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

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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.

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Hot flash relief

A panel assembled by the National Institutes of Health to evaluate treatments for menopause-related vasomotor symptoms examined data for a number of treatments and determined the following results:

  • Estrogen, either by itself or with progestin, was determined to be the most consistently effective therapy for hot flashes and night sweats. Using it in the lowest dose and for the shortest time with a careful assessment of its risk for a particular woman was advised.
  • Antidepressants have been studied in a few well-designed, short-term studies with small numbers of participants. Results have been mixed, but some, such as paroxetine, might decrease hot flashes.
  • Dehydroepiandrosterone (DHEA) has not been studied for long-term risks in large randomized trials. A few small studies suggest a potential benefit for the treatment of hot flashes and sexual arousal.
  • Tibolone is a synthetic steroid compound with relatively weak hormonal activity. It is not available in the United States but has been used in Europe and Canada for treatment of vasomotor symptoms, sexual dysfunction and osteoporosis prevention for almost 20 years. Despite its widespread clinical use, there are not very many studies of its effects. These studies did suggest benefit for hot flashes and sleep disturbances. There are adverse effects that include pain, weight gain and headache.
  • Progestin or progesterone has been studied in a small number of studies that produced conflicting data. Adverse effects have not been studied.
  • Androgens (testosterone) can be administered in a variety of forms, including injections, subcutaneous pellets, gels, transdermal patches and oral testosterone in combination with estrogen. Studies comparing combination oral testosterone-estrogen with estrogen alone found positive effects for improving libido. There were no added benefits for hot flashes, vaginal dryness or sleep disturbances.
  • Bioidentical (and "natural") hormones are treatments with individually compounded recipes of a variety of steroids in various dosage forms, with the composition and dosages based on a person's salivary hormone concentration. There is a paucity of data on the benefits and adverse effects of these compounds.
  • Phytoestrogens and isoflavones have been studied in a substantial number of trials motivated by epidemiological data showing differences in levels of menopausal symptoms in countries with different levels of these nutrients in their diets. Studies of soy extract showed more promise than studies of dietary soy in treatment of vasomotor symptoms.
  • Botanicals included black cohosh, kava, red clover and dong quai root have been studied and found to be ineffective in reducing hot flashes.
  • Acupuncture might be effective at reducing hot flashes in a subset of women but there is only limited evidence from few, well-designed studies.
  • Behavioral interventions such as paced respiration (a type of slow, deep breathing that requires special training) showed early promise, but while it improved quality of life, it did not improve vasomotor symptoms.

Source: National Institutes of Health state-of-the-science conference statement on the management of menopause related symptoms, March 21-23

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External links

Statements from the National Institutes of Health's conference on management of menopause-related symptoms, March 21-23 (link)

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