NIH panel promotes a revised view of menopause
■ A close look at the science uncovered scant evidence for safe and effective alternatives to estrogen.
By Susan J. Landers — Posted April 11, 2005
Washington -- Menopause is not a disease, stressed a panel of experts assembled by the National Institutes of Health last month to sort through the research behind the symptoms and treatments for this natural transition that some women and their physicians continue to find problematic.
The panel members noted that many women move through menopause with few disabling symptoms and said the tendency -- in the United States at least -- to "medicalize" this life change could lead to the overuse of risky treatments.
Effective treatments for such symptoms as hot flashes, night sweats and vaginal dryness pretty much vanished overnight when serious health problems associated with the use of estrogen, which worked well to banish those ills, turned up in the 2002 Women's Health Initiative.
Doctors and patients have been struggling since then to find safe and effective alternatives. Unfortunately, the panel did not discover any magic potions.
After two days of hearing from experts, the 11-member panel drafted a state-of-the-science conference statement that is more a collation of the research rather than a presentation of new information, said panel member Cassandra E. Henderson, MD, chief of maternal and fetal medicine at Our Lady of Mercy Medical Center in Bronx, N.Y.
Nevertheless, panel members did find that estrogen in low doses of 0.3 mg per day could help women whose postmenopausal symptoms create a serious burden in their lives. "We found very little downside to starting low and going slow," said panel Chair Carol Mangione, MD, professor of medicine at the David Geffen School of Medicine at the University of California, Los Angeles.
The panel cautioned that women and their physicians should weigh individual risks and potential benefits carefully before embarking on treatment with even low-dose estrogen. Studies like the WHI found that estrogen increased risks of breast cancer, stroke and deep vein thrombosis and/or pulmonary embolism.
Although lower doses are thought to be less risky, there is no research on its long-term use, the panel said.
What is known is that low-dose estrogen can reduce the number of hot flashes by 60% to 70%, said Bruce Ettinger, MD, clinical professor of medicine at the University of California, San Francisco, School of Medicine. Dr. Ettinger presented research to the panel. Low-dose estrogen also can be safely teamed with less progestin, Dr. Ettinger said, although there is currently no consensus on the best dose and schedule.
Since many physicians are apparently still prescribing estrogen at doses of 0.625 mg a day for postmenopausal women, the panel's findings should raise awareness that lowering this dose is a good treatment approach, Dr. Mangione said.
Topical estrogen is also an effective treatment for vaginal dryness and pain during intercourse, the panel found. But because there have not been any long-term studies, the risk of topical estrogen, if any, remains unknown.
Symptoms and treatment
In sorting through the symptoms that have been attributed to menopause, panelists found that hot flashes, night sweats and vaginal dryness are clearly tied to menopause, and there is evidence that sleep disturbances also could be linked.
But the evidence is weak that mood disorders, cognitive disturbance and urinary incontinence can be tied to menopause, the panel determined.
"We found very few symptoms that are tied to the natural fluctuations in hormone levels during menopause, and this distinction may have serious implications for women's treatment decisions," Dr. Mangione said.
But few treatments other than estrogen have been studied thoroughly, the panel said. While there have been small studies on the effectiveness of antidepressants for the treatment of hot flashes, results have been mixed, the panel wrote in a draft statement.
Some, such as paroxetine, can decrease hot flashes to a moderate degree, but they carry such side effects as diminished libido, insomnia, headache and nausea.
Studies of soy extracts suggest that they might have some mitigating effect on hot flashes, according to the statement; however, dietary soy did not show benefit. A few small studies also found some benefit for dehydroepiandrosterone, or DHEA, to alleviate hot flashes.
Other dietary supplements, including botanicals such as black cohosh, kava, red clover leaf and dong quai root, did not seem effective, and all botanicals share the problem that they lack the standardized doses necessary to carry out effective trials.
"In general," the panel said, "the study of botanicals as treatments for hot flashes is still in its infancy."
Acupuncture and a type of slow, deep breathing both showed promise when tested in small groups.
The panelists, with expertise in obstetrics-gynecology, internal medicine, endocrinology, rheumatology, psychology and geriatric research, were described in an NIH statement as being free of academic or financial bias on the conference topic.