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Remember July 2002? Some think of it as the summer that changed women's health care forever. That's when researchers abruptly halted part of the Women's Health Initiative (WHI), a major federally funded clinical study designed to assess the effect of long-term use of hormone therapy (HT) on women's health. Early results indicated that postmenopausal women using a combination estrogen/progestin medication called Prempro faced a slightly increased risk of breast cancer, heart disease, stroke and blood clots, results that were deemed too risky to ethically allow women to continue on the drug.
Almost overnight, it seemed, women were ditching their hormone therapy like a bad stock. Doctors around the country counseled patients to stop taking hormones, and even the U.S. Food and Drug Administration (FDA) jumped into the fray, requiring that a so-called "black box," the agency's strongest warning label, be added to all estrogen products warning women of the potential risks.
What a difference two years can make. When investigators announced in March 2004 that they were ending the other major part of the WHI study early-the one involving the estrogen-only product, Premarin-because results showed participants had a slightly increased risk of stroke, the world took the news relatively calmly, with little of the hysteria and media frenzy that ensued in 2002.
It may be now that women are realizing they shouldn't have thrown the baby out with the bathwater, says Carol Landau, PhD, a clinical professor of psychiatry and human behavior at Brown Medical School in Providence, RI, whose clinical practice focuses on menopausal women. Just as the original findings of the WHI were oversimplified, she says, so, too, was the message of what women should do about them.
"I think the message here is that hormone therapy is still appropriate for recently menopausal women with significant symptoms," says JoAnn E. Manson, MD, DrPH, the Elizabeth F. Brigham Professor of Women's Health at Harvard Medical School, Boston, MA, and a principal investigator of the WHI.
The key is tailoring hormone therapy to an individual woman's needs. And, with more than 20 varieties of hormone therapy on the market today, ranging from creams and gels, to patches, rings and pills, that's easier to do than ever before.
Here's the reality behind the WHI: In 2002 the WHI found that women taking the hormone therapy Prempro, composed of progestin (a synthetic progestogen known as medroxyprogesterone acetate or MPA) and conjugated equine estrogen, had a 26 percent increased risk of invasive breast cancer, a 29 percent increased risk of heart attack, a 41 percent higher rate of stroke and more than a 100 percent increase in blood clots in the lung. Later results also found women taking Prempro had twice the risk of dementia compared to those not using any hormones.
When examined in terms of individual risk, the results paint a far less frightening picture. Of 10,000 women taking HT, over the course of one year 23 additional women would develop dementia, eight more would have blood clots in the lung, strokes, or breast cancer, and seven more would have heart attacks or other coronary events, than women not taking Prempro. But don't forget the study's good news: Over the course of a year, those 10,000 women taking Prempro would have five fewer hip fractures and six fewer incidences of colon cancer.
Since July 2002, researchers and health care professionals have raised significant questions about the WHI. For instance, many experts note that with an average participant age of 63, the women in the study started taking hormone therapy 10 to 15 years later than most women do, a delay that could have significantly affected the outcome.
Plus, the North American Menopause Society, in a statement on the WHI released in September 2003, cautioned that the effects of hormone therapy on the risk for breast cancer and osteoporotic fractures on perimenopausal women-the ones most likely to need hormone therapy for symptom relief-have not been established.
Whether you stop hormone therapy or continue it, you need to consider your own health risks and where you are in the menopausal process. "Women who are recently menopausal have a very low baseline risk of heart disease," says Dr. Manson.
And while the research is pretty clear about the fact that starting hormone therapy 10 to 20 years after menopause is not advisable, especially for the purpose of preventing chronic disease, Dr. Manson says, "there are very few women in that age group who experience the primary symptom that drives most women to hormone therapy in the first place: hot flashes. As far as its use for moderate to severe hot flashes, I think it still has a role in clinical practice for short-term treatment and is the most effective treatment out there."
Indeed, the WHI study found that 77 percent of the 2,000 women in the study who complained of hot flashes said their flashes diminished while on Prempro. Of course, keep in mind that women with severe hot flashes were not included in the study to begin with, since they would have known immediately whether they were taking the drug or a placebo. The results of the medication's effectiveness in reducing hot flashes have not been released yet.
While there are non-hormonal options for hot flashes (including some antidepressants, some antiseizure and antihypertensive medications, as well as black cohosh, an herb), none are as effective as hormone therapy and none are FDA-approved for the purpose.
It's important that women don't ignore their symptoms and be aware that they still have hormonal options in the post-WHI world, suggests Dr. Landau. "My view is there is no need to 'tough it out,'" she says. Untreated hot flashes can lead to depression due to lack of sleep, cautions Dr. Landau.
Thus, she and other experts recommend that women who feel they still need hormone therapy for symptom relief talk to their health care professionals about starting on the lowest possible dose, then gradually increasing it until they're comfortable. They might also consider using trans-dermal hormonal options, such patches or gels, instead of taking hormones orally, says Dr. Manson. Because transdermal estrogens are metabolized by the liver in much lower concentrations than estrogens taken orally, estrogens from transdermal formulations are less likely to increase clotting factors, triglycerides and inflammatory markers such as CRP, all of which can play a role in heart disease and stroke.
For problems with vaginal dryness and sexual dysfunction, which can interfere with intimate relationships, women may want to consider a topical estrogen formulation, such as an estrogen ring or estrogen cream, suggests Dr. Manson. These formulations work locally on the areas to which they are applied and only small amounts are absorbed by the body as compared with oral formulations.
To read a full version of this issue or subscribe to the National Women's Health Report, visit: http://www.healthywomen.org; call toll free: 1-877-986-9472; or write to:
National Women's Health Resource Center, 157 Broad StreetSuite 315, Red Bank, NJ 07701
This publication was supported by an educational grant from Solvay Pharmaceuticals
The National Women's Health Report provides health information for women interested in making informed decisions about their health. This information does not suggest individual diagnosis or treatment. This publication is not a substitute for medical attention. The publisher cannot accept responsibility for application of the information herein to individual medical conditions. The National Women's Health Resource Center does not endorse or promote any medical therapy or device. Opinions expressed by individuals consulted for this issue do not necessarily reflect those of the Resource Center.
The National Women's Health Report is now available online. Visit http://www.healthywomen.org to subscribe.
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