Everything You Wanted to Know about Bioidentical Hormone Replacement Therapy (“BHRT”)
Much has been in the news, online, and on television regarding BHRT. Unfortunately, much of it is misinformation. Let’s set the record straight about bioidenticals and better understand hormonal delivery systems.
I am all for bioidenticals. They are the only type of HRT I have utilized for 15 years—not because they’ve become a buzzword and a cash cow for certain authors, shameless marketers, and less-than-well-trained practitioners, but because they make sense (commonsense and medical sense). A principal advantage is that they can be delivered transdermally (through the skin).
What are “bioidenticals?” Why is transdermal delivery such an advantage? And what is the difference between “FDA-approved BHRT” and “compounded BHRT?”
Simply said, a bioidentical compound is a substance that is biologically identical to what is produced by the body (or, in the case of a menopausal woman, what was but is no longer being produced). Premenopausal ovaries produce mostly estradiol (“E2”), plus a modest amount of estrone (“E1”—the strongest and potentially most dangerous estrogen for the breast).
The ovaries do not produce any estriol (“E3”), a weak estrogen produced in the human body only by the placenta during pregnancy. Estriol (E3) is frequently touted as a panacea by some less-than-knowledgeable
practitioners. Since E3 is weak, it has little effect on the breast in low doses. It also has little effect on menopausal symptoms, cardiovascular protection, bone density protection, etc., unless it is given in doses 10X higher than E2. And then, of course, it would theoretically have the same potential breast effect as E2.
Estriol may be great- I don’t know, because unfortunately, there is virtually no evidence-proven research on estriol. Taking estriol and estrone is truly self-experimentation, a fact that compounders of “BiEst” (E2+E3) and “TriEst”(E1+E2+E3) fail to mention. Both compounds are probably not “bad for ya,” but there is little evidence-proven research on the stuff.
How are Bioidenticals Made?
Several plants, including soybeans and wild Mexican yam, are “plant sterols.” They have chemical structures similar to sex steroids (estrogen, progesterone, testosterone.) In the lab, chemists can split off side chains from these sterols to actually produce, or “synthesize” the sex steroids, estradiol, testosterone and progesterone. Voila! A “bioidentical.”
You can’t, however, eat soybeans or yam, or buy soy or yam-containing products from the health food store and expect the same benefits; the human body lacks the enzymes to convert these foods into hormone.
Differences in Bioidenticals
There are 2 types of bioidentical hormones: FDA approved and non-FDA approved.
FDA-approved bioidentical hormones include:
· Estrace oral tablets
· All patches (Vivelle Dot, Climara, generic patches, etc)
· Prometrium (oral micronized progesterone)
These products come in a variety of dosages, which can be further customized by an experienced practitioner.
Non-FDA-approved bioidentical hormones include:
· Compounded testosterone
· Progesterone cream
· Compounded capsules
· Compounded estradiol
Interestingly, FDA-approved and non-FDA approved are virtually the same things. There is no difference in safety or risk between the two categories, although marketers present it differently. The only difference is that the FDA requires the drug companies producing approved products to go through an extensive product testing protocol, providing safety, reliability, blood levels depending on application site and delivery system, etc.
Compounders using the same stuff do not need to comply with FDA requirements, so may tout their product as “better” or “safer,” when in fact their product is virtually the same as the drug companies make, perhaps a bit less reliable, as there is no data re: concentrations of these hormones depending on application site, or adjusting for the several different types of creams and gels utilized.
Bottom line: Both FDA-approved and non-FDA-approved bioidentical hormone products are OK, but one is not necessarily safer or more effective than the other. Compounded products are cheaper, as the supplier has not spent the money required for FDA-mandated testing.
Many healthcare practitioners, in order to account for the uncertain blood levels, use quite high hormonal doses. This may be OK in the short term, but I would be worried about “paying the piper” long-term, when it comes to possibly increased risk of breast cancer with these high doses, in the absence of any FDA safety data.
Importance of the Delivery System
Since we know the non-FDA-approved and FDA-approved bioidentical hormone products are essentially the same. Where do the differences come in? The answer is the delivery system.
Several recent well-done, evidence-supported studies have shown that many of the proven risks of hormone therapy (including blood clots, stroke, and increased short-term cardiovascular risk) are the risks not of the hormone, but of “oral administration.” When taken orally, the product must be metabolized by the liver, whereas transdermally (through the skin) administered products go directly into the bloodstream.
Orally-administered estrogen is metabolized by the liver, and in that process releases clotting factors, increasing risk of stroke and blood clots. Also released are sex hormone binding globulin (“SHBG”) which binds to testosterone, removing it from circulation and diminishing sex drive; thyroid binding globulin (“TBG”), removing some thyroid hormone; and cortisol binding globulin (“CBG”), fractionally decreasing cortisol levels, possibly leading to a slower metabolic rate.
Also proven by recent studies is the fact that not all progestogens are “created equal…” Progestins (synthetic progesterone), especially medroxyprogesterone (“Provera”), is the least safe, secondary to adverse effects both on the breast and cardiovascular system.
There is no place, in this day and age, for either orally-administered estrogen, or the drug Provera (medroxyprogesterone), other than for very short-term administration. Healthcare providers still using oral estrogens or synthetic progestins (especially Provera) long-term are out of touch with present data. Practitioners promising more safety and individualization with “compounded bioidenticals” are marketers, out to make a buck.
Suggesting that untested and unproven regimens that have been supported only by marketers and celebrities and not by thorough and well-done scientific studies may be a more facile and in vogue approach for some, but it is one that flirts with failure and potentially leads to serious safety issues.
Compounding is fine. It is generally safe, and most compounders are knowledgeable, helpful, and careful. It is a nifty way to combine different hormonal combinations, but it is not safer nor the only way to take BHRT.