PMID- 35806900 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20230308 IS - 2077-0383 (Print) IS - 2077-0383 (Electronic) IS - 2077-0383 (Linking) VI - 11 IP - 13 DP - 2022 Jun 22 TI - 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. LID - 10.3390/jcm11133615 [doi] LID - 3615 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 < 0.027). When used in a real-world setting to treat patients with moderate-severe LUTS/BPH, 6-month treatment with TAM + HESr was as effective as TAM + 5ARI, but with better tolerability. FAU - Alcaraz, Antonio AU - Alcaraz A AD - Urology Department, Hospital Clinic, Universitat de Barcelona, IDIBAPS (Institut d'Investigacions Biomediques August Pi i Sunyer), 08036 Barcelona, Spain. FAU - Castro-Diaz, David AU - Castro-Diaz D AUID- ORCID: 0000-0002-4484-9159 AD - Urology Department, Hospital Universitario de Canarias, 38320 Tenerife, Spain. FAU - Gacci, Mauro AU - Gacci M AD - Unit of Minimally Invasive and Robotic Urologic Surgery and Kidney Transplantation, Careggi University Hospital (AOUC), University of Florence, 50134 Florence, Italy. AD - Department of Experimental and Clinical Medicine, University of Florence, 50134 Florence, Italy. FAU - Salonia, Andrea AU - Salonia A AUID- ORCID: 0000-0002-0595-7165 AD - Division of Experimental Oncology/Unit of Urology, URI, IRCCS Ospedale San Raffaele, 20132 Milan, Italy. FAU - Ficarra, Vincenzo AU - Ficarra V AD - Department of Human and Pediatric Pathology "Gaetano Barresi", Urology Section, University of Messina, 98125 Messina, Italy. FAU - Carballido-Rodriguez, Joaquin AU - Carballido-Rodriguez J AD - Urology Department, Hospital Universitario Puerta de Hierro Majadahonda, 28222 Majadahonda, Spain. FAU - Rodriguez-Antolin, Alfredo AU - Rodriguez-Antolin A AD - Urology Department, Research Institute i + 12, Hospital Universitario 12 de Octubre, 28041 Madrid, Spain. FAU - Medina-Polo, Jose AU - Medina-Polo J AUID- ORCID: 0000-0003-3626-8669 AD - Urology Department, Research Institute i + 12, Hospital Universitario 12 de Octubre, 28041 Madrid, Spain. AD - Urology Unit, HM Hospital, 28050 Madrid, Spain. AD - ROC Clinic, 28010 Madrid, Spain. FAU - Fernandez-Gomez, Jesus M AU - Fernandez-Gomez JM AUID- ORCID: 0000-0001-9344-2980 AD - Urology Department, Hospital Universitario Central de Asturias, 33011 Oviedo, Spain. FAU - Cozar-Olmo, Jose M AU - Cozar-Olmo JM AD - Urology Department, Hospital Universitario Virgen de las Nieves, 18014 Granada, Spain. FAU - Bucar-Terrades, Santiago AU - Bucar-Terrades S AD - Urology Department, Hospital El Pilar, Quironsalud, 08006 Barcelona, Spain. FAU - Perez-Leon, Noemi AU - Perez-Leon N AD - Gran Sol Primary Care Center, 08914 Badalona, Spain. FAU - Brenes-Bermudez, Francisco J AU - Brenes-Bermudez FJ AD - SEMERGEN Nefro-Urology Working Group, 08338 Premia de Dalt, Spain. FAU - Molero-Garcia, Jose M AU - Molero-Garcia JM AUID- ORCID: 0000-0002-4426-2593 AD - San Andres Primary Care Center, 28021 Madrid, Spain. FAU - Fernandez-Pro-Ledesma, Antonio AU - Fernandez-Pro-Ledesma A AD - Menasalbas Primary Care Center, 45128 Toledo, Spain. FAU - Herdman, Michael AU - Herdman M AD - Insight Consulting and Research, 08301 Mataro, Spain. AD - Saw Swee Hock School of Public Health, National University of Singapore, Singapore 117549, Singapore. FAU - Angulo, Javier C AU - Angulo JC AUID- ORCID: 0000-0002-1735-8792 AD - Clinical Department, Universidad Europea de Madrid, 28905 Getafe, Spain. AD - Urology Department, Hospital Universitario de Getafe, 28905 Getafe, Spain. FAU - Manasanch, Jose AU - Manasanch J AUID- ORCID: 0000-0003-3633-8778 AD - SEMERGEN, 08329 Teia, Spain. FAU - On Behalf Of The Qualiprost Study Group AU - On Behalf Of The Qualiprost Study Group LA - eng GR - Not apply/Pierre Fabre Iberica, S.A. (Spain)/ PT - Journal Article DEP - 20220622 PL - Switzerland TA - J Clin Med JT - Journal of clinical medicine JID - 101606588 PMC - PMC9267652 OTO - NOTNLM OT - 5-alpha-reductase inhibitors OT - BPH OT - combination therapy OT - hexanic extract of Serenoa repens OT - moderate-severe LUTS OT - prostate OT - quality of life OT - tamsulosin OT - urinary symptoms COIS- D.C.-D.: speaker for Astellas, Medtronic, Nobel, Recordati, Boston Scientific, and consultant for Bayer; M.G.: speaker honorarium and travel grant for Pierre Fabre; J.M.-P.: speaker for Astellas Pharma, Boston Scientific, Coloplast, Gebro Pharma, GSK, Lacer, Pierre Fabre, and Wellspect; F.J.B.-B.: speaker and consultant for GSK, Almirall, Pierre Fabre Iberica, Astellas, Lacer, Recordati, Lilly, Pfizer, Ferrer, and Zambon; M.H.: honoraria or consulting fees from Pierre Fabre, Novartis, and Merck; J.M. has been medical advisor with Pierre Fabre Iberica S.A., a company that commercializes an extract of Serenoa repens. The other authors do not declare any conflict of interest. EDAT- 2022/07/10 06:00 MHDA- 2022/07/10 06:01 PMCR- 2022/06/22 CRDT- 2022/07/09 01:16 PHST- 2022/05/05 00:00 [received] PHST- 2022/06/13 00:00 [revised] PHST- 2022/06/16 00:00 [accepted] PHST- 2022/07/09 01:16 [entrez] PHST- 2022/07/10 06:00 [pubmed] PHST- 2022/07/10 06:01 [medline] PHST- 2022/06/22 00:00 [pmc-release] AID - jcm11133615 [pii] AID - jcm-11-03615 [pii] AID - 10.3390/jcm11133615 [doi] PST - epublish SO - J Clin Med. 2022 Jun 22;11(13):3615. doi: 10.3390/jcm11133615.