Natural Hormones at Menopause
Many women, concerned about the health risks of conventional hormone therapy drugs, look for natural alternatives, such as herbs and dietary supplements. One kind of alternative -- products known as natural hormones, or bio-identical hormones -- has attracted substantial new interest since the Women's Health Initiative results increased awareness of the health risks caused by conventional hormone therapy products. The expanded interest has been driven in large part by unsubstantiated promotional claims by the companies and pharmacies that make and distribute so-called natural hormones that their products are safer than conventional hormone therapy drugs. It is very important to know that products are not necessarily safe just because they're natural. The same questions we ask about drugs need to be answered for alternative therapies too.
The National Women's Health Network has urged the Food and Drug Administration (FDA) to exercise better oversight of alternative hormone products, petitioning the agency in 2005 to do more to ensure that women get reliable and accurate information about them.
Making an informed choice for an alternative
Just as pharmaceutical companies promote drugs, there is a large industry that produces and sells alternative health care products. Alternative health care practitioners are subject to similar influences from these companies as conventional doctors are from drug companies. Whether they are recommended by a doctor, a nurse practitioner, a naturopath or the cashier at the health food store, women should be skeptical of products that claim they will extend life, reverse aging, restore youth or prevent disease without causing any adverse effects.
This fact sheet provides a brief overview of the National Women's Health Network's perspective on the natural hormones that are commonly recommended to women at menopause. Two other types of alternatives to hormone therapy are described in a separate fact sheet, Herbs and Phytoestrogens. More detailed information on all three is available in the Network's book The Truth About Hormone Replacement Therapy.
Natural hormones are powerful chemicals
Just like those synthesized in a lab, hormones made from natural substances are powerful chemicals that affect many parts of the body. The natural hormones most commonly recommended for women at menopause are estriol and Tri-Est(rogen), natural progesterone, and DHEA. Natural hormones are prescribed by health care providers and sold at special pharmacies, called compounding pharmacies, which mix the hormones into forms that women can use - usually pills or topical creams. DHEA pills and topical progesterone creams may also be found over-the-counter.
Estriol is a weak estrogen that is sometimes promoted as part of the mixture tri-estrogen or Tri-Est which contains estrone, estradiol and estriol. High doses of estriol relieve hot flashes and other menopausal symptoms.4,5 It also seems to be beneficial in maintaining bone mineral density.6,7 Estriol is touted as an estrogen that doesn't cause cancer, and some even claim that it prevents breast cancer. There is no reasonable scientific evidence that estriol has anticancer effects or that it is safer than other estrogens.
Melatonin regulates daily wake-sleep cycles, and there is evidence that it helps sleep quality. Some scientists think that nightly surges in melatonin may reduce the risk of certain cancers, but this has not been proven. There's no evidence that melatonin retards aging, a claim often made in promoting it to menopausal women. There's no information available about the long-term effects of taking melatonin every night.
Natural progesterone is promoted in creams and in under-the-tongue forms to prevent hot flashes, osteoporosis and even breast cancer. Natural progesterone proponents say it has different effects than synthetic progestins and is safe, but this is unproven. The only claim for natural progesterone that's supported by evidence is that it can help hot flashes. There is no credible evidence that it improves bone [8,9]. While oral progestins protect against estrogen-induced endometrial cancer, natural progesterone cream is not potent enough to offer this protection. Oral progestins in hormone therapy has been shown to increase breast cancer risk. A large French study indicates that oral progesterone in hormone therapy is less likely than synthetic progestins to increase breast cancer risk.
DHEA is promoted for anti-aging, anticancer and anticardiovascular disease properties as well as for relieving vaginal dryness and increasing bone mineral density. Despite animal evidence to support these claims, some research indicates that taking DHEA may actually increase women's risks for cancer and heart disease.1,2,3 Research does show that DHEA may help reduce the vaginal thinning that occurs after menopause and maintain or even increase bone mineral density. In women, DHEA can cause acne and increase facial and body hair.
The FDA takes action, but is it enough?
In January 2008 the FDA took action against misleading marketing claims about natural hormones that are sold by compounding pharmacies, telling the pharmacies that the safety and effectiveness claims they were making about bio-identical hormone products "are unsupported by medical evidence, and are considered false and misleading by the agency." The FDA identified several specific claims as misleading including statements that natural hormones are better or safer than conventional hormone therapy; that natural hormones can treat or prevent Alzheimer's disease, stroke and cancer; and the use of the term bio-identical which implies "a benefit for the drug, for which there is no medical or scientific basis." The agency also warned that selling products containing estriol is a violation of federal law because it has never been approved by the FDA.
While the NWHN was encouraged by these actions, we remain concerned that these steps are not sufficient to protect women's health. It is imperative that the FDA Commissioner publish regulations to govern appropriate labeling and advertising of pharmacy-compounded hormone products and that all labeling and advertisements for natural hormones provided to patients and health care professionals include the following information:
- the product is not approved by the FDA
- the product was compounded in a pharmacy and is not subject to FDA standards for good manufacturing practices
- the product has not been demonstrated as safe or effective in clinical trials.
REFERENCES
1. Barrett-Connor E, et al. A prospective study of dehydroepiandrosterone sulfate and cardiovascular disease. NEJM 315: 1519-1524, 1986.
2. Barrett-Connor E, et al. Absence of an inverse relation of dehydroepiandrosterone sulfate with cardiovascular disease mortality in postmenopausal women. NEJM 317: 711, 1987.
3. Labrie F, et al. Effect of 12-month dehydroepiandrosterone replacement therapy on bone, vagina and endometrium in post-menopausal women. J Endocrinol Metab 82: 3498-3505, 1997.
4. Cardozo L, Bachmann G, McClish D, et al. Meta-analysis of estrogen therapy in the management of urogenital atrophy in post-menopausal women: second report of the Hormones and Urogenital Therapy Committee. Obsts Gynecol 92(4 pt. 2): 722-727, 1998.
5. Tzingounis, VA, Aksu MF, Greenblatt RB. Estriol in the management of menopause. JAMA 239: 1638-1641, 1978.
6. Minaguchi H, Uemura T, Shrasu K, et al. Effect of estriol on bone loss in postmenopausal Japanese women: a multicenter prospective open study. J Obsts Gynaecol Res 22: 259-265, 1996.
7. Itoi H, Minakami H, Iwasaki R, Sato I. Comparison of the long-tem effects of oral estriol with the effects of conjugated estrogens on serum lipid profile in early menopausal women. Maturitas 36(3): 271-282, 2000.
8. Lee JR. Osteoporosis reversal with transdermal progesterone. Lancet 336: 1327, 1990.
9. Leonetti HB, Longo S, Anasati JN. Transdermal progesterone cream for vasomotor symptoms and postmenopausal bone loss. Obstet Gynecol 94: 225-228, 1999.
10. US Food and Drug Administration. Compounded Menopausal Hormone Therapy. Found online at: http://www.fda.gov/cder/pharmcomp/BHRT_qa.htm. Accessed January 21, 2008.
Updated: 1/08