New NIH Research Initiative to Test
Treatments for Menopausal Symptoms
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:
A number of different treatment strategies are under consideration.
Possible treatments to be studied during the five-year project period
- Harvard Medical School, Boston; Lee Cohen, M.D., and Hadine
- 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.
- Antidepressants such as paroxetine (Paxil) or escitalopram
- Paced respiration (slow deep breathing also known as relaxation
- 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
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
The NIA leads the federal effort supporting and conducting research
on aging and the medical, social and behavioral issues of older
people. For more information on menopause, go to Menopause: Time
for a Change, http://www.nia.nih.gov/HealthInformation/Publications/Menopause/.
For more information on research and aging, go to www.nia.nih.gov or
call toll free 800-222-2225.
The NICHD sponsors research on development, before and after birth;
maternal, child and family health; reproductive biology and population
issues; and medical rehabilitation. For more information, visit
the Institute’s Web site at www.nichd.nih.gov/.
The NCCAM’s mission is to explore complementary and alternative
medical practices in the context of rigorous science, train CAM
researchers and disseminate authoritative information to the public
and professionals. For additional information, call NCCAM's Clearinghouse
toll free at 888-644-6226, or visit the NCCAM Web site at nccam.nih.gov.
The ORWH serves as a focal point for women’s health research at
the NIH. For further information, go to orwh.od.nih.gov/.
The National Institutes of Health (NIH) — The Nation's
Medical Research Agency — includes 27 Institutes and
Centers and is a component of the U.S. Department of Health and
Human Services. It is the primary federal agency for conducting
and supporting basic, clinical and translational medical research,
and it investigates the causes, treatments, and cures for both
common and rare diseases. For more information about NIH and
its programs, visit www.nih.gov.