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Is Bio Identical Hormone Replacement Therapy (BHRT) Safe?

Our hormones control most of our body’s functions. They are the messengers between the organs and cells of our body. Thus, they play a vital role in health and well-being, and are involved in the majority of our organism’s functions like digestion, cognition, libido and growth. It is thus common for a slight hormonal disturbance to cause very disabling diseases.

Many studies have been done to solve these hormonal problems, and recently bio identical hormone replacement therapy (BHRT) has emerged as an interesting alternative to classic hormonal therapies. While it can be used in many indications such as insulin resistance or fibromyalgia, it is mostly used in hormone replacement therapy for menopause.

The purpose of this article is to clarify the therapeutic modalities of BHRT and exposing its advantages, disadvantages and side effects.

First of all, menopause is a natural phenomenon, not an illness. The term menopause etymologically means “stopping of periods” and classically means stopping of the reproductive function in women. It usually occurs around 50. All hormones that change during menopause (estrogen, progesterone and testosterone) fall into the category of “sex steroids” derived from cholesterol.

Hormone replacement therapy aims to reduce the symptoms of menopause. The conventional one uses synthetic hormones. However, since 2002, thousands of menopausal women stopped their classic hormonal treatment due to fear, among others, of risks of breast cancer, stroke and myocardial infarction.

Few women know, but there are two types of hormone therapy to treat the symptoms of menopause: the synthetic and the bio-identical one. Doctors claim that hormones are bio-identical are safer for health than conventional hormones.

What are bio-identical hormones?

When we talk about hormones, the term “bio-identical” simply means identical to the hormones that our body products (including the chemical composition).

Long neglected, the bio identical hormone replacement therapy has emerged in 2002 after the Women’s Health Initiative study that proved the implication of the classic hormone replacement therapy in many cardiovascular and gynecological pathologies (myometrial infarction, breast cancer…).

It should be noted that synthetic formulations of progesterone and estrogen have been developed because natural formulations cannot be patented (their composition is already known). They therefore have little financial interest for pharmaceutical companies.

Bio identical hormones have the same chemical structure of hormones made by the body itself, they counteract hormonal imbalances linked to menopause while having much less side effects than their synthetic analogues.

What are the treatment modalities?

A blood test is done to measure the rate of hormone deficiency. Recent mammography, imaging of the uterus and ovaries are also needed.

In a second step – and after exclusion of any possible contra-indication -, the administration of the substitution hormones is carried out orally or transcutaneously (patch, gel or cream).

It should be noted that the main hormones used are estrogen and progesterone, there are also pregnenolone, DHEA and testosterone. All these hormones are in their original form.

An effective response to treatment at the lowest dose is sought, with a gradual dosage of hormones. Patients therefore also benefit from regular medical monitoring.

Why stamps, gels and creams?

The hormones taken orally are absorbed by the digestive tract and then transported to the liver before being released into the body. In fact, almost 90% of the dose taken by mouth remains in the liver. In other words, only 10% of the dose taken circulates in the body to exert the expected beneficial effects.

This passage is responsible for the majority of the undesirable effects, the possibility of administering the BHRT transcutaneously presents thus an important advantage. This route of administration (patches and gels) allows the body to directly absorb almost 100% of the hormones. There is no loss linked to liver passage or over-activation of liver enzymes.

However, bio-identical progesterone orally has an advantage for women who suffer from insomnia: during passage through the liver, some metabolites that have beneficial effects on sleep are manufactured.

What are the benefits?

BHRT has many advantages:

  • Action against osteoporosis
  • Can improve mood and psychological well-being
  • Relieves the symptoms of menopause
  • Improves blood circulation
  • Improves physical performance
  • Can affect some effects of aging of the body
  • Stimulates sexual function
  • Positive action on cognitive function
  • Action on the texture and elasticity of the skin and tissues.

After detailing the benefits and therapeutic modalities, it is necessary to look into the safety of the use of this therapy.

Are bio-identical hormones safe?

  • From a chemical point of view:

Hormone therapy with bioidentical hormones “is a common term to describe a drug that consists of estrogen, progesterone, or other synthetic hormones that are chemically the same as natural hormones produced primarily by the ovaries.

Bioidentical hormones are most often obtained by modifying the molecular configuration of certain plant sterols with the help of enzymes. Bio-identical hormones are safe not because of this manufacturing process but because the message they bring to our cells is the same as that of our endogenous hormones.

So, our cells recognize these substances and know exactly how to react according to the programming that nature has inscribed in cellular intelligence, which is not the case for non-bio-identical hormones.

  • For the route of administration:

Bio-identical hormones are administered transdermally (cream or gel) to respect the way in which nature circulates the hormones in our body, this minimizes certain dangers inherent to the first passage in the liver (this is a problem related to taking oral hormones, including oral contraceptives).

  • Regarding dosages:

In addition, if the dosages correspond to the normal levels of hormones for our age and the balance is maintained between estrogen and progesterone, bio identical therapy is, according to more and more doctors and experts, the safest approach to hormone replacement therapy.

  • Regarding the synthesis:

The main drawbacks and risks associated with this therapy are related to this aspect. The North American Menopause Society asserts that BHRT carries risks for the safety, in particular concerning respect of doses because these preparations often uncontrolled. In addition, there is a lack of scientific data on efficacy and safety, and the governments have minimal regulation and oversight on this.

This lack of studies is however to be relativized because most studies are conducted or encouraged by pharmaceutical companies, which are not interested in these products because they cannot be patented.

In addition, it is questionable whether these preparations contain impurities, whether they are effective and whether they have been prepared in a sterile way.

It is therefore important to know the structures that respect the dosages, the standards of preparation and which undergo quality control of their products, in order to use BHRT at lower risk.

So let’s get on with the question: Where to get the BHRT?

Where to get bio-identical hormones?

Like synthetic hormones, bio identical hormones affect metabolism and can have significant effects even at low doses. This is why the diagnosis of hormonal deficiency and the choice to undertake hormone replacement therapy are reserved for doctors who have previously undergone exhaustive training.

Bioidentical hormone preparations are not generally available in normal pharmacies. Only a few specialized pharmacies have developed the necessary expertise to prepare formulations from progesterone, estrogen and testosterone in their natural and micronized form according to the dosing specifications prescribed by the treating physician.

Bioidentical hormones can be prepared in capsules or transdermal creams. The transdermal cream as mentioned above has the advantage of avoiding the first-pass effect in the liver. Keep in mind that the dosages may vary according to the age, the hormonal state (pre or postmenopausal) and the importance of the symptoms that need to be corrected.


To conclude, bio identical hormones seem to be an increasingly recognized alternative to reducing the symptoms of menopause while avoiding the adverse effects and risks associated with synthetic hormones replacement therapy.

However, treatment with identical bio-hormones seems to be hampered by certain obstacles, as there are not enough studies for possible adverse effects. Structures offering this type of therapy should be monitored for quality and dosage of the products, and patients undergoing treatment should be closely monitored.