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Serenoa repens for benign prostatic hyperplasia.

  • 2012-12-12
  • The Cochrane database of systematic reviews 12
    • James Tacklind
    • Roderick Macdonald
    • Indy Rutks
    • Judith U Stanke
    • Timothy J Wilt

Study Design

Type
Meta-Analysis
Sample size
n = 5,666
Population
men with lower urinary tract symptoms consistent with BPH
Methods
systematic review and meta-analysis of randomized controlled trials comparing Serenoa repens (alone or in combination) with placebo or other interventions for at least four weeks
Funding
Unclear

Background

Benign prostatic hyperplasia (BPH) is a nonmalignant enlargement of the prostate, which can lead to obstructive and irritative lower urinary tract symptoms (LUTS). The pharmacologic use of plants and herbs (phytotherapy) for the treatment of LUTS associated with BPH is common. The extract of the berry of the American saw palmetto, or dwarf palm plant, Serenoa repens (SR), which is also known by its botanical name of Sabal serrulatum, is one of several phytotherapeutic agents available for the treatment of BPH.

Objectives

This systematic review aimed to assess the effects and harms of Serenoa repens in the treatment of men with LUTS consistent with BPH.

Search methods

We searched for trials in general and in specialized databases, including the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE®, EMBASE, CINAHL®, Web of Science, SCOPUS, BIOSIS Previews®, LILACS, ClinicalTrials.gov, Controlled-Trials.com, World Health Organization (WHO), and Google Scholar. We also handsearched systematic reviews, references, and clinical practice guidelines. There were no language restrictions.

Selection criteria

Trials were eligible if they randomized men with symptomatic BPH to receive preparations of SR (alone or in combination) for at least four weeks in comparison with placebo or other interventions, and included clinical outcomes, such as urologic symptom scales, symptoms, and urodynamic measurements. Eligibility was assessed by at least two independent observers (JT, RM).

Data collection and analysis

One review author (JT) extracted Information on patients, interventions, and outcomes which was then checked by another review author (RM). The main outcome measure for comparing the effectiveness of SR with active or inert controls was change in urologic symptom-scale scores, with validated scores taking precedence over non validated ones. Secondary outcomes included changes in nocturia and urodynamic measures. The main outcome measure for harms was the number of men reporting side effects.

Main results

In a meta-analysis of two high quality long-term trials (n = 582), Serenoa repens therapy was not superior to placebo in reducing LUTS based on the AUA (mean difference (MD) 0.25 points, 95% confidence interval (CI) -0.58 to 1.07). A 72 week trial with high quality evidence, using the American Urological Association Symptom Score Index, reported that SR was not superior to placebo at double and triple doses. In the same trial the proportions of clinical responders (≥ three-point improvement) were nearly identical (42.6% and 44.2% for SR and placebo, respectively), and not significant (RR 0.96, 95% CI 0.76 to 1.22).This update, which did not change our previous conclusions, included two new trials with 444 additional men, an 8.5% (5666/5222) increase from our 2009 updated review, and a 28.8% (1988/1544) increase for our main comparison, SR monotherapy versus placebo control (17 trials). Overall, 5666 men were assessed from 32 randomized, controlled trials, with trial lengths from four to 72 weeks. Twenty-seven trials were double blinded and treatment allocation concealment was adequate in 14.In a trial of high quality evidence (N = 369), versus placebo, SR did not significantly decrease nightly urination on the AUA Nocturia scale (range zero to five) at 72 weeks follow-up (one-sided P = 0.19).The three high quality, moderate-to-long term trials found peak urine flow was not improved with Serenoa repens compared with placebo (MD 0.40 mL/s, 95% CI -0.30 to 1.09).Comparing prostate size (mean change from baseline), one high quality 12-month trial (N = 225) reported no significant difference between SR and placebo (MD -1.22 cc, 95% CI -3.91 to 1.47).

Authors' conclusions

Serenoa repens, at double and triple doses, did not improve urinary flow measures or prostate size in men with lower urinary tract symptoms consistent with BPH.

Research Insights

  • Saw Palmetto→Increased Clinical Response

    the proportions of clinical responders (≥ three-point improvement) were nearly identical (42.6% and 44.2% for SR and placebo, respectively), and not significant (RR 0.96, 95% CI 0.76 to 1.22).

    Effect
    Neutral
    Effect size
    Small
    Dose
    double and triple doses
  • Saw Palmetto→Increased Peak Urine Flow

    peak urine flow was not improved with Serenoa repens compared with placebo (MD 0.40 mL/s, 95% CI -0.30 to 1.09).

    Effect
    Neutral
    Effect size
    Small
    Dose
    not specified for this outcome (three high quality trials)
  • Saw Palmetto→Reduced Lower Urinary Tract Symptom

    Serenoa repens therapy was not superior to placebo in reducing LUTS based on the AUA (mean difference (MD) 0.25 points, 95% confidence interval (CI) -0.58 to 1.07).

    Effect
    Neutral
    Effect size
    Small
    Dose
    double and triple doses
  • Saw Palmetto→Reduced Nocturia

    versus placebo, SR did not significantly decrease nightly urination on the AUA Nocturia scale (range zero to five) at 72 weeks follow-up (one-sided P = 0.19).

    Effect
    Neutral
    Effect size
    Small
    Dose
    not specified for this outcome (trial with 369 men)
  • Saw Palmetto→Reduced Prostate Size

    no significant difference between SR and placebo (MD -1.22 cc, 95% CI -3.91 to 1.47).

    Effect
    Neutral
    Effect size
    Small
    Dose
    not specified for this outcome (one high quality 12-month trial)

Adverse Events Reported

  • Saw Palmetto→Overall tolerability

    No significant difference between SR and placebo (MD -1.22 cc, 95% CI -3.91 to 1.47) for prostate size; harms outcome not specifically quantified.

    Finding
    No significant difference
  • Saw Palmetto→adverse events (general)

    The main outcome measure for harms was the number of men reporting side effects.

    Finding
    Reported
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