The Safety of Bio-Identical Hormones

The Safety Of Bio-Identical Hormones

by Jeffrey Dach MD

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.(1)

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)

Common Signs of Estrogen Deficiency (4)

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

Above list courtesy of Uzzi Reiss MD OB GYN. (4)

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)

Do Bio-Identical Hormones Cause Breast Cancer?(7)
The answer is no. According to the French Cohort study, there is no increase in breast cancer 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. To read about this, see: Breast Cancer Prevention and Iodine Supplementation by Jeffrey Dach MD.(10)

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)

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)

Left Chart: This chart shows data from the second arm of the WHI in JAMA 2004.(14)
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.

A Listing of a Few Monster Hormones:

Chemically Altered forms of progesterone:
Dienogest, Desogestrel, Drospirenone, Dydrogesterone, Ethisterone, Etonogestrel, Ethynodiol diacetate, Gestodene, Gestonorone, Levonorgestrel, Lynestrenol, Medroxyprogesterone, Megestrol, Norelgestromin, Norethisterone, Norethynodrel, Norgestimate, Norgestrel, Norgestrienone, Tibolone

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.

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)(30)(31) To avoid these monster hormones, the IUD (intra-uterine device) is available.

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)

Conclusion

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.

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