Here are some recent
studies done on the effects of colloidal gold in humans. This is not
our research and cannot be substantiated first hand.
Effect of Colloidal Metallic Gold on Cognitive Functions: A Pilot
Study
Guy E. Abraham, MD; Souhaila A. McReynolds; Joel S. Dill, PhD
Optimox Corporation, Torrance, California
Abstract
In order to evaluate the effect of colloidal metallic gold on cognitive
functions, the revised Wechsler Intelligence scales battery of tests
(WAIS-R) was administered to 5 subjects aged 15 to 45 years, before,
after 4 weeks on colloidal gold at 30 mg/day and again 1 to 3 months
off the gold preparation. The WAIS-R total scores (I.Q) were calculated
by adding the sum of the verbal test scores to the sum of the performance
scores. After 4 weeks on colloidal gold, there was a 20% increase
in I.Q scores with mean + SE of 112.8 + 2.3 pre gold and 137 + 3.8,
post gold (p <0.005). Both the performance and verbal test scores
contributed equally to this increase in I.Q scores. The effect of
the colloidal gold persisted in 3 subjects after 1 to 2 month off
gold, where as in 2 subjects who took the tests 3 months after stopping
the gold , I.Q scores were down to baseline levels.
Introduction
It is generally accepted that intelligence or cognitive functioning
is the sum of many mental capacities. For this reason, tests that
were developed to measure intelligence quotient (I.Q) comprised a
series of subtests evaluating the several dimensions of intelligence.
Of the several I.Q tests available, educators have found that the
Full Scale I.Q score of the Wechsler intelligence scales (WIS) battery,
which is calculated from the sum of the individual scores of 11 tests,
(6 verbal and 5 performance tests) is an excellent predictor of academic
achievement.1 The revised version of this I.Q test (WAIS-R) has been
used extensively to assess the effect of deficiencies and supplementation
of specific nutrients2,3 and the effects of sex, race, age and education4-7
on mental performance.
Gold is a precious metal which belongs to the transition group I in
the periodic table and exists in nature in two basic forms: metallic
gold and gold salts. Metallic gold is non-toxic, used extensively
in dentistry and is widely available in colloidal form as a nutritional
supplement for human consumption. One of us (GEA) has observed a significant
subjective improvement of mental performance in 21 adult subjects
after ingestion of a preparation of colloidal metallic gold (Aurasol®)
for 3 to 9 months at a daily dosage of 15 mg of gold (unpublished).
In order to use an objective and more standardized approach in evaluating
the effect of colloidal gold on mental performance, the WAIS-R battery
of tests7 was performed on 5 subjects (4 females, 1 male) age 15-45
years, before, during and after the ingestion of the same colloidal
gold preparation at 30 mg/day. The results suggest that colloidal
gold at 30 mg/day improved significantly the I.Q scores after only
one month of administration.
Materials and Methods
Aqueous dispersion of colloidal metallic gold was prepared by a modification
of the citrate reduction method of Frens. The concentration of gold
in this preparation (Aurasol® ) was 30 mg per ounce of fluid.Five
subjects were recruited for this study ( 4 females and 1 male) with
ages ranging from 15 to 45 years. The subjects were evaluated using
the WAIS-R procedure.7 Verbal scores, performance scores and total
scores (I.Q) for each subject were calculated. The WAIS-R battery
was performed on each subject before gold administration, after ingesting
30 mg of colloidal gold daily for one month, and again after being
off the gold preparation for 1 to 3 months. The statistical significance
of the data was assessed by Student's paired t test.9
Results
The group of tests called verbal are non-learning and therefore is
not influenced significantly by repetition. The performance tests
can be learned with repetition and this should be taken into consideration
when evaluating the results displayed in Table I. The mean scores
+ standard error (SE) were respectively for pre- and post-gold administration:
verbal 61.4 + 2.4 and 75.4 + 4.5 (p<0.005); performance 51.4 +
0.83 and 61.6 + 1.9 (p<0.01); total scores (IQ) 112.8 + 2.3 and
137 + 3.8 (p<0.005). Since both the verbal (non-learning and performance
(learning) scores contributed equally to the increased values observed
in the total IQ scores following colloidal gold, the positive effect
of colloidal gold cannot be attributed solely to learning the correct
responses on the second test due to repetition.
It is of interest to note that in two subjects (#1 and #2) who repeated
the battery 3 months after stopping colloidal gold, the total IQ scores
were close to baseline pre-gold levels whereas, in 2 subjects who
performed the test 1 month after stopping the gold, (#3 and #5) and
in one subject (#4) who did so after 2 months off colloidal gold,
the total IQ scores were still elevated above baseline, suggesting
that the effect of the gold on mental performance has a carry-over
of one to two months after stopping the use of this preparation.
Discussion
The WIS battery of tests is an excellent predictor of scholastic performance.1
In fact, according to Lezak,10 the average scores on a WIS battery
provide just about as much information as do average scores on a school
report card. We have observed a significant increase (20%) of the
mean IQ scores in 5 subjects aged 15 to 45 years after only one month
on oral colloidal metallic gold at 30 mg/day. This effect persisted
for up to 2 months following discontinuation of the gold preparation.
To our knowledge, this is the first study evaluating the effect of
colloidal gold on mental performance. Possible mechanisms of action
of the colloidal gold preparation are only speculative at this time.
However, the potential applications of a non-toxic colloidal metal
with marked and rapid positive effect on mental performance are without
question of great practical value, not only in scholastic performance
but also in the workplace.
The encouraging results of this pilot study warrant further evaluation
of colloidal metallic gold in a larger number of subjects of different
age groups. Testing various amounts of gold would assist in quantifying
the response of the IQ tests in term of cumulative amount of gold
ingested in order to investigate a possible dose-response relationship.
Using the smallest amount of colloidal gold that results in a desirable
effect on mental performance and scholastic achievement would keep
the cost of such a program as low as possible.
References
- Lezak, M.D., In: Neuropsychological
Assessment. New York, Oxford University Press; 1995:690.
- Goodwin, J.S., Goodwin, J.M., Garry,
P.J. Association between nutritional status and cognitive functioning
in a healthy elderly population. J Amer. Med. Assoc., 1983; 249:2917-2921.
- Southon, S., Wright, A.J., Finglas,
P.M., Bailey, A.L., et. al. Dietary intake and micronutrient status
of adolescents: effect of vitamin and trace element supplementation
on indices of status and performance in tests of verbal and non-verbal
intelligence. Br. J. Nutr., 1994; 71:897-918.
- Kaufman, A.S., McLean, J.E., Reynolds,
C.R. Sex, race, residence, region, and education differences on
the 11 WAIS-R subtests. J. Clin. Psychology, 1988; 44:231-248.
- Kaufman, A.S., McLean, J., Reynolds,
C. Analysis of WAIS-R factor patterns sex and race. J. Clin. Psychology,
1991; 47:548-557.
- Kaufman, A.S., Reynolds, C.R., McLean,
J.E. Age and WAIS-R intelligence in a national sample of adults
in the 20 to 74 year age range: A cross-sectional analysis with
educational level controlled. Intelligence, 1989; 13:235-253.
- Kaufman, A.S. Assessing adolescent
and adult intelligence. Boston, Allyn and Bacon Inc.; 1990.
- Abraham, G.E., Himmel, P.B. Management
of Rheumatoid Arthritis: Rationale for the Use of Colloidal Metallic
Gold. In Press, J. Nutr. Med., 1997.
- Huntsberger, D.V., Leaverton, P.E.,
In: Statistical Inference in the Biomedical Sciences. Boston,
Allyn and Bacon Inc.; 1970:135.
- Lezak, M.D., In: Neuropsychological
Assessement. New York, Oxford University Press;1995:691.
Colloidal Gold in the Treatment
of Rheumatoid Arthritis (RA)
Peter B. Himmel, Jorge D. Flechas, Guy E. Abraham
Gold salts (aurothiolates) once the primary therapy for active RA
has in recent years declined in its use because of apparent lack
of long term efficacy, toxic side effects, and delayed onset of
action. One of us (GEA) postulated that the active ingredient in
aurothiolates is colloidal gold generated by in vivo disproportionation
with subsequent clustering of monoatomic gold, and that the side
effects were due to the aurothiolates themselves and the trivalent
cationic gold generated from the disproportionation. If this postulate
is valid one would expect colloidal gold to have therapeutic effects
in RA and devoid of side effects.
Methods:
10 patients (6 female, 4 male; average age 50 +/- 3.16 (SE) with
long standing erosive RA ( 9 of 10 seropositive) were given an oral
dose of 30 to 60 mg a day of colloidal gold (Aurasol-tm) for a period
of 1 month. Clinical exams were performed weekly and laboratory
studies done on weeks 1, 2, 4. Gold toxicity was evaluated by questioning
the patient as to pruritus, rashes, oral ulcers, metallic taste,
GI disturbance. The blood was checked for a drop in WBC, Hb, platelet
count, BUN, creatinine or eosinophil elevation; and urine for proteinuria.
Efficacy was evaluated by an 86 Joint Count Index scoring for joint
tenderness and swelling: AM stiffness; the Modified Health Assessment
Questionnaire (MHAQII) by T. Pincus and an ESR.
Results:
Statistically significant improvement were found on each weekly
exam for joint tenderness and swelling beginning with the first
week 58.8 to 18.2 (p<0.01) for tenderness; 42.5 to 15.9 (p<0.01)
for swelling. Joint swelling reduced further to a value of 13.0
(p<0.001) by week 4. Patients fatigue decreased from 5.32 to
3.35 (p<0.05) over the month and a feeling of satisfaction in
ones ability to do activities was apparent after 1 week, 3.1 to
2.5 (p<0.01) and persisted. No laboratory tests indicative of
gold toxicity were noted. One patient reported 2 chancre sores which
cleared while on therapy, 8 of 10 patients responded to colloidal
gold.
Conclusion:
In this pilot study colloidal gold (Aurasol-tm) was found to be
rapid acting (within one week) by reducing joint tenderness and
swelling, without side effects, improved ones feeling of satisfaction
in the ability to perform activities and reduce fatigue in 8 out
of 10 patients with long standing erosive RA. The study will continue
for one year. More definitive controlled trials should now be undertaken
with colloidal gold.
Note:
The study has now completed its eighth month with all ten of the
original patients still enrolled. The patients continue to do well
with no significant side effects noted. This data is being compiled
to be submitted for publication.
Management of Rheumatoid Arthritis:
Rationale for the Use of Colloidal Metallic Gold
Guy E. Abraham MD FACN1 and Peter B. Himmel MD2
1Optimox Corporation, Torrance, CA, USA and 2 Himmel Health, Wakefield,
RI, USA
In Press - J. Nutr. Med., Vol. 7 - Dec. 1997
- Abstract
- Introduction
- Materials
and Methods
- Results
- Discussion
- References
Abstract
Gold salts of monovalent gold (AU I) with a gold-sulfur ligand (aurothiolates)
are the only form of gold currently in use for the management of
Rheumatoid Arthritis (RA). Aurothiolates have limited success and
are associated with a high incidence of side effects. Metallic gold
(AUo) is non-toxic and used extensively in dentistry. Monoatomic
metallic gold is generated in vivo from AUI salts, during oxydation
to AU III. Monoatomic gold tends to form clusters of colloid particles.
It is postulated that the active ingredient in aurotherapy is AUo
and the side effects are caused by AU III. To test this postulate,
10 RA patients with long standing erosive bone disease not responding
to previous treatment, were recruited from a private practice. Clinical
and laboratory evaluation were performed prior to oral administration
of 30 mg of colloidal metallic gold daily, and thereafter weekly
for 4 weeks and monthly for an additional 5 months. There was no
clinical or laboratory evidence of toxicity in any of the patients.
The effects of the colloidal gold on tenderness and swelling of
joints were rapid and dramatic, with a significant decrease in both
parameters after the first week, which persisted during the study
period. The mean scores for tenderness and swelling were respectively
for the pre-and post- 1 week = 58.8 and 18.2 (p<0.01); and 42.5
and 15.9 (p<0.01).
By 24 weeks of gold administration, the mean scores were 10 times
lower than pre-treatment levels being respectively 5.4 and 3.3 for
tenderness and swelling. As a group, there were significant improvement
of functional status after 24 weeks of gold therapy: 3 patients
were in clinical remission and one patients status improved from
totally disabled to full-time work. Evaluated individually, 9 of
10 patients improved markedly after 24 weeks of colloidal gold at
30 mg/day. Cytokines interleukin-6 (IL-6) and Tumor necrosis factor
(TNFa) were significantly suppressed by the colloidal gold with
pre- and post-24 week mean values of 270 and 104 (p<0.05) for
IL-6; and 207 and 74 (p<0.05) for TNFa. The results of this open
trial in 10 patients with long standing erosive RA not responding
to previous treatment support the postulate that colloidal gold
is indeed the active ingredient in aurothiolate therapy, and that
the side effects are mainly due to the trivalent gold (AU III) generated
by oxydation of AU I. Colloidal metallic gold could become an effective
and safte alternative to the aurothiolates in the management of
RA patients. Keywords: rheumatoid arthritis, colloidal metallic
gold.
Introduction
Aurothiolates have been used in the treatment of rheumatoid arthritis
(RA) since their introduction by Forestier in 1929 (1). In a follow-up
publication, Forestier reported that the only forms of gold effective
in the management of RA were organic compounds containing monovalent
cathionic gold (AU I) covently bound to a sulfur moiety (aurothiolates),
and given by weekly intramuscular injection to achieve a total cummulative
dose of 2.5 to 3 gm (2). He stated that colloidal gold was ineffective,
but did not mention the dosage, the form of colloidal gold, whether
metallic or cathionic, neither the method of administration. Several
subsequent reports by various investigators have confirmed the short
term efficacy of the parenteral forms of aurothiolates in RA (3),
but in more recently published clinical studies with the parenteral
aurothiolates, several side effects were reported: Pulmonary damage
(4-7), myelotoxicity, leukopenia, thrombocytopenia, and anemia (8-12).
In a recent longitudinal study of 822 RA patients receiving parenteral
aurothiolate therapy over a 5 year period (13), no statistical improvement
was observed in two outcome variables evaluated: functional assessment
and number of painful joints. In an attempt to minimize the side
effects of injectable gold complexes, an oral preparation was introduced
in 1976 (14). However, this preparation caused diarrhea/loose stools
in 50% of the patients, was less effective than the parenteral forms
of aurothiolates and produce the same side effects as the injectable
forms of gold salts although to a lesser extent.
Since chemical complexes of monovalent gold readily disproportionate
in solution with formation of metallic monoatomic gold and trivalent
gold according to the reaction: 3AU+® 2AUo + AU +++ (15), it would
be expected that monovalent gold organocomplexes, such as the aurothiolates
if administered orally or parenterally, would disproportionate in
vivo with formation of metallic monoatomic gold and trivalent gold
(AU III). In vivo clustering of metallic gold atoms would eventually
form colloidal particles of gold. One of us (GEA) postulated that
the active ingredient in aurothiolate therapy is colloidal metallic
gold generated by in vivo disproportionation with subsequent clustering
of monoatomic metallic gold to form colloidal gold; and that the
side effects were due mainly to the trivalent gold (AU III) generated
from disproportionation (Fig 1). If this postulate is valid, one
would expect colloidal metallic gold to have therapeutic effects
in RA and devoid of side effects. Metallic gold is non-toxic, used
extensively in dentistry and is widely available in colloidal form
as a nutritional supplement for human consumption. The above postulate
was tested in 10 patients with long standing erosive RA with minimal
to no response to previous treatment. The results obtained support
the postulate that colloidal metallic gold is indeed the active
ingredient in aurothiolate therapy and offer a more effective and
safer alternative to aurothiolate therapy in R.A. patients.
Materials and Methods
A. Colloidal metallic gold:
Aqueous dispersions of colloidal gold (Aurasol®) were prepared by
one of us (GEA) at a final concentration of 1000 mg/L, (1000 PPM)
by the citrate method of Maclagan (16) and Frens (17), with several
proprietary modifications. The sizes of the colloid particles were
less than 20 nm in several batches, confirmed by quantitative recovery
after passing through a 20 nm filter. Accelerated shelf-life studies
proved the stability of the aqueous dispersion for up to 2 years
at ambient temperature. The following metals were measured in the
aqueous colloidal gold dispersion and were undectable at 0.5 PPM
(<0.5 mg/L): Antimony, arsenic, barium, beryllium, cadmium, chromium,
cobalt, copper, lead, mercury, molybdenum, nickel, selenium, silver,
thallium, vanadium, and zinc. Lead levels were measured again in
a more sensitive assay and were undetectable at 50 PPB (<0.05
mg/L). Sterilization was achieved by microfiltration through 100
nm pore size and sodium benzoate was used as anti-microbial preservative.
B. R.A. Patients:
In order to minimize the placebo effect, the 10 worse cases (9 of
10 seropositive) with long standing (7-40 years duration) erosive
RA with minimal to no response to previous treatment, were recruited
from the private practice of one of us (PBH). Nine of 10 patients
received previously aurothiolate therapy without effect and 5 of
the 9 experienced side effects of skin rash, stomatitis and proteinuria.
The clinical data on these patients are displayed in Table I. Six
of the ten patients were totally work-disabled. After informed consent
was obtained, the patients underwent complete clinical and laboratory
evaluations before and weekly afterward for 4 weeks and monthly
for an additional 5 months of oral colloidal gold administration.
The inflammatory cytokines, tumor necrosis factor a (TNFa) and interleukin-6
(IL-6) were evaluated prior to and 24 weeks following gold administration
(Immunoscience Lab, Beverly Hills, CA). Paired data analysis was
used for the evaluation of response to colloidal gold (18).
Performance parameters were assessed by the method of Pincus, et.
al., (19). The severity of swelling and tenderness was assessed
for 86 joints, based on the quantitation of Lansbury (20), and the
classification described in the Dictionary of the Rheumatic Diseases
(21). The American Rhematology Association (ARA) functional class
by Steinbrocker, et al., (22) was used to evaluate functional status:
Class I: Complete functional capacity with ability to carry on all
usual duties without handicaps; Class II: Functional capacity adequate
to conduct normal activities despite handicap or discomfort or limited
mobility of one or more joints; Class III: Functional capacity adequate
to perform only few or none of the duties of usual occupation or
or self care; Class IV: Largely or wholly incapacited with patient
bed ridden or confined to wheel chair, permitting little or no self
care.
Since preliminary data by one of us (GEA) suggested that amounts
up to 15 mg/day of colloidal gold was without clinical effect in
RA, patients 1 through 5 received 30 mg/day for the first week and
60 mg/day for the second week, whereas patients 6 through 10 received
60mg/day for the first week and 30 mg/day for the second week. Except
for one patient, no significant difference was found between these
two amounts on the clinical parameters evaluated. The patients were
therefore continued on the trial at 30 mg/day for a duration of
24 weeks.
Results
The effects of the colloidal gold (Aurasol®) on tenderness and swelling
of joints were rapid and dramatic, with a significant decrease in
both parameters after the first week, which persisted during the
study period. The mean scores for tenderness and swelling were respectively
for the pre- and post- 1 week = 58.8 and 18.2 (p<0.01); and 42.5
and 15.9 (p<0.01). By 24 weeks of gold administration, the mean
scores were 10 times lower than pre-treatment levels being respectively
5.4 and 3.3 for tenderness and swelling. Duration of AM joint stiffness
(in hours) showed a decreasing trend that reached statistical significance
with pre-and post 24 week mean scores of 2.8 and 0.4 respectively
(p<0.01).
The mean body weight after 24 weeks on colloidal gold was not significantly
different from the pre-treatment mean value. As a group, there were
significant changes in ARA functional class, and physician's estimate
of disease activity. Pre- and post- 24 week mean values were 2.9
and 2.3 (P<0.05) for ARA functional class; and 3.1 and 1.5 (P<0.01)
for physician's estimate of disease activity. After 24 weeks on
colloidal gold, 3 patients (#5, #6, #7) were in clinical remission.
Work status improved in 3 patients (#3, #5, #6), with the most impressive
results in patient #6, who changed from totally disabled to full
time work, and ARA class IV to class I. The inflammatory cytokines
IL-6 and TNFa were significantly suppressed by the colloidal gold
with pre- and post-24 week mean values of 270 and 104 (p<0.05)
for IL-6; and 207 and 74 (p<0.05) for TNFa.
There was no clinical or laboratory evidence of toxicity in the
patients. Specifically no change was observed in subsets of white
blood cells and platelets in the RA patients, supporting the absence
of cytotoxicity from colloidal gold. There was no significant change
in hemoglobin, hematocrit, liver function tests, BUN, serum creatinine
and urinalysis in the RA patients and the levels of these parameters
remained within normal limits during the study period. Clinically,
there were no reports or signs of skin rashes, stomatitis, gastrointestinal
disturbances, vasomotor reactions, myalgias, arthralgias, pruritus,
headache or metallic taste. Evaluated individually, 9 of 10 patients
improved markedly after 24 weeks of colloidal gold at 30 mg/day.
Discussion
In studies performed in vitro (23) and in vivo (24), administered
metallic colloidal gold particles are ultimately sequestered within
lysosomes of phagocytes, visible under electron microscopy (EM).
After administration of aurothiolates to RA patients, gold particles
visible under EM selectively accumulate in the lysosomes of synovial
cells and macrophages (25). It is believed that stabilization of
lysosomes by these gold particles plays a role in their therapeutic
actions (26). Electron probe x-ray analysis of lysosomes revealed
that the form of gold present in lysosomes obtained from patients
receiving aurothiolates is devoid of sulfur atoms and therefore
cannot be in the form of aurothiolates (26). Since disproportionation
of aurothiolates generate monoatomic metallic gold with a diameter
of 0.28 nm, a size below the resolution of EM, the only way the
gold particles in the lysosomes could be visible under EM is by
clustering of metallic monoatomic gold to form colloidal gold particles.
These results are consistent with the postulate that the gold in
lysosomes is in the form of colloid particles of metallic gold.
Therefore, the argument that colloidal metallic gold is the active
ingredient from aurotherapy seems very plausible.
The results of this open trial in 10 patients with long standing
erosive RA not responding to previous treatment support the postulate
that colloidal gold is indeed the active ingredient in aurothiolate
therapy, and that the side effects are mainly due to the trivalent
gold (AU III) generated by in vivo disproportionation. Common sense
would favor the active ingredient in its pure state over a precursor
that generates both the active form and another form causing side
effects. The most prevalent side effects of aurotherapy are skin
rash and diarrhea. Trivalent gold cause contact dermatitis and skin
rash (27). The diarrheogenic action of aurothiolates can be explained
by their ability to stimulate intestinal secretion in vitro, an
effect shared by trivalent gold (28). Aurothiolates cause adverse
immune reactions in up to one third of RA patients (29-31). Some
of these side effects can be reproduced in susceptible mouse strains
following long-term exposure to the aurothiolates: increased serum
levels of IgM, IgG and IgE formation, of IgG antinuclear antibodies,
and granular IgG deposits along the glomerular basement membrane
(32-34). T-lymphocytes from susceptible mice fail to be sensitized
to the aurothiolates but mount a secondary response to Au (III)
salts, suggesting the adverse immune reactions to the aurothiolates
are elicited by T cell sensitization to Au (III) formed in vivo
through oxidation of Au (I) (35).
A placebo effect in these RA patients is very unlikely since their
favorable clinical response was associated with the concurrent suppression
of the inflammatory cytokines TNFa and IL-6. The powerfull anti-inflammatory
properties of colloidal gold while devoid of cytotoxicity and side
effects could make it usefull in other inflammatory and immune complexes
diseases. Tissue levels of colloidal gold in the therapeutic ranges
could be achieved rapidly with increased dosages without the risks
of complications reported for the aurothiolates. Colloidal metallic
gold could become an effective and safe alternative to the aurothiolates
in the management of R.A. patients.
Since colloidal metallic gold catalyzes electron-transfer in oxydation
reduction reactions (36), one possible mechanism of action of colloidal
gold could be in potentiating the suppressive effect of antioxydants
on free radical formation. The mechanisms of action of colloidal
gold however remain speculative at this time, and we are currently
investigating such mechanisms in animal models. Acknowlegement:
The authors wish to thank Ralf Albrecht for usefull discussions,
and Pat Kellum for skillfull secretarial assistance.
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