PLACEBO-CONTROLLED EVALUATION OF THE EFFICACY AND TOLERABILITY OF PERMIXON(R) IN BENIGN PROSTATIC HYPERPLASIA AFTER EXCLUSION OF PLACEBO RESPONDERS

A double-blind placebo-controlled multicentre study was conducted to a ssess the efficacy and tolerability of the 5 alpha-reductase inhibitor Permixon(R) in patients with symptomatic benign prostatic hyperplasia (BPH) who had previously been shown to be unresponsive to the placebo effect. Following a 30-day single-blind placebo run-in period, 176 no nresponders to placebo (those patients showing <30% improvement in pea k urinary flow rate) were randomised to double-blind oral treatment wi th Permixon(R) 160mg twice daily or matching placebo for 30 days. Impr ovement in dysuria severity was seen in a significantly greater propor tion of Permixon(R) recipients (31.3%) than placebo recipients (16.1%) . Daytime urinary frequency fell significantly in Permixon(R)-treated patients (11.3%) reduction), but was unchanged in placebo recipients. Nocturnal urinary frequency fell to a significantly greater extent wit h Permixon(R) (32.5% reduction) than with placebo (17.7% reduction). P ermixon(R) produced a significantly greater increase in mean peak urin ary flow rate than did placebo (28.9 vs 8.5%). The global efficacy of Permixon(R) was judged by the patients and physicians to be satisfacto ry factory or better in 71.3 and 56.6% of cases, respectively; corresp onding values for placebo were 67.5 and 47.2%, respectively The overal l tolerability of Permixon(R) was comparable to that of placebo. In co nclusion, Permixon(R) appears to be significantly more effective than placebo and well tolerated in the short term treatment of mild to mode rate symptomatic BPH.