Randomized Trial Of Saw Palmetto Versus Placebo Published In New England Journal Of Medicine Suggests No Benefit
Dr. Bent and colleagues at the University of California, San Francisco and its affiliated VA and Kaiser Permanente hospitals report a prospective, randomized trial of saw palmetto vs. placebo in the February 9, 2006 issue of the New England Journal of Medicine.
Between 2001 and 2004 225 men with moderate to severe symptoms of BPH were randomized to placebo or 160mg of saw palmetto twice a day. Eligibility criteria included an AUA symptom score >8 and a peak urinary flow rate >15cc/sec. Participants had 8 follow-up visits over 12 months with primary endpoints being symptom scores and flow rates. Secondary endpoints included post-void residual urine, prostate volume, quality of life and adverse events.
Men on saw palmetto did not have increased adverse events compared to placebo. Saw palmetto did not result in improvements in any outcomes measured compared to placebo.
A strength of this study is that the placebo group took an extract similar to saw palmetto in consistency, appearance and taste. The results demonstrated that blinding to treatment was effective, and this minimizes a decreased response in the placebo arm. However, the mechanism of action of saw palmetto is not known and whether appropriate levels of relevant compounds were achieved can not be verified. This of course, is a problem with herbal therapy and a reality for those taking saw palmetto.
N Engl J Med 2006; 354:557-66
Written By Christopher P. Evans, M.D.
Bent S, Kane C, Shinohara K, Neuhaus J, Hudes ES, Goldberg H, Avins AL
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