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The efficacy and safety of DHEA therapy

The efficacy and safety of DHEA therapy 50 mg/day in postmenopausal women presenting with low libido – a study conducted by the Women's Health Program in the Department of Medicine, Monash University.

Presented at the 19th Annual Meeting of the North American Menopause Society, Orlando, Florida 26th of September 2008.

Dehydroepiandrosterone (DHEA) and its sulphate DHEAS are the most abundant circulating sex steroid hormones in women. Levels of DHEA and DHEAS decline with age. It has been proposed that restoring the circulating levels of these steroids to those found in young people may have anti-aging effects and improve wellbeing, sexual function and cognition. DHEA is sold over the counter as a nutritional supplement in the United States and is not uncommon we used in Australia for its proposed "anti-ageing" properties. However this is not supported by the published literature.

Overall, the interpretation of data from randomised clinical studies conducted in well women is limited by inadequate sample size and short duration of treatment resulting in inconsistent results for the outcomes of libido, wellbeing and prevention of cognitive decline.

Notably, safety data for DHEA therapy are lacking.

The aim of this study was to evaluate the efficacy and safety of DHEA 50 mg per day versus placebo therapy in postmenopausal women presenting for the management of low libido. The primary outcomes of interest included:

  1. The effects of DHEA on sexual function
  2. The effects of DHEA on the well-being and mood
  3. The effects of DHEA on menopausal symptoms, particularly hot flushes
  4. The safety of DHEA in terms of clinical side-effects, cholesterol profile, liver function and endometrial (uterine lining) safety.

Sexual function, mood and well-being and menopausal symptoms were evaluated using validated questionnaires at baseline and throughout the study period. Hormone levels were measured by liquid chromatography mass spectrometry in the Department of Professor Fernand Labrie, Laval University, Quebec Canada.

93 women aged 40 to 65 years were recruited from the community and randomised to receive either DHEA 50 mg/day or placebo therapy. The tablets were identical and neither the investigator s nor the patients knew what treatment they were receiving for the duration of the study.

The primary findings from the study were that DHEA therapy resulted in significant increases in blood levels of DHEA DHEA sulfate and total and free testosterone. Treatment with DHEA did not improve any of the sexual function parameters measured, nor did it result in improvements in mood and well-being or menopausal symptoms.

DHEA therapy was associated with more reporting of acne and excess body hair and two women in the DHEA treatment group withdrew from the study because of these side-effects. DHEA had no adverse effects on liver function, total cholesterol, LDL cholesterol, triglycerides, fasting insulin or fasting glucose. However treatment was associated with a small but statistically significant reduction in HDL cholesterol (higher HDL cholesterol levels are associated with lower cardiovascular disease risk). No adverse effects on the endometrium (uterine lining) were observed.

In summary, we did not observe any benefits of DHEA therapy for postmenopausal women in this study. Taken together with other findings in the published literature evidence to support the use of DHEA by postmenopausal women is lacking and such therapy cannot be recommended for the treatment of postmenopausal lowered libido or menopausal symptoms.