Saw Palmetto and Reduced Lower Urinary Tract Symptom

Research synthesisLow evidenceSmall effect3 studies · 1 beneficial · 2 neutral · 0 harmful

Across 3 studies (1 systematic review, 1 meta-analysis, 1 RCT) on saw palmetto for reducing lower urinary tract symptoms in men with BPH, 2 found no benefit (neutral, small effect) while 1 reported a beneficial small effect. The median study duration was 168 days. Most evidence comes from studies using 320-960 mg/day doses in clinical populations.

Effective dose range: 320-960 mg/day
Studied populations: men with symptomatic benign prostatic hyperplasia (BPH)

Caveats: Evidence base is small (only 3 studies) — conclusions should be considered preliminary. Many of the included studies did not reach statistical significance — effect may be smaller than the predominant direction suggests.

Generated Jul 15, 2026

Doses used in studies

mg/day: 320–960 (median 560, IQR 400–800) — 2 studies

Time to effect

Median: 5.6 months · IQR 5.6 months–5.6 months · Range 5.6 months–5.6 months — Reported in 1 of 3 studies

Safety in these studies

Overall tolerabilityNo significant difference
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.
from: Serenoa repens for benign prostatic hyperplasia.
adverse eventsNo significant difference
Adverse events of Serenoa repens extracts were few and mild, and incidences were not statistically significantly different vs placebo.
from: Serenoa repens monotherapy for benign prostatic hyperplasia (BPH): an updated Cochrane sys
Overall tolerabilityReported
Adverse events were generally mild and comparable to placebo.
from: Serenoa repens monotherapy for benign prostatic hyperplasia (BPH): an updated Cochrane sys
adverse events (general)Reported
The main outcome measure for harms was the number of men reporting side effects.
from: Serenoa repens for benign prostatic hyperplasia.

3 of 3 papers

Serenoa repens monotherapy for benign prostatic hyperplasia (BPH): an updated Cochrane systematic review.
- 2012-05-02
- Systematic Review · n = 2,008
- BJU international 109(12)
- - Roderick MacDonald
  - James W Tacklind
  - Indulis Rutks
  - Timothy J Wilt
- PubMed: 22551330
- DOI: 10.1111/j.1464-410x.2012.11172.x
4 Insights on
- Reduced Lower Urinary Tract Symptom
- High evidence
- Clinical
Serenoa repens therapy was no better than placebo in reducing LUTS based on the AUASI/IPSS (weighted mean difference [WMD]-0.16 points, 95% confidence interval [CI]-1.45 to 1.14)
Effect
Neutral
Effect size
Small
Significant
No
Dose
320 mg/day
Serenoa repens for benign prostatic hyperplasia.
- 2012-12-12
- Meta-Analysis · n = 5,666
- The Cochrane database of systematic reviews 12
- - James Tacklind
  - Roderick Macdonald
  - Indy Rutks
  - Judith U Stanke
  - Timothy J Wilt
- PubMed: 23235581
- DOI: 10.1002/14651858.cd001423.pub3
5 Insights on
- Reduced Lower Urinary Tract Symptom
- High evidence
- Clinical
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
Significant
No
Dose
double and triple doses
Long-term efficacy and safety of a combination of sabal and urtica extract for lower urinary tract symptoms--a placebo-controlled, double-blind, multicenter trial.
- 2005-06-01
- RCT · n = 257
- World journal of urology 23(2)
- - N Lopatkin
  - A Sivkov
  - C Walther
  - S Schläfke
  - A Medvedev
  - J Avdeichuk
  - G Golubev
  - K Melnik
  - N Elenberger
  - U Engelmann
- PubMed: 15928959
- DOI: 10.1007/s00345-005-0501-9
1 Insight on
- Reduced Lower Urinary Tract Symptom
- High evidence
- Large Human Trial
- Clinical
Patients randomized to placebo showed a marked improvement in LUTS (as measured by the I-PSS) after being switched to PRO 160/120 during the control period (P=0.01, one tailed, in comparison to those who had been treated with PRO 160/120 in the double-blind phase).
Effect
Beneficial
Effect size
Small
Significant
Yes
Dose
320 mg/day

Saw Palmetto and Reduced Lower Urinary Tract Symptom

Serenoa repens monotherapy for benign prostatic hyperplasia (BPH): an updated Cochrane systematic review.

Serenoa repens for benign prostatic hyperplasia.

Long-term efficacy and safety of a combination of sabal and urtica extract for lower urinary tract symptoms--a placebo-controlled, double-blind, multicenter trial.