Pregabalin for the treatment of men with chronic prostatitis/chronic pelvic pain syndrome: a randomized controlled trial.
BACKGROUND
Evidence suggests that the urogenital pain of chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) may be neuropathic.


METHODS
This randomized, double-blind, placebo-controlled trial was conducted across 10 tertiary care centers in North America to determine whether pregabalin, which has been proved effective in other chronic pain syndromes, is effective in reducing CP/CPPS symptoms. In 2006-2007, 324 men with pelvic pain for at least 3 of the previous 6 months were enrolled in this study. Men were randomly assigned to receive pregabalin or placebo in a 2:1 ratio and were treated for 6 weeks. Pregabalin dosage was increased from 150 to 600 mg/d during the first 4 weeks. The primary outcome was a 6-point decrease in the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) total score. Multiple secondary outcomes were assessed.


RESULTS
Of 218 men assigned to receive pregabalin, 103 (47.2%) reported at least a 6-point decrease in the NIH-CPSI total score at 6 weeks compared with 35.8% (38 of 106 men) assigned to receive placebo (P = .07, exact Mantel-Haenszel test, adjusting for clinical sites). Compared with the placebo group, men assigned to receive pregabalin experienced reductions in the NIH-CPSI total score and subscores (P < .05), a higher Global Response Assessment response rate (31.2% and 18.9%; P = .02), and improvement in total McGill Pain Questionnaire score (P = .01). Results for the other outcomes did not differ between groups.


CONCLUSIONS
Pregabalin therapy for 6 weeks was not superior to placebo use in the rate of a 6-point decrease (improvement) in the NIH-CPSI total score in men with CP/CPPS.


BACKGROUND
clinicaltrials.gov Identifier: NCT00371033.
Pontari
Michel A
MA
Department of Urology, Temple University School of Medicine, Philadelphia, Pennsylvania 19140, USA. Pontarm@tuhs.temple.edu
Krieger
John N
JN
Litwin
Mark S
MS
White
Paige C
PC
Anderson
Rodney U
RU
McNaughton-Collins
Mary
M
Nickel
J Curtis
JC
Shoskes
Daniel A
DA
Alexander
Richard B
RB
O'Leary
Michael
M
Zeitlin
Scott
S
Chuai
Shannon
S
Landis
J Richard
JR
Cen
Liyi
L
Propert
Kathleen J
KJ
Kusek
John W
JW
Nyberg
Leroy M
LM
Schaeffer
Anthony J
AJ
D000328:Adult; D000368:Aged; D000700:Analgesics / Q000627:therapeutic use*; D002170:Canada; D002908:Chronic Disease; D004311:Double-Blind Method; D006785:Hospitals, University; D006801:Humans; D008297:Male; D008875:Middle Aged; D017699:Pelvic Pain / Q000175:diagnosis / Q000188:drug therapy* / Q000209:etiology; D000069583:Pregabalin; D011472:Prostatitis / Q000150:complications*; D016896:Treatment Outcome; D014481:United States; D005680:gamma-Aminobutyric Acid / Q000031:analogs & derivatives* / Q000627:therapeutic use
D000700:Analgesics; D000069583:Pregabalin; D005680:gamma-Aminobutyric Acid