A randomized placebo‐controlled multicentre study to evaluate the safety and efficacy of finasteride for male chronic pelvic pain syndrome (category IIIA chronic nonbacterial prostatitis)

摘要: OBJECTIVE To determine if finasteride can reduce symptoms in men with a clinical diagnosis of chronic nonbacterial prostatitis (National Institutes Health, NIH, category IIIA pelvic pain syndrome, CPPS) compared placebo. PATIENTS AND METHODS Men (76) CPPS enrolled four North American research centres were randomized after 2-week placebo run-in to or for 6 months. The primary efficacy variable was subjective overall assessment (SOA); the secondary variables included NIH symptom index (NIH-CPSI) and safety data. Patients assessed at screening, baseline (after run-in), 3 6 months. RESULTS Sixty-four patients had least one on medication (31 placebo, 33 finasteride); 75% 54% group mild improvement (defined as > 25% SOA), 44% 27%, respectively, moderate marked (>50% SOA). trend similar NIH-CPSI scores. Five seven reported medication-related adverse events. CONCLUSION This placebo-controlled pilot study suggests that benefit some CPPS, but results do not justify recommending monotherapy, except who also have benign prostatic hyperplasia. A larger, properly powered study, possibly evaluating combination other therapies specifically hyperplasia, is required confirm any benefit.