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Understanding Bioidentical Hormone Replacement Therapy

Miriam Martinez Callejas discusses bioidentical hormone replacement therapy

Never has there been a time when the topic of hormone replacement therapy (HRT) has been discussed with such prevalence. But the history of hormone replacement therapy (HRT) started as long ago as the 1920s.

In 1923, Allen and Doisy reported localising, extracting, and partially purifying oestrogen.1 They also determined some actions of oestrogen in animal models.2 This bioassay for detecting oestrogenic activity would provide a basis for future hormone research and facilitate the identification of oestrogens in many different sources, including mammalian tissues, excreta, and plants.1 Perhaps as significantly, the new assays facilitated oestrogen synthesis.3

It was during the Great Depression in the United States in 1933 that the first form of bio-identical hormone therapy derived from the urine of pregnant women was commercially produced and sold.1

In the 1990s, hormone replacement became very popular,4 but following the Women’s Health Initiative report in 2002 claiming that the combination of conjugated equine oestrogen (CEE) and medroxyprogesterone acetate increased breast cancer risk and did not improve quality of life, use declined.4-5

In the following years, new studies emerged showing that the use of HRT in younger women or early postmenopausal women had a beneficial effect on the cardiovascular system, reducing coronary disease and all-cause mortality.4,6 Fast-forward to today, and as awareness increases around menopause and the benefits of HRT, we are seeing more and more coverage in the press debating its pros and cons.

Among those debates is that surrounding bioidentical hormone replacement therapy or BHRT, which has emerged as a nuanced alternative to traditional hormone replacement therapies in the management of hormonal imbalances.7

With so much information out there, it can be difficult, even for medical practitioners, to cut through the noise and decipher what is the difference between the types of hormone replacement available and what to prescribe their patients.

In this article, I will explain the difference between HRT, body-identical hormones and bioidentical hormones in a bid to address some of the myths and misconceptions.

Before offering any sort of hormone replacement to patients to treat the symptoms, it is important to understand the functions of hormones in the body and the options available to you to ensure you are making the right choices.8 Training is key to this.

IS HORMONE REPLACEMENT JUST FOR MENOPAUSE?

The reduction of hormone levels is a crucial aspect of the ageing process in both men and women and while this often coincides with menopause for women, hormone replacement can be used to address hormonal imbalances, whether menopause-related or otherwise.9

By incorporating an understanding of hormones into your practice, you can address patients’ needs holistically, targeting both internal and external aspects of ageing.10

CONVENTIONAL HORMONE REPLACEMENT THERAPY (HRT)

Hormone-replacement therapy (HRT) with small doses of oestrogen (and progestogen for women with an intact uterus) can help relieve menopausal symptoms that result from hormonal deficiency as a result of natural menopause or surgical menopause.11-12

Conventional hormone replacement therapy (HRT) usually involves the substitution of naturally declining hormones with either synthetic or partially synthetic alternatives or body-identical hormones. Certain HRT options, like progestins sold on the market, are entirely synthetic, while others, such as conjugated equine oestrogen, are semi-synthetic and sourced from animals.

BODY IDENTICAL HORMONES

The terms “bioidentical hormones” and “body identical hormones” are often used interchangeably, as they both refer to hormones that are chemically and structurally identical to the hormones naturally produced in the human body. However, there are some differences in how these terms are used.

Body-identical is a term that was created to differentiate medication that is produced by large pharmaceutical companies and licensed for sale on the UK market from compounded medication. Body-identical hormone medications include Evorel, Estradot, Utrogestan, Oestrogel, Lenzetto, Sandrena, and IntraRosa. These are readily prescribed on the NHS.

BIOIDENTICAL HORMONE REPLACEMENT THERAPY (BHRT)

Although it has been available for years, bioidentical compounded hormone therapy has only recently been growing in popularity because of the need for specialised medications for individual patients.

The further advances in healthcare and diagnostic testing reveal individual variations and compounding offers a better treatment and approach to the progression of a disease when the existing medication cannot.

Bioidentical hormones, derived from natural sources such as soy and yams, possess molecular structures identical to those produced endogenously. While they undergo laboratory modification from natural materials, their final structure mimics that of human hormones, setting them apart from synthetic alternatives as they are identified as our own. This distinction underscores the fundamental difference between bioidentical hormones and synthetic or animal-derived hormones HRT.

SAFETY AND EFFICACY OF BHRT

The debate surrounding the safety and efficacy of BHRT compared to traditional synthetic and animal-derived HRT, such as conjugated equine oestrogens (CEE), medroxyprogesterone acetate (MPA) and other synthetic progestins, has garnered significant attention, particularly in the UK.13 While bioidentical hormones, especially progesterone, oestradiol, and estriol, have gained acceptance, compounded BHRT remains a subject of scrutiny.

The British Menopause Society (BMS) divides the concept of bioidentical hormone therapy (BHRT) into two categories: compounded BHRT and regulated BHRT.14-15 While it advocates for the utilisation of bioidentical hormones, especially progesterone, the BMS remains sceptical about compounded BHRT due to insufficient evidence supporting its effectiveness.15

Despite this, we are seeing a rising demand for BHRT, stemming from accumulated scientific and anecdotal data suggesting its potential benefits and containing the same ingredient as body identical HRT.16

Research suggests that BHRT may offer advantages in terms of safety and efficacy because BHRT closely mimics human hormones.17-18

Bioidentical progesterone, for example, has demonstrated atherosclerotic plaque-inhibiting properties, contrasting with synthetic progestins’ adverse effects on cardiovascular health and insulin resistance.19-22

PERSONALISED DOSAGE AND TAILORED TREATMENT

The Lancet recently proposed an empowerment model for menopause in which the patient is an expert in their own condition, and the healthcare worker supports the patient to become an equal and active partner in managing their own care.23

One of the key advantages of BHRT lies in its ability to provide personalised dosage regimens tailored to individual needs. In the UK, where tailored medications are increasingly available, clinicians can optimise hormone therapy by adjusting dosage forms and combinations to achieve precise dosing. This personalised approach enhances patient safety and satisfaction, addressing specific clinical needs that may not be met by standardised treatments.

COMPOUNDING

Compounding pharmacies play a vital role in providing customised medications, especially when approved drugs are not suitable or available in the required form or strength.24 Regulated by the General Pharmaceutical Council in the UK, compounding pharmacies ensure quality standards while offering tailored solutions to patients’ healthcare needs. Through informed communication and patient education, these pharmacies empower clinicians and patients to make informed decisions regarding BHRT.

CONCLUSION

Bioidentical hormone replacement therapy (BHRT) represents a modern approach to hormonal balance, offering personalised solutions and potential benefits over traditional HRT. While controversies persist, the growing body of evidence supporting the safety and efficacy of BHRT underscores its relevance in contemporary healthcare practices. By embracing innovation and adopting a patient-centred approach, practitioners can harness the therapeutic potential of bioidentical hormones to optimise patient outcomes and promote overall well-being.

MIRIAM MARTINEZ CALLEJAS

Miriam Martinez Callejas is the superintendent pharmacist and co-founder of Roseway Labs. She holds a Master’s Degree in Pharmacy with international experience in bio-pharmacy research, compounding and nutrition.

REFERENCES

1. Kohn GE, Rodriguez KM, Hotaling J, Pastuszak AW. The History of Estrogen Therapy. Sex Med Rev. 2019 Jul;7(3):416-421. Doi: 10.1016/j.sxmr.2019.03.006. Epub 2019 May 27.

2. Allen Eand Doisy EA, An ovarian hormone: Preliminary report on its localization, extraction and partial purification, and action in test animals. Journal of the American Medical Association, 1923. 81(10): p. 819–821.

3. Lieberman S, Are the differences between estradiol and other estrogens, naturally occurring or synthetic, merely semantical? The Journal of Clinical Endocrinology & Metabolism, 1996. 81(2): p. 850–851.

4. Cagnacci A, Venier M. The Controversial History of Hormone Replacement Therapy. Medicina (Kaunas). 2019 Sep 18;55(9):602.

5. Bluming, Avrum Z. MD1; Hodis, Howard N. MD2; Langer, Robert D. MD, MPH3. ‘Tis but a scratch: a critical review of the Women’s Health Initiative evidence associating menopausal hormone therapy with the risk of breast cancer. Menopause 30(12):p 1241-1245, December 2023.

6. Hodis HN, Mack WJ. Menopausal Hormone Replacement Therapy and Reduction of All-Cause Mortality and Cardiovascular Disease: It Is About Time and Timing. Cancer J. 2022 May-Jun 01;28(3):208-223.

7. Stanczyk FZ, Matharu H, Winer SA. Bioidentical hormones. Climacteric. 2021 Feb;24(1):38-45. doi: 10.1080/13697137.2020.1862079. Epub 2021 Jan 6.

8. Palacios S, Stevenson JC, Schaudig K, Lukasiewicz M, Graziottin A. Hormone therapy for first-line management of menopausal symptoms: Practical recommendations. Womens Health (Lond). 2019 Jan-Dec;15:1745506519864009.

9. https://www.ncbi.nlm.nih.gov/books/NBK279050/ [accessed 21.3.24]

10. https://www.aestheticnursing.co.uk/content/clinical/understanding-bioidenticalhormones-and-their-effect-on-quality-of-life/ 

11. Vigneswaran K, Hamoda H. Hormone replacement therapy -Current recommendations. Best Pract Res Clin Obstet Gynaecol. 2022 May;81:8-21. doi: 10.1016/j.bpobgyn.2021.12.001. 

12. https://www.cmaj.ca/content/195/19/E677 [accessed 21.3.24] 

13. Holtorf K. The bioidentical hormone debate: are bioidentical hormones (estradiol, estriol, and progesterone) safer or more efficacious than commonly used synthetic versions in hormone replacement therapy? Postgrad Med. 2009 Jan;121(1):73-85. 

14. https://www.prescribingpractice.com/content/clinical-focus/understandingbioidentical-hormones-and-their-effect-on-quality-of-life/#:~:text=The%20 British%20Menopause%20Society%20(BMS,of%20evidence%20of%20their%20 efficacy [accessed 3.4.24] 

15. https://thebms.org.uk/publications/consensus-statements/bioidentical-hrt/ [accessed 3.4.24] 

16. L’hermite M, Simoncini T, Fuller S, Genazzani AR. Could transdermal estradiol + progesterone be a safer postmenopausal HRT? Areview. Maturitas. 2008 Jul-Aug;60(3-4):185-201. 

17. Ruiz AD, Daniels KR, Barner JC, Carson JJ, Frei CR. Effectiveness of compounded bioidentical hormone replacement therapy: an observational cohort study. BMC Womens Health. 2011 Jun 8;11:27. 

18. Liu Y, Yuan Y, Day AJ, Zhang W, John P, Ng DJ, Banov D. Safety and efficacy of compounded bioidentical hormone therapy (cBHT) in perimenopausal and postmenopausal women: a systematic review and meta-analysis of randomized controlled trials. Menopause. 2022 Feb 14;29(4):465-482. 

19. Campagnoli C, Clavel-Chapelon F, Kaaks R, Peris C, Berrino F. Progestins and progesterone in hormone replacement therapy and the risk of breast cancer. J Steroid Biochem Mol Biol. 2005 Jul;96(2):95-108. 

20. Asi N, Mohammed K, Haydour Q, Gionfriddo MR, Vargas OL, Prokop LJ, Faubion SS, Murad MH. Progesterone vs. synthetic progestins and the risk of breast cancer: a systematic review and meta-analysis. Syst Rev. 2016 Jul 26;5(1):121. 

21. Simon JA. What’s new in hormone replacement therapy: focus on transdermal estradiol and micronized progesterone. Climacteric. 2012 Apr;15 Suppl 1:3-10.

22. Huber JC, Campagnoli C, Druckmann R, et al. Recommendations for estrogen and progestin replacement in the climacteric and postmenopause. European Progestin Club. Maturitas 1999;33:197-209. 

23. https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(23)02799-X/ fulltext [accessed 14.3.24] 

24. Gudeman J, Jozwiakowski M, Chollet J, Randell M. Potential risks of pharmacy compounding. Drugs R D. 2013 Mar;13(1):1-8.

This article appears in May 2024

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May 2024
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Welcome to the May issue of Aesthetic Medicine Magazine
This month, we delve into the intricate relationship between menopause and wellness
Meet the experts
Meet our editorial advisory board
Hot off the press
The latest industry news
The future of menopause care
We look at the Menopause in Aesthetics trend report for 2024
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The need for greater education about safety in aesthetics outside of London
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Looking for back issues?
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