Serenoa Repens Monotherapy For Benign Prostatic Hyperplasia (BPH): An Updated Cochrane Systematic Review

Effect None
Values Weighted mean difference versus placebo was insignificant (-0.16 for IPSS/AUASI scores, 0.40 mL/s for maximum urinary flow rates) for medium- and long-term trials
Trial Design Meta analysis
Trial Length n/a
Number of Subjects 2008
Gender Male
Age Range 45-64, 65+
Notes for this study:
17 randomized trials of saw palmetto monotherapy in mostly white men with BPH were examined with study lengths ranging from 4-72 weeks. Saw palmetto was found to be no better than placebo for reducing lower urinary tract symptoms or maximum urinary flow rate. A long-term study found no effect on nighttime urination frequency, but pooling shorter-term studies found a reduction in frequency of 0.79 times per night on average, although the studies were heterogeneous. Adverse events were not statistically different from placebo.
Funding issues for this study:
None

Saw Palmetto For Benign Prostatic Hyperplasia

Effect None
Values AUASI score difference between saw palmetto and placebo: 0.04 points; 95%CI, -0.93-1.01. Maximal urinary flow rate difference: 0.43mL/min, 95% CI -0.52-1.38.
Trial Design Randomized trial
Trial Length 6+ Months
Number of Subjects 225
Gender Male
Age Range 45-64, 65+
Notes for this study:
320mg daily saw palmetto extract in patients with moderate to severe BPH saw no statistically significant change in AUASI scores, peak urinary flow rate, or secondary measures after 12 months of treatment. Side effects between placebo and saw palmetto were similar.
Funding issues for this study:
None

Serenoa Repens Extract For Benign Prostate Hyperplasia: A Randomized Controlled Trial

Effect None
Trial Design Randomized trial
Trial Length 1-6 months
Number of Subjects 100
Gender Male
Age Range 45-64, 65+
Notes for this study:
No significant differences in flow rates or IPSS score dosing with 320mg of saw palmetto over 12 weeks.

Randomized, Double-blind, Placebo-controlled Trial Of Saw Palmetto In Men With Lower Urinary Tract Symptoms

Effect Decrease
Values IPSS scores decreased from 16.7 to 12.3 in the saw palmetto group compared with a decrease of 15.8 to 13.6 in placebo; a statistically significant effect.
Trial Design Randomized trial
Trial Length 1-6 months
Number of Subjects 85
Gender Male
Age Range 45-64, 65+
Notes for this study:
A statistically significant effect on IPSS score versus placebo.

Improving BPH Symptoms And Sexual Dysfunctions With A Saw Palmetto Preparation? Results From A Pilot Trial

Effect Decrease
Values IPSS score from 14.4  +/- 4.7 to 6.9 +/- 5.2 after 8 weeks
Trial Design Non-controlled trial
Trial Length 1-6 months
Number of Subjects 82
Gender Male
Age Range 30-44, 45-64, 65+
Notes for this study:
82 men received 320 saw palmetto extract daily for 8 weeks. International Prostate Symptom Score (IPSS) decreased from 14.4 ± 4.7 to 6.9 ± 5.2 over this time period, SDys score measured using the brief Sexual Function Inventory improved from 22.4  to 31.4, and Urolife BPH QoL-9 score improved from 137.3 to 195.0 over this time period, with all these results being statistically significant. This was an open-label, uncontrolled trial, however.
Funding issues for this study:
The specific brand of saw palmetto used, Prostasan, was manufactured by the funder of the study, and the lead author is an employee of the manufacturer.

Observational Database Serenoa Repens (DOSSER): Overview, Analysis And Results. A Multicentric SIUrO (Italian Society Of Oncological Urology) Project

Effect Decrease
Trial Design Cohort
Trial Length 1-6 months
Number of Subjects 226
Gender Male
Age Range 45-64, 65+
Notes for this study:
In a retrospective analysis of subjects with benign prostatic hyperplasia using saw palmetto (320mg of a lipidosterolic extract) either alone or with an alpha-blocker noted that both groups experienced benefits to PSA concentrations (decrease) and urinary complications (urinary flow and void) with no noticeable affect on their sex lives as assessed by IIEF-5.

Effect Of Increasing Doses Of Saw Palmetto Extract On Lower Urinary Tract Symptoms: A Randomized Trial

Effect None
Values AUASI score dropped -2.20 points in the saw palmetto group and -2.99 points in the placebo group. The 1-sided p-value was not significant.
Trial Design Randomized trial
Trial Length 6+ Months
Number of Subjects 369
Gender Male
Age Range 45-64, 65+
Notes for this study:
Men over 45 years of age with AUA symptom score between 8 and 24 were randomly assigned to placebo or escalating doses of saw palmetto, which consisted of 320mg for first 24 weeks, 640mg for next 24 weeks, and 960mg for the final 24 weeks, for a total of 72 weeks. Serum PSA levels were measured with no difference between the saw palmetto group and placebo at any of the time points. Mean AUASI score decreased significantly over the course of the study in both placebo and saw palmetto groups (14.42 to 12.22 for saw palmetto, 14.69 to 11.70 for placebo), with no statistically significant difference between them. Many additional secondary measure were taken, including AUASI QoL, objective and subjective urinary flow measures, and sexual function measures. All were not significantly different between placebo and saw palmetto.
Funding issues for this study:
Manufacturer donated saw palmetto and matching placebo, but had no role in funding or design otherwise