Drug – bio-affecting and body treating compositions – Antigen – epitope – or other immunospecific immunoeffector – Conjugate or complex
Reexamination Certificate
1999-08-03
2001-03-06
Tate, Christopher (Department: 1651)
Drug, bio-affecting and body treating compositions
Antigen, epitope, or other immunospecific immunoeffector
Conjugate or complex
C424S641000
Reexamination Certificate
active
06197309
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates generally to a composition that provides an all-natural, non-surgical preventative of or improvement to disorders of the prostate gland. More specifically, the invention relates to a composition for the prevention of or improvement of prostatitis, and for relieving symptoms and improving objective signs of prostatitis.
DESCRIPTION OF THE RELATED ART
The prostate gland (or prostate) is a walnut-sized, mucous-producing organ in males that lies just below the urinary bladder. The prostate typically grows and enlarges throughout life. The only known function of the prostate is to produce a secretion that nourishes and protects the sperm during reproduction. The urethra, the canal that in most mammals discharges urine from the bladder, passes through the prostate gland. Unfortunately, this anatomical feature creates problems, often associated with difficulty in urination, as males age.
In men, the prostate gland is the source of several common disorders including prostatitis and benign prostatic hypertrophy (BPH), wherein the prostrate gland becomes inflamed or enlarged. Prostatitis is defined as an inflammation or infection of the prostate gland. While prostatitis may be acute, associated with systemic findings of fever, chills and rigors, most cases of prostatitis are chronic and tend to be incurable with relatively frequent recurrences despite optimal standard therapy. Chronic prostatitis (inflammation or infection of the prostate) is common to all adult men. It is associated with virtually all cases of prostate cancer and is present in every prostate biopsy regardless of other findings. Chronic prostatitis may not cause significant symptoms in many men, but in others it can be a devastating disease that severely affects the quality of life of those afflicted. It is difficult to diagnose and even more difficult to treat.
The most common symptom of chronic prostatitis is pelvic pain, followed by various voiding symptoms, impotence, and infertility. Pain from prostatitis is usually located in the groin, testicles, and penis, just above the rectum or in the suprapubic area over the bladder. Pain is frequently associated with ejaculation. Typical voiding symptoms produced by prostatitis include getting up at night to void (nocturia), frequency and urgency of urination, incomplete voiding, decreased force of the urinary stream, intermittency of the stream and a need to push or strain to void. Impotence or erection difficulties and male infertility are also associated with prostatitis.
A wide variety of therapies are available, but few actually work in more than a small percentage of cases. None of the standard treatments is able to improve the health and well being of the prostate.
In the treatment of prostatitis, physicians have traditionally recommended everything from doing nothing to multiple and extended courses of antibiotics, other drugs, and lifestyle changes. Those patients who truly have an identifiable infection of the prostate benefit from antibiotics. These need to be continued for at least 6-12 weeks and, in some cases, long-term or indefinite antibiotic suppression therapy is necessary.
BPH occurs naturally in most males over 50 years of age. At this age, the male body begins to transform testosterone (male sex hormone) into dihydroxytestosterone (DHT) at higher levels within the prostate. This is primarily due to the higher levels of the enzyme reductase, which causes the conversion of testosterone to DHT. DHT has a tendency to bind to prostatic receptor cells, which ultimately results in prostate enlargement. It is usually a benign condition, and therefore, in some cases there is no need for surgery. However, enlargement of the prostate gland can cause many uncomfortable and annoying symptoms. Worsening symptoms may require prostate surgery. Nearly 400,000 prostate surgical procedures are performed annually to treat enlarged prostates. Numerous laboratories are conducting research in an attempt to find a cure for BPH.
Treatments for prostate disorders include alpha blockers, e.g., HYTRIN (terazosin HCl, Abbott Laboratories, Abbott Park, Illinois), CARDURA (Roerig Pharmaceuticals, Alexandria, Virginia) and FLOMAX (tamsulosin HCl, Boehringer Ingelheim Pharmaceuticals, Ridgefield, Conn.), which are designed to relax the muscle tension in the prostate and improve urinary flow. They do tend to improve voiding difficulties and relax tension in the prostate. However, they are expensive, need to be taken indefinitely in high doses, may often have significant side effects and do not cure the underlying problem or prevent recurrences.
There are also other treatments for prostate disorder. For example, PROSCAR (finasteride, Merck Human Health, White House Station, N.J.) can shrink prostate tissue, but there is no proof it helps in the treatment of prostatitis. Allopurinol, a drug that reduces uric acid levels in the body, has been used to treat prostatitis based on the theory that uric acid crystals may form in the prostate and cause inflammation. Anti-inflammatory agents, such as ibuprofen, and hot sitz baths have been helpful in treating the discomfort caused by prostatitis in many patients, but neither of these treatments actually cures the disease and the benefits wear off rapidly.
Irritative voiding symptoms may be relieved by bladder relaxing agents such as oxybutynin (DITROPAN Alza Corporation, Palo Alto, Calif.), while antidepressants such as amitriptyline (ELAVIL AstraZeneca, Wilmington, Del.) have been helpful in various chronic pain conditions such as prostatitis associated with depression. Biofeedback, behavioral therapy, referral to a pain clinic and psychological treatment have all been recommended for patients with prostatitis and occasionally offer some relief to selected individuals. For the most part, current treatment methods for prostatitis are generally rather disappointing.
Prostatic massage plus antibiotics has been used with some success. However, proponents of prostatic massage (championed in the Philippines) have little reproducible data to support their methods. Other drawbacks include intense discomfort/pain at the time of massage, the need for accurate cultures of the prostatic fluid, and a dependence on antibiotics to ultimately effect the cure.
There are natural elements that have known benefits in treating enlargement of the prostate gland and prostatitis. It is widely accepted that zinc has positive effects in reducing an enlarged prostate, but studies have indicated that zinc administered orally does not reach prostatic tissue very effectively. Therefore, the prostate does not reap its full benefits. Other studies have shown that
Pygeum africanum
extract has definite effects in reducing the size of the prostate.
Extensive studies have shown that Saw palmetto (
Serenoa repens
) effectively reduces the size of the enlarged prostate and restores function. T. J. Wilt et al. recently reviewed 18 randomized controlled trials involving the effects of saw palmetto on 2,939 men and found that the evidence suggests that
S. repens
(Saw palmetto extract) improves urologic symptoms and flow measures, and that when compared with PROSCAR,
S. repens
produces similar improvement in urinary tract symptoms and urinary flow and was associated with fewer adverse treatment events. T. J. Wilt et al., “Saw Palmetto Extracts for Treatment of Benign Prostatic Hyperplasia,”
JAMA
280:1604-09 (1998). The Saw palmetto berry contains oil composed of sterols and various saturated and unsaturated fatty acids from which the purified, fat soluble extract are used medicinally.
Another natural product known to produce beneficial effects on the enlarged prostate is pumpkin seed. Pumpkin seeds have been used as a folk remedy for centuries, and it is believed that Hungarian gypsies, Ukrainians and Transylvanians do not suffer from BPH because they eat pumpkin seeds from childhood as part of their daily diet. Additionally, the Chinese use a combination of three amino acids: glycine, L-alanine, and glutamic acid, to treat di
DeWitt Ross & Stevens SC
Tate Christopher
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