Pressure ulcers, also known as bed sores, pressure sores or decubitus ulcers develop as a result of a localised injury to the skin or underlying tissue, or both. The ulcers usually arise over a bony prominence, and are recognised as a common medical problem affecting people confined to a bed or wheelchair for long periods of time. Anabolic steroids are used as off-label drugs (drugs which are used without regulatory approval) and have been used as adjuvants to usual treatment with dressings, debridement, nutritional supplements, systemic antibiotics and antiseptics, which are considered to be supportive in healing of pressure ulcers. Anabolic steroids are considered because of their ability to stimulate protein synthesis and build muscle mass. Comprehensive evidence is required to facilitate decision making, regarding the benefits and harms of using anabolic steroids.

To assess the effects of anabolic steroids for treating pressure ulcers.

In March 2017 we searched the Cochrane Wounds Specialised Register; the Cochrane Central Register of Controlled Trials (CENTRAL); Ovid MEDLINE (including In-Process & Other Non-Indexed Citations); Ovid Embase and EBSCO CINAHL Plus. We also searched clinical trials registries for ongoing and unpublished studies, and scanned reference lists of relevant included studies as well as reviews, meta-analyses and health technology reports to identify additional studies. There were no restrictions with respect to language, date of publication or study setting.

Published or unpublished randomised controlled trials (RCTs) comparing the effects of anabolic steroids with alternative treatments or different types of anabolic steroids in the treatment of pressure ulcers.

Two review authors independently carried out study selection, data extraction and risk of bias assessment.

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.

Review Question

We reviewed the evidence about the effect of anabolic steroids (medicines designed to increase muscle mass) for treating people with pressure ulcers.

Background

Pressure ulcers are also known as bed sores, pressure sores or decubitus ulcers. Pressure ulcers are a common medical problem amongst people confined to a bed or wheelchair for long periods of time. Lack of movement and sustained pressure on the skin over bony parts of the body such as the hips, heels, lower back and elbows can cause the skin to break down and an ulcer to form. People at risk of pressure ulcers include those with spinal cord injuries, elderly people and people with long-term illnesses. Pressure ulcers affect quality of life and can have serious complications such as infection, if they do not heal. As well as being painful and troublesome to patients, pressure ulcers represent a significant cost to healthcare systems due to the nursing time involved in treatment. There are a variety of treatments that are usually used for pressure ulcers including wound dressings and specially-designed beds and cushions to reduce pressure on certain areas of the body.

Anabolic steroids are a type of medicine used to increase muscle mass. They can be used as an alternative to, or alongside, conventional treatments for pressure ulcers. They are thought to promote the growth of skeletal muscle and to restore muscle mass, which could help pressure ulcers to heal. However, it has been found that oxandrolone (a commonly-used anabolic steroid) can cause potential liver damage. Anabolic steroids may also increase the risk of heart attack or stroke. We wanted to find out whether anabolic steroids were effective in treating pressure ulcers, and if they had any harmful effects.

Study characteristics

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.

Key results

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.

Quality of the evidence

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.