Safety of Bioidentical Hormones
Bioidentical hormones are substances with the exact same molecular structure as what your body would normally produce if it could and they generate the same physiologic responses as your body’s natural hormones. The US Patent Office considers bioidentical hormones natural, regardless of their source and as a result, they cannot be patented.
The most common bioidentical hormones are estrogen and progesterone which are created by compounding pharmacies to relieve the symptoms of menopause and hormonal imbalances. Bioidentical hormones are made from ingredients derived from plants such as yams and soy, and have been available for more than 20 years.
There are those who claim there are many dangers of bioidentical hormones, often making reference to the Women’s Health Initiative (WHI) study from 2002. This study looked only at synthetic or non-bioidentical hormones, which are significantly different from natural bioidentical hormones. For more specific information on this study visit The Bioidentical Hormone Debate.
Unlike non-bioidentical hormones, natural bioidentical hormones fit perfectly into the hormone receptors of your body because they are identical to your natural-made hormones. This perfect fit allows your body to completely utilize the hormone without the side effects that are common with non-bioidentical hormones.
Safety of Bioidentical Hormones and the FDA
Hormonal imbalances contribute to the risk of stroke, heart attack and even breast cancer and when used properly, bioidentical hormone replacement therapy can reduce this risk. Critics argue that the safety of bioidentical hormones should be confirmed by the FDA, and in fact the FDA has approved over 20 natural bioidentical hormone products including estrogen, progesterone and testosterone.
Compounding pharmacies that make bioidentical hormones are regulated by state and local government, not the FDA. However, those recommended by BodyLogicMD are regulated by the Professional Compounding Centers of America (PCCA) and accredited by the Pharmacy Compounding Accreditation Board, for high quality assurance.
New Evidence Supporting the Safety of Bioidentical Hormones
In January, 2009 the Holtorf Medical Group, Inc. of Torrance, CA performed a comprehensive analysis of over 200 physiological and clinical studies (including the WHI study) concerning synthetic and bioidentical hormones.
“Many physicians and so-called experts state that there is no evidence that bioidentical hormones are safer than synthetic HRT,” argues Dr. Kent Holtorf. “A thorough review of the medical literature however, clearly supports the claim that bioidentical hormones have some distinctly different, often opposite, physiological effects to those of their synthetic hormones.” Dr. Holtorf continues to say “the medical literature demonstrates that bioidentical hormone replacement therapy is highly effective and carries a reduced, rather than an increased risk of breast cancer and cardiovascular disease.”
This analysis looked at the many long-term and short-term studies of synthetic hormones and the short-term studies of bioidentical hormones. To date, there have been no long-term studies of bioidentical hormones, but each short-term study shows positive results both in the relief of symptoms of hormonal imbalances like insomnia, cognitive problems, depression, anxiety etc. and in the decreased risk of heart disease and breast cancer. Meanwhile, both long-term and short-term studies show synthetic hormones to be less effective at treating symptoms and to increase the risk of breast cancer and cardiovascular disease.
Bioidentical progesterone and estrogen have repeatedly been shown to reduce and eliminate the breast-cell proliferation rates while synthetic versions of these hormones, especially progestin, have been shown to increase breast cancer risk significantly. In terms of cardiovascular disease, bioidentical progesterone maintains and enhances the heart protective effects of estrogen, decreasing the risk for heart attack and stroke. This occurs in part to the bioidentical progesterone augmenting HDL (the good cholesterol) effects. Synthetic progestin does just the opposite, reducing HDL and working against estrogen, causing increased risk of heart disease.
Estriol, the bioidentical estrogen, was banned in January, 2008 by the FDA which stated that while its effectiveness to treat symptoms was not in question, the safety and effectiveness was unproven. In the 30 years that this estriol has been used, the FDA has not received any report of an adverse event with the use of estriol. The FDA banned estriol for a lack of evidence that it was safer than the synthetic estrogen and because there was no standardized dose. We’ve discussed that one-size-fits-all dosage is not effective and not safe since everyone has different needs. Estriol is completely unique when compared to synthetic estrogen and actually has been associated with a reduction in the risk of breast cancer and heart disease.
In conclusion, this analysis states “With respect to the risk for breast cancer, heart disease, heart attack, and stroke, substantial scientific and medical evidence demonstrates that bioidentical hormones are more effective forms of HRT than the commonly used synthetic versions.”
Upon publication of this new information, many mainstream doctors “are now realizing that societies such as The Endocrine Society, The North American Menopause Society and The American College of Obstetricians and Gynecologists (ACOG) have either failed to adequately review the medical literature on bioidentical hormones or more likely have let their significant relationships with the pharmaceutical companies influence their positions on the issue,” as stated by Dr. Kent Holtorf of the Holtorf Medical Group.
As one gynecologist, Dr. Eldred Taylor stated “As a board certified, OB/GYN trained at Emory University I am embarrassed by what I learned in residency concerning hormone physiology. It is a crime that this information is not taught in residencies. Instead we are bombarded by propaganda and misinformation by the so-called leaders in our field.”
So, are bioidentical hormones safe?
In our opinion, bioidentical hormones are effective when used properly and under the care and medical supervision of an expert physician trained specifically in bioidentical hormone replacement therapy (BHRT). In our physician directory you can find some of the most highly trained physicians in BHRT to ensure that you are in good hands. We also invite you to read what some patients have to say about their success with bioidentical hormones.
For access to medical research studies on the efficacy of bioidentical hormones, click here.