“The use of compounded bioidentical hormone
replacement therapies is not recommended
given the issues related to their purity, potency and safety”.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)

Bioidentical Hormones

What are bioidentical hormones?

DotS the definition of bioidentical hormones may vary. On page one in Menopausal Hormone Therapy the European Menopause and Andropause Society’s definition is:

“‘Bioidentical hormones’ is a term used to describe plant-derived preparations (like approved MHT drugs) modified to be structurally identical to human hormones such as estradiol and progesterone”.2

Bioidentical Hormone Therapy

What is bioidentical hormone therapy?

DotS the definition of bioidentical hormone therapy 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? the (United States) Mayo Clinic author’s definition is:

“The term “bioidentical” means the hormones in the medicine are chemically the same as those the body makes. In fact, the hormones in bioidentical medicines may not be any different from those in traditional hormone therapy. In the United States, many hormone therapy medicines approved by the Food and Drug Administration (FDA) and prescribed by healthcare professionals have bioidentical hormones in them”.3

On page 771 in The 2022 Hormone Therapy Position Statement of The North American Menopause Society, published July 2022, and endorsed by multiply organizations, the North American Menopause Society (NAMS) AMS explain:

“The term bioidentical hormone therapy (similar to endogenous) can be misleading because there are both government-approved and compounded bioidentical hormone therapies. Government approved (in the United States, FDA-approved) bioidentical hormones include estradiol, estrone, and MP, which are regulated and monitored for purity and efficacy. These are dispensed with package inserts containing extensive product information (based on RCTs) and may include black-box warnings for AEs. In contrast, compounded bioidentical hormone therapies are prepared by a compounding pharmacist using a provider’s prescription. These therapies may combine multiple hormones (estradiol, estrone, estriol, DHEA, testosterone, progesterone) and use untested, unapproved combinations or formulations or are administered in nonstandard or untested routes such as subdermal implants, pellets, or troches”.4

cBHRT

What is cBHRT (Compounded Bioidentical Hormone Replacement Therapy)?

DotS the definition of cBHRT may vary. In Bioidentical HRT: Summary of Key Terminologies the British Menopause Society’s (BMS) 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”.5

rBHRT

What is rBHRT (Regulated Bioidentical Hormone Replacement Therapy)?

DotS the definition of rBHRT may vary. In Bioidentical HRT: 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”.6

What is MHRA?

In this context MHRA can be an abbreviation for the (United Kingdom) Medicines & Healthcare Products Regulatory Agency.

Approved or Not

Are compounded bioidentical hormones approved by individual Country Drug Regulatory bodies for example the FDA?

In Compounding and the FDA: Questions and Answers – Are Compounded Drugs Approved By FDA? the (United States) Food and Drug Administration (FDA) elaborate on:

“Compounded drugs are not FDA-approved. This means that FDA does not verify the safety, effectiveness or quality of compounded drugs before they are marketed. Consumers and health care professionals rely on FDA’s drug approval process for verification of safety, effectiveness and quality”.7

Natural or Not

Are bioidentical hormones natural?

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? the Mayo Clinic author explains:

“The term “natural” means the hormones in the medicine come from plant sources. They’re not created in a lab right from the beginning. But many of these substances still need to be processed by a commercial lab to become bioidentical”.8

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

Bioidentical Hormones“Some doctors prescribe pharmacy-compounded hormones, which are also known as ‘bioidentical’ hormones. These are mixtures of different hormones made up in compounding pharmacies. The hormones are promoted as ‘natural’ and ‘exactly like our own’, which is not true.

Pharmacy-compounded preparations can contain oestrogens, progesterone and sometimes other hormones such as testosterone. The preparations are made into capsules, creams, gels, drops (applied to the tongue), lozenges or troches (soft square-shaped tablets) that are sucked inside the cheek.

All hormone therapies are manufactured synthetically. Hormones are only natural when they are in the human body”.9

Safe or Not

Are bioidentical hormones safe?

In Bioidentical Hormones: Risks and Benefits – What Are the Risks of Bioidentical Hormones?, published 15 May 2022, the (United States) Cleveland Clinic elaborate on:

“Many healthcare providers who use bioidentical hormones claim they are safer than traditional hormone therapy treatments. But there have been no large research studies of bioidentical hormones to show evidence of this”.10

On page 771 in The 2022 Hormone Therapy Position Statement of The North American Menopause Society, published July 2022, and endorsed by multiply organizations, the NAMS explain:

“There is a dearth of safety and efficacy data with little or no high-quality pharmacokinetic data to provide evidence of safety and efficacy of compounded bioidentical hormone therapy and insufficient evidence to support overall clinical use of compounded bioidentical hormone therapy for treatment of menopause symptoms. Compounded bioidentical hormone therapy presents safety concerns, such as minimal government regulation and monitoring, overdosing and underdosing, presence of impurities and lack of sterility, lack of scientific efficacy and safety data, and lack of a label outlining risks”.11

Hormone Testing or Not

Is serum, saliva or urine hormone testing necessary to prescribe bioidentical hormones?

On page 771 in The 2022 Hormone Therapy Position Statement of The North American Menopause Society, published July 2022, and endorsed by multiply organizations, the NAMS note:

“Compounded bioidentical hormone therapy has been prescribed or dosed on the basis of serum, salivary, or urine hormone testing; however, the use of such testing to guide hormone therapy dosing is considered unreliable because of differences in hormone pharmacokinetics and absorption, diurnal variation, and interindividual and intraindividual variability”.12

Recommended or Not

Hormone TherapyDo menopause societies and other organizations, recommend the use of bioidentical hormones?

On page four in the International Menopause Society’s Leaflet for Women for World Menopause Day on 18 October Menopause and Menopause Hormone Therapy: 2. What Is MHT?, the International Menopause Society note:

“It’s important to note that custom-compounded bioidentical hormone therapy is NOT recommended because it lacks regulation, rigorous safety and efficacy testing, batch standardization, and purity measures”.13

In Menopause Management Options: Pharmacy-Compounded Hormones (Bioidentical Hormones), last updated 20 September 2024, the JH note:

“We do not recommend the use of pharmacy-compounded menopause hormone therapy”.14

In Bioidentical HRT: Summary of Key Terminologies, reviewed March 2024, the BMS include:

  • “cBHRT products are not recommended by the BMS they are not evidence based for effectiveness and safety and because rBHRT options are available”.15

In The 2023 Practitioner’s Toolkit for Managing Menopause: Management – Considerations for All Women At Menopause: Menopausal Hormone Therapy, published online 30 October 2023, the authors also note:

  • “The prescription of individually formulated and compounded hormone preparations is not recommended”.16

In Hormone Replacement Therapy (HRT): Alternatives To Hormone Replacement Therapy (HRT) – Herbal Remedies and Complementary Medicines for Menopause Symptoms: Bioidentical or “Natural” Hormones, last reviewed 07 February 2023, the (United Kingdom) NHS explain:

“Bioidentical hormones are made from plant sources and are described as being similar or identical to human hormones.

Some people claim that these hormones are a “natural” and safer alternative to standard HRT medicines.

However, bioidentical hormones are not recommended because:

  • They’re not regulated and it’s not clear how safe they are – there’s no good evidence to suggest they’re safer than standard HRT
  • It’s not known how effective they are in reducing menopause symptoms
  • The balance of hormones used in bioidentical preparations is usually based on the hormone levels in your saliva, but there’s no evidence that these levels are related to your symptoms”.17

On page four in the Joint Position Statement By the British Menopause Society, Royal College of Obstetricians and Gynaecologists and Society for Endocrinology on Best Practice Recommendations for the Care of Women Experiencing the Menopause, first published online 10 June 2022, one of the recommendations is:

  • “The use of compounded bioidentical hormone replacement therapies is not recommended given the issues related to their purity, potency and safety. The potential benefits of bioidentical hormone therapy can be achieved using conventionally licensed products available through NHS prescribing without having to resort to compounded varieties from specialist pharmacies”.18

Body Identical Hormones

Are body identical hormones available?

In Hormone Replacement Therapy (HRT): Alternatives To Hormone Replacement Therapy (HRT) – Herbal Remedies and Complementary Medicines for Menopause Symptoms: Bioidentical or “Natural” Hormones the NHS note:

“Body identical hormones are different. Because they have been regulated, tested and thoroughly researched, they can be prescribed to treat menopause symptoms”.19

Government Approved

Are government approved bioidentical hormones available?

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? the author notes:

“Some FDA-approved products come from plants. Examples include Estrace, Alora and other products that contain estrogens, and Prometrium, a natural progesterone”.20

In Menopause Management Options: Pharmacy-Compounded Hormones (Bioidentical Hormones) the JH include:

Note: in Australia, doctors can prescribe conventional menopause hormone therapies (MHT) that are identical to those hormones made in your body. These products have been thoroughly tested for safety and effectiveness”.21

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:

“It’s important to have a face-to-face meeting with your health practitioner to discuss the risks and benefits of different treatments for menopause”.22

Health Topics A-Z

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Links

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Sources

Where may I find the Sources quoted?

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Sources

  1. Hamoda, H., Mukherjee, A., Morris, E., Baldeweg, S. E., Jayasena, C. N., Briggs, P., Moger, S. Joint Position Statement By the British Menopause Society, Royal College of Obstetricians and Gynaecologists and Society for Endocrinology on Best Practice Recommendations for the Care of Women Experiencing the Menopause. First Published Online 10 June 2022:3-4. https://journals.sagepub.com/doi/full/10.1177/20533691221104879 Accessed: 07 October 2024
  2. Menopausal Hormone Therapy. 2022:1. European Menopause and Andropause Society https://emas-online.org/wp-content/uploads/2022/05/Menopausal-hormone-therapy.pdf Accessed: 07 October 2024
  3. Burnett, T. Bioidentical Hormones: Are They Safer? 03 October 2024. https://www.mayoclinic.org/diseases-conditions/menopause/expert-answers/bioidentical-hormones/faq-20058460 Accessed: 07 October 2024
  4. The 2022 Hormone Therapy Position Statement of The North American Menopause Society. July 2022:771. North American Menopause Society https://www.menopause.org/docs/default-source/professional/nams-2022-hormone-therapy-position-statement.pdf Accessed: 07 October 2024
  5. Bioidentical HRT: Summary of Key Terminologies. Reviewed: March 2024. British Menopause Society https://thebms.org.uk/publications/consensus-statements/bioidentical-hrt/ Accessed: 07 October 2024
  6. Bioidentical HRT: Summary of Key Terminologies. Reviewed: March 2024. British Menopause Society https://thebms.org.uk/publications/consensus-statements/bioidentical-hrt/ Accessed: 07 October 2024
  7. Compounding and the FDA: Questions and Answers – What Is Compounding? Content Current As of: 05 August 2024. Food and Drug Administration https://www.fda.gov/drugs/guidancecomplianceregulatoryinformation/pharmacycompounding/ucm339764.htm Accessed: 07 October 2024
  8. Burnett, T. Bioidentical Hormones: Are They Safer? 03 October 2024. https://www.mayoclinic.org/diseases-conditions/menopause/expert-answers/bioidentical-hormones/faq-20058460 Accessed: 07 October 2024
  9. Menopause Management Options: Pharmacy-Compounded Hormones (Bioidentical Hormones). Last Updated: 20 September 2024 | Last Reviewed: 19 August 2022. Jean Hailes for Women’s Health https://jeanhailes.org.au/health-a-z/menopause/menopause-management/ Accessed: 07 October 2024
  10. Bioidentical Hormones: Risks and Benefits – What Are the Risks of Bioidentical Hormones? 15 May 2022. Cleveland Clinic https://my.clevelandclinic.org/health/articles/15660-bioidentical-hormones Accessed: 07 October 2024
  11. The 2022 Hormone Therapy Position Statement of The North American Menopause Society. July 2022:771. North American Menopause Society https://www.menopause.org/docs/default-source/professional/nams-2022-hormone-therapy-position-statement.pdf Accessed: 07 October 2024
  12. The 2022 Hormone Therapy Position Statement of The North American Menopause Society. July 2022:771. North American Menopause Society https://menopause.org/wp-content/uploads/press-release/ht-position-statement-release.pdf Accessed: 07 October 2024
  13. Menopause and Menopause Hormone Therapy: 2. What Is MHT? 2024:4. International Menopause Society https://www.imsociety.org/wp-content/uploads/2024/10/2024-WMD-Leaflet_English.pdf Accessed: 07 October 2024
  14. Menopause Management Options: Pharmacy-Compounded Hormones (Bioidentical Hormones). Last Updated: 20 September 2024 | Last Reviewed: 19 August 2022. Jean Hailes for Women’s Health https://jeanhailes.org.au/health-a-z/menopause/menopause-management/ Accessed: 07 October 2024
  15. Bioidentical HRT: Summary of Key Terminologies. Reviewed: March 2024. British Menopause Society https://thebms.org.uk/publications/consensus-statements/bioidentical-hrt/ Accessed: 07 October 2024
  16. Davis, S. R., Taylor, S., Hemachandra, C., Magraith, K., Ebeling, P. R., Jane, F., and Islam, R. M. The 2023 Practitioner’s Toolkit for Managing Menopause: Management – Considerations for All Women At Menopause: Menopausal Hormone Therapy. Published Online: 30 October 2023 https://www.tandfonline.com/doi/full/10.1080/13697137.2023.2258783 Accessed: 07 October 2024
  17. Hormone Replacement Therapy (HRT): Alternatives To Hormone Replacement Therapy (HRT) – Herbal Remedies and Complementary Medicines for Menopause Symptoms: Bioidentical or “Natural” Hormones. Last Reviewed: 07 February 2023. NHS https://www.nhs.uk/medicines/hormone-replacement-therapy-hrt/alternatives-to-hormone-replacement-therapy-hrt/herbal-remedies-and-complementary-medicines-for-menopause-symptoms/ Accessed: 07 October 2024
  18. Hamoda, H., Mukherjee, A., Morris, E., Baldeweg, S. E., Jayasena, C. N., Briggs, P., Moger, S. Joint Position Statement By the British Menopause Society, Royal College of Obstetricians and Gynaecologists and Society for Endocrinology on Best Practice Recommendations for the Care of Women Experiencing the Menopause. First Published Online 10 June 2022:3-4. https://journals.sagepub.com/doi/full/10.1177/20533691221104879 Accessed: 07 October 2024
  19. Hormone Replacement Therapy (HRT): Alternatives To Hormone Replacement Therapy (HRT) – Herbal Remedies and Complementary Medicines for Menopause Symptoms: Bioidentical or “Natural” Hormones. Last Reviewed: 07 February 2023. NHS https://www.nhs.uk/medicines/hormone-replacement-therapy-hrt/alternatives-to-hormone-replacement-therapy-hrt/herbal-remedies-and-complementary-medicines-for-menopause-symptoms/ Accessed: 07 October 2024
  20. Burnett, T. Bioidentical Hormones: Are They Safer? 03 October 2024. https://www.mayoclinic.org/diseases-conditions/menopause/expert-answers/bioidentical-hormones/faq-20058460 Accessed: 07 October 2024
  21. Menopause Management Options: Pharmacy-Compounded Hormones (Bioidentical Hormones). Last Updated: 20 September 2024 | Last Reviewed: 19 August 2022. Jean Hailes for Women’s Health https://jeanhailes.org.au/health-a-z/menopause/menopause-management/ Accessed: 07 October 2024
  22. Menopause Management Options: Pharmacy-Compounded Hormones (Bioidentical Hormones). Last Updated: 20 September 2024 | Last Reviewed: 19 August 2022. Jean Hailes for Women’s Health https://jeanhailes.org.au/health-a-z/menopause/menopause-management/ Accessed: 07 October 2024
Topic Last Updated: 07 October 2024 – Topic Last Reviewed: 07 October 2024