Compounded Bioidentical Hormones have received a great deal of coverage in news, on talk shows, and in magazines over the past several years. Claims of weight loss, increasing energy, improve mood, are safer, and many others have been made. Hopefully this article can help you answer questions and dismiss many of the myths surrounding this highly published, highly marketed topic.
The term Bioidentical Hormones is not a medical term, it is a marketing term used to imply an exact copy of the hormones produced in the body. Providers of these compounds often claim they are “A natural, safer alternative to prescription drugs, Can help with weight loss, Prevent Alzheimer’s” and many others unfounded benefits. In addition, these providers often suggest that Bioidentical Hormones can only be obtained from a compounding pharmacy.
The fact is that there are many FDA-approved bioidentical hormone products available in the U.S. today. In fact, they have been available in the U.S. since 1975! Most all FDA-approved bioidentical hormones have been available in the U.S. for a long time and have extensive studies to support their safety and effectiveness. As an example, EstroGel was one of the first bioidenticals in the world with use in France since 1974, FDA-approval in the U.S. in 2004, and now used in more than 70 countries.
To better understand what is meant by Bioidentical Hormones, specifically estrogens and progestone, the following may be helpful. The 3 primary human estrogens are: E1, Estrone; Serves as the primary ‘”reservoir” of estrogen, and dominant estrogen remaining AFTER menopause. It is produced primarily in the ovaries, body fat, and breast. E2, Estradiol; Serves as the primarily active estrogen BEFORE menopause and is LOST at menopause when follicles are gone. It is produced primarily in the ovaries with some made from testosterone in the brain, breast, and muscle. E3, Estriol; A weak estrogen made by the placenta during pregnancy. There is only one progestin, Progesterone, which is converted to other progestins.
The only FDA-approved estrogen bioidentical hormone is estradiol. Perimenopausal and postmenopausal women do not need the hormones estrone and estriol. However, compounding pharmacies often use Estriol or E3, which is not FDA-approved. Furthermore, pharmacies and doctors may not (or should not by law) use Estriol unless they have an investigational new drug (IND) application with the FDA. Obviously many doctors and pharmacies violate this FDA regulation but are not sanctioned because the FDA does not regulate compound pharmacies, the state does.
These compounding pharmacies obtain the bioidentical or natural hormones, Estradiol, Progesterone, and Testosterone in USP raw powder from for the SAME suppliers the drug companies do. They use different amounts of each but the hormones are the same. Many formulations are based on Saliva testing to “individualize” hormone therapy. It is well documented that hormone levels in saliva vary widely and do not correlate well with blood levels. In addition, it is also known that the plastic tubes used to collect saliva alter hormone levels. Saliva testing is not reliable, period. If your compounder suggest the saliva test, be wary.
Providers and compounding pharmacies often include Progesterone claiming additional health benefits. The fact is progesterone does not add additional benefit and should only be included when a woman has not had a hysterectomy. Progesterones should not be prescribed in women whom have had a hysterectomy. Progesterones may increase breast cancer risk, promote weight gain, cause depression, increase cholesterol, and do not prevent bone loss.
The use of testosterone in menopausal women has been studied and shows some benefit at low doses to treat vasomotor symptoms and decreased libido. Higher dosages have been associated with elevated cholesterol, triglycerides, male pattern hair growth, and acne.
So what are the FDA-approved Bioidentical Hormones?
EstroGel, gel, 2004
Estace cream, 1984
Estrasorb, lotion 2006
Estring, ring 1996
Divigel, gel 2007
Prochieve 4% gel 1997
Elestrin gel, 2008
Vivelle Dot, 98
Vagifem Tabs, 98
Evamist spray, 2008
The true indications for hormone therapy are obvious, vasomotor symptoms, vaginal dryness, preventing bone loss, and it is best to start them as close to menopause as possible. Recent data has suggested advantages of transdermal (patch) administration over oral administration but further studies are needed.
The North American Menopause Society and others have revised their position statements on hormone therapy as of 2010 stating the use of hormone therapy around the time of menopause has a favorable benefit-risk ratio. The go on to state that hormonal therapy may decrease total mortality when started soon after menopause but does not appear to reduce mortality when started after age 60.
An FDA survey on quality control of compounded drugs analyzed 29 compounded products from 12 compounders for sterility, potency, and uniformity. The found 10 of the 29 products (34%) of compounded drugs failed at least one quality test. They also reported the products contained less of the active drug than stated on the label in 25% of the products.
So, if you want Bioidentical Hormones, consider FDA approved drugs. Less than 2% failed testing and most of them are covered by your insurance.
For further information, please see www.thebuzonbios.com
This site contains the best video presentation on Bioidentical Hormones I have found to date. Be sure and watch the 2009 video first, then the 2010 video. It really is a great resource. Tell a friend.
J. Kyle Mathews, MD
Plano OB Gyn Associates
Plano Urogynecology Associates.