Compounded Bioidentical Hormones…Are They Really the Best Fit?

Thanks to Samantha on Sex and the City and Oprah, compounded bioidentical hormones have gotten a whole lot of press. They have been billed as the best thing since sliced bread. They have become the good guy, while the prescription drugs (a.k.a. conventional hormone replacement therapy, or HRT) have become the bad guy. Bioidentical hormones have been called “natural,” “organic,” and everything in between.

Unfortunately, most women are being sold snake oil, and what they are getting is far from natural. They are victims of false advertising and in most cases are unaware of what compounded bioidentical hormones actually are and how they differ from standard hormone therapy, if at all.

The public and medical opinion on hormone replacement therapy for post- and perimenopausal women has run quite the gamut. The pendulum has swung further on this issue than almost any other topic in gynecology. Before the results of the Women’s Health Initiative (a large study initiated in 1991 to examine estrogen and progesterone’s impact on postmenopausal women) were released in 2002, HRT was lauded as the fountain of youth.

Estrogen and progesterone in the postmenopausal woman were not only believed to improve the nagging symptoms of menopause (hot flashes, vagina dryness, etc.) but also to improve a woman’s overall health. The results of this large study showed almost exactly the opposite. This led GYNs to turn their HRT-writing prescription pads in ASAP and caused women to quickly trash their stash! However, a closer examination of the study and the study population over the past 10 to 15 years has called into question a lot of the initial findings and negative hype.

It now seems that HRT in the right woman (again, the right woman) is no longer the devil and actually can be pretty helpful. While it is no longer believed to improve overall health and prevent things like heart disease, stroke, and breast cancer, it can be useful for women with beyond-bothersome menopausal symptoms.

So if HRT was good, then bad, and now sort of good, what is all the hype about compounded bioidenticals? Did they, too, follow this trend? What are they, and what makes them so different? Bioidentical hormones are plant-derived hormones similar to those produced by our bodies. They include both products that are and are not approved by the FDA.

Think of the FDA as the FBI; they are there to keep you safe when it comes to anything drug- or medicine-related. They test products, procedures, and techniques and make sure things look kosher before you use them. However, the FDA does not oversee the production of compounded bioidentical hormones. They have not checked these drugs for safety, efficacy, potency, purity, or quality. Basically, the inmates are running the asylum. Overdosing and underdosing are both more than possible, and you can’t be sure that what you took on Monday is going to be the same thing you take on Tuesday.

You might now ask, what is compounding? Is it just a fancy way to say “mixing”? Basically, yes. Compounding is creating an individualized product based on the prescription written by the health care provider. Given that the product is custom made, there is no regulation over what is put into that “cocktail.” While you may think your vodka cranberry drink tastes better with a little more vodka, it might not be good for you. And unfortunately, given that it has deviated from the traditional vodka cranberry, no one will be checking to make sure it’s safe.

Now don’t get us wrong; compounding has its place in medicine. It has traditionally been used when specific products are not available or if different preservatives, routes, or ingredients are needed to deliver a medication. An example is the following…you need to take progesterone but it traditionally comes mixed in peanut oil—but you are allergic to peanut oil. Therefore you can’t take the medication UNLESS it is compounded with something else (aka sesame oil). Changes like this are what compounding was meant for!

But give me a little of this, mixed with some of that, and a splash of something else (a.k.a. blending) is not what compounding is or was intended to do. However, this blending concept is how it is often sold and marketed when used to describe hormone replacement therapy. When we were all down on HRT, compounded bioidenticals gained foot traffic because they appeared, and were billed to be, a safe alternative. They were marketed as the same good but no bad. The story was bought by many hook, line, and sinker and led many women to have a false sense of security about what they were putting into their bodies.

Many practitioners who prescribe bioidentical hormones tout them as personalized or tailored. They sell them as a perfect fit (sort of like those jeans that you are always trying to find!). But in reality, you don’t really know what you are buying, ingesting, or drinking. They are free from warning labels and any information on risks. But while ignorance can certainly be bliss, in many cases, this is not one of them! For example, if you are not taking enough progesterone in comparison to estrogen, you can put yourself at risk for uterine cancer—it’s just not a good situation.

And let’s take it one step further. Those that tout compounded bioidentical hormones will tell you they can check your levels through your saliva and can further tailor your treatment according to what they find. There is no evidence that hormone levels in saliva have any biological meaning; while we can pick up some things from your spit, we cannot pick up the level of your circulating hormones. So chew on this: don’t put yourself in danger because you want something natural. Compounded bioidentical hormones are not necessarily the answer.

The specific medications, the dosage, and the way the medications are delivered (oral, patch, vaginal) should be made to order for you. However, this should be done with FDA-approved medications where your doctor knows exactly what they are writing for you and you know exactly what you are ingesting. So while, yes, medicine should be tailored to you, the tailoring should not come in how the medication is mixed but rather how it is administered.

While we all agree that you need a good designer, some designs are not meant to be worn (think midriff shirts). So while you can look, please don’t buy. If the salesperson tells you it looks good, don’t believe it…just like bioidentical hormones, it’s not necessarily the best fit!