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| |  Lycopene, Saw Palmetto Fail in Prostate Health Trials By Ed Susman SAN ANTONIO, TX -- May 26, 2005 -- Two popular natural treatments for prostate health -- lycopene and saw palmetto -- proved ineffective in controlled clinical trials, researchers reported here May 22nd at the American Urological Association (AUA) Annual Meeting. Peter Clark, MD, assistant professor of urology at Wake Forest University in Winston-Salem, North Carolina, presented results of a study that tested the impact of lycopene -- the compound that makes tomatoes red -- on men with recurrent prostate cancer. The goal of the trial was to see if lycopene could control PSA levels. The investigators enrolled 36 men with recurrent cancer who were administered different doses of lycopene extract, ranging from 15 to 120 mg a day, for 12 months. At the end of the trial, doctors determined that lycopene had no effect on the recipients: -- None of the 35 patients who completed the study showed any response. -- The PSA doubling time prior to entry into the trial averaged 3.7 years; at the end of the trial, the doubling time was 4.1 years, not a statistical difference. -- The PSA slope -- another method of analyzing the marker -- prior to lycopene was 0.010; after lycopene, it was 0.011. Again, that represented no change. A similar negative finding was reported for an experiment involving saw palmetto, an herbal remedy widely used for treatment of benign prostatic hyperplasia. Andrew Avins, MD, assistant professor of medicine and epidemiology at the University of California, San Francisco, California, explained that the aim of the trial was to see if the use of saw palmetto could improve urinary flow among men with benign prostatic hyperplasia. The placebo-controlled trial, funded by the National Institutes of Health's National Institute on Complementary and Alternative Medicine, enrolled 225 men with documented disease. Over 1 year, the men made 8 office visits for evaluation in several urinary-health-related outcomes. "In contrast to most prior studies," said Dr. Avins, "we found no significant benefit of saw palmetto on urinary symptoms or objective measures of benign prostatic hyperplasia over a 1-year period." "We have shown, however, that well-designed clinical trials can be performed to determine if alternative therapies are effective," he concluded.
[Presentation title: Prospective Dose Escalation Trial of Lycopene in Men With Recurrent Prostate Cancer Following Definitive Local Therapy. Abstract 1014.]
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