Safety
Bioidentical hormones are expected to carry the same risks and benefits as their non-bioidentical counterparts, but there have been no studies that directly compare compounded bioidentical hormones with their non-bioidentical counterparts. Hormones—as used in CHRT—have been studied for years and their risk, benefit, and effectiveness profiles are known and demonstrated through considerable research.
In 2002, the Women's Health Initiative study (WHI), which was designed to demonstrate additional benefits for conventional hormone therapy (study participants were given Prempro or a placebo), was terminated prematurely after preliminary data indicated small increases in the risks of breast cancer, heart attack and stroke in older women using Prempro. The early termination of the WHI study (which used conjugated equine estrogens) and the subsequent publicity about these previously unappreciated risks led to a decline in prescriptions for CHRT. The results of the WHI were used by BHRT prescribers to promote bioidentical hormones as safer than the FDA-regulated preparations despite a lack of evidence; according to the FDA, the results found by the study apply to all estrogens. BHRT has since been strongly promoted as a natural alternative with fewer risks than CHRT, though there is no evidence to support this claim. BHRT practitioners recommend compounded products due to their claim that they more closely mimic the composition and ratio of circulating hormones in a woman's body than do commercially manufactured products.
The Endocrine Society issued a position statement that bioidentical hormones carry essentially the same risks and benefits as non-bioidentical molecules. In February 2009 the American Congress of Obstetricians and Gynecologists re-iterated its position (of November 2005) that there are no proven benefits in regard to the safety or efficacy of compounded bioidentical hormones, nor are there any benefits in salivary testing of hormone levels or customized dosing of hormones. The Mayo Clinic states that there is no evidence that pharmacy-compounded BHRT is safer or more effective than conventional hormone replacement, and that some bioidentical hormones are already available in certain FDA-approved products. The American Cancer Society also stated that "natural" and "bioidentical" hormones present the same risks as synthetic hormone replacement therapy such as heart disease, blood clots, strokes and an increased risk of breast cancer with long-term use.
The U.S. Food and Drug Administration has warned several pharmacies about making unsubstantiated claims about the safety and effectiveness of compounded hormone products. The North American Menopause Society has stated that compounded bioidentical hormones have not been approved by the FDA; there is no guarantee of purity, potency, efficacy or safety, and they may contain unknown contaminants. The Australian Menopause Society has similarly stated that there is no evidence that bioidentical hormones administered using lozenges are any safer than their approved counterparts. The International Menopause Society has stated "There are no medical or scientific reasons to recommend unregistered 'bioidentical hormones'. The measurement of hormone levels in the saliva is not clinically useful. These ‘customized’ hormonal preparations have not been tested in studies and their purity and risks are unknown."
In November 2006, the American Medical Association adopted a policy requesting that the FDA better monitor and regulate bioidentical hormones, releasing an editorial stating that compounded bioidentical molecules were expected to have the same risks as conventional hormones until proven otherwise.
Erika Schwartz, author of The Hormone Solution (Warner 2002), and bioidentical advocate Kent Holtorf published peer-reviewed papers stating that there is evidence to support a superior safety profile for bioidentical hormones when compared with non-bioidentical hormones, as well as improved relief of postmenopausal symptoms and better bone density and serum lipoprotein levels. Deborah Moskowitz, a Doctor of Naturopathic Medicine who works for a manufacturer of a bioidentical product, also published an article stating that bioidentical hormones are superior to non-bioidentical hormones in safety and effectiveness though this review was criticized for " to demonstrate that BHRT has a good safety profile, but the data presented only serve to demonstrate similar risks to conventional HRT."
The alternative medicine watchdog site Quackwatch recommends against the use of bioidentical hormones due to lack of quality control over compounding, posing the same risks as conventional hormones, the use of unnecessary saliva testing, and for including the non-FDA-approved hormone estriol. Stephen Barrett, the site's owner, concludes his review with the statement "The bottom line for consumers is very simple: Steer clear of anyone who prescribes "bioidentical" hormones or recommends saliva testing as the basis for evaluating hormone status."
Read more about this topic: Bioidentical Hormone Replacement Therapy
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