Efficacy and Safety of the Hexanic Extract of Serenoa repens vs. Watchful Waiting in Men with Moderate to Severe LUTS-BPH: Results of a Paired Matched Clinical Study

Alcaraz Asensio, Antonio; Gacci, Mauro; Ficarra, Vincenzo; Medina Polo, José; Salonia, Andrea; Fernández Gómez, Jesús M.; Ciudin, Alexandru; Castro Diaz, David; Rodríguez Antolín, Alfredo; Carballido Rodríguez, Joaquín; Cózar Olmo, José M.; BúcarTerrades, Santiago; Pérez León, Noemí; Brenes Bermúdez, Francisco J.; Molero García, José M.; Fernández-Pro Ledesma, Antonio; Herdman, Michael; Manasanch, José; Angulo, Javier C.; QUALIPROST Study Group

Efficacy and Safety of the Hexanic Extract of Serenoa repens vs. Watchful Waiting in Men with Moderate to Severe LUTS-BPH: Results of a Paired Matched Clinical Study

We investigated changes in symptoms and quality of life (QoL) in men with moderate-to-severe lower urinary tract symptoms associated with benign prostatic hyperplasia (LUTS/BPH) receiving the hexanic extract of Serenoa repens (HESr) and compared results with a matched group on watchful waiting (WW)....

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Autores:	Alcaraz Asensio, Antonio, Gacci, Mauro, Ficarra, Vincenzo, Medina Polo, José, Salonia, Andrea, Fernández Gómez, Jesús M., Ciudin, Alexandru, Castro Diaz, David, Rodríguez Antolín, Alfredo, Carballido Rodríguez, Joaquín, Cózar Olmo, José M., BúcarTerrades, Santiago, Pérez León, Noemí, Brenes Bermúdez, Francisco J., Molero García, José M., Fernández-Pro Ledesma, Antonio, Herdman, Michael, Manasanch, José, Angulo, Javier C., QUALIPROST Study Group
Tipo de recurso:	artículo
Estado:	Versión publicada
Fecha de publicación:	2022
País:	España
Institución:	Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)
Repositorio:	Recercat. Dipósit de la Recerca de Catalunya
OAI Identifier:	oai:recercat.cat:2445/202098
Acceso en línea:	https://hdl.handle.net/2445/202098
Access Level:	acceso abierto
Palabra clave:	Qualitat de vida Homes Malalties de l'aparell urinari Quality of life Men Diseases of the urinary organs

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spelling	Efficacy and Safety of the Hexanic Extract of Serenoa repens vs. Watchful Waiting in Men with Moderate to Severe LUTS-BPH: Results of a Paired Matched Clinical StudyAlcaraz Asensio, AntonioGacci, MauroFicarra, VincenzoMedina Polo, JoséSalonia, AndreaFernández Gómez, Jesús M.Ciudin, AlexandruCastro Diaz, DavidRodríguez Antolín, AlfredoCarballido Rodríguez, JoaquínCózar Olmo, José M.BúcarTerrades, SantiagoPérez León, NoemíBrenes Bermúdez, Francisco J.Molero García, José M.Fernández-Pro Ledesma, AntonioHerdman, MichaelManasanch, JoséAngulo, Javier C.QUALIPROST Study GroupQualitat de vidaHomesMalalties de l'aparell urinariQuality of lifeMenDiseases of the urinary organsWe investigated changes in symptoms and quality of life (QoL) in men with moderate-to-severe lower urinary tract symptoms associated with benign prostatic hyperplasia (LUTS/BPH) receiving the hexanic extract of Serenoa repens (HESr) and compared results with a matched group on watchful waiting (WW). Data was from a real-world, open-label, prospective, multicenter study. This sub-group analysis included patients with moderate-to-severe symptoms receiving either the HESr 320 mg/daily for six months (HESr) or who remained untreated for LUTS/BPH (WW). Changes in urinary symptoms and QoL were measured by IPSS and BII questionnaires. Two statistical approaches (iterative matching and propensity score pairing) were used to maximize between-group comparability at baseline. Tolerability was assessed in the HESr group. After iterative matching, data for analysis was available for 783 patients (102 WW, 681 HESr). IPSS scores improved by a mean (SD) of 3.8 (4.4) points in the HESr group and by 2.2 (4.5) points in the WW group (p = 0.002). Changes in BII score were 1.8 (2.4) points and 1.0 (2.2) points, respectively (p < 0.001). Three patients (0.9%) treated with the HESr reported mild adverse effects. Moderate-severe LUTS/BPH patients treated for six months with the HESr showed greater improvements in symptoms and QoL than matched patients on WW, with a very low rate of adverse effects.MDPI2023202320222023info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersion12 p.application/pdfhttps://hdl.handle.net/2445/202098Articles publicats en revistes (IDIBAPS: Institut d'investigacions Biomèdiques August Pi i Sunyer)reponame:Recercat. Dipósit de la Recerca de Catalunyainstname:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)InglésReproducció del document publicat a: https://doi.org/10.3390/jcm11040967Journal of Clinical Medicine, 2022, vol. 11, num. 4, p. 967https://doi.org/10.3390/jcm11040967cc by (c) Alcaraz Asensio, Antonio et al., 2022http://creativecommons.org/licenses/by/4.0/info:eu-repo/semantics/openAccessoai:recercat.cat:2445/2020982026-05-29T05:05:01Z
dc.title.none.fl_str_mv	Efficacy and Safety of the Hexanic Extract of Serenoa repens vs. Watchful Waiting in Men with Moderate to Severe LUTS-BPH: Results of a Paired Matched Clinical Study
title	Efficacy and Safety of the Hexanic Extract of Serenoa repens vs. Watchful Waiting in Men with Moderate to Severe LUTS-BPH: Results of a Paired Matched Clinical Study
spellingShingle	Efficacy and Safety of the Hexanic Extract of Serenoa repens vs. Watchful Waiting in Men with Moderate to Severe LUTS-BPH: Results of a Paired Matched Clinical Study Alcaraz Asensio, Antonio Qualitat de vida Homes Malalties de l'aparell urinari Quality of life Men Diseases of the urinary organs
title_short	Efficacy and Safety of the Hexanic Extract of Serenoa repens vs. Watchful Waiting in Men with Moderate to Severe LUTS-BPH: Results of a Paired Matched Clinical Study
title_full	Efficacy and Safety of the Hexanic Extract of Serenoa repens vs. Watchful Waiting in Men with Moderate to Severe LUTS-BPH: Results of a Paired Matched Clinical Study
title_fullStr	Efficacy and Safety of the Hexanic Extract of Serenoa repens vs. Watchful Waiting in Men with Moderate to Severe LUTS-BPH: Results of a Paired Matched Clinical Study
title_full_unstemmed	Efficacy and Safety of the Hexanic Extract of Serenoa repens vs. Watchful Waiting in Men with Moderate to Severe LUTS-BPH: Results of a Paired Matched Clinical Study
title_sort	Efficacy and Safety of the Hexanic Extract of Serenoa repens vs. Watchful Waiting in Men with Moderate to Severe LUTS-BPH: Results of a Paired Matched Clinical Study
dc.creator.none.fl_str_mv	Alcaraz Asensio, Antonio Gacci, Mauro Ficarra, Vincenzo Medina Polo, José Salonia, Andrea Fernández Gómez, Jesús M. Ciudin, Alexandru Castro Diaz, David Rodríguez Antolín, Alfredo Carballido Rodríguez, Joaquín Cózar Olmo, José M. BúcarTerrades, Santiago Pérez León, Noemí Brenes Bermúdez, Francisco J. Molero García, José M. Fernández-Pro Ledesma, Antonio Herdman, Michael Manasanch, José Angulo, Javier C. QUALIPROST Study Group
author	Alcaraz Asensio, Antonio
author_facet	Alcaraz Asensio, Antonio Gacci, Mauro Ficarra, Vincenzo Medina Polo, José Salonia, Andrea Fernández Gómez, Jesús M. Ciudin, Alexandru Castro Diaz, David Rodríguez Antolín, Alfredo Carballido Rodríguez, Joaquín Cózar Olmo, José M. BúcarTerrades, Santiago Pérez León, Noemí Brenes Bermúdez, Francisco J. Molero García, José M. Fernández-Pro Ledesma, Antonio Herdman, Michael Manasanch, José Angulo, Javier C. QUALIPROST Study Group
author_role	author
author2	Gacci, Mauro Ficarra, Vincenzo Medina Polo, José Salonia, Andrea Fernández Gómez, Jesús M. Ciudin, Alexandru Castro Diaz, David Rodríguez Antolín, Alfredo Carballido Rodríguez, Joaquín Cózar Olmo, José M. BúcarTerrades, Santiago Pérez León, Noemí Brenes Bermúdez, Francisco J. Molero García, José M. Fernández-Pro Ledesma, Antonio Herdman, Michael Manasanch, José Angulo, Javier C. QUALIPROST Study Group
author2_role	author author author author author author author author author author author author author author author author author author author
dc.subject.none.fl_str_mv	Qualitat de vida Homes Malalties de l'aparell urinari Quality of life Men Diseases of the urinary organs
topic	Qualitat de vida Homes Malalties de l'aparell urinari Quality of life Men Diseases of the urinary organs
description	We investigated changes in symptoms and quality of life (QoL) in men with moderate-to-severe lower urinary tract symptoms associated with benign prostatic hyperplasia (LUTS/BPH) receiving the hexanic extract of Serenoa repens (HESr) and compared results with a matched group on watchful waiting (WW). Data was from a real-world, open-label, prospective, multicenter study. This sub-group analysis included patients with moderate-to-severe symptoms receiving either the HESr 320 mg/daily for six months (HESr) or who remained untreated for LUTS/BPH (WW). Changes in urinary symptoms and QoL were measured by IPSS and BII questionnaires. Two statistical approaches (iterative matching and propensity score pairing) were used to maximize between-group comparability at baseline. Tolerability was assessed in the HESr group. After iterative matching, data for analysis was available for 783 patients (102 WW, 681 HESr). IPSS scores improved by a mean (SD) of 3.8 (4.4) points in the HESr group and by 2.2 (4.5) points in the WW group (p = 0.002). Changes in BII score were 1.8 (2.4) points and 1.0 (2.2) points, respectively (p < 0.001). Three patients (0.9%) treated with the HESr reported mild adverse effects. Moderate-severe LUTS/BPH patients treated for six months with the HESr showed greater improvements in symptoms and QoL than matched patients on WW, with a very low rate of adverse effects.
publishDate	2022
dc.date.none.fl_str_mv	2022 2023 2023 2023
dc.type.none.fl_str_mv	info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion
format	article
status_str	publishedVersion
dc.identifier.none.fl_str_mv	https://hdl.handle.net/2445/202098
url	https://hdl.handle.net/2445/202098
dc.language.none.fl_str_mv	Inglés
language_invalid_str_mv	Inglés
dc.relation.none.fl_str_mv	Reproducció del document publicat a: https://doi.org/10.3390/jcm11040967 Journal of Clinical Medicine, 2022, vol. 11, num. 4, p. 967 https://doi.org/10.3390/jcm11040967
dc.rights.none.fl_str_mv	cc by (c) Alcaraz Asensio, Antonio et al., 2022 http://creativecommons.org/licenses/by/4.0/ info:eu-repo/semantics/openAccess
rights_invalid_str_mv	cc by (c) Alcaraz Asensio, Antonio et al., 2022 http://creativecommons.org/licenses/by/4.0/
eu_rights_str_mv	openAccess
dc.format.none.fl_str_mv	12 p. application/pdf
dc.publisher.none.fl_str_mv	MDPI
publisher.none.fl_str_mv	MDPI
dc.source.none.fl_str_mv	Articles publicats en revistes (IDIBAPS: Institut d'investigacions Biomèdiques August Pi i Sunyer) reponame:Recercat. Dipósit de la Recerca de Catalunya instname:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)
instname_str	Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)
reponame_str	Recercat. Dipósit de la Recerca de Catalunya
collection	Recercat. Dipósit de la Recerca de Catalunya
repository.name.fl_str_mv
repository.mail.fl_str_mv
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Efficacy and Safety of the Hexanic Extract of Serenoa repens vs. Watchful Waiting in Men with Moderate to Severe LUTS-BPH: Results of a Paired Matched Clinical Study

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