“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)

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

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 Australasian Menopause Society’s (AMS) definition is:

“…‘body-identical’ hormone therapy refers to pharmaceutical products that have the same chemical structure as those produced in the human body”.4

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 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”.5

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: 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”.6

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”.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 (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”.8

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”.9

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

“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

Testing or Not

Is serum, saliva or urine hormone testing necessary?

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

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)”.14

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”.15

In Hormone Replacement Therapy (HRT) Alternatives: Bioidentical or “Natural” Hormones the (United Kingdom) NHS include:

“Many standard HRT hormones are made from natural sources, but unlike bioidentical hormones, they’re closely regulated and have been well researched to ensure they’re as effective and safe as possible”.16

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”.17

Recommended or Not

Do menopause societies, women’s health organizations and other organization, recommend the use of compounded hormone therapy?

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

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

“We do not recommend the use of pharmacy-compounded menopause hormone therapy”.19

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”.20

Health Topics A-Z

Where may I find Health Topics related to Bioidentical Hormones?

In Health Topics A-Z you may find:

Links

Where may I find Links related to Bioidentical Hormones?

Your Country may have Links similar to:

Sources

Where may I find the Sources quoted?

You may find the Sources quoted at:

Sources

  1. Menopause Management Options: Pharmacy-Compounded Hormones (Bioidentical Hormones). Last Updated: 08 September 2022 | Last Reviewed: 19 August 2022. Jean Hailes for Women’s Health https://jeanhailes.org.au/health-a-z/menopause/menopause-management/ Accessed: 28 November 2022
  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: 28 November 2022
  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: 28 November 2022
  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: 28 November 2022
  5. 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: 28 November 2022
  6. Complementary and Herbal Therapies for Hot Flushes: 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: 28 November 2022
  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: 28 November 2022
  8. Burnett, T. Bioidentical Hormones: Are They Safer? 10 December 2021. https://www.mayoclinic.org/diseases-conditions/menopause/expert-answers/bioidentical-hormones/faq-20058460 Accessed: 28 November 2022
  9. 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: 28 November 2022
  10. Menopause Management Options: Pharmacy-Compounded Hormones (Bioidentical Hormones). Last Updated: 08 September 2022 | Last Reviewed: 19 August 2022. Jean Hailes for Women’s Health https://jeanhailes.org.au/health-a-z/menopause/menopause-management/ Accessed: 28 November 2022
  11. Bioidentical Hormones: Risks and Benefits – What Are the Risks of Bioidentical Hormones? 15 May 2022. Cleveland Clinic https://www.menopause.org/docs/default-source/professional/nams-2022-hormone-therapy-position-statement.pdf Accessed: 28 November 2022
  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: 28 November 2022
  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: 28 November 2022
  14. 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: 28 November 2022
  15. 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: 28 November 2022
  16. Hormone Replacement Therapy (HRT) Alternatives: Bioidentical or “Natural” Hormones. Page Last Reviewed: 09 September 2019. NHS https://jeanhailes.org.au/health-a-z/menopause/menopause-management Accessed: 28 November 2022
  17. Menopause Management Options: Pharmacy-Compounded Hormones (Bioidentical Hormones). Last Updated: 08 September 2022 | Last Reviewed: 19 August 2022. Jean Hailes for Women’s Health https://jeanhailes.org.au/health-a-z/menopause/menopause-management/ Accessed: 28 November 2022
  18. Hamoda et al. 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 10 June 2022:3-4. https://journals.sagepub.com/doi/full/10.1177/20533691221104879 Accessed: 28 November 2022
  19. Menopause Management Options: Pharmacy-Compounded Hormones (Bioidentical Hormones). Last Updated: 08 September 2022 | Last Reviewed: 19 August 2022. Jean Hailes for Women’s Health https://jeanhailes.org.au/health-a-z/menopause/menopause-management/ Accessed: 28 November 2022
  20. Menopause Management Options: Pharmacy-Compounded Hormones (Bioidentical Hormones). Last Updated: 08 September 2022 | Last Reviewed: 19 August 2022. Jean Hailes for Women’s Health https://jeanhailes.org.au/health-a-z/menopause/menopause-management/ Accessed: 28 November 2022
Topic Last Updated: 28 November 2022 – Topic Last Reviewed: 28 November 2022

Print Friendly, PDF & Email