TY - JOUR
T1 - Pregabalin for the treatment of men with chronic prostatitis/chronic pelvic pain syndrome
T2 - A randomized controlled trial
AU - Pontari, Michel A.
AU - Krieger, John N.
AU - Litwin, Mark S.
AU - White, Paige C.
AU - Anderson, Rodney U.
AU - McNaughton-Collins, Mary
AU - Nickel, J. Curtis
AU - Shoskes, Daniel A.
AU - Alexander, Richard B.
AU - O'Leary, Michael
AU - Zeitlin, Scott
AU - Chuai, Shannon
AU - Landis, J. Richard
AU - Cen, Liyi
AU - Propert, Kathleen J.
AU - Kusek, John W.
AU - Nyberg, Leroy M.
AU - Schaeffer, Anthony J.
PY - 2010/9/27
Y1 - 2010/9/27
N2 - 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 CP/CPPS. Trial Registration: clinicaltrials.gov Identifier: NCT00371033
AB - 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 CP/CPPS. Trial Registration: clinicaltrials.gov Identifier: NCT00371033
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U2 - 10.1001/archinternmed.2010.319
DO - 10.1001/archinternmed.2010.319
M3 - Article
C2 - 20876412
AN - SCOPUS:77957683070
SN - 0003-9926
VL - 170
SP - 1586
EP - 1593
JO - Archives of Internal Medicine
JF - Archives of Internal Medicine
IS - 17
ER -