- Comment in:
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Ann Intern Med. 2004 Oct 19;141(8):639-40.
- Summary for patients in:
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Ann Intern Med. 2004 Oct 19;141(8):I8.
Ciprofloxacin or tamsulosin in men with chronic prostatitis/chronic pelvic pain syndrome: a randomized, double-blind trial.
Alexander RB,
Propert KJ,
Schaeffer AJ,
Landis JR,
Nickel JC,
O'Leary MP,
Pontari MA,
McNaughton-Collins M,
Shoskes DA,
Comiter CV,
Datta NS,
Fowler JE Jr,
Nadler RB,
Zeitlin SI,
Knauss JS,
Wang Y,
Kusek JW,
Nyberg LM Jr,
Litwin MS;
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
BACKGROUND: Chronic 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. OBJECTIVE: To 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. DESIGN: Randomized, double-blind trial with a 2 x 2 factorial design comparing 6 weeks of therapy with ciprofloxacin, tamsulosin, both drugs, or placebo. SETTING: Urology outpatient clinics at 10 tertiary care medical centers in North America. PATIENTS: Patients 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. MEASUREMENTS: The authors evaluated NIH-CPSI total score and subscores, patient-reported global response assessment, a generic measure of quality of life, and adverse events. Interventions: Ciprofloxacin, 500 mg twice daily; tamsulosin, 0.4 mg once daily; a combination of the 2 drugs; or placebo. RESULTS: The 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. LIMITATIONS: Treatment lasting longer than 6 weeks was not tested. Patients who had received less pretreatment may have responded differently. CONCLUSION: Ciprofloxacin and tamsulosin did not substantially reduce symptoms in men with long-standing CP/CPPS who had at least moderate symptoms.
PMID: 15492337 [PubMed - indexed for MEDLINE]
