Anabolic steroids have been used to treat lower extremity ulcerations, including venous and cryofibrinogenemic
ulcers and
lipodermatosclerosis (LDS). Yet there have been no studies to determine the severity and reversibility of side effects of
anabolic steroids on liver
enzymes and
lipid profiles in elderly patients. We therefore evaluated, in a prospective, randomized, double-blinded, placebo-controlled trial, the extent and reversibility of abnormal liver
enzymes and
lipid profiles in patients with LDS and venous
leg ulcers treated with
stanozolol at 2 mg twice daily for up to 6 months. Follow-up laboratory testing was done for 2 months after
cessation of treatment. A total of 44 patients with LDS and
venous ulcers were enrolled and treated with either leg compression alone (placebo) or leg compression plus oral
stanozolol 2 mg twice daily (active). Baseline and follow-up laboratory testing of liver
enzymes and
lipid profiles were obtained. A total of 21 active and 23 placebo patients were treated and evaluated. We measured liver
enzymes (
aspartate aminotransferase [AST/
SGOT],
alanine aminotransferase [ALT/
SGPT], γ-glutamyl
transferase [GGT]) and
lipid profile components (
high-density lipoprotein [HDL],
low-density lipoprotein [
LDL], total
cholesterol) before, during, and after the treatment period. We found that AST/
SGOT and ALT/
SGPT became significantly elevated in 29% (P = .0415 at 2 months) and 33% (P = .0182 at 1 month) of patients treated with
stanozolol or placebo, respectively, with return to baseline in the posttreatment period. Unexpectedly, 91% of patients on
stanozolol developed a significant (P < .0001) decrease in HDL levels, by as much as 37 U/L. All patients remained asymptomatic and levels returned to baseline after discontinuation of the
drug. We conclude that low-dose
stanozolol, 2 mg twice daily, produces asymptomatic and temporary elevation of liver
transaminases and depression of the HDL level in a significant proportion of patients.