Increasing Dose of Saw Palmetto No Better Than Placebo in BPH

Results comparable to placebo in benign prostatic hyperplasia-related urinary tract symptoms

WEDNESDAY, Sept. 28 (HealthDay News) -- Saw palmetto fruit extract (Serenoa repens) at doses up to three times the standard daily dose has no greater effect than placebo on lower urinary tract symptoms (LUTS) attributable to benign prostatic hyperplasia (BPH), according to a study published the Sept. 28 issue of the Journal of the American Medical Association.

Michael J. Barry, M.D., from Massachusetts General Hospital in Boston, and colleagues investigated the effect of up to three times the standard daily dose of saw palmetto extract on LUTS attributed to BPH. Between 2008 and 2010, 369 men (aged 45 years or older) with peak urinary flow rate of 4 mL/s, an American Urological Association Symptom Index (AUASI) score between 8 and 24, and no further exclusions were randomized to successively receive one, two, and then three gelcaps (320 mg) of saw palmetto extract or placebo, with dose increases at 24 and 48 weeks. The difference in AUASI score between baseline and 72 weeks was the primary outcome. Secondary outcomes included measures of urinary bother, nocturia, continence, erectile and ejaculatory function, prostatitis symptoms, participant's global assessments, and sleep quality.

The investigators found that the mean AUASI score decreased between baseline and 72 weeks for both saw palmetto (from 14.42 to 12.22 points) and placebo (from 14.69 to 11.70 points). The corresponding group mean difference in AUASI score change was 0.79 points, favoring placebo. No adverse effects attributable to saw palmetto extract were identified, nor was the extract more effective than placebo for secondary outcomes.

"Increasing doses of a saw palmetto fruit extract did not reduce lower urinary tract symptoms more than placebo," the authors write.

The saw palmetto and placebo were provided by Rottapharm/Madaus, manufacturers of saw palmetto. Several of the study authors disclosed financial relationships with the pharmaceutical and medical device industries.

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