Is Bio-Identical Hormone Therapy Safe?
Bio-identical hormones can offer welcome relief to debilitating menopause symptoms, but not without risk. Research is ongoing, but here's what we know now.
By Regina Boyle Wheeler
Medically Reviewed by Lindsey Marcellin, MD, MPH
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Just what is bio-identical hormone therapy? Is it a “natural” and safe alternative to standard hormone replacement therapy for menopause symptoms — or is it a potentially risky menopause treatment?
Interest in bio-identical hormone therapy started to take off in 2002 when a large study called the Women’s Health Initiative (WHI) was halted after researchers discovered an increased risk of breast cancer, heart attack, stroke, and other problems in post-menopausal women taking hormone replacement therapy.
The hormone used in that trial was an FDA-approved combination of non-bio-identical estrogen and progesterone. Many women stopped taking hormone replacement therapy (HRT), and some went looking for alternatives.
Unlike conventional hormone therapy that uses synthetic hormones or animal-based hormones that are slightly different from a woman’s own hormones, bio-identical hormones are biochemically the same as those made by the ovaries during a woman’s reproductive years, explains Charla Blacker, MD, a reproductive endocrinologist at Henry Ford Hospital in Detroit.
“The three major hormones made by ovaries are estradiol, progesterone, and testosterone,” says Dr. Black. “There are others that can be included such as DHEA or pregnenolone; however, most physicians do not include them as part of a mixture to replace a woman’s reproductive hormones.”
Within the category of bio-identical hormones, there are two types: preparations pre-made and distributed by major pharmaceutical companies and those made up in a compounding pharmacy. Both kinds can be created in a number of forms, including pills, creams, patches, and gels as well as vaginal rings.
The Controversy Over Bio-Identical Hormone Therapy
While the individual ingredients likely used by compounding pharmacies are approved by the U.S. Food and Drug Administration (FDA), the actual finished product is not. Prescription pharmaceuticals (such as the conventional hormone preparations) are FDA-regulated and guaranteed to be the same strength each time; whereas, compounding pharmacy versions of bio-identical hormones can contain slightly different dosages from batch to batch.
Compounded bio-identical hormones are sometimes touted as “all natural” and safer than standard hormone replacement therapy. Some well-known celebrities swear by them, saying they feel decades younger. But according to the American Congress of Obstetricians and Gynecologists (ACOG), there have been no large long-term clinical trials that have studied their safety and effectiveness. ACOG believes that compounded bio-identical hormones should be considered to carry the same risks as FDA-approved drugs, such as those uncovered in the WHI study, and possibly even more.
Robert S. Wool, MD, an ob-gyn at Noble Hospital, Mercy Medical Center, and Baystate Medical Center and in private practice in Westfield and Springfield, Mass., has concerns as well. “In my honest opinion, I believe bio-identical hormones (filled at a compounding pharmacy) are a marketing ploy,” he says. “They are the same hormones, estrogen and progesterone, but are ‘custom made’ for each patient that requests them.”
The FDA Take on Bio-Identical Hormone Therapy
FDA makes the following points about compounded bio-identical hormone therapy:
- Since compounded bio-identical hormones are not FDA-approved, the federal government does not put them through rigorous safety evaluations. While drug companies are required to include safety warnings on drug labels and report adverse side effects, compounding pharmacies are not required to do either.
- Preparation methods can vary from one pharmacist to another and from one pharmacy to another, so women may not get consistent amounts of hormones. (However, the International Academy of Compounding Pharmacies says compounding pharmacies are regulated at the state level and there are national standards and guidelines for compounded drugs.)
- Some compounded hormone preparations contain estriol, a very weak estrogen that is not FDA-approved for use in any drug.
- A woman’s prescription is sometimes based on results of saliva hormone testing done at the compounding pharmacy. The FDA and other groups say the test should not be used to adjust hormone doses because hormone levels are unpredictable and can vary greatly, even in one day.
- Despite some marketers’ claims, bio-identical hormones cannot cure Alzheimer’s disease, heart disease, or cancer.
- The North American Menopause Society (NAMS) says that although custom-compounded hormones may relieve menopause symptoms, they should be used only by women who cannot tolerate FDA-approved drugs.
The Pros and Cons of HRT
More research needs to be done on the benefits and risks of bio-identical hormones as compared to traditional hormone therapy. However, here is what is known at this point in time.
“An increasing number of studies indicate that estrogen itself does not seem to increase the rate of breast cancer whether given as estradiol, Premarin, or another form of estrogen,” says Dr. Blacker. “However, the addition of synthetic progestins, such as medroxyprogesterone acetate, norethindrone acetate, and others, are associated with higher rates of breast cancer in women using combined hormonal therapy. There is some data that [suggest] progesterone — the natural hormone — does not increase the rate of breast cancer, however.”
Other advantages include women possibly experiencing less bleeding and less puffiness when on natural progesterone instead of some synthetic progestins. It is also easy to measure blood serum levels in women who are not responding to the hormone in the way that they should.
On the other hand, just like conventional hormone therapy, bio-identical hormones do have risks and are not right for everyone. Women who have had breast cancer or endometrial cancer, strokes, or blood clots would not want to take bio-identical hormones.
Compounded bio-identical hormones are often not covered by insurance, notes Blacker, though that may be changing. Insurance companies will typically cover estradiol in oral or patch form and some gels and lotions, while progesterone is usually covered but often with a higher co-pay. As all insurance companies are different, be sure to check for your plan’s specific coverage.
Talk to your doctor about whether the risks of any kind of hormonal menopause treatment outweigh the benefits for you. If you have a history of breast cancer, cardiovascular disease, or some other serious conditions, you might not be a good candidate. Your doctor may be able to prescribe other treatments or suggest lifestyle changes that could help.
Video: Bio Identical Hormone Pellet Therapy
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