Anabolic steroids for Treating Pressure Ulcers

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SCIENCE
Anabolic steroids for Treating Pressure Ulcers
Key Take-Away: 

Pressure ulcers or bed sores are a common manifestation in individuals who are restrained to bed or wheelchair for a longer duration. No high-quality evidence supporting the use of anabolic steroids in the treatment of pressure ulcers was found.

Pressure ulcers, also known as bed sores, pressure sores or decubitus ulcers develop as a result of a localized injury to the skin or underlying tissue, or both. The ulcers usually arise over a bony prominence and are recognized as a common medical problem affecting people confined to a bed or wheelchair for long periods of time. 

ABSTRACT: 
Background: 

Pressure ulcers, also known as bed sores, pressure sores or decubitus ulcers develop as a result of a localized injury to the skin or underlying tissue, or both. The ulcers usually arise over a bony prominence and are recognized 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 and have been used as adjuvants to usual treatment with dressings, debridement, nutritional supplements, systemic antibiotics, and antiseptics, which are supportive in the 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 the decision making, regarding the benefits and harms of anabolic steroids. The aim of this study was to assess the effects of anabolic steroids in the treatment of pressure ulcers.

Methods: 

During March 2017, published or unpublished randomized controlled trials (RCTs) comparing the effects of anabolic steroids with alternative treatments or different types of anabolic steroids in the treatment of pressure ulcers were searched.

The databases like the Cochrane Wounds Specialized Register; the Cochrane Central Register of Controlled Trials (CENTRAL); Ovid MEDLINE (including In-Process & Other Non-Indexed Citations); Ovid Embase and EBSCO CINAHL Plus were searched. Also, clinical trials registries for ongoing and unpublished studies and scanned reference lists of relevant included studies as well as reviews, meta-analyses, and health technology reports were searched to identify additional studies. There were no restrictions with respect to language, date of publication or study setting. Two review authors independently carried out study selection, data extraction and risk of bias assessment.

Results: 

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; SD 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 the 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, it was uncertain whether oxandrolone improves or reduces the complete healing of pressure ulcers, as the study assessed the certainty of the evidence as very low. There was a 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 considered as being related to the treatment. It was 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, the incidence of a different type of infection, cost of treatment and quality of life were not reported in the 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) showed that oxandrolone had no benefit over placebo for improving ulcer healing.

Conclusion: 

There is no high-quality evidence supporting the use of anabolic steroids in the treatment of pressure ulcers. Further well-designed, multicenter trials, at low risk of bias, are necessary to assess the effect of anabolic steroids on pressure ulcers; however, careful consideration of the current trial and its early termination is required while planning the future research.

 

Source:

Cochrane Database of Systematic Reviews

Link to the source:

http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD011375.pub2/abstract?system

The original title of the article:

Anabolic steroids for treating pressure ulcers

Authors

Derry S et al.

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