Hormone levels begin to decrease during perimenopause
Perimenopause (the time around menopause) is a phase of drastic hormonal shifts in your body. Your ovaries, which have been making estrogen and progesterone throughout your reproductive years, gradually stop producing these hormones. This can cause unpleasant symptoms like hot flashes, mood swings, and genital discomfort. Hormone therapy can help you cope with these changes by increasing your body’s estrogen (and usually progesterone) levels.
But not all hormones are the same. Your body makes three kinds of estrogen: estradiol, estrone, and estriol. Estradiol is the most powerful form of estrogen and comes mainly from your ovaries. Estrone is made in your ovaries, adrenal glands, and fat tissue. Estriol is made by the placenta during pregnancy. After menopause, estrone becomes your main source of estrogen.
Bio-identical hormone therapy: To compound or not to compound
Bio-identical hormone therapy (BHT) is a way to treat menopausal symptoms with hormones that match the ones that your body makes. The FDA has approved several bio-identical hormones, such as micronized progesterone (Prometrium), estradiol (Estrace, Vivelle-Dot, Delestrogen, DepoEstradiol, Divigel, Elestrin, Alora, Estraderm, Estradot, Estrasorb, Estrogel, Evamist, Femtrace, Menostar, Minivelle, Vivelle, and Climara), and DHEA (Intrarosa).
Compounded BHT are custom-made by a pharmacist based on a prescription from a healthcare provider. They are not regulated by the FDA, and they are also not generally covered by insurance. Although compounded BHT are typically processed from plant sources such as soy or yams, they need to be further modified in the lab before they can be given to patients. Some FDA-approved BHT, such as Estrace and Alora, are sourced from plants as well.
Whether hormone replacement is FDA-approved or compounded, none of these therapies actually come from human bodies. Aside from conjugated equine estrogens, they are synthesized commercially by editing other compounds or by building the molecules from scratch.
Compounded BHT is mixed with fillers and preservatives to create the correct consistency and to avoid product spoilage, much like FDA-approved capsules and creams.
Whenever the FDA approves a drug, the drug company must report any known side effects. In contrast, compounding pharmacies aren't required to report side effects to the FDA. This can contribute to the myth that compounded BHT has a lower risk of side effects; the data simply does not exist.
In one study, researchers sent prescriptions for estradiol and progesterone pills to 13 different compounding pharmacies. They found that both the estradiol and progesterone doses were significantly different between pharmacies (8). When they tested different layers of compounded BHT creams, both estradiol and progesterone levels were slightly higher in samples taken from the top and middle versus bottom layers. These types of inconsistencies can have serious implications for safety and effectiveness. In summary, there is not much gained by choosing compounded hormone therapy over FDA-approved hormone therapy.
Next steps
There is no scientific evidence that BHT works any better than traditional hormone therapy in easing menopause symptoms. There’s also no evidence that it's any less risky than traditional hormone therapy.
Some sellers advertise hormone replacement using the term “bio-identical” in order to suggest that compounded bio-identical hormones are more natural, safe, and effective than FDA-approved
options. However, there is no proof to back up these claims. In fact, compounded bioidentical hormone therapies may have more risks than benefits. There may be slight inconsistencies in the dosing from batch to batch, which can make them less effective or cause side effects. They may also have higher levels of estrogen, progesterone, DHEA, and testosterone than you need, which can increase your risk for serious health problems such as cancer, cardiovascular disease, and stroke.
BHT from compounding pharmacies is not usually preferred by menopause providers who follow the most recent research, unless a patient is allergic to an ingredient in the standard FDA-approved products. At Phases, we always adjust our care according to the latest evidence. That's why we tend to prescribe the FDA-approved options that have a proven record of safety and effectiveness. We are committed to providing our patients with the best possible care.
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Sources:
1. Compounded Bioidentical Menopausal Hormone Therapy | ACOG. https://www.acog.org/clinical/clinical-guidance/clinical-consensus/articles/2023/11/compounded-bioidentical-menopausal-hormone-therapy
2. Misconception and Concerns about Bioidentical Hormones Used for Custom … https://academic.oup.com/jcem/article/97/3/756/2536306
3. NAMS Practice Pearl - North American Menopause Society. https://www.menopause.org/docs/default-source/professional/nams-practice-pearl-cbht.pdf
5. Bioidentical hormones: Are they safer? Mayo Clinic.
6. Neither Natural Nor Safe: Compounded Bioidentical Hormones Need Better Evidence.
7. Pinkerton, J. V. The truth about bioidentical hormone therapy.
8. Stanczyk et al. Determination of estradiol and progesterone content in capsules and creams from compounding pharmacies. Menopause (2019).
Determination of estradiol and progesterone content in capsules and creams from compounding pharmacies - PMC (nih.gov)
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