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Task Force Issues Caution on Combined Hormone Therapy

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Press Release Date: October 15, 2002

The U.S. Preventive Services Task Force today recommended against the use of combined estrogen and progestin therapy for preventing cardiovascular disease and other chronic conditions in postmenopausal women.

The Task Force, sponsored by the Agency for Healthcare Research and Quality, found evidence for both benefits and harms of combined estrogen and progestin therapy, one of the most commonly prescribed hormone regimens. However, the Task Force concluded that harmful effects of the combined therapy are likely to exceed the chronic disease prevention benefits for most women.

The Task Force further concluded that the evidence is insufficient to recommend for or against the use of estrogen alone for prevention of chronic conditions in postmenopausal women who have had a hysterectomy. A study of estrogen therapy in women who have had hysterectomies is continuing as part of the National Institutes of Health Women's Health Initiative because it has not yet found clear benefit or harm. Estrogen alone, or estrogen and progestin together, are commonly referred to as hormone therapy or hormone replacement therapy.

On October 23-24, NIH will hold a scientific workshop that will review the results from one component of the WHI clinical trial in the context of other completed and ongoing federally funded research on menopausal combination hormone therapy. Subsequently, the Food and Drug Administration will host a public session on this topic.

An estimated 14 million American women take hormone therapy to help relieve hot flashes and other menopausal symptoms as well as to prevent chronic conditions such as heart disease, which is the leading cause of death among U.S. women. The use of hormone therapy to treat hot flashes or other symptoms of menopause was not evaluated by the Task Force. The Task Force concluded that women considering starting or continuing hormone therapy to relieve menopausal symptoms should discuss their individual risks for specific chronic conditions and personal preferences with their clinician.

The scientific review for the Task Force examined hundreds of studies, including a recently terminated trial within the NIH's Women's Health Initiative, which reported the effects of taking combined estrogen and progestin therapy on a variety of chronic diseases. The Task Force concluded that combined hormone therapy could increase bone mineral density and reduce the risk of fractures and may reduce the risk of colorectal cancer. They found equally strong evidence, however, that combined hormone therapy increases the risk for breast cancer, blood clots, stroke, and gallbladder disease. In addition, evidence reviewed by the Task Force suggests that hormone therapy does not reduce the risk of heart disease and that estrogen and progestin combined actually increase the risk of heart attacks. The effects of hormone therapy on dementia, cognitive function, and ovarian cancer are uncertain.

"These recommendations reflect the scientific evidence concerning the long-term effects of HRT, but there are no easy answers for women," said Task Force Chairman Alfred Berg, M.D., M.P.H., Professor and Chair, Department of Family Medicine, University of Washington, Seattle. "It is, therefore, especially important that women talk to their clinicians to decide what is best for them."

The Task Force is the leading independent panel of private-sector experts in prevention and primary care. It conducts rigorous, impartial assessments of all the scientific evidence for a broad range of preventive services and its recommendations are considered the gold standard for clinical preventive services. The Task Force based its conclusion on a report from a team led by Heidi Nelson, M.D., M.P.H., and Linda Humphrey, M.D., M.P.H., from AHRQ's Evidence-based Practice Center at Oregon Health & Science University in Portland. These reports were published in the August 20 Annals of Internal Medicine and the August 21 Journal of the American Medical Association.

The Task Force grades the strength of the evidence as "A" (strongly recommends), "B" (recommends), "C" (no recommendation for or against), "D" (recommends against) or "I" (insufficient evidence to recommend for or against screening).

In 1996, the Task Force found insufficient evidence to recommend for or against taking hormone therapy to prevent chronic conditions. Now, after reviewing additional studies, including the new clinical trial data that showed the risks of hormone therapy, the Task Force recommended against taking estrogen and progestin to prevent long-term health problems (a "D" recommendation) and found insufficient evidence to recommend for or against the use of estrogen alone in women who have had a hysterectomy (an "I" recommendation).

The NIH meeting later this month will provide information about what recent Women's Health Initiative study results mean for women who are taking hormone therapy and what alternatives are available for specific conditions. The FDA meeting will review the extent to which the WHI results might be extrapolated to other combination estrogen/progestin products and doses, the known benefits for approved indications in light of these new data, and the implications for future clinical trials of hormone therapy.

The hormone therapy recommendations and background evidence for clinicians are available on the AHRQ Web site as well as the Annals of Internal Medicine Web site. Previous Task Force recommendations, summaries of the evidence, and related materials are available from the AHRQ Publications Clearinghouse by calling (800) 358-9295 or sending an E-mail to AHRQPubs@ahrq.hhs.gov. Clinical information also is available from the National Guideline Clearinghouse at http://www.guideline.gov.

For more information, please contact AHRQ Public Affairs, (301) 427-1364.


 

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