| United States Patent |
5,629,286 |
| Brewitt |
May 13, 1997 |
The present invention comprises homeopathic dilutions of growth factors and
methods for their use. Disorders which may be effectively treated with the
compositions of the present invention include chronic viral disorders, such as
HIV, AIDS, chronic fatigue syndrome and Epstein-Barr viral infections, cancer
and diabetes. Homeopathic dilutions of growth factors are preferably
administered orally. In an alternative embodiment, patients are treated with
radio frequency signals corresponding to homeopathic dilutions of growth
factors.
| Inventors: |
Brewitt; Barbara (5557 - 36th Ave.
NE., Seattle, WA 98105-2313) |
| Appl. No.: |
710040 |
| Filed: |
September 10, 1996 |
| U.S. Class: |
514/2; 530/351; 530/303 |
| Intern'l Class: |
A01N 037/18 |
| Field of Search: |
604/890.1 128/907
530/350,351,300-303 514/2,3 |
References Cited [Referenced
By]
U.S. Patent Documents
| 4341762 |
Jul., 1982 |
Haast |
424/88. |
| 4377514 |
Mar., 1983 |
Ruhenstroth-Bauer et al. |
424/95. |
| 4537512 |
Aug., 1985 |
Boiron et al. |
366/132. |
| 4704273 |
Nov., 1987 |
McMichael |
424/85. |
| 4880626 |
Nov., 1989 |
McMichael |
424/88. |
| 4986985 |
Jan., 1991 |
Grossman et al. |
424/195. |
| 5093317 |
Mar., 1992 |
Lewis et al. |
514/12. |
| 5114722 |
May., 1992 |
Zoubek et al. |
424/551. |
| 5162037 |
Nov., 1992 |
Whitson-Fischman |
600/12. |
| 5336508 |
Aug., 1994 |
Marty |
424/618. |
| 5427800 |
Jun., 1995 |
Cingotti |
424/489. |
| 5431881 |
Jul., 1995 |
Palacios |
422/61. |
Other References
|
Benveniste, J., Transfer of Biological Activity by Electromagnetic
Fields, Frontier Perspectives 3(2): 13-15, 1993.
Benveniste et al., L'agitation de solutions hautement diluees
n'induit pas d'activite biologique specifique, C.R. Acad.Sci.Paris
312(II): 461-66, 1991.
Liboff, A., Geomagnetic Cyclotron Resonance in Living Cells, Journal
of Biological Physics 13: 99-102, 1985.
Davenas et al., Human basophil degranulation triggered by very
dilute antiserum against IgE, Nature 333: 816-818, Jun. 1988.
Bourguignon et al., Electric Stimulation of Human Fibroblast Causes
an Increase in Ca.sup.2+ Influx and the Exposure of Additional
Insulin Receptors, Journal of Cellular Physiology 140: 379-385,
1989.
William Boericke, The Characteristic and Guiding Symptoms of All
Remedies, Pocket Manual of Homeopathic Materia Medica, p. 279, 1927. |
Primary Examiner: Hafer; Robert A.
Assistant Examiner: Smith; Chalin
Attorney, Agent or Firm: Speckman; Ann W. Sleath; Janet
Parent Case Text
CROSS-REFERENCE TO RELATED APPLICATIONS
This application is a contination of U.S. application Ser. No. 08/488,722
filed Jun. 8, 1995, now abandoned, which is a continuation-in-part of prior
U.S. application Ser. No. 08/221,365 filed Mar. 31, 1994, now abandoned.
Claims
1. A composition comprising a homeopathic dilution of one or more purified
growth factors, said factors comprising cell signalling polyeptides.
2. A composition as recited in claim 1, wherein said one or more purified
growth factors is selected from the group consisting of granulocyte
macrophage-colony stimulating factor, granulocyte-colony stimulating factor,
macrophage-colony stimulating factor, tumor necrosis factor, transforming
growth factors, epidermal growth factors, stem cell factor, platelet-derived
growth factors, nerve growth factors, fibroblast growth factors,
insulin-like growth factor, growth hormone, interleukin-1, interleukin-2,
keratinocyte growth factor, ciliary neurotrophic growth factor, Schwann
cell-derived growth factor, vaccinia virus growth factor, bombyxin, neu
differentiation factor, v-Sis and glial growth factor/acetylcholine
receptor-inducing activity.
3. A composition as recited in claim 1 wherein said homeopathic dilution of
a growth factor is in a liquid form.
4. A composition as recited in claim 1 wherein said homeopathic dilution of
said one or more growth factors is in a liquid form.
5. A composition as recited in claim 4 wherein the concentration of said
homeopathic dilution is between about 10.sup.-6 molar and about
10.sup.-100,000 molar.
6. A composition as recited in claim 1 wherein said homeopathic dilution of
a growth factor is impregnated on a solid medium.
7. A composition as recited in claim 6 wherein said solid medium comprises a
tablet.
8. A composition consisting essentially of a homeopathic dilution of one or
more growth factors, said factors comprising cell signalling poylpeptides.
9. A composition as recited in claim 8, wherein said one or more growth
factors is selected from the group consisting of granulocyte
macrophage-colony stimulating factor, granulocyte-colony stimulating factor,
macrophage-colony stimulating factor, tumor necrosis factor, transforming
growth factors, epidermal growth factors, stem cell factor, platelet-derived
growth factors, nerve growth factors, fibroblast growth factors, instalin-like
growth factor, growth hormone, interleukin-1, interleukin-2, keratinocyte
growth factor, ciliary neurotrophic growth factor, Schwann cell-derived
growth factor, vaccinia virus growth factor, bombyxin, neu differentiation
factor, v-Sis and glial growth factor/acetylcholine receptor-inducing
activity.
10. A composition as recited in claim 8 wherein the concentration of said
homeopathic dilution is between about 10.sup.-6 molar and about
10.sup.-100,000 molar.
11. A composition prepared by making a first solution containing one or more
purified growth factors, said factors comprising cell signalling
polypeptides, and subsequently making one or more serial dilutions of the
first solution to produce a homeopathic dilution of less than about
10.sup.-6 molar.
12. A composition as recited in claim 11 wherein said one or more purified
growth factors is selected from the group consisting of granulocyte
macrophage-colony stimulating factor, granulocyte-colony stimulating factor,
macrophage-colony stimulating factor, tumor necrosis factor, transforming
growth factors, epidermal growth factors, stem cell factor, platelet-derived
growth factors, nerve growth factors, fibroblast growth factors,
insulin-like growth factor, growth hormone, interleukin-1, interleukin-2,
keratinocyte growth factor, ciliary neurotrophic growth factor, Schwann
cell-derived growth factor, vaccinia virus growth factor, bombyxin, neu
differentiation factor, v-Sis and glial growth factor/acetylcholine
receptor-inducing activity.
13. A composition as recited in claim 11 wherein the concentration of said
homeopathic dilution is between about 10.sup.-6 molar and about
10.sup.-100,000 molar.
Description
FIELD OF THE INVENTION
This invention relates to the treatment of disorders such as chronic viral
infections, cancer and diabetes and more particularly to the use of
homeopathic dilutions of growth factors to treat such disorders.
BACKGROUND OF THE INVENTION
One aspect of this invention relates to the treatment of chronic viral
infections by administration of homeopathic dilutions of growth factors.
Chronic viral infections, such as herpes simplex virus, Epstein-Barr virus (EBV),
human immunodeficiency virus (HIV), papilloma virus, Coxsackie B, hauta
virus and hepatitis virus, affect signal transduction mechanisms with
deleterious effects within and between the host's immune and nervous
systems. During chronic viral infection, host cell signal transduction and
cell cycle regulation are altered, often causing cell injury and cell death.
Viruses lack the necessary biochemical machinery to manufacture proteins and
must therefore insert their genetic material into a host cell genome in
order to proliferate. Viruses consist of a protein coat and genetic
material. RNA viruses additionally contain reverse transcriptase, an enzyme
that translates the RNA into a DNA strand before insertion in the host cell
genome.
During viral infection, the protein coat binds to the host cell's surface
membrane enabling viral genetic information to subsequently enter the host
cell. Entry occurs via various methods, one of which is attachment to
specific membrane receptors, including growth factor receptors. For example,
the cell receptors for the Epstein Barr and herpes simplex type 1 viruses
have been identified as the third component of the complement receptor and
the fibroblast growth factor receptor, respectively. Insertion of viral
genetic information into the host cell's genome subverts the cell's normal
metabolic and genetic mechanisms in order to prioritize viral gene
expression and replication.
Chronic, or long-term, viral infections occur when the virus overcomes or
effectively disrupts the normal neuronal and immunological defense
mechanisms of the host. During early infection, several viruses, such as
herpes simplex virus, EBV, human herpes 6 virus (HH6V), hepatitis and HIV
can be asymptomatic as immune responses and viral replication remain in
balance in specific cell populations. Viral replication occurs in response
to extracellular stimuli (Garcia-Blanco, M. A. and Cullen, B. R. 1991
Science 254:815-820). Infections persist as continuous viral replication
occurs without substantial disruption of host cell function. Chronic viral
infections terminate only when viral replication is disrupted.
Viral infection erodes feedback communication between the host's immune and
nervous systems. For example, synthesis of adrenocorticotrophic hormone
(ACTH) by lymphocytes after viral infection disrupts the normal feedback
loop between pituitary/hypothalamus secretion of ACTH and the adrenal
gland's synthesis of glucocorticoids in response to ACTH signals.
Over-expression of ACTH causes increased expression of glucocorticoids which
consequentially down-regulates the pituitary and suppresses the activities
of T lymphocytes. This constant stress response often leads to extreme
fatigue and exhaustion in patients with chronic vital infections. In an
immune compromised patient, chronic infection leads to entry of virions into
the bloodstream, the lymphatic vessels and/or the nerve pathways resulting
in infection of new and distant cell populations.
Long-term DNA viral infections correlate with chronic or cancerous
illnesses. For example, hepatitis B viral infection was correlated with
liver cirrhosis 44% of the time and primary hepatocellular carcinoma 58% of
the time compared to 17% in a control group. EBV infection was correlated
with Hodgkin's disease of the mixed cellularity type 60% of the time. Herpes
type viral nucleic acid sequences from herpes simplex 1 and 2,
cytomegalovirus and EBV was found in the cerebrospinal fluid of patients
with acute encephalitis. HH6V has been found to be a cofactor in causing
chronic fatigue syndrome and AIDS. The ability of viruses to cause cancer is
contained within specific sequences of the viral genome, known as oncogenes,
that modulate gene transcription and regulation.
Gene transcription and regulation are modulated under normal conditions by
growth factors. Growth factors are cell signalling polypeptides that bind to
specific cell membrane receptors and initiate a cascade of intracellular
events that affect cell proliferation and differentiation. As stated above,
many growth factors bind to the same cell surface receptors as viruses and
therefore activate the same metabolic pathways used by viral infected or
transformed cells.
There are gene sequence homologies between growth factors, proto-oncogenes
and viral oncogenes. Normal non-cancer cells contain proto-oncogenes that
are homologous to the oncogene sequences found in some cancer causing
viruses. Proto-oncogene as well as oncogene sequences have the power to
regulate the cell cycle. Growth factors regulate the cell cycle by
manipulating proto-oncogenes. Some proto-oncogene sequences are homologous
with growth factors or their receptors. For example, the B chain of
platelet-derived growth factor (PDGF) is homologous to the proto-oncogene
c-sis (Doolittle, R. F., et al. 1983 Science 221:275-77). The receptor for
epidermal growth factor (EGF) is homologous to the proto-oncogene c-erb.beta.
(Downward, et al. 1984 Nature 307:521-527).
Growth factors and viruses use the same transcription sites to regulate cell
proliferation and/or viral replication, and are thus in a somewhat
competitive state with one another. For example, TGF.beta. plays a critical
role in the transmission of biological information by acting as an on/off
switch that couples cell behavior to the external environment. Within the
TGF.beta. promoter lies the proto-oncogene c-fos which codes for key
transcription factors located at AP-1 transcription sites. Subversion of c-fos
gene expression by HIV enhances HIV transcription and replication
independent of control sites located at tat and NF.sub.k 62 (Roebuck, K. A.
et al. 1993 J. Clin. Invest. 92:1336-1348). Viral transcription in the human
T-cell leukemia virus type 1 (HTLV-1), a virus with many characteristics
similar to HIV, is tightly regulated by a Tax transactivator site located at
the c-fos AP-1 site within the TGF.beta. promoter (Kim etal. 1990 J. Exp.
Med. 172:121-129). When the TGF.beta. promoter is activated so is HTLV-1
Tax. Chronic viral infection coincides with aberrant expression of growth
factors throughout the body as viruses have evolved to successively overcome
the regulatory actions of their competitors, growth factors.
Chronic viral infections can lead to up-regulation of growth factor
expression. For example, HIV infection up-regulates expression of tumor
necrosis factor alpha (TNF.alpha.) and transforming growth factor beta (TGF.beta.).
Over-expression of either of these growth factors disrupts normal
transcriptional control of gene expression, leading to suppression of
hematopoietic progenitor cells and increased HIV replication. TGF.beta.,
secreted by HIV-infected lymphocytes, also promotes growth of Kaposi's
sarcoma cells, fibroblasts and endothelial cells.
Specific hemopoietic growth factors have been used to treat diseases such as
AIDS and cancer. Hemopoietic growth factors are logical therapeutic
immunomodulators to use for treatment of chronic viral infections and other
diseases for several reasons. First, endogenous growth factors such as
granulocyte-macrophage colony stimulating factor (GM-CSF) and macrophage
colony stimulating factor (M-CSF) stimulate proliferation of hemopoietic
progenitor cells. Second, lymphocytes, macrophages and natural killer cells
that normally produce these factors are quantitatively and qualitatively
defective after infection by HIV, HH6V or EBV. Third, primates infused with
GM-CSF showed low toxicity with some positive but inconsistent rises in
platelet number.
However, clinical studies on AIDS patients using GM-CSF and M-CSF at
pharmacological concentrations (ug/kg/day) have produced mixed results. For
example, injections or intravenous administration of GM-CSF at
concentrations of 0.5-0.8 ug/kg/day transiently increased leukocyte,
neutrophil, eosinophil and monocyte counts in AIDS patients with no
significant rise in platelet counts or change in reticulocyte and lymphocyte
counts (Miles, S. 1992 AIDS Res. Hum. Retroviruses 8:1073-1080).
Subcutaneous injections of 0.25-4.0 ug/kg/day improved leukocyte counts with
no improvement in hemoglobin or platelet counts. However, the side effects
included increased HIV replication, increased levels of P24 antigen, chills,
nausea, myalgia and flu-like symptoms (Poli, G. et al. 1991 J. Exp. Med.
173:589-597; Scadden, D. T. 1990 Hematopoietic Growth Factors in Trans.
Med., Wiley-liss Inc., New York, pp. 163-176). GM-CSF also occasionally
caused thrombocytopenia. Granulocyte colony stimulating factor (G-CSF) has
been effective in correcting neutropenia with some minor increases in
lymphocyte counts. Additionally, hemoglobin and reticulocytes increased in
numbers in patients given G-CSF alone or in combination with erythropoietin.
However, resumption of treatment with AZT after use of these growth factors
led to severe anemia. Pharmacological doses of growth factors often have
harsh side effects.
Homeopathy,
which dates back to the nineteenth century, is founded on the principles of
pharmacology. One of the earliest laws of pharmacology, representing the
homeopathic effect, is known as the Arndt-Schultz law. Formulated by Arndt
in 1888 and restated by Hueppe, the law states: for every substance, small
doses stimulate, moderate doses inhibit, large doses kill. Allopathic
medicine, with its emphasis on moderate drug doses, works to inhibit
undesired physical symptoms and to kill undesired pathogens. Homeopathic
medicine begins with small doses and moves towards higher and higher
dilutions to stimulate the body's own natural electromagnetic forces.
Homeopathic and allopathic principles can be represented on the same
sinusoidal curve (shown in FIG. 1). There are several harmonic
concentrations over a log scale of dilutions that give the same desired
effect. Oscillatory data demonstrating the stimulating and inhibiting effect
of log dilutions of anti-IgE antisera which caused human basophil
degranulation have been generated and reproduced (Davehas, E., Beauvais, F.
et al. Nature 333:816-818, 1988; Beneviste, J., Davenas, E. et al. C. R.
Acad. Sci. Paris 312, series II, pp. 461-466, 1991). Control studies using
dilutions of antihuman IgG antisera or simply distilled water did not
produce this same effect. One of the basic tenets of homeopathic medicine is
that a cure for a disease can be evoked by using a high dilution medicine
that resembles but is different from the cause of the disease. Homeopathy
is widely accepted as a useful therapeutic throughout Europe, the British
Commonwealth countries and India, and has been demonstrated to have
characteristic and reproducible effects. A critical review of more than 100
controlled and/or clinical studies of homeopathy
determined that patients received positive healing benefits from homeopathy
beyond the placebo effect (Kleijnen, J. et al. 1991 Brit. Med. J.
302:316-323).
Many homeopathic medicines are used at concentrations of micrograms
(10.sup.-6 M) and nanograms (10.sup.-12 M); however, other homeopathic
dilutions exceed Avogadro's number (6.023.times.10.sup.-23). When
homeopathic compounds are diluted 1:10, with repeated succusions (similar to
vortexing) and repetitively diluted by this procedure at least 24 times a
potency is achieved (10.sup.-24) that is so highly dilute that the
probability of a single molecule of the original substance remaining in the
volume used is less than 1.times.10.sup.-10. Homeopathic practitioners
believe that the potency of a compound increases with increasing dilutions.
The standard homeopathic dosage is 10-15 drops of a 10.sup.-12 molar, or 6C,
solution administered two to three times per day. A 10.sup.-60 molar or 30C
may be given only one time per day. A 10.sup.-400 molar or 200C may be given
only one time per month or year. A 6C dilution approximates 1 ng/ml, which
is used in cell culture but would be considered a lower than physiological
dose when administered to a patient either orally or by injection.
Highly dilute homeopathic medicines have been effective in treating some
viruses in vivo. Homeopathic dilutions of 1.times.10.sup.-200 to
1.times.10.sup.-1000 of typhoidinum, hydrophobinum, tuberculinum, nux vomica
and malandrinum 100% inhibited pock-like lesions caused by a chicken embryo
DNA virus on the chorio-allantoic membrane compared to controls (Singh, L.
M. and Gupta, G. 1985 Brit. Homeopathy
74:168-174). Other homeopathic medicines, the same medicines at different
homeopathic concentrations or control phosphate buffered solution (PBS), had
lesser to no effect.
One of the advantages of homeopathic medicine in the treatment of chronic
viral infections is apparent in terms of viral mutation. One of the problems
associated with the use of allopathic pharmaceuticals is the drug resistance
that develops as viruses mutate during frequent cycles of replication. For
example, detailed kinetic studies on HIV viral load with antiviral therapy
have demonstrated that the half-life of HIV in plasma is every two days. In
other words, 30% of the viral load measured on any given day was produced in
the last 24 hours. HIV is the most rapidly replicating and mutating virus
known to man. Homeopathic therapeutics are superior to allopathic
therapeutics in the treatment of chronic viral infections since homeopathic
medicines, such as high dilutions of growth factors, have no molecules that
viruses, such as HIV, can mutate against. Homeopathic dilutions of growth
factors probably activate signal transduction pathways without using
signaling molecules.
While the exact mechanism of action of homeopathic medicines is unknown,
magnetic image resonance measurements on serial dilutions of substances
indicate that the hydroxyl (OH) groups in the solvent of solutions continue
to change as dilutions become successively higher (Sacks, A. D. 1983 J.
Holistic Med. 5:175-176; Smith, R. and Boericke, G. 1968 J. Am. Inst. Homeopathy
61:197-212; Smith, R. and Boericke, G. 1966 J. Am. Inst. Homeopathy
59:263-279). It is clear that the specific effects of homeopathics are of a
non-molecular origin, yet provide potent biological information that is
clinically effective. It has been postulated that highly dilute compounds
transfer biological activity to cells by electromagnetic fields (Benveniste,
J. 1993 Frontier Perspectives 3:13-15).
Experiments in several laboratories have provided evidence that a specific
biological activity can be initiated and/or modulated by highly dilute
substances that contain hardly a molecule. An argument against a molecular
basis for the activity is that heating dilutions to 70.degree. F. for 30
minutes or exposure to magnetic field strengths of 50 Hz, 150 gauss, for 15
minutes totally suppresses these effects. Del Giudice et al. have
hypothesized that interactions between the electric dipoles of water and the
radiation fields of a charged molecule generate a permanent polarization of
water which becomes coherent and has the ability to transmit specific
information to cell receptors, somewhat like a laser (Del Giudice, E.,
Preparata, G., Vitiello, G. 1988, Phys. Rev. Lett. 61:1085-1088).
The cell surface membrane is the interface between electromagnetic waves and
biological activity of cells. Cell membranes maintain a carefully controlled
surface potential that is transiently altered by electromagnetic fields,
viral attachment, and binding of neurotransmitters, hormones and growth
factors to their receptors. Liboff suggests that specific ionic currents are
induced by Faraday's Law which affects the cell surface receptors and ion
channels. (A. R. Liboff 1985, J. Biol. Physics 13:99-102.) In specific
regions of the cell, such as the location of ionic channels and cell
receptors, there may be reduced wave scattering. Ionic species or charged
side chains on cell receptors, will follow a resonating circular or helical
well-defined orbit under the influence of electromagnetic signals. Liboff
points out that channelized ions are constrained to move along helical
paths. Similarly, receptor molecules are constrained within the lipid
bilayer and will resonate with specific frequencies given proper periodic
stimulus. Any movement or conformational changes of growth factor receptors
will induce signal transduction processes. The well-ordered water molecules
that participate in intermolecular hydrogen bonding networks are present in
the interface regions between growth factors and their receptors, however
they are not significant for protein binding (Clackson, T. and Wells, J. A.,
1995 Science 267:383-386). Ordered water molecules are observed in several
other protein-protein interfaces and can be present in both the bound and
unbound states. For example, water molecules which fill gaps between
imperfectly packed regions of human growth hormone receptors' extracellular
domain in the ligand/receptor bound state are fully available for
electromagnetic activation in the unbound state. The integration of these
separate schools of thought suggests that high dilutions of substances
create changes in electromagnetic forces inducing resonance in cell surface
signal proteins thus transferring biological activity through cell receptors
or ionic channels and initiating signal transduction processes.
Bioelectromagnetics underlies biochemical reactions. The science of
bioelectromagnetics studies the interactions of electromagnetic fields in
living systems (Rubik, R. and Flower, R. G. 1994 Electromagnetic
applications in medicine, Expanding Medical Horizons: Report to NIH on the
Status of Alternative Medicine, U.S. Govt. Printing office, Washington,
D.C.; Tenforde, T. S. and Kaune, W. T. 1987 Health Physics 53:585-606).
Electrical stimulation of cells temporally changes the cell's membrane
potential and evokes consequential changes of RNA, DNA and protein synthesis
(Bourguignon, G. J. and Bourguignon, L. Y. 1987 FASEB J. 1:398-402; Rodan,
G. A. et al. 1978 Science 190:690-692). Several studies on the effects of
administering electromagnetic signals have been published. For example,
Thomas et al. demonstrated behavioral changes in rats following
administration of a cyclotron electromagnetic field which resonates for the
signal for unhydrated lithium ions (Thomas J. R. et al. 1986
Bioelectromagnetics 7:349-357). Researchers also report inhibition of tumor
growth after administration of human interferon alpha (IFN.alpha.) plus DC
current (Sersa, G. and Miklavcic, D. 1990 Molecular Biotherapy 2:165-168).
Electrical stimulation of epidermal fibroblast cells has been shown to
regulate both transforming growth factor-beta and insulin receptors (Falanga,
V., Bourguignon G. J., Brougiugnon, L. Y. 1987 J. Invest. Dermatol. 88:488;
Bourguignon, G. J., Jy, W., Bourguignon, L. Y. 1989 J. Cell. Physiol.
140:379-385). The cell membrane, and in fact the whole body, respond to
electrical and magnetic stimuli and are thus receptive to communications
beyond the level of biochemical and molecular mechanisms.
Few effective treatments are available for disorders such as chronic viral
infections, cancer and diabetes. Insulin-dependant diabetes, while regulated
by insulin still has many systemic complications. Despite more than ten
years of aggressive research, both conventional and naturopathic, no
definitive treatment exists for HIV infection or acquired immunodeficiency
syndrome (AIDS). There thus continues to be a need in the art for effective
treatments for chronic viral infections, cancer and diabetes.
SUMMARY OF THE INVENTION
It is an object of the present invention to provide an effective treatment
for disorders including chronic vital infections, cancer and diabetes which
will slow the progression of disease and/or relieve disease symptoms. An
additional objective is to provide such a treatment which does not lead to
unwanted side effects. Another objective of the present invention is to
provide such a treatment at a reasonable cost.
These and other objectives are achieved by administering homeopathic
dilutions of growth factors, or electromagnetic signals, preferably radio
frequency signals, corresponding to homeopathic dilutions of growth factors,
to patients.
Growth factors are cell signalling polypeptides which modulate cell
proliferation and differentiation by binding to specific cell membrane
receptors. Binding of growth factors to cell membrane receptors initiates a
cascade of intracellular events that affect gene transcription and
expression within the cell. Growth factors range in size from 3,500 to
250,000 daltons and, unlike hormones, generally act on nearby cells via
autocrine and paracrine mechanisms. However, they may also act as second
messengers for hormone signals.
Proteins, such as growth factors, may evolve from a common ancestor to the
point where they no longer share amino acid sequence similarity. However
their relatedness may be evident from a structural comparison. Polypeptide
growth factors, a diverse group of regulatory agents, have similar
protomeric structures. McDonald and Hendrickson have classified growth
factors into six superfamilies based on homology of characteristic three
dimensional structures (1993 Cell 73:421-424). X-Ray crystallographic and
NMR studies have shown that growth factors contain relatively few recurring
structural folds despite their diversity. When structural folding is
considered, several proteins previously regarded as hormones, such as
insulin and growth hormone, are subsumed into the definition of growth
factors. Cytokines and growth factors are very similar in both size and
function. The term "growth factor" as used herein, therefore
encompasses cytokines and some hormones as well as the traditional growth
factors.
A specific growth factor may have many cell sources and can use different
signal transduction pathways at different times and with different cells.
Growth factors are involved in complex feedback loops between the immune,
nervous and endocrine systems.
The homeopathic dilutions of growth factors of the present invention are
preferably of a concentration of less than about 10.sup.-6 molar, and
preferably between about 10.sup.-6 molar and about 10.sup.-100,000 molar.
Some of the homeopathic dilutions may thus contain less than one molecule of
growth factor. Homeopathic dilutions of growth factors are preferably
administered orally, including liquid or solid form, such as pellets or
tablets, however they may also be injected at key acupuncture or skin
conductance points.
Growth factors which may be utilized in the present invention include
granulocyte macrophage-colony stimulating factor (GM-CSF),
granulocyte-colony stimulating factor (G-CSF), macrophage-colony stimulating
factor (M-CSF), tumor necrosis factor (TNF.alpha.), transforming growth
factors (TGFs), epidermal growth factors (EGF), stem cell factor (SCF)
platelet-derived growth factors (PDGF), nerve growth factor (NGF),
fibroblast growth factors (FGF), insulin-like growth factors (IGF), growth
hormone, interleukin-1, interleukin-2, keratinocyte growth factor, ciliary
neurotrophic growth factor, Schwann cell-derived growth factor, vaccinia
virus growth factor, insulin, bombyxin, neu differentiation factor, v-Sis,
glial growth factor/acetylcholine receptor-inducing activity and other
proteins that belong to their structural superfamilies.
Chronic viral infections that may be treated using the homeopathic dilutions
of growth factors of the present invention include HIV, EBV, herpes simplex,
papilloma, cytomegalovirus, Coxsackie B, hauta virus, human herpes 6 virus
and hepatitis viral infections. Other disorders which may be effectively
treated using the methods of the present invention include insulin-dependent
and non-insulin dependent diabetes, and cancers such as leukemia and
adenocarcinoma.
DESCRIPTION OF THE FIGURES
FIG. 1 is a sinusoidal curve demonstrating the stimulating and inhibiting
effects of homeopathic and allopathic medicines.
FIGS. 2A and B show electrical conductance points for the hand and foot as
determined by Voll.
FIG. 3 shows the different outputs measured by the LISTEN system.
FIGS. 4A-C show the absolute counts of CD4, CD8 and CD2 lymphocytes in
HIV-positive patients during three months of oral administration of
homeopathic dilutions of growth factors compared to administration of
placebo. All patients were taking natural medicines; none were taking
antiretrovirals, human proteases, or other conventional HIV treatments. No
patients were taking steroidal therapy.
FIG. 5 shows a scattergram of the RNA count of HIV viral load in
HIV-positive patients following three months of treatment with homeopathic
dilutions of growth factors compared to administration of placebo.
FIGS. 6A and B show the percentage change and absolute change, respectively,
in erythrocyte sedimentation rates in HIV-positive patients following three
months of oral administration of homeopathic dilutions of growth factors
compared to placebo.
FIG. 7 shows the weight changes in HIV-positive patients following three
months of treatment with homeopathic dilutions of growth factors compared to
administration of placebo.
FIGS. 8A-D show the change in serum calcium and phosphorus levels in
HIV-positive patients following three months of oral administration of
homeopathic dilutions of growth factors compared to administration of
placebo. FIGS. 8A and C show the absolute changes. FIGS. 8B and D show
percentage changes.
FIGS. 9A and B show electrical conductance values for HIV-positive patients
prior to treatment with either homeopathic dilutions of growth factors or
placebo. FIGS. 9C and D show five measurements of electrical conductance at
four key skin conductance points, associated with the spleen, thymus, nerves
and brain in HIV-positive patients administered either homeopathic dilutions
of growth factors or placebo, respectively. The measurements were taken
during the course of a three month clinical study.
FIG. 10 shows the change in platelet count over time in an HIV-positive
patient with thrombocytopenia both before and during treatment with
homeopathic dilutions of growth factors.
FIGS. 11A and B show the change in peripheral blood lymphocyte counts for
two HIV-positive patients following treatment with radio frequency signals
corresponding to homeopathic dilutions of growth factors. Neither of these
patients were taking any conventional therapeutics. Both were taking natural
medicines.
FIG. 12 shows the change in peripheral blood lymphocyte counts over time for
a control HIV-positive patient who was not taking any conventional medicine,
only natural medicines. This patient did not receive any radio frequency
signals corresponding to homeopathic dilutions of growth factors.
FIG. 13 shows the change in total T lymphocyte cells, CD8 and CD4 counts for
an HIV-positive patient prior to and following administration of radio
frequency signals corresponding to homeopathic dilutions of growth factors.
FIG. 14 shows the mean values of electrical conductances for fifteen
patients with chronic EBV infection before treatment.
FIG. 15 shows the electrical conductances of eleven EBV patients after
treatment with homeopathic growth factor signals and naturopathic
supplements.
FIG. 16 shows the electrical conductances for two cancer patients prior to
treatment with the LISTEN system.
FIG. 17 shows the change in white blood cell count in a patient with chronic
lymphocytic leukemia both before and during treatment with radio frequency
signals corresponding to homeopathic dilutions of growth factors and
homeopathic liquid dilutions of growth factors.
FIG. 18 shows the electrical conductances for two patients with insulin
dependent diabetes prior to treatment with the LISTEN system.
DETAILED DESCRIPTION
The homeopathic dilutions of the present invention typically comprise
between 1.times.10.sub.-6 and 1.times.10.sup.-100,000 molar dilutions of
growth factor in a pharmaceutically acceptable diluent. The preferred
homeopathic diluent is 100% grain alcohol. However, other diluents are known
in the art and may be employed in the present invention to increase
solubility and stability of lyophilized growth factors. The homeopathic
dilutions are preferably administered orally, but may also be injected into
acupuncture or skin conductance points, or administered intravenously. In a
preferred embodiment, homeopathic dilutions of growth factors are
administered by means of liquids or tablets which retain the memory of the
homeopathic dilution. The tablets are made from a suitable organic material,
such as lactose (Botanical Labs., Bellingham, Wash.) by methods well known
in homeopathy
(see, for example, the United States Homeopathic Pharmacopeia). Alternative
methods of administration may also be used, such as topical application.
Example 1 describes the preliminary results of a double-blind placebo
controlled clinical study evaluating the effects of administration of
homeopathic dilutions of growth factors on lymphocyte counts in HIV patients
using liquid dilutions.
Radio frequency signals corresponding to homeopathic dilutions of growth
factors may be administered as illustrated by Examples 2-8, in which Example
2 describes a one time evaluation of homeopathic growth factor signals on
HIV-positive patients; Example 3 demonstrates the effect of repeated
administrations of homeopathic growth factor signals on two HIV-positive
patients compared to a control patient who was not treated with radio
frequency signals corresponding to homeopathic dilutions of growth factors;
Example 4 shows a four-year longitudinal study of an HIV-positive patient
treated with homeopathic growth factor signals; Example 5 describes the
effects of administration of homeopathic growth factor signals on patients
with Epstein-Barr viral infections (EBV); Example 6 describes the treatment
of two cancer patients with signals corresponding to homeopathic growth
factors; Example 7 demonstrates the effects of administration of homeopathic
growth factor signals to a patient with chronic lymphocytic leukemia; and
Example 8 demonstrates the effects of administration of homeopathic growth
factor signals to two diabetic patients.
In Examples 2-8 patients were treated using the Life Information System TEN
(LISTEN) (BioSource, Inc., Orem, Utah) which determines skin resistance or
electrical conductance. The basic tenet behind the LISTEN system is that the
points on the body normally referred to as "acupuncture points"
have an optimal electrical resistance (100,000 ohms) in healthy subjects
which changes during illness. Each acupuncture point is associated with a
specific meridian, or line of electrical conductance, which in turn is
associated with a particular organ or system of the body (Voll, R. 1977
Topographic positions of the measurement points in electro-acupuncture. 1st
English edition, H. Schuldt translator, Medizinish Literarische
Verlagsgesellschaft mbH, C. Beckers Buchdruckerei GmbH & Co. KG, M. Sc.
Uelzen, Germany, vols 1-4+supplement). Furthermore, Voll showed that the
electrical activity at each of these points is related to the functional
status of the specific organ or system (See, for example, Am. J. Acupuncture
8:97-104, 1980). FIGS. 2A and 2B illustrate hand and foot conductance points
as defined by Voll. Points coded LY are related to lymph tissue, LU to lung
tissue, LA to large intestine, NE to the nervous system, TR to
neuroendocrine points, SP to spleen and PA to the pancreas.
By determining the electrical resistance at different points on a patient,
it is possible to determine which organs are affected by a disease. For
example, Bergsmann and Woolley-Hart demonstrated significant differences in
electrical conductances between human patients with and without liver
disease at acupuncture points corresponding to the liver (Am. J. Acupuncture
1:27-32, 1973). During the 1930-1940s Burr and associates at Yale published
more than sixteen papers on bioelectric potential, or skin conductance, and
its significance as an indicator of physiological states, such as cancer, in
animal models (See, for example, Langman L. and Burr, H. S. (1949) Am. J.
Obstet. Gyn. 57:274-281). In addition, a patient can be treated by providing
a radio frequency electrical signal which restores electrical conductance at
specific points to normal levels.
The LISTEN system is a modified computer-based system which, in addition to
determining electrical resistance at specific conductance points, can be
used to administer radio frequency signals corresponding to specific
compounds, such as homeopathic dilutions of growth factors. These signals
are generated by digital codes pre-programmed into the system by the
manufacturer. The patient to be evaluated holds a source electrode, or brass
bar, covered with wet gauze in one hand. The practitioner holds a second
brass electrode, or probe, like a pen and touches a specific conductance
point in the other hand or in a foot with the probe while firmly supporting
the finger or toe.
Conductance points are said to be approximately 3 mm in diameter and located
in the epidermal layer of the skin, often at the neck of the bones. In order
to obtain the most accurate and reproducible measurement, the probe is
placed at a 45.degree. angle to the bone. Three tests are conducted per
point in order to determine the reliability of the measurement.
The LISTEN system determines three significant outputs: the rising slope;
the maximal conductance; and the falling slope as shown in FIG. 3. The
maximum is defined as the electrical conductance (ohms) produced at a
patient's skin point in response to a maximal 5 volt stimulus. An internal
clock calculates the time in seconds for the ohm meter to reach maximal
conductance, and then during a constant one second period records the
maximum and minimum conductance. The rising slope equals the maximum
conductance divided by the seconds of time to reach maximum. The falling
slope equals the maximum minus the minimum divided by seconds of time (in
this case 1 second). Optimal resistance at an acupuncture skin point is
100,000 ohms (Zong-xiang 1981 Am. J. Acupuncture 9:203-216), scaled on this
Y-axis at a value of 50 arbitrary units. Conductances in the range of 48-54
units at all skin conductance points on the hands and feet are thus
indicative of optimal human vitality or state of health. Calibration of the
LISTEN device with a resistor occurs every six months so that 50
units=100,000 ohms with 1% precision. Preliminary studies on 28 points in 15
`healthy` individuals determined that the mean maximum conductance was
50.3.+-.0.58 units (SEM) with a rise of 20.1.+-.0.57 units/sec.
The general protocol followed in Examples 2-8 is outlined below. Baseline
conductance measurements were obtained on the right side plus one left side
point for the spleen meridian in order to discover which points varied in
their maximum and minimum from the optimal range of 48-54 and which points
varied in rise from 14.+-.0.3 and fall from 1.25.+-.0.3. The areas in the
body most out of balance were thus determined. The point with the highest
abnormal reading or the highest point in the area with the greatest numbers
of imbalanced energy was selected. The Specific Listings category of the
LISTEN system was blind scanned in order to determine which growth factor
was most likely to balance the specific point in terms of maximum-minimum
readings and rise and fall readings. A radio frequency signal corresponding
to the selected growth factor was then administered to the patient for a
period of one second to determine if it alone would balance the electrical
conductance at the chosen point. All available growth factor signals were
tested in this manner until it was determined which growth factor or
combination of growth factors balanced all the points. If chronically low
points could not be brought back into the normal range, a growth factor
signal was selected which brought the conductance reading as close to normal
as possible. In the following examples, all points were brought back into
the normal range.
Some patients in Table VI were then challenged with radio frequency signals
corresponding to a variety of viruses. Each virus signal was tested for its
ability to raise the patient's normal reading. Readings above 75 were
considered to be a positive test. A signal corresponding to both the
selected growth factor and the virus that "stressed" the normal
point was subsequently administered to determine whether the selected growth
factor could balance the electrical conductance under "stress"
conditions.
The LISTEN system may be employed to determine whether a therapeutic agent
would be effective in returning one or more specific organs or tissues of
the body to optimal vitality by administering a signal corresponding to the
therapeutic agent to the skin conductance point related to that organ or
tissue and determining whether the signal returns the conductance at that
point to the optimal level. The LISTEN system can thus be used to screen
multiple therapeutic agents for efficacy in treating a specific disorder.
EXAMPLE 1
Twenty-one HIV-positive patients were enrolled in a double-blind placebo
controlled study to evaluate the therapeutic efficacy of oral administration
of homeopathic dilutions of growth factors in raising lymphocyte counts in
HIV seropositive (HIV+) patients. In order to qualify for the study,
patients had to be over 18 years of age, have CD4 counts in the range of
180-550 cells/mm.sup.3, fall within CDC classifications A1, A2, B1, B2, B3
and C2, and not be receiving any conventional HIV therapy, such as
recombinant soluble CD4, nucleoside or non-nucleoside reverse transcriptase
inhibitors, TAT antagonists, antisense oligonucleotides, ribozyme therapy,
transdominant proteins, protease inhibitors, glucosidase inhibitors,
adoptive immunotherapy or ribonucleotide reductase inhibitors, either during
or three weeks prior to the commencement of the study. The patients were
randomly assigned to either a placebo group or a treatment group, with 11
patients being enrolled in the treatment group and 10 in the placebo group.
Homeopathic dilutions of insulin-like growth factor (IGF.sub.1),
transforming growth factor (TGF.beta.1), BB-platelet-derived growth factor
(BB-PDGF) and granulocyte macrophage-colony stimulating factor (GM-CSF) were
prepared as follows. IGF.sub.1, TGF.beta.1, and BB-PDGF (all from Genzyme,
Boston, Mass.) were diluted to a 10.sup.-4 concentration, equivalent to a
homeopathic potency of 3C in either 1M acetic acid or 0.10% trifluoroacetic
acid and 30% acetonitrile which was then evaporated off. GM-CSF (tradename
Leukine, Immunex Corp., Seattle, Wash.) was diluted to a 10.sup.-4
concentration in sterile water. Serial dilutions of 1:100 were made
according to the protocol described in the United States Homeopathic
Pharmacopeia to provide potencies of 30C (10.sup.-60) for BB-PDGF and
TGF.beta.1, 200C (10.sup.-400) for GM-CSF, and 1M (10.sup.-2,000) for
IGF.sub.1, BB-PDGF, and TGF.beta.1, including 0.5% bovine serum albumin (BSA)
for stability. The final dilutions were prepared in a 20% glycerine base
solution in water without alcohol.
Patients in the treatment group were orally administered 10 drops each of
BB-PDGF (both 30C and 1M dilutions), TGF.beta.1 (both 30C and 1M dilutions),
IGF.sub.1 (1M dilution) and GM-CSF (200C dilution) three times per day. All
growth factor dilutions were administered at the same time. The dilutions of
each growth factor were contained in a separate bottle, thus four bottles of
homeopathic dilutions of growth factors or four bottles of placebo were
given to each participant. Patients in the control group were administered
dilutions of 20% glycerine alone, which tasted and appeared to be the same
substance but contained no growth factor dilutions.
FIG. 4A shows the CD4 lymphocyte counts during three months of oral
administration of homeopathic dilutions of growth factors compared to
placebo treatment. The data show that CD4 lymphocyte counts in patients
receiving homeopathic dilutions of growth factors remained stable or
increased, while patients receiving placebo continued to lose CD4 lymphocyte
counts. CD4 cells are generally associated with helper T lymphocyte cells.
The two groups started with approximately the same CD4 lymphocyte counts.
Specifically, the treatment group had initial CD4 counts of 338.+-.41
cells/mm.sup.3 and the placebo group had initial CD4 counts of 335.+-.39
cells/mm.sup.3. Following two months of treatment, the CD4 lymphocyte counts
for the two groups were significantly different, with the treatment group
having a count of 340.+-.32 cells/mm.sup.3 and the placebo group having a
CD4 count of 244.+-.36 cells/mm.sup.3. This represents a statistically
significant difference of P<0.05 between the two groups after two months
of treatment. After three months the treatment group had a CD4 lymphocyte
count of 354.+-.44 compared to the placebo group CD4 lymphocyte count of
257.+-.36 cells. The fall in CD4 lymphocyte counts in the placebo group is
similar to that found in other studies on the treatment of HIV+patients
using only natural medicine without growth factors.
As shown in FIGS. 4B and 4C, no statistically significant changes were
observed in CD8 and CD2 lymphocyte counts between the placebo and treatment
group at the end of the three month study. CD8 cells are associated with
suppressor T lymphocyte function and CD2 cells represent total T
lymphocytes.
Data on the RNA count of viral HIV load for the study participants
(treatment group n=10, placebo group n=10) at the end of the three month
study is presented as a scattergram in FIG. 5. As shown in FIG. 5, six
patients in the treatment group had less than 50,000 HIV RNA copies/ml with
a mean of 14,530.+-.2,896 copies/ml compared to one patient with 46,360
copies/ml in the placebo group. This represents a three fold lower viral
load in persons administered homeopathic dilutions of growth factor compared
to placebo (P<0.002).
The difference in erythrocyte sedimentation rates (ESR) between the
treatment and placebo groups was statistically significant at the end of the
three month study as shown in FIG. 6. Both groups started with similar ESR
values (24.+-.6.8 mm/hr for the treatment groups compared to 19.6.+-.4.9
mm/hr for the placebo group). Following three months of oral administration
of homeopathic dilutions of growth factors, the ESR values for the treatment
group had decreased to 15.5.+-.4.03 mm/hr a decrease of 32.1.+-.15.6%. In
contrast, the placebo group ESR values increased to 22.1.+-.5.7 mm/hr, an
increase of 4.2.+-.8.44% (P<0.005).
ESR values represent non-specific measures of inflammation and/or infection.
ESR values rise steadily as HIV disease progresses. Research has shown that
ESR values may be a useful addition to the CD4 count and beta
2-microglobulin in assessing the stage of HIV disease (Schwartlardes, B. et
al. 1993 AIDS 7:813-21). Increased ESR values during disease progression in
HIV-positive patients have been reported in a group of patients taking
natural medicines (Standish, L. et al. 1992 J. Naturopathic Medicine
3:42-64). The difference in ESR values seen between the treatment and
placebo groups in the present study is consistent with HIV-related disease
progression in the placebo group. The treatment group continued to improve
in health and lower their HIV-related symptoms. The decrease in ESR values
demonstrates that homeopathic dilutions of growth factors positively and
specifically affect lymphocytes and lower the chronic inflammatory reactions
caused by HIV infection, or other chronic viral infections. There were no
significant changes in hemoglobin or hematocrit in either group during the
three month clinical study.
FIG. 7 shows the average weight change in patients in the treatment group
versus those in the placebo group during the three month study. There was a
weight gain of 4.88.+-.1.92 (SEM) pounds in the treatment group compared to
a loss of 3.95.+-.1.43 pounds in the placebo group. Weight gain in the
treatment group was statistically significant compared to the weight loss in
the placebo group (P<0.001). Weight gain may be associated with using
homeopathic dilutions of insulin-like growth factor which, in
pharmacological doses, is known to participate in anabolic processes in the
body.
FIGS. 8A-D show the change in serum calcium and phosphorus levels following
three months of oral administration of homeopathic dilutions of growth
factors compared to administration of placebo. Calcium is a significant
mineral in the body and participates in numerous metabolic functions.
Phosphorus contributes to formation and utilization of ATP, phosphorylated
metabolic intermediates and nucleic acids. In the form of phosphilpids and
inositol polyphosphates, it plays critical roles in the signal transduction
mechanisms after growth factor stimulation. Lymphocytes from HIV-infected
individuals show aberrant inositol polyphosphate metabolism which reverses
after AZT therapy (Nye et al. 1990). Both calcium and phosphorus are poorly
absorbed in some HIV-positive persons.
All participants were within the normal ranges for serum calcium at entry
into the study with a mean value of 8.87.+-.0.074 mg/dl. However, this is
lower than a cohort of an equal number of age/sex matched non-HIV.sup.+
patients whose serum calcium levels were 9.2.+-.0.085 mg/dl. Because calcium
plays a critical role in signal transduction processes elicited by growth
factors and because study participants were on the low side of normal, all
participants were asked to add 1000 milligrams of calcium into their diet,
if they were not using it already, to maximize the potential action of the
high dilution growth facts. Calcium citrate or calcium chelated to several
amino acids and acidic moleties were recommended for maximal absorption.
During the clinical study, the treatment group started with serum calcium
values of 8.8.+-.0.10 mg/dl and increased their serum calcium levels to
9.5.+-.0.12 mg/dl which represents a 7.14.+-.1.2% increase. In contrast, the
placebo group entered the study with serum calcium values of 8.96.+-.0.13
mg/dl and ended the study with values of 9.04.+-.0.07 mg/dl, which is a
2.05.+-.1.2% increase. The difference in serum calcium levels between the
two groups was statistically significant (P<0.003). The increase in
calcium is consistent with increased body weight seen in the treatment group
compared to the placebo group and may reflect greater absorption from the
intestines.
Similarly, during the three-month double blind study, persons treated with
combinations of homeopathic dilutions of growth factors increased serum
phosphorus levels by 8.11.+-.3.27% while phosphorus levels in the placebo
group decreased by 10.39.+-.4.99%.
There was no evidence that oral administration of homeopathic dilutions of
growth factors had toxic effects on any of the participants. None of the
subjects in the treatment group had high liver enzyme function tests (LFT),
SGPT (alanine aminotransferase), SGOT (aspartate aminotransferase), GGPT
(gamma glutamyltranspeptidase) at baseline or after any of the months of
treatment. Three patients in the placebo group, however, had high LFT's at
baseline and four patients in the placebo group had high LFT'after the three
month clinical study. Thus, the randomization process did not equally
distribute persons with poor liver function.
The differences in liver function between placebo and treatment patients at
baseline raises the possibility that differences in CD4 lymphocyte counts
between the groups could have been due to differences in health at baseline
and not due to administration of homeopathic dilutions of growth factors. In
order to address this possibility, changes in CD4 lymphocyte counts were
correlated with LFT at baseline to determine whether patients who had
abnormal LFT were also the patients who lost the most CD4 cells during the
study. Table I indicates no obvious correlation between high liver enzymes
and loss of CD4 cells in the three people taking placebo.
TABLE I
______________________________________
Patient #5 Patient #7 Patient #17
Months CD4 cells/mm.sup.3
CD4 cells/mm.sup.3
CD4 cells/mm.sup.3
______________________________________
0 541 302 207
1 241 373 131
2 264 350 122
3 501 329 137
Total Change
-40 +27 -70
in CD4 cells
______________________________________
During the study there were no opportunistic infections in the treatment
group and two in the placebo group; pneumocystis carini pneumonia and severe
autoimmune demyelinating polyneuropathy and myelopathy.
LISTEN measurements of electrical conductance at key skin points associated
with organs known to be involved in HIV also indicate significant
differences between the treatment and placebo groups during the three month
clinical study.
Prior to commencement of treatment, the LISTEN system was employed to
determine electrical conductance for each patient at 112 skin conductance
points. Each conductance point correlates to specific organs and tissues of
the body according to the Electroacupuncture According to Voll (EAV) system
(see, for example, Am. J. Acupuncture 8:97-104, 1980). The optimal range for
conductance (50.78 relative units.+-.3.05 Std. Der.) was identified from
measurements on 34 non-viral infected "healthy" controls. In the
HIV-positive patients, electrical conductances at 16 of the skin points were
found to be outside the normal range, with 13 of the points being above
optimal, 1 being below optimal, and 2 falling at the lowest end of optimal,
as shown in FIG. 9A and B. These points, which correlate with the lymphatic
system, lungs, cell metabolism, spleen, nerves, the neuroendocrine organs
(including thymus-thyroid) and the liver are known to be key areas directly
disrupted by HIV invention.
We continued to evaluate electrical conductance at four key areas (spleen,
thymus, nerve and brain) not easily measurable by conventional means to
evaluate over time the progress of these patients. Electrical conductances
at these four key skin points were measured five times over the course of
the three-month clinical study (every three weeks). As shown in FIGS. 9C and
D measurements of spleen 1 electrical conductance were low in both groups at
the onset of the study. The treatment group remained closer to the optimal
range of electrical conductance throughout the study than did the placebo
group. After six weeks, spleen 1 measurements were in the optimal range for
the treatment group, while the placebo group's conductances peaked but did
not reach optimal values. Both groups fell below their entry conductance
measurements at the end of the study. The thymus, nerves and brain
conductances were initially higher in the treatment group and improved,
entering the optimal range three out of five times during the study. In
contrast, the placebo group's conductances for thymus, nerves and brain
remained out of the optimal range three out of five times. These data
demonstrate the LISTEN's ability to prognostically and non-invasively
determine if a given therapeutic, such as homeopathic dilutions of growth
factors, is able to improve the health status of viral infected patients and
acts upon the target tissues infected by the virus.
FIG. 10 shows a change in platelet counts over a three-year period for an
HIV-positive patient with idiopathic thrombocytopenia purpura. Prior to the
commencement of treatment, the patient had a CD4 count of 6 cells/mm.sup.3.
At the beginning of the timeline shown in FIG. 9, the patient was treated
with prednisone for three months. During the first two weeks of prednisone
treatment, the platelet counts increased from 6,000 to 17,000 cells/.mu.l,
and then dropped to 2,000-3,000 and stayed at that level for the next two
years. Following oral administration of the same homeopathic dilutions of
growth factors used in the three-month clinical study described above, the
platelet count increased to 13,000. Immediately prior to treatment with
homeopathic dilutions of growth factors, the patient was treated with shark
liver oil and alkylglycerols. No intervention other than prednisone and
homeopathic dilutions of growth factors effected the platelet count.
EXAMPLE 2
Using the protocol outlined above, eleven HIV positive patients with CD4
counts in the range 67-570 cells/mm.sup.3 were evaluated with the LISTEN
system to determine whether electrical conductances could be balanced with
growth factor signals. Electrical conductance was measured at points known
to be weak in HIV and AIDS patients, including points corresponding to the
spleen (SPCL), spleen lymphocytes homing to the upper body (SP1L), spleen
lymphocytes homing to the lower body and gastrointestinal tract (SP2L),
spleen blood filtering function (SP3L), environmentally related allergies
(AL1R), general allergies (ALCR), lymph tissue of lungs (LY4R), lymph nodes
(LY1R), general lymph function (LYCR), lymph drainage of tonsils/throat
(LY1aR) and connective tissue (FICR).
Signals corresponding to growth factors at potencies of 6C (1:100 diluted
six times=10.sup.-12), 30C (1:100), diluted thirty times=10.sup.-60 ), 200C
(1:100 diluted 200 times=10.sup.-400), 1000C (1:100 diluted 1000
times=10.sup.-2000), also termed "1M", were administered.
Table II, shows the results of a preliminary study to test which signals
corresponding to different potencies growth factors would balance electrical
conductances (i.e., electrical conductance achieved optimal range) in eleven
HIV-positive patients with CD4 counts ranging from 66 to 400 cells/mm.sup.3.
TABLE II
______________________________________
Appeared
No. of People
6C 30C 200C 1000C
______________________________________
Nerve Growth Factor
7/11 3 2 1 4
(NGF)
Insulin-like Growth
10/11 6 4 6 7
Factor-1 (IGF.sub.1)
Acidic Fibroblast
6/11 2 3 1 5
Growth Factor (.alpha.FGF)
Basic Fibroblast Growth
6/11 2 2 5 4
Factor (.beta.FGF)
BB Platelet-derived
9/11 3 5 1 5
Growth Factor
(BB-PDGF)
AA Platelet-derived
8/11 3 4 3 2
Growth Factor
(AA-PDGF)
AB Platelet-derived
7/11 3 5 3 4
Growth Factor
(AB-PDGF)
Transforming Growth
5/11 2 2 4 3
Factor alpha (TGF.alpha.)
Epidermal Growth
5/11 0 2 2 3
Factor (EGF)
Stem Cell Factor (SCF)
5/11 3 1 3 2
Transforming Growth
6/11 3 3 1 6
Factor-beta 1 (TGF.beta.1)
Transforming Growth
4/11 1 2 2 1
Factor-beta 2 (TGF.beta.2)
Granulocyte-Macro-
7/11 2 0 4 3
phage Colony Stimu-
lating Factor (GM-CSF)
Tumor Necrosis Factor
7/11 4 2 4 4
alpha (TNF.alpha.)
Macrophage Colony
7/11 2 2 2 4
Stimulating Factor
(M-CSF)
______________________________________
In ten of the eleven patients, administration of insulin-like growth factor
(IGF.sub.1) signal brought the electrical conductance back into the normal
range, with some patients responding to more than one dilution. BB
Platelet-derived growth factor (BB-PDGF) and AA-platelet-derived growth
factor (AA-PDGF) were also highly effective in returning electrical
conductance measurements to normal. Signals corresponding to higher
dilutions of growth factors appeared to be more effective in restoring the
electrical conductance to normal values.
Tables III and IV show which radio frequency signals corresponding to
homeopathic dilutions of growth factors balanced electrical conductance at
spleen acupuncture points and lymphatic skin conductance points (labelled
YES) and which did not balance electrical conductance (labelled NO) for five
HIV-positive patients with CD4 counts of 225-395 cells/mm.sup.3 (Table III)
and five HIV-positive patients with CD4 counts of 66-170 cells/mm.sup.3
TABLE III
______________________________________
YES YES YES YES NO NO NO NO
6c 30c 200c 1M 6c 30c 200c 1M
______________________________________
PDGF.sub.BB
1 5 3 4 3 0 2 1
GM-CSF 3 0 4 5 1 4 1 2
TGF.sub.B1
1 4 2 3 3 1 4 1
IGF.sub.1
2 2 3 4 2 3 1 2
Insulin 1 4 4 3 3 1 1 2
TNF.sub.a
1 3 5 5 3 3 0 0
PDGF.sub.AA
1 5 3 3 3 0 2 2
PDGF.sub.AB
1 4 1 4 3 1 4 2
TGF.sub.a
1 2 3 2 3 3 2 1
TGF.sub.B2
2 1 2 3 2 3 3 2
SCF 2 1 3 4 2 3 2 1
MCSF 2 2 3 0 2 2 3 5
EGF 2 3 3 4 2 2 2 1
NGF 2 4 2 3 3 1 3 2
aFGF 2 2 1 4 3 3 4 2
bFGF 2 3 3 5 2 1 2 0
totals 26 45 43 66 40 31 31 25
______________________________________
TABLE IV
______________________________________
YES YES YES YES NO NO NO NO
6c 30c 200c 1M 6c 30c 200c 1M
______________________________________
PDGF.sub.BB
2 2 0 0 1 2 5 5
GM-CSF 0 0 2 3 1 3 3 2
TGF.sub.B1
2 2 0 5 1 2 5 4
IGF1 3 2 2 3 0 2 3 2
Insulin 2 1 2 2 1 3 3 2
TNF.sub.a
2 2 3 5 1 2 2 0
PDGF.sub.AA
3 1 1 0 0 3 4 5
PDGF.sub.AB
2 2 1 1 1 2 4 4
TGF.sub.a
3 1 2 0 0 3 4 5
TGF.sub.B2
2 2 1 1 1 2 4 4
SCF 2 2 2 3 1 2 3 1
MCSF 1 0 1 4 2 5 4 1
EGF 1 2 0 0 2 2 5 5
NGF 3 1 1 1 1 3 4 4
aFGF 1 1 0 2 2 3 5 3
bFGF 0 1 2 2 3 3 3 3
totals 31 22 20 32 18 42 61 50
______________________________________
The group with the higher CD cell counts was overall more responsive to
signals of growth factors, responding positively 180 times to radio
frequency signals corresponding to homeopathic dilutions of growth factors,
compared to only 105 times in the group with lower CD4 cells counts. There
was almost an inverse relationship between the higer and lower CD4 cell
count groups in terms of YES and NO responses to the growth factors tested
in this study. The group with CD4 cell counts above 225 cells/rem.sup.3
primarily responded YES to PDGF at 10.sup.-60 and 10.sup.-2000, GM-CSF at
10.sup.-400 and 10.sup.-2000, TGF.sub.B 1 at 10.sup.-60, and IGF.sub.1 at
10.sup.-2000, With positive responses to these growth factors, in general, a
total of 46 times and negative responses only 31 times. In contrast,
patients with CD4 cell counts of 170 cells/mm3 or lower primarily responded
NO 41 times and responded YES only 30 times.
In a separate study, an asymptomatic HIV-positive patient was given a
simultaneous radio frequency signal challenge of HIV using the LISTEN system
while scanning dilutions specifically for .beta.FGF to determine which
dilutions between 6.times. and 6C might be useful. Signals corresponding to
dilutions of 20.times., 30.times., 200.times., 400.times., 600.times.,
800.times. and 6C were found to bring the electrical conductances back into
the optimal range.
EXAMPLE 3
Two HIV-positive patients were treated with signals for homeopathic
dilutions of growth factors using the LISTEN system several times per week
for a period of three months using the protocol outlined above.
Peripheral blood lymphocyte counts were obtained for both patients at, or
shortly after, the commencement of treatment with homeopathic growth factor
signals and again at the end of the study. Prior to the commencement of
treatment, both patients had a CD4 count of less than 200. Patient 2 was
treated with homeopathic growth factor signals alone, while patient 1 was
treated with a combination of homeopathic growth factor signals and, in
addition, was treated therapeutically with homeopathic medicines and/or some
botanicals corresponding to the digital codes from the LISTEN. Neither
patient was on anti-retroviral therapy.
Signals of homeopathic growth factors corresponding to a combination of
dilutions were administered for one second to skin points associated with
organs and tissues known to be weak in HIV and AIDS patients, as outlined in
Example 2. Growth factors were selected based on their ability to
effectively return conductance levels to normal. The number of times that
signals corresponding to specific growth factors returned electrical
conductance levels to optimal are shown in Table V.
TABLE V
______________________________________
NUMBER OF
APPEARANCES
Patient Patient
GROWTH FACTORS One Two
______________________________________
Nerve Growth Factor (NGF)
14 7
Insulin-like Growth Factor-1 (IGF.sub.1)
4 8
Acidic Fibroblast Growth Factor (.alpha.FGF)
13 6
Basic Fibroblast Growth Factor (.beta.FGF)
4 0
BB Platelet-derived Growth
Factor (BB-PDGF) 1 8
AA Platelet-derived Growth Factor
(AA-PDGF) 5 0
AB Platelet-derived Growth Factor
(AB-PDGF) 0 0
Transforming Growth Factor alpha (TGF.alpha.)
10 0
Epidermal Growth Factor (EGF)
3 0
Stem Cell Factor (SCF) 5 0
Transforming Growth Factor-beta 1
(TGF.beta.1) 5 0
Transforming Growth Factor-beta 2
(TGF.beta.2) 0 2
Granulocyte/Macrophage-Colony
Stimulating Factor (GM-CSF)
0 2
Tumor Necrosis Factor alpha (TNF.alpha.)
0 0
Macrophage-Colony Stimulating Factor
0 0
(M-CSF)
______________________________________
Nerve growth factor (NGF), acidic fibroblast growth factor (.alpha.FGF) and
transforming growth factor alpha (TGF.alpha.) were most effective in
bringing the electrical conductance measurements back into the normal range.
Prior to being treated with homeopathic growth factor signals, patient 2 had
been treated with a variety of different botanicals. For the four-month
period immediately prior to the commencement of homeopathic growth factor
treatment, patient 2 was treated with the botanical bitter melon (called
momordica) which resulted in increases in CD8, CD3, CD2 and CD19 counts of
more than 50 percent. Bitter melon (momordica) was then discontinued. As
shown in FIG. 11A, administration of signals corresponding to homeopathic
growth factors resulted in a slight increase in patient 2's peripheral blood
lymphocyte counts without any other medical treatment. The average loss of
CD4 cells in HIV-positive patients is 20% of the cells per year.
For patient 1, administration of signals corresponding to homeopathic
dilutions of growth factors increased the CD4 count by 76%, while the CD8,
CD2 and CD3 counts increased by 38%, as shown in FIG. 11B.
These results are in marked contrast to the typical course of progression
for HIV and AIDS in which the lymphocyte count continues to drop as the
disease progresses. FIG. 12 shows the decrease in peripheral blood
lymphocyte counts over time for a typical HIV-positive patient. This patient
did not receive any homeopathic growth factor treatment or conventional HIV
therapy, but did receive botanical supplements.
EXAMPLE 4
FIG. 13 shows the change in total T lymphocyte cell, CD8 and CD4 counts for
an HIV-positive patient over a period of four years. This patient was
infected with HIV in 1982. In September 1992 (month 21) the CD4 cell count
plummeted to 106 cells/mm.sup.3. The average annual decrease in CD4 cells in
this range is reported to be 32 cells/mm.sup.3 when taking anti-retroviral
therapeutics (Dept. of Epidemiology, University of Washington). However,
after three months of daily treatments with radio frequency signals
corresponding to homeopathic dilutions of growth factors, the CD4 cells
increased by 138 cells/mm.sup.3 and by month 33, in September 1993, the CD4
cell count was 225 cells/mm, 199 cells/mm.sup.3 higher than the previous
year. Each time the patient received the growth factor radio frequency
signals, lymphocyte counts increased. When the patient did not receive the
growth factor signals, the CD4 lymphocyte counts dropped, despite the fact
that the patient was continually receiving weekly acupuncture treatments.
For example, between months 30 and 33 (june 1993 and September 1993) the
patient regularly balanced electrical conductance points (four office
visits, no growth factor signals administered). The CD8 and total T
lymphocyte cell counts increased 300-350 cells/mm.sup.3, but the CD4 cells
dropped 17 cells/mm.sup.3. The CD4 cells continued to drop until growth
factor signals were given regularly (months 38 to 42; February to June
1994). During this time the patient had seven office visits and during four
of them (2 in March, 1 in April and 1 in May) was treated with growth factor
signals for NGF, AB-PDGF, IGF.sub.1, .beta.FGF, and TGF.alpha.. During this
five month period the patient's CD4 count rose 30 cells/mm.sup.3, from 180
cells/mm.sup.3 to 210 cells/mm.sup.3. The CD8 and total T lymphocyte counts
also rose 430-475 cells/mm.sup.3. CD8 cell counts above 500 cells/mm.sup.3
correlate with low viral replication and perhaps longer survival due to
their secretion of growth factors yet to be characterized (1994
International Conference on AIDS).
There was only one time period (months 33-38; September 1993 to February
1994) that a single growth factor signal, IGF.sub.1, was given, and CD4, CD8
and total T lymphocyte cell counts dropped 45 cells, 475 cells and 700
cells, respectively. This may be due to only giving one growth factor
signal, or more probably to the death of this patient's father, and
extensive transcontinental travel and exhaustion during the terminal stages
of the father's illness. Grief and loss are well known stress factors that
depress immune function. This patient did not receive any conventional drug
treatments.
EXAMPLE 5
Electrical conductances of fifteen Epstein-Barr virus (EBV) patients were
measured at acupuncture points for the immune system using the LISTEN
system. The results are shown in FIG. 14. Higher than normal conductances
were found at points corresponding to: lymph drainage of tonsils/throat
(LY1aR) lymph tissue of lungs (LY4R); connective tissue (FICR); spleen
lymphocytes homing to the lower body and gastrointestinal tract (SP2L); and
spleen B lymphocytes and blood purification duties of spleen (SP3L). These
results coincide with the clinical symptoms of patients with chronic EBV
infection.
Eleven of the fifteen patients were subsequently treated for 3-9 months with
a combination of homeopathic growth factor signals and botanicals
corresponding to the LISTEN digital codes. Each patient was treated once per
month using the previously outlined protocol. As shown in FIG. 15,
significant improvement in electrical conductances occurred. Fewer clinical
symptoms were also observed and reported by the patients. For example, the
patients had less upper respiratory distress, less sore throats, more
energy, fewer complaints regarding tendonitis, and somewhat improved
digestion. These are all typical complaints of EBV patients.
Five of these patients were tested for the ability of signals corresponding
to different dilutions of growth factors to normalize electrical
conductances during one appointment. The results are shown in Table VI.
TABLE VI
______________________________________
Intake
Titer Growth
Patient
EBV Titers
Levels Factor Dilution
______________________________________
#1 VCA IgG 892 AA PDGF 6C
#2 VCA IgG 640 AA PDGF 800x, 30C
EA 80 BB PDGF 800x, 6C
EBNA pos AB PDGF 800x
TGF.beta.1 800x
TGF.beta.2 800x
TGF.alpha. 800x
.alpha.FGF 6C
IGF1 800x, 6C
200C, 1000C
#3 VCA IgG 640 Stem Cell 30C
Factor
EA 80
EBNA neg
#4 VCA IgG 160 AA PDGF 6C
EA 80
EBNA pos
#5 VCA IgG 1280 IGF1 6C, 12C,
1000C
EA neg Insulin 30C
EBNA 40 TGF.beta.1 600x, 6C,
1000C
.beta.FGF 6C, 1000C
TGF.alpha. 30C, 1000C
NGF 6C
Growth Hormone
1000C
______________________________________
As outlined above, a dilution of 6C is equal to 1:100 diluted six times
(10.sup.-12 M). A dilution of 800.times. is equal to 1:10 diluted 800 times.
Prior to treatment, each of the five patients was tested for the presence of
the following EBV titers: viral capsid antigen (VCA), early antigen (EA),
and Epstein-Barr nuclear antigen (EBNA), as shown in Table III. In non-EBV
infected subjects these titers are either negative or close to zero. Patient
1 was symptomatic with sore throat, sinus drainage and swollen glands at
time of electrical conductance testing. Patients 2 and 5 were similar in
that both had gall bladder surgery, hysterectomies, fibromyalgia, and were
over forty and over-weight. Patient 2 also had chronic HPV and HSV
infection. Patient 5's fasting blood sugar readings were indicative of
mature onset of non-insulin dependent diabetes. Patient 3 was additionally
diagnosed as having multiple sclerosis. Patient 4 was additionally diagnosed
as having rheumatoid arthritis.
All available growth factor signals were tested for patients 1 and 3-5.
Based on the earlier HIV data, potentially useful growth factors were tested
on patient 2 to determine effective dilutions, as shown in Table VI.
Patient 5 was balanced on each of seven individual appointments using only
growth factors. The growth factors were able to bring the electrical
conductances into the normal range of 45-55 at every acupuncture point (over
30 points), often without additional supplementation with naturopathic
medicines.
As described earlier all five patients demonstrated improved clinical
symptoms. The growth factors found to be effective in treating these EBV
patients included PDGF, TGF.beta., .alpha.FGF, IGF1, NGF, insulin, growth
hormone, and stem cell factor.
EXAMPLE 6
Two cancer patients were administered signals corresponding to homeopathic
dilutions of growth factors using the standard LISTEN protocol. Patient 1
had chronic myeloid leukemia (CML), which is a stem cell disease in which
stem cells fail to respond to physiologic feedback signals that regulate
growth and differentiation of hematopoietic precursors. This patient had
just begun treatment with alpha-interferon several hours before testing with
the LISTEN system. Patient 2 had an adenocarcinoma (renal cell carcinoma)
removed from her left side approximately 18 months prior to this study, and
had metastases to the lung, skull and possibly to the bones and liver at the
commencement of this study.
As shown in FIG. 16, these two patients had significantly different
electrical conductances. Both patients' electrical conductances were
normalized by administration of specific homeopathic growth factor signals
and naturopathic supplements. For patient 1, signals corresponding to
combined dilutions of IGF1 were found to bring the conductances back into
the normal range. For patient 2, signals corresponding to 30.times., 100C
and 1000C dilutions of NGF, an 8.times. dilution of AA PDGF, and 6C and 30C
dilutions of TGF.beta.1 were found to be effective. The naturopathic
supplements alone did not balance the electrical conductances.
Patient 2, following treatment using the LISTEN system five times per week
for one month, no longer tested positive for cancer, using the serum AMAS.TM.
test (Anti-Malignin Antibody in Senun determined with TARGET.TM. Reagent;
Oncolab, Inc., Boston, Mass.; Abrams, M. B. et al. 1994 Cancer Detection and
Prevention 18:65-78). In this test, the higher the component result number,
the more indicative the result is of cancer. The AMAS.TM. normal range for
S-TAG is 0-399; for F-TAG 0-299; and for net-TAG 0-99. The specific results
of the AMAS.TM.test for this patient after one month of treatment were as
follows: S-TAG 184 .mu.g/ml (normal); F-TAG 79 .mu.g/ml (normal); and
net-TAG 105 .mu.g/ml (borderline). AMAS.TM.test results continued to improve
with continued administration of radio frequency signals corresponding to
homeopathic dilutions of growth factors. Two months later, after continued
treatment, the results of the AMAS.TM.test were as follows: S-TAG 152 .mu.g/ml
(17% decrease); F-TAG 70 .mu.g/ml (11% decrease) and net-TAG 82 .mu.g/ml
(now in normal range with a 22% decrease). All component measurements
indicated that normal results had been achieved. The results of blood
chemistry analyses for Patient 2 before treatment and after one month of
treatment with signals corresponding to TGF.beta.1 are shown in Table VII.
TABLE VII
______________________________________
Blood Chemistry
Before Treatment
After Treatment
______________________________________
Chemistry
Sodium 139 meg/l 143
Potassium 3.3 meg/l 4.8
Chloride 100 meg/l 108
CO.sub.2 25 meg/l 23
Glucose 173 (high) mg/dl
149 (high but
closer to normal)
Calcium 8.7 mg/dl 9.0
Bun 18.0 mg/dl 18.0
Creatinine 1.2 mg/dl 1.2
Bun/Creat. 15.0 15.1
Uric Acid 5.5 mg/dl 6.2 (high)
Cholesterol 301 (high) mg/dl
357 (high)
Triglycerides
523 (high) 305 (high but
closer to normal)
Albumin 4.0 g/dl 4.1
Globulin 2.6 g/dl 2.5
A/G ratio 1.5 1.6
Total Bilirubin
0.6 mg/dl 0.4
Direct Bilirubin
0.4 mg/dl 0.0
Alkaline Phosphatase
62 u/l 108
LDH 136 u/l 150
AST (SGOT) 8 u/l 15
ALT (SGPT) 8 u/l 18
CBC
WBC 7 .times. 1000/ul
5.9
RBC 3.93 (Low) mil/ul
4.49 (resolved)
Hemoglobin 11.7 (Low) g/dl
13.6 (resolved)
Hematocrit 35.1 (Low) % 41.7 (resolved)
MCV 89.3 fl 92.9
MCH 29.8 pg 30.3
MCHC 33.3% 32.6
Neutrophils 55.9% 62.9%
Lymphocytes 34.4% 32.7%
Monocytes 7.4% (monocytosis)
2.4% (resolved)
Eosinophils 1.4% 1.2%
Basophils 0.9% 0.8%
Platelet count
342,000/ul 348,000/ul
______________________________________
Prior to treatment, Patient 2 had anemia, as indicated by the hemoglobin,
hematocrit and red blood cell count (RBC), and immune stress, indicated by
slightly elevated monocyte counts. Following treatment with radio frequency
signals corresponding to TGF.beta.1 for a period of one month, the patient's
anemia and monocytosis had resolved. The patient's liver enzyme values (SGOT
and SGPT) were also greatly improved, as was the alkaline phosphatase level.
EXAMPLE 7
FIG. 17 shows the change in white blood cell count in a patient with chronic
lymphocytic leukemia both before and during treatment first with radio
frequency signals corresponding to homeopathic dilutions of growth factors
and subsequently with both radio signals in combination with orally
administered homeopathic dilutions of growth factors.
This patient was diagnosed with chronic lymphocytic leukemia in April 1992.
From April 1993 to April 1994 (months -12 to 0 on the time scale) the white
blood cell count doubled from 24,700 to 49,000 cells/mm.sup.3. In April 1994
(months 0 to 7) the patient began receiving radio frequency signals
corresponding to growth factors on a weekly basis. During this treatment
period, the white blood cell count maintained a relatively low
nonprogressive state, as noted by the significantly different regression
line during that time versus the general treatment period regression line.
The patient initially progressed to higher counts of white blood cells when
orally administered 10.sup.-12 M and 10.sup.-24 M dilutions of GM-CSF plus
radio frequency signals corresponding to homeopathic dilutions of growth
factors. The white blood cell counts were dramatically decreased by
introducing homeopathic dilutions of 10.sup.-60 M and 10.sup.-2,000 M BB-PDGF
plus a homeopathic dilution of HH6V into the protocol. With the addition of
10.sup.-60 M and 10.sup.-2,000 M TGF.beta. to the protocol, the patient's
white blood cell count dropped back down to 41,000 cells/mm.sup.3. The
regression line demonstrates a downward trend.
EXAMPLE 8
A study was performed using the LISTEN system on two patients with
insulin-dependent diabetes. Both patients were between 11 and 12 years of
age and were treated within one year of onset of disease. Patient 1
serum-tested positive for Coxsackie B3 virus, which has been implicated
through epidemiological studies to be a causative factor in the onset of
diabetes. Patient 2 was not tested for Coxsackie B virus. The highly
abnormal conductances of these patients shown in FIG. 18 were brought into
the normal range by the administration of signals corresponding to
naturopathic supplements plus a 6C dilution of insulin. On one occasion,
patient 1's conductance points were completely balanced with signals
corresponding to combined dilutions of stem cell factor or vasopressin
without the need for additional signals of naturopathic supplements. These
corrections in electrical conductance correspond with greater control of
blood glucose level.
In a separate treatment session, all available signals for homeopathic
growth factors were scanned to determine which signal would bring patient
2's conductances back to the normal range. A signal corresponding to a
600.times.dilution of .beta.FGF was found to be most effective.
Although the present invention has been described in terms of specific
embodiments, changes and modifications can be carried out without departing
from the scope of the invention which is intended to be limited only by the
scope of the appended claims.
* * * * *
