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(12) Patent Application Publication (10) Pub. No.: US 2007/004.1994 A1 Mcdowell, JR

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(12) Patent Application Publication (10) Pub. No.: US 2007/004.1994 A1 Mcdowell, JR US 2007004.1994A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2007/004.1994 A1 McDowell, JR. (43) Pub. Date: Feb. 22, 2007 (54) COMPOSITIONS AND METHODS FOR Publication Classification TREATING PROSTATE DSORDERS (51) Int. Cl. A6IR 36/85 (2007.01) (75) Inventor: John W. McDowell JR. Rehoboth, DE A6IR 36/06 (2006.01) (US) (52) U.S. Cl. ...................................... 424/195.15; 424/774 Correspondence Address: (57) ABSTRACT UANET M. KERR P.O. BOX 60 Compositions and methods are described for the treatment TAYLORS ISLAND, MD 21669 (US) of prostatitis, benign prostatic hypertrophy, and prostate cancer. The compositions contain either aqueous extracts or dried mixtures of selenium- and zinc-enriched cannabis (73) Assignee: SLGM Medical Research Institute plant material, Shiitake mushrooms, and maitake mush rooms. The compositions are effective in treating prostate disorders by alleviating pain and Voiding symptoms, (21) Appl. No.: 11/207,700 decreasing inflammation and prostate size, reducing cellular proliferation in prostate tissue, and/or reducing PSA levels (22) Filed: Aug. 20, 2005 to within the normal range of 0-4. US 2007/004. 1994 A1 Feb. 22, 2007 COMPOSITIONS AND METHODS FOR TREATING 0007 Benign prostatic hyperplasia (BPH) is a noncan PROSTATE DISORDERS cerous enlargement of the prostate and is common in men over age 40. Symptoms associated with BPH are similar to CROSS-REFERENCE TO RELATED those observed with prostatitis. The etiology of BPH is APPLICATIONS unknown, but may involve hormonal changes associated with aging. With age, testosterone is converted into dihy 0001. Not Applicable droxytestosterone (DHT) at higher levels within the prostate via the enzyme, 5-alpha-reductase. DHT binds to androgen STATEMENT REGARDING FEDERALLY receptors, stimulating growth of the prostate. This growth SPONSORED RESEARCH OR DEVELOPMENT can eventually lead to progressive restriction or obstruction of urine outflow. Incomplete bladder emptying causes Stasis 0002) Not Applicable and predisposes to infection with secondary inflammatory changes in the bladder. Treatment is directed toward reduc REFERENCE TO SEQUENCE LISTING, A ing prostate size, stabilizing renal function, eradicating TABLE, OR A COMPUTER PROGRAM LISTING infection, and discontinuing drugs that may induce obstruc COMPACT DISC APPENDIX tion. The most widely used drug therapy has been systemic 0003) Not Applicable administration of an alpha blocker. Administration of a 5-alpha-reductase inhibitor, which decreases the conversion of testosterone to DHT has also been used. These drugs can FIELD OF THE INVENTION have undesirable side effects of postural hypotension, impo 0004 The present invention relates to compositions and tence, and decreased libido. Surgery is the most definitive methods of using the compositions for the treatment of therapy, and the most widely used Surgical procedure is prostatic disorders in men. More specifically, the invention transurethral resection of the prostate. However, approxi relates to compositions comprising ingredients having anti mately 5 to 10% of patients experience some post Surgical inflammatory, antioxidant, and antitumorigenic activities, problems including impotence and incontinence. and methods of using these compositions to reduce the 0008 Prostate cancer, i.e., adenocarcinoma of the pros incidence of or to treat prostatitis, benign prostatic hyper tate, is the most common malignancy in men greater than 50 plasia (BPH), and adenocarcinoma of the prostate. years in the US. The incidence increases with each decade of life. Prostate cancer is generally slowly progressive and BACKGROUND OF THE INVENTION may cause no symptoms. In late disease, symptoms of bladder outlet obstruction, urethral obstruction, and hema 0005 The prostate is a gland of the male reproductive turia may appear and metastasis to the bone may occur. One system that is located in front of the rectum and just below of the most common means of monitoring for prostate the bladder. The prostate, comprised largely of muscular and cancer is the routine analysis of serum prostate-specific glandular tissue, is wrapped around the urethra, which antigen (PSA). PSA is currently the most sensitive marker carries urine from the bladder out through the tip of the for monitoring prostate cancer progression and response to penis. The primary function of the prostate is to produce therapy. It has been established that increased PSA levels fluid for semen that transports sperm. During the male above the normal range of 0-4 ma be indicative of prostate orgasm, muscular contractions Squeeze the prostate's fluid cancer, although elevated levels have been detected in men propelling sperm and seminal fluid into the urethra; the suffering from prostatitis or BPH. Current traditional treat sperm and seminal fluid leave the penis during ejaculation. ment regimens for prostate cancer range from minimally 0006 Disorders of the prostate are fairly common during invasive treatments, such as watchful waiting, which the aging process and include prostatitis, benign prostatic requires observation of cancer for signs of progression, to hyperplasia (BPH), and adenoma of the prostate, or prostate major Surgery. Treatment regimens such as radiation therapy cancer. Prostatitis, which may or may not be the result of an and cryotherapy eradicate cancer cells but pose risks Such as infection, is generally defined as an inflammation of the incontinence and impotence. Similarly, treatments directed prostate. Symptoms associated with prostatitis are pain, to decreasing testosterone production or blocking the action Voiding symptoms Such as nocturia, frequency and urgency of androgens, i.e., anti-hormone therapy, may result in hot of urination, incomplete voiding, and decreased force and/or flashes or impotence. Radical prostatectomy or Surgical intermittency of the urinary stream, impotence, and infer removal of the prostate, and radiation therapy are the most tility. The cause of non-infection related prostatitis is common treatment methods for prostate carcinoma. How unknown, and therefore, is difficult to treat. Successful ever, radical prostatectomy often results in impotence and treatment of acute bacterial prostatitis and chronic bacterial urinary incontinence. Similarly, radiation therapy has also prostatitis with antibiotics is well established. Inflammatory been known to produce impotence, incontinence, cystitis, chronic pelvic pain syndrome is generally treated with and proctitis. Immunotherapy, i.e., providing agents that antibiotics and anti-inflammatory agents. Alpha blockers can stimulate or boost the immune response is currently under be prescribed to relax muscle tension in the prostate and investigation. Therapeutic modalities can include any one improve urinary flow. However, alpha blockers are expen of or a combination of Surgery, radiotherapy, cryotherapy, sive, need to be taken indefinitely in high doses, may have or hormone therapy depending on the stage of the cancer. significant side effects, and do not cure the underlying 0009 No single cause of prostate cancer has been iden problem or prevent recurrences. Ameliorating the discom tified. However, associations between risk factors, both fort caused by prostatitis with anti-inflammatory agents or nutritional and non-nutritional, and disorders of the prostate hot sitz baths can be beneficial, but these treatments are have been noted. The major known non-nutritional risk temporary and do not cure the disease. factors for prostate cancer are age, race and family history. US 2007/004. 1994 A1 Feb. 22, 2007 With regard to nutritional risk factors, epidemiological stud prostate comprising herbal extracts and zinc. Wheeler (U.S. ies have shown a possible link between high fat diets and Pat. No. 6,197,309) discloses a prostate formula with anti prostate cancer (Thomas, J. A., Nutr. Rev. 57(4):95-103. oxidant, anti-inflammatory, and immunity booster properties 1999). In particular, diets that consist of high levels of red comprising herbal extracts, Zinc, and selenium. meat and dairy products have been correlated with an increase in the risk of advanced prostate cancer. It has also 0013 The immunopotentiating activities and therapeutic been shown that reducing dietary fat intake can reduce effectiveness of polysaccharides obtained from Shiitake circulating levels of testosterone and other hormones that are (lentinus edodes) and maitake (grifola) mushrooms are known to fuel the growth of prostate cancer cells. known in the art. Gorsek (U.S. Pat. No. 6,582,723) discloses 0010 Alterations in the concentration of certain micro an enzymatic extract of Shiitake mushrooms for treating nutrients in blood and prostate tissue have also been noted. cancer by boosting the immune system and helping the For example, a strong association between low serum sele regression of metastases. Nanba et al. (U.S. Pat. No. 5,854. nium levels and an increased incidence of prostate cancer 404) discloses an antitumor Substance with high immuno has been reported. Selenium is essential for glutathione potentiating activity. The Substance is a polysaccharide peroxidase activity, an enzyme that protects cells from isolated from grifola. Keith et al. (U.S. Pat. No. 6,805,866) oxidative damage. Results from in vitro studies indicate disclose a composition of mushrooms that has immunoen growth suppression of prostate cancer cells with addition of hancing properties. These properties have been associated Selenium; this growth Suppression has
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