—Findings Inconsistent with Benefits Demonstrated by Other Studies—
WASHINGTON, D.C., February 8, 2006 — A new study on saw palmetto’s role in relieving symptoms of benign prostatic hyperplasia—problems with the lower urinary tract—showed inconsistent conclusions to those found in the existing body of scientific literature on the popular dietary supplement.
“The results from this study are particularly puzzling,” said Andrew Shao, Ph.D., vice president, Council for Responsible Nutrition (CRN), “given that more than 20 studies have shown promising findings for saw palmetto in alleviating symptoms commonly associated with prostate problems, such as frequent urination, a low stream of urination, and a feeling of heaviness in the prostate. While this trial is an important piece of research, it should by no means close the book on saw palmetto research. Science is an evolutionary process, so it is inappropriate to simply discount the benefits previously found.”
The study was funded by the National Institute of Diabetes and Digestive and Kidney Diseases and the National Center for Complementary and Alternative Medicine and published in the February 9 issue of the New England Journal of Medicine.
Dr. Shao called the trial “well-designed and well implemented” but noted that the disappointing conclusions may have resulted from an inappropriate study population. The study examined men with moderate-to-severe symptoms of benign prostatic hyperplasia, when most of the literature cites positive results among men with mild-to-moderate symptoms. “It may be,” said Dr. Shao, “that exclusion of those patients with mild symptoms from the study may have reduced the ability to detect the benefits we’ve seen in other trials. Future trials need to explore in more detail the response of those with both mild and moderate symptoms.”
Mark Blumenthal, founder and executive director of the American Botanical Council (ABC), a non-profit educational organization specializing in information on herbals said, “Since the study raised the bar from mild to moderate symptoms to moderate to severe, the researchers should have also had a third arm in the trial testing a higher dosage to see if there was a dose-response relationship at that level.”
Mr. Blumenthal pointed to a meta-analysis published by the Cochrane Collaboration showing 21 clinical trials involving over 3,000 men, that concluded that saw palmetto was safe and showed benefit compared to placebo and compared to finasteride with significantly fewer side effects than the drug.
As the interest and demand from consumers looking for alternative therapies continues to grow, saw palmetto represents one more option in an arsenal for fighting prostate problems. The ABC Clinical Guide to Herbs cites a strong safety profile for saw palmetto, with rare cases of gastrointestinal disturbance reported, and the potential for nausea if taken on an empty stomach. Men taking saw palmetto should discuss use or potential use with their doctor to determine if the supplement is appropriate for them.
Most recent sales figures (2004) from Nutrition Business Journal placed U.S. sales of saw palmetto at $134 million, ranking the herbal supplement in the top ten herbal sellers.
The Council for Responsible Nutrition (CRN), founded in 1973, is a Washington, D.C.-based trade association representing dietary supplement industry ingredient suppliers and manufacturers. CRN members adhere to a strong code of ethics, comply with dosage limits and manufacture dietary supplements to high quality standards under good manufacturing practices.
Judy Blatman at 202-204-7962