Aidshiv wasting

A number of randomised placebo-controlled studies of androgen therapy in HIVpositive men with AIDS wasting have reported increased lean mass, but minimal effects on total body weight, possibly due to concomitantly reduced fat mass. In the most comprehensive study (Grinspoon etal. 1998; Grinspoon etal. 2000), 51 men selected for both weight loss and low serum testosterone concentration were randomised to receive testosterone enanthate 300 mg or oil-based placebo intramuscularly every three weeks for six months. Although total weight, fat mass (DEXA), total body water content (bioimpedance) and physical function were not changed by testosterone therapy, fat-free mass (DEXA), lean mass (total body potassium) and muscle mass (urinary creatinine excretion) were all increased (Grinspoon etal. 1998). The increased lean body mass was sustained during the open-label six month extension (Grinspoon etal. 1999). In contrast, the other four studies have examined body compositional changes less comprehensively (Batterham and Garsia 2001; Dobs etal. 1999) or not at all (Berger etal. 1996; Coodley and Coodley 1997). The first randomised 63 HIV seropositive men suffering from wasting and weakness to receive either 15 mg or 5 mg oxandrolone daily or placebo for 16 weeks (Berger et al. 1996). Both oxandrolone (but not control) groups demonstrated transient weight gain within the first month, peaking at the first week. Subsequently, while the high-dose group maintained mean weight gain and the other groups less so, the within-group variance increased, suggesting major within-group heterogeneity in time-course. There was also no clear dose-response relationship. A second placebo-controlled crossover study randomised 39 men with HIV-associated weight loss to receive injections of either testosterone cypionate 200 mg or placebo (of unstated type) every fortnight for three months before crossing over to the other treatment (Coodley and Coodley 1997). Although testosterone improved one of five aspects of quality of life (overall well-being), no change in the other components or in weight was detected. However, the null effect could have been due to the lack of washout between treatments. A third study selected men with HIV-associated weight loss with serum testosterone concentrations in the low normal range (Dobs etal. 1999). This multi-centre, placebo-controlled study randomised 133 men to receive trans-scrotal testosterone patch (delivering nominal 6 mg testosterone per day) or matching placebo daily for 12 weeks. Testosterone treatment did not alter weight or lean mass (bioimpedance); however, inconsistent improvements in quality of life were observed. These findings are supported by a study that randomised 15 men to receive nandrolone decanoate (100 mg/fortnight), megestrol acetate (400 mg/day) or dietary advice alone and reported that nandrolone did not increase weight or lean mass (bioimpedance) (Batterham and Garsia 2001).

Recent studies in men with AIDS wasting examining the additional effect of exercise have been confirmatory. These studies have examined the effect of intramuscular testosterone therapy with or without exercise in a 2-by-2 factorial design. In both studies, men were selected on the basis of HIV-associated weight loss and exposed to exercise consisting of a progressive resistance programme three times each week throughout the study. In the first study (Bhasin et al. 1998), 61 men were randomised to receive testosterone enanthate 100 mg/wk and/or resistance exercise for 16 weeks. Among the 49 evaluable men, testosterone or resistance exercise increased body weight, thigh muscle volume (MRI), muscle strength and lean body mass (deuterium oxide dilution and DEXA) compared with the control (placebo, no exercise) group, but the combination did not promote further gains. Quality of life was not altered. In the other study (Fairfield et al. 2001; Grinspoon etal. 2000), 50 men were randomised to receive testosterone enanthate 200 mg/wk and/or resistance exercise for 12 weeks. Among the 43 evaluable men, testosterone or resistance exercise increased body weight, lean mass (DEXA) and some components of strength, and reduced fat mass (DEXA) (Grinspoon etal. 2000). The effect of the combination over testosterone therapy or exercise alone was not reported. Another study of 24 men with HIV-associated weight loss treated all with progressive resistance exercise and testosterone enanthate 100 mg each week "to suppress endogenous testosterone production" and then randomised half to additionally receive oxandrolone 20 mg each day or placebo tablets for 8 weeks (Strawford etal. 1999). The addition of oxandrolone was reported to increase lean tissue accrual and strength however the lack of a no-treatment control and the concurrent use of two androgens limits interpretation.

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