“Bioidentical hormones are hormones from plant sources that are chemically similar or identical to hormones produced in the human body”.1

Umbrella
What may the Bioidentical Hormones Umbrella include?

Depending on the Source (DotS) this Umbrella may include:

  • Bioequivalent Hormone Therapy
  • Bioidentical Hormone Medications
  • Bioidentical Hormone Replacement Therapy (BHRT)
  • Bioidentical Hormone Therapy (BHT)
  • Bioidentical Hormones
  • Bioidenticals
  • Custom-Compounded Bioidentical Hormone Therapy (C-CHT)
  • Custom-Made Bioidentical Hormones
  • Custom-Mixed Bioidentical Hormones
  • Hormone Therapy Alternatives
  • Natural Hormone Therapies
  • Pharmacy Compounded Hormones
  • ‘Compounded’ Bioidentical Hormone Replacement Therapy (cBHRT)
  • ‘Regulated’ Bioidentical Hormone Replacement Therapy (rBHRT)

Background

What is the background of bioidentical hormones for the treatment of menopause symptoms?

In Bioidentical Custom Compounded Hormone Therapy the Australasian Menopause Society (AMS) explain:

“Many patients are attracted to the concept of using hormones that are the same as those which are produced by the ovary pre-menopause. This gained traction after the publication of the Women’s Health Initiative study. There was a suggestion from some that the adverse findings were secondary to the “synthetic” hormones used in that study and that the same would not occur with the use of natural hormones. This has led to an industry of the compounding of ‘bioidentical’ hormones which are often in the form of creams, troches and pessaries. These are widely used by many women at considerable expense”.2

Bioidentical Hormones

What are bioidentical hormones?

DotS the definition of bioidentical hormones may vary. In Menopausal Symptoms: In Depth: What the Science Says About Complementary Approaches for Menopause Symptoms – Other Complementary Approaches: Bioidentical Hormones the (United States) National Center for Complementary and Integrative Health’s (NCCIH) definition is:

“Bioidentical hormones are hormones from plant sources that are chemically similar or identical to hormones produced in the human body”.3

Body-Identical Hormone Therapy

What is body-identical hormone therapy?

DotS the definition of body-identical hormone therapy may vary. In Bioidentical Custom Compounded Hormone Therapy the AMS’s definition is:

“‘Bioidentical’ hormone therapy refers to compounded products which are marketed as hormones that are identical to those produced by the body. The production of these products is not subject to the regulatory conditions of approved pharmaceutical products. In contrast ‘body-identical’ hormone therapy refers to pharmaceutical products that have the same chemical structure as those produced in the human body”.4

Bioidentical Hormone Therapy

What is bioidentical hormone therapy?

DotS the definition of bioidentical hormone therapy may vary. In Menopause FAQs: Hormone Therapy for Menopause Symptoms – Q. I’ve heard about something called bioidentical hormones. What are they? the North American Menopause Society’s (NAMS) definition is:

“The term bioidentical hormone therapy began as a marketing term for custom-compounded hormones. But it is taken to mean hormones that have the same chemical and molecular structure as hormones that are produced in the body. Bioidentical hormones do not have to be custom-compounded (meaning custom mixed). There are many well-tested, FDA-approved hormone therapy products that meet this definition and are commercially available from retail pharmacies in a variety of doses that will allow you and your doctor to customize your therapy to meet your needs”.5

What is FDA?

FDA can be an abbreviation for the (United States) Food and Drug Administration.

Pharmacy-Compounded Hormones

What are pharmacy-compounded hormones?

In Menopause Management: Pharmacy-Compounded Hormones the (Australian) Jean Hailes for Women’s Health (JH) definition is:

“Pharmacy-compounded hormones (sometimes referred to as bioidentical hormones) are mixtures of hormones made in compounding pharmacies that are promoted as hormones ‘exactly like our own’ hormones. They can contain oestrogens, progesterone and sometimes other hormones such as testosterone. The hormones are made into capsules, creams, gels, drops applied to the tongue, lozenges or troches (soft square-shaped tablets) sucked in the cheek”.6

Products

What are two kinds of bioidentical hormone products?

In Menopausal Symptoms: In Depth: What the Science Says About Complementary Approaches for Menopause Symptoms – Other Complementary Approaches: Bioidentical Hormones the NCCIH elaborate on:

“Two kinds of bioidentical hormone products are used to treat menopause symptoms: (1) those that have gone through the same FDA approval process as other types of hormone therapy, and (2) custom-mixed preparations that compounding pharmacies prepare individually for patients”.7

Natural or Not

Are bioidentical hormones natural?

The JH explain:

“These hormone products are often marketed using the term ‘natural’, but all hormone therapies are manufactured synthetically in a process similar to the manufacture of the oral contraceptive pill. It is misleading to suggest these preparations have advantages over pharmaceutical oestrogen therapies approved by the TGA (the Therapeutic Goods Administration)”.8

In what country is the TGA?

Australia.

Safer or Not

Are bioidentical hormones safer than HT?

Depending on the compounder, seller, company or other, the answer to the question “Are bioidentical hormones safe?” may vary.

In Bioidentical Hormones: Are They Safer? a (United States) Mayo Clinic author explains:

Bioidentical Hormones

“No, they aren’t. According to the Food and Drug Administration (FDA) and several medical specialty groups, the hormones marketed as “bioidentical” and “natural” aren’t safer than hormones used in traditional hormone therapy, and there’s no evidence they’re any more effective”.9

On page one in Bioidentical Hormone Therapy: Custom-Compounded Versus Government Approved – Bioidentical Custom-Compounded Hormones the NAMS elaborate on:

“Government-approved hormone products are required by law to come with a package insert that describes possible risks and side effects. Custom-compounded hormones are not required to come with this information, but this does not mean they are safer. They contain the same active hormones (such as estradiol and progesterone), so they share the same risks”.10

In Bioidentical Custom Compounded Hormone Therapy: Safety Concerns About Compounded Bioidentical Hormones the AMS elaborate on their concerns about:

  • “Risk of endometrial hyperplasia and neoplasia
  • Quality Control and contaminents”.11

In Menopause Management: Pharmacy-Compounded Hormones some of the JH’s “questions about the safety and effectiveness of pharmacy-compounded hormones”, include:

  • “We have no research evidence that the recommended doses of the hormone preparations made by compounding pharmacists are safe or effective
  • It has been claimed this form of hormone therapy does not cause side effects, but this therapy is similar to all prescription hormone therapies, and therefore should have the same risks and benefits. This is unproven and unlikely, with many women presenting with known complications of oestrogen and testosterone therapy while on compounded hormonal preparations”.12

In Hormone Help Desk: ET, EPT, and More: Bioidentical Hormone Therapy (BHT) the NAMS elaborate on:

“Despite many marketing claims, there is no scientific evidence that custom-compounded BHT is safer or more effective than the many government-approved therapies mentioned above. Studies indicate that compounded products are not supervised as closely as FDA-approved hormone products”.13

In Bioridiculous the author explains:

“There is nothing inherently evil about producing compounded medication. It is a choice that is made when FDA-approved alternatives either do not exist or are not appropriate. It is a technique that our pharmacist colleagues wish to preserve, and it is an important option for the rare patient who is allergic to the colorings or fillers in common medications. Yet, the marketing of bioidentical hormones as a truly safe and effective alternative to FDA-approved hormone treatments for menopause cannot be condoned when FDA-approved preparations that are exactly the same as the hormones made by the body are available and will work superbly well for almost everyone”.14

Compounding

What is compounding?

DotS the definition of compounding may vary. In Compounding and the FDA: Questions and Answers – What Is Compounding? the FDA elaborate on:

“Drug compounding is often regarded as the process of combining, mixing, or altering ingredients to create a medication tailored to the needs of an individual patient. Compounding includes the combining of two or more drugs. Compounded drugs are not FDA-approved”.15

Compounded Bioidentical Hormones

What are compounded bioidentical hormones?

DotS the definition of compounded bioidentical hormones may vary. In Complementary and Herbal Therapies for Hot Flushes | New: January 2018: Compounded Bioidentical Menopausal Hormone Therapy the AMS note:

“Compounded “bioidentical” hormones contain hormonal preparations which are aimed at correcting “hormonal imbalances” which may occur at menopause. However, there is no evidence to support the effectiveness or safety of these products. Not only is evidence lacking to support superiority claims of compounded bioidentical hormones over conventional MHT, these claims also pose the additional risks of variable purity and potency, and lack efficacy and safety data. The Committee on Gynecologic Practice of the American College of Obstetricians and Gynecologists, the Practice Committee of the American Society for Reproductive Medicine and the US Endocrine Society have raised major concerns about the safety and efficacy of these products and recommend that patients be counselled to avoid their use”.16

Custom-Compounded Elephants

What maybe some elephants in the custom-compounded bioidentical hormone therapy room?Bioidentical HormonesIn Compounding and the FDA: Questions and Answers – Are Compounded Drugs Approved By FDA? the FDA elaborate on:

“Compounded drugs are not FDA-approved. This means that FDA does not verify the safety or effectiveness of compounded drugs. Consumers and health professionals rely on the drug approval process for verification of safety, effectiveness, and quality. Compounded drugs also lack an FDA finding of manufacturing quality before such drugs are marketed”.17

In What Is Custom-Compounded Therapy? the NAMS note:

“A few consumers may need custom-compounded products to avoid allergies to certain ingredients or to provide dosages or mixtures that are not available commercially. However, custom-mixed hormones can pose risks. They do not have government approval because individually mixed preparations have not been tested to prove that they are absorbed appropriately or provide predictable levels in blood and tissue. And there is no scientific evidence about the effects of these combinations of hormones on the body, either good or bad”.18

In What Is Custom-Compounded Therapy? the NAMS also note:

“Preparation methods vary from one pharmacist to another and from one pharmacy to another, which means that consumers may not receive consistent amounts of medication. In addition, inactive ingredients may vary and there can be batch-to-batch differences. Reliable sterility and freedom from undesired contaminants are also concerns. What’s more, these preparations can be expensive because they are often not covered by insurance plans”.19

Saliva Testing Elephants

What may be some elephants in the saliva testing room?Bioidentical Hormones

In What Is Hormone Testing? the NAMS explain:

“Saliva testing is often a part of custom-compounded “bioidentical hormone therapy” with hormones. But saliva testing is not only unnecessary; it has also has also not been proven to be accurate or reliable. Because hormone levels vary day to day as well as throughout the day, even a blood test cannot accurately reflect the body’s hormone levels”.20

In What Is Hormone Testing? the NAMS also note:

“NAMS does not recommend saliva testing to determine hormone levels and does not recommend custom-compounded products over well-tested, government-approved products for the majority of women”.21

2015 NAMS Survey

What did the 2015 NAMS survey findings include about compounded hormones?

In More Women Are Seeking and Receiving Compounded Hormones the author elaborates on:

“Adverse effects of hormone therapy were not common among the survey respondents, but the women who used compounded HT reported higher rates of vaginal bleeding and acne than women who used FDA-approved hormones, and four women who used compounded hormones reported that they had endometrial cancer(cancer of the uterine lining), whereas none who used FDA-approved hormones reported a case”.22

2016 Endocrinology Scientific Statement

What were the results of the Compounded Bioidentical Hormones in Endocrinology Practice: An Endocrine Society Scientific Statement published on 01 April 2016?

In Compounded Bioidentical Hormones In Endocrinology Practice: An Endocrine Society Scientific Statement the Endocrinology Society’s Results were:

“Results
Overall, there is a general lack of standardization and quality control regarding how custom-compounded bioidentical hormones are produced and administered, leading to the possibility of overdosing, underdosing, or contamination. There is also recent evidence of patient harm and death associated with treatment, as seen with fungus-contaminated glucocorticoid preparations. With estrogen, progestin, and dehydroepiandrosterone treatments, the practice of baseline hormone measurements to replace “abnormal” hormone deficiencies has no basis in medical practice. Furthermore, there is no evidence that monitoring compounded HT with serial salivary or blood testing is effective, except in the case of thyroid hormone. Finally, no evidence supports the popularized notion that custom-compounded bioidentical hormones have fewer risks when compared with Food and Drug Administration (FDA)-approved hormone treatments”.23

2016 Revised Global Consensus Statement

What is one of the points of consensus about custom-compounded hormone therapy?

One of the points of consensus in the Revised Global Consensus Statement on Menopausal Hormone Therapy: Section B: General Principles Governing the Use of MHT – endorsed by seven menopause-related organizations – published online 20 June 2016, is:

Bioidentical Hormones
  • “The use of custom-compounded hormone therapy is not recommended because of lack of regulation, rigorous safety and efficacy testing, batch standardization, and purity measures”.24

2019 BMS Consensus Statement

What are the aims of the BMS Consensus Statement on Bioidentical HRT reviewed in February 2019?

In BMS Consensus Statement on Bioidentical HRT: Introduction the British Menopause Society (BMS) explain:

“The aims of this paper are to clarify the:

  • Differences between custom ‘compounded’ bioidentical hormone replacement therapy (cBHRT) and conventionally prescribed ‘regulated’ bioidentical hormone replacement therapy (rBHRT)
  • Issues which have caused confusion regarding the regulation and prescribing of these hormones
  • Scientific rationale for the potential advantages of regulated bioidentical hormone replacement therapy (rBHRT) compared to other types of conventional HRT”.25

Government Approved

What government approved hormone products may be available?

On page one in Bioidentical Hormone Therapy: Custom-Compounded Versus Government Approved the NAMS explain for the United States:

“If you prefer to treat your bothersome menopause symptoms with hormones that are chemically identical to those you produced naturally before menopause, ask your health care provider to prescribe estradiol and progesterone products that are scientifically tested and government approved. Estradiol is available as an oral tablet, skin patch, topical gel, topical spray, and vaginal ring. Low doses of estradiol used in the vagina (to treat vaginal dryness and painful intercourse but not hot flashes) are available as a vaginal tablet, cream, and ring. Progesterone is available as an oral capsule (see table below for product names)”.26

Health Care Provider

What if I choose to use bioidentical hormones?

If you choose to use bioidentical hormones it may be in your best interest to also choose to tell your health care providers you are doing this. The JH caution:

“Further research and regulation of pharmacy-compounded hormones is needed before they can be recommended for use with menopausal symptoms. It is important when seeking any medical treatment that you consult a health practitioner face-to-face, rather than over the phone. Receiving advice or a prescription for medication without the proper advice is not advised”.27

In Bioridiculous the author elaborates on:

“There is very good reason to beware the inflated promises made by the bioidentical industry and to take better care of yourself during your menopause transition by going to the real experts—licensed medical professionals who have knowledge of the process of menopause and its treatment. Be leery of websites and experts who provide only their own product and recommend only their own tests. If it sounds too good to be true—it probably is. There are better and safer ways to cope with this important life transition, and most women will not require treatment for more than a few years, when risks remain very low. So choose science”.28

Health Topics A-Z

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Links

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Sources

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  1. Menopausal Symptoms: In Depth: What the Science Says About Complementary Approaches for Menopause Symptoms – Other Complementary Approaches: Bioidentical Hormones. Last Updated: May 2017. This Page Last Modified 27 March 2018. National Center for Complementary and Integrative Health https://nccih.nih.gov/health/menopause/menopausesymptoms Accessed: 01 October 2019
  2. Bioidentical Custom Compounded Hormone Therapy. Content Updated: May 2018. Australasian Menopause Society https://www.menopause.org.au/hp/information-sheets/212-bioidentical-hormones-for-menopausal-symptoms Accessed: 01 October 2019
  3. Menopausal Symptoms: In Depth: What the Science Says About Complementary Approaches for Menopause Symptoms – Other Complementary Approaches: Bioidentical Hormones. Last Updated: May 2017. This Page Last Modified 27 March 2018. National Center for Complementary and Integrative Health https://nccih.nih.gov/health/menopause/menopausesymptoms Accessed: 01 October 2019
  4. Bioidentical Custom Compounded Hormone Therapy. Content Updated: May 2018. Australasian Menopause Society https://www.menopause.org.au/hp/information-sheets/212-bioidentical-hormones-for-menopausal-symptoms Accessed: 01 October 2019
  5. Menopause FAQs: Hormone Therapy for Menopause Symptoms – Q. I’ve heard about something called bioidentical hormones. What are they? North American Menopause Society http://www.menopause.org/for-women/menopause-faqs-hormone-therapy-for-menopause-symptoms Accessed: 01 October 2019
  6. Menopause Management: Pharmacy-Compounded Hormones. Last Updated 26 September 2019 — Last Reviewed 17 December 2017. Jean Hailes for Women’s Health http://jeanhailes.org.au/health-a-z/menopause/menopause-management/ Accessed: 01 October 2019
  7. Menopausal Symptoms: In Depth: What the Science Says About Complementary Approaches for Menopause Symptoms – Other Complementary Approaches: Bioidentical Hormones. Last Updated: May 2017. This Page Last Modified 27 March 2018. National Center for Complementary and Integrative Health https://nccih.nih.gov/health/menopause/menopausesymptoms Accessed: 01 October 2019
  8. Menopause Management: Pharmacy-Compounded Hormones. Last Updated 26 September 2019 — Last Reviewed 17 December 2017. Jean Hailes for Women’s Health http://jeanhailes.org.au/health-a-z/menopause/menopause-management/ Accessed: 01 October 2019
  9. Laughlin-Tommaso, S. K. Bioidentical Hormones: Are They Safer? 19 January 2018. https://www.mayoclinic.org/diseases-conditions/menopause/expert-answers/bioidentical-hormones/faq-20058460 Accessed: 01 October 2019
  10. Bioidentical Hormone Therapy: Custom-Compounded Versus Government-Approved – Bioidentical Custom-Compounded Hormones. 2015:1. North American Menopause Society http://www.menopause.org/docs/default-source/2015/mn-bioidenticals.pdf Accessed: 01 October 2019
  11. Bioidentical Custom Compounded Hormone Therapy: Safety Concerns About Compounded Bioidentical Hormones. Content Updated: May 2018. Australasian Menopause Society https://www.menopause.org.au/hp/information-sheets/212-bioidentical-hormones-for-menopausal-symptoms Accessed: 01 October 2019
  12. Menopause Management: Pharmacy-Compounded Hormones. Last Updated 26 September 2019 — Last Reviewed 17 December 2017. Jean Hailes for Women’s Health http://jeanhailes.org.au/health-a-z/menopause/menopause-management/ Accessed: 01 October 2019
  13. Hormone Therapy Help Desk: ET, EPT, and More: Bioidentical Hormone Therapy (BHT). North American Menopause Society http://www.menopause.org/for-women/menopauseflashes/menopause-symptoms-and-treatments/hormone-help-desk-et-ept-and-more Accessed: 01 October 2019
  14. Santoro, N. Bioridiculous. 05 April 2017. http://www.menopause.org/for-women/menopause-take-time-to-think-about-it/consumers/2017/04/05/bioridiculous Accessed: 01 October 2019
  15. Compounding and the FDA: Questions and Answers – What Is Compounding? Content Current As of: 21 June 2018. Food and Drug Administration http://www.fda.gov/drugs/guidancecomplianceregulatoryinformation/pharmacycompounding/ucm339764.htm Accessed: 01 October 2019
  16. Complementary and Herbal Therapies for Hot Flushes | New: January 2018: Compounded Bioidentical Menopausal Hormone Therapy. Content Updated: January 2018. Australasian Menopause Society https://www.menopause.org.au/hp/information-sheets/734-complementary-and-herbal-therapies-for-hot-flushes Accessed: 01 October 2019
  17. Compounding and the FDA: Questions and Answers – Are Compounded Drugs Approved By FDA? Content Current As of: 21 June 2018. Food and Drug Administration http://www.fda.gov/drugs/guidancecomplianceregulatoryinformation/pharmacycompounding/ucm339764.htm Accessed: 01 October 2019
  18. What Is Custom-Compounded Therapy? North American Menopause Society http://www.menopause.org/publications/clinical-practice-materials/bioidentical-hormone-therapy/what-is-custom-compounded-therapy- Accessed: 01 October 2019
  19. What Is Custom-Compounded Therapy? North American Menopause Society http://www.menopause.org/publications/clinical-practice-materials/bioidentical-hormone-therapy/what-is-custom-compounded-therapy- Accessed: 01 October 2019
  20. What Is Hormone Testing? North American Menopause Society http://www.menopause.org/publications/clinical-practice-materials/bioidentical-hormone-therapy/what-is-hormone-testing- Accessed: 01 October 2019
  21. What Is Hormone Testing? North American Menopause Society http://www.menopause.org/publications/clinical-practice-materials/bioidentical-hormone-therapy/what-is-hormone-testing- Accessed: 01 October 2019
  22. Utian, Wulf. More Women Are Seeking and Receiving Compounded Hormones. 12 October 2015. http://www.menopause.org/for-women/menopause-take-time-to-think-about-it/consumers/2015/10/12/more-women-are-seeking-and-receiving-compounded-hormones Accessed: 01 October 2019
  23. Compounded Bioidentical Hormones in Endocrinology Practice: An Endocrinology Scientific Statement. The Journal of Clinical Endocrinology & Metabolism, Volume 101, Issue 4, 1 April 2016, Pages 1318–1343, https://academic.oup.com/jcem/article/101/4/1318/2804494 Accessed: 01 October 2019
  24. De Villiers, T. J., Hall, J. E., Pinkerton, J. V., Pérez, S. C., Rees, M., Yang, C, and Pierroz, D. D. Revised Global Consensus Statement on Menopausal Hormone Therapy: Section B: General Principles Governing the Use of MHT. Climacteric, 2016;19:4:314 http://www.imsociety.org/manage/images/pdf/ba6379e868044bec13015ac2b84f2753.pdf Accessed: 01 October 2019
  25. BMS Consensus Statement on Bioidentical HRT: Introduction. Reviewed: February 2019. British Menopause Society https://thebms.org.uk/publications/consensus-statements/bioidentical-hrt/ Accessed: 01 October 2019
  26. Bioidentical Hormone Therapy: Custom-Compounded Versus Government-Approved. 2015:1. North American Menopause Society http://www.menopause.org/docs/default-source/2015/mn-bioidenticals.pdf Accessed: 01 October 2019
  27. Menopause Management: Pharmacy-Compounded Hormones. Last Updated 26 September 2019 — Last Reviewed 17 December 2017. Jean Hailes for Women’s Health http://jeanhailes.org.au/health-a-z/menopause/menopause-management/ Accessed: 01 October 2019
  28. Santoro, N. Bioridiculous. 05 April 2017. http://www.menopause.org/for-women/menopause-take-time-to-think-about-it/consumers/2017/04/05/bioridiculous Accessed: 01 October 2019
Topic Last Updated: 08 October 2019 – Topic Last Reviewed: 01 October 2019
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