To take hormones or not to take them? That is the question that plagues women suffering from nasty menopausal symptoms—those hot flashes and night sweats and the severe sleep deprivation and crankiness that come with them. Some women still opt for traditional hormone therapy, like Prempro, estrogen combined with progesterone, given to protect against endometrial cancer which can be triggered by using estrogen alone. But they're told to take the lowest dose for the shortest duration of time to minimize the increased risk of breast cancer associated with postmenopausal hormone use.
Other women have turned to what they believe to be a safer alternative: bioidentical hormones. These compounds are identical in molecular structure to the sex hormones produced in a woman's ovaries. For this reason, some experts theorize, they may act differently than those hormones most commonly used to treat menopausal symptoms, like conjugated equine estrogens, made from horses' urine, or medroxyprogesterone acetate, made in a lab. Indeed, recent research suggests that bioidentical hormones, created from plant chemicals, may not be as damaging to breast tissue as the most widely-used hormone regimens. A February study using data from the Women's Health Initiative found that taking a combination of estrogen and medroxyprogesterone acetate for five years doubled a woman's annual risk of getting breast cancer; the researchers didn't find the same increased breast cancer risk from women with hysterectomies, who were able to safely take estrogen alone, leading to theories that non-identical forms of progesterone called progestins are the primary culprit.
[See more on hormones and breast cancer.]
A European study of more than 80,000 postmenopausal women published last year in the journal Breast Cancer Research Treatment found that those who took progestins along with estrogen for an average of eight years had about a 70 percent higher risk of breast cancer than those who took bioidentical progesterone or who didn't use hormones at all. "Progesterone is definitely starting to look like a better hormone" than progestins, says Adriane Fugh-Berman, a physician and associate professor in the complementary and alternative medicine master's program at Georgetown University Medical Center. "There's some preliminary basic science showing that it might not stimulate the growth of breast cancer cells as much as synthetic progestins." She says bioidentical estrogens in a spray, gel, or suppository form, which enter the bloodstream directly through the skin, may offer protection against an increased risk of blood clots normally associated with estrogen pills, which enter the blood by passing through the liver, potentially spurring the production of blood-clotting proteins.
Still, Fugh-Berman stresses, "we shouldn't assume human hormones are our friends. After all, women with naturally higher estrogen levels have higher rates of breast cancer, and men with higher testosterone levels have higher rates of prostate cancer. So more is not always better." Where bioidenticals may come in handy, she says, is to treat that subgroup of menopausal women who suffer miserably through sleepless sweaty nights and seek a product that may be safer than traditional hormone therapy. But most doctors agree that those who take bioidenticals should still follow the "lowest dose for the shortest amount of time" rule of thumb.
At the moment, that message may be getting lost in the homage being paid to bioidentical hormones by megawatt celebrities like Oprah Winfrey and actress and bestselling author Suzanne Somers. A January Oprah show featured both discussing their positive experiences on the hormones, which came across as a virtual cure-all for aging. Somers, who takes much higher doses of bioidentical hormones than most experts recommend, believes that the supplements keep her young and feeling sexy and are preventing her breast cancer from coming back. On her website, Winfrey writes, "After one day on bioidentical estrogen, I felt the veil lift. After three days, the sky was bluer, my brain was no longer fuzzy, my memory was sharper. I was literally singing and had a skip in my step."
Many medical experts have expressed alarm over the hype. Susan Love, a breast cancer surgeon and author of Dr. Susan Love's Breast Book, says Somers is taking a "crazy" approach to breast cancer prevention. "It isn't the flavor of the hormones," Love says, "but the fact that we're not supposed to have high levels of hormones during the second half of life." Days after the Oprah show aired, the American College of Obstetricians and Gynecologists issued a press release reiterating the group's stance against the use of "so-called bioidentical hormones." The organization is particularly concerned about the use of those hormones that are compounded from individual ingredients on a patient-by-patient basis by pharmacies. The process can vary widely from pharmacist to pharmacist. Unlike with drugs made in large manufacturing facilities, there is no way of knowing if the product is pure or contains a standardized dose.
Like traditional hormone therapy, some bioidentical products—including estradiol and progesterone in pill form and certain gels, vaginal rings, skin patches, and creams—are FDA-approved drugs. (This chart provides a full list.) However, the bioidentical estrogen estriol is not, nor are any of the products being hawked on the Internet, at cosmetic counters, or in health-food stores. Nor are those formulated in individual compounding pharmacies. The FDA has taken the position that "bioidentical hormones" is a marketing term not recognized by the agency, and the agency "cannot assure their safety or effectiveness" if they haven't been approved as drugs. It has warned several pharmacies to stop making misleading safety and effectiveness claims about their products.
But that hasn't stopped some doctors from claiming that bioidenticals are essential for preventing age-related diseases. In a similar fashion to the way gynecologists used to routinely prescribe Premarin and Prempro to every menopausal woman, these doctors believe that bioidenticals can help stave off breast cancer, heart disease, Alzheimer's, and osteoporosis. "I've reviewed the studies," contends Kent Holtorf, a family practitioner with a private practice in Torrance, California. "Synthetic progestins increase the proliferation of breast cancer cells, whereas bioidentical progesterone decreases it." He says he prescribes progesterone to treat precancerous breast lesions and gives bioidentical estrogen to halt the progression of cardiovascular disease. And he doesn't worry about his patients staying on bioidenticals for years or even decades or see any reason to restrict prescribing them only to those with menopausal symptoms. "I'm not going to say these hormones have no risks," Holtorf says. "There are always risks to anything you take, but I look at particular patients and see if the risks outweigh the benefits."
While Holtorf's practices are certainly on the fringe, more and more doctors these days feel comfortable prescribing FDA-approved bioidentical hormones for the relief of menopausal symptoms. Isaac Schiff, chief of obstetrics-gynecology at Massachusetts General Hospital in Boston, says he doesn't believe there's enough evidence to show bioidenticals are any safer than traditional hormone therapy, but he will prescribe estradiol or progesterone pills if a woman asks for bioidentical hormones to relieve menopausal symptoms. He'll also explain that while estradiol is, indeed, made by the ovaries, it gets converted by the liver into estrone, which is not. "If she wants a true bioidentical, I'll prescribe an estrogen skin patch or gel in which estradiol bypasses the liver and remains in its original form." He also tells patients that believing "one estrogen is safer than another when it comes to breast cancer, I think, is wishful thinking." Others like, Fugh-Berman, believe there's enough evidence now to say that progesterone is probably a safer bet than synthetic progestins when it comes to considering breast cancer risks.
So how should you proceed if you have menopausal symptoms and want to try bioidentical hormones? Here's our user's guide.