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http://retroconference.org/2004/cd/PDFs/725.pdf
Double-blind, randomized, placebo-controlled phase III trial of oxymetholone for the treatment of HIV-wasting
Study Design: Double-blind, randomized, placebo-controlled trial of 89 HIV-positive women and men with wasting assigned to the anabolic steroid oxymetholone (50 mg BID or TID) or placebo for 16 weeks followed by open-label treatment.Results: Oxymetholone led to a significant weight gain of 3.0 ±0.5 and 3.5 ±0.7 kg in the TID and BID groups, respectively (p<0.05 for each treatment versus placebo), while individuals in the placebo group gained an average of 1.0 ±0.7 kg. Body cell mass increased in the oxymetholone BID group (3.8 ±0.4 kg; p<0.0001) and in the oxymetholone TID group (2.1 ±0.6 kg; p<0.005), corresponding to 12.4% and 7.4% of baseline BCM, respectively. The most important adverse event was liver-associated toxicity. Overall, 35% of patients in the TID, 27% of patients in the BID oxymetholone group and no patients the placebo group had a greater than 5 times baseline increase for ALT during the double-blind phase of the study.
Conclusions: Oxymetholone can be considered an effective anabolic steroidin eugonadal male and female patients with AIDS-associated wasting. The BID (100 mg/day) regimen appeared to be equally effective to the TID (150 mg/day) regimenin terms of weight gain, LBM and BCM and was associated with less, but still significant liver toxicity.
DISCUSSION
Oxymetholone equaled or surpassed the gains in weight and LBM observed with cytokine inhibitors, nutritional supplements and rGH, its side effect profile was different. The suppression of pituitary gonadotropins, that regulate the endogenous testosterone, occurs by a negative feed back loopand represents a well-known side effect of anabolic steroids. When other first-line therapies such as optimizing nutritional status and gonadal function or the use of exercise have failed, oxymetholone can be considered an effective anabolic steroidin male and female patients with AIDS wasting, promoting significant gains in LBM and BCM. Reference:
Double-blind, randomized, placebo-controlled phase III trial of oxymetholone for the treatment of HIV-wasting
Study Design: Double-blind, randomized, placebo-controlled trial of 89 HIV-positive women and men with wasting assigned to the anabolic steroid oxymetholone (50 mg BID or TID) or placebo for 16 weeks followed by open-label treatment.Results: Oxymetholone led to a significant weight gain of 3.0 ±0.5 and 3.5 ±0.7 kg in the TID and BID groups, respectively (p<0.05 for each treatment versus placebo), while individuals in the placebo group gained an average of 1.0 ±0.7 kg. Body cell mass increased in the oxymetholone BID group (3.8 ±0.4 kg; p<0.0001) and in the oxymetholone TID group (2.1 ±0.6 kg; p<0.005), corresponding to 12.4% and 7.4% of baseline BCM, respectively. The most important adverse event was liver-associated toxicity. Overall, 35% of patients in the TID, 27% of patients in the BID oxymetholone group and no patients the placebo group had a greater than 5 times baseline increase for ALT during the double-blind phase of the study.
Conclusions: Oxymetholone can be considered an effective anabolic steroidin eugonadal male and female patients with AIDS-associated wasting. The BID (100 mg/day) regimen appeared to be equally effective to the TID (150 mg/day) regimenin terms of weight gain, LBM and BCM and was associated with less, but still significant liver toxicity.
DISCUSSION
Oxymetholone equaled or surpassed the gains in weight and LBM observed with cytokine inhibitors, nutritional supplements and rGH, its side effect profile was different. The suppression of pituitary gonadotropins, that regulate the endogenous testosterone, occurs by a negative feed back loopand represents a well-known side effect of anabolic steroids. When other first-line therapies such as optimizing nutritional status and gonadal function or the use of exercise have failed, oxymetholone can be considered an effective anabolic steroidin male and female patients with AIDS wasting, promoting significant gains in LBM and BCM. Reference:
