Bio-Identical Hormones: They’re Not What You Think
Heads Up: If you are taking bio-identical hormones, YOU ARE TAKING HORMONES.
“Bio-identical” is a marketing term, and if anyone tells you differently, they are either misinformed or lying. It’s not surprising, really – nobody can quite agree on what it means. Depending upon who you are talking to, “bio-identical” could mean “plant-derived,” “not artificial,” “chemically identical to human hormones,” or “compounded;” the term does not address anything at all relating to the manufacturing, source or delivery of the preparation. Even the Endocrine Society, in its official position paper on the subject[i], expresses concern about the use of the term to describe many different products, as well the implied safety and efficacy of the same. In fact, the bio-identical hormone preparations that you obtain by prescription from a compounding pharmacy are using the very same commercially available drugs used in conventional hormone therapy to whip up concoctions that are not commercially available: any hormone can be made to be bio-identical in a lab, but not without the same sorts of potentially serious side effects that come with the conventionally available preparations. And yet somehow this is being sold as a “safer” alternative[ii].
Let’s unpack the claims. Women are being told that bio-identical hormones are safer than “synthetic” hormones, and that these “natural” alternatives not only eliminate the vasomotor symptoms that plague menopausal women, but also protect against breast cancer, heart disease, endometrial cancer, fibroids, and more. This is an especially interesting claim, since bio-identical hormone preparations, again, made from some of the very same hormones that starred in the infamous WHI study[iii], showed pretty conclusively that hormone therapy – either estrogen only or estrogen-progestin – increased risk of stroke, breast cancer, dementia and incontinence, though it did increase “quality of life” for women with hot flashes. Okay, so maybe hormone therapy helps with hot flashes – which are horrible! I wouldn’t wish them on anyone – but there are literally dozens of other solutions for that specific symptom that have been scientifically proven to work as well as or even better than HRT, so why is hormone therapy the go-to? It defies logic.
It doesn’t help, of course, that celebrities like Suzanne Somers have jumped on the bio-identical bandwagon with no fewer than three heavily promoted books on the subject (wait, didn’t she have breast cancer?) trumpeting a message that is being repeated ad-nauseam by the monumental marketing budgets of companies like bio-TE and others – you’ve seen the ads. And when nearly every visit to the doctor yields basically the same message; that the benefits outweigh the risks, or even that there is no evidence that bio-identical HRT is unsafe, it can seem like the obvious solution.
But let’s be clear that a lack of evidence that something causes harm is not the same as proof that it is safe[iv]. Hormones are hormones, regardless of the origin; studies since WHI have shown that bio-identical hormone therapy is not as benign as you would be led to believe, with increased levels of hormones in the blood leading to a similar incidence of cancers.[v] [vi] I don’t dispute that hormone therapy helps some women feel better – many of my friends are enthusiastic proponents. (Here’s my plea to stop!) Flooding your system with an unnaturally elevated level of hormones can, for some, almost immediately eliminate the symptoms of menopause, and it is so easy! A pellet once a quarter or a couple of pills each night, and you can live symptom-free. But at what cost? This is where we willingly suspend all disbelief, and the consequences may be dire.
Because compounding pharmacies are not subject to FDA oversight, they do not have to meet any manufacturing standards (other than their own, presumably). Their preparations are not regulated, so dosages may vary widely. One study of compounding pharmacies found that only 1 in 10 made progesterone suppositories that fell within the FDA-approved levels for similar products[vii]. The inconsistency and lack of manufacturing oversight is something to be wary of, as there have been many instances of contamination from compounded formulations leading to sickness, like a 2012 outbreak of meningitis traced to injections contaminated with bacteria[viii]. This inconvenient fact is often waved off and/or diminished by insisting on the benefits of having a formulation tailored to your exact hormone profile, but the truth is that the correlation between saliva, blood serum, and tissue levels of hormones vary by a multitude of factors, and there is not a standard correlation between hormone levels and perceived symptoms. So, what is the exact level and combination of hormones that should be prescribed for your particular symptoms? No one really knows. One literature review concludes that while individualized formulations might work for some menopause symptoms, “their use is not supported by evidence regarding pharmacokinetics, safety, and efficacy.”[ix]
All this is to say that it’s time to bring back a healthy dose of skepticism when it comes to evaluating potential courses of treatment for menopause. It’s easy to get swept up in the fervor of click-bait internet stories, big advertising, celebrity endorsements, and the promise of a magic pill when you are drenched in sweat after another sleepless night. But make no mistake: there is clear danger in ANY hormone therapy and claims that bio-identical or compounded formulations are safer than conventional hormone treatment flies in the face of scientific data.
With so much at stake, why aren’t women flocking to the yoga studio or turning to nutritional or herbal protocols with same enthusiasm? Weightlifting[x], yoga[xi], walking, certain essential vitamins[xii], herbal preparations, and dietary protocols have all proven to be hugely effective in eliminating the most common symptoms of menopause, namely those dreaded hot flashes, brain fog, and fatigue. Maybe the resistance to these solutions lies in the perceived effort needed to effect a result – after all, getting a pellet surgically implanted in your ass takes fifteen minutes and lasts three months; committing to what essentially amounts to a lifestyle overhaul takes a concentrated effort each and every day.
I get it – you’re busy. It all seems overwhelming, and you just want relief. But here’s the thing: you don’t need what’s being sold. You can start wherever you are right now and make a few tweaks to your diet, your exercise routine, your lifestyle – and see amazing changes in your health and happiness. Does it take some time and effort? Absolutely. But with so much evidence on the side of taking a natural, non-hormonal approach to menopause, it just doesn’t make sense to take the risk of pursuing HRT, bio-identical or not.
[i] https://www.endocrine.org/advocacy/priorities-and-positions/bioidentical-hormones
[ii] https://www.ncbi.nlm.nih.gov/pubmed/28509626
[iii] https://www.ncbi.nlm.nih.gov/pubmed/12117397
[iv] https://www.ncbi.nlm.nih.gov/pubmed/17627398
[v] https://www.ncbi.nlm.nih.gov/pubmed/11959894/
[vi] https://www.ncbi.nlm.nih.gov/pubmed/14710223
[vii] https://www.ncbi.nlm.nih.gov/pubmed/15595573
[viii] https://www.ncbi.nlm.nih.gov/pubmed/23526368
[ix] https://www.ncbi.nlm.nih.gov/pubmed/15167316
[x] https://www.ncbi.nlm.nih.gov/pubmed/31239119
[xi] https://www.ncbi.nlm.nih.gov/pubmed/29452777/
[xii] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4161099/