Hormone Replacement Therapy

 

The endocrine system of the human body is incredibly complex, and there is much more yet to be known, and known well, then is currently known. In American medicine it is more common to resist the replacement of hormones, particularly in males, and to encourage prescription drug therapies. (What do I mean by encouraging prescription drug therapies? The New York Times reported on 12/4/02 that drug companies spent approximately $19.1 billion on promotional advertising in 2001. And that was over 10 years ago.)

 

Simple logic would seem to dictate that replacing those naturally occurring substances which maintain bodily functions and help us to feel vital would be a good thing. (Please refer to the Introduction and General Health sections of my health plan.) Since hormones are naturally occurring substances and not generally patentable, they are not subject to US FDA approval. This means pharmaceutical companies have no motivation to spend the money on research for something that cannot possibly benefit their shareholders.

 

A doctor prescribing compounded prescription, off label, or over-the-counter hormones is by definition outside of the “standard of care”. This places him in a maverick position that is an extra burden in an already burdensome profession. A doctor who takes such a position on purpose is generally thought of as a quack, if not overtly called one. I will just offer once again; those who argue against hormone replacement are arguing against simply boosting back to optimal healthy levels those substances which currently exist in the individual’s body in a bio-identical form, previously existed at the same levels, and would cause the individual to become very sick or die were they not to have any. One can be hopeful that this situation may change in the future. For a time it was become a cause celeb for Oprah Winfrey, but HRT has more or less fallen out of view again. The one real driving force is the aging population of Baby Boomers. They are a huge population, and the first of modern times to not as a group automatically accept “growing old gracefully”.

 

An excellent example of how typical health care providers are locked in a mold of resistance to provable fact would be the care of my father in the last year or two of his life. He had a number of compromised health issues, among which was basic congestive heart failure. Since testosterone has such a powerful positive relationship with the heart, I suggested to his internist that we try testosterone therapy. He was adamant that it was a very bad idea. Only after securing a promise from him that he would not remove my father from his practice did I convince my father to see Dr. James Nagel in Chico, California.

 

My father was complaining of considerable bilateral breast pain. Lab results of testosterone and estradiol showed testosterone at about one fourth of optimal and estradiol in the neighborhood of 15 times normal. Dr. Nagel commenced therapy of testosterone and the aromatase inhibitor Arimidex, a drug developed for the purpose of limiting estradiol (estrogen) production. In very short order breast pain disappeared and cardiac output improved. His doctor very plainly admitted to me that he was wrong and the testosterone therapy had been very beneficial. Yet within six months he was back to calling the therapy “snake oil” and my father some time later discontinued the therapy. The extension of my father’s life by some months some might call unimportant in the large scale of life, but it allowed my daughter to be present at his passing. My daughter and I were in China for 2½ months fighting for her husband’s life only a few months before my father passed away. My son-in-law subsequently died and we went through the process of bringing his body back to the states. Since my daughter loved her grandfather very much, it made a huge difference to our family. Having to lose her grandfather while she was losing her husband in China would have been an even greater burden to bear.

 

Melatonin

3 mg 1-2 hrs before bed

 

Insulin

For Type II, age onset diabetics dosing is entirely idiomatic. For the long-acting insulins Lantus and Levemir, I recommend splitting the 24 hour dosing and weighting the dosing heavier in the evening as nighttime basal insulin needs are greater during this time period.

 

Progesterone

This hormone is crucial for overall health in both sexes and normally drops in level with aging. Its levels and cycles are very different by gender and should be managed accordingly. The largest mistake with this hormone is that it is a female hormone and irrelevant to male HRT. This is a mistake of the first order. Its analysis and application should always be included in any overall HRT program for either gender.

 

Estrogen (Estradiol)

At one time the prescription drug Premarin, a synthetic (non-human) estrogen made from pregnant horse mare's urine, was the number one prescribed drug in the United States. Female consumer pressure brought about the marketing of bio-identical estradiol. Simple reality is estrogen replacement could have and still could be accomplished very inexpensively. Progesterone is inexpensively produced and marketed in transdermal cream form at health food stores. There is no practical difference between this process and the ability of the same companies to produce similar products containing estradiol or testosterone. The singular circumstance differentiating the latter two is that they are classified as dangerous to general population by the federal government, thus creating an entirely artificial landscape to the benefit of large scale pharmaceutical companies.

 

Somatropin

It is a virtual tragedy that this hormone's general (non-scientific) name is “Human Growth Hormone”. This grossly misleading name to the hormone's total function in the human body has done a gigantic disservice to the general public's understanding. It would be better named “cell repair, healing, and cell maintenance hormone” because it repairs just about everything in the body at the cellular level. Without it, tissue atrophies. This is what occurs with age when the pituitary release of somatropin declines to deficient levels. Adequate levels of somatropin protect the heart, increase the amount of muscle, decrease the amount of body fat, increase the humidity of the skin, fortify the immune system, make bones stronger, improve vision, elevate mood, and in general improve all glandular and organ functions of the body. HRT of somatropin also increases the blood supply that reaches the brain and other neurons everywhere in the body thereby helping to prevent the loss of brain cells. (see brain health)

 

In a study reported In the European Journal of Endocrinology in January 2007, a research university in Sweden looked at the relationship of long term somatropin replacement and bone mineral density. The study included 87 hypo-pituitary adults across a 10 year period. While a very positive result of the bone mineral density measurement of the sample group was seen, an important attendant observation was that across a 10 year long period there were no noted side effects of somatropin replacement therapy. This is exactly the opposite of what nearly all members of the American heath care establishment parrot day in and day out.

 

In a review published in 1998 in the Journal of Clinical Endocrinology and Metabolism, a panel of researchers reviewed more than two dozen studies between 1989 and 1997 on the effects of somatropin replacement. Simply put, all of the above positive results and more are documented and the only real negative affects are those associated with supra-physiological (unnaturally high) doses.

 

Currently under development in the US, Europe and South Korea are forms of Somatropin that would be long-acting in nature. (China's largest Somatropin manufacturer is already shipping their long-acting form.)  Somatropin, like Humalog insulin, has a serum half-life of about 30 minutes. A sustained release delivery form of the hormone similar to Levemir or Lantus insulin will be a huge step forward in being able to more closely mimic the body's natural delivery of the hormone.

 

Note: this hormone generates a great deal of emotionalism in its discussion and use in treatment. In an attempt to diffuse typical biased, heated, but uninformed opinions, instead of the unfortunate generic name “growth hormone”, in this discussion I use the hormone's scientific name, Somatropin.

 

Testosterone

10 mg approximate systemic delivery through transdermal gel. This would be a typical conservative healthy male dose. A 90 day supply of brand name, patented Androgel if simply purchased at retail would run somewhere over $1000. An excellently run compounding pharmacy in my home town can prepare a 90 day supply containing the same amount of testosterone USP for a retail price of about $65. It's application system is far superior to Androgel's foil packets as well. A typical female produces about 10% of the typical systemic male level. An example of the subjective quality of life importance of this hormone in females could be easily demonstrated, albeit in a highly politically incorrect fashion. There exists an inconvenient phenomenon that is just a plain and easily observable scientific fact. Women from genetic pools containing large amounts of African genes as a group typically have testosterone levels that are much higher than gene pools of European Caucasians. If one thinks this is an insignificant fact I dare you to randomly line up a hundred healthy, 30 year old African-American women and magically reduce their testosterone levels to typical Caucasian levels. Call them back a month later for a subjective reporting of the results of the experiment. I'll let you carry out that part of the experiment yourself as I wouldn't want to be in the same room with you and your 100 test subjects.

 

For the purposes of observing some of the wide-ranging importance of testosterone in human health the following information is helpful:

 

Heart (Testosterone)

Testosterone is a muscle-building hormone, the heart is the hardest working muscle in the body, there are more cellular sites for receiving testosterone in the human heart than in any other muscle of the human anatomy. Consider that all of the following cardiovascular risk factors go up as testosterone levels go down:

 

-Cholesterol and triglyceride levels go up, leading to increased arterial plaque

-Coronary artery and major artery dilation diminish, vasoconstriction equals greater risk of cardiac events

-Rising blood pressure

-Increased insulin output, which leads to obesity, elevated blood pressure, adult onset diabetes, and increased cortisone output

-Increased central abdominal fat, increased waste/hip ratio

-Increased estrogen levels in men, associated with higher stroke and heart attack rates

-Increased fibrogin, the basis of most blood clots; combined with a simultaneous drop in plasminogen, the natural clot buster

-Decreased somatropin (growth hormone) leading to a decline in energy, strength, stamina, heart muscle mass, and heart output

-Decreased energy and strength, causing decreased physical activity leading to obesity

 

No other single factor in the male body correlates with more risk factors for heart disease than testosterone. This personal health plan is not intended to be a book or a research paper; one could load the booklet full of medical studies to try and prove a point. A single citing would be research done by Dr. Gerald Phillips at Columbia University. He published his study results in 1994 and showed that the lower the patients’ testosterone level, the greater degree of heart disease as measured by narrowing of the coronary arteries. Other major risk factors: fibrinogen, plasminogen, insulin, and HDL provided a powerful convergence of observed effects and mechanisms.

 

Diabetes (Testosterone)

It was a well established fact 20 years ago that testosterone levels and insulin levels are quite causally related. Most people who understand the process understand that people who are obese usually are insulin resistant. Testosterone, together with somatropin, helps to lower insulin resistance and to moderate the effects of stress hormones such as adrenaline and cortisol so the pancreatic cells making insulin don’t get “burned out” trying to produce the extra needed to combat the insulin resistance.

 

Brain (Testosterone)

In the August 2006 Annals of Neurology journal an article appeared named “Endogenous sex hormones, cognitive decline, and future dementia in old men.” The nine year long study including 2300 men found that higher testosterone levels in older men were not associated with an increased risk for dementia or Alzheimer’s disease. The study did find a direct correlation between high estradiol levels and risk for cognitive decline and Alzheimer’s. (The higher the estradiol level, the higher the risk.)

 

Cancer (Testosterone)

The most powerful sex hormones in men and women are testosterone and estradiol respectively. As men age a chemical process takes place where an enzyme called aromatase converts testosterone to estradiol and other estrogens. This is one of the agents of loss of sex drive for men, as well as the chief causative agent in age onset gynomastia (man boobs). While gynomastia is the brunt of many jokes, since a local physician died of breast cancer and as a guy I have gone through a mammogram, a sonogram, and a breast core biopsy to rule out a malignancy, it is not a funny subject to me. I take limiting estradiol to normal healthy levels for a male seriously. Arimidex is an anti-aromatase medication. Progesterone is naturally anti-estrogen and is a normally occurring hormone in men.

 

The discussion of how best to mitigate both benign prostatic hypertrophy and cancer of the prostate is a complicated and controversial one. Just one analogy may prove illuminating. Chemotherapy for breast cancer now includes alternating anti-estrogen and estrogen supplementation therapy. This flies directly in the face of previous beliefs regarding sex hormones and breast cancer. The point is that contrary to some doctors opinions, testosterone replacement therapy is far less suspect in BPH and cancer of the prostate then has been promulgated in the past. Again, following the money trail, the pharmaceutical giant Merck paid for a study it had hoped would definitively prove the efficacy of their patented prescription drug, Proscar. The study results showed that Saw Palmetto actually had more than twice as great an effect on increasing the urine flow rate in men with BPH as did Proscar. Even though Proscar very often causes impotence and Saw Palmetto has no side effects, Merck still actively promotes its prescription drug.

 

Sex, Men, and et cetera (Testosterone)

In the current negative, supercharged, feminized, and politically correct public discourse on “alternative”, non-establishment medicine, it is impossible in any general forum to dispassionately discuss the positive benefits of testosterone replacement therapy. It is not my intent here to mount an indictment of the powerful medical establishment's predominant views. I will simply state that the loss of a healthy male's testosterone level spells the end of normal sexual function. This would be depressing enough for most men, but is often accompanied by symptoms of mental fatigue, inability to concentrate, and a general feeling of being “burned out”. The relative degree to which the usual subsequent depression is mostly physiological or mostly circumstantial is entirely unimportant to a man who feels that his quality life has ended.

 

Thyroid

Typically 90 mg (Armour) - Thyroid might be called the “heat” hormone, it regulates metabolism in the body. Thyroid hormone therapy is usually delivered as prescription synthetic T4, such as Cytomel or Synthroid. The old porcine form Armour thyroid delivers bio-identical T3 and T4 in a more natural ratio. Care should be exercised when making comparisons to the reduction of thyroid stimulating hormone “normally” seen when prescribing the more potent synthetic T4’s. Since TSH will respond to the T3 of the Armour, too little thyroid may be prescribed. Additionally, using TSH as the only indicator for hormone level adjustment makes the assumption that the master hormone system is optimally healthy while the production system is broken. Measurement of the free T4 level is crucial to the decision making process.

 

Miscellaneous

Of the seven bio-identical (human form) hormones listed above, five are very easily and inexpensively manufactured and two, insulin and somatropin, are necessarily of recombinant DNA origin. Both of these hormones must be delivered subcutaneously.  Thyroid and Melatonin  can be dosed orally.  After Estrogen, Progesterone, and Testosterone are regulated to constant levels, one can use a compounding pharmacy to make up a single transdermal cream (with the possible addition of DHEA if desired) to be used as a convenient and sensible delivery system for these hormones. The prescription product called AndroGel, the first of the major prescription forms of testosterone, makes a tremendous amount of money for its manufacturer. The patent is on the delivery system as testosterone itself, being a naturally occurring substance, is not patentable. And the delivery system is little more than hair gel in little packets. The cost of production to the manufacturer of AndroGel compared to the selling price, making an annual profit measured in billions, is difficult not to assess as immoral.