“Optimize your hormones naturally!”
“Customize treatment to your unique needs with personalized dosages of plant-based hormones!”
“Avoid one-size-fits all, synthetic hormone treatments, and choose compounded bioidentical HRT solutions that are precise, tailored to each individual patient.”
You’ve definitely seen these claims on ads promoting “bioidentical hormone therapy,” but what does phrase that actually mean? According to medical experts, many of the hormone-related words and phrases popular on social media have been co-opted by companies to put fear in your head and money in their pockets by selling you a “compounded,” or custom hormone formula said to be more “natural” for your body to absorb.
The truth is, you likely don’t need a customized formula for a safe hormone treatment that your body can easily process. There are many FDA-approved hormone therapy treatment options that aren’t compounded. When it comes to menopause hormone therapy, the term “bioidentical” hormones — which really just entails hormones that are engineered to be almost identical to those produced by the human body and used therapeutically — is often misused in a way that can be misleading and even harmful in some cases. Here’s what you need to know about bioidentical hormone therapy.
‘Bioidentical’ is essentially a marketing term.
“Bioidentical” is a term used when discussing menopause hormone therapy, a medical treatment used to boost hormone levels and help relieve moderate to severe menopausal symptoms such as hot flashes, vaginal dryness, and insomnia. In this context, bioidentical refers to the chemicals that are structured very similarly to the hormones made by the human ovaries: progesterone and estradiol, says Stephanie Faubion, MD, Director of the Mayo Clinic’s Center for Women’s Health and medical director of The Menopause Society. The hormones are indeed similar to the ones naturally found in your body, but calling them “bioidentical” to imply that they’re more “natural” may be misleading.
Even when they’re derived from plants, hormone products need to be processed in a lab to become something the human body can use in a therapeutic way. The term “bioidentical” means that the hormones are chemically or structurally identical to the hormones that your body produces, but they are not the same exact substances. They are still synthetic, so there really is no such thing as bioidentical.
“Bioidentical is a misnomer,” according to Flow Space Advisory Council member Heidi Snyder Flagg, MD. “There are some things that are ‘biosimilar’ but nothing that is exactly the same as what the body produces.” Like most drugs, she explains, biosimilar drugs are synthesized in a lab using chemical formulations that mimic naturally occurring hormones. “The term ‘bioidentical’ is a little bit problematic, because it has become a marketing term,” adds Dr. Flagg.
There’s no proof that compounded hormone therapy is safer or more effective than standard hormone therapy.
Compounded bioidentical hormones are no safer and no more effective than standard FDA-approved hormone therapy. According to the American College of Obstetricians and Gynecologists (ACOG), evidence to support marketing claims of safety and effectiveness of custom-compounded hormone therapy is lacking. That’s why medical associations and experts recommend against using custom compounded hormone therapy.
Many companies that sell medications marketed as “custom” or “compounded” formulas that are typically not FDA-approved imply that the “bioidentical hormones” are more “natural” and thus safer and more effective than traditional hormone therapy — but that is not necessarily true, per the Mayo Clinic. Compounding pharmacies are specialty pharmacies in which ingredients are combined, mixed, or altered to create a customized medication for a person with a licensed practitioner’s prescription, according to the American Pharmacists Association.
“Estradiol is approved by the FDA and available in many doses and forms (pills, patches, sprays, gels, vaginal rings, creams) and FDA-approved progesterone is available as an oral pill. There are not many reasons to compound hormone therapy,” stresses Dr. Faubion. In other words, the majority of women should be able to find an FDA-approved product from the large variety in type of delivery and doses available.
Medications produced in compounded pharmacies are not regulated in the same way that commercial, mass-manufactured drugs are. Compounded drugs do not go through a comparable extensive process to evaluate efficacy and safety.
Standard (non-compounded) medication gets run through the gauntlet of the FDA, according to Dr. Flagg. “It is a very multi-layered and lengthy process, including clinical trials, testing on people, which leads to robust safety data,” she says, adding “I use FDA-approved biosimilar products, first line, when I’m treating my patients with hormone therapy.” The FDA variety of hormone therapy is regulated for purity, potency, safety, and consistency, but the compounded variety is not, says Dr. Faubion.
In addition to the assertions that hormone therapy can be customized based on results of saliva tests or other testing — for which there is no scientific basis, as hormone levels vary day to day — there are other reasons women may believe that the compounded hormone therapies are safer or less likely to trigger side effects, such as a lack of warning labels, says Dr. Flagg. Custom-compounded hormone therapy doesn’t include information packets about the warnings FDA-approved hormone therapy products are required to have, regarding the increased risks of serious problems such as heart attack, stroke, and blood clots in postmenopausal women. The missing package insert may add to the perception that the risks are not the same as an FDA-approved product, Dr. Faubion adds.
What’s more, compounded drugs don’t have to produce proof regarding batch and dose standardization or purity. And because of that, they could be more likely to contain counterfeit drugs, says Dr. Flagg.
On top of that, the difference between the expense of FDA-approved hormone therapy treatments and compounded treatments can be significant. Health insurance plans are more likely to cover the cost of FDA-approved medications compared to less-regulated compounded drugs. Seeking out compounded biosimilar hormone therapy may mean paying out of pocket, so it’s a good idea to investigate how much you’d be paying before picking up a compounded prescription.
Most women do not need a custom or compounded hormone therapy formula.
There are some situations in which compounded drugs might be essential, such as when a patient is unable to swallow the traditional form of the drug or has an allergy to a component of the mass-produced version of the drug, says Dr. Faubion. “Micronized progesterone [a plant-based version of the hormone] contains peanut oil, so in a patient with a peanut allergy, a pharmacist in a compounded pharmacy can use olive oil instead. Or, if a patient reacts to the preservative in the cream version of vaginal estradiol, they can use a custom preservative-free cream to put the estradiol in,” she explains.
But those needs are unusual, not typical. Dr. Flagg, founder and managing partner of Spring Ob/Gyn, a private practice in New York City, agrees that while there is a legitimate role and need for compounding for some people, it is not common. “I find it unusual and infrequent that I run into a patient who cannot tolerate the FDA-approved forms that we have.”
If you aren’t sure about the medication that your health provider is recommending, visit one who is certified by the Menopause Society. (Find one via their directory).
The bottom line is this: If you need a specifically formulated, compounded drug to treat your menopause symptoms, your doctor can tell you based on your medical history. Otherwise, you could get caught in the marketing trap of a less regulated and potentially less effective, more expensive form of hormone therapy treatment.