Bioidentical Hormones for Menopause: What They Are and How They Work
When you have spent some time reading about the treatments of menopause, you have almost surely encountered such a term as bioidentical hormones. It is applied extensively, especially in wellness areas and it is often used with such words as natural, personalised and safer. It sounds compelling. It also causes a great deal of confusion.
It is not surprising that the term bioidentical causes confusion since it carries a very different meaning in different contexts. In one sense, it refers to government-approved medications that are rigorously tested in terms of hormones. In another usage, it characterizes unregulated custom-mixed products sold by a compounding pharmacy or by other private clinics.
They both are referred to as bioidentical. However, they are not identical, and the distinction between the two has an enormous impact on safety, effectiveness, and cost.
In this post, the terms are unravelled, and you know what bioidentical hormones really mean, how they act, and have as clear an overview as possible of what the evidence actually substantiates.
In its simplest form, a bioidentical hormone is a hormone whose chemical structure is the same as that of a hormone that the human body synthesizes. The primary hormones when we refer to menopause are oestradiol (most active form of oestrogen), progesterone, and to some extent testosterone.
The logic behind this is that, in case a replacement hormone is identical to the molecules that the body produces, the body should treat it in the same way that it treats its own hormones.
This is a reasonable scientific concept. Molecular structure does play a role in how a hormone will interact with receptors throughout the body and there is a credible evidence that different forms of progesterone, such as, have different risk profiles. Later on that.
This is the first fact that surprises the majority of people: all hormones that are used in any sort of hormone therapy, be it a standard prescribed MHT or the so-called bioidentical products offered by a compounding pharmacy, are produced in a lab. All of them are not directly produced out of the human body or out of plants in a ready to use form. The estradiol and progesterone that are utilized in all these products are normally created out of plant derivatives, most often soy or yam but then they are subject to chemical treatment to form the resulting hormone molecule. The source of the plants does not render the final product more natural in any significant biological way.
This is the point at which the term bioidentical divides into two entirely different things, and, on which, most of the confusion, and some of the actual danger, accrue.
Most of the currently existing standard menopausal hormone therapies (MHT) available in Australia by a GP prescription do include body-identical hormones. Patch, gel and sprays contain the oestrogen component and this is usually oestradiol which is chemically the same as the oestrogen that was produced by the ovaries prior to menopause. A regulated, approved product, micronised progesterone, is also a form of progesterone that is similar to the progesterone molecule found in the body.
These products have undergone a long-term clinical testing. The doses are standardised and regulated. Their effectiveness and safety have been researched in large groups over years. You can tell right what dose you are receiving, each time. They are registered in Australia by the Therapeutic Goods Administration (TGA), and are much cheaper than the compounded ones.
These are technically bioidentical hormones. However, they are hardly sold as such, and that is one of the reasons why the misunderstanding remains.
Quite the opposite, compounded bioidentical hormone therapy is known as cBHT. It includes a specialist pharmacy compounding a tailor-made hormone preparation, usually founded on a test of the hormones of a woman in blood or saliva, and creating an individual cream, lozenge, gel, or capsule.
This is what most women will find attractive: the notion that your treatment is uniquely designed to your own hormone profile, that it is natural, and that it is somehow safer or more advanced than off-the-shelf. None of those assertions are backed up by reality.
The Australasian Menopause Society does not approve of the compounded bioidentical hormone therapy. Nor does the International Menopause Society, the North American Menopause Society, the US Endocrine Society or the British Menopause Society. This is the same in all the large menopause specialist organisations worldwide. The causes are unique and would be well worth knowing.
Controlled pharmaceutical products undergo high standards of quality control during the entire manufacturing process. A specific, confirmed dosage is found in each tablet, patch, or capsule. With compounded preparations, this assurance does not exist. The production is crafted, in limited batches, usually in limited amounts. Dose may change widely with each batch, and they do not test independently what you are actually receiving.
This is crucial since hormone treatment needs dosing. Too little and it does not work. Exceed this and you run the risk of even more side effects than you have with regular MHT that lacks the safety data informing you where these limits really are.
Millions of women have been using standard MHT products over decades, and their effects, both positive and negative, have been followed by large scale research. Their risk profile is well known to us. This type of testing has not been done on compounded products. We just lack the data to know whether they have the same, less or more risks to the regulated alternatives.
This is not an imaginary issue. A report published in the Medical Journal of Australia of Australian women developing endometrial cancer following the use of compounded bioidentical hormone therapy was published. The possible reason was that the compounded progestogen ingredient failed to sufficiently safeguard the uterine lining as regularly administered products do. In such women who have not gone through menopause and still have a uterus, oestrogen, when taken without the protection of progesterone, may thicken the uterine lining leading to cancer, with time.
This is a very critical and least known safety point. Compounded bioidentical progesterone delivered through progesterone cream, one of the most widespread methods, is inefficiently taken in by the skin. Despite the fact that progesterone cream does yield enough concentration in the blood, it cannot seem to accumulate sufficient concentration in the uterine lining to safeguard the lining against oestrogen.
This protection has been demonstrated by oral micronised progesterone, the regulated body-identical progesterone. The compounded version applied as a cream has not. In the case of a woman who has her uterus intact, it is an actual, documented safety risk and not a hypothetical possibility.
Various practices that prescribe compounded bioidentical hormones rely on saliva tests of hormone levels. This is is individual and scientific. The issue lies in the fact that, hormone level testing in saliva is not regarded by any of the major menopause specialist organisations as a reliable diagnostic tool.
The hormones in the perimenopause and menopause change drastically on hourly and daily basis. A single saliva test is literally a photo of one single time and that photo cannot possibly inform you accurately of what is going on in the body in general, much less form the foundation of a tailor-made hormone prescription. The same is true in blood tests in this transition period.
A clinical picture of a woman, her symptoms, her medical history and her response to treatment over time is the proper foundation upon which symptom management of menopause should be based as opposed to a single hormone level in a test tube.
Compounded bioidentical hormones are generally much more costly than controlled, TGA-approved ones. The extra price of the compounded products does not provide extra safety or efficacy since the regulated products include the same body-identical hormone molecules, at proven and effective doses, and are backed by decades of safety data. It provides a higher risk at a higher price.
This is where most of the discussion on bioidentical hormones falls short and it is arguably the most significant aspect of the entire story.
In case what you desire is hormone therapy using the same molecules as the hormones that your body made before menopause, then that is already available on a routine GP prescription in Australia. There is no need to visit a private clinic or a compounding pharmacy.
Oestradiol patches and gels deliver body equivalent oestrogen by passing through the skin, and are common as regulated products approved by the TGA. A regulated product called micronised progesterone, the body-identical form of progesterone and having a lower profile of breast cancer risk than older synthetic progestogens, is also available in Australia.
The bioidentical term has been so effectively applied as a marketing term within the private compounding services that most women are not aware that they can request their GP to provide them with body-identical hormones, and they will receive exactly what they want at a fraction of the cost with a full safety record attached to it.
To comprehend why such a lot of women are so attracted to compounded bioidentical hormones a bit of background is needed.
A 2002 study on hormone therapy in women, Women’s Health Initiative, as mentioned in an earlier blog in this series, created a great deal of panic. A great number of women discontinued their treatment. The medicines involved in that trial were more of the older synthetic hormones especially a synthetic progestogen form which does have a higher risk profile than body-identical products. There were practitioners, in the decades which followed, who were correct in pointing to newer, body-identical hormones as potentially safer. They were not mistaken about that.
The problem emerged however where what followed. The concept of natural, personalised, compounded bioidentical hormones created a market niche as the safe alternative to mainstream HRT. It also borrowed the credibility of body-identical science and avoided regulation and testing that render those products safe. The vocabulary overlapped. The products diverged.
Those women who were naturally suspicious of the traditional system were able to follow a parallel route that was more natural, personal and thought out. Its marketing was good. The evidence was nonexistent.
In case you want hormone treatment that incorporates body-identical hormones, this is what to do and what to watch out.
The term, bioidentical hormones, is a specific sounding term that is applied loosely to encompass two very different things. The science of body-identical hormones is real and significant. It is the manner in which science has been used as a tool by the compounding industry to develop a high-end, unregulated alternative that goes awry.
The moral of the story is simple. You do not have to go beyond the regulated system, in order to find hormone therapy which is as close to the hormones of your body as possible. Request your GP regarding body-identical oestrogen and micronised progesterone. They are accessible, inexpensive, proven, and suggested by all major organisations on menopause management in Australia and other nations.
It is not surprising that the attraction of something natural, personalised and tailored is so great. All you need is to ensure that what you are receiving is indeed those things, and not merely being sold as such at a large price premium and without the safety evidence to support that claim.