Once upon a time most of us moved here, to LA, from other states or countries. And we love it! As veteran Los Angelinos we live, work and of course, look at others in this, our youth and media oriented city. The inevitable follows: we would like to look like a celebrity worthy of an appearance on Oprah or at least appear younger than our chronologic age. So when we see ads politely inquiring whether we are developing a bulge above our jeans, flushing, flashing (from heat, not exhibitionism), sleeping poorly, loosing our libido or worse… wrinkling; we go on the alert. Who can resist that spiel? : Step right up and spit here; we’ll see what you’re missing and order you a very special, made- just- for- you therapy. Rub this cream on, swallow these capsules, put these drops under your tongue and don’t worry, these “bioidentical” hormones are chockfull of health, not like the ones made by those big, bad pharmaceutical companies.
Many of my tenured (note I refrain form using the adjective “old”) and new patients want to know if they should start these “bioidentical” hormones or switch to them. To quote Shakespeare, who was hormonally clueless but recognized some distressing female symptoms: Here’s the rub.
“Bioidentical” is a marketing term. It’s as ingenious as the word natural when it comes to selling a product; both appeal to consumers’ aversion to artificial ingredients. But remember, hemlock is natural.
When the term “bioidentical” is used by compounding pharmacies and celebrities who are often selling their products or touting their own books, it refers to formulations of various types of estrogens, progesterone, adrenal hormones, and androgens (male hormones) compounded within creams, gels, lotions, capsules, drops, capsules, and even suppositories. The compounded estrogens are often a combination of weak forms of estrogen (estrone or estriol) as well as the stronger estradiol. In order to get significant relief of menopausal symptoms, large doses of the estriol or estrone have to be used and there is no evidence that this is safer than the lower dose of estradiol which, by the way, was produced by our ovaries and accepted by nearly every cell in our bodies during our reproductive years. Estradiol is the estrogen contained in many of the FDA approved hormone therapy medications, and/or the metabolite (the end result after processing in the body) of these medications. Nearly all plant derived estrogen therapy, both individually compounded formulations and pharmaceutical products come from the same soy and yam precursors. They all undergo chemical conversion to become hormones. ( The concept of plant gathering followed by stomping created a great “I Love Lucy” sketch and will work for grape juice and ultimately wine, but will not result in a biologically active hormone product, no matter how skillful the stomping and crushing.) Compounding pharmacies may claim that the combination of their estrogens is either safer or more natural than any of the products that are commercially prepared by pharmaceutical companies. No clinical studies published in reputable peer review journals have shown this to be true. As for the claim that estriol may reduce the risk of breast cancer; this is pure speculation based on old studies that were usually carried out on animals. The FDA has unequivocally stated that it is not aware of any credible scientific evidence to support claims made regarding the safety and effectiveness of compounded “bioidentical” hormone replacement drugs. They have taken action against seven pharmacy operations that claim their compounded “bioidentical drugs” which contain hormones such as estrogen, progesterone and estriol are superior to FDA-approved menopausal hormone therapy medications. The American College of Obstetricians and Gynecologists (my professional entity) has the same concerns stating that “most compounded products have not undergone rigorous clinical tasting for safety or efficacy and issues regarding purity, potency and quality”.
Doctors who prescribe these “bioidentical” hormones often use salivary (spit) testing to tailor the amount of hormones they prescribe. But salivary hormone levels vary tremendously throughout the day and differ from woman to woman. Moreover we don’t have studies that demonstrate a correlation between the levels of spit hormones and a woman’s clinical state or her response to hormone preparations. The major mavens on menopause (we have a society for everything), The North American Menopause Society, does not recommend saliva testing to determine hormone levels, nor do they recommend custom compounded products over “well tested, government approved products for the majority of women”. All these institutions are concerned that patients do not see the black box warnings that are prominently displayed with FDA approved medications…the ones that state that hormones should not be used if you have had certain conditions that include estrogen related cancers and blood clots and the concerns about risks for long term use.
Finally who pays? Sometimes insurance companies do, but often the patient is stuck with a bill that is higher than the one she would pay (or co-pay) for commercially prepared hormones. Moreover if the practitioner who prescribes “bioidentical” hormones also sells them from her or his office, there is a potential conflict of interest.
Some hormones including testosterone and DHEA (used for low libido or specific deficiency disorders) may not be available in pharmaceutical products and will have to be compounded. As a matter of full disclosure, I do prescribe compounded hormones when the latter are needed or when a patient becomes allergic to standard therapy. But I advise all my patients that there are no free hormones, no matter how they are made. There is an indication and contraindication to every medication and it’s imperative that your physician use appropriate, up-to-date studies in order to inform you of both.
Unfortunately, no hormone will provide you with that lost fountain of youth. But when prescribed for significant symptoms in appropriate doses, hormone therapy will help you feel better. Exercise, proper nutrition, weight control, hair color, make-up, and the right lighting are the only proven (and risk free) ways to help you feel and look your best.