scholarly journals Efficacy and tolerability of the hexanic extract of Serenoa repens compared to tamsulosin in moderate-severe LUTS-BPH patients

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Antonio Alcaraz ◽  
Alfredo Rodríguez-Antolín ◽  
Joaquín Carballido-Rodríguez ◽  
David Castro-Díaz ◽  
José Medina-Polo ◽  
...  

AbstractIn 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.

2020 ◽  
Vol 26 (1) ◽  
Author(s):  
Mohamed Elbadry ◽  
Ahmed Issam Ali ◽  
Eman Saleh ◽  
Amal Kamal ◽  
Ahmed H. Gabr

Abstract Background Benign prostatic hyperplasia (BPH) is a common problem in aging males which has a potential impact on patients’ health-related quality of life. In the present prospective study, we evaluated the effect of adding solifenacin to tamsulosin, compared to tamsulosin alone on overactive bladder symptoms scores (OABSS) and patients’ quality of life (QoL) in patients with filling lower urinary tract symptoms due to BPH. Methods Patients included in our study were randomly assigned into 2 groups: group 1 included patients with BPH who received tamsulosin alone and group 2 included patients with BPH who received a combination of tamsulosin and sofinacin. Treatment period was 12 weeks in both groups. Quality of life and overactive bladder symptoms score questionnaires were obtained and compared in both groups before and after treatment. Results No significant differences were found between both groups before treatment. At the end of treatment period, The QoL score for Group 1 patients was significantly greater than the other group (mean rank was 138.98 in tamsulosin group versus 62.02 in the combination group, P-value < 0.01). Similarly, OABSS for tamsulosin only group was significantly higher than combined treatment patients (mean rank was 145.03 in tamsulin group versus 55.98 in the combination group, P-value < 0.01). Conclusion Adding solifenacin to tamsulosin was associated with an improvement of QoL and OABSS in patients with irritative urinary symptoms due to BPH when compared with tamsulosin monotherapy.


2021 ◽  
Vol 8 ◽  
Author(s):  
Jianwei Cui ◽  
Dehong Cao ◽  
Yunjin Bai ◽  
Jiahao Wang ◽  
Shan Yin ◽  
...  

Background: Tadalafil has been approved for the treatment of benign prostatic hyperplasia (BPH) for nearly 10 years. However, there are insufficient evidence-based studies of the efficacy and safety of tadalafil in treating lower urinary tract symptoms of BPH (LUTS/BPH).Objective: To evaluate the therapeutic effect and clinical safety of tadalafil monotherapy (5 mg once daily for 12 weeks) for LUTS/BPH.Methods: A total of 13 studies (15 randomized clinical trials [RCTs]) were extracted from the following databases: PubMed, Cochrane Central Register of Controlled Trials, Embase, and Web of Science for the period up to July 2021. The quality of the included RCTs was evaluated independently by two authors, who, respectively, extracted data according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses principles. Conflicts were settled by a discussion with two-third of senior authors. All data analyses were conducted by the Review Manager, version 5.4.Results: Regarding efficacy, 12-week trials indicated that 5 mg once daily tadalafil showed a significantly lower and, consequently, better total International Prostate Symptom Score (IPSS) than the placebo did (mean difference [MD]: −1.97, 95% CI: −2.24 to −1.70; P &lt; 0.00001). In addition, significant differences were found between the tadalafil regimen and the placebo in the IPSS voiding subscore (MD: −1.30, 95% CI: −1.48 to −1.11; P &lt; 0.00001), the IPSS storage subscore (MD: −0.70, 95% CI: −0.82 to −0.58; P &lt; 0.00001), the IPSS quality of life (MD: −0.29, 95% CI: −0.35 to −0.22; P &lt; 0.00001), and BPH impact index (MD: −0.58, 95% CI: −0.76 to −0.40; P &lt; 0.00001). The safety analysis did not show a significant difference in serious adverse events between the two groups (risk ratio: 1.27, 95% CI: 0.80–2.01; P = 0.31), although the adverse events occurred at a higher incidence in the tadalafil group than in the placebo.Conclusions: This study demonstrates that once daily 5 mg tadalafil is a potentially effective and safe treatment choice with excellent tolerability for patients with LUTS/BPH.Systematic Review Registration: Identifier (CRD42021228840).


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