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MORE FACTS: CLINICAL STUDIES ON hGH

"After ninety, there's no need to worry about dying. Not many people die over the age of ninety."
- George Burns          

CHAPTER 2

Recently, the FDA has approved hGH therapy for adults who are deficient, which includes nearly everyone over the age of 40. This is an important step in recognizing aging as a disease and opening the doors to the acceptance of a variety of anti-aging therapies. The approval of Humatrope, manufactured by Eli Lilly, is based on clinical data that demonstrate its effectiveness in increasing lean muscle mass, decreasing body fat, increasing exercise capacity, and raising HDL cholesterol ("good cholesterol") levels. Several major pharmaceutical companies have research teams who are racing to release the first FDA approved growth hormone secretagogue. There are already natural hGH secretagogues available over the counter, which are being continually refined and formulated to exceed the efficacy of growth hormone itself.

Why is there so much focus on growth hormone, and what does all of this mean for those of us who suddenly have these substances available? To put it simply, there is no other substance known to man that has such far reaching ability to prevent and reverse the aging process.

Studies published in the New England Journal of Medicine and other journals show that hGH may reverse human biological aging by:

  • Restoring muscle mass
  • Decreasing body fat
  • Thickening the skin, reducing wrinkles
  • Restoring lost hair
  • Restoring hair color
  • Increasing energy
  • Increasing sexual function
  • Improving cholesterol profile
  • Restoring size of liver, pancreas, heart and other organs that shrink with age
  • Improving vision
  • Improving memory
  • Elevating mood
  • Improving sleep
  • Normalizing blood pressure
  • Increasing cardiac output and stamina
  • Improving immune function
  • Assisting in wound healing

It may seem too good to be true that a single substance could have so many far-reaching effects, but as we look more closely at the scientific evidence from human studies and at the physiologic interaction between growth hormone and the body's various systems that affect these areas, everything begins to fall into place. By the time Dr. Rudman began his work in 1985, the safety of growth hormone had already been well established through its use in children with GH deficiency. Decades earlier, growth hormone from pituitary extract had been shown to decrease body fat significantly in laboratory rats. Dr. Rudman hypothesized that the changes in body composition which become apparent around age 35 had to do with declining hormone levels, and he began by testing hGH to examine its effects on lean body mass and body fat. Dr. Rudman studied 12 men between the ages of 61 and 80 who experienced significant changes in body composition with age, but who were otherwise healthy. These men were overweight and had significantly low levels of growth hormone. They were instructed not to alter their lifestyle in any way throughout the course of this six-month study. Despite the fact that they did not alter their diet, exercise, or smoking habits-the men who were given hGH gained an average of 8.8% in lean muscle mass while losing 14% of their body fat. They experienced localized increase in bone density and their skin became thicker and firmer. According to Rudman and his associates, the subjects of this study reversed these parameters of aging by 10-20 years. This represented the biggest breakthrough in anti-aging medicine at the time and led to a wide acceptance that, in the words of Dr. Rudman, "The overall deterioration of the body that comes with growing old is not inevitable."

In his study, Dr. Rudman used dosages of hGH that produced blood levels that exceeded those that the body would normally maintain. He and his researchers concluded that because these extremely high doses caused some side effects, including edema and carpal tunnel syndrome, "the optimum hormone dose is only one quarter to one half as great as was previously believed."

Subsequent studies have confirmed the conclusions of Dr. Rudman's study to show that lower doses of growth hormone used to replace diminished levels within a physiologic boundary, produce the same degree of benefit without any side effects. Studies done in Europe and in the United States demonstrate that hGH therapy, when used properly, improves cardiac output and stamina while restoring many of the other functions to potentially extend length and quality of life.

 

 

Metabolic Rate

In 1989, Dr. Franco Salomon and his associates in London, England demonstrated that growth hormone given to deficient adults over a course of 6 months resulted in an increase in lean body mass of over 10% and a 7% reduction of body fat. These subjects experienced an increase in basal metabolic rate as well as improved strength and exercise performance, which had previously been below normal.

Heart Failure

In Italy, Dr. Serafino Fazio recently evaluated the effects of growth hormone with moderate to severe heart failure.
The researchers found that hGH, when combined with standard heart failure treatment, resulted in increased efficiency of the heart's energy consumption and ability to pump a higher volume of blood while increasing circulation by reducing peripheral vascular resistance. This research opens the door for growth hormone to not only enhance cardiovascular output in healthy people, but to be used as an adjunctive treatment for patients with heart disease.

 

Osteoporosis

Adults who are growth hormone deficient are known to have low bone density. Growth hormone has a significant effect on the formation of new bone tissue and, as we will see in the work that Dr. Chein has done, seems to have a significant effect on restoring lost bone tissue. Standard medical protocols offer the option of slowing bone loss, but they do not cause new bone to be formed. GH and IGF-1 both stimulate osteoblast activity, which increases the formation of new bone. With standard therapy as it exists, most medical doctors would not expect to see any measurable increase in bone density in one year, yet increases of 3% to 5% per year are standard for many patients receiving growth hormone therapy.

 

Wasting Diseases

Growth Hormone is known to increase the uptake of amino acids by muscle cells, making it an excellent candidate for patients with wasting diseases like AIDS. People who experience high levels of physiologic stress such as surgery or severe burns often have difficulty in recovery from injury and develop symptoms of wasting. The use of growth hormone in these circumstances has been successful and continued study is underway. One of the underlying problems in recovering from muscle wasting is the inability to properly absorb nutrients; growth hormone not only assists in muscle formation, but in the absorption of nutrients in the digestive tract.

 

Digestive Tract Disorders

Studies by Doug Wilmore, M.D. and associates at Harvard's Brigham & Women's Hospital in Boston demonstrate the effectiveness of hGH injections combined with the amino acid L-Glutamine in regenerating the digestive tracts of patients with short bowel syndrome. Before therapy, the digestive tracts of these patients were incapable of digesting food; hence, patients had to be fed intravenously. After therapy, the same patients were able to eat solid food and absorb nutrients effectively. This work holds great promise for the number of people with colitis and Crohn's disease whose diseases typically continue to worsen with standard medical protocols. It also suggests yet another way that growth hormone therapy works to reverse the aging process. All of us experience a decline in nutrient absorption as we age due to the thinning of the lining of the digestive tract. In fact, the permeability of the digestive tract lining has been directly correlated with the onset of a variety of illnesses. When the digestive tract lining becomes very thin a patient may be told that she has Leaky Gut Syndrome-a condition that may lead to a variety of autoimmune diseases, rheumatism, allergies, and arthritis.

 

202 Patients

The largest study of the effects of growth hormone on humans has taken place at the Palm Springs Life Extension Institute under the direction of Dr. Edmund Chein, director of the institute, and his associate Dr. Leon Terry, a neuro-endocrinologist from the Department of Neurology at the Medical College of Wisconsin. Dr. Chein follows a growth hormone protocol that involves restoring GH levels is for patients who are deficient (IGF-1 less than 350 in ng/ml) with low dose, high frequency injections. Dr. Chein, by combining hGH with other hormones that are shown to be low, has developed a program that he claims has been 100% effective for all his patients. He guarantees that his patients will experience an increase in bone density of 1.5 - 2.5% every 6 months, as well as a loss of 10% body fat and an increase of 10% muscle mass. These processes may continue until the patient attains the body composition of a twenty-year-old.

Recently, Dr. Terry collected the data of patients who have been treated at the Life Extension Institute and has written up the amazing results. The following assessment figures were derived from 308 randomly selected self-assessment questionnaires that were completed by 202 patients during the term of their therapy between the years of 1994 and 1996.

 

                                                            ASSESSMENT
                             Effects of Growth Hormone Administration in 202 Patients
                                                      (Low Dose-High Frequency)
     L. Cass Terry, M.D., Ph.D. & Edmund Chein, M.D. Medical College of Wisconsin & Palm Springs Life Extension Institute

                                                              IMPROVEMENT


    Strength, Exercise & Body Fat
   
Muscle Strength................................
    Muscle Size......................................
    Body Fat..........................................
    Exercise Tolerance............................
    Exercise End....................................

    Skin & Hair
   
Skin Texture.....................................
    Skin Thickness.................................
    Skin Elasticity...................................
    Wrinkle Disappearance......................
    New Hair Growth...............................

    Healing, Flexibility & Resistance
   
Healing of old injuries.........................
    Healing of other injuries......................
    Healing Capacity...............................
    Back Flexibility.................................
    Resistance to Common Illness...........
 



88%
81%
72%
81%
83%
 

71%
68%
71%
51%
38%


55%
61%
71%
53%
73%
 


Sexual Function
Sexual Potency/Frequency...............
Duration of Penile Erection................
Frequency of Nighttime Urination.......
Hot Flashes.....................................
Menstrual Cycle Regulation..............

Energy, Emotions, & Memory
Energy Level....................................
Emotional Stability...........................
Attitude Toward Life..........................
Memory..........................................

 

 



 


75%
62%
57%
58%
39%


84%
67%
78%
62%

 

 


 

 

In general, these improvements were reported to occur within I to 3 months of the on -set of therapy with a tendency to continue improving over 6 months of treatment. Chein and Terry are currently studying the effects of hGH replacement therapy on triglycerides, HDL and LDL cholesterol, PSA, blood pressure, and cardiovascular fitness.

It is important to note that Drs. Chein and Terry believe in a total approach to deterring the aging process by replacing a variety of hormones that are deficient, using aerobic and resistance training, dietary evaluation, and stress reduction.
We believe in the importance of this well-rounded approach as well. From clinical experience, when a wider range of hormones are replaced to overcome deficiency, greater results may be obtained with lower doses. As we detail in future chapters, using the proper diet and exercise techniques to stabilize insulin and enhance growth hormone release are essential to attaining optimal results.

Chein and Terry have demonstrated a 61% increase in IGF-1 levels after I to 2 months of hGH therapy with low dose high frequency (LD-HF) injections without the major side effects found in studies that involve much higher dose lower frequency injection of hGH. However, some patients experienced minor joint pain and fluid retention, which disappeared after the initial two months of therapy. While the LD-HF protocol appears to more closely mimic the patterns of the body's own growth hormone release when compared with the high dose low frequency dosing used by Rudman; it does not precisely duplicate our natural release patterns. This may account for the minor side effects found in Chein's patients.

 

Can the Side Effects be Overcome?

Upon recognizing the importance of restoring growth hormone to physiologic levels in order to maximize the effectiveness and reduce side effects, it is important to examine the effects of natural secretagogues. Natural secretagogues may be our best hope for raising growth hormone in an entirely physiologic manner because of the ability to stimulate the endocrine system to release its own growth hormone, Reference to the stimulation of the endocrine system rather than the pituitary alone, reflects the complex interactions among the liver, pancreas, adrenals, thyroid, hypothalamus, and pituitary that effect the release and response to growth hormone.


"Once we've identified the fight materials to use, the most challenging obstacles in attaining consistent and significant growth hormone release are 1) absorption and 2) delivery to the proper receptor sites. Our team has researched and developed an array of Chaperone Molecule delivery systems that address gastric absorption, transport through the bloodstream, and attachment to appropriate receptors. What's exciting is that we're using all natural substances."

                                                                                             -Pharmacologist James Jamieson

There are a variety of nutrients and other natural substances that have been demonstrated to increase the release of growth hormone. For instance, the amino acid L-glutamine has been shown to increase growth hormone by 15%, while the endogenously produced substance, L-dopa, has been shown to restore youthful levels of growth hormone for men over the age of 60. The amino acid arginine is used as a standard in measuring growth hormone secretory potential, where the patient is loaded with arginine and subsequent IGF-I levels are measured. It is plausible that the proper combination of natural substances could produce a synergistic effect that would exceed that of any single nutrient if the proper knowledge of biochemistry and clinical response were combined with the right pharmacology. But, in order to arrive at an effective means of accomplishing this - we must understand...

_______________________________

I've noticed my hair is turning darker.

-M.B. (Female, Age 76)

"I saw a definite change in my overall feeling within a few weeks. I am 62 years old and before starting this regime, I felt like I was 82. After 2 months I now breathe better with no more wheezing, my body is firmer,
my stamina has improved, my memory is much better and I feel as if I were a 45 year old again."

-B.S. (Male, Age 62)

_______________________________

 

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