Are Bioidentical Hormones Safe?
by Dana Burnett
Several women have turned to bioidentical hormones to find safe, effective relief from menopausal symptoms. Yet, many “health experts” disapprove of the increasingly popular therapy. An article recently published by ABC News criticized the use of bioidentical hormones, as medical experts argue bioidentical hormones are not safe for hormone replacement therapy. These experts advocate that “bioidentical” is a popular marketing term, which has no accepted medical implications.
They suggest:
1. Prescribed synthetic hormones are “chemically-matched” to hormones produced in the body.
2. Compounded hormones are not approved by the FDA and may have the same health risks of traditional treatments, including cardiovascular complications and cancer.
3. Hormone preparations do not need to be customized for every woman.
4. Compounding pharmacists use a different method that contains a varied amount of hormones.
5. Some compounding pharmacists use estriol, which is not approved in the United States.
These statements can be easily clarified and refuted:
1. Synthetic hormones are “chemically-altered” to match hormones in the body; yet, these chemical alterations pose problems because the body does not recognize the molecular structure. Synthetic estrogen is sourced from pregnant equine urine and synthetic progesterone comes from a progesterone derivative. These compounds are from nonhuman sources that are foreign to the body. Several studies, including the Women’s Health Initiative in 2002, have indicated that traditional hormone replacement has negative health outcomes, including breast cancer and cardiovascular disease.
2. In contrast, bioidentical hormones are “molecularly-similar” to hormones produced in the body, including estriol, estradiol, and progesterone. Though the FDA neglects to approve bioidentical hormones, they have been studied and recognized to be safer and more effective than synthetic HRT. Synthetic hormones have abnormal metabolites that lead to many side effects in the body, whereas bioidentical hormones are more easily absorbed. Furthermore, bioidentical progesterone actually reduces breast cancer, stroke, and heart disease risks, which are elevated with synthetic progesterone.
3. Hormone replacement therapy is not “one size fits all”. It should be individualized for woman, according to their serum hormone levels and their menopausal symptoms.
4. A qualified compounding pharmacy should be regulated by the state and ensured by the Pharmacy Compounding Accreditation Board (PCAB) to demonstrate rigorous quality and safety standards are continuously maintained. Currently, there are only 60 compounding pharmacies nationwide that meet PCAB’s rigorous standards to receive their seal of approval.
5. Estriol has been used worldwide for decades without negative effects. The FDA even recognizes estriol has no adverse effects, but continues to restrict its use.
Evidence-Based Support for Bioidentical Hormones
Though critics claim there is no support for the safety and efficacy of bioidentical hormones, medical studies prove otherwise. Research on estrogen (estriol, estradiol) finds that this therapy can support mood, protect bones, and maintain cardiovascular health. Additionally, estriol lessens breast cancer risks, which increase in postmenopausal women not using hormone replacement therapy. Micronized progesterone balances cholesterol and improves estrogen’s efficacy. Furthermore, it reduces the proliferation of breast cancer cells.
Irrefutable Conclusions
The use of bioidentical hormones will continue to gain newsworthy attention, as popularity increases among menopausal women. Various media opinions have formed over the safety of bioidentical hormones, only leading to greater confusion among millions. For more clarity, the use of bioidentical hormones should be founded upon evidence-based research, which shows bioidentical hormones can be a safe and effective therapy for alleviating menopausal symptoms and providing greater health protection.
References
Campagnoli C, Clavel-Chapelon F, Kaaks R, Peris C, Berrino F. Progestins and progesterone in hormone replacement therapy and the risk of breast cancer. J Steroid Biochem Mol Biol. 2005; 96(2):95-108.
Fournier A, Berrino F, Riboli E, Avenel V, et al. Breast cancer risk in relation to different types of hormone replacement therapy in the E3N-EPIC cohort. Int J Cancer. 2005; 114:448–454.
Fournier A, Berrino F, Clavel-Chapelon F. Unequal risks for breast cancer associated with different hormone replacement therapies: results from the E3N cohort study. Breast Cancer Research and Treatment. 2008; 107(1):103-111.
Hargrove JT, Maxson WS, Wentz AC, Burnett LS. Menopausal hormone replacement therapy with continuous daily oral micronized estradiol and progesterone. Obstet Gynecol. 1989 Apr; 73(4):606-612.
Holtorf K. The bioidentical hormone debate: are bioidentical hormones (estradiol, estriol, and progesterone) safer or more efficacious than commonly used synthetic versions in hormone replacement therapy? Postgrad Med. 2009 Jan;121(1):73-85.
Marchione M. (2009, October 25). Bioidenticals not FDA-approved, contain estrogen. Retrieved on October 27, 2009 from http://abcnews.go.com/Health/wireStory?id=8911735
Pasqualini JR. Differential effects of progestins on breast tissue enzymes. Maturitas. 2003; 46(1):45-54.
Schneider C, Jick SS, Meier CR. Risk of cardiovascular outcomes in users of estradiol/dydrogesterone or other HRT preparations. Climateric. 2009 Jun; 26:1-9.
Soares CN, Almeida OP, Joffe H, Cohen LS. Efficacy of estradiol for the treatment of depressive disorders in perimenopausal women. Arch Gen Psychiatry. 2001; 58:529-534.
Stanosz S, Zochowska E, Safranow K, Sieja K, Stanosz M. Influence of modified transdermal hormone replacement therapy on the concentrations of hormones, growth factors, and bone mineral density in women with osteopenia. Metabolism. 2009 Jan; 58(1):1-7.
Teede HJ. Sex hormones and the cardiovascular system: effects on arterial function in women. Clin Exp Pharmacol Physiol. 2007 Jul; 34(7):672-676.
