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Article

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

by
Antonio Alcaraz
1,
David Castro-Díaz
2,
Mauro Gacci
3,4,
Andrea Salonia
5,
Vincenzo Ficarra
6,
Joaquín Carballido-Rodríguez
7,
Alfredo Rodríguez-Antolín
8,
José Medina-Polo
8,9,10,
Jesús M. Fernández-Gómez
11,
José M. Cózar-Olmo
12,
Santiago Búcar-Terrades
13,
Noemí Pérez-León
14,
Francisco J. Brenes-Bermúdez
15,
José M. Molero-García
16,
Antonio Fernández-Pro-Ledesma
17,
Michael Herdman
18,19,
Javier C. Angulo
20,21,
José Manasanch
22,* and
on behalf of the QUALIPROST Study Group
†
1
Urology Department, Hospital Clínic, Universitat de Barcelona, IDIBAPS (Institut d’Investigacions Biomèdiques August Pi i Sunyer), 08036 Barcelona, Spain
2
Urology Department, Hospital Universitario de Canarias, 38320 Tenerife, Spain
3
Unit of Minimally Invasive and Robotic Urologic Surgery and Kidney Transplantation, Careggi University Hospital (AOUC), University of Florence, 50134 Florence, Italy
4
Department of Experimental and Clinical Medicine, University of Florence, 50134 Florence, Italy
5
Division of Experimental Oncology/Unit of Urology, URI, IRCCS Ospedale San Raffaele, 20132 Milan, Italy
6
Department of Human and Pediatric Pathology “Gaetano Barresi”, Urology Section, University of Messina, 98125 Messina, Italy
7
Urology Department, Hospital Universitario Puerta de Hierro Majadahonda, 28222 Majadahonda, Spain
8
Urology Department, Research Institute i + 12, Hospital Universitario 12 de Octubre, 28041 Madrid, Spain
9
Urology Unit, HM Hospital, 28050 Madrid, Spain
10
ROC Clinic, 28010 Madrid, Spain
11
Urology Department, Hospital Universitario Central de Asturias, 33011 Oviedo, Spain
12
Urology Department, Hospital Universitario Virgen de las Nieves, 18014 Granada, Spain
13
Urology Department, Hospital El Pilar, Quirónsalud, 08006 Barcelona, Spain
14
Gran Sol Primary Care Center, 08914 Badalona, Spain
15
SEMERGEN Nefro-Urology Working Group, 08338 Premià de Dalt, Spain
16
San Andrés Primary Care Center, 28021 Madrid, Spain
17
Menasalbas Primary Care Center, 45128 Toledo, Spain
18
Insight Consulting and Research, 08301 Mataró, Spain
19
Saw Swee Hock School of Public Health, National University of Singapore, Singapore 117549, Singapore
20
Clinical Department, Universidad Europea de Madrid, 28905 Getafe, Spain
21
Urology Department, Hospital Universitario de Getafe, 28905 Getafe, Spain
22
SEMERGEN, 08329 Teià, Spain
 
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*
Author to whom correspondence should be addressed.
†
Members of the study group are listed in Appendix A.
J. Clin. Med. 2022, 11(13), 3615; https://doi.org/10.3390/jcm11133615
Submission received: 5 May 2022 / Revised: 13 June 2022 / Accepted: 16 June 2022 / Published: 22 June 2022
(This article belongs to the Section Nephrology & Urology)
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Abstract

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.
Keywords: moderate-severe LUTS; BPH; combination therapy; tamsulosin; 5-alpha-reductase inhibitors; hexanic extract of Serenoa repens; quality of life; urinary symptoms; prostate moderate-severe LUTS; BPH; combination therapy; tamsulosin; 5-alpha-reductase inhibitors; hexanic extract of Serenoa repens; quality of life; urinary symptoms; prostate

Share and Cite

MDPI and ACS Style

Alcaraz, A.; Castro-Díaz, D.; Gacci, M.; Salonia, A.; Ficarra, V.; Carballido-Rodríguez, J.; Rodríguez-Antolín, A.; Medina-Polo, J.; Fernández-Gómez, J.M.; Cózar-Olmo, J.M.; et al. 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. J. Clin. Med. 2022, 11, 3615. https://doi.org/10.3390/jcm11133615

AMA Style

Alcaraz A, Castro-Díaz D, Gacci M, Salonia A, Ficarra V, Carballido-Rodríguez J, Rodríguez-Antolín A, Medina-Polo J, Fernández-Gómez JM, Cózar-Olmo JM, et al. 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. Journal of Clinical Medicine. 2022; 11(13):3615. https://doi.org/10.3390/jcm11133615

Chicago/Turabian Style

Alcaraz, Antonio, David Castro-Díaz, Mauro Gacci, Andrea Salonia, Vincenzo Ficarra, Joaquín Carballido-Rodríguez, Alfredo Rodríguez-Antolín, José Medina-Polo, Jesús M. Fernández-Gómez, José M. Cózar-Olmo, and et al. 2022. "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" Journal of Clinical Medicine 11, no. 13: 3615. https://doi.org/10.3390/jcm11133615

APA Style

Alcaraz, A., Castro-Díaz, D., Gacci, M., Salonia, A., Ficarra, V., Carballido-Rodríguez, J., Rodríguez-Antolín, A., Medina-Polo, J., Fernández-Gómez, J. M., Cózar-Olmo, J. M., Búcar-Terrades, S., Pérez-León, N., Brenes-Bermúdez, F. J., Molero-García, J. M., Fernández-Pro-Ledesma, A., Herdman, M., Angulo, J. C., Manasanch, J., & on behalf of the QUALIPROST Study Group. (2022). 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. Journal of Clinical Medicine, 11(13), 3615. https://doi.org/10.3390/jcm11133615

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