23 May Oxandrolone and Healing of Chronic Pressure Ulcers in Spinal Cord Injury
MedicalResearch.com eInterview with
Dr. William A. Bauman, MD
Veterans Affairs Rehabilitation Research and Development
National Center of Excellence for the Medical Consequences of Spinal Cord Injury
Suite 7A-13, James J. Peters Veterans Affairs Medical Center
130 West Kingsbridge Road, Bronx, NY 10468;
MedicalResearch.com: What are the main findings of the study?
Dr. Bauman: In a prospective, randomized two-group, double-blind, placebo-controlled, intention-to-treat clinical trial, we determined whether SCI in-patients with a full thickness (Stage III or IV) pressure ulcers of the pelvic region who received 24 weeks or less of optimized clinical care and an oral anabolic steroid agent, oxandrolone, have a greater percent of healed target pressure ulcers than those who received placebo and the same clinical care. There was no significant difference in proportion of pressure ulcers that healed between the treatment and placebo groups [treatment recipients 24.1% (95% CI, 16.0% to 32.1%) and placebo recipients 29.8% (CI, 21% to 38.6%) with a difference, -5.7 percentage points (CI, -17.5 to 6.8 percentage points)]. Also, the rate of healing of wounds at 28 days was not significantly different between the groups (50.9% of the oxandrolone group and 43.3% of the placebo group had healing of ≥30.0%), nor was the number of wounds that remained closed at 8 weeks significantly different (16.7% of the oxandrolone group and 15.4% of the placebo group). No serious adverse events were related to drug administration but a significantly greater proportion of patients had elevated liver enzymes in the treatment group [treatment recipients 32.4% (95% CI, 23.6% to 41.2%) and placebo recipients 2.9%% (CI, 0.0% to 6.1%).
Thus, oxandrolone showed no benefit over placebo for improving healing of chronic pressure ulcers of the pelvic region or the proportion that remained closed after 8 weeks of treatment.
MedicalResearch.com: Were any of the findings unexpected?
Dr. Bauman:It was somewhat surprising that these patients with nonhealing wounds were not more malnourished at study initiation. It was predicted by the nominal group method that 80 percent of the patients at time of enrollment would have moderate to severe malnutrition; oxandrolone was hypothesized to reverse this adverse dietary condition, and thus promote wound healing. However, at baseline only 24 percent in the placebo treatment group and 20 percent in the oxandrolone treatment group) had moderate to severe malnutrition on a global nutritional assessment tool (VA Nutritional Assessment Tool). This unexpected finding may have lessened the impact of therapy with oxandrolone.
MedicalResearch.com: What should clinicians and patients take away from your report?
Dr. Bauman: Treatment with an anabolic steroid agent may not improve outcome in those with chronic stage 3 or 4 wounds. Possibly, more individualized criteria should be used prior to placing a patient on an anabolic steroid agent.
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Dr. Bauman: There is a better appreciation of what we do not know with regard to chronic pressure ulcer healing:
(1) Is the result of an anabolic agent to treat the SCI population generalizable to the population-at-large, especially to the elderly?
(2) Should an anabolic steroid agent be considered if there is no evidence of moderate to severe malnutrition?
(3) What other variables should be controlled for in a study to permit a single pharmacological intervention, such an anabolic agent, to be tested for efficacy?
Adult hospitalizations in the United States that recorded the diagnosis of pressure ulcers were estimated to total $11 billion in 2006. As the general population ages, the cost to society to provide pressure ulcer care will continue to escalate. Although this research is expensive, the cost to society of not studying this problem, thereby reducing the possibility to finding more effective therapies, is far greater, not to mention the enormous debilitating consequences to the patient with a nonhealing wound.
Just because an anabolic steroid agent appeared to be of little or no benefit to improve chronic pressure ulcer healing performed in a generally well nourished SCI population, it would be wrong not to appreciate that it still may hold efficacy in other study populations, or even in those with spinal cord injury if malnourished.
William A. Bauman, Ann M. Spungen, Joseph F. Collins, Dennis W. Raisch, Chester Ho, George A. Deitrick, Bernard A. Nemchausky, Lance L. Goetz, Jai S. Park, Michael Schwartz, John L. Merritt, Vidya Jayawardena, Paul Sandford, Sunil Sabharwal, Sally A. Holmes, Fahima Nasar, Roy Sasaki, Vandana Punj, Karin F. Zachow, Walter C. Chua, MaryKutty D. Thomas, Rose C. Trincher†; The Effect of Oxandrolone on the Healing of Chronic Pressure Ulcers in Persons With Spinal Cord Injury A Randomized Trial. Annals of Internal Medicine. 2013 May;158(10):718-726.