Bioidentical Hormone Debate Continues
Two doctors from the Cleveland Clinic, one of which has represented pharmaceutical companies that manufacture synthetic hormones, recently published a paper that lambasts any perceived benefits of bioidentical hormones.
The paper, published December’s Cleveland Clinic Journal, states there that there is no evidence that bioidentical hormones provide aging benefits, reduced side effects, or present a legitimate option to FDA-approved pharmaceutical synthetic hormones.
Could there really be no benefit of prescribing a hormone combination that comes from natural sources and designed specifically for the individual patient by the physician?
As to the effectiveness of bioidentical hormone therapy, this was established in a recent study by the University of Texas Health Science Center. The researchers followed 296 women who received bioidentical hormone therapy between 2003 and 2010, using six community pharmacies and local physicians. Among the women, 71% used topical forms and 43% took oral versions.
The study found that the women overall experienced a 25% reduction in emotional mood swings and irritability, 22% less anxiety, and a 14% reduction of night sweats.
The researchers concluded that, “This study demonstrates that compounded bioidentical hormone replacement therapy improves mood symptoms.”
The Cleveland Clinic’s paper also stated that bioidentical hormone therapy has never been proven to reverse the aging process. Indeed the research has neither studied this nor found it to be true.
But the paper also stated that there is no evidence that bioidentical hormone therapy is safer than synthetic hormone therapy. Is this true?
A 2009 review of clinical evidence by Kent Holtorf, MD, found that it is. Dr. Holtorf reviewed clinical research and found that:
1) “Patients report greater satisfaction with hormone replacement therapies that contain progesterone compared with those that contain a synthetic progestin.”
2) Bioidentical hormones have different molecular structures and significantly different metabolic effects from synthetic versions.
3) Clinical research and physiological data has found progesterone not to have the risk for breast cancer associated with synthetic progestins.
4) Estriol acts differently in the body from estradiol, estrone, and equine hormones. Thus estriol “would be expected to carry less risk for breast cancer,” stated the paper.
5) Progestins from pharmaceutical hormones come with “a variety of negative cardiovascular effects, which may be avoided with progesterone.”
Dr. Holtorf’s paper concluded that bioidentical hormones are linked with reduced risks of breast cancer and heart disease, “and are more efficacious than their synthetic and animal-derived counterparts.”
The Cleveland Clinic paper also claims that bioidentical hormones are synthetic.
“Bioidentical hormones are synthesized by chemically extracting diosgenin from plants such as yams and soy. Diosgenin is chemically modified to yield the precursor progesterone, which is then used to synthesize bioidentical estrogens and androgens,” the paper states.
While different compounders use different practices – some more natural than others – there is also a debate here on the definition of “natural.”
The paper explains the source of synthetic pharmaceutical hormones: “Nonbioidentical estrogen products include conjugated equine estrogens (CEE), which is extracted from the urine of pregnant mares. The two predominant estrogens found in CEE are equilin sulfate (native to horses) and estrone sulfate.”
Many women object to being given hormones that have been extracted from horses. Some feel this is a form of animal cruelty. Others simply do not want to have hormones produced by a horse circulating within their body.
The paper goes on to categorize some of the other synthetic ingredients in pharmaceutical hormones:
“Other nonbioidentical products include ethinyl estradiol, which is used in most combined oral contraceptives. It is formed after a minor chemical modification of estradiol that makes it one of the most potent estrogens. The ethinyl group at carbon 17 of ring D of the steroid nucleus greatly slows the hepatic and enzymatic degradation of the molecule and, thereby, makes oral ethinyl estradiol 15 to 20 times more active than oral estradiol. Mestranol is an inactive prodrug that is converted in the body to ethinyl estradiol.”
Bioidentical hormones are prepared for individual patients by compounding pharmacists, who design a particular formula for a patient based upon the physician’s testing of the patient. Bioidentical hormone therapy typically follows a saliva test given by a physician, whereupon the physician will write a script for a compounded formula. The compounding pharmacy will combine multiple hormone sources, including dehydroepiandrosterone, pregnenolone, testosterone, progesterone, estrone, estradiol, and estriol, depending upon the patient’s test results.
Could it be that women are opposed to putting all these chemicals into the body?
Because the human body converts the raw materials consumed from plant sources to make its hormones—such as diosgenin, bioidentical hormones are considered natural because they move closer to duplicating the process that occurs naturally within the body.
While the debate rages on, both sides admit that further research is needed to establish absolute information. For now, it is absolutely known, according to the Women’s Health Initiative and other studies, that pharmaceutical hormone therapy comes with the following risk factors:
The Cleveland Clinic’s Dr. Thacker disclosed, “that she has taught and spoken for Bayer and Novogyne Pharmaceuticals, makers of menopausal hormone therapies.”
Pattimakiel L, Thacker HL. Bioidentical hormone therapy: clarifying the misconceptions. Cleve Clin J Med. 2011 Dec;78(12):829-36.
Ruiz AD, Daniels KR, Barner JC, Carson JJ, Frei CR. Effectiveness of compounded bioidentical hormone replacement therapy: an observational cohort study. BMC Womens Health. 2011 Jun 8;11:27.
Holtorf K. The bioidentical hormone debate: are bioidentical hormones (estradiol, estriol, and progesterone) safer or more efficacious than commonly used synthetic versions in hormone replacement therapy? Postgrad Med. 2009 Jan;121(1):73-85.