Clinical efficacy of roxithromycin in men with chronic prostatitis/chronic pelvic pain syndrome in comparison with ciprofloxacin and aceclofenac: A prospective, randomized, multicenter pilot trial

Roxithromycin is effective in the treatment of intracellular organisms, including chlamydia and mycoplasma, and exhibits anti-inflammatory and immunomodulatory effects on respiratory diseases. To explore the potential therapeutic benefit of roxithromycin in chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS), this study compared the effect of roxithromycin with ciprofloxacin and aceclofenac. A total of 75 patients with CP/CPPS were randomized to three groups in open-label: group 1, ciprofloxacin; group 2, aceclofenac; and group 3, roxithromycin. The patients were treated for 4 weeks and were subsequently followed for 12 weeks. Changes from baseline in the total and domain scores of the NIH Chronic Prostatitis Symptom Index (NIH-CPSI) were evaluated. The NIH-CPSI score decreased in the roxithromycin, ciprofloxacin, and aceclofenac groups to a similar degree. The NIH-CPSI initial and 12-week total scores were 20.3 and 10.0, respectively, in group 1; 23.6 and 14.3, respectively, in group 2; and 21.1 and 9.8, respectively, in group 3. The three treatment arms did not differ significantly with respect to the efficiency of treatment (p > 0.05). Compared to patients in groups 1 and 2, group 3 patients with Category IIIb disease exhibited favorable results upon follow-up 12 weeks after treatment. The International Prostate Symptom Score (IPSS), uroflowmetry, and post-void residual volume were equivalent between the groups. Roxithromycin exhibits similar or favorable effects on the improvement of CP/CPPS compared to ciprofloxacin and aceclofenac. Roxithromycin could be used as a new therapeutic agent for CP/CPPS. Further study of the immunomodulatory action of roxithromycin in CP/CPPS is required. (ClinicalTrials.gov Identifier: NCT01843946).