Abstract: The review contains only one trial with a total of 212 participants, all with spinal cord injury and open pressure ulcers classed as stage III and IV. The participants were mainly male (98.2%, 106/108) with a mean age of 58.4 (standard deviation 10.4) years in the oxandrolone group and were all male (100%, 104/104) with a mean age of 57.3 (standard deviation 11.6) years in the placebo group. This trial compared oxandrolone (20 mg/day, administered orally) with a dose of placebo (an inactive substance consisting of 98% starch and 2% magnesium stearate) and reported data on complete healing of ulcers and adverse events. There was very low-certainty evidence on the relative effect of oxandrolone on complete ulcer healing at the end of a 24-week treatment period (risk ratio RR) 0.81, 95% confidence interval (CI) 0.52 to 1.26) (downgraded twice for imprecision due to an extremely wide 95% CI, which spanned both benefit and harm, and once for indirectness, as the participants were mostly male spinal cord injury patients). Thus, we are uncertain whether oxandrolone improves or reduces the complete healing of pressure ulcers, as we assessed the certainty of the evidence as very low. There was low-certainty evidence on the risk of non-serious adverse events reported in participants treated with oxandrolone compared with placebo (RR 3.85, 95% CI 1.12 to 13.26) (downgraded once for imprecision and once for indirectness, as the participants were mostly male spinal cord injury patients). Thus, the treatment with oxandrolone may increase the risk of non-serious adverse events reported in participants. There was very low-certainty evidence on the risk of serious adverse events reported in participants treated with oxandrolone compared with placebo (RR 0.54, 95% CI 0.25 to 1.17) (downgraded twice for imprecision due to an extremely wide 95% CI, which spanned both benefit and harm, and once for indirectness, as the participants were mostly male spinal cord injury patients). Of the five serious adverse events reported in the oxandrolone-treated group, none were classed by the trial teams as being related to treatment. We are uncertain whether oxandrolone increases or decreases the risk of serious adverse events as we assessed the certainty of the evidence as very low. Secondary outcomes such as pain, length of hospital stay, change in wound size or wound surface area, incidence of different type of infection, cost of treatment and quality of life were not reported in the included trial. Overall the evidence in this study was of very low quality (downgraded for imprecision and indirectness). This trial stopped early when the futility analysis (interim analysis) in the opinion of the study authors showed that oxandrolone had no benefit over placebo for improving ulcer healing. There is no high quality evidence to support the use of anabolic steroids in treating pressure ulcers. Further well-designed, multicenter trials, at low risk of bias, are necessary to assess the effect of anabolic steroids on treating pressure ulcers, but careful consideration of the current trial and its early termination are required when planning future research.

Plain-language summary: In March 2017, we searched for randomised controlled trials, which compared the use of anabolic steroids with other treatments for pressure ulcers. We found only one trial involving a total of 212 participants. This trial compared the effects of an anabolic steroid (oxandrolone capsules) with a placebo (dummy treatment containing no active medicine) on pressure ulcer healing in people with spinal cord injuries. The participants were mostly male (98.2%) with a mean age of 58.4 years in the oxandrolone group, which was comparable with the participants in the placebo group (male: 100%; mean age: 57.3 years). The trial was conducted over 24 weeks with a further follow-up for eight weeks. The trial was ended early as the trial authors deemed that the interim results suggested that there was unlikely to be a benefit from treatment with oxandrolone. Because of the limited data available from one trial, we remain uncertain whether anabolic steroids have beneficial effects on pressure ulcer healing, whether the treatment causes increased serious adverse events and if the treatment may increase the risk of non-serious adverse events. Overall, the evidence from this study was judged to be of very low quality. More, better-designed studies are necessary to provide evidence as to whether anabolic steroids are beneficial or not in treating pressure ulcers. This plain language summary is up to date as of March 2017.