Important News About Hormone Therapy

It was almost 20 years ago that I first learned about bioidentical hormone therapy from a talk given by Christiane Northrup, MD, (author of Women’s Bodies, Women’s Wisdom and The Wisdom of Menopause) at the first meeting I ever attended of the American Holistic Medical Association. By the way, the line-up of speakers included not only Chris, who was one of the original founders, but also Deepak Chopra, Larry Dossey, Andrew Weil, Alan Gaby, Bernie Siegel, Frank Lipman, and Caroline Myss, all before they’d become household names in what was later named (by Dr. Weil) “integrative medicine.”

The popular prescription hormone replacement therapy (HRT) of the day was, and still is, Premarin, which Chris reminded us was nothing more than the concentrated urine of pregnant horses (pregnant mare urine=Premarin). Alan Gaby would tell us, as only he could, that American women were “scarfing down hoss piss,” emphasizing that being piss also meant even the horse didn’t want it. Unless you have a strong stomach, don’t click to this web page, the ASPCA’s comments on Premarin and animal cruelty.

If you’re a women who still has her uterus, taking estrogen requires adding the second sex hormone, progesterone, to prevent uterine cancer. The popular progesterone product was, and still is, a synthetic molecule called Provera (medroxyprogesterone), and it’s currently available combined with Premarin into a single product, Prempro.

During that talk all those years ago, Dr Northrup was worried about Prempro because there was data emerging from Europe of increased breast cancer and stroke risks in women using it. From Big Pharma, nothing but denials were being published in the US.

Chris Northrup was taking no chances, though, sticking with bioidentical hormones for her patients.

Bioidentical means “biologically identical”

These hormones are manufactured (estrogen from soybeans, progesterone from the Mexican wild yam) so that the final molecule is identical to the one made by human females. By the way, bioidentical testosterone for both men and women is available as well, but you won’t find these available in the pharmacy of your local Walgreen’s or CVS. Each prescription for bioidentical hormones is made up individually at an independently owned compounding pharmacy.

Because no one can patent a human molecule, Big Pharma isn’t interested in developing or testing bioidentical hormones, and for this reason bioidenticals haven’t undergone the rigorous FDA requirements reserved for other prescription drugs. Mainly, Big Pharma regards bioidenticals as a most annoying competitor to its own hormones. In fact it’s tried all sorts of sneaky ploys to get them pulled from the market, including instigating a congressional ban on compounding pharmacies themselves.

It seemed counter-intuitive to Dr Northrup (and now, after prescribing bioidentical hormones for many years, to me as well) that the very same hormone a woman produces in her body would actually increase her cancer risk. In fact Chris mentioned that, in her own experience, there seemed a slightly smaller risk of breast cancer among bioidentical hormone users, noting that these impressions of her own patient population required larger studies to prove.

Stroke and blood clot have always been a problem with hormones as well. Doctors know that clots and strokes occur more frequently among birth control pill users, especially if they smoke. The same risk would likely apply for hormone replacement therapy of any stripe, synthetic or bioidentical.

Fast forward a decade

The controversial Women’s Health Initiative (WHI) study frightened everybody, doctors and patients alike, by showing an increased risk of breast cancer among Prempro users compared to non-users. But a couple of years later, when all the sturm und drang cleared, it turned out the WHI study had enough flaws (not the least inadvertently including some women who already had breast cancer) to suggest that instead of never again prescribing HRT, doctors could write Prempro prescriptions with certain caveats, among them regular breast examinations for users and that women should use it only as long as it took to get past menopause-related hot flashes.

What was really needed, and would simply never occur in the US because Big Pharma could not profit from the results, was a study using bioidentical hormones. However, the French health care system (essentially not-for-profit and which regular readers know I admire immensely) was willing to study synthetic vs bioidentical hormone replacement. They tracked almost 100,000 women in the E3n study and results have been published over the past several years.

The main points of the E3n study are extremely important to any woman contemplating or currently using hormone replacement of any kind:

• Different risks were associated with the different types of hormones used in the study. The US WHI study used only Prempro (horse estrogen plus medroxyprogesterone). The E3n study used only bioidentical estrogen but varied the type of progesterone, including bioidentical progesterone and medroxyprogesterone.
• There were increased breast cancer risks in all women taking estrogen replacement, but the main source of risk turned out to be less the estrogen than the progesterone type that had been selected. When bioidentical estrogen was combined with bioidentical progesterone, the risk of developing breast cancer was dramatically lower than when bioidentical estrogen was combined with medroxyprogesterone. Although taking bioidentical HRT did not protect women from developing breast cancer as Chris Northrup had hoped, what she observed way back then was correct: the risks were much lower with bioidenticals than when using Big Pharma hormones.
• Finally, unlike the WHI study using Prempro, there were no increased stroke or blood clot risks when using bioidentical hormones.

Some years back, Big Pharma had hoped Premarin would do more than help hot flashes. Untested evidence began to appear–that hormones might prevent osteoporosis, Alzheimer’s disease, heart disease, and strokes. With the exception of being useful for osteoporosis, the WHI study quashed hopes for prevention of everything else. There was a higher stroke and heart attack risk with Premarin (nothing significant about Alzheimer’s) and, now, from the E3n, no stroke or clot risks with bioidenticals.

Ultimately, hormone replacement is truly useful for just one condition: menopausal symptoms. Hot flashes and night sweats usually stop dead in their tracks when a women takes the dose of bioidentical hormones best for her (doses can vary quite widely). The route of administration–capsules vs creams–doesn’t make much difference and is your choice. At WholeHealth Chicago we prescribe both capsules and creams, including the new Wiley Protocol, which varies the hormone dose depending on the day of a woman’s cycle synchronized with phases of the moon (menses=moon, remember?).

I remain amazed by the gynecologists over at my nearby Goliath (Northwestern Memorial Hospital) who continue to give stern lectures about bioidenticals being “untested by the FDA” when women ask about them.

We hear all about this finger-wagging when these same women arrive at our center. The French E3n data is available for all physicians online, translated and ready to read, if only…

Be well,

David Edelberg, MD