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Estrogen plus progestin not helpful to quality of life in postmenopausal women

Taking a combination of the hormones estrogen and progestin does not improve the quality of life for women who are free of menopause-related symptoms, but does expose them to a slightly higher risk of heart attacks, strokes and breast cancer, a new multi-center national study concludes. For that reason, medical scientists now recommend against the combined therapy in the absence of such symptoms.

From the University of North Carolina:
Estrogen plus progestin not helpful to quality of life in postmenopausal women, new national study shows

By DAVID WILLIAMSON
UNC News Services

CHAPEL HILL — Taking a combination of the hormones estrogen and progestin does not improve the quality of life for women who are free of menopause-related symptoms, but does expose them to a slightly higher risk of heart attacks, strokes and breast cancer, a new multi-center national study concludes. For that reason, medical scientists now recommend against the combined therapy in the absence of such symptoms.

The latest findings from the Women’s Health Initiative study, to be reported in the May 8 issue of the New England Journal of Medicine, were released today (March 17) because of the important clinical implications.

Dr. Jennifer Hays of Baylor College of Medicine in Houston was first author of the report, which involved scores of top researchers.

“The strength of this finding is not only the large number of study participants — 16,608 postmenopausal women 50 to 79 years old — but also that they were randomly assigned to receive daily estrogen plus progestin or placebo,” said Dr. Gerardo Heiss, professor of epidemiology at the University of North Carolina at Chapel Hill School of Public Health.

After a year, participants were asked about their general health, the limitations they experienced as a result of physical or emotional health problems and also about their energy, social functioning, memory, sleep disturbances and sexual functioning, said Heiss, a member of the study’s steering committee.

Last summer, he and colleagues, including Drs. Ellen Wells and David Ontjes of the UNC School of Medicine, collaborated on a paper showing the two hormones together boosted slightly the risk of breast cancer, heart attacks and stroke, while showing somewhat beneficial effects on the risk of colon cancer and hip fractures. An independent data and safety monitoring board halted that study early since the risks exceeded the benefits.

“What Women’s Health Initiative researchers have now found indicates that the women in the combination hormone group had no benefit from being in the combination hormone group in terms of general health, energy, mental health, depression, memory or sexual functioning, compared to the women who were in the placebo group,” he said.

Results from the carefully conducted experiment indicate that combination hormone therapy does not make a difference in how postmenopausal women feel, compared to their peers who are not taking the two hormones, the scientist said. Combination hormone therapy therefore does not seem to be warranted in the absence of menopausal symptoms.

“These results do not apply to therapy with estrogen alone,” Heiss said. “That portion of the WHI study is continuing, and we have no results at this time about the benefits and risks of estrogen alone in postmenopausal women.”

Much of the credit for the important new Women’s Health Initiative findings belongs to the many women who agreed to participate as “pioneer” subjects, he said.

In an accompanying commentary, Dr. Deborah Grady of the University of California at San Francisco said there is no role for hormone therapy in the treatment of women without menopausal symptoms.

“Women with vasomotor symptoms (such as hot flashes and sweating) must weigh the risks associated with treatment against the benefit of symptom relief,” she wrote. “Vasomotor symptoms occur in about two thirds of women and are very distressing in 10 to 20 percent. We clearly need to identify new treatments that are highly effective and safe.”

The National Heart, Lung and Blood Institute sponsors the continuing larger study.

Other interventions are being tested in the Women’s Health Initiative to learn whether, for example, reducing fat in the diet and supplementing calcium and vitamin D can improve the health of postmenopausal women. Results from the assessment of estrogen alone in women with intact uteruses might not be available for another two to three years.

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Note: Heiss can be reached at (919) 962-3253, Hays at (713) 798-4712 and Grady at (415) 260-2670.

School of Public Health Contact: Lisa Katz, (919) 966-7467
News Services Contact: David Williamson, (919) 962-8596




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