Are Bioidentical Hormones Safe ? by Jeffrey Dach MD
Posted Dec 16 2010 9:57am
Are Bio-Identical Hormones Safe?
by Jeffrey Dach MD ( Link to the original article)
Are Women's Bio-identical hormones safe? What is the safety of bio-identical hormones as routinely used in medical practice? The answer to this question is YES, bioidentical hormones are much safer and more effective than the synthetic chemically altered hormones commonly used in medical practice.
The Safety of Water compared to Bio-Identical Hormones
Water is safe, beneficial and required for health. Yet, even so, drinking excess amounts of water causes death from Fatal Water Intoxication .( 1 )
Left Image: Water with Droplets Courtesy of Wikimedia
Similarly, just like water, bio-identical hormones are safe and beneficial when used at proper dosages. Like excessive water, excessive hormone dosage may result in their own adverse side effects. Excess estrogen, for example, causes fluid retention, breast sensitivity and enlargement, and disordered mood.
Humans Have Bio-Identical Hormones.
Another answer to the safety question is that bio-identical hormones are found in the human body naturally. Any harmful substance in the human body would impair survival, and over millions of years of evolution would be eliminated by natural selection. This is the basic concept of Darwinian evolution which is accepted by mainstream medical science.
A 50 Million Year Medical Experiment
Consider the following medical experiment, performed over the last 50 million years with the help of our friend, Darwinian evolution .( 2 ) Bio-Identical Hormones have been present in the human body for 50 million years, and we humans are still here on the planet. I would consider that a successful medical experiment, wouldn't you?
Either Excess or Deficiency of Anything Can be Harmful
One of our routine labs tests called the Chem Panel measures electrolytes and glucose levels in the blood. The body automatically maintains these within narrow ranges to maintain health. If levels deviate above or below these normal ranges, this causes a serious health disturbance. For example elevated potassium levels causes cardiac arrest. Magnesium deficiency causes muscle spasm and arrythmia. Excessive amounts of Vitamins A and D are toxic. Hormones levels enjoy a considerably wide range of acceptable limits. Even so, 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 )
Mental fogginess Forgetfulness Depression Minor anxiety Mood change Difficulty falling asleep Hot flashes Night sweats Temperature swings Day-long fatigue Reduced stamina Decreased sense of sexuality Lessened self-image and attention to appearance Dry eyes, skin, and vagina Loss of skin radiance Feel balanced 2nd part of cycle Sagging breasts and loss of fullness Pain with sexual activity Weight gain Increased back and joint pain Episodes of rapid heartbeat Headaches and migraines Gastrointestinal discomfort Constipation
Common Signs of Excess Estrogen (takes longer to notice)
Breast tenderness or pain Increased breast size Water retention, fingers, legs Impatient, snappy behavior, but with clear mind Pelvic cramps Nausea
Common Signs of Progesterone Deficiency
No period at all (no ovulation) The period comes infrequently (every few months) Heavy and frequent periods (large clots, due to buildup in the uterus) Spotting a few days before the period. (Progesterone level is dropping) PMS Cystic breasts Painful breasts Breasts with lumps Most cases of endometriosis, adenomyosis, and fibroids. Anxiety, irritability, nervousness and water retention
No Reported Adverse Events from Bio-Identical Hormones
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 last year, according to an FDA press conference January 2008.( 6 )
Based on data from the French Cohort study , there is no increased breast cancer risk in women using bio-identical hormones.(8)
However, having said that, avoiding excess environmental estrogens as well as excessive estrogen levels from any source, is the key to preventing breast cancer.(9) My previous article covers our program for breast cancer prevention which includes iodine supplementation, Indole-3-carbinol and fiber.
Left Image: Eiffel Tower Paris France Courtesy of Wikimedia Commons
Do Bio-Identical Hormones Cause Heart Disease?
Again, the answer is no. A study of CAT calcium scores by JoAnn E. Manson in the June 2007 JAMA actually showed less heart disease in the women taking unopposed 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 Womens Health 2005 . ( 12 ) Animal studies with monkeys show that bioidentical estrogen (estradiol) prevents and inhibits heart disease. This study was published in Arteriosclerosis by Adams in 1990.
A Closer Look at the Women's Health Initiative WHI Study
Understanding the Women's Health Inititative (WHI) study is not difficult, and is very important to answer the question of hormone safety. The WHI study was the large NIH sponsored medical study which compared synthetic hormones to placebo in two large groups of women. The WHI study consisted of two arms. The first arm used the synthetic hormones Premarin and Provera, and the second arm used Premarin alone.( 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 (see provera diagram below).( 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 )
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 study was published, 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. Wyeth is still trying to recoup that money by manipulating the FDA. They want the FDA to ban their competition, the bio-identical hormones or their components.(36) (37)(38) Use this easy tool to email your Congressman and voice your opposition to Wyeth's attempts to ban estriol and other bio-identical hormones.( 17 ) While you are at it, tell your Congressman that synthetic hormones are chemically altered monsters that should be banned.
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, provera commonly given to prevent endometrial cancer. Rather, they were only given Premarin (the horse hormone, also called CEE, for Conjugated Equine Estrogen). Unlike the first arm of the study, these women had no increase in breast cancer risk .( 18 ) (see chart below)
The blue bars represents adverse events in the placebo group. The red bars represents adverse events in women (ages 50-59) on premarin only, with no Provera (progestin). Note that the Red bars are all Lower than the Blue bars. The Red bar (Premarin-only) group shows LESS heart disease, LESS breast cancer and LESS Mortality when compared to placebo (blue bar). Chart Courtesy of Susan Ott MD Bone Physiology .( 19 )
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 )
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 )
Provera Proven to Cause Breast Cancer
In fact, medical studies prove that Provera causes breast cancer. In these studies, Primates were treated with either Progesterone or Provera showing that the Provera causes breast cancer, while the Progesterone provides protection from breast cancer.( 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.
Image Left: Another Monster: Boris Karloff from Frankenstein 1931.Courtesy of Wikimedia.
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.
Chemically altered forms of estrogen: Dienestrol, Diethylstilbestrol, Ethinylestradiol, Fosfestrol, Mestranol
Chemically alered hormones in BCP's Birth Control Pills:
levonorgestrel and ethinyl estradiol [oral contraceptive] (ALESSE 28, AVIANE, NORDETTE, SEASONALE, TRIPHASIL, TRIVORA-28); norethindrone and ethinyl estradiol (COMBI PATCH, LOESTRIN FE 1/20, NEOCON 1/35, ORTHO-NOVUM 7/7/7, OVCON 35); norgestimate and ethinyl estradiol (ORTHO-CYCLEN, ORTHOTRI-CYCLEN, TRINESSA); norgestrel and ethinyl estradiol (LO/OVRAL 28, LOW-OGESTREL), desogestrel and ethinyl estradiol (DESOGEN, MIRCETTE, ORTHO-CEPT), drospirenone and ethinyl estradiol (YASMIN)
Chemically altered forms of testosterone: Androstanolone, Fluoxymesterone, Mesterolone, Methyltestosterone
How to make a Monster Hormone,Add a Side-Chain (in Red below) Below Images:Courtesy of wikemedia commons.
Human Progesterone Provera - the Monster Hormone
Take a good look at human bio-identical Progesterone (Upper left), and the chemically altered version (upper right) Provera (medroxyprogesterone). The added side-chain is labeled in RED on the right side of the Provera molecule. This side-chain (in red) has been added in order to make a totally new structure that can be patented, and is the only difference with progesterone (upper left). In the process of adding this side-chain, a Monster was created. In the opinion of John R Lee MD, "to prescribe a chemically altered version of progesterone called Provera is medical malpractice", and yet this practice is common in mainstream medicine.
An Illustration which Explains 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 .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 (.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 confered by high levels of progesterone. This was confirmed in a 2007 study by Rajkumar who showed that hormone treatment protected genetically engineered mice from developing breast cancer. ( 26 )
Left image Pregnancy, courtesy of wikipemedia commons.
Here is a listing of people involved in the early development of birth control pills: Russell Marker, Percy Lavon Julian, Carl Djerassi, Luis E. Miramontes, George Rosenkranz, Gregory Pincus, Min Chueh Chang, John Rock.( 32 )
In the future of medicine, I predict that progesterone will replace progestins as oral contraception . The bio-identical hormone, Progesterone, will be used in the birth control pills of the future. Early research on contraception was done with progestereone, and research was switched to synthetic progestins to obtain a patent and make a profit. Another consideration was ease of use of the oral tablet, at the time available only as a progestin. Bio-Identical progesterone suppresses ovulation and was the original agent investigated in early research for a contraceptive agent. However, timing and dosages were never officially worked out, so we currently are left with the synthetic birth control pills by default. Again, the IUD can be used instead to avoid the monster hormones. I predict that new research outside the US in the next decade will establish progesterone as the hormone of choice for birth control. Most likely, funding for this research will come from a foreign government agency, in a country with universal health care which has economic incentives to make a healthier pill.
More on Breast Cancer and Hormone Levels
If high estrogen levels were the primary cause of breast cancer, we would expect to find more breast cancer mortality in women with higher hormone levels at age 30, and less breast cancer in women with low hormone levels at age 60 (post-menopausal). However, what we find is the exact opposite. According to the CDC , mortality from breast cancer is 7 times higher in the older women aged 60 (0.7 per cent), compared to younger women aged 30 (0.1 per cent). Mortality from breast cancer is 700 % higher in post-menopausal women with low hormone levels.( link )
In conclusion, bio-identical hormones used at appropriate dosages are safe, effective, and beneficial for health. On the other hand, any chemical alteration of a human hormone creates a monster hormone, which is not bioidentical. These monster hormones should never have been approved for marketing and sale to the American people. These monster hormones are unsafe, causing cancer and heart disease, and should be banned immediately.
Excellent Articles on Safety and Superiority of BioIdentical Hormones Compared to Synthetics
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, MD
( 3 ) http://www.johnleemd.com/store/premenstrual_syndrome.html Excerpted From: WHAT YOUR DOCTOR MAY NOT TELL YOU ABOUT BREAST CANCERBalance 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
( 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 ANTIINFLAMMATORY DRUGS M. MICHAEL WOLFE , M.D., DAVID R. LICHTENSTEIN, M.D.,AND GURKIRPAL SINGH, M.D.
( 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
( 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.
( 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! Please contact your congressional representative, senators, and the White House immediately. HOMECoalition.org.
( 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.
( 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.
( 30 ) http://www.worstpills.org/results.cfm?disease_id=26 Oral Contraceptives on Worst Pills.org. The pill can cause many adverse effects. Some of them are merely a nuisance, while others can be life-threatening. The pill can cause headaches, bloating, nausea, irregular bleeding and spotting, breast tenderness, weight gain, or vision changes. Other more serious adverse effects that can occur from a few months to a few years after starting oral contraceptives include high blood pressure, gallbladder disease, liver tumors, depression, and metabolic disorders, such as diabetes. Temporary infertility has been associated with the period of time right after pill use is stopped. But the two most dangerous risks associated with taking birth control pills are blood clots and cancer.
( 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
FDA's Assault of Bioidentical Hormones Demonstrates Pro-Pharma Loyalties, Disregard for Consumer Choice Tuesday, February 05, 2008 by: Mike Adams
( 37 ) http://www.drerika.com/blog?action=viewBlog&blogID=-751271156172620113 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.
( 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; Thomas C. Register; Deborah L. Golden; Janice D. Wagner; J. Koudy Williams .Arteriosclerosis, Thrombosis, and Vascular Biology. 1997;17:217-221.
http://www.postgradmed.com/index.php?article=1949 Postgraduate Medicine: Volume 121: No.1 January 2009. 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, MD Conclusion: Physiological data and clinical outcomes demonstrate that bioidentical hormones are associated with lower risks, including the risk of breast cancer and cardiovascular disease, and are more efficacious than their synthetic and animalderived counterparts. Until evidence is found to the contrary, bioidentical hormones remain the preferred method of HRT. Further randomized controlled trials are needed to delineate these differences more clearly.
http://online.wsj.com/article/SB123717056802137143.html MARCH 16, 2009 The Truth About Hormone Therapy Wall Street Journal By ERIKA SCHWARTZ , KENT HOLTORF , and DAVID BROWNSTEIN, Mainstream medicine has been given a wake-up call on a matter critical to the health of 65 million women in the U.S. At issue are the options for treatment of menopause
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. Dr. Holtorf is the Medical Director of the Holtorf Medical Group, Inc, Center for Hormone Imbalance and Fatiguing Conditions in Los Angeles, specializing in CFS, FM, hypothyroidism, chronic illness and the treatment of complex endocrine dysfunction. He is board certified and is a Board Examiner for the American Academy of Anti-Aging Medicine. He is also chief of the Medical Advisory Board for the Fibromyalgia and Fatigue Centers, Inc.
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)
http://www.medscape.com/viewarticle/408096_print Special Article: Addressing Postmenopausal Estrogen Deficiency: A Position Paper of the American Council on Science and Health January 26, 2001 Sander Shapiro, MD Medscape General Medicine 3(1), 2001.
http://www.iupac.org/publications/pac/2002/pdf/7410x1957.pdf Natural and synthetic substances related to human health. The dubious honor of being the most powerful toxic substance goes to a protein produced by the bacterium, Clostridium botulinum. This protein is responsible for fatal food poisoning—botulism—being produced when the bacterium grows in the absence of oxygen in canned or preserved food. 2002 IUPAC, Pure and Applied Chemistry 74, 1957–1985
Hormone Levels, Age and Breast Cancer http://www.cdc.gov/cancer/breast/statistics/age.htm Risk of Breast Cancer by Age, CDC .Percent of U.S. Women Who Die from Breast Cancer Over 10-, 20-, and 30-Year Intervals. According to Their Current Age, 2002–2004. Age 30 is 0.1% age 60 is 0.7% .
Inhibition of Coronary Artery Atherosclerosis by 17-beta Estradiol in Ovariectomized Monkeys, Lack of an Effect of Added Progesterone Michael R. Adams, Jay R. Kaplan, Stephen B. Manuck, Donald R. Koritnik, John S. Parks, Mary S. Wolfe, and Thomas B. Clarkson (Arteriosclerosis 10:1051-1057, November/December 1990)
We conclude that physiologic estrogen replacement therapy with or without added progesterone inhibits atherosclerosis progression in ovariectomized monkeys. This may explain why estrogen replacement therapy results in reduced risk of coronary heart disease in postmenopausal women.
The reader is advised to discuss the comments on these pages with his/her personal physicians and to only act upon the advice of his/her personal physician Also note that concerning an answer which appears as an electronically posted question, I am NOT creating a physician -- patient relationship. Although identities will remain confidential as much as possible, as I can not control the media, I can not take responsibility for any breaches of confidentiality that may occur. Finally, the material produced by myself may be reproduced for personal use, provided that appropriate credit is given.
The reader is advised to discuss the comments on these pages with his/her personal physicians and to only act upon the advice of his/her personal physician. Also note that concerning an answer which appears as an electronically posted question, I am NOT creating a physician -- patient relationship. Although identities will remain confidential as much as possible, as I can not control the media, I can not take responsibility for any breaches of confidentiality that may occur.
Copyright (c) 2010,11 Jeffrey Dach MD All Rights Reserved. This article may be reproduced on the internet without permission, provided there is a link to this page and proper credit is given.
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