Efficacy and tolerability of the hexanic extract of Serenoa repens compared to tamsulosin in moderate-severe LUTS-BPH patients
Alcaraz Asensio, Antonio (Institut d'Investigacions Biomèdiques August Pi i Sunyer)
Rodríguez-Antolín, A. (Instituto de Investigación Sanitaria Hospital 12 de Octubre (i+12))
Carballido, Joaquín (Hospital Universitario Puerta de Hierro Majadahonda (Madrid))
Castro Díaz, David (Hospital Universitario de Canarias (La Laguna))
Medina-Polo, J. (Instituto de Investigación Sanitaria Hospital 12 de Octubre (i+12))
Fernández-Gómez, J.M. (Hospital Universitario Central de Asturias)
Ficarra, V. (Urology Department. University of Messina)
Palou, Juan (Institut d'Investigació Biomèdica Sant Pau)
Ponce de León Roca, Javier (Institut d'Investigació Biomèdica Sant Pau)
Angulo, Javier C (Hospital Universitario de Getafe (Madrid))
Esteban-Fuertes, M. (Hospital Nacional de Paraplejicos. Toledo)
Cózar-Olmo, J.M. (Hospital Universitario Virgen de las Nieves (Granada))
Pérez-León, N. (Gran Sol Primary Care Center)
Molero-García, J.M. (San Andrés Primary Care Center)
Fernández-Pro Ledesma, A. (Centro de Salud Menasalbas)
Brenes-Bermúdez, F.J. (SEMERGEN Nefro-Urology Working Group)
Manasanch, J. (Pierre Fabre Ibérica S.A.)
Universitat Autònoma de Barcelona

Fecha:	2021
Resumen:	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.
Nota:	Altres ajuts: Pierre Fabre Ibérica S.A.
Derechos:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original.
Lengua:	Anglès
Documento:	Article ; recerca ; Versió publicada
Materia:	Female ; Humans ; Lower Urinary Tract Symptoms ; Male ; Middle Aged ; Phytotherapy ; Plant Extracts ; Prostatic Hyperplasia ; Quality of Life ; Serenoa ; Tamsulosin ; Treatment Outcome
Publicado en:	Scientific reports, Vol. 11 Núm. 1 (december 2021) , p. 19401, ISSN 2045-2322

DOI: 10.1038/s41598-021-98586-5
PMID: 34588509

11 p, 1.1 MB

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