BJU Int. 2004 May;93(7):991-5.

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).

Nickel JC, Downey J, Pontari MA, Shoskes DA, Zeitlin SI.

Queen's University, Kingston, ON, Canada.

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