• Richard B Alexander, Kathleen J Propert, Anthony J Schaeffer, J Richard Landis, J Curtis Nickel, Michael P O'Leary, Michel A Pontari, Mary McNaughton-Collins, Daniel A Shoskes, Craig V Comiter, Nand S Datta, Jackson E Fowler, Robert B Nadler, Scott I Zeitlin, Jill S Knauss, Yanlin Wang, John W Kusek, Leroy M Nyberg, Mark S Litwin, and Chronic Prostatitis Collaborative Research Network.
• Veterans Affairs Maryland Health Care System and University of Maryland School of Medicine, Baltimore, Maryland 21201, USA. ralexander@smail.umaryland.edu
• Ann. Intern. Med. 2004 Oct 19;141(8):581-9.

BackgroundChronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) in men is principally defined by pain in the pelvic region lasting more than 3 months. No cause of the disease has been established, and therapies are empirical and mostly untested. Antimicrobial agents and alpha-adrenergic receptor blockers are frequently used.ObjectiveTo determine whether 6-week therapy with ciprofloxacin or tamsulosin is more effective than placebo at improving symptoms in men with refractory, long-standing CP/CPPS.DesignRandomized, double-blind trial with a 2 x 2 factorial design comparing 6 weeks of therapy with ciprofloxacin, tamsulosin, both drugs, or placebo.SettingUrology outpatient clinics at 10 tertiary care medical centers in North America.PatientsPatients were identified from referral-based practices of urologists. One hundred ninety-six men with a National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) score of at least 15 and a mean of 6.2 years of symptoms were enrolled. Patients had received substantial previous treatment.MeasurementsThe authors evaluated NIH-CPSI total score and subscores, patient-reported global response assessment, a generic measure of quality of life, and adverse events.InterventionsCiprofloxacin, 500 mg twice daily; tamsulosin, 0.4 mg once daily; a combination of the 2 drugs; or placebo.ResultsThe NIH-CPSI total score decreased modestly in all treatment groups. No statistically significant difference in the primary outcome was seen for ciprofloxacin versus no ciprofloxacin (P = 0.15) or tamsulosin versus no tamsulosin (P > 0.2). Treatments also did not differ significantly for any of the secondary outcomes.LimitationsTreatment lasting longer than 6 weeks was not tested. Patients who had received less pretreatment may have responded differently.ConclusionCiprofloxacin and tamsulosin did not substantially reduce symptoms in men with long-standing CP/CPPS who had at least moderate symptoms.

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