Is Natural Always Better?
So often, when we hear the word “natural” we automatically think it is better. Many women assume that “natural” hormones would be better or safer — but the term “natural” is open to interpretation.
Any product whose principal ingredient has an animal, plant, or mineral source is technically natural. It doesn’t matter whether the substance is ground, put into capsules, and sold over the counter — or extracted in a laboratory, manufactured by a pharmaceutical company, and made available only by prescription. For example, the soy plant is the source of supplements that some women take to ease menopausal symptoms; it’s also used, along with yams, to make the estrogen in the FDA-approved hormone drug Estrace.
But unlike Estrace, soy supplements aren’t regulated and haven’t been rigorously tested in humans, so we don’t know whether they’re safe or effective. There’s some evidence that certain soy components may actually stimulate breast tumor growth. So “natural” doesn’t necessarily equal “safe” — and may simply be a euphemism for “unregulated.”
What is a Bioidentical Hormone?
Bioidentical hormone replacement therapy (BHRT), also known as bioidentical hormone therapy or natural hormone therapy, is a poorly-defined term referring to the use of hormones that are identical, on a molecular level, with endogenous hormones (hormones that occur naturally in your body) in hormone replacement therapy.
What Are The Claims about BHRT?
Hormone levels decline as we age; bioidentical hormone therapy is claimed to replenish the hormones that your body needs to function. Bioidentical hormone doctors and compounding pharmacies use natural or bioidentical hormones versus bio-similar or synthetic hormones. It is claimed that bioidentical hormones are molecule-by-molecule, exactly the same as the hormones (estrogen, testosterone, progesterone, cortisol, dhea, estradiol and estriol) present in the human body. The bioidentical hormone replacement physician assesses each individual’s needs and work to restore these hormones and customize a medical plan specifically for you.
What We Do Know About BHRT?
Marketers of bioidentical hormones say their products have these advantages over standard hormone therapy:
- They’re derived from plant chemicals, not synthesized in a laboratory. Some FDA-approved products (Estrace, Climara patch and Vivelle-Dot patch, and Prometrium natural progesterone) are also derived from plants.
- They’re produced in doses and forms that differ from those in FDA-approved products. Some bioidentical hormone products are available without a prescription, but most require a prescription. Also, for many nonstandard combinations, you need to go through a compounding pharmacy. Compounding pharmacies specialize in making medications customized for individual needs, such as inability to swallow solids or allergy to a binding agent in a tablet. However, products from compounding pharmacies have not been subject to the same rigorous quality assurance standards that standard commercially available hormonal preparations have to meet.
- They’re custom made for you, based on a test of your saliva to assess your unique hormonal needs. Unfortunately, however, the hormone levels in your saliva don’t reflect the levels in your blood or correspond to menopause symptoms.
Are There Dangers of BHRT?
Basically, every medication and therapy has risks and benefits. It is our job as health care providers, and your jobs as patients to make informed, educational decisions about your health. We weight the risks versus benefits, and usually choose the one that outweighs the other.
The risk involved in prescribing a hormonal product depends on its chemical composition and biochemical properties, not on how it was made. However, many offbeat physicians are prescribing compounded “bioidentical” products as though they are safer than standard prescription drug products. On October 31, 2005, the American College of Obstetricians and Gynecologists (ACOG) warned against these products and the saliva tests typically used by those who prescribe them. In strongly worded documents, ACOG stated:
- There is no scientific evidence to support claims of increased efficacy or safety for individualized estrogen or progesterone regimens prepared by compounding pharmacies.
- Hormone therapy does not belong to a class of drugs with an indication for individualized dosing. Salivary hormone level testing used by proponents to “tailor” this therapy isn’t meaningful because (a) salivary levels are not as accurate as blood levels and (b) they can vary within each woman depending on her diet, the time of day, the specific hormone being tested, and other variables.
- Most compounded products have not undergone rigorous clinical testing for either safety or efficacy. There are also concerns regarding their purity, potency, and quality.
- The FDA requires manufacturers of FDA-approved products that contain estrogen and progestin to include a black box warning that reflects the findings of the Women’s Health Initiative. However, compounded products (including “bioidentical” hormones) are not approved by the FDA and have been exempt from having to provide patient package inserts that contain warnings and contraindications for estrogens and progestin.
- Given the lack of well-designed and well-conducted clinical trials of these compounded hormones, all of them should be considered to have the same safety issues as those hormone products that are approved by the FDA and may also have additional risks unique to the compounding process.
The bottom line is to weight the risks versus benefits of any medication or therapy. Do not jump on the bandwagon of BHRT just because Oprah Winfrey and Suzanne Somers say to. After all, I don’t recall any of them having any formal training as a health care provider. Become an educated consumer. I hope this helps to educate you on BHRT.