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Published Online: 11 August 2014

Risks and Effectiveness of Compounded Bioidentical Hormone Therapy: A Case Series

Publication: Journal of Women's Health
Volume 23, Issue Number 8


After the publication of the Women's Health Initiative, attitudes towards management of menopausal symptoms changed dramatically. One alternative that has received much media attention is the use of bioidentical hormone therapy (BHT). The media and celebrity endorsements have promoted a number of misconceptions about the risks and benefits associated with the various forms of BHT. This article will review the available evidence regarding the safety and efficacy of BHT in comparison to conventional hormone therapy. We will also review several cases seen in our midlife women's referral clinics, which demonstrate concerns for the safety and efficacy of BHT, including unexplained endometrial cancer in otherwise healthy BHT users. Due to the lack of sufficient data to support the efficacy or safety of BHT, we recommend the use of United States Food and Drug Administration–approved regimens in the management of menopausal symptoms.

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Hersh AL, Stefanick ML, Stafford RS. National use of postmenopausal hormone therapy: Annual trends and response to recent evidence. JAMA 2004;291:47–53.
Rossouw JE, Anderson GL, et al. Risks and benefits of estrogen plus progestin in healthy postmenopausal women: Principal results from the Women's Health Initiative randomized controlled trial. JAMA 2002;288:321–333.
Hing E, Brett KM. Changes in U.S. prescribing patterns of menopausal hormone therapy, 2001–2003. Obstet Gynecol 2006;108:33–40.
Pattimakiel L, Thacker HL. Bioidentical hormone therapy: Clarifiying the misconceptions. Cleve Clin J Med 2011;78:829–836.
Files JA, Ko MG, Pruthi S. Bioidentical hormone therapy. Mayo Clin Proc 2011;86:673–680.
US Food and Drug Administration (FDA). Compounded Menopausal hormone therapy questions and answers. Available at Accessed January 18, 2014.
Sood R, Warndahl RA, et al. Bioidentical compounded hormones: A pharmacokinetic evaluation in a randomized clinical trial. Maturitas 2013;74:375–382.
Reginster JY, Sarlet N, et al. Minimal levels of serum estradiol prevent postmenopausal bone loss. Calcif Tissue Int 1992;51:340–343.
Ettinger B, Pressman A, et al. Associations between low levels of serum estradiol, bone density, and fractures among elderly women: The Study of Osteoporotic Fractures. J Clin Endocrinol Metab 1998;83:2239–2243.
MacLennan AH, Broadbent JL, Lester S, Moore V. Oral oestrogen and combined oestrogen/progestogen therapy versus placebo for hot flushes. Cochrane Database Syst Rev 2004; CD002978.
Ruiz AD, Daniels KR, Braner JC, Carson JJ, Frei CR. Effectiveness of compounded bioidentical hormone replacement therapy: an observational cohort study. BME Womens Health 2011;11:27.
Stephenson K, Neuenschwander PF, Kurdowska AK. The effects of compounded bioidentical transdermal hormone therapy on hemostatic, inflammatory, immune factors; cardiovascular biomarkers; quality-of-life measures; and health outcomes in perimenopausal and postmenopausal women. Int J Pharm Compd 2013;17:74–85.
Eden JA, Hacker NF, Fortune M. Three cases of endometrial cancer associated with “bioidentical” hormone replacement therapy. Med J Aust 2007;187:244–245.
Committee on Gynecologic Practice and the American Society for Reproductive Medicine Practice Committee. Committee opinion No. 532: Compounded bioidentical menopausal hormone therapy. Obstet Gynecol 2012;120:411–415.
Archer DF. Neoplasia of the female reproductive tract. Effects of hormone therapy. Endocrine 2004;24:259–263.
Gillet JY, Andre G, et al. Induction of amenorrhea during hormone replacement therapy: Optimal micronized progesterone dose. A multicenter study. Maturitas 1994;19:103–115.
US Food and Drug Administration (FDA). Report: Limited FDA survey of compounded drug products. Available at Accessed January 18, 2014.
Fugh-Berman A, Bythrow J. Bioidentical hormones for menopausal hormone therapy: Variation on a theme. JGIM 2007;22:1030–1034.
Whelan AM, Jurgens TM,Trinacty M. Bioidentical progesterone cream for menopause-related vasomotor symptoms: Is it effective? Ann Pharmacother 2013;47:112–116.
Lippman M, Monaco ME, Bolan G. Effects of estrone, estradiol, and estriol on hormone-responsive human breast cancer in the long-term tissue culture. Cancer Res 1977;37:1901–1907.
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 Res Treat 2008;107:307–308.
Chang KJ, Lee TT, Linares-Cruz G, Fournier S, de Ligniéres B. Influences of percutaneous administration of estradiol and progesterone on human breast epithelial cell cycle in vivo. Fertil Steril 1995;63:785–791.
Foidart JM, Colin C, et al. Estradiol and progesterone regulate the proliferation of human breast epithelial cells. Fertil Steril 1998;69:963–969.
Simon JA. What if the Women's Health Initiative has used transdermal estradiol and oral progesterone instead? Menopause 2014;21:1–15.
Harvey JA, Pinkerton JV, et al. Breast density changes in a randomized controlled trial evaluating bazedoxifene/conjugated estrogens. Menopause 2013;20:138–145.
US Food and Drug Administration (FDA). FDA takes action against compounded menopause hormone therapy drugs. Available at Accessed January 18, 2014.
Committee on Gynecologic Practice and the American Society for Reproductive Medicine Practice Committee (ACOG). ACOG Practice Bulletin No. 141: Management of menopausal symptoms. Obstet Gynecol 2014;123:202–216.
Santen RJ, Allred DC, Ardoin SP, et al. Postmenopausal hormone therapy: An Endocrine Society scientific statement. J Clin Endocrinol Metab 2010;95:s1–s66.
Sturdee DW, Pines A. International Menopause Society Writing Group, et al. Updated IMS recommendations on postmenopausall hormone therapy and preventive strategies for midlife health. Climacteric 2011;14:302–320.
Committee on Gynecologic Practice and the American Society for Reproductive Medicine Practice Committee. Committee opinion No. 556: Postmenopause estrogen therapy: Route of administration and risk of venous thromboembolism. Obstet Gynecol 2013;121:891–896.

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cover image Journal of Women's Health
Journal of Women's Health
Volume 23Issue Number 8August 2014
Pages: 642 - 648
PubMed: 25111856


Published online: 11 August 2014
Published in print: August 2014


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    Ruth Davis
    Cleveland Clinic Lerner College of Medicine of Case Western University, Cleveland, Ohio.
    Pelin Batur
    Cleveland Clinic Lerner College of Medicine of Case Western University, Cleveland, Ohio.
    Primary Care Women's Health, Medicine Institute, Cleveland Clinic, Cleveland Ohio.
    Holly L Thacker
    Center for Specialized Women's Health, Cleveland Clinic Lerner College of Medicine of Case Western University, Cleveland, Ohio.
    Women's Health Institute, Cleveland Clinic, Cleveland, Ohio.


    Address correspondence to:Pelin Batur, MDCleveland Clinic5001 Rockside Road, IN30Cleveland, OH 44131E-mail: [email protected]

    Author Disclosure Statement

    The authors declare no competing financial interests exist.

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