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Climacteric 2021 Feb 6;24(1):38-45. Epub 2021 Jan 6.

Departments of Obstetrics and Gynecology.

After the results of the Women's Health Initiative trials were published, patient and clinician interest in potential alternatives to conventional hormone therapy (HT) has grown. A commonly used alternative therapy involves custom-compounded steroid hormone preparations, formulated by compounding pharmacies. Many postmenopausal women consider the hormones as natural or bioidentical, in contrast to hormones used in conventional HT, which they consider synthetic. Read More

PLoS One 2018 16;13(5):e0197064. Epub 2018 May 16.

Department of Preventive Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois, United States of America.

Objective: By the 1990s it became popular for women to use hormone therapy (HT) to ease menopause symptoms. Bioidentical estrogen and progesterone are supplements whose molecular structures are identical to what is made in the human body, while synthetic supplements are ones whose structures are not. After the Women's Health Initiative found that the combined use of the synthetics conjugated equine estrogen (CEE) and medroxyprogesterone acetate (MPA) increased breast cancer risk, prescriptions for synthetic HT declined considerably. Read More

Climacteric 2018 08 9;21(4):346-354. Epub 2018 Apr 9.

a TherapeuticsMD , Boca Raton , FL , USA.

A need exists for a regulatory agency-approved hormone therapy (HT) with naturally occurring hormones combining progesterone (P4) and estradiol (E2), since no single product contains both endogenous hormones. Many women choose HT with P4 and millions of women around the world are using unapproved, poorly regulated compounded HT. The use of natural P4 in HT results, for the most part, in favorable outcomes without deleterious effects, as shown in clinical studies of postmenopausal women. Read More

J Steroid Biochem Mol Biol 2017 11 22;174:27-39. Epub 2017 Jul 22.

Department of Biochemistry, Stellenbosch University, Private Bag X1, Matieland 7602, South Africa. Electronic address:

Conventional hormone therapy (HT) containing estrogens such as ethinylestradiol (EE) have been associated with an increased risk of breast cancer and cardiovascular disease resulting in women seeking safer alternatives that are claimed to have fewer health risks. One such alternative gaining popularity, is custom-compounded bioidentical (b)HT formulations containing bioidentical estradiol (bE) and estriol (bE). However, the preparation of these custom-compounded estrogens is not regulated, and depending on the route of synthesis, steroid mixtures with differing activities may be produced. Read More

Int J Pharm Compd 2017 Jan-Feb;21(1):6-16

Frances Payne Bolton School of Nursing at Case Western Reserve University.

The use of compounded bioidentical hormone replacement therapy by menopausal women has become a popular alternative to traditional synthetic conjugated equine estrogen and progestin hormone replacement therapy due to safety concerns raised by recent studies. However, due to the lack of randomized, large-scale trials to evaluate the efficacy and side-effect profile of compounded bioidentical hormone replacement therapy many healthcare providers are reluctant to prescribe such therapy. The purpose of this study was to compare women's menopausal symptom relief and side effects experienced when using compounded bioidentical hormone replacement therapy and traditional hormone replacement therapy. Read More

Climacteric 2017 Aug 16;20(4):331-338. Epub 2017 Mar 16.

a Service de Gynécologie-Obstétrique , CHU Brugmann, Université Libre de Bruxelles , Bruxelles , Belgium.

The many advantages of registered bioidentical sex hormones over registered, conventional, non-bioidentical menopausal hormone therapy (MHT) are considered. The transdermal route of estrogen administration avoids excess venous thromboembolic and ischemic stroke events. There is some indication that conjugated equine estrogens are more thrombogenic and most likely induce some hypertensive responses; estradiol might also be superior to conjugated equine estrogens (CEE) in terms of global cardiovascular health. Read More

Integr Med (Encinitas) 2017 Feb;16(1):42-49

, is an independent nutrition research consultant in Los Angeles, California. , is vice president for health sciences division, the director of the Human Nutrition Institute, and an associate professor of clinical sciences at the University of Bridgeport in Bridgeport, Connecticut. He is also the chief medical officer for Designs for Health, Inc, in Suffield, Connecticut.

Context: Three natural forms of vitamin B are commercially available: methylcobalamin (MeCbl), adenosylcobalamin (AdCbl), and hydroxycobalamin (OHCbl), all of which have been shown in clinical studies to improve vitamin B status. They are bioidentical to the B forms occurring in human physiology and animal foods. In contrast, cyanocobalamin (CNCbl), a synthetic B compound used for food fortification and in some supplements, occurs only in trace amounts in human tissues as a result of cyanide intake from smoking or other sources. Read More

Int J Pharm Compd 2016 Nov-Dec;20(6):447-454

Frances Payne Bolton School of Nursing at Case Western Reserve University.

The use of compounded bioidentical hormone replacement therapy by menopausal women has become a popular alternative to traditional synthetic conjugated equine estrogen and progestin hormone replacement therapy due to safety concerns raised by recent studies. However, due to the lack of randomized, large-scale trials to evaluate the efficacy and side-effect profile of compounded bioidentical hormone replacement therapy many healthcare providers are reluctant to prescribe such therapy. The purpose of this study was to compare women's menopausal symptom relief and side effects experienced when using compounded bioidentical hormone replacement therapy and traditional hormone replacement therapy. Read More

Int J Pharm Compd 2016 Sep-Oct;20(5):359-364

Frances Payne Bolton School of Nursing at Case Western Reserve University.

The use of compounded bioidentical hormone replacement therapy by menopausal women has become a popular alternative to traditional synthetic conjugated equine estrogen and progestin hormone replacement therapy due to safety concerns raised by recent studies. However, due to the lack of randomized, large-scale trials to evaluate the efficacy and side-effect profile of compounded bioidentical hormone replacement therapy many healthcare providers are reluctant to prescribe such therapy. The purpose of this study was to compare women's menopausal symptom relief and side effects experienced when using compounded bioidentical hormone replacement therapy and traditional hormone replacement therapy. Read More

Stem Cells Transl Med 2015 Mar 9;4(3):261-8. Epub 2015 Feb 9.

BAMM Labs, Canary Center at Stanford for Early Cancer Detection, Stanford University School of Medicine, Palo Alto, California, USA; BAMM Labs, Department of Medicine and Center for Infertility and Reproductive Surgery, Obstetrics Gynecology and Reproductive Biology, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA

Hormone replacement therapies have become important for treating diseases such as premature ovarian failure or menopausal complications. The clinical use of bioidentical hormones might significantly reduce some of the potential risks reportedly associated with the use of synthetic hormones. In the present study, we demonstrate the utility and advantage of a microfluidic chip culture system to enhance the development of personalized, on-demand, treatment modules using embryoid bodies (EBs). Read More

Pharmacotherapy 2014 4;34(4):410-23. Epub 2014 Jan 4.

Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California, San Diego, La Jolla, California.

Menopausal symptoms affect a significant portion of women. Traditional treatment with manufactured hormone therapy can alleviate these symptoms, but many women and their health care providers are concerned about the risks, such as venous thromboembolism and certain types of cancer, demonstrated with manufactured hormone therapy. Compounded bioidentical hormone therapy has been proposed and is often used as a solution for these concerns. Read More

J Am Board Fam Med 2011 Mar-Apr;24(2):202-10

Division of General Internal Medicine, Women's Health Clinic, Mayo Clinic, Rochester, MN 55905, USA.

Bioidentical hormones are compounds that have exactly the same chemical and molecular structure as endogenous human hormones. In contrast, nonbioidentical, or synthetic, hormones are structurally dissimilar from endogenous hormones. Although available for years, bioidentical compounded hormone therapy (BCHT) has gained popularity in the United States only recently. Read More

Tissue Eng Part A 2010 Oct;16(10):3085-98

Institute of Neuroanatomy, Hannover Medical School, Hannover, Germany.

With the aim to develop new biomaterials for peripheral nerve grafts, the current study used bioidentical polysialic acid (polySia) as complement in synthetic conduits. polySia provides an important guidance cue during nervous system development and regeneration. First in vivo results on the use of cell-free and Schwann cell-containing synthetic peripheral nerve grafts complemented with soluble exogenous K1-polySia are presented. Read More

Int J Pharm Compd 2010 Mar-Apr;14(2):165-9

Ryerson University, Toronto, Ontario, Canada.

The objective of this exploratory qualitative study was to describe (1) the key factors affecting women's initial decision to explore the use of bioidentical hormone, (2) where women gather their information on bioidentical hormones, (3) the enablers and barriers to obtaining bioidentical hormones, and (4) how to improve the bioidentical hormone replacement therapy access path. The study was conducted in a compounding pharmacy located in a large urban area in southern Ontario, Canada. The participants included four postmenopausal women between the ages of 46 and 72 who self-identified as users of bioidentical hormone replacement therapy and with comprehensive provincial healthcare coverage. Read More

Postgrad Med 2009 Jul;121(4):172

Postgrad Med 2009 Jan;121(1):73-85

Holtorf Medical Group, Inc., Torrance, CA 90505, USA.

Background: The use of bioidentical hormones, including progesterone, estradiol, and estriol, in hormone replacement therapy (HRT) has sparked intense debate. Of special concern is their relative safety compared with traditional synthetic and animal-derived versions, such as conjugated equine estrogens (CEE), medroxyprogesterone acetate (MPA), and other synthetic progestins. Proponents for bioidentical hormones claim that they are safer than comparable synthetic and nonhuman versions of HRT. Read More

Womens Health (Lond) 2008 Mar;4(2):163-71

The University of Alabama at Birmingham, Department of Obstetrics & Gynecology, Division of Reproductive Endocrinology & Infertility, 340 OHB, 619 19th Street South, Birmingham, AL 35249, USA.

'Bioidentical hormones' is a term created by the lay media to refer to chemicals derived from plants that are modified to be structurally identical to endogenous human hormones. These compounds include estradiol, estrone, estriol, progesterone, testosterone and dehydroepiandrosterone when prescribed for menopausal women. Patients assume bioidentical hormones are natural and safer than synthetic hormones with regard to the risk of developing breast cancer and other diseases, but there is little evidence to support this belief. Read More

Curr Opin Obstet Gynecol 2008 Aug;20(4):400-7

Auburn University, Harrison School of Pharmacy, Auburn, Alabama, USA.

Purpose Of Review: In the practice of 'bioidentical hormone therapy', it is our belief that pharmacists are compounding bioidentical hormone therapy with the best intentions. These pharmacists are, however, ill informed regarding the lack of scientific underpinning associated with the efficacy and safety of the practice of bioidentical hormone therapy. It is the purpose of this review to systematically examine the scientific rigor of the arguments posed by the proponents of bioidentical hormone therapy, and to differentiate the practice of bioidentical hormone therapy from the legitimate practice of pharmacy compounding. Read More

Altern Med Rev 2006 Sep;11(3):208-23

Numerous forms of estrogens and progestins are utilized for the treatment of menopausal complaints and associated conditions that occur temporally. Although known to be different with respect to molecular structure, receptor affinity, metabolism, and other physiological traits, most have been treated as if they were clinically identical. The majority of these hormone preparations, commonly referred to as hormone replacement therapy (HRT), should perhaps be more aptly referred to as hormone substitution therapy, as most of the therapies utilized do not exactly match those produced in the body. Read More