ANAHEIM, CA, June 5, 2001 - Additional results from the first U.S. randomized placebo-controlled trial of saw palmetto for benign prostatic hyperplasia (BPH) were presented today at the American Urological Association annual meeting in Anaheim, CA.
Using needle biopsies to extract prostate tissue from patients before and after treatment with either saw palmetto or placebo, researchers noted a 32 percent decrease in dihydrotestosterone (DHT) - a hormone associated with BPH - in the saw palmetto treated patients after six months of treatment. No statistically significant changes in DHT levels were noted in the placebo-controlled patients.
“Although the study is not conclusive, the results corroborate existing data that suggest that saw palmetto may be an effective treatment for reducing the symptoms of BPH,” said study investigator Leonard S. Marks, MD, director of the Urological Sciences Research Foundation.
“This is an important study,” said Mark Blumenthal, founder and executive director of the nonprofit American Botanical Council (ABC). “This research helps pinpoint some of the biochemical mechanisms by which saw palmetto works to help alleviate symptoms of BPH. The data were derived from specific objective criteria -- the analysis of prostate tissue -- instead of relying on questionnaires from the patients and physician’s observations reported in earlier studies.”
According to Dr. Marks, this study helps document the anecdotal benefits of saw palmetto that patients and physicians alike have been reporting for years, and bolsters existing data generated by uncontrolled studies. In addition, he says, this herb offers an attractive safety profile. “With the exception of occasional stomach upset, no major side effects have been reported with saw palmetto use,” said Dr. Marks.
In Germany, the Commission E, a panel of medical and pharmacy experts within the German government, has approved the use of saw palmetto for early stage BPH at the dosage of 320 mg per day. Dr. Marks advises anyone considering taking this herb to consult his physician to make sure he is a suitable candidate for saw palmetto. He also added that saw palmetto does not affect results of the prostate specific antigen (PSA) test, used by physicians to screen men for prostate cancer. In contrast, finasteride, a leading prescription drug for treatment of BPH, can lower PSA results by as much as 50 percent.
An estimated 50 percent of men over the age of fifty will develop benign prostatic hyperplasia. The condition occurs when the prostate, a walnut-sized gland located below the bladder, becomes inflamed and presses against the urethra, interrupting normal urine flow. Symptoms include a weak or intermittent urine stream, dribbling or pain at the time of urination or the sense that the bladder hasn’t emptied completely and increased frequency or urgency of urination (particularly at night).
Saw palmetto (known in science by its Latin name Serenoa repens) is a small palm tree native to Florida. The fruits or berries were eaten as a food by Seminole Indians, and have been used by physicians since the late 1800s and early 1900s to treat various conditions associated with the male genito-urinary tract. Modern medical research on saw palmetto has been conducted primarily in western Europe. The results of 18 controlled clinical trials on saw palmetto were critically reviewed in the Journal of the American Medical Association in 1998 and the researchers concluded that saw palmetto preparations are safe and effective in treating many of the symptoms associated with BPH. ABC’s Blumenthal emphasized that Dr. Marks’ study is consistent with the previous studies that document the safety and efficacy of saw palmetto extract in treating symptoms of BPH and helps to provide a basis for explaining the success of those studies.
The new trial was funded by research grants obtained through Urological Sciences Research Foundation, with support from Nutrilite, a Division of Alticor. The product used in this study is made by Nutrilite and contains saw palmetto extract (106mg), plus nettle root extract (80mg), pumpkin seed oil (160mg), and other natural ingredients in a capsule that is taken three times daily.
The Urological Sciences Research Foundation is a California non-profit organization founded in 1992 by current medical director, Leonard S. Marks, MD. The primary mission of the foundation is to help advance the understanding of common urologic problems, increase the range of effective treatments for such conditions, and inform the medical and lay public of these problems and treatments. Additional information is available at the Foundation web site http://www.usrf.org.
The American Botanical Council is the nation's leading non-profit organization dealing with research and educational issues regarding herbs and medicinal plants. The 12-year-old organization occupies a 2.5 acre site in Austin, Texas where it publishes HerbalGram, a peer-reviewed journal on herbal medicine and other educational materials. Information contact: ABC at PO Box 144345, Austin, TX 78714-4345, ph: 512-926-4900, fx: 512-926-2345. Website: www.herbalgram.org.
Note to Editors:
The study referred to in this release was just published in the journal Urology (Marks LS, Hess DL, DoreFJ. Tissue Effects of Saw Palmetto and Finasteride: Use of Biopsy Cores for In Situ Quantification of Prostatic Androgens. Urology 2001;57:999-1005.)
Some of the data that form the basis of this clinical trial were previously published in the Journal of Urology in 1999 by Dr. Marks and colleagues (Marks LS, Partin AW, Epstein JI, et al. Effects of a saw palmetto herbal blend in men with symptomatic benign prostatic hyperplasia. J Urol. 2000 May; 163(5):1451-6.)
The citation for the meta-analysis of 18 clinical trials on saw palmetto in JAMA noted above is: Wilt, T.J. et al. Saw palmetto extracts for treatment of benign prostatic hyperplasia: a systematic review. JAMA 1998;280(18):1604-1609.