title: Effect of increasing doses of saw palmetto extract on lower urinary tract symptoms: a randomized trial.
abstract: BACKGROUND
  Saw palmetto fruit extracts are widely used for treating lower urinary tract symptoms attributed to benign prostatic hyperplasia (BPH); however, recent clinical trials have questioned their efficacy, at least at standard doses (320 mg/d).
  
  
  OBJECTIVE
  To determine the effect of saw palmetto extract (Serenoa repens, from saw palmetto berries) at up to 3 times the standard dose on lower urinary tract symptoms attributed to BPH.
  
  
  METHODS
  A double-blind, multicenter, placebo-controlled randomized trial at 11 North American clinical sites conducted between June 5, 2008, and October 10, 2010, of 369 men aged 45 years or older, with a peak urinary flow rate of at least 4 mL/s, an American Urological Association Symptom Index (AUASI) score of between 8 and 24 at 2 screening visits, and no exclusions.
  
  
  METHODS
  One, 2, and then 3 doses (320 mg/d) of saw palmetto extract or placebo, with dose increases at 24 and 48 weeks.
  
  
  METHODS
  Difference in AUASI score between baseline and 72 weeks. Secondary outcomes included measures of urinary bother, nocturia, peak uroflow, postvoid residual volume, prostate-specific antigen level, participants' global assessments, and indices of sexual function, continence, sleep quality, and prostatitis symptoms.
  
  
  RESULTS
  Between baseline and 72 weeks, mean AUASI scores decreased from 14.42 to 12.22 points (-2.20 points; 95% CI, -3.04 to -1.36) [corrected]with saw palmetto extract and from 14.69 to 11.70 points (-2.99 points; 95% CI, -3.81 to -2.17) with placebo. The group mean difference in AUASI score change from baseline to 72 weeks between the saw palmetto extract and placebo groups was 0.79 points favoring placebo (upper bound of the 1-sided 95% CI most favorable to saw palmetto extract was 1.77 points, 1-sided P = .91). Saw palmetto extract was no more effective than placebo for any secondary outcome. No clearly attributable adverse effects were identified.
  
  
  CONCLUSIONS
  Increasing doses of a saw palmetto fruit extract did not reduce lower urinary tract symptoms more than placebo.
  
  
  BACKGROUND
  clinicaltrials.gov Identifier: NCT00603304.
authors.affiliation: Department of Medicine, Massachusetts General Hospital, 50 Staniford St, Ninth Floor, Boston, MA 02114, USA. mbarry@partners.org
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Barry
authors.forename: Sreelatha
authors.initials: S
authors.lastname: Meleth
authors.forename: Jeannette Y
authors.initials: JY
authors.lastname: Lee
authors.forename: Karl J
authors.initials: KJ
authors.lastname: Kreder
authors.forename: Andrew L
authors.initials: AL
authors.lastname: Avins
authors.forename: J Curtis
authors.initials: JC
authors.lastname: Nickel
authors.forename: Claus G
authors.initials: CG
authors.lastname: Roehrborn
authors.forename: E David
authors.initials: ED
authors.lastname: Crawford
authors.forename: Harris E
authors.initials: HE
authors.lastname: Foster
authors.forename: Steven A
authors.initials: SA
authors.lastname: Kaplan
authors.forename: Andrew
authors.initials: A
authors.lastname: McCullough
authors.forename: Gerald L
authors.initials: GL
authors.lastname: Andriole
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Naslund
authors.forename: O Dale
authors.initials: OD
authors.lastname: Williams
authors.forename: John W
authors.initials: JW
authors.lastname: Kusek
authors.forename: Catherine M
authors.initials: CM
authors.lastname: Meyers
authors.forename: Joseph M
authors.initials: JM
authors.lastname: Betz
authors.forename: Alan
authors.initials: A
authors.lastname: Cantor
authors.forename: Kevin T
authors.initials: KT
authors.lastname: McVary
mesh_terms: D000368:Aged; D000726:Androgen Antagonists / Q000008:administration & dosage*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D006801:Humans; D008297:Male; D008875:Middle Aged; D010936:Plant Extracts / Q000008:administration & dosage*; D011470:Prostatic Hyperplasia / Q000150:complications*; D028024:Serenoa; D016896:Treatment Outcome; D014555:Urination Disorders / Q000188:drug therapy* / Q000209:etiology
chemical_list: D000726:Androgen Antagonists; D010936:Plant Extracts; C040972:saw palmetto extract