title: Ciprofloxacin or tamsulosin in men with chronic prostatitis/chronic pelvic pain syndrome: a randomized, double-blind trial.
abstract: 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.
  
  
  METHODS
  Randomized, double-blind trial with a 2 x 2 factorial design comparing 6 weeks of therapy with ciprofloxacin, tamsulosin, both drugs, or placebo.
  
  
  METHODS
  Urology outpatient clinics at 10 tertiary care medical centers in North America.
  
  
  METHODS
  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.
  
  
  METHODS
  The authors evaluated NIH-CPSI total score and subscores, patient-reported global response assessment, a generic measure of quality of life, and adverse events.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  Treatment lasting longer than 6 weeks was not tested. Patients who had received less pretreatment may have responded differently.
  
  
  CONCLUSIONS
  Ciprofloxacin and tamsulosin did not substantially reduce symptoms in men with long-standing CP/CPPS who had at least moderate symptoms.
authors.affiliation: Veterans Affairs Maryland Health Care System and University of Maryland School of Medicine, Baltimore, Maryland 21201, USA. ralexander@smail.umaryland.edu
authors.forename: Richard B
authors.initials: RB
authors.lastname: Alexander
authors.forename: Kathleen J
authors.initials: KJ
authors.lastname: Propert
authors.forename: Anthony J
authors.initials: AJ
authors.lastname: Schaeffer
authors.forename: J Richard
authors.initials: JR
authors.lastname: Landis
authors.forename: J Curtis
authors.initials: JC
authors.lastname: Nickel
authors.forename: Michael P
authors.initials: MP
authors.lastname: O'Leary
authors.forename: Michel A
authors.initials: MA
authors.lastname: Pontari
authors.forename: Mary
authors.initials: M
authors.lastname: McNaughton-Collins
authors.forename: Daniel A
authors.initials: DA
authors.lastname: Shoskes
authors.forename: Craig V
authors.initials: CV
authors.lastname: Comiter
authors.forename: Nand S
authors.initials: NS
authors.lastname: Datta
authors.forename: Jackson E
authors.initials: JE
authors.lastname: Fowler
authors.forename: Robert B
authors.initials: RB
authors.lastname: Nadler
authors.forename: Scott I
authors.initials: SI
authors.lastname: Zeitlin
authors.forename: Jill S
authors.initials: JS
authors.lastname: Knauss
authors.forename: Yanlin
authors.initials: Y
authors.lastname: Wang
authors.forename: John W
authors.initials: JW
authors.lastname: Kusek
authors.forename: Leroy M
authors.initials: LM
authors.lastname: Nyberg
authors.forename: Mark S
authors.initials: MS
authors.lastname: Litwin
mesh_terms: D000317:Adrenergic alpha-Antagonists / Q000627:therapeutic use*; D000328:Adult; D000890:Anti-Infective Agents / Q000627:therapeutic use*; D002908:Chronic Disease; D002939:Ciprofloxacin / Q000627:therapeutic use*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D006801:Humans; D008297:Male; D008875:Middle Aged; D017699:Pelvic Pain / Q000188:drug therapy*; D010919:Placebos; D011472:Prostatitis / Q000188:drug therapy*; D013449:Sulfonamides / Q000627:therapeutic use*; D013577:Syndrome; D000077409:Tamsulosin; D017211:Treatment Failure
chemical_list: D000317:Adrenergic alpha-Antagonists; D000890:Anti-Infective Agents; D010919:Placebos; D013449:Sulfonamides; D002939:Ciprofloxacin; D000077409:Tamsulosin