U.S. patent application number 11/801632 was filed with the patent office on 2007-09-13 for homeopathic drug composition and methods of use thereof.
Invention is credited to Char Tara Albert, Neal Koller, Floyd Taub.
Application Number | 20070212406 11/801632 |
Document ID | / |
Family ID | 30770293 |
Filed Date | 2007-09-13 |
United States Patent
Application |
20070212406 |
Kind Code |
A1 |
Taub; Floyd ; et
al. |
September 13, 2007 |
Homeopathic drug composition and methods of use thereof
Abstract
The present invention comprises homeopathic preparations of
compounds, methods for using such preparations and delivery systems
for the treatment of disease symptoms through the administration of
these homeopathic compositions.
Inventors: |
Taub; Floyd; (Silver Spring,
MD) ; Koller; Neal; (Annapolis, MD) ; Albert;
Char Tara; (Timonium, MD) |
Correspondence
Address: |
BRYAN CAVE LLP
211 NORTH BROADWAY
SUITE 3600
ST. LOUIS
MO
63102-2750
US
|
Family ID: |
30770293 |
Appl. No.: |
11/801632 |
Filed: |
May 10, 2007 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10206470 |
Jul 29, 2002 |
|
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11801632 |
May 10, 2007 |
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Current U.S.
Class: |
424/450 ;
424/464; 424/641; 424/642 |
Current CPC
Class: |
A61K 31/185 20130101;
A61K 45/06 20130101; A61K 41/0004 20130101 |
Class at
Publication: |
424/450 ;
424/464; 424/641; 424/642 |
International
Class: |
A61K 33/30 20060101
A61K033/30; A61K 9/127 20060101 A61K009/127; A61K 9/20 20060101
A61K009/20 |
Claims
1. A homeopathic composition having a homeopathic potency selected
from the group consisting of 5X, 6X, 7X, 8X and 9X, wherein said
composition is prepared by (a) dissolving carbobenzoxy Beta-alanyl
taurine or a salt thereof into a solvent to achieve a first
solution and (b) serially diluting and succussing the first
solution using said solvent to achieve said homeopathic
potency.
2. The composition according to claim 1, additionally comprising at
least one component selected from the group consisting of: a
vitamin, a mineral, an amino acid, and traditional
homeopathics.
3. The composition according to claim 1, wherein said composition
is administered by aerosol spray.
4. The composition as recited in claim 1, wherein the composition
is impregnated on a solid medium.
5. The composition as recited in claim 4, wherein said solid medium
is selected from the group consisting of tablets, capsules, pellets
(globules), and gel caps.
6. The homeopathic composition according to claim 1, wherein said
solvent is ethanol, water, or a combination thereof.
7. The homeopathic composition according to claim 1 wherein said
composition includes a pharmaceutically acceptable topical
preparation.
8. The homeopathic composition according to claim 7, wherein said
topical preparation is selected from a group consisting of:
ointments, creams, lotions, liquids and gels.
9. The homeopathic composition according to claim 8, wherein said
topical preparation is hydrophilic ointment.
10. The homeopathic composition according to claim 1, wherein said
composition is a liposomal preparation.
11. The homeopathic composition according to claim 10, wherein said
liposomal preparation is selected from a group consisting of:
ointments, creams, lotions, liquids and gels.
12. The homeopathic composition according to claim 11, wherein said
liposomal preparation is a liquid.
13. The homeopathic composition according to claim 12, wherein said
liposomal liquid is administered by aerosol spray.
14. The homeopathic composition according to claim 11, wherein said
liposomal preparation is an ointment.
15. A homeopathic composition comprising carbobenzoxy Beta-alanyl
taurine or a salt thereof and a solvent, wherein said composition
is prepared using the Hahnemannian or Korsakovian method of
attenuation or dilution.
16. A homeopathic composition, wherein the composition is produced
by a process comprising the following steps: (a) preparing a first
solution by diluting carbobenzoxy Beta-alanyl taurine or a salt or
derivative thereof into a solvent; (b) preparing a second solution
by further diluting said first solution into said solvent and
succussing said second dilution; and (c) if necessary to achieve a
desired homeopathic potency, preparing one or more additional
solutions by serially diluting the second solution into said
solvent and succussing each such additional solution.
17. The homeopathic composition of claim 16, wherein said solvent
is water, ethanol, or a combination thereof.
18. The homeopathic composition of claim 16, wherein said desired
homeopathic potency is selected from the group consisting of: 5X,
6X, 7X, 8X, and 9X.
19. The homeopathic composition of claim 18, wherein said
composition has a homeopathic potency selected from the group
consisting of 6X and 8X.
20. The homeopathic composition of claim 18, wherein said
composition further comprises at least one component selected from
the group consisting of: a vitamin, a mineral, an amino acid, and
traditional homeopathics.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of and claims priority to
U.S. application Ser. No. 10/206,470, filed Jul. 29, 2002, which
claims priority to U.S. provisional patent application Ser. No.
60/307,137, filed Jul. 24, 2001.
FIELD OF THE INVENTION
[0002] This invention relates to homeopathic preparations of
compounds as well as methods and systems for delivery of such
preparations and treatment of disease symptoms by administering
such preparations. In particular, the present invention provides
for homeopathic preparations of Taurox compounds.
BACKGROUND OF THE INVENTION
[0003] In 1790, while Samuel Hahnemann was translating a materia
medica from English into German, he came across a reference that
the prevalent prescription for malaria at that time was cinchona
bark. The reason stated for its efficacy was that it was quite
bitter. Dr. Hahnemann was well versed in the current use of
medicine and felt that there must be another reason besides its
bitter qualities that made it work because many other medicines
were bitter but ineffective in the treatment of malaria. By
experimenting on himself, through taking cinchona bark and
observing the effects he was able to produce the symptoms of
malaria: chills, fever, palpitations, and sweats. These
observations were included in his translated text as a
footnote.
[0004] The more Hahnemann studied and translated medicine and
medical texts, the clearer it became to him that if healthy people
took massive amounts of a particular drug, the drug would actually
cause the same symptoms it was supposed to cure. Hahnemann then
reasoned that the symptoms of a sick patient could be matched to
symptoms that a drug produced. His experiments along the lines of
his reasoning lead to the development of a new branch of medicine,
which he called homeopathy, from the Latin words, homeo, meaning
the same, and pathos, meaning illness.
[0005] In order to demonstrate the effectiveness of a homeopathic
drug, the drug is tested by a "proving" in order to see how the
drug will effect an otherwise healthy person. Hundreds of compounds
have been tested according to such "proving". Homeopathic
repertories provide listings of the human anatomy and set forth
symptoms that have been observed on such body part and treatments
for the symptoms. On the other hand, books referred to as "Materia
Medicae" set forth the homeopathic drugs and identify the maladies
and symptoms each drug treats. Moreover, where a repertory lists a
symptom, it classifies possible treating compounds as either first,
second or third degree remedies for that symptom. Typically, a
homeopathic practitioner will prescribe first degree indications
for a particular symptom although sometimes second indications may
be employed on a case-by-case basis. Very seldom would a
homeopathic practitioner think to use a third degree indication and
such listings are provided only to note that, on rare occasions,
that the remedy has been known to cure the symptom but that it is
not recognized by a "proving".
[0006] The current materia medicas have up to 5,000 proven drugs
listed. The drugs are derived from plants, minerals and animal
substances. The remedies are listed in alphabetical order in the
materia medica. The materia medica has grown to include not just
symptoms that were proven but also to include toxicological
symptoms as well as symptoms that were actually cured in sick
patients using that particular remedy. The symptoms in the materia
medica are categorized in order from the top of the body on down.
So all the symptoms in the head are categorized together, then the
eyes, ears, nose and so on until the extremities.
[0007] Some remedies have only 40 symptoms listed in the materia
medica, while others have 15,000 symptoms. Since it is impossible
to remember all the symptoms of each remedy, about 150 years ago
the information was collated into a reference form. All the
remedies that affect a certain place in a certain way were placed
under a particular category. The book that contained these
categories is called a repertory. The categories listed in the
repertory are called rubrics.
[0008] The repertory of the materia medica is actually a reference
tool that lists all the symptoms cured or produced and list every
remedy that has treated that particular category/rubric. For
example, a rubric might list: Head: pain, above left eye, 3 pm
lasting to 6 pm, with one remedy listed under the rubric. Rubrics
can be very specific like this one, or very general. A general
rubric would be Head; pain, and that general rubric would contain
hundreds and hundreds of remedies. The more specific the rubric the
better for a homeopath, as it truly indicates a closer match.
However, specific rubrics are likely to be too specific and
incomplete and therefore misleading.
[0009] Hugo Schultz, in 1887, postulated that the effect of a
stimulus on a living cell is indirect and proportional to its
intensity and quantity. Schultz demonstrated that very low
concentrations of yeast toxins increased yeast growth over 100
fold. Around the same time, the psychiatrist Rudolph Arndt
developed his "Basic Law of Biology," which states that weak
stimuli slightly accelerate the vital activity, middle-strong
stimuli raise it, strong stimuli suppresses it, and very strong
stimuli halt vital activity. These separate observations were
formulated by Arndt in 1888 into one of the earliest laws of
pharmacology representing the homeopathic effect, the Arndt-Schultz
law, which states: every stimulus on a living cell elicits an
activity, which is inversely proportional to the intensity of the
stimulus (Martius F. Das Arndt-Schultz Gnindgesetz, Muench Med.
Wschr., 1923, 70(31):1005-1006). This law was later restated by
Hueppe as: for every substance, small doses stimulate, moderate
doses inhibit, large doses kill. Allopathic medicine, with its
emphasis on moderate to high drug doses, works to inhibit undesired
physical symptoms and to kill undesired pathogens. Homeopathic
medicine begins with small doses and moves towards higher and
higher dilutions to stimulate the body's own natural defenses.
[0010] One of the basic tenets of homeopathic medicine is that a
cure for a disease can be evoked by using a high dilution medicine
that resembles but is different from the cause of the disease.
Homeopathy is widely accepted as a useful therapeutic throughout
Europe, the British Commonwealth countries and India, and has been
demonstrated to have characteristic and reproducible effects. A
critical review of more than 100 controlled and/or clinical studies
of homeopathy determined that patients received positive healing
benefits from homeopathy beyond the placebo effect (Kleijnen, J. et
al. 1991 Brit. Med. J. 302:316-323; Linde, K., Clausius, N.,
Ramirez, G., Melchart, D., Eitel, F., Hedges, L. V., Jonas, W. B.,
1997, Lancet, 350:834-843; Reilly, D., et al, 1994, Lancet,
344:1601-1608).
[0011] After a base preparation is made, either by an extract or
maceration of an herbal compound or the dissolving of a selected
compound in a solvent, a series of dilutions are prepared from the
initial batch, called the "mother tincture". Homeopathic drugs are
diluted according to either the decimal "X" or centesimal "C"
scales. For a "3X" preparation, the mother tincture is diluted with
nine parts of the desired diluent, in either liquid or powder form.
The resultant mixture is then diluted a second time, in a ratio of
one part mixture to ten parts solvent and the resulting mixture is
diluted a third time in a ration of one to ten. Therefore, the 3X
drug is actually at 10.sup.-3 potency of the mother tincture.
Similarly, a 6X dilution would be at 10.sup.-6 potency of the
original solution. In the "C scale" each dilution is done with
ninety-nine parts diluent to the original mixture. Therefore, a 3C
solution is at 10.sup.-6 potency of the original mixture and thus
corresponds to a 6X potency. These scales are recognized by the
Homeopathic Pharmacopeia of the United States (H.P.U.S.).
[0012] Many homeopathic medicines are used at concentrations of
micrograms (10.sup.-6 M) and nanograms (10.sup.-12 M); however, in
other homeopathic preparations, the dilutions exceed Avogadro's
number (6.023.times.10.sup.-23). When compounds are diluted 1:10
(or 1:100), with repeated succusions (violent shaking or pounding)
and repetitively diluted by this procedure these compounds are
prepared and labeled as homeopathic remedies. A variety of dilution
or attenuation methods are known in the art, the most common
methods are the Hannemannina and the Korsakovian methods. If a
dilution has been repeated at least 24 times, a potency is achieved
(10.sup.-24) that is so highly dilute that the statistical
probability of a single molecule of the original substance
remaining in the volume used is low. Homeopathic practitioners
believe that the original molecules effect a change in the solvent
and that each successive dilution further increases both this
change and the potency of the remedy regardless of the presence of
molecules of the original material in much the same manner as
bronze casting reproduces an original sculpture made of wax or clay
with the need for wax or clay in the final sculpture. In
traditional homeopathic practice, a frequent homeopathic dosage is
10-15 drops of a 10.sup.-12 molar, or 6 C, solution administered
two to three times per day. A 10.sup.-60 molar or 30 C may be given
one to three times per day. A 10.sup.-400 molar or 200 C may be
given only one time per month or year. The beneficial activity of
such highly diluted remedies are derived exclusively from the
changes in the energy field or the solvent of the remedy caused by
the original molecules. Scientific researchers at Harvard
University have reported that changes in NMR spectra of the solvent
occur as a result of this process.
[0013] In contrast many homeopathic medicines, especially
combination products and those sold OTC, have dilutions between 2x
and 24x. Especially those at dilutions between 3x and 10x have very
substantial number of molecules and thus their beneficial effects
are a summation of the physical chemical effects of the molecules
plus the energy and enhanced solvent effects. This invention
applies equally to these low dilutions and to the super molecular
dilutions described above. For general use the preparations with
significant number of molecules remaining 2x to 20x are a preferred
embodiment of this invention.
[0014] A scientific discipline called "hormesis" has recently
received increasing acceptance. This field documents that low doses
of otherwise toxic materials are not toxic and may produce ill
defined but clearly beneficial effects. This phenomenon has not
previously been used therapeutically. One aspect of this invention
is that doses labeled hormetic are not only not toxic but may be
used in a therapeutic manner. The dose range that this phenomenon
occurs is below that of standard pharmaceutical or toxicological
effects. It is often but not necessarily above the dose used in
homeopathic medicine. The scientific principle behind it is akin to
the principle of homeopathy. Although these preparations may not be
prepared by the classical methods of homeopathic pharmacists they
are included in the definition of homeopathic preparations for the
purpose of this invention.
[0015] Analogous to chemical homeopathy/hormesis it has been found
that, contrary to the accepted views on radiation, that low doses
of radiation (including that given off by radon) are not harmful.
One aspect of this invention is that low doses of radiation defined
herein as a homeopathic dose of radiation is prophylactic and
therapeutic.
[0016] Highly dilute homeopathic medicines have been effective in
treating some conditions, including viral infections, in vivo. For
example, homeopathic dilutions of 1.times.10.sup.-200 to
1.times.10.sup.1000 of typhoidinum, hydrophobinum, tuberculinum,
nux vomica and malandrinum caused 100% inhibition of pock-like
lesions caused by a chicken embryo DNA virus on the
chorio-allantoic membrane as compared to controls (Singh, L. M. and
Gupta, G. 1985 Brit. Homeopathy 74:168-174). In contrast, the same
medicines at different homeopathic concentrations, or control
phosphate buffered solution (PBS), had lesser or no effect.
[0017] A common principle of homeopathy is the Law of Similars,
which was founded in the science of pharmacology and states that a
drug has two effects on the body, a direct effect and the
subsequent reaction of the body to the drug, evoking symptoms or
side effects. This approach follows a rule that, where a substance
produces a specified disease symptom or indication at a high dosage
level in a healthy person, that symptom will be effectively treated
in an ill person by a substantially dilute dose of the same
substance. In other words, a symptom of a disease may be treated by
a minor amount of a compound that will cause such symptom in a
healthy person when administered at greater levels. The U.S. FDA
defines homeopathy as "the practice of treating the syndromes and
conditions which constitute disease with remedies that have
produced similar syndromes and conditions in healthy subjects." The
U.S. FDA accepts as a homeopathic drug "any drug labeled as being
homeopathic which is listed in the Homeopathic Pharmacopeia of the
United States (HPUS), an addendum to it or its supplements. The
potencies of homeopathic drugs are specified in terms of dilution,
i.e., 1.times.1/10 dilution, 2.times.1/100 dilution, etc.
Homeopathic drug products must contain diluents commonly used in
homeopathic pharmaceutics. Homeopathic drugs are for the most part,
natural substances, although synthetic substances can be used. They
are distributed as over the counter, through mass distribution
channels without physician prescription, or as prescription,
through highly controlled channels requiring physician
prescription. The operative principals for homeopathic drugs are to
utilize very low concentrations of drug, generally well below the
Minimum Toxic Dose (MTD) for humans, and to manufacture them in a
certain way with certain materials generally by a series of
dilution steps with a defined process of vigorous agitation, termed
succussion, between each step. Homeopathic drugs, due to their low
concentrations. Homeopathic OTC drugs, in particular, are
considered very safe and thus distributed through mass market
channels. Homeopathic OTCs are ubiquitous and readily available to
the general populace via the same or similar channels as vitamins,
foods and nutritional supplements. Other drugs, sometimes known as
standard drugs, allopathic drugs or ethical pharmaceuticals, are
natural or synthetic substances usually presented for use at high
concentrations much nearer the potentially toxic level. Allopathic
drugs thought to be safe for the general population may also be
categorized as over the counter and may be distributed through mass
distribution channels without physician prescription. Allopathic
drugs, when available by prescription, are distributed through
highly controlled channels requiring physician prescription.
Allopathic drugs are manufactured under strict methods and utilize
materials that are specific to each drug. Thus, the distribution of
allopathic drugs is very controlled and they are not readily
available to the general populace.
[0018] The U.S. FDA specifies a dietary supplement product may make
no statements on the effect it has on the structure or function of
the body as distinguished from drug claims that a product
diagnoses, treats, prevents, cures, or mitigates disease. Dietary
supplements should be presented at concentrations very far away
from their toxic doses; they are distributed through mass market
channels, are ubiquitous and readily available to the general
populace, similar to vitamins and foods.
[0019] Table 1 is a comparison of the toxic doses for various
classes of ingestible compounds and shows the relationship of the
above compounds with their toxic doses. TABLE-US-00001 TOXIC DOSE
COMPARISON Ingestible Compound Toxic Dose Level Ethical
Pharmaceutical 0.1-0.5 toxic dose level OTC Drug 0.1-0.3 toxic dose
level Dietary Supplement 0.001-01 toxic dose level Homeopathic
Medicine <0.000001 toxic does level
[0020] Because homeopathic drugs are at very low concentration
levels, far from their toxic dose they are very safe. This safety
reduces the need to establish a detailed, extensive body of
scientific evidence that presents their disease performance
characteristics. As a result there is considerably less detailed
information for homeopathic drugs versus other drugs. Additionally,
contributing to the limited scientific evidence for homeopathic
drugs, is the fact that homeopathy has been known and used for
hundreds of years reducing the need and arguing against the expense
to perform detailed modern scientific and clinical trials. Another
reason for reduced scientific information for homeopathic drugs is
the process to present a homeopathic drug to the user follows a
shorter and less costly regulatory approval process versus
allopathic drugs. As a consequence, the performance characteristics
and benefits of homeopathic drugs are not nearly as well known to
the caregiver and patient communities as are other drugs. In fact,
one fundamental tenant of homeopathy is that each patient is an
individual. The ideal remedy for one patient is thus likely to be
counterproductive for another. Homeopathic physicians use their
skill in evaluating individual patients to choose appropriate
remedies. As the remedies are not toxic initial use may be
considered a therapeutic trial and the physician will adjust the
remedy and dose dependent on the clinical results seen in that
patient. Population statistics are of no or limited value to
homeopathic physicians or individual patients. Homeopaths believe
that most patients are not approximated by an average or median,
i.e. size M does not fit all.
[0021] Allopathic drugs, as a result of their high concentrations
near toxic levels, are required to have extensive scientific
evidence of safety and efficacy before they are presented for use.
The cost and time to develop allopathic drug's scientific evidence
to satisfy the regulatory approval process are much greater than
the cost and time for homeopathic drugs.
[0022] Because Dietary Supplements are so very far away from their
MTD and because they make no disease claims, the need to establish
a detailed, extensive body of scientific evidence that presents
their performance is nonexistent. While they fall under regulatory
control, the regulatory requirements in dietary supplements are
limited mainly to the primary compliance with truth in advertising
requirements only. This approval process requires statistical
documentation of statistical likelihood of success before a drug
may be sold. Nevertheless therapy is individualized for each person
and successful therapy of most all chronic diseases requires
numerous drug and dosage adjustments for that patient. Genomics is
the current term allopathic medicine is using to justify unique
treatment of individuals, a position analogous to that
traditionally used by homeopaths.
[0023] There is a great need for drugs that are very safe as a
result of low concentrations, which are given at concentrations far
from their toxic level and that frequently result in benefits to
the patients. These drugs are defined by scientific evidence of
characteristics and benefits based on disease performance similar
to allopathic drugs and are readily available through mass
distribution channels similar to foods or nutritional supplements.
Such low concentration/high potency/scientific evidence based/mass
distribution channel drugs are more effective because their
scientific evidence of performance and benefits is based on disease
experience and claims which allow users to make better decisions
and achieve healthier life status.
SUMMARY OF THE INVENTION
[0024] Accordingly, the homeopathic preparations of the present
invention are non-toxic and do not produce undesirable side
effects. They can be formulated and provided to a large patient
population at a reasonable cost by means of delivery systems that
are convenient and safe. Homeopathic preparations of the present
invention are preferably administered via oral or topical delivery
systems, or using eye drops, nasal or throat sprays, transdermal
delivery, or other routes of administration except for those
designated to be given by prescription they do not involve
injection and that do not require sterile equipment or the
participation of health care professionals. Alternatively, the
present invention may also be administered by means of
intracutaneous, intramuscular, intravenous, or subcutaneous
injection or given under the care of a health practitioner.
[0025] The homeopathic preparations of the present invention
preferably comprise one or more potencies of
3,3'-(dithiodi-2,1-ethanediylamino)bis[-N-(3-oxopropyl carbamic
acid)] or carbobenzoxy alanyl taurine (herein after "Taurox SB") at
a concentration, or homeopathic potency, of less than about
10.sup.-6 molar, and more preferably between about 10.sup.-6 molar
and about 10.sup.-100,000 molar. Some of the homeopathic
preparations may thus contain few or no molecules of Taurox SB
however a more preferred embodiment will contain significant
numbers of molecules. Homeopathic preparations of the present
invention are defined as comprising Taurox SB if the preparation is
derived from or originated from a preparation comprising a
measurable quantity Taurox SB.
[0026] Additional features and advantages of this invention will be
set forth in the description that follows, and will in part be
apparent from the description or may be learned by practice of the
invention. The objectives and other advantages of the invention
will be realized and obtained by the process particularly pointed
out in the written description and the claims hereof.
[0027] To achieve these and other advantages and in accordance with
the purpose of the invention to provide a homeopathic preparation
of Taurox SB. It is also an object of present invention that the
homeopathic preparation of Taurox SB include additional components
such as vitamins, minerals, amino acids and other traditional
homeopathics.
[0028] It is an object of the present invention to provide a
homeopathic composition comprising Taurox SB having a homeopathic
potency selected from the group of dilutions consisting of 2X, 3X,
4X, 5X, 6X, 7X, 8X, 9X, 10X, 11X, 12X, and and so on to 24 X
H.P.U.S. It is a further object of the present invention to
administer the homeopathic composition in a liquid form,
particularly as an aerosol spray.
[0029] It is an object of the present invention to provide a new
and useful homeopathic composition that is effective in treating or
ameliorating symptoms arising from degenerative changes or
infectious diseases or proliferative diseases or metabolic disease
disorders. These symptoms may arise as a result of viral
infections, immune reactions, immune disorders and fatigue.
[0030] It is a further object of the present invention to provide a
new and useful homeopathic composition that can be used to treat
and/or ameliorate the symptoms of a particular individual whose
physiology would benefit for this remedy. In homeopathy it is know
that the appropriate remedy for a person will adjust his or her
body so that an illness, regardless of the allopathic proximate
cause, will be treated or ameliorated.
[0031] Another object of the present invention is to provide a
homeopathic composition which can be administered orally in the
treatment viral infection, particularly rhinovirus, influenza
virus, hepatitis B virus, hepatitis C virus, herpes virus (CMV, HSC
and EBV) and HIV infections.
[0032] It is a further object of the present invention to provide a
homeopathic composition which can be administered orally in the
treatment of bacterial, fungal, parasitic and prion infections. A
further object of the present invention provides a homeopathic
composition which can be administered orally in combination with
other remedies.
[0033] Still a further object of the present invention is to
provide a homeopathic composition at selected potencies that
effectively treats the symptoms arising from degenerative changes,
physiological disorders, metabolic disorders, proliferative
disorders, immune dysfunctions, infectious processes, viral
infections, immune reactions, immune disorders and fatigue.
[0034] According to the present invention, a homeopathic
composition is disclosed for use in treating symptoms arising from
outbreaks of bacterial infections, proliferation abnormalities,
degenerative changes, viral infections, immune reactions and
fatigue. This homeopathic composition comprises a mixture that
includes Taurox SB. Preferably, this mixture includes a dilution of
Taurox SB in a potency range of 3X to 24X.
[0035] In any event, this mixture may include a pharmaceutically
acceptable carrier solvent, preferably ethanol, and the mixture may
be processed into a dosage unit selected from a group consisting of
tablets, capsules, pellets (globules), liposomal sprays, wafers,
lactose pillules and gel caps. Alternatively, the mixture includes
a pharmaceutically acceptable topical preparation, preferably
selected from a group consisting of ointments, creams, lotions,
liquids, liposomal ointments and gels. A further object of the
present invention includes a pharmaceutical topical preparation
that is a hydrophilic ointment.
[0036] The present invention also contemplates administering the
composition in a dosage unit is in a dry form wherein the solution
includes an ethanol carrier solvent and wherein the solution is
placed in a selected quantity of a pharmaceutically acceptable
dried compound and processed to allow a majority of the ethanol and
other carrier solvent(s) to evaporate. Moreover, the dosage unit
may be administered orally from one to three to four times per day
until relief is achieved. The oral administration may include the
step of placing the composition under the tongue of the patient.
The present invention also contemplates administering the
composition as a cream or ointment by applying the homeopathic
composition topically to the immune response eruption one to three
to four times per day.
[0037] The present invention also contemplates intermittent or
single day use. It is an object of the present invention to provide
a method for modulating additive cravings or compulsive behavior.
In particular, the present invention provides a method to modulate
cravings for tobacco, marijuana, and other drugs of addiction, food
cravings, other addictions and other compulsive behaviors. The
present invention contemplates in modulating additive cravings or
compulsive behaviors by administering the composition multiple
times per hour.
[0038] It is a further object of the present invention to provide a
method for modulating virus levels in the serum of a patient
comprising administering an effective amount of the homeopathic
composition a patient. In particular, the present invention
provides for a method for modulating the virus levels or decreasing
the symptoms of Hepatitis B virus, Hepatitis C virus, CMV, HSV, EBV
and HIV. It is an object of the present invention to provide a
method for modulating fatigue in a patient by administering an
effective amount of the homeopathic composition to such a
patient.
[0039] It is an object of the present invention to provide a method
for modulating immune reactions and immune dysfunctions,
particularly insufficient immune response and allergic reactions in
a patient by administering an effective amount of the homeopathic
composition to a patient in need of treatment. It is an object of
the present invention to provide a homeopathic composition that is
a liposomal preparation. In particular, the liposomal preparation
is selected from a group consisting of ointments, creams, lotions,
liquids and gels.
[0040] It is an object of the present invention to provide a
homeopathic composition made by either the Hannemannian or
Korssakovian methods of attenuation (dilution).
DETAILED DESCRIPTION OF THE INVENTION
[0041] The present invention is directed to homeopathic
preparations. Several compounds have been developed which fall
within the definitions of a drug. Some of these definitions are
located in articles recognized in the official United States
Pharmacopeia, official Homeopathic Pharmacopeia of the United
States, or official National Formulary, or any supplement to any of
them or their equivalents abroad. These drugs are extremely potent
but may be used at concentrations significantly below minimum toxic
dose. These drugs when prepared by the classic homeopathic
procedures are most appropriately tested and prescribed or used by
the methods for classical homeopathic products. These preparations
are safe for mass marketing through, for example, dietary
supplement marketing channels.
[0042] Compounds of the present invention include beta-alethine
(U.S. Pat. No. 6,245,561, incorporated by reference in its entirety
herein), beta-alanyl-taurine, carbobenzoxy beta-alanyl-taurine
(U.S. Pat. No. 6,096,536, incorporated by reference in its entirety
herein) and other modifications of beta-alethine or
beta-alanyl-taurine. In a preferred embodiment, the compound
3,3'-(dithiodi-2,1-ethanediylamino)bis[N-(3-oxopropyl carbamic
acid)] or carbobenzoxy alanyl taurine is manufactured in a
specific, dilution step method using known diluents, each step
completed by a vigorous shaking process termed succussion. Taurox
SB is a low molecular weight benzyl sulfonic acid and is also known
as Immuvant and Taurlmmune. Taurox SB is a chemical modified form
of a chemical combination of the nutrient taurine and a derivative
of the amino acid alanine. Taurine is a "conditionally essential"
nutrient in the development and support of brain and retina tissue
and an important component of human breast milk and formulae's.
Alanine is a non essential amino acid. The structural formula of
Taurox SB is shown below: ##STR1##
[0043] Taurox SB may generally be supplied at three different
concentrations in 20.0% ethanol/80.0% water designated
respectively: Rx, OTC, and Ped strengths. However once of ordinary
skill in the art would know that Taurox SB may be supplied in any
concentration in a variety of mixtures and designated in any
manner. Taurox SB is preferably stored at ambient temperature
(generally 20.degree. to 25.degree. C.; 68.degree. to 77.degree.
F.) but may also be stored in a broader temperature range.
[0044] Taurox SB has been evaluated in homeopathic provings
included in its Materia Medica are increasing energy, effective
against headaches, colds, viruses, allergies, muscle aches and
pains, PMS as well neurological problems, appetite abnormalities,
irritable bowel syndrome or loose stools and coughs. One of the
target patient populations to receive the homeopathic composition
of the present invention are those patients with historically
documented, measurable symptoms relevant to the Materia Medica
and/or pharmacology of Taurox SB. Taurox SB may be administered to
patients to treat, ameliorate or prevent any of the following
symptoms: Sub-optimal immune function as indicated by chronic or
recurrent disease states, viruses, colds, flu, hepatitis, HIV,
human papilloma virus infections (warts) infecting the laryngeal,
skin, and genitals, coughs, bronchitis, bronchiectasis, COPD,
recurrent urinary track infections, recurrent upper respiratory
infections, seborrheic keratosis, lichen planus, dysplasias, basal
cell carcinomas as well as other cancers, periodontal disease, and
immune deficiency diseases. Another target population is those
patients suffering from immune conditions such as allergy,
irritable bowel syndrome and loose stools, asthma, fibromyalgia and
psoriasis. Similarly, those patients with metabolic conditions such
as cachexia (cancer or viral related), fatigue ("chronic fatigue"
or viral, immune, or cancer-related fatigue) and appetite
abnormalities are also included as a target population of patents
to receive the homeopathic composition of the present invention.
Also included in the target population of patients to receive the
homeopathic composition are those patients who suffer from pain
and/or central nervous system ailments such as headaches, muscle
aches and pains, pre-menstrual syndrome (PMS) and neurological
problems. A further target population of patients to receive the
homeopathic compositions are patients with addictions to tobacco,
marijuana, alcohol, and other drugs of abuse such as cocaine,
heroin, amphetamines and morphine. Still another target population
of patients to receive the homeopathic compositions are patients
with compulsive behaviors that are addictives (possibly due to
endogenous release drug-drug like molecules).
[0045] The homeopathic preparations of the present invention
typically comprise between 1.times.10.sup.-6 and 1.times.10
.sup.-100,000 molar concentrations or between 2X and 10X of Taurox
SB in a pharmaceutically acceptable diluent. Homeopathic
preparations preferably comprise a concentration of 2X or less and
alternatively or additionally, 1.times.10.sup.-6 M Taurox SB or
less and, alternatively or additionally, comprise a concentration
of 1.times.10.sup.-12 M Taurox SB or less, preferably a
concentration of 1.times.10.sup.-24 M Taurox SB or less, and in
some cases comprise a concentration of 1.times.10.sup.-60 M Taurox
SB or less. Homeopathic preparations of the present invention
preferably comprise a homeopathic potency of Taurox SB of one or
more of the following potencies: 2X or more to 20X or 1C or more to
220C or 1M or more to 100M. Homeopathic preparations are prepared
under standard scales of attenuation and preparation under which
each successive attenuation (ordilution) ortrituration contains
just 1/10, 1/100, or 1/50,000 as much drug substance as the
preceding attenuation. These scales are know as the decimal (X),
the centesimal (C) and the fifty millesimal systems (ML) (HPUS
Abstracts, 2001, incorporated by reference in its entirety herein).
Under the decimal scale of attenuation, one gram of tincture, one
milliliter of 1X solution or gram (1.0 g) of 1X trituation
represents 0.1 gram of a dry crude medical substance. One
milliliter of 2X attenuation, or 1 gram of second trituration
contains 0.01 gram of the dry crude medicinal substance. Subsequent
attenuations are made by serial progression, succussing or
triturating one part of the preceding attenuation to nine parts of
the vehicle. Thus a 3X liquid contains 10.sup.-3 gram of the dry
crude medicinal substance. Under the centesimal scale of
attenuation, one milliliter of the first centesimal liquid
attenuation (1 C) or one gram of the first centesimal trituration
represents 0.01 gram (10.0 mg) of the dry crude medicinal
substance. Subsequent attenuations are made by serial progression,
succussing or triturating one part of the preceding attenuation to
ninety-nine parts of the vehicle. Thus a 3C attenuation has
10.sup.-6 gram of the dry crude medicinal substance. Under the
fifty millesimal scale of attenuation, one milliliter of the first
millesimal attenuation (1LM) represents 4.0.times.10.sup.9 g of dry
crude medicinal substance. One milliliter of the second millesimal
attenuation (2LM) represents 8.0.times.10.sup.14 g of dry crude
medicinal substance.
[0046] Homeopathic liquid attenuations are designated according to
the method of attenuation. The designations, which must appear on
the labels are X or D on the decimal scale made by the Hahnemannian
method of attenuation, CH or C on the centesimal scale made by the
Hahnemannian method of attenuation, CK or K on the centesimal scale
made by the Korsakovian method of attenuation, LM on the fifty
millesimal scale made by the Hahnemannian method of attenuation. A
Korsakovian attenuation uses a clean stoppered glass vial of
appropriate capacity into which a measured volume of the substance
is added. The vial is succussed followed emptying of the vial to
remove 99 percent if the original volume. To the remaining 1
percent original volume 99 part diluent is added to make the first
Korsakovian attenuation (1 CK). The process is repeated resulting
in a 2CK dilution or attenuation.
[0047] While these are the classic methods of dilution or
attenuation one skilled in the art may readily make virtually
equivalent preparations using alternative methods of dilution
and/or succussion and alternative volumes and weights of materials.
Such alternative methods are included within this invention. Note
that uppercase and lower case (x, c, ml) are used
interchangeably
Homeopathic Preparations of Taurox SB
[0048] 1X Taurox SB
[0049] A homeopathic preparation of 1X Taurox SB starts with 1.0 g
of TAUROX SB weighed into a clean 10 ml volumetric flask fitted
with ground glass stopper followed by the addition of USP purified
water to just below the mark. Using Karl Fisher titration, add
proportionately more than 1.0 g based on the water content of
sample. The flask is stopped and shaken to dissolve the TAUROX SB.
If any undissolved solid remains, the preparation is solicited and
warmed until the solid is dissolved. After cooling to room
temperature, USP purified water is added to the mark and mixed
well. This solution contains 1.0 g of solids in 10.0 ml of solution
that is the correct ratio for a 1xSolution (Class A, HPUS).
[0050] 2X Taurox SB
[0051] A 2X homeopathic TAUROX SB composition is prepared by first
transferring the contents of the prepared 1X composition contained
in the 10 ml volumetric flask to a tarred 125 ml Erlenmeyer flask
with a ground glass stopper. The transfer is effected using about
40-60 ml of USP purified water followed by the drop wise addition
of water to 100.0 g. This preparation will have 1.0 g of solids in
100.0 ml of solution that is the correct ratio for a 2x Solution.
The flask is stopped and succussed.
[0052] 3X Taurox SB
[0053] A 3X homeopathic TAUROX SB composition is prepared by
weighing 5.0 g of the 2X concentrate into a tarred 125 ml
Erlenmeyer flask labeled 3X with a ground glass stopper. Purified
USP water is added to 50.0 g, the flask is stopped and successed.
As another option, any other weight of 2X may be used so long as
the final weight of this step is 10 times the weight of 2X
homeopathic TAUROX SB used and the container size is adjusted to be
not less than 40% or more than 75% full. (The best amount to work
with is 67% of the capacity of the container).
[0054] 4X Taurox SB
[0055] A 4X homeopathic TAUROX SB compositions is prepared as above
for the 3X Taurox SB except the 3X preparation is used as the
starting material. Once succussed the resulting product is 4X
homeopathic TAUROX SB.
[0056] 5X through 1 OX Taurox SB
[0057] The 5X through 10X compositions are prepared using a 20%
solution in enough volume to make the desired final product volume.
Briefly, each preparation is made by adding to a clean 100 ml
graduated cylinder 21 parts of alcohol, USP (95% ethyl alcohol),
followed by adding purified USP water to 100 mis volume. The
resulting 20% (v/v) alcohol solution is transferred to a clean
container and mixed well. Optionally, the alcohol and water may be
weighed into a container such that the final composition is 20%
Alcohol, USP by volume. The density of Alcohol, USP (95% ethyl
alcohol) is about 0.82 g/ml and water is 1.00 g/ml. Using a tarred
clean dry 10 ml volumetric flask the weight is determined the
weight and hence the density of a 10.0 ml sample of the 20% alcohol
solution.
[0058] A 5X homeopathic TAUROX SB composition is prepared by
weighing 10.0 g of the 4X homeopathic TAUROX SB composition into at
tarred 250 ml Erlenmeyer flask with ground glass stopper, followed
by the addition of a sufficient weight of the 20% alcohol solution
to make 90.0 mL. For example: if the density of the 20% alcohol
solution is 0.96 g/ml then to make 90 mis of solution 86.4 g of
solution is needed to make 180 ml. The flask is stopped and
succussed.
[0059] A 6X homeopathic TAUROX SB composition is prepared using the
density value for the 20% alcohol solution to calculate the weight
of 140 ml of 5X homeopathic TAUROX SB composition required (e.g. if
the density is 0.96 g/ml weight would be 134.4 g of 5X). That
weight is measured into a 2,000 ml Erlenmeyer flask with ground
glass stopper and diluted to 1,400 ml with 20% alcohol solution.
Calculate the weight needed for this dilution (i.e. the weight
needed to add 1,260 ml) in the same way as for 5X homeopathic
TAUROX SB. Stopper and succuss. This produces 6x homeopathic TAUROX
SB.
[0060] A 7X homeopathic TAUROX SB composition is prepared using the
steps as described for the 6X homeopathic TAUROX SB, and using a
tarred 250 ml Erlenmeyer flask with a ground glass stopper. The
amount of 6X homeopathic TAUROX SB equivalent to 14 ml of solution
(about 13.4 g) is weight and 20% alcohol solution is added to 140
ml. The flask is stopped and succussed.
[0061] A 8X homeopathic TAUROX SB composition is prepare by
transferring all 140 ml of 7X homeopathic TAUROX SB composition to
a tarred 2,000 ml Erlenmeyer flask with ground glass stopper. Again
the volume of solution required is calculated using the density and
sufficient a weight of 20% alcohol solution is added to make the
volume ten times that of the 7X. The flask is stopped and
succussed.
[0062] A 9X homeopathic TAUROX SB composition is prepared by
transferring 13 g (14 ml) of 8xhomeopathic TAUROX SB to a tarred
250 ml Erlenmeyer flask with ground glass stopper and adding a
sufficient weight of 20% alcohol solution to make the volume ten
times that of the starting volume of 8x(total about 140 ml or 134.4
g). The flask is stopped and succussed.
[0063] A 10X homeopathic TAUROX SB composition is prepared by
transferring all 140 ml of the 9X homeopathic TAUROX SB to a tarred
2,000 ml Erlenmeyer flask with ground glass stopper. The volume of
solution is calculated before, using the density and a sufficient
weight of 20% alcohol solution is added to make the volume ten
times that of the 9xhomeopathic TAUROX SB. The flask is stopped and
succussed.
[0064] General Manufacture:
[0065] Other volumes than described above may be used. All
dilutions should conform to the 1/10 v/v ratios described in the
above or others to meet traditional homeopathic guidelines. However
this invention is not limited to strict adherence to the exact
recipes as described herein as there are numerous ways of
generating virtually equivalent preparations which are known those
skill in the art.
[0066] The typical guidelines for preparation of the preferred
embodiment follow. No container should be too full to success
effectively (for example not less than 40% full and not more than
75% full). Ideally the volume to success is about 67% of the
capacity of the container. The original concentrate (1X or 2X)
should not be stored and used to make further solutions (unless
they are maintained sterile) as they must be freshly prepared due
to the absence of alcohol. For 3X and later concentrations the
preceding dilution can be used. For example, additional 4X can be
made from stored 3X. It is suggested to make any dilution in 20%
alcohol if it is to be stored for later use. Homeopathic TAUROX SB
made in 20% alcohol can be stored at room temperature. Therefore,
if a 3xstock homeopathic TAUROX SB is desired it should be prepared
from the freshly made 2X homeopathic TAUROX SB using 20% alcohol as
the diluent. Subsequent dilutions from the stored 3X homeopathic
TAUROX SB must be prepared with 20% alcohol. All materials used to
prepare homeopathic TAUROX SB dilutions must be clean and reserved
only for the manufacture of homeopathic TAUROX SB.
[0067] Various diluents or substrates may be used, depending on the
desired delivery system. Appropriate diluents for the following
delivery systems are well known: oral administration in liquid or
solid form; eye drops; nasal sprays; throat sprays; injectables;
topical preparations; and transdermal preparations. One or more
potencies of Taurox SB and/or one or more additional constituents,
such as a purified growth factor, vitamins, minerals, amino acids,
or traditional homeopathic preparations, may be combined in a
preparation. The preferred homeopathic diluents for oral
administration are a solution of purified water, glycerin, citric
acid and a preservative such as sodium benzoate; or a solution of
purified water, glycerin, potassium sorbate, and/or a form of
proteinated-copper in a cationic state, and a preservative such as
sodium benzoate. Other diluents for oral delivery, including
various alcohol-containing solutions, are known in the art and may
be employed in the present invention to increase solubility and
stability of Taurox SB. The homeopathic preparations of the present
invention are preferably administered orally, but may also be
prepared in topical formulations for application to the skin;
administered transdermally; by intracutaneous, intramuscular,
intravenous, or subcutaneous injection; or administered in the form
of eye drops or nasal and throat sprays. Lotions for topical and
transdermal application, and buffered salt solutions for eye
applications, are well characterized and widely used in the
cosmetic industry, which are readily adaptable to the preparation
of the present invention. Additionally, carrier solutions for
intranasal administration of substances are well known in the art
and widely used in drug delivery systems.
[0068] In a preferred embodiment, homeopathic preparations of
Taurox SB are prepared in a tablet form that dissolves in the
mouth. The tablets are made from a suitable organic material, such
as lactose (Dolisos, Las Vegas, Nev.), or sucrose by methods well
known in homeopathy, as described in the United States Homeopathic
Pharmacopoeia. In particular, tablets are generally produced in two
forms, as tablet triturates or compressed tablets. Tablet
triturates are produced by preparing a homeopathic preparation of
Taurox SB, and adding binders as necessary. Binding solutions are
composed of a binder, such as gum arabic, microcrystalline
cellulose, a preservative if necessary, an inert lubricant, and
purified water. The tablets are then molded by hand or preferably
by automated equipment, and the tablets are then dried by
introducing them into a dehumidified environment with a relative
humidity of 35-40%, and an ambient temperature of 70 to 110.degree.
F. Compressed tablets are formed by compression of a dry material
and contain no special coating. They are compressed from powdered
or crystalline solids, and, as with tablet triturates, may contain
binders, excipients, lubricants, and disintegrators. Compressed
tablets are produced by adding the homeopathic preparation of
Taurox SB to the lactose preparation until thoroughly moistened.
Binders may be added at this time as necessary, as described above
for tablet triturates. The moistened material is granulated by
passing through an appropriate mesh screen, and the moistened
granulation is introduced into a dehumidified environment and
subsequently dried as described above. The dried granulation is
then regranulated through the mesh screen and lubricants, such as
mineral oil, talc, calcium stearate, corn starch, are added as
necessary. The mixture is then compressed in a rotary tablet
compressor or any similar apparatus to the desired tablet size.
[0069] One preferred embodiment is inclusion in a single liquid,
pellet or other form two or more potencies for example a 6X and a
20C might be included in a single preparation. This may result in a
preparation advantageous for several reasons including obtaining
full benefit of molecular and submolecular functionalities.
[0070] Taurox SB Pre-Clinical Studies
[0071] Pharmacology Studies--Human Cells in Culture
[0072] Taurox SB was shown to enhance components of early T cell
activation, including increased intracellular calcium, up regulated
expression of the CD69 T cell activation marker and enhanced
proliferation of peripheral mononuclear cells in culture (Dunn et
al, 2000, incorporated by reference in its entirety herein). Tumor
necrosis factor alpha (TNF-alpha) and interferon gamma message were
also up regulated in the presence of Taurox SB, unless the cells
also were exposed to high levels of exogenous stimulation in which
case a normalization was seen. Taurox SB decreased or did not
change the amount of secreted TNF-alphamessage (which might cause
toxicity) while causing enhanced expression of active cell surface
protein. Taurox SB increased granzyme activity in T cells. The
Taurox SB--mediated increase in surface TNF-alpha, was able to
effect killing of HL60 tumor cells in vitro. While some effects
require high does, serial diluted and vigorously agitated low doses
alter bioelectric properties and the key cell signal
mobilization.
[0073] Whole Animal Laboratory Studies
[0074] The result of the chemical synthetic process beginning with
beta-alethine specified in Knight, et al (incorporated by reference
in its entirety herein) 1994 results in a molecule now identified
as Taurox SB. (Knight et al, called the molecule made by this
process the benzyl derivative of "Vitalethine"). In vivo studies
where Taurox SB was the sole agent, it was shown to have potent
anti-tumor effects against melanoma and myeloma models at low doses
with negligible toxicity. (Knight et al 1994, incorporated by
reference in its entirety herein).
[0075] Taurox SB may also be effective at stimulating immune
response following a single injection of antigen. Taurox SB may
help avoid the problems of local irritation and necrosis and the
systemic symptoms found with complete Freund's adjuvant (CFA). The
choice of CFA as the gold standard for antibody production in the
pn14-protein conjugate system is supported by the data from van de
Wijgert et al, 1991 regarding alternative adjuvants (Immunogenicity
of streptococcus pneumoniae type 14 capsular polysaccharide.
Infection and Immunity, 59(8):2750-7, incorporated by reference in
its entirety herein). No adjuvant gave a greater total IgG response
than CFA, and CFA caused an approximately 10-fold greater IgG
response to pn14-BSA conjugate than no adjuvant.
[0076] In a preferred embodiment of the present invention,
homeopathic Taurox SB increases the effectiveness of a vaccine or
otherwise modifies an immune response.
[0077] Toxicology Studies:
[0078] Several studies suggest that TAUROX SB (as other attenuated
substances) has an unusually wide margin of safety between the
effective dose and the amount of material that can be harmful.
Single-dose studies of TAUROX SB in adult male and female CD-1mice
suggested a maximally tolerated dose (MTD) of about 150 mg/kg
administered as an IV bolus. Acute toxicology studies performed by
MidAtlantic Bio-Research did not demonstrate an acute lethal
response until doses exceeding 133 mg/kg of TAUROX SB were reached.
From a study performed by Dovetail Technologies, Inc. no toxic side
effects were observed following either oral or subcutaneous daily
doses of 400 ug/kg of TAUROX SB for 9 days. During the 14-day
post-administration period, the animals all gained the appropriate
amount of weight as compared to their saline-injected controls and
there was no morbidity/mortality. Following euthanasia there were
no abnormal findings in the gross necropsies. Similar findings were
obtained in animals receiving 2000 mg/kg orally for 14 days. Thus,
the toxic doses levels of the compounds appear high (assuming a
similar biochemical pathway and not correcting for a different
surface-area-to-weight ratio), a dose of 9,975 mg (9.9 g) would not
be lethal for a 75-kg person.
[0079] Human Studies
[0080] Safety: As of Mar. 30, 2001, a total of 39 normal volunteers
have received from 14 to 28 doses of TAUROX SB as part of the
homeopathic proving process, without any severe adverse effects. As
of Jul. 18, 2002, over 40 patients with various complaints have
participated in clinical trials for 1-6 months (1-2 drops of 8x or
6x daily), without any severe adverse effects. Many of those
patients report improvements in their conditions (see below)
[0081] Efficacy:
[0082] Thirty-nine (39) patients have completed the first
homeopathic proving trial. The study design was a true double blind
and placebo-controlled. An apparent physiological placebo effect
was observed in 26% of patients where placebo was given. In
contrast, 92% of those receiving TAUROX SB were identified as
having physiologic affects by the evaluating physician who did not
know whether the subjects were receiving placebo or drug. While
there is too little data from the clinical trials on most medical
conditions to assess efficacy, benefits for some indications are
suggested by the preliminary data (see below).
[0083] This double-blind placebo-controlled "proving" study was
performed by David Riley. (Riley, Proving Report--Taurox SB. David
Riley, M. D., Integrative Medicine Institute, Apr. 16, 2001,
incorporated by reference in its entirety herein).
[0084] Rationale
[0085] TAUROX SB pre-clinical data suggest that Taurox SB may play
a role in immune stimulation. TAUROX SB studies of human cells in
culture suggest a calcium dependent mechanism leads to increased
proinflammatory cytokine production in unstimulated cells and an
immune modulation in highly stimulated cells. TAUROX SB animal
toxicity studies suggest that the proposed dose is over 1
million-fold lower than the toxic dose. TAUROX SB initial human
experiences in the homeopathic proving process are consistent with
low toxicity and immunomodulation. Numerous potential applications
were suggested.
[0086] The symptoms and liver degeneration in patients with
hepatitis are caused by an interaction of the virus and the
person's own immune system. Immune system molecules (cytokines) are
known to cause fatigue. Immune system molecules and immune system
cells cause allergies.
[0087] The allopathic pharmaceutical activity of Taurox SB is
described in Dunn et al, Immunostimmulatory Effects of Taurox
SB.TM., U MD, Dept. of Cell Biology and Molecular Genetics,
manuscript submitted for publication; Dunn Immunostimmulatory
Effects of Taurox SB.TM., Thesis, Univ. of MD, Dept. of
Pharmacology and Experimental Therapeutics, 2000, incorporated by
reference in its entirety herein. In contrast, homeopathic Taurox
SB has been diluted, potentized and prepared according to accepted
homeopathic practices. One drop per day is taken under the tongue.
This dosage is far below the lowest dose found to have any
allopathic pharmaceutical effects in the above studies. Although
the drop contains many billions of molecules (about
1,000,000,000,000 molecules) but still has less than one millionth
the dose of standard pharmaceutical drugs.
EXAMPLE 1
[0088] Decreased Fatigue Studies
[0089] Table 2 shows the clinical data of the eight patients who
entered the study with at least moderate fatigue (24 pts or
higher). They all experienced reduced fatigue while taking Taurox
SB. TABLE-US-00002 TABLE 2 Decreased Fatigue (Lower numbers
indicate less fatigue) Patient Week of Study ID 0 1 2 3 4 5 6 7 8 9
10 11 12 13 14 15 16 17 18 19 20 21 22 101 28 27 24 24 27 26 20 16
16 20 14 14 19 19 20 21 19 19 17 15 16 16 102 41 48 47 48 40 35 48
48 48 46 37 35 22 22 22 103 37 31 24 21.5 9 201 29 39 36 21 23 202
30 39 25 17 10* 401 25 20 29 21 9 8 507 33 32.5 31 703 48 44 44 44
44 41 37 41 41 32.5 39.5 39.5 39.5 39.5
[0090] To date, many patients have experienced reduced fatigue and
improved sleep after taking Taurox. For example, Patients 103, a
49-year-old male, entered the study with Chronic Fatigue Syndrome,
allergies, oral herpes and fibromyalgia. He took the 8x dose for
about 2 months. He reported increased energy, no eruptions of
herpes and one cold that resolved more quickly than usual. He noted
some decrease in frequency of allergy and fibromyalgia
symptoms.
[0091] Patient 202 has breast cancer and melanoma and entered the
study for fatigue and PMS. She reported, greater energy and better
sleep. Patient 507 has arthritis and Irritable Bowel Syndrome
(IBS). She reported less fatigue and improvement in IBS. Patient
703 has severe Chronic Fatigue Syndrome and numerous other
conditions, including IBS. She reports less fatigue and complete
resolution of IBS. Additional patients who had fatigue and
allergies are described in the allergies example below.
[0092] Summary: All eight patients with at least moderate fatigue
report improvements. The average score decreased by 43% This change
is statistically significant (p=0.002).
EXAMPLE 2
[0093] Decreased Allergies
[0094] Table 3. Table 3 is the clinical data from all patients who
reported at least moderate allergies at the pre-study. Most
patients reported a decrease in allergies while taking Taurox SB.
TABLE-US-00003 TABLE 3 Allergy Study (Lower numbers indicates less
frequent allergies) Patient Week of Study ID 0 1 2 3 4 5 6 7 8 9 10
11 102 10 10 10 10 10 8.5 8.5 8.5 8.5 10 10 103 8 7 3 3 3 3 3 402 6
3 2 2 3 201 10 5 1 0 1 701 10 10 10 10 10 10 401 9 9 3 3 2 2 3 4 3
702 10 10 10 5 6 3 703 10 10 10 10 10 10 10 10 10
[0095] Patient 102, a middle-aged female, entered the study with
lymphocytopenia, allergies, cough, PMS, fibromyalgia and muscle
aches and pains. On the 8X dose, her lymphocyte count improved and
she reported improvements in energy, an overall feeling of
well-being and less pain.
[0096] Patient 702, a middle-aged female, entered the study with
massive uterine fibroids, allergies, fatigue and PMS. On the 8X
dose, she reported marked reduction of her severe allergic response
to known allergens, such as perfume, less severe PMS, less
discomfort from the fibroids and improved ability to work.
[0097] Patient 401 has lung cancer; she entered the study because
of fatigue and allergies. On the 8X dose for 3 mouths, her allergy
symptoms were less frequent and less severe. She believes the drug
is helping with her recovery from chemotherapy. She has been able
to maintain her appetite and weight and has less fatigue.
[0098] Summary: Five of the eight patients with significant
allergies report a 82% average reduction in symptom frequency. This
change is statistically significant (p=0.017).
EXAMPLE 3
[0099] Decreased Hepatitis C Viral Load
[0100] Table 4 indicates the hepatitis C viral load in a patient.
TABLE-US-00004 TABLE 4 Hepatitis C Viral Load Nov. 23, 2001 2.59
Jan. 7, 2002 1.84 Jan. 25, 2002 1.49 Feb. 13, 2002 1.89 Feb. 26,
2002 0.99 Mar. 26, 2002 1.92
[0101] Patient 101 is a middle-aged Asian female, who is thought to
have contracted Hepatitis C (genotype 1) through a blood
transfusion in 1984. In mid 1992, she was notified of the viral
antibodies in her system through a rejected blood donation, though
she did not become symptomatic until late 1992. In 1999, she had
received Interferon Alpha Therapy (IFN). After an initial good
response, she failed IFN therapy due to viral escape. IFN caused
severe deliberating side effects, severe fatigue, weight loss, low
White Blood Cell counts and depression. It provided only temporary
stoppage of viral proliferation. The patient entered the Taurox SB
study in late 2001 due to fatigue. She took Taurox SB at strengths
of 6X or 8X over a period of 4 months. Her viral load decreased by
about 40% on average and her overall mood also improved. Test
results showed that patient 101 had a maximal viral load decrease
of 62%.
[0102] Patient 101 also reported less fatigue on both doses. The
largest decrease in viral count and fatigue occurred on 6X Taurox
SB. The previously required daily naps became unnecessary upon
initiation of 6X Taurox SB. After she completed the trial and
stopped taking Taurox SB, she frequently required lengthy daily
naps. Her liver enzymes decreased on Taurox SB as compared to both
pre- and post-Taurox treatment.
[0103] Recently, a second HCV patient began therapy. This patient
(number 706) has also experienced decreased fatigue on Taurox SB.
Quantitative HCV counts are not available on this patient.
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