You may have heard about bioidentical hormones for treating your menopause symptoms and feel confused about how they are different from FDA-approved medications.
In a nutshell, bioidentical HT products have not been tested for safety and efficacy by the FDA. They are compounded in local pharmacies that have limited regulation, which means there are real safety concerns surrounding the use of these hormones. Read on to learn more about these products and safer alternatives.
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What is hormone therapy (HT)?
HT, also referred to as hormone replacement therapy (HRT) and menopausal hormone therapy (MHT), refers to FDA-cleared medications that are proven to be safe and effective treatments for menopause symptoms including hot flashes, mood changes, and sleep problems.
Quality control for HT
FDA-regulated forms of HT are quality-controlled at multiple points in the manufacturing process. This means we know exactly what they contain in terms of dose, quality, and composition.
FDA-regulated medications have also been subject to clinical trials – the only kind of research study that the FDA accepts to prove the safety and efficacy of medications. In some cases, these trials have been carried out multiple times over many years with thousands of patients. Although there are always some questions that remain, this means that we have a good understanding of the risks, benefits, and safety profiles of each treatment. FDA-regulated HT is produced by pharmaceutical companies and leaves the factory packaged and ready for the consumer.
What is compounded bioidentical HT (cBHT)?
Bioidentical HT technically means that the hormones used are identical to those produced by the body. However, in practice, the term bioidentical HT refers to compounded products – such as pills, creams, and suppositories – that are mixed together individually for each person. This may sound good – who doesn’t love getting things “custom-made” – but when it comes to HT, there are considerable risks to consider, such as overdosing, underdosing, and inconsistent dosing.
One difference between bioidenticals and FDA-approved HT is that the amount and type of hormone prescribed is often based on blood or saliva tests, which supposedly measure the levels of various types of estrogen circulating in the body. However, there is no evidence that these blood or saliva tests improve the efficacy or safety of the hormones.
In addition, some people think that compounded bioidentical HT is a more natural option, but this isn’t the case. cBHT does contain hormones identical to those naturally produced by your body (derived from vegetable products), but so do many FDA-approved HT products. The latter contain hormones that have undergone rigorous and repeated testing in manufacturing facilities. You can read more about body-identical HT further on in this blog.
Let’s find out why compounded bioidentical HT is not currently FDA-approved…
What are the risks of compounded bioidentical HT?
The FDA and the North American Menopause Society and the Endocrine Society do not recommend cBHT as it is not clear how effective they are and it is very clear that there are serious safety concerns.
Problem 1: Unregulated hormones
cBHT is not regulated or quality-controlled in the same way as traditional pharmaceuticals. This means that you cannot be sure what they contain. The doses and ingredients could be different batch-to-batch – meaning the effects of your medications could vary from month to month, and there could even be contaminants.
Unreliable dosages are particularly risky. Higher levels of estrogen and progesterone could potentially lead to an increase in the serious risks associated with HT. Doses lower than stated can potentially lead to poorly treated symptoms and even a risk of endometrial cancer if the dose of progesterone is too low to protect the lining of the uterus.
How might this happen? The end product can be affected by several factors including:
- The compounding pharmacist’s choice of ingredients
- Testing of ingredients
- Hygiene standards in the pharmacy
- Compounder skill
- Quality systems
A review concluded: “…different compounders may use different processes to compound an identical prescription, and as a result, compounded bioidentical preparations ordered with identical prescriptions and labeled with the same name will likely vary between compounders. Indeed, the FDA has received adverse event reports that reveal harmful variations in compounding.”
That said, compounding pharmacies perform a vital service for many patients where there is no alternative conventionally-produced medication available. For example, if someone is allergic to a coloring used in certain tablets, a compounding pharmacy may be able to custom-produce a colorless version for them.
Problem 2: Unproven tests
It’s not just the compounding that can be an issue in cBHT. Other practices surrounding this type of hormone replacement can be equally problematic.
The blood, urine, and saliva tests sometimes promoted as a better way to choose the dose of cBHT are not proven to be superior to relying on the severity of your symptoms and side effects. These tests can cost hundreds of dollars and are not usually covered by insurance. Providers who promote compounded bioidenticals have a financial incentive to order these tests – even though they don’t improve your care.
Experts agree that FDA-approved medications should be adjusted based on how well your symptoms are being controlled and whether you are experiencing any side effects. A saliva or blood test gives only a brief snapshot of what is happening in your body. Your hormones are fluctuating all the time and the risk is you may be prescribed too much or not enough, which could have consequences for your symptom control and long-term health.
Problem 3: How it is used
Another issue concerns how it is taken. Many cBHT products mix progesterone and estrogen together in a transdermal formulation to be applied on your skin, such as a cream or gel. However, it is widely understood that progesterone is not absorbed well through the skin. It is very dangerous if you are not getting enough progesterone, as this hormone plays a vital role in protecting the lining of the uterus from abnormal thickening, which can lead to cancer.
Problem 4: Cost
It is no coincidence that people who promote cBHT and unproven, repeated blood
or saliva hormone tests, charge hundreds and sometimes thousands of dollars a month and don’t accept insurance. The fact is that insurance companies will not pay for these unnecessary tests and dangerous and ineffective treatments!
Businesses can charge whatever they want and often make unrealistic and unsubstantiated claims about their cBHT in order to sell them.
In summary
It’s easy to understand why people feel drawn to cBHT when those selling them promise so much, but it is much safer to talk to a healthcare provider who follows evidence-based recommendations and does not suggest unnecessary and expensive hormone tests.
Your healthcare provider will take into account your full medical history before recommending an appropriate way forward. cBHT is not recommended as these products are unregulated, and it’s unclear if they are safe. Instead, FDA-approved body identical hormones will be recommended, which are available from your healthcare provider on prescription.
If you are still struggling with menopause symptoms despite being on conventional HT, speak to your healthcare provider. They will be able to suggest alternative strategies.
What does the term body-identical HT mean?
Body-identical hormone therapy refers to FDA-approved medications containing hormones that are identical to those produced by the body. They are made by chemically modifying plant-sourced ingredients.
cBHT also uses body-identical hormones, but – as previously discussed – medications are safest when they are manufactured in facilities that meet rigorous FDA manufacturing standards for purity and consistency.
Note that no plants produce human hormones that can be extracted without chemical modification.
Some businesses promoting cBHT suggest that this is the case, but it is simply not possible to extract progesterone or estrogen directly from plants.
HT can contain estrogen alone, or a combination of estrogen and progesterone. Body-identical versions of both hormones are available and widely prescribed.
What are body-identical HT products called?
Body-identical estrogen products contain estradiol. This is mainly derived from chemically modifying substances found in plants, including yams.
Body-identical estrogen products currently on the market include estradiol pills, patches, gels, and sprays.
If you also take progesterone, the only body-identical form is called ‘micronized progesterone’, which is available on its own in a product called Prometrium, or in combination with estrogen in a tablet called Bijuve. Evidence suggests that body-identical micronized progesterone, is lower-risk than man-made or synthetic versions called progestins.
Find out more about the different types of HT.
How do I know if the provider of my HT is reputable?
It can sometimes be very tricky to work out if the health advice you receive is reliable, especially when websites and marketing information look slick and professional.
The best place to start is by having a conversation with your healthcare provider. They will be able to check your medical records – including your past medical history and family history among other things – and advise on the safest form of HT for you.
Final word
Body-identical HT is the most effective treatment available for many menopause symptoms. It is also the most studied treatment available for menopause, meaning that we have lots of information about its effects and safety. When body-identical HT is produced by regulated pharmaceutical companies, there are strict quality control processes in place to guarantee the strength, purity, and safety of the product supplied.
Unregulated cBHT is not currently recommended due to concerns about the safety of the medications provided, the testing processes used to recommend doses, and the way these hormones are administered.
Your healthcare provider will be able to recommend the best treatment for you.
Find out more about menopause on our blog or in our symptoms library.
- Files, J. A., Ko, M. G., & Pruthi, S. (2011). Bioidentical Hormone Therapy. Mayo Clinic Proceedings, 86( 7 ), 673–680
- National Academies of Sciences, Engineering, and Medicine; Health and Medicine Division; Board on Health Sciences Policy; Committee on the Clinical Utility of Treating Patients with Compounded Bioidentical Hormone Replacement Therapy; Jackson LM, Parker RM, Mattison DR, editors. The Clinical Utility of Compounded Bioidentical Hormone Therapy: A Review of Safety, Effectiveness, and Use. Washington (DC): National Academies Press (US); 2020 Jul 1. 5, Compounded Bioidentical Hormone Preparations
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