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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. (Austin, TX)
Assignee: 
Roby; Russell R. (Austin, TX)
Appl. No.: 
10/294,512
Filed: 
November 14, 2002


 

Patheon


Abstract

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 Invention

TECHNICAL FIELD

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 INVENTION

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 INVENTION

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 disorders.

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 achieved.

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 pharmaceutically-acceptable carrier.

DETAILED DESCRIPTION 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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