• Register
X
Forgot Password

If you have forgotten your password you can enter your email here and get a temporary password sent to your email.

X

Leaving Community

Are you sure you want to leave this community? Leaving the community will revoke any permissions you have been granted in this community.

No
Yes

Effect of increasing doses of saw palmetto extract on lower urinary tract symptoms: a randomized trial.

CONTEXT: 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. DESIGN, SETTING, AND PARTICIPANTS: 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. INTERVENTIONS: One, 2, and then 3 doses (320 mg/d) of saw palmetto extract or placebo, with dose increases at 24 and 48 weeks. MAIN OUTCOME MEASURES: 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. CONCLUSION: Increasing doses of a saw palmetto fruit extract did not reduce lower urinary tract symptoms more than placebo. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00603304.

Pubmed ID: 21954478

Authors

  • Barry MJ
  • Meleth S
  • Lee JY
  • Kreder KJ
  • Avins AL
  • Nickel JC
  • Roehrborn CG
  • Crawford ED
  • Foster HE
  • Kaplan SA
  • McCullough A
  • Andriole GL
  • Naslund MJ
  • Williams OD
  • Kusek JW
  • Meyers CM
  • Betz JM
  • Cantor A
  • McVary KT
  • Complementary and Alternative Medicine for Urological Symptoms (CAMUS) Study Group

Journal

JAMA

Publication Data

September 28, 2011

Associated Grants

  • Agency: NIDDK NIH HHS, Id: U01 DK063778-08
  • Agency: NIDDK NIH HHS, Id: U01 DK063788-09S1
  • Agency: NIDDK NIH HHS, Id: U01 DK063795
  • Agency: NIDDK NIH HHS, Id: U01 DK063795-08
  • Agency: NIDDK NIH HHS, Id: U01 DK063797-07
  • Agency: NIDDK NIH HHS, Id: U01 DK063825
  • Agency: NIDDK NIH HHS, Id: U01 DK063825-08S2
  • Agency: NIDDK NIH HHS, Id: U01 DK063831-09
  • Agency: NIDDK NIH HHS, Id: U01 DK063833-08
  • Agency: NIDDK NIH HHS, Id: U01 DK063835-08
  • Agency: NIDDK NIH HHS, Id: U01 DK063840-07S2
  • Agency: NIDDK NIH HHS, Id: U01 DK063862-08
  • Agency: NIDDK NIH HHS, Id: U01 DK063866-07S1
  • Agency: NIDDK NIH HHS, Id: U01 DK063883-08
  • Agency: NIDDK NIH HHS, Id: U01 DK63778
  • Agency: NIDDK NIH HHS, Id: U01 DK63788
  • Agency: NIDDK NIH HHS, Id: U01 DK63795
  • Agency: NIDDK NIH HHS, Id: U01 DK63797
  • Agency: NIDDK NIH HHS, Id: U01 DK63825
  • Agency: NIDDK NIH HHS, Id: U01 DK63831
  • Agency: NIDDK NIH HHS, Id: U01 DK63833
  • Agency: NIDDK NIH HHS, Id: U01 DK63835
  • Agency: NIDDK NIH HHS, Id: U01 DK63840
  • Agency: NIDDK NIH HHS, Id: U01 DK63862
  • Agency: NIDDK NIH HHS, Id: U01 DK63866
  • Agency: NIDDK NIH HHS, Id: U01 DK63883

Mesh Terms

  • Aged
  • Androgen Antagonists
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Humans
  • Male
  • Middle Aged
  • Plant Extracts
  • Prostatic Hyperplasia
  • Treatment Outcome
  • Urination Disorders