This post is sponsored by Vertical Pharmaceuticals, LLC.
This post was written by Dr. Tara Allmen, in collaboration with FabOverFifty. Dr. Allmen is a renowned gynecologist, menopause expert, and author of Menopause Confidential: A Doctor Reveals the Secrets to Thriving Through Midlife, Haper Collins, 2017.
Hormone therapy can be tricky waters to navigate, especially as you hear many women today talking about “natural” alternative options. I always say it’s best to start at the beginning, know your facts, so you can make the most informed decision about your health and wellness.
A widespread search for “natural” alternatives began in earnest.
That brings us to the story of bioidentical hormone therapy. Bioidentical hormone popularity has soared in the last decade, so let’s understand what they are and what they’re not.
Let me first make it clear to all of you, according to ACOG (American College of Obstetricians and Gynecologists) and NAMS (North American Menopause Society), hormone therapy is the most effective way to treat menopause symptoms including hot flashes. If you are a generally healthy woman within 10 years of your last menstrual period, you should consider trying hormone therapy to treat your symptoms.1
Unlike the conventional hormone therapy such as oral tablets that contain a combination of synthetic estrogen and a synthetic progestin, bioidentical hormones have the same chemical structure as those made naturally by a woman’s ovaries before menopause.1 Bioidentical hormones are not actually found in nature. Instead, they are synthesized from plants and made into estrogen and progesterone.2
Now here comes a very important teaching moment. There are two types of bioidentical hormones available. The first type is regulated by the FDA for both effectiveness and safety. You can be confident that it has undergone rigorous scientific testing and has been produced with the highest quality standards, FDA-approved hormone therapy has been scientifically proven to treat menopause symptoms.
The FDA-approved bioidentical hormones for menopausal symptoms include estradiol and progesterone. Estradiol comes in many different forms, alone or in combination with progesterone, including a patch, vaginal ring, tablets and a gel.
The second type of bioidentical hormones get a tremendous amount of media attention, in part because the actress and author, Suzanne Somers recommends it. Often described as “personalized”, these formulations are custom-blended and packaged into capsules, pellets, and creams by compounding pharmacies. These products do not undergo scientific testing for safety, quality and effectiveness. Compounding pharmacists often utilize saliva testing, which has no clinically meaningful place in the treatment of symptomatic menopausal women. Saliva hormone levels don’t correspond to those in your bloodstream nor do they have any correlation with menopause symptoms.3 Yet more than 2.5 million women are turning to compounding pharmacy formulations, because they believe all the hype. Most importantly, compounded bioidentical hormone labeling is not required to include risks, warnings, contraindications, or drug interactions so they may appear safer even though they are not.4 In addition, compounded hormones are often not covered by commercial insurance plans.
What you also need to know is that what’s on the label may not be what you are getting. The FDA found 34% of compounding products failed at least one quality test and 90% failed potency tests because they contained far less than the labeled active ingredients.2 Some may even contain non-FDA–approved hormones or may have undesirable additives or preservatives.4 In addition, the FDA5, the American College of Obstetricians and Gynecologists6, the North American Menopause Society (NAMS)7 and the Mayo Clinic3 all have recommended staying away from compounded bioidentical hormones.
The Menopause Journey should be easier to navigate when you have the best scientific information available. Based on my extensive research, I recommend that women try FDA approved bioidentical hormone therapy rather than compounded hormones when treating menopause symptoms such as hot flashes. That said, I always advise midlife women to seek out a healthcare professional who specializes in menopausal medicine and can become a partner on the road to finding the right treatment choice specifically for you.
Check out the North American Menopause Society’s website, menopause.org, for the most up-to-date information and a list of certified U.S. menopause specialists near you.
Fab Over Fifty is partnering with Vertical Pharmaceuticals, LLC to address menopause symptoms and treatment options, vitally important subjects for our community. Dr. Tara Allmen is a paid spokesperson for Vertical Pharmaceuticals, LLC.
¹ Deuter, D. http://awomanshealth.com/bioidentical-or-synthetic-new-choices-in-hormone-replacement-therapy/
² Barrett, S. 2013. http://www.pharmwatch.org/strategy/bioidentical.shtml
3 Laughlin-Tommaso, S. http://www.mayoclinic.org/diseases-conditions/menopause/expert-answers/bioidentical-hormones/faq-20058460
4 Pinkerton, J. Constantine, G.D. Compounded non-FDA–approved menopausal hormone therapy prescriptions have increased: results of a pharmacy survey. Menopause. 2015. Vol. 23, No. 4, pp. 359-367.
5 FDA. Bio-Identicals: Sorting Myth from Facts. 2008. https://www.fda.gov/ForConsumers/ConsumerUpdates/ucm049311.htm
6 ACOG. 2012. Compounded Bioidentical Menopausal Hormone Therapy. https://www.acog.org/Resources-And-Publications/Committee-Opinions/Committee-on-Gynecologic-Practice/Compounded-Bioidentical-Menopausal-Hormone-Therapy
7 NAMS. Bioidentical Hormone Therapy, Menopause Relief. https://www.menopause.org/publications/clinical-practice-materials/bioidentical-hormone-therapy