The study was funded primarily by the National Institute of Diabetes and Digestive and Kidney Diseases, with additional funding from the National Center for Complementary and Alternative Medicine.
About Saw Palmetto
Saw palmetto (Serenoa repens) preparations are made from the fruit of a small palm tree which is native to Florida and was a former staple food of Seminole Indians. Saw palmetto berries were widely used by Eclectic physicians of the late 19th and early 20th centuries for a variety of indications, including treating the male reproductive system.
Saw palmetto extracts are widely used in Europe and in the past decade in the United States as a natural therapy to help maintain normal prostate and urinary function, particularly by treating the symptoms of BPH in men with mild to moderate cases of BPH.
A meta-analysis (statistical analysis of a group of studies) of 18 clinical trials published in the Journal of the American Medical Association  and another on 21 clinical trials carried out on over 3000 men as reviewed by the Cochrane Collaboration  have confirmed the safety and efficacy of saw palmetto extract preparations in treating symptoms of BPH, usually of stage 1 and 2. The latest meta-analysis  concludes that the clinical literature supports the use of saw palmetto preparations in treating symptoms of BPH in stages 1 and 2, and that saw palmetto preparations have shown efficacy and greater safety when compared to conventional pharmaceutical drugs (e.g., finasteride, aka Proscar®).
The safety and efficacy of saw palmetto preparations have gained international recognition by various governments and professional health groups. Saw palmetto has been approved by the German government’s respected Commission E  and the Canadian government’s Natural Health Products Directorate.  It is also recognized by leading scientists and physicians in Western Europe through a positive monograph by the European Scientific Cooperative on Phytotherapy (ESCOP), which acknowledges its efficacy for symptomatic treatment of micturition (urinary) disorders in mild to moderate BPH. . The World Health Organization also recognizes the efficacy of saw palmetto for treating lower urinary tract symptoms secondary to BPH stages I and 2.  Additional recent reviews of the medical and scientific literature have concluded that saw palmetto extract preparations are safe and effective for treating symptoms of BPH. These include The ABC Clinical Guide to Herbs  and others. 
Saw palmetto is frequently combined with other herbs that have shown benefit for prostate function to produce safe and effective preparations that have been clinically documented. For example, a leading European saw palmetto preparation also contains the root of nettle (Urtica dioica), for which several recent randomized controlled clinical trials have shown safety and efficacy, the most recent, conducted on 257 men in Russia, was published in July 2005 .
The large success of most saw palmetto trials has driven preparations of this traditional herb to large consumer acceptance, not only among natural health enthusiasts, but also in the mainstream market. In 2004 and 2005 retail sales of saw palmetto preparations ranked third (behind only garlic and echinacea), according to market report articles in the ABC’s quarterly, peer-reviewed article HerbalGram. [11,12] The NEJM article cited a 2002 survey showing that about 2.5 million men were estimated to have been using saw palmetto preparations. ABC estimates that saw palmetto retails sales in all channels of trade in the U.S. may be as high as $100-120 million or possibly more.