Effects of Oxandrolone on Outcome Measures in the Severely Burned: A Multicenter Prospective Randomized Double-Blind Trial

Severe burns induce pathophysiologic problems, among them catabolism of lean mass, leading to protracted hospitalization and prolonged recovery. Oxandrolone is an anabolic agent shown to decrease lean mass catabolism and improve wound healing in the severely burned patients. We enrolled 81 adult subjects with burns 20% to 60% TBSA in a multicenter trial testing the effects of oxandrolone on length of hospital stay. Subjects were randomized between oxandrolone 10 mg every 12 hours or placebo. The study was stopped halfway through projected enrollment because of a significant difference between groups found on planned interim analysis. We found that length of stay was shorter in the oxandrolone group (31.6 + or - 3.1 days) than placebo (43.3 + or - 5.3 days; P less than .05). This difference strength- ened when deaths were excluded and hospital stay was indexed to burn size (1.24 0.15 days/% TBSA burned vs 0.87 + or - 0.05 days/% TBSA burned, P less than .05). We conclude that treatment using oxandrolone should be considered for use in the severely burned while hepatic transaminases are monitored. Published in the Journal of Burn Care Research, v27 p131-139, April 2006. Presented at the meeting of the American Burn Association, held in Vancouver BC, Canada, 24-27 March 2004.