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.

Alcaraz, AntonioCastro-Díaz, DavidGacci, MauroSalonia, AndreaFicarra, VincenzoCarballido-Rodríguez, JoaquínRodríguez-Antolín, AlfredoMedina-Polo, JoséFernández-Gómez, Jesús MCózar-Olmo, José MBúcar-Terrades, SantiagoPérez-León, NoemíBrenes-Bermúdez, Francisco JMolero-García, José MFernández-Pro-Ledesma, AntonioHerdman, MichaelAngulo, Javier CManasanch, JoséOn Behalf Of The Qualiprost Study Group,2023-05-032023-05-032022-06-222077-0383http://hdl.handle.net/10668/21303The 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 (penAttribution 4.0 Internationalhttp://creativecommons.org/licenses/by/4.0/5-alpha-reductase inhibitorsBPHcombination therapyhexanic extract of Serenoa repensmoderate-severe LUTSprostatequality of lifetamsulosinurinary symptomsEfficacy 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.research article35806900open access10.3390/jcm11133615PMC9267652https://www.mdpi.com/2077-0383/11/13/3615/pdf?version=1655977335https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9267652/pdf