The Latest on Hormone Therapy for Women
Kareem IliyaIts not often that a middle-aged former sitcom star is at the center of an important health debate. But Suzanne Somerss hormone therapy—she takes bioidentical hormones, injects her vagina with a hormone called estriol, and rubs estrogen or progesterone cream on her arms every day—has put her in the limelight.
While her hormone replacement routine is extreme (she even continued taking hormones after she was diagnosed with breast cancer in 2000, a controversial move), she does seem to have beaten off what she calls “The Seven Dwarves of Menopause: Itchy, Bitchy, Sleepy, Sweaty, Bloated, Forgetful, and All Dried Up.” Seeing Somers (shes 62, but looks younger), you cant help but wonder if she isnt on to something.
But hormones? It wasnt that long ago that a large clinical trial, called the Womens Health Initiative (WHI), showed that estrogen-progesterone hormone replacement therapy (HRT) upped womens risks of breast cancer, heart disease, stroke, and blood clots. The research caused a global panic and led to a dramatic drop in the use of HRT.
Later, the results of the trial were questioned, but the backlash remained: Some doctors and experts are still leery about hormones—even as the buzz about them grows. In fact, earlier this year, while Somers was touting her hormone therapy on Oprah, researchers were putting the finishing touches on a new study that links HRT with an increased risk of ovarian cancer.
No wonder women are confused! To complicate matters, this debate is being played out at a time when womens bodies are already steeped in hormones. We start our periods earlier and absorb estrogenlike chemicals from the environment. That makes the questions—Are hormones safe or not? Are bioidenticals like Suzanne Somers takes better than traditional hormone therapy?—even more urgent. Here, the answers.
Next Page: In the beginning: The Pill [ pagebreak ]
In the beginning: The Pill
Roughly 30 percent of American women are introduced to hormones via the Pill, the most popular form of birth control, which is also regularly prescribed as a way to mute PMS, control erratic periods, and diminish hormonal acne. In most cases, the Pill contains both estrogen and progesterone, which work together to prevent the body from releasing an egg every month.
For most healthy women the risk of getting pregnant far outweighs any potential risk posed by being on the Pill, says Margaret Wierman, MD, professor of medicine, physiology, and biophysics at the University of Colorado and chief of endocrinology at the Denver VA Medical Center. In fact, years of studies show that using the Pill doesnt increase the risk of breast cancer for women with no underlying predisposition.
There is a slightly elevated chance of blood clots, and if you smoke, have high blood pressure or migraines with aura, taking the Pill may hike your risks of heart attacks or stroke.
“But as long as a woman is in reasonably good health and doesnt smoke, she can take the Pill for as long as she likes—even in her 40s and up until menopause,” says Mary Jane Minkin, MD, clinical professor of obstetrics and gynecology at Yale School of Medicine.
Reducing the number of times a woman ovulates is actually good for her, says Serina Floyd, MD, assistant professor of obstetrics and gynecology at the Duke University School of Medicine: “The longer you take the Pill the more it protects against endometrial and ovarian cancers.”
Research shows that women who took the Pill for five or more years had about half the risk of getting ovarian cancer as nonusers. And if you do get ovarian cancer, a new study suggests that your odds of dying from it may go down if you took the Pill earlier in life. Even pills that are continuous are safe, Dr. Floyd says: “You can take the Pill 365 days a year and, yes, youre exposed to more estrogen—but that doesnt translate into more risk.”
The HRT confusion
If the research supporting the Pill is bedrock, youll find duct tape and glue holding up the house of HRT. Marketed as the answer to womens prayers, HRT was designed to replace an aging womans waning hormones and wipe out such menopausal symptoms as night sweats and hot flashes. As an added bonus, the extra estrogen was also thought to help prevent age-related heart disease and osteoporosis.
During the 1990s, “hormones were considered the holy grail of antiaging,” says Wulf Utian, MD, PhD, executive director of the North American Menopause Society and professor emeritus of reproductive biology at Case Western Reserve University School of Medicine. Up to 40 percent of menopausal women in the United States took HRT.
But that all came to an end in 2002, when the WHI clinical trial dealt HRT a death blow. “A lot of fish were inundated with estrogen that summer because every woman in America flushed her hormones down the toilet,” Dr. Minkin says. “When women hear that something may increase their risk of breast cancer, they panic.” Even after it turned out that the negative impact for younger women may have been overstated because of an age disparity (the average age of a woman entering menopause is 51; the average age of women in the trial was 64), HRT couldnt shed its bad rap.
Next Page: Enter bioidenticals [ pagebreak ]
During the period when traditional hormone replacement was persona non grata, many women began wondering about bioidentical hormones, which are made from plants—soy and yams—and after processing have the same molecular structure as the bodys own hormones. (Most traditional hormones are derived from the urine of pregnant mares.)
Because bioidenticals mimic a womans natural hormones, celebrity advocates like Somers and Robin McGraw (wife of Dr. Phil of Oprah fame) tout them as safer than other hormones. Over-the-counter and bioidentical progesterone creams, sold as a way to quell pre- and perimenopausal hot flashes and other symptoms, also caught on like wildfire. But should you bite? Not so fast, say some womens-health experts.
“The notion that a hormone is safer just because it is bioidentical is a lie,” Dr. Utian says, “but the public is desperate for a silver bullet.” Also at issue is the fact that many bioidentical hormone treatments are whipped up by a compounding pharmacist according to a doctors prescription, not unlike a chef following a recipe.
This makes Dr. Utian and many others nervous because the end products arent approved by the Food and Drug Administration (FDA) for dose, purity, and safety. But proponents of compounding, like C.W. Randolph Jr., MD, co-founder and medical director of the Natural Hormone Institute of America in Jacksonville, Florida, say the ability to individualize a hormone blend (usually estrogen, progesterone, and sometimes testosterone) to meet each patients needs trumps the FDAs cookie-cutter approach.
Dr. Randolph, whos also a registered pharmacist, says he has treated more than 15,000 women with compounded hormones—for everything from progesterone deficiency in their 30s to menopausal symptoms in their 50s. (He also sells his own OTC progesterone cream online.) Like anything, he says, the product is only as good as the pharmacist mixing it.
For women who want the best of both worlds—Somerss apparent vitality and the governments stamp of approval—there are a number of FDA-approved bioidentical products, including Vivelle-Dot, Estrasorb, and Prometrium, as well as generics. This is a great compromise, Dr. Utian says. “You can get FDA-approved bioidenticals in a prescription from your doctor at a fraction of the price.” Your doc can help you decide which product is best.
One thing you wont find in an FDA-approved product for women is testosterone, a serious shortfall, according to some practitioners. “About 50 percent of menopausal women experience declining testosterone,” says JoAnn Pinkerton, MD, medical director of the Midlife Health Center and professor of obstetrics and gynecology at the University of Virginia. Low testosterone levels often take the heat for a common postmenopausal complaint: an AWOL sex drive.
Although a testosterone patch for women was highly anticipated, the FDA nixed it due to safety concerns. “Research shows that a high dose increases the number of satisfying sexual encounters by just one a month, and it does have side effects,” Dr. Wierman says. Still, a knowledgeable doc can prescribe testosterone “off-label,” if you need it. And a low dose is considered safe by many. Proponents point to Europe, where women have used testosterone to turbocharge a flagging sex drive for years.
Next Page: The debate heats up [ pagebreak ]
The debate heats up
As alternative hormone therapies become more popular (even Oprah has tried bioidenticals and said she loved them), experts are lining up on both sides of the debate. Progesterone creams seem to incite particularly strong feelings. Dr. Randolph is a proponent of using bioidentical progesterone creams to treat pre-, peri-, and menopausal symptoms; he goes so far as to say that “all pre- and perimenopausal women need some progesterone” and that “conventional doctors are behind the times.” But menopause experts like Dr. Utian say that its all marketing hype: “Women need to see through the noise being generated by so-called experts.”
Whether docs are for or against compounded bioidenticals and progesterone creams has a lot to do with whether they believe in hormonal testing. Its a huge point of contention between docs like Dr. Randolph—who uses either blood or saliva testing to measure womens hormone levels, and then prescribes custom compounded hormones to treat them—and experts like Dr. Utian and Dr. Minkin, who believe testing is unnecessary at best and exploitative at worst. Says Dr. Utian, “There is absolutely no rationale for measuring blood hormone levels for the purposes of giving hormone therapy, because levels change from moment to moment and day to day during a 28-day cycle.”
Anne Ford, MD, assistant professor of obstetrics and gynecology at the Duke University School of Medicine, takes a slightly more moderate view: “Very rarely do I test. I know a lot of compounding people think you should test salivary estrogen levels, but the normal level is so broad that it seems like a waste of money.”
She will prescribe compounded hormones if a patient needs them, but when it comes to OTC progesterone creams she tells her patients that “there are no large randomized trials saying the cream makes a difference, and we dont know how much is absorbed.” Many are low-strength yam-based products, and putting them on isnt going to hurt, she says; at best, there may be a placebo effect.
Next Page: Whats a woman to do? [ pagebreak ]
Whats a woman to do?
So should you or shouldnt you try any kind of hormones? “I think the fallacy is that either no woman should get estrogen or all women should get estrogen,” Dr. Wierman says. “Hormones shouldnt be put into the water supply. But they shouldnt be restricted, either. We need to figure out the right dose for the right person.”
To figure out if HRT is right for you, you have to go beyond the buzz and determine your own risks and benefits, says Dr. Pinkerton, who prescribes both traditional hormones and bioidenticals. Factors to consider include: your cancer history, your age (younger than age 60 and within 10 years of menopause is best), the intensity and frequency of your symptoms (20 hot flashes a day versus 2), and how much your symptoms interfere with your quality of life (chronic insomnia, for example, needs to be addressed).
If you have a personal history of breast cancer, HRT is not recommended. (Even Suzanne Somers got resistance from her doc when she continued hormones after her breast cancer diagnosis.) Thats because theres some evidence that extra estrogen may breathe new life into otherwise-dormant breast cancer cells. And, after all, breast cancer diagnoses dropped by an estimated 14,000 cases in 2003 after hormone use declined the year before. That HRT-and–breast cancer link still worries docs.
But women who dont have a breast cancer risk and who fill the bill in other ways can benefit enormously from low-dose hormone therapy, many doctors believe. Even after HRTs fall from grace, Dr. Minkin continued to prescribe it. “Im pro-estrogen,” she says. “I think its fabulous for hot flashes.” And younger women (not the older ones over-represented in the WHI study) are less likely to experience harmful side effects, she says.
If you choose HRT, the FDA strongly recommends that you take the lowest effective dose—whether its a pill, patch, cream, synthetic or bioidentical—for the shortest period of time. The recent study linking HRT to ovarian cancer supports the short-and-sweet approach: Hormone users saw their risks drop to nonuser levels after being off of hormones for two years.
Also critical to the safe use of hormones is having a doctor wholl do the trial and error with you, Dr. Ford says. It takes time to find the lowest-dose product that relieves symptoms for each patient, she says. Some therapies dont work for some women because of the way theyre metabolized in the liver.
“Switching from pills to transdermal patches—which arent processed first through the liver and, therefore, have lower risks for blood clots—may work better for some women,” she says. Dont think your doc wants to spend that kind of time with you (perhaps her practice is more geared to delivering babies)? Look for someone with special training in womens hormones, such as a Certified Menopause Practitioner; you can find one at Menopause.org.
When it comes to taking bioidenticals that havent been FDA-approved, know that its buyer beware. At the very least, get a recommendation for a compounding pharmacy from your doctor. Ask the pharmacist how many years he or she has been compounding hormones. “The longer the better,” Dr. Randolph says. To find a compounder whos accredited by the Pharmacy Compounding Accreditation Board, visit PCAB.info.