| Disease | LIPIDO-STEROLIC EXT. OF SERENOA REPENS (LSESR)-PERMIXON-HAS BEEN SHOWN TO HAVE AN EQUIV. EFFICACY TO FINASTERIDE IN PATIENTS WITH BENIGN PROSTATIC HYPERPLASIA (BPH), TO DATE, THERE HAS BEEN NO VALID COMPARISON OF PHYTOTHERAPY WITH ALPHA-
BLOCKERS. THE AIM OF THIS STUDY WAS TO ASSESS THE EQUIV. EFFICACY OF PERMIXON AND TAMSULOSIN. EIGHT HUNDRED AND ELEVEN MEN WITH SYMPTOMATIC BPH (I-PSS>10) WERE RECRUITED IN 11 EUROPEAN COUNTRIES FOR A 12-MO, DOUBLE-BLIND RANDOMIZED TRIAL. AFTER
A 4-WK RUN-IN PERIOD, 704 PATIENTS WERE RANDOMLY ASSIGNED TO EITHER TAMSULOSIN O.4 MG/DAY(N=345) OR PERMIXON 320 MG/DAY (N=350). I-PSS, QOL AND Q-MAX WERE EVALUATED AT BASELINE AND PERIODICALLY FOR 1 YR. PROSTATE VOL. AND SERUM PROSTATE-
SPECIFIC ANTIGEN (PSA) WERE MEASURED AT SELECTION AND AT ENDPOINT. THE ENDPOINT ANAL. WAS PERFORMED ON THE PER-PROTOCOL POPULATION OF 542 PATIENTS (TAMSULOSIN: N=273; PERMIXON: N=269). AT 12 MO, I-PSS DECREASED BY 4.4 IN EACH GROUP AND NO
DIFFERENCES WERE OBSD. IN EITHER IRRITATIVE OR OBSTRUCTIVE SYMPTOM IMPROVEMENTS. THE INCREASE IN Q-MAX WAS SIMILAR IN BOTH TREATMENT GROUPS (1.8ML/S PERMIXON, 1.9 ML/S TAMSULOSIN). PSA REMAINED STABLE WHILE PROSTATE VOL. DECREASED SLIGHTLY IN
THE PERMIXON-TREATED PATIENTS. THE TWO COMPDS. WERE WELL TOLERATED, HOWEVER, EJACULATION DISORDERS OCCURRED MORE FREQUENTLY IN THE TAMSULOSIN GROUP. THIS STUDY DEMONSTRATES THAT PERMIXON AND TAMSULOSIN ARE EQUIV. IN THE MEDICAL TREATMENT OF
LOWER URINARY TRACT SYMPTOMS IN MEN WITH BPH, DURING AND UP TO 12 MO OF THERAPY. |