Sunday, August 21, 2011

Safe Use of Hormones: the Hard Evidence

by Etsuko Ueda, August 2011

"Is it safe? " is the big question on many people's mind when it comes to hormone supplementation today. I believe that question has been settled. In What Your Doctor May Not Tell You About Breast Cancer, estrogen is aptly called as "angel of life and angel of death". It's angel of life because it promotes cell growth and proliferation, the most noticeable for women being the monthly cycle of uterine lining buildup in preparation for pregnancy. It is angel of death because when it is not under progesterone's control, it can run amuck, creating and aiding the generation and growth of cancerous cells, blood clots, and coronary vascular spasm to list just a few. Don't confuse this protective role of progesterone with the destructive nature of progesterone substitutes (aka progestine or progestogen, there are several), which has been clearly demonstrated by WHI Clinical Trials in the U.S. and other studies that used progesterone substitutes.

It is very important to note that the only large scale long term study that compared real progesterone with progesterone substitutes so far is the French E3N cohort study series. They produced three reports so far, and all of them (breast cancer risk, blood clot risk, asthma onset risk) show a combination of transdermal estradiol + real progesterone is as safe as not using any hormone, while any other estrogen + progesterone substitute combination or estrogen only therapy shows increased risks.
The E3N studies show estrogen + progesterone is safer than estrogen alone supplementation. The same thing happens with your own hormones when progesterone and estrogen goes out of balance . This is known as estrogen dominance, and it is the primary reason why so many women develop various health problems during the decade leading up to menopause (see Estrogen dominance: it's not just a theory).
Actually, it is not just estrogen, but other hormones (DHEA, androstenedione, testosterone: probably because they easily convert to estrogen in various tissues) can become health hazard also, when progesterone is low. It was demonstrated with breast cancer, both for premenopause women and for postmenopausal women.
It isn't just breast cancer, blood clot, and asthma onset, that progesterone is known to protect you from. In his 1993 edition of "Progesterone in Orthomolecular Medicine", Ray Peat, a biologist listed a wide range of progesterone's protective role from embryo to old age, based on his studies and others' available back then:
  • Prevents acute poisoning of many kinds
  • Reduces the incidence of birth defects
  • Reduces the incidence of cancer of uterus, breast, and kidney
  • Reduces the incidence of epilepsy, habitual miscarriages, auto-immune diseases
  • Regulates heart and vascular smooth muscle, prevent spasm
  • Neutralize excessive estrogen and cortisol
  • Improve metabolic efficiency
  • Resolve hypoxia
  • Reduces edema
  • normalize fluid pressure in bursitis, glaucoma, swollen cartilage, etc.
  • Influence the brain development and intelligence of the baby
  • Promote magnesium uptake and blocks calcium uptake (this has a profound implication in blood clotting, blood sugar stability, diuretic kidney function, histamine release control, phagocytosis and other immune functions, Glucagon, insulin, vascular spasm, vascular tone, nerve stabilization (against over excitation, seizure, epilepsy, sleep apnea) , and protection against toxic or excitotoxic cell death)
Today, there are endless variety of thousands of studies that back up Ray Peat's conclusion, demonstrating how bio-identical natural hormones protect women's health or men's. Below are only a small fraction of the studies out there on the protective role of hormones in the field of neuroscience alone. Although the public is still kept in dark, the evidence is overwhelming. Only the clinical studies designed to show it in women are few and far between. Of course, those lucky enough to have learned of transdermal natural progesterone (sold as skin cream in the U.S.) aren't waiting for their doctors to catch up.

The wasted large scale clinical trials

The WHI Clinical Trials was supposed to give us enough data to answer many questions surrounding menopausal hormone therapy. Instead, they exposed an entire generation of menopausal women to dangerous drugs, scared and confused consumers and doctors alike, and sent researchers chasing dead-end false leads. All because it used a wrong form of hormone therapy (Premarin + Provera), the adverse effects of which have been known for quite some time, and yet, the pharmaceutical industry and medical establishment have chosen to ignore, if not hide (see The Hormone War is Heating Up).

The only safe and effective form of HRT is transdermal Estradiol+ real Progesterone continuous Regimens as the E3N Cohort Studies above and others have clearly shown. However, even when real estrogen and progesterone is used, it is not uncommon to see studies (or prescriptions for that matter) that use more than 10 times of the optimal ranges (around 0.03 ~ 0.05mg of estradiol + 10 ~ 20 mg of progesterone per day, both transdermal. See Hormones: Dos and Don'ts) .
In the French E3N cohort study, the natural progesterone used was primarily oral (paired with 0.05mg transdermal estradiol, 100mg per day progesterone in capsule has been the most common form of natural progesterone prescription). The studies so far has not reported any adverse health hazard associated with natural oral progesterone use, however, there are many people who cannot tolerate 100mg per day oral progesterone, including myself, because of dizziness or tiredness it induces (progesterone and its metabolites act as tranquilizer through GABAa receptors, and given a large enough dose, induce dizziness and tiredness, while the same mechanism prevents over excitation of neurons and make your brain feel calm in optimal dose).
Therefore, many of the existing study results with oral progesterone are of only a limited use from a practical point of view.

The responsibility of the people who design large scale studies with serious implications
Perhaps the people most disturbed by the WHI results were estrogen researchers themselves. Estrogen looked so promising as the ultimate fountain of youth. At least that was what they were trying to sell. From my vantage point, there is no excuse for not knowing the detrimental effects of the particular estrogen (Premarin) and fake progesterone (Provera=medroxyprogesterone acetate) used in the studies before hand. There has been enough research indicating the risks, even before the clinical trial was launched in 1991 (actual recruitment 1993-1998). They knew the danger as early as 1961 (see Estrogens, progestogens and thrombosis, F . R. Rosendaal, at. al. 2003). By 1967 a study was conducted (Records Unit and Research Advisory Service of the Royal College of General Practitioners. Oral contraception and thromboembolic disease. J R Coll General Pract 1967;). Medroxyprogesterone acetate (the progesterone substitute used in the WHI clinical trials) has been used as contraceptive for many years with a long list of adverse side effects. By 1984 the superiority of bio-identical (natural) progesterone was demonstrated (Oral progesterone and estrogen/progestogen therapy. Effects of natural and synthetic hormones on subfractions of HDL cholesterol and liver proteins. U B Ottosson 1984).

Large scale long term clinical studies: Are they really necessary to determine the effects?
Risks and benefits can be evaluated much earlier, long before the actual diagnosable symptoms appear as clinical end points. In other words, you don't have to wait to see if people get sick to see the effects of the treatments. There are various indicators and markers that can tell what biological processes are activated or suppressed that are critical to the disease development. For example, bone breakdown and formation processes can be monitored by their chemical byproducts for osteoporosis development and reversal. So are blood clots and plaque formation risks in a form of reactive C-protein, fibrinogens, cholesterols, etc. Infrared camera breast exam can detect abnormal pattern of blood vessel development long before the cancerous lumps. It is about time to rethink the barbaric practice of clinical trials that is designed to see if a certain treatment would cure the illness or end up killing the patients.

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