title: A randomized, placebo controlled, multicenter study to evaluate the safety and efficacy of rofecoxib in the treatment of chronic nonbacterial prostatitis.
abstract: OBJECTIVE
  We determine the effects of treatment with rofecoxib and placebo in patients with chronic prostatitis.
  
  
  METHODS
  Patients diagnosed with chronic nonbacterial prostatitis were randomized to 6 weeks of 25 or 50 mg., rofecoxib or placebo in a double-blind multicenter study with a 1-week run in of placebo. End points included the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) (average pain score item 4 primary end point), and patient global assessment questions of pain, disease activity and response to therapy.
  
  
  RESULTS
  A total of 161 patients were randomized in the study. The NIH-CPSI total, domain and pain scores significantly decreased from baseline in all groups and, although the mean scores numerically favored the rofecoxib groups, the difference was not significantly different among groups. There was a trend for the percentage of patients with a 25% (or 6 point) improvement in total score being superior on rofecoxib versus placebo with the difference being significantly different (p <0.05) for the 50 mg. rofecoxib group. Patient global assessment of pain, response to therapy and disease activity also favored rofecoxib over placebo (p <0.05, p = 0.07, p = 0.06, respectively). Of the patients 79% on 50 mg. rofecoxib versus 59% on placebo reported no or mild pain, and 56% of patients on 50 mg. rofecoxib versus 27% on placebo experienced significant improvement in quality of life (p <0.005). Rofecoxib was generally well tolerated.
  
  
  CONCLUSIONS
  To our knowledge this study is the first to evaluate rofecoxib versus placebo in patients with prostatitis and the first large multicenter treatment study to use the NIH-CPSI. Subjective assessment with patient global questions may be more sensitive to change than the NIH-CPSI and, therefore, may be a better tool to use in future therapeutic trials. Although 6 weeks of rofecoxib treatment appear to benefit many men diagnosed with chronic prostatitis/chronic pelvic pain syndrome further studies are needed.
authors.affiliation: Department of Urology, Queen's University, Kingston General Hospital, Ontario, Canada.
authors.forename: J Curtis
authors.initials: JC
authors.lastname: Nickel
authors.forename: Michel
authors.initials: M
authors.lastname: Pontari
authors.forename: Timothy
authors.initials: T
authors.lastname: Moon
authors.forename: Marc
authors.initials: M
authors.lastname: Gittelman
authors.forename: Gholam
authors.initials: G
authors.lastname: Malek
authors.forename: Jean
authors.initials: J
authors.lastname: Farrington
authors.forename: Jay
authors.initials: J
authors.lastname: Pearson
authors.forename: David
authors.initials: D
authors.lastname: Krupa
authors.forename: Mark
authors.initials: M
authors.lastname: Bach
authors.forename: Jennifer
authors.initials: J
authors.lastname: Drisko
mesh_terms: D000328:Adult; D000368:Aged; D002908:Chronic Disease; D052246:Cyclooxygenase 2 Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D006801:Humans; D007783:Lactones / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D010147:Pain Measurement; D017699:Pelvic Pain / Q000188:drug therapy* / Q000209:etiology; D011472:Prostatitis / Q000175:diagnosis / Q000188:drug therapy*; D013450:Sulfones
chemical_list: D052246:Cyclooxygenase 2 Inhibitors; D007783:Lactones; D013450:Sulfones; C116926:rofecoxib