AUA: Antibiotic Treatment No Better than Placebo in Chronic
Prostatitis/Chronic Pelvic Pain Syndrome

By Jill Stein

CHICAGO, IL -- April 28, 2003 -- A six-week course of therapy with the antibiotic levofloxacin produces quick, significant improvement in symptoms in men with chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS), according to results announced here April 26th at the 2003 Annual Meeting of the American Urological Association.

The investigators emphasized, however, that while the improvement continued during and after treatment, the level of improvement was not different from that associated with placebo.

Dr. J. Curtis Nickel, from the department of urology at Queen's University, and associates with the Prostatitis Research Group in Kingston, Ontario, Canada, presented results in 70 men with a diagnosis of CP/CPPS confirmed by National Institutes of Health (NIH) category III criteria (non-bacterial prostatitis/prostatodynia).

Patients in the study were randomized to levofloxacin 500 mg/day or placebo. At enrollment, all subjects experienced symptoms of discomfort or pain in the pelvic region for at least 3 months during the prior 6 months.

Both treatment groups experienced a progressive improvement in symptoms and the levofloxacin group had a larger decrease in symptom score and a higher number of responders than placebo.

The decrease in NIH- Chronic Prostatitis Symptom Index (CPSI) in the levofloxacin group compared to the placebo group was most pronounced at 3 weeks.

There was a numerical but not significant increased responder rate in the levofloxacin group compared to the placebo group at 3, 6, and 12 weeks measured by the percentage of patients with a 25% and six-point decrease in total NIH-CPSI. Similar differences were noted in the Subjective Global Assessment questionnaire.

Side effects were generally mild and were reported in 12.5% of the antibiotic and 23% of the placebo groups, respectively."The results show that the early improvement in the levofloxacin group did
not evolve into a significant benefit compared to placebo," said Dr. Nickel. An assessment of the clinical implications of this study can only be made after larger, multi-center, randomized, placebo-controlled trials are completed, he added.

The study was funded by Janssen-Ortho Canada.


[Study title: Levofloxacin Treatment for Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS) in Men: A randomized Placebo Controlled Multicenter trial. Abstract 104.]