“Further research and regulation of pharmacy-compounded hormones is needed before they can be recommended for use with menopausal symptoms”.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

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)”.4

What is FDA?

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

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:

“…‘body-identical’ hormone therapy refers to pharmaceutical products that have the same chemical structure as those produced in the human body”.5

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”.6

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”.7

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”.8

Compounded Bioidentical Hormone Replacement Therapies

What are Compounded Bioidentical Hormone Replacement Therapies (cBHRT)?

In Bioidentical HRT: Part A – Explanation of cBHRT: Licensing In UK – Medicines and Healthcare Products Regulatory Agency (MHRA) the British Menopause Society (BMS) explain:

“Compounded bioidentical hormone replacement therapies are manufactured as creams, lozenges and vaginal preparations by ‘Specialist Pharmacies’ which have proliferated both physically and online in the UK and abroad. These cBHRT products:

  • Do not follow the same regulatory pathway of evaluation by the MHRA as conventional pharmaceutical products
  • Have not been through the rigorous process of drug development which conventional medicines and products such as rBHRT undergo
  • Have not been scientifically evaluated in controlled randomised clinical trials for effectiveness and safety against placebo or conventional HRT”.9

What is UK?

UK can be an abbreviation for the United Kingdom.

cBHRT

What is cBHRT?

DotS the definition of cBHRT may vary. In Bioidentical HRT: Part B – Explanation of rBHRT: Summary of Key Terminologies the BMS’s definition is:

“cBHRT: Compounded Bioidentical Hormone Replacement Therapy: Precise duplicates of human hormones which are produced by specialist pharmacies and do not follow the same MHRA regulatory pathway as conventional rBHRT”.10

What is MHRA?

MHRA can be an abbreviation for Medicines and Healthcare Products Regulatory Agency in the United Kingdom.

rBHRT

What is rBHRT?

DotS the definition of rBHRT may vary. In Bioidentical HRT: Part B – Explanation of rBHRT: Summary of Key Terminologies the BMS’s definition is:

“rBHRT: Regulated Bioidentical Hormone Replacement Therapy: Precise duplicates of human hormones developed in a conventional way by the pharmaceutical industry and authorised by the regulators such as the MHRA in the UK”.11

Custom-Compounded Elephants

What maybe some elephants in the custom-compounded bioidentical hormone therapy room?Bioidentical Hormones

In 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”.12

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”.13

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”.14

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”.15

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”.16

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. This fact sheet discusses only the custom-mixed products”.17

Natural or Not

Are bioidentical hormones natural?

In Bioidentical Custom Compounded Hormone Therapy the AMS explain:

“It is important to realise that no hormone used in any preparation of pharmaceutical grade menopausal hormone therapy (MHT) or compounded “bioidentical therapy” is ‘natural’. They are all synthesised in the laboratory from some precursor by enzymatic manipulation”.18

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? Are bioidentical or natural hormones safer and more effective than hormones used in traditional hormone therapy for menopause symptoms? 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 that they’re any more effective”.19

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”.20

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”.21

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”.22

North America

What does the NAMS note about bioidentical hormones for menopause symptoms?

In Bioidentical Hormone Therapy: Custom Compounded versus Government Approved dated 2020, the NAMS elaborate on:

“If you prefer to treat your bothersome menopause symptoms with hormones that are chemically identical to those you produced naturally before menopause, ask your healthcare 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)”.23

Australia

What does the JH note about pharmaceutically produced MHT products in Australia?

In Menopause Management: Pharmacy-Compounded Hormones the JH notes:

“Women seeking compounded hormone therapy should know that the majority of pharmaceutically produced MHT products in Australia contain oestradiol, identical to the main oestrogen the body makes before menopause, hence, by definition, it is ‘bioidentical’. There is also a progestogen now available in Australia called ‘micronised progesterone’. This hormone is identical to the progesterone made by the body before menopause, so there is an option to use ‘bioidentical’ hormone therapy containing oestradiol and progesterone that has been thoroughly tested for safety and effectiveness in women around menopause”.24

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:

  • “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”.25

2019 BMS Consensus Statement

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

In 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”.26

2020 NASEM Study

What was the conclusion of the (United States) National Academies of Science, Engineering, and Medicine (NASEM) Study on the Clinical Utility of Treating Patients with Compounded “Bioidentical” Hormone Therapy?

In National Academies of Science, Engineering, and Medicine (NASEM) Study on the Clinical Utility of Treating Patients with Compounded “Bioidentical” Hormone Therapy provided to the (United States) Food and Drug Administration (FDA) on 01 July 2020, the study leads explain:

“Based on its research and analysis, NASEM determined there was a lack of rigorous evidence of safety and effectiveness from well-designed or properly controlled clinical studies. NASEM found information about the safety and effectiveness of cBHT came mostly from low quality data, such as anecdotal claims, patient reports, and prescriber testimonies. Further, there is limited federal and state-level oversight of the quality and use of cBHT preparations. Given the lack of high-quality clinical evidence and minimal oversight of cBHT, NASEM concluded that their wide-spread use poses a public health concern”.27

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”.28

Health Topics A-Z

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In Health Topics A-Z you may find:

Links

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Sources

Where may I find the Sources quoted?

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Sources

  1. Menopause Management: Pharmacy-Compounded Hormones. Last Updated: 30 July 2020 | Last Reviewed: 17 December 2017. Jean Hailes for Women’s Health https://jeanhailes.org.au/health-a-z/menopause/menopause-management/ Accessed: 14 October 2020
  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: 14 October 2020
  3. Menopausal Symptoms: In Depth: What the Science Says About Complementary Approaches for Menopause Symptoms – Other Complementary Approaches: Bioidentical Hormones. Last Updated: May 2017. National Center for Complementary and Integrative Health https://www.nccih.nih.gov/health/menopausal-symptoms-in-depth Accessed: 14 October 2020
  4. Menopause FAQs: Hormone Therapy for Menopause Symptoms – Q. I’ve heard about something called bioidentical hormones. What are they? North American Menopause Society https://www.menopause.org/for-women/menopause-faqs-hormone-therapy-for-menopause-symptoms Accessed: 14 October 2020
  5. 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: 14 October 2020
  6. Compounding and the FDA: Questions and Answers – What Is Compounding? Content Current As of: 21 June 2018. Food and Drug Administration https://www.fda.gov/drugs/guidancecomplianceregulatoryinformation/pharmacycompounding/ucm339764.htm Accessed: 14 October 2020
  7. 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: 14 October 2020
  8. Menopause Management: Pharmacy-Compounded Hormones. Last Updated:  30 July 2020 | Last Reviewed: 17 December 2017. Jean Hailes for Women’s Health https://jeanhailes.org.au/health-a-z/menopause/menopause-management/ Accessed: 14 October 2020
  9. Bioidentical HRT: Part A – Explanation of cBHRT: Licensing In UK – Medicines and Healthcare Products Regulatory Agency (MHRA). Reviewed: October 2019. British Menopause Society https://thebms.org.uk/publications/consensus-statements/bioidentical-hrt/ Accessed: 14 October 2020
  10. Bioidentical HRT: Part A – Explanation of cBHRT: Licensing In UK – Medicines and Healthcare Products Regulatory Agency (MHRA). Reviewed: October 2019. British Menopause Society https://thebms.org.uk/publications/consensus-statements/bioidentical-hrt/ Accessed: 14 October 2020
  11. Bioidentical HRT: Part B – Explanation of rBHRT: Key Terminologies. Reviewed: October 2019. British Menopause Society https://thebms.org.uk/publications/consensus-statements/bioidentical-hrt/ Accessed: 14 October 2020
  12. Compounding and the FDA: Questions and Answers – Are Compounded Drugs Approved By FDA? Content Current As of: 21 June 2018. Food and Drug Administration https://www.fda.gov/drugs/guidancecomplianceregulatoryinformation/pharmacycompounding/ucm339764.htm Accessed: 14 October 2020
  13. What Is Custom-Compounded Therapy? North American Menopause Society https://www.menopause.org/publications/clinical-practice-materials/bioidentical-hormone-therapy/what-is-custom-compounded-therapy- Accessed: 14 October 2020
  14. What Is Custom-Compounded Therapy? North American Menopause Society https://www.menopause.org/publications/clinical-practice-materials/bioidentical-hormone-therapy/what-is-custom-compounded-therapy- Accessed: 14 October 2020
  15. What Is Hormone Testing? North American Menopause Society https://www.menopause.org/publications/clinical-practice-materials/bioidentical-hormone-therapy/what-is-hormone-testing- Accessed: 14 October 2020
  16. What Is Hormone Testing? North American Menopause Society https://www.menopause.org/publications/clinical-practice-materials/bioidentical-hormone-therapy/what-is-hormone-testing- Accessed: 14 October 2020
  17. Menopausal Symptoms: In Depth: What the Science Says About Complementary Approaches for Menopause Symptoms – Other Complementary Approaches: Bioidentical Hormones. Last Updated: May 2017. National Center for Complementary and Integrative Health https://www.nccih.nih.gov/health/menopausal-symptoms-in-depth Accessed: 14 October 2020
  18. 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: 14 October 2020
  19. Burnett, T. Bioidentical Hormones: Are They Safer? 03 December 2019. https://www.mayoclinic.org/diseases-conditions/menopause/expert-answers/bioidentical-hormones/faq-20058460 Accessed: 14 October 2020
  20. Bioidentical Hormone Therapy: Custom-Compounded Versus Government-Approved – Bioidentical Custom-Compounded Hormones. 2020:1. North American Menopause Society https://www.menopause.org/docs/default-source/2015/mn-bioidenticals.pdf Accessed: 14 October 2020
  21. 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: 14 October 2020
  22. Menopause Management: Pharmacy-Compounded Hormones. Last Updated:  30 July 2020 | Last Reviewed: 17 December 2017. Jean Hailes for Women’s Health https://jeanhailes.org.au/health-a-z/menopause/menopause-management/ Accessed: 14 October 2020
  23. Bioidentical Hormone Therapy: Custom-Compounded Versus Government-Approved – Bioidentical Custom-Compounded Hormones. 2020:1. North American Menopause Society https://www.menopause.org/docs/default-source/2015/mn-bioidenticals.pdf Accessed: 14 October 2020
  24. Menopause Management: Pharmacy-Compounded Hormones. Last Updated:  30 July 2020 | Last Reviewed: 17 December 2017. Jean Hailes for Women’s Health https://jeanhailes.org.au/health-a-z/menopause/menopause-management/ Accessed: 14 October 2020
  25. 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 https://www.imsociety.org/manage/images/pdf/ba6379e868044bec13015ac2b84f2753.pdf Accessed: 14 October 2020
  26. Bioidentical HRT: Introduction. Reviewed: October 2019. British Menopause Society https://thebms.org.uk/publications/consensus-statements/bioidentical-hrt/ Accessed: 14 October 2020
  27. National Academies of Science, Engineering, and Medicine (NASEM) Study on the Clinical Utility of Treating Patients with Compounded “Bioidentical” Hormone Therapy. 01 July 2020. National Academies of Science, Engineering, and Medicine https://www.fda.gov/drugs/human-drug-compounding/national-academies-science-engineering-and-medicine-nasem-study-clinical-utility-treating-patients Accessed: 14 October 2020
  28. Menopause Management: Pharmacy-Compounded Hormones. Last Updated: 30 July 2020 | Last Reviewed: 17 December 2017. Jean Hailes for Women’s Health https://jeanhailes.org.au/health-a-z/menopause/menopause-management/ Accessed: 14 October 2020

Topic Last Updated: 14 October 2020 – Topic Last Reviewed: 14 October 2020
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