Clinical
Studies
CLINICAL
STUDIES FOR THE COLD SORE ELIMINATOR AT NATIONAL PREVENTION, A CALIFORNIA
STATE LICENSED MEDICAL CLINIC UNDER SUPERVISION OF A CALIFORNIA
LICENSED M.D., DR. MIRKA JAROS
Medical
Information for Cold Sores and Herpes
Dr. Peter
H. Lathrop proposed that low voltage electrical current actually
recharges the energy level of the cell, which changes the biochemical
working of the cell at micro levels. This has been shown in recent
studies to increase ATP energy production by up to 500%, and increased
protein absorption into the cell between 30 and 40 %.
Recent studies have shown that diseased or damaged cells give off
mitogenic radiation at a different frequency than healthy cells.
Treating the cell with a defined frequency can oscillate the cell
back to its healthy state. As an aside, this may be demonstrated
by laser research. The property of semi-conductivity is ascribed
to biological structures due to intricately organized zones of conductants
and delocalized electrons that create a bioplasma; this gives the
cell the properties of a crystal. When a homogenous substance such
as a crystal or metal tuning fork vibrate at one frequency, it will
affect another substance or tuning fork some distance away. Both
will end at some harmonious, but different vibration. Taking into
account that particles and waves are believed to be completely interchangeable
at the atomic and subatomic levels, the electrodynamic field is
the interrelationship of particles that are affecting each other
through change and movement. These relationships are refineable
in terms of oscillation and vibrations.
During electrical stimulation of pathological tissue, the electrons
react with water molecules at the cathode side to produce hydroxyl
ions, while at the anode side, protons are formed. Thus, between
the anode and cathode interface, a proton gradient and a potential
gradient across the tissue and the medium are created. Hence, protons
under the influence of the concentration difference should move
from anode to cathode. Since the rate of proton formation at the
anodic interface is equal to the rate of proton consumption at the
cathodic interface, the net pH of the system, medium and tissue,
remains undisturbed. As the migrating protons reach the mitochondria
membrane-bound ATPase, ADP will be formed.
Thus, when we discuss the current passing through the membrane capacitance,
the changes haven't physically penetrated the membrane itself; the
current can pass through the membrane even though ions cannot. And
so, by increasing the cell's potential, we increase the cell's own
ability to produce energy.
It would appear that we may use low voltage electrical fields to
penetrate the protein envelope of the Herpes virus, stimulate
the cell capacitance via the increase of mitochondria function,
return the cell to normal functioning, and break up the polypeptide
structure of the virus core.
In order to test this theory, the subject, to the potential lesion
site created a small low voltage electrical device.
The subjects carried
on clinical studies over a period of six years both in-house, and
privately.
Subjects
Ninety-six
men and women between the ages of 19 and 37 participated in the
study that took place over a period of five years of clinical trials.
Subjects were placed in one of three groups as follows: Group One
-23 controls. These subjects were administered no electrical stimulation.
Some of these subjects sporadically used some form of drug therapy.
Group Two consisted of 50 subjects who were seen in a medical clinic
with their treatment supervised by a MD. These patients took no
drugs and were treated solely with electrical stimulation. Group
Three consisted of 23 subjects who were issued a small electrical
stimulation device designed by Dr. Peter Lathrop and Steve Johnston.
All of the subjects in this study suffered from either Herpes Simples
1 (mouth herpes), or Herpes Simplex 2 (genital herpes). Prior onset
of the disease ranged from 1.5 to 5 years. Other staff included
Chiropractors, RN's, Medical Scientists, a California licensed Psychologist
and Licensed Medical Assistants. This facility was one of 19 offices
participating in a Nationwide Herpes Research and Treatment program.
The study was designed by Dr. Peter Lathrop and supervised by Mirka
Jaros, M.D. Data analysis took place at the University of California,
San Diego by a physician and graduate students in the Departments
of Biochemistry and Medicine as part of a university sponsored internship
program in Biomedical Electronics.
The following persons took part in this analysis: Katharina Sunnerhagen,
M.D., Brenda Dudas, and Robert Wester.
Group One subjects reported onset, progress and resolve of their
lesions on a daily basis.
Group Two subjects were treated in the clinic commencing with the
onset of the lesion and four times a week until the lesion resolved.
Treatment consisted of the application of low voltage electrical
stimulation delivered to the lesion by the use of a non-invasive
stainless steel probe.
Group Three subjects were issued low voltage electrical stimulators
and told to take them with them and keep them handy at all times.
These subjects were further instructed to be acutely aware of the
onset of the next occurrence of itching, tingling, pain, or ache
in the area. They were further instructed that it was crucial that
they be not only aware of the onset, but immediately be able to
access the stimulation unit and use it at the site of the potential
lesion as follows: "Use the Cold Sore Eliminator to
make contact with the potential lesion site for 15 seconds. Continue
this procedure once per hour for eight hours without interruption
on the first day of recognition of preliminary symptoms." These
subjects were further told that if a lesion should begin to occur,
they should continue this procedure until the lesion resolved itself.
Results
Table
1: Comparison of Treatment Procedures
STUDY
GROUPS |
SEX
Males
Females |
HERPES SIMPLEX |
AVG LENGTH OF LESION
(DAYS)
Males
Females |
Controls |
7 |
4 |
I |
9 |
7 |
6 |
6 |
II |
10 |
8 |
Total
= 23 |
Average
= 8.5 |
Clinically
- Treated |
13 |
15 |
I |
3 |
4 |
12 |
10 |
II |
4 |
3 |
Total
= 50 |
Average
= 3.5 |
Self
- Treated (Cold Sore Eliminator) |
5 |
6 |
I |
0 |
0 |
4 |
8 |
II |
0 |
1 |
Total
= 23 |
Average
= 0.25 Days |
As can be seen, the three
groups studied were compared as to sex, number of days of persistence
of lesion, and type of herpes.
The
most successful treatment groups were those subjects who treated
themselves with the Cold Sore Eliminator prior to onset of the lesion.
Average length of the lesion for this group was .25 days. Group
Two, or the clinically treated subjects, averaged 3.5 days of persistence
of lesion.
Group One controls fared the worst in comparison with the treatment
groups' average length of lesion for this group was 8.5 days.
A three-way analysis of variance was performed in order to compare
the results of the three groups. When compared with the control
group, both the clinically treated and the self-treated groups demonstrated
a shorter time of persistence significant at the .001 level. The
self-treated group demonstrated an even more significant reduction
in time of lesion persistence than the clinically treated group
at the .001 level.
The data presented appears to support the hypotheses that low voltage
electrical current, when applied to the lesion site, can significantly
reduce the time of persistence of that lesion resulting from either
Herpes Simplex 1 or 2.
Data further demonstrates more dramatically that self-treatment
with low voltage electrical current within the first 15 minutes
of the occurrence of a Herpes Simplex lesion, can prevent the occurrence
of a lesion at the site of stimulation.
Data further indicates that there was no significant difference
in results of treatment with regard to sex or type of simplex manifested.
Discussion
The hypothesis
proposed at the beginning of the paper was supported by the data.
The average length of persistence of a Herpes Simplex lesion in
controls who underwent no electrical stimulation, average 8.5 days
(this figure being affected somewhat by the spurious use of drugs
by some of the patients some of the time). As can be seen in Table
1, intervention by low voltage electrical current appeared to have
a significant effect on shortening the length of persistence of
the lesion, the self-treated group demonstrating the most significant
results in terms of little or no manifestation of the lesion. Low
voltage electrical current, when applied to the lesion site, or
the possible lesion site, appears to, as proposed earlier, penetrate
the protein envelope barrier which protects the virus from destruction.
As the herpes virus manifests itself via the nervous system. a treatment
route was designed to pervade that system and attack the virus using
the electrical properties of the nervous system at the cell level
to combat the virus.
An electrical current can, therefore, be assumed to be able to radically
change the response of the healthy cell to the invading virus. This
appears to be accomplished by stimulating the mitochondria function
of the cell to return to normal the ionic balance inside and outside
the cell. This study has been an example of the electrical manipulation
of the biochemistry of pathological cells in a viral medium. It
was found that both pathological cells and virus might possibly
be affected to a significant extent with the application of low
voltage electrical stimulation at the site of the interaction. The
most significant affect appears to be created by the treatment of
a virus produced pathological state at the onset, whereby the virus
has not had an opportunity to fully invade the system, or reach
its fullest strength.
The key to effective treatment of the Herpes virus, whether it is
Herpes Simplex 1 or Herpes Simplex 2, is the treatment by low voltage
electrical stimulation at the possible site of a lesion, as indicated
by tingling or other pre-lesion symptoms, as soon as the symptoms
are felt.
The results of this study would further indicate the need for
the Herpes virus patient to be provided with and carry with them
at all times, the Cold Sore Eliminator, that they would be able
to use immediately upon manifestation of a pre-lesion condition.
Background of the Cold
Sore Eliminator
MsoNormal">Herpes
Simplex is caused by herpesvirus homonomous types 1 and 2. Infections
due to the virus are worldwide, and they are considered to be one
of the most common sexually-transmitted diseases. Herpes Simplex
affects 92 million Americans. Type 2 appears to be more neurogenic
and accounts for about 80% of the genital infections. There is about
a 60-80% risk of sexual passage of the infection in those repeatedly
exposed to an infected conjugal partner, indicating that circulating
antiviral antibodies, which rise fourfold following an outbreak,
do not prevent superinfection. Type 1 Herpes Simplex is generally
associated with infection in and around the mouth, and with other
Herpes Simplex infections above the waist. Typically, it is characterized
by a cluster of small blisters or watery vesicles on the skin or
on mucus membranes. The lesions are commonly called cold sores or
fever blisters. They most frequently occur on the lips and face
and occasionally on the trunk and hands. The Type 1 virus may also
infect the eye, causing corneal ulcers and visual impairment.
The occurrence
of a lesion is often signalled by tingling with burning in the skin
area, which becomes red and covered with vesicles. These vesicles
break and form a crust. The skin appears normal within six to ten
days after the onset of the lesion, unless there has been secondary
infection. Lesions may often reappear at the same site for many
years, and may be precipitated by any one of a number of factors,
such as sunburn, upper respiratory and gastrointestinal tract infections,
fevers, emotional stress, or anxiety.
Herpes
Simplex Virus Type 2 is associated with genital infections. Herpes
genital infections are most often transmitted through sexual contact.
Sexual practices involving oral/genital contact may be responsible
for some crossover infections, while other infections occur through
hand/genital/mouth contacts. The incubation period for Herpes genital
infection is usually four to five days, but may be as short as 24
hours and as long as two weeks. The first symptoms may be pain or
itching at the site of infection. This is followed within a day
or two by the appearance of blister-like lesions that may occur
singularly or in groups. In males, the common sites of infection
include the foreskin, the glans and the shaft of the penis. In females,
the blister may occur on the labia, the clitoris, the opening of
the vagina, or, occasionally, on the cervix. Within a few days,
the blisters rupture and merge to form large areas of denuded tissue
surrounded by swollen, inflamed skin. At this stage, the lesions
may become exquisitely painful with intense burning and irritation.
In females especially, urination may cause great discomfort. Generalized
symptoms such as fever and malaise may develop, and lymph glands
in the groin may enlarge. Lesions may persist at this stage for
a week or more and complete healing may take four to six weeks.
Genital herpes infections generally are more severe in females and
may become so uncomfortable and disabling as to require hospitalization.
Reoccurrences of herpes genital infection are not uncommon, and
may be associated with emotional stress, trauma, intercourse, and
other infections or menstruation. Symptoms may not be as severe
in the recurrent infections as in the initial ones.
A variety
of treatments have been used for genital herpes, but none has been
entirely satisfactory. Drying agents such as alcohol, spirits of
camphor, and ether have been used. Other methods of treatment include
the use of ointments and creams, topical anesthetics, and antiseptic
solutions. As of today, no satisfactory vaccine has been found.
In superficial infections, topical agents such as Idoxuridine (IDU),
Triflurothymidine, or Acyclovir are sometimes effective. General
cleansing with soap and water is recommended, but keeping lesions
moist may aggravate the inflammation and delay healing.
The
Herpes Virus
In general,
viruses are the smallest infectious agents (20-300 nanometers in
diameter), containing a molecule of nucleic acid (RNA or DNA) as
the genome. Nucleic acid is encased in a protein shell. Viruses
replicate only in living cells. The viral nucleic acid contains
information necessary for programming the infected host cell to
synthesize the number of specific macromolecules. Toward the end
of the replicative cycle, more viral nucleic acids and coat proteins
are produced. The coat proteins assemble together to form the symmetric
protein shell which encloses the nucleic acid genome. These empty
capsids are byproducts of the viral replicative cycle. The capsid
encases and stabilizes the viral nucleic acid against the extracellular
environment and facilitates the attachment, and perhaps penetration
of the virus upon contact with new susceptible cells. The viral
nucleocapsid, is about 100 nanometers in diameter, and possesses
cubic symmetry with 162 capsomeres and is surrounded by a lipid
containing envelope. The enveloped virion is 100 to 150 millimeters
in diameter. Latent infections may occur and last for the life span
of the host, even in the presence of circulating antibodies. The
concept that herpes virus persists in the nuclei of cells in the
sensory ganglia suggests that any topical treatment will be ineffective
in destroying the virus in these hidden locations.
The structural
proteins of the herpes viruses have several important functions.
They serve to protect the viral genome against inactivation by nuclei,
participate in the attachment of the virus particle to a susceptible
cell, and are responsible for the structural symmetry for the virus
particle. Other proteins, which synthesize in infectious cells,
include those which enable the viral nucleic acid to replicate and
those which alter some function or structure of the host cell.
Approximately
25 viruses have been placed in the herpes virus group. They all
contain a core of double stranded DNA surrounded by a protein coat
that exhibits isocahedril symmetry, which in turn is enclosed in
an envelope which contains essential lipids.
The structural
proteins of Herpes Simplex virus include nine polypeptides, which
have been found in the enveloped virion, two polypeptides, which
are associated with the envelope, two arginine polypeptides within
the virus core, as well as guanine and cytosine.
The virus
enters the cell either by fusion with the cell membrane or by pinocytosis.
It is then uncoated, and the DNA becomes associated with the nucleus.
Soon after infection, the virus codes for its own DNA polymerase
and other enzymes such as thymidine kinase, which is associated
with the DNA replication. Viral proteins are synthesized in the
cytoplasm and are then transmitted to the nucleus for virus assembly.
Infection
of the Healthy Cell With Herpes Virus
Herpes
virus nucleocapsids are assembled in the cell nucleus and acquire
envelopes from the nuclear rather than the cytoplasmic membranes.
Virus is assembled in the nucleus and approaches the nuclear membrane.
At the point of contact, the inner nuclear membrane becomes thicker
and progressively envelopes the virus particle. It finally pinches
off, leaving the nuclear membrane intact and enveloped particle
free in the perinuclear cisterna. Nucleocapsids may also acquire
envelopes by budding into nuclear vacuoles. These vacuoles seem
to be indentations of a nuclear membrane, and are continuous with
the perinuclear cisterna.
The virus
particle is now transported from the vicinity of the nucleus toward
an extracellular location in the following sequence: the outer lamella
of the nuclear envelope wraps around the enveloped nucleocapsid
and sequesters it from the cell cytoplasm. When the vacuole reaches
the cytoplasmic membrane, the enveloped virion is released outside
the cell.
An additional
route seems to be through the cisternae of the endoplasmic reticulum
to the exterior of the cell. Later in the infection, unenveloped
particles may also appear in the cytoplasm where they may be enveloped,
but breaks in the nuclear membrane are also present at this time.
The envelopment process occurs whenever the nucleocapsid comes into
contact with a cell membrane and may represent a cellular defense
mechanism. Since the nuclear membrane is the first membrane encountered,
it would be the primary site of envelopment.
In the
past, treatment for Herpes Simplex lesions has consisted primarily
of topical application of drugs for symptomatic relief of Herpes
lesions, such as analgesics and anesthetics for the relief of pain,
which have had minimal therapeutic effect on the lesions. Also,
various treatments involving painting of the lesions with acridine
dyes, and then exposing them to ultraviolet light, have been tried
without significant therapeutic effect, and with an associated risk
of producing malignant cells.
More
recently, it has been proposed to treat Herpes Simplex 1 and 2 with
ultrasound, such as set forth in U.S. Pat. No. 4,646,725 issued
Mar. 3, 1987, and U.S. Pat. No. 4,309,989 issued Jan. 12, 1982 wherein
a method for massaging a medication into the skin by ultrasound
is disclosed.
These
suggested treatments have not found wide acceptance to date, and
the present invention is directed toward a method and apparatus
for a more therapeutic treatment involving cell stimulation by electrical
and magnetic fields and the like. To aid in the understanding of
the present invention, the following review of the neural/electrical
systems of the body will be helpful.
The
Electrical Control of the Body
The human
body and its physiological processes are made up of a universe of
electrical activity. Chemical reactions involve electrical ion transfer,
development of potential, electrostatic interaction, and changes
in an electromagnetic field. Physiological processes are controlled
by electrical interaction.
The body
uses a capacitive state to generate a potential from which stored
energy is used to run cellular processes. The cell membrane is an
electric capacitor in which two conducting media, the intra-cellular
and the extra-cellular salt solutions are separated by the non-conducting
membrane. The electrical potential across the capacitor is proportional
to the number of charges that are held on its plates. At this basic
level, cell energy function can be manipulated electronically.
Damage
to this system, in the form of a pathological or viral state, causes
a current of injury to the overall electromagnetic environmental
balance of the system. Laboratory research by applicant and others
has shown that a negative charge acts as a trigger for healing growth
control systems.
Embryonic
cells know which respective tissues to differentiate into, the nervous
system uses electrical pathways for orientation of growth and regeneration,
and this current is used in lower organisms for control of cellular
differentiation and limb.
The cell
membrane is made of a bi-layer of phospholipid sheets. A single
phospholipid has a charged polar head group with a (hydrophobic)
hydrocarbon tail. Two sheets of these asymmetric molecules, placed
tail to tail, gives rise to a leaflet membrane with the polar heads
facing out on both sides. The polar groups are hydrophilic and interact
with the aqueous exterior/interior, thereby forcing the hydrophobic
tails to interact and hold the membrane together. This hydrophobic
core is at its lowest energy state which maintains this structure.
Due to the charged groups on the outside and the hydrophobic groups
inside, the membrane itself is impermeable to most molecules and
ions which makes it an ideal organizational structure for a living
mechanism. The cell may selectively determine what it allows in
or out utilizing transport mechanisms.
An integral
membrane protein (IMP) is a large molecule that spans the entire
lipid-lipid bi-layer. Part of the protein is on the outside, extracytoplasmic
surface. It crosses through the membrane interior and extrudes into
the inside cytoplasmic portion of the cell. These proteins interact
hydrophilicly on the outside on the extracytoplasmic and cytoplasmic
sides with charged proteins while interacting with the non-polar
interior with hydrophobic proteins. This insures their stability
and direct orientation within the cell membrane. The IMP is a long
string of amino acids and may span the membrane many times (by going
back and forth as a thread may span a clothes seam) and in so doing,
create a pore or channel in which ions or molecules may selectively
pass.
Passage
through the membrane of molecules and ions depends on a variety
of factors such as concentration on both sides, electrical charge,
membrane potential, and molecular size. The cell mediates transport
through the IMP. Passive transport or simple diffusion is the process
by which small, non-charged molecules "migrate" from a
high concentration to a lower one or "down its concentration
gradient." The rate limiting step is the movement through the
hydrophobic interior of the membrane.
Facilitated
diffusion is much faster than passive transport because it utilizes
the IMP to create a pore/channel through which molecules may pass
(therefore, the rate limiting exterior step is based on how it permeates
the polar, then hydrophobic interior, etc.). The process is specific
as to which ion or molecules may go through each channel. The rate
of transport is determined largely by cellular concentration gradients
and permeability of the channels. In certain cases, the permeability
of these pores changes by external influence. One of these external
influences is electrical current.
Active
transport is the third mechanism by which the cell uses membrane
proteins to regulate its environment and control species concentrations
on either side of the cell. Active transport requires the absorption
of energy to drive the transport of a molecule or ion. The transfer
may go up or down the concentration gradient or may carry an ion
across the membrane and hydrophobic interior. This is not possible
by diffusion. The protein complex that accomplishes this reaction
turns the stored energy of a molecule such as adenosine triphosphate
(ATP) into a potential stored energy by forming a gradient of ions
or molecules across the membrane. ATP is the energy currency of
the cell, it has a highly exergenic bond of the third phosphate
group. The reaction hydrolyzing this bond liberates energy which
is used to fuel biochemical reactions. The formula being ATP . ADP+Pi.
An ATPase is an enzyme that catalyzes the hydrolysis of ATP.
This
concentration gradient of charge for moving ions to one side or
chemical for moving a solute such as sugar to the interior, that
we develop, is a form of potential energy that can accomplish work
for the cell. This is in accordance with conservation of energy
i.e., energy in the form of ATP is converted to a chemical/electrical
gradient.
An integral
membrane protein essential to the cell is the Na+/K+ATPase. The
protein spans both sides of the plasma membrane creating a controllable
gate with a chemical that separates the respective ions to either
side of the membrane. The separation is in unequal concentrations
and creates an electrochemical gradient or potential across the
membrane. This unequal charge distribution has the property of capacitance
and acts as a battery with a potential determined by ionic differences.
Discharged distribution of stored energy is the basis of cellular
control of biochemical processes and the primary function of our
nervous system. Electric current profused through the tissues creates
a force of electrically charged ions present at interfaces between
different types of tissues and cell membranes. Conduction of current
through the tissues depends on ionic movement.
When
electrical currents are introduced into the body, ions accumulate
at the tissue interfaces and at the cell membranes, creating a charge
that is opposite to the charge at the voltage applied at the electrodes.
The potential difference that occurs between each electrode and
the tissue is created by an electrolytic polarization. This phenomenon
occurs in living tissue, and is comparable to a conductor with capacitance.
The device
is used by applying the two metal tips of the probes to the body
on either side of the area that contains the lesion or is being
irritated as by tingling or pain or other indication of the onset
of development of a lesion. The device should be applied as soon
as possible after the onset of symptoms and preferably within the
first fifteen minutes. The device is held to the skin in the affected
area for approximately two to twenty seconds and this process is
then repeated hourly for up to eight hours or longer if a lesion
actually erupts. In the case where a lesion does develop, the procedure
continues until healing. The specific duration and time intervals
can be adjusted to best match a particular symptom.
Low voltage
electrical current, when applied to the lesion site, or a possible
lesion site, appears to penetrate the protein envelope barrier which
protects the virus from destruction. As the herpes virus manifests
itself via the nervous system, a treatment route is provided to
pervade the system and attack the virus using the electrical properties
of the nervous system at the cell level, to combat the virus.
An electrical
current can radically change the response of the healthy cell to
the invading virus. This appears to be accomplished by stimulating
the mitochondrial function of the cell to return to normal the ionic
balance inside and outside the cell. The foregoing clinical study
has been an example of the electrical manipulation of the biochemistry
of pathological cells in a viral medium. It was found that both
pathological cells and virus are affected to a significant extent
with the application of low voltage electrical stimulation at the
site of that interaction. The most significant affect appears to
be created by the treatment of a virus produced pathological state
at the onset, whereby the virus has not had an opportunity to fully
invade the system, or reach its fullest strength.
The key
to effective treatment of the herpes virus, whether it is Herpes
Simplex 1 or Herpes Simplex 2, is the beginning of treatment by
low voltage electrical stimulation at the possible site of a lesion,
as indicated by tingling or other pre-lesion symptoms, as soon as
the symptoms are felt. Delay beyond the first 12-18 hours after
the first symptoms will usually result in lesions occurring, although
if treated, the duration is greatly reduced.
The
results of this study would further indicate the need for the Herpes
virus patient to be provided with and carry with them at all times,
the Cold Sore Eliminator, that they would be able to use immediately
upon manifestation of a pre-lesion condition.
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