USE OF ANDROGEN FOR TREATING GASTROINTESTINAL DISORDERS

Abstract

By lowering the amount of Sexual Hormone Binding Globulin (SHBG) and, thereafter, raising the serum testosterone level in a person's body, an effective method for treating gastrointestinal disorders such as irritable bowel syndrome and inflammatory bowel disease, including Crohn's Disease and ulcerative colitis, is achieved. First and second androgens, namely, anabolic steroids, are used to lower the SHBG and, thereafter, raise the serum testosterone level in the body, respectively. The SHBG is lowered and the testosterone level is increased until an equilibrium between the SHBG and the second androgen is reached which normalizes the Free Androgen Index (FAI) in the person's body. Preferably, the first androgen used herein to lower the SHBG is stanozolol and the second androgen used herein to normalize the FAI is testosterone.

Claims

1. A method for treating gastrointestinal disorders, comprising the steps of: (a) administering to a person a predetermined amount of a first androgen over a period of time of from about four to about eight weeks to lower the Sexual Hormone Binding Globulin (SHBG) of the person to a pre-selected level; (b) thereafter, administering a second androgen to the person over a period of time of from about four to about eight weeks to raise the serum testosterone level of the person to achieve an acceptable Free Androgen Index (FAI) according to the gender of the person; and wherein achieving an acceptable FAI minimizes the symptoms of a gastrointestinal disorder.

2. The method of claim 1 wherein the gastrointestinal disorder is irritable bowel syndrome.

3. The method of claim 1 wherein the gastrointestinal disorder is inflammatory bowel disease.

4. The method of claim 3 wherein the gastrointestinal disorder is Crohn's disease.

5. The method of claim 3 wherein the gastrointestinal disorder is ulcerative colitis.

6. The method of claim 3 wherein the first and the second androgens are steroids.

7. The method of claim 6 wherein the first androgen is selected from the group consisting of dihydroepiandrosterone, androstenedione, androstenediol, androsterone, dihydrotestosterone, testosterone, nandrolone, stanozolol, oxandrin, furazabol, dioxadol, danazol, and anadrol.

8. The method of claim 6 wherein the second androgen is selected from the group consisting of testosterone and nandrolone.

9. The method of claim 8 wherein the first androgen is stanozolol.

10. The method of claim 8 wherein the second androgen is testosterone.

11. The method of claim 6 wherein the first androgen is administered orally in an amount ranging from about 4.0 milligrams to about 8.0 milligrams daily for about four to eight weeks to lower the SHBG.

12. The method of claim 11 wherein the person is male and the second androgen is administered as an injection in an amount ranging from about 100 milligrams to about 250 milligrams, once a week, for about four to about eight weeks.

13. The method of claim 11 wherein the person is a female and the second androgen is administered as an injection in an amount which ranges from about 15 milligrams to about 70 milligrams, once a week, for about four to about eight weeks.

14. The method of claim 3 wherein the SHBG is lowered to about 5 nanomoles per liter to about 15 nanomoles per liter for a male and to about 30 nanomoles per liter to about 45 nanomoles per liter for a female.

15. The method of claim 3 wherein the FAI after treatment ranges from about 1 to about 2 for a male and from about 0.03 to about 0.10 for a female.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0022] As noted above, the present invention provides a method for treating gastrointestinal disorders such as IBS and IBD, including Crohn's disease and ulcerative colitis.

[0023] To avoid having to resort to surgery or alternative medications commonly employed to treat IBS and IBD, the present method comprises the steps of, first, lowering the SHBG in the body through the utilization of a first androgen and, thereafter, once the SHBG reaches the desired reduced level, utilizing a second androgen to raise the serum testosterone level, thereby reaching an acceptable FAI to manage symptoms of gastrointestinal disorders.

[0024] As is known to one of ordinary skill in the art, the FAI in a person is determined by a ratio of the serum testosterone level with respect to the SHBG in that person. In other words, FAI=testosterone level/SHBG. Thus, the severity of gastrointestinal disorders exhibited by IBD and IBS is an inverse relationship between the amount of SHBG in comparison to the serum testosterone level in a patient.

[0025] Therefore, by first lowering the amount of SHBG with the first androgen and, then, adding the second androgen into the body to raise the serum testosterone level, a desired FAI may be reached and the effective treatment of gastrointestinal disorders caused by environmental toxins is substantially increased.

[0026] More specifically, by utilizing selected amounts of the first androgen, it is possible to lower the amount of SHBG in the body to a predetermined amount.

[0027] Generally, the first androgen is administered over a period of time of about four to about eight weeks in order to lower the SHBG to within a range of about 30 nanomoles per liter (nmol/l) to about 45 nmol/l for a female and to within a range of about 5 nmol/l to about 15 nmol/l for a male.

[0028] After the treatment with the first androgen to lower the SHBG to the specified range, it is necessary to, then, add the second androgen into the system to raise the serum testosterone level to a normal level.

[0029] In practicing the present invention, both natural and synthetic androgens may be used.

[0030] Representative natural androgens, for example, dihydroepiandrosterone, androstenedione, androstenediol, androsterone, dihydrotestosterone, testosterone, nandrolone, and the like, may be used herein.

[0031] Synthetic androgens that lower the SHBG, such as stanozolol, oxandrin, furzabolin, dianabol, danazol, anadrol, and the like, may also be used. It is possible, although not preferred, to use a combination of both natural and synthetic androgens to lower the SHBG.

[0032] In the practice hereof, the first androgen, used to lower the SHBG, is an anabolic steroid. Anabolic steroids are well-known and commercially available.

[0033] Among the preferable and useful anabolic steroids for lowering the SHBG in accordance herewith are stanozolol, dianabol, danazol, and anadrol.

[0034] Most preferably, stanozolol is used as the first androgen for lowering the SHBG. The stanozolol can be administered either orally or as an injectable.

[0035] The gender of the patient or person determines the amount of steroid necessary to lower the SHBG in order to achieve the desired FAI. For a male, the FAI should range from about 1 to about 2. For a female, the FAI should range from about 0.03 to about 0.10. Thus, a male needs to have an SHBG level of from about 5 nmol/l to about 15 nmol/l and a female from about 30 nmol/l to about 45 nmol/l in order to ultimately achieve the desired FAI.

[0036] Regardless of gender, generally, from about 4.0 milligrams (mgs) to about 8.0 mgs of the stanozolol is administered orally, daily, for about four to about eight weeks in order to effectuate specific lowering of the SHBG.

[0037] Where injections are used, generally, from about 10.0 mgs to about 50.0 mgs are injected, once a week, for about four to about eight weeks.

[0038] As noted above, after the SHBG has been reduced to an acceptable level, the second androgen, such as a steroid, is, then, administered into the body to rebalance the equilibrium in the body between the SHBG and the second androgen. Among the useful second androgens are testosterone and nandrolone. Preferably, the second androgen is testosterone.

[0039] Depending on the gender of the patient, the amount of testosterone added back into the body will vary.

[0040] Where the patient is a male, generally from about 100 mgs to about 250 mgs of “added back” testosterone is administered as an injection, once a week, for about four to about eight weeks.

[0041] With a female patient, the amount of testosterone administered will generally range from about 15 mgs to about 70 mgs, once a week, for about four to about eight weeks.

[0042] The administration of the first and second androgens may be continued indefinitely until desired levels of SHBG and testosterone have been achieved. Preferably, periodic measurements of SHBG and testosterone levels in the patient are taken in order to determine if the desired ranges have been achieved. It is to be understood that it is well known to those of ordinary skill in the art to measure SHBG and testosterone levels in a patient using any standard blood or saliva test.

[0043] By following the steps described herein, generally, in about four to eight weeks, equilibrium between the SHBG and the testosterone is achieved and the FAI will fall within the desired range identified above. Furthermore, by administering the specified amounts of androgen, described above, there is a concomitant “re-balancing” of an appropriate testosterone level in relation to the decrease in SHBG.

[0044] It is contemplated that by employing the above method to reduce high levels of SHBG in a person's body and, thereafter, raise the serum testosterone level, a satisfactory FAI can be achieved, thereby treating IBS and IBD. As a result thereof, symptoms and side effects of gastrointestinal disorders may be managed and minimized.