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Articles - Prostate Enlargement (BPH)
... "there is a need for standardization and randomized controlled trials for the use of these agents in men with voiding symptoms and enlarged prostate glands." There is an increasing interest among men concerning the use of herbal treatments for the symptoms produced by an enlarged prostate gland. Because of the availability of herbal treatments, their popular use is not surprising. Total annual sales of all natural health care products in the United States will approach one billion dollars by the end of this year. These products are considered supplements by the FDA and some American physicians are not very knowledgeable regarding these products and many are unable to advise their patients concerning their use. In contrast, the use of plant extracts in some European countries is exceedingly common and often recommended as initial treatment for men with enlarged prostates. Because of the findings of several European studies and the public's increased awareness and incentives to lower health care costs, the use of herbal supplements is undergoing a rigorous change. Many people refer to the use of these products as "alternative medicine". Perhaps a more appropriate term may be "complementary medicine" as the use of any supplement, whether it be a regular daily vitamin or prescription medication, is certainly complementary to good health. Enlargement of the prostate, or benign prostatic hyperplasia (BPH), causes obstruction of the bladder, thereby producing a myriad of clinical symptoms. The most common of these are the need to urinate several times each night, difficulty in starting a stream or maintaining a stream, urgency with difficulty to postpone urination, and in extreme cases complete blockage of the urinary stream. Taken together, these symptoms are called prostatism, and although BPH is their most common cause, other problems such as prostate and bladder infections and intrinsic bladder disorders may produce the same collection of symptoms. The degree to which these symptoms are bothersome is highly variable and run a spectrum from very mild to severe. The most popular natural product used for the treatment of BPH in the United States is saw palmetto. This is an American plant that grows in marshy areas in Florida, South Carolina, Georgia, and Louisiana. The extract used comes from the plant's berries and consists of 90 percent fatty acids. Studies have indicated that the extract interferes with the synthesis of testosterone and other male hormone products. Saw palmetto may also cause the inhibition of hormones that bind to prostate receptor sites. A number of clinical trials have suggested that saw palmetto leads to definite improvement in symptoms suffered by men with enlarged prostates. This extract is well tolerated and has minimal side effects of gastro-intestinal upset in just 2-4 percent of people taking the preparation. It is generally exceptionally well tolerated and has no significant side effects and no significant toxicity. Another product sold in this country is produced from flower pollen extract called Cernitin and Prostaphil. These are widely available in drug and health food stores and consist of extract of Phytosterol, a plant hormone. Limited studies in Europe have demonstrated this to also be effective in relieving the symptoms of prostatism and has an exceptionally high safety profile with essentially no significant toxicity. Pygeum africanum is a large evergreen tree found in tropical Africa which also contains Phytosterols that are presumed to be active in relieving symptoms secondary to BPH. This preparation may also have significant anti-inflammatory effects within the prostate gland. This product is seen in a variety of compounded preparations sold for the treatment of urinary tract symptoms secondary to benign prostatic hyperplasia. There is a tremendous interest in the United States in the use of natural remedies and complementary medicine to treat a variety of medical conditions. The growth of health food and vitamin stores, aggressive direct marketing and the popularity of the Internet have all contributed to an increase in the use of these botanical medicinal preparations. Unlike standard therapies for BPH, such as Hytrin, Cardura, and Proscar, there have been few properly conducted placebo controlled trials of plant extracts in men. One of the primary reasons for lack of scientific study of these agents is the absence of significant financial incentive among American companies to support research since these products are not subject to patent protection. One of the difficulties in assessing the benefits of these agents is the lack of standardization. Vast differences are likely to exist between similar products sold by different manufacturers. Further confusion can also occur in the use of natural remedies in patients with BPH because of the sale of combination products which often include multiple plant extracts as well as a variety of vitamins and minerals. Clearly, there is a need for standardization and randomized controlled trials for the use of these agents in men with voiding symptoms and enlarged prostate glands. It is only through such properly conducted trials that the true value of these plant extracts can be reliably determined. Because of the apparent effectiveness of saw palmetto, the Department of Urology at the DeKalb Clinic will be engaged in a controlled clinical trial to study the effectiveness of this medication. This is being accomplished in conjunction with the University of Chicago and will run over the next six to twelve months. Medication will be provided free of charge and all patients will be considered that meet entrance criteria. Any person interested can call the urology department at 758-8671 ext. 302. Dr. Burstein is a board certified urologist practicing at DeKalb Clinic.
The use of herbal medicines has certainly taken off recently in the United States. Indeed, many diseases are treated initially and very effectively in Europe using these botanical preparations. Of most importance to our male patients with Benign Enlargement of the Prostatic is the use of Saw Palmetto. In the United States, this is considered a dietary supplement by the Federal Food and Drug Administration. However, in Germany it is approved by Commission E for treatment of stage I and stage II benign prostatic hyperplasia. Saw Palmetto (serenoa repens) is a dwarf palm that grows in the southeastern United States. Its dried, ripe fruit contains saturated and unsaturated free fatty acids, conjugated sterols, and high molecular weight polysaccharide flavonoids. Fat soluble extracts are standardized to contain 85-95% fatty acids and sterols. The actions are considered anti-androgenic and have clinical applications for the relief of lower urinary tract symptoms produced by an enlarged prostate gland. The only contra-indication known is for females that are pregnant and currently breast feeding. Side effects are infrequent gastrointestinal disturbances and headaches. Excessive intake may cause diarrhea. As far as herb/drug interactions are concerned, Saw Palmetto may interfere with hormonal therapy such as contraceptive pills, patches and hormone replacement therapy. Most importantly, an effective dosage to reduce symptoms is needed. We have found the most effective dosage is 160 mg extract, standardized to contain 85-95% fatty acids and sterols, taken twice a day.( Two capsules may be taken at the same time). Dried fruit can be taken 1-2 grams, 3 times a day, and a tincture of 1-2 cc, of whole plant tincture. The solid extract can be obtained at any pharmacy. Attention must be given to make sure of the proper dosage of 160 mg with up to 95% fatty acid content. Currently, multiple studies are underway to define, more specifically, the benefit of Saw Palmetto and other botanical medications.
The Department of Urology at the DeKalb Clinic has completed a controlled clinical trial to study the effectiveness of saw palmetto. This was accomplished in conjunction with the University of Chicago and appears in the December 2001 issue of the peer-reviewed journal Urology. Any person interested in receiving a reprint can call the urology department at 758-8671 ext. 2302. The abstract follows: RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL OF SAW PALMETTO IN MEN WITH LOWER URINARY TRACT SYMPTOMS GLENN S. GERBER, DIMITRI KUZNETSOV, BERNARD C. JOHNSON, AND JAY D. BURSTEIN ABSTRACT
Objectives. The use of nontraditional therapies in men with lower urinary tract symptoms (LUTS) has increased greatly in recent years owing to a variety of factors.1 These include patient dissatisfaction with standard pharmacologic and surgical treatments, increased marketing of nonprescription products through the media and internet, and a philosophical congruence between alternative therapies and patient values and beliefs. The most popular phytotherapeutic agent in men with benign prostatic hyperplasia and voiding dysfunction is saw palmetto (Serentra repens).4 This agent is derived from the berry of the American dwarf palm tree found in many areas of the southeastern United States. A number of placebo-controlled trials have been published concerning the use of saw Palmetto in men with LUTS.5-9 Many of these studies have suggested significant subjective and objective improvement in patients with benign prostatic hyperplasia.5,6 However, most of these trials were limited by several factors, including small patient numbers, brief study intervals of 1 to 3 months, and/or the absence of standardized testing instruments, such as symptom scores.5-9 In addition, several investigators have used meta-analyses of saw palmetto and have concluded that this alternative agent is beneficial in men with LUTS.10,11 Despite the results of these studies, many physicians remain sketical about the benefits of saw palmetto, and it has been suggested that any improvement in symptoms was largely induced by a placebo effect.12 For these reasons, there is a continued call for randomized, placebo-controlled trials of saw palmetto to determine the magnitude and level of efficacy of this agent"·4,10
Material and Methods.
The study drug and placebo were provided by Nutraceutical
Corp., Ogden, Utah. |
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DeKalb Clinic Urology
217 Franklin St
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