Pregabalin for the treatment of men with chronic prostatitis/chronic pelvic pain
syndrome: a randomized controlled trial.
Author(s): Pontari MA, Krieger JN, Litwin MS, White PC, Anderson RU, McNaughton-Collins M,
Nickel JC, Shoskes DA, Alexander RB, O'Leary M, Zeitlin S, Chuai S, Landis JR,
Cen L, Propert KJ, Kusek JW, Nyberg LM Jr, Schaeffer AJ; Chronic Prostatitis
Collaborative Research Network-2.
Affiliation(s): Department of Urology, Temple University School of Medicine, Philadelphia,
Pennsylvania 19140, USA. Pontarm@tuhs.temple.edu
Publication date & source: 2010, Arch Intern Med. , 170(17):1586-93
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.
CONCLUSION: 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
TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00371033.