The Cancer Journal, May/June 2022: Special edition on hormone therapy and breast cancer

‘Concerns About Compounded Bioidentical Menopausal Hormone Therapy’

In this article, Dr Louise Newson summarises a review by JoAnn V Pinkerton in the latest issue of The Cancer Journal and welcomes the clarification of concerns regarding bio-identical HRT. 

With current issues surrounding supply of HRT and ongoing fears regarding its safety, women are often turning to privately prescribed compounded ‘bio-identical’ HRT. This review article in The Cancer Journal May/June 2022 issue clarifies the concerns regarding this form of hormone replacement. 

Often promoted as ‘individualised or precision medicine’, JoAnn V Pinkerton breaks down the myths surrounding compounded bio-identical HRT (cBHT) and the belief held by patients – especially since the findings of the Womens Health Institute study were released in 2002 – that this offers a safer alternative to FDA-approved hormonal therapies despite their lack of government approval in the USA (or the UK).  

cBHT are compounded in special pharmacies and custom made into tablets, lozenges and creams – often with a combination of hormones and doses. One of the major concerns with cBHT is that the progesterone is often given in a cream format, combined with oestrogen or testosterone for example. We know that progesterone is poorly absorbed through the skin which raises concerns surrounding the protection of the endometrium.  

Furthermore, the marketing of these products as ‘plant derived’ with a chemical structure similar to endogenous human hormones fails to take in to account the widely available FDA-approved body-identical hormonal treatments such as estradiol in oral, transdermal and vaginal therapies, micronised progesterone in oral and vaginal formulations, a combined oral estradiol and progesterone oral therapy, vaginal dehydroepiandrosterone (Prasterone) and transdermal testosterone.  

There is a complete lack of randomised trials demonstrating the efficacy or safety of cBHT for treating menopausal symptoms whilst concerns remain regarding its purity, potency and overall quality, as they are not subject to government oversight.  

Pelleted hormonal therapy, whereby the hormone is released over a 3-6 month period, are governed by rules relating to nutritional supplements and vitamins and are also not subjected to government oversight in the USA. There are many concerns regarding the lack of reversibility, bleeding, lack of information on release rates, adequate progesterone cover for endometrial protection and potential overdose.  

Pinkerton concludes: 

“The use of customized cBHT should not be routinely prescribed.”

This article relates to: 

Concerns About Compounded Bioidentical Menopausal Hormone Therapy 

Pinkerton, JoAnn V. MD, FACOG, NCMP  

The Cancer Journal: 5/6 2022 – Volume 28 – Issue 3 – p 241-245 

doi: 10.1097/PPO.0000000000000597