Bioidentical Hormones Revisited

Recently, I was browsing through an online discussion board about the pros and cons of hormone replacement therapy. I ran across this comment from a participant: “I’m going to try bioidentical hormones like Suzanne Somers. I’ve heard they’re safer.” Whoa! I thought. Let’s do some objective homework first, and weigh the risks before you jump in. Celebrity endorsements notwithstanding, bioidentical hormone replacement therapy (bHRT) is neither the miracle cure nor fountain of youth touted by Ms. Somers. Nor is it some kind of snake oil concocted by salacious quacks or unscrupulous doctors and pharmacists. The truth is, of course, much more nuanced. As a physician, I’d always opt for more treatment choices when it comes to helping women with the unpleasantries of menopause. I want more drugs in the arsenal, more ways to treat hot flashes, sleeplessness, and loss of libido. However, the entire topic of bioidentical hormones is so laden with emotion and misinformation that it takes a very fine point to tease fact from hyperbole. We laid the groundwork on bioidenticals before, but the issue continues to befuddle and mislead, so let’s circle back and fill in some gaps. Any hormone therapy, whether bioidentical or synthetic, is only intended to ease menopausal symptoms. Hormones were never meant to keep your memory sharp or your hair shiny or your skin taut. Hormones are not a fountain of youth. The latest medical guidelines state that hormones should be taken at the lowest possible dose for the shortest period of time needed to ease symptoms. This is because hormones, whether bioidentical or synthetic, are drugs and they interact with other systems in the body, sometimes in ways that are not well understood.
Point #1. Menopause isn’t a disease; it’s a natural transition. Hormone therapy is intended neither to keep your hormones “in harmony” nor to keep menopause at bay indefinitely. Hormone therapy is intended to ease the symptoms of the menopausal transition when they are interfering with your life.
Next, bioidenticals aren’t necessarily “natural” and therefore “safer.” The marketing message that hooks women is that bioidentical hormones are derived from “natural” sources and are therefore safer than hormones from other sources. Bioidenticals are estrogens that are indeed made from plant sources, but they are processed (synthesized, if you will) to create a hormone that can be absorbed by humans. “All plant-derived hormone preparations, whether they come from a compounding pharmacy or a large commercial pharmacy, require a chemical process to synthesize the final product,” writes Dr. Oz in this article. With bioidenticals, however, you end up with a molecule that is exactly like (identical to) human hormones, whereas non-bioidentical hormones are similar but not identical. Any hormone, whether those your body produces or those you ingest, affects your body. Also, the delivery method, whether a patch, pill, or vaginal cream, also affects the way your body absorbs and responds to the hormone.
Point #2: Don’t equate “bio” with something “natural” and therefore risk free. Taking any hormone involves some risk. (Decisions about hormone therapy need to be based on careful consideration for each individual—understanding both the potential risks and benefits for that woman.) Bioidentical hormones are so-called because the molecule is identical to the human hormone and because they are derived from plant sources, even though they must be synthesized to be useful.
“So ‘natural’ doesn’t necessarily equal ‘safe’—and may simply be a euphemism for ‘unregulated,’” according to this article in the Harvard Women’s Health Watch. You can, we should note, get bioidentical hormones that are FDA approved and regulated. Many familiar brands of hormonal rings, creams, patches, pills, and gels are both commercially manufactured by pharmaceutical companies and bioidentical. These include Estrace, Femring, Vivelle, Vagifem, and Prometrium, and more. You know what you’re getting with these products. You know that the active ingredient is in the form and dosage that the label says it is. That kind of uniformity and “safety” is the assurance provided by FDA testing and approval.
Point #3: Many major brands of commercially manufactured hormones are both bioidentical and FDA approved.
Next, let’s understand what “custom-compounding” means. Many bioidenticals are touted as natural, safe, and custom-made just for you to bring your hormones back in balance. Custom-compounded drugs are made in small, customized batches by pharmacies that specialize in custom-compounding. They can be prescribed by a clinician. Custom-compounding is very helpful when a patient needs a special dosage of a medication, or a different delivery method, or is allergic to a filler in a commercial drug. Maybe, for example, you need a lower dose of progesterone than is commercially available, or you need it in a vaginal cream, and the big pharmas only make it for administering orally. However, neither the process nor the product is FDA-regulated or approved, and in fact, studies have shown that they are much less consistent than commercial products. In a few highly publicized cases, contaminated medications distributed by custom-compounders have been responsible for serious illness, infection, and death. An example is the outbreak of fungal meningitis in the fall of 2012. The problem with custom-compounded hormones arises with claims of customized products that are safe, natural, and that will restore hormonal balance, among other things. In actuality, it’s not possible to accurately pinpoint hormonal levels in an individual because they are constantly changing. The hypothalamus, pituitary and ovaries (the HPO axis, as we call it) work in a very integrated and precise way to direct hormone production. Our replacements aren’t able to replicate that concert of events, but we can do a good job of replacing the hormones more consistently, which many women prefer to the ‘ups and downs’ we’re familiar with. The only way to determine an effective dose is through symptom control—the lowest dose that relieves a woman’s symptoms. “Salivary and blood testing of hormone levels used by custom compounders is meaningless for midlife women as their hormone levels vary throughout the day, and from day to day” is the North American Menopause Society position. “This doesn’t mean that you shouldn’t consider compounded hormones. Just realize that, in a real sense, you’re going to be an experiment of one,” says the Harvard Medical Watch article. Also realize that custom-compounded drugs usually aren’t covered by insurance, and the regimen of testing and compounding gets expensive very quickly.
Point #4. Custom-compounding of drugs is a time-honored practice of making drugs in small batches or according to specific needs (while the processes and products aren’t subject to federal regulation or oversight). Claims that these products are healthier, safer, or somehow contain properties lacking in commercial products should be viewed with suspicion.

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