMA), physical functioning (PF), costs, and cost-effectiveness in dollars/quality-adjusted life-years ($/QALYs).

Results

The OX and PRT subjects had increases in CSMA, although these increases did not differ significantly from the NA arm;

Only PRT caused significant improvements in PF and 7 measures of strength;

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.

In conclusion, the authors note,

(1) Oxandrolone and progressive resistance training induce similar improvements in body composition, but resistance training improves quality of life more than nutrition or oxandrolone, particularly among patients with impaired physical functioning.

(2) Progressive resistance training was the most cost-effective intervention, and oxandrolone was the least cost-effective intervention.

Discussion

This is the first study to directly compare nutrition therapy alone with 2 investigational strategies for wasting and the first to test OX for these outcomes. The results demonstrate that 2 different interventions supported with nutrition, OX and PRT, had comparable effects on body composition in AIDS wasting. In contrast to OX, however, training had a stronger effect on protein and caloric intake as well as strength and a stronger effect on PF, after consideration of baseline functioning, than either of the other 2 interventions.

One explanation for the additional PF benefits of the exercise intervention may be that although both groups gained muscle, the quality of the muscle produced may differ between the treatments. This possibility is supported by the absence of strength increase accompanying the muscle mass increase seen with OX.

Dietary intervention alone successfully achieved increases in calorie and protein intake (more so than OX) and lean body mass, although the benefits did not translate into measurably increased muscle mass or quality of life. The finding that intensive nutrition therapy alone is effective in increasing dietary intake and lean mass is important, given the safety and low cost of this approach.

Although hypogonadal men with HIV infection should clearly be treated with testosterone, the recommended course of treatment of women and eugonadal men with wasting is still uncertain. Although additional testosterone seems to be of benefit, many patients and providers would prefer an oral androgen if it were safe and effective.

The lack of a significant difference between the changes in muscle with OX and nutrition and the stronger benefits of nutrition and exercise on PF do not support the overall benefit of the OX, however. Although the subjects in this study did not experience any side effects, given our results and the potential toxicity of OX, it is difficult to justify the wide use of this agent for HIV wasting.

This study shows the superiority of exercise over OX in improving PF when there is room for improvement and a dramatic effect on strength, lean body mass and dietary intake, with a low risk of adverse effects at a lower cost and greater cost-effectiveness. These results should encourage providers, patients, and third-party payers regarding its benefit as a medical therapy. It also confirms the ability of dietary counseling with supplementation to improve nutrition, increasing caloric and protein intake rather than just displacing other sources of energy, and to improve lean body mass.

03/25/05

Reference
A H Shevitz and others. A Comparison of the Clinical and Cost-Effectiveness of 3 Intervention Strategies for AIDS Wasting. Journal of Acquired Immune Deficiency Syndromes 38(4): 399-406. April 1, 2005.

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