Abstract

Objective: The aim of this study was to investigate the efficacy and safety of Serenoa repens extract (Prostagood®)in the treatment of lower urinary tract (LUT) symptoms due to benign prostatic hyperplasia (BPH).

Materials and methods: A prospective, open-labelled, multicenter study was designed including 106 patients (mean age 59.2±7.1) with LUT symptoms due to BPH [mean International Prostate Symptom Score (I-PSS) 18.5±5.0]. Following a 2 week run-in period of no treatment, patients received Prostagood® (160 mg Serenoa repens extract/softgel twice daily) for 12 weeks. 

Results: Serenoa repens extract treatment caused a significant improvement in the I-PSS score (12.1±6.7 vs. 18.4±4.9, p<0.001), the SF-36 score (74.1±15.9 vs. 76.9±13.4, p=0.021), and the life quality index score of the I-PSS (median 3 vs. 4, p<0.001). Maximum urine flow (Qmax) increased significantly from 9.7±3.0 mL/sec to 10.9±4.4 mL/secec (p=0.003) with treatment, while no significant change was observed in the urine flow (Qmean) (4.8±1.7 mL/sec vs. 5.1±1.9 mL/sec, p=0.178), micturition volume and duration (273.1 ±138.5 mL vs. 282.4±144.3 mL, p=0.424 and 65.4±34.5 sec vs. 67.4±38.2 sec, p=0.580 respectively), peak flow time (13.3±15.6 sec vs.14.4±15.4 sec, p=0.447), prostate volume (36.9±16.9 mL vs.38.8±19.0 mL, p=0.173) and postvoid residual urine volume (63.3±38.0 mL vs. 71.3±59.3 mL, p=0.141). There was no differences in prostate specific antigen (PSA) between baseline and end of study (2.2±2.2 ng/dL vs. 2.1±2.2 ng/dL, p=0.545).

Conclusion: Serenoa repens extract decreases LUT symptoms due to BPH, and improves patients’ quality of life. It is efficacious according to some of the uroflowmetric parameters and it is well tolerated.