A controlled trial found no benefit from alfuzosin for men with chronic prostatitis-chronic pelvic pain syndrome who had not previously received the drug.
Chronic pelvic pain due to prostatitis is common and has significant adverse effects on the quality of life for men who suffer it. In most cases persisting longer than 3 months, the cause is thought to be non-infectious, and it is generally referred to as the chronic prostatitis-chronic pelvic pain syndrome. Treatment with alpha-adrenergic receptor blocking drugs (alpha-blockers) has been reported to be useful in reducing symptoms, especially for men who have not previously received these drugs, however the trials have been small and results have been equivocal. This study aimed to test an alpha-blocker, alfuzosin, as a treatment for this syndrome in men who had recently been diagnosed and who had not previously received a drug of this type.
Participants were men with symptoms of the syndrome diagnosed within the previous two years, and not previously treated with an alpha-blocker. Other exclusion criteria included recent use of a 5-alpha reductase inhibitor, documented UTI, and use of potentially interacting medications. They were randomised to treatment with alfuzosin or placebo for twelve weeks, and were assessed for symptoms at baseline, week 6, and week 12. Symptoms were scored according to a standard measure, the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI): this ranges from 0 to 43, with higher scores indicating more severe symptoms. Power calculations indicated that a total study sample of 270 participants would be required. Primary outcome was a decrease of 4 points in the symptom score, the minimum considered to be clinically relevant.
Initially, 2957 potential participants were contacted: 2172 were ineligible, 322 declined participation, and 75 did not respond, leaving 388 who agreed to participate. Of these, 272 were actually randomised to treatment, 134 to placebo and 138 to alfuzosin, of whom 233 (117 and 116 respectively) completed the study. There was no significant difference in the primary outcome measure between the two groups, with 49.3% in both having a 4-point or greater decrease in symptom score. Additionally, no significant differences were seen in secondary outcomes, including adverse event rates.
Based on the results, the authors conclude that a twelve-week course of alfuzosin did not give a clinically meaningful reduction in symptoms of chronic prostatitis-chronic pelvic pain syndrome in this study group. They discuss the findings, noting that they do not exclude a possible benefit from longer term treatment, or in men with a shorter duration of symptoms. Nevertheless, they do not support the routine use of these drugs as initial therapy in this patient group