Bio-Identical Hormones, Oprah and Some Important Facts
Posted Feb 10 2009 10:07am
(We recently asked Sangeeta Pati, FACOG to reflect on the impact of Oprah's recent shows on HRT and give us her thoughts on bio-identical hormones. Dr. Patti will be presenting an important workshop addressing hormone therapy at the upcoming 17th World Congress on Anti-Aging Medicine in Orlando this spring. At the conference doctors can also commence their Anti-Aging Board Certification training.)
Logic dictates that human identical, bio-identical products are the only acceptable products when we are restoring hormones or nutrients. Why use a product that acts like the real thing when you can get the real thing? Oprah's show brings to the forefront of discussion the real need to help women (and I should add men) who suffer from symptoms and the real need for people to continue their quest for better health and options.
I would like to comment on three issues that came up during Oprah's recent show on hormone replacement therapy:
1. Risk in women? When women consider hormone replacement, the looming question is about the risks, especially of breast cancer, strokes and heart attacks. On review, women are the most protected during their 30's when they have the highest (balanced) hormone levels. It is only after menopause that women have increased risk of stroke, heart attack and breast cancer. Data suggests that it is hormone imbalances that contribute to breast cancer. We know that, most breast cancers occur after menopause; precisely at the time when the ovaries stop producing the normal balance of hormones.
Why? First, progesterone, which prevents breast cell division, declines beginning in one's late 30's. Second, approximately 10 years later comes an imbalance of the estrogens. Estriol (E3) , which is breast and clot protective, decreases from 80% to 10%. Estrone (E1), which is breast and clot stimulating, goes up from 10% to 80%. The increased E1 is undesirable as E1 is converted to forms of estrogen (i.e. 16-OH E1) which are carcinogenic to the breast. So, restoration of protective hormone levels needs to be considered a possible preventative step against breast cancer.
Large studies so far have used, synthetic, hormones (not identical to human hormones) with a ratio of estrogen weighted towards E1 like the large Women's Health Initiative (WHI) study published in 2002, which was followed by much confusion. Reanalysis of this study and many others has eventually led to the following three solid conclusions on hormone restoration in women.
When started within 10 years of menopause, hormones are protective to the heart and brain. "Progestins" (not identical to bio-identical progesterone) have been shown to increase clots and breast cancer in 5 trials compared with natural "progesterone" which is associated with protection. Bio-identical Estradiol (E2) delivered through the skin has been shown to decrease clots and risk of stroke and heart attacks, as opposed to E1, delivered through the mouth (i.e. Oral PremarinTM used in WHI) which increases clot heart attack and stroke risk because of the first pass through the liver which makes clotting factors.
So, when restoring hormones, we aim to use protective forms (E2, E3) and protective delivery routes (transdermal). We aim for protective levels for the heart, brain, bone, skin and organs by measuring levels.
2. Not enough long term studies on bio-identical hormones? This was stated a few times during Oprah's show. First, nature gave us these hormones and when they are balanced in our 20's and 30's we are most protected. Second, the FDA has over 20 bio-identical hormone products approved and on the market such as Climara® patch, Vivelle® dot, Evamist® spray, and Prometrium® capsules (progesterone). Each one of these products has been studied extensively, enough to get FDA approval. There is a very good reason why pharmaceutical companies are currently busy developing new "bio-identical" hormone products at an increasing pace. They can not patent the hormone, since it is a natural product, however they patent the delivery systems ( i.e patch, dot, spray, gel). We should ask ourselves why they are not patenting the "other" hormone products.
3. The compounding pharmacy. There is no need to be on one extreme end with the position that there is no role for compounding or on the other extreme end where there is no role for the pharmaceutical. At times one needs a 25 mg dose of progesterone, which is only available at the compounding pharmacy. At times one needs 100 mg of progesterone, which is available at CVS® and Walgreens®. At times one needs Estradiol at .05 mcg available as Climara patch at CVS and Walgreens. At times one needs a lower dose available compounded. I use both, depending on what suits the patient best.
When choosing a compounding pharmacy check credentials, certifications, quality checks, sterility processes and membership in PCCA and other national organizations that assess their quality standards and adherence to the principles of compounding medicine. reported by http://www.worldhealthnet.com/