Dec. 28, 2008 Alfuzosin, a drug commonly prescribed for men with chronic prostatitis, a painful disorder of the prostate and surrounding pelvic area, failed to significantly reduce symptoms in recently diagnosed men who had not been previously treated with this drug, according to a clinical trial sponsored by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), part of the National Institutes of Health (NIH).
The study is to be published in the New England Journal of Medicine.
"Although these results are disappointing, it is just as important to find out what doesn’t work as it is to know what does," said NIDDK Director Griffin P. Rodgers, M.D. "We have conclusively shown that a drug commonly prescribed for men with chronic prostatitis did not significantly reduce symptoms compared to a placebo."
Chronic prostatitis, which has no known cause and no uniformly effective therapy, is the most common type of prostatitis seen by physicians. Men with this condition experience pain in the genital and urinary tract areas, lower urinary tract symptoms such as pain in the bladder area and during urination, and sexual problems that can severely affect their quality of life. Population-based surveys estimate that 6 percent to 12 percent of men have prostatitis-like symptoms.
A total of 272 men diagnosed with chronic prostatitis were randomly assigned to take either alfuzosin or an identical-looking placebo. Of these, 233 men completed the trial. The primary outcome was a decrease (improvement) in the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) of at least four points over 12 weeks of treatment. A 4-point decrease in the NIH-CPSI score has been shown to be the minimal clinically significant difference perceived by patients as beneficial. The index measures the three most important symptoms of chronic prostatitis — pain, problems with urination, and negative effects on quality of life.
The rates of response of the NIH-CPSI in the alfuzosin group and placebo groups were the same — 49.4 percent. In addition, there were no significant differences between the two groups in the changes over time in most of the secondary outcomes, including the total NIH-CPSI score and a global response assessment.
Despite a lack of rigorous evidence supporting the use of antibiotics or alpha blockers for chronic prostatitis, more than three-fourths of primary care physicians often prescribe antibiotics and more than one-half regularly prescribe alpha blockers such as alfuzosin for the condition, according to a recent survey supported by NIDDK. Alpha blockers are a class of drugs that relax the smooth muscle of the bladder and prostate.
"Our findings do not support the use of alpha blockers for treating new cases of chronic prostatitis," said J. Curtis Nickel, M.D., of Queen’s University in Kingston, Ontario, Canada, and lead author of the study. "But the results of our study will inform future clinical trials of alpha blockers and other potential therapies."
Sanofi-Aventis, Paris, provided the study drug and placebo at no cost. The company was not involved in the design of the study, the analysis of data, or the preparation of the manuscript.
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