Last summer, the federal government halted part of a major study of hormone-replacement therapy, saying a common combination of medications used by women to ease the symptoms of menopause, and possibly protect themselves from heart disease and osteoporosis, might be doing more harm than good.
All at once, the popular treatment regimen was thrown into controversy.
As confusing and frustrating as the controversy has been, however, some pharmacies and a physician here say the experience has helped spotlight an alternative treatment, called bio-identical hormone-replacement therapy. They claim bio-identical hormones have many of the same benefits as conventional hormone-replacement therapywhich, for a woman who hasnt had a hysterectomy, typically uses a synthetic hormone and a derivative of horse urinewith potentially lower risks.
We have been overwhelmed with people wanting more information on these bio-identical hormones, says Cathy Hudek, director of pharmacy at FirstPharma, a Spokane company that compounds, or custom makes, such treatments.
Bio-identical hormones are taken from soy or wild yams and are processed in a laboratory to produce a pure hormone that has the same molecular structure as a human hormone, Hudek says.
Youre just replacing the same thing your body was making, she says.
Dont, however, confuse bio-identical with natural, says Dr. Cheryle Hart, a gynecologist here who has prescribed bio-identical hormones for four years through her Wellness Workshop.
Premarin (an estrogen replacement) is from horse urine and thats considered natural, but thats not bio-identical, Hart says. A brand called Estrace (another estrogen replacement) is synthetic and bio-identical. Bio-identical simply implies that it is the same molecule that the human body makes. Its a big difference.
Bio-identical hormones are available only with a doctors prescription and almost always are compounded in specific combinations and doses for each patient. They can be administered in a variety of ways, from capsules, to topical creams, to lozenges. Therapies such as Premarin are more one-size-fits-all medications that arent compounded in doses for individual patients.
The cost of bio-identical hormones is roughly equal to the cost of conventional hormone-replacement therapy, and most of the better insurance companies pay for it, says Mike Coppedge, a pharmacist who owns Acology Prescription Compounding Inc., in Coeur dAlene.
Hart says she typically prescribes bio-identical hormone-replacement therapy for women who want to manage the side effects of menopause, such as hot flashes and insomnia. She still prescribes synthetic hormones when theres a medical reason, such as controlling excessive menstrual bleeding or regulating menstrual cycles, she says.
Synthetic hormones are stronger than bio-identicals, Hart explains. It takes several months to adjust someones periods with bio-identicals because theyre weaker. Even the so-called mini-pill, a birth-control pill that uses a very low dose of a synthetic version of the hormone progestin, is 100 times stronger than the bio-identicals, Hart says.
Thats why were promoting (bio-identical hormones) for long-term use, she says. Theyre just strong enough to do the job, but not too strong to cause the concerning side effects.
And what of those side effects?
The use of synthetic hormones has long been recognized as having the potential to cause bloating, nausea, headaches, and tender breasts, but women continued taking them because of their beneficial effects.
Then, last summer, the National Institutes of Health stopped, three years early, a long-term study of the use of combined hormone-replacement therapy (progestin and estrogen), saying the risk of such therapy outweighed its benefits. Results of the first five years of the Womens Health Initiative study showed that women who took the most common form of combined hormone-replacement therapy, Prempro, had a significantly higher risk of breast cancer, stroke, heart attack, and dangerous blood clots than did women who took a placebo. Prempro is made from Premarin, an estrogen replacement that is made from the urine of pregnant mares, and Provera, a synthetic progestin replacement.
Its not possible to say for sure whether bio-identical hormones pose the same level of risk, Hudek says.
There havent been any large studies on these natural hormones because nobody wants to pay for it, she says. Because such hormones are derived from natural sources, they cant be patented, and without that ability, drug companies have no reason to pay for extensive testing, she says.
Still, she says, because bio-identical hormones are the same as those your body produces, if those drugs were going to cause cancer, youd see a lot of cancer in women who are 25, 30 years old whose levels are very high, and thats not the case, she says.
Nancy Woods, the Seattle-based dean of the University of Washington School of Nursing and an expert on menopause-related health issues, says she would err on the side of caution when dealing with any estrogen-containing therapy.
One of the things we have to keep in mind here is that while the Womens Health Initiative and HERS (another big hormone-replacement therapy study) did not evaluate all possible estrogen compounds, that absence of data doesnt mean absence of risk, she says.
Coppedge, the Coeur dAlene pharmacist, says he tells women that nothing is perfect, so they need to consider the benefits versus the risk. If they decide the benefit of hormone-replacement therapy outweighs the risk, the best thing to do is go with the safest and most natural estrogen possible, and keep the dosage as low as possible, he says.
Further, Hart, the gynecologist, says she measures hormone levels in her patients to ensure that theyre not getting more than they needthat theyre taking only as much as their bodies once produced.
I couldnt believe when I started measuring how much excess women were taking. They dont need so much, she says.
FirstPharmas Hudek also says she believes its important to take bio-identical hormones in a cream or sublingual form, such as a lozenge or drop thats absorbed directly into the lining of the mouth, so that the hormones arent metabolized by the liver.
Kelly Armstrong, pharmacist and owner of Fifth & Browne Pharmacy here, says she ramped up her bio-identical hormone compounding business a year ago due to increased demand for the productsbefore the Womens Health Initiative study results were made public.
Its just been an area of interest for people, she says. It just seems more common sense, I guess, to be putting something back into your body that was already there.
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