Barbara Brewitt, Ph.D., James Hughes, M.D.,
Elizabeth A. Welsh, Ph.D., Robert Jackson, D.C.
Human growth hormone (hGH) receives a good deal of public attention for the ability to build lean body mass, increase physical performance, enhance immune function, and improve body composition and shape.(1-7) Lean body mass includes muscle, bone, and organ density, i.e., the body's fat-free mass. Maintenance of lean body mass extends life, because muscle weakness, organ failure, and death are direct results of lost lean body mass.(8, 9) In one study, men, ages 61-80 years old, who injected pharmacologic concentrations of 50 mg of recombinant hGH 3 times per week for 6 months improved in health achieving a state that is more similar to a youthful state by raising lean body mass by 8 percent, decreasing fat by 14 percent, increasing spleen and liver sizes by 18 percent, and increasing bone density.(10) Other clinical studies on adults with growth-hormone deficiency (GHD) found that hGH replacement therapy improved subjects' body composition and quality of life.(3-5, 11, 12)
Problems Associated with Too Much or Too Little hGH
The American Association of Clinical Endocrinology defines GHD as a cluster of self-perceived symptoms as listed in Table 1. Age-related declines in hGH and insulin-like growth factor (IGF)-1 levels are also used to define GHD. Following puberty, hGH declines exponentially.(13) Growth-hormone (GH) secretion peaks at 31 years of age, then declines by 14-50 percent per dectension. In acromegaly, the most striking problems are enlargement of the heart, lungs, liver, thymus, and spleen. Hyperthyroidism may result in addition to hyperglycemia and glucosuria. Finally, overgrowth of the bones in the face, hands, and feet occur. The jaw protrudes and becomes massive, with thick lips and an overly large tongue, and there is accentuation of the orbital and frontal ridges. The adrenal, thyroid, and parathyroid glands hypertrophy or overgrow.
The most notable abnormality caused by excess hGH is early hypersexual drive followed by gonadal atrophy, impotence, and amenorrhea. Positive and negative effects of hGH highlight the body's complex feedback mechanisms, which respond to various time dependent and environmental conditions to achieve homeostasis. It may be possible to develop a new, nontoxic, delivery for hGH as an over-the-counter medicine to address the self-diagnosed symptoms of GHD during the aging process. Oral supplementation with homeopathic hGH necessitates systematic evaluation for efficacy. In clinical practice, homeopathic drugs have demonstrated effectiveness repeatedly, (22-24) bringing the body closer to homeostasis.(25)
Some Homeopathy Basics
Homeopathy uses drugs that have been highly diluted to produce safe, less expensive, and nontoxic medicines. Injectable recombinant hGH is expensive, often costing $1,000 or more per month. Samuel Hahnemann, M.D., the founder of homeopathy, developed the well-known Law of Similars after years of observing the interactions between drugs and the body.26He identified two elements underlying the fundamental principle of pharmacology, i.e., a drug has a physiologic effect on the body and the body reacts positively and negatively to a drug, producing symptoms. Dr. Hahnemann found that, by serially diluting drugs into homeopathic preparations, he could induce patients to experience key positive attributes of drugs without having their associated negative reactions. The first systematic study of drug action was the homeopathic practice of "proving" potential medicines on healthy volunteers.(27) Typically, a homeopathic drug proving includes assessment of the drug's action on healthy subjects at concentrations high enough to produce or alleviate symptoms in sensitive individuals. Data collected from self perceived symptoms on verum (treatment) versus placebo are compared to determine each drug's guiding symptoms and characteristics.
The Three Studies
We evaluated the efficacy of homeopathic recombinant human growth hormone (HhGH) in three different double-blind placebo-controlled studies. First, we evaluated if there was statistical significance between treatment and placebo; second, we evaluated different treatment effects based on the concentration of treatment. Our results suggest that HhGH provides a safe, affordable, statistically significant method of improving body composition and shape, in terms of increasing upper-arm size, decreasing hip size, and increasing chest size. We also demonstrated improved self-perceived quality-of-life parameters over the placebo effect.
A total of 162 healthy people, ages 18-72 years old, were evaluated for serum IGF-1 levels in three differently designed phase I/II, double-blind placebo-controlled trials (DBPCT).
The first study, the Seattle Study, was a 30-day study on 15 subjects, 18 57 years old, who exercised 3 to 5 times per week.
The second study, the Santa Fe, Proving Study, included 46 subjects, 19-59 years old, who participated in a homeopathic proving in which the identity of the test substance was not revealed. All subjects noted their symptoms daily. All subjects were given placebo and instructed to chew 1 tablet 3 times per day for 7 days or until symptoms began, at which point they stopped taking the medication, but continued to record their symptoms in journals that were kept during the study. After this time, there was a 14 day washout period during which no substance was given; however the subjects described symptoms in their journals. Subjects were then given either a single 6X or 6C HhGH or placebo. These tablets were administered for 7 days or until symptoms began. Symptoms produced by placebo were compared to symptoms produced by verum.
The third study, the Boulder Study, enrolled 101 individuals who did not exercise regularly, 29-72 years old, in a 42-day, DBPCT with a crossover after 21 days to the opposite test substance, i.e., treatment was crossed to placebo and vice versa. Test subjects were selected to receive one of two formulations of HhGH, a 6X + 12C (higher concentration of hGH) or a 6C + 100C + 200C (lower concentration of hGH) or placebo, in the form of chewable tablets for 21 days. Following this period, subjects crossed over to another set of tablets that contained either placebo (if they had been given HhGH previously) or one of two formulations of HhGH (if they had been given placebo previously) for an additional 21 days. Subjects were instructed to chew 1 tablet 3 times per day, upon rising, in mid afternoon, and in the evening. Additionally, one group was given 6C + 100C + 200C HhGH for 42 days. Another group of three subjects, ages 33, 35, and 62, years old exercised regularly, without taking treatment or placebo. Blood analyses were performed by AAL Reference Laboratories (Santa Ana, California).
Subjects in the Seattle and Boulder studies, but not in the Santa Fe study knew the benefits of the test substance. The three studies are summarized below:
Preparation of Homeopathic hGH and
Manual Measurements-Boulder Study
Statistical questions were addressed by:
Weight changes. Weight loss occurred during HhGH treatment but not during placebo in the same subjects (P = 0.03, Figure 1). Individuals on either HhGH treatment maintained -2.07 ± 0.52 lb lower body weight per month versus the weight maintained during the placebo period (P<0.0002). Additionally, subjects on 6X + 12C HhGH tended to lose another -1.2 ± 0.6 lbs per month versus subjects on 6C + 100C + 200C HhGH ( P = 0.05).
Figure 1. (above) Weight change in subjects on placebo compared to either of the HhGH formulations. Standard error bars are shown.
Figure 2. (above) Upper-arm circumference change in subjects on placebo compared to when these crossed over to HhGH. Standard error bars are shown. Body shape. Figure 2 shows an upward trend in upper-arm size (+0.29 ± 0.09 inches) after HhGH compared to a downward trend on placebo (-0.21 ± 0.11 inches; P<0.0001). Trends in upper-arm measurements had statistically divergent time-and-treatment differences between HhGH and placebo (P = 0.01). Neither age nor gender affected outcome; only HhGH determined outcome.
Figure 3. (above) Hip circumference change in subjects on placebo compared to either of the HhGH formulations. Standard error bars are shown. Figure 3 illustrates the decreasing trend in hip size in subjects on HhGH compared to an upward trend for those on placebo ( P= 0.02). At the end of the study, a time-and-treatment effect correlated to a loss of -2.09 ± 0.50 inches per month versus placebo ( P<0.001). Men on 6X+ 12C HhGH lost more hip inches than did women on the same formula (P<0.05). In addition, baseline hip size was a highly significant parameter for responsiveness to 6X + 12C HhGH (P<0.001). Chest measurement between treatment and placebo did not vary statistically. However, both treatment groups differed from each other statistically (Figure 4). Chest size of subjects on 6X + 12C HhGH averaged +0.4 ± 0.2 inches larger at the end of the study than the chest size of subjects on 6C + 100C + 200C HhGH (P = 0.02).
Figure 4. (above) Chest circumference change in subjects on placebo compared to either of the HhGH formulations. Standard error bars are shown. Waist measurements decreased continually by -0.9 ± 0.3 inches over the 42-day period following treatment with 6C + 100C + 200C HhGH (Figure 5). Subjects on placebo decreased waist size minimally (-0.5 ±0.3 inches). Waist size of subjects on 6X + 12C HhGH decreased by -0.3 ± 0.2 inches after 21 days and the subjects continued to lose inches in waist size once treatment stopped with a loss of 0.8 ± 0.4 inches at the end of the study. Three people who only exercised reduced waist size by -2.3 ± 0.9 inches in 42 or fewer days.
Figure 5. (above) Waist circumference change. Subjects administered 6C+100C+200C throughout the 42-day study (upper graph) or administered 6X+12C for 21 days and then crossed over to placebo for 21 days. Lower graph shows Subjects on placebo for 21 days and subjects who only used regular exercise for throughout the 42-day study.
Insulin Like Growth Factor-1 Measurements-All Three Study Sites
Nearly all baseline measurements of IGF-1 in the Seattle and Santa Fe studies fell below the mean average reference range (P<0.0001). In the Boulder study, baseline serum IGF-1 levels were more evenly distributed around the mean average range; 53 percent of individuals in the Boulder study had levels above and 46 percent of subjects had levels below the mean average reference range. All three test sites showed age-related declines in baseline serum IGF-1 levels (Figure 6). There was a statistically significant decline of -1.6 ng/mL/year-of-age in serum IGF-1evel (P<0.003); therefore, when entering the study, persons who were 10 years older than other subjects had on average -16 ng/mL lower IGF-1 levels than those subjects at baseline.
Figure 6. Baseline serum IGF-1 levels in subjects of different ages and exercise routines from all three study sites, Boulder, Seattle and Santa Fe.
Oral administration of HhGH stimulated an upward trend in IGF-1 levels by 14 ± 31 ng/mL/month (Table 4). In contrast, placebo demonstrated an average downward trend of -71 ng/mL per month. There was a difference of -81 ± 54.5 ng/mL in IGF-1 between treatment and placebo.
The randomization process in Boulder did not distribute the subjects' IGF-1 levels, ages, or genders evenly into treatment and placebo groups baseline. Because of age differences in Boulder, statistical significance was not measured in serum IGF-1 levels with this small sample size although the trends over time were opposite in direction.
In treated individuals using either HhGH formula, 28 percent increased serum IGF-1 levels above 12 percent and up to 78 percent in 21 days (P = 0.058). In contrast, 17 percent of individuals on placebo had increased serum IGF-1 levels above 12 percent and up to 62 percent during the same time frame.
Individuals who were most responsive to treatment produced an age-and time-related bell shaped curve (data not shown). Subjects who were most responsive to early treatment effects on IGF-1 levels were 31-57 years old. Subjects who were more than 32 years old in Seattle increased serum IGF-1 levels by 18 ± 5 percent within the first 15 days of treatment. Boulder subjects who were 35-57 years old had increased serum IGF-1 by a mean of 45 percent (12-78 percent). In contrast, subjects who were between 18-32 years old in Seattle showed no change in IGF-1 during the first 15 days; however these subjects had increased IGF-1 levels by 26 ± 10 percent after 30 days of treatment (data not shown).
Reproducible rises in serum IGF-1 levels occurred in the different cities and in the different study designs (Figure 7). In Boulder, a treatment effect occurred once the placebo group crossed over to treatment (Figure 7A). The 6X + 12C HhGH stimulated serum IGF-1 levels to rise 25 ± 14 percent after 21 days of use. The 6C + 100C + 200C HhGH increased serum IGF-1 levels by 21 ± 13 percent, closely replicating the increase found in Seattle (Figure 7B). Seattle subjects had increased serum IGF-1 levels by 16 ± 8 percent after 30 days. The Santa Fe Proving reproduced the increased serum IGF-1 measured in Boulder with 6X + 12C HhGH (Figure 7C). Serum IGF-1 increased by 18 ± 10 percent in Santa Fe subjects treated with a single potency of 6X HhGH after only 7 days. In contrast, there was no significant increase in serum IGF-1 caused by oral administration of a single potency of 6C HhGH or caused by placebo after 7 days in Santa Fe. Placebo groups had no significant change in serum IGF-1 in the three study sites. Subjects in Boulder experienced a transient-rise in serum IGF-1 during the first 10 days of the study and the exercise-only group had decreased serum IGF-1 levels by -28 ± 4 percent after the first 21 days (Figure 7A). After 42 days of exercise only, there was no net change (-3 ± 3 percent) in serum IGF-1.
Figure 7. (above) Percent change in serum IGF-1 levels in three different double-blind placebo-controlled sites of: A] Boulder subjects 35-57 years old; B] Seattle subjects who exercised 3-5 times per week; and C] Santa Fe subjects. In Santa Fe, subjects took placebo for 7 days, took nothing for 14 days for the washout period, and then were given either placebo or 6C+100C+200C or 6X+12C for seven day. Standard error bars are shown.
Lean body mass. Lean body mass increased on 6C + 100C + 200C HhGH compared to placebo (Figure 8). The 6C + 100C + 200C HhGH stimulated lean body mass increase by +2.5 ± 1.2 lbs in the first 21 days (Figure 8A.) The placebo group experienced no net gain in lean body mass (1.6 ± 1.9 lbs) after the first 21 days. Once the placebo group was crossed over to 6C + 100C + 200C HhGH, lean body mass increased +2.1 ± 0.98 lbs, reproducing the earlier findings in Boulder (Figures 8A and 8B). In contrast, those people on 6X + 12C HhGH experienced no net gain in lean mass (0.05± 1 lb) after the first 21 days. Overall, the placebo group decreased in lean mass by -0.26 ± 0.09 lbs per month compared to the treatment group (data not shown; P = 0.004). The greater the lean body mass at baseline, the greater the ability to gain lean body mass was by the end of the study ( P = 0.006). The baseline lean body mass was statistically indicative of how well a person could add lean body mass on 6X + 12C HhGH, ( P<0.01). Women responded less well because they were -7.3 ± 3.5 lbs lower in lean body mass than men at baseline (P = 0.04)
Figure 8. (above) Change in lean mass in subjects who: A] were given 6C+100C+200C or 6X+12C for the first 21 days or B] were given placebo and then crossed over to 6C+100C+200C HhGH. Standard error bars are shown. A treatment effect occurred in terms of gain in lean body mass/total body mass (Figure 9). There were positive gains with both treatments at all time points compared to negative losses in lean body mass with placebo or when using only exercise. A positive ratio indicated greater gain in lean body mass compared to total body mass. Placebo and exercise only groups experienced negative ratios between lean body mass/total weight, indicating gains in fat rather than in lean body mass.
Figure 9. (above) Lean-mass to total-mass ratio in subjects who were given: A] 6C+100C+200C HhGH or 6X+12C HhGH or placebo, respectively, for 10 days; or B] same conditions for 21 days; or C] 6C+100C+200C HhGH for 42 days; or D] exercised only for 42 days. Standard error bars are shown.
There was a statistically significant time effect with regard to systolic blood pressure, whereby the treatment group experienced a downward trend compared to an upward trend in subjects on placebo +14.06 ±5.48 mm/Hg per month, P = 0.01 (Figure 10). When subjects on placebo crossed over to 6X + 12C HhGH, these same individuals had decreased systolic pressure by -4 ± 3 percent. Prolonged treatment over 42 or fewer days with 6C + 100C + 200C HhGH produced decreased systolic blood pressure in subjects by -8 ± 4 percent.
Figure 10. (above) Systolic blood pressure in subjects on placebo who crossed over to 6C+100C+200C HhGH or crossed over to 6X+12C or who were given 6C+100C+200C HhGH for 42 days.
Guiding Symptoms and
Uneven, random distribution of men and women into the different groups may have affected the statistical significance of treatment compared to placebo. In Boulder, the subjects in placebo group were younger by an average of 2 years than the people in treatment group. There was a statistically significant response effect related to each subject's age, gender, and baseline values with 6X +12 C HhGH. Entry-level lean body mass had a proportionate effect on how much lean body mass could be gained. Thus, the health status of a person upon entering the study was statistically significant on his or her ability to respond to HhGH. Two treatment effects of HhGH that were not significantly influenced by baseline status were body weight and hip size.
Age-related declines in normal serum IGF-1 levels have been reported.(35) We also observed age-related and time-related responsiveness to HhGH in terms of changes in serum IGF-1 levels. Subjects in the Seattle and Boulder studies between 32-57 years old responded rapidly to treatment. Within the first 21 days of HhGH therapy, IGF-1 levels rose 18±5 percent in Seattle and 21±13 percent in Boulder, while younger subjects required longer treatment periods to achieve similar levels. A clinical study on healthy elderly subjects 78 ± 2.5 years old injecting 0.03 mg/kg per week had peak increases in serum IGF-1 levels in the first month of 9 ± 3 percent.(11) Because of the age- and time-related variables, further study with larger sample sizes of subjects clustered into specific age, gender-, and time-matched groups may be necessary to show statistical significance.
Homeopathic hGH Produced
Multiple Beneficial Effects of
Treatment Were Demonstrated
Similar to injectable hGH, chewable tablets of HhGH had positive effects on lean body mass, produced weight and fat loss, relieved fatigue, produced body shape changes, and improved psychologic well-being.
Homeopathic hGH also improved self-perceived measures related to quality of life significantly, such as energy increase, weight loss, improved vision, increased libido, improved sleep quality, improved breathing, and improved skin softness. Thus, an oral formulation that was at least 4,000 times lower in concentration than an injectable hGH provided some of the same benefits of the injectable hGH without its side effects.
Oral administration of HhGH lowered systolic blood pressure after 3 and 6 weeks, depending upon the formula that was used. Injectable hGH at 700 µg per day, 3 times per week, for 6 months, corrected systolic heart function that was caused by left-ventricle low-mass index.(40) The degree of change in systolic function induced by HhGH requires further and more extensive clinical study.
It is noteworthy that subjects who enrolled in this study reported unique self-perceived benefits, far above the placebo effect and never-before associated with hGH injections. For example, subjects reported relief from bleeding gums, less phlegm build-up, relief from coughing, relief from anger, relief from apathy, and relief from urogenital discharges. These unique characteristics derived from HhGH underlie the possibility that a different signaling pathway is utilized than the pathway commonly outlined by molecular biologists. (41) In this way, HhGH is a different type of medicine than injectable hGH. It is conceivable that the serial dilution and shaking methods used to prepare homeopathic medicines contribute to significant alterations in the physical and chemical properties of the solvent and evoke bioelectric field signals to users.(42-45) The degree of effectiveness of HhGH compared to injectable hGH requires further study. It is obvious that the number of molecules in a preparation is not equal to the biologic activity evoked at the physiologic level. The transfer of information to cells via nonmolecular mechanisms of action are being investigated by several laboratories.(43, 46, 47)
The current double-blind placebo-controlled study represents a clinical demonstration of Hahnemann's Law of Similars, i.e. positive actions of hGH can be gained with a homeopathic formulation. Conventional clinical practitioners administer pharmacologic concentrations of injectable hGH for 3-4 weeks until optimal physiologic responses are achieved and then they cycle the dose to every 3-4 days at lower concentrations with periods of no treatment.(48) The same dosing schedule of 3-4 weeks with daily HhGH followed with cycling the dose to every 3-4 days may be ideal for achieving optimal quality-of-life benefits without negative effects. Additional and long term studies are necessary to determine if side-effects above placebo effects occur with HhGH. In our studies, no toxic side effects were reported.
Hahnemann's Law of Similars Was
Exercise and Serum Insulin-Like
Homeopathic hGH Works; More
Studies Can Bolster Findings
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Barbara Brewitt, Ph.D., is chief scientific officer at Biomed Comm., Inc., Seattle, Washington; James Hughes, M.D., is the medical director of Hilton Head Longevity Center, Bluffton, South Carolina; Elizabeth A. Welsh, Ph.D., is the head of growth factor research and therapeutics at Biomed Comm., Inc., Seattle, Washington; Robert Jackson, D.C., is a chiropractic physician and consultant at Applewood Health Center, Wheat Ridge, Colorado.