EFFECTS OF OXANDROLONE ON LEAN BODY MASS (LBM) IN SEVERE BURN PATIENTS: A RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED TRIAL

In severe burns, hyper-metabolic conditions due to elevation of pro-inflammatory cytokines and stress hormones usually occur. Unregulated hypermetabolism can lead to muscle protein catabolism, inducing weakness, infection, and delayed wound healing. Oxandrolone is known as an anabolic agent with minor side effects. This study aims to determine the effect of oxandrolone on lean body mass (LBM) in severe burn patients. A randomized, double blind and placebo controlled trial was conducted in the burn centre of the Dr. Soetomo Hospital. Severe burn patients who met the inclusion criteria were randomized into two groups, oxandrolone and placebo group. Oxandrolone was given with a dose 0.1 mg/kg twice a day for 14 consecutive days. Estimated lean body mass (eLBM) for each group was measured on admission (day 0) and day 14. Fourteen burn patients were enrolled in this study. Lean body mass reduced significantly from 48.69±7.71 to 46.70±7.96 in the placebo group (p-value 0.008) by independent t-test. There was no significant decrease of LBM in the oxandrolone group. Delta LBM (∆ eLBM) before and after treatment was 0.38±1.64 in the oxandrolone group, and-1.32±1.23 in the placebo group (p-value = 0.049). There were no adverse effects during the administration to the oxan-drolone group. In severe burn patients, oxandrolone could prevent reduction of LBM compared to placebo and is relatively safe. These findings suggest the efficacy of oxandrolone in preventing muscle catabolism as a part of hypermetabolism in burn patients.