Efficacy and tolerability of the hexanic extract of Serenoa repens compared to tamsulosin in moderate-severe LUTS-BPH patients

Abstract In a subset analysis of data from a 6-month, multicenter, non-interventional study, we compared change in symptoms and quality of life (QoL), and treatment tolerability, in men with moderate to severe lower urinary tract symptoms associated with benign prostatic hyperplasia (LUTS/BPH) recei...

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Autores principales: Antonio Alcaraz, Alfredo Rodríguez-Antolín, Joaquín Carballido-Rodríguez, David Castro-Díaz, José Medina-Polo, Jesús M. Fernández-Gómez, Vincenzo Ficarra, Joan Palou, Javier Ponce de León Roca, Javier C. Angulo, Manuel Esteban-Fuertes, José M. Cózar-Olmo, Noemí Pérez-León, José M. Molero-García, Antonio Fernández-Pro Ledesma, Francisco J. Brenes-Bermúdez, José Manasanch
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Publicado: Nature Portfolio 2021
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spelling oai:doaj.org-article:dbfb0dfd6b60488a9466f0e9d31282262021-12-02T19:16:47ZEfficacy and tolerability of the hexanic extract of Serenoa repens compared to tamsulosin in moderate-severe LUTS-BPH patients10.1038/s41598-021-98586-52045-2322https://doaj.org/article/dbfb0dfd6b60488a9466f0e9d31282262021-09-01T00:00:00Zhttps://doi.org/10.1038/s41598-021-98586-5https://doaj.org/toc/2045-2322Abstract In a subset analysis of data from a 6-month, multicenter, non-interventional study, we compared change in symptoms and quality of life (QoL), and treatment tolerability, in men with moderate to severe lower urinary tract symptoms associated with benign prostatic hyperplasia (LUTS/BPH) receiving tamsulosin (TAM, 0.4 mg/day) or the hexanic extract of Serenoa repens (HESr, 320 mg/day) as monotherapy. Symptoms and QoL were assessed using the IPSS and BII questionnaires, respectively. Patients in the treatment groups were matched using two statistical approaches (iterative and propensity score matching). Within the iterative matching approach, data was available from a total of 737 patients (353 TAM, 384 HESr). After 6 months, IPSS scores improved by a mean (SD) of 5.0 (4.3) points in the TAM group and 4.5 (4.7) points in the HESr group (p = 0.117, not significant). Improvements in QoL were equivalent in the two groups. TAM patients reported significantly more adverse effects than HESr patients (14.7% vs 2.1%; p < 0.001), particularly ejaculation dysfunction and orthostatic hypotension. These results show that HESr is a valid treatment option for men with moderate/severe LUTS/BPH; improvements in urinary symptoms and QoL were similar to those observed for tamsulosin, but with considerably fewer adverse effects.Antonio AlcarazAlfredo Rodríguez-AntolínJoaquín Carballido-RodríguezDavid Castro-DíazJosé Medina-PoloJesús M. Fernández-GómezVincenzo FicarraJoan PalouJavier Ponce de León RocaJavier C. AnguloManuel Esteban-FuertesJosé M. Cózar-OlmoNoemí Pérez-LeónJosé M. Molero-GarcíaAntonio Fernández-Pro LedesmaFrancisco J. Brenes-BermúdezJosé ManasanchNature PortfolioarticleMedicineRScienceQENScientific Reports, Vol 11, Iss 1, Pp 1-11 (2021)
institution DOAJ
collection DOAJ
language EN
topic Medicine
R
Science
Q
spellingShingle Medicine
R
Science
Q
Antonio Alcaraz
Alfredo Rodríguez-Antolín
Joaquín Carballido-Rodríguez
David Castro-Díaz
José Medina-Polo
Jesús M. Fernández-Gómez
Vincenzo Ficarra
Joan Palou
Javier Ponce de León Roca
Javier C. Angulo
Manuel Esteban-Fuertes
José M. Cózar-Olmo
Noemí Pérez-León
José M. Molero-García
Antonio Fernández-Pro Ledesma
Francisco J. Brenes-Bermúdez
José Manasanch
Efficacy and tolerability of the hexanic extract of Serenoa repens compared to tamsulosin in moderate-severe LUTS-BPH patients
description Abstract In a subset analysis of data from a 6-month, multicenter, non-interventional study, we compared change in symptoms and quality of life (QoL), and treatment tolerability, in men with moderate to severe lower urinary tract symptoms associated with benign prostatic hyperplasia (LUTS/BPH) receiving tamsulosin (TAM, 0.4 mg/day) or the hexanic extract of Serenoa repens (HESr, 320 mg/day) as monotherapy. Symptoms and QoL were assessed using the IPSS and BII questionnaires, respectively. Patients in the treatment groups were matched using two statistical approaches (iterative and propensity score matching). Within the iterative matching approach, data was available from a total of 737 patients (353 TAM, 384 HESr). After 6 months, IPSS scores improved by a mean (SD) of 5.0 (4.3) points in the TAM group and 4.5 (4.7) points in the HESr group (p = 0.117, not significant). Improvements in QoL were equivalent in the two groups. TAM patients reported significantly more adverse effects than HESr patients (14.7% vs 2.1%; p < 0.001), particularly ejaculation dysfunction and orthostatic hypotension. These results show that HESr is a valid treatment option for men with moderate/severe LUTS/BPH; improvements in urinary symptoms and QoL were similar to those observed for tamsulosin, but with considerably fewer adverse effects.
format article
author Antonio Alcaraz
Alfredo Rodríguez-Antolín
Joaquín Carballido-Rodríguez
David Castro-Díaz
José Medina-Polo
Jesús M. Fernández-Gómez
Vincenzo Ficarra
Joan Palou
Javier Ponce de León Roca
Javier C. Angulo
Manuel Esteban-Fuertes
José M. Cózar-Olmo
Noemí Pérez-León
José M. Molero-García
Antonio Fernández-Pro Ledesma
Francisco J. Brenes-Bermúdez
José Manasanch
author_facet Antonio Alcaraz
Alfredo Rodríguez-Antolín
Joaquín Carballido-Rodríguez
David Castro-Díaz
José Medina-Polo
Jesús M. Fernández-Gómez
Vincenzo Ficarra
Joan Palou
Javier Ponce de León Roca
Javier C. Angulo
Manuel Esteban-Fuertes
José M. Cózar-Olmo
Noemí Pérez-León
José M. Molero-García
Antonio Fernández-Pro Ledesma
Francisco J. Brenes-Bermúdez
José Manasanch
author_sort Antonio Alcaraz
title Efficacy and tolerability of the hexanic extract of Serenoa repens compared to tamsulosin in moderate-severe LUTS-BPH patients
title_short Efficacy and tolerability of the hexanic extract of Serenoa repens compared to tamsulosin in moderate-severe LUTS-BPH patients
title_full Efficacy and tolerability of the hexanic extract of Serenoa repens compared to tamsulosin in moderate-severe LUTS-BPH patients
title_fullStr Efficacy and tolerability of the hexanic extract of Serenoa repens compared to tamsulosin in moderate-severe LUTS-BPH patients
title_full_unstemmed Efficacy and tolerability of the hexanic extract of Serenoa repens compared to tamsulosin in moderate-severe LUTS-BPH patients
title_sort efficacy and tolerability of the hexanic extract of serenoa repens compared to tamsulosin in moderate-severe luts-bph patients
publisher Nature Portfolio
publishDate 2021
url https://doaj.org/article/dbfb0dfd6b60488a9466f0e9d3128226
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