TY - JOUR
T1 - Alfuzosin and symptoms of chronic prostatitis-chronic pelvic pain syndrome
AU - Nickel, J. Curtis
AU - Krieger, John N.
AU - McNaughton-Collins, Mary
AU - Anderson, Rodney U.
AU - Pontari, Michel
AU - Shoskes, Daniel A.
AU - Litwin, Mark S.
AU - Alexander, Richard B.
AU - White, Paige C.
AU - Berger, Richard
AU - Nadler, Robert
AU - O'Leary, Michael
AU - Men, Long Liong
AU - Zeitlin, Scott
AU - Chuai, Shannon
AU - Landis, J. Richard
AU - Kusek, John W.
AU - Nyberg, Leroy M.
AU - Schaeffer, Anthony J.
PY - 2008/12/18
Y1 - 2008/12/18
N2 - BACKGROUND: In men with chronic prostatitis-chronic pelvic pain syndrome, treatment with alpha-adrenergic receptor blockers early in the course of the disorder has been reported to be effective in some, but not all, relatively small randomized trials. METHODS: We conducted a multicenter, randomized, double-blind, placebo-controlled trial to evaluate the efficacy of alfuzosin, an alpha-adrenergic receptor blocker, in reducing symptoms in men with chronic prostatitis-chronic pelvic pain syndrome. Participation in the study required diagnosis of the condition within the preceding 2 years and no previous treatment with an alpha-adrenergic receptor blocker. Men were randomly assigned to treatment for 12 weeks with either 10 mg of alfuzosin per day or placebo. The primary outcome was a reduction of at least 4 points (from baseline to 12 weeks) in the score on the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) (range, 0 to 43; higher scores indicate more severe symptoms). A 4-point decrease is the minimal clinically significant difference in the score. RESULTS: A total of 272 eligible participants underwent randomization, and in both study groups, 49.3% of participants had a decrease of at least 4 points in their total NIH-CPSI score (rate difference associated with alfuzosin,?0.1%; 95% confidence interval, -11.2 to 11.0; P = 0.99). In addition, a global response assessment showed similar response rates at 12 weeks: 33.6% in the placebo group and 34.8% in the alfuzosin group (P = 0.90). The rates of adverse events in the two groups were also similar. CONCLUSIONS: Our findings do not support the use of alfuzosin to reduce the symptoms of chronic prostatitis-chronic pelvic pain syndrome in men who have not received prior treatment with an alpha-blocker. (ClinicalTrials.gov number, NCT00103402.).
AB - BACKGROUND: In men with chronic prostatitis-chronic pelvic pain syndrome, treatment with alpha-adrenergic receptor blockers early in the course of the disorder has been reported to be effective in some, but not all, relatively small randomized trials. METHODS: We conducted a multicenter, randomized, double-blind, placebo-controlled trial to evaluate the efficacy of alfuzosin, an alpha-adrenergic receptor blocker, in reducing symptoms in men with chronic prostatitis-chronic pelvic pain syndrome. Participation in the study required diagnosis of the condition within the preceding 2 years and no previous treatment with an alpha-adrenergic receptor blocker. Men were randomly assigned to treatment for 12 weeks with either 10 mg of alfuzosin per day or placebo. The primary outcome was a reduction of at least 4 points (from baseline to 12 weeks) in the score on the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) (range, 0 to 43; higher scores indicate more severe symptoms). A 4-point decrease is the minimal clinically significant difference in the score. RESULTS: A total of 272 eligible participants underwent randomization, and in both study groups, 49.3% of participants had a decrease of at least 4 points in their total NIH-CPSI score (rate difference associated with alfuzosin,?0.1%; 95% confidence interval, -11.2 to 11.0; P = 0.99). In addition, a global response assessment showed similar response rates at 12 weeks: 33.6% in the placebo group and 34.8% in the alfuzosin group (P = 0.90). The rates of adverse events in the two groups were also similar. CONCLUSIONS: Our findings do not support the use of alfuzosin to reduce the symptoms of chronic prostatitis-chronic pelvic pain syndrome in men who have not received prior treatment with an alpha-blocker. (ClinicalTrials.gov number, NCT00103402.).
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U2 - 10.1056/NEJMoa0803240
DO - 10.1056/NEJMoa0803240
M3 - Article
C2 - 19092152
AN - SCOPUS:58049201997
SN - 0028-4793
VL - 359
SP - 2663
EP - 2673
JO - New England Journal of Medicine
JF - New England Journal of Medicine
IS - 25
ER -