“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 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”.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 NAMS also note:

“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.

Drug Compounding

What is drug compounding?

DotS the definition of drug compounding may vary. In Compounding and the FDA: Questions and Answers – What Is Compounding? the (United States) Food and Drug Administration’s (FDA) definition is:

“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”.7

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 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”.8

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 (United States) Mayo Clinic author explains:

“The term “natural” means the hormones in the product come from plant or animal sources. They’re not made in a lab. But many of these products still need to be commercially processed to become bioidentical”.9

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”.10

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”.11

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”.12

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”.13

Recommended or Not

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

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”.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 Menopause Management Options: Pharmacy-Compounded Hormones (Bioidentical Hormones), last updated 19 December 2023, the JH note:

“We do not recommend the use of pharmacy-compounded menopause hormone therapy”.16

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”.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?

Yes. In Bioidentical Hormone Therapy: Custom Compounded versus Government Approved published in 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)”.20

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”.21

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”.22

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”.23

Health Topics A-Z

Where may I find Health Topics A-Z related to Bioidentical Hormones?

In Health Topics A-Z you may find:

Links

Where may I find Links related to Bioidentical Hormones?

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Sources

Where may I find the Sources quoted?

You may find the Sources quoted at:

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: 16 April 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: 16 April 2024
  3. 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: 16 April 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: 16 April 2024
  5. Bioidentical HRT: Summary of Key Terminologies. Reviewed: March 2024. British Menopause Society https://thebms.org.uk/publications/consensus-statements/bioidentical-hrt/ Accessed: 16 April 2024
  6. Bioidentical HRT: Summary of Key Terminologies. Reviewed: March 2024. British Menopause Society https://thebms.org.uk/publications/consensus-statements/bioidentical-hrt/ Accessed: 16 April 2024
  7. Compounding and the FDA: Questions and Answers – What Is Compounding? Content Current As of: 29 June 2022. Food and Drug Administration https://www.fda.gov/drugs/guidancecomplianceregulatoryinformation/pharmacycompounding/ucm339764.htm Accessed: 16 April 2024
  8. Compounding and the FDA: Questions and Answers – What Is Compounding? Content Current As of: 29 June 2022. Food and Drug Administration https://www.fda.gov/drugs/guidancecomplianceregulatoryinformation/pharmacycompounding/ucm339764.htm Accessed: 16 April 2024
  9. Burnett, T. Bioidentical Hormones: Are They Safer? 07 December 2022. https://www.mayoclinic.org/diseases-conditions/menopause/expert-answers/bioidentical-hormones/faq-20058460 Accessed: 16 April 2024
  10. Menopause Management Options: Pharmacy-Compounded Hormones (Bioidentical Hormones). Last Updated: 08 December 2023 | Last Reviewed: 19 August 2022. Jean Hailes for Women’s Health https://jeanhailes.org.au/health-a-z/menopause/menopause-management/ Accessed: 16 April 2024
  11. 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: 16 April 2024
  12. 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: 16 April 2024
  13. 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: 16 April 2024
  14. 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://thebms.org.uk/publications/consensus-statements/bioidentical-hrt/ Accessed: 16 April 2024
  15. Bioidentical HRT: Summary of Key Terminologies. Reviewed: March 2024. British Menopause Society https://thebms.org.uk/publications/consensus-statements/bioidentical-hrt/ Accessed: 16 April 2024
  16. Menopause Management Options: Pharmacy-Compounded Hormones (Bioidentical Hormones). Last Updated: 08 December 2023 | Last Reviewed: 19 August 2022. Jean Hailes for Women’s Health https://jeanhailes.org.au/health-a-z/menopause/menopause-management/ Accessed: 16 April 2024
  17. 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: 16 April 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: 16 April 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://thebms.org.uk/publications/consensus-statements/bioidentical-hrt/ Accessed: 16 April 2024
  20. Bioidentical Hormone Therapy: Custom Compounded versus Government Approved. 2020. North American Menopause Society https://www.menopause.org/docs/default-source/2015/mn-bioidenticals.pdf Accessed: 16 April 2024
  21. Burnett, T. Bioidentical Hormones: Are They Safer? 07 December 2022. https://www.mayoclinic.org/diseases-conditions/menopause/expert-answers/bioidentical-hormones/faq-20058460 Accessed: 16 April 2024
  22. Menopause Management Options: Pharmacy-Compounded Hormones (Bioidentical Hormones). Last Updated: 08 December 2023 | Last Reviewed: 19 August 2022. Jean Hailes for Women’s Health https://jeanhailes.org.au/health-a-z/menopause/menopause-management/ Accessed: 16 April 2024
  23. Menopause Management Options: Pharmacy-Compounded Hormones (Bioidentical Hormones). Last Updated: 08 December 2023 | Last Reviewed: 19 August 2022. Jean Hailes for Women’s Health https://jeanhailes.org.au/health-a-z/menopause/menopause-management/ Accessed: 16 April 2024
Topic Last Updated: 16 April 2024 – Topic Last Reviewed: 16 April 2024

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