Are Women’s Bio-identical hormones safe? Bio-identical hormones exist naturally in the human body, so it is axiomatic that these are safe. However, we are interested in a slightly different question. What is the safety of bio-identical hormones as routinely used in medical practice? Let’s try to answer this question.
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. 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.
Consider the following medical experiment, performed over the last 50 million years with the help of our friend, Darwinian evolution. 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.
Common Signs of Estrogen Deficiency:
Decreased sense of sexuality
Difficulty falling asleep
Dry eyes, skin, and vagina
Episodes of rapid heartbeat
Feel balanced 2nd part of cycle
Headaches and migraines
Increased back and joint pain
Lessened self-image and attention to appearance
Loss of skin radiance
Pain with sexual activity
Sagging breasts and loss of fullness
Common Signs of Excess Estrogen (takes longer to notice)
Breast tenderness or pain
Impatient, snappy behavior, but with clear mind
Increased breast size
Water retention, fingers, legs
Common Signs of Progesterone Deficiency
Anxiety, irritability, nervousness and water retention
Breasts with lumps
Heavy and frequent periods (large clots, due to buildup in the uterus)
Most cases of endometriosis, adenomyosis, and fibroids.
No period at all (no ovulation)
Spotting a few days before the period. (Progesterone level is dropping)
The period comes infrequently (every few months)
Above list courtesy of Uzzi Reiss MD OB GYN.
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.
Do Bio-Identical Hormones Cause Breast Cancer?
The answer is no. According to the French Cohort study, there is no increase in breast cancer in women using bio-identical hormones. 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. To read about this, see: Breast Cancer Prevention and Iodine Supplementation by Jeffrey Dach MD.
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). These same results had already been published 2 years previously in a calcium score study by Budoff in J Womens Health 2005. 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.
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.
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. 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.
The WHI Culprit was the Synthetic Progestin (an altered form of Progesterone) so 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.
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.
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.
In part 2 of this article Dr Dach examines the role of the media in promoting fear of hormones and the confusion generated by their inability to distinguish between synthetic and natural hormones.
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.
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