Abilites; Update-Human growth hormone (hGH)

Barbara Brewitt, Ph.D., James Hughes, M.D., Elizabeth A. Welsh, Ph.D., Robert Jackson, D.C.

First Published in Alternative and Complementary Therapies, 1999, 5 (December): 372-385
Published in Natural Pharmacy September.2000

Human growth hormone (hGH) is well known for its ability to build lean mass, increase physical performance, enhance immune function and improve body composition and shape. _{1 2 3 4 5 6 7} Lean mass includes muscle, bone and organ density; lean mass loss below a threshold results in shortened life, muscle weakness, organ failure and death. _{8 9} Men aged 61-80 years old injecting 50 mg recombinant hGH three times a week regained youthfu
Exponential declines in hGH occur per decade ₁₃ dependent on activity level, diet, onset of chronic disease or gender. ₁₄ Women's declines are slower _{15 16} The American Association of Clinical Endocrinology (AACE) and the American College of Endocrinology suggest GHD is an age-related event characterized by fatigue accompanied with a cluster of self-perceived symptoms (Table 1) while others use serum hGH and IGF-1 levels. Pharmaceutical companies characterize 70,000 U.S adults17 with GHD while others cite 40% in persons 60-88yrs old 18 and 1 per 4000 people overall. ₁₉

Table 1 - Symptoms of Growth Hormone Deficiency _{14 20}
Fatigue - Key Symptom plus clusters of the following symptoms

• Decreased lean body mass
• Abdominal obesity and weight gain
• Decreased physical strength and decreased vitality
• Decreased muscle mass
• Reduced cardiac performance
• Impaired sense of well being
• Poor sleep
• Social Isolation
• Emotional Fragility
• Cold Extremities

Table 2 - Highlights toxic side effects from injectable hGH (0.15mg/day to 5.0 mg/day) or untreated acromegaly. _{21 22} The efficacy of non-toxic homeopathic medicines were systematically first studied by Samuel Hahnemann, M. D. ₂₃ Today's randomized, double-blind, placebo controlled clinical studies and meta-analyses validate homeopathy's effectiveness. _{24 25 26 27} Hahnemann's Law of Similars uses a founding principle of pharmacology, i.e. drugs produce positive and negative symptoms. Hahnemann observed that serially diluted and agitated homeopathic drugs maintained their key benefits without stimulating negative reactions. Abridged list of over 40 adverse side effects from pharmacological concentrations of hGH Peripheral Edema _{5 22}

• Cardio-Vascular and heart disease _{27 28 29}
• Increased Tissue Turgor ₃₀
• Musculoskeletal distress ₃₀
• Loss of lean mass ₃₁
• Joint disorders ₂₂
• SGOT Increase ₃₂
• Hypertension and sodium retention ₃₃
• SGPT Increase ₃₂
• Increased Sweating ₂₈
• Pain ₂₂
• Upper respiratory tract infections ₂₈
• Arthralgia _{21 22}
• Headaches ₂₁

We evaluated the efficacy of two formulas of homeopathic recombinant hGH (HrhGH) from three different randomized, double-blind, placebo controlled studies in healthy people 18-72 years old. We evaluated treatment versus placebo plus differences between formulas/concentration.

Results:

Weight Loss and Body Shape Changes Individuals on either HrhGH treatment lost -2.07 ± 0.52 lb/ month versus placebo (P<0.0002) (Figure 1). An additional -1.2 ± 0.6 lbs lost/month on 6X + 12C HrhGH versus 6C + 100C + 200C HrhGH (P = 0.05). Upper arm size increased +0.29 ± 0.09 inches on HrhGH versus -0.21 ±0.11 inches on placebo (P<0.0001) and HrhGH trends versus placebo diverged significantly (P = 0.01) (Figure 2).

Treatment:

Stimulated hip size losses of -2.09 ± 0.50 inches/month versus placebo (P<0.001) and trends diverged significantly (P = 0.02) (Figure 3). Baseline hip size and male gender were significant variables affecting responsiveness to 6X + 12C HrhGH (P<0.001). Chest size on 6X + 12C HrhGH increased +0.4 ± 0.2 inches compared to 6C + 100C + 200C HrhGH, P = 0.02 (Figure 4).

Waist measurements decreased -0.9 ± 0.3 inches over the 42-day period using 6C + 100C + 200C HrhGH (Figure 5) versus -0.5 ± 0.3 inches on placebo. Waist size on 6X + 12C HrhGH decreased by -0.3 ± 0.2 inches after 21 days with continued loss of -0.8 ± 0.4 inches after stopping HrhGH. Three people who only exercised reduced waist size by -2.3 ± 0.9 inches in 42- days.

Insulin-like Growth Factor-1 Measurements

Many baseline serum IGF-1 levels were below the mean reference average (P<0.0001) with significant age-related declines of -1.6 ng IGF-1/ml/year-of-age (P<0.003). Entry randomization did not evenly distribute subject's IGF-1 levels, age or gender between treatments and placebo. HrhGH stimulated upward trends +14 ± 31 ng IGF-1 /ml/month versus downward trends of -71 ng IGF-1/ml per month on placebo yielding a difference of -81 ± 54.5 ng/ml IGF-1.

Table 4- Boulder Study

Both HrhGH formulas increased serum IGF-1 levels above placebo in 21 days (P = 0.058) in the majority of subjects. Subjects 31-57 years old reproducibly raised IGF-1 levels in 15 days on HrhGH and 18-32 years old increased by 26 ± 10% after 30 days compared to no change on placebo or exercise only (Figure 7).

Lean mass

Lean mass reproducibly increased +2.5 ± 1.2 lbs on 6C + 100C + 200C HrhGH in 21 days compared to no gain on placebo (Figures 8a & 8b). The greater the lean mass at baseline, the greater the ability to gain lean mass (P = 0.006), especially on 6X + 12C HrhGH (P<0.01). Women had -7.3 ± 3.5 lbs less lean mass than men at baseline (P = 0.04).

Table 5 - Guiding Symptoms for HrhGH

*Subjects were unclear as to the question of libido, thus responded if libido increased from an existing decreased state or increased from a normal state. Placebo Group #1 knew the study substance evaluated whereas Placebo Group #2 had no idea of the substances being studied.

Blood Pressure

HrhGH treatment lowered systolic blood pressure -14.06 ± 5.48 mm/Hg per month versus placebo, P = 0.01 (Figure 9). Systolic pressure decreased -4 ± 3% when placebo crossed to 6X + 12C HrhGH and by -8 ± 4 % with 42 days of 6C + 100C + 200C HrhGH.

Guiding symptoms and characteristics

Self-perceived GHD symptoms improved with treatment versus placebo (Table 5). Fatigue reported by 46% of enrollees at entry, improved in 70% of treated subjects versus placebo. Symptoms of abdominal obesity, weight gain, decreased physical strength, decreased libido, poor sleep, depression, and mood swings, reported in 21-31% of enrollees at entry were effectively relieved with treatment. Subjects also reported relief from bleeding gums, less phlegm build-up, relief from coughing, relief from anger, relief from apathy, and relief from urogenital discharges on treatment versus placebo.

Discussion

Chewable HrhGH tablets significantly improved physical, physiological, and self-perceived, quality-of-life benefits versus placebo in terms of weight loss, decreased hip-size and increased upper arm size. HrhGH's positive effects on weight loss and decreased hip size were not influenced by any other variables. Statistically significant were time treatment effects from 6C + 100C + 200C HrhGH and gender-, age- and baseline-dependent effects from 6X + 12C HrhGH.

Rises in serum IGF-1 levels occurred with both formulas of HrhGH versus placebo or exercise. HrhGH evoked quantifiable physiological changes in the bloodstream even though the molecular mechanism of action is not characterized. Healthy adults 32-57 years old responded rapidly to treatment, raising serum IGF-1 by 21 ± 13%, while younger subjects required longer treatment periods to achieve similar or higher levels. Age- and time-related variables are cause for further study with larger sample sizes.

HrhGH lowered systolic blood pressure. The degree of change in systolic function from HrhGH mandates extensive clinical study. HrhGH improved energy, vision, libido, sleep quality, breathing, and skin softness without side effects. Unique self-perceived benefits above placebo were less phlegm build-up and relief from bleeding gums, coughing, anger, apathy, and abnormal urogenital discharges. Symptoms relieved by HrhGH treatment often matched the symptoms known to be caused from toxic doses of injectable hGH such as headaches, edema, pain, and anxiety. Reductions in systolic blood pressure from HrhGH is consistent with the findings that excessive hGH in patients with acromegaly directly correlated to cardiac abnormalities.29 34

A dosing schedule similar to that of prescription hGH (daily for 3-4 weeks then cycling to every 3-4 days) may be ideal to achieve optimal quality of life benefits without aggravations 35. Overall, HrhGH is an effective oral therapy evoking positive physiological and psychological benefits beyond placebo without toxicity.

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