New NIH Research Initiative to Test Treatments for Menopausal Symptoms

Wednesday, September 17, 2008

Clinical Trials to Target Hot Flashes, Night Sweats

Women troubled by hot flashes and night sweats during the years around menopause want safe, effective treatment options. A new research initiative from the National Institutes of Health (NIH) will establish a multisite research network to conduct clinical trials of promising treatments for the most common symptoms of the menopausal transition.

The initiative — Menopause Strategies: Finding Lasting Answers for Symptoms and Health (MsFLASH) — is led by the National Institute on Aging (NIA) in collaboration with the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), the National Center for Complementary and Alternative Medicine (NCCAM) and the Office of Research on Women’s Health (ORWH), all parts of the NIH. The MsFLASH network will be coordinated by principal investigators Andrea Z. LaCroix, Ph.D., and Garnet Anderson, Ph.D., both of the Fred Hutchinson Cancer Research Center in Seattle. The network centers will collectively receive approximately $4.4 million each year of the initiative, which is projected to run for five years.

"Studies such as the Women’s Health Initiative, which raised concerns about the safety of using menopausal hormone therapy, underscore the urgent need for treatments that have been proven safe and effective for alleviating menopausal symptoms," said NIA Director Richard J. Hodes, M.D. "MsFLASH will speed the evaluation of treatments deemed promising by an independent panel at the recent NIH State-of-the-Science Conference on the Management of Menopause-Related Symptoms."

In addition to the Data Coordinating Center, five clinical research centers make up the MsFLASH network, which will conduct randomized clinical trials to test a variety of approaches for treating menopausal symptoms. "Different approaches will be studied for efficacy against hot flashes and night sweats in diverse groups of women in trials with either placebo or usual-care control groups. Investigators will also look at possible effects on other symptoms at middle age, including sleep disturbance, mood disorder, vaginal dryness and sexual function," said Judy Hannah, MsFLASH program official from the NIA’s Division of Geriatrics and Clinical Gerontology.

The MsFLASH centers and principal investigators are:

• Harvard Medical School, Boston; Lee Cohen, M.D., and Hadine Joffe, M.D.

• Indiana University School of Medicine, Indianapolis; Janet S. Carpenter, R.N., Ph.D.

• Kaiser Permanente, Northern California, Oakland; Barbara Sternfeld, Ph.D., and Bette Caan, Ph.D.

• University of Pennsylvania School of Medicine, Philadelphia; Ellen Freeman, Ph.D.

• Group Health Center for Health Studies, Seattle, Katherine Newton, Ph.D.; and University of Washington School of Medicine, Seattle; Susan Reed, M.D.

A number of different treatment strategies are under consideration. Possible treatments to be studied during the five-year project period include:

• Antidepressants such as paroxetine (Paxil) or escitalopram (Lexapro)

• Paced respiration (slow deep breathing also known as relaxation breathing)

• Yoga

• Low-dose estradiol patch and low-dose estradiol gel

• Exercise programs, both moderate and vigorous

"For decades, estrogen with or without progesterone has been the treatment of choice for relieving menopause-related symptoms because of the lack of alternative therapies of comparable proven efficacy," noted Sherry Sherman, Ph.D., NIA project scientist for the Menopause Strategies Network. "The collaborative, multidisciplinary, multicenter approach of MsFLASH will enable researchers to test other options—including behavioral and complementary and alternative medicine approaches—to determine whether they are also effective against hot flashes."

Currently, menopausal hormone therapy is still considered the most effective way to control moderate to severe menopausal symptoms such as hot flashes and night sweats. Experts recommend that when it is used, physicians prescribe the lowest effective dose for the shortest period necessary, but some women are reluctant to use menopausal hormone therapy because of possible side effects. Women can experience menopausal symptoms for several years before menopause — the date of their last menstrual period — and sometimes for many years after. For some women with severe menopausal symptoms, the resulting discomfort can greatly diminish their quality of life.

The 2005 NIH State-of-the-Science meeting featured presentations from experts on the biology and symptoms of the menopause transition and on established and potential new treatments for symptomatic relief. An independent panel evaluated the data from the presentations and from an evidence-based search of the literature and published its recommendations on the NIH Web site and in the Annals of Internal Medicine.

Source: NIH

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Time Stamp: 9/17/2008 at 3:44:03 PM UTC