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Age Management Medicine: A bio-identical “natural” hormone replacement for men and women, to regulate consistent hormone levels in the body which restores the quality of life that age has disrupted.

National Institute of Aging Study


Age Management is a medical specialty that emphasizes preventive medicine first-focusing on the prevention of disease, slowing the aging process, and enhancing health. Hormone modulation is the second component of Anti-Aging medicine, and it is geared towards enhancing performance, as well as preventing disease. Prior to discussing the specifics of hGH and testosterone, it should be noted that lifestyle modification, sound nutritional practice, and careful monitoring are essential to achieve the maximum benefit from hormone modulation.

Testosterone levels decline gradually in men, starting from approximately age 30, and this decline continues throughout life. In women, levels decline precipitously at menopause, along with estrogens and progesterone. In both sexes, along with this decline in testosterone, comes a decrease in libido, lean body mass, strength, energy, mood, sexual performance and mental acuity.

Somatopause is the decline in growth hormone level that occurs gradually from young adulthood throughout life, and it occurs in both sexes at roughly the same rate. This decline in growth hormone leads to a decline in IGF-1, the hormone that is made in the liver in response to growth hormone. The decline in IGF-1 also parallels the decline of all the attributes mentioned above under testosterone. In addition, with lower IGF-1 levels we also see a decrease in skin thickness, bone density, aerobic capacity, and the healing rate of wounds. On the other hand, some things go up as growth hormone (and IGF-1) go down; these are: body fat, waistline, waist to hip ratio (an indicator for risk of heart attack), LDL cholesterol, average days of illness, and hospitalization rate.

Given the similarity of problems associated with the drop in both of these hormones, one might ask: is it the decrease in testosterone or growth hormone (IGF-1) that results in state of decline in body composition and functional capacity associated with aging? This is the question undertaken by the National Institute on Aging, under the guidance of Marc Blackman M.D. of Johns Hopkins University in 1994. They initiated a study of men and women, aged 61 to 84, who were in somatopause, as well as either andropause (for men) or menopause (for women). The objective was to determine whether the supplementation of growth hormone, estrogen plus progesterone, or testosterone, had any affect above placebo in the restoration of body composition and functional capacity in the aging population; and if so, which hormones were responsible for which benefits, and to what degree relative to one another.

This was a very ambitious study and a beautifully designed one. The study was double blind, which means neither the practitioner nor the patient knew whether they were receiving the real hormone or placebo. Enrollees in the study were randomly distributed to either the placebo or the hormone group. It was done in multiple different centers to minimize practitioner bias and it was, of course, placebo controlled. The men were divided into four groups to be administered the following:

1. Growth hormone plus placebo
2. Testosterone plus placebo
3. Growth hormone plus testosterone
4. Placebo plus placebo
Women were divided into four similar groups, the only difference being that estrogen plus progesterone was administered to women instead of testosterone.

The outcomes of the study (results) can be summarized as follows:

1. Total body weight did not change in any of the groups.

2. Lean body mass increased in both men and women who were on sex hormones alone (Testosterone in men, estrogen plus progesterone in women), or growth hormone alone, or both sex hormones and growth hormone. Lean body mass increased more in men on growth hormone plus testosterone, than on men who were on either of those hormones alone.

3. Strength was increased primarily by testosterone. Growth hormone had little or no effect on strength by itself, and estrogen plus progesterone had no effect on strength in women.

4. Aerobic capacity was primarily boosted by growth hormone. Testosterone improved aerobic capacity ever so slightly, but growth hormone improved it substantially. Interestingly, the combination of growth hormone and testosterone were again additive, meaning those on both hormones did better than those on either hormone alone.

5. Women on estrogen and progesterone did not reduce body fat. Men on testosterone reduced body fat by 3-5%. Men and Women on growth hormone reduced body fat by 14%. Once again, testosterone and growth hormone were additive. Men on both of these hormones decreased body fat by 17-18%.

6. LDL (bad cholesterol) was reduced in those on growth hormone. Total cholesterol also came down in the growth hormone groups, and the ratio of total cholesterol to HDL (coronary risk ratio) also declined, indicating less risk for heart attack.

7. No benefit of testosterone on cholesterol levels was mentioned on the report in this study. However, many other studies in the literature point to the fact that in men, testosterone lowers triglycerides and raises HDL cholesterol, both of which reduce risk for heart attack. In some studies on women, testosterone is shown to lower HDL (good cholesterol), indicating a potentially increased risk for heart attack. We approach this by monitoring the HDL carefully in women on testosterone. We have found that in some women the HDL goes down, and in others it does not. When it does go down we have several options:

a) We can reduce the testosterone dose or stop it all together;
b) We can use another agent to raise HDL cholesterol, such as Niacin (Vitamin B3);
c) Or we can use another agent for cholesterol control so that we bring the coronary risk ratio down where it should be.
The particular course we take varies with patient preference. The most important task is to continually monitor the testosterone and HDL level going forward so that we are able to learn how each individual's physiology is affected by the various interventions, arriving at the best possible benefit with the least possible risk.

8. Blood pressure did not change in any of the groups except one: those men on growth hormone and testosterone experienced a statistically significant decrease in diastolic blood pressure.

9. Side effects were non-existent in the testosterone group. The group of women on estrogen plus progesterone experienced some breast swelling and tenderness and rarely some irregular menstrual type bleeding. The patients on growth hormone did experience some fluid retention, although it was minor, and easily controlled by reducing the dose. The symptoms of fluid retention were water weight gain and mild joint discomfort (again, remedied by reducing the dosage).

Prostate health is a big concern for men, and often comes up when discussing risks of supplementing growth hormone and/or testosterone. In the NIA Study, both PSA (Prostate Specific Antigen) and international prostate symptom scores (IPSS) were followed. In men on testosterone alone, no change in either of these numbers occurred. In men on growth hormone plus testosterone, however, the PSA declined while there was no change in the IPSS. This was very reassuring to those of us practicing Anti-Aging medicine. Not only were there no prostate complications and no increase in prostate symptoms, but also the PSA actually dropped in men on growth hormone plus testosterone.

Our observations of men and women on testosterone, in general, show an increase in muscle mass, strength, libido, and energy levels, as well as mood elevation. We also often see improved sexual and cognitive performance. Cognitive performance is difficult to attribute to a particular hormone however, since we are also making lifestyle modifications and adding a variety of nutriceuticals, some of which are designed to enhance memory and cognitive function.

Our observation of men and women on growth hormone is that they sleep better and awaken refreshed. They have more energy and improved aerobic capacity. They are dropping body fat and increasing muscle mass and getting sick less often. Average bone density increases over the course of a year. Skin becomes thicker and smoother with fewer wrinkles. Spider veins also tend to decrease as a virtue of thickening of the skin. The cholesterol profile usually improves as LDL (bad) cholesterol generally goes down with the use of growth hormone. Finally, there is an enhanced feeling of well being, often described as mood elevation.

Testosterone is dosed in women using a vanishing cream that is applied every morning to the skin. Men may use the vanishing cream, but we prefer to use injectible testosterone. The patient takes an injection about once a week. We teach patients to do this right in the office, and very nearly 100% of patients are able to give themselves injections at home with very little discomfort. It becomes very routine. More importantly, the results of the injectible testosterone seem to be much better than any other method we've looked at, particularly in strength, energy, and libido. Our goal for laboratory measuring of our results is to see the testosterone level rise to the upper normal for men, and certainly not beyond that. This is another instance where monitoring the level is critical. We check the levels at least every three months.

Growth hormone is administered by subcutaneous injection, using a tiny 30-gauge needle that often is not even felt; there is now even a needle-less option. This is done six mornings a week. The dose of growth hormone is based on a patient's age, sex, weight, IGF-1 level, his or her response to therapy, and the affordability.

The cost of the growth hormone program can range from $300 - $500 per month. Monitoring of IGF-1 level, as with other indicators, is critical.

In closing, we must keep in mind that we are not treating hormone levels; we are treating patients. Hormones are merely an important tool in providing our patients with an enhanced quality of life and a longer potential life span.
 
Age Management Medicine and Anti-Aging Medicine are not interchangeable terms. There are substantive differences between the two that require clarification.
 
Age Management Medicine is defined as preventive medicine focused on regaining and maintaining optimal health and vigor. This medical specialty incorporates well-known and accepted markers of disease-risk into proactive patient management and uses hormone modulation for the endocrinologically normal by identifying hormone levels that yield superior health outcomes. For most hormones, this is simply the upper 33% of the normal range for a patients age. The exceptions are insulin and cortisol that should be modulated to the lower 33% of the normal range.
 
Age Management Medicine recognizes that successful therapies necessitate healthy lifestyle including optimal low glycemic index nutrition, appropriate nutrient supplementation, and the absolute need for physical exercise. Age Management Medicine focuses on the synergy of all of these elements in order to enhance vitality and extend our health span. While we may or may not be able to increase longevity, we are able to prevent premature disability and death and enhance quality of life.
 
Contrary to Age Management Medicine, the term Anti-Aging Medicine has gained a great amount of negative notoriety while making uncorroborated implications. The Anti-Aging industry continues to promote products that are useless and in some cases fraudulent in nature. Anti-Aging Medicine claims that aging is a disease. It is not a disease, but rather a process that we all experience.
 
The most important element necessary for the success of any medical therapy is the expertise and experience of the physicians in whom you place your trust for your health care. Dr. Johnson has a wealth of experience in hormone modulation therapies, nutritional strategies and exercise science.

The Role of Natural Hormones in Managing Menopause

As women age and approach their 40’s, subtle and in some cases more obvious changes in hormone levels can result in noticeable changes in how they feel. In some cases, symptoms develop at ages as early as the 30’s. Birth control pill users may notice symptoms that indicate hormone imbalance that require medical attention. Premature menopause can develop from surgery to the ovaries, uterus, tubal ligation, radiation or chemotherapy. Surgery induced menopause requires immediate hormone replacement. Chemotherapy and radiation can be damaging to the ovaries and interfere with hormone production. While we usually think of estrogen lacking around this time, in some cases women can be helped with progesterone replacement only. Progesterone can be especially helpful for those who aren’t ovulating monthly (major source of progesterone). Maybe you have noticed changes like you’re not sleeping as well at night, or you seem more irritable and anxious lately. Perhaps you’re having more frequent headaches, or you are experiencing urination problems. Sometime a visit to your health provider is helpful. Other times you leave the office frustrated and feel that you haven’t accomplished your goals. I’ve found that some practitioners aren’t interested in working closely with their patients who are experiencing annoying hormone imbalance problems. Assessing and managing women with a hormone imbalance requires considerable time and expertise. Objective data (hormone testing levels), along with a complete physical and a detailed history are important in evaluating possible hormone problems. Let’s assume that your medical provider makes a diagnosis of hormone imbalance and with your permission decides to start hormone replacement. What are your choices? What hormones are available? Should you take the traditional hormone replacement, which is most often an estrogen that is either horse derived or synthetic, and a progestin (prevent uterine overgrowth) that is also synthetic? If you’re not offered alternatives (herbs, nutritional supplements, stress reduction, bio-identical hormones), then you will most likely follow the path of most women today, traditional hormone replacement. However, it’s not too late to educate yourself about healthier alternatives. In this newsletter we will investigate why many health professionals feel that menopausal women are being underserved by using commercially available formulations for their symptom management, bone density benefits, and heart disease.

Currently, conventional medicine uses strong synthetic hormones and birth control pills for most hormone related problems (PMS, infertility, post-hysterectomy, menstrual irregularities, menopause). These synthetic chemicals don’t fit perfectly into the hormone receptors that are found in our brain, bone, uterus, and other tissues in the body. I often use the analogy of a lock and key. If you use the wrong key to unlock your car door, you may find that the key enters the lock, however there isn’t a perfect fit and therefore, the lock doesn’t unlock and the door doesn’t open. Hormones that we produce in our body are made to fit exactly into the receptors that are located on the cells through-out our body. A hormone produced in the testes or ovary will always make a perfect match with the cell receptor. A synthetic hormone will never make a perfect match. It may bind to the receptor, however, it will produce a different action then the intended natural hormone. This different action accounts for the high likelihood of side effects that we see with traditional hormone replacement. We don’t see these side effects (if dosed appropriately) when we use hormones that are chemically identical to the ovarian hormone that we are replacing. In addition, the synthetic and horse obtained hormones are metabolized by the liver and excreted out of the body in a much slower and less complete fashion then a natural hormone would be. It makes sense that the body is set up to produce and excrete sex hormones in a safe and efficient method. Our body isn’t equipped with special cells and enzymes to breakdown and excrete man made hormones as efficiently as our own hormones. So what happens to these unnatural hormones? They may accumulate in the body and produce even more toxic effects. This helps to explain why so many women complain of unbearable side effects with traditional hormones. So far we have identified two differences between synthetic hormones and the hormones produced by our body. One difference being the binding ability and subsequent physiologic response that separates synthetic hormones from our natural hormones. The second difference being the metabolism and excretion by the body. There is a third difference. Synthetic hormones are more potent then natural hormones. Therefore, they suppress your own natural hormone production. We know that bio-identical hormones, when dosed appropriately, do not inhibit normal ovarian hormone production. We do not want to suppress the natural hormone production, we only want to supplement it.

So what can we do if we require hormone replacement (based on blood levels, medical history and physical exam), but we don’t want to take what’s usually offered? If you’re already using bio-identical hormones (chemically identical to human hormones) then you’ve already researched and made your decision. For those of you that are undecided, or are presently taking the synthetics, I would like to explain what your options are for hormone replacement. Before we do that I want to explain why the marketplace allows only synthetic hormone replacement.

I first need to explain why drug companies manufacture synthetic hormones and why doctors prescribe them. In the United States drug manufacturers research and eventually apply for a patent on hormones that appear promising in their studies. They spend millions of dollars proving that their hormone is safe and effective. Therefore, they expect and receive the right to be the exclusive distributor of that hormone. Through advertisements and continuing education programs, doctors learn about these hormones and eventually prescribe them for their patients. Natural hormones (those that are identical to ovarian hormone) are not patentable.

This means that anyone who manufactures and sells them won’t have exclusive distribution rights. Therefore, there is much less profit and very little incentive to manufacture them. This is where compounding pharmacists enter the hormone distribution process. Compounding pharmacies buy bulk hormones powders from chemical suppliers, and formulate the hormones into capsules, creams, lozenges, etc. We don’t have salespeople that market our products to prescribers. Our formulations become known primarily via word of mouth. We don’t have expensive studies to compare our compounded formulations to manufactured hormones, however we know that we are quite simply, replacing ovarian hormone with a hormone that is identical to the ovarian hormone. Some practitioners are annoyed at our lack of studies and will dismiss natural hormones. None the less, consumers interest in the natural alternatives continues to grow, and we find ourselves frequently explaining what natural hormones are to the public and to health practitioners. This continued interest has resulted in several community talks each year that I give on natural hormone replacement.

What are the bio-identical hormones that women require for proper hormone balance? The bio-identical hormones are as follows; estrone, estradiol, estriol, progesterone, DHEA, testosterone, and pregnenolone. All are available to compounding pharmacists in powder form from chemical suppliers. There are three estrogens produced by the ovary; estrone (E1), estradiol (E2), and estriol (E3). Estradiol is the most potent of the three and is an important hormone from puberty to menopause. Estrone is less potent then estradiol, and becomes an important hormone after menopause. Estriol is the least potent of the three, and is especially important for vaginal dryness and urinary problems. It is also the major estrogen during pregnancy. Estriol is touted to be the “safe” estrogen, and may compete with estradiol for receptor binding sites on the cell. The theory being that estriol is the least proliferative (less stimulating to breast and uterine cell growth) of the three estrogens, and therefore the safest.

By using the “right” balance of hormones, we might gain the benefits of hormone replacement without increasing the risk of cancer. Traditional estrogen replacement replaces only one of the three estrogens (only estradiol or estrone), and omits the “safe” estrogen, estriol. As reported in our last newsletter, women have a natural balance of weak and strong estrogens. For best health, there should be more weak estrogen (estriol) then strong (estradiol and estrone). The strong estrogens can cause breast cells to multiply and increase the risk of cancer.

In 1966, the Journal of the American Medical Association (JAMA) published the article “Reduced Estriol Excretion in Patients with Breast Cancer.” Their conclusion was that breast cancer patients had more strong estrogens and less weak estrogens then women who don’t get breast cancer. We know that the body fat produces strong estrogens, which might explain why heavier women get more breast cancer.

Another JAMA article in 1978 titled “Estriol, the Forgotten Estrogen,” supported the theory of supplementing with estriol in patients who have had breast cancer. If estriol can block the strong estrogens form binding to the hormone receptors, it should, therefore, theoretically decrease the risk of cancer. I have included the references for these two articles at the bottom of this page.




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