Tighter Restrictions Urged for Use of Hormone Therapy

Women and their doctors are now getting some help making the complicated decisions about hormone therapy.

But the guidance only goes so far--and doesn’t resolve such basic questions as how long a woman can safely take hormones.

Responding to recent studies that cast doubt on the role of hormone therapy in preventing major ailments such as heart disease, the North American Menopause Society last week released a report summarizing what is known about hormones and recommending appropriate uses for the drugs.

Many post-menopausal women have been taking hormone therapy based on the conviction that it might help prevent heart disease and even some types of cancer.

However, a major study, the Women’s Health Initiative, found that hormone therapy with estrogen and progesterone slightly increases the risk of heart disease, stroke and breast cancer.

Based on this information, the authors of the new report--a panel of leading experts in menopause--are recommending much tighter restrictions on the use of hormones.

“These guidelines bring the focus back on why hormone replacement was actually introduced in the first place: to deal with menopausal-related symptoms,” said Dr. Wulf Utian, executive director of the North American Menopause Society.

The guidelines were released at the group’s annual meeting last week in Chicago.

“The way the original news [regarding the Women’s Health Initiative] was dumped onto women and their health providers, without any real commentary or analysis of what it meant, created enormous chaos. While we don’t profess that this is a final answer, we think that providing some well-considered recommendations will be of value.”

Given what is now known about hormone therapy, the panel recommended:

* Hormone therapy be confined to treatment for menopausal symptoms, such as hot flashes and vaginal dryness.

* Hormone therapy (both estrogen-plus-progestogen and estrogen alone) should not be used for prevention of heart disease.

* Even though some hormone therapy products are approved for the prevention of osteoporosis, alternative treatments should be considered because of the risk associated with hormone therapy.

* Hormone therapy should be limited to the shortest duration possible to treat symptoms.

* Lower-than-standard doses of hormone therapy should be considered when treating menopausal symptoms.

The advisory committee could not reach a consensus on several points, however, including how long to prescribe hormone therapy for such problems as hot flashes.

Previously, short-term therapy was considered to be three to five years; long-term therapy was defined as longer than three to five years--but there are no data on when the risks of hormone therapy begin to outweigh the benefits.

The panel recommended that women and their doctors reevaluate the need for hormones at each visit.

Nor could the panel agree whether hormone therapy should be recommended to women with premature menopause. Moreover, the doctors could not decide whether the findings of the Women’s Health Initiative, which studied a traditional hormone regimen consisting of conjugated equine estrogens (known as Premarin) and medroxyprogesterone acetate, could be generalized to other types of hormone therapy, such as estrogen skin patches and plant-based hormone products.

Women and their doctors shouldn’t assume that other forms of hormone therapy are any safer, the report cautions.

“We chose to put out a report saying, look, we don’t know all the answers,” said Utian. “Even a group of experts cannot come out with consensus on certain points. That is good for the public to know.”

The guidelines appear to be founded on a rigorous examination of the scientific data, said Cindy Pearson, director of the National Women’s Health Network, a consumer organization based in Washington, D.C.

“This is a big step forward,” Pearson said. “If this had been common practice in the last 10 years, millions fewer women would have used hormone replacement therapy. Women have had life-threatening conditions that we now know are associated with hormone replacement therapy.”

While the guidelines should help educate women and doctors on the appropriate use of hormones, Pearson said she worries that misleading advertising from dietary supplement manufacturers, pharmaceutical companies, compounding pharmacies and other businesses selling menopausal remedies may confuse consumers.

“There are so many companies sending messages directly to women and to health care providers, making claims that haven’t been proven,” she said.