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May 2004
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Alternatives to hormone replacement therapy come under scrutiny

Paula Amato, MD
Paula Amato, MD

The past few years have been hard on women in menopause. First, the Women’s Health Initiative, the largest study of women’s health ever undertaken, advised that the health benefits of taking a combination of estrogen and progestin did not outweigh the health risks. As a result, millions of women around the world stopped taking these hormones. This year, the same study determined that for most women who had had hysterectomies, the risk of taking estrogen did not outweigh the benefits.

The WHI is a major 15-year research program to address the most common causes of death, disability and poor quality of life in postmenopausal women -- cardiovascular disease, cancer, and osteoporosis. Because hormone therapy was thought to prevent cardiovascular disease as well as osteoporosis, testing its effects on women’s health was natural. The results of the study were surprising to many women and their physicians.

There are other drugs that fight osteoporosis, and many women turned to them for that problem. The hot flashes, however, remained. While some women resorted to late-night showers, cool packs and high electricity bills associated with extreme air conditioning, others turned to alternative or herbal treatments such as black cohosh and soy products that contain phytoestrogens.

Donald Marcus, MD
Donald Marcus, MD

The situation is ironic. Convinced by science that their hormone replacement therapy is not good for them, these women jump toward treatments about which there is little or no information. Baylor College of Medicine researchers Donald Marcus, MD, and Paula Amato, MD, reviewed the medical literature and found little to recommend the therapies. Their study appears in a recent issue of the journal Climacteric.

“I see many women who come to me with symptoms and want advice,” said Amato, a BCM assistant professor of obstetrics and gynecology. “When the WHI results came out, many women stopped taking their hormones and turned to alternative therapies. I don’t blame them (the patients). Unfortunately, there are problems with the alternatives because they are not regulated.”

While some women have always used the alternatives, Amato said the issue has come to the fore in the wake of the WHI results.

“The thing most women don’t realize is that there is little verification of the claims made by these herbal preparations,” said Marcus, a BCM professor of medicine (allergy, immunology and rheumatology). “For example, black cohosh has no estrogenic properties. Soy isoflavones, which are a component of soy, have some properties of estrogen but lack others. There is no evidence they are effective for treating hot flashes.”

In many cases, claims that these preparations help are made in advertisements, which are not regulated by the U.S. Food and Drug Administration. Prescription and over-the-counter medications that receive FDA approval must meet the agency’s advertising guidelines as well.

“Women who criticized physicians for prescribing hormones with incomplete evidence are now turning to alternative compounds that have not been tested or approved,” said Marcus.

As with any other treatment, said Amato, the risks of alternative therapies must be weighed against their benefits. Currently, neither risks nor the benefits are well defined.

“I don’t think they view the herbal compounds as medicines,” said Amato. “They believe they work.”

When her patients come to her with concerns about hot flashes, she weighs the benefits and the risks.

“I start some of my patients on low-dose anti-depressants,” she said. Until studies of herbal compounds are complete and they are better understood, she will not recommend them to her patients.

“Some of these things don’t work, but our position is that they need to be studied,” she said.

Climacteric 6:278-284, 2003.

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