Chapter 10. The Safety of Bioidentical Hormones

Chapter Ten:

The Safety of Bioidentical Hormones

Bioidentical Hormones are safer and more effective than synthetic hormones. (1-2)

Do You Have Hormone Excess or Hormone Deficiency  ?

A deficiency or an excess of women's bio-identical hormones can produce adverse symptoms.  This is called estrogen deficiency/excess, and progesterone deficiency/excess, and they each have typical signs and symptoms easily recognized.(3)

Above list courtesy of Uzzi Reiss MD from his book, Natural Hormone Balance for Women: Look Younger, Feel Stronger, and Live Life with Exuberance. and also see Dr. Reiss’s book, “The Natural SuperWoman”, by Uzzi Reiss MD and Yfat Reiss Gendell. (4)(42)

No Adverse Events from Bio-Identical Hormones Reported to the FDA: NONE

Over-the-counter pain pills (NSAIDs) such as aspirin, naproxen™ and ibuprofen™ are considered fairly safe.  After all, you don't need a prescription to buy them, yet they cause an estimated 16,500 deaths in the US annually, mostly from gastric bleeding.(5)  Compare this to no reported adverse events from bio-identical hormones in 2008, according to an FDA press conference January 2008.(6)  Bioidentical hormones must be considered safer when compared to commonly available over the counter pain remedies.  However, one must remember that hormonal excess or deficiency is associated with the adverse events and the symptoms listed above.

  Do Hormones Cause Breast Cancer? (7)

The 2002 WHI (Women’s Health Initiative) study revealed that synthetic hormones increase the risk of breast cancer.  However, Bioidentical Hormones do not.  How do we know this?  The French Cohort Study showed there was no increased risk of breast cancer in women using bio-identical hormones.(8)(43)  Rather, the 2008 French Cohort Study by Fournier showed that in women using hormone replacement combination drugs, increased breast cancer was associated with synthetic progestin use, while women using bioidentical progesterone had no increased breast cancer (compared to non-hormone users).(43)  Remember, in addition to avoiding synthetic hormones, the addition of Iodine supplementation is our most useful tool for prevention of breast cancer. See the chapter on breast cancer prevention with iodine supplementation for more on this.(10)

Do Bio-Identical Hormones Cause Heart Disease ? 

Again, we know from the 2002 WHI study that synthetic hormones cause heart disease, and bioidentical hormones do not.   Calcium score is an accepted measure of heart disease risk.  A study of CAT calcium scores by JoAnn E. Manson in the June 2007 JAMA actually lower scores, and less heart disease in the women taking estrogen (they had hysterectomies and were not given the synthetic progestins).(11)  These same results had already been published 2 years previously in a calcium score study by Budoff in J Women’s Health 2005. (12)  Clearly the data shows that bioidentical hormones are protective and prevent heart disease, while synthetic hormones increase heart disease risk.
 
What Was the Women's Health Initiative - WHI Study

The WHI study was the large NIH sponsored medical study in which synthetic hormones were given to women.  The WHI study consisted of two arms.  The first arm used the combined synthetic hormones Premarin™ and Provera™,  and the second arm used Premarin™ alone.  The WHI results were published in JAMA in 2002 and 2004.(13-14)

What is Premarin and Provera?

Premarin™ and Provera™ are not bio-identical hormones.  Premarin™ is a hormone obtained from pregnant horses, which contains Equilin, a horse hormone not found in humans.(15)  Provera™ is a synthetic hormone which is not found anywhere in the natural world . (16)   The Premarin™ and Provera combination is called PremPro™, a synthetic hormone pill commonly prescribed by mainstream medicine.  Prempro™ was the hormone preparation used in the first arm of the WHI study.(13)  Prempro™ is currently in litigation in drug court.  Women are seeking damages from the PremPro™ manufacturer claiming Prempro™ caused their breast cancer.

WHI study First Arm:

The WHI study (first arm published in JAMA 2002) was terminated early because the combination of premarin™ and provera™ (Prempro™) caused increased breast cancer and heart disease.(13)  Immediately after this WHI  study was published in JAMA in 2002, there was a massive switch by women to bio-identical hormones which resulted in a 4 billion dollar loss for Wyeth, the maker of Prempro™.

WHI Study (Second Arm):

All the women in the second arm of the WHI study had prior hysterectomies (uterus absent), so they did not need the synthetic progestin, called Provera, which is required to prevent the endometrial cancer caused by Premarin alone.   Rather, this post-hysterectomy group was given  Premarin  alone (the horse hormone, also called CEE, for Conjugated Equine Estrogen).  Unlike the first arm of the study, these women had no increased risk of breast cancer. (18)   Premarin causes endometrial cancer, so the mainstream medical system always gives Provera (progestins) to prevent endometrial cancer, unless of course, the uterus is absent from prior hysterectomy.(20)(56)(57)

The WHI Culprit was the Synthetic Progestin (an altered form of Progesterone)

Back to the first arm of the WHI which used Prempro, it is clear from the data that the  culprit which caused breast cancer and heart disease was Provera™, a synthetic monster hormone.  This is nothing new.  For years, Provera™  has been known to cause heart disease and breast cancer.(21-22)(39)  Three previous large scale human studies revealed increased breast cancer  with progestin use.  The Breast Cancer Detection Demonstration Project published in JAMA in 2000 showed an eight fold increase in breast cancer for estrogen-progestin users compared to estrogen alone users. (53)  The Swedish Record Review published in 1996 had a four fold increase in breast cancer with progestin use. (54) The Million Woman study published in Lancet in 2003 had a fourfold increase in breast cancer for estrogen-progestin combination users compared to estrogen alone users.(55)  A 2007 animal study with primates treated with either bioidentical progesterone or a progestin (Provera™) showed that the progestin drug (Provera™) worsens breast cancer biomarkers, while the bioidentical progesterone provides a beneficial effect on breast tissue and reduces cancer markers.(22)
 
Monster Hormones are Chemically Altered

Chemically altered hormones were used in the WHI study, and are routinely handed out by the medical system.  These altered hormones are monsters that should never have been approved for marketing to the American people.  They should be banned.  

The Media Says Hormones Cause Cancer and Heart Disease

If bio-identical hormones are so safe, then why do the newspapers say that women's hormones cause breast cancer and heart disease?(23)  The answer is that the media and the medical profession routinely confuse synthetic chemically altered monster hormones with the bio-identical hormones.  The drug companies intentionally create this confusion because they want to hide the fact that synthetic hormones are monsters that should be banned.

Chemically altered hormones were made because of a quirk in our legal system which grants patent protection for chemically altered versions of a natural substance.  The natural hormones were chemically altered so that they could be patented to protect profits from competition.  Naturally occurring bio-identical hormones by law cannot be patented.   Examples of monster synthetic hormones are provera, all progestins, and birth control pills which are never found in nature. These are the monster hormones.

 An Illustration Explaining the Problem of Synthetic Drugs

Supposing a biochemist working for a drug company has an idea to alter the chemical structure of vitamin C so a patent can be obtained.  The biochemist adds a chlorine molecule to the vitamin C carbon ring, and gives is a new name "super-Vitamin C", which is really a chlorinated version of vitamin C.  Next they do a one year medical study with 5,000 people taking the chlorinated vitamin C tablet every day, and another 5000 people taking a placebo.  After the year is up, they count a 0.5 per cent incidence of heart disease events in the Super Vitamin C group and a 1.0 percent in the placebo group.   FDA approval is easily obtained based on reduction in heart disease events by 50 per cent (0.5 per cent is 50% of 1.0 %).  The drug company is at liberty to spend million dollars on television advertising designed to rake in millions more for the new heart prevention miracle drug.  This absurd scenario is now the norm for our medical system.  Why would anyone want to spend money for a monster version of vitamin C when the real thing is available for pennies?  Why use a monster hormone when human hormones  are available?  Compared to their monster counterparts, Bio-Identical Hormones are more effective, have fewer adverse side effects, and are less costly.

High Hormone Levels of Early Pregnancy Confer Protection from Breast Cancer.

During the 16th century in Italy, breast cancer was quite rare.  An Italian doctor, Bernardino Ramazzini, noted in 1713 the relatively high incidence of breast cancer in nuns and wondered whether this was related to celibate lifestyle.(24)  Recent studies confirm that early pregnancy and multiple pregnancies confer protection from breast cancer, while no pregnancies (as in the nuns) leads to increased risk of breast cancer.(25)  This protection is thought to be conferred by high levels of progesterone.  This was confirmed in a 2007 study by Rajkumar showing hormone treatment protected genetically engineered mice from developing breast cancer. (26)

Progesterone, the Great Protector

Progesterone is so safe, it is available over the counter without a prescription.  In addition, a deficiency of progesterone is associated with an increase in breast cancer risk.(27)  Progesterone is known to be protective and prevents breast cancer.(28)

Why Don't Birth Control Pills use Natural Progesterone?

Birth Control Pills, BCP's, are very effective at preventing pregnancy by suppressing ovulation. However, BCP's contain synthetic hormones which have adverse side effects.(29-31)  To avoid these monster hormones,  the IUD (intra-uterine device) is available.  Make sure you ask the doctor for a plain IUD, without the implanted hormones.  In the future, BCP’s will be made from natural progesterone which is available in highly absorbable micronized oral capsules.

Articles with Related interest:

Bioidentical Homrones Prevent Osteoarthritis

Bioidentical Hormones Prevent Heart Disease

The Importance of Bioidentical Hormones

The Importance of the Pelvic Sonogram

The Safety of Bioidentical Hormones

For More Reading, See These Recommended Articles:

1) The_Bioidentical_Hormone_Debate_Ken_Holtorf_MD-3.pdf
161.3 KB

The Bioidentical Hormone Debate: Are Bioidentical Hormones (Estradiol, Estriol, and Progesterone) Safer or More Efficacious than Commonly Used Synthetic Versions in Hormone Replacement Therapy?  Kent Holtorf, MD1 Postgraduate Medicine, Volume 121, Issue 1, January 2009.  (1)

2) Hormones__in_wellness_and_disease_prevention_common_practices_current_state_evidence_Erika_Schwartz_Kent_Holtorf.pdf
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Hormones in Wellness and Disease Prevention: Common Practices, Current State of the Evidence, and Questions for the Future. Erika T. Schwartz, MD, Kent Holtorf, MD Prim Care Clin Office Pract 35 (2008) 669–705 . (2)

3) The Case for Bioidentical Hormones  Steven F Hotze MD. 2008.(33)

4) The Safety of Bioidentical Hormones — the Data vs. the Hype by Jacob Teitelbaum, MD From the Townsend Letter June 2007.(34)

5)  Bioidentical vs. Synthetic HRT, A Review of the Literature  by the Bio-Identical Hormone Initiative, Erika Schwartz MD, David Brownstein MD, Kent Holtorf MD.(40)(41)

Books on Bioidentical Progesterone by John R Lee MD (35)

What Your Doctor May Not Tell You About Menopause: The Breakthrough Book on Natural Progesterone, by John R Lee MD,  (Warner Books, 1996)(35)

What Your Doctor May Not Tell You About Premenopause: Balance Your Hormones and Your Life from Thirty to Fifty, by John R Lee,  (Warner Books, 1999)(35)

References for Chapter 10, The Safety of Bioidentical Hormones

(1) 
The_Bioidentical_Hormone_Debate_Ken_Holtorf_MD-3.pdf 161.3 KB


The Bioidentical Hormone Debate: Are Bioidentical Hormones (Estradiol, Estriol, and Progesterone) Safer or More Efficacious than Commonly Used Synthetic Versions in Hormone Replacement Therapy?  Kent Holtorf, MD1 Postgraduate Medicine, Volume 121, Issue 1, January 2009



(2) Hormones__in_wellness_and_disease_prevention_common_practices_current_state_evidence_Erika_Schwartz_Kent_Holtorf.pdf
454.6 KB

Hormones in Wellness and Disease Prevention: Common Practices, Current State of the Evidence, and Questions for the Future. Erika T. Schwartz, MD, Kent Holtorf, MD Prim Care Clin Office Pract 35 (2008) 669–705 .

(3)  http://www.johnleemd.com/store/premenstrual_syndrome.html
Excerpted From: WHAT YOUR DOCTOR MAY NOT TELL YOU ABOUT BREAST CANCER: Balance Your Hormones and Your Life from Thirty to Fifty. PHYSIOLOGICAL EFFECTS OF ESTROGEN AND PROGESTERONE. How Hormone Balance Can Help Save Your Life. by John R. Lee, M.D., David Zava, Ph.D. and Virginia Hopkins. Warner Books 2002

(4) http://www.uzzireissmd.com/
Natural Hormone Balance for Women: Look Younger, Feel Stronger, and Live Life with Exuberance. by Uzzi Reiss MD

(5) http://www.drtheo.com/news/NSAIDs.pdf
Medical Progress. p 1888. June 17, 1999 The New England Journal of Medicine. Gastrointestinal Toxicity of NonSteroidal  Anti-inflammatory Drugs by  M. Michael Wolfe et al.

(6) http://www.fda.gov/downloads/NewsEvents/Newsroom/MediaTranscripts/ucm122174.pdf Transcript of FDA Press Conference on FDA Actions on Bio-Identical Hormones
FTS HHS FDA Susan Cruzan January 9, 2008

(7) http://www.womentowomen.com/breasthealth/estrogenbreastcancer.aspx
Causes of Breast Cancer- the Estrogen Controversy, Dixie Mills MD

(8) http://www.ncbi.nlm.nih.gov/pubmed/12626212
Climacteric. 2002 Dec;5(4):332-40. Combined hormone replacement therapy and risk of breast cancer in a French cohort study of 3175 women.de Lignières B et al. French Cohort Study.

 (9) http://www.johnleemd.com/store/cancer_progest.html
Breast Cancer Book Intro. WHAT YOUR DOCTOR MAY NOT TELL YOU ABOUT BREAST CANCER. How Hormone Balance Can Help Save Your Life
By John R. Lee, M.D., David Zava Ph.D., and Virginia Hopkins INTRODUCTION
 
(10)  Breast Cancer Prevention and Iodine Supplementation by Jeffrey Dach MD

(11) http://content.nejm.org/cgi/content/short/356/25/2591
Estrogen Therapy and Coronary-Artery Calcification. NEJM Volume 356:2591-2602  June 21, 2007  Number 25. JoAnn E. Manson, M.D., et al.

(12) http://www.ncbi.nlm.nih.gov/pubmed/15989413
J Women’s Health (Larchmt). 2005 Jun;14(5):410-7. Effects of hormone replacement on progression of coronary calcium as measured by electron beam tomography.Budoff MJ, et al.

(13) http://jama.ama-assn.org/cgi/content/abstract/288/3/321
Risks and Benefits of Estrogen Plus Progestin in Healthy Postmenopausal Women
Principal Results From the Women's Health Initiative Randomized Controlled Trial
Writing Group for the Women's Health Initiative Investigators JAMA. 2002;288:321-333. First Arm.

(14) http://jama.ama-assn.org/cgi/content/full/291/14/1701
Effects of Conjugated Equine Estrogen in Postmenopausal Women With Hysterectomy
The Women's Health Initiative Randomized Controlled Trial.  JAMA. 2004;291:1701-1712. Second Arm. This is the Second Arm of the Study. Premarin Only.

(15) http://en.wikipedia.org/wiki/Premarin
Premarin From Wikipedia, the free encyclopedia

(16) http://en.wikipedia.org/wiki/Medroxyprogesterone
Provera, Medroxyprogesterone,

(17) http://homecoalition.org/TakeAction Take Action. Write a letter to your elected officials using our online advocacy tool. Act now to defend your right to bio-identical hormones!

(18) http://jama.ama-assn.org/cgi/content/full/295/14/1647
Effects of Conjugated Equine Estrogens on Breast Cancer and Mammography Screening in Postmenopausal Women With Hysterectomy. Marcia L. Stefanick, PhD et al. for the WHI Investigators. JAMA. 2006;295:1647-1657. Conclusions  Treatment with CEE alone for 7.1 years does not increase breast cancer incidence in postmenopausal women with prior hysterectomy.

(19)  http://courses.washington.edu/bonephys/opestrogen.html#WHI
Osteoporosis and Bone Physiology, Susan Ott, MD, Associate Professor, Department of Medicine, University of Washington.  A Review of the results from the Women's Health Initiative.

(20) http://www.ncbi.nlm.nih.gov/pubmed/3358913
The dose-effect relationship between 'unopposed' oestrogens and endometrial mitotic rate: its central role in explaining and predicting endometrial cancer risk.Key TJ, Pike MC.
Br J Cancer. 1988 Feb;57(2):205-12.

(21) http://atvb.ahajournals.org/cgi/content/full/24/7/1171
Should Progestins Be Blamed for the Failure of Hormone Replacement Therapy to Reduce Cardiovascular Events in Randomized Controlled Trials?  Kwang Kon Koh; Ichiro Sakuma. Arteriosclerosis, Thrombosis, and Vascular Biology. 2004;24:1171.

(22) http://www.ncbi.nlm.nih.gov/pubmed/16841178 Effects of estradiol with micronized progesterone or medroxyprogesterone acetate on risk markers for breast cancer in postmenopausal monkeys.Wood CE et al. Breast Cancer Res Treat. 2007 Jan;101(2):125-34.

(23) http://www.time.com/time/magazine/article/0,9171,1002897,00.html
The Truth About Hormones Monday, Jul. 22, 2002 Time Magazine. By CHRISTINE GORMAN AND ALICE PARK

(24) http://www.ama-assn.org/amednews/2006/04/17/hlsa0417.htm
AMA Medical News. Collecting clues: Cancer registries might have an answer. By Kathleen Phalen Tomaselli, AM News correspondent. April 17, 2006.

(25) http://breast-cancer-research.com/content/7/3/131
The protective role of pregnancy in breast cancer. Jose Russo et al. Breast Cancer Research 2005, 7:131-142doi:10.1186/bcr1029

(26) http://www.pubmedcentral.nih.gov/articlerender.fcgi?tool=pubmed&pubmedid=17257424
Hormone-induced protection of mammary tumorigenesis in genetically engineered mouse models Lakshmanaswamy Rajkumar et al.Breast Cancer Res. 2007; 9(1): R12.

(27) http://aje.oxfordjournals.org/cgi/content/abstract/114/2/209
BREAST CANCER INCIDENCE IN WOMEN WITH A HISTORY OF PROGESTERONE DEFICIENCY  LINDA D. COWAN et al. American Journal of Epidemiology Vol. 114, No. 2: 209-217

(28) http://www.annclinlabsci.org/cgi/content/abstract/28/6/360
Progesterone inhibits growth and induces apoptosis in breast cancer cells: inverse effects on Bcl-2 and p53.  B Formby and TS Wiley. Annals of Clinical and Laboratory Science, Vol 28, Issue 6, 360-369
 
(29) http://en.wikipedia.org/wiki/Birth_control_pill
Combined oral contraceptive pill. From Wikipedia, the free encyclopedia. (Redirected from Birth control pill)

(30) http://www.worstpills.org/results.cfm?disease_id=26
Oral Contraceptives on Worst Pills.org. The pill can cause many adverse effects.

(31)  http://www.jeffreywarber.com/hc%20pages/pillsideeffects.html
Birth Control Pill Adverse Side Effects by Jeffrey Warber MD

(32) http://www.quickoverview.com/reproductive/birth-control-pill.html
History and Development of an effective combined oral contraceptive. People Involved.

(33) http://www.jpands.org/vol13no2/hotze.pdf Point/Counterpoint: The Case for Bioidentical Hormones Steven F. Hotze, M.D.Donald P. Ellsworth, M.D.Journal of American Physicians and Surgeons Volume 13 Number 2 Summer 2008

(34)  http://www.townsendletter.com/June2007/painfree0607.htm
The Safety of Bioidentical Hormones — the Data vs. the Hype by Jacob Teitelbaum, MD

(35) http://www.johnleemd.com/store/main_books.html John Lee Web Site: Books by John R Lee MD

(36)   http//:naturalnews.com/022595.html FDA's Assault of Bioidentical Hormones Demonstrates Pro-Pharma Loyalties, Disregard for Consumer Choice Tuesday, February 05, 2008 by: Mike Adams 

(37)  http://supplementsdiets.com/g/wyeth-bioidentical-hormones/329.html
February 16, 2008. Women, Doctors Wage Crucial Battle With FDA To Save Bioidentical Hormones From Wyeth's Wrath. A major coalition of informed women and their doctors have launched an all out war on the Federal Drug Administration's (FDA) cynical and corrupt decision to ban compounded hormones containing Estriol.

(38) FDA Declares War on BioIdentical Hormones by Jeffrey Dach MD

(39) http://atvb.ahajournals.org/cgi/content/full/17/1/217
Medroxyprogesterone Acetate Antagonizes Inhibitory Effects of Conjugated Equine Estrogens on Coronary Artery Atherosclerosis. Michael R. Adams et al..Arteriosclerosis, Thrombosis, and Vascular Biology. 1997;17:217-221.

(40)
Bioidentical vs. Synthetic HRT, A review of the literature Erika Schwartz

(41) Bio-Identical Hormone Initiative, Erika Schwartz MD, David Brownstein MD, Kent Holtorf MD

(42) The Natural Superwoman: The Scientifically Backed Program for Feeling Great, Looking Younger, and Enjoying Amazing Energy at Any Age , Uzzi Reiss, Yfat Reiss Gendell,  Avery (November 8, 2007)

(43)  Breast Cancer Res Treat. 2008 January ; 107(1): 103–111.Unequal risks for breast cancer associated with different hormone replacement therapies: results from the E3N cohort study. Agnès Fournier et al.

(44) http://www.endfatigue.com/health_articles_f-n/Menapause-safety_effectiveness_bioidentical_hormones.html The Safety and Effectiveness of Bio-Identical Hormones: Natural (Bio-Identical) vs. Synthetic HRT. Kent Holtorf, M.D.

(45) http://www.thorne.com/media/hormones11-3.pdf
A Comprehensive Review of the Safety and Efficacy of Bioidentical Hormones for the Management of Menopause and Related Health Risks Deborah Moskowitz, ND.  Altern Med Rev 2006;11(3):208-223)

(46) http://www.drcranton.com/hrt/hrt_references.htm
Hormone Replacement References.  Most references below are linked to the National Library of Medicine (MEDLINE)

(47) http://www.medscape.com/viewarticle/408096_print
Addressing Postmenopausal Estrogen Deficiency: A Position Paper . January 26, 2001 Sander Shapiro, MD Medscape General Medicine 3(1), 2001.

(48) Scientific Literature on Hormones on Dr Erika.com

(49) http://www.womeninbalance.org/research/
research available women in balance.

(50) http://www.fimdefelice.org/archives/arc.promise.html
The Promise and Problems of Natural Substances in Medicine Stephen L. DeFelice, M.D.

(51) http://www.nwhn.org/healthinfo/detail.cfm?info_id=9&topic=Fact%20Sheets
Menopause Hormone Therapy and Breast Cancer. National Women's Health Network

(52) http://www.bmj.com/cgi/content/full/310/6979/598/b BMJ 1995;310:598 (4 March) Letters Risk factors for breast cancer , BMJ

(53) http://jama.ama-assn.org/content/283/4/485.abstract   Menopausal Estrogen and Estrogen-Progestin Replacement Therapy and Breast Cancer Risk. Catherine Schairer, PhD et al.  JAMA. 2000;283(4):485-491.

(54) http://onlinelibrary.wiley.com/doi/10.1002/(SICI)1097-0215(19960729)67:3%3C327::AID-IJC4%3E3.0.CO;2-T/pdf   see also http://www.ncbi.nlm.nih.gov/pubmed/8707404  
Cancer incidence and mortality in women receiving estrogen and estrogen-progestin replacement therapy—long-term follow-up of a Swedish cohort.  Ingemar Persson et al. International Journal of Cancer Volume 67, Issue 3, pages 327–332, 29 July 1996

(55) http://www.ncbi.nlm.nih.gov/pubmed/12927427    Lancet. 2003 Aug 9;362(9382):419-27. Breast cancer and hormone-replacement therapy in the Million Women Study. Beral V; Million Women Study Collaborators.

(56) http://www.nejm.org/doi/full/10.1056/NEJM197512042932303 Increased Risk of Endometrial Carcinoma among Users of Conjugated Estrogens.  Harry K. Ziel, M.D., and William D. Finkle, Ph.D. N Engl J Med 1975; 293:1167-1170 December 4, 1975

(57) http://www.ncbi.nlm.nih.gov/pubmed/213722  N Engl J Med. 1979 Jan 4;300(1):9-13. Endometrial cancer and estrogen use. Report of a large case-control study. Antunes CM, Strolley PD, Rosenshein NB, Davies JL, Tonascia JA, Brown C, Burnett L, Rutledge A, Pokempner M, Garcia R.