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Hormone Questions Linger

Experts Address Women's Concerns


By Suz Redfearn

Special to The Washington Post

Tuesday, July 30, 2002; Page HE01


The uproar prompted by this month's findings on the negative effects of hormone replacement therapy (HRT) hasn't abated, judging by reader responses to a Health section query.


In their requests for further information on the risks and benefits of specific therapies and options for alternative treatments, women voiced confusion, anger, worry and, in some cases, a sense of betrayal. "If these products have been sold for 40 years, yet no large-scale clinical studies on their safety were done until five years ago, why should we trust FDA (Food and Drug Administration) approval of any drug as safe and effective?" wrote Joyce Cohen of Falls Church, one of the more than 100 readers who responded


Two major studies set off the furor. The first, being conducted as part of the National Institutes of Health's Women's Health Initiative (WHI), was called off after Prempro, a popular estrogen and progesterone combination therapy, was shown to increase risk of stroke, heart disease and breast cancer in post-menopausal women. The second, being conducted by the National Cancer Institute (NCI), showed that post-menopausal women who took estrogen had a 60 percent greater chance of contracting ovarian cancer than did women who took no hormones.


About 17 million women in the United States take hormones to relieve menopausal symptoms including hot flashes, sleep disturbances and vaginal dryness.


We address some of our readers' most common questions here. In the weeks ahead, we'll explore others. As always, we advise you to talk with your doctor about all treatment decisions.


I've been taking oral contraceptives for peri-menopausal symptom management. What is the implication of the WHI study for women like me -- or for any women taking oral contraceptives, for that matter?


According to Elizabeth Mandell, assistant professor of obstetrics and gynecology in the University of Virginia's Women's Place Mid-Life Health Center, the WHI data can't be applied to peri-menopausal women (those in the transitional period before they stop menstruating) who are taking the pill. That's because, although birth control pills and Prempro both offer a combination of estrogen and progesterone, there are important differences in the two kinds of drugs.


First, Prempro is taken all month, while oral contraceptives are prescribed to be taken for three weeks, then stopped for one week -- to mimic the body's natural hormonal cycle. Some think this cycling may be protective.


Age also appears to be a protective factor. Jacques Rossouw, acting director of the WHI, explained that post-menopausal women have a higher baseline risk of ills such as heart disease, stroke, blood clots and breast cancer than younger women, and it's now clear that adding estrogen and progesterone to their systems exacerbates those serious risks. Since women taking oral contraceptives -- either for birth control or to manage peri-menopausal symptoms -- are younger and healthier than post-menopausal women, Rossouw said, their overall health risk is seen as low.


However, the pill does put women -- especially smokers who are over 35 years of age -- at an elevated risk for blood clots. Women should not take the pill if they smoke, experience migraine headaches that involve visual disturbances (associated with stroke), or have heart problems, liver disease or a history of blood clots.


Birth control pills have been studied extensively and shown to be safe. Rossouw said younger women may also tolerate the pill better because they are still producing the hormones naturally.


Many of the articles I've read about HRT say there's an increased risk of this or that and a decreased risk of something else -- but no numbers are given. Can you put the health risks in perspective?


Before stopping its eight-year study at the five-year mark, the WHI came to the following conclusions:


? Each year 30 out of 10,000 postmenopausal women taking no therapy fall ill to heart disease. For every year women took HRT, they increased their risk of heart disease by seven per 10,000. This means that for every 10,000 women taking HRT, 37 could expect to fall ill to heart disease the first year, 44 the next year, 51 the following year, and so forth. While the absolute risks are small, the increases were viewed as significant, and women's heart risks escalated the longer they stayed on the drugs.


? For stroke, risk rose from 21 per 10,000 (for post-menopausal women not taking HRT) to 29 per 10,000 among those taking HRT, increasing eight per 10,000 per year.


? For pulmonary embolism, risk increased from eight per 10,000 in the post-menopausal women not taking HRT to 16 per 10,000 among HRT users, increasing eight per 10,000 per year.


? For invasive breast cancer, risk rose from 30 per 10,000 among post-menopausal women not taking HRT to 38 per 10,000 among those taking HRT, increasing eight per 10,000 per year.


? For colorectal cancer, risk decreased after taking HRT, from 16 per 10,000 in non-HRT users to 10 per 10,000 HRT users.


? Risk of hip fractures went down, too, from 15 per 10,000 for non-HRT users to 10 per 10,000 HRT users.


For quantitative risks associated with estrogen only, see the next question.


I've had a hysterectomy and have been taking estrogen only for several years. Should I stop, in light of new findings by the National Cancer Institute tying this to an increased risk of ovarian cancer?


James V. Lacey Jr., NCI epidemiologist and lead author of the NCI study, says he hopes this research alone doesn't cause women to go off estrogen, which most women take in the form of Premarin. The study, he said, is meant to help doctors and patients with intact ovaries but no uterus better understand just one of their possible risks. Says Lacey, each estrogen patient should review with their doctor the risks and benefits of estrogen in their particular situation. For some, regardless of any risk factors, staying on may be wise. An example, said Lacey, are women at high risk for osteoporosis, against which estrogen has been shown to be protective. Others who have reason to fear ovarian cancer may consider discontinuing.


"It's very, very subjective," said Lacey.


He added that if a patient has no ovaries, they have almost no risk of ovarian cancer, though in some rare cases tissues left behind from extracted ovaries may form cancerous cells.


Some doctors argue that the NCI study wasn't particularly compelling. Says Mandell, that's because the study evaluated retrospective observational data -- that is, researchers looked at the medical records of women diagnosed with ovarian cancer, examining whether or not they took estrogen. Findings from such studies are not regarded as conclusive as those obtained from randomized, rigorous, double-blind studies, said Mandell.


Additionally, she said, the numbers in the NCI study weren't dramatic. According to the study, 4.4 women out of every 10,000 postmenopausal women not taking estrogen will develop ovarian cancer each year, while researchers found that 6.5 out of every 10,000 taking estrogen developed the disease. The real increases didn't come until the women had been on estrogen for 10 years, when risk increased 80 percent.


Lacey himself added that, even given the increase in risk seen in his data, ovarian cancer is still considered a rare disease, occurring in 329 women out of 44,421 during the 1979 to 1998 study.


The WHI is continuing its study of estrogen use in women who have had hysterectomies. The trial is scheduled to wrap up in 2005.


Is there any value to topical, over-the-counter progesterone creams? Do they carry the same risks as the pills?


No conclusive studies have been done on the many such creams that claim to reduce symptoms of menopause, according to Larry Seidman, clinical assistant professor of obstetrics and gynecology at the Medical College of Pennsylvania. And since these products are not regulated by the Food and Drug Administration, purported uses are not required to be substantiated and their potency may vary batch to batch.


"I don't think we can assume any of them are effective or can't cause side effects," said Seidman.


Some endocrinologists say the progesterone in the creams is not a molecule the human body can recognize, and thus rubbing it onto the skin is useless.


That said, many women swear the creams help with breast tenderness, bloating and the PMS-like symptoms of menopause, said Mandell.



For relief of hot flashes and other menopause symptoms, do any alternative therapies have value?


Menopausal women spend about $600 million annually on alternative treatments for menopause, according to the National Center for Complementary and Alternative Medicine.


Much of that money goes to buy soy products, from supplements to tofu to soy milk. These contain phytoestrogens, plant-based isoflavones that are the slightly weaker cousins of estrogen.


Clinical trials suggest that soy may take the edge off hot flashes, but doctors say its effect is nowhere near estrogen's. It's not known whether large doses of soy promote some forms of breast cancer.


Interest in soy stems from population studies in China and Japan, where soy is a large part of the diet. But doctors say consuming soy at menopause may be too late, as many of the benefits may come from ingesting it throughout one's life. Soy appears to lower total cholesterol, but the doses needed are uncertain. It has had mixed results for bone strengthening. And high doses may interfere with other medications, including tamoxifen. Doctors generally recommend sticking with soy-rich foods and avoiding supplements.


Black cohosh, a plant native to the East Coast, has been used in Europe for symptoms of menopause for more than 50 years. In the United States, it is sold over-the-counter as the dietary supplement Remifemin. Studies show that 40 percent of women taking it have been able to control their menopausal symptoms -- roughly the same as placebo. The National Institutes of Health has a study underway on black cohosh.


How does the WHI study affect medical thinking about using HRT to ward off Alzheimer's disease? My mother was afflicted with this disease for 10 years, and one reason I took HRT was to gain some protection.


While some observational studies over the last decade have hinted that HRT can protect against Alzheimer's disease, with estrogen having a positive effect on brain receptors, more recent research casts doubt on this. The WHI is now studying the matter.


The Medical College of Philadelphia's Larry Seidman likens studies suggesting a protective mental benefit to those that, a few years before, suggested that because HRT lowered cholesterol, it offered a heart benefit -- a claim now recognized as invalid.


While Cynthia Pearson, executive director of the Women's Health Network, a Washington-based watchdog group, thinks there are still good reasons (hot flashes, vaginal dryness) for at least some women to take HRT, if only temporarily, protection against Alzheimer's disease is not one of them."You really are doing an experiment on yourself if that's why you're on estrogen," said Pearson.


For now, though, it's a matter of balancing risks. Says Mandell, if along with a family history of Alzheimer's you have menopausal symptoms as well as heightened risk for colorectal cancer and hip fractures -- both of which HRT has been shown to protect against -- then you may want to take your chances with HRT.


"At this point, it's a leap to say that HRT may protect against Alzheimer's," said Mandell. "But down the road, we may find that out, and it may affect a lot of people's decisions."?

:wow:  :but:

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