Swp8.0

Saw Palmetto Research

39 peer-reviewed studies · Evidence score: 8/10

Saw palmetto for BPH: A Cochrane review

Tacklind J et al. • Cochrane Database of Systematic Reviews (2012)

Saw palmetto was not superior to placebo for BPH symptoms.

Not superior to placebo in recent trials
Older studies showed benefit
Safe and well-tolerated

Systematic Reviewn=5,000

DOI

Clinical Efficacy of Serenoa repens Versus Placebo Versus Alpha-blockers for the Treatment of Lower Urinary Tract Symptoms/Benign Prostatic Enlargement: A Systematic Review and Network Meta-analysis of Randomized Placebo-controlled Clinical Trials

Russo GI et al. • European urology focus (2021)

In this network meta-analysis, we demonstrated that SeR did not show clinically meaningful improvement in LUTS and PF.

In this network meta-analysis, we demonstrated that SeR did not show clinically meaningful improvement in LUTS and PF.
Further research warranted to confirm findings

Meta-Analysisn=8,564

DOI

Serenoa repens (saw palmetto) for lower urinary tract symptoms/benign prostatic hyperplasia: A systematic review and meta-analysis of randomized controlled trials

Vela-Navarrete R et al. • BJU International (2018)

Saw palmetto extract significantly improved urinary flow rate and nocturia compared to placebo in men with BPH.

Significant improvement in maximum urinary flow rate vs placebo
Reduced nocturia frequency compared to placebo
Hexanic lipidosterolic extract (Permixon) showed most consistent results

Meta-Analysisn=5,222

DOI

Pathophysiology, conventional treatments, and evidence-based herbal remedies of hair loss with a systematic review of controlled clinical trials

Allam AT et al. • Naunyn-Schmiedeberg's archives of pharmacology (2025)

This systematic-review examined the effects of Saw Palmetto.

However, study design limitations and outcome variability necessitate further rigorous, standardized research.
This review aims to offer an integrative, evidence-informed perspective on the therapeutic potential of herbal medicine for hair loss in clinical evidence.
Further research warranted to confirm findings

Systematic Review

DOI

Benign prostatic hyperplasia and male lower urinary tract symptoms (LUTS)

McNicholas T et al. • BMJ clinical evidence (2011)

We performed a GRADE evaluation of the quality of evidence for interventions.

Systematic review examining Beta-Sitosterol efficacy
Further research warranted to confirm findings

Systematic Review

DOI

Concurrent Use of Prescription Drugs and Herbal Medicinal Products in Older Adults: A Systematic Review

Agbabiaka TB et al. • Drugs & aging (2017)

The prevalence of concurrent prescription drugs and HMP use among older adults is substantial and potential interactions have been reported.

Prevalence of concurrent use by older adults varied widely between 5.3 and 88.3%.
The prevalence of concurrent prescription drugs and HMP use among older adults is substantial and potential interactions have been reported.
Knowledge of the extent and manner in which older adults combine prescription drugs will aid healthcare professionals in appropriately identifying and managing patients at risk.

Systematic Review

DOI

Benign prostate hyperplasia and nutrition

Das K et al. • Clinical nutrition ESPEN (2019)

Lifestyle changes, diet modification and certain nutritional supplements can favorably influence BPH symptoms.

Lifestyle changes, diet modification and certain nutritional supplements can favorably influence BPH symptoms.
Further research warranted to confirm findings

Systematic Review

DOI

Serenoa repens for benign prostatic hyperplasia

Tacklind J et al. • The Cochrane database of systematic reviews (2009)

Serenoa repens was not more effective than placebo for treatment of urinary symptoms consistent with BPH.

In this update 9 new trials involving 2053 additional men (a 64.8% increase) have been included.
A sensitivity analysis, utilizing higher quality, larger trials (>/= 40 subjects), demonstrated no significant difference (WMD -0.31 nocturnal visits, 95% CI -0.70 to 0.08, P > 0.05; 5 trials) (I(2) = 11%).
Serenoa repens was not more effective than placebo for treatment of urinary symptoms consistent with BPH.

Meta-Analysisn=419

DOI

Interactions between herbal medicines and prescribed drugs: an updated systematic review

Izzo AA et al. • Drugs (2009)

While the significance of many interactions is uncertain, several interactions, particularly those with St John's wort, may have serious clinical consequences.

Echinacea might affect the clearance of caffeine (a CYP1A2 probe) and midazolam (a CYP3A4 probe).
No interactions have been reported for saw palmetto (Serenoa repens).
Numerous interactions between herbal medicines and conventional drugs have been documented.

Systematic Review

DOI

Serenoa repens (saw palmetto): a systematic review of adverse events

Agbabiaka TB et al. • Drug safety (2009)

However, higher quality reporting of adverse events is essential if safety assessments are to be improved in future.

Currently available data suggest that S. repens is well tolerated by most users and is not associated with serious adverse events.
The majority of adverse events are mild, infrequent and reversible, and include abdominal pain, diarrhoea, nausea and fatigue, headache, decreased libido and rhinitis.
We found no evidence for drug interactions with S. repens.

Systematic Reviewn=26

DOI

Evidence-based systematic review of saw palmetto by the Natural Standard Research Collaboration

Ulbricht C et al. • Journal of the Society for Integrative Oncology (2006)

Here presented is an evidence-based systematic review including written and statistical analysis of scientific literature, expert opinion, folkloric precedent, history, pharmacology, kinetics/dynamics, interactions, adverse effects, toxicology, and dosing.

Here presented is an evidence-based systematic review including written and statistical analysis of scientific literature, expert opinion, folkloric precedent, history, pharmacology, kinetics/dynamics, interactions, adverse effects, toxicology, and dosing.
Further research warranted to confirm findings

Systematic Review

DOI

Beneficial Effects of Saw Palmetto Fruit Extract on Urinary Symptoms in Japanese Female Subjects by a Multicenter, Randomized, Double-Blind, Placebo-Controlled Study

Yamada S et al. • Nutrients (2022)

In conclusion, the present study is the first to demonstrate the potential of SPE to mitigate LUTS in adult women.

The daytime frequency of urination in overactive bladder symptom score (OABSS) Q1 was also significantly improved by the SPE treatment.
A subgroup analysis revealed that SPE alleviated the symptoms of daytime frequency (CLSS Q1) and nocturia (CLSS Q2) in a subset of subjects with a CLSS Q5 score of 1 or higher.
In conclusion, the present study is the first to demonstrate the potential of SPE to mitigate LUTS in adult women.

RCTn=76

DOI

Efficacy and safety of a hexanic lipidosterolic extract of Serenoa repens (Permixon) in the treatment of lower urinary tract symptoms: PERMPRO study

Alcaraz A et al. • European Urology Focus (2021)

Permixon (320 mg/day) was non-inferior to tamsulosin for LUTS/BPH treatment with a superior safety profile.

Non-inferior to tamsulosin in IPSS score improvement
Superior ejaculatory function preservation vs tamsulosin
Significantly fewer sexual side effects than alpha-blocker comparator

RCTn=1,026

DOI

Beneficial effects of saw palmetto (Serenoa repens) fruit extract on the urinary symptoms of healthy Japanese adults with possible lower urinary tract symptoms: A randomized, double-blind, placebo-controlled study

Kimura M et al. • Nutrition and health (2025)

The consumption of SPE improved urinary frequency-related quality of life such as bother of urinary symptoms in healthy Japanese adults (UMIN000045334).

After SPE intervention for 12 weeks, the score of symptom bother by frequent urination during the daytime hours was significantly improved and the daytime frequency of urination assessed using the urinary log was significantly decreased.
The other outcomes were subjective urinary symptoms and urinary frequencies.
The final efficacy analysis dataset was per protocol set, and 33 participants in each group were analyzed.

RCTn=34

DOI

Treatment assignment guesses by study participants in a double-blind dose escalation clinical trial of saw palmetto

Lee JY et al. • Journal of alternative and complementary medicine (New York, N.Y.) (2014)

Blinding of treatment assignment was successful in this study.

For participants assigned to saw palmetto, 22.5%, 24.7%, and 29.8% correctly thought they were taking saw palmetto, and 37.3%, 40.0%, and 44.4% incorrectly thought they were on placebo at 24, 48, and 72 weeks, respectively.
For placebo participants, 21.8%, 27.4%, and 25.2% incorrectly thought they were on saw palmetto, and 41.6%, 39.9%, and 42.6% correctly thought they were on placebo at 24, 48, and 72 weeks, respectively.
The treatment arms did not vary with respect to the distributions of participants who guessed they were on saw palmetto (p=0.823) or placebo (p=0.893).

RCTn=151

DOI

Fixed-dose combination PRO 160/120 of sabal and urtica extracts improves nocturia in men with LUTS suggestive of BPH: re-evaluation of four controlled clinical studies

Oelke M et al. • World journal of urology (2014)

PRO 160/120 significantly improved nocturnal voiding frequency compared to placebo and similar to tamsulosin or finasteride.

In the pooled analysis of placebo-controlled trials, nocturnal voids improved by 0.8 (29 %) with PRO 160/120 compared to 0.6 (18 %) with placebo (p = 0.015, Wilcoxon test, one-tailed).
The 69 % responder rate to PRO 160/120 was significantly superior to the placebo response (52 %; p = 0.003, χ (2)-test, two-tailed).
PRO 160/120 significantly improved nocturnal voiding frequency compared to placebo and similar to tamsulosin or finasteride.

RCTn=922

DOI

The Safety and Efficacy of a Novel Saw Palmetto (Serenoa repens) Extract for Promoting Hair Growth in Adults With Self-Perceived Thinning Hair: 180-Day Results

Ablon G • Journal of cosmetic dermatology (2026)

The daily use of a proprietary saw palmetto (Serenoa repens) extract safely and effectively promotes hair growth in men and women with self-perceived thinning hair.

Mean (SD) change in baseline total terminal hair count was +18.6 (29.6) with active vs. -10.1 (30.5) with placebo (p < 0.001; 283% greater improvement).
Total vellus hair count increased +6.6 (15.6) vs. -2.1 (15.7) (p < 0.05; 414% greater improvement).
Total hair density rose +25.1 (27.7) vs. -12.2 (38.8) (p < 0.001; 306% greater improvement).

RCTn=60

DOI

Measuring the efficacy of Serenoa repens (USPlus) extract with mobile uroflowmetry

Winograd J et al. • The Canadian journal of urology (2024)

Our findings support the efficacy of USP-verified Saw Palmetto extract in alleviating LUTS in men with BPH.

Results from 46 patients using 320 mg daily of USP-verified Saw Palmetto extract revealed significant improvements in IPSS and QoL scores at 12 weeks compared to baseline, particularly in patients with moderate symptoms.
Our findings support the efficacy of USP-verified Saw Palmetto extract in alleviating LUTS in men with BPH.
Further studies are warranted in larger, diverse cohorts over longer follow up periods.

RCTn=46

A double blind, placebo-controlled randomized comparative study on the efficacy of phytosterol-enriched and conventional saw palmetto oil in mitigating benign prostate hyperplasia and androgen deficiency

Sudeep HV et al. • BMC urology (2020)

This study demonstrates the efficacy of β-sitosterol enriched saw palmetto oil superior to conventional oil thus extending the scope of effective BPH and androgen deficiency treatment with improved quality of life through the intake of functional ingredients.

This study demonstrates the efficacy of β-sitosterol enriched saw palmetto oil superior to conventional oil thus extending the scope of effective BPH and androgen deficiency treatment with improved quality of life through the intake of functional ingredients.
Further research warranted to confirm findings

RCTn=99

DOI

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

Barry MJ et al. • JAMA (2011)

Increasing doses of a saw palmetto fruit extract did not reduce lower urinary tract symptoms more than placebo.

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).
Increasing doses of a saw palmetto fruit extract did not reduce lower urinary tract symptoms more than placebo.

RCTn=369

DOI

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