Evidence Summaries

The level of evidence is downgraded by study quality (stopping early for benefit), imprecise results and indirectness (mainly male patients)

A Cochrane review ¹ included 1 study with a total of 212 subjects. All patients had 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 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 (RR 0.81, 95% CI 0.52 to 1.26).

The risk of non-serious adverse events reported in participants treated with oxandrolone compared with placebo was slightly elevated (RR 3.85, 95% CI 1.12 to 13.26). The risk ratio of serious adverse events reported in participants treated with oxandrolone compared with placebo was not elevated (RR 0.54, 95% CI 0.25 to 1.17). Of the five serious adverse events reported in the oxandrolone-treated group, none were classed by the trial teams as being related to treatment. 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.

References