Muscle mass

A number of studies have examined the effects of androgen therapy as an adjunct to elective surgery using improved nitrogen balance as a surrogate for muscle mass for their endpoint. The best designed study randomised 60 patients after colorectal cancer surgery to receive either a single injection of stanozolol (50 mg) or no extra treatment. Participants were also randomised among three types of post-operative, peripheral-vein nutrition (standard dextrose-saline, amino acid supplementation or glucose-amino acid-fat mixture) and stratified by gender (Hansell et al. 1989). The primary end-point was cumulative nitrogen balance for the first four post-operative days and this was consistently and significantly influenced only by nutritional supplementation. Stanozolol augmented nitrogen balance only on the third post-operative day in the group receiving amino acid supplements. This was largely attributable to its effects in women and was no improvement over standard post-operative care on other post-operative days, with other nutritional supplements or had any influence on a wide range of other metabolic variables. Importantly neither convalescence nor complication rates were influenced by androgen or nutritional therapy.

Four other studies have largely confirmed these findings. The first randomised 44 men with tuberculosis requiring pulmonary resection to treatment with either high-dose norethandrolone (50 mg daily) or no extra treatment within strata of different intensity of postoperative hyperalimentation (Webb et al. 1960). This showed a modest, transient effect of androgen therapy on positive nitrogen balance restricted to the first three post-operative days which was absent during the second three post-operative days. The second study randomised 36 patients to one injection of stanozolol (50 mg) or placebo one day before surgery with similar outcomes (Blamey et al. 1984). A third study randomised 30 men after gastric surgery for duodenal ulcer (vagotomy/pyloroplasty) to a single post-operative injection of nandrolone decanoate (50 or 100 mg), parenteral nutrition, both, or to standard treatment (Tweedle et al. 1973). This study reported that the eight day post-operative nitrogen balance was best with the combination of nandrolone plus parenteral nutrition and that each alone was superior to standard treatment but no clinical outcome measures were reported. The fourth study randomised 20 patients recovering from multiple trauma to receive either nandrolone decanoate injections (50 mg on day 3 plus 25 mg on day 6) or no extra treatment. It found that nandrolone plus standard enteral or parenteral nutrition was superior to no extra treatment in nitrogen balance, urinary 3-methyl histidine excretion and amino acid retention for the first ten days of hospitalisation (Hausmann etal. 1990). The only clinical outcome measure, however, was six-month survival, which did not differ according to androgen therapy.

Other studies, however, have been unable to detect any clinical benefits. One well-designed study randomised 48 patients requiring hyperalimentation to supplemental treatment with either nandrolone decanoate (50 mg) or placebo injections biweekly aiming to determine whether nitrogen balance could be improved within the first 21 days post-operatively (Lewis etal. 1981). No benefit was observed in nitrogen balance, weight gain, creatinine output, and serum albumin or immune function. These negative findings were supported by another study that examined a higher nandrolone dose. This study randomised 24 patients requiring intravenous alimentation to nandrolone decanoate (100 mg before starting and repeated one week later) or no extra treatment and found increased fluid but not nitrogen balance and did not find any clinical benefits (Young et al. 1983). Another study has examined the use of oral oxandrolone in a study that randomised 60 patients (including five women) requiring enteral nutrition to oxandrolone 20 mg each day or placebo for no more than 28 days and reported no differences in nitrogen balance or clinically relevant outcomes such as infection rate or length of stay (Gervasio etal. 2000).

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