Bioidentical Hormones, Compounding, and Evidence-Based Medicine: What Women's Health Practitioners Need to Know

Hormone therapy and breast cancer: emerging steroid receptor mechanisms

“…There are three main endogenous human estrogens, namely E 2 , estriol (E 3 ) and estrone (E 1 ), the latter being the most abundant circulating estrogen in postmenopausal women (Table 1). However, E 1 is not present in sufficient levels to prevent symptoms of menopause, such as amenorrhea, hot flushes, night sweats, vaginal atrophy and mood fluctuations (Johnson 1998, Greendale et al 1999, Bosarge & Freeman 2009. HT was first administered in the 1930s not only to alleviate these menopausal symptoms (Cuzick 2008), but also to prevent the medical implications of decreased endogenous estrogen levels including osteoporosis, Alzheimer's disease, arthritis, coronary heart disease and cataract formation (Johnson 1998, Greendale et al 1999).…”

“…Unlike FDA-approved HT, which is available in standardized doses, a customized dose of bHT is prescribed based on a saliva test that estimates serum hormone levels (Boothby et al 2004, Santoro et al 2016. However, this method contradicts a global consensus that the lowest possible dose of HT that effectively relieves menopausal symptoms should be prescribed (Bosarge & Freeman 2009, The North American Menopause Society (NAMS) 2012 Hormone Therapy Position Statement Advisory Panel 2012, de Villiers et al 2013). Moreover, numerous studies have shown a poor correlation between hormone levels found in saliva and serum, due to saliva hormone levels fluctuating based on time of day, diet and other variables (Boothby et al 2004, Cirigliano 2007, Fugh-berman & Bythrow 2007, Bosarge & Freeman 2009, Chervenak 2009, Santoro et al 2016.…”

“…However, this method contradicts a global consensus that the lowest possible dose of HT that effectively relieves menopausal symptoms should be prescribed (Bosarge & Freeman 2009, The North American Menopause Society (NAMS) 2012 Hormone Therapy Position Statement Advisory Panel 2012, de Villiers et al 2013). Moreover, numerous studies have shown a poor correlation between hormone levels found in saliva and serum, due to saliva hormone levels fluctuating based on time of day, diet and other variables (Boothby et al 2004, Cirigliano 2007, Fugh-berman & Bythrow 2007, Bosarge & Freeman 2009, Chervenak 2009, Santoro et al 2016. The safety and efficacy of custom-compounded bHT is controversial and proponents of bioidentical hormones claim that these hormones are natural and identical in structure to endogenous human hormones; hence, they are safer than conventional HT products (Chervenak 2009).…”

“…The safety and efficacy of custom-compounded bHT is controversial and proponents of bioidentical hormones claim that these hormones are natural and identical in structure to endogenous human hormones; hence, they are safer than conventional HT products (Chervenak 2009). This is despite the fact that the proposed 'natural' hormones used in custom-compounded bHT are in fact semi-synthetic and synthesized in a similar manner to the bioidentical hormones used in FDA-approved HT (Cirigliano 2007, Fugh-berman & Bythrow 2007, Bosarge & Freeman 2009, Chervenak 2009. However, because of this 'natural' classification, custom-compounding pharmacies may legally dispense products containing bioidentical hormones without obtaining FDA approval for each product (Fugh-berman & Bythrow 2007, Chervenak 2009.…”

“…Uncertainty remains regarding the efficacy and safety of custom-compounded bHT, especially pertaining to these multiple-hormone combination therapies (Pinkerton 2012(Pinkerton , 2014. Although proponents of bHT claim that there is in fact evidence to support the efficacy and safety of custom-compounded bHT in terms of breast cancer risk (Boothby et al 2004, Bosarge & Freeman 2009, these claims are unsubstantiated due to the lack of large-scale, double-blinded clinical trials investigating custom-compounded multiple-hormone bHT regimens at various doses.…”