Efficacy and tolerability of the lipidosterolic extract of Serenoa repens (Permixon) in benign prostatic hyperplasia: a double-blind comparison of two dosage regimens.
This 3-month double-blind, randomized, parallel-group study compared the efficacy and tolerability of two regimens of the lipido-sterolic extract of Serenoa repens (Permixon) (two 160-mg capsules once daily [OD] and one 160-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 baseline; 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-PSS quality-of-life (QoL) scores, maximum and mean urinary flow rates, and residual urine volume; this benefit was further increased at month 3 for I-PSS total score and QoL and residual volume, and was maintained for maximum and mean flow rates. A highly significant decrease (P < .001) in residual urine was observed in both groups. No significant differences were noted between regimens. Clinical adverse events occurred at a similar incidence in both groups (BID, 24%; OD, 22%) and were deemed unrelated or unlikely to be related to Permixon.