Our most trusted medical source answers your most commonly asked health question.
Posted on April 05, 2011
Every time we run a menopause story on Faboverfifty--and we’ve run many--we get the same questions: What is the difference between using bio-identical hormone therapy and non-bio-identical hormone therapy? Which one is natural? Which one is safe?
There’s enormous confusion around this topic, and it’s not hard to see why: everyone from Suzanne Somers to Oprah has a (strong) opinion, and it’s impossible to know who to trust.
So we turned to one source we completely trust: The Center for Specialized Women's Health at The Cleveland Clinic. Dr. Lynn Pattimakiel, MD, specializes in women’s health and hormones at the clinic, and--lucky for us--she’s not trying to sell anything. Dr. Pattimakiel’s only job is to research and share the latest, best information on hormones and health. How refreshing is that?
What is the difference between bio-identical hormones and non-bio-identical hormones?
Bio-identical hormones are chemically identical to the hormones a woman naturally produces in her body. They are synthesized by chemically extracting diosgenin (a precursor) from yams and other similar plant products.
Non-bio-identical hormones (also called synthetic hormones) are derived from other sources, for example the urine of a pregnant mare. They do not have the identical chemical structure as hormones that are naturally produced in the female body.
There are bioidentical and non-bioidentical versions of estrogen and progestogen, which are the two hormones we use most often to treat menopausal symptoms.
Is one better than the other?
It really depends on a woman’s individual needs. For example, some women are allergic to certain formulations of bioidentical hormones, so we opt for the non-bioidentical versions. Prometrium, for example, is a bioidentical hormone that is micronized in peanut oil, which women can have allergies to. We try to tailor hormone treatment individually to a woman and her needs.
Is one more “natural”?-- I often hear bioidentical referred to as “natural.”
“Natural” is a marketing term--not a scientific term. The only “natural” hormones are the ones found in your body. Both bioidentical and non-bioidentical hormones are man-made.
Why is there so much confusion around this issue?
I think the big confusion is between compounded hormone therapy (CHT) and bioidentical hormone therapy. And there is a huge difference between those two. Compounding hormone therapy claims to be “bioidentical,” and “natural,” but it can claim anything because it’s not regulated by the FDA.
What exactly is compounding hormone therapy?
Compounding pharmacies mix together different formulations of hormones in different quantities, as directed. These hormones are bio-dientical, but they are not FDA approved. That means there is no regulation on the quality, grade or consistency of the medications that are produced. Patients also have to pay out of pocket because insurance will not cover it.
Why do people choose the compounding pharmacies?
Practitioners of compounding therapy advertise the fact that they’re creating a “natural” cocktail of hormones just for you. They use techniques such as salivary testing to determine your hormone levels, and then they concoct a mixture of hormones to try to regulate that level. These techniques haven’t been well-proven and we don’t believe salivary testing is very accurate.....But, a lot of people are turning on their TV and getting information from celebrities. People come to us and say, “I want bio-identical. I want what Suzanne Sommers had.” [Editor’s note: Suzanne Sommers is the most well-known celebrity proponent of compounding hormone therapy.] And they can have bio-identical, but we recommend they take the FDA-approved version that we prescribe. That way we know exactly what's in it.
Are there any serious risks to using the compounding hormone therapy?
Yes. Compounding pharmacists prescribe progesterone creams, and we’re very against that. If you are on estrogen and you have a uterus, you need to be on a progestogen as well to protect against endometrial cancer. But progesterone cream isn’t enough--you need to be on a systemic progestogen to balance the estrogen. We’ve actually seen women come into our clinic with endometrial cancer because they’ve been taking estrogen for years and only using a progesterone cream.
Is there any time you recommend someone use a compounding pharmacist?
Sometimes, if there's a hormone that's not available yet in an FDA-approved form. For example, testosterone is a hormone that is available in Europe right now, but for some reason--I’m not sure why--it hasn’t been approved in the US to treat female sexual dysfunction. It’s available to men, but not to women. So some physicians work with a compounding pharmacist to prescribe off-label testosterone to help libido and sexual function. You’d want to talk to your provider about that and she would have to make it clear that there are risks associated with taking anything that’s not FDA approved.
The Women’s Health Initiative study famously found a link between hormone replacement therapy and breast cancer. It scared a lot of women away from using hormones. Did that study use bio-identical or non-bio-identical hormones?
That was non-bio-identical--a combined conjugated equine estrogen (in part made from horse urine) plus progestin. In women without a uterus, treated with estrogen only, there was actually a decreased risk of breast cancer seen. This decreased risk persisted, even after stopping estrogen.
Is it fair to say, then, that the risks found in the Women’s Health Initiative study may not be the same for bio-identical hormones?
The risks are still there. Any hormone therapy--which includes birth control--comes with an increased risk of blood clot or stroke. Also, if you use combined hormone therapy--estrogen and progestogen--for more than five years, there’s a slight increased risk of breast cancer. The estrogen and progestogen are still stimulating the same organs, whether they’re bio-identical or non-bio-identical.
It’s important to note that the WHI study was done with patients who were, on average, at least 10 years past menopause--much older than the average age that we would start people on hormone therapy. When they looked at the data by age, the risks were not as high. But that hasn’t been as widely publicized as the first study.
Have there been any similar long-term studies done with bio-identical hormones?
No. There have been long-term studies comparing the bio-dientical patch to the oral hormone therapy, but that was more about the method (patch vs. oral) than about the type of estrogen. People tend to have lower risk of blood clot and stroke on the patch than they do on the oral medication.
So despite the risks, you still recommend hormone therapy?
Yes! We would never say hormones are a fountain of youth--no matter what form you take--but there is a place for hormone therapy in patients who are low risk and who have severe-enough symptoms that they need it. There’s no reason to suffer hot flashes, sexual dysfunction, etc. As long as a woman is being monitored by a good doctor, her quality of life can be drastically improved with hormone therapy. So, for many women with menopausal symptoms, the benefits of hormone therapy outweigh the risk.
With so many people calling themselves “women’s health experts,” how do you know if you have a “good doctor”? How do you know who to trust?
Well, if your doctor is trying to sell you something--especially if it’s something you have to pay for out of pocket--that’s a red flag. We would advise to stay away from compounding pharmacies that promote progesterone cream and salivary testing. There are many physicians in North America who are certified menopause experts and can be found online.