Many bioidenticals are compounded by pharmacists who blend various ingredients in specific amounts to create just-for-you medications. A compounding pharmacist may also create alternative delivery systems (a cream or lozenge, for instance) to commercial ones. However, some so-called bioidentical hormones are already available in commercial products, including those delivered through a skin patch or gel. Mainstream doctors prescribe these all the time (some common brands include Estrace, Climara, and Prometrium) but won't claim that they have any special powers and may not emphasize that they are bioidentical.
Unlike commercially available products, compounded formulas are not regulated by the FDA. "With an FDA-approved hormone, you know that it has been produced in an FDA-approved facility. And if a drug company gets FDA approval for a drug in capsule form, it has to go through the approval process again before selling the same ingredient in a cream or another form," says Larry Sasich, assistant professor of pharmacy at the Lake Erie College of Medicine, in Pennsylvania. "In many compounded products, we don't know the source of the hormones or how well they work in the form provided. What consumers may be dealing with is a shadow drug industry, one that produces untested products."
Sometimes there's a good reason for compounding: You need a lower dose of testosterone than the one contained in the formula approved for men; you're allergic to the peanut-oil base in a particular product; your doctor wants you to use a lozenge. However, with a compounded formula, there's very little quality assurance -- you can't be sure you're getting the right dose, and you can't know how much of the hormone will enter your bloodstream from the compounded cream, lozenge, gel, or capsule.
But is there really such a thing as a harmless hormone? "Even hormones made by your body can hurt you," says Adriane Fugh-Berman, MD, who teaches in the complementary and alternative medicine program at Georgetown University. "There's lots of data that indicates women with higher natural levels of estrogen are at a higher risk for breast cancer."
Bioidentical hormones have not been studied in clinical trials in the U.S., which frees promoters to claim that, among other things, estriol is not only safe but may prevent cancer because it is weaker than the other estrogens. But any estrogen needs to be taken with caution. For years, oral estriol was prescribed in Europe without the standard progesterone accompaniment to protect against endometrial cancer. Then a study in Sweden revealed that taking one to two milligrams a day of estriol alone doubled the risk of endometrial cancer. In another study in Sweden of 5,000 women, published in February 2006, stronger estrogens increased the risk of ductal and lobular breast cancer. That's really no surprise, but here's what was -- even low-dose oral estriol (about one milligram a day) doubled the risk of lobular breast cancer in women who took it for fewer than five years. "We need more studies, but at this point, we cannot rule out an increased risk for breast cancer even with the less potent estriol," says lead researcher Lena Rosenberg, MD, of the Karolinska Institute, in Stockholm, Sweden.
The role of hormone therapy in the peri- and post menopause is to re-establish the balance that has been lost by the body's bumpy transition from the gently rolling cyclicity of the reproductive years to the lack of estrogen (and frequently testosterone) when the ovaries cease functioning. Many different estrogens, progestogens, combina-tions and delivery systems are available.
In this (usually temporary) replacement, it makes sense to utilize compounds and delivery systems that are best accepted by a woman's body.
A bioidentical is a compound that is biologically identical to that (previously) produced by the body. Also erroneously called "natural hormones", bioidenticals are synthesized in the lab, usually from plant sources (soy beans, wild Mexican yam) to be biologically identical to the hormones secreted from a woman's own ovaries.
Bioidentical hormones include: (1) Estradiol ("E2")--the primary hormone from the ovary. (2) Estrone ("E1")--also secreted from the ovary and to a small degree from adrenal glands; very biologically active. (3) Estriol ("E3")--a byproduct of E1 and E2 metabolism; a weak estrogen. Estriol is not normally secreted from the ovary. (4) Testosterone. (5) Progesterone.
Bioidentical Adrenal Hormones: (1) Pregnenolone. (2) DHEA.
The whole idea of bioidentical hormonal balancing is to re-establish your individual homeostatic hormonal milieu, regain your strength and confidence and then, at your own pace, manage your hormonal taper down all of the way to "taper off", if possible.
A picture is beginning to emerge from all of the confusing results of recent studies. (1) Hormonal therapy is much safer if started at peri-menopause (or early post menopause) rather than many years after menopause. (2) The safest way to administer hormone therapy is to utilize the lowest effective dose of estrogen, giving progestagen (bioidentical progesterone or a mild synthetic) intermittently (if at all), utilizing testosterone in low doses. The testosterone potentiates the action of estrogen and may have (in low doses) an inhibitory effect on cancer-cell proliferation in the breast. Dormant breast tumors that are hormonally sensitive usually have both estrogen and progesterone receptors, so giving both (whether the synthetic or bioidentical) is potentially more dangerous in the long run. (3) After stability is obtained, very slowly, and at the individual's own pace, taper hormone therapy with the goal, after three-seven years, of tapering off all together if tolerated. (4) Some women may wish to continue on low-term hormone therapy. If so, the safest is microdose estrogen, without progesterone, with or without a low dose of testosterone. There probably is an increased risk of breast cancer, but the numbers are extremely small (and estrogen offers bone and colon cancer protection); many women will elect to take this risk because of quality of life factors. IV. Sexual Health: Testosterone, Estrogen, Vaginal Health and Couple's Issues.
It's not just estrogen that's a troublemaker: In June 2006, researchers at the Harvard School of Public Health reported that, after accounting for other common risk factors, postmenopausal women not taking hormones who ranked in the top 20 percent in testosterone levels were at least three times more likely to become diabetic than those naturally low in testosterone. "The research does raise some concerns that testosterone therapy [which is prescribed to boost libido] may possibly increase the risk of diabetes in women," says JoAnn E. Manson, MD, chief of the division of preventive medicine at the Brigham and Women's Hospital, in Boston.
It's a fallacy that if hormones don't come from a pharmaceutical company, then there's no cancer, stroke, or other disease risk associated with them.
The WHI study, whose results scared so many women away from hormone therapy, looked at just one drug, Prempro, a specific combination of oral estrogen and synthetic progestin. Over the past 15 years, information has accumulated establishing the lowest effective doses for treating menopausal symptoms, and many low-dose products and topical formulas (patches, gels, creams) are now on the market.
"We've gone through the same process with menopausal hormones as we did with oral contraceptives," says Wulf Utian, MD, of the North American Menopause Society. "The first birth control pills could have killed an elephant. But the hormones in second-, third- and fourth-generation pills became progressively lower, so now you get only a small fraction of what was in the pills in the early 1960s."
The scientific community is only just beginning to put bioidenticals to the test, but some early results don’t bode well for the so-called “natural” alternative. The findings of the Million Woman Study in 2003 indicated that bioidenticals increased the risk of breast cancer. Another study’s findings released in 2003 reported that bioidenticals did not slow the progression of artherosclerosis.
Alternatives to the Alternatives
Dr. Dale, who has developed her own line of homeopathic treatments for the hormonal fluctuations in the body, says that homeopathy is effective and safe when it comes to treating the symptoms of menopause and perimenopause. She also recommends dietary changes, which, she says, can have an immediate impact. “If a woman eliminates sugar, alcohol and caffeine, it will diminish hot flashes within 24 hours.”
“I felt so much better when I was able to give up caffeine and lay off sugar,” says Pam Myers, 61, of Detroit Lakes, MN, who tried HRT for a year when menopause struck at age 53. After abandoning HRT because of worries about its safety, she tried herbal remedies. “I took black cohosh as an herbal supplement, which helped with hot flashes,” she says.
While the National Center for Complementary and Alternative Medicine (NCCAM), a branch of the National Institutes for Health, is currently sponsoring studies of botanicals and herbal supplements as viable treatment options for the symptoms of menopause, very little scientific research has been done on the subject to date. Most testaments to their efficacy—and their possible dangers—are anecdotal. “There are many potential alternatives to estrogen [hormone replacement therapy],” claimed a 2005 conference statement of the NIH’s State of the Science panel convened to review the management of menopause-related symptoms. “However, their effectiveness and long-term safety need to be studied in rigorous clinical trials in diverse populations of women.”
Among today’s most common alternative treatments sought out by women is the herb black cohosh, which some women have used for relief of hot flashes. Ginseng has been said to help with mood swings and insomnia, and the herb kava is reported to reduce anxiety in people of all ages.
A surge of interest in bioidentical hormonal therapy came about because of a book published by actress/self-proclaimed fitness guru, Suzanne Sommers 's , Ageless: Bioidentical Hormones and Beyond. Needless to say, cosmetic/plastic surgery and liposuction have played a large role in her youthful appearance.
In short, hormones, no matter what their source is, exert very powerful effects on/in the body. The body has a complicated compensatory biofeedback system in which hormones play a major role. Taking external hormonal supplementation will cause the body to make changes to restore previous balances and the end result will still be the same. Symptom improvements most likely, will be temporary. Contact the appropriate healthcare professional familiar with natural/synthetic hormonal replacement.
