Bioidentical Hormones...the Studies that Back Up Efficacy and Safety

by Suzanne Somers 1/4/2011 9:39:00 AM

Americans are becoming more and more aware that there is a new approach to aging.  We now have tools and knowledge available teaching us new ways to begin the reversal process. 

As I've written about in  many of my books disease prevention and successful aging begins and ends with bioidentical hormone replacement. The effects of real hormone replacement are so remarkable and life altering (for the better), that it threatens big business.  As a result the opposition continues to discredit the theory of restoration to optimal health through hormone replacement. Big business realizes that if we all get to feel this good on real hormone replacement then we won't need many (or any) of their drugs.  But as information infiltrates (hopefully in part due to my books) millions of people are now choosing restoration and in doing so realize that we can not only turn back the clock but in  many cases eliminate degenerative disease risk---and with it the subsequent need for hospitalization, toxic drugs, and nursing home confinement.

I am constantly attacked for offering information on this 'other way' to age, through hormone replacement, avoiding pharmaceuticals unless absolutely necessary, and eating good, real, nutritious food.  It makes one wonder what I am espousing that bothers everyone so much.  They say there are no studies for the facts presented in my books. So to quiet all those in big business who would like to discredit and dismiss the information and education I have so meticulously researched  and rather than provide legitimacy to any particular group whose interest is ensuring that Americans predictably succumb to horrific age-related pathologies, I have chosen to take the high road and publish a meticulous rebuttal. The data was compiled by scientific experts who disagree with the absurd notion that aging humans should stand by and do nothing to reduce their risk of degenerative disease. What follows is my rebuttal to the inaccurate and misleading claims that have been made against the natural approaches I advocate to maintain optimal health.

My position: I have long stated that bioidentical female hormone replacement offers significant safety and efficacy advantages over conventional hormone replacement therapy.

What my critics say:  There are no published studies in peer-reviewed journals showing that bioidentical hormones are safer than other menopause treatments.

My rebuttal to the critics: I have always said that based on the peer-reviewed data, that non-bioidentical progestin increases cancer risk, while bioidentical progesterone does not. A review of the peer-reviewed literature supports this position.

In fact, at least thirteen studies document that non-bioidentical progestin significantly increases estrogen-stimulated breast cell replication and growth.{References: Climacteric. 2002 Sep;5(3):229-35.; J Steroid Biochem Mol Biol. 2005 Jul;96(2):95-108.; Breast Cancer Res Treat. 2001 Aug;68(3):187-98.; J Clin Endocrinol Metab. 1999 Dec;84(12):4559-65.; Cancer Res. 1992 Dec 1;52(23):6539-46.; Mol Cell Endocrinol. 1994 Jun;102(1-2):45-52.; Cancer Res. 1990 Dec 15;50(24):7858-62.; Biochem Biophys Res Commun. 1987 Jun 15;145(2):706-11.; Br J Cancer. 1993 May;67(5):945-52.; Breast Cancer Res Treat. 2007 Jan;101(2):125-34.; Breast Cancer Res Treat. 1998 Apr;48(3):221-9.; Am J Obstet Gynecol. 1996 Jan;174(1 Pt 1):93-100.; Cancer Lett. 1986 Feb;30(2):213-8.}

In stark contrast, at least seven studies have shown that bioidentical progesterone does not induce estrogen-stimulated breast cell proliferation. {References: Fertil Steril. 1995 Apr;63(4):785-91.; Fertil Steril. 1998 May;69(5):963-9.; Climacteric. 2003 Sep;6(3):221-7.; Jpn J Cancer Res. 1985 Aug;76(8):699-704.; J Gynecol Obstet Biol Reprod (Paris). 1990;19(3):269-74.; J Steroid Biochem Mol Biol. 2000 Jun;73(3-4):171-81.; Breast Cancer Res Treat. 1986;8(3):179-88.}

Numerous studies have demonstrated an increased risk of breast cancer with the use of non-bioidentical progestins. {References: 25. Int J Cancer. 2005;114:448-54.; JAMA. 2003 Jun 25;289(24):3243-53.; Cancer Causes Control. 2002 Nov;13(9):847-54.; Br J Cancer. 2005 Jun 6;92(11):2049-58.; Br J Cancer. 2005 Apr 11;92(7):1293-7.; Cancer Epidemiol Biomarkers Prev. 2002 Jul;11(7):593-600.; Int J Cancer. 2004 May 1;109(5):721-7.; Maturitas. 2004 Sep 24;49(1):44-50.; Int J Cancer. 1999 May 5;81(3):339-44.; JAMA. 2000 Aug 9;284(6):691-4.; J Natl Cancer Inst. 2000 Feb 16;92(4):328-32.; Am J Obstet Gynecol. 2004 Apr;190(4):1141-67.;  Obstet.Gynecol. 2002 Dec;100(6):1148-58.; JAMA. 2003 Jun 25;289(24):3254-63.}

However, the use of bioidentical progesterone has not been associated with an increased risk of breast cancer. Quite the contrary, research has revealed that bioidentical progesterone decreases the risk of breast cancer.

For example, in a study published in the journal Breast Cancer Research and Treatment, 80,000 postmenopausal women using various forms of HRT were followed for more than 8 years. Women who used estrogen in combination with non-bioidentical progestins had a 69% increased risk of breast cancer, compared to women who had never used HRT. However, for women who used bioidentical progesterone in combination with estrogen, the increased risk of breast cancer was eliminated with a significant reduction in breast cancer risk compared with non-bioidentical progestin use. {Reference: Breast Cancer Res Treat. 2008 Jan;107(1):103-11.}

In another investigation, researchers found a 40% increased risk of breast cancer for women who used estrogen with non-bioidentical progestin. Interestingly, in women who used estrogen combined with bioidentical progesterone, there was a promising trend toward a reduced risk of breast cancer, compared to women who had never used HRT.{Reference: Int J Cancer. 2005;114:448-54.} In essence, bioidentical progesterone appeared to protect women against the development of breast cancer. These findings confirm work done six years earlier that found a trend toward a reduced risk of breast cancer in 1,150 women using bioidentical progesterone, compared to non-users of progesterone. {Reference: Cancer Detect Prev. 1999;23(4):290-6.}

My position:  Estriol is an essential natural estrogen missing from FDA-approved estrogen drugs. It is available as a topical cream from compounding pharmacies that will usually start a woman off with a compound cream containing 80% estriol and 20% estradiol. There is evidence showing estriol may help protect against breast cancer and provide other benefits.

What my critics say:  Estriol tablets (not cream) when given orally to 24 women with breast cancer showed tumor growth in six women and two developed endometrial hyperplasia--a precancerous condition of the uterus.

My rebuttal to the critics:  It is an unfair and inaccurate inference to suggest that I advocate the use of oral estriol tablets. I advocate the use of transdermal applications, not oral hormone tablets, which are metabolized differently in the body. Giving oral estriol tablets to women with existing breast cancer is different than healthy women taking it. Yet after my encounter with breast cancer, I choose to take an estriol-based cream, natural progesterone and numerous other natural therapies to boost my immune system to reduce the odds of my cancer returning.  Endometrial hyperplasia will develop in some women who are given an estrogen compound without natural progesterone. This is common medical knowledge, yet my critics attack the inappropriate delivery of estriol (in the form of tablets and not cream) given without natural progesterone in a high risk group to claim that estriol is harmful. This is like comparing apples to oranges, but my critics use it to discredit the proper use of bioidentical hormones nonetheless.

A 2004 study was published in the International Journal of Cancer reported on the use of hormone replacement therapy (HRT) and breast cancer incidence in 31,451 postmenopausal women. The analysis of the data determined that women who used estriol did not have an increased risk of breast cancer, compared to women who never used HRT.{Reference: Int J Cancer. 2004 Oct 20;112(1):130-4.}

Additional evidence of estriol's safety was provided by a study that compared use of HRT in 3,345 women over age 50 with breast cancer to 3,454 women without breast cancer. Those women who used non-bioidentical estrogen (like Premarin(r)) had a risk of breast cancer that was double that of women who never used HRT. However, women who used low-dose oral or topical estriol did not have an increased risk of breast cancer, compared to women who never used HRT. {Reference: Int J Cancer. 1999 May 5;81(3):339-44.}

The increased risk of uterine cancer in users of non-bioidentical estrogen is well-established in the scientific literature.{Reference: Engl J Med. 1975 Dec 4;293(23):1167-70.; Am J Obstet Gynecol. 1977 Mar 15;127(6):572-80.; Am J Epidemiol. 2009 Jul 1;170(1):12-23.}

In contrast, the use of topical lower-potency estriol is not associated with an increased risk of uterine cancer.{Reference: Lancet. 1999 May 29;353(9167):1824-8.} A review of 12 studies determined that the use of intravaginal estriol did not result in endometrial proliferation (abnormal overgrowth of the cells lining the uterus with the potential to become cancerous). {Reference: Fertil Steril. 2003 Jan;79(1):221-2.}

Although several studies suggest that the oral route of administration of estriol (in tablet form) appears relatively safe over the short term (e.g., less than five years), topical application is preferred for long-term use. For example, one study found an increased risk of endometrial atypical hyperplasia and endometrial cancer with oral use of estriol, but not with topically applied estriol over a five-year period. Compared with individuals who did not take estriol, those who took oral estriol for at least five years had a significantly greater risk of uterine cancer, and women using topical estriol for at least five years did not have any increased risk. {Reference: Lancet. 1999 May 29;353(9167):1824-8.}

As I mentioned earlier, women taking any kind of estrogen should balance it with the appropriate dose of natural progesterone (and definitely NOT synthetic progestins that have been shown to increase breast cancer risk).

I do not advocate the use of oral hormone formulations as critics sometime erroneously claim. I suggest the use of transdermal applications because of the safety benefits associated with topical (through the skin delivery) rather than oral hormone tablets.

My position:  I strongly advocate for bioidentical hormone restoration therapy in the context of healthy lifestyle choices to include beneficial nutrients found in cruciferous vegetables shown in peer-reviewed, published studies to support healthy estrogen metabolism and high doses of supplemental vitamin D.

What my critics say:  There still is not solid proof that bioidentical hormones won't cause some of the problems associated with FDA-approved unnatural-to-the-body estrogens and progestins.

My rebuttal to the critics: Estrogen is not one compound. It comprises different forms that metabolize in the body to ones that can either promote cancer or protect against it. Compounds found in cruciferous vegetables (such as cauliflower, broccoli, cabbage and Brussels sprouts) help neutralize an estrogen metabolite called 16 alpha-hydroxyestrone that promotes hormone-dependent tissue growth.

For example, major reductions in cancer risk and specific protective mechanisms against hormone-responsive cancers like breast cancer are observed with cruciferous vegetables {References: J Nutr. 2004 May;134(5):1134-8.; Nutr Cancer. 2002;42(1):1-9.; Cancer Res. 1999 Aug 15;59(16):3991-7.; Cancer Epidemiol Biomarkers Prev. 2000 May;9(5):477-85.; Mutat Res. 2007 May;635(2-3):90-104.; Cancer Res. 2005 Sep 15;65(18):8548-57.; Cancer Epidemiol Biomarkers Prev. 2000 Aug;9(8):773-9.; J Natl Cancer Inst. 1997 May 21;89(10):718-23.; J Cell Biochem.Suppl. 1997;28-29:111-6.}

Studies have also found a strong correlation between blood levels of vitamin D and the risk of breast cancer. A case-control study comparing 1,394 postmenopausal breast cancer patients with 1,365 controls showed that low blood levels of vitamin D were significantly related to breast cancer risk. In fact, women with the highest levels of vitamin D had a nearly 70% reduction in their risk of breast cancer, compared to women with the lowest vitamin D levels. {Reference: Carcinogenesis. 2008 Jan;29(1):93-9.}

Similar research examining the relationship between blood levels of vitamin D and breast cancer risk revealed that women with blood vitamin D levels of approximately 52 ng/mL had a 50% lower risk of breast cancer compared with women who had vitamin D levels below 13 ng/mL.{Reference: J Steroid Biochem Mol Biol. 2007 Mar;103(3-5):708-11.}

In another study, the effects of administering 1,100 IU a day of vitamin D were evaluated in 1,180 postmenopausal women. After only four years, the risk of developing any cancer was 60% lower in the vitamin D group, compared with those in the control group. {Reference Am J Clin Nutr. 2007 Jun;85(6):1586-91.}

We know that cancer results from the accumulation of mutations in genes that regulate cellular proliferation. As we age, we develop more of these mutations, thus placing us at far greater cancer risk. Vitamin D favorable effects hundreds of cell proliferation regulating genes and by this mechanism, confers substantial protection against breast and other cancers.

So in summary:

Given the above evidence, aging women should feel confident that bioidentical hormone replacement, when appropriately prescribed, offers a safer and potentially more effective alternative to conventional hormone replacement than with non-bioidentical hormone drugs to help relieve menopausal symptoms and optimize long-term health. The addition of several proven nutrients (such as vitamin D) to a bioidentical hormone regimen can help optimize estrogen metabolism and reduce cancer risk further offering a balanced approach to health maintenance.

Those critics who advocate that aging women can do nothing to forestall normal aging processes are condemning their followers to becoming statistics in mainstream medicine's anticipatory revenue assembly line. Drugs for symptoms. Continued aging requires more drugs. More revenue. Instead, I personally prefer to take affirmative steps to guard my health rather than do nothing but wait for premature disease and aging to strike.

I live by the rule of example...if others want what I have relative to health and vitality, then they can feel safe in doing what I do. Because as you can see from the research above, I do my homework.

   

Sincerely,

 

 
Suzanne Somers

 

For more information, please visit www.SuzanneSomers.com.

 


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About Suzanne

Suzanne Somers is one of America’s most popular and beloved personalities. In a multifaceted career, she has achieved extraordinary success as an actress, New York Times bestselling author, entrepreneur, singer, comedienne, and lecturer. Suzanne has authored 20 books, including eleven New York Times bestsellers, as well as five of which were #1 New York Times bestsellers. There are currently more than 10 million copies of her books in print. As one of America’s most informed and dedicated health care advocates, Suzanne has been acknowledged for her leading role in bringing information on today’s groundbreaking anti-aging medical protocols, preventive care, long-term health, and hormone replacement therapies to women and men across the country.

Click here for Suzanne's full biography.