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.
Scientific reports. 2021 Sep 29*** epublish ***
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
Urology Department, Hospital Clínic, Universitat de Barcelona, IDIBAPS, Barcelona, Spain., Urology Department, Research Group in Men's Integral Health, Instituto de Investigación i+12, Hospital Universitario 12 de Octubre, Madrid, Spain., Urology Department, Hosp. Univ. Puerta de Hierro Majadahonda, Majadahonda, Madrid, Spain., Urology Department, Hosp. Univ. de Canarias, Tenerife, Spain., Urology Department, Hosp. Univ. Central de Asturias, Oviedo, Spain., Urology Department, University of Messina, Messina, Italy., Urology Department, Fundació Puigvert, Autonoma University of Barcelona, Barcelona, Spain., Urology Department, Hosp. Univ. de Getafe. Getafe, Madrid, Spain., Urology Department, Hosp. Nal. de Parapléjicos, Toledo, Spain., Urology Department, Hosp. Univ. Virgen de Las Nieves, Granada, Spain., Gran Sol Primary Care Center, Badalona, Barcelona, Spain., San Andrés Primary Care Center, Madrid, Spain., Menasalbas Primary Care Center, Toledo, Spain., SEMERGEN Nefro-Urology Working Group, Barcelona, Spain., Pierre Fabre Ibérica S.A., Barcelona, Spain. .