Objective: The objective of this systematic review and meta-analysis was to evaluate the efficacy and safety of using oxandrolone in patients with severe burns. Materials and method: PubMed, Medline, Ovid, Cochrane Library, Elsevier Science, ProQuest, and Springer Link databases were searched. Randomized trials were included, and clinically important measures were selected. The outcomes were pooled with Revman 5.2. Other outcomes that could not be pooled were described in detail. Results: Finally, 15 randomized controlled trials (RCTs) were identified for analysis in this review, including 806 participants. 1. Mortality, infection, and hepatic function: Oxandrolone therapy did not affect mortality (relative risk (RR) = 0.85, 95% confidence interval (CI) = (0.38, 1.89), P = 0.69) or infection (RR = 0.87, (0.69, 1.11), P = 0.26). The two groups (oxandrolone group vs. control group) showed no significant difference in liver dysfunction (RR = 1.15, (0.83, 1.59), P = 0.41). All the 15 RCTs reported no incidence of hepatic insufficiency in controls or treatment groups. 2. In the catabolic phase: Treatment with oxandrolone shortened length of stay by 3.02 (2.37, 3.66) days, donor-site healing time by 4.41 (3.41, 5.41) days, the time between surgical procedures by 0.63 (0.11, 1.16) days, as well as reduced weight loss by 5 (3.70, 6.30) kg and nitrogen loss by 8.19 (6.87, 9.52) g/day, with all P < 0.00001. 3. In the rehabilitative phase: Treatment with oxandrolone shortened the length of stay to 6.45 (4.20, 8.69) days, as well as decreased weight loss by 0.86 (0.76, 0.96) kg/week and reduction of lean body mass by 5% (3.34, 6.66), with all P < 0.00001. 4. Long-term parameters: Oxandrolone treatment led to an additional gain in lean body mass of 3.99% (3.08, 4.89) after 6 months and 10.78% (9.92, 11.64) after 12 months in patients with severe burns, with all P < 0.00001. Conclusion: The treatment of severe burns with oxandrolone is significantly effective without obvious side effects. (C) 2015 Elsevier Ltd and ISBI. All rights reserved.