Ciprofloxacin or tamsulosin in men with chronic prostatitis/chronic pelvic pain syndrome: a randomized, double-blind trial.
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.
Alexander
Richard B
RB
Veterans Affairs Maryland Health Care System and University of Maryland School of Medicine, Baltimore, Maryland 21201, USA. ralexander@smail.umaryland.edu
Propert
Kathleen J
KJ
Schaeffer
Anthony J
AJ
Landis
J Richard
JR
Nickel
J Curtis
JC
O'Leary
Michael P
MP
Pontari
Michel A
MA
McNaughton-Collins
Mary
M
Shoskes
Daniel A
DA
Comiter
Craig V
CV
Datta
Nand S
NS
Fowler
Jackson E
JE
Nadler
Robert B
RB
Zeitlin
Scott I
SI
Knauss
Jill S
JS
Wang
Yanlin
Y
Kusek
John W
JW
Nyberg
Leroy M
LM
Litwin
Mark S
MS
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
D000317:Adrenergic alpha-Antagonists; D000890:Anti-Infective Agents; D010919:Placebos; D013449:Sulfonamides; D002939:Ciprofloxacin; D000077409:Tamsulosin