Title: Methods and compositions
for the treatment of pain and other hormone-allergy-related symptoms using
dilute hormone solutions
United States Patent: 7,179,798
Issued: February 20, 2007
Inventors: Roby; Russell R.
Assignee: Roby; Russell R.
Appl. No.: 10/294,512
Filed: November 14, 2002
A method and composition for the
treatment of hormone allergy is disclosed. The method relates to using
progesterone dilutions, or any other steroid hormone, to treat the
systemic symptoms of hormone allergy, including pain. The composition of
the hormone dilutions ranges from 10.sup.-1 to 10.sup.-5. The hormone
dilution may be administered sublingually, or, in the alternative, an
intradermal route of administration may be chosen. Hormone dilutions may
be administered at daily intervals or on any other treatment schedule as
required to alleviate a patient's symptoms.
Description of the
The present invention relates
in general to the treatment of pain and other hormone-allergy-related
symptoms and in specific to the use of a dilute hormone solution for the
treatment of pain and hormone-allergy symptoms.
BACKGROUND OF THE
Hormone allergy has been
previously described in the medical literature as premenstrual asthma.
Skobeloff E. M., Spivey W. H., Silverman R. A., Ekin B. A., Harchelroad F.
P., Alessi T. V.: The effect of the menstrual cycle on asthma presentations
in the emergency department. Arch Intern Med 1996; 156: 1837 40. Claude F.:
Asthma et menstruation. Presse Med 1938; 46: 755 759; Eliasson O., Scherzer
H., DeGraff A. C.: Morbidity in asthma in relation to the menstrual cycle. J
Allergy Clin Immunol 1986: 77: 87 94; Chandler M. H., Schuldheisz S.,
Phillips B., Muse K. N.: Pre-menstrual asthma: the effect of estrogen on
symptoms, pulmonary function, and beta 2-receptors. Pharmacology 1997;
17(2): 224 234.
Premenstrual asthma is a condition where premenstrual fluctuations in
hormones such as estrogen and progesterone cause the exacerbation of
clinical symptoms. Exacerbations of symptoms appear to occur during the
premenstrual period when progesterone levels are high. Several references
have been made to a possible reaction to hormones. The first report of
hormonal influence on asthma symptoms appeared in a case report by Frank
from 1931. Frank, R T: The hormonal causes of pre-menstrual tension. Arch
Neurol Psychiatry 1931; 26: 1053 57. Severe aggravation of asthma symptoms
in one patient were clearly linked to oral contraceptives. Derimov, GS,
Oppenheimer J: Exacerbation of premenstrual asthma caused by an oral
contraceptive. Ann Allergy Asthma Immunol 1998; 81: 243 46.
Skobeloff et. al reported a four-fold increase in the presentation of
asthmatic women to the emergency department during the perimenstrual
interval (days 26 to 04 of the menstrual cycle). When Skobeloff's data is
superimposed over the hormone levels during the menstrual cycle, it shows
that the peak emergency room visits occurred during the premenstrual period
when the progesterone is highest relative to estrogen (FIG. 1).
There has been little investigation, however, into the systemic
manifestations or treatment of hormone allergy, or the effect of hormones on
organ systems other than the female reproductive tract. While there is
documentation in the literature supporting the influence of hormones on
premenstrual asthma, applicant knows of no established mode of action.
SUMMARY OF THE
In accordance with teachings
of the present invention, a method and composition for treatment of hormone
allergy using steroid hormone dilutions, specifically progesterone, estrogen
and testosterone is provided.
Observations that lead to and are a part of the present invention, suggest
the possibility of an allergic reaction to the steroid hormone progesterone
as a possible cause of clinical symptoms or premenstrual asthma and other
One aspect of the present invention includes a previously unrecognized
treatment for asthma, headache, sinus congestion, muscular pain, and bone
and joint pain that involves desensitizing a body's response to its own
innate hormones. The treatment may be applied to any mammal including
humans. In an exemplary embodiment, the mammal is female.
While hormones may fluctuate throughout the menstrual cycle, treatment is
not limited to any specific point in the menstrual cycle. In an exemplary
embodiment, however, dilute solutions of progesterone are administered
sublingually, every day or every other day, as needed, until there is an
alleviation of a patient's clinical symptoms. These dilute formulations are
very similar to the type of dilutions that an allergist typically uses when
treating allergic symptoms from external substances, or allergens, which are
foreign to the body. However, in treating a patient with hormone allergy,
instead of desensitizing the patient to a foreign substance, the patient is
desensitized to his or her own innate hormone(s).
Existing clinical treatments do not generally use sublingual administration
of dilute hormone solutions to treat allergy symptoms. In addition, many of
the symptoms that can be treated with hormone dilutions are not recognized
as conventional allergy symptoms, such as bone and joint pain, muscular
pain, and headache. Other symptoms which respond to treatment with hormone
dilutions are recognized as classic allergy symptoms such as sinus
congestion, ear and throat pain, eye and skin irritation.
In accordance with another aspect of the present invention, dilutions of a
hormone solution, such as progesterone are used to treat hormone allergy
symptoms. A hormone dilution ranging in concentration from 5 mg/ml to 0.5 .mu.g/ml
is administered sublingually. The strength of the dilution selected for
treatment may be based on the severity of the patient's symptoms and prior
treatment history. The amount, frequency and strength of the hormone
dilution may be varied depending on severity of symptoms and on response
In an alternative embodiment of the invention, the route of administration
may be intradermal.
In accordance with a further aspect of this invention a dilute progesterone
solution (concentration 5 mg/ml to 0.5 .mu.g/ml) or a dilute estrogen
solution (concentration 5 mg/ml to 0.5 .mu.g/ml) may be administered to
treat hormone allergy symptoms in females.
In accordance with another aspect of this invention a dilute testosterone
solution (concentration 5 mg/ml to 0.5 .mu.g/ml) may be used to treat
allergy symptoms in males. Other steroid hormone solutions may also be used.
All solutions of the present invention may be administered in a
OF THE INVENTION
The present invention relates
to a treatment of systemic allergic manifestations and pain caused at least
in part by steroid hormones. Such manifestations have been observed and
treated in female patients. For the condition of acute asthma alone, data on
83 patients treated with dilute progesterone has been collected. Measuring
symptom response rate on a 10-point scale, a response rate of 93% overall
was observed. The average reduction in symptom severity on the 10-point
scale was 3.1 points. The present data show a 57% reduction in symptoms on
average. These results are statistically significant at a level of p<0.0001.
A composition of the present invention may include a standard solution of
aqueous progesterone, or any other indicated steroid hormone, diluted with
normal saline to achieve concentrations of 5 mg/ml to 0.5 .mu.g/ml. The
strength of a dilution selected for treatment may be based on a severity of
the patient's symptoms and prior treatment history. This selection
methodology may be similar to that used in treatments with foreign allergens
and appropriate selections for an individual patient will be apparent to one
skilled in the art.
Typically, 0.1 cc of a hormone dilution (0.5 mg 0.05 .mu.g per dose) is
administered sublingually every other day. The frequency of administration
may be increased to every day or more often, as required, to achieve a
desired treatment response. The strength of the hormone dilution selected
for treatment may also be varied depending on severity of symptoms and on
response achieved. Response to therapy may be measured on a 10-point point
scale of symptom severity as reported by a patient to a clinical provider.
Additional tests for abatement of symptoms may also be used. Treatment of
hormone allergy symptoms may continue for months or years as indicated by
each patient's clinical condition.
Claim 1 of 2 Claims
1. A method for treating at least one
symptom of a hormone allergy, the method comprising: administering
sublingually to a subject about 0.1 milliliter of a 0.05 milligram per
milliliter estrogen dilution; and administering sublingually to the
patient at least one additional estrogen dilution, wherein the at least
one symptom is selected from the group consisting of shortness of breath,
nasal congestion, eye irritation, and any combination and wherein relief
of the at least one symptom occurs in about 20 seconds after the at least
one additional estrogen dilution administration.
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