It's been seven years since the U.S. Food and Drug Administration issued its warning about potential health risks associated with hormone replacement therapies containing synthetic estrogen, prompting millions of mid-life women to toss their prescriptions.
In the years since, the FDA has approved new, safer hormone formulations to treat menopausal symptoms ranging from hot flashes and night sweats to vaginal dryness. They're used by millions of women.
But "one-pill-fits-all" treatment isn't for everyone, says Kay Leslie of St. Petersburg, who tried several estrogen-based medications without relief from the daily discomforts of menopause. "I really didn't want to be on a synthetic hormone for the rest of my life, especially if it's not resolving my problems," she says.
Instead, the 48-year-old financial manager decided to take a less conventional approach to restoring her body's hormonal balance known as bioidentical hormone therapy. Used by natural medicine practitioners for years, the controversial therapy gained national attention recently when featured on Oprah Winfrey's daytime talk show.
Unlike synthetics, bioidentical hormones are derived from plant sources — soy and yams — and are touted as an exact chemical match to the body's natural hormones. Some plant-derived hormone products are made by drug companies, approved by the FDA and sold in standard doses.
But the hormone therapies plugged by celebrities like Winfrey and actor-turned-author Suzanne Somers — as well as women like Kay Leslie — are the custom blends mixed by special compounding pharmacies on a case-by-case basis. The formulations can then be made into tablets, creams, suppositories, oral drops and nasal sprays. The ingredients are legal, but the custom compounding is not FDA-approved.
"If it's done with responsible measurements and monitoring, it's a very safe approach," says Dr. George Springer, a natural medicine chiropractor at Lifeworks Wellness Center in Clearwater, where mid-life women have been successfully treated with compounded bioidentical hormones for more than 10 years.
Kay Leslie's first visit to the clinic last year included a complete wellness exam and a series of diagnostic tests, including an analysis of estrogen, progesterone, testosterone, adrenal and thyroid hormones. Based on the findings, a hormone cream compounded specific to her needs was formulated. She's been using the cream, which can be rubbed on the inner wrist, upper arm or thigh, for about six months.
"I have never been so happy. I haven't felt this normal in 10 years," says Leslie, who's finally free of the hot flashes, night sweats, insomnia and other symptoms of menopause.
In other words, she feels like her life is back in balance. So, too, are her hormone levels, which is the goal of individually compounded bioidentical hormones, notes Springer. By getting hormones back in synch, menopause symptoms typically subside, including what Springer calls the "big five": hot flashes, insomnia with fatigue, vaginal dryness, loss of libido and mood swings.
Experts advise caution
The medical community is at odds over compounded bioidenticals, and earlier this year the FDA issued warnings to a handful of compounding pharmacies for making misleading claims. Experts recommend that consumers look for compounding pharmacies accredited by the Pharmaceutical Compounding Accreditation Board (www.pcab.org).
Professional groups, including the American College of Obstetrics and Gynecology and the North American Menopause Society, insist there isn't adequate scientific evidence to support compounded bioidentical therapy and say individually mixed compounds can't be tested for consistency. But that hasn't stopped the growing interest in bioidenticals.
BodyLogicMD, a national physician network specializing in bioidentical hormone therapy, says it opens a new location every month, including a Tampa practice earlier this year. The physician-owned practices combine bioidentical hormone therapy with fitness and nutrition programs. Individualized hormone products are compounded by a national compounding pharmacy.
"Many women breeze right through menopause, and some aren't as lucky," says Tampa's BodyLogic anti-aging physician, Robert Rubin. "Stress can impact when you start your menopause and how severe the symptoms are, but everybody's different. Your needs are different and your complaints are different."
For all the discord over how bioidentical hormones are compounded, there's one thing medical experts do agree on: Hormones alone aren't a magic cure. A healthy lifestyle combining good nutrition, exercise, stress reduction and other positive measures are essential to achieving a healthy balance during the menopausal years.
Yvonne Swanson is a freelance writer in St. Petersburg specializing in health and gardening. She may be contacted at firstname.lastname@example.org.