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Menopause-Related Symptoms NIH State-of-the-Science Conference on Management of Menopause-Related Symptoms March 21−23, 2005 William H. Natcher Conference Center National Institutes of Health Bethesda, Maryland Sponsored by: • National Institute on Aging, NIH • Office of Medical Applications of Research, NIH Co-sponsored by: • Office of Research on Women’s Health, NIH • National Center for Complementary and Alternative Medicine, NIH • National Cancer Institute, NIH • National Heart, Lung, and Blood Institute, NIH • National Institute of Child Health and Human Development, NIH • National Institute of Mental Health, NIH • U.S. Food and Drug Administration • Office on Women’s Health, U.S. Department of Health and Human Services U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Contents Introduction......................................................................................................................................1 Agenda .............................................................................................................................................5 Panel Members...............................................................................................................................13 Speakers .........................................................................................................................................15 Planning Committee.......................................................................................................................19 Abstracts ........................................................................................................................................23 I. Menopause-Related Symptoms: Definitions, Overview, and Association With Physiologic and Hormonal Changes Defining the Menopause Transition Sherry S. Sherman, Ph.D. ...........................................................................................................25 The Menopausal Transition Nanette F. Santoro, M.D..............................................................................................................29 Symptoms During the Perimenopause: Prevalence, Severity, Trajectory, and Significance in Women’s Lives Nancy Fugate Woods, Ph.D., R.N., F.A.A.N..............................................................................31 Symptoms and Health-Related Quality of Life and the Menopausal Transition Karen A. Matthews, Ph.D. ..........................................................................................................37 II. Menopause-Related Symptoms: Predictors, Risk Factors, and Characteristics (Time of Appearance, Severity, Frequency, and Persistence) A Universal Menopausal Syndrome? Nancy Avis, Ph.D..........................................................................................................................43 Perimenopause: Urogenital and Bleeding Issues Bradley J. Van Voorhis, M.D......................................................................................................47 Mood, Depression, and Reproductive Hormones in the Menopause Transition Peter J. Schmidt, M.D..................................................................................................................53 Sexuality Lorraine Dennerstein, A.O., M.B.B.S., Ph.D., D.P.M., FRANZCP ........................................57 Symptoms During the Menopausal Transition: Evidence From Cohort Studies Elizabeth Haney, M.D..................................................................................................................61 iii III. Treatments for Symptoms During the Menopausal Transition: Benefits and Harms of Commonly Used Interventions Background/History: Estrogens and Progestins (Formulations, Doses, Routes of Administration, and Schedule): Trends in Use and FDA Issues Marcia L. Stefanick, Ph.D...........................................................................................................65 Symptom Relief Versus Unwanted Effects: Role of Estrogen-Progestin Dosage and Regimen Bruce Ettinger, M.D. ...................................................................................................................69 Estrogens With and Without Progestin: Benefits and Risks of Short-Term Use Andrea Z. LaCroix, Ph.D............................................................................................................73 Therapeutic Effects of Progestins, Androgens, and Tibolone for Menopausal Symptoms James H. Liu, M.D. ......................................................................................................................81 Diagnosis and Management of Mood Disorder During the Menopause Transition Lee S. Cohen, M.D. ......................................................................................................................87 Hormonal Treatment of Menopause-Related Symptoms: Evidence From Randomized Controlled Trials Heidi D. Nelson, M.D., M.P.H., F.A.C.P. ...................................................................................91 IV. Alternative and Complementary Strategies for Managing Symptoms Menopause: Review of Botanical Dietary Supplement Research Tieraona Low Dog, M.D..............................................................................................................95 Other Complementary and Alternative Medicine Modalities: Acupuncture, Magnets, Reflexology, and Homeopathy Janet S. Carpenter, Ph.D., R.N.................................................................................................103 Centrally Active, Nonhormonal Hot Flash Therapies Charles L. Loprinzi, M.D..........................................................................................................109 Hot Flashes: Behavioral Treatments, Mechanisms, and Relationship With Sleep Robert R. Freedman, Ph.D........................................................................................................113 Nonhormonal Treatment of Menopause-Related Symptoms: Evidence From Randomized Controlled Trials Heidi D. Nelson, M.D., M.P.H., F.A.C.P. .................................................................................117 iv V. Strategies and Issues for Managing Menopause-Related Symptoms in Diverse Populations Special Considerations: Bilateral Oophorectomy and Premature Menopause Susan L. Hendrix, D.O. .............................................................................................................121 Breast Cancer, Menopause, and Long-Term Survivorship: Critical Issues for the Twenty-First Century Patricia A. Ganz, M.D. ..............................................................................................................125 Ethnic/Racial Diversity Valerie Montgomery-Rice, M.D. ..............................................................................................129 Lifestyle Factors: Are They Related to Vasomotor Symptoms and Do They Modify the Effectiveness or Side Effects of Hormone Therapy? Gail A. Greendale, M.D.............................................................................................................135 The Impact of Risk Status, Pre-Existing Morbidity, and Polypharmacy on Treatment Decisions Concerning Menopausal Symptoms Nananda F. Col, M.D., M.P.P., M.P.H., F.A.C.P. ...................................................................141 Issues Related to Discontinuation of Menopausal Hormone Therapy Deborah Grady, M.D., M.P.H...................................................................................................147 Managing Symptoms: Where Have We Come From and Where Do We Go? Isaac Schiff, M.D........................................................................................................................151 v Introduction Background Women going through the menopause transition may experience a variety of symptoms, ranging from hot flashes, night sweats, and problems sleeping to loss of sexual desire, depression, vaginal dryness, and urinary and bleeding complaints. As many as two-thirds of all women may experience vasomotor symptoms, such as hot flashes and night sweats, in the years around the menopause transition. For some, the resulting discomfort greatly diminishes their quality of life. For many decades, menopausal hormone therapy (MHT) using estrogen (or, in a woman with a uterus, a combination of estrogen and progestin) has been the therapy of choice for relieving menopause-related symptoms. But recently, several large clinical trials have found mixed results—a greater chance of serious health problems, such as blood clots, stroke, heart disease, or breast cancer, and benefits like fewer hip fractures in certain groups of women using MHT. It is not clear how these findings apply to women with symptoms because these clinical trials were not designed to study such women, but rather to test whether MHT could prevent chronic diseases or conditions of aging, such as heart disease or cognitive decline. Nevertheless, many women and their doctors are concerned about the use of MHT for their menopausal symptoms and interested in learning about alternatives. Research has identified a number of hormonal and nonhormonal approaches that show promise for managing menopause-related symptoms. A careful examination of these strategies for symptom management is urgently needed to provide women and their health care providers with options that will best control their symptoms and restore their quality of life. Conference Process To address this need, the National Institute on Aging and the Office of Medical Applications of Research, of the
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