The neW ENGLAND JOURNAL of MEDICINE BLISHED IN 1813 FEBRUARY 9,200G VOL.354 NO. Saw Palmetto for Benign Prostatic Hyperplasia Stephen Bent,M.D.Christopher Kane,M.D..Katsuto Shinohara,M.D..John Neuhaus,Ph.D. Esther S.Hudes,Ph.D.,M.P.H.,Harley Goldberg,D.O.,and Andrew L.Avins,M.D.,M.P.H. ABsTRACT BACKGROUND From the Osher Center LA )and th METHODS omly assigne d 225 mer ovethe age of 49 year ty of Ca of treatm ent with saw palmetto extract 60 me twice a day or placebo.Thep and the mary outcome measures were changes in the scores on the American Urological s) Association Symptom Index (AUASI)and the maximal urinary flow rate.Second and th ent San RESULTS 山N配 minute:95 percent confidence interval,-0.52 to 1.38),prostate size,residual vol- ume after voidi tigen levels during the one-year study.The incide CONCLUSIONS In this study,saw palmetto did enign prostatic hyperplasia.(Clin N ENGLJ MED 354:6 WWW.NEJM.ORG FEBRUARY 9.2006 557 d Journal of Medici ciety. n engl j med 354;6 www.nejm.org february 9, 2006 557 The new england journal of medicine established in 1812 february 9, 2006 vol. 354 no. 6 Saw Palmetto for Benign Prostatic Hyperplasia Stephen Bent, M.D., Christopher Kane, M.D., Katsuto Shinohara, M.D., John Neuhaus, Ph.D., Esther S. Hudes, Ph.D., M.P.H., Harley Goldberg, D.O., and Andrew L. Avins, M.D., M.P.H. Abstract From the Osher Center for Integrative Medicine, Department of Medicine (S.B., A.L.A.), the Division of General Internal Medicine, Department of Medicine (S.B., A.L.A.), and the Departments of Epide￾miology and Biostatistics (J.N., E.S.H., A.L.A.) and Family Practice (H.G.), Uni￾versity of California, San Francisco, San Francisco; the General Internal Medicine Section, Department of Medicine (S.B., A.L.A.), and the Urology Section (C.K., K.S.), San Francisco Veterans Affairs Medical Center, San Francisco; and the Division of Research, Kaiser Permanente Northern California, Oakland (H.G., A.L.A.). Address reprint requests to Dr. Bent at San Francisco VAMC, 111-A1, 4150 Clement St., San Francisco, CA 94121 or at bent@itsa.ucsf.edu. N Engl J Med 2006;354:557-66. Copyright © 2006 Massachusetts Medical Society. Background Saw palmetto is used by over 2 million men in the United States for the treatment of benign prostatic hyperplasia and is commonly recommended as an alternative to drugs approved by the Food and Drug Administration. Methods In this double-blind trial, we randomly assigned 225 men over the age of 49 years who had moderate-to-severe symptoms of benign prostatic hyperplasia to one year of treatment with saw palmetto extract (160 mg twice a day) or placebo. The pri￾mary outcome measures were changes in the scores on the American Urological Association Symptom Index (AUASI) and the maximal urinary flow rate. Secondary outcome measures included changes in prostate size, residual urinary volume after voiding, quality of life, laboratory values, and the rate of reported adverse effects. Results There was no significant difference between the saw palmetto and placebo groups in the change in AUASI scores (mean difference, 0.04 point; 95 percent confidence interval, –0.93 to 1.01), maximal urinary flow rate (mean difference, 0.43 ml per minute; 95 percent confidence interval, –0.52 to 1.38), prostate size, residual vol￾ume after voiding, quality of life, or serum prostate-specific antigen levels during the one-year study. The incidence of side effects was similar in the two groups. Conclusions In this study, saw palmetto did not improve symptoms or objective measures of benign prostatic hyperplasia. (ClinicalTrials.gov number, NCT00037154.) The New England Journal of Medicine Downloaded from nejm.org on October 18, 2011. For personal use only. No other uses without permission. Copyright © 2006 Massachusetts Medical Society. All rights reserved