Because it seemed logical to clarify the role of dehydroepiandrosterone (DHEA) in patients with adrenal insufficiency, 24 affected women were randomly assigned, in a double-blind study, to receive either 50 mg of DHEA or a placebo by mouth each morning for 4 months, with a crossover after a 1-month washout period. Fourteen women had primary adrenal insufficiency, most often as a result of autoimmune adrenalitis. Surgery was the most common cause of secondary adrenal insufficiency. Serum hormone levels were estimated, patient well-being was assessed using psychological questionnaires, and sexual function was assessed using visual analogue scales. Participants were evaluated before and after 1 and 4 months of treatment and again 1 month after the final treatment.Serum levels of DHEA, DHEA sulfate, and androstenedione rose to normal during active treatment. Serum testosterone and dihydrotestosterone increased to the low-normal range, whereas estrone and estradiol levels did not change significantly. Sex hormone–binding globulin levels were significantly lower after 4 months on DHEA than after placebo. Serum levels of insulin-like growth factor I increased significantly only in women with primary adrenal insufficiency. Serum levels of total and high-density lipoprotein cholesterol fell significantly during DHEA treatment. DHEA but not placebo significantly reduced scores for depression, anxiety, hostility, and obsessive-compulsive traits and was associated with higher levels of general well-being. Women given DHEA had more sexual thoughts and interest and were more satisfied with both the mental and physical aspects of their sexuality. Five women had androgenic side effects from DHEA, and a large majority had some skin-related effects by the end of the study; most, however, were mild and transient. Three women had a slight temporary rise in serum aminotransferase.These findings suggest that DHEA should be a part of any hormone replacement regimen in women with adrenal insufficiency. It will be of interest to learn whether it also has beneficial effects in men.N Engl J Med 1999;341:1013–1020
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