Increasing Dosage of Saw Palmetto Does Not Appear to Reduce UrinarySymptoms From Enlarged Prostate
CHICAGO—Men with urinary problems related to an enlarged prostate whoreceived increasing doses of the fruit extract saw palmetto did not experience areduction in these symptoms compared to men who received placebo, accordingto a study in the September 28 issue of
."Benign prostatic hyperplasia [BPH; an enlarged prostate gland] is a commoncause of bothersome lower urinary tract symptoms (LUTS) among older men andmay be treated with medications, minimally invasive therapies, or surgery. Plantextracts are also widely used for LUTS in the United States and Europe. Themost common are extracts of the fruit of the saw palmetto dwarf palm tree,"according to background information in the article. In a 2007 U.S. survey, 17.7percent of adults reported use of a natural product in the last 30 days and 5.1percent of users had taken saw palmetto. Several recent clinical trials havequestioned the efficacy of the use of saw palmetto in treating LUTS. Symptomsof LUTS may include urination frequency, urgency and hesitancy.Michael J. Barry, M.D., of Massachusetts General Hospital, Boston, andcolleagues conducted a study to determine if a standard daily dose of sawpalmetto extract increased to a double and then a triple daily dose over 72weeks would improve LUTS attributed to BPH. The multicenter, placebo-controlled randomized trial was conducted at 11 North American clinical sitesbetween June 2008 and October 2010. The trial included 369 men, ages 45years or older, with a certain minimum peak urinary flow rate and an AmericanUrological Association Symptom Index (AUASI; a self-administered 7-item indexassessing frequency of LUTS [range, 0-35 points]) score of between 8 and 24 at2 screening visits. Participants received 1, 2, and then 3 doses (320 mg/d) of saw palmetto extract or placebo, with dose increases at 24 and 48 weeks.In an analysis of the group average changes in AUASI scores between thebeginning of the study and at 72 weeks, the AUASI score decreased an averageof 2.20 points with saw palmetto extract and 2.99 points with placebo, a groupaverage difference of 0.79 points favoring placebo. "The proportion of participants achieving a 3-point decrease in AUASI score at 72 weeks was 42.6percent in the saw palmetto extract group and 44.2 percent in the placebogroup," the authors write. "In addition, the analysis of dose response alsoshowed no greater improvement with saw palmetto extract vs. placebo at anydose level."The researchers also found that saw palmetto extract was no better than placebofor any of the secondary outcomes, including measures of urinary bother,nocturia (excessive urination at night), and indices of sexual function,continence, sleep quality, and prostatitis symptoms. No clearly attributableadverse effects were identified."In conclusion, we found that saw palmetto extract used at up to 3 times thestandard daily dose had no greater effect than placebo on improving lowerurinary symptoms or other outcomes related to BPH."