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In a trial of alpha-blocker therapy for men with newly diagnosed chronic prostatitis/chronic pelvic pain syndrome, placebo and treatment groups had the same proportion of responders: 49 percent.
"It was a great hypothesis ruined by good science," said J. Curtis Nickel, MD, professor of urology, Queens University in Kingston, Ontario, who presented the results of the Chronic Prostatitis Collaborative Research Network study of alfuzosin (Uroxatral) for alpha blocker-naïve men whose disease state was diagnosed within 2 years prior to the study.
Although hopes for a good outcome were dashed, well-designed and controlled trials are just what the field needs for urologists to find treatments that truly help their patients and avoid the expense, side effects, and, most important, continued suffering when they resort to treatments that do not really work.
Investigators defined response as a four-point decrease in the NIH CPSI total score, which was considered the minimum for clinical significance. The secondary outcome measure was the GRA, with response defined as moderate to marked improvement in overall symptoms.
The hopeful investigators had predicted a response rate of 40% in the placebo arm and 60% in the alfuzosin arm, and the trial process further raised expectations.
"The trial ran flawlessly," Dr. Nickel said. "It's not very often when you're part of a clinical trial where the enrollment turned out exactly as you had targeted."
But on the major outcome measure, each group had the same proportion of responders: 49%. Based on the GRA, the percentage of responders was nearly as well matched: 33.5% for placebo and 34.8% for alfuzosin. None of the differences in scores on any of the other questionnaires reached statistical significance.
Often prescribed for men with CP/CPPS, anti-inflammatory medications and antibiotics were also shown in very large, randomized, placebo-controlled trials not to work as well as expected.
Consequently, urologists pinned their hope on alpha-blockade because smaller trials had shown improvement with the agent, because alpha-blockers improve lower urinary tract symptoms in BPH, and because pharmacologic research indicated some potential in these agents for reducing pain and neurogenic inflammation.
The trial outcome may not be an argument for abandoning alpha-blockade entirely in men with CP/CPPS because these medications are valuable for LUTS in BPH, which patients may also have.
Other limitations include the possibility that the use of a different alpha-blocker for a longer period of time in a targeted group of patients (eg, only patients with associated voiding symptoms) may have shown better results. But urologists can aim to relieve symptoms such as pain with targeted therapies and may look to techniques such as pelvic floor-directed physical therapy, acupuncture, and transrectal electrical stimulation, which increasingly show efficacy in relieving CP/CPPS.