|
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
The Role Of Somatotroph-Specific
Peptides And IGF-1 Intermediates As An Alternative To hGH Injections October 30, 1997 Background The age-reversing effects of growth hormone injections have been established in several clinical trials. Results consistently demonstrate increased muscle mass, reduction in body fat, enhanced immune function, improved healing rate of injuries, increased endurance, improved sexual function, hair regrowth, thickening of the skin, and improved mental function. Side effects include edema, carpal tunnel syndrome, allergic response, possible down-regulation of endogenous GH and promotion of cancerous tumor growth. These side effects, the high cost and inconvenience of GH injections, and the knowledge that hGH continues to be produced, but not released by pituitary somatotrophs, has led to an abundance of research on GH secretagogues, which appear to stimulate the release of GH within physiologic boundaries. This research often involves the use of injectable peptides and other sensitive materials, which are marginally effective at raising IGF-1 levels, and consequently have not generally elicited the symptomatic improvement demonstrated with GH injection therapy. Abstract Thirty-six individuals with low levels of Insulin-like Growth Factor Type 1 (IGF-1 <350ng/ml), were evaluated clinically for changes in existing symptomatology and serum IGF-1 levels over a period of 12 weeks while being administered Symbiotropin, a combination of anterior pituitary peptides, sequenced glycoamino acid complex, pharmaceutical saccharides, a plant-derived source of L-Dopa, and botanical regulators of insulin and IGF-1. Patients experienced a 30% average increase in IGF-1. Patient self-assessments in areas of endurance and body composition, hair and skin, sexual function, healing and immunity, and mental function reflect significant improvement in all 23 areas of evaluation, with range of 21% - 74% of patients reporting improvement in these areas. Additional clinical observations reflect significant improvements in blood sugar management in diabetic patients, lowered prostate-specific antigen (PSA), improved cardiac and pulmonary function, blood pressure management, and improvement in menopausal symptoms. Introduction Unlike other endocrine hormones, which diminish in production with age, hGH is continuously produced by pituitary somatotrophs well into the 70's and 80's, except in the presence of certain pituitary disorders. However, in a state referred to as somatopause, circulating growth hormone levels diminish due to a variety of influences that cause hGH to remain sequestered in pituitary somatotrophs. Age-related increase in production of the hypothalamic hormone somatostatin plays a dominant role in limiting growth hormone release. Age-related decrease in the hypothalamic hormone growth hormone releasing hormone (GHRH) limits hGH release. Excessive carbohydrate intake and diminishing pancreatic function lead to decreased growth hormone release due to poor blood sugar management. Pituitary receptors have been identified that respond to specific hGH-releasing peptides. Hypothalamic receptors have been identified that respond to peptides, which inhibit somatostatin and stimulate GHRH. Management of growth hormone secretion through the use of peptides and other compounds generally increases the amplitude and frequency of growth hormone release within physiologic boundaries. CHARACTERISTICS OF GH DEFICIENCY Anabolic Tone Reduced lean body mass and/or skeletal
muscle mass Elevated LDL cholesterol Osteopenia (lack of bone) Insulin resistance (in obese people)
Thin skin Reduced glomerular filtration and
renal plasma flow Reduced energy AREAS OF IGF-1 ACTIVITY Synthesized by Leukocytes Method Thirty-six patients, 18 women and 18 men, were selected for this study based on IGF-1 measurements that indicate GH deficiency. Initial IGF-1 measurements ranged from 21 to 276. Patients were instructed to take two Symbiotropin effervescent tablets dissolved in water four hours after the last meal and prior to retiring. This schedule was maintained in five-day cycles, with two days separating each cycle for a term of twelve weeks. IGF-1 levels were measured before the onset of Symbiotropin therapy and then at four week intervals. Patient self-assessments were performed every four weeks throughout the twelve week term. Additional clinical observations were made during routine office visits. Results The results of patient self-assessments indicate symptomatic response to Symbiotropin within the first four weeks in all patients, with continued improvement between the fourth and twelfth week. Improved energy, endurance, and body composition were among the most frequently reported improvements within the first four weeks. New hair growth, restoration of hair color, thickening of skin, and disappearance of skin discoloration generally occurred between the eighth and twelfth weeks, with continued improvement beyond the twelve week term. It should be noted that the results of this patient self-assessment are not adjusted for areas that did not apply to each individual Average increase in IGF-1 through first 12-week cycle of Symbiotropin No side effects were observed that could be attributed to Symbiotropin. One female patient was removed from the study due to a citric acid allergy that was aggravated by Symbiotropin. IGF-1 measurements indicate continued increases in IGF-1 throughout the twelve week term. Measurements taken during the first four weeks indicate increases of over 200% and averaging over 18%. Eight week measurements indicate increases of over 100% and averaging 24%. Twelve week measurements indicate a 30% average increase in IGF-1. Rate of symptomatic response occurred independent of the rate of IGF-1 increase. Conclusion Symbiotropin appears to offer benefits that are similar to those found with hGH injections. Symptomatic improvements generally occur more rapidly and with fewer side effects. Cost is approximately 1/10 of hGH injections, while the convenience of a drink allows for greater compliance. Symptomatic improvements with Symbiotropin, which were not included in the patient self-assessment, indicate that its therapeutic potential may exceed that of hGH injections. Consistent and significant improvement in diabetes, BPH, hypertension, cardiomyopathy, pulmonary disorders, rheumatism, Crohn's disease, obesity, and chronic fatigue syndrome, all warrant further investigation into Symbiotropin's therapeutic potential. REFERENCES Bierich JR. Multicenter clinical trial of authentic recombinant somatropin in growth hormone deficiency. Acta Paediatr Scand Suppl 1987; 337:135-140. Ho KY, Evans WS, Blizzard RM, et al. Effects of sex and age on the 24 hour profile of growth hormone secretion in man: importance of endogenous estradiol concentrations. J Clin Endocrinol Metab 1987; 64: 51-58. Hall K, Sara VR. Somatomedin levels in childhood, adolescence and adult life. J Endocrinol Metab 1984; 13:91-112. Meites J. Neuroendocrine biomarkers of aging in the rat. Exp Gerontol 1988; 23:349-58. Finkelstien JW, Boyar RM, Roffwarg HP, Krean J, Hellman L. Age-related change in the twenty-four-hour spontaneous secretion of growth hormone. J Clin Endocrin Metab 1972; 35:665-70. Clemmons DR, Van Wyk JJ. Factors controlling blood concentrations of somatomedin C. Clin Endocrinol Metab 1984; 13:113-43. Florini JR, Prinz PN, Vitiello MV, Hintz RL. Somatomedin C levels in healthy young and old men: relationship to peak and 24-hour integrated levels of growth hormone. J Gerontol 1985; 40:2-7. Jorgenson JOL, Pedersen SA, Thuesen L, et al. Beneficial effects of growth hormone treatment in GH-deficient adults. Lancet 1989; 1: 1221-5. Salomon F, Cuneo RC, Hesp R, Sonksen PH. The effects of treatment with recombinant growth hormone on body composition and metabolism in adults with growth hormone deficiency. N Engl J Med 1989; 321:1797-803. van der Werff ten Bossch JJ, Bot A. Effects of human pituitary growth hormone on body composition. Neth J Med 1987; 30:220-7. Crist DM, Peake GT, Mackinnon LT, Sibbit WL Jr, Kraner JC. Exogenous growth hormone treatment alters body composition and increases natural killer cell activity in women with impaired endogenous growth hormone secretion. Metabolism 1987; 36: 1115-7. Unterman TG, Vasquez RM, Slas AJ, Martyn PA, Phillips LS. Nutrition and somatomedin. Usefulness of somatomedin in nutritional assessment. Am J Med 1985; 78:228-34. Rudman D. Growth hormone, body composition, and aging. J Am Geriatr Soc 1985; 33: 800-7. Rudman D, Feller AG, Nagraj HS, Gergans GA, Lalitha PY, GoldbergAF, et al. Effects of human growth hormone in men over 60 years old. N Engl J Med 1990; 323:1-6. Kelly PJ, Eisman JA, Stuart MC, Pocock NA, Sambrook PN, Gwinn TH. Somatomedin-C, physical fitness, and bone density. J Clin Endocrinol Metab 1990; 70:718-23. Rizza RA, Mandarino LJ, Gerich JE. Effects of growth hormone on insulin action in man: mechanisms of insulin resistance, impaired suppression of glucose production, and impaired stimulation of glucose utilization. Novak LP. Aging, total body potassium, fat-free mass, and cell mass in males and females between the ages of 18 and 85 years. J Gerontol 1972; 27: 438-43. |
|
Triune-Being
Research Organization Ltd. 9549 107th Avenue, Edmonton, Alberta, T5H
0T6 Canada
Phone: 780-421-4284 Fax: please call for number - 604387 page hits since January 1, 2000 disclaimer |