This article is more than 5 years old. Information may no longer be current.
Bioidentical … to what?
All hormones should meet recognized standards of safety, efficacy, purity, and consistency of dose.
Click Here to Manage Email Alerts
The name is appealing.
Bioidentical suggests that the hormones bearing this description will be identical to those hormones previously made by the individual and will restore the patient to that sense of well being the patient previously had. Search the Internet and you will find testimonials to the feeling of “wellness” that these hormones seem to provide. There are also complaints about organizations that criticize the use of these products and expressions of concern about government agencies that might deny individuals access to these preparations.
What are the problems, then, with preparations that promise that they are identical to nature’s own hormones and which seem to make some people feel better?
|
|
There is no evidence that bioidentical hormones are safe or effective. There are no long-term randomized control trials available in which the hormones called “bioidentical” have been the object of the study. The FDA has warned pharmacies that sell these products that their claims regarding safety and efficacy are false and misleading and are not supported by medical evidence. (A consumer oriented statement by the FDA can be found at http://www.fda.gov/consumer/updates/bioidenticals010908.htm).
The compounding pharmacies that make these drugs, unlike the drug companies, are not required to report adverse events associated with the use of these substances and they do not do any long-term tracking of adverse events. Long-term tracking is important since adverse events with these hormones may take years to uncover.
The American Association of Clinical Endocrinologists has issued a statement, which is available on its website. AACE shares the FDA’s concern about undocumented statements regarding the use of these substances to prevent Alzheimer’s disease and prevent cardiovascular events and cancer. The president of AACE, Richard Hellman, MD, stated on the AACE website that “unfounded claims may mislead consumers and health care professionals.” Hellman supports freedom of individuals to make informed personal choices, but he emphasizes that such informed decisions should be based upon “objective evidence from peer reviewed and published scientific studies.”
The Endocrine Society has also commented. Its position paper emphasizes that the Women’s Health Initiative, which studied “traditional hormone therapy” (a preparation containing conjugated estrogen) and reported adverse outcomes (increased risk of CVD and breast cancer) did not demonstrate that it was the structure of the hormones that caused the adverse outcomes (the study did not compare different preparations). Therefore, it is not possible to say that any other estrogen containing preparation (even a bioidentical one) would have resulted in a different outcome. The Endocrine Society position paper points out that there actually are a few FDA approved bioidentical hormones available (estradiol and progesterone) but even these have not been evaluated in long term studies.
There are some other issues.
Many of these preparations contain estriol, a “weak” estrogen whose safety and efficacy is unknown. The preparations are compounded in a way that is not precisely controlled. An individual may receive a dose that is too high or too low (separate from the issue of whether the hormone itself is safe or effective). The dosing may be adjusted based on salivary levels of hormones, but again there is no evidence that this is the correct way to determine dosing.
The argument that since some patients state that they feel better on these bioidentical hormones, they must be doing something, is not a good way to prescribe therapy. Saturated fats taste good, but hopefully no physician would recommend such a diet. Few individuals would get on an airplane unless that plane meets standards of safety and “efficacy”. These same individuals and their physicians should insist that all hormones should meet recognized standards of safety, efficacy, purity, and consistency of dose.
Endocrine Today ran a cover story about the bioidentical hormone issue. Find it here.
Donald A. Bergman, MD, is a Clinical Professor of Medicine at Mount Sinai School of Medicine, New York, Immediate Past President of the American College of Endocrinology, Past President of the American Association of Clinical Endocrinologists, and a member of the Endocrine Today Editorial Board.