Bioidentical Hormones Update July 2020

Bioidentical Hormones Update July 2020, includes a recent study which “concluded that their wide-spread use poses a public health concern”.

NASEM Study

What was the conclusion of the recent (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:

Bioidentical Hormones Update July 2020

“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”.

cBHRT

What is cBHRT?

Depending on the Source the definition of cBHRT may vary. In Bioidentical HRT: Part B – Explanation of rBHRT: Summary of Key Terminologies reviewed 19 October 2019, the British Menopause Society’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”.

North America

What does the North American Menopause Society (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 proscribe 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)”.

Australia

What does the (Australian) Jean Hailes for Women’s Health 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”.

The Bottom Line

What is the current bottom line with bioidentical hormones for menopause symptoms?

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

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

Health Topics A-Z

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Health Topics A-Z

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  1. 9 Myths and Misunderstandings About Menopausal Hormone Therapy (MHT): 7. Myth – Compounded Bioidentical Hormone Therapy Is Safer Than Conventional MHT
  2. Bioidentical Custom Compounded Hormone Therapy
  3. Bioidentical Hormones Update July 2020 Bioidentical HRT
  4. Bioidentical Hormone Therapy
  5. Bioidentical Hormone Therapy: Custom Compounded versus Government Approved
  6. Bioidentical Hormones
  7. Bioidentical Hormones Explained – A British Menopause Society Video
  8. Bioidentical Hormones – Ask Dr Jean
  9. Bioidentical Hormones: Are They Safer?
  10. Compounded Bioidentical Hormone Therapy
  11. Compounded Bioidentical Hormone Therapy [Video]
  12. Compounding and the FDA: Questions and Answers – Are Compounded Drugs Approved By FDA?
  13. Menopause Management: Pharmacy-Compounded Hormones
  14. NAMS Applauds NASEM Efforts on Compounded Bioidentical Hormone Therapy
  15. National Academies of Science, Engineering, and Medicine (NASEM) Study on the Clinical Utility of Treating Patients With Compounded “Bioidentical” Hormone Therapy
  16. National Center for Complementary and Integrative Health: Menopausal Symptoms: In Depth: What the Science Says About Complementary Health Approaches for Menopausal Symptoms – Other Complementary Approaches: Bioidentical Hormones
  17. National Center for Complementary and Integrative Health: Natural Doesn’t Necessarily Mean Safer, or Better
  18. Video Series-2020 – TSECs—A New Treatment for Hot Flashes and Night Sweats
  19. Video Series-2020 – What You Need to Know About Bioidentical Hormone Therapy
  20. Video Series-2021 – What Women Need To Know About Hormone Therapies

Last Updated: 18 January 2021 – Last Revised: 16 July 2020
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