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Saw palmetto no more effective than placebo for urinary symptoms
Date:9/27/2011

t was a multicenter study with a larger sample size and tested different doses of a carefully analyzed saw palmetto product," Briggs said. "The NIH is committed to bringing rigorous science to the study of natural products and to building the evidence base that can guide consumer decisions."

The study was a double-blind randomized placebo-controlled clinical trial conducted at 11 North American clinical sites from June 2008 to October 2010. A cohort of 369 men aged 45 years or older participated, each with a peak urine flow rate of at least four milliliters per second at the beginning of the study -- which is less than normal. Also, all had an American Urological Association Symptom Index (AUASI) score of between eight and 24 -- a lower score is better. The AUASI score ranges from zero to 35. Escalating doses of saw palmetto or placebo were given, starting at one, then two, and then three pills of 320 milligrams per day, with dose increases at 24 and 48 weeks.

The study measured the differences between the AUASI score at the start of the trial and after 72 weeks of treatment. Secondary measures included improvements in frequency, nocturia (nighttime urination), peak urine flow, prostate-specific antigen (PSA) level, sexual function, incontinence and sleep quality.

Between baseline and 72 weeks, mean AUASI scores decreased from 14.4 to 12.2 points with saw palmetto extract and from 14.7 to 11.7 points with placebo. The group average change in AUASI score from baseline to 72 weeks between the saw palmetto and placebo groups was 0.79 points, favoring placebo. Saw palmetto was not more effective than placebo in reducing urinary symptoms for any of the secondary outcomes.

According to Joseph M. Betz, Ph.D., director of the Analytical Methods and Reference Materials program at ODS and a study co-author, the study used a very well-characterized saw palmetto product. Through batch testing, study investigators took extreme care
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Contact: Bill Polglase
NIDDKMedia@mail.nih.gov
301-496-3583
NIH/National Institute of Diabetes and Digestive and Kidney Diseases
Source:Eurekalert

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