A discussion of bioidentical, FDA-approved and compounded Menopausal Hormone Therapy. A deep dive.
This is part one of a three-part series.
At Women Living Better, we strive to provide accurate information so you can make informed choices about your health and wellness — even when we don’t have the answer. The goal of this article is to clarify the differences among menopausal hormone therapy formulations, but the first decision to be made is whether or not to try menopausal hormone therapy (MHT) to manage your menopausal symptoms.
The decision about whether to use MHT is a decision that requires a discussion with a knowledgeable healthcare provider. Your personal risk factors and the degree of symptom interference in your life should be weighed carefully.
Note: This article is US-centric. The regulations around hormone therapy differ by country and regulatory body.
FYI: MHT has been approved by the FDA for two sets of symptoms in women: vasomotor symptoms (aka night sweats or hot flashes) and genitourinary symptoms (aka vulvar and vaginal changes/dryness). It is also approved for the prevention of bone loss and for use when a person stops producing estrogen at a young age. (This can be due to surgery, from medications, or it can happen naturally in a small percentage of women.)
If you and your healthcare provider decide MHT is a good option for you, the next task is to determine which products among the many options meet your needs and are effective and safe. It is this part of the MHT puzzle which we will cover in this article. We want you to feel knowledgeable enough to be an equal partner in that discussion.
We know that busy lives make a three-bullet summary an appealing format for complicated issues. However, MHT is a topic that requires some in-depth explanation to understand the subtle, but substantial, differences among options. Stick with us, we share the (July 2020) findings of an independent expert committee, created visuals, and a question/answer format to make this complex topic more digestible.
One more thing before we dive in: TERMS. There are (too) many terms and it can be a further source of confusion.
- You might see MHT referred to as HRT for Hormone Replacement Therapy. This term has been phased out. It is normal for a woman to have declining levels of hormones after her final menstrual period. The word “replacement” suggests something is lacking or missing and needs to be put back. It is not and MHT does not mimic women’s reproductive hormones.
- You might also see the term HT used for Hormone Therapy. We were using this term until an advisor pointed out that HT could be used to describe be treatment for thyroid or diabetes. We are referring only to menopause.
- Menopausal Hormone Therapy (MHT) is the specific use of hormones (most often an estrogen and a progestogen) for menopausal symptoms versus using them for birth control. Same hormones, a different goal and different amounts.
Part I: Menopausal Hormone Therapy (MHT) Overview, Defining Compounding and New Information from an Expert Committee
MHT Options: An Overview of Choice Points and Product Categories
Women Living Better 2021
The illustration above allows us to call out a misconception that has long been associated with MHT — the idea that you have to choose between a bioidentical product and an FDA-approved product! It is not an either/or — you can get a product that is both bioidentical and FDA-approved.
Read on to learn the definitions of compounded and bioidentical and what being “FDA-approved” tells you about a product.
Compounded hormone therapy — sometimes called compounded bioidentical hormone therapy, abbreviated as cBHT — refers to the non-FDA-approved bioidentical options (pictured on the far-right branch of the decision tree above).
What is compounding?
Compounding is the creation of a custom drug for an individual patient based on a physician’s prescription. A compounding pharmacist mixes (or formulates) an active ingredient with other inactive ingredients called excipients to create a final product. Excipients can be colorants used to make the final product an appealing color; binders used to hold all the ingredients together; preservatives to keep the product stable for longer or other ingredients that aid in manufacturing or administration.
Compounding has historically been used — and is still used — by many healthcare providers in two situations. First, compounding is used when a patient is allergic to one or more of the excipients used in an FDA-approved product (such as peanut oil in the case of Prometrium®, a progesterone product). Second, when available FDA-approved products don’t offer a certain dosage level of a medication (e.g., 50 mg desired and 100 mg tablets are the lowest dose available), a compounded product can meet this need.
Although we mostly hear about compounded therapies with respect to menopausal hormone therapy, many other drugs are also compounded. Some clinicians prescribe a compounded medication when there is no FDA-approved product available. An example would be testosterone for women where the only FDA-approved products are for men and the concentration is too high. The use of testosterone in women for libido is called “off-label” as it has not been approved for this indication (i.e., symptom) by the FDA. However, the International Menopause Society released guidelines supporting its use in 2019.1
1. International consensus on testosterone treatment for women
Why is there so much debate about cBHT and what new information is available?
The use of compounded products for MHT is a contentious topic. There are women who feel like cBHT has “saved their lives” and physicians who dedicate their entire practice to delivering these products to patients. However, there are also many experts who believe that cBHT products pose a serious risk to users’ health.
A recent recommendation by an independent expert committee found the use of compounded hormone therapy products was only justified in the two situations mentioned above — allergy and dosing — and determined that there wasn’t sufficient evidence for other uses. Their in-depth report highlighted how little data exists about the use of cBHT products.
The committee’s recommendation was: “…there is insufficient evidence to support the clinical utility of cBHT. Based on [an] examination of the evidence, to address public health concerns, the committee recommends restricted use of cBHT, assessments of their difficulty to compound, and additional education, oversight, and research.” 1
1. The Clinical Utility of Compounded Bioidentical Hormone Therapy (cBHT) A Review of Safety, Effectiveness, and Use Consensus Study Report Highlights, July 2020, NASEM. Download available here.
Who sponsored this committee and who was on it?
In February of 2018 the FDA asked The Board on Health Sciences Policy
within the National Academies of Sciences, Engineering, and Medicine (NASEM) to form a committee to investigate the use of compounded hormone therapy.
The twelve-person committee was made up of experts from many backgrounds including, “drug research and development, pharmacology, toxicology, endocrinology, epidemiology, health literacy, pharmaceutical compounding and manufacturing, health risk mitigation, and health policy.”1
1. Recommendations by The Board on Health Sciences Policy within the National Academies of Sciences, Engineering, and Medicine, 1. p.245. Download available here.
What is the National Academy of Science (NASEM)?
The National Academy of Science was founded by a congressional charter in 1863 during Abraham Lincoln’s presidency. “Each year, thousands of the world’s leading experts serve pro bono (i.e., for free) on study committees that address some of society’s toughest challenges. Our rigorous process produces independent, objective reports that present the evidence-based consensus on these issues.” 1
1. https://www.nationalacademies.org/about
What information did the committee consider?
The committee searched national and international libraries to identify scientific articles about the safety and effectiveness of compounded hormone therapy products. They interviewed people from the compounding industry including compounding pharmacists and prescribers of compounded hormone therapy products. Importantly, they also heard testimony from women who used compounded bioidentical hormone (cBHT) products.
Up Next
Part II: The Women’s Health Initiative and its Impact on Hormone Therapy Usage
