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Saw Palmetto Extract Shows No Benefit in Improving BPH Outcomes

  • Authors: News Author: Jim Kling
    CME Author: Charles P. Vega, MD
  • CME Released: 10/4/2011
  • Valid for credit through: 10/4/2012
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Target Audience and Goal Statement

This article is intended for primary care clinicians, urologists, and other specialists who care for men with benign prostatic hypertrophy.

The goal of this activity is to provide medical news to primary care clinicians and other healthcare professionals in order to enhance patient care.

Upon completion of this activity, participants will be able to:

  1. Assess the potential benefits of treatment with saw palmetto for men with benign prostatic hypertrophy.
  2. Compare standard- vs high-dose regimens of saw palmetto in the treatment of benign prostatic hypertrophy.


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  • Jim Kling

    Freelance writer for Medscape, LLC.


    Disclosure: Jim Kling has disclosed no relevant financial relationships.


  • Brande Nicole Martin

    CME Clinical Editor, Medscape, LLC


    Disclosure: Brande Nicole Martin has disclosed no relevant financial relationships.

CME Author(s)

  • Charles P. Vega, MD

    Health Sciences Clinical Professor; Residency Director, Department of Family Medicine, University of California, Irvine


    Disclosure: Charles P. Vega, MD, has disclosed no relevant financial relationships.

CME Reviewer(s)

  • Sarah Fleischman

    CME Program Manager, Medscape, LLC


    Disclosure: Sarah Fleischman has disclosed no relevant financial relationships.

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Saw Palmetto Extract Shows No Benefit in Improving BPH Outcomes

Authors: News Author: Jim Kling CME Author: Charles P. Vega, MDFaculty and Disclosures

CME Released: 10/4/2011

Valid for credit through: 10/4/2012


Clinical Context

Many adults seek natural remedies for chronic medical conditions, and saw palmetto for the treatment of benign prostatic hypertrophy (BPH) is one of the most popular. A meta-analysis of controlled trials of saw palmetto by Tacklind and colleagues, which appeared in the April 15, 2009, issue of The Cochrane Database of Systematic Reviews, found that saw palmetto was not superior to placebo or active comparators in reducing symptoms of BPH. Saw palmetto also did not improve prostate size or objective measurements of peak urine flow.

One deficiency of previous trials of saw palmetto has been a failure to examine any dose-response effect associated with treatment. The current randomized controlled trial by Barry and colleagues examines this issue.

Study Synopsis and Perspective

Saw palmetto fruit extract was no better than placebo in the treatment of lower urinary tract symptoms in men with enlarged prostates, according to a study published in the September 28 issue of JAMA.

Saw palmetto extract is a popular alternative medicine for the relief of lower urinary tract symptoms in men with enlarged prostates. An effect could be a result of antiandrogenic, anti-inflammatory, and antiproliferative properties, but none of these mechanisms have been proven.

Previous trials of saw palmetto extract have yielded mixed results at standard doses (320 mg/day), with an early trial showing a positive effect, but more recent, larger trials showing none, write Michael J. Barry, MD, from the Department of Medicine, Massachusetts General Hospital, Boston, and colleagues.

Between June 2008 and October 2010, the researchers conducted a double-blind, placebo-controlled, randomized trial using up to 3 times the standard dose of the extract. Participants included 369 men aged 45 years or older. Patients had a peak urinary flow rate of at least 4 mL/second, an American Urological Association Symptom Index (AUASI) score between 8 and 24, and no exclusions.

Participants received 1 dose of the extract, then 2 doses at 24 weeks, and then 3 doses at 48 weeks. In the treated group, at 72 weeks there was a decrease of mean AUASI scores from 14.42 to 12.22 points (−2.20 points; 95% confidence interval [CI], −3.04 to −0.36 points) compared with a decrease from 14.69 to 11.70 points (−2.99 points; 95% CI, −3.81 to −2.17 points) in the placebo group.

The difference in AUASI score decline was 0.79 between the 2 groups (upper bound of the 1-sided 95% CI most favorable to saw palmetto extract was 1.77 points; 1-sided P = .91). The researchers observed no favorable effect of saw palmetto extract on any secondary outcomes, which included measures of urinary bother, nocturia, peak uroflow, postvoid residual volume, prostate-specific antigen level, participants' global assessments, sexual function, continence, sleep quality, and prostatitis symptoms.

The researchers also observed no adverse effects that could be attributed to saw palmetto extract.

Although the current study adds to the evidence that saw palmetto extract has no clinical benefit, men may continue to turn to it because natural remedies remain a popular alternative to prescription drugs, which can cause bothersome adverse effects such as sexual dysfunction, according to Allan Pantuck, MD, an associate professor of urology at the University of California, Los Angeles, David Geffen School of Medicine. Dr. Pantuck was not involved in the study.

Patients may perceive a benefit because the symptoms of an enlarged prostate can wax and wane over time. "When symptoms do lessen to some extent, people can attribute that improvement to the supplement, when this may just be the natural history of the disease. If patients didn't perceive some benefit from [saw palmetto extract], it wouldn't be so popular," Dr. Pantuck told Medscape Medical News.

The authors of the study report receiving grant money, royalties, or consultancy fees from, or holding stock options in, or other considerations from a number of pharmaceutical companies that market treatments for enlarged prostate, including Merck, GlaxoSmithKline, Pfizer, Watson, Astellas, Ferring, Taris, Triton, Farr Labs, Trillium, Cernelle, Johnson & Johnson, Amgen, Bayer, Caris, France Foundation, GenProbe, Steba Biotech, Ortho-Clinical Diagnostics, Envisioneering Medical, Viking Medical, Augmenix, Cambridge Endo, Myriad Genetics, Sanofi-Aventis, Lilly/ICOS, Allergan, and Neotract. Dr. Pantuck has disclosed no relevant financial relationships.

JAMA. 2011;12:1344-1351.

Study Highlights

  • Men 45 years or older were eligible for study participation if they had an AUASI score between 8 and 24.
  • The AUASI score ranges between 0 and 35, with higher numbers indicating more severe symptoms. Participants also had a peak uroflow of at least 4 mL/second. Men with recent pharmacologic treatment of BPH or any invasive treatment of BPH were excluded from study participation.
  • Participants received 1, 2, or 3 capsules daily containing 320 mg each of saw palmetto, with matching placebo. The dosage of saw palmetto could be escalated at study weeks 24 and 48.
  • The main study outcome was the AUASI score at 72 weeks after randomization. Researchers also measured prostate-specific quality of life, nocturia, uroflow, and adverse events associated with study therapy.
  • The study analysis accounted for demographic factors as well as the baseline severity of BPH.
  • 369 men underwent randomization. The mean age of study participants was 61 years, and 80% were non-Hispanic white. The mean AUASI score at baseline was 14.69.
  • 306 men completed all 72 weeks of treatment. Queries from the study investigators confirmed that participants were generally unsure of their treatment assignment to saw palmetto or to placebo.
  • The mean AUASI score decreased by mean values of 2.20 and 2.99 points in the saw palmetto group and the placebo group from baseline to week 72, respectively. The difference between treatment groups was not significant.
  • No dose of saw palmetto was significantly superior to placebo in improving BPH symptom scores.
  • In addition, saw palmetto failed to improve nocturia, prostate-specific quality-of-life scores, or uroflow vs placebo.
  • Mean subjective measurements found that participants believed that both study treatments provided modest relief from BPH symptoms at best.
  • Subgroup analysis based on race/ethnicity and other variables failed to alter the main study outcomes.
  • The rate of adverse events was similar in comparing the saw palmetto group vs the placebo group.

Clinical Implications

  • A previous systematic review of saw palmetto in the treatment of BPH by Tacklind and colleagues generally found that it failed to improve study outcomes.
  • Saw palmetto failed to improve BPH outcomes vs placebo in the current trial by Barry and colleagues, regardless of dosing.

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