“Bioidentical hormones” are hogwash, and not fit for female consumption.
I am seeing more and more menopausal women coming to my office who have been treated with pellet injections. The injections are placed into the buttocks and contain a mixture of hormones that are marketed as being “bioidentical.” They claim to be free of side effects and custom-designed for each woman’s needs, with the goal of improving virtually all aspects of her life, including her menopause symptoms.
How have they come into the mainstream and what are they about? Here are some tips on navigating the confusing information that you are likely to find on the internet and, unfortunately, in your doctor’s office.
Custom-compounded hormones in any form are not FDA approved for use
These hormones, due to a loophole in the law, are exempt from the Food and Drug Administration (FDA) requirement to prove efficacy and safety.
Practically speaking, this means that marketers can say just about whatever they want, and they do.
Because of the lack of what is called “Phase IV reporting” of side effects, there is no systematic collection of adverse reactions to these powerful hormone concoctions, either.
So there are often additional claims that these treatments must be safe because there have not been reports of harm. In other words, the purveyors of these treatments have almost no regulations imposed upon what they can allege their product will do, and they are under no obligation to report to you any side effects or adverse long-term effects of their treatments. You, the consumer, take on all of the risk.
“Bioidentical” is a meaningless term
I ask my patients who request bioidentical hormones for menopause symptoms to tell me what the term means to them, so I can better understand their wishes. Most of the time, what my patient tells me is that she prefers hormones that are chemically identical to the ones that are naturally found in a woman’s bloodstream. I take this to mean that she wants menopause treatment that is as physiologic (or natural) as possible.
There is a large variety of FDA-approved hormonal medications. So it is quite easy to provide menopausal hormones in FDA-approved forms that meet the criteria of being “bioidentical” hormones. There seems to be an assumption that all custom-compounded hormones are ‘bioidentical’ and that all FDA approved hormones are not. Neither of these notions is correct.
It’s a lucrative market, and the marketers own internet traffic on this topic
We have all grown accustomed to looking everything and anything up on Google and expecting that, on balance, we are going to get the information we need. Sure, we may have to wade through a lot of chaff, but I know for myself that I usually approach an internet search with confidence that I can find the wheat on my own. This is not always the case.
As we just learned in the recent presidential election, information flow can be directed toward us in a way that influences how we think and that preys on our intellectual or emotional insecurities. Hormone therapy, menopause and menopause symptoms tend to be very fraught topics for women, and can bring up some negative issues associated with aging, loss of fertility and risks of treatments. Make no mistake: The people who are marketing these non-FDA approved treatments that require virtually no scientific backup know all of this, and are targeting their internet advertising dollars as effectively as they can!
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If it seems too good to be true, it probably is – including for curing menopause symptoms
So bottom line: Take a step back when you are reading a lot of testimonials from satisfied customers who report that everything – absolutely everything – that was wrong in their lives was made right by injecting an unapproved, unstudied, uncontrolled pellet full of hormones into their rear end. Take a deep breath, and then take a critical look at what is being said. There isn’t a medication in the world that provides:
- Life-saving benefits.
- Reversal of the course of heart disease, diabetes, obesity, fibromyalgia, arthritis and high cholesterol.
- Lowered risk for Alzheimer’s disease, breast cancer and osteoporosis.
(I just took these points off the book jacket of a pellet doctor.)
Buyer beware! The doctors who promulgate these treatments often quote each other’s work, and it’s worth making the effort to look up the references used in their work. Studies and authors who quote themselves for most of the references, or who have a very limited group of the same people who are quoted over and over may be working in an intellectual echo chamber, and not hearing all the information.
Signs of scientific rigor include the referencing and performance of randomized, clinical trials with control groups of women who did not get the treatment. Careful assessment of the study end points is also critical when making claims about long-term safety and reduction of risks.
For example, if all of the women who get breast cancer in a study drop out because they are sick and do not attend the follow-up visits, guess what happens when I report the risk of breast cancer over time? Magically, my research participants with cancer never get counted, and it looks like my treatment is highly beneficial! This is an especially dangerous path that can be followed when there is not an untreated control group that I am also following over the same period of time.
Are the studies that are being used to support these claims published in peer reviewed journals? This is an easy thing to check. If not, the quality of the science is likely to be poor. Many marketers of custom compounded hormones want you to think that there is a medical conspiracy against them, so they can appear to be New Age mavericks who are being persecuted by some kind of medical “deep state.” Don’t believe it.
Save your pellets to feed to your rabbits. Meanwhile, talk to a board-certified endocrinologist, reproductive endocrinologist or OB-GYN about your menopause symptoms and your concerns about hormone therapy and get a reality check.