TY - JOUR
T1 - The effect of oxandrolone on the healing of chronic pressure ulcers in persons with spinal cord injury
AU - Bauman, William A.
AU - Spungen, Ann M.
AU - Collins, Joseph F.
AU - Raisch, Dennis W.
AU - Ho, Chester
AU - Deitrick, George A.
AU - Nemchausky, Bernard A.
AU - Goetz, Lance L.
AU - Park, Jai S.
AU - Schwartz, Michael
AU - Merritt, John L.
AU - Jayawardena, Vidya
AU - Sandford, Paul
AU - Sabharwal, Sunil
AU - Holmes, Sally A.
AU - Nasar, Fahima
AU - Sasaki, Roy
AU - Punj, Vandana
AU - Zachow, Karin F.
AU - Chua, Walter C.
AU - Thomas, Marykutty D.
AU - Trincher, Rose C.
PY - 2013/5/21
Y1 - 2013/5/21
N2 - Background: Anabolic steroids have been reported to improve wound healing. Objective: To determine whether oxandrolone increases the percentage of target pressure ulcers (TPUs) that heal compared with placebo and whether healed ulcers remain closed 8 weeks after treatment. Design: Parallel-group, placebo-controlled, randomized trial conducted from 1 August 2005 to 30 November 2008. Patients, clinical care providers, study personnel, and statisticians were blinded to treatment assignment. (ClinicalTrials.gov: NCT00101361) Setting: 16 inpatient spinal cord injury (SCI) services at Veterans Affairs medical centers. Patients: 1900 prescreened, 779 screened, and 212 randomly assigned inpatients with SCI and stage III or IV TPUs. Intervention: Oxandrolone, 20mg/d(n108), or placebo (n104) until the TPU healed or 24 weeks. Measurements: The primary outcome was healed TPUs. The secondary outcome was the percentage of TPUs that remained healed at 8-week follow-up. Results: 24.1% (95% CI, 16.0% to 32.1%) of TPUs in oxandrolone recipients and 29.8% (CI, 21.0% to 38.6%) in pla-cebo recipients healed (difference,5.7percentage points [CI, 17.5 to 6.8 percentage points]; P0.40). At 8-week follow-up, 16.7% (CI, 9.6% to 23.7%) of oxandrolone recipients and 15.4% (CI, 8.5% to 22.3%) of placebo recipients retained a healed TPU (difference, 1.3 percentage points [CI,8.8 to 11.2 percentage points]; P0.70). No serious adverse events were related to oxandrolone. Liver enzyme levels were elevated in 32.4% (CI, 23.6% to 41.2%) of oxandrolone recipients and 2.9% (CI, 0.0% to 6.1%) of placebo recipients (P < 001). Limitations: Selection of severe wounds may have reduced treatment response. Approximately one third of patients did not complete the study in the treatment and placebo groups. The study was terminated after a futility analysis showed a low probability of detecting a significant difference between the groups. Conclusion: Oxandrolone showed no benefit over placebo for improving healing or the percentage of TPUs that remained closed after 8 weeks of treatment.
AB - Background: Anabolic steroids have been reported to improve wound healing. Objective: To determine whether oxandrolone increases the percentage of target pressure ulcers (TPUs) that heal compared with placebo and whether healed ulcers remain closed 8 weeks after treatment. Design: Parallel-group, placebo-controlled, randomized trial conducted from 1 August 2005 to 30 November 2008. Patients, clinical care providers, study personnel, and statisticians were blinded to treatment assignment. (ClinicalTrials.gov: NCT00101361) Setting: 16 inpatient spinal cord injury (SCI) services at Veterans Affairs medical centers. Patients: 1900 prescreened, 779 screened, and 212 randomly assigned inpatients with SCI and stage III or IV TPUs. Intervention: Oxandrolone, 20mg/d(n108), or placebo (n104) until the TPU healed or 24 weeks. Measurements: The primary outcome was healed TPUs. The secondary outcome was the percentage of TPUs that remained healed at 8-week follow-up. Results: 24.1% (95% CI, 16.0% to 32.1%) of TPUs in oxandrolone recipients and 29.8% (CI, 21.0% to 38.6%) in pla-cebo recipients healed (difference,5.7percentage points [CI, 17.5 to 6.8 percentage points]; P0.40). At 8-week follow-up, 16.7% (CI, 9.6% to 23.7%) of oxandrolone recipients and 15.4% (CI, 8.5% to 22.3%) of placebo recipients retained a healed TPU (difference, 1.3 percentage points [CI,8.8 to 11.2 percentage points]; P0.70). No serious adverse events were related to oxandrolone. Liver enzyme levels were elevated in 32.4% (CI, 23.6% to 41.2%) of oxandrolone recipients and 2.9% (CI, 0.0% to 6.1%) of placebo recipients (P < 001). Limitations: Selection of severe wounds may have reduced treatment response. Approximately one third of patients did not complete the study in the treatment and placebo groups. The study was terminated after a futility analysis showed a low probability of detecting a significant difference between the groups. Conclusion: Oxandrolone showed no benefit over placebo for improving healing or the percentage of TPUs that remained closed after 8 weeks of treatment.
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U2 - 10.7326/0003-4819-158-10-201305210-00006
DO - 10.7326/0003-4819-158-10-201305210-00006
M3 - Article
C2 - 23689765
AN - SCOPUS:84878077007
VL - 158
SP - 718
EP - 726
JO - Annals of Internal Medicine
JF - Annals of Internal Medicine
SN - 0003-4819
IS - 10
ER -