You have questions, we have answers. Here’s what’s safe and what’s not, based on the best information available.
Less than a decade ago, artificial hormones were sold as the fountain of youth to women coping with menopause symptoms. Pharmaceutical companies and many doctors touted hormone therapy (HT) as the cure for everything from sagging skin to memory loss, and about 15 million women filled prescriptions in 1999. Then in the summer of 2002, shocking results from the largest study ever undertaken on HT, the National Institutes of Health’s Women’s Health Initiative (WHI), suggested supplemental hormones’ risks far outweighed their benefits, increasing a woman’s risk of heart disease, breast cancer and stroke.
This study of mixed hormone supplementation, a therapy that combined estrogen and progestin, was halted abruptly. Two years later, the trial of estrogen-only supplementation was stopped as well with similar findings. Hormone use in the United States dropped by about 65 percent during that time as Wyeth, the maker of Premarin and Prempro, the hormone drugs used in the WHI study, faced the first of 5,000 lawsuits from users who developed serious health problems. So far, Wyeth has lost two and won two of the cases. The most recent judgment awarded $3 million to a Prempro user in Ohio who developed breast cancer; Wyeth representatives say the company will appeal the judgment.
Fast-forward to last year’s report of a dramatic 7 percent drop in breast cancer rates in women older than 50 between 2002 and 2003. Some experts said the good news was a direct result of millions of women stopping hormone therapy after the WHI results were publicized.
So what’s a woman thinking about her menopausal future to do? And what about the sudden media buzz on “bioidentical” hormones inspired by Suzanne Somers’ best-selling Ageless: The Naked Truth About Bioidentical Hormones?
Read on for what we know — and we are still discovering — about hormone therapy as it applies to you.
Q: What on earth is happening to me? Are my hormones going crazy?
A: Not all of them: Many of the body’s organs and tissues make some kind of hormone (such as insulin), which is secreted into the bloodstream to carry instructions from one cell to another. But the female sex hormones, of which estrogen and progesterone are the best known, do fluctuate and then diminish.
During menopause, the ovaries, after a valiant last-ditch effort, stop producing estrogen, as well as eggs. This means your body no longer needs to make progesterone, which normally would prepare the uterus’ lining for possible egg implantation. “With this lack of estrogen and progesterone, many women experience hot flashes and vaginal dryness and thinning,” says Isaac Schiff, M.D., chief of obstetrics-gynecology at Massachusetts General Hospital and a professor of gynecology at Harvard Medical School.
However, Schiff says, the body does continue to make some estrogen after menopause — the adrenal glands produce androgens (male-like hormones), which are then converted to estrogen. And body fat produces estrogen as well, which is why excess weight is believed to be a risk factor for certain reproductive cancers.
Q: Does my age matter in making a decision about using hormones?
A: Yes, it appears to in one respect. Overall, the WHI findings showed that estrogen plus progestin (the synthetic form of progesterone) increased heart-disease risk by 24 percent. However, WHI participants in their 50s actually saw a 37 percent drop in heart disease. “It seems that if women wait several years after menopause, and the vessels are already damaged, hormone use can be detrimental to the heart,” says Schiff. “But taken earlier, it may protect vessels.”
One of the criticisms of the WHI findings was that the median age of participants was 63 — a good 12 or so years older than the age at which most women seek treatment for menopause symptoms. (Average age of menopause for U.S. women is 51.)However, considering all the as-yet-unanswered questions brought up by the WHI, no one is suggesting taking hormone therapy solely for your heart — at least not yet. A new study, the Kronos Early Estrogen Prevention Study (KEEPS), currently underway at seven sites around the country, is looking at the risks and benefits of hormone use in recently menopausal women.
Q: Does hormone therapy make sense for anyone? Are there circumstances where the benefits outweigh the now-well-known risks?
A: Maybe. For women with severe hot flashes or a high risk of osteoporosis who can’t take other bone-strengthening drugs because they’re ineffective or cause side effects, HT may be the best option, according to a newly updated position statement by the North American Menopause Society, based in Mayfield, OH.
True, WHI and other research shows a higher risk of stroke, blood clots and breast cancer in women who take estrogen-progestin therapy, no matter what their ages. (Women who had hysterectomies and took only estrogen actually show a lowered risk of breast cancer, but if you have a uterus, you need a progestin combination to help protect against endometrial cancer.) However, “women with acute symptoms — intense hot flashes and vaginal atrophy specifically — have few effective alternatives to [supplemental] hormones,” says Nanette Santoro, M.D., professor and director of the division of reproductive endocrinology at Albert Einstein College of Medicine/Montefiore Medical Center, Bronx, N.Y.
Some experts now say a one- to five-year course of hormone therapy at the lowest effective dose may make sense for women who find their symptoms unbearable. “Analyzing individual risk factors and a woman’s personal healthy history with their doctors is the smartest choice for women who are suffering,” Santoro says. “For certain women, hormone therapy may make sense, and it may help protect against diabetes or osteoporosis. There’s just no pat, made-for-everyone answer.”
One caveat: women who have had a heart attack, stroke or an estrogen-receptive cancer ( such as breast cancer or endometrial cancer — or are at increased risk for these conditions because of family history or other factors — should avoid taking hormones altogether.
Q: But “bioidentical” hormones are a safer option, right?
A: No, probably not. Little more than a marketing term, “bioidentical” is used to describe hormones derived from soy and yams (pharmaceutical hormones Premarin and Prempro are synthesized from the urine of pregnant mares). “The word has been abused by compounding pharmacies, some doctors and some marketers who are trying to make out that these formulations are identical to the hormones your body made before menopause,” says Wulf Utian, M.D., Ph.D., executive director of the North American Menopause Society and a consultant in women’s health at The Cleveland Clinic in Ohio. “This is a total fallacy.”
What does appear to be safer is reducing hormone supplementation to the lowest effective level. Since the WHI results were announced five years ago, pharmaceutical companies have been scrambling to deliver lower-dose HT formulations — some contain only about half the estrogen and progestin found in earlier versions. Also newer to the market are alternatives like transdermal patches, creams and vaginal rings that may deliver medication with fewer side effects.
Further confusing the issues surrounding so-called bioidenticals is the fact that the term is used to refer to both non-U.S. Food and Drug Administration-approved formulations that are compounded by pharmacists for individual use, and certain pharmaceutical brands that are FDA-approved. Commercial bioidenticals with the FDA stamp include Vivelle-Dot, Climara or Estraderm. So if these plant-derived option sound more appealing to you, consult with your ob-gyn. Just realize that your body most likely can’t tell the difference and the dosage appears more important than the actual formula in predicting health complications.