Lycopene, Saw Palmetto Fail in Prostate Health Trials

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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, United States, 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 mg 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, United States, explained that the
aim of the trial was 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 one year, the men made
eight 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 one-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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