The lipidosterolic extract of Serenoa repens in the treatment of benign prostatic hyperplasia: a comparison of two dosage regimens.

This 6-month double-blind, randomized, parallel-group study compared two dose regimens of Libeprosta, the lipidosterolic extract of Serenoa repens in 100 male outpatients with lower urinary tract symptoms suggestive of benign prostatic hyperplasia (BPH). The patients received two 80-mg tablets twice daily or two 80-mg tablets three times daily. Baseline evaluations included maximum and mean urinary flow rates, postvoid residual urine volume, and International Prostate Symptom Score (I-PSS) total and quality-of-life scores. Both regimens significantly reduced the I-PSS mean total score from baseline values (P<.001); improvements achieved statistical significance after month 3 and were maintained for the duration of the study. Significant improvements from baseline also occurred in quality-of-life scores, maximum and mean urinary flow rates, and residual urine volume (P<.05). The decrease in residual urine with both regimens was highly significant (P<.001). No significant differences in efficacy were noted between the two dose groups, and no treatment-related complications or clinical adverse events occurred. In this clinical study, the lipidosterolic extract of Serenoa repens was a well-tolerated agent that may significantly improve lower urinary tract symptoms and flow measurements in men with BPH.