Homeopathic Human Growth Hormone for Physiologic
and Psychologic Health
Alternative and Complementary Therapies
Vol.5, No.6, December 1999
Three Double-Blind Placebo-Controlled Studies
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 attentionfor
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, 9In 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.10Other 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.13Growth-hormone
(GH) secretion peaks at 31 years of age, then declines by 14-50 percent
per decade, depending upon gender, activity level, and diet or the onset
of chronic disease.14 Women have slower, yet more statistically significant,
age-related declines of GH. 15, 16 The prevalence of GHD is
not agreed upon and symptoms may occur in a large number of adults.14
Pharmaceutical company representatives state that GHD is present in approximately
70,000 U.S. adults,17while other people say that the incidence
is at 40 percent in persons 60-88 years old18 or others state
1 out of every 4000 people.19
Table 2 documents some adverse side effects after 6 months to
1 year use of pharmacologic doses of injectable hGH (0.15 mg per day to
5.0 mg per day) or the associated pathologies of acromegaly. 20, 21
Gigantism and acromegaly are excellent human models for understanding
the dangers of excessive GH. Gigantism is caused by the presence of excess
hGH before puberty, with consequences that can include extreme height,
abnormal proportion s of the body to the arms and legs, and early death.
Acromegaly is caused by the presence of excess hGH after full skeletal
growth has occurred. Both of these pathophysiologies are accompanied by
a host of abnormal metabolic changes, such as those that cause glucose
intolerance, occasional diabetes mellitus, osteoporosis, respiratory problems,
decreased bone mineral density, cardiac arrythmias, and hypertension.
Table 1: Symptoms of Growth Hormone Deficiency
|Fatigue is the key symptom and there are clusters of the following
decreased lean body mass
abdominal obesity and weight gain
decreased physical strength
decreased muscle mass
reduced cardiac performance
impaired sense of well being
source : http://www.AACE.com
and Ref. 14.
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,
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
Our results suggest that HhGH provides a safe, affordable, statistically
significant method of improving body composition and shape.
Table 2: Abridged List of Adverse Side Effects From Pharmacologic
Concentrations of hGH
Cardiovascular and heart diseasec,d,e
Increased tissue turgorf
Musculoskeletal distress d
Loss of lean body mass g
Hypertension and sodium retentionh
SGPT increase f
Upper respiratory tract infectionsj
|aRef. 5; b Ref. 21;
c Ref. 51; d Mardh, G., Lundin, K., Borg, Jonsson,
B., Lindeberg, Å. Growth hormone replacement therapy in adult hypopituitary
patients with growth hormone deficiency: Combined data from 12 European
placebo-controlled clinical trials. Endocrinol Metab 1 (suppl A): A43-A49,
1994; e Lombardi, G., Colao, A., Ferone, P., Marzullo, P.M.,
Landi, M.L. Longobardi, S., lervolino, F., Cuocolo, A., Fazio, S., Merola,
B., Sacca, L, Cardiovascular aspects in acromegaly: Effects of treatment,
Metabolism 45 (suppl I): S57-S60, 1996; fSource Serano Laboratories,
Norwell, Massachusetts, product insertion for injectable recombinant human
growth hormone; gLee P.D.K. Pivarnik, J.M., Bukar, J.G., Muurahainen,
N., Berry, P.S., Skolnik, P.R., Nerad, J.L, Kudsk, K.A. Jackson, L., Ellis,
K.J., Gesundheit, N,A randomized, placebo-controlled trail of combined
insulin-like growth factor 1 and low dose growht hormone therapy for wasting
associated with human immunodeficiency virus infection. J Clin Endocrino
Metab 81 :2968-2975, 1996;hHo, K,Y., Weissberger, A.J. The antinatriuretic
action of biosynthetic human growth hormone in man involves activation
of the renin-angiotensin system. Metabolism 39: 133-137, 1990; Genentech
Inc., Apple Valley, Minnesota, product insert for injectable recombinant
human growth hormone; Ref. 27; k Ref. 20.
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.
Subjects and Methods
Studies, Subjects, and Protocols
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 midafternoon,
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
in Table 3.
Weight loss occured during HhGH treatment but not during pacebo in
the same subjects.
Table 3: Summary of Three Studies
||Potency of test substance(s)
||6C+100C+200C animal source GH
||6X recombinant single potency
||6X recombinant single potency
||6X + 12C recombinant
||6C+100C+200C recombinant b
a Santa Fe used a washout period of 14 days in between placebo
and treatment; bOne arm of the crossover design tested unbuffered
hGH crossing to buffered hGH; thus, these subjects were given the 6C +
100C +200C HhGH for 42 days (n=14).
Preparation of Homeopathic hGH and Subject Pool
In Seattle, HhGH was derived from purified human growth hormone and serially
diluted and hand succussed to produce a final tablet of 6C + 100C + 200C
HhGH. Hand succussion was withheld during placebo preparation. In Santa
Fe, single 6X (10-6 molar) and 6C (10-12 molar) HhGH
and placebo were prepared. In Boulder, 6C + 100C + 200C HhGH, 6X + 12C
HhGH, and placebo were prepared as they were in Seattle. Dropouts occurred
in the Boulder Study during the first 21 days as follows: 6X + 12C HhGH,
21 percent; unbuffered HhGH, 14 percent; placebo, 9 percent; and 6C + 100C
+ 200C HhGH, 9 percent. Results on serum IGF-1 are from all three studies,
all other results are from Boulder.
Manual Measurements-Boulder Study
Body composition was determined by using bioelectric impedance analysis
(Bioanalogics, Beaverton, Oregon) as validated.28-30 Blood pressure
was monitored every 10 days as was body shape via tape measurements around
the circumference of each subject’s upper arms, upper chest, hips, and
In Seattle, subjects voluntarily arrived at the laboratory for blood tests
at a consistent time of day that was most convenient for them, most generally
from 9-11 am or 2-5 pm. None of the subjects on placebo arrived for the
final blood draw. In Boulder, serum IGF-1 was determined at 5-7 pm to control
for potential diurnal changes.
For statistical comparison, multivariate analyses were used for different
outcomes in the four crossover groups of the Boulder study (n=69). There
were two types of analyses conducted for each parameter tested. Pearson
and Wilcoxson ranking were done, using The GENMOD Procedure software (SAS
® Institute, Inc., Cary, North Carolina). There was no adjustment for
multiple testing because there were separate statistical questions; thus,
possibilities for statistically significant artifacts are present. Controls
were built into all analyses by testing for differences in age, gender,
and baseline values.
Statistical questions were addressed by:
comparing HhGH treatment to placebo for each endpoint by:
testing 6C + 100C + 200C HhGH versus 6X + 12C HhGH.
testing 6C + 100C + 200C HhGH versus placebo as in question #1.
testing 6X + 12C HhGH versus placebo as in question 1.
testing mean differences between treatment and placebo.
testing time trends
testing time and treatment trends
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 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.
Table 4: Boulder Study
||50 ± 2
||198 ± 19
|6C + 100C + 200C
||50 ± 2
||172 ± 11
||42 ± 2
||194 ± 11
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
Table 5: Guiding Symptoms for HhGH
||Santa Fe Placebo
||6X + 12C
|Relief from fatigue
|Skin and extremities
|Relief from dry scaly skin
|Relief from floaters
|Bleeding gums stopped
|Less shortness of breath
|Less phlegm buildup
|Less abdominal obesity
|Relief from discharges
|Decreased libido a
|Increased libedo a
|Improved physical appearance
|relief from jaw pain
|Relief from apathy
|Relief from anxiety
|Relief from anger
|Improved quality of sleep
|Relief from headaches
|Relief from weakness in arms and legs
|Relief from joint swelling
|Relief from knee swelling
NOTE: Bold numbers indicate that the results were 5 percent greater
than those obtained with placebo effects in Santa Fe subjects, who had
no knowledge of the substance that was being tested on them. This percentage
is accepted as significantly above placebo by the Homeopathic Pharmacopoeia
of the United States.
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
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
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
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 Characteristics
Self-perceived symptoms of GHD improved with either treatment versus placebo,
as noted in Table 5. In Boulder or Santa Fe, respectively, fatigue, reported
by 46 percent of enrollees when they entered the study, improved in 69
percent and 70 percent of subjects after either treatment compared to 36
percent and 58 percent on placebo. Other age-related GHD symptoms, such
as abdominal obesity, weight gain, decreased physical strength, decreased
libido, poor sleep, depression, and mood swings, reported in 21-31 percent
of enrollees at study entry were relieved effectively with treatment. Subjects
also reported relief from bleeding gums, less buildup of phlegm, relief
from coughing, relief from anger, relief from apathy, and relief from urogenital
discharges on treatment compared to placebo.
Chewable tablets of homeopathic recombinant human growth hormone promoted
significant physical, physiologic, and self-perceived quality-of-life benefits
compared to placebo in healthy adults, ages 18-72 years old. Statistically
significant were weight loss, decreased hip size and increased upper-arm
size compared to placebo after 21 days of HhGH. Decreased hip size corresponds
directly to less fat storage. Injectable pharmacologic hGH at concentrations
of 0.125 international units(IU)/kg per week and 0.250 IU/kg per week reduced
hip size statistically after 6 months. 31 The weight loss measured
in Boulder was consistent with increased lean body mass. Clinical studies
on GHD subjects who had injected pharmacologic concentrations of hGH for
6 months showed no marked changes in body weight.4, 5 31-33
6C + 100C + 200C HhGH evoked statistically significant treatment and time
effects and 6X + 12C HhGH evoked statistically significant changes that
were sensitive to gender, age, and baseline parameters. Specifically, males
responded better to 6X + 12C HhGH in increasing upper-arm size, decreasing
hip size, decreasing fat, and increasing lean body mass. The greatest weight
loss occurred in participants who were using 6X + 12C HhGH. Reproducible
increases of more than 2 lbs in lean body mass occurred in subjects using
the 6C + 100C + 200C HhGH for 21 days compared to placebo. Chest size in
men increased significantly in 21 days on 6X + 12C HhGH versus 6C + 100C
+ 200C HhGH.
Human GH stimulates lipolysis in adipose tissue directly. The findings
in this HhGH study are consistent with hGH’s effect on fuel redistribution
via the preferential utilization of fat over glucose. 34 A given
subject’s upper-arm size at the end of the study was influenced by baseline
age and arm size, i.e., the younger the person, the greater were the increases
in upper-arm size at the end of the study. Clinical studies with injectable
GH demonstrated that the dosing schedule for people who are more than 60
years old is considerably less than that required with younger people.20
It may also be important that different HhGH concentrations be provided
to different age groups.
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
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.
There were three major findings from these different double-blind placebo-controlled
Homeopathic hGH Produced Physiologic Effects
The first finding was that oral administration of HhGH produced physiologic
effects. Rises in serum IGF-1 levels occurred with both 6C + 100C + 200C
HhGH and 6X + 12C HhGH compared to transient rises and final downward trends
in subjects who were on placebo. It is important to note that 6X + 12C
HhGH stimulated a rapid 18 ± 10 percent physiologic rise in serum
IGF-1 level after only 7 days in Santa Fe subjects who were not aware of
what substance was being tested. These three studies are the first double-blind
placebo-controlled studies to demonstrate differences in the bloodstreams
of healthy people in response to HhGH. There have been several double-blind
placebo-controlled studies that used a combination of four homeopathic
growth factors on people infected with human immunodeficiency virus (HIV)
that demonstrated measurable increases in peripheral blood lymphocyte counts
and decreases in viral load.36-39 Although homeopathy’s molecular
mechanism of action remains to be fully elucidated, HhGH clearly evokes
quantifiable physiologic changes in the bloodstream.
Multiple Beneficial Effects of Treatment Were Demonstrated
The second significant finding from these studies is that pharmacological
benefits of injectable hormonal replacement were experienced with a homeopathic
oral chewable tablet. Injectable growth hormone is well known for its positive
effects on lean body mass, producing weight and fat loss, improving pulmonary
function, lowering blood pressure, relieving fatigue, improving vision,
producing body shape changes, and improving psychologic well-being, skin
quality, sleep quality, and libido among other benefits.
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 4000 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
Hahnemann’s Law of Similars Was Applicable
The third significant implication of these findings relates to the other
part of Hahnemann’s Law of Similars, which states: “Whatever symptoms and
syndromes a substance causes in large or toxic doses, it can heal when
given in specifically prepared, exceedingly small homeopathic doses.”49
Subjects who received HhGH in these three differently designed studies
reported relief from symptoms that they reported when they entered the
studies. Symptoms relieved by HhGH treatment often matched the symptoms
known to be caused by toxic doses of injectable hGH. Specifically relieved
above placebo were headaches, edema, pain, and anxiety. Reductions in systolic
blood pressure from HhGH are consistent with the findings that excessive
hGH in patients with acromegaly correlated directly with cardiac abnormalities.
Exercise and Serum Insulin-Like Growth-Factor-1 Levels
Serum IGF 1 has been cited most frequently as a reliable measure of hGH
physiologic activity, however serum IGF-1 levels are not good indicators
of GHD.14 We found that a statistically significant number of
people enrolled in these studies were below national laboratory reference
ranges for serum IGF-1. The potential high frequency of GHD within the
general population observed in these studies suggest that stress, exercise,
and lifestyle/diet in American society may play a significant role in aging.
It is noteworthy that the participants from the Seattle study had a history
of exercising at least 3-5 times per week. Yet, these “healthy subjects,”
who were 18-57 years old were all below the normal reference range for
serum IGF-1 levels at baseline. Additionally, 3 people in Boulder that
exercised regularly and did not administer treatment or placebo fell below
their baseline values of serum IGF-1 throughout much of the study. Thus,
exercise without adequate nutrition may contribute to low serum IGF-1 levels.
Homeopathic hGH Works; More Studies Can Bolster Findings
The data collected in the Boulder study on lean body mass raises an interesting
question related to the dose-response curve between lean body mass gain
and concentration of hGH administered to the body. Lean body mass increased
after pharmacologic doses of injectable hGH by approximately 7 percent
in patients with hypothalamic-pituitary disease or GHD, and/or in healthy
elderly subjects (ranging from 0.03 mg/kg per week to 0.55 mg per week)
for 6-12 months. 11, 20, 52Loss of fat mass did not always accompany
the lean body mass increases of 0.88-1.1 lbs per month induced by injectable
hGH. In our studies with healthy adults, chewable tablets of the 6C + 100C
+ 200C HhGH, lean body mass increased by approximately 3.2 ± 1.7
lbs per month during a short-term 3-week treatment period). Further research
is warranted with age-matched, gender-matched, and baseline-specific controls
on larger sample sizes and for longer-term treatment periods to test if
HhGH produces long-term positive results at far lower concentrations than
injectable hGH. Overall, HhGH is an effective oral therapy that evokes
positive physiologic and psychologic benefits above the placebo effect
VitaLabs, Jonesboro, Georgia, and Biomed Comm. Inc., Seattle, Washington,
sponsored this research. The Mountain Whisper Light Statistical Group,
also in Seattle, made itself available for statistical consulting. We would
like to thank Drs. Garry Gordon and Beverly Rubik for their reviews and
editorial comments on this research.
Wolfe, J. Growth hormone: A physiological fountain of youth? J Anti-Aging
Med 1:9-25, 1998. :p>
Klatz, R., Kahn, C. Grow Young with hGH. New York: HarperCollins,
DeBoer, H., Blok, G.J., van der Veen, E.A. Clinical aspects of growth hormone
deficiency in adults. Endocr Rev 16:63-86, 1995.
Bengtsson, B.Å., Eden, S., Lonn, L., et al. Treatment of adults with
growth hormone (GH) deficiency with recombinant human GH. J Clin Endocrinol
Metab 76:309-317, 1993.
Jørgensen, J.O., Pedersen, S.A., Thuesen, L.L., et al. Beneficial
effects of growth hormone treatment in GH-deficient adults. Lancet
Kelley, K.W. The role of growth hormone in modulation of the immune response.
Ann NY Acad Sci 594:95-103, 1990.
Crist, D.M., Peake, G.T., Mackinnon, L.T., Sibbitt, W.L., Kraner, J.C.
Exogenous growth hormone treatment alters body composition and increases
natural killer cell activity in women with impaired endogenous growth hormone
secretion. Metabolism 36:1115-1117, 1987.
Griffin, G.E., Paton, N.I., Cofrancesco, Jr., J., Arastéh, K., Bauer,
G., Schwenk, A., Mauss, S., Mulligan, K. Nutrition and quality of life
in HIV infection: The role of growth hormone in HIV-associated wasting.
J Clin Res 1:199-218, 1998.
Kotler, D.P., Tierney, A.R., Wang, J., Pierson, Jr., R.N. Magnitude
of body-cell-mass depletion and the timing of death from wasting in AIDS.
Am J Clin Nutr 50:444-447, 1989.
Rudman, D. Feller, A.G., Nagraj, H.S., Gergans, G.A., Lalitha, P.Y., Goldberg,
A.F., Schlenker, R.A., Cohn, L., Rudman, I.W., Mattson, D.E. Effects of
human growth hormone in men over sixty years old. N Engl J Med 323:1-6,
Cuttica, C.M., Castoldi, L., Gorrini, G.P., Peluffo, F., Delitala, G.,
Fillippa, P., Fanciulli, G., Giusti, M. Effects of six-month administration
of recombinant human growth hormone to healthy elderly subjects. Aging
Clin Exp Res 9:193-197, 1997.
Cuneo, R.C., Salomon, F., McGauley, G.A., Sönksen, P.H. The growth
hormone deficiency syndrome in adults. Clin Endocrinol [Oxford]
Rudman, D. Growth hormone, body composition and aging. J Am Ger Soc
Ho, K.Y., Veldhuis, J.D. Diagnosis of growth hormone deficiency in adults.
Endocrinol Metab 1(suppl. A):S61-S63, 1994.
Gregerman, R.I., Bierman, E.I.L. Aging and hormones. In: Williams, R.H.
( ed.) Textbook of Endocrinology. (5th ed.) Philadelphia:
W.B. Saunders, 1981, p. 1192.
Ho, K.Y., Weissberger, A.J. Secretory patterns of growth hormone according
to sex and age. Horm Res 33 (suppl 4):7-11, 1990.
Pramik, M.J. Recombinant human growth hormone. Genetic Engineering News,
January 1,1999, pp. 15, 27, 31.
Gelato, M.C. Aging and immune function: A possible role for growth
hormone. Hormone Res 45:46-49, 1996.
Kiess, W., Kessler, U., Schmitt, S., Funk, B. Growth hormone and insulin-like
growth factor-1: Basic aspects. In: Flyvberg A. Ørskov, H., Alberti,
G. (eds.) Growth Hormone and Insulin-Like Growth Factor-1 in Human and
Experimental Diabetes. New York: John Wiley & Sons, 1993, pp. 1-22.
Toogood, A.A., Shalet, S.M. Growth hormone replacement therapy in the elderly
with hypothalamic-pituitary disease: A dose-finding study. J Clin Endocrinol
Metab 84:131-136, 1999.
Holloway, L., Butterfield, G., Hintz, R.L., Gesundheit, N., Marcus R. Effects
of recombinant human growth hormone on metabolic indices, body composition,
and bone turnover in healthy elderly women. J Clin Endocrinol Metab
Linde, K., Clausius, N., Ramirez, G., Melchart, D., Eitel, F., Hedges,
L.V., Jonas, W.B. Are the clinical effects of homeopathy placebo effects?
A meta-analysis of placebo-controlled trials. Lancet 350:834-843,
Reilly, D., Taylor, M.A., Beattie, N.G.M., Campbell, J.H., McSharry,
C., Aitchison, T.C., Carter R., Stevenson, R.D. Is evidence for homeopathy
reproducible? Lancet 344:1601-1606, 1994.
Kleijnen, J., Knipschild, P., ter Riet, G. Clinical trials of homeopathy.
Br Med J 302:316-323, 1991.
Van Wijk, R., Wiegant, F.A.C. The similiar principle as a therapeutic strategy:
A research program on stimulation of self-defense in disordered mammalian
cells. Altern Ther Health Med 3:33-38, 1997.
O’Reilly, W.B. (ed.) (Decker, S., transl.) Organon of the Medical Art,
6th ed. Redmond WA: Birdcage Books, 1996.
Endler, P.C., Schulte, J. Ultra High Dilution: Physiology and Physics.
Boston: Kluwer Academic Publishers, 1994, p. ix.
Girandola, R.N., Contarsy, S. The validity of bioelectrical impedance to
predict human body composition., Olympic Scientific Congress, September
10, 1988, Seoul, Korea. In: Olympic Scientific Congress. New Horizons
of Human Movement, Seoul: Olympic Scientific Congress, 1988, p. 9
Jodoin, R.R., Trott, S.G., Shizgal, H.M. Determination of whole body composition
from whole body electrical impedance. Surg Forum 39:50-52, 1988.
McDougall, D., Shizgal, H.M. Body composition measurements from whole body
resistance and reactance. Surg Forum 37:42-44, 1986.
Stiegler, C., Leb, G. One year of replacement therapy in adults with growth
hormone deficiency. Endocrinol Metab 1 (suppl. A):A37-A42, 1994.
Whitehead, H.M., Boreham, C., McIlrath, E.M., Sheridan, B., Kennedy,
L., Atkinson, A.B., Hadden, D.R. Growth hormone treatment of adults with
growth hormone deficiency: Results of a 13-month placebo controlled cross-over
study. Clin Endocrinol Metab (Oxford) 36:45-52, 1992.
Salomon, F., Cuneo, R.C., Hesp, R., Sönksen, P.H. The effects of treatment
with recombinant human growth hormone on body composition and metabolism
in adults with growth hormone deficiency. N Eng J Med 321:1797-1803,
Møller, N. The role of growth hormone in the regulation of human
fuel metabolism. In: Flyvberg, A., Ørskov, H., Alberti, G. (eds.)
Growth Hormone and Insulin-Like Growth Factor-1 in Human and
Experimental Diabetes. New York: John Wiley & Sons, 1993, pp. 77-108
Prewett, N.A., Bettica, P., Mohan, S., et al. Age-related decreases in
insulin-like growth factor-1 and transforming growth factor-b in femoral
cortical bone from both men and women: Implications for bone loss with
aging. J Endocrinol Metab 78:1011-1016, 1994.
Brewitt, B., Traub, M., Hangee-Bauer, C. Patrick, L., Standish, L.J. Recovery
of homeostasis and functional immune system: Positive short term and long
term effects with homeopathic growth factors IGF-1, PDGF-BB, TGF beta 1
and GM-CSF. In: Standish, L.J., Calabrese, C., Galantino, M.L. (eds.) AIDS
and Alternative Medicine: The Current State of the Science.
New York: Harcourt Publishers International, in press.
Brewitt, B. Homeopathic growth factors-support for the functional immune
system [presentation at Alternative Medicine Symposium at the meeting].
12th World AIDS Conference, June 28-July 3, 1998, Geneva, Switzerland.
Brewitt, B. Homeopathic growth factors support long term survival and maintain
low viral loads [poster presentation, abstr. 60495]. 12th World AIDS Conference,
June 28-July 3, 1998, Geneva, Switzerland.
Brewitt, B., Standish, L.J. High dilution growth factors/cytokines:
Positive immunologic, hemotologic and clinical effects in HIV/AIDS patients
[abstr. Th.B.4108]. In: Abstracts of the XIth International Conference
on AIDS, July 7-12, 1996, Vancouver, Canada, vol. 2.
Edán, S., Johnston, D.G. Cardiovascular risk factors in growth hormone
deficiency and effect of growth hormone replacement therapy. Endocrinol
Metab 1 (suppl. A):A67-A69, 1994.
Spagnoli, A., Rosenfeld, R.G. The mechanisms by which growth hormone
brings about growth: The relative contributions of growth hormone and insulin-like
growth factors. Endocrinol Metab. Clin N Am 1996; 25:615-631.
Elia, V., Niccoli, M. Thermodynamics of extremely diluted aqueous solutions.
Ann NY Acad Sci 879:241-248, 1999.
Brewitt, B. Bioelectromagnetic medicine and HIV/AIDS treatment: Clinical
data and hypothesis for mechanism of action. In: Standish, L.J., Calabrese,
C., Galatino, M.L. (eds.) AIDS and Alternative Medicine: The Current
State of the Science. New York: Harcourt Publishers International,
Lo, S.Y., Lo, A., Chong, L.W. Physical properties of water with I E
structures. Modern Physics Lett B 10:921-930, 1996.
Brewitt, B. Quantitative analysis of electrical skin conductance in diagnosis:
Historical and current views of bioelectric medicine. J Nat Med
Benveniste, J. Transfer of biological activity by electromagnetic fields.
Frontier Perspectives 3:12-15, 1993.
Bourguignon, G.J., Jy, W., Bourguignon, L.Y.W. Electric stimulation of
human fibroblasts causes an increase in Ca +2
influx and the exposure of additional insulin receptors. J Cell Physiol
Janssen, Y.J.H., Frölich, M., Roelfsema, F. The absorption profile
and availability of a physiological subcutaneously administered dose of
recombinant human growth hormone (GH) in adults with GH deficiency. Br
J Clin Pharmacol 47:273-278, 1999.
Ullman, D. The Consumer’s Guide to Homeopathy. New York: Jeremy
Tarcher/G. Putnam’s Sons, 1995, p. 5.
Saccà, L. Cittadini A., Fazio, S. Growth hormone and the heart.Endocr
Rev 15:555-573, 1994.
Maison, P., Balkau, B., Simon, D., Chanson, P., Rosselin, G., Eschwêge,
E. Growth hormone as a risk for premature mortality in healthy subjects:
Data from the Paris prospective study. Br Med J 316:1132-1133, 1998.
Bramnert, M., Berntorp, E., Groop, L., Manhem, P. Effects of growth hormone
replacement therapy on blood pressure regulation and coagulation factors.
Endocrinol Metab 1(suppl. A):A57, 1994.
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.
Alternative Research Data Vault
6941 58th Way
Pinellas Park, Florida 33780