Efficacy and safety of drug with plant extract of saw palmetto in patients with lower urinary tract symptoms because of benign prostatic enlargement

Abstract

Background : Benign prostatic enlargement (BPE) is the most frequent cause of lower urinary tract symptoms (LUTS) in men. The objective of this study was to evaluate the efficacy and safety of Prostasan, the plant extract of saw palmetto in men with LUTS/BPE. Methods : The study was approved by the Ethical Committee of the Republic of Slovenia. In a prospective, open clinical study, men between 45 and 80 years of age with at least moderate LUTS/BPE, normal serum PSA, in a good physical condition were included after having given their written informed consent . At the beginning of this study, the digito-rectal examination of the prostate was performed together with the evaluation of IPSS and quality of life, total PSA in serum, uroflow and transabdominal US measurement of prostate volume. They were also asked about their erectile dysfunction and libido. All patients received Prostasan 320 mg per day for 12 months. The same parameters as at the beginning of the study were assessed after 6 and 12 months. The subjective assessments of the efficacy and safety of the drug were also recorded byinvestigators and by patients. The side effects of the treatment were recorded at both follow-ups. For statistical analyses, t-test and chi-square tests were used. Results : 72 men out of 76 (94.7 %) with LUTS/BPE completed the trial. They were 62.7 ± 8.54 years old. IPSS score and quality of life were reduced from 14.46 ± 5.36  to  11.08 ± 3.92 (p = 0.0000)  and  from  2.72 ± 0,96  to  2.25 ± 1.05 (p = 0.0001) respectively after 12 months of treatment. The uroflow increased from 13.94 ± 5.00 to 15.34 ± 4.07 ml/s (p = 0.0005). Total PSA did not change significantly. After 12 months, prostate volume decreased by 3 % (p = 0.0392). Prostasan had no important influence on erectile function or libido. The majority of patients and doctors rated the efficacy of drug as good (69.7 % and 72.4 % ) and safe (86.8 % and 88.2 %), respectively. Seven patients (9.2 %) reported drug-related side effects. Conclusions : According to our 12-month clinical trial, we could conclude that Prostasan is a safe and efficient natural drug for the treatment of men with mild to moderate LUTS/BPE.