The study, reported by Nelson B. Watts, associate professor of medicine at the School of Medicine, found that treatment with estrogen plus low-dose androgen increases spinal bone mineral density -- a benefit not provided by estrogen alone -- without causing significant adverse effects on liver function. The study also indicated that the oral hormone combination produces statistically significant reductions in menopausal symptoms such as hot flashes and vaginal dryness.
The study of 66 patients was designed to compare the effects of an oral estrogen-androgen combination therapy on bone, menopausal symptoms and lipoprotein profiles in postmenopausal women. The results represent the first long-term, comprehensive clinical investigation of the therapeutic effectiveness and safety of estrogen-androgen as a postmenopausal hormone replacement therapy.
Study findings regarding bone mineral density suggest that estrogen plus low-dose androgen may have a more positive effect on a woman's osteoporosis risk than estrogen alone. After 12 months of treatment, patients treated with the estrogen-androgen combination experienced statistically significant increases in spinal bone density, a site where fractures commonly occur in osteoporotic women. A trend toward further improvement after an additional 12 months of treatment was also observed. Conversely, while treatment with estrogen alone maintained bone mineral density at pretreatment levels, estrogen alone did not produce significant increases in bone mineral density.
The increase was even more striking in patients who received no hormonal treatment in the two years prior to the study, and then received estrogen-androgen therapy for 24 months. According to Watts, these findings suggest that estrogen-androgen may be a preferred treatment for previously untreated patients in late menopause.
"These data suggest that treatment with estrogen-androgen may result in stronger bone than with estrogen alone, which could be very beneficial to the management of osteoporosis," said Watts.
Menopausal symptoms of somatic origin (hot flashes, vaginal dryness and insomnia) improved significantly among patients in both treatment groups. In addition, several investigational open and controlled clinical trials have shown that postmenopausal estrogen-androgen replacement appears to expand the scope of therapeutic benefits (beyond those conferred by estrogen alone) by providing relief of psychosomatic and psychological symptoms, such as lack of energy, decreased libido and depressed mood. Data on psychosomatic and psychological variables were not present in the current study due to insufficient numbers of evaluable, symptomatic patients.
Overall, the combination of hormone therapy was well tolerated over the two years of treatment. Both groups showed similar and significant decreases in total cholesterol at 24 months, with only two of 24 patients in the estrogen-androgen group falling below the desirable range for high-density lipoprotein (HDL) cholesterol levels at 24 months. Watts emphasized that because the effects of hormone replacement therapy on lipid levels vary widely on an individual basis, women need to be monitored closely by their physicians.
The most commonly reported adverse events were headache and edema in the estrogen-treated group, and breast pain, hirsutism, edema and acne in the estrogen-androgen group.
"Our study results indicate that estrogen-androgen therapy relieves symptoms and provides certain benefits not conferred by estrogen alone," reported Watts. "For this reason, combination estrogen-androgen therapy should be considered an option when selecting a hormone replacement regimen for postmenopausal women, especially for those women who do not respond to estrogen alone or whose symptoms are not completely alleviated by estrogen."
-- Sarah Goodwin