Consensus Panel Cautious on Menopause Management: Effectiveness and Long-Term Safety of Alternatives to Estrogen Need to Be Studied in Rigorous Trials, Advisory Panel Said

Article excerpt

BETHESDA, MD. -- Night sweats, hot flashes, vaginal dryness, and sleep disturbances appear to be connected to the onset of menopause, but other midlife symptoms--such as mood disorders, urinary incontinence, and somatic complaints--may not be, according to a consensus statement issued by a federal advisory panel.

"We reviewed the evidence for [about 10] symptoms often stated as happening at time of menopause and possibly due to menopause ... and we pruned the list," said panelist Lois M. Verbrugge, Ph.D., research professor and senior research scientist at the University of Michigan's Institute of Gerontology in Ann Arbor.

Dr. Verbrugge and her colleagues on the 12-member panel drafted a consensus statement at a conference on management of menopause-related symptoms sponsored by the National Institutes of Health.

The panel also looked at the available evidence on treatment of menopause symptoms and determined that low-dose estrogen, given for short periods to women who are not at high risk of breast cancer, has been shown to be effective for many patients who suffer from hot flashes. The panel defined "low-dose" as doses equivalent to 0.3 mg conjugated estrogen, 0.5 mg oral micronized estradiol, 25 mcg transdermal estradiol, or 2.5 mcg ethinyl estradiol.

The panel noted that although higher doses of estrogen--equivalent to 0.625 mg conjugated estrogen--increase the risk of stroke and deep vein thrombosis and, when combined with progestin, breast cancer, the exact risk of those outcomes with low-dose estrogen has not been quantified.

"Risk-benefit analyses are important for women whose vasomotor symptoms are severe and create a burden on daily life. These women may be willing to assume greater risk for the sake of reducing their symptoms," the panelists wrote.

Women at high risk for serious medical outcomes with the use of estrogen include those with a history of breast cancer or an elevated risk of breast or ovarian cancer based on genetic factors or family history, and those who have or are at risk for cardiovascular disease, the panel noted.

"Women with these risk factors may be particularly motivated to seek nonhormonal therapies to treat menopausal symptoms," they wrote. "A few small studies in breast cancer survivors suggest that some antidepressants (such as venlafaxine) can effectively treat vasomotor symptoms in women with breast cancer; other treatments, including clonidine and megestrol acetate, have also shown positive effects in a few studies."

As for other treatments, the jury is still out on most of them, according to the panel. "There are many potential alternatives to estrogen," the panel wrote. "However, their effectiveness and long-term safety need to be studied in rigorous clinical trials in diverse populations of women. …