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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.
Eur Urol Focus. 2020 Jan 15 [Online ahead of print]EU

Abstract

CONTEXT

International guidelines do not make any specific recommendations on Serenoa repens (SeR) for the treatment of male lower urinary tract symptoms (LUTS) secondary to benign prostatic enlargement (BPE), due to product heterogeneity and methodological limitations of the published trials and meta-analyses.

OBJECTIVE

We aimed to compare the clinical efficacy of hexanic extract of SeR (HESr) versus non-HESr (nHESr) versus placebo versus alpha-blockers (ABs) in patients affected by LUTS secondary to BPE through a network meta-analysis method.

EVIDENCE ACQUISITION

The search was conducted until December 31, 2018 using Medline, Scopus, and Web of Science databases without restriction. We included randomized controlled trials (RCTs) with at least one comparison between SeR, ABs, or placebo for the treatment of LUTS/BPE. Outcomes of the study were the mean change in the International Prostate Symptom Score (IPSS) and peak flow (PF). This systematic review has been registered on PROSPERO (CRD42018084360).

EVIDENCE SYNTHESIS

In total, 2115 articles were identified. After the global assessment, 22 RCTs matched with the inclusion criteria, including 8564 patients. For IPSS, the mean efficacies against placebo were +0.48 and -1.69 for HESr and nHESr, respectively, at 3 mo; 0.59 for nHESr at 6 mo; and -1.31 and -3.30 for nHESr and HESr, respectively, at 12 mo. For PF, the mean efficacies against placebo were +0.53 and +2.82 for HESr and nHESr, respectively, at 3 mo; +1.85 for nHESr at 6 mo; and +4.05 and +5.52 for HESr and nHESr, respectively, at 12 mo. Based on the surface under the cumulative ranking curve rankograms, terazosin showed the highest score (99.6%), while alfuzosin, tamsulosin, silodosin, HESr, and nHESr showed scores of 53.7%, 42.3%, 68.5%, 36.7%, and 47.3%, respectively.

CONCLUSIONS

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

PATIENT SUMMARY

In the present study, we found no clinically meaningful improvement of Serenoa repens for the treatment of lower urinary tract symptoms/benign prostatic enlargement. The analysis showed that the benefit over placebo was minimal and may not justify its clinical use before higher level of evidence will be available.

Authors+Show Affiliations

Urology Section, University of Catania, Catania, Italy. Electronic address: giorgioivan1987@gmail.com.Urology Section, University of Catania, Catania, Italy.Urology Section, University of Catania, Catania, Italy.USC Institute of Urology, University of Southern California, Los Angeles, CA, USA.Department of Urology, University Hospitals Leuven, Leuven, Belgium.Department of Urology, Martha-Maria Hospital Nuremberg, Nuremberg, Germany.Department of Urology, Herlev and Gentofte Hospital, Herlev, Denmark.Division of Experimental Oncology/Unit of Urology, Urological Research Institute, IRCCS Ospedale San Raffaele, Milan, Italy.Urology Section, University of Catania, Catania, Italy.Department of Urology, Maastricht University Medical Center, Maastricht, The Netherlands.Department of Urology, Rouen University Hospital, Rouen Cedex, France.Department of Urology, University of Florence, Florence, Italy.Department of Urology, University of Florence, Florence, Italy.Department of Urology, University of Florence, Florence, Italy.No affiliation info available

Pub Type(s)

Journal Article
Review

Language

eng

PubMed ID

31952967

Citation

Russo, Giorgio Ivan, et al. "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." European Urology Focus, 2020.
Russo GI, Scandura C, Di Mauro M, et al. 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. Eur Urol Focus. 2020.
Russo, G. I., Scandura, C., Di Mauro, M., Cacciamani, G., Albersen, M., Hatzichristodoulou, G., Fode, M., Capogrosso, P., Cimino, S., Marcelissen, T., Cornu, J. N., Gacci, M., Minervini, A., & Cocci, A. (2020). 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. European Urology Focus. https://doi.org/10.1016/j.euf.2020.01.002
Russo GI, et al. 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. Eur Urol Focus. 2020 Jan 15; PubMed PMID: 31952967.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Russo,Giorgio Ivan, AU - Scandura,Carmen, AU - Di Mauro,Marina, AU - Cacciamani,Giovanni, AU - Albersen,Maarten, AU - Hatzichristodoulou,Georgios, AU - Fode,Mikkel, AU - Capogrosso,Paolo, AU - Cimino,Sebastiano, AU - Marcelissen,Tom, AU - Cornu,Jean Nicolas, AU - Gacci,Mauro, AU - Minervini,Andrea, AU - Cocci,Andrea, AU - ,, Y1 - 2020/01/15/ PY - 2019/12/04/received PY - 2019/12/26/revised PY - 2020/01/07/accepted PY - 2020/1/19/entrez KW - Benign prostatic hyperplasia KW - Lower urinary tract symptoms KW - Medical therapy KW - Phytotherapy KW - Prostate KW - Saw palmetto JF - European urology focus JO - Eur Urol Focus N2 - CONTEXT: International guidelines do not make any specific recommendations on Serenoa repens (SeR) for the treatment of male lower urinary tract symptoms (LUTS) secondary to benign prostatic enlargement (BPE), due to product heterogeneity and methodological limitations of the published trials and meta-analyses. OBJECTIVE: We aimed to compare the clinical efficacy of hexanic extract of SeR (HESr) versus non-HESr (nHESr) versus placebo versus alpha-blockers (ABs) in patients affected by LUTS secondary to BPE through a network meta-analysis method. EVIDENCE ACQUISITION: The search was conducted until December 31, 2018 using Medline, Scopus, and Web of Science databases without restriction. We included randomized controlled trials (RCTs) with at least one comparison between SeR, ABs, or placebo for the treatment of LUTS/BPE. Outcomes of the study were the mean change in the International Prostate Symptom Score (IPSS) and peak flow (PF). This systematic review has been registered on PROSPERO (CRD42018084360). EVIDENCE SYNTHESIS: In total, 2115 articles were identified. After the global assessment, 22 RCTs matched with the inclusion criteria, including 8564 patients. For IPSS, the mean efficacies against placebo were +0.48 and -1.69 for HESr and nHESr, respectively, at 3 mo; 0.59 for nHESr at 6 mo; and -1.31 and -3.30 for nHESr and HESr, respectively, at 12 mo. For PF, the mean efficacies against placebo were +0.53 and +2.82 for HESr and nHESr, respectively, at 3 mo; +1.85 for nHESr at 6 mo; and +4.05 and +5.52 for HESr and nHESr, respectively, at 12 mo. Based on the surface under the cumulative ranking curve rankograms, terazosin showed the highest score (99.6%), while alfuzosin, tamsulosin, silodosin, HESr, and nHESr showed scores of 53.7%, 42.3%, 68.5%, 36.7%, and 47.3%, respectively. CONCLUSIONS: In this network meta-analysis, we demonstrated that SeR did not show clinically meaningful improvement in LUTS and PF. PATIENT SUMMARY: In the present study, we found no clinically meaningful improvement of Serenoa repens for the treatment of lower urinary tract symptoms/benign prostatic enlargement. The analysis showed that the benefit over placebo was minimal and may not justify its clinical use before higher level of evidence will be available. SN - 2405-4569 UR - https://www.unboundmedicine.com/medline/citation/31952967/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 L2 - https://linkinghub.elsevier.com/retrieve/pii/S2405-4569(20)30018-3 DB - PRIME DP - Unbound Medicine ER -