U.S. patent application number 16/141486 was filed with the patent office on 2019-01-24 for method for testing and treating delayed food allergies.
The applicant listed for this patent is John Shea. Invention is credited to John Shea.
Application Number | 20190022254 16/141486 |
Document ID | / |
Family ID | 51935516 |
Filed Date | 2019-01-24 |
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United States Patent
Application |
20190022254 |
Kind Code |
A1 |
Shea; John |
January 24, 2019 |
Method for Testing and Treating Delayed Food Allergies
Abstract
A method for testing, treating, and preventing delayed food
allergies includes: receiving detailed symptom, medical, and
dietary histories from a patient; formulating a combination of one
or more food extracts at selected concentrations for sublingual
administration over a trial period; determining whether the
patient's symptoms have improved, worsened, or had no change, in
response to the administration of the combination; and altering the
combination in response to whether the patient's symptoms have
improved, worsened, or not changed, so as to induce immune system
food tolerance.
Inventors: |
Shea; John; (Burleson,
TX) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Shea; John |
Burleson |
TX |
US |
|
|
Family ID: |
51935516 |
Appl. No.: |
16/141486 |
Filed: |
September 25, 2018 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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14457879 |
Aug 12, 2014 |
10080810 |
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16141486 |
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13003999 |
Jan 13, 2011 |
8802056 |
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PCT/US09/51025 |
Jul 17, 2009 |
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14457879 |
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61081513 |
Jul 17, 2008 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61K 49/0004
20130101 |
International
Class: |
A61K 49/00 20060101
A61K049/00 |
Claims
1. A method for testing delayed food allergies in a patient,
comprising: receiving symptom, medical, and dietary histories from
the patient; assigning a first number according to the patient's
age, assigning a second number based on the patient's asthma
symptoms, assigning a third number based on the patient's headache
symptoms, and assigning a fourth number based on the patient's
gastrointestinal symptoms; and adding the first number, the second
number, the third number, and the fourth numbers together to
determine a sum; selecting a solution formed from a selected
dilution of a custom tailored combination of food extracts based
upon the sum and the symptom, medical, and dietary histories of the
patient; sublingually administering the solution to the patient;
periodically evaluating whether the patient's gastrointestinal,
headache, and asthma symptoms have improved, worsened, or have not
changed in response to the administration of the solution; and
periodically modifying the solution by altering the dilution of
and/or the combination of food extracts within the solution based
upon whether the patient's gastrointestinal, headache, and asthma
symptoms have improved, worsened, or have not changed since the
previous evaluation, until the patient's symptoms are reduced or
eliminated.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation U.S. patent application
Ser. No. 14/457,879, filed 12 Aug. 2014, titled "Method for Testing
and Treating Delayed Food Allergies," which issued as U.S. Pat. No.
10,080,810 on 25 Sep. 2018, which is a continuation-in-part of U.S.
patent application Ser. No. 13/003,999, filed 13 Jan. 2011, titled
"Method for Testing and Treating Delayed Food Allergies," which
issued as a U.S. Pat. No. 8,802,056 on 12 Aug. 2014, which is a
U.S. national-stage application of International PCT Appl. No.
PCT/US2009/051025, filed 17 Jul. 2009, titled "Method for Testing
and Treating Delayed Food Allergies," which claims priority to U.S.
Provisional Appl. No. 61/081,513, filed 17 Jul. 2008, titled
"Method for Testing and Treating Delayed Food Allergies," all of
which are hereby incorporated by reference for all purposes as if
fully set forth herein.
BACKGROUND
1. Field of the Invention
[0002] Beginning in the early 1900's, the term "allergy" was used
to denote a generic immune response. Then, in the early 1960's,
based upon advancements in the identification and understanding of
the antibody Immunoglobulin E (IgE), Dr. Phillip Gell and Dr. Robin
Coombs developed the well-known Gell and Coombs Classification
System, in which immune mechanisms of tissue injury are classified
into four types of reactions, based upon the immunopathological
damage done: Type I--Immediate Hypersensitivity; Type II--Cytotoxic
Hypersensitivity; Type III--Immune Complex; and Type IV--Delayed
Type Hypersensitivity. According to Drs. Gell and Coombs, only
immune reactions involving the IgE antibody should be referred to
as "allergies." Type I reactions are considered related to IgE,
while Type II-IV reactions are generally considered non-IgE
mediated reactions.
[0003] Although the Gell and Coombs Classification System has
become widely accepted, many physicians and lay people use the term
"allergy" to denote any adverse immune response, i.e., Type I, II,
III, or IV. One reason for this continued use of the term "allergy"
to refer to all four types of reactions is that although IgE
reactions are present in life-threatening reactions, such as to
food, IgE reactions are also present in typical seasonal reactions
to pollens and molds, and in reactions to mites and animal dander.
Typically, Type I reactions are sudden. Some Type I reactions may
result in life-threatening symptoms. Other Type I reactions produce
chronic symptoms, such as reactions to ragweed.
[0004] A "delayed food allergy" is a chronic reaction to a food or
foods that would not normally occur in most people. Delayed food
allergies have been described in many ways, including; food
sensitivities, chronic delayed food hypersensitivities, chronic
food allergies, hidden food allergies, and food allergy-addictions.
Delayed food allergies, which are typically classified as Gell and
Coombs Type IV reactions, typically do not include immediate food
allergies to specific, known foods, which can result in anaphylaxis
and death, such as an acute peanut allergy or other Gell and Coombs
Type I reactions.
[0005] There are many types of delayed food allergies. Delayed food
allergies are caused by a wide variety of foods and bring about a
wide variety of signs and symptoms. One sign of a delayed food
allergy is dark circles under the eyes. Symptoms include: mental
and physical fatigue, alternating dependent nocturnal nasal
blockage, waking with a dry mouth, snoring, drooling while asleep,
deep ear itching, persistent runny and itchy nose, chronic throat
clearing, migraine and common headaches, repeated sneezing,
rhinitis-induced sinus and ear infections, skin itching and hives,
cough, wheezing, exercise-induced asthma, intermittent
tinnitus/hearing loss, hyperactivity, gastrointestinal issues such
as diarrhea, gas, abdominal bloating, and irritable bowel.
[0006] There are many different methods of testing for allergens
that trigger delayed food allergies. Some tests are designed only
for inhalant allergens, some tests are designed only for food
allergens, and some tests are designed to test both types of
allergens. For example, intracutaneous skin tests using dilutions
of common airborne allergens are commonly used to test for inhalant
allergens. However, with intracutaneous skin tests, the airborne
allergens are uncommonly mixed into a single solution. In addition,
intracutaneous skin tests are used to test for immediate food
allergies, but only with great caution, starting with weak
dilutions. This is because the risk of potentially lethal
anaphylactic reactions is too high. For those patients who have IgE
mediated allergies, the radioallergosorbent (RAST) test can be
used. The RAST test measures the allergen-specific IgE antibodies
in a patient's blood. Other types of blood tests such as serum IgG
and ALCAT have had limited usefulness because of poor specificity
to detect delayed food allergies, or food sensitivities. Other
methods for testing delayed food allergies include: elimination
diets, rotation diets, and provocation/neutralization (P/N) tests.
These tests also have limited usefulness, primarily due to
difficulty in making any significant changes in a patient's
diet.
[0007] The elimination diet is often used to identify delayed food
allergies and requires users to change their diet. The elimination
diet requires a patient suffering from delayed food allergies to
eliminate certain foods or classes of foods from the patient's
diet, and then slowly reintroduce each food type, in an attempt to
identify the food allergen. Typically, a suspected food is removed
from the patient's diet for four days, reintroduced to the
patient's diet, and the patient is monitored for symptoms to
reappear over a 24-hour period after reintroduction. This method is
difficult to police and extremely taxing to the patient. Moreover,
the elimination diet is quite difficult for even the highly
motivated patient to successfully perform. The patient is asked to
purchase, prepare, and eat foods that are not normally in the
patient's diet, and that are often not palatable for the patient
with delayed food allergies, who is usually a "picky eater."
[0008] The rotation diet is another traditional method of
identifying delayed food allergies, particularly in patients with
chronic symptoms. In the rotation diet, the suspected food is only
ingested every three or four days, then the patient is observed for
symptoms within a day.
[0009] Provocation/neutralization tests can be done with either
intracutaneous injections or sublingual drops. The purpose of the
P/N test is to provoke an allergic reaction and then find a
neutralizing dose of the allergen. With intracutaneous injections,
the patient receives a series of injections, each injection having
a different dilution of a suspected allergen. After the injection,
the injection site is inspected, and the patient's symptoms are
monitored, to determine whether the patient is allergic to the
suspected allergen. This process takes a relative long period of
time to administer. For example, the patient may have to remain in
the physician's office all day, testing a single food every half
hour to one hour. In some cases, it can take up to two days for a
patient's symptoms to occur and resolve themselves. This is
particularly true in instances when the patient has a bad reaction
to a test.
[0010] Provocation/neutralization tests may also be conducted using
sublingual drops. In this method, extracts of certain individual
foods at certain concentrations are administered one after another
until the allergen is identified by symptom provocation. The
extracts used in conventional sublingual testing are obtained by
physicians from extract manufacturers in certain standardized
concentrations. Commonly a mixture of 50% water and 50% glycerin,
by volume. This process is expensive and time consuming. For
example, it is not uncommon for a patient to spend an entire day or
more at a physician's office or clinic undergoing testing.
[0011] Elimination diets, rotation diets, and
provocation/neutralization tests require the patients to make
changes to their diets in order to cause or not cause allergic
reactions from the offending food or suspected offending food.
These dietary changes are burdensome because of the widespread use
of typical offending foods and the reasonableness of eliminating
those foods from the patient's diet. Additionally during
provocation/neutralization testing the diet of patient must be
strictly controlled to isolate the offending food from other
allergens.
[0012] Recently, sublingual drops of solutions containing multiple
food allergens have become available. However, these solutions are
homeopathic, in which the food extracts are at very low
concentrations. These remedies are available without a prescription
and without the patient undergoing an examination by a physician.
In other words, no dietary or medical history is taken to determine
if indeed there are symptoms possibly related to food sensitivity,
which food extracts to include in the solution, and which
concentration of extracts is to be tried.
[0013] All too often, patients with delayed food allergies go to
their doctors, but do not get any relief of their symptoms. Their
doctors often lack the training and experience to offer adequate
dietary and medical histories that could uncover symptoms of
delayed food allergies, and the patients are told to try to get
relief from oral as well as nasal spray decongestants,
antihistamines, headache and/or migraine medications, steroid
and/or bronchodilator medications for asthma, or go see an
allergist. The patient may become "addicted" to decongestant nose
spray for many years, with associated side effects. The patient may
try to rely upon external nasal strips for relief, with only
partial temporary relief of but one of the symptoms of delayed food
allergy: nasal congestion. If the patient schedules an appointment
with an allergist, the allergist primarily runs tests on inhalant
allergens, and only a few skin tests for foods, and is mainly
interested in IgE mediated, Type I reactions, and the narrow set of
symptoms associated therewith. If the allergist cannot help the
patient, the allergist often recommends surgery on the nasal airway
and nasal decongestants. This is often because allergists typically
do not treat non-IgE mediated disease. These allergists typically
classify these patients as having "vasomotor rhinitis" or
"perennial non-allergenic rhinitis". The problem with nasal surgery
is that if the cause of the problem was a delayed food allergy, the
surgery is usually only helpful for a limited time, as the symptoms
often begin to return a few months after the surgery. Moreover, the
many other symptoms related to delayed food allergies, including
those set forth above, are not addressed at all. Although many
attempts to test and treat delayed food allergies have been made,
considerable shortcomings remain.
DESCRIPTION OF THE DRAWINGS
[0014] The novel features believed characteristic of the
embodiments of the present application are set forth in the
appended claims. However, the embodiments themselves, as well as a
preferred mode of use, and further objectives and advantages
thereof, will best be understood by reference to the following
detailed description when read in conjunction with the accompanying
drawings, wherein:
[0015] FIG. 1A is a chart showing extracts used in a "super-combo"
vial of solution according to the present application.
[0016] FIG. 1B is a chart showing extracts used in a "basic" vial
of solution according to the present application.
[0017] FIG. 1C is a chart showing extracts used in an "ultra-combo"
vial of solution according to the present application.
[0018] FIG. 1D is a chart showing extracts used in a "drink combo"
vial of solution according to the present application.
[0019] FIG. 1E is a chart showing extracts used in a "beer" vial of
solution according to the present application.
[0020] FIG. 1F is a chart showing extracts used in a "wine" vial of
solution according to the present application.
[0021] FIG. 1G is a chart showing extracts used in a "GOT" vial of
solution according to the present application.
[0022] FIG. 2A is a diagram of a method for testing and, treating
delayed food allergies according to the present application.
[0023] FIG. 2B is a continuation of the diagram of FIG. 2A
according to the present application.
[0024] FIG. 2C is a continuation of the diagram of FIG. 2A
according to the present application.
[0025] FIG. 2D is a continuation of the diagram of FIG. 2A
according to the present application.
[0026] FIG. 3 is a chart showing responses of patients with HART
(headache, asthma, and rhinitis triad) symptoms to the method for
testing and treating delayed food allergies disclosed in the
present application.
[0027] FIG. 4 is a chart showing responses of patients with various
symptoms to the method for testing and treating delayed food
allergies disclosed in the present application.
[0028] FIG. 5 is a chart showing responses of patients with asthma
and rhinitis symptoms to the method for testing and treating
delayed food allergies disclosed in the present application.
[0029] FIG. 6 is a chart showing responses of patients to the
method for testing and treating delayed food allergies disclosed in
the present application.
[0030] FIG. 7 is a chart showing responses of patients with HART
(headache, asthma, and rhinitis triad) symptoms to the method for
testing and treating delayed food allergies disclosed in the
present application.
[0031] FIG. 8A is a chart showing responses of patients with
headache and rhinitis symptoms to the method for testing and
treating delayed food allergies disclosed in the present
application.
[0032] FIG. 8B is a chart showing responses of patients with
headache and rhinitis symptoms to the method for testing and
treating delayed food allergies disclosed in the present
application.
[0033] FIG. 9 is a chart showing responses of patients with asthma
and rhinitis symptoms to the method for testing and treating
delayed food allergies disclosed in the present application.
[0034] FIG. 10A is a chart showing responses of patients to the
method for testing and treating delayed food allergies disclosed in
the present application.
[0035] FIG. 10B is a chart showing responses of patients with
headache and rhinitis symptoms to the method for testing and
treating delayed food allergies disclosed in the present
application.
[0036] FIG. 11 is a chart showing responses of patients with HART
(headache, asthma, and rhinitis triad) symptoms to the method for
testing and treating delayed food allergies disclosed in the
present application.
[0037] FIGS. 12A and 12B represent a chart showing a Food
Sensitivity Questionnaire for use in the method for testing and
treating delayed food allergies disclosed in the present
application.
[0038] FIG. 13 is a chart showing a Delayed Food Allergy Evaluation
Guide for use in the method for testing and treating delayed food
allergies disclosed in the present application.
[0039] FIG. 14 is a chart showing a Sublingual Food Drop Guide for
use in the method for testing and treating delayed food allergies
disclosed in the present application.
[0040] FIG. 15 is a chart showing Sublingual Management Strategies
for Food Sensitivity for use in the method for testing and treating
delayed food allergies disclosed in the present application.
[0041] FIG. 16 is a chart showing a SLIT Log for use in the method
for testing and treating delayed food allergies disclosed in the
present application.
[0042] While the assembly and method of the present application is
susceptible to various modifications and alternative forms,
specific embodiments thereof have been shown by way of example in
the drawings and are herein described in detail. It should be
understood, however, that the description herein of specific
embodiments is not intended to limit the invention to the
particular embodiment disclosed, but on the contrary, the intention
is to cover all modifications, equivalents, and alternatives
falling within the spirit and scope of the present application as
defined by the appended claims.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
[0043] Illustrative embodiments of the apparatus for containing
regurgitation are provided below. It will of course be appreciated
that in the development of any actual embodiment, numerous
implementation-specific decisions will be made to achieve the
developer's specific goals, such as compliance with
assembly-related and business-related constraints, which will vary
from one implementation to another. Moreover, it will be
appreciated that such a development effort might be complex and
time-consuming, but would nevertheless be a routine undertaking for
those of ordinary skill in the art having the benefit of this
disclosure.
[0044] The present application represents the discovery of a system
and method of testing, treating, and preventing delayed food
allergies. With the system and method of the present application,
delayed food allergies can be identified and treated, while the
patient continues to eat the foods he wants without changes to
their diet. Moreover, the system and method of the present
application may be used to prevent certain delayed food allergies
from evolving. It should be appreciated that even though the system
and method of the present application is tailored towards human
patients; the methods disclosed herein can also be applied towards
testing, treating, and preventing delayed food allergies in
non-humans.
[0045] The preferred embodiment of the present application utilizes
sublingual drops that target receptors under the tongue called
dendritic cells, which detect molecules in an allergy drop solution
and present them to immune system T-cells. These regulatory T-cells
are thought to induce and maintain tolerance to antigens. The
patient commonly notes symptom changes within days of starting a
two week trial vial, then usually notes return of symptoms within 2
days.
[0046] The food mix in the various allergy drop solutions may
contain foods to which the patient is sensitive, as well as foods
to which there no sensitivity. These foods to which there is no
sensitivity are kept in the treatment vials to help prevent
development of future sensitizations. Furthermore, the process of
eliminating a common food from the diet is so impractical, that
almost all patients are not interested in separating and testing
sublingually the individual foods found in the food mixes.
[0047] The dietary history is important because what is most often
consumed is most often the culprit. However, because the dietary
history is imperfect and the food culprit is commonly ingested in a
"hidden form", the dietary history is usually of little benefit.
Examples of "hidden" foods include onion hidden in ketchup and whey
hidden in bread and cereal. The majority of patients with food
sensitivities respond to the foods present in the "super-combo"
mix. Previous attempts to test and treat delayed food allergies
utilize dietary changes to determine and treat the delayed food
allergies. Utilizing dietary changes for the testing, treating, and
prevention of delayed food allergies is flawed because of the
difficulty of detecting the offending food and the elimination of
the offending food from the user's diet.
[0048] Illustrative embodiments of the present application are
described below. In the interest of clarity, not all features of an
actual implementation are described in this specification. It will
of course be appreciated that in the development of any such actual
embodiment, numerous implementation-specific decisions must be made
to achieve the developer's specific goals, such as compliance with
system-related and business-related constraints, which will vary
from one implementation to another. Moreover, it will be
appreciated that such a development effort might be complex and
time-consuming but would nevertheless be a routine undertaking for
those of ordinary skill in the art having the benefit of this
disclosure.
[0049] Referring to FIG. 1A in the drawings, a chart 100 listing
the extracts used in the preferred embodiment of a "super-combo"
vial of solution according to the present application is shown.
Wheat, corn, dairy, egg, yeast, garlic, onion and tomato (WCDEYGOT)
are believed to be some of the most common foods that cause chronic
food sensitivity.
[0050] The WCDEYGOT is administered as food extracts (commonly
available food allergy extracts) in a water and glycerin solution,
disposed within a dropper vial, in a specific dilution. This
solution is referred to as a "super-combo" vial. According to the
preferred embodiment, the optimum starting dilution of the present
application is determined by using an algorithm based upon patient
age, headache and asthma severity: (see Optimum Starting Dilution
Algorithm Chart).
[0051] Optimum Starting Dilution Algorithm Chart
[0052] The optimum starting dilution is the sum of four factors
based on age, asthma, headache, and rhinitis:
TABLE-US-00001 AGE+ ASTHMA+ HEADACHE+ RHINITIS =DILUTION 2-20 = 2
Mild = 0 Mild = 0 Mild = 0 30 = 3 Moderate = Moderate = 1 Moderate
= 1 1 40 = 4 Severe = 2 Severe = 2 Severe = 2 50 = 5 60 = 6 70 = 7
80 = 8 90 = 9 100 = 10
Examples
[0053] 13 year old female with recurrent severe migraine: 2+2=#4
Dilution
[0054] 63 year old male with mild headache: 6+0=#6 Dilution
[0055] 29 year old female with asthma treated a few times a year
but with rather chronic severe migraine headaches: 2+0+2=#4
Dilution
[0056] 71 year old male with moderate headaches: 7+1=#8
Dilution
[0057] 33 year old female with chronic severe asthma and daily
severe headache: 3+2+2=#7 Dilution
[0058] The various dilutions are created by starting with the
concentrate provided by the allergy extract company, and making 1/5
dilutions using a diluent comprised of 1 part glycerin and 1 part
water, by volume. A number 1 dilution is 1/5 C is created by
diluting 1 cc of food extract concentrate with 4 cc of a diluent,
by volume. A number 2 dilution is 1/25 C is realized by diluting 1
cc of 1/5 C solution with 4 cc of the diluent, by volume. A 1/125 C
is realized by diluting 1 cc of 1/25 C solution with 4 cc of the
diluent, by volume, and so on for further dilution. (see the
Dilution chart)
TABLE-US-00002 DILUTION CHART CONCENTRATE 1/1 #1 DILUTION 1/5 #2
DILUTION 1/25 #3 DILUTION 1/125 #4 DILUTION 1/625 #5 DILUTION
1/3,125 #6 DILUTION 1/15,625 #7 DILUTION 1/78,125 #8 DILUTION
1/390,625 #9 DILUTION 1/1,953,125 #10 DILUTION 1/9,765,625
[0059] It is believed that the various dilutions have the ability
to provide an immunotherapeutic response, thereby inducing immune
system food tolerance. It should be understood that there could be
a homeopathic affect, as well, or in addition to, the
immunotherapeutic affect of the procedure of the present
application. However, it will be appreciated that with some
patients, depending upon their dietary and medical history, this
concentration is too strong and may cause temporary exacerbation of
food reactions from over-reaction of the immune system. In such
cases, the solution may be diluted or otherwise adjusted.
Sublingual drops target receptors under the tongue called dendritic
cells, which detect molecules in an allergy drop solution and
present them to immune system T-cells. These regulatory T-cells are
thought to induce and maintain tolerance to antigens. T-cells send
a message to the other cells that the food extracts are tolerated,
although the exact method is unknown. The T-cells' messages to
other cells are sent directly (cell-to-cell) or indirectly (via
cytokines made by the other cells). In the preferred embodiment,
other common foods in the patient's diet can be administered as
food extracts in addition to the extracts in the "super-combo"
vial. In an alternative embodiment, soy, another common food
allergen, can be administered as a food extract in addition to the
extracts in the "super-combo" vial.
[0060] Referring now also to FIG. 1B in the drawings, there is
shown a chart 110 listing the extracts used in a preferred
embodiment of a "basic" vial solution according to the present
application. Wheat, corn, dairy, egg, yeast (WCDEY) are believed to
be some of the most common foods that cause delayed food allergies
(chronic food sensitivity). The WCDEY are administered as food
extracts in a water and glycerin solution, disposed within a
dropper vial, in a specific dilution. This solution is referred to
as a "basic" vial. Other common foods in the patient's diet can be
administered as food extracts in addition to the extracts in the
"basic" vial. For example, soy can be administered as a food
extract in addition to the extracts in the "basic" vial.
[0061] Referring now also to FIG. 1C in the drawings, there is
shown a chart 120 listing the extracts used in a preferred
embodiment of an "ultra-combo" vial solution according to the
present application. Soy, rice, potato, chocolate, cinnamon,
coconut, sugar, beef, pork, apple, orange, black pepper, chicken,
banana, lemon, and oat are believed to be other common foods that
cause delayed food allergies (chronic food sensitivity). The
aforementioned food extracts are administered in a water and
glycerin solution, disposed within a dropper vial, in a specific
dilution. This solution is referred to as an "ultra-combo" vial.
Other common foods in the patient's diet can be administered as
food extracts in addition to the extracts in the "ultra-combo"
vial.
[0062] Referring now also to FIG. 1D in the drawings, there is
shown a chart 130 listing the extracts used in a preferred
embodiment of a "drink-combo" vial solution according to the
present application. Tea, white grape, concord grape, brewer yeast,
barley, hops, coffee, and tea are believed to be other common foods
that cause delayed food allergies (chronic food sensitivity). The
aforementioned food extracts are administered in a water and
glycerin solution, disposed within a dropper vial, in a specific
dilution. This solution is referred to as a "drink-combo" vial.
Other common foods in the patient's diet can be administered as
food extracts in addition to the extracts in the "drink-combo"
vial.
[0063] Referring now also to FIG. 1E in the drawings, there is
shown a chart 140 listing the extracts used in a preferred
embodiment of a "beer" vial solution according to the present
application. Brewer yeast, barley, and hops are believed to be
other common foods that cause delayed food allergies (chronic food
sensitivity). The aforementioned food extracts are administered in
a water and glycerin solution, disposed within a dropper vial, in a
specific dilution. This solution is referred to as a "beer" vial.
Other common foods in the patient's diet can be administered as
food extracts in addition to the extracts in the "beer" vial.
[0064] Referring now also to FIG. 1F in the drawings, there is
shown a chart 150 listing the extracts used in a preferred
embodiment of a "wine" vial solution according to the present
application. Yeast, white grape, and concord grape are believed to
be other common foods that cause delayed food allergies (chronic
food sensitivity). The aforementioned food extracts are
administered in a water and glycerin solution, disposed within a
dropper vial, in a specific dilution. This solution is referred to
as a "wine" vial. Other common foods in the patient's diet can be
administered as food extracts in addition to the extracts in the
"wine" vial.
[0065] Referring now also to FIG. 1G in the drawings, there is
shown a chart 160 listing the extracts used in a preferred
embodiment of a "GOT" vial solution according to the present
application. Garlic, onion, and tomato are believed to be other
common foods that cause delayed food allergies (chronic food
sensitivity). The aforementioned food extracts are administered in
a water and glycerin solution, disposed within a dropper vial, in a
specific dilution. This solution is referred to as a "GOT" vial.
Other common foods in the patient's diet can be administered as
food extracts in addition to the extracts in the "GOT" vial.
[0066] Referring now also to FIG. 2A in the drawings, a flowchart
200 depicting the preferred embodiment of a method for testing and
treating delayed food allergies according to the present
application is shown. Method 200 begins at 202, in which a detailed
symptom and medical history of the patient is taken. Chart 1200,
shown in FIGS. 12A and 12B, represents a food sensitivity
questionnaire for facilitating taking the patient symptom and
medical history. Referring now also to FIG. 13 in the drawings, a
chart 1300 is a delayed food allergy evaluation guide used in
method for testing and treating delayed food allergies disclosed in
the present application is illustrated. Chart 1300 is used to
facilitate acquiring patient symptom and medical history data. The
method then proceeds to 204. At 204, a dietary history of foods
common in the patient's diet is taken. In the preferred embodiment,
the patient is asked for a list of favorite foods and/or foods
frequently consumed in the patient's diet. The taking of these
detailed histories is are important steps in the process of the
subject application, as the patient's symptoms, and medical and
dietary histories, play important roles in the selection of the
type, make-up, and extract concentration levels of the initial and
subsequent vials that are administered to the patient. The method
then proceeds to 206. It should be apparent that the method does
not require or utilize invasive testing such as prick testing,
blood testing, or intradermal injections to test, treat, or prevent
delayed food allergies. Patients typically do not like invasive
testing and the method by not utilizing invasive testing increases
the likelihood of patients remaining in the process.
[0067] At 206, an initial solution is prepared for sublingual
administration. In the preferred embodiment, the initial solution
is a "super-combo" vial, wherein WCDEYGOT are combined with
glycerin and water. In an alternative embodiment, the initial
solution is a GOT vial or "basic" vial. The "basic" vial is often
the initial solution administered to small children, and the
"super-combo" vial is usually the initial solution administered to
adults and older children. The method then proceeds to 208.
[0068] At 208, the solution is administered to the patient over a
trial period. In the preferred embodiment, the solution is
administered three times daily. For example, a single drop is
placed under the tongue first thing in the morning, at
mid-afternoon, and at bedtime, with the best results occurring if
the drops are not administered at or during a mealtime. The trial
period preferably lasts two weeks. Worsening of the patient's
symptoms may occur. In approximately 10% of patients; when this
occurs, it routinely will start to occur during the first few days
of drop use. The patient is asked to discontinue that drop
dilution, and obtain a weaker dilution for another 2 week trial
period. If improvement occurs, there will be a gradual decrease in
symptoms over several days, then when the drops are stopped after
the two week trial period, the original symptoms quickly return
during the first few days off the drops. Referring now also to FIG.
14 in the drawings, a chart 1400 is a sublingual food drop guide
used in method for testing and treating delayed food allergies
disclosed in the present application is illustrated. Chart 1400 is
used to facilitate acquiring patient symptom data during the method
disclosed in the present application. Referring now also to FIG. 16
in the drawings, a chart 1600 is a SLIT log used in method for
testing and treating delayed food allergies disclosed in the
present application is illustrated. Chart 1600 is used to
facilitate acquiring patient symptom data during the method
disclosed in the present application. The method then proceeds to
210. It should be apparent that the method does not require nor
suggest the patient change their diet. Changes in diet during the
method would adversely affect the testing and treating by adding an
independent variable of dietary changes. Thereby resulting in
confusion in the doctor and patient if the initial dilution was
working or if the change in diet caused the change in symptoms.
[0069] At 210, it is determined whether the patient's symptoms are
improving, getting worse, or experiencing no change. In the
preferred embodiment, the patient is brought in to a first
follow-up consultation to give an account of the degree of the
symptoms as compared with the degree of the symptoms at the initial
consultation. If the patient's symptoms have improved since the
initial consultation, the method proceeds to 212 (continued in FIG.
2B). If the patient's symptoms have gotten worse since the initial
consultation, the method proceeds to 234 (continued in FIG. 2C). If
the patient's symptoms experience no change since the initial
consultation, the method proceeds to 246 (continued in FIG.
2D).
[0070] Referring now also to FIG. 2B in the drawings, there is
shown a continuation of the diagram of FIG. 2A according to the
present application. At 212, it is determined whether the food
extracts in the initial solution will be separated and the
offending extracts further identified. For example, a cost benefit
analysis of further testing and treatment may be undertaken. If it
is decided that the initial solution will be separated and further
identified, the method proceeds to 216. If it is decided that the
initial solution will not be separated and further identified, the
method proceeds to 214.
[0071] At 214, because the patient experienced an improvement in
symptoms with the initial solution, the patient continues
administration of the current solution at the current
concentration, and monitors the diet. The method then proceeds to
215. At 215, the patient returns to the doctor's office in six
months for a second follow-up consultation. At 216, administration
of the initial solution is ceased for a period of time. In the
preferred embodiment, the patient continues eating foods that cause
allergy symptoms without administering drops for up to two weeks,
or until symptoms return. The method then proceeds to 217.
[0072] At 217, solution A and solution B are prepared by separating
the food extracts in the initial solution. In the preferred
embodiment, a "super-combo" vial was used as the initial solution,
and solution A contains WCDEY food extracts, glycerin, and water at
a 1/25 C concentration, and solution B contains GOT food extracts,
glycerin, and water at a 1/25 C concentration. The method then
proceeds to 218.
[0073] At 218, solution A is administered to the patient over a
trial period. In the preferred embodiment, the solution is
administered three times daily. A single drop is placed under the
tongue first thing in the morning, at mid-afternoon, and at
bedtime. The trial period preferably lasts two weeks; alternatively
the trial period is five days with an additional two days of no
drops being applied. The method then proceeds to 220.
[0074] At 220, it is determined whether the patient's symptoms are
getting better or experience no change. In the preferred
embodiment, the patient is brought in for a second follow-up
consultation to give an account of the degree of the symptoms as
compared with the degree of the symptoms at the first follow-up
consultation. If the patient's symptoms have improved since the
first follow-up consultation, the method proceeds to 222. If the
patient's symptoms experience no change since the first follow-up
consultation, the method proceeds to 227.
[0075] At 222, administration of solution A is ceased for a period
of time. In the preferred embodiment, the patient continues eating
foods that cause allergy symptoms without administering drops for
up to two weeks, or until symptoms return. The method then proceeds
to 224.
[0076] At 224, a unique solution is prepared by separating the food
extracts in the initial solution. In the preferred embodiment, the
unique solution contains one or more WCDEY food extracts, glycerin,
and water at a 1/25 C concentration. The unique solution must have
at least one less food extract than solution A, unless other food
extracts are added. It is preferred that the food extracts chosen
for the unique solution be chosen based on the patient's dietary
history. The method then proceeds to 225.
[0077] At 225, the unique solution is administered to the patient
over a trial period. In the preferred embodiment, the solution is
administered three times daily. In a second exemplary embodiment, a
single drop is placed under the tongue first thing in the morning,
at mid-afternoon, and at bedtime. The trial period preferably lasts
two weeks; alternatively the trial period is five days. The method
then proceeds to 226.
[0078] At 226, it is determined whether all food extracts and
combinations thereof have been used. The unique solution must be
unique; meaning that the exact same combination of extracts must
not have been used in the unique solution for this patient before.
If all extracts and combinations thereof have been used in the
unique solution for this patient, the method proceeds to 233. If
all extracts and combinations thereof have not been used in the
unique solution for this patient, the method proceeds to 224.
[0079] At 227, solution B is administered to the patient over a
trial period. In the preferred embodiment, the solution is
administered three times daily. A single drop is placed under the
tongue first thing in the morning, at mid-afternoon, and at
bedtime. The trial period preferably lasts two weeks; alternatively
the trial period is five days. The method then proceeds to 220.
[0080] At 228, it is determined whether the patient's symptoms are
getting better or experience no change. In the preferred
embodiment, the patient is brought in for a third follow-up
consultation to give an account of the degree of the symptoms as
compared with the degree of the symptoms at the second follow-up
consultation. If the patient's symptoms have improved since the
second follow-up consultation, the method proceeds to 229. If the
patient's symptoms experience no change since the second follow-up
consultation, the method proceeds to 246 (continued in FIG.
2C).
[0081] At 229, administration of solution B is ceased for a period
of time. In the preferred embodiment, the patient continues eating
foods that cause delayed allergy symptoms without administering
drops for up to two weeks, or until symptoms return. The method
then proceeds to 230.
[0082] At 230, a unique solution is prepared by separating the food
extracts in the initial solution. In the preferred embodiment, the
unique solution contains one or more GOT food extracts, glycerin,
and water at a 1/25 C concentration. The unique solution must have
at least one less food extract than solution B, unless other food
extracts are added. The food extracts chosen for the unique
solution are preferably chosen based on the patient's dietary
history. The method then proceeds to 231.
[0083] At 231, the unique solution is administered to the patient
over a trial period. In the preferred embodiment, the solution is
administered three times daily. A single drop is placed under the
tongue first thing in the morning, at mid-afternoon, and at
bedtime. The trial period preferably lasts two weeks; alternatively
the trial period is five days. The method then proceeds to 232.
[0084] At 232, it is determined whether all food extracts and
combinations thereof have been used. The unique solution must be
unique; meaning that the exact same combination of extracts must
not have been used in the unique solution for this patient before.
If all extracts and combinations thereof have been used in the
unique solution for this patient, the method proceeds to 233. If
all extracts and combinations thereof have not been used in the
unique solution for this patient, the method proceeds to 230.
[0085] At 233, the method for testing and treating delayed food
allergies ends. In the preferred embodiment, the results on the
patient's symptoms by the different unique solutions are analyzed
and the food allergies are identified. A long-term customized
treatment plan, based upon the analysis, is initiated with the
patient. Returning visits and evaluations may be prescribed.
[0086] It is the intent of the procedure to continue to weaken or
strengthen the food extracts until the patient has satisfactory
symptom relief without symptom provocation.
[0087] Referring now also to FIG. 2C in the drawings, there is
shown a continuation of the diagram of FIG. 2A according to the
present application. At step 234 a dilution procedure is initiated,
with each additional concentration being diluted by 1/5. At 235, it
is determined whether the initial solution concentration has been
diluted to 1/9,765,625 C. In the preferred embodiment, the
1/9,765,625 C concentration of the initial solution is too low to
affect the patient. If the 1/9,765,625 C concentration has been
reached, the method proceeds to 236. If the 1/9,765,625 C
concentration has not been reached, the method proceeds to 238.
[0088] At 238, administration of the initial solution is ceased for
a period of time. In the preferred embodiment, the patient
continues eating foods that cause allergy symptoms without
administering drops for up to two weeks, or until symptoms return.
The method then proceeds to 240.
[0089] At 240, the solution concentration is diluted in order to
find a weaker dilution that will be less likely to provoke
symptoms. In the preferred embodiment, the initial solution is
diluted by combining 1 cc of food extract with 4 cc of a diluent,
by volume. The diluent is comprised of 1 part glycerin and 1 part
water, by volume. Glycerin is used as a preservative. The diluted
solution is preferably diluted to 1/5 of its parent concentration.
The method then proceeds to 242.
[0090] At 242, a diluted solution is administered to the patient
over a trial period. In the preferred embodiment, the solution is
administered three times daily. A single drop is placed under the
tongue first thing in the morning, at mid-afternoon, and at
bedtime. The trial period preferably lasts two weeks. The method
then proceeds to 244.
[0091] At 244, it is determined whether the patient's symptoms are
getting better or experience no change. In the preferred
embodiment, the patient is brought in for a second follow-up
consultation to give an account of the degree of the symptoms as
compared with the degree of the symptoms at the first follow-up
consultation. If the patient's symptoms have improved since the
first follow-up consultation, the method proceeds to 212 (continued
in FIG. 2B). If the patient's symptoms experience no change since
the first follow-up consultation, the method proceeds to 234.
[0092] At 236, the method for testing and treating delayed food
allergies ends. In the preferred embodiment, the results on the
patient's symptoms experience no change, so the patient may try
another food mix such as "Ultra-combo" or the patient may want to
try a rotation or elimination diet with the patient returning in
six months for a follow-up consultation. It should be understood
that very weak dilutions may be needed in the very sensitive
patient.
[0093] Referring now also to FIG. 2D in the drawings, there is
shown a continuation of the diagram of FIG. 2A according to the
present application. At 246, administration of the initial solution
is ceased for a period of time. In the preferred embodiment, the
patient continues eating foods that cause allergy symptoms without
administering drops for up to two weeks, or until symptoms return.
The method then proceeds to 248.
[0094] At 248, solution C is prepared by adding food extracts from
foods that are common to the patient's diet, as disclosed by the
patient's dietary history. In the preferred embodiment, the unique
solution contains soy, glycerin, and water at a 1/25 C
concentration. The food extracts chosen for the unique solution are
preferably chosen based on the patient's dietary history,
especially considering foods frequent in the patient's diet. The
method then proceeds to 250.
[0095] At 250, solution C is administered to the patient over a
trial period. In the preferred embodiment, the solution is
administered three times daily. A single drop is placed under the
tongue first thing in the morning, at mid-afternoon, and at
bedtime. The trial period preferably lasts two weeks. The method
then proceeds to 252.
[0096] At 252, it is determined whether the patient's symptoms are
getting better or experience no change. In the preferred
embodiment, the patient is brought in for a second follow-up
consultation to give an account of the degree of the symptoms as
compared with the degree of the symptoms at the first follow-up
consultation. If the patient's symptoms have improved since the
first follow-up consultation, the method proceeds to 212. If the
patient's symptoms experience no change since the first follow-up
consultation, the method can either proceed to 246 or may try
another food mix such as "Ultra-combo" or the patient may want to
try a rotation or elimination diet with the patient returning in
six months for a follow-up consultation.
[0097] In a hypothetical case, a patient having delayed food
allergies discloses a symptom history detailing the symptoms
suffered. Additionally, the patient discloses a dietary history
detailing foods common to the patient's diet. A "super-combo" vial
is prepared for the patient. The patient administers one sublingual
drop three times daily for two weeks. The patient then returns for
a first follow-up consultation to provide an update or change in
patient symptoms: better, worse or same.
[0098] If, after the first follow-up consultation, the patient's
symptoms have gotten better, the patient and doctor discuss whether
to separate the extracts and further identify the allergen, or to
continue the current regimen and monitor the patient's diet for six
months, then checkup. If the decision is to separate and identify
the extracts in the "super-combo" vial, the extracts are divided
into two groups. Group 1 can contain VVCDEY, and group 2 can
contain GOT. The patient ceases administration of the sublingual
drops for as short as three days, but as long as two weeks, after
which, the vial containing group 1 extracts is administered to the
hypothetical patient for a period of two weeks. The patient then
returns for a second follow-up consultation to provide an update or
change in patient symptoms: better, worse or same.
[0099] If, after the second follow-up consultation, the patient's
symptoms have gotten better, the allergen is contained in the group
1 solution and the food extracts contained in the group 1 solution
are separated so to further isolate and identify the allergen. A
solution containing only one food extract, glycerin, and water is
administered to the patient for two weeks, the patient then returns
for a follow-up consultation to provide an update or change in
patient symptoms: better, worse or same. This process of
administration for two weeks followed by a follow-up consultation
is repeated with a solution containing one food extract from group
one until all the extracts have been individually administered. In
this way, the offending food allergen can be isolated and
identified, thereby equipping the patient with the knowledge of
what foods can cause the patient's allergic reaction.
[0100] Referring now also to FIG. 3 in the drawings, a chart 300
detailing patient responses to the method for testing and treating
delayed food allergies disclosed in the present application is
illustrated. Data from 39 consecutive patients, with follow up,
with headache, asthma, and rhinitis triad (HART) symptoms is
represented in chart 300.
[0101] Referring now also to FIG. 4 in the drawings, a chart 400
detailing patient responses to the method for testing and treating
delayed food allergies disclosed in the present application is
illustrated. Data from 59 consecutive patients with various
symptoms is represented in chart 400. For example, after taking the
sublingual drops of the patients experiencing nasal blockage, 28
patients experienced improvement, 17 patients experienced no
change, and 1 patient experienced a worsening of the nasal
blockage. Chart 400 also reveals that of the patients experiencing
snoring symptoms, 5 patients experienced improvement, 9 experienced
no change, and 0 patients experienced a worsening of the symptom,
after taking the sublingual drops.
[0102] Referring now also to FIG. 5 in the drawings, a chart 500
detailing patient responses to the method for testing and treating
delayed food allergies disclosed in the present application is
illustrated. Data from 49 consecutive patients with asthma and
rhinitis symptoms is represented in chart 500. Following an
administration of sublingual drops to 49 patients, 41 of the
patients experienced an improvement in their symptoms, 2
experienced a worsening of symptoms, 2 experienced no change in
their symptoms, and 4 without follow up. In addition, 23 patients
reordered the sublingual drops. Chart 500 represents 49 actual
patients that were experiencing asthma and rhinitis symptoms prior
to receiving sublingual drops according to the present
application.
[0103] Referring now also to FIG. 6 in the drawings, a chart 600
detailing patient responses to the method for testing and treating
delayed food allergies disclosed in the present application is
illustrated. Data from 712 consecutive patients, with follow up,
having sublingual drops according to the method of the present
application is represented in chart 600. Following an
administration of sublingual drops to 712 patients, 437 of the
patients experienced an improvement in their symptoms, 87
experienced a worsening of symptoms, and 188 experienced no change
in their symptoms. In addition, 258 patients reordered the
sublingual drops and 103 patients reordered the sublingual drops
again. Chart 600 represents 712 actual patients that received
sublingual drops according to the method of the present
application.
[0104] Referring now also to FIG. 7 in the drawings, a chart 700
detailing patient responses to the method for testing and treating
delayed food allergies disclosed in the present application is
illustrated. Data from 42 consecutive patients with headache,
asthma, and rhinitis triad (HART) symptoms is represented in chart
700. Following an administration of sublingual drops to 42
patients, 35 of the patients experienced an improvement in their
symptoms, 2 experienced a worsening of symptoms, 2 experienced no
change in their symptoms, and 3 patients did not follow up. In
addition, 18 patients reordered the sublingual drops. Chart 700
represents 42 actual patients that were experiencing headache,
asthma, and rhinitis triad (HART) symptoms prior to receiving
sublingual drops according to the present application.
[0105] Referring now also to FIG. 8A in the drawings, a chart 800
detailing patient responses to the method for testing and treating
delayed food allergies disclosed in the present application is
illustrated. Data from 57 consecutive patients with headache and
rhinitis symptoms is represented in chart 800. Following an
administration of sublingual drops to 57 patients, 41 of the
patients experienced an improvement in their symptoms, 4
experienced a worsening of symptoms, 7 experienced no change in
their symptoms, and 5 patients did not follow up. In addition, 22
patients reordered the sublingual drops. Chart 800 represents 57
actual patients that were experiencing headache and rhinitis
symptoms prior to receiving sublingual drops according to the
present application.
[0106] Referring now also to FIG. 8B in the drawings, a chart 810
detailing patient responses to the method for testing and treating
delayed food allergies disclosed in the present application is
illustrated. Of 57 patients experiencing headache and rhinitis
symptoms, 71.9% of the patients expressed an improvement in their
symptoms, 7% expressed a worsening of symptoms, and 12.3% expressed
no change in their symptoms. Additionally, 8.8% of the patients did
not follow up.
[0107] Referring now also to FIG. 9 in the drawings, a chart 900
detailing patient responses to the method for testing and treating
delayed food allergies disclosed in the present application is
illustrated. Of 49 patients experiencing asthma and rhinitis
symptoms, 83.7% of the patients expressed an improvement in their
symptoms, 4.1% expressed a worsening of symptoms, and 4.1%
expressed no change in their symptoms. Additionally, 8.2% of the
patients did not follow up.
[0108] Referring now also to FIG. 10A in the drawings, a chart 1000
detailing patient responses to the method for testing and treating
delayed food allergies disclosed in the present application is
illustrated. Following an administration of sublingual drops to 712
patients, 61.4% of the patients expressed an improvement in their
symptoms, 12.2% expressed a worsening of symptoms, and 26.4%
expressed no change in their symptoms. Thus, 73.6% of patients
experienced a positive response, i.e., improving or worsening of
symptoms, to the sublingual drops. The 26.4% of patients that
experienced no change in their symptoms either transitioned to an
elimination or rotation diet, or chose to have limited further
follow-up. Chart 1000 represents actual patients that have
responded to follow-up inquiries; i.e., provided an update or
change in patient symptoms: better, worse or same.
[0109] Referring now also to FIG. 10B in the drawings, a chart 1010
detailing patient responses to the method for testing and treating
delayed food allergies disclosed in the present application is
illustrated. Following an administration of sublingual drops to 933
patients, 46.8% of the patients expressed an improvement in their
symptoms, 9.3% expressed a worsening of symptoms, and 20.2%
expressed no change in their symptoms. Additionally, 23.7% of the
patients did not follow up.
[0110] Referring now also to FIG. 11 in the drawings, a chart 1100
detailing patient responses to the method for testing and treating
delayed food allergies disclosed in the present application is
illustrated. Following an administration of sublingual drops to 933
patients experiencing headache, asthma, and rhinitis triad (HART)
symptoms, 83.3% of the patients expressed an improvement in their
symptoms, 4.8% expressed a worsening of symptoms, and 4.8%
expressed no change in their symptoms. Additionally, 7.1% of the
patients did not follow up.
[0111] As set forth above, the taking of detailed symptom, medical,
and dietary histories is important to the procedure of the subject
application. In the preferred embodiment, a guide is provided to
assist a health care provider in taking a patient's symptom
history. In the preferred embodiment, the guide form takes the form
of a point system in which a selected point value is assigned to
selected symptoms. The results from the guide form can be used to
evaluate the patient and select an appropriate initial vial and
subsequent vials.
[0112] The following table represents an exemplary point system for
use in evaluating symptoms of delayed food allergies:
TABLE-US-00003 Guide Form for Evaluating Delayed Food Allergy
Symptoms Symptom Point Value Nasal blockage that is more severe
when trying to sleep 100 points without the head elevated, that
alternates from side to side, with the "down side" more blocked,
causing a dry mouth; water is often kept at the bedside; drool
spots on the pillow are common Itching of the inner corner of the
eye, the throat, or deep 50 Points in the ear Repeated sneezing,
several times in a row 50 Points Craving certain foods or drinks,
such as milk, cheese, 50 Points chocolate, coffee, soft drinks,
etc. Chronic sinus/middle ear infections 50 Points History of nasal
polyps or prior sinus surgery 50 Points Chronic drippy nose, wiping
the nose often 50 Points Chronic headache/migraine 50 Points
Repeated throat clearing 50 Points Chronic cough 50 Points Asthma
with exercise 50 Points Snoring that is bothersome at times 25
Points Dark circles under the eyes 25 Points Skin itching/hives 25
Points Fatigue episodes 25 Points Total:
[0113] With the foregoing table, the points are added together for
each symptom that the patient is experiencing all year, indoors and
outdoors. In this exemplary guide form, a delayed food allergy
reaction is suggested by a total point value of 100 or more, a
total point value of 200 or more suggests a moderate problem, and a
total point value of 300 or more suggests a severe problem. It will
be appreciated that the foregoing guide form is merely an example
of a worksheet-type tool for recording and evaluating delayed food
allergy symptoms, and that alternative guide forms having more or
fewer symptoms and point values may be used.
[0114] The following are several examples of the use of the therapy
of the subject application on actual patients:
Example 1: Improved (Partial); 37-Year Old Female
[0115] Presented on 11 Mar. 2008 with nasal congestion. Had nasal
polypectomy in 1987 and 1989. Has continued to have sinus
infections, treated about twice a year for 20 years. These
infections cause fatigue, pain in the right cheek and brow areas,
and worsening of nasal blockage. Claritin, Zyrtec, Benadryl
(antihistamines) produce little relief. Tomato products induce
reflux symptoms. Has perennial rhinitis symptoms typical for
delayed food sensitivities: repeated sneezing (up to 20 times in a
row), and chronic mouth breathing. Inhalant allergy screen with
intracutaneous tests showed mild to moderate reaction to mixes of:
weed, tree, mold, mite; negative response to grass and animal
danders.
[0116] Received #2 "super-combo" food sublingual immunotherapy
(SLIT) and "not sure if any better," perhaps because of overlying
sinusitis, but "felt better" regarding less fatigue, less nasal
congestion, and reduced repeated sneezing.
[0117] Received sinus endoscopic surgery with adenoidectomy on 29
Apr. 2008.
[0118] Postoperatively, on 8 May 2008, she reported that she had
found by rotating her diet that beans, taco, corn, chocolate caused
eye itching; she has since been limiting these in the diet, but not
excluding them. Exam showed half of nasal airway was blocked with
edema, even with use of #2 "super-combo" SLIT. Further history was
obtained, that she had been drinking soy shakes at least daily, for
2 years. So she was placed on a separate vial of Soy #3 dilution,
while still on the #2 "super-combo".
[0119] A few days later, she reported that the addition of the #3
Soy caused significant increase of nasal congestion. So she was
given a vial of Soy #5 dilution, with clearing of nasal congestion
within a week.
[0120] Soy #5 was added to "super-combo" #2 SLIT, with continued
resolution of nasal congestion.
[0121] PLAN: continue Soy #5 added to "super-combo" #2 SLIT, and
monitor diet (rotate/eliminate as needed).
Example 2: Improved; 74-Year Old Female
[0122] Presented on 7 Jan. 2002 with nearly life-long sinusitis,
nasal polyps, multiple sinus procedures, eventually developed
fungal sinusitis, referred by a rhinologist, for chronic
management. Had typical symptoms of perennial rhinitis symptoms
from delayed food sensitivities: nocturnal dependent alternating
nasal blockage, repeated sneezing spells, inner corner of eye
itching. Developed recurrence of fungal sinusitis in March 2008.
Because of severe polypoid edema and the copious fungal mucin,
which could not be adequately removed in the clinic, she was
scheduled for a surgical procedure to clear the sinuses. She was
placed on #2 "super-combo" food SLIT on 8 Apr. 2008. In surgery, on
16 Apr. 2008, there was found no evidence of any fungal mucin and
no edema of the sinuses or nasal cavities. NONE.
[0123] She reported that she had "enormous relief" within the first
two weeks of using the drops: (%0 relief--symptom) 50% --fatigue;
60% --alternating nasal blockage; 85% --repeated sneezing; 90%
--runny nose; 75% --throat clearing; 98% --skin itching;
75%--cough. Still waking with some dry mouth, but thinks related to
medications.
[0124] PLAN: continue "super-combo" food SLIT at #2 dilution, and
monitor diet (rotate/eliminate as needed).
[0125] Addendum: friend gave her a 5# bag of Vidalia onions. She
had onions several times a day for several days, and experienced
moderate return of rhinitis, especially runny nose. She eliminated
onion, and in a few days, symptoms were relieved, using SLIT.
[0126] PLAN: limit onions, continue SLIT, monitor diet
(rotate/eliminate as needed).
Example 3: Worse; 33-Year Old Male
[0127] Presented on 2 Apr. 2008 with nasal blockage worsening for
several months, awakening with shortness of breath from intense
nasal blockage. Occasionally will sneeze a couple times in a row.
Exam showed geographic tongue and nasal mucosal edema. Received
"super-combo" food SLIT at the standard #2 dilution.
[0128] Seen 18 Jun. 2008, and noted snoring worsened on the drops,
the nose was more open a week after stopping the drops. Given #3
dilution of "super-combo" food SLIT.
[0129] Seen 1 Jul. 2008, and reports no more snoring, nasal
blockage 80% better.
[0130] PLAN: continue "super-combo" food SLIT at the #3 dilution
three times a day, and monitor diet and relate to any worsening of
nasal blockage, and to any return of snoring (wife will
monitor).
Example 4: No Change; 45-Year Old Male
[0131] Presented 17 Apr. 2008 with nasal congestion worsening 6
weeks, worsening when trying to sleep supine. Exam showed very
severe septal deviation to the left, resulting in no airway on that
side. Right nasal airway was hyperpatent. Received two week trial
vial of "super-combo" food SLIT.
[0132] On 5 May 2008, reported no change in symptoms with SLIT.
Suggested try off tea and diet drinks, which he has had
regularly.
[0133] Seen 27 May 2008 with nasal blockage persistent. Inhalant
allergies evaluated, mildly positive.
[0134] PLAN: continue monitoring diet changes and related nasal
blockage. Consider nasal surgery for deviated septum. Consider
trial vial with Soy, other foods.
[0135] It should be understood that the solutions, concentrations,
extracts, and make-up, of the vials, trial periods, and procedures
set forth herein may be changed, altered, and modified, while
remaining within the scope of this application. In addition,
although the present application has been described in terms of
liquid sublingual drops, it should be understood that the therapy
and procedures of the present application may also be conducted
with both liquid and solid forms of delivery, including drops,
sprays, capsules, tablets, powders, flakes, quick-dissolving
strips, and any other suitable form of sublingual
administration.
[0136] Although the methods of the subject application are
particularly well suited for the testing, treatment, and prevention
of Gell and Coombs Type IV reactions, it will be appreciated that
the systems and methods of the present application may also be used
to test, treat, and prevent Gell and Coombs Type I, II, and III
reactions. Moreover, it is believed that administration of
sublingual drops according to the present application may prevent
the allergic march from childhood allergic skin disorders, such as
eczema, into asthma and other allergic diseases. For example, the
applicant has conducted an in-house retrospective study and found
that all children with exercise-induced asthma who were treated
with the therapy and procedure of the present application, no
longer require the use of pulmonary inhalers. In addition, all
children with chronic headaches who were treated with the therapy
and procedure of the present application no longer suffer from
headaches and no longer require pain medication. Furthermore, 2/3
of adults with asthma who were treated with the therapy and
procedure of the present application no longer require the use of
an inhaler. All children, and 2/3 of adults with "HART" or Headache
Asthma Rhinitis Triad have experienced nearly complete resolution
of symptoms while using food SLIT, with marked reduction in need
for expensive medications which only offer partial temporary
relief. These medications are known to commonly produce undesirable
side effects.
[0137] Referring now also to FIG. 15 in the drawings, a chart 1500
detailing an overview of sublingual management strategies for food
sensitivities (delayed food allergy) is shown. Chart 1500 is meant
to provide an overview or guide to a practitioner so as to better
understand the method as disclosed in the present application.
[0138] It is evident by the foregoing description that the
invention of the subject application has significant benefits and
advantages, in particular: (1) the initial test is a multi-food
test, and not single-food test; (2) there is no need to keep the
patient in the clinic a day or more to test a handful of foods;
instead, the patient takes the first drop in the office, or at
home, and continues the drops, three times a day, at home, work
etc., looking for symptoms to change; (3) after the two week trial,
the patient completes a symptom questionnaire, and informs the
office whether their symptoms are better, worse, or have no change;
(4) the process manipulates the combination and concentration of
allergens; (5) the patient enjoys the ability to undergo testing
and treatment as well as potential prevention of allergy symptoms,
while continuing to eat the foods to which they may have a delayed
allergy. Commonly, after the patient becomes aware that foods are
causing symptoms, and learning what those symptoms are, the patient
learns to reduce these food culprits in the diet to avoid
"breakthrough" symptoms from overeating the culpable food.
[0139] This method does not utilize invasive testing such as prick
testing, intradermal injections, or blood testing. Additionally the
method does not utilize applying patches of allergens to the skin
to induce allergic reactions. This application is concerned with
delayed food allergies while not performing invasive testing.
Invasive testing breaks the skin of the patient through injections,
blood draws, or skin pricks. Invasive testing is not preferable for
the testing, treating, or prevention of delayed food reactions
because of the amount of time required for the delayed food
reactions to occur. Furthermore, invasive testing reduces the
likelihood that a user will be tested and treated because of
typical patient's dislike of invasive testing.
[0140] In those cases where the initial starting dilution is too
strong a more diluted algorithm is utilized to provide a starting
point for the patients without the side effects resulting from a
too strong dilution. The typical starting dilution is the sum of
four factors based on age, asthma, headache, and gastrointestinal
issues. In some instance a coarsely gradated initial starting
dilution chart is preferred because of the evaluation from the
patients includes only three types of severity of the symptoms such
as mild, moderate, and severe.
TABLE-US-00004 TYPICAL STARTING DILUTION ALGORITHM CHART (Course)
GASTRO- AGE+ ASTHMA+ HEADACHE+ INTESTINAL =DILUTION 2-20 = 2 Mild =
3 Mild = 3 Mild = 3 30 = 3 Moderate = Moderate = 6 Moderate = 6 6
40 = 4 Severe = 9 Severe = 9 Severe = 9 50 = 5 60 = 6 70 = 7 80 = 8
90 = 9 100 = 10
Examples
[0141] 13 year old female with recurrent severe migraine: 2+9=#11
Dilution
[0142] 63 year old male with mild headache: 6+3=#9 Dilution
[0143] 29 year old female with asthma treated a few times a year
but with rather chronic severe migraine headaches: 2+3+9=#14
Dilution
[0144] 71 year old male with moderate headaches: 7+6=#13
Dilution
[0145] 33 year old female with chronic severe asthma and daily
severe headache:
[0146] 3+9+9=#21 Dilution
[0147] The various dilutions are created by starting with the
concentrate provided by the allergy extract company, and making 1/5
dilutions using a diluent comprised of 1 part glycerin and 1 part
water, by volume. A number 1 dilution is 1/5 C is created by
diluting 1 cc of food extract concentrate with 4 cc of a diluent,
by volume. A number 2 dilution is 1/25 C is realized by diluting 1
cc of 1/5 C solution with 4 cc of the diluent, by volume. A 1/125 C
is realized by diluting 1 cc of 1/25 C solution with 4 cc of the
diluent, by volume, and so on for further dilution. (see the
Expanded Dilution chart) The amount of dilution is correlated to
the severity of the conditions and very, very small amounts of
dilutions such as one part per four hundred trillion can cause
reactions. This is similar to the allergic reaction someone
allergic to peanuts gets when a package of peanuts is opened across
a room. The parts of peanuts to air is likewise very, very small
but still causes allergic reactions in some.
TABLE-US-00005 EXPANDED DILUTION CHART CONCENTRATE 1/1 #1 DILUTION
1/5 #2 DILUTION 1/25 #3 DILUTION 1/125 #4 DILUTION 1/625 #5
DILUTION 1/3,125 #6 DILUTION 1/15,625 #7 DILUTION 1/78,125 #8
DILUTION 1/390,625 #9 DILUTION 1/1,953,125 #10 DILUTION 1/9,765,625
#11 DILUTION 1/48,828,125 #12 DILUTION 1/244,140,625 #13 DILUTION
1/1,220,703,125 #14 DILUTION 1/6,103,515,625 #15 DILUTION
1/30,517,578,125 #16 DILUTION 1/152,587,890,625 #17 DILUTION
1/762,939,453,125 #18 DILUTION 1/3,814,697,265,625 #19 DILUTION
1/19,073,486,328,125 #20 DILUTION 1/95,367,431,640,625 #21 DILUTION
1/476,837,158,203,125
[0148] While the expanded dilution chart has been expanded to
include up to a #21 dilution, it should be obvious that further
weaker dilutions are contemplated by this application. Weaker
dilutions are typical utilized for those with severe conditions and
or advanced age. Initial utilization of too strong a dilution will
negatively impact the patients experience and reduce the likelihood
of success.
[0149] In some instance a finely gradated initial starting dilution
chart is preferred because of the evaluation from the patients
includes nine types of severity of the symptoms such as mild,
moderate, and severe with clarification of the severity being more
or less than typical. For example is some one stated they had
moderate asthma they would score a 5 but if they reported their
severity as more than moderate but not severe they would score a 6.
Like wise when a patient reports having less mild gastrointestinal
issues they would score a 1.
TABLE-US-00006 AGE+ ASTHMA+ HEADACHE+ GASTROINTESTINAL =DILUTION
2-20 = 2 SEVERITY LESS MILD 1 1 1 30 = 3 MILD 2 2 2 40 = 4 MORE
MILD 3 3 3 50 = 5 LESS MODERATE 4 4 4 60 = 6 MODERATE 5 5 5 70 = 7
MORE MODERATE 6 6 6 80 = 8 LESS SEVERE 7 7 7 90 = 9 SEVERE 8 8 8
100 = 10 MORE SEVERE 9 9 9
Examples
[0150] 19 year old female with recurrent more severe migraine:
2+9=#11 Dilution
[0151] 43 year old male with less mild headache: 4+1=#5
Dilution
[0152] 39 year old female with average asthma treated a few times a
year but with rather chronic severe average migraine headaches:
3+2+8=#13 Dilution
[0153] 51 year old male with average moderate gastrointestinal
issues: 5+5=#10 Dilution
[0154] In an alternative embodiment an additional level of severity
is added to the typical starting dilution chart to create a typical
extreme starting dilution chart. Typically those patients with the
worse severity the practitioner has experienced would receive the
highest score from the chart such as a ten. This allows the
severity of the symptoms to be normalized against the collected
history of clinical experience. A category of extreme severity
results from the fact patients are tested with severe conditions
worse than all other patients the practitioner has treated over
time and forces a new level of severity to document the increase in
severity relative to the other patients treated over time.
TABLE-US-00007 TYPICAL EXTREME STARTING DILUTION ALGORITHM CHART
(Fine) AGE+ ASTHMA+ HEADACHE+ GASTROINTESTINAL =DILUTION 2-20 = 2
SEVERITY LESS MILD 1 1 1 30 = 3 MILD 2 2 2 40 = 4 MORE MILD 3 3 3
50 = 5 LESS MODERATE 4 4 4 60 = 6 MODERATE 5 5 5 70 = 7 MORE
MODERATE 6 6 6 80 = 8 LESS SEVERE 7 7 7 90 = 9 SEVERE 8 8 8 100 =
10 MORE SEVERE 9 9 9 EXTREME 10 10 10
Examples
[0155] 29 year old female with the worst recurring migraines the
practitioner has seen: 2+10=#12 Dilution
[0156] 63 year old male with worst recurring gastrointestinal issue
the practitioner has seen and mild asthma: 6+10+2=#18 Dilution
[0157] It should be apparent that methods of testing, treating, and
preventing delayed food allergies have been described. These
methods are improvements at least because they: preclude the need
for invasive testing and do not require the user to adjust their
diet.
[0158] The particular embodiments of the present application
disclosed may be modified and practiced in different but equivalent
manners apparent to those skilled in the art having the benefit of
the teachings herein. Furthermore, no limitations are intended to
the details of construction or design herein shown, other than as
described in the claims below. It is therefore evident that the
particular embodiments disclosed above may be altered or modified
and all such variations are considered within the scope and spirit
of the present application. Accordingly, the protection sought
herein is as set forth in the claims below. It is apparent that an
application with significant advantages has been described and
illustrated. Although the present application is shown in a limited
number of forms, it is not limited to just these forms, but is
amenable to various changes and modifications without departing
from the spirit thereof.
* * * * *