Lack of Evidence For Claims
Bioidentical hormones have been advertised, marketed and promoted as a risk-free panacea that is safer than standard HRT. Literature reviews by private practitioners who sell bioidentical preparations suggest benefits and advantages in the use of BHRT over its conventional counterpart, but there is significant skepticism over claims made about BHRT; there is no peer-reviewed evidence that compounded bioidentical hormones are safer or more effective than FDA-approved formulations or that they carry less risk. The hormones are expected to carry the same risks as their conventional counterparts, while the risks of including estriol—a hormone normally produced in large amounts only in pregnant women—have not been studied. The United States Food and Drug Administration (FDA) warned that claims about compounded BHRT products are unsupported by medical evidence—unlike claims about manufactured, FDA-approved products. The chief medical editor of Endocrine Today called compounded BHRT a "marketing concept" with no scientific backing, and the FDA warned that pharmacies use these terms to imply that the drugs are natural and have the same effects as endogenous hormones. Other claims include compounded BHRT's ability to prevent or treat conditions such as heart disease, stroke, Alzheimer’s disease, endometrial and breast cancer; fewer side effects; and custom blending to uniquely address individuals. There is no credible evidence to support these claims. Bioidentical hormones and compounded BHRT are expected to have the same risks and benefits as CHRT; the latter benefits from years of study and regulation, while compounded BHRT has no scientific data to support claims of superior safety or efficacy. The following specific claims have been made for the efficacy of bioidentical hormones and compounded BHRT, with varying evidence to support or contradict them:
| Claim | Evidence |
|---|---|
| Bioidentical hormones fit precisely into human hormone receptors while conventional hormones fit "cockeyed"; this mismatch causes serious side effects | Synthetic progestins and endogenous progesterone have different binding affinities for different receptors, depending on the model and animal used; these differing pharmacodynamics have not been associated with specific side effects |
| The body is unable to metabolize synthetic hormones | The biological half-life for synthetic hormones is between five minutes and two days |
| Lack of progesterone causes irregular or painful, heavy menses | Oral progesterone is no more effective than placebo at alleviating symptoms of premenstrual syndrome |
| Progesterone can counteract stress, increase metabolism and decrease abdominal fat | There is no evidence to support weight loss due to progesterone |
| "Normal" levels of progesterone protect against breast cancer | The claim is based on a single study of infertile patients during child-bearing years. Some evidence exists supporting a link between hormonal treatment for infertility and a reduced risk of breast cancer, but these benefits may not translate to women seeking relief from the symptoms of menopause |
| Progesterone therapy can prevent cardiovascular disease and atherosclerosis, and raise good cholesterol | The use of micronized progesterone does not affect cardiovascular risk |
| The side effects reported in the Women's Health Initiative study were due to the synthetic nature of the hormones used | "Cardiovascular benefit has not been proven with micronized progesterone in observational or experimental research...a multicenter, case–control study was conducted in postmenopausal women aged 45–70 years to examine potential differences in cardiovascular risk between the subtypes of synthetic progestins and micronized progesterone...Micronized progesterone and pregnane derivatives were not associated with an increased venous thromboembolism risk, whereas norpregnane derivatives...were associated with increased risk of thromboembolism...Thus, certain progestins are associated with increased cardiovascular risk, whereas pregnane derivatives and micronized progesterone neither increase nor decrease cardiovascular risk in the doses studied" |
| Proponents claim that bioidentical hormones, in addition to the demonstrated benefit of improving bone-mineral density, protecting the eyes and skin from drying out, regulating the menstrual cycle, improving mental function, improving blood cholesterol and reducing hot flashes and night sweats associated with menopause | There is no published evidence (derived from controlled research) supporting the claims of superior beneficial effects for bioidentical hormones as compared to conventional hormome therapy. Risk data have been published for conventional hormone therapy, and CHRT is not recommended to manage any chronic diseases, or for the prevention of cardiovascular disease |
| Estriol can decrease the risk of breast cancer | Estriol has been shown to cause breast cancer cell growth |
| Pharmacists use their expertise regarding bioidentical hormones to meet the needs of their clients and improve health outcomes | Compounding is a legitimate practice, but there is no evidence that clearly illustrates the benefits and risks of BHRT |
In 2006, actress Suzanne Somers released the book Ageless: The Naked Truth About Bioidentical Hormones endorsing the use of bioidentical hormones. The book was criticized by a group of doctors who (though generally supportive of BHRT) state that more research is required, and object to protocols mentioned in the book—because of their potential danger and the promoters' lack of qualifications. Somers' book may have raised the profile of BHRT for the growing number of menopausal women, but also may have caused confusion by making unsubstantiated claims for BHRT and referring to bioidentical hormones as non-drug products with fewer risks. Bioidentical hormones have also been discussed on The Oprah Winfrey Show, with Somers as a guest.
Bioidentical-hormone proponents Erika Schwartz and Kent Holtorf criticized a 2008 literature review on bioidentical hormones for addressing only compounded bioidentical hormones and not reviewing FDA-approved bioidentical products, which they believed added to the existing confusion. Michael Cirigliano and Judi Chervenak have stated in reviews of literature on BHRT that large-scale, peer-reviewed studies should be used to establish the safety, efficacy and beliefs about the use of bioidentical hormones. Two 2008 studies conducted in France found that estradiol plus micronized progesterone did not increase the incidence of breast cancer, while a comparison of estradiol plus different types of progestins found a reduced risk of invasive breast cancer with micronized progesterone. Christine Derzko stated that the evidence supported the use of bioidentical estrogen plus progesterone, but since the trial was an observational cohort study rather than a randomized controlled trial that compared different types of hormones head-to-head, more data was required before concluding bioidentical hormones were safer and preferred. Derzko concluded that there was weak (but promising) preliminary evidence that bioidentical hormones may present equal (or possibly lower) risks than conventional HRT; however, there was no data supporting the use of compounding. Derzko recommended following evidence-based medicine and cited concerns over BHRT by numerous medical organizations—requirements for oversight over compounding, black box warnings for all bioidentical products, and the establishment of a mandatory adverse-events registry.
M. Sarah Rosenthal, Director of the University of Kentucky Program for Bioethics and Patients’ Rights, has stated that she believes BHRT is an experimental therapy that is often prescribed by practitioners who sell the products, and are thus in an unethical position of conflict of interest. Rosenthal has also described problematic issues with BHRT including patients receiving information from popular books while lacking the scientific literacy to separate rhetoric from evidence about hormone replacement, illegitimate claims of a "big pharam" conspiracy to suppress bioidentical prescribing, the extra and unnecessary cost of the products that are often not covered by insurance plans, and the inaccurate depiction of bioidentical prescribing as "cutting edge science" rather than unproven alternative medicine.
Read more about this topic: Bioidentical Hormone Replacement Therapy, Criticisms
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