Bioidentical Hormone Therapy (HT): Is It Better Than Synthetic Hormone Therapy

Bioidentical Hormone Replacement Therapy: Is It Better Than Synthetic Hormone Therapy

Are you looking for alternatives to hormone therapy? They’ve been controversial for more than two decades, giving rise to a plant-based option known as bioidentical hormones. They’re similar to the hormones produced in the body, and well-known celebrities endorse some of these bioidentical products. But, not all bioidentical products are not created equally. It’s important to understand the different types and the advantages and disadvantages of each.

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    What are bioidentical hormones?

    Before we get to what you may have heard about these hormones through marketing, let’s talk about the definition of bioidentical hormones.
     
    They have the exact chemical and molecular structure of the hormones produced in the body.
     
    While bioidentical hormones have gained in popularity recently, they’ve been around since the 1930s. The first bioidentical hormone therapy was created from the urine of pregnant women.
     
    Today, they’re plant-based, typically derived from soy or yams.
     
    That plant base may make you think they’re more “natural” and a safer and more effective alternative to the sometimes controversial topic of hormone therapy and the assessment of its pros and cons.
     
    However, “natural” is not risk-free and not always better.
     

    Types of bioidentical hormones

    Like hormone therapy, there are two different types of bioidentical hormones. And they come in different formulations – pills, creams, gels, injections, patches, and pellets.
     
    There are FDA-approved and custom-compounded bioidentical hormones.
     
    Know the difference, as the two types are often confused, and distinct differences exist.
     

    FDA-approved bioidentical hormone therapy

    FDA-approved therapies commonly used by menopausal women include Estrace, Vivelle Dot, and Prometrium.
     
    The FDA even gave Vivielle Dot clearance to use the term “bioidentical” to describe its product.
     
    These FDA-approved bioidentical hormones come from plants, and there may be advantages for some women.
     
    Listen as the British Menopause Society explains some of these at the 1:33 mark, including the benefits of transdermal application on blood clotting and stroke.
     
    He also talks about the lower side effect profile for bioidentical progesterone.
    While there may be some benefits, government-approved bioidentical hormones have package inserts in the United States. They contain extensive product information, and there may be black box warnings for adverse events.
     

    Custom-compounded bioidentical hormone therapy (c-BHT)

    The second type – custom-compounded hormone therapy (c-BHT) – is under scrutiny.
     
    The FDA does not approve compounded medications in general, which means their safety, quality, and efficacy have not been verified by the FDA.
     
    Although the lack of FDA approval does not mean de facto that compounded medications are dangerous or ineffective. However, finding a pharmacy with the expertise to create an accurate formulation is difficult. Additionally, there is a long history of issues related to formulations with too little or too much of the components of the medication as well as contamination of the product, which has sometimes resulted in serious injury or even death.
     
    Doctors prescribe the custom-compounded therapy based on saliva, blood, or other testing results.
     
    The Menopause Society states in its 2022 hormone therapy position statement that this testing is unreliable.
     
    Still, some doctors use the results to prescribe a product that’s custom-made at a compounding pharmacy. The therapies may combine multiple hormones with untested, unapproved combinations and formulations, according to The Menopause Society position statement.
     

    Personalized medicine

    Still, some doctors tout custom-compounded bioidentical hormone therapy (BHT) since treatment is personalized/individualized.
     
    There is value in personalized medicine. At pausitive health, we often talk about menopause being a unique journey. What works for you may not work for your friend or your sister.
     
    But it’s a common misconception that hormone therapy is not individualized and that c-BHT offers a more personalized approach.
     
    The Menopause Society stresses the importance of an individualized approach to hormone therapy – one that considers the risks and benefits based on age, menopause onset, dosage, and health conditions – rather than one-size-fits-all management.
     
    But it’s common to see custom-compounded bioidentical hormones advertised as the more customized approach to addressing the hormonal changes in a woman’s body.
    Bioidentical Hormone Replacement Therapy or Synthetic Hormone Therapy

    Unsubstantiated claims

    There are many unsubstantiated claims, including that c-BHT is safer than standard hormone therapy.

    The Menopause Society reports there are also unsubstantiated claims that c-BHT helps with weight loss, prevents Alzheimer’s disease and breast cancer, and gives you control over aging.


    Most claims lack scientific data to back them up.

    C-BHT risks

    There are other potential risks too.

    The     FDA does not regulate compounding pharmacies so the therapy preparation can vary dramatically from batch to batch. So, women can overdose or underdose, leading to risks and/or inadequate symptom relief.

    Contamination is also a concern.

    Without safety testing and regulations, warning labels about the risks of hormone therapy may not be on the packaging.
    The lack of standardization of the pills, creams, and pellets led the National Academies of Science, Engineering, and Medicine (NASEM) to push for an FDA restriction of cBHTs for patients who can’t benefit from an FDA-approved hormone therapy product.

    “Consumers may be lured by the prospect of personalized medicine and avoiding perceived ‘one-size-fits-all’ treatments,” said Donald Mattison, Chief Medical Officer of Risk Sciences International and chair of the committee that wrote the report. 

    “However, cBHT preparations, across doses and dosage forms, are not supported by a sufficient body of evidence to inform providers and patients of potential benefits and harms. Providers have an obligation to educate patients about the potential risks of using cBHTs, and present a clear rationale if they do need to prescribe them.” 

    NASEM concluded their widespread use poses a public health concern.

    Compounding pharmacies respond

    The Alliance for Pharmacy Compounding (APC) said the NASEM study “feels a lot like the movie Groundhog Day, only without Bill Murray for laughs. Which is to say: We’ve seen this sort of thing before.”

    The group agreed more studies are needed and that compounders should not make claims about the safety, efficacy, or superiority of compounded therapies compared to FDA-approved drugs.

    APC president, Shawn Hodges, said in the APC statement,
    “The purpose of pharmacy compounding is to offer therapies that are not available from a traditional manufacturer. Our role is to help patients whose needs are not met by commercially available medications. Compounding is an art — It’s a drug made for the patient, not the masses. In the context of women’s health, pharmacists for decades have safely compounded specific strengths and dosage forms of hormones to meet each patient’s individual needs. While it’s impossible to conduct extensive drug studies for every possible combination of hormones, there is data beyond what NASEM shared today that substantiates the clinical rationale for use. This is evident by the overwhelmingly positive outcomes that our female patients share with our pharmacists every day.”

    The Menopause Society 2022 position on bioidentical hormones

    In its latest position statement on hormone therapy, The Menopause Society said compounded hormone therapy should only be considered if a woman can’t tolerate a government-approved therapy “for reasons such as allergies to ingredients in a government-approved hormone therapy formulation or for a dose or formulation not currently available in government-approved therapies.”

    They say prescribers should indicate the medical indication for compounding therapy over government-approved therapies.

    While they support shared     decision-making for hormones, The Menopause Society says patient preference alone should not be the justification for the use of compounded therapies.

     

    It’s a personal choice

    No matter what you decide, know you don’t have to suffer in silence as you go through the menopause journey. You have options, many of which are not hormones.

    You are the CEO of your health and well-being. After all, no one else will experience what you feel in your body.

    Don’t focus on what everyone else is doing. Instead, do your research and collaborate with your healthcare practitioner to explore options and determine the best fit for you based on your clinical status, personal and family medical history, and life circumstances.

    Bioidentical Hormone Therapy | The Menopause Society

    Kohn GE, Rodriguez KM, Hotaling J, Pastuszak AW. The History of Estrogen Therapy. Sex Med Rev. 2019 Jul;7(3):416-421. doi: 10.1016/j.sxmr.2019.03.006. Epub 2019 May 27. PMID: 31147294; PMCID: PMC7334883.

    Pattimakiel L, Thacker H. Bioidentical hormone therapy: Clarifying the misconceptions. Current Drug Therapy. 2021, Volume 78, Number 12. doi:10.3949/ccjm.78a.10114

    Bioidentical hormones explained – a British Menopause Society video | British Menopause Society

    What Does an FDA Black Box Warning Mean? | GoodRx Health

    APC’s Official Statement on the NASEM Report | Alliance for Pharmacy Compounding

    The 2022 hormone therapy position statement of The Menopause Society. Menopause. The Journal of The Menopause Society. Vol. 29, No. 7, pp. 767-794 DOI: 10.1097/GME.0000000000002028

    Pinkerton J. Menopause Matters from The Menopause Society: The Truth About Bioidentical Hormone Therapy. The Female Patient. 2022 Vol 37. 

    Prescribers Should Restrict the Use of Non-FDA-Approved Compounded Bioidentical Hormones, Except for Specific Medical Circumstances | National Academies Sciences, Engineering, Medicine

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