Levofloxacin for chronic prostatitis/chronic pelvic pain syndrome in men: a randomized placebo-controlled multicenter trial.
OBJECTIVE
To perform a Canadian multicenter randomized placebo-controlled trial to evaluate the safety and efficacy of 6 weeks of levofloxacin therapy compared with placebo in chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS). Uncontrolled studies have supported the use of antibiotics in CP/CPPS.


METHODS
Men with a National Institutes of Health (NIH) diagnosis of CP/CPPS (specifically, no infection localized to the prostate) were randomized to levofloxacin (500 mg/day) or placebo for 6 weeks in 11 Canadian centers. Patients were assessed at baseline and at 3, 6, and 12 weeks with the NIH Chronic Prostatitis Symptom Index (NIH-CPSI) and global patient assessments (subjective global assessment and patient assessment questionnaire).


RESULTS
Eighty men (average age 56.0 years, range 36 to 78; duration of symptoms 6.5 years, range 0.6 to 32) were randomized to receive levofloxacin (n = 45) or placebo (n = 35). All were evaluated in an intent-to-treat analysis. Both groups experienced progressive improvement in symptoms as measured by the NIH-CPSI. However, the difference in response was not statistically or clinically significant at end of treatment (6 weeks) or at the end of the follow-up visits (12 weeks). No patients withdrew because of adverse events. One patient withdrew before the 6-week assessment. Adverse events (all mild) were reported in 20% of the levofloxacin group and 17% of the placebo group.


CONCLUSIONS
This pilot placebo-controlled study showed that 6 weeks of levofloxacin therapy in men diagnosed with CP/CPPS resulted in symptom improvement that was not significantly different from that with placebo at end of treatment or follow-up. The clinical ramifications of these findings need to be addressed.
Nickel
J Curtis
JC
Department of Urology, Queen's University, Kingston General Hospital, Kingston, Ontario, Canada.
Downey
Joe
J
Clark
Janet
J
Casey
Richard W
RW
Pommerville
Peter J
PJ
Barkin
Jack
J
Steinhoff
Gary
G
Brock
Gerald
G
Patrick
Allan B
AB
Flax
Stanley
S
Goldfarb
Bernard
B
Palmer
Bruce W
BW
Zadra
Joseph
J
D000328:Adult; D000368:Aged; D000890:Anti-Infective Agents / Q000009:adverse effects / Q000627:therapeutic use*; D002908:Chronic Disease; D004311:Double-Blind Method; D006801:Humans; D064704:Levofloxacin; D008297:Male; D008875:Middle Aged; D015242:Ofloxacin / Q000009:adverse effects / Q000627:therapeutic use*; D017699:Pelvic Pain / Q000188:drug therapy*; D010865:Pilot Projects; D011472:Prostatitis / Q000188:drug therapy*; D012449:Safety; D016896:Treatment Outcome
D000890:Anti-Infective Agents; D064704:Levofloxacin; D015242:Ofloxacin