Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Meta-Analysis
. 2009 Apr 15:(2):CD001423.
doi: 10.1002/14651858.CD001423.pub2.

Serenoa repens for benign prostatic hyperplasia

James Tacklind  1 , Roderick MacDonald, Indy Rutks, Timothy J Wilt
Affiliations
Meta-Analysis

Serenoa repens for benign prostatic hyperplasia

James Tacklind et al. Cochrane Database Syst Rev. .

Update in

Abstract

Background: Benign prostatic hyperplasia (BPH), a nonmalignant enlargement of the prostate, 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 (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 of Serenoa repens in the treatment of LUTS consistent with BPH.

Search strategy: Trials were searched in computerized general and specialized databases (MEDLINE, EMBASE, and The Cochrane Library), by checking bibliographies, and by handsearching the relevant literature.

Selection criteria: Trials were eligible if they (1) randomized men with symptomatic BPH to receive preparations of Serenoa repens (alone or in combination) for at least four weeks in comparison with placebo or other interventions, and (2) included clinical outcomes such as urologic symptom scales, symptoms, and urodynamic measurements. Eligibility was assessed by at least two independent observers.

Data collection and analysis: Information on patients, interventions, and outcomes was extracted by at least two independent reviewers using a standard form. The main outcome measure for comparing the effectiveness of Serenoa repens with placebo or other interventions was the change in urologic symptom-scale scores. Secondary outcomes included changes in nocturia and urodynamic measures. The main outcome measure for side effects or adverse events was the number of men reporting side effects.

Main results: In this update 9 new trials involving 2053 additional men (a 64.8% increase) have been included. For the main comparison - Serenoa repens versus placebo - 3 trials were added with 419 subjects and 3 endpoints (IPSS, peak urine flow, prostate size). Overall, 5222 subjects from 30 randomized trials lasting from 4 to 60 weeks were assessed. Twenty-six trials were double blinded and treatment allocation concealment was adequate in eighteen studies.Serenoa repens was not superior to placebo in improving IPSS urinary symptom scores, (WMD (weighted mean difference) -0.77 points, 95% CI -2.88 to 1.34, P > 0.05; 2 trials), finasteride (MD (mean difference) 0.40 points, 95% CI -0.57 to 1.37, P > 0.05; 1 trial), or tamsulosin (WMD -0.52 points, 95% CI -1.91 to 0.88, P > 0.05; 2 trials).For nocturia, Serenoa repens was significantly better than placebo (WMD -0.78 nocturnal visits, 95% CI -1.34 to -0.22, P < 0.05; 9 trials), but with the caveat of significant heterogeneity (I(2) = 66%). 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 superior to finasteride (MD -0.05 nocturnal visits, 95% CI -0.49 to 0.39, P > 0.05; 1 trial), or to tamsulosin (per cent improvement) (RR) (risk ratio) 0.91, 95% CI 0.66 to 1.27, P > 0.05; 1 trial).Comparing peak urine flow, Serenoa repens was not superior to placebo at trial endpoint (WMD 1.02 mL/s, 95% CI -0.14 to 2.19, P > 0.05; 10 trials), or by comparing mean change (WMD 0.31 mL/s, 95% CI -0.56 to 1.17, P > 0.05; 2 trials).Comparing prostate size at endpoint, there was no significant difference between Serenoa repens and placebo (MD -1.05 cc, 95% CI -8.84 to 6.75, P > 0.05; 2 trials), or by comparing mean change (MD -1.22 cc, 95% CI -3.91 to 1.47, P > 0.05; 1 trial).

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

PubMed Disclaimer

Conflict of interest statement

DECLARATIONS OF INTEREST

None.

Figures

Analysis 1.1
Analysis 1.1
Comparison 1 Serenoa repens versus placebo, Outcome 1 Symptom Score (points) at endpoint.
Analysis 1.2
Analysis 1.2
Comparison 1 Serenoa repens versus placebo, Outcome 2 IPSS total score WMD (0 to 35 (35 most severe)).
Analysis 1.3
Analysis 1.3
Comparison 1 Serenoa repens versus placebo, Outcome 3 Nocturia (times/evening) at endpoint.
Analysis 1.4
Analysis 1.4
Comparison 1 Serenoa repens versus placebo, Outcome 4 Peak urine flow (mL/s) at endpoint.
Analysis 1.5
Analysis 1.5
Comparison 1 Serenoa repens versus placebo, Outcome 5 Peak urine flow (mL/s) WMD.
Analysis 1.6
Analysis 1.6
Comparison 1 Serenoa repens versus placebo, Outcome 6 Patient self-rating for improved symptoms (# events “very good” and “good”).
Analysis 1.7
Analysis 1.7
Comparison 1 Serenoa repens versus placebo, Outcome 7 Physician-assessed improvement of symptoms.
Analysis 1.8
Analysis 1.8
Comparison 1 Serenoa repens versus placebo, Outcome 8 Prostate size (cc) at endpoint.
Analysis 1.9
Analysis 1.9
Comparison 1 Serenoa repens versus placebo, Outcome 9 Prostate size (cc) WMD.
Analysis 1.10
Analysis 1.10
Comparison 1 Serenoa repens versus placebo, Outcome 10 Study withdrawals.
Analysis 1.11
Analysis 1.11
Comparison 1 Serenoa repens versus placebo, Outcome 11 Any adverse events.
Analysis 2.1
Analysis 2.1
Comparison 2 Combination Cernitin®, Serenoa repens, B-sitosterol, and vitamin E versus placebo, Outcome 1 AUA total score WMD.
Analysis 2.2
Analysis 2.2
Comparison 2 Combination Cernitin®, Serenoa repens, B-sitosterol, and vitamin E versus placebo, Outcome 2 AUA nocturia WMD.
Analysis 2.3
Analysis 2.3
Comparison 2 Combination Cernitin®, Serenoa repens, B-sitosterol, and vitamin E versus placebo, Outcome 3 Peak urine flow (mL/s) at endpoint.
Analysis 2.4
Analysis 2.4
Comparison 2 Combination Cernitin®, Serenoa repens, B-sitosterol, and vitamin E versus placebo, Outcome 4 Adverse events.
Analysis 2.4
Analysis 2.4
Comparison 2 Combination Cernitin®, Serenoa repens, B-sitosterol, and vitamin E versus placebo, Outcome 4 Adverse events.
Analysis 2.5
Analysis 2.5
Comparison 2 Combination Cernitin®, Serenoa repens, B-sitosterol, and vitamin E versus placebo, Outcome 5 Study withdrawals.
Analysis 3.1
Analysis 3.1
Comparison 3 Serenoa repens/Urtica dioica (PRO 160/120) versus placebo, Outcome 1 IPSS total score at endpoint.
Analysis 3.2
Analysis 3.2
Comparison 3 Serenoa repens/Urtica dioica (PRO 160/120) versus placebo, Outcome 2 IPSS total score WMD.
Analysis 3.3
Analysis 3.3
Comparison 3 Serenoa repens/Urtica dioica (PRO 160/120) versus placebo, Outcome 3 Peak urine flow (mL/s) at endpoint.
Analysis 3.4
Analysis 3.4
Comparison 3 Serenoa repens/Urtica dioica (PRO 160/120) versus placebo, Outcome 4 Peak urine flow (mL/s) WMD.
Analysis 3.5
Analysis 3.5
Comparison 3 Serenoa repens/Urtica dioica (PRO 160/120) versus placebo, Outcome 5 Study withdrawals.
Analysis 3.6
Analysis 3.6
Comparison 3 Serenoa repens/Urtica dioica (PRO 160/120) versus placebo, Outcome 6 Patient self-rating for improved symptoms (# events “very good” and “good”).
Analysis 4.1
Analysis 4.1
Comparison 4 Serenoa repens (Permixon®) versus finasteride, Outcome 1 IPSS total score at endpoint.
Analysis 4.2
Analysis 4.2
Comparison 4 Serenoa repens (Permixon®) versus finasteride, Outcome 2 Nocturia (times/evening).
Analysis 4.3
Analysis 4.3
Comparison 4 Serenoa repens (Permixon®) versus finasteride, Outcome 3 Peak urine flow (mL/s) WMD.
Analysis 4.4
Analysis 4.4
Comparison 4 Serenoa repens (Permixon®) versus finasteride, Outcome 4 Prostate size (cc) at endpoint.
Analysis 4.5
Analysis 4.5
Comparison 4 Serenoa repens (Permixon®) versus finasteride, Outcome 5 Study withdrawals.
Analysis 5.1
Analysis 5.1
Comparison 5 Serenoa repens/Urtica dioica (PRO 160/120) versus finasteride, Outcome 1 IPSS total score at endpoint.
Analysis 5.2
Analysis 5.2
Comparison 5 Serenoa repens/Urtica dioica (PRO 160/120) versus finasteride, Outcome 2 Peak urine flow (mL/s) WMD.
Analysis 5.3
Analysis 5.3
Comparison 5 Serenoa repens/Urtica dioica (PRO 160/120) versus finasteride, Outcome 3 Study withdrawals.
Analysis 6.1
Analysis 6.1
Comparison 6 Serenoa repens versus Pygeum africanum, Outcome 1 Patient self-rating for improved symptoms (# events “very good” and “good”).
Analysis 6.2
Analysis 6.2
Comparison 6 Serenoa repens versus Pygeum africanum, Outcome 2 Nocturia (times/evening) at endpoint.
Analysis 7.1
Analysis 7.1
Comparison 7 Serenoa repens versus gestonorone caproate, Outcome 1 Peak urine flow (mL/s) at endpoint.
Analysis 8.1
Analysis 8.1
Comparison 8 Serenoa repens versus tamsulosin, Outcome 1 IPSS total score WMD.
Analysis 8.2
Analysis 8.2
Comparison 8 Serenoa repens versus tamsulosin, Outcome 2 Peak urine flow (mL/s) WMD.
Analysis 8.3
Analysis 8.3
Comparison 8 Serenoa repens versus tamsulosin, Outcome 3 Nocturia (% improvement).
Analysis 8.4
Analysis 8.4
Comparison 8 Serenoa repens versus tamsulosin, Outcome 4 Incomplete emptying (% improvement).
Analysis 8.5
Analysis 8.5
Comparison 8 Serenoa repens versus tamsulosin, Outcome 5 Prostate size (cc) WMD.
Analysis 8.6
Analysis 8.6
Comparison 8 Serenoa repens versus tamsulosin, Outcome 6 Study withdrawals.
Analysis 8.7
Analysis 8.7
Comparison 8 Serenoa repens versus tamsulosin, Outcome 7 Any adverse effects.
Analysis 9.1
Analysis 9.1
Comparison 9 Serenoa repens+Urtica dioica (PRO 160/120) versus tamsulosin, Outcome 1 Pts w/any efficacy data in the full analysis set who responded to treatment (defined as IPSS ≤ 7 at endpoint).
Analysis 9.2
Analysis 9.2
Comparison 9 Serenoa repens+Urtica dioica (PRO 160/120) versus tamsulosin, Outcome 2 Adverse events.
Analysis 9.3
Analysis 9.3
Comparison 9 Serenoa repens+Urtica dioica (PRO 160/120) versus tamsulosin, Outcome 3 Study withdrawals.
Analysis 10.1
Analysis 10.1
Comparison 10 Serenoa repens (Permixon®)+tamsulosin versus placebo+tamsulosin, Outcome 1 IPSS total score WMD.
Analysis 10.2
Analysis 10.2
Comparison 10 Serenoa repens (Permixon®)+tamsulosin versus placebo+tamsulosin, Outcome 2 Peak urine flow (mL/s) WMD.
Analysis 10.3
Analysis 10.3
Comparison 10 Serenoa repens (Permixon®)+tamsulosin versus placebo+tamsulosin, Outcome 3 Prostate size (cc) WMD.
Analysis 10.4
Analysis 10.4
Comparison 10 Serenoa repens (Permixon®)+tamsulosin versus placebo+tamsulosin, Outcome 4 Study withdrawals.
Analysis 10.5
Analysis 10.5
Comparison 10 Serenoa repens (Permixon®)+tamsulosin versus placebo+tamsulosin, Outcome 5 Any adverse events.
Analysis 11.1
Analysis 11.1
Comparison 11 Serenoa repens (Permixon®) versus Serenoa repens+tamsulosin, Outcome 1 IPSS total score WMD.
Analysis 11.2
Analysis 11.2
Comparison 11 Serenoa repens (Permixon®) versus Serenoa repens+tamsulosin, Outcome 2 Peak urine flow (mL/s) WMD.
Analysis 11.3
Analysis 11.3
Comparison 11 Serenoa repens (Permixon®) versus Serenoa repens+tamsulosin, Outcome 3 Prostate size (cc) WMD.
Analysis 11.4
Analysis 11.4
Comparison 11 Serenoa repens (Permixon®) versus Serenoa repens+tamsulosin, Outcome 4 Any adverse events.
Analysis 12.1
Analysis 12.1
Comparison 12 Prostataplex™ versus placebo, Outcome 1 Peak urine flow (mL/s) at endpoint.
Analysis 12.2
Analysis 12.2
Comparison 12 Prostataplex™ versus placebo, Outcome 2 Prostate size (cc) at endpoint.
Analysis 12.3
Analysis 12.3
Comparison 12 Prostataplex™ versus placebo, Outcome 3 Study withdrawals.
Figure 1
Figure 1
Forest plot of comparison: 1 Serenoa repens versus placebo, outcome: 1.4 Peak urine flow (mL/s) at endpoint.
See this image and copyright information in PMC

Update of

References

References to studies included in this review
    1. Bauer HW, Casarosa C, Cosci M, Fratta M, Blessmann G. Saw palmetto fruit extract for treatment of benign prostatic hyperplasia. Results of a placebo-controlled double-blind study [German] [Sabalfrucht–Extrakt zur Behandlung der benignen Prostatahyperplasie. Ergebnisse einer plazebokontrollierten Doppelblindstudie] MMW Fortschritte der Medizin. 1999;141(25):127–32. - PubMed
    1. Bent S, Kane C, Shinohara K, Neuhaus J, Hudes E, Goldberg H, Avins AL. Saw palmetto for benign prostatic hyperplasia. The New England Journal of Medicine. 2006;354(6):557–66. - PubMed
    1. Boccafoschi C, Annoscia S. [Confronto fra estratto di serenoa repens e placebo mediate prova clinica controllata in pazienti con adenomatosi prostatica] Urologia. 1983;50:1257–68.
    1. Braeckman J. A double-blind, placebo-controlled study of the plant extract Serenoa repens in the treatment of benign hyperplasia of the prostate. European Journal of Clinical Research. 1997;9:247–59.
    1. Carbin BE, Larsson B, Lindahl O. Treatment of benign prostatic hyperplasia with phytosterols. British Journal of Urology. 1990;66(6):639–41. [MEDLINE: 1991091633] - PubMed
References to studies excluded from this review
    1. Adriazola Semino M, Lozano Ortega JL, Garcia Cobo E, Tejeda Banez E, Romero Rodriguez F. Symptomatic treatment of benign hypertrophy of the prostate. Comparative study of prazosin and serenoa repens [Tratamiento sintomatico de la hipertrofia benigna de prostata. Estudio comparativo entre prazosin y Serenoa repens] Archivos Espanoles de Urologia. 1992;45(3):211–3. [MEDLINE: 1993037631] - PubMed
    1. Comar OB, Di Rienzo A. Mepartricin versus Serenoa repens: double-blind study in 20 cases of benign prostate hypertrophy. Rivista Italiana di Biologia e Medicina. 1986;6(2):122–5.
    1. Di Siverio F, D’Eramo G, Lubrano C, Flammia GP, Sciarra A, Palma E, Caponera M, Sciarra F. Evidence that Serenoa repens extract displays an antiestrogenic activity in prostatic tissue of benign prostatic hypertrophy patients. European Urology. 1992;21(4):309–14. [MEDLINE: 1993093014] - PubMed
    1. Gerber GS, Zagaja GP, Bales GT, Chodak GW, Contreras BA. Saw palmetto (Serenoa repens) in men with lower urinary tract symptoms: effects on urodynamic parameters and voiding symptoms. Urology. 1998;51(6):1003–7. - PubMed
    1. Grasso M, Montesano A, Buonaguidi A, Castelli M, Lania C, Rigatti P, Rocco F, Cesana BM, Borghi C. Comparative effects of alfuzosin versus Serenoa repens in the treatment of symptomatic benign prostatic hyperplasia. Archivos Españoles de Urología. 1995;48(1):97–103. [MEDLINE: 1995251418] - PubMed
Additional references
    1. Abrams PH, Griffiths DJ. The assessment of prostatic obstruction from urodynamic measurements and from residual urine. British Journal of Urology. 1979;51(2):129–34. - PubMed
    1. Bales G, Christiano AP, Kirsh E, Gerber GS. Phytotherapeutic agents in the treatment of lower urinary tract symptoms: a demographic analysis of awareness and use at the University of Chicago. Urology. 1999;54:86–9. - PubMed
    1. Barnes PM, Powell-Griner E, McFann K, Nahin RL. Complementary and alternative medicine use among adults: United States, 2002. Advance data from vital and health statistics of the National Center for Health Statistics. 2004;27(343):1–19. - PubMed
    1. Berry SL, Coffey DS, Walsh PC, Ewing LL. The development of human benign prostatic hyperplasia with age. The Journal of Urology. 1984;132:474–9. [MEDLINE: 1984292487] - PubMed
    1. Boyle P, Robertson C, Lowe F, Roehrborn C. Updated meta-analysis of clinical trials of Serenoa repens extract in the treatment of symptomatic benign prostatic hyperplasia. BJU International. 2004;93(6):751–6. - PubMed
References to other published versions of this review
    1. Wilt TJ, Ishani A, Stark G, Mac Donald R, Lau J, Mulrow C. Saw palmetto extracts for treatment of benign prostatic hyperplasia: a systematic review. Journal of the American Medical Association. 1998;280(18):1604–9. - PubMed
    1. Wilt T, Ishani A, Mac Donald R. Serenoa repens for benign prostatic hyperplasia. Cochrane Database of Systematic Reviews. 2002;(3) doi: 10.1002/14651858.CD001423. - DOI - PubMed
References

    1. Saw Palmetto Fruit. Sabalis serrulatae fructus. European Pharmacopoeia. Council of Europe.

    1. Saw palmetto. USP, United States Pharmacopeia.

    1. Guideline on declaration of herbal substances and herbal preparations in herbal medicinal products/traditional herbal medicinal products in the SPC (Summary of product characteristics). EMEA adopted guideline. London, 26 July 2007 Doc. Ref: EMEA/HMPC/CHMP/CVMP/287539/2005

    1. Reflection papers on markers used for quantitative and qualitative analyses of herbal medicinal products and traditional herbal medicinal products. EMEA adopted guideline. London, 15 July 2008. Doc. Ref. EMEA/HMPC/253629/2007

    1. Gaedcke F, Steinhoff B. Herbal medicinal products. Scientific and regulatory basis for development, quality assurance and marketing authorisation. CRC Press; Boca Raton: 2003.