Bioidentical Custom Compounded Hormone Therapy: 3 reasons you should stop using these.
Don’t get me wrong. I am a big believer in hormone therapy. Hormone replacement therapy does a world of good. Starting hormones in your 50s or within ten years of your last menstrual period, treats hot flashes, keeps your bones strong, your skin soft, the vagina healthy and decreases your risk of cardiovascular disease. These are proven benefits. Proven through meticulous research on the benefits of hormones, their safety profiles and how well they work.
What does the evidence tell us?
In the early 2000s, standard hormone therapies got a bad reputation- namely a specific combination of hormones called Prempro(estrogen + progestin) and Premarin (estrogen alone). A large study, called the Women’s Health Initiative (WHI), showed that women on Prempro had an increased risk of blood clot, breast cancer, heart attack and stroke. This scared multitudes of women and many abruptly stopped their hormones.
The bad reputation deserves a do-over. The researchers continued to collect data and followed the study participants. It turns out that over the next 20 years, when the results of the WHI were reevaluated and broken down by age groups, women in the 50-59 year old age group actually had a decreased risk of heart attack, a decreased risk of dying and no increased risk of stroke. The risk of breast cancer was not dependent on age. Women on estrogen and progesterone together (Prempro) had an increased risk of breast cancer but women on estrogen alone (Premarin) had a decreased risk of breast cancer. Is it the progesterone in Prempro that caused the increased risk of breast cancer? We don’t know. What we do know is that a progesterone called Prometrium was not shown to increase the risk of breast cancer in a metanalysis over a 5 year time period. Women with a history of hormone sensitive breast cancer should not use hormones.
What does bioidentical mean?
Bioidentical means that the hormone you are taking is the same chemical structure as your own ovaries make. Compounded means a medicine is made in a pharmacy from scratch. Not all bioidentical hormones are custom compounded. In fact, there are 16 “bioidentical” hormones that are standard FDA approved prescriptions. The North American Menopause Society and the American College of Obstetrics and Gynecology recommend that women use FDA approved prescriptions because they have been studied in large clinical trials and have been proven to be safe and effective. Custom compounded hormones have not.
Compounded Bioidentical hormones- BUSTED
When it comes to custom compounded bioidenticals, women have been led to believe that these were “better, safer and more natural” than standard FDA approved hormone formulations. There is absolutely no proof that this is true. Also, custom compounded hormones are not required to come with a package insert delineating the risks of use, which may lead some women to believe they are safer.
Don’t increase your risk of uterine cancer!
Women who have a uterus need to take a progestin when they take estrogen for symptoms like hot flashes. Taking estrogen alone increases the risk that a woman will develop uterine cancer (unless she has had a hysterectomy). Standard prescription FDA approved hormones have to prove to the FDA that women who take them get enough progestin to prevent them from developing uterine cancer. Compounded bioidenticals have not proven that the amount of progestin they contain is enough to prevent uterine cancer. Why risk it when there are formulations that have been shown prevent the risk of uterine cancer?
You don’t know how much hormone you are getting.
Compounding pharmacies are not regulated by the FDA. This means that their products are not tested for quality, purity or strength. The doses from compounding pharmacies can vary batch to batch. If there is a regulated prescription bioidentical available, choose that one. You know exactly how much you are getting with each dose.
Compounding Pharmacies are not bad.
I am not saying compounding pharmacies are bad. They are great!. They fill a niche when a medicine doesn’t exist in an FDA approved product or for people who are sensitive or allergic to some of the ingredients in an FDA approved product. I use a compounded pharmacy for testosterone replacement because there is no FDA approved product. You can also use an FDA approved formulation for men-which is recommended by an International Consensus panel on the use of testosterone in women. Women need 1/10 of the amount of testosterone that a man needs, so with products designed for men, it may be hard to measure out the correct dose and they tend to be expensive because they are not covered by insurance. This is why I chose to use compounded testosterone for my patients.
The North American Menopause Society (menopause.org)
It is difficult to sort through all of the information on the internet and know what to believe. Thankfully, the North American Menopause Society is a nonprofit organization dedicated to promoting the health and quality of life of women at midlife. Hormone replacement is not a one size fits all or the answer to every problem. With that said, there is definitely a role for hormones for some women. Just make sure to choose the safest way to use them.
Dr. Becky Kaufman Lynn is a gynecologist and the founder of the Evora Women’s Health. She is a North American Menopause Society Certified Physician who has been treating menopausal women for over 20 years. Her practice is located in St. Louis, Missouri. Dr. Lynn offers a comprehensive midlife wellness program helping women lead healthy lives. Go to evorawomen.com for more information about her practice or to schedule an appointment or send us an email at info@evorawomen.com. Dr. Lynn also sees patients via telehealth in Illinois and Tennessee.
