RT Journal Article T1 Efficacy and Tolerability of 6-Month Treatment with Tamsulosin Plus the Hexanic Extract of Serenoa repens versus Tamsulosin Plus 5-Alpha-Reductase Inhibitors for Moderate-to-Severe LUTS-BPH Patients: Results of a Paired Matched Clinical Study. A1 Alcaraz, Antonio A1 Castro-Díaz, David A1 Gacci, Mauro A1 Salonia, Andrea A1 Ficarra, Vincenzo A1 Carballido-Rodríguez, Joaquín A1 Rodríguez-Antolín, Alfredo A1 Medina-Polo, José A1 Fernández-Gómez, Jesús M A1 Cózar-Olmo, José M A1 Búcar-Terrades, Santiago A1 Pérez-León, Noemí A1 Brenes-Bermúdez, Francisco J A1 Molero-García, José M A1 Fernández-Pro-Ledesma, Antonio A1 Herdman, Michael A1 Angulo, Javier C A1 Manasanch, José A1 On Behalf Of The Qualiprost Study Group, K1 5-alpha-reductase inhibitors K1 BPH K1 combination therapy K1 hexanic extract of Serenoa repens K1 moderate-severe LUTS K1 prostate K1 quality of life K1 tamsulosin K1 urinary symptoms AB The objective of this subset analysis was to evaluate and compare the efficacy and tolerability of two combination treatments for men with moderate-to-severe lower urinary tract symptoms associated with benign prostatic hyperplasia (LUTS/BPH). Data were from a real-world, open-label, prospective, and multicenter study performed in outpatient urology clinics. Men with moderate-to-severe LUTS/BPH received 6-month treatment with tamsulosin (TAM) in combination with either the hexanic extract of S. repens (HESr) or a 5-alpha-reductase inhibitor (5ARI). Changes in urinary symptoms and quality of life were measured using the IPSS and BII questionnaires, respectively. Treatment tolerability was assessed by recording adverse effects (AEs). Patients in the two study groups were matched using iterative and propensity score matching approaches. After iterative matching, data were available from 136 patients (n = 68 treated with TAM + 5ARI, n = 68 with TAM + HESr). After 6 months of treatment, mean (SD) IPSS total score improved by 7.7 (6.3) and 6.7 (5.0) points in the TAM + 5ARI and TAM + HESr groups, respectively (p = 0.272); mean BII total scores improved by 3.1 (2.9) and 2.9 (2.4) points (p = 0.751), respectively. AEs were reported by 26.5% and 10.3% of patients in the same groups, mostly affecting sexual function (p SN 2077-0383 YR 2022 FD 2022-06-22 LK http://hdl.handle.net/10668/21303 UL http://hdl.handle.net/10668/21303 LA en DS RISalud RD Apr 8, 2025