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Published with the permission of Jean Hailes for Women’s Health.
IN recent years, bioidentical hormones have gained popularity as a more “natural” alternative to hormone replacement therapy (HRT) for treatment of menopausal symptoms such as hot flushes, vaginal dryness and difficulty concentrating.
Bioidentical hormones are based on extracts such as yam and soybean, hence their “natural” appeal. However, claims that they are safer and more natural than HRT – also known as menopausal hormone therapy (MHT) – are misleading and not based on scientific evidence.
We spoke to Dr Sonia Davison, Jean Hailes endocrinologist, and Dr Amanda Newman, specialist women’s health GP, to find out the situation regarding bioidentical hormones.
What is “bioidentical”?
The term “bioidentical” refers to compounds that claim to be identical, in chemical make-up and molecular structure, to hormones that the human body produces. They are marketed as being gentler on the body because they are absorbed through the skin or the lining of the cheek, in the form of lozenges, troches or creams.
Not so natural
Women who take bioidentical hormones often choose them over HRT/MHT because they believe they are made only from plant extracts and not synthesised in a laboratory. In reality, just like vitamin supplements, these hormones are commercially processed.
“Bioidentical hormone therapy (BHT) is not more natural,” says Dr Davison. “In fact, bioidentical hormones are made from synthesised substances, just like [HRT].”
Dr Newman added: “Also, just because a substance is derived from something natural, it doesn’t mean it is safe. Tobacco is a beautiful green leafy plant”.
Science and safety
While medications used in HRT/MHT have been stringently studied in large clinical trials to ensure safety and to assess side effects and efficacy, similar long term, high quality research has not been conducted on BHT, says Dr Davison.
“HRT products are made in a very strict environment, and have undergone stringent testing and government approval before they are able to be used in women or allowed to be made available by prescription,” says Dr Davison.
“Bioidentical hormones bypass this process and are not approved by the government’s Therapeutic Goods Administration, so there are no guarantees that bioidentical custom-compounded hormones are safe.”
The Australasian Menopause Society, the International Menopause Society and the United States Endocrine Society don’t support the use of bioidentical HRT.
Dr Davison says that an emerging problem with bioidentical hormones is due to the form of progestogen they might use, which is needed to protect the endometrium.
“It may not be protective of the lining of the womb and as a result, may lead to thickening of the endometrium and an increased risk of cancer,” Dr Davison explains.
Custom compounding is misleading
To buy bioidentical hormones, you can’t just go to any chemist. First, you see a health practitioner. They will often conduct a saliva test, or order a blood test to check your hormone levels. You then take their prescription for bioidentical hormones to a compounding pharmacist, who makes up the hormones especially for you.
This customised compounding makes women think that bioidentical hormones are better suited to their specific hormonal imbalances, but this is untrue. In fact, saliva tests are not considered a reliable method for establishing hormone levels. Blood tests are also not necessarily reliable, as women’s hormones during perimenopause and menopause can change from day to day, or even hour to hour, says Dr Newman.
“Women respond in different ways to this hormonal chaos,” she says. “For some women it makes no difference to how they feel, whereas other women may [have] severe symptoms, despite having similar blood results.”
The cost of bioidentical hormones is also considerably higher than conventional HRT.
Mistaken fears about hormone replacement therapy/menopausal hormone therapy
There have been reports in the media about the risks of HRT in relation to cancer, further illness and disease.
However, over the past few years, re-evaluation of the data from the Women’s Health Initiative, and recent comprehensive reviews of evidence on HRT, have found HRT is both an effective and a safe treatment for the relief of menopause symptoms (here and here), and prevention of osteoporosis, for healthy women.
Women who may be at risk if they take HRT – whether traditional or bioidentical – include those who:
- have previously been diagnosed with breast cancer;
- have previously been diagnosed with cardiovascular disease; or
- have had a venous thrombosis or deep vein thrombosis.
As bioidentical hormones have not undergone rigid long term clinical trials, it is not clear whether long term use may cause health problems. A Cochrane review stated that “no data are yet available about the safety of BHT with regard to long-term outcomes such as heart attack, stroke and breast cancer”.
New hormone replacement therapy options
To ensure patients are getting the right advice and information on HRT and BHT, it is important to get good quality medical care. A GP or women’s health specialist can offer advice based on scientific studies and will also discuss the benefits and risks of hormone therapy. This discussion should take into account personal factors, including health conditions, or family history of health conditions, such as heart disease or breast cancer.
“There are several different types of HRT available, and one type may be more suitable for you than another,” says Dr Newman. “You can choose from tablets, skin patches or gel in a variety of doses and combinations.”
How long is it safe to use hormone replacement therapy?
Dr Davison says there is “no correct time frame” for using HRT, as it depends on the woman’s individual circumstances and the hormone therapy involved. But for the majority of women, this will be a few years.
Dr Newman says women aged under 60 years generally benefitted from using HRT.
“We certainly know that under the age of 60, women [treated with] HRT, compared with women who do not take HRT, have both better morbidity and mortality outcomes,” says Dr Newman.
“Overall the scientific studies are positive regarding women with menopausal symptoms taking HRT. The same cannot be said for bioidentical hormones because they have not been widely or appropriately researched.”
Further information about menopause treatment options can be found here.
Jean Hailes for Women’s Health can be reached at 1800 JEAN HAILES (532 642)
The statements or opinions expressed in this article reflect the views of the authors and do not represent the official policy of the AMA, the MJA or MJA InSight unless that is so stated.
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Dear J Reynolds,
In regard to Dr Eden, he has prescribed bio-identical hormones and still does. The name body identical is just a marketing tool to make people think there is a difference. Bio-identical hormones, which are the same as body identical hormones, are still by prescription only. They are not ALL natural but are certainly the same as what is now termed body identical. The compounding pharmacy that Dr Eden used is well known. He may now use the term body identical but is fully aware that they are one and the same. Just because a product has TGA approval or FDA approval (usually for a fee) does not make it safe. If that were so, there would not be the hundreds of recalls every year.
It is not only lay people that are confused!
Let’s get some real intelligence here. For those who call themselves professionals, it may be worth checking your grammar and spelling before posting comments. To answer briefly, ‘Anonymous no 2’ (in other words not the original poster): to even suggest that we all know that HRT or MHT has a limited role in managing symptoms, especially in those under 60 yrs shows just how little experience you have in regard to the treatment of such women. Certainly lifestyle improvement goes a long way but there are hundreds of thousands of women who will testify that they get real results from their hormone supplementation. In actual fact, the large majority of women between 50 and 60 yrs of age are the main benefactors.
Only a poorly informed ‘professional’ would even suggest that women might get the same benefits from eating more yams or soy although reduction of red meat consumption is a sensible suggestion.
I think you will find that Professor John Eden (as an expert in gynae endocrinology) refers to body identical hormones as those hormones being produced that are ‘identical’ in chemical and molecular structure to those hormones found in the body. He does not advocate the use of ‘bio-identical’ hormones which is the term commonly used by proponents of ‘natural’ menopause treatments using formulations that are compounded, unregulated and untested. The terminology can be pretty confusing – seemingly even for medical professionals (so imagine how confused lay people are).
https://www.whria.com.au/wp-content/uploads/2017/02/John-Eden-Monograph-FINAL.pdf features an article from the Womens health and research institute.
I am not the original commentator from Comment number 1.
i found this article very well balanced.
what I however am concerned is that among us professionals, we still have members who sput nonevidence based ideas to patients. we all know that HRT or MHT has a limited role in managing symptoms, especially in those under 60yrs. however, the guidelines are there to use them for as short a period of time as possible. we should all be striving to improve lifestyle of those women as we all should be aware that losing weight, becoming physically active etc are other ways of improving hot flashes, but also improving post-menopausal bone health. it is sad that so many women who go on MHT are just being given those on a continuous basis without reviewing the need, and I think this is where we should be striving to improve.
whether something is natural or not, is debatable, as it is usually through a lab technique that it becomes a tablet etc
so, perhaps women should eat more yams or soy instead – it may be of value to cut there red meat consumption to cook soy/tofu based meals.
Actually, the Jean Hailes Foundation, Australasian Menopause Society, the International Menopause Society, and United States Endocrine Society do not really find against BHT and a number of their experts not only prescribe them but have written, supporting their use. e g Prof J Eden and Dr B Wren. Dr Eden has even been filmed talking to a patient and has a bottle of compounded BHT prescribed by him for the patient he has prescribed it for.
There is quite a lot of evidence in support of BHT although further large scale studies are needed. One study conducted in France is particularly supportive of the benefits of BHT in particular micronised bio-identical progesterone. By all means let us use our intellects and let us also not ignore the 40% of women in western countries who are currently getting relief from bio-identical hormone medication prescribed by intelligent and learned doctors as equally credentialed as some of the experts quoted in this particular article. Do some more research and perhaps you just might indeed find the source of funding of these experts can be linked to the pharmaceutical industry.
I don’t understand why an Anonymous person is allowed to post ?
I believe in free speech, but I am disappointed in a professional setting ,for someone not having the courage of your convictions ,or putting up meaningful opinion rather than unsubstantiated accusations .
I wonder on what basis “anonymous” has to believe that the Jean Hailes foundation, Australasian menopause society, the International menopause society, and United States endocrine society are ALL biased, ill-informed, or part of the pharmaceutical companies!!
Particularly given the anonymous posting, I can only imagine it is by virtue of the evidence being at odds with their business of charging women a fortune for unproven saliva tests and “individualised” compounded prescriptions? Which to me is far more biased and unethical than standard evidence based care.
I hope we can practice what is safe and effective. That is HRT not BHT. Let’s use our intellects to weigh up evidence not our emotions.
I’m with Cate Swannell on this. It is really disappointing that some medical practitioners promote BHT, which has no safety data, uses delivery methods which are potentially unreliable, and costs a lot of money. Pharmaceutical HRT by contrast has lots of safety data, very reliable delivery methods, and is affordable.
From the editor: Actually it’s written by the Jean Hailes for Women’s Health research institute, dear “Anonymous”, and published with permission. Let’s not go casting aspersions, eh?
This is a biased piece of reporting and is full of inaccuracies and written by an ill informed doctor or written by the pharmaceutical industry.