Bio-Identical Hormone Replacement

Bio-Identical Hormone Replacement

Dr. F. Arden Pinault ND, MS, LAc

Bioidentical hormone replacement therapy (BHRT} is the use of hormones that are identical on a molecular level (same size, shape and form) with endogenous hormones made in the human body. Typical hormones used in BHRT include Estradiol, Estriol, Progesterone, Testosterone, DHEA, Pregnenolone and Human Growth Hormone. 


It is often advantageous to do testing of hormone levels through either blood or saliva to determine which hormones need replacing and how much is needed to reach a targeted level of hormones in the body. 



BHRT can be achieved though the use of creams, capsules, tablets, sublingual drops, troches (sublingual lozenge), or patches. Some hormones are best taken by mouth whereas hormones such as Estrogen and Testosterone should NOT be taken by mouth but by transdermal means only. BHRT products can be obtained through regular pharmacies or Compounding pharmacies which can custom make the hormones in different forms.


Bioidentical hormones were first used for menopausal symptom relief in the 1930s, after Canadian researcher James Collip developed a method to extract an orally active estrogen from the urine of pregnant women and marketed it as the active agent in a product called Emmenin. It was supplanted on the market when its manufacturer, Ayerst (later Wyeth Pharmaceuticals), began producing the more-easily manufactured conjugated equine estrogens in 1941 under the brand name Premarin; by 1992, Premarin was the most widely prescribed drug in the United States. 


In the 1970s, research and reports indicating risks from synthetic conjugated estrogens began to appear. Investigations determined that the addition of a progestogen to estrogen treatment reduced the risks. As early as 1980, the British Medical Journal (now The BMJ) recommended oral bioidentical progesterone as an option when side effects from synthetic progestogens otherwise mandated discontinuing treatment. In May 1998 the FDA approved Prometrium, an oral bioidentical progesterone.


Physicians John R. Lee and Jonathan Wright were pioneers in the field of BHT.  Lee authored several popular books on BHT and promoted custom-compounded BHT, with the goal of achieving what he called a "natural hormone balance". He based this goal on the clinical testing of saliva to establish where "deficiencies" existed. Lee also believed that progesterone acted as a panacea and general health tonic for many health conditions, Jonothan Wright also authored a popular book on BHT. Compared to previous bioidentical formulas that only used estradiol, he promoted a triple-estrogen formula called Triest, which combined three estrogens found in human females: estriol, estradiol and estrone. It was based on an unpublished study whose conclusions accounted for how estrogens are processed and excreted in the body, particularly how the liver processes oral estrogens, converting most of them to estrone. No follow-up was performed by Wright to replicate these observations. Wright may have been the first proponent of BHT to use the term bioidentical the word he coined to describe unpatentable, plant-derived molecules he believed were identical to human hormones.


It may also be combined with blood and saliva testing of hormone levels, and the use of pharmacy compounding to obtain hormones in an effort to reach a targeted level of hormones in the body. Specific hormones used in BHT  include estrone, estradiol, progesterone, testosterone, dehydroepiandrostere(DHEA), and estriol.


Bioidentical hormones were first used for menopausal symptom relief in the 1930s, after Canadian researcher James Collip developed a method to extract an orally active estrogen from the urine of pregnant women and marketed it as the active agent in a product called Emmenin. It was supplanted on the market when its manufacturer, Ayerst (later Wyeth Pharmaceuticals), began producing the more-easily manufactured conjugated equine (horse) estrogens in 1941 under the brand name Premarin; by 1992, Premarin was the most widely prescribed drug in the United States. In the 1970s, research and reports indicating risks from synthetic conjugated estrogens began to appear. Investigations determined that the addition of a progestogen to estrogen treatment reduced the risks. As early as 1980, the British Medical Journal (now The BMJ) recommended oral bioidentical progesterone as an option when side effects from synthetic progestogens otherwise mandated discontinuing treatment. In May 1998 the FDA approved Prometrium, an oral bioidentical progesterone product produced by Solvay Pharmaceutical. 

Physicians John R. Lee and Jonathan Wright were pioneers in the field of BHT. Lee authored several popular books on BHT and promoted custom-compounded BHT, with the goal of achieving what he called a "natural hormone balance". He based this goal on the clinical testing of saliva to establish where "deficiencies" existed.

Is BHRT Safe?

In 2002 a study called the “Women’s Health Initiative Study” was released. In the study 14,000 women were followed who took Premarin, Prempro or no hormones. Premarin contains non-bioidentical equine (Horse) estrogens, Prempro is Premarin with non-bioidentical Progestins. After 5 years the study had to be terminated for ethical reasons as the women taking Premarin, and in particular Prempro were developing diseases such as cancers, osteoporosis, heart disease and dementia. Clinicians were using these types of HRT to treat and prevent these conditions so both clinicians and patients lost confidence in HRT as it became clear they were not safe.  Overnight 50% of women using HRT stopped using their products.



For the last 20 years many clinicians have mistakenly taken the results of the women’s health initiative study to say Estrogen is not safe especially if taken for more than 5 years. Unfortunately, many clinicians do not understand that the study demonstrated what could happen when non-bioidentical hormones derived from a different species than humans were introduced to a human female body.

Since the release of the Women’s Health Initiative Study (WHIS) many studies have been published on the use of Bioidentical Hormones. In 2014 Dr. Kent Holtorf published a meta-analysis (a study of studies) looing at over 160 studies that followed women who took BHRT. These studies showed that the use of BHRT was safe and did not cause the conditions found when non-bioidentical hormones were given to human women. Some studies did find that if a woman already had cancer, the BHRT could make the cancer grow faster.


Since the WHIS, the use of bio-identical hormones has been the preferred type of HRT. Make sense, right? If you want to give a human female hormone replacement, those hormones should be in the same size, shape and configuration as the hormones made by human beings.

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