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.
Stepanov
V N
VN
Russian Academy of Medicine, Moscow, Russia.
Siniakova
L A
LA
Sarrazin
B
B
Raynaud
J P
JP
D000368:Aged; D000726:Androgen Antagonists / Q000008:administration & dosage* / Q000627:therapeutic use; D004311:Double-Blind Method; D006801:Humans; D008297:Male; D008875:Middle Aged; D010936:Plant Extracts / Q000008:administration & dosage* / Q000627:therapeutic use; D011446:Prospective Studies; D011470:Prostatic Hyperplasia / Q000188:drug therapy*; D011788:Quality of Life; D028024:Serenoa; D018709:Statistics, Nonparametric; D014554:Urination / Q000187:drug effects
D000726:Androgen Antagonists; D010936:Plant Extracts; C040972:saw palmetto extract