Efficacy and tolerability of the lipidosterolic extract of Serenoa repens (Permixon (R)) in benign prostatic hyperplasia: A double-blind comparison of two dosage regimens

This 3-month double-blind, randomized, parallel-group study compared the ef ficacy and tolerability of two regimens of the lipido-sterolic extract of S erenoa repens (Permixon(R)) (two 160-mg capsules once daily [OD] and one 16 0-mg capsule twice daily [BID]) in 100 outpatients with symptomatic benign prostatic hyperplasia (BPH). Both regimens significantly (P<.0001) reduced the International Prostate Symptom Score (I-PSS) mean total score from base line; improvements achieved statistical significance after the first month and were maintained for the duration of the study. Significant (P<.05) and rapid improvements from baseline to the end of month 1 also occurred in I-P SS quality-of-life (QoL) scores, maximum and mean urinary flow rates, and r esidual urine volume; this benefit was further increased at month 3 for I-P SS total score and QoL and residual volume, and was maintained for maximum and mean flow rates. A highly significant decrease (P<.001) in residual uri ne was observed in both groups. No significant differences were noted betwe en regimens. Clinical adverse events occurred at a similar incidence in bot h groups (BID, 24%; OD, 22%) and were deemed unrelated or unlikely to be re lated to Permixon(R).