| United States Patent |
5,162,037 |
| Whitson-Fischman |
November 10, 1992 |
A method for treating pathogenic conditions of the human body by preparing a
homeopathic mixture of at least one herb, herbal extract or other compound
exhibiting therapeutic properties, adding a magnetically permeable substance to
the mixture if necessary, magnetizing the resulting mixture to impart a
substantially unipolar magnetic charge on the mixture and administering the
magnetized mixture through one or more specific acupuncture points associated
with producing a desired response to the particular condition being treated. The
invention is also directed to the treatment of various diseases through the
oral, auricular, topical or injectable administration of magnetically influenced
homeopathic medicaments.
| Inventors: |
Whitson-Fischman; Walter (New York,
NY) |
| Assignee: |
Whitson Laboratories, Inc. (New York,
NY) |
| Appl. No.: |
696759 |
| Filed: |
May 7, 1991 |
| U.S. Class: |
600/12; 600/15; 128/907 |
| Intern'l Class: |
A61N 002/00 |
| Field of Search: |
600/9,12,15 128/907 |
References Cited [Referenced
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Bolger |
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DE. |
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Jul., 1971 |
DE. |
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Nov., 1987 |
DE. |
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Aug., 1975 |
FR. |
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Jul., 1983 |
JP. |
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Jun., 1986 |
JP. |
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Jul., 1988 |
JP. |
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| 1147411 |
Mar., 1985 |
SU |
600/12. |
| 1335297 |
Sep., 1987 |
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600/9. |
| 1264511 |
Feb., 1972 |
GB. |
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| WO78/00005 |
Dec., 1978 |
WO. |
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Other References
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Orekhov et al., "Prevention . . . Aspirin", The Lancet,
Sep. 5, 1987. |
Primary Examiner: Cohen; Lee S.
Attorney, Agent or Firm: Haug; Edgar H. Kilcoyne; John M.
Parent Case Text
FIELD OF THE INVENTION
This application is a continuation-in-part of application Ser. No. 540,295,
filed Jun. 19, 1990, abandoned, which in turn is a continuation of
application Ser. No. 176,731, filed Apr. 1, 1988, abandoned.
Claims
1. A method for treating pathogenic conditions of the human body comprising
the steps of:
preparing a mixture of at least one herb, herbal extract or other compound
having therapeutic properties to which a particular condition being treated
is responsive;
adding a magnetically permeable substance to the mixture if necessary;
magnetizing the resulting mixture in a magnetic field during delivery to
impart a substantially unipolar magnetic charge on said mixture; and
administering the magnetized mixture through one or more specific
acupuncture points of the body which are associated with producing a desired
response to the particular condition being treated.
2. The method of claim 1 wherein the mixture is magnetized in a magnetic
field of less than ten gauss.
3. The method of claim 1 wherein the magnetized mixture is topically
administered to the body.
4. The method of claim 3 wherein a therapeutic amount of the magnetized
mixture is placed over at least one pair of bilateral acupuncture points on
the surface of the body.
5. The method of claim 4 wherein the mixture is magnetized by placing a
source of magnetic flux in proximity to the mixture while it is placed over
the bilateral acupuncture points on the surface of the body.
6. The method of claim 1 wherein the magnetized mixture is injectably
administered to the body.
7. The method of claim 6 wherein a therapeutic amount of the magnetized
mixture is injected into at least one pair of bilateral acupuncture points
of the body.
8. The method of claim 1 wherein the magnetized mixture is auricularly
administered to the body.
9. The method of claim 8 wherein a therapeutic amount of the magnetized
mixture is impregnated into metal rods inserted into a device fitted to be
placed over the ear, the metal rods being located in said device such that
the magnetized mixture is in contact with at least one auricular acupuncture
point when the device is placed over the ear.
10. The method of claim 1 wherein the magnetized mixture is orally
administered to the body.
11. The method of claim 10 wherein a therapeutic amount of the magnetized
mixture is administered to acupuncture points in the mouth by means of an
oral delivery device which is magnetically transparent and permeable
comprising a rod portion connected to a porous ball portion, said rod
portion being capable of accepting and holding a magnetic charge, and said
ball portion being impregnated with an effective amount of said mixture,
wherein said rod portion of the device is magnetized so that the desired
charge is at the ball portion, and wherein the patient places the ball
portion of the device under the tongue to influence the acupuncture points.
12. A method for the treatment of conditions of the human body including
injuries, illnesses, pathogenic diseases, allergies and chemical and
hormonal imbalances, the method comprising the administration of a
combination of oral, injectable and topical forms of a therapeutic amount of
a magnetized solution containing a solute of one or more therapeutic herbs
or herbal extracts or other compounds having properties to which the
particular condition being treated is responsive, the solute being dissolved
in a vehicle, where the vehicle for the oral and topical form is a mixture
of 99+% alcohol, and the vehicle for the injectable form is a mixture of
99+% alcohol diluted with sterile isotonic saline, together with a
magnetically permeable, non-toxic substance if necessary; and wherein the
oral form is impregnated into a solid placed in the mouth to release the
magnetized mixture contained therein, thereby stimulating acupuncture points
in the mouth; wherein the topical form is also impregnated into a solid and
affixed as a transdermal patch to at least one suitable acupuncture point;
and wherein the injectable form is injected into at least one specific
acupuncture point of the body related to the part of the body or the
condition being treated; the oral, topical and injectable treatments being
administered in appropriate dosages for a sufficient period of time
depending on the severity of the condition and the response of the patient
being treated, with provision for a further period of maintenance treatments
of different dosage and frequency of administration where symptoms of the
condition persist.
13. The method of claim 12 wherein the condition being treated is traumatic
injury to one or more joints, muscles, tendons and ligaments and the solute
of the magnetized solution comprises an effective amount of one or more
herbs or extracts selected from the group consisting of Arnica Montana,
Symphytum officianalis, Moschus moschiferous, Cow bezoar, Pupalia geniculata,
Snake's gall, Rhus Toxicum, Germanuim dioxide, Plantago asiatica, Causticum,
Helianthemum canadense, Ornithogalum umbellatum, Clematis crispa, Impatiens
pallida, Prunus Cerasus and pineal gland.
14. The method of claim 12 wherein the oral dosage is a metal rod and sphere
impregnated with a solution having a homeopathic potency of 30.times.,
administered initially as one rod and sphere per day, reduced to one every
other day and finally to once per week over the course of treatment; wherein
the topical dosage is a transdermal patch, impregnated with a solution
having a homeopathic potency of 30.times., placed over at least one
acupuncture point two times per week for a first phase of treatment and once
per week on successive weeks over a maintenance phase of treatment; wherein
the injectable dosage is an injection of 0.2 cc per acupuncture point of the
injectable solution having a homeopathic potency of 30.times., administered
to the acupuncture points and related local acupuncture points for the
specific injured member being treated, the injections being given initially
2 times per week for a first phase of treatment and once per week on
successive weeks over the balance of a therapeutic phase as well as a
maintenance phase of treatment; and wherein the duration of the oral,
topical and injectable modes of treatment is from about 12 weeks, followed
by a period of maintenance for as long as symptoms of the condition persist.
15. The method of claim 12 wherein the condition being treated is
hypothyroidism and the solute of the magnetized solution comprises an
extract of thyroid gland.
16. The method of claim 15 wherein the injectable and topical dosages are
administered bilaterally to each of the two LI-11 acupuncture points 2 times
per week for the first week of treatment and once per week on successive
weeks over the course of treatment; and wherein the duration of the oral,
topical and injectable modes of treatment is six weeks, followed by a period
of maintenance of several weeks for as long as the symptoms of the condition
persist.
17. The method of claim 12 wherein the condition being treated is one or
more of pre-menstrual syndrome, menopause and reproductive hormonal
imbalance in female human beings and the solute of the magnetized solution
comprises the herb Angelica sinensis or an extract thereof and an extract of
pineal gland.
18. The method of claim 15 wherein the injectable and topical dosages are
administered bilaterally to each of the two LI-11 acupuncture points from 1
to 2 times per week for the first week of treatment and once per week on
successive weeks over the course of treatment; and wherein the duration of
the oral, topical and injectable modes of treatment is from 4 to 8 weeks,
followed by a period of maintenance of several weeks for as long as the
symptoms of the condition persist.
19. The method of claim 12 wherein the condition being treated is emotional
depression and tension, and the solute of the magnetized solution comprises
one or more herbs or herbal extracts selected from the group consisting of
Helianthemum canadense, Ornithogalum umbellatum, Clematis crispa, Impatiens
pallida, Prunus cerasus, Valeriana officinalis and pineal gland.
20. The method of claim 17 wherein the injectable and topical dosages are
administered bilaterally to the SP-6 acupuncture points a total of four to
six times, followed by a period of maintenance of several weeks for as long
as symptoms of the condition persist.
21. The method of claim 12 wherein the condition being treated is a
reduction in the body's natural immune system and the solute of the
magnetized solution comprises one or more herbs or extracts selected from
the group consisting of Panex ginseng, Astragalus membranaceous, Snake
venom, thymus gland, Rubia cordifolia and pineal gland.
22. The method of claim 20 wherein the injectable and topical dosages are
administered bilaterally to one of the following pairs of acupuncture
points: HE-5, HE-6 and HE-7, given 2 times per week for the first week of
treatment and once per week on successive weeks over the course of
treatment; and wherein the duration of the oral, topical and injectable
modes of treatment is 6 weeks, followed by a period of maintenance of
several weeks for as long as symptoms of the condition persist.
23. The method of claim 22 wherein the injectable and topical dosages are
administered bilaterally to each of the two LI-4 acupuncture points 2 times
per week for the first week of treatment and once per week on successive
weeks over the course of treatment; and wherein the duration of the oral,
topical and injectable modes of treatment is 6 to 8 weeks, followed by a
period of maintenance of several weeks for as long as the symptoms of the
condition persist.
24. The method of claim 12 wherein the condition being treated is
hypoglycemia and the solute of the magnetized solution comprises a mixture
of sulfur and glycerin.
25. The method of claim 24 wherein the injectable and topical dosages are
administered bilaterally to each of the two ST-36 acupuncture points, given
2 times per week for the first week of treatment and one per week on
successive weeks over the course of treatment; and wherein the duration of
the oral, topical and injectable modes of treatment is from 6 to 8 weeks,
followed by a period of maintenance of several weeks for as long as symptoms
of the condition persist.
26. The method of claim 12 wherein the condition being treated is a general
or localized bacterial infection of the body, and the solute of the
magnetized solution comprises one or more herbs or extracts selected from
the group consisting of Seniccio scandens, Scutellaria baicalensis, Magnolia
officinalis, Lonicera japonica, Andrographis paniculata, Centella asiatica
minor, Leptotaenia multifida, Moschus moschiferous, Cow bezoar, Pupalia
geniculata, Snake's gall and pineal gland.
27. The method of claim 26 wherein the injectable and topical dosages have a
homeopathic potency of 30.times., and are administered bilaterally to each
of the two IL-11 acupuncture points, given 2 times per weeks for the first
week of treatment and one per week on successive weeks over the course of
treatment; and wherein the duration of the oral, topical and injectable
modes of treatment is 6 to 12 weeks depending on the pathogen being treated,
followed by a period of maintenance of several weeks for as long as the
symptoms of the condition persist.
28. The method of claim 12 wherein the condition being treated is a general
virus infection of the body and the solute of the magnetized solution
comprises one or more herbs or extracts selected from the group consisting
of Centella asiatica minor, Pyrrosia lingua, Hypericum perfoliatum,
Trichosanthes Kirilowii, Artemasia apiacea and pineal gland.
29. The method of claim 28 wherein the injectable and topical dosages have a
homeopathic potency of 30.times., and are administered bilaterally to each
of the two TW-5 acupuncture points, given 1 or 2 times per week for the
first week of treatment and once per week on successive weeks over the
course of treatment; and wherein the duration of the oral, topical and
injectable modes of treatment is from 8 to 12 weeks, followed by a period of
maintenance of several weeks for as long as symptoms of the condition
persist.
30. The method of claim 12 wherein the condition being treated is a cold
caused by the rhino-virus or influenza and the solute of the magnetized
solution comprises one or more herbs or extracts selected from the group
consisting of Lonicera confusa, Chrysanthemum indicum, Vitex negundo, Evodia
lepta, Ilex asprella, Menthol crystal, Baphicacanthus cusia, Centella
asiatica minor and pineal gland.
31. The method of claim 30 wherein the injectable and topical dosages are
administered bilaterally to each of the two TW-5 acupuncture points, given 2
times per week for the first week of treatment and once per week on
successive weeks over the course of treatment; and wherein the duration of
the oral, topical and injectable modes of treatment is three weeks, followed
by a period of maintenance of several weeks for as long as symptoms of the
condition persist.
32. The method of claim 12 wherein the condition being treated is one or
more of hay fever and airborne allergies, and the solute of the magnetized
solution comprises one or more herbs or extracts selected from the group
consisting of Gentiana luta, Citrus aurantium, Tanacetum vulgare, Cnicus
benedictus, Menyanthes trifoliata, Grindelia robusta, Ephedra sinica,
Centipeda minima, pineal gland and Centella asiatica minor.
33. The method of claim 32 wherein the injectable and topical dosages are
administered bilaterally to each of the two PE-6 acupuncture points or the
auricular lung point, given 2 times per week for the first week of treatment
and once per week on successive weeks over the course of treatment; and
wherein the duration of both the oral and injectable modes of treatment is
from 2 to 4 weeks, followed by a period of maintenance of several weeks for
as long as the symptoms of the condition persist.
34. The method of claim 12 wherein the condition being treated is one or
more of local and systemic fungus and yeast infections, and the solute of
the magnetized solution comprises one or more herbs or extracts selected
from the group consisting of Malaleuca alternifolio, Centella asiatica
minor, citrus seed, Tacoma conspicus and pineal gland.
35. The method of claim 34 wherein the injectable and topical dosages are
administered bilaterally to the SP-6 acupuncture point, given 2 times per
week for the first week of treatment and once per week on successive weeks
over the course of treatment; and wherein the duration of the oral, topical
and injectable modes of treatment is from 6 to 12 weeks, followed by a
period of maintenance of several weeks for as long as symptoms of the
condition persist.
36. The method of claim 12 wherein the condition being treated is
infestation with intestinal parasites and the solute of the magnetized
solution comprises one or more herbs or extracts selected from the group
consisting of Osbeckia chinensis, Pulsattila chinensis, Punica granatum,
Acalpha australis, Cephaelis ipecacuanha, Picrasma ailanthoides, Asarum
sieboldi, Brucea javanica, Magnolia officinalis, Artemisia apiacea, Dichroa
febrifuga, Centella asiatica minor, citrus seed and pineal gland.
37. The method of claim 36 wherein the injectable and topical dosages are
administered bilaterally to the ST-36 and ST-37 acupuncture points which are
used alternately and treatments are given 2 times per week for the first
week and once per week on successive weeks over the course of treatment; and
wherein the duration of both the oral and injectable modes of treatment is
from six to eight weeks, followed by a period of maintenance of several
weeks if required.
38. The method of claim 12 wherein the condition being treated is acute or
chronic muscular and joint pain and the solute of the magnetized solution
comprises one or more herbs or extracts selected from the group consisting
of Arnica Montana, Symphytum officianalis, Moschus moschiferous, Cow bezoar,
Pupalia geniculata, Snake's gall, Rhus Toxicum, Germanuim dioxide, Plantago
asiatica, Causticum, Helianthemum canadense, Ornithogalum umbellatum,
Clematis crispa, Impatiens pallida, Prunus Cerasus and pineal gland.
Description
This invention relates to homeopathic medicaments and methods for the
treatment of illness and injury in human beings using such homeopathic
medicaments.
More particularly, the invention relates to homeopathic methods of treatment
of conditions including illnesses, pathogenic diseases, allergies, chemical
and hormonal imbalances, addictive chemical dependencies, and physical
injuries to the human body. The methods of treatment include oral, topical,
auricular and injectable forms of homeopathic formulations which are
magnetically treated or influenced during administration to a patient
through specific acupuncture points.
BACKGROUND OF THE INVENTION
Homeopathy is an
ancient healing art and forms a vital part of medical therapy. The practice
of homeopathy is
widespread, particularly in eastern cultures and many European countries.
Homeopathic medicine teaches the use of natural based remedies and, as such,
provides an alternative to traditional allopathic medicine which relies
heavily on the use of petrochemical based pharmaceuticals. There has been a
large increase in interest in homeopathic medicine in the United States in
recent years due, in large part, to a growing disenchantment with allopathic
medications and the complications and side effects arising from their use.
Frequently, the administration of allopathic medications results in serious
side effects more deleterious to the patient than the basic condition being
treated. Today, more and more individuals are looking for a gentler, safer
path to good health free of the risks and side effects associated with
traditional allopathic medicines. Furthermore, such medicines are often
prohibitively expensive, particularly for patients who are indigent or
elderly.
Homeopathic remedies, on the other hand, use pharmaceutical preparations
based on the use of herbs or herbal extracts. Homeopathic remedies function
in a totally different manner than chemical-based pharmaceuticals in that
they do not require administering high concentrations of active ingredients
to produce the desired effects. Traditional allopathic pharmaceuticals can
be thought of as working quantitatively, that is, the results achieved are
generally proportional to the potency and frequency of the dosage
administered. By comparison, homeopathic pharmaceuticals can be thought of
as working qualitatively in that even the minutest quantities of their
active ingredients produce a therapeutic effect by inducing natural body
mechanisms to return to their proper level of activity characteristic of a
healthful or uninjured state. Homeopathic remedies function by inducing
natural body mechanisms and processes to return to their optimum healthful
level of operation, that is, their natural biological "set
points".
Through our modern understanding of genetics, each bodily member and process
is seen as the result of codes programmed into each individual cell.
Homeopathic medicine seeks to utilize natural substances, particularly
herbs, to induce naturally and gently the body to restore its equilibrium,
that is, for all function and processes to return to their set points.
Homeopathic medicine looks upon illness and disease as being a state of
disequilibrium from the body's optimal set points. A fundamental precept of
homeopathic medicine is that a small force or stimulating agent can produce
disproportionally greater results, if optimally and effectively applied.
Thus, proper administration of a small quantity of a homeopathic medicine
can have a large effect in restoring the body to its proper state of
equilibrium.
A further advantage of homeopathic medicaments is that they are relatively
inexpensive as compared to traditional chemical-based pharmaceuticals.
Another fundamental precept in the formulation of homeopathic
pharmaceuticals is that repetitive dilution from an original concentrate
does not diminish efficacy of the formulation. Thus, large quantities of
homeopathic pharmaceuticals can be prepared from a relatively small amount
of starting solution. Further, the starting ingredients themselves are
natural and relatively inexpensive. The formulation of solutions of
homeopathic pharmaceuticals is also a relatively simple process.
Additionally, homeopathy
utilizes various medicaments in extremely dilute form. For example, all the
medicines used in accordance with the present invention are generally used
at a potency of 30.times. which is a 1-10 dilution taken to the 30th power.
One of the long standing adjustments that was made long ago was a
determination of exactly what materials are suitable as diluents. The list
is small and primarily restricted to 200 proof Ethyl alcohol, distilled
water, sugar and milk sugar. With the possible exception of distilled water,
none of these are really totally inert. All the others contribute some
identity of their own. As a matter of fact, both sugar and milk sugar are
listed as medicants (when in homeopathic dilution) in the homeopathic
materia medica.
One example of a homeopathic medicament is extract of pineal gland. As noted
in the technical text, "The Pineal Gland" by Russel J. Reiter
(Raven Press, N.Y. 1984), the pineal gland occupies a unique physiological
niche. Its function has been described as being "the regulator of
regulators". The primary action of the pineal gland is believed to be
to "govern or restrict the production and/or the secretion of hormones
from other endocrine glands."
Since conventional allopathic medications utilize massive chemical
intervention as the modus operandi with the actual destruction of the
offending pathogen as the ultimate goal, there is little possibility for an
interface between the powerful but very subtle activity of the pineal gland
and the mighty action of petrochemicals. Homeopathy,
however, since it is a vastly more subtle form of medication, appears to be
able to intensify the actions of the pineal.
To make the base tincture of the pineal gland, one portion of a freeze dried
animal sample of the gland itself is comminuted and then macerated in pure
ethanol for ten days with daily agitation. At the end of this time, the
extract is filtered. An equal sample of the same material is added to
distilled water, brought to a slow simmer and maintained at this point while
it is allowed to steep for one hour. At the end of this time, the water
extract is also filtered.
Equal amounts of the alcohol and the water extracts are combined to form the
base tincture.
In contrast, the manufacture of traditional chemical-based pharmaceuticals
generally involves a complicated and costly chemical manufacturing process.
Moreover, because the effectiveness of such traditional chemical-based
pharmaceuticals resides in the potency of the formulation administered,
dilution of the pharmaceutical to a lower potency results in reduced
effectiveness. Generally, all such chemical-based pharmaceuticals must be
formulated at or near the concentration level or potency at which they will
ultimately be administered. Thus, in order to produce large quantities of a
pharmaceutical, proportionately large manufacturing facilities are required,
which only further adds to the expensiveness of the chemical-based
pharmaceuticals utilized in classical allopathic medicine.
Another ancient and long accepted healing art is acupuncture which is
believed to have originated in the Orient. Acupuncture involves the relief
of symptoms and the cure of illness and injury by the controlled stimulation
of points on the human body which regulate or interact with the functioning
of specific organs or bodily members to which the acupuncture points are
related.
Over the many years that acupuncture has been practiced, specific points on
the human body have been determined which regulate or interact with the
functioning of all bodily members and processes. Thus, the appropriate
points for stimulation for any given condition are known to skilled
practitioners in the art.
One particular acupuncture treatment system developed in Japan by Dr. Yoshio
Manaka is based on a conception of the human body as encompassing two basic
systems, an energetic system and an informational system. The energetic
system utilizes the greater portion of energy in the body. The informational
system controls the energetic system and response to both external and
internal stimuli. Acupuncture is viewed as a therapeutic modality which
interacts with and regulates the body's informational system. By influencing
the informational system, large changes can be induced with minimal
stimulation while allowing the body to function as naturally as possible
while its processes are gradually restored to their equilibrium set points.
A recent development in methods of medical treatment has been the discovery
of the therapeutic properties of magnetic and electro-magnetic fields and
their use in the treatment of illness and injury. Modern science has
demonstrated that all living beings exhibit an electro-magnetic field about
them. Homeopathic medicine teaches that illness and injury create
disturbances to the body's natural electro-magnetic fields. The
administration of therapeutic fields restores the body's natural fields to
their equilibrium levels. The therapeutic effects of the application of
pulsed magnetic fields in the treatment of traumatic injuries to limbs,
muscles, tendons, bones and the like, as well as in the treatment of illness
such as arthritis, is well-known in the art of medical science.
The human body's susceptibility to magnetic fields is due in large part to
the electrolytic properties of many of the chemical constituents of the
body. All electrolytic substances are capable of conducting an electric
current, and whenever an electric current is flowing a magnetic field is
created. The greater the electrolytic properties of the substance, the
greater is its conductivity and therefore the greater the resulting magnetic
field created during current flow.
The body generates a magnetic field of its own due partly to the presence of
iron-carrying charged particles flowing in the blood stream. Other
electrolytic substances in the body such as potassium and sodium, in ionic
form, are present in substantial amounts and contribute to the body's
overall bioelectric/biomagnetic field. It is well known that blood cells are
readily polarized when placed in a magnetic field due to the high iron
concentration in the blood. Under certain conditions, magnetic fields alter
the orientation of blood cells and induce changes in the biological
reactions in which they participate, thereby modifying the probability of
chemical bond formation.
Human blood is very slightly alkaline with respect to body cells which are
more acidic. Magnetic fields can be used to induce reactions which restore
the pH of the blood.
For example, in a condition prompted by over-acidity of the blood, that is,
one characterized by a low pH, application of magnetic field energy
emanating from the north pole of a magnet, which, by convention, is
considered to be negative, and which, homeopathically, is considered to be
alkaline, helps to restore the blood to its normal pH level.
It has also been shown that the blood's leucocyte count is influenced by
magnetic fields. The number of leucocytes in the blood increases depending
on prevailing magnetic field conditions.
Therapeutic treatments utilizing magnetic energy operate to produce two
curative effects. Therapeutic magnetic fields produce a treatment component
which in the case of traumatic physical injury causes a reduction in
swelling, a reduction of edema, a draining of fluid build-up due to
inflammation and a desensitization to pain.
Therapeutic magnetic energy fields also produce a stimulating component
which in the case of traumatic physical injury dilates blood vessels and
increases blood circulation, disperses fluid build-up due to inflammation,
and strengthens and promotes the healing of damaged tissue.
The application of pulsed magnetic energy has been observed to cause
transcutaneous electrical neural stimulation and contributes to the
reduction of chronic pain by causing the release of natural pain relieving
substance at the spinal cord level and by causing the release of endorphins
and ACTH at the pituitary gland level.
As a result of research into the fields of homeopathic pharmaceutical
medicine, acupuncture and biomagnetic therapy, a new modality of medical
treatment has been developed which combines the features of all three of the
above treatment methods in a novel way. Accordingly, a new and unique method
of medical treatment has been discovered which is more efficacious than any
of the three methods individually as described above.
OBJECTS OF THE INVENTION
Accordingly, a primary object of the present invention is to disclose a new
modality of medical therapy which utilizes aspects of homeopathic
pharmaceutical therapy, acupuncture therapy and biomagnetic therapy, in
combination.
A further object of the invention is to devise a full range of modes of
administration of magnetically influenced homeopathic remedies, including
topical, injectable, auricular and oral forms.
A further object of the invention is to provide particular homeopathic
pharmaceutical formulations for the treatment of specific illnesses,
physical injuries and other chemical and hormonal disequilibrium conditions
of the human body with precisely determined acupuncture sites to which the
homeopathic pharmaceutical remedies are to be applied in the treatment of
each specific condition.
A further object of the invention is to provide appropriate means for
inducing the biomagnetic field in the homeopathic pharmaceutical remedy for
each form of administration.
SUMMARY OF THE INVENTION
The present invention is directed to a method of treatment of human illness
and injury by administering to the patient homeopathic medicaments through
selected acupuncture points stimulated by a controlled magnetic field. A
very broad spectrum of human illness can be effectively treated by
homeopathic medicament of the instant invention through selection of the
appropriate homeopathic remedy, preparation of a mixture of the homeopathic
remedy and a magnetically permeable component and magnetization of the
resulting mixture during administration to the patient through specific
acupuncture sites.
Various embodiments of the invention include administering therapeutic
amounts of the magnetic mixture in oral, injectable, topical and auricular
forms. Further, depending upon the condition being treated, the dosage and
frequency of administration will vary. In a particularly preferred
embodiment, the patient is administered with a regimen of oral, transdermal
and injectable dosages.
BRIEF DESCRIPTION OF THE DRAWINGS
Aspects of the present invention are illustrated by the accompanying
drawings in which:
FIG. 1 shows a preferred embodiment of an oral delivery vehicle for the
administration of homeopathic medicaments;
FIG. 2 shows an embodiment for the topical administration of a homeopathic
medicament; and
FIG. 3 shows a preferred embodiment for imparting a magnetic field to the
injectable form of the homeopathic medicaments; and
FIG. 4 shows a cross-sectional view through a mold of an ear, with pins
inserted therein, for the auricular administration of a homeopathic
medicament.
DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS OF THE INVENTION
The homeopathic medicaments of the present invention, when administered
through specific acupuncture sites, have demonstrated remarkable efficacy in
the treatment of a wide range of afflictions, many of which have no known
cure in the realm of allopathic medicine. Effective delivery systems for
these homeopathic formulations have been devised including topical,
injectable, auricular and oral forms.
In accordance with the teaching of the present invention, the homeopathic
medicament, when administered as an injectable, is first carefully mixed
with an effective amount of a magnetically permeable ingredient. Although
numerous compounds are suitable, it has been found that ferrous gluconate is
particularly effective. The herb-based homeopathic medicament is then
prepared for administration to the patient depending upon the specific
delivery system used. During administration to the patient, the medicament,
whether or not it is mixed with a magnetically permeable ingredient, is
charged or influenced by a magnetic field which imparts a unipolar charge to
the medicament as it enters the body through a pre-selected acupuncture
point. Since a magnet has two poles, to effect a unipolar charge to the
medicament, the poles of the delivery devices are separated. The medicament
and the body are only exposed to one pole. The other pole is outside of, or
away from, the body. In this way, the medicament is exposed to the influence
of only one pole. Such application of a magnetic charge at, or in close
proximity to, the acupuncture site is believed to stimulate or activate the
acupuncture site thereby enhancing the therapeutic efficacy of the
medicaments being administered.
Acupuncture points can be stimulated with heat, electricity, ultrasound,
laser beams, mechanical vibration, etc. However, stimulation by magnetism
has been found to be one of the most effective, and yet, at the same time,
is one of the most benign.
Particularly effective results have been achieved when applying relatively
small levels of magnetic charge in the range of 1 to 10 gauss to the
medicament as it is being administered into the acupuncture point. Such low
levels of magnetic flux can aptly be described as homeopathic. It has
further been found that the most effective acupuncture sites are located in
the arms and legs below the elbow and knee, respectively. These points are
commonly referred to as "command points" and are well known to
those skilled in the art.
Having described the invention in its most fundamental terms, the various
forms of administration of medicaments will now be described in detail.
Reference is made to the accompanying figures where appropriate.
One delivery system used is by injection. The formulation dosage and
duration of treatment for the injectable medicaments is described in detail
in the formulation examples which follow. Since it has been observed that
injecting homeopathic medicaments demonstrate unexpected and significantly
enhanced efficacy when a unipolar magnetic charge is imparted to the
medicament during administration or injection into an acupuncture point, a
device has been developed to enable the administering physician to suitably
charge the medicament. One such device is shown in FIG. 3.
This device consists of a housing 10. Within the housing 10 is an electronic
circuit which delivers a pulsed DC current to the electromagnetic coil 12
with a frequency in the range of about 5 to 10 Hz. The electromagnetic coil
12 is positioned to impart a controlled magnetic charge to core 14. A
syringe or hypodermic needle 16 used to inject the homeopathic medicament
can be positioned in housing 10 such that the point of the needle or syringe
is in close proximity to the end of the core 14 as shown in FIG. 3. The
entire length of the hypodermic needle is magnetized. The end of the needle
which is to enter the skin at the acupuncture point is given the desired
charge. Each molecule of the medicament going down the needle receives a
magnetic charge. Although the charge dissipates when it hits the skin,
during the instant before this happens, the acupuncture point is stimulated
by being bombarded by a series of magnetic impulses.
Another alternative delivery system used is the topical. One particularly
preferred topical system is illustrated in FIG. 2. The topical patch 52 is
made of a porous material such as sintered metal capable of absorbing a
therapeutic amount of homeopathic medicament. The patch 52 has an extended
opening therethrough on the underside of which is tightly fitted a metal
sphere or ball 50 which can readily accept and retain a magnetic charge.
Suitable materials used to prepare the metal sphere or ball 50 include iron,
steel and other ferrous alloys that are magnetically efficient. The patch 52
can then be impregnated with a therapeutic amount of desired homeopathic
medicament. A unipolar magnetic charge is then imparted to the metallic core
50 of patch 52 after it is affixed to a suitable acupuncture point.
In one embodiment, the patch is a dome shaped "donut" shaped
device with a hole in the center as shown in FIG. 2. The patch is formed by
a metal sintering process and is made of a stainless steel alloy that is
virtually non-magnetic. Because it is made of sintered metal, the device is
porous and can be impregnated with a liquid solution of the desired
medication as described later. On the underside of the device, the ball
bearing 50 is press fitted into place within the opening so that it
partially projects below the surface. The ball is made of a ferrous alloy
that is extremely permeable magnetically and will also retain the magnetic
charge. The ball typically is not formed by the sintering process, and it is
not porous so it will not absorb any liquid medication. The patch can be
mounted on a circle of surgical adhesive tape 56, all of which can be
protected by one or more "peel off" strips of release paper 54
similar to the type used with adhesive bandages.
Still another form of administering homeopathic medicaments is orally.
With reference to FIG. 1, this oral device can aptly be described as a
medicinal "lollipop" consisting of a rod portion 40 and a ball or
bulbous portion 42. In one embodiment, the rod 40 is made up of a stainless
steel alloy that is capable of holding a magnetic charge. The ball portion
42 can have an inert core. The ball portion 42 can also be coated with a
homeopathic composition made of ferrous gluconate mixed with sugar to a
dilution in the range of 3.times. to 4.times.. It can then be impregnated
with an alcohol tincture containing the desired homeopathic medicament of
the desired homeopathic dilution. The entire device can be encased in a
sanitary wrapping. To use the "lollipop", the entire device in its
wrapping if desired, is first placed in a suitable electromagnetic field. In
this way, all of the metallic elements of the device are magnetized with one
end of the rod portion being charged with one polarity and the other end of
the rod portion being charged with the opposite polarity. In this manner,
the therapeutic portion of the device having a desired unipolar charge can
influence the ball portion which is placed under the tongue of the patient
in order to contact the acupuncture points in the mouth.
In a specific embodiment, the "handle" or rod 40 of the
"lollipop" is made of a stainless steel or ferrous metal of such
alloy that will readily accept magnetism and will hold the charge well. At
one end, the metal rod 40 is forced into a hole in the ball portion 42
formed of sintered stainless steel. The specific stainless steel alloy used
to form the ball is magnetically transparent so that it will not readily
accept a magnetic charge. The alloy is also porous so that it can be
impregnated with an alcoholic tincture of the desired homeopathic
therapeutic remedy in the desired potency.
The "lollipop" oral delivery device can be positioned under the
tongue in the same way an oral thermometer is used. It will directly
influence three specific acupuncture points. They are: Jin Jin (which
translates as Golden Fluid), Yu-Yeh (Jade Fluid) and Hai Chuen (Sea Spring).
The first two are located on the left and right sides of the vinculum lingua
when the tongue is rolled up. The third point is under the tongue on the
midline about 1/16th inch up from the vinculum lingua.
As a result of this procedure, the acupuncture points in the patient's
mouth, and especially those located under the tongue, are influenced by a
homeopathic medication whose action has been intensified through the use of
the polarized magnetic force.
It is not necessary that the oral device actually contact the acupuncture
points as long as it is placed under the tongue in the general area. The sub
lingual acupuncture points under the tongue will be influenced by the
homeopathic medication with which the ball has been impregnated.
Simultaneously the same sites will also be influenced by the selected
unipolar magnetic force. The portion of the "stick" that has been
charged with the undesired polarity is outside of the mouth during this
entire procedure to prevent any influence of the opposite and undesired
magnetic charge. At the conclusion of the period of treatment, the entire
device is discarded.
Yet another form of administering the homeopathic medicaments is by
auricular measures. An auricular device is illustrated in FIG. 4. In one
such device, a mold 75 is made of a patient's ear by gently pressing
standard mold compound into place so that it takes on the anatomical
contours of the ear and is about 1/8 to 1/4 inches thick. The mold material
is carefully removed so as to preserve the features of the material and is
cured; to the consistency of firm rubber.
Small rods 60 formed of sintered stainless steel, in a ferrous alloy that is
magnetically efficient, are fitted through holes punched in the ear mold.
The holes 65 coincide with the specific acupuncture points in the ear that
are to be influenced. The rods have a rounded point 70 on one end and are
sufficiently long as to extend through the mold and firmly contact the
auricular acupuncture points.
Prior to use, the sintered metal rods are impregnated with the desired
homeopathic medicament as described elsewhere and then dried. They are
positioned in the holes pierced in the molds using forceps to avoid
contamination. The molds are placed back on the patient's ears and then the
desired magnetic charge is induced.
Impregnating with Medicament
In certain preferred embodiments, the sintered metal donut of the patch, and
the ball of the oral lollipop, are porous so that they will absorb an
alcohol tincture of the medicament after which they are dried and packaged.
Merely soaking the metal may not be effective. Instead, in one embodiment,
the sintered metal pieces can be placed into a suitable container with
enough alcohol tincture added to completely cover them. The entire system
goes into a vacuum chamber and a vacuum then pulled producing an intense
surge of tiny bubbles rising to the surface as an indication that, in the
lowered atmospheric pressure, the air entrapped in the interstices of the
sintered metal is being forced out.
After about ten minutes of vacuum, the container and contents are allowed to
return to normal atmosphere. When this happens, the alcohol tincture is
forced into the minute pores of the sintered metal parts. After about ten
minutes the metal pieces absorb all the tincture that they will accept.
Since the air was forced out of the pores of the metal when the container
was under vacuum, it can only be replaced by the tincture when normal
pressure returns because the sintered metal pieces remain completely
submerged in the solution.
In a particularly preferred embodiment, all the medicaments used are at a
30.times. potency. The dilution sequence used to achieve the 30.times.
potency in this embodiment is carried out with 99+% ethanol.
With respect to the transdermal patch, after being impregnated with the
desired medication and then dried, each transdermal patch can be mounted on
a circle of surgical adhesive tape that has a hole punched in the center.
The hole in the top surface of the patch is aligned with the hole in the
adhesive tape. The remainder of the adhesive tape surface can be covered and
protected by one or more "peel-off" strips of release paper of a
similar type to that used in the well known adhesive bandages. The paper
strips are formed with cut-out segments so that the metal donut will project
through.
For convenience, the transdermal patches are packaged in a paper envelope
and supplied in pairs since the units are often applied bilaterally to
acupuncture points on the patient's limbs.
To use the transdermal device, a two-unit package containing patches that
have been impregnated with the appropriate medication is chosen. The
protective backing from each adhesive circle is removed and the unit is
positioned so that the ball bearing on the underside is precisely aligned
with the selected acupuncture point on the patient's skin. The unit is
affixed to the skin by pressing the rim of adhesive tape (the part that
extends beyond the circumference of the donut) firmly against the patient's
skin.
When a magnetic charge is applied, the magnetic force will only influence
the ball bearing since the donut segment of the unit is formed of an alloy
that is not permeable to magnetism. Further, the magnetic charge is applied
in such a manner that the portion of the ball in proximity with one end of
the electromagnetic coil of an electromagnetic stimulating device is given a
charge of one polarity while the bottom portion of the ball that is in
contact with the patient's skin automatically assumes the opposite (and
therapeutically desirable) charge.
In application, the part of the ball bearing that is in contact with the
skin will exert a magnetic force upon the acupuncture point of only the
single desired polarity. The opposite magnetic polarity, the one that, for
the specific medical purpose, is not as desirable in this instance, is on
the opposite (or upper) side of the ball and so does not directly influence
the acupuncture point.
The patient leaves the patches in place on his skin for the period of time
recommended by his physician (usually 4 to 6 hours) before peeling them off
and discarding them.
The following are examples which illustrate embodiments of various aspects
of the invention. The examples are provided to illustrate the scope of the
invention and are not intended to be limiting. Other applications or aspects
of the invention within its broad scope will be apparent to those skilled in
the art.
FORMULATION EXAMPLES
A. Injectable
Example 1
An injectable dosage form of an herb-based homeopathic medicament designated
FNG-11, for the treatment of fungus and yeast infections, having a
homeopathic potency of 30.times. was prepared from an original concentrated
tincture menstruum containing extracts of the herbs Malaleuca alternifolio,
Centella asiatica minor and Tacoma conspicua, extract of citrus seed and
extract of pineal gland in 99+% alcohol. The original concentrated tincture
was diluted to 29.times. potency (10.sup.-29 times the original
concentration) with sterile distilled water. Sufficient ferrous gluconate
solution, a magnetically permeable substance, was added to sterile isotonic
saline to make a homeopathic potency of 4.times.(10.sup.-4). The 29.times.
dilution of the medicament was added to the ferrous gluconate/isotonic
saline solution to prepare the final 30.times. medicament. The purpose of
the ferrous gluconate/isotonic saline solution is to enable the final
medicament to hold a magnetic charge when it is passed through a magnetic
field. Injectable dosage portions of 0.2 cc volumes were set aside as needed
depending upon the number of acupuncture points being used. The formulations
injected were controllably magnetized during administration through the
acupuncture sites as described above.
Example 2
An injectable dosage form of an herb-based homeopathic medicament,
designated HG-9, for the treatment of intestinal parasites, particularly
Giardia lamblia and Entamoeba histolytica, was prepared from an original
concentrated tincture menstruum containing extracts of the herbs Osbeckia
chinensis, Pulsatilla chinensis, Punica granatum, Acalpha australis,
Cephaelis ipecacuanha, Picrasma ailanthoides, Asarum sieboldi, Brucea
javanica, Magnolia officinalis, Artemisia apiacea, Dichroa febrifuga, and
Centella asiatica minor, extract of citrus seed and extract of pineal gland
in 99+% alcohol. The original concentrated tincture was diluted to 29.times.
potency (10.sup.-29 times the original concentration) with sterile distilled
water. Sufficient ferrous gluconate solution, a magnetically permeable
substance, was added to sterile isotonic saline to make a homeopathic
potency of 4.times.(10.sup.-4). The 29.times. dilution of the medicament was
added to the ferrous gluconate/isotonic saline solution to prepare the final
30.times. medicament. The purpose of the ferrous gluconate/isotonic saline
solution is to enable the final medicament to hold a magnetic charge when it
is passed through a magnetic field. Injectable dosage portions of 0.2 cc
volumes were set aside as needed. The formulations injected were
controllably magnetized during administration through the acupuncture sites
as described above.
Example 3
An injectable dosage form of an herb-based homeopathic medicament designated
VR-27, for the treatment of broad spectrum viral infections, having a
homeopathic potency of 30.times. was prepared from an original concentrated
tincture menstruum containing extracts of the herbs Centella asiatica minor,
Pyrrosia lingua, Hypericum perfoliatum, Trichosanthes kirilowii and
Artemisia apiacea, and extract of pineal gland in 99+% alcohol. The original
concentrated tincture was diluted to 29.times. potency (10.sup.-29 times the
original concentration) with sterile distilled water. Sufficient ferrous
gluconate solution, a magnetically permeable substance, was added to sterile
isotonic saline to make a homeopathic potency of 4.times.(10.sup.-4). The
29.times. dilution of the medicament was added to the ferrous gluconate/isotonic
saline solution to prepare the final 30.times. medicament. The purpose of
the ferrous gluconate/isotonic saline solution is to enable the final
medicament to hold a magnetic charge when it is passed through a magnetic
field. Injectable dosage portions of 0.2 cc volumes were set aside as
needed. The formulations injected were controllably magnetized during
administration through the acupuncture sites as described above.
Example 4
An injectable dosage form of an herb-based homeopathic medicament designated
SPN-7, for the treatment of traumatic injury to muscles, tendons, ligaments,
and for the treatment of sprains, was prepared from an original concentrated
tincture menstruum containing extracts of the herbs Panex notoginseng and
Gynura segetum, and Moschus moschiferous and extract of pineal gland in 99+%
alcohol. The original concentrated tincture was diluted to 29.times. potency
(10.sup.-29 times the original concentration) with sterile distilled water.
Sufficient ferrous gluconate solution, a magnetically permeable substance,
was added to sterile isotonic saline to make a homeopathic potency of
4.times.(10.sup.-4). The 29.times. dilution of the medicament was added to
the ferrous gluconate/isotonic saline solution to prepare the final
30.times. medicament. The purpose of the ferrous gluconate/isotonic saline
solution is to enable the final medicament to hold a magnetic charge when it
is passed through a magnetic field. Injectable dosage portions of 0.2 cc
volumes were set aside as needed. The formulations injected were
controllably magnetized during administration through the acupuncture sites
as described above.
Example 5
An injectable dosage form of a homeopathic medicament, designated TYR-10,
for the treatment of hypothyroidism, was prepared from an original
concentrated tincture menstruum containing an extract of thyroid gland, in
99+% alcohol. The original concentrated tincture was diluted to 29.times.
potency (10.sup.-29 times the original concentration) with sterile distilled
water. Sufficient ferrous gluconate solution, a magnetically permeable
substance, was added to sterile isotonic saline to make a homeopathic
potency of 4.times.(10.sup.-4). The 29.times. dilution of the medicament was
added to the ferrous gluconate/isotonic saline solution to prepare the final
30.times. medicament. The purpose of the ferrous gluconate/isotonic saline
solution is to enable the final medicament to hold a magnetic charge when it
is passed through a magnetic field. Injectable dosage portions of 0.2 cc
volumes were set aside as needed. The formulations injected were
controllably magnetized during administration through the acupuncture sites
as described above.
Example 6
An injectable dosage form of an herb-based homeopathic medicament,
designated HRM-4, for the treatment of premenstrual syndrome, menopause,
menstrual discomfort and irregularities, and reproductive hormonal
imbalance, was prepared from an original concentrated tincture menstruum
containing an extract of the herb Angelica sinensis and extract of pineal
gland in 99+% alcohol. The original concentrated tincture was diluted to
29.times. potency (10.sup.-29 times the original concentration) with sterile
distilled water. Sufficient ferrous gluconate solution, a magnetically
permeable substance, was added to sterile isotonic saline to make a
homeopathic potency of 4.times.(10.sup.-4). The 29.times. dilution of the
medicament was added to the ferrous gluconate/isotonic saline solution to
prepare the final 30.times. medicament. The purpose of the ferrous gluconate/isotonic
saline solution is to enable the final medicament to hold a magnetic charge
when it is passed through a magnetic field. Injectable dosage portions of
0.2 cc volumes were set aside as needed. The formulations injected were
controllably magnetized during administration through the acupuncture sites
as described above.
Example 7
An injectable dosage form of a homeopathic medicament, designated HYT-12,
for the treatment of hypothyroidism, was prepared from an original
concentrated tincture menstruum containing a solution of iodine crystals and
extract of pineal gland in 99+% alcohol. The original concentrated tincture
was diluted to 29.times. potency (10.sup.-29 times the original
concentration) with sterile distilled water. Sufficient ferrous gluconate
solution, a magnetically permeable substance, was added to sterile isotonic
saline to make a homeopathic potency of 4.times.(10.sup.-4). The 29.times.
dilution of the medicament was added to the ferrous gluconate/isotonic
saline solution to prepare the final 30.times. medicament. The purpose of
the ferrous gluconate/isotonic saline solution is to enable the final
medicament to hold a magnetic charge when it is passed through a magnetic
field. Injectable dosage portions of 0.2 cc volumes were set aside as
needed. The formulations injected were controllably magnetized during
administration through the acupuncture sites as described above.
Example 8
An injectable dosage form of an herb-based homeopathic medicament for the
treatment of nervous tension, designated RLX-22, was prepared from an
original tincture menstruum containing extracts of the herbs Helianthemum
canadense, Ornithogalum umbellatum, Clematis crispa, Impatiens pallida,
Prunus Cerasus and Valeriana officinalis, and extract of pineal gland in
99+% alcohol. The original concentrated tincture was diluted to 29.times.
potency (10.sup.-29 times the original concentration) with sterile distilled
water. Sufficient ferrous gluconate solution, a magnetically permeable
substance, was added to sterile isotonic saline to make a homeopathic
potency of 4.times.(10.sup.-4). The 29.times. dilution of the medicament was
added to the ferrous gluconate/isotonic saline solution to prepare the final
30.times. medicament. The purpose of the ferrous gluconate/isotonic saline
solution is to enable the final medicament to hold a magnetic charge when it
is passed through a magnetic field. Injectable dosage portions of 0.2 cc
volumes were set aside as needed. The formulations injected were
controllably magnetized during administration through the acupuncture sites
as described above.
Example 9
An injectable dosage from of an herb-based homeopathic medicament,
designated IMM-2, for restoring and strengthening the body's natural immune
system, having a homeopathic potency of 30.times. was prepared from an
original concentrated tincture menstruum containing extracts of the herbs
Panex ginseng, Astragalus membranaceus and Rubia cordifolia, and Snake
venom, extract of thymus gland, and extract of pineal gland in 99+% alcohol.
The original concentrated tincture was diluted to 29.times. potency
(10.sup.-29 times the original concentration) with sterile distilled water.
Sufficient ferrous gluconate solution, a magnetically permeable substance,
was added to sterile isotonic saline to make a homeopathic potency of
4.times.(10.sup.-4). The 29.times. dilution of the medicament was added to
the ferrous gluconate/isotonic saline solution to prepare the final
30.times. medicament. The purpose of the ferrous gluconate/isotonic saline
solution is to enable the final medicament to hold a magnetic charge when it
is passed through a magnetic field. Injectable dosage portions of 0.2 cc
volumes were set aside as needed. The formulations injected were
controllably magnetized during administration through the acupuncture sites
as described above.
Example 10
An injectable dosage form of a homeopathic medicament for the treatment of
hypoglycemia, designated HYG-6, was prepared from an original concentrated
tincture menstruum containing sulfur and vegetable glycerin in 99+% alcohol.
The original concentrated tincture was diluted to 29.times. potency
(10.sup.-29 times the original concentration) with sterile distilled water.
Sufficient ferrous gluccanate solution, a magnetically permeable substance,
was added to sterile isotonic saline to make a homeopathic potency of
4.times.(10.sup.-4). The 29.times. dilution of the medicament was added to
the ferrous gluconate isotonic saline solution to prepare the final
30.times. medicament. The purpose of the ferrous gluconate/isotonic saline
solution is to enable the final medicament to hold a magnetic charge when it
is passed through a magnetic field. Injectable dosage portions of 0.2 cc
volumes were set aside as needed. The formulations injected were
controllably magnetized during administration through the acupuncture sites
as described above.
Example 11
An injectable dosage form of an herb-based homeopathic medicament,
designated INF-16, for the treatment of bacterial infections, particularly
staph and strep, was prepared from an original concentrated tincture
menstruum containing extracts of her herbs Seniccio scandens, Scutellaria
baicalensis, Magnolia officinalis, Lonicera japonica, Andrographis
paniculata, Centella asiatica minor, Leptotaenia multifida and Pupalia
geniculata, and Moschus moschiferous, Cow bezoar, Snake's gall and extract
of pineal gland in 99+% alcohol. The original concentrated tincture was
diluted to 29.times. potency (10.sup.-29 times the original concentration)
with sterile distilled water. Sufficient ferrous gluconate solution, a
magnetically permeable substance, was added to sterile isotonic saline to
make a homeopathic potency of 4.times.(10.sup.-4). The 29.times. dilution of
the medicament was added to the ferrous gluconate/isotonic saline solution
to prepare the final 30.times. medicament. The purpose of the ferrous
gluconate/isotonic saline solution is to enable the final medicament to hold
a magnetic charge when it is passed through a magnetic field. Injectable
dosage portions of 0.2 cc volumes were set aside as needed. The formulations
injected were controllably magnetized during administration through the
acupuncture sites as described above.
Example 12
An injectable dosage from of an herb-based homeopathic medicament,
designated FLU-17, for the treatment of viral infections due to colds and
influenza, particularly rhino-virus, was prepared from an original
concentrated tincture menstruum containing extracts of the herbs Lonicera
confusa, Chrysanthemum indicum, Vitex negundo, Evodia lepta, Ilex asprella,
Baphicacanthus cusia and Centella asiatica minor, and Menthol crystal and
extract of pineal gland in 99+% alcohol. The original concentrated tincture
was diluted to 29.times. potency (10.sup.-29 times the original
concentration) with sterile distilled water. Sufficient ferrous gluconate
solution, a magnetically permeable substance, was added to sterile isotonic
saline to make a homeopathic potency of 4.times.(10.sup.-4). The 29.times.
dilution of the medicament was added to the ferrous gluconate/isotonic
saline solution to prepare the final 30.times. medicament. The purpose of
the ferrous gluconate/isotonic saline solution is to enable the final
medicament to hold a magnetic charge when it is passed through a magnetic
field. Injectable dosage portions of 0.2 cc volumes were set aside as
needed. The formulations injected were controllably magnetized during
administration through the acupuncture sites as described above.
Example 13
An injectable dosage form of an herb-based homeopathic medicament,
designated ALL-5, for the treatment of hayfever and airborne allergies, was
prepared from an original concentrated tincture menstruum containing
extracts of the herbs Gentiana lutea, Citrus aurantium, Tanacetum vulgare,
Cnicus benedictus, Menyanthes trifoliata, Grindelia robusta, Ephedra sinica,
Centipeda minima and Centella asiatica minor, and extract of pineal gland in
99+% alcohol. The original concentrated tincture was diluted to 29.times.
potency (10.sup.-29 times the original concentration) with sterile distilled
water. Sufficient ferrous gluconate solution, a magnetically permeable
substance, was added to sterile isotonic saline to make a homeopathic
potency of 4.times.(10.sup.-4). The 29.times. dilution of the medicament was
added to the ferrous gluconate/isotonic saline solution to prepare the final
30.times. medicament. The purpose of the ferrous gluconate/isotonic saline
solution is to enable the final medicament to hold a magnetic charge when it
is passed through a magnetic field. Injectable dosage portions of 0.2 cc
volumes were set aside as needed. The formulations injected were
controllably magnetized at the time of administration through the
acupuncture sites as described above.
Example 14
An injectable dosage form of an herb-based homeopathic medicament,
designated APN-25, for the treatment of chronic muscular and joint pain,
having a homeopathic potency of 5.times. was prepared from an original
concentrated tincture menstruum containing extracts of the herbs Arnica
Montana, Symphytum officianalis, Pupalia geniculata, Rhus Toxicum, Plantago
asiatica, Causticum (a homeopathic medicament prepared from burnt lime),
Helianthemum canadense, Ornithogalum umbellatum, Clematis crispa, Impatiens
pallida and Prunus Cerasus, and Moschus moschiferous, Cow bezoar, Snake's
gall, Germanium dioxide, and extract of pineal gland in 99+% alcohol. The
original concentrated tincture was diluted to 29.times. potency (10.sup.-29
times the original concentration) with sterile distilled water. Sufficient
ferrous gluconate solution, a magnetically permeable substance, was added to
sterile isotonic saline to make a homeopathic potency of
4.times.(10.sup.-4). The 29.times. dilution of the medicament was added to
the ferrous gluconate/isotonic saline solution to prepare the final
30.times. medicament. The purpose of the ferrous gluconate/isotonic saline
solution is to enable the final medicament to hold a magnetic charge when it
is passed through a magnetic field. Injectable dosage portions of 0.2 cc
volumes were set aside as needed. The formulations injected were
controllably magnetized during administration through the acupuncture sites
as described above.
Example 15
An injectable dosage form of a homeopathic medicament, designated ADR-3, for
the treatment of hypoadrenalism, was prepared from an original concentrated
tincture menstruum containing extract of adrenal gland in 99+% alcohol. The
original concentrated tincture was diluted to 29.times. potency (10.sup.-29
times the original concentration) with sterile distilled water. Sufficient
ferrous gluconate solution, a magnetically permeable substance, was added to
sterile isotonic saline to make a homeopathic potency of
4.times.(10.sup.-4). The 29.times. dilution of the medicament was added to
the ferrous gluconate/isotonic saline solution to prepare the final
30.times. medicament. The purpose of the ferrous gluconate/isotonic saline
solution is to enable the final medicament to hold a magnetic charge when it
is passed through a magnetic field. Injectable dosage portions of 0.2 cc
volumes were set aside as needed. The formulations injected were
controllably magnetized at the time of administration through the
acupuncture sites as described above.
Example 16
An injectable dosage form of a homeopathic medicament, designated CIR-18, to
promote circulation, was prepared from an original concentrated tincture
menstruum containing Germanium dioxide and extract of pineal gland in 99+%
alcohol. The original concentrated tincture was diluted to 29.times. potency
(10.sup.-29 times the original concentration) with sterile distilled water.
Sufficient ferrous gluconate solution, a magnetically permeable substance,
was added to sterile isotonic saline to make a homeopathic potency of
4.times.(10.sup.-4). The 29.times. dilution of the medicament was added to
the ferrous gluconate/isotonic saline solution to prepare the final
30.times. medicament. The purpose of the ferrous gluconate/isotonic saline
solution is to enable the final medicament to hold a magnetic charge when it
is passed through a magnetic field. Injectable dosage portions of 0.2 cc
volumes were set aside as needed. The formulations injected were
controllably magnetized at the site of administration through the
acupuncture sites as described above.
Example 17
An injectable dosage form of an herb-based homeopathic medicament,
designated DTX-28, for the removal of toxicity, was prepared from an
original concentrated tincture menstruum containing extracts of the herbs
Nux vomica, Plantago asiatica, and Carduus marianus, and Germanium dioxide
and extract of pineal gland in 99+% alcohol. The original concentrated
tincture was diluted to 29.times. potency (10.sup.-29 times the original
concentration) with sterile distilled water. Sufficient ferrous gluconate
solution, a magnetically permeable substance, was added to sterile isotonic
saline to make a homeopathic potency of 4.times.(10.sup.-4). The 29.times.
dilution of the medicament was added to the ferrous gluconate/isotonic
saline solution to prepare the final 30.times. medicament. The purpose of
the ferrous gluconate/isotonic saline solution is to enable the final
medicament to hold a magnetic charge when it is passed through a magnetic
field. Injectable dosage portions of 0.2 cc volumes were set aside as
needed. The formulations injected were controllably magnetized during
administration through the acupuncture sites as described above.
Example 18
An injectable dosage form of an herb-based homeopathic medicament,
designated TON-29, for tonification, was prepared from an original
concentrated tincture menstruum containing extracts of the herbs Verbena
hastata, Ephedra sinensis, Turner aphrodisiaca, Sabel serrulata, Hydrocotyle
asiatica, Linosma ovata, Panex ginseng and Echinacea angustifolia, and
extract of pineal gland in 99+% alcohol. The original concentrated tincture
was diluted to 29.times. potency (10.sup.-29 times the original
concentration) with sterile distilled water. Sufficient ferrous gluconate
solution, a magnetically permeable substance, was added to sterile isotonic
saline to make a homeopathic potency of 4.times.(10.sup.-4). The 29.times.
dilution of the medicament was added to the ferrous gluconate/isotonic
saline solution to prepare the final 30.times. medicament. The purpose of
the ferrous gluconate/isotonic saline solution is to enable the final
medicament to hold a magnetic charge when it is passed through a magnetic
field. Injectable dosage portions of 0.2 cc volumes were set aside as
needed. The formulations injected were controllably magnetized during
administration through the acupuncture sites as described above.
Example 19
An injectable dosage form of an herb-based homeopathic medicament,
designated OPT-37, for the treatment of senile macular degeneration, was
prepared from an original concentrated texture menstruum containing extracts
of the herbs Euphrasia officinalis, Pupalia geniculata, Ginkgo biloba,
Vaccinium myrtillus and Hypericum perforiatum, and Moschus moschiferous, Cow
bezoar, Snake's gall and extract of pineal gland in 99+% alcohol. The
original concentrated tincture was diluted to 29.times. potency (10.sup.-29
times the original concentration) with sterile distilled water. Sufficient
ferrous gluconate solution, a magnetically permeable substance, was added to
sterile isotonic saline to make a homeopathic potency of
4.times.(10.sup.-4). The 29.times. dilution of the medicament was added to
the ferrous gluconate/isotonic saline solution to prepare the final
30.times. medicament. The purpose of the ferrous gluconate/isotonic saline
solution is to enable the final medicament to hold a magnetic charge when it
is passed through a magnetic field. Injectable dosage portions of 0.2 cc
volumes were set aside as needed. The formulations injected were
controllably magnetized during administration through the acupuncture sites
as described above.
Example 20
An injectable dosage form of an herb-based homeopathic medicament,
designated LVB-38, for the treatment of liver disfunction, was prepared from
an original concentrated tincture menstruum containing extracts of the herbs
Desmodium stracifolium and Carduus marianus, and extract of pineal gland in
99+% alcohol. The original concentrated tincture was diluted to 29.times.
potency (10.sup.-29 times the original concentration) with sterile distilled
water. Sufficient ferrous gluconate solution, a magnetically permeable
substance, was added to sterile isotonic saline to make a homeopathic
potency of 4.times.(10.sup.-4). The 29.times. dilution of the medicament was
added to the ferrous gluconate/isotonic saline solution to prepare the final
30.times. medicament. The purpose of the ferrous gluconate/isotonic saline
solution is to enable the final medicament to hold a magnetic charge when it
is passed through a magnetic field. Injectable dosage portions of 0.2 cc
volumes were set aside as needed. The formulations injected were
controllably magnetized during administration through the acupuncture sites
as described above.
Example 21
An injectable dosage form of an herb-based homeopathic medicament,
designated TMR-41, for the reduction of tumors, was prepared from the
original concentrated tincture menstruum containing extracts of the herbs
Hypericum japonicum, Prunella vulgaris, Chrysanthemum indicum, Linum
usitatissimum, Ulmus fulva, Nymphaea odorata and Centella asiatica minor,
and extract of pineal gland in 99+% alcohol. The original concentrated
tincture was diluted to 29.times. potency (10.sup.-29 times the original
concentration) with sterile distilled water. Sufficient ferrous gluconate
solution, a magnetically permeable substance, was added to sterile isotonic
saline to make a homeopathic potency of 4.times.(10.sup.-4). The 29.times.
dilution of the medicament was added to the ferrous gluconate/isotonic
saline solution to prepare the final 30.times. medicament. The purpose of
the ferrous gluconate/isotonic saline solution is to enable the final
medicament to hold a magnetic charge when it is passed through a magnetic
field. Injectable dosage portions of 0.2 cc volumes were set aside as
needed. The formulations injected were controllably magnetized during
administration through the acupuncture sites as described above.
Example 22
An injectable dosage form of an herb-based homeopathic medicament,
designated ISC-43, for the treatment of inflammatory conditions and rouleau
cell formation, was prepared from the original concentrated tincture
menstruum containing extracts of the herbs Ilex pubescents, Salvia
multiorrhiza, Andrographis paniculata, Ganoderma japonicum, Pupalia
geniculata and Centella asiatica minor, and Moschus moschiferous, Cow bezoar,
Snake's gall, Germanium dioxide and extract of pineal gland in 99+% alcohol.
The original concentrated tincture was diluted to 29.times. potency
(10.sup.-29 times the original concentration) with sterile distilled water.
Sufficient ferrous gluconate solution, a magnetically permeable substance,
was added to sterile isotonic saline to make a homeopathic potency of
4.times.(10.sup.-4). The 29.times. dilution of the medicament was added to
the ferrous gluconate/isotonic saline solution to prepare the final
30.times. medicament. The purpose of the ferrous gluconate/isotonic saline
solution is to enable the final medicament to hold a magnetic charge when it
is passed through a magnetic field. Injectable dosage portions of 0.2 cc
volumes were set aside as needed. The formulations injected were
controllably magnetized during administration through the acupuncture sites
as described above.
Example 23
An injectable dosage form of an herb-based homeopathic medicament,
designated TBR-44, for the treatment of tuberculosis, was prepared from an
original concentrated tincture menstruum containing extracts of the herbs
Centella asiatica minor and Artemesia apiacea, and Tuberculimum (homeopathic
tincture) and extract of pineal gland in 99+% alcohol. The original
concentrated tincture was diluted to 29.times. potency (10.sup.-29 times the
original concentration) with sterile distilled water. Sufficient ferrous
gluconate solution, a magnetically permeable substance, was added to sterile
isotonic saline to make a homeopathic potency of 4.times.(10.sup.-4). The
29.times. dilution of the medicament was added to the ferrous gluconate/isotonic
saline solution to prepare the final 30.times. medicament. The purpose of
the ferrous gluconate/isotonic saline solution is to enable the final
medicament to hold a magnetic charge when it is passed through a magnetic
field. Injectable dosage portions of 0.2 cc volumes were set aside as
needed. The formulations injected were controllably magnetized during
administration through the acupuncture sites as described above.
B. Oral Form
Example 24
An oral dosage form of the herb-based homeopathic medicament FNG-11, having
the components as in Example 1 above, having a homeopathic potency of
30.times., was prepared in accordance with the procedure described above in
connection with impregnating the lollipop illustrated in FIG. 1. Similarly,
a transdermal dosage form was prepared also as described above.
Example 25
An oral or transdermal dosage form of the herb-based homeopathic medicament
HG-9, having the components as in Example 2, having a homeopathic potency of
30.times., was prepared according to the method of Example 24.
Example 26
An oral or transdermal dosage form of the herb-based homeopathic medicament
VR-27, having the components as in Example 3, having a homeopathic potency
of 30.times., was prepared according to the method of Example 24.
Example 27
An oral or transdermal dosage form of the herb-based homeopathic medicament
SPN-7, having the components as in Example 4, having a homeopathic potency
of 30.times., was prepared according to the method of Example 24.
Example 28
An oral or transdermal dosage form of the homeopathic medicament TYR-10,
having the components as in Example 5, having a homeopathic potency of
30.times., was prepared according to the method of Example 24.
Example 29
An oral or transdermal dosage form of the herb-based homeopathic medicament
HRM-4, having the components as in Example 6, having a homeopathic potency
of 30.times., was prepared according to the method of Example 24.
Example 30
An oral or transdermal dosage form of the homeopathic medicament HYT-12,
having the components as in Example 7, having a homeopathic potency of
30.times., was prepared according to the method of Example 24.
Example 31
An oral or transdermal dosage form of the herb-based homeopathic medicament
RLX-22, having the components as in Example 8, having a homeopathic potency
of 30.times., was prepared according to the method of Example 24.
Example 32
An oral or transdermal dosage form of the herb-based homeopathic medicament
IMM-2, having the components as in Example 9, having a homeopathic potency
of 30.times., was prepared according to the method of Example 24.
Example 33
An oral or transdermal dosage form of the homeopathic medicament HYG-6,
having the components as in Example 10, having a homeopathic potency of
30.times., was prepared according to the method of Example 24.
Example 34
An oral or transdermal dosage form of the herb-based homeopathic medicament
INF-16, having the components as in Example 11, having a homeopathic potency
of 30.times., was prepared according to the method of Example 24.
Example 35
An oral or transdermal dosage form of the herb-based homeopathic medicament
FLU-17, having the components as in Example 12, having a homeopathic potency
of 30.times., was prepared according to the method of Example 24.
Example 36
An oral or transdermal dosage form of the herb-based homeopathic medicament
ALL-5, having the components as in Example 13, having a homeopathic potency
of 30.times., was prepared according to the method of Example 24.
Example 37
An oral or transdermal dosage form of the herb-based homeopathic medicament
APN-25, having the components as in Example 14, having a homeopathic potency
of 30.times., was prepared according to the method of Example 24.
Similarly, oral or transdermal dosage forms of the homeopathic medicaments
as in Examples 15-23, having homeopathic potency of 30.times., were prepared
according to the method of Example 24.
CLINICAL EXAMPLES
AIDS Study Protocol
This study program ran for about 60 weeks comprising the therapeutic phase.
Many patients continued on and participated in the maintenance/prophylaxis
aspect for a total participation of approximately 21/2 years.
Example 38
The treatment regimen in this example utilized a series of specifically
prepared homeopathic medicaments formulated from totally natural botanicals,
minerals and other natural substances, and compounded into highly dilute
(30.times.) homeopathic preparations. Each material was used in triad form:
an injectable, an oral and a transdermal patch.
The list of these special medicaments together with the condition treated is
as follows:
______________________________________
IMM-2 immunity boost
ADR-3 adrenal insufficiency
HG-9 intestinal parasites
TYR-10 thyroid regulation
FNG-11 Candida albicans/other systemic fungus
infections
INF-16 bacterial infection
FLU-17 common cold, flu
CIR-18 circulatory problems
RLX-22 tension and nervousness
APN-25 pain in muscles, tendons, ligaments
VR-27 viral infections
DTX-28 detoxification
TON-29 general tonic
OPT-37 optical problems (Guillain-Barre Syndrome)
LVB-38 liver boost
TMR-41 internal tumors
ISC-43 red cell "clumping"
TBR-44 tuberculosis
______________________________________
COMPONENTS OF TREATMENT
Injection
Homeopathic medicaments were injected into the body at specific acupuncture
points. A 0.2 cc quantity was introduced into each bilateral point with a 30
ga 1/2" needle. For example, the bi-lateral acupuncture point used in
conjunction with VR-27, the anti-viral, is identified on traditional Chinese
charts as TW-5. Other points used with different Homeopathic medicaments for
treating peripheral conditions (as noted below) were ST-36,37; SP-6,9;
LI-11; GB-34, etc. These points are all categorized in Traditional Chinese
Medicine as Command Points and are regarded as being especially effective.
Further, they were selected on the basis of previous trial and error
applications to determine which would be most effective for each specific
malady. Generally, only one pair of points was used to treat each disease
entity. All of the injection sites are located distally to the knee and
elbow. As a result, they were easily located through the use of anatomical
landmarks and present little risk of injury to the patient.
Oral Medication
In addition to being given a series of injections, each patient received
oral (lollipop) homeopathic medication. The therapeutic component consisted
of the same botanical herbs that comprised the injectable medication. This
medication format was also in the highly dilute form traditionally
characteristic of all homeopathic medicaments.
Topical Application
The third treatment modality was a transdermal patch that was taped to the
skin directly over the appropriate acupuncture points. The patches contained
the same formulations in the same highly dilute form as noted above,
compounded into a preparation suitable for this type of application.
Thus, the complete therapeutic modality utilized the interlocking action of homeopathy,
acupuncture, magnetism and herbalism all of which share a long history of
providing effective healing for a wide variety of disease entities. In
application, the homeopathic remedies used within this study were introduced
into the body by injection via the acupuncture points while their action was
reinforced by the parallel use of the same homeopathic medication in oral
form and as a transdermal application.
Stimulation
In each of the three forms, the medications delivered to the body were
magnetically stimulated at the time of introduction. Like the medicaments
themselves, the stimulation was at a homeopathic level.
Treatment of Peripheral Disease Problems
Although this study focused upon the viral component of use of VR-27 as a
therapeutic agent, AIDS cannot be considered to be a single disease entity.
Usually patients present with a variety of subsidiary symptoms closely
associated with the primary viral infection. Commonly seen are such other
viral diseases as herpes, CEBV, CMV and hepatitis. Bacterial infections
include staphylococcus, streptococcus and chlamydia. Fungal infections
include Candida albicans in various manifestations. Parasitical infections
include Entamoeba histolytica and Giardia lamblia. Pneumocyctis carinii and
Syphilis may also be present.
Therefore, although outside the scope of the primary investigation, this
test program also employed a parallel series of homeopathic/acupuncture
treatments for these associated medical conditions where they existed. The
following homeopathic formulations were used for treating the above noted
medical conditions:
______________________________________
FNG-11 (for treatment of fungal infections)
INF-16 (for treatment of bacterial infections)
HG-9 (for treatment of intestinal parasites)
DTX-26 (for detoxifying)
IMM-2 (for encouraging the rebuilding of the immune
system)
______________________________________
In addition, other medicaments selected from the other homeopathic
medicaments described were used where such applications were indicated.
CRITERIA FOR PATIENT INCLUSION AND EXCLUSION
Inclusion
As primary criteria, the first screening was in accordance with the criteria
developed by the Walter Reed Army Hospital to ascertain the presence of
AIDS.
As a prime criteria, the patients had to be HIV positive with a Western Blot
confirmation.
Further screening was on the basis of:
A. Abnormal number of T-4 lymphocytes and abnormal ratio of T-4 to T-8
lymphocytes under 0.6.
B. Age 18 to 60
C. Ability to provide informed consent
D. Ability to keep all appointments
The final group selected included a total of 28 patients. There was a second
evaluation procedure for the participants to identify the presence of other
medical conditions.
Exclusion
The following categories of patients were excluded from the study:
1. Patients on a treatment regimen that utilized highly potent, toxic or
immuno-suppressive drugs such as AZT.
2. Patients receiving medications or supplements of such potency or in
sufficient dosage as to interfere with the activity of the homeopathic
medications.
3. Patients who were already being treated for life threatening diseases of
such severity that, in the opinion of the Administering Physician, they were
terminal.
TREATMENT SCHEDULE FOR PATIENTS IN THE STUDY
For the first 52 weeks, the patients were treated twice a week. During this
period, two medicaments were generally administered at each visit, with
DTX-28 forming a constant along with the regularly scheduled medications.
During this period, treatment was semi-customed to address each patient's
most pressing medical needs with medicines selected from the following
materials:
Anti-Pathogens
VR-27
INF-16
HG-9
FNG-11
According to the patient's pattern of response, the treatment was gradually
broadened to include:
Adjunct Medication
IMM-2
ADR-3
TYR-10
After the first 60 weeks, the treatment schedule was modified to once a
week. As patients began to show favorable response, Anti-Pathogens were only
used on alternate visits with maintenance and prophylaxis medications
filling in the blanks in the schedule.
During this phase, when the need for direct therapeutic action was not as
intense, some additional medications to deal with specific problems were
also used. For example, when there was concern about a possible epidemic of
Influenza, all patients were given two treatments with FLU-17. One patient
was given OPT-37 to deal with his Guillain-Barre Syndrome.
Maintenance Medication
CIR-18
TON-29
RLX-22
ISC-43
TESTS USED WITHIN THE STUDY FOR PATIENTS ACCEPTED AFTER SCREENING
Each patient received a series of weekly, biweekly and monthly lab tests to
provide the tightest possible monitoring of incremental results.
Intake and End-Of-Study Tests
Clinical work-up: Karnofsky score
Laboratory Procedures:
P-24 antigen
Total T-cells+T4/T8 ratio, absolute B-cells
Beta-2-Microblobulin
Neopterin
Circulating Immune Complex, C1Q & C3B
Antibody titers: (IGG & IGM)
Herpes I & II
CMV
EB-VCA
EBV-EA
Hepatitis B diagnostic panel
HIV (quantitative antibody)
CEIA (Candida antibody)
LA-Candida (Candida antigen)
Complete blood count, differential, platelets, hemoglobin and hematocrit
Sedimentation rate
Urethral smear (male) and vaginal smear (female) for Chlamydia
Rectal swab for parasites
Cryptosporidium (stool sample if diarrhea is present)
Candida quantitative culture (mouth lavage)
Gonorrhea culture (urethral or vaginal)
Syphilis serology--RPR, FTA confirmation quantitative
Chem 25 with liver battery
B12-folic acid-iron assays (if hemoglobin below 10 GM/DL) with reticulocyte
count
Urinalysis
Multi-skin tests for DTHS-CMI Multi-Test
Weekly Testing
HIV Antigen (when initially positive)
Antibody titers--(IGG)
Herpes I & II
CMV
EB-VCA
EBV EA
Hepatitis B (to follow chronic carriers)
HIV (quantitative antibody)
CEIA (Candida antibody)
FTA (quantitative)
Chem 25 (with liver battery)
Complete blood count, differential, platelets, hemoglobin, and hematocrit
(if hemoglobin drops below 10 GM/DL, do anemia profile)
Sedimentation rate
Urinalysis
Interval Testing
Candida quantitative culture (mouth lavage)
Total T-cells+T4/T8 ratio, absolute B-cells
Beta 2-Microblobulin
Multi-skin tests for DTHS-CMI Multi-Test
Neopterin
Rectal swab (for intestinal parasites)
TESTING AND RESULTS
I. Analysis of DTHS--Delayed Type Hypersensitivity Skin Tests
As noted in the Merck Manual (fifteenth edition), the T-cell-mediated
portion of the immune system, which is responsible for delayed skin tests
and delayed hypersensitivity, is an important defense against malignant
cells, viral infections, fungal infections and some bacteria.
Delayed Hypersensitivity Skin Tests are valuable screening tests for T-cell
deficiency. The presence of one or more positive delayed skin tests
generally indicates an intact T-cell system.
Many HIV studies regard this measurement as one of the most commonly
monitored parameters of immune functioning.
The favorable direction of the following statistics is in direct contrast
with the usual expectations.
Abstract
Twenty-seven HIV-positive patients enrolled in the study were assessed on
the number and total size of positive reactions to skin test antigens for
cellular hypersensitivity at five points in time. Results indicated
improvement over time with respect to both the number and total size of
positive skin test reactions.
Results and Discussion
Tables 1 and 2 give the mean number of reactions, and the mean size of the
reactions at each time. Trace reactions refer to values of 0.50 mm. The
complete data are provided in Table 3.
TABLE 1
__________________________________________________________________________
MEAN NUMBER OF POSITIVE SKIN REACTIONS
PATIENTS
PATIENTS IN
WITH-
TREATMENT DRAWING
THROUGH BEFORE
ALL FEBRUARY FEBRUARY
PATIENTS
1991 1991
MEAN N MEAN N MEAN N
__________________________________________________________________________
INTAKE 0.26 27
0.36 11
0.19 16
JAN/FEB 1989
0.86 22
0.57 7
1.00 15
AUGUST 1989
2.29 14
2.30 10
2.25 4
FEBRUARY 1990
4.00 12
3.88 8
4.25 4
FEBRUARY 1991
4.55 11
4.55 11
-- --
__________________________________________________________________________
TABLE 2
__________________________________________________________________________
MEAN TOTAL SIZE OF ALL POSITIVE REACTIONS
PATIENTS
PATIENTS IN
WITH-
TREATMENT DRAWING
THROUGH BEFORE
ALL FEBRUARY FEBRUARY
PATIENTS
1991 1991
MEAN N MEAN N MEAN N
__________________________________________________________________________
INTAKE 0.63 27
1.00 11
0.38 16
JAN/FEB 1989
0.95 22
0.29 7
1.27 15
AUGUST 1989
5.49 14
6.17 10
3.80 4
FEBRUARY 1990
13.13 12
12.88 8
13.63 4
FEBRUARY 1991
10.70 11
10.70 11
-- --
__________________________________________________________________________
NOTE: The two patients with intake at February 1989 are included only in
the intake entries (not in the January/February 1990 entries).
TABLE 3
__________________________________________________________________________
DELAYED HYPERSENSITIVITY SKIN TEST (CMI MULTI SKIN TEST) DATA
INTAKE JAN/FEB-89
PATIENT
NOV/DEC-88
10 WEEKS AFTER
# OR AS NOTED
INTAKE TEST
AUG-89 FEB-90
FEB 91
__________________________________________________________________________
1 0/0 2/2T drop-out
2/6 + 1T
2 0/0 3/2.5 + 2T 3/2.7 + 2T
5/20.5
3 0/0 0/0 drop-out
3/12.5
4 2/2T (6.89) 1/1T 4/14.5
5/12.5
5 0/0 2/2T drop-out
6 0/0 0/0 2/1.5 + 1T
4/15.5
4/8
7 1/5 (2/89) 2/9.5 4/16
9 1/1T (2/89) 1/1T 4/10.5
10 0/0 0/0 drop-out
11 0/0 1/1T drop-out
12 0/0 2/2T 2/8 4/13.5
4/12 + 1T
13 1/5 (6/89) 3/12 4/15 6/19.75
14 0/0 (6/89) 4/12 5/14.5
4/2 + 3T
15 0/0 0/0 1/1 absent
2/7 + 1T
16 0/0 0/0 drop-out
17 0/0 0/0 drop-out
18 0/0 0/0 died-(Ap-89)
19 0/0 2/2T drop-out
2/10
20 0/0 0/0 4/9.9 4/10 + 1T
21 0/0 1/1T 3/5.75 + 1T
2/6 3/2.5 + 2T
23 0/0 1/1T 3/3T 4/10
24 0/0 1/1T absent 4/13.5
6/9 + 3T
25 0/0 0/0 drop-out
26 2/5 2/10.5 2/9.5 4/13.5
27 0/0 2/2T drop-out
28 0/0 0/0 drop-out
29 0/0 0/0 1/1T 4/10.5
7/12.5 + 2T
__________________________________________________________________________
NOTE: Patient #8 was an HIV negative partner of participating patient. No
skin tests were done on #8. Patient #22 did not complete initial 12 week
phase of treatment. Patient #22 had only one skin test with 0/0 response.
Absent means that patient was not in attendance at clinic on the day
scheduled for group skin tests.
Numbers to the left of the slash are the number of positive reactions.
Numbers to the right of the slash are the total sizes of all positive
reactions.
A "T" indicates that the size of the reaction is a trace.
There is clearly an increase in the number of positive skin reactions over
the course of the study. Not surprisingly, since the overwhelming majority
of patients had no reactions at intake, there was also an increase in the
total size of all of the positive reactions (p<0.01).
Summary
The following measurements were assessed on the twenty seven HIV-positive
patients enrolled in the study:
1. The number of positive reactions to DTHS skin test antigens for cellular
hypersensitivity at five points in time.
2. The total size of positive reactions to DTHS skin test antigens for
cellular hypersensitivity at five points in time.
The results indicate significant improvement over the course of the study as
indicated by increases in both the number of positive reactions to skin
tests and the total size of those positive reactions.
II. Analysis of Karnofsky Performance Sales
Abstract
Twenty seven HIV-positive patients enrolled in the study were assessed on
the Karnofsky Performance Scale at three points in time. Results indicate
improvement over time with respect to percentage on this clinical
classification system. A sample Karnofsky Performance scale is as follows:
______________________________________
SAMPLE KARNOFSKY PERFORMANCE SCALE
______________________________________
Able to carry on normal
100% Normal, no complaints, no
activity; no special evidence of disease.
care is needed.
90% Able to carry on normal
activity; minor signs of
disease.
80% Normal activity with effort;
some signs or
symptoms of disease
Unable to work; able to
70% Cares for self; unable to
live at home and care carry on normal activity or
for most personal needs;
to do active work.
a varying amount of
assistance is needed.
60% Requires occasional
assistance but is able to
care for most of his needs.
50% Requires considerable
assistance and frequent
medical care.
Unable to care for self;
40% Disabled; requires special
requires equivalent of care and assistance.
institutional or
hospital care; disease
may be progressing
rapidly.
30% Severely disabled;
hospitalization is indicated
although death not imminent.
20% Very sick; hospitalization
necessary; active supportive
treatment is necessary.
10% Moribund; fatal processes
progressing rapidly.
0% Dead.
______________________________________
Results and Discussion
Significant improvement as measured by the Karnofsky score was noted between
intake and March, 1991, for the eleven patients who had completed the
Therapeutic phase of the treatment and were continuing on the
Maintenance/Prophylaxis phases (p=0.0077). All eleven patients had Karnofsky
scores of 100% in March, 1991, (see Tables 4-6). Further examination of the
data indicated that these eleven patients exhibited significant improvement
as early as February/March, 1990, when ten of the eleven had already
achieved Karnofsky scores of 100%, and one patient had a score of 95%.
There was clear evidence of improvement in the eleven patients who continued
in the study through March, 1991. All eleven patients achieved Karnofsky
scores of 100% (ten reached this level as early as February/March, 1990, the
one patient not at 100% at this time was at 95%). The four patients who
completed the Therapeutic phase but did not continue with the full
Maintenance/Prophylaxis phase had achieved scores of 100% by February/March,
1990. These four, as well as the twelve patients who withdrew between April
and June, 1989, had comparable values at intake.
TABLE 4
__________________________________________________________________________
KARNOFSKY SCORE DATA
INTAKE
PATIENT
NOV/DEC 1988
# OR AS NOTED
FEBRUARY/MARCH 1990
MARCH 1991
__________________________________________________________________________
1 90% drop-out
2 90% 100% no maintenance
3 90% 50% drop-out
returned for
follow-up
4 100% (6/90)
100% 100%
5 80% drop-out
6 80% 100% 100%
7 100% (2/89)
100% 100%
9 80% (2/89)
100% some
maintenance
10 90% drop-out
11 90% drop-out
12 85% 100% 100%
13 80% (6/89)
100% 100%
14 90% (6/89)
100% 100%
15 90% 100% 100%
16 80% drop-out
17 90% drop-out
18 80% died - (Ap-89)
19 80% 100% drop-out
returned for
follow-up
20 90% 100% 100%
21 80% 100% 100%
23 90% 100% no maintenance
24 90% 100% 100%
25 80% 60% drop-out
returned for
follow-up
26 80% 100% no maintenance
27 80% drop-out
28 90% drop-out
29 70% 90-100% 100%
__________________________________________________________________________
NOTE: Patient #8 was an HIV negative partner of participating patient.
Patient #22 did not complete initial 12 week phase of treatment.
TABLE 5
__________________________________________________________________________
FREQUENCIES OF KARNOFSKY SCORES
ALL AVAILABLE DATA
KARNOFSKY SCORE
INTAKE FEB/MARCH 1990
MARCH 1991
__________________________________________________________________________
50% 0 1* (5.6%)
0
60% 0 1* (5.6%)
0
70% 1 (3.7%)
0 0
80% 11 (40.7%)
0 0
85% 1 (3.7%)
0 0
90% 12 (44.4%)
0 0
95% 0 1 (5.6%) 0
100% 2 (7.4%)
15* (83.3%)
11 (100%)
__________________________________________________________________________
*Three patients are included in Feb/March 1990 who had withdrawn from the
study prior to this date. These are their scores (50%, 60%, 100%) when
they returned for followup.
TABLE 6
__________________________________________________________________________
FREQUENCIES OF KARNOFSKY SCORES FOR THE ELEVEN
PATIENTS WHO COMPLETED THERAPEUTIC PLUS
MAINTENANCE/PROPHYLAXIS TREATMENT
KARNOFSKY SCORE
INTAKE FEB/MARCH 1990
MARCH 1991
__________________________________________________________________________
70% 1 (9%) 0 0
80% 3 (27%)
0 0
85% 1 (9%) 0 0
90% 4 (36%)
0 0
95% 0 1 (9%) 0
100% 2 (18%)
10 (91%) 11 (100%)
__________________________________________________________________________
Summary
Karnofsky Performance Scores were measured at three points in time. Patients
who completed twelve months of the study reached the score of 100% by
February, 1990. Those patients who continued with the
Maintenance/Prophylaxis treatment maintained their score of 100% through
February, 1991 (the last measurement point).
Those patients who completed the Therapeutic portion of the study scored
between 95% and 100% on the Karnofsky Performance Scales. This is in
contrast to the usual pattern that shows an unremitting decline with the
passage of time.
III. Analysis of Body Weight and Oral Temperature Variability
These two basic Vital Signs were recorded weekly for all patients in the
study. Although simple and easy to take, these criteria are strong
indicators of patient stability or decline.
HIV positive patients are particularly vulnerable to various wasting
diseases as they progress through the stages of AIDS. It was interesting to
note that none of the patients exhibited wasting during any phase of this
treatment.
In HIV patients, oral temperatures tend to be either excessively high or
excessively low (as a result of active bacterial, viral fungal or other
infection). Frequently, the active HIV patient exhibits a sub-normal
temperature (approximately 97.degree. F.) reflecting chronic, low grade
viral infection. In almost all of the patients in this study, temperatures
assumed normal profiles compared to intake values, and remained remarkably
stable for the duration of each patient's treatment.
Abstract
Twenty seven HIV-positive patients enrolled in the study were monitored
weekly for total body weight and oral temperature. Records indicate that no
wasting syndrome was evident at any point in time for any patient.
Temperatures were basically stable from week to week, with a greater
proportion of temperature readings in the normal range as the study
progressed.
Results and Discussion
The temperatures recorded for the patients as a whole are displayed in Table
7.
As shown in Table 7, the percentage of all readings which fell into the
normal range increased steadily over the course of the study. At intake,
29.63% of the patients had normal temperatures. Between Weeks 1-12, the
percentage rose to 50.18%. Weeks 13-24 show 61.40%, and Weeks 25-36 show
60.95%. After Week 37, the number of normal temperature readings shows
another sizeable increase to 79.48%.
It should be pointed out that no wasting syndrome was experienced by any of
the patients in the Study. In fact, records showed that 10 patients out of
27 (37.03%) actually gained weight during their participation in the
Project.
TABLE 7
__________________________________________________________________________
FREQUENCIES OF TEMPERATURE READINGS
TEMPERATURE
INTAKE
WEEKS 1-12
WEEKS 13-24
WEEKS 25-36
WEEKS 37+
__________________________________________________________________________
>100 1 3 3 0 1
(VERY HIGH)
(3.70%)
(1.10%)
(1.10%) (0.00%) (0.85%)
99.1-100 1 13 13 4 2
(HIGH) (3.70%)
(4.76%)
(4.76%) (3.81%) (2.71%)
98.2-99.0 8 137 167 64 93
(NORMAL) (29.63%)
(50.18%)
(61.40%)
(60.95%)
(79.48%)
97.0-98.1 17 119 89 37 21
(LOW) (62.96%)
(43.59%)
(32.72%)
(35.24%)
(17.95%)
<97.0 0 1* 0 0 0
(VERY LOW)
(0.00%)
(0.37%)
(0.00%) (0.00%) (0.00%)
__________________________________________________________________________
*The one reading of "VERY LOW" represents a patient whose temperature was
recorded as 94.8. It seems likely that this is a data entry error.
However, it has been included in the table.
Summary
Both weights and temperatures were stable from week to week. The proportion
of recorded temperatures in the normal range gradually became higher as the
study progressed. Conversely, the proportion of chronically low temperatures
decreased.
IV. Statistical Analysis Of Symptom Data Generated By Patients Who Completed
Treatment And Maintenance Phases Of The Study
Abstract
Twenty-seven HIV-positive patients enrolled in the study were evaluated for
the presence or absence of a series of forty symptoms presented from intake
to two later points in time. Six scales were constructed as subsets of the
original forty symptoms examined plus a TOTAL compilation. While borderline
improvement was noted for one of the scales, significant improvement was
evident for the other five scales. The TOTAL category (evaluation of overall
number of symptoms present) also showed marked and progressive improvement.
The attached Tables 8 and 9 list the individual symptoms that have been
grouped as follows:
Group 5 (symptoms most related to HIV disease progression)
Group 3 (symptoms moderately related to HIV disease progression)
Group 1 (symptoms mildly related to HIV disease progression)
The additional scales were:
FUNGAL (symptoms due to fungal infection)
QUALITY (daily quality of life)
WELL BEING (sense of well being)
TOTAL (all symptoms)
Results and Discussion
The results indicate that patients improved from intake to November, 1990.
The mean number of symptoms per patient was reduced from 8.08 at intake to
1.73 in November (a decrease of 79%). This decrease was consistent across
all of the scales. Group 5 symptoms decreased 87%, Group 3 symptoms
decreased 67%, Group 1 symptoms decreased 87%, FUNGAL symptoms decreased
85%, WELL BEING symptoms decreased 85% and QUALITY symptoms decreased 76%.
(See Table 10).
Summary
Data consisting of the presence or absence of a series of forty symptoms
were collected on twelve patients infected with HIV at three points in time.
The results indicate clear improvement from intake to November, 1990, as
measured by the number of symptoms present. With the exception of one scale,
"Sense of Well Being" in which improvement was only borderline,
the other five scales all provide evidence indicative of significant
improvement.
TABLE 8
__________________________________________________________________________
TOTAL NUMBER OF SYMPTOMS AND
MEAN NUMBER OF SYMPTOMS PER PATIENT*
INTAKE MAY NOVEMBER
(NOV-DEC 1988)
1990 1990
__________________________________________________________________________
TOTAL # OF SYMPTOMS
97 (8.08) 47 (3.92)
19 (1.73)
GROUP 5 SYMPTOMS 34 (2.83) 10 (0.83)
4 (0.36)
(SYMPTOMS MOST RELATED
TO HIV PROGRESSION)
BURNING MOUTH (THRUSH)
1 1 0
SHORTNESS OF BREATH
3 0 0
DIARRHEA 2 0 0
LACK OF APPETITE 1 0 0
BONE/MUSCLE ACHE 5 2 1
NIGHT SWEATS 0 2 0
ARTHRITIS-LIKE ACHES
1 0 0
TROUBLE BREATHING 1 0 0
FATIGUE 7 2 1
ATHLETE'S FOOT 4 1 1
JOCK ITCH 2 0 0
FINGER/TOE NAIL FUNGUS
3 2 1
LACK OF SEXUAL DESIRE
2 0 0
BURN/ITCH/GROIN/SCROTUM
1 0 0
VAGINAL ITCH 1 0 0
VAGINAL BURNING 0 0 0
VAGINAL SORENESS 0 0 0
GROUP 3 SYMPTOMS 39 (3.25) 24 (2.00)
12 (1.08)
(SYMPTOMS MODERATELY
RELATED TO HIV
PROGRESSION)
HEADACHE 4 2 1
COUGH 3 0 0
CLOUDY EYESIGHT 3 2 1
SORE THROAT 1 0 0
BLEEDING GUMS 3 2 1
HAIR LOSS 1 0 0
EYE FOCUS PROBLEMS
5 1 0
TROUBLE SLEEPING 3 2 1
BUMPS THAT ITCH 3 2 0
SWOLLEN GLANDS 5 5 5
UNFRESHED SLEEP 5 5 3
DEPRESSION 3 3 0
__________________________________________________________________________
*Means appear in parentheses
TABLE 9
__________________________________________________________________________
TOTAL NUMBER OF SYMPTOMS AND
MEAN NUMBER OF SYMPTOMS PER PATIENT*
INTAKE MAY NOVEMBER
(NOV-DEC 1988)
1990 1990
__________________________________________________________________________
GROUP 1 SYMPTOMS 24 (2.00) 13 (1.08)
3 (0.27)
SYMPTOMS MILDLY RELATED
TO HIV PROGRESSION)
SINUS TROUBLE 1 2 1
COLDS 2 0 0
SORE GUMS 1 2 0
COLD HANDS/FEET 3 1 0
TINGLING SKIN 1 0 0
LOSS OF CONCENTRATION
3 2 0
MOOD CHANGES 5 2 1
ANXIOUSNESS 4 4 1
VAGINAL INFECTION 1 0 0
VAGINAL DISCHARGE 2 0 0
IRREGULAR PERIODS 1 0 0
FUNGAL SYMPTOMS 14 (1.17) 4 (0.33)
2 (0.18)
BURNING MOUTH (THRUSH)
ATHLETE'S FOOT
JOCK ITCH
FINGER/TOE NAIL FUNGUS
BURN/ITCH/GROIN/SCROTUM
VAGINAL ITCH
VAGINAL BURNING
VAGINAL SORENESS
VAGINAL DISCHARGE
SENSE OF WELL BEING
14 (1.17) 8 (0.67)
2 (0.18)
SYMPTOMS
LACK OF SEXUAL DESIRE
LOSS OF CONCENTRATION
MOOD CHANGES
ANXIOUSNESS
QUALITY OF LIFE SYMPTOMS
27 (2.25) 16 (1.33)
6 (0.55)
HEADACHE
SHORTNESS OF BREATH
DIARRHEA
TROUBLE SLEEPING
NIGHT SWEATS
FATIGUE
UNFRESHED SLEEP
DEPRESSION
__________________________________________________________________________
*Means appear in parenthesis
TABLE 10
__________________________________________________________________________
PERCENTAGE DECREASE IN THE NUMBER OF SYMPTOMS PRESENT
INTAKE TO
MAY 1990 TO
INTAKE TO
MAY 1990
NOVEMBER 1990
NOVEMBER 1990
(18 MONTHS)
(6 MONTHS)
(24 MONTHS)
__________________________________________________________________________
TOTAL # OF SYMPTOMS
50% decrease
56% decrease
79% decrease
GROUP 5 71% decrease
57% decrease
87% decrease
(SYMPTOMS MOST
RELATED TO HIV
PROGRESSION)
GROUP 3 38% decrease
46% decrease
67% decrease
(SYMPTOMS
MODERATELY
RELATED TO HIV
PROGRESSION)
GROUP 1 46% decrease
75% decrease
87% decrease
(SYMPTOMS MILDLY
RELATED TO HIV
PROGRESSION)
FUNGAL SYMPTOMS
71% decrease
45% decrease
85% decrease
SENSE OF WELL BEING
43% decrease
73% decrease
85% decrease
SYMPTOMS
QUALITY OF LIFE
41% decrease
62% decrease
76% decrease
SYMPTOMS
__________________________________________________________________________
*Intake was from November to December 1988
V. Statistical Analysis of Drug Related Toxicity As Indicated by SGOT and
SGPT
These two basic laboratory markers (SGOT and SGPT) function as widely
accepted indicators of liver function in relation to drug toxicity. However,
several factors should be noted in conjunction with these measurements.
As expressed in Clinical Interpretation of Laboratory Tests (Ninth Edition)
Frances K. Widmann, M.D., a medical textbook on the diagnostic use of
laboratory procedures noted:
"The two enzymes most often associated with hepatocellular damage are
aminotransferases that catalyze the reversible transfer to an amino group
between an amino acid and an alpha-keto acid. The enzymes are called
glutamic-oxaloacetic transaminase (GOT) and glutamic-pyruvic transaminase (GPT)."
"Because the liver has such substantial reserve capacity,
hepatocellular loss must be far advanced before it becomes clinically
apparent. It is possible to detect ongoing hepatocellular damage by
measuring functional indices and by observing in the circulation the
products of damaged or necrotic hepatocytes. Enzyme tests are often the only
indications of early or localized liver disease."
When measured with the serum, these tests are often called SGOT and SGPT.
In the HIV-positive patient population, these two values may be elevated
when baseline bloodwork is performed. This elevation can be caused by
hepatitis (either chronic or acute), acute viral infections (such as
Hepatitis B or EBV), cirrhosis of the liver or previous use of recreational
drugs (such as heroin). In spite of these potential complications, SGOT and
SGPT can be used to evaluate toxicity of any drug being administered.
When a patient's baseline values are within a normal range, a dangerous
toxic reaction would be indicated by readings of four-times the maximum
normal range. If a patient presents with elevated liver enzymes, judgment
concerning toxicity must be based on evaluation of two factors: how high the
actual elevation is and also how quickly it becomes evident.
Only one patient showed a pattern unlike the others. He experienced a
sudden, acute elevation of these blood markers during the last three
recorded weeks of treatment. It is reported that, when questioned by the
Head Nurse, he admitted that he had begun an additional treatment modality.
By mutual agreement, he terminated his participation in this study.
All other patients in this study showed no evidence of toxicity induced by
the medicaments used for treatment. In fact, blood tests showed that many
patients who entered the study with considerable elevation in both SGOT and
SGPT demonstrated significant decrease from the original high levels. Those
who entered with relatively normal values either further decreased or
remained at the same level. It is notable that no treatment related toxicity
developed in any patient during the entire period of the study.
Abstract
Levels of two liver enzymes, SGOT and SGPT, were measured weekly for up to
sixty weeks on the patients enrolled in the study to assess drug related
toxicity. These tests indicated that levels of both SGOT and SGPT remained
stable over the course of treatment. The percentage of observations that
fell within normal ranges for both SGOT and SGPT also remained stable over
time.
Results and Discussion
Table 11 lists the median levels of SGOT and SGPT of all measurements on
each patient at intake and then at four more time intervals:
A. Week 1 to Week 12
B. Week 13 to Week 24
C. Week 25 to Week 36
D. Week 37 to the final measurement
The number and percentage of times these measures were in the normal range
and above the normal range are listed in Table 12.
The percentage of normal measures is seen to be quite stable over time. As
with the medians, the percentage of times that measures were in the normal
range appears to improve substantially after 36 weeks. For median SGPT
levels, the largest improvement occurred after 24 weeks. However, the later
time intervals include proportionately more of the patients who had remained
in treatment then do the earlier intervals.
Summary
The available data on these patients indicates that drug related toxicity
did not increase over time. Further, medians of all observations and the
percentage of observations in normal ranges remained stable over the course
of the study. It can be stated that the medicaments administered to the
patients did not cause any drug related toxicity.
TABLE 11
__________________________________________________________________________
MEDIANS OF SGOT AND SGPT USING ALL AVAILABLE DATA
TREATMENT
TREATMENT
TREATMENT
TREATMENT
INTAKE WEEKS 1-12
WEEKS 13-24
WEEKS 25-36
WEEKS 37+
__________________________________________________________________________
SGOT
MEDIAN
36.00 37.50 37.50 37.00 34.00
SGPT
MEDIAN
33.00 38.50 34.00 28.00 27.50
NUMBER
27 274 264 117 104
OF TESTS
__________________________________________________________________________
TABLE 12
__________________________________________________________________________
COMPARISON OF NUMBER AND PERCENT OF SGOT AND SGPT TEST
RESULTS WITHIN NORMAL RANGE AND ABOVE NORMAL RANGE
TREATMENT
TREATMENT
TREATMENT
TREATMENT
INTAKE
WEEKS 1-12
WEEKS 13-24
WEEKS 25-36
WEEKS 37+
__________________________________________________________________________
SGOT
NORMAL RANGE
NUMBER 19 162 157 80 69
PERCENT 70.4% 59.1% 57.3% 59.8% 66.3%
ABOVE NORMAL
RANGE
NUMBER 8 112 107 47 35
PERCENT 29.6% 40.9% 42.7% 40.2% 33.7%
SGPT
NORMAL RANGE
NUMBER 20 217 208 95 93
PERCENT 74.1% 79.2% 78.8% 81.2% 89.4%
ABOVE NORMAL
RANGE
NUMBER 7 57 56 22 11
PERCENT 25.9% 20.8% 21.2% 18.8% 10.6%
__________________________________________________________________________
VI. Additional Clinical Findings at the Conclusion of Therapeutic Phase of
the Study
The Patient Population was divided into two segments.
A. ACTIVE--Those who completed the full study and have remained on the
maintenance portion of the program. (12 patients)
B. DROP-OUTS--Those who left before the end of the study and never completed
treatment.
Group A: (Active)
Upon final examination, all the patients in Group A had fairly normal
physical examinations and a healthy robust appearance. Two of the patients
stated that they had problems with psoriasis which were much improved over
the course of therapy.
One patient in Group A developed Hairy Leukoplakia after UV therapy for
folliculitis, but this was resolved after cessation of the UV therapy.
Mood Changes: Many instances of depression and other emotional problems were
reported in the intake histories. With the Exception of a single patient who
opted to return to the mood elevating drugs he had formerly been taking, all
of the patients exhibited generally cheerful, optimistic outlooks.
Fatigue: Initially, there were subjective complaints of fatigue by most of
the patients. At the conclusion of the study, all 12 patients are leading
normal lives and are working. All generally stated that they had increased
levels of energy.
Pulse: Initially many pulse rates were rapid and approximately 90. At the
conclusion of the treatment, all patients exhibited strong, regular pulse of
60-75.
Night sweats: Many patients complained of recurrent episodes of this malady
upon entering the study. None reported any incidents of the problem when
questioned at the conclusion of treatment.
General physical stamina: According to preliminary reports, several patients
complained of limited physical strength and, in one instance, one patient
presented with arthritis sufficiently severe that he could only walk with
the aid of two canes. At the final examination, all reported that they were
leading normal and demanding, fully strenuous physical lives. Many of them
resumed regular workout sessions at the gym and one worked weekends
unloading trucks.
Non-Development of AIDS Defining Disease Conditions: Almost none of the
ancillary diseases that may be expected to become evident in the patient
population during the course of a study occurred. The following disease
entities did NOT become evident in the patients during at least the 18 month
time span after the start of the study.
1. Pneumocystis Carinii Pneumonia
2. Candidiasis of the esophagus, trachea, bronchi or lungs.
3. Extrapulmonary Cryptococcosis
4. Cryptosporidiosis with diarrhea
5. Cytomegalovirus disease of an organ
6. Herpes Simplex virus infection with persisting mucocutaneous ulcer
7. Karposi's sarcoma
8. Primary lymphoma of the brain
9. Mycobacterium avium
10. Progressive multi-focal leukoencephalopathy
11. Toxoplasmosis of the brain
12. Coccidioidomycosis
13. Histoplasmosis
14. Isospororsis
15. Non-Hodgkins lymphoma of any type
16. Pulmonary tuberculosis
17. Salmonella septicemia
Alleviation of AIDS Related Conditions: The following medical problems, when
originally present, were either resolved or significantly improved during
the study so that at the end of the study the patients were essentially
symptom free:
1. Oral Hairy Leukoplakia
2. Persistent fungal infections including thrush, athletes foot, jock itch,
onychomycosis, etc.
3. Lymphadenopathy
4. Reiters Syndrome
5. Guillain-Barre Syndrome
6. Gastrointestinal complaints
7. Various viral conditions such as:
Herpes Simplex
Herpes Zoster (shingles)
8. Psoriasis
9. Syphilis
Group B (Drop-Outs)
Three of the patients in Group B had, for the most part, fairly normal
physical examinations. Two of them had developed Hairy Leukoplakia. One
case, according to the patient, had resolved with a course of Zovirax. Two
of these patients went on AZT, although one was intolerant to the therapy
and had to discontinue it. One is taking Zovirax. However, the subjective
impression of these three patients was that they appeared healthier than
would be the normal pattern at this phase of the disease. In general they
seemed to be in good shape.
Two patients were significantly worse physically with a frank diagnosis of
AIDS. Both had developed Pneumocystis pneumonia (PCP); one had developed
cryptococcal meningitis and had progressive Karposi's Sarcoma; the other had
thrush, wasting and fatigue at the time of examination.
No clinical examination was possible on the remaining patients.
VII. Final Impressions
If one compares the natural history of HIV, with average T-4 cells in the
low 300's, a progressive decline in the health status of these patients
could be expected over the 18 months duration of this treatment.
Additionally, more and more frequent occurrence of illnesses, general
fatigue and ongoing weight loss could be expected. However, none of this
occurred in the study.
In general, two years after intake, the Study patient population could be
expected to present with an extensive range of opportunistic diseases.
Instead, with the minor clinical exceptions noted above, the patients were
in good health.
As already discussed, it is important to note that, although many of the
test procedures described above deal with AIDS, the same procedures also
relate to the medical problems that affect the non-AIDS patient population.
AIDS is not a single disease. Although much of the media coverage has given
this impression, AIDS is not merely the HIV virus.
Just as the name indicates, AIDS is a syndrome or collection of medical
conditions. The element that binds AIDS patients together is that they all
have a compromised immune system. Beyond this, a wide range of other disease
entities can be present or absent. The list of possibilities includes
intestinal parasites, systemic fungus (Candida albicans and others), viral
diseases (EBV, CMV, herpes, hepatitis, etc.), bacterial problems (Staph,
Strep, etc.), tuberculosis, syphilis, etc.
None of these disease entities are unique to AIDS. They also afflict the
general public either in the form of individual diseases or else in such
groupings as Chronic Fatigue Syndrome (CFS). For this reason, the method,
procedures and individual medicaments that treat AIDS have applications that
extend far beyond that.
The terms and expressions which have been employed are used as terms of
description and not of limitation, and there is no intention in the use of
such terms or expressions of excluding any equivalents of the features shown
and described or portions thereof, it being recognized that various
modifications are possible within the scope of the invention.
* * * * *
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| United States Patent |
5,162,037 |
| Whitson-Fischman |
November 10, 1992 |
Magnetically influenced homeopathic pharmaceutical
formulations, methods of their preparation and methods of their
administration
Abstract
A method for treating pathogenic conditions of the human body by
preparing a homeopathic mixture of at least one herb, herbal extract or
other compound exhibiting therapeutic properties, adding a magnetically
permeable substance to the mixture if necessary, magnetizing the resulting
mixture to impart a substantially unipolar magnetic charge on the mixture
and administering the magnetized mixture through one or more specific
acupuncture points associated with producing a desired response to the
particular condition being treated. The invention is also directed to the
treatment of various diseases through the oral, auricular, topical or
injectable administration of magnetically influenced homeopathic
medicaments.
| Inventors: |
Whitson-Fischman; Walter (New
York, NY) |
| Assignee: |
Whitson Laboratories, Inc. (New
York, NY) |
| Appl. No.: |
696759 |
| Filed: |
May 7, 1991 |
| U.S. Class: |
600/12; 600/15;
128/907 |
| Intern'l Class: |
A61N 002/00 |
| Field of Search: |
600/9,12,15 128/907 |
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Orekhov et al., "Prevention . . . Aspirin", The
Lancet, Sep. 5, 1987. |
Primary Examiner: Cohen; Lee S.
Attorney, Agent or Firm: Haug; Edgar H. Kilcoyne; John M.
Parent Case Text
FIELD OF THE INVENTION
This application is a continuation-in-part of application Ser. No.
540,295, filed Jun. 19, 1990, abandoned, which in turn is a continuation
of application Ser. No. 176,731, filed Apr. 1, 1988, abandoned.
Claims
1. A method for treating pathogenic conditions of the human body
comprising the steps of:
preparing a mixture of at least one herb, herbal extract or other
compound having therapeutic properties to which a particular condition
being treated is responsive;
adding a magnetically permeable substance to the mixture if necessary;
magnetizing the resulting mixture in a magnetic field during delivery to
impart a substantially unipolar magnetic charge on said mixture; and
administering the magnetized mixture through one or more specific
acupuncture points of the body which are associated with producing a
desired response to the particular condition being treated.
2. The method of claim 1 wherein the mixture is magnetized in a magnetic
field of less than ten gauss.
3. The method of claim 1 wherein the magnetized mixture is topically
administered to the body.
4. The method of claim 3 wherein a therapeutic amount of the magnetized
mixture is placed over at least one pair of bilateral acupuncture points
on the surface of the body.
5. The method of claim 4 wherein the mixture is magnetized by placing a
source of magnetic flux in proximity to the mixture while it is placed
over the bilateral acupuncture points on the surface of the body.
6. The method of claim 1 wherein the magnetized mixture is injectably
administered to the body.
7. The method of claim 6 wherein a therapeutic amount of the magnetized
mixture is injected into at least one pair of bilateral acupuncture
points of the body.
8. The method of claim 1 wherein the magnetized mixture is auricularly
administered to the body.
9. The method of claim 8 wherein a therapeutic amount of the magnetized
mixture is impregnated into metal rods inserted into a device fitted to
be placed over the ear, the metal rods being located in said device such
that the magnetized mixture is in contact with at least one auricular
acupuncture point when the device is placed over the ear.
10. The method of claim 1 wherein the magnetized mixture is orally
administered to the body.
11. The method of claim 10 wherein a therapeutic amount of the
magnetized mixture is administered to acupuncture points in the mouth by
means of an oral delivery device which is magnetically transparent and
permeable comprising a rod portion connected to a porous ball portion,
said rod portion being capable of accepting and holding a magnetic
charge, and said ball portion being impregnated with an effective amount
of said mixture, wherein said rod portion of the device is magnetized so
that the desired charge is at the ball portion, and wherein the patient
places the ball portion of the device under the tongue to influence the
acupuncture points.
12. A method for the treatment of conditions of the human body including
injuries, illnesses, pathogenic diseases, allergies and chemical and
hormonal imbalances, the method comprising the administration of a
combination of oral, injectable and topical forms of a therapeutic
amount of a magnetized solution containing a solute of one or more
therapeutic herbs or herbal extracts or other compounds having
properties to which the particular condition being treated is
responsive, the solute being dissolved in a vehicle, where the vehicle
for the oral and topical form is a mixture of 99+% alcohol, and the
vehicle for the injectable form is a mixture of 99+% alcohol diluted
with sterile isotonic saline, together with a magnetically permeable,
non-toxic substance if necessary; and wherein the oral form is
impregnated into a solid placed in the mouth to release the magnetized
mixture contained therein, thereby stimulating acupuncture points in the
mouth; wherein the topical form is also impregnated into a solid and
affixed as a transdermal patch to at least one suitable acupuncture
point; and wherein the injectable form is injected into at least one
specific acupuncture point of the body related to the part of the body
or the condition being treated; the oral, topical and injectable
treatments being administered in appropriate dosages for a sufficient
period of time depending on the severity of the condition and the
response of the patient being treated, with provision for a further
period of maintenance treatments of different dosage and frequency of
administration where symptoms of the condition persist.
13. The method of claim 12 wherein the condition being treated is
traumatic injury to one or more joints, muscles, tendons and ligaments
and the solute of the magnetized solution comprises an effective amount
of one or more herbs or extracts selected from the group consisting of
Arnica Montana, Symphytum officianalis, Moschus moschiferous, Cow bezoar,
Pupalia geniculata, Snake's gall, Rhus Toxicum, Germanuim dioxide,
Plantago asiatica, Causticum, Helianthemum canadense, Ornithogalum
umbellatum, Clematis crispa, Impatiens pallida, Prunus Cerasus and
pineal gland.
14. The method of claim 12 wherein the oral dosage is a metal rod and
sphere impregnated with a solution having a homeopathic potency of
30.times., administered initially as one rod and sphere per day, reduced
to one every other day and finally to once per week over the course of
treatment; wherein the topical dosage is a transdermal patch,
impregnated with a solution having a homeopathic potency of 30.times.,
placed over at least one acupuncture point two times per week for a
first phase of treatment and once per week on successive weeks over a
maintenance phase of treatment; wherein the injectable dosage is an
injection of 0.2 cc per acupuncture point of the injectable solution
having a homeopathic potency of 30.times., administered to the
acupuncture points and related local acupuncture points for the specific
injured member being treated, the injections being given initially 2
times per week for a first phase of treatment and once per week on
successive weeks over the balance of a therapeutic phase as well as a
maintenance phase of treatment; and wherein the duration of the oral,
topical and injectable modes of treatment is from about 12 weeks,
followed by a period of maintenance for as long as symptoms of the
condition persist.
15. The method of claim 12 wherein the condition being treated is
hypothyroidism and the solute of the magnetized solution comprises an
extract of thyroid gland.
16. The method of claim 15 wherein the injectable and topical dosages
are administered bilaterally to each of the two LI-11 acupuncture points
2 times per week for the first week of treatment and once per week on
successive weeks over the course of treatment; and wherein the duration
of the oral, topical and injectable modes of treatment is six weeks,
followed by a period of maintenance of several weeks for as long as the
symptoms of the condition persist.
17. The method of claim 12 wherein the condition being treated is one or
more of pre-menstrual syndrome, menopause and reproductive hormonal
imbalance in female human beings and the solute of the magnetized
solution comprises the herb Angelica sinensis or an extract thereof and
an extract of pineal gland.
18. The method of claim 15 wherein the injectable and topical dosages
are administered bilaterally to each of the two LI-11 acupuncture points
from 1 to 2 times per week for the first week of treatment and once per
week on successive weeks over the course of treatment; and wherein the
duration of the oral, topical and injectable modes of treatment is from
4 to 8 weeks, followed by a period of maintenance of several weeks for
as long as the symptoms of the condition persist.
19. The method of claim 12 wherein the condition being treated is
emotional depression and tension, and the solute of the magnetized
solution comprises one or more herbs or herbal extracts selected from
the group consisting of Helianthemum canadense, Ornithogalum umbellatum,
Clematis crispa, Impatiens pallida, Prunus cerasus, Valeriana
officinalis and pineal gland.
20. The method of claim 17 wherein the injectable and topical dosages
are administered bilaterally to the SP-6 acupuncture points a total of
four to six times, followed by a period of maintenance of several weeks
for as long as symptoms of the condition persist.
21. The method of claim 12 wherein the condition being treated is a
reduction in the body's natural immune system and the solute of the
magnetized solution comprises one or more herbs or extracts selected
from the group consisting of Panex ginseng, Astragalus membranaceous,
Snake venom, thymus gland, Rubia cordifolia and pineal gland.
22. The method of claim 20 wherein the injectable and topical dosages
are administered bilaterally to one of the following pairs of
acupuncture points: HE-5, HE-6 and HE-7, given 2 times per week for the
first week of treatment and once per week on successive weeks over the
course of treatment; and wherein the duration of the oral, topical and
injectable modes of treatment is 6 weeks, followed by a period of
maintenance of several weeks for as long as symptoms of the condition
persist.
23. The method of claim 22 wherein the injectable and topical dosages
are administered bilaterally to each of the two LI-4 acupuncture points
2 times per week for the first week of treatment and once per week on
successive weeks over the course of treatment; and wherein the duration
of the oral, topical and injectable modes of treatment is 6 to 8 weeks,
followed by a period of maintenance of several weeks for as long as the
symptoms of the condition persist.
24. The method of claim 12 wherein the condition being treated is
hypoglycemia and the solute of the magnetized solution comprises a
mixture of sulfur and glycerin.
25. The method of claim 24 wherein the injectable and topical dosages
are administered bilaterally to each of the two ST-36 acupuncture
points, given 2 times per week for the first week of treatment and one
per week on successive weeks over the course of treatment; and wherein
the duration of the oral, topical and injectable modes of treatment is
from 6 to 8 weeks, followed by a period of maintenance of several weeks
for as long as symptoms of the condition persist.
26. The method of claim 12 wherein the condition being treated is a
general or localized bacterial infection of the body, and the solute of
the magnetized solution comprises one or more herbs or extracts selected
from the group consisting of Seniccio scandens, Scutellaria baicalensis,
Magnolia officinalis, Lonicera japonica, Andrographis paniculata,
Centella asiatica minor, Leptotaenia multifida, Moschus moschiferous,
Cow bezoar, Pupalia geniculata, Snake's gall and pineal gland.
27. The method of claim 26 wherein the injectable and topical dosages
have a homeopathic potency of 30.times., and are administered
bilaterally to each of the two IL-11 acupuncture points, given 2 times
per weeks for the first week of treatment and one per week on successive
weeks over the course of treatment; and wherein the duration of the
oral, topical and injectable modes of treatment is 6 to 12 weeks
depending on the pathogen being treated, followed by a period of
maintenance of several weeks for as long as the symptoms of the
condition persist.
28. The method of claim 12 wherein the condition being treated is a
general virus infection of the body and the solute of the magnetized
solution comprises one or more herbs or extracts selected from the group
consisting of Centella asiatica minor, Pyrrosia lingua, Hypericum
perfoliatum, Trichosanthes Kirilowii, Artemasia apiacea and pineal
gland.
29. The method of claim 28 wherein the injectable and topical dosages
have a homeopathic potency of 30.times., and are administered
bilaterally to each of the two TW-5 acupuncture points, given 1 or 2
times per week for the first week of treatment and once per week on
successive weeks over the course of treatment; and wherein the duration
of the oral, topical and injectable modes of treatment is from 8 to 12
weeks, followed by a period of maintenance of several weeks for as long
as symptoms of the condition persist.
30. The method of claim 12 wherein the condition being treated is a cold
caused by the rhino-virus or influenza and the solute of the magnetized
solution comprises one or more herbs or extracts selected from the group
consisting of Lonicera confusa, Chrysanthemum indicum, Vitex negundo,
Evodia lepta, Ilex asprella, Menthol crystal, Baphicacanthus cusia,
Centella asiatica minor and pineal gland.
31. The method of claim 30 wherein the injectable and topical dosages
are administered bilaterally to each of the two TW-5 acupuncture points,
given 2 times per week for the first week of treatment and once per week
on successive weeks over the course of treatment; and wherein the
duration of the oral, topical and injectable modes of treatment is three
weeks, followed by a period of maintenance of several weeks for as long
as symptoms of the condition persist.
32. The method of claim 12 wherein the condition being treated is one or
more of hay fever and airborne allergies, and the solute of the
magnetized solution comprises one or more herbs or extracts selected
from the group consisting of Gentiana luta, Citrus aurantium, Tanacetum
vulgare, Cnicus benedictus, Menyanthes trifoliata, Grindelia robusta,
Ephedra sinica, Centipeda minima, pineal gland and Centella asiatica
minor.
33. The method of claim 32 wherein the injectable and topical dosages
are administered bilaterally to each of the two PE-6 acupuncture points
or the auricular lung point, given 2 times per week for the first week
of treatment and once per week on successive weeks over the course of
treatment; and wherein the duration of both the oral and injectable
modes of treatment is from 2 to 4 weeks, followed by a period of
maintenance of several weeks for as long as the symptoms of the
condition persist.
34. The method of claim 12 wherein the condition being treated is one or
more of local and systemic fungus and yeast infections, and the solute
of the magnetized solution comprises one or more herbs or extracts
selected from the group consisting of Malaleuca alternifolio, Centella
asiatica minor, citrus seed, Tacoma conspicus and pineal gland.
35. The method of claim 34 wherein the injectable and topical dosages
are administered bilaterally to the SP-6 acupuncture point, given 2
times per week for the first week of treatment and once per week on
successive weeks over the course of treatment; and wherein the duration
of the oral, topical and injectable modes of treatment is from 6 to 12
weeks, followed by a period of maintenance of several weeks for as long
as symptoms of the condition persist.
36. The method of claim 12 wherein the condition being treated is
infestation with intestinal parasites and the solute of the magnetized
solution comprises one or more herbs or extracts selected from the group
consisting of Osbeckia chinensis, Pulsattila chinensis, Punica granatum,
Acalpha australis, Cephaelis ipecacuanha, Picrasma ailanthoides, Asarum
sieboldi, Brucea javanica, Magnolia officinalis, Artemisia apiacea,
Dichroa febrifuga, Centella asiatica minor, citrus seed and pineal
gland.
37. The method of claim 36 wherein the injectable and topical dosages
are administered bilaterally to the ST-36 and ST-37 acupuncture points
which are used alternately and treatments are given 2 times per week for
the first week and once per week on successive weeks over the course of
treatment; and wherein the duration of both the oral and injectable
modes of treatment is from six to eight weeks, followed by a period of
maintenance of several weeks if required.
38. The method of claim 12 wherein the condition being treated is acute
or chronic muscular and joint pain and the solute of the magnetized
solution comprises one or more herbs or extracts selected from the group
consisting of Arnica Montana, Symphytum officianalis, Moschus
moschiferous, Cow bezoar, Pupalia geniculata, Snake's gall, Rhus Toxicum,
Germanuim dioxide, Plantago asiatica, Causticum, Helianthemum canadense,
Ornithogalum umbellatum, Clematis crispa, Impatiens pallida, Prunus
Cerasus and pineal gland.
Description
This invention relates to homeopathic medicaments and methods for the
treatment of illness and injury in human beings using such homeopathic
medicaments.
More particularly, the invention relates to homeopathic methods of
treatment of conditions including illnesses, pathogenic diseases,
allergies, chemical and hormonal imbalances, addictive chemical
dependencies, and physical injuries to the human body. The methods of
treatment include oral, topical, auricular and injectable forms of
homeopathic formulations which are magnetically treated or influenced
during administration to a patient through specific acupuncture points.
BACKGROUND OF THE INVENTION
Homeopathy
is an ancient healing art and forms a vital part of medical therapy. The
practice of homeopathy
is widespread, particularly in eastern cultures and many European
countries. Homeopathic medicine teaches the use of natural based
remedies and, as such, provides an alternative to traditional allopathic
medicine which relies heavily on the use of petrochemical based
pharmaceuticals. There has been a large increase in interest in
homeopathic medicine in the United States in recent years due, in large
part, to a growing disenchantment with allopathic medications and the
complications and side effects arising from their use. Frequently, the
administration of allopathic medications results in serious side effects
more deleterious to the patient than the basic condition being treated.
Today, more and more individuals are looking for a gentler, safer path
to good health free of the risks and side effects associated with
traditional allopathic medicines. Furthermore, such medicines are often
prohibitively expensive, particularly for patients who are indigent or
elderly.
Homeopathic remedies, on the other hand, use pharmaceutical preparations
based on the use of herbs or herbal extracts. Homeopathic remedies
function in a totally different manner than chemical-based
pharmaceuticals in that they do not require administering high
concentrations of active ingredients to produce the desired effects.
Traditional allopathic pharmaceuticals can be thought of as working
quantitatively, that is, the results achieved are generally proportional
to the potency and frequency of the dosage administered. By comparison,
homeopathic pharmaceuticals can be thought of as working qualitatively
in that even the minutest quantities of their active ingredients produce
a therapeutic effect by inducing natural body mechanisms to return to
their proper level of activity characteristic of a healthful or
uninjured state. Homeopathic remedies function by inducing natural body
mechanisms and processes to return to their optimum healthful level of
operation, that is, their natural biological "set points".
Through our modern understanding of genetics, each bodily member and
process is seen as the result of codes programmed into each individual
cell. Homeopathic medicine seeks to utilize natural substances,
particularly herbs, to induce naturally and gently the body to restore
its equilibrium, that is, for all function and processes to return to
their set points. Homeopathic medicine looks upon illness and disease as
being a state of disequilibrium from the body's optimal set points. A
fundamental precept of homeopathic medicine is that a small force or
stimulating agent can produce disproportionally greater results, if
optimally and effectively applied. Thus, proper administration of a
small quantity of a homeopathic medicine can have a large effect in
restoring the body to its proper state of equilibrium.
A further advantage of homeopathic medicaments is that they are
relatively inexpensive as compared to traditional chemical-based
pharmaceuticals. Another fundamental precept in the formulation of
homeopathic pharmaceuticals is that repetitive dilution from an original
concentrate does not diminish efficacy of the formulation. Thus, large
quantities of homeopathic pharmaceuticals can be prepared from a
relatively small amount of starting solution. Further, the starting
ingredients themselves are natural and relatively inexpensive. The
formulation of solutions of homeopathic pharmaceuticals is also a
relatively simple process.
Additionally, homeopathy
utilizes various medicaments in extremely dilute form. For example, all
the medicines used in accordance with the present invention are
generally used at a potency of 30.times. which is a 1-10 dilution taken
to the 30th power.
One of the long standing adjustments that was made long ago was a
determination of exactly what materials are suitable as diluents. The
list is small and primarily restricted to 200 proof Ethyl alcohol,
distilled water, sugar and milk sugar. With the possible exception of
distilled water, none of these are really totally inert. All the others
contribute some identity of their own. As a matter of fact, both sugar
and milk sugar are listed as medicants (when in homeopathic dilution) in
the homeopathic materia medica.
One example of a homeopathic medicament is extract of pineal gland. As
noted in the technical text, "The Pineal Gland" by Russel J.
Reiter (Raven Press, N.Y. 1984), the pineal gland occupies a unique
physiological niche. Its function has been described as being "the
regulator of regulators". The primary action of the pineal gland is
believed to be to "govern or restrict the production and/or the
secretion of hormones from other endocrine glands."
Since conventional allopathic medications utilize massive chemical
intervention as the modus operandi with the actual destruction of the
offending pathogen as the ultimate goal, there is little possibility for
an interface between the powerful but very subtle activity of the pineal
gland and the mighty action of petrochemicals. Homeopathy,
however, since it is a vastly more subtle form of medication, appears to
be able to intensify the actions of the pineal.
To make the base tincture of the pineal gland, one portion of a freeze
dried animal sample of the gland itself is comminuted and then macerated
in pure ethanol for ten days with daily agitation. At the end of this
time, the extract is filtered. An equal sample of the same material is
added to distilled water, brought to a slow simmer and maintained at
this point while it is allowed to steep for one hour. At the end of this
time, the water extract is also filtered.
Equal amounts of the alcohol and the water extracts are combined to form
the base tincture.
In contrast, the manufacture of traditional chemical-based
pharmaceuticals generally involves a complicated and costly chemical
manufacturing process. Moreover, because the effectiveness of such
traditional chemical-based pharmaceuticals resides in the potency of the
formulation administered, dilution of the pharmaceutical to a lower
potency results in reduced effectiveness. Generally, all such
chemical-based pharmaceuticals must be formulated at or near the
concentration level or potency at which they will ultimately be
administered. Thus, in order to produce large quantities of a
pharmaceutical, proportionately large manufacturing facilities are
required, which only further adds to the expensiveness of the
chemical-based pharmaceuticals utilized in classical allopathic
medicine.
Another ancient and long accepted healing art is acupuncture which is
believed to have originated in the Orient. Acupuncture involves the
relief of symptoms and the cure of illness and injury by the controlled
stimulation of points on the human body which regulate or interact with
the functioning of specific organs or bodily members to which the
acupuncture points are related.
Over the many years that acupuncture has been practiced, specific points
on the human body have been determined which regulate or interact with
the functioning of all bodily members and processes. Thus, the
appropriate points for stimulation for any given condition are known to
skilled practitioners in the art.
One particular acupuncture treatment system developed in Japan by Dr.
Yoshio Manaka is based on a conception of the human body as encompassing
two basic systems, an energetic system and an informational system. The
energetic system utilizes the greater portion of energy in the body. The
informational system controls the energetic system and response to both
external and internal stimuli. Acupuncture is viewed as a therapeutic
modality which interacts with and regulates the body's informational
system. By influencing the informational system, large changes can be
induced with minimal stimulation while allowing the body to function as
naturally as possible while its processes are gradually restored to
their equilibrium set points.
A recent development in methods of medical treatment has been the
discovery of the therapeutic properties of magnetic and electro-magnetic
fields and their use in the treatment of illness and injury. Modern
science has demonstrated that all living beings exhibit an
electro-magnetic field about them. Homeopathic medicine teaches that
illness and injury create disturbances to the body's natural
electro-magnetic fields. The administration of therapeutic fields
restores the body's natural fields to their equilibrium levels. The
therapeutic effects of the application of pulsed magnetic fields in the
treatment of traumatic injuries to limbs, muscles, tendons, bones and
the like, as well as in the treatment of illness such as arthritis, is
well-known in the art of medical science.
The human body's susceptibility to magnetic fields is due in large part
to the electrolytic properties of many of the chemical constituents of
the body. All electrolytic substances are capable of conducting an
electric current, and whenever an electric current is flowing a magnetic
field is created. The greater the electrolytic properties of the
substance, the greater is its conductivity and therefore the greater the
resulting magnetic field created during current flow.
The body generates a magnetic field of its own due partly to the
presence of iron-carrying charged particles flowing in the blood stream.
Other electrolytic substances in the body such as potassium and sodium,
in ionic form, are present in substantial amounts and contribute to the
body's overall bioelectric/biomagnetic field. It is well known that
blood cells are readily polarized when placed in a magnetic field due to
the high iron concentration in the blood. Under certain conditions,
magnetic fields alter the orientation of blood cells and induce changes
in the biological reactions in which they participate, thereby modifying
the probability of chemical bond formation.
Human blood is very slightly alkaline with respect to body cells which
are more acidic. Magnetic fields can be used to induce reactions which
restore the pH of the blood.
For example, in a condition prompted by over-acidity of the blood, that
is, one characterized by a low pH, application of magnetic field energy
emanating from the north pole of a magnet, which, by convention, is
considered to be negative, and which, homeopathically, is considered to
be alkaline, helps to restore the blood to its normal pH level.
It has also been shown that the blood's leucocyte count is influenced by
magnetic fields. The number of leucocytes in the blood increases
depending on prevailing magnetic field conditions.
Therapeutic treatments utilizing magnetic energy operate to produce two
curative effects. Therapeutic magnetic fields produce a treatment
component which in the case of traumatic physical injury causes a
reduction in swelling, a reduction of edema, a draining of fluid
build-up due to inflammation and a desensitization to pain.
Therapeutic magnetic energy fields also produce a stimulating component
which in the case of traumatic physical injury dilates blood vessels and
increases blood circulation, disperses fluid build-up due to
inflammation, and strengthens and promotes the healing of damaged
tissue.
The application of pulsed magnetic energy has been observed to cause
transcutaneous electrical neural stimulation and contributes to the
reduction of chronic pain by causing the release of natural pain
relieving substance at the spinal cord level and by causing the release
of endorphins and ACTH at the pituitary gland level.
As a result of research into the fields of homeopathic pharmaceutical
medicine, acupuncture and biomagnetic therapy, a new modality of medical
treatment has been developed which combines the features of all three of
the above treatment methods in a novel way. Accordingly, a new and
unique method of medical treatment has been discovered which is more
efficacious than any of the three methods individually as described
above.
OBJECTS OF THE INVENTION
Accordingly, a primary object of the present invention is to disclose a
new modality of medical therapy which utilizes aspects of homeopathic
pharmaceutical therapy, acupuncture therapy and biomagnetic therapy, in
combination.
A further object of the invention is to devise a full range of modes of
administration of magnetically influenced homeopathic remedies,
including topical, injectable, auricular and oral forms.
A further object of the invention is to provide particular homeopathic
pharmaceutical formulations for the treatment of specific illnesses,
physical injuries and other chemical and hormonal disequilibrium
conditions of the human body with precisely determined acupuncture sites
to which the homeopathic pharmaceutical remedies are to be applied in
the treatment of each specific condition.
A further object of the invention is to provide appropriate means for
inducing the biomagnetic field in the homeopathic pharmaceutical remedy
for each form of administration.
SUMMARY OF THE INVENTION
The present invention is directed to a method of treatment of human
illness and injury by administering to the patient homeopathic
medicaments through selected acupuncture points stimulated by a
controlled magnetic field. A very broad spectrum of human illness can be
effectively treated by homeopathic medicament of the instant invention
through selection of the appropriate homeopathic remedy, preparation of
a mixture of the homeopathic remedy and a magnetically permeable
component and magnetization of the resulting mixture during
administration to the patient through specific acupuncture sites.
Various embodiments of the invention include administering therapeutic
amounts of the magnetic mixture in oral, injectable, topical and
auricular forms. Further, depending upon the condition being treated,
the dosage and frequency of administration will vary. In a particularly
preferred embodiment, the patient is administered with a regimen of
oral, transdermal and injectable dosages.
BRIEF DESCRIPTION OF THE DRAWINGS
Aspects of the present invention are illustrated by the accompanying
drawings in which:
FIG. 1 shows a preferred embodiment of an oral delivery vehicle for the
administration of homeopathic medicaments;
FIG. 2 shows an embodiment for the topical administration of a
homeopathic medicament; and
FIG. 3 shows a preferred embodiment for imparting a magnetic field to
the injectable form of the homeopathic medicaments; and
FIG. 4 shows a cross-sectional view through a mold of an ear, with pins
inserted therein, for the auricular administration of a homeopathic
medicament.
DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS OF THE INVENTION
The homeopathic medicaments of the present invention, when administered
through specific acupuncture sites, have demonstrated remarkable
efficacy in the treatment of a wide range of afflictions, many of which
have no known cure in the realm of allopathic medicine. Effective
delivery systems for these homeopathic formulations have been devised
including topical, injectable, auricular and oral forms.
In accordance with the teaching of the present invention, the
homeopathic medicament, when administered as an injectable, is first
carefully mixed with an effective amount of a magnetically permeable
ingredient. Although numerous compounds are suitable, it has been found
that ferrous gluconate is particularly effective. The herb-based
homeopathic medicament is then prepared for administration to the
patient depending upon the specific delivery system used. During
administration to the patient, the medicament, whether or not it is
mixed with a magnetically permeable ingredient, is charged or influenced
by a magnetic field which imparts a unipolar charge to the medicament as
it enters the body through a pre-selected acupuncture point. Since a
magnet has two poles, to effect a unipolar charge to the medicament, the
poles of the delivery devices are separated. The medicament and the body
are only exposed to one pole. The other pole is outside of, or away
from, the body. In this way, the medicament is exposed to the influence
of only one pole. Such application of a magnetic charge at, or in close
proximity to, the acupuncture site is believed to stimulate or activate
the acupuncture site thereby enhancing the therapeutic efficacy of the
medicaments being administered.
Acupuncture points can be stimulated with heat, electricity, ultrasound,
laser beams, mechanical vibration, etc. However, stimulation by
magnetism has been found to be one of the most effective, and yet, at
the same time, is one of the most benign.
Particularly effective results have been achieved when applying
relatively small levels of magnetic charge in the range of 1 to 10 gauss
to the medicament as it is being administered into the acupuncture
point. Such low levels of magnetic flux can aptly be described as
homeopathic. It has further been found that the most effective
acupuncture sites are located in the arms and legs below the elbow and
knee, respectively. These points are commonly referred to as
"command points" and are well known to those skilled in the
art.
Having described the invention in its most fundamental terms, the
various forms of administration of medicaments will now be described in
detail. Reference is made to the accompanying figures where appropriate.
One delivery system used is by injection. The formulation dosage and
duration of treatment for the injectable medicaments is described in
detail in the formulation examples which follow. Since it has been
observed that injecting homeopathic medicaments demonstrate unexpected
and significantly enhanced efficacy when a unipolar magnetic charge is
imparted to the medicament during administration or injection into an
acupuncture point, a device has been developed to enable the
administering physician to suitably charge the medicament. One such
device is shown in FIG. 3.
This device consists of a housing 10. Within the housing 10 is an
electronic circuit which delivers a pulsed DC current to the
electromagnetic coil 12 with a frequency in the range of about 5 to 10
Hz. The electromagnetic coil 12 is positioned to impart a controlled
magnetic charge to core 14. A syringe or hypodermic needle 16 used to
inject the homeopathic medicament can be positioned in housing 10 such
that the point of the needle or syringe is in close proximity to the end
of the core 14 as shown in FIG. 3. The entire length of the hypodermic
needle is magnetized. The end of the needle which is to enter the skin
at the acupuncture point is given the desired charge. Each molecule of
the medicament going down the needle receives a magnetic charge.
Although the charge dissipates when it hits the skin, during the instant
before this happens, the acupuncture point is stimulated by being
bombarded by a series of magnetic impulses.
Another alternative delivery system used is the topical. One
particularly preferred topical system is illustrated in FIG. 2. The
topical patch 52 is made of a porous material such as sintered metal
capable of absorbing a therapeutic amount of homeopathic medicament. The
patch 52 has an extended opening therethrough on the underside of which
is tightly fitted a metal sphere or ball 50 which can readily accept and
retain a magnetic charge. Suitable materials used to prepare the metal
sphere or ball 50 include iron, steel and other ferrous alloys that are
magnetically efficient. The patch 52 can then be impregnated with a
therapeutic amount of desired homeopathic medicament. A unipolar
magnetic charge is then imparted to the metallic core 50 of patch 52
after it is affixed to a suitable acupuncture point.
In one embodiment, the patch is a dome shaped "donut" shaped
device with a hole in the center as shown in FIG. 2. The patch is formed
by a metal sintering process and is made of a stainless steel alloy that
is virtually non-magnetic. Because it is made of sintered metal, the
device is porous and can be impregnated with a liquid solution of the
desired medication as described later. On the underside of the device,
the ball bearing 50 is press fitted into place within the opening so
that it partially projects below the surface. The ball is made of a
ferrous alloy that is extremely permeable magnetically and will also
retain the magnetic charge. The ball typically is not formed by the
sintering process, and it is not porous so it will not absorb any liquid
medication. The patch can be mounted on a circle of surgical adhesive
tape 56, all of which can be protected by one or more "peel
off" strips of release paper 54 similar to the type used with
adhesive bandages.
Still another form of administering homeopathic medicaments is orally.
With reference to FIG. 1, this oral device can aptly be described as a
medicinal "lollipop" consisting of a rod portion 40 and a ball
or bulbous portion 42. In one embodiment, the rod 40 is made up of a
stainless steel alloy that is capable of holding a magnetic charge. The
ball portion 42 can have an inert core. The ball portion 42 can also be
coated with a homeopathic composition made of ferrous gluconate mixed
with sugar to a dilution in the range of 3.times. to 4.times.. It can
then be impregnated with an alcohol tincture containing the desired
homeopathic medicament of the desired homeopathic dilution. The entire
device can be encased in a sanitary wrapping. To use the
"lollipop", the entire device in its wrapping if desired, is
first placed in a suitable electromagnetic field. In this way, all of
the metallic elements of the device are magnetized with one end of the
rod portion being charged with one polarity and the other end of the rod
portion being charged with the opposite polarity. In this manner, the
therapeutic portion of the device having a desired unipolar charge can
influence the ball portion which is placed under the tongue of the
patient in order to contact the acupuncture points in the mouth.
In a specific embodiment, the "handle" or rod 40 of the
"lollipop" is made of a stainless steel or ferrous metal of
such alloy that will readily accept magnetism and will hold the charge
well. At one end, the metal rod 40 is forced into a hole in the ball
portion 42 formed of sintered stainless steel. The specific stainless
steel alloy used to form the ball is magnetically transparent so that it
will not readily accept a magnetic charge. The alloy is also porous so
that it can be impregnated with an alcoholic tincture of the desired
homeopathic therapeutic remedy in the desired potency.
The "lollipop" oral delivery device can be positioned under
the tongue in the same way an oral thermometer is used. It will directly
influence three specific acupuncture points. They are: Jin Jin (which
translates as Golden Fluid), Yu-Yeh (Jade Fluid) and Hai Chuen (Sea
Spring). The first two are located on the left and right sides of the
vinculum lingua when the tongue is rolled up. The third point is under
the tongue on the midline about 1/16th inch up from the vinculum lingua.
As a result of this procedure, the acupuncture points in the patient's
mouth, and especially those located under the tongue, are influenced by
a homeopathic medication whose action has been intensified through the
use of the polarized magnetic force.
It is not necessary that the oral device actually contact the
acupuncture points as long as it is placed under the tongue in the
general area. The sub lingual acupuncture points under the tongue will
be influenced by the homeopathic medication with which the ball has been
impregnated.
Simultaneously the same sites will also be influenced by the selected
unipolar magnetic force. The portion of the "stick" that has
been charged with the undesired polarity is outside of the mouth during
this entire procedure to prevent any influence of the opposite and
undesired magnetic charge. At the conclusion of the period of treatment,
the entire device is discarded.
Yet another form of administering the homeopathic medicaments is by
auricular measures. An auricular device is illustrated in FIG. 4. In one
such device, a mold 75 is made of a patient's ear by gently pressing
standard mold compound into place so that it takes on the anatomical
contours of the ear and is about 1/8 to 1/4 inches thick. The mold
material is carefully removed so as to preserve the features of the
material and is cured; to the consistency of firm rubber.
Small rods 60 formed of sintered stainless steel, in a ferrous alloy
that is magnetically efficient, are fitted through holes punched in the
ear mold. The holes 65 coincide with the specific acupuncture points in
the ear that are to be influenced. The rods have a rounded point 70 on
one end and are sufficiently long as to extend through the mold and
firmly contact the auricular acupuncture points.
Prior to use, the sintered metal rods are impregnated with the desired
homeopathic medicament as described elsewhere and then dried. They are
positioned in the holes pierced in the molds using forceps to avoid
contamination. The molds are placed back on the patient's ears and then
the desired magnetic charge is induced.
Impregnating with Medicament
In certain preferred embodiments, the sintered metal donut of the patch,
and the ball of the oral lollipop, are porous so that they will absorb
an alcohol tincture of the medicament after which they are dried and
packaged.
Merely soaking the metal may not be effective. Instead, in one
embodiment, the sintered metal pieces can be placed into a suitable
container with enough alcohol tincture added to completely cover them.
The entire system goes into a vacuum chamber and a vacuum then pulled
producing an intense surge of tiny bubbles rising to the surface as an
indication that, in the lowered atmospheric pressure, the air entrapped
in the interstices of the sintered metal is being forced out.
After about ten minutes of vacuum, the container and contents are
allowed to return to normal atmosphere. When this happens, the alcohol
tincture is forced into the minute pores of the sintered metal parts.
After about ten minutes the metal pieces absorb all the tincture that
they will accept. Since the air was forced out of the pores of the metal
when the container was under vacuum, it can only be replaced by the
tincture when normal pressure returns because the sintered metal pieces
remain completely submerged in the solution.
In a particularly preferred embodiment, all the medicaments used are at
a 30.times. potency. The dilution sequence used to achieve the 30.times.
potency in this embodiment is carried out with 99+% ethanol.
With respect to the transdermal patch, after being impregnated with the
desired medication and then dried, each transdermal patch can be mounted
on a circle of surgical adhesive tape that has a hole punched in the
center. The hole in the top surface of the patch is aligned with the
hole in the adhesive tape. The remainder of the adhesive tape surface
can be covered and protected by one or more "peel-off" strips
of release paper of a similar type to that used in the well known
adhesive bandages. The paper strips are formed with cut-out segments so
that the metal donut will project through.
For convenience, the transdermal patches are packaged in a paper
envelope and supplied in pairs since the units are often applied
bilaterally to acupuncture points on the patient's limbs.
To use the transdermal device, a two-unit package containing patches
that have been impregnated with the appropriate medication is chosen.
The protective backing from each adhesive circle is removed and the unit
is positioned so that the ball bearing on the underside is precisely
aligned with the selected acupuncture point on the patient's skin. The
unit is affixed to the skin by pressing the rim of adhesive tape (the
part that extends beyond the circumference of the donut) firmly against
the patient's skin.
When a magnetic charge is applied, the magnetic force will only
influence the ball bearing since the donut segment of the unit is formed
of an alloy that is not permeable to magnetism. Further, the magnetic
charge is applied in such a manner that the portion of the ball in
proximity with one end of the electromagnetic coil of an electromagnetic
stimulating device is given a charge of one polarity while the bottom
portion of the ball that is in contact with the patient's skin
automatically assumes the opposite (and therapeutically desirable)
charge.
In application, the part of the ball bearing that is in contact with the
skin will exert a magnetic force upon the acupuncture point of only the
single desired polarity. The opposite magnetic polarity, the one that,
for the specific medical purpose, is not as desirable in this instance,
is on the opposite (or upper) side of the ball and so does not directly
influence the acupuncture point.
The patient leaves the patches in place on his skin for the period of
time recommended by his physician (usually 4 to 6 hours) before peeling
them off and discarding them.
The following are examples which illustrate embodiments of various
aspects of the invention. The examples are provided to illustrate the
scope of the invention and are not intended to be limiting. Other
applications or aspects of the invention within its broad scope will be
apparent to those skilled in the art.
FORMULATION EXAMPLES
A. Injectable
Example 1
An injectable dosage form of an herb-based homeopathic medicament
designated FNG-11, for the treatment of fungus and yeast infections,
having a homeopathic potency of 30.times. was prepared from an original
concentrated tincture menstruum containing extracts of the herbs
Malaleuca alternifolio, Centella asiatica minor and Tacoma conspicua,
extract of citrus seed and extract of pineal gland in 99+% alcohol. The
original concentrated tincture was diluted to 29.times. potency
(10.sup.-29 times the original concentration) with sterile distilled
water. Sufficient ferrous gluconate solution, a magnetically permeable
substance, was added to sterile isotonic saline to make a homeopathic
potency of 4.times.(10.sup.-4). The 29.times. dilution of the medicament
was added to the ferrous gluconate/isotonic saline solution to prepare
the final 30.times. medicament. The purpose of the ferrous gluconate/isotonic
saline solution is to enable the final medicament to hold a magnetic
charge when it is passed through a magnetic field. Injectable dosage
portions of 0.2 cc volumes were set aside as needed depending upon the
number of acupuncture points being used. The formulations injected were
controllably magnetized during administration through the acupuncture
sites as described above.
Example 2
An injectable dosage form of an herb-based homeopathic medicament,
designated HG-9, for the treatment of intestinal parasites, particularly
Giardia lamblia and Entamoeba histolytica, was prepared from an original
concentrated tincture menstruum containing extracts of the herbs
Osbeckia chinensis, Pulsatilla chinensis, Punica granatum, Acalpha
australis, Cephaelis ipecacuanha, Picrasma ailanthoides, Asarum sieboldi,
Brucea javanica, Magnolia officinalis, Artemisia apiacea, Dichroa
febrifuga, and Centella asiatica minor, extract of citrus seed and
extract of pineal gland in 99+% alcohol. The original concentrated
tincture was diluted to 29.times. potency (10.sup.-29 times the original
concentration) with sterile distilled water. Sufficient ferrous
gluconate solution, a magnetically permeable substance, was added to
sterile isotonic saline to make a homeopathic potency of
4.times.(10.sup.-4). The 29.times. dilution of the medicament was added
to the ferrous gluconate/isotonic saline solution to prepare the final
30.times. medicament. The purpose of the ferrous gluconate/isotonic
saline solution is to enable the final medicament to hold a magnetic
charge when it is passed through a magnetic field. Injectable dosage
portions of 0.2 cc volumes were set aside as needed. The formulations
injected were controllably magnetized during administration through the
acupuncture sites as described above.
Example 3
An injectable dosage form of an herb-based homeopathic medicament
designated VR-27, for the treatment of broad spectrum viral infections,
having a homeopathic potency of 30.times. was prepared from an original
concentrated tincture menstruum containing extracts of the herbs
Centella asiatica minor, Pyrrosia lingua, Hypericum perfoliatum,
Trichosanthes kirilowii and Artemisia apiacea, and extract of pineal
gland in 99+% alcohol. The original concentrated tincture was diluted to
29.times. potency (10.sup.-29 times the original concentration) with
sterile distilled water. Sufficient ferrous gluconate solution, a
magnetically permeable substance, was added to sterile isotonic saline
to make a homeopathic potency of 4.times.(10.sup.-4). The 29.times.
dilution of the medicament was added to the ferrous gluconate/isotonic
saline solution to prepare the final 30.times. medicament. The purpose
of the ferrous gluconate/isotonic saline solution is to enable the final
medicament to hold a magnetic charge when it is passed through a
magnetic field. Injectable dosage portions of 0.2 cc volumes were set
aside as needed. The formulations injected were controllably magnetized
during administration through the acupuncture sites as described above.
Example 4
An injectable dosage form of an herb-based homeopathic medicament
designated SPN-7, for the treatment of traumatic injury to muscles,
tendons, ligaments, and for the treatment of sprains, was prepared from
an original concentrated tincture menstruum containing extracts of the
herbs Panex notoginseng and Gynura segetum, and Moschus moschiferous and
extract of pineal gland in 99+% alcohol. The original concentrated
tincture was diluted to 29.times. potency (10.sup.-29 times the original
concentration) with sterile distilled water. Sufficient ferrous
gluconate solution, a magnetically permeable substance, was added to
sterile isotonic saline to make a homeopathic potency of
4.times.(10.sup.-4). The 29.times. dilution of the medicament was added
to the ferrous gluconate/isotonic saline solution to prepare the final
30.times. medicament. The purpose of the ferrous gluconate/isotonic
saline solution is to enable the final medicament to hold a magnetic
charge when it is passed through a magnetic field. Injectable dosage
portions of 0.2 cc volumes were set aside as needed. The formulations
injected were controllably magnetized during administration through the
acupuncture sites as described above.
Example 5
An injectable dosage form of a homeopathic medicament, designated
TYR-10, for the treatment of hypothyroidism, was prepared from an
original concentrated tincture menstruum containing an extract of
thyroid gland, in 99+% alcohol. The original concentrated tincture was
diluted to 29.times. potency (10.sup.-29 times the original
concentration) with sterile distilled water. Sufficient ferrous
gluconate solution, a magnetically permeable substance, was added to
sterile isotonic saline to make a homeopathic potency of
4.times.(10.sup.-4). The 29.times. dilution of the medicament was added
to the ferrous gluconate/isotonic saline solution to prepare the final
30.times. medicament. The purpose of the ferrous gluconate/isotonic
saline solution is to enable the final medicament to hold a magnetic
charge when it is passed through a magnetic field. Injectable dosage
portions of 0.2 cc volumes were set aside as needed. The formulations
injected were controllably magnetized during administration through the
acupuncture sites as described above.
Example 6
An injectable dosage form of an herb-based homeopathic medicament,
designated HRM-4, for the treatment of premenstrual syndrome, menopause,
menstrual discomfort and irregularities, and reproductive hormonal
imbalance, was prepared from an original concentrated tincture menstruum
containing an extract of the herb Angelica sinensis and extract of
pineal gland in 99+% alcohol. The original concentrated tincture was
diluted to 29.times. potency (10.sup.-29 times the original
concentration) with sterile distilled water. Sufficient ferrous
gluconate solution, a magnetically permeable substance, was added to
sterile isotonic saline to make a homeopathic potency of
4.times.(10.sup.-4). The 29.times. dilution of the medicament was added
to the ferrous gluconate/isotonic saline solution to prepare the final
30.times. medicament. The purpose of the ferrous gluconate/isotonic
saline solution is to enable the final medicament to hold a magnetic
charge when it is passed through a magnetic field. Injectable dosage
portions of 0.2 cc volumes were set aside as needed. The formulations
injected were controllably magnetized during administration through the
acupuncture sites as described above.
Example 7
An injectable dosage form of a homeopathic medicament, designated
HYT-12, for the treatment of hypothyroidism, was prepared from an
original concentrated tincture menstruum containing a solution of iodine
crystals and extract of pineal gland in 99+% alcohol. The original
concentrated tincture was diluted to 29.times. potency (10.sup.-29 times
the original concentration) with sterile distilled water. Sufficient
ferrous gluconate solution, a magnetically permeable substance, was
added to sterile isotonic saline to make a homeopathic potency of
4.times.(10.sup.-4). The 29.times. dilution of the medicament was added
to the ferrous gluconate/isotonic saline solution to prepare the final
30.times. medicament. The purpose of the ferrous gluconate/isotonic
saline solution is to enable the final medicament to hold a magnetic
charge when it is passed through a magnetic field. Injectable dosage
portions of 0.2 cc volumes were set aside as needed. The formulations
injected were controllably magnetized during administration through the
acupuncture sites as described above.
Example 8
An injectable dosage form of an herb-based homeopathic medicament for
the treatment of nervous tension, designated RLX-22, was prepared from
an original tincture menstruum containing extracts of the herbs
Helianthemum canadense, Ornithogalum umbellatum, Clematis crispa,
Impatiens pallida, Prunus Cerasus and Valeriana officinalis, and extract
of pineal gland in 99+% alcohol. The original concentrated tincture was
diluted to 29.times. potency (10.sup.-29 times the original
concentration) with sterile distilled water. Sufficient ferrous
gluconate solution, a magnetically permeable substance, was added to
sterile isotonic saline to make a homeopathic potency of
4.times.(10.sup.-4). The 29.times. dilution of the medicament was added
to the ferrous gluconate/isotonic saline solution to prepare the final
30.times. medicament. The purpose of the ferrous gluconate/isotonic
saline solution is to enable the final medicament to hold a magnetic
charge when it is passed through a magnetic field. Injectable dosage
portions of 0.2 cc volumes were set aside as needed. The formulations
injected were controllably magnetized during administration through the
acupuncture sites as described above.
Example 9
An injectable dosage from of an herb-based homeopathic medicament,
designated IMM-2, for restoring and strengthening the body's natural
immune system, having a homeopathic potency of 30.times. was prepared
from an original concentrated tincture menstruum containing extracts of
the herbs Panex ginseng, Astragalus membranaceus and Rubia cordifolia,
and Snake venom, extract of thymus gland, and extract of pineal gland in
99+% alcohol. The original concentrated tincture was diluted to
29.times. potency (10.sup.-29 times the original concentration) with
sterile distilled water. Sufficient ferrous gluconate solution, a
magnetically permeable substance, was added to sterile isotonic saline
to make a homeopathic potency of 4.times.(10.sup.-4). The 29.times.
dilution of the medicament was added to the ferrous gluconate/isotonic
saline solution to prepare the final 30.times. medicament. The purpose
of the ferrous gluconate/isotonic saline solution is to enable the final
medicament to hold a magnetic charge when it is passed through a
magnetic field. Injectable dosage portions of 0.2 cc volumes were set
aside as needed. The formulations injected were controllably magnetized
during administration through the acupuncture sites as described above.
Example 10
An injectable dosage form of a homeopathic medicament for the treatment
of hypoglycemia, designated HYG-6, was prepared from an original
concentrated tincture menstruum containing sulfur and vegetable glycerin
in 99+% alcohol. The original concentrated tincture was diluted to
29.times. potency (10.sup.-29 times the original concentration) with
sterile distilled water. Sufficient ferrous gluccanate solution, a
magnetically permeable substance, was added to sterile isotonic saline
to make a homeopathic potency of 4.times.(10.sup.-4). The 29.times.
dilution of the medicament was added to the ferrous gluconate isotonic
saline solution to prepare the final 30.times. medicament. The purpose
of the ferrous gluconate/isotonic saline solution is to enable the final
medicament to hold a magnetic charge when it is passed through a
magnetic field. Injectable dosage portions of 0.2 cc volumes were set
aside as needed. The formulations injected were controllably magnetized
during administration through the acupuncture sites as described above.
Example 11
An injectable dosage form of an herb-based homeopathic medicament,
designated INF-16, for the treatment of bacterial infections,
particularly staph and strep, was prepared from an original concentrated
tincture menstruum containing extracts of her herbs Seniccio scandens,
Scutellaria baicalensis, Magnolia officinalis, Lonicera japonica,
Andrographis paniculata, Centella asiatica minor, Leptotaenia multifida
and Pupalia geniculata, and Moschus moschiferous, Cow bezoar, Snake's
gall and extract of pineal gland in 99+% alcohol. The original
concentrated tincture was diluted to 29.times. potency (10.sup.-29 times
the original concentration) with sterile distilled water. Sufficient
ferrous gluconate solution, a magnetically permeable substance, was
added to sterile isotonic saline to make a homeopathic potency of
4.times.(10.sup.-4). The 29.times. dilution of the medicament was added
to the ferrous gluconate/isotonic saline solution to prepare the final
30.times. medicament. The purpose of the ferrous gluconate/isotonic
saline solution is to enable the final medicament to hold a magnetic
charge when it is passed through a magnetic field. Injectable dosage
portions of 0.2 cc volumes were set aside as needed. The formulations
injected were controllably magnetized during administration through the
acupuncture sites as described above.
Example 12
An injectable dosage from of an herb-based homeopathic medicament,
designated FLU-17, for the treatment of viral infections due to colds
and influenza, particularly rhino-virus, was prepared from an original
concentrated tincture menstruum containing extracts of the herbs
Lonicera confusa, Chrysanthemum indicum, Vitex negundo, Evodia lepta,
Ilex asprella, Baphicacanthus cusia and Centella asiatica minor, and
Menthol crystal and extract of pineal gland in 99+% alcohol. The
original concentrated tincture was diluted to 29.times. potency
(10.sup.-29 times the original concentration) with sterile distilled
water. Sufficient ferrous gluconate solution, a magnetically permeable
substance, was added to sterile isotonic saline to make a homeopathic
potency of 4.times.(10.sup.-4). The 29.times. dilution of the medicament
was added to the ferrous gluconate/isotonic saline solution to prepare
the final 30.times. medicament. The purpose of the ferrous gluconate/isotonic
saline solution is to enable the final medicament to hold a magnetic
charge when it is passed through a magnetic field. Injectable dosage
portions of 0.2 cc volumes were set aside as needed. The formulations
injected were controllably magnetized during administration through the
acupuncture sites as described above.
Example 13
An injectable dosage form of an herb-based homeopathic medicament,
designated ALL-5, for the treatment of hayfever and airborne allergies,
was prepared from an original concentrated tincture menstruum containing
extracts of the herbs Gentiana lutea, Citrus aurantium, Tanacetum
vulgare, Cnicus benedictus, Menyanthes trifoliata, Grindelia robusta,
Ephedra sinica, Centipeda minima and Centella asiatica minor, and
extract of pineal gland in 99+% alcohol. The original concentrated
tincture was diluted to 29.times. potency (10.sup.-29 times the original
concentration) with sterile distilled water. Sufficient ferrous
gluconate solution, a magnetically permeable substance, was added to
sterile isotonic saline to make a homeopathic potency of
4.times.(10.sup.-4). The 29.times. dilution of the medicament was added
to the ferrous gluconate/isotonic saline solution to prepare the final
30.times. medicament. The purpose of the ferrous gluconate/isotonic
saline solution is to enable the final medicament to hold a magnetic
charge when it is passed through a magnetic field. Injectable dosage
portions of 0.2 cc volumes were set aside as needed. The formulations
injected were controllably magnetized at the time of administration
through the acupuncture sites as described above.
Example 14
An injectable dosage form of an herb-based homeopathic medicament,
designated APN-25, for the treatment of chronic muscular and joint pain,
having a homeopathic potency of 5.times. was prepared from an original
concentrated tincture menstruum containing extracts of the herbs Arnica
Montana, Symphytum officianalis, Pupalia geniculata, Rhus Toxicum,
Plantago asiatica, Causticum (a homeopathic medicament prepared from
burnt lime), Helianthemum canadense, Ornithogalum umbellatum, Clematis
crispa, Impatiens pallida and Prunus Cerasus, and Moschus moschiferous,
Cow bezoar, Snake's gall, Germanium dioxide, and extract of pineal gland
in 99+% alcohol. The original concentrated tincture was diluted to
29.times. potency (10.sup.-29 times the original concentration) with
sterile distilled water. Sufficient ferrous gluconate solution, a
magnetically permeable substance, was added to sterile isotonic saline
to make a homeopathic potency of 4.times.(10.sup.-4). The 29.times.
dilution of the medicament was added to the ferrous gluconate/isotonic
saline solution to prepare the final 30.times. medicament. The purpose
of the ferrous gluconate/isotonic saline solution is to enable the final
medicament to hold a magnetic charge when it is passed through a
magnetic field. Injectable dosage portions of 0.2 cc volumes were set
aside as needed. The formulations injected were controllably magnetized
during administration through the acupuncture sites as described above.
Example 15
An injectable dosage form of a homeopathic medicament, designated ADR-3,
for the treatment of hypoadrenalism, was prepared from an original
concentrated tincture menstruum containing extract of adrenal gland in
99+% alcohol. The original concentrated tincture was diluted to
29.times. potency (10.sup.-29 times the original concentration) with
sterile distilled water. Sufficient ferrous gluconate solution, a
magnetically permeable substance, was added to sterile isotonic saline
to make a homeopathic potency of 4.times.(10.sup.-4). The 29.times.
dilution of the medicament was added to the ferrous gluconate/isotonic
saline solution to prepare the final 30.times. medicament. The purpose
of the ferrous gluconate/isotonic saline solution is to enable the final
medicament to hold a magnetic charge when it is passed through a
magnetic field. Injectable dosage portions of 0.2 cc volumes were set
aside as needed. The formulations injected were controllably magnetized
at the time of administration through the acupuncture sites as described
above.
Example 16
An injectable dosage form of a homeopathic medicament, designated
CIR-18, to promote circulation, was prepared from an original
concentrated tincture menstruum containing Germanium dioxide and extract
of pineal gland in 99+% alcohol. The original concentrated tincture was
diluted to 29.times. potency (10.sup.-29 times the original
concentration) with sterile distilled water. Sufficient ferrous
gluconate solution, a magnetically permeable substance, was added to
sterile isotonic saline to make a homeopathic potency of
4.times.(10.sup.-4). The 29.times. dilution of the medicament was added
to the ferrous gluconate/isotonic saline solution to prepare the final
30.times. medicament. The purpose of the ferrous gluconate/isotonic
saline solution is to enable the final medicament to hold a magnetic
charge when it is passed through a magnetic field. Injectable dosage
portions of 0.2 cc volumes were set aside as needed. The formulations
injected were controllably magnetized at the site of administration
through the acupuncture sites as described above.
Example 17
An injectable dosage form of an herb-based homeopathic medicament,
designated DTX-28, for the removal of toxicity, was prepared from an
original concentrated tincture menstruum containing extracts of the
herbs Nux vomica, Plantago asiatica, and Carduus marianus, and Germanium
dioxide and extract of pineal gland in 99+% alcohol. The original
concentrated tincture was diluted to 29.times. potency (10.sup.-29 times
the original concentration) with sterile distilled water. Sufficient
ferrous gluconate solution, a magnetically permeable substance, was
added to sterile isotonic saline to make a homeopathic potency of
4.times.(10.sup.-4). The 29.times. dilution of the medicament was added
to the ferrous gluconate/isotonic saline solution to prepare the final
30.times. medicament. The purpose of the ferrous gluconate/isotonic
saline solution is to enable the final medicament to hold a magnetic
charge when it is passed through a magnetic field. Injectable dosage
portions of 0.2 cc volumes were set aside as needed. The formulations
injected were controllably magnetized during administration through the
acupuncture sites as described above.
Example 18
An injectable dosage form of an herb-based homeopathic medicament,
designated TON-29, for tonification, was prepared from an original
concentrated tincture menstruum containing extracts of the herbs Verbena
hastata, Ephedra sinensis, Turner aphrodisiaca, Sabel serrulata,
Hydrocotyle asiatica, Linosma ovata, Panex ginseng and Echinacea
angustifolia, and extract of pineal gland in 99+% alcohol. The original
concentrated tincture was diluted to 29.times. potency (10.sup.-29 times
the original concentration) with sterile distilled water. Sufficient
ferrous gluconate solution, a magnetically permeable substance, was
added to sterile isotonic saline to make a homeopathic potency of
4.times.(10.sup.-4). The 29.times. dilution of the medicament was added
to the ferrous gluconate/isotonic saline solution to prepare the final
30.times. medicament. The purpose of the ferrous gluconate/isotonic
saline solution is to enable the final medicament to hold a magnetic
charge when it is passed through a magnetic field. Injectable dosage
portions of 0.2 cc volumes were set aside as needed. The formulations
injected were controllably magnetized during administration through the
acupuncture sites as described above.
Example 19
An injectable dosage form of an herb-based homeopathic medicament,
designated OPT-37, for the treatment of senile macular degeneration, was
prepared from an original concentrated texture menstruum containing
extracts of the herbs Euphrasia officinalis, Pupalia geniculata, Ginkgo
biloba, Vaccinium myrtillus and Hypericum perforiatum, and Moschus
moschiferous, Cow bezoar, Snake's gall and extract of pineal gland in
99+% alcohol. The original concentrated tincture was diluted to
29.times. potency (10.sup.-29 times the original concentration) with
sterile distilled water. Sufficient ferrous gluconate solution, a
magnetically permeable substance, was added to sterile isotonic saline
to make a homeopathic potency of 4.times.(10.sup.-4). The 29.times.
dilution of the medicament was added to the ferrous gluconate/isotonic
saline solution to prepare the final 30.times. medicament. The purpose
of the ferrous gluconate/isotonic saline solution is to enable the final
medicament to hold a magnetic charge when it is passed through a
magnetic field. Injectable dosage portions of 0.2 cc volumes were set
aside as needed. The formulations injected were controllably magnetized
during administration through the acupuncture sites as described above.
Example 20
An injectable dosage form of an herb-based homeopathic medicament,
designated LVB-38, for the treatment of liver disfunction, was prepared
from an original concentrated tincture menstruum containing extracts of
the herbs Desmodium stracifolium and Carduus marianus, and extract of
pineal gland in 99+% alcohol. The original concentrated tincture was
diluted to 29.times. potency (10.sup.-29 times the original
concentration) with sterile distilled water. Sufficient ferrous
gluconate solution, a magnetically permeable substance, was added to
sterile isotonic saline to make a homeopathic potency of
4.times.(10.sup.-4). The 29.times. dilution of the medicament was added
to the ferrous gluconate/isotonic saline solution to prepare the final
30.times. medicament. The purpose of the ferrous gluconate/isotonic
saline solution is to enable the final medicament to hold a magnetic
charge when it is passed through a magnetic field. Injectable dosage
portions of 0.2 cc volumes were set aside as needed. The formulations
injected were controllably magnetized during administration through the
acupuncture sites as described above.
Example 21
An injectable dosage form of an herb-based homeopathic medicament,
designated TMR-41, for the reduction of tumors, was prepared from the
original concentrated tincture menstruum containing extracts of the
herbs Hypericum japonicum, Prunella vulgaris, Chrysanthemum indicum,
Linum usitatissimum, Ulmus fulva, Nymphaea odorata and Centella asiatica
minor, and extract of pineal gland in 99+% alcohol. The original
concentrated tincture was diluted to 29.times. potency (10.sup.-29 times
the original concentration) with sterile distilled water. Sufficient
ferrous gluconate solution, a magnetically permeable substance, was
added to sterile isotonic saline to make a homeopathic potency of
4.times.(10.sup.-4). The 29.times. dilution of the medicament was added
to the ferrous gluconate/isotonic saline solution to prepare the final
30.times. medicament. The purpose of the ferrous gluconate/isotonic
saline solution is to enable the final medicament to hold a magnetic
charge when it is passed through a magnetic field. Injectable dosage
portions of 0.2 cc volumes were set aside as needed. The formulations
injected were controllably magnetized during administration through the
acupuncture sites as described above.
Example 22
An injectable dosage form of an herb-based homeopathic medicament,
designated ISC-43, for the treatment of inflammatory conditions and
rouleau cell formation, was prepared from the original concentrated
tincture menstruum containing extracts of the herbs Ilex pubescents,
Salvia multiorrhiza, Andrographis paniculata, Ganoderma japonicum,
Pupalia geniculata and Centella asiatica minor, and Moschus
moschiferous, Cow bezoar, Snake's gall, Germanium dioxide and extract of
pineal gland in 99+% alcohol. The original concentrated tincture was
diluted to 29.times. potency (10.sup.-29 times the original
concentration) with sterile distilled water. Sufficient ferrous
gluconate solution, a magnetically permeable substance, was added to
sterile isotonic saline to make a homeopathic potency of
4.times.(10.sup.-4). The 29.times. dilution of the medicament was added
to the ferrous gluconate/isotonic saline solution to prepare the final
30.times. medicament. The purpose of the ferrous gluconate/isotonic
saline solution is to enable the final medicament to hold a magnetic
charge when it is passed through a magnetic field. Injectable dosage
portions of 0.2 cc volumes were set aside as needed. The formulations
injected were controllably magnetized during administration through the
acupuncture sites as described above.
Example 23
An injectable dosage form of an herb-based homeopathic medicament,
designated TBR-44, for the treatment of tuberculosis, was prepared from
an original concentrated tincture menstruum containing extracts of the
herbs Centella asiatica minor and Artemesia apiacea, and Tuberculimum
(homeopathic tincture) and extract of pineal gland in 99+% alcohol. The
original concentrated tincture was diluted to 29.times. potency
(10.sup.-29 times the original concentration) with sterile distilled
water. Sufficient ferrous gluconate solution, a magnetically permeable
substance, was added to sterile isotonic saline to make a homeopathic
potency of 4.times.(10.sup.-4). The 29.times. dilution of the medicament
was added to the ferrous gluconate/isotonic saline solution to prepare
the final 30.times. medicament. The purpose of the ferrous
gluconate/isotonic saline solution is to enable the final medicament to
hold a magnetic charge when it is passed through a magnetic field.
Injectable dosage portions of 0.2 cc volumes were set aside as needed.
The formulations injected were controllably magnetized during
administration through the acupuncture sites as described above.
B. Oral Form
Example 24
An oral dosage form of the herb-based homeopathic medicament FNG-11,
having the components as in Example 1 above, having a homeopathic
potency of 30.times., was prepared in accordance with the procedure
described above in connection with impregnating the lollipop illustrated
in FIG. 1. Similarly, a transdermal dosage form was prepared also as
described above.
Example 25
An oral or transdermal dosage form of the herb-based homeopathic
medicament HG-9, having the components as in Example 2, having a
homeopathic potency of 30.times., was prepared according to the method
of Example 24.
Example 26
An oral or transdermal dosage form of the herb-based homeopathic
medicament VR-27, having the components as in Example 3, having a
homeopathic potency of 30.times., was prepared according to the method
of Example 24.
Example 27
An oral or transdermal dosage form of the herb-based homeopathic
medicament SPN-7, having the components as in Example 4, having a
homeopathic potency of 30.times., was prepared according to the method
of Example 24.
Example 28
An oral or transdermal dosage form of the homeopathic medicament TYR-10,
having the components as in Example 5, having a homeopathic potency of
30.times., was prepared according to the method of Example 24.
Example 29
An oral or transdermal dosage form of the herb-based homeopathic
medicament HRM-4, having the components as in Example 6, having a
homeopathic potency of 30.times., was prepared according to the method
of Example 24.
Example 30
An oral or transdermal dosage form of the homeopathic medicament HYT-12,
having the components as in Example 7, having a homeopathic potency of
30.times., was prepared according to the method of Example 24.
Example 31
An oral or transdermal dosage form of the herb-based homeopathic
medicament RLX-22, having the components as in Example 8, having a
homeopathic potency of 30.times., was prepared according to the method
of Example 24.
Example 32
An oral or transdermal dosage form of the herb-based homeopathic
medicament IMM-2, having the components as in Example 9, having a
homeopathic potency of 30.times., was prepared according to the method
of Example 24.
Example 33
An oral or transdermal dosage form of the homeopathic medicament HYG-6,
having the components as in Example 10, having a homeopathic potency of
30.times., was prepared according to the method of Example 24.
Example 34
An oral or transdermal dosage form of the herb-based homeopathic
medicament INF-16, having the components as in Example 11, having a
homeopathic potency of 30.times., was prepared according to the method
of Example 24.
Example 35
An oral or transdermal dosage form of the herb-based homeopathic
medicament FLU-17, having the components as in Example 12, having a
homeopathic potency of 30.times., was prepared according to the method
of Example 24.
Example 36
An oral or transdermal dosage form of the herb-based homeopathic
medicament ALL-5, having the components as in Example 13, having a
homeopathic potency of 30.times., was prepared according to the method
of Example 24.
Example 37
An oral or transdermal dosage form of the herb-based homeopathic
medicament APN-25, having the components as in Example 14, having a
homeopathic potency of 30.times., was prepared according to the method
of Example 24.
Similarly, oral or transdermal dosage forms of the homeopathic
medicaments as in Examples 15-23, having homeopathic potency of
30.times., were prepared according to the method of Example 24.
CLINICAL EXAMPLES
AIDS Study Protocol
This study program ran for about 60 weeks comprising the therapeutic
phase. Many patients continued on and participated in the
maintenance/prophylaxis aspect for a total participation of
approximately 21/2 years.
Example 38
The treatment regimen in this example utilized a series of specifically
prepared homeopathic medicaments formulated from totally natural
botanicals, minerals and other natural substances, and compounded into
highly dilute (30.times.) homeopathic preparations. Each material was
used in triad form: an injectable, an oral and a transdermal patch.
The list of these special medicaments together with the condition
treated is as follows:
______________________________________
IMM-2 immunity boost
ADR-3 adrenal insufficiency
HG-9 intestinal parasites
TYR-10 thyroid regulation
FNG-11 Candida albicans/other systemic fungus
infections
INF-16 bacterial infection
FLU-17 common cold, flu
CIR-18 circulatory problems
RLX-22 tension and nervousness
APN-25 pain in muscles, tendons, ligaments
VR-27 viral infections
DTX-28 detoxification
TON-29 general tonic
OPT-37 optical problems (Guillain-Barre Syndrome)
LVB-38 liver boost
TMR-41 internal tumors
ISC-43 red cell "clumping"
TBR-44 tuberculosis
______________________________________
COMPONENTS OF TREATMENT
Injection
Homeopathic medicaments were injected into the body at specific
acupuncture points. A 0.2 cc quantity was introduced into each bilateral
point with a 30 ga 1/2" needle. For example, the bi-lateral
acupuncture point used in conjunction with VR-27, the anti-viral, is
identified on traditional Chinese charts as TW-5. Other points used with
different Homeopathic medicaments for treating peripheral conditions (as
noted below) were ST-36,37; SP-6,9; LI-11; GB-34, etc. These points are
all categorized in Traditional Chinese Medicine as Command Points and
are regarded as being especially effective. Further, they were selected
on the basis of previous trial and error applications to determine which
would be most effective for each specific malady. Generally, only one
pair of points was used to treat each disease entity. All of the
injection sites are located distally to the knee and elbow. As a result,
they were easily located through the use of anatomical landmarks and
present little risk of injury to the patient.
Oral Medication
In addition to being given a series of injections, each patient received
oral (lollipop) homeopathic medication. The therapeutic component
consisted of the same botanical herbs that comprised the injectable
medication. This medication format was also in the highly dilute form
traditionally characteristic of all homeopathic medicaments.
Topical Application
The third treatment modality was a transdermal patch that was taped to
the skin directly over the appropriate acupuncture points. The patches
contained the same formulations in the same highly dilute form as noted
above, compounded into a preparation suitable for this type of
application.
Thus, the complete therapeutic modality utilized the interlocking action
of homeopathy,
acupuncture, magnetism and herbalism all of which share a long history
of providing effective healing for a wide variety of disease entities.
In application, the homeopathic remedies used within this study were
introduced into the body by injection via the acupuncture points while
their action was reinforced by the parallel use of the same homeopathic
medication in oral form and as a transdermal application.
Stimulation
In each of the three forms, the medications delivered to the body were
magnetically stimulated at the time of introduction. Like the
medicaments themselves, the stimulation was at a homeopathic level.
Treatment of Peripheral Disease Problems
Although this study focused upon the viral component of use of VR-27 as
a therapeutic agent, AIDS cannot be considered to be a single disease
entity. Usually patients present with a variety of subsidiary symptoms
closely associated with the primary viral infection. Commonly seen are
such other viral diseases as herpes, CEBV, CMV and hepatitis. Bacterial
infections include staphylococcus, streptococcus and chlamydia. Fungal
infections include Candida albicans in various manifestations.
Parasitical infections include Entamoeba histolytica and Giardia
lamblia. Pneumocyctis carinii and Syphilis may also be present.
Therefore, although outside the scope of the primary investigation, this
test program also employed a parallel series of homeopathic/acupuncture
treatments for these associated medical conditions where they existed.
The following homeopathic formulations were used for treating the above
noted medical conditions:
______________________________________
FNG-11 (for treatment of fungal infections)
INF-16 (for treatment of bacterial infections)
HG-9 (for treatment of intestinal parasites)
DTX-26 (for detoxifying)
IMM-2 (for encouraging the rebuilding of the immune
system)
______________________________________
In addition, other medicaments selected from the other homeopathic
medicaments described were used where such applications were indicated.
CRITERIA FOR PATIENT INCLUSION AND EXCLUSION
Inclusion
As primary criteria, the first screening was in accordance with the
criteria developed by the Walter Reed Army Hospital to ascertain the
presence of AIDS.
As a prime criteria, the patients had to be HIV positive with a Western
Blot confirmation.
Further screening was on the basis of:
A. Abnormal number of T-4 lymphocytes and abnormal ratio of T-4 to T-8
lymphocytes under 0.6.
B. Age 18 to 60
C. Ability to provide informed consent
D. Ability to keep all appointments
The final group selected included a total of 28 patients. There was a
second evaluation procedure for the participants to identify the
presence of other medical conditions.
Exclusion
The following categories of patients were excluded from the study:
1. Patients on a treatment regimen that utilized highly potent, toxic or
immuno-suppressive drugs such as AZT.
2. Patients receiving medications or supplements of such potency or in
sufficient dosage as to interfere with the activity of the homeopathic
medications.
3. Patients who were already being treated for life threatening diseases
of such severity that, in the opinion of the Administering Physician,
they were terminal.
TREATMENT SCHEDULE FOR PATIENTS IN THE STUDY
For the first 52 weeks, the patients were treated twice a week. During
this period, two medicaments were generally administered at each visit,
with DTX-28 forming a constant along with the regularly scheduled
medications. During this period, treatment was semi-customed to address
each patient's most pressing medical needs with medicines selected from
the following materials:
Anti-Pathogens
VR-27
INF-16
HG-9
FNG-11
According to the patient's pattern of response, the treatment was
gradually broadened to include:
Adjunct Medication
IMM-2
ADR-3
TYR-10
After the first 60 weeks, the treatment schedule was modified to once a
week. As patients began to show favorable response, Anti-Pathogens were
only used on alternate visits with maintenance and prophylaxis
medications filling in the blanks in the schedule.
During this phase, when the need for direct therapeutic action was not
as intense, some additional medications to deal with specific problems
were also used. For example, when there was concern about a possible
epidemic of Influenza, all patients were given two treatments with
FLU-17. One patient was given OPT-37 to deal with his Guillain-Barre
Syndrome.
Maintenance Medication
CIR-18
TON-29
RLX-22
ISC-43
TESTS USED WITHIN THE STUDY FOR PATIENTS ACCEPTED AFTER SCREENING
Each patient received a series of weekly, biweekly and monthly lab tests
to provide the tightest possible monitoring of incremental results.
Intake and End-Of-Study Tests
Clinical work-up: Karnofsky score
Laboratory Procedures:
P-24 antigen
Total T-cells+T4/T8 ratio, absolute B-cells
Beta-2-Microblobulin
Neopterin
Circulating Immune Complex, C1Q & C3B
Antibody titers: (IGG & IGM)
Herpes I & II
CMV
EB-VCA
EBV-EA
Hepatitis B diagnostic panel
HIV (quantitative antibody)
CEIA (Candida antibody)
LA-Candida (Candida antigen)
Complete blood count, differential, platelets, hemoglobin and hematocrit
Sedimentation rate
Urethral smear (male) and vaginal smear (female) for Chlamydia
Rectal swab for parasites
Cryptosporidium (stool sample if diarrhea is present)
Candida quantitative culture (mouth lavage)
Gonorrhea culture (urethral or vaginal)
Syphilis serology--RPR, FTA confirmation quantitative
Chem 25 with liver battery
B12-folic acid-iron assays (if hemoglobin below 10 GM/DL) with
reticulocyte count
Urinalysis
Multi-skin tests for DTHS-CMI Multi-Test
Weekly Testing
HIV Antigen (when initially positive)
Antibody titers--(IGG)
Herpes I & II
CMV
EB-VCA
EBV EA
Hepatitis B (to follow chronic carriers)
HIV (quantitative antibody)
CEIA (Candida antibody)
FTA (quantitative)
Chem 25 (with liver battery)
Complete blood count, differential, platelets, hemoglobin, and
hematocrit (if hemoglobin drops below 10 GM/DL, do anemia profile)
Sedimentation rate
Urinalysis
Interval Testing
Candida quantitative culture (mouth lavage)
Total T-cells+T4/T8 ratio, absolute B-cells
Beta 2-Microblobulin
Multi-skin tests for DTHS-CMI Multi-Test
Neopterin
Rectal swab (for intestinal parasites)
TESTING AND RESULTS
I. Analysis of DTHS--Delayed Type Hypersensitivity Skin Tests
As noted in the Merck Manual (fifteenth edition), the T-cell-mediated
portion of the immune system, which is responsible for delayed skin
tests and delayed hypersensitivity, is an important defense against
malignant cells, viral infections, fungal infections and some bacteria.
Delayed Hypersensitivity Skin Tests are valuable screening tests for
T-cell deficiency. The presence of one or more positive delayed skin
tests generally indicates an intact T-cell system.
Many HIV studies regard this measurement as one of the most commonly
monitored parameters of immune functioning.
The favorable direction of the following statistics is in direct
contrast with the usual expectations.
Abstract
Twenty-seven HIV-positive patients enrolled in the study were assessed
on the number and total size of positive reactions to skin test antigens
for cellular hypersensitivity at five points in time. Results indicated
improvement over time with respect to both the number and total size of
positive skin test reactions.
Results and Discussion
Tables 1 and 2 give the mean number of reactions, and the mean size of
the reactions at each time. Trace reactions refer to values of 0.50 mm.
The complete data are provided in Table 3.
TABLE 1
__________________________________________________________________________
MEAN NUMBER OF POSITIVE SKIN REACTIONS
PATIENTS
PATIENTS IN
WITH-
TREATMENT DRAWING
THROUGH BEFORE
ALL FEBRUARY FEBRUARY
PATIENTS
1991 1991
MEAN N MEAN N MEAN N
__________________________________________________________________________
INTAKE 0.26 27
0.36 11
0.19 16
JAN/FEB 1989
0.86 22
0.57 7
1.00 15
AUGUST 1989
2.29 14
2.30 10
2.25 4
FEBRUARY 1990
4.00 12
3.88 8
4.25 4
FEBRUARY 1991
4.55 11
4.55 11
-- --
__________________________________________________________________________
TABLE 2
__________________________________________________________________________
MEAN TOTAL SIZE OF ALL POSITIVE REACTIONS
PATIENTS
PATIENTS IN
WITH-
TREATMENT DRAWING
THROUGH BEFORE
ALL FEBRUARY FEBRUARY
PATIENTS
1991 1991
MEAN N MEAN N MEAN N
__________________________________________________________________________
INTAKE 0.63 27
1.00 11
0.38 16
JAN/FEB 1989
0.95 22
0.29 7
1.27 15
AUGUST 1989
5.49 14
6.17 10
3.80 4
FEBRUARY 1990
13.13 12
12.88 8
13.63 4
FEBRUARY 1991
10.70 11
10.70 11
-- --
__________________________________________________________________________
NOTE: The two patients with intake at February 1989 are included only in
the intake entries (not in the January/February 1990 entries).
TABLE 3
__________________________________________________________________________
DELAYED HYPERSENSITIVITY SKIN TEST (CMI MULTI SKIN TEST) DATA
INTAKE JAN/FEB-89
PATIENT
NOV/DEC-88
10 WEEKS AFTER
# OR AS NOTED
INTAKE TEST
AUG-89 FEB-90
FEB 91
__________________________________________________________________________
1 0/0 2/2T drop-out
2/6 + 1T
2 0/0 3/2.5 + 2T 3/2.7 + 2T
5/20.5
3 0/0 0/0 drop-out
3/12.5
4 2/2T (6.89) 1/1T 4/14.5
5/12.5
5 0/0 2/2T drop-out
6 0/0 0/0 2/1.5 + 1T
4/15.5
4/8
7 1/5 (2/89) 2/9.5 4/16
9 1/1T (2/89) 1/1T 4/10.5
10 0/0 0/0 drop-out
11 0/0 1/1T drop-out
12 0/0 2/2T 2/8 4/13.5
4/12 + 1T
13 1/5 (6/89) 3/12 4/15 6/19.75
14 0/0 (6/89) 4/12 5/14.5
4/2 + 3T
15 0/0 0/0 1/1 absent
2/7 + 1T
16 0/0 0/0 drop-out
17 0/0 0/0 drop-out
18 0/0 0/0 died-(Ap-89)
19 0/0 2/2T drop-out
2/10
20 0/0 0/0 4/9.9 4/10 + 1T
21 0/0 1/1T 3/5.75 + 1T
2/6 3/2.5 + 2T
23 0/0 1/1T 3/3T 4/10
24 0/0 1/1T absent 4/13.5
6/9 + 3T
25 0/0 0/0 drop-out
26 2/5 2/10.5 2/9.5 4/13.5
27 0/0 2/2T drop-out
28 0/0 0/0 drop-out
29 0/0 0/0 1/1T 4/10.5
7/12.5 + 2T
__________________________________________________________________________
NOTE: Patient #8 was an HIV negative partner of participating patient. No
skin tests were done on #8. Patient #22 did not complete initial 12 week
phase of treatment. Patient #22 had only one skin test with 0/0 response.
Absent means that patient was not in attendance at clinic on the day
scheduled for group skin tests.
Numbers to the left of the slash are the number of positive reactions.
Numbers to the right of the slash are the total sizes of all positive
reactions.
A "T" indicates that the size of the reaction is a trace.
There is clearly an increase in the number of positive skin reactions
over the course of the study. Not surprisingly, since the overwhelming
majority of patients had no reactions at intake, there was also an
increase in the total size of all of the positive reactions (p<0.01).
Summary
The following measurements were assessed on the twenty seven
HIV-positive patients enrolled in the study:
1. The number of positive reactions to DTHS skin test antigens for
cellular hypersensitivity at five points in time.
2. The total size of positive reactions to DTHS skin test antigens for
cellular hypersensitivity at five points in time.
The results indicate significant improvement over the course of the
study as indicated by increases in both the number of positive reactions
to skin tests and the total size of those positive reactions.
II. Analysis of Karnofsky Performance Sales
Abstract
Twenty seven HIV-positive patients enrolled in the study were assessed
on the Karnofsky Performance Scale at three points in time. Results
indicate improvement over time with respect to percentage on this
clinical classification system. A sample Karnofsky Performance scale is
as follows:
______________________________________
SAMPLE KARNOFSKY PERFORMANCE SCALE
______________________________________
Able to carry on normal
100% Normal, no complaints, no
activity; no special evidence of disease.
care is needed.
90% Able to carry on normal
activity; minor signs of
disease.
80% Normal activity with effort;
some signs or
symptoms of disease
Unable to work; able to
70% Cares for self; unable to
live at home and care carry on normal activity or
for most personal needs;
to do active work.
a varying amount of
assistance is needed.
60% Requires occasional
assistance but is able to
care for most of his needs.
50% Requires considerable
assistance and frequent
medical care.
Unable to care for self;
40% Disabled; requires special
requires equivalent of care and assistance.
institutional or
hospital care; disease
may be progressing
rapidly.
30% Severely disabled;
hospitalization is indicated
although death not imminent.
20% Very sick; hospitalization
necessary; active supportive
treatment is necessary.
10% Moribund; fatal processes
progressing rapidly.
0% Dead.
______________________________________
Results and Discussion
Significant improvement as measured by the Karnofsky score was noted
between intake and March, 1991, for the eleven patients who had
completed the Therapeutic phase of the treatment and were continuing on
the Maintenance/Prophylaxis phases (p=0.0077). All eleven patients had
Karnofsky scores of 100% in March, 1991, (see Tables 4-6). Further
examination of the data indicated that these eleven patients exhibited
significant improvement as early as February/March, 1990, when ten of
the eleven had already achieved Karnofsky scores of 100%, and one
patient had a score of 95%.
There was clear evidence of improvement in the eleven patients who
continued in the study through March, 1991. All eleven patients achieved
Karnofsky scores of 100% (ten reached this level as early as
February/March, 1990, the one patient not at 100% at this time was at
95%). The four patients who completed the Therapeutic phase but did not
continue with the full Maintenance/Prophylaxis phase had achieved scores
of 100% by February/March, 1990. These four, as well as the twelve
patients who withdrew between April and June, 1989, had comparable
values at intake.
TABLE 4
__________________________________________________________________________
KARNOFSKY SCORE DATA
INTAKE
PATIENT
NOV/DEC 1988
# OR AS NOTED
FEBRUARY/MARCH 1990
MARCH 1991
__________________________________________________________________________
1 90% drop-out
2 90% 100% no maintenance
3 90% 50% drop-out
returned for
follow-up
4 100% (6/90)
100% 100%
5 80% drop-out
6 80% 100% 100%
7 100% (2/89)
100% 100%
9 80% (2/89)
100% some
maintenance
10 90% drop-out
11 90% drop-out
12 85% 100% 100%
13 80% (6/89)
100% 100%
14 90% (6/89)
100% 100%
15 90% 100% 100%
16 80% drop-out
17 90% drop-out
18 80% died - (Ap-89)
19 80% 100% drop-out
returned for
follow-up
20 90% 100% 100%
21 80% 100% 100%
23 90% 100% no maintenance
24 90% 100% 100%
25 80% 60% drop-out
returned for
follow-up
26 80% 100% no maintenance
27 80% drop-out
28 90% drop-out
29 70% 90-100% 100%
__________________________________________________________________________
NOTE: Patient #8 was an HIV negative partner of participating patient.
Patient #22 did not complete initial 12 week phase of treatment.
TABLE 5
__________________________________________________________________________
FREQUENCIES OF KARNOFSKY SCORES
ALL AVAILABLE DATA
KARNOFSKY SCORE
INTAKE FEB/MARCH 1990
MARCH 1991
__________________________________________________________________________
50% 0 1* (5.6%)
0
60% 0 1* (5.6%)
0
70% 1 (3.7%)
0 0
80% 11 (40.7%)
0 0
85% 1 (3.7%)
0 0
90% 12 (44.4%)
0 0
95% 0 1 (5.6%) 0
100% 2 (7.4%)
15* (83.3%)
11 (100%)
__________________________________________________________________________
*Three patients are included in Feb/March 1990 who had withdrawn from the
study prior to this date. These are their scores (50%, 60%, 100%) when
they returned for followup.
TABLE 6
__________________________________________________________________________
FREQUENCIES OF KARNOFSKY SCORES FOR THE ELEVEN
PATIENTS WHO COMPLETED THERAPEUTIC PLUS
MAINTENANCE/PROPHYLAXIS TREATMENT
KARNOFSKY SCORE
INTAKE FEB/MARCH 1990
MARCH 1991
__________________________________________________________________________
70% 1 (9%) 0 0
80% 3 (27%)
0 0
85% 1 (9%) 0 0
90% 4 (36%)
0 0
95% 0 1 (9%) 0
100% 2 (18%)
10 (91%) 11 (100%)
__________________________________________________________________________
Summary
Karnofsky Performance Scores were measured at three points in time.
Patients who completed twelve months of the study reached the score of
100% by February, 1990. Those patients who continued with the
Maintenance/Prophylaxis treatment maintained their score of 100% through
February, 1991 (the last measurement point).
Those patients who completed the Therapeutic portion of the study scored
between 95% and 100% on the Karnofsky Performance Scales. This is in
contrast to the usual pattern that shows an unremitting decline with the
passage of time.
III. Analysis of Body Weight and Oral Temperature Variability
These two basic Vital Signs were recorded weekly for all patients in the
study. Although simple and easy to take, these criteria are strong
indicators of patient stability or decline.
HIV positive patients are particularly vulnerable to various wasting
diseases as they progress through the stages of AIDS. It was interesting
to note that none of the patients exhibited wasting during any phase of
this treatment.
In HIV patients, oral temperatures tend to be either excessively high or
excessively low (as a result of active bacterial, viral fungal or other
infection). Frequently, the active HIV patient exhibits a sub-normal
temperature (approximately 97.degree. F.) reflecting chronic, low grade
viral infection. In almost all of the patients in this study,
temperatures assumed normal profiles compared to intake values, and
remained remarkably stable for the duration of each patient's treatment.
Abstract
Twenty seven HIV-positive patients enrolled in the study were monitored
weekly for total body weight and oral temperature. Records indicate that
no wasting syndrome was evident at any point in time for any patient.
Temperatures were basically stable from week to week, with a greater
proportion of temperature readings in the normal range as the study
progressed.
Results and Discussion
The temperatures recorded for the patients as a whole are displayed in
Table 7.
As shown in Table 7, the percentage of all readings which fell into the
normal range increased steadily over the course of the study. At intake,
29.63% of the patients had normal temperatures. Between Weeks 1-12, the
percentage rose to 50.18%. Weeks 13-24 show 61.40%, and Weeks 25-36 show
60.95%. After Week 37, the number of normal temperature readings shows
another sizeable increase to 79.48%.
It should be pointed out that no wasting syndrome was experienced by any
of the patients in the Study. In fact, records showed that 10 patients
out of 27 (37.03%) actually gained weight during their participation in
the Project.
TABLE 7
__________________________________________________________________________
FREQUENCIES OF TEMPERATURE READINGS
TEMPERATURE
INTAKE
WEEKS 1-12
WEEKS 13-24
WEEKS 25-36
WEEKS 37+
__________________________________________________________________________
>100 1 3 3 0 1
(VERY HIGH)
(3.70%)
(1.10%)
(1.10%) (0.00%) (0.85%)
99.1-100 1 13 13 4 2
(HIGH) (3.70%)
(4.76%)
(4.76%) (3.81%) (2.71%)
98.2-99.0 8 137 167 64 93
(NORMAL) (29.63%)
(50.18%)
(61.40%)
(60.95%)
(79.48%)
97.0-98.1 17 119 89 37 21
(LOW) (62.96%)
(43.59%)
(32.72%)
(35.24%)
(17.95%)
<97.0 0 1* 0 0 0
(VERY LOW)
(0.00%)
(0.37%)
(0.00%) (0.00%) (0.00%)
__________________________________________________________________________
*The one reading of "VERY LOW" represents a patient whose temperature was
recorded as 94.8. It seems likely that this is a data entry error.
However, it has been included in the table.
Summary
Both weights and temperatures were stable from week to week. The
proportion of recorded temperatures in the normal range gradually became
higher as the study progressed. Conversely, the proportion of
chronically low temperatures decreased.
IV. Statistical Analysis Of Symptom Data Generated By Patients Who
Completed Treatment And Maintenance Phases Of The Study
Abstract
Twenty-seven HIV-positive patients enrolled in the study were evaluated
for the presence or absence of a series of forty symptoms presented from
intake to two later points in time. Six scales were constructed as
subsets of the original forty symptoms examined plus a TOTAL
compilation. While borderline improvement was noted for one of the
scales, significant improvement was evident for the other five scales.
The TOTAL category (evaluation of overall number of symptoms present)
also showed marked and progressive improvement.
The attached Tables 8 and 9 list the individual symptoms that have been
grouped as follows:
Group 5 (symptoms most related to HIV disease progression)
Group 3 (symptoms moderately related to HIV disease progression)
Group 1 (symptoms mildly related to HIV disease progression)
The additional scales were:
FUNGAL (symptoms due to fungal infection)
QUALITY (daily quality of life)
WELL BEING (sense of well being)
TOTAL (all symptoms)
Results and Discussion
The results indicate that patients improved from intake to November,
1990. The mean number of symptoms per patient was reduced from 8.08 at
intake to 1.73 in November (a decrease of 79%). This decrease was
consistent across all of the scales. Group 5 symptoms decreased 87%,
Group 3 symptoms decreased 67%, Group 1 symptoms decreased 87%, FUNGAL
symptoms decreased 85%, WELL BEING symptoms decreased 85% and QUALITY
symptoms decreased 76%. (See Table 10).
Summary
Data consisting of the presence or absence of a series of forty symptoms
were collected on twelve patients infected with HIV at three points in
time. The results indicate clear improvement from intake to November,
1990, as measured by the number of symptoms present. With the exception
of one scale, "Sense of Well Being" in which improvement was
only borderline, the other five scales all provide evidence indicative
of significant improvement.
TABLE 8
__________________________________________________________________________
TOTAL NUMBER OF SYMPTOMS AND
MEAN NUMBER OF SYMPTOMS PER PATIENT*
INTAKE MAY NOVEMBER
(NOV-DEC 1988)
1990 1990
__________________________________________________________________________
TOTAL # OF SYMPTOMS
97 (8.08) 47 (3.92)
19 (1.73)
GROUP 5 SYMPTOMS 34 (2.83) 10 (0.83)
4 (0.36)
(SYMPTOMS MOST RELATED
TO HIV PROGRESSION)
BURNING MOUTH (THRUSH)
1 1 0
SHORTNESS OF BREATH
3 0 0
DIARRHEA 2 0 0
LACK OF APPETITE 1 0 0
BONE/MUSCLE ACHE 5 2 1
NIGHT SWEATS 0 2 0
ARTHRITIS-LIKE ACHES
1 0 0
TROUBLE BREATHING 1 0 0
FATIGUE 7 2 1
ATHLETE'S FOOT 4 1 1
JOCK ITCH 2 0 0
FINGER/TOE NAIL FUNGUS
3 2 1
LACK OF SEXUAL DESIRE
2 0 0
BURN/ITCH/GROIN/SCROTUM
1 0 0
VAGINAL ITCH 1 0 0
VAGINAL BURNING 0 0 0
VAGINAL SORENESS 0 0 0
GROUP 3 SYMPTOMS 39 (3.25) 24 (2.00)
12 (1.08)
(SYMPTOMS MODERATELY
RELATED TO HIV
PROGRESSION)
HEADACHE 4 2 1
COUGH 3 0 0
CLOUDY EYESIGHT 3 2 1
SORE THROAT 1 0 0
BLEEDING GUMS 3 2 1
HAIR LOSS 1 0 0
EYE FOCUS PROBLEMS
5 1 0
TROUBLE SLEEPING 3 2 1
BUMPS THAT ITCH 3 2 0
SWOLLEN GLANDS 5 5 5
UNFRESHED SLEEP 5 5 3
DEPRESSION 3 3 0
__________________________________________________________________________
*Means appear in parentheses
TABLE 9
__________________________________________________________________________
TOTAL NUMBER OF SYMPTOMS AND
MEAN NUMBER OF SYMPTOMS PER PATIENT*
INTAKE MAY NOVEMBER
(NOV-DEC 1988)
1990 1990
__________________________________________________________________________
GROUP 1 SYMPTOMS 24 (2.00) 13 (1.08)
3 (0.27)
SYMPTOMS MILDLY RELATED
TO HIV PROGRESSION)
SINUS TROUBLE 1 2 1
COLDS 2 0 0
SORE GUMS 1 2 0
COLD HANDS/FEET 3 1 0
TINGLING SKIN 1 0 0
LOSS OF CONCENTRATION
3 2 0
MOOD CHANGES 5 2 1
ANXIOUSNESS 4 4 1
VAGINAL INFECTION 1 0 0
VAGINAL DISCHARGE 2 0 0
IRREGULAR PERIODS 1 0 0
FUNGAL SYMPTOMS 14 (1.17) 4 (0.33)
2 (0.18)
BURNING MOUTH (THRUSH)
ATHLETE'S FOOT
JOCK ITCH
FINGER/TOE NAIL FUNGUS
BURN/ITCH/GROIN/SCROTUM
VAGINAL ITCH
VAGINAL BURNING
VAGINAL SORENESS
VAGINAL DISCHARGE
SENSE OF WELL BEING
14 (1.17) 8 (0.67)
2 (0.18)
SYMPTOMS
LACK OF SEXUAL DESIRE
LOSS OF CONCENTRATION
MOOD CHANGES
ANXIOUSNESS
QUALITY OF LIFE SYMPTOMS
27 (2.25) 16 (1.33)
6 (0.55)
HEADACHE
SHORTNESS OF BREATH
DIARRHEA
TROUBLE SLEEPING
NIGHT SWEATS
FATIGUE
UNFRESHED SLEEP
DEPRESSION
__________________________________________________________________________
*Means appear in parenthesis
TABLE 10
__________________________________________________________________________
PERCENTAGE DECREASE IN THE NUMBER OF SYMPTOMS PRESENT
INTAKE TO
MAY 1990 TO
INTAKE TO
MAY 1990
NOVEMBER 1990
NOVEMBER 1990
(18 MONTHS)
(6 MONTHS)
(24 MONTHS)
__________________________________________________________________________
TOTAL # OF SYMPTOMS
50% decrease
56% decrease
79% decrease
GROUP 5 71% decrease
57% decrease
87% decrease
(SYMPTOMS MOST
RELATED TO HIV
PROGRESSION)
GROUP 3 38% decrease
46% decrease
67% decrease
(SYMPTOMS
MODERATELY
RELATED TO HIV
PROGRESSION)
GROUP 1 46% decrease
75% decrease
87% decrease
(SYMPTOMS MILDLY
RELATED TO HIV
PROGRESSION)
FUNGAL SYMPTOMS
71% decrease
45% decrease
85% decrease
SENSE OF WELL BEING
43% decrease
73% decrease
85% decrease
SYMPTOMS
QUALITY OF LIFE
41% decrease
62% decrease
76% decrease
SYMPTOMS
__________________________________________________________________________
*Intake was from November to December 1988
V. Statistical Analysis of Drug Related Toxicity As Indicated by SGOT
and SGPT
These two basic laboratory markers (SGOT and SGPT) function as widely
accepted indicators of liver function in relation to drug toxicity.
However, several factors should be noted in conjunction with these
measurements.
As expressed in Clinical Interpretation of Laboratory Tests (Ninth
Edition) Frances K. Widmann, M.D., a medical textbook on the diagnostic
use of laboratory procedures noted:
"The two enzymes most often associated with hepatocellular damage
are aminotransferases that catalyze the reversible transfer to an amino
group between an amino acid and an alpha-keto acid. The enzymes are
called glutamic-oxaloacetic transaminase (GOT) and glutamic-pyruvic
transaminase (GPT)."
"Because the liver has such substantial reserve capacity,
hepatocellular loss must be far advanced before it becomes clinically
apparent. It is possible to detect ongoing hepatocellular damage by
measuring functional indices and by observing in the circulation the
products of damaged or necrotic hepatocytes. Enzyme tests are often the
only indications of early or localized liver disease."
When measured with the serum, these tests are often called SGOT and
SGPT.
In the HIV-positive patient population, these two values may be elevated
when baseline bloodwork is performed. This elevation can be caused by
hepatitis (either chronic or acute), acute viral infections (such as
Hepatitis B or EBV), cirrhosis of the liver or previous use of
recreational drugs (such as heroin). In spite of these potential
complications, SGOT and SGPT can be used to evaluate toxicity of any
drug being administered.
When a patient's baseline values are within a normal range, a dangerous
toxic reaction would be indicated by readings of four-times the maximum
normal range. If a patient presents with elevated liver enzymes,
judgment concerning toxicity must be based on evaluation of two factors:
how high the actual elevation is and also how quickly it becomes
evident.
Only one patient showed a pattern unlike the others. He experienced a
sudden, acute elevation of these blood markers during the last three
recorded weeks of treatment. It is reported that, when questioned by the
Head Nurse, he admitted that he had begun an additional treatment
modality. By mutual agreement, he terminated his participation in this
study.
All other patients in this study showed no evidence of toxicity induced
by the medicaments used for treatment. In fact, blood tests showed that
many patients who entered the study with considerable elevation in both
SGOT and SGPT demonstrated significant decrease from the original high
levels. Those who entered with relatively normal values either further
decreased or remained at the same level. It is notable that no treatment
related toxicity developed in any patient during the entire period of
the study.
Abstract
Levels of two liver enzymes, SGOT and SGPT, were measured weekly for up
to sixty weeks on the patients enrolled in the study to assess drug
related toxicity. These tests indicated that levels of both SGOT and
SGPT remained stable over the course of treatment. The percentage of
observations that fell within normal ranges for both SGOT and SGPT also
remained stable over time.
Results and Discussion
Table 11 lists the median levels of SGOT and SGPT of all measurements on
each patient at intake and then at four more time intervals:
A. Week 1 to Week 12
B. Week 13 to Week 24
C. Week 25 to Week 36
D. Week 37 to the final measurement
The number and percentage of times these measures were in the normal
range and above the normal range are listed in Table 12.
The percentage of normal measures is seen to be quite stable over time.
As with the medians, the percentage of times that measures were in the
normal range appears to improve substantially after 36 weeks. For median
SGPT levels, the largest improvement occurred after 24 weeks. However,
the later time intervals include proportionately more of the patients
who had remained in treatment then do the earlier intervals.
Summary
The available data on these patients indicates that drug related
toxicity did not increase over time. Further, medians of all
observations and the percentage of observations in normal ranges
remained stable over the course of the study. It can be stated that the
medicaments administered to the patients did not cause any drug related
toxicity.
TABLE 11
__________________________________________________________________________
MEDIANS OF SGOT AND SGPT USING ALL AVAILABLE DATA
TREATMENT
TREATMENT
TREATMENT
TREATMENT
INTAKE WEEKS 1-12
WEEKS 13-24
WEEKS 25-36
WEEKS 37+
__________________________________________________________________________
SGOT
MEDIAN
36.00 37.50 37.50 37.00 34.00
SGPT
MEDIAN
33.00 38.50 34.00 28.00 27.50
NUMBER
27 274 264 117 104
OF TESTS
__________________________________________________________________________
TABLE 12
__________________________________________________________________________
COMPARISON OF NUMBER AND PERCENT OF SGOT AND SGPT TEST
RESULTS WITHIN NORMAL RANGE AND ABOVE NORMAL RANGE
TREATMENT
TREATMENT
TREATMENT
TREATMENT
INTAKE
WEEKS 1-12
WEEKS 13-24
WEEKS 25-36
WEEKS 37+
__________________________________________________________________________
SGOT
NORMAL RANGE
NUMBER 19 162 157 80 69
PERCENT 70.4% 59.1% 57.3% 59.8% 66.3%
ABOVE NORMAL
RANGE
NUMBER 8 112 107 47 35
PERCENT 29.6% 40.9% 42.7% 40.2% 33.7%
SGPT
NORMAL RANGE
NUMBER 20 217 208 95 93
PERCENT 74.1% 79.2% 78.8% 81.2% 89.4%
ABOVE NORMAL
RANGE
NUMBER 7 57 56 22 11
PERCENT 25.9% 20.8% 21.2% 18.8% 10.6%
__________________________________________________________________________
VI. Additional Clinical Findings at the Conclusion of Therapeutic Phase
of the Study
The Patient Population was divided into two segments.
A. ACTIVE--Those who completed the full study and have remained on the
maintenance portion of the program. (12 patients)
B. DROP-OUTS--Those who left before the end of the study and never
completed treatment.
Group A: (Active)
Upon final examination, all the patients in Group A had fairly normal
physical examinations and a healthy robust appearance. Two of the
patients stated that they had problems with psoriasis which were much
improved over the course of therapy.
One patient in Group A developed Hairy Leukoplakia after UV therapy for
folliculitis, but this was resolved after cessation of the UV therapy.
Mood Changes: Many instances of depression and other emotional problems
were reported in the intake histories. With the Exception of a single
patient who opted to return to the mood elevating drugs he had formerly
been taking, all of the patients exhibited generally cheerful,
optimistic outlooks.
Fatigue: Initially, there were subjective complaints of fatigue by most
of the patients. At the conclusion of the study, all 12 patients are
leading normal lives and are working. All generally stated that they had
increased levels of energy.
Pulse: Initially many pulse rates were rapid and approximately 90. At
the conclusion of the treatment, all patients exhibited strong, regular
pulse of 60-75.
Night sweats: Many patients complained of recurrent episodes of this
malady upon entering the study. None reported any incidents of the
problem when questioned at the conclusion of treatment.
General physical stamina: According to preliminary reports, several
patients complained of limited physical strength and, in one instance,
one patient presented with arthritis sufficiently severe that he could
only walk with the aid of two canes. At the final examination, all
reported that they were leading normal and demanding, fully strenuous
physical lives. Many of them resumed regular workout sessions at the gym
and one worked weekends unloading trucks.
Non-Development of AIDS Defining Disease Conditions: Almost none of the
ancillary diseases that may be expected to become evident in the patient
population during the course of a study occurred. The following disease
entities did NOT become evident in the patients during at least the 18
month time span after the start of the study.
1. Pneumocystis Carinii Pneumonia
2. Candidiasis of the esophagus, trachea, bronchi or lungs.
3. Extrapulmonary Cryptococcosis
4. Cryptosporidiosis with diarrhea
5. Cytomegalovirus disease of an organ
6. Herpes Simplex virus infection with persisting mucocutaneous ulcer
7. Karposi's sarcoma
8. Primary lymphoma of the brain
9. Mycobacterium avium
10. Progressive multi-focal leukoencephalopathy
11. Toxoplasmosis of the brain
12. Coccidioidomycosis
13. Histoplasmosis
14. Isospororsis
15. Non-Hodgkins lymphoma of any type
16. Pulmonary tuberculosis
17. Salmonella septicemia
Alleviation of AIDS Related Conditions: The following medical problems,
when originally present, were either resolved or significantly improved
during the study so that at the end of the study the patients were
essentially symptom free:
1. Oral Hairy Leukoplakia
2. Persistent fungal infections including thrush, athletes foot, jock
itch, onychomycosis, etc.
3. Lymphadenopathy
4. Reiters Syndrome
5. Guillain-Barre Syndrome
6. Gastrointestinal complaints
7. Various viral conditions such as:
Herpes Simplex
Herpes Zoster (shingles)
8. Psoriasis
9. Syphilis
Group B (Drop-Outs)
Three of the patients in Group B had, for the most part, fairly normal
physical examinations. Two of them had developed Hairy Leukoplakia. One
case, according to the patient, had resolved with a course of Zovirax.
Two of these patients went on AZT, although one was intolerant to the
therapy and had to discontinue it. One is taking Zovirax. However, the
subjective impression of these three patients was that they appeared
healthier than would be the normal pattern at this phase of the disease.
In general they seemed to be in good shape.
Two patients were significantly worse physically with a frank diagnosis
of AIDS. Both had developed Pneumocystis pneumonia (PCP); one had
developed cryptococcal meningitis and had progressive Karposi's Sarcoma;
the other had thrush, wasting and fatigue at the time of examination.
No clinical examination was possible on the remaining patients.
VII. Final Impressions
If one compares the natural history of HIV, with average T-4 cells in
the low 300's, a progressive decline in the health status of these
patients could be expected over the 18 months duration of this
treatment. Additionally, more and more frequent occurrence of illnesses,
general fatigue and ongoing weight loss could be expected. However, none
of this occurred in the study.
In general, two years after intake, the Study patient population could
be expected to present with an extensive range of opportunistic
diseases. Instead, with the minor clinical exceptions noted above, the
patients were in good health.
As already discussed, it is important to note that, although many of the
test procedures described above deal with AIDS, the same procedures also
relate to the medical problems that affect the non-AIDS patient
population.
AIDS is not a single disease. Although much of the media coverage has
given this impression, AIDS is not merely the HIV virus.
Just as the name indicates, AIDS is a syndrome or collection of medical
conditions. The element that binds AIDS patients together is that they
all have a compromised immune system. Beyond this, a wide range of other
disease entities can be present or absent. The list of possibilities
includes intestinal parasites, systemic fungus (Candida albicans and
others), viral diseases (EBV, CMV, herpes, hepatitis, etc.), bacterial
problems (Staph, Strep, etc.), tuberculosis, syphilis, etc.
None of these disease entities are unique to AIDS. They also afflict the
general public either in the form of individual diseases or else in such
groupings as Chronic Fatigue Syndrome (CFS). For this reason, the
method, procedures and individual medicaments that treat AIDS have
applications that extend far beyond that.
The terms and expressions which have been employed are used as terms of
description and not of limitation, and there is no intention in the use
of such terms or expressions of excluding any equivalents of the
features shown and described or portions thereof, it being recognized
that various modifications are possible within the scope of the
invention.
* * * * *
