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.
Department of Urology, St. Vincent's Hospital, The Catholic University of Korea, College of Medicine, Suwon, Republic of Korea.
Hyun-Sop
HS
Choe
Department of Urology, St. Vincent's Hospital, The Catholic University of Korea, College of Medicine, Suwon, Republic of Korea. Electronic address: lee.seungju@gmail.com.
Seung-Ju
SJ
Lee
Department of Urology, Uijeongbu St. Mary's Hospital, The Catholic University of Korea, College of Medicine, Uijeongbu, Republic of Korea.
Chang Hee
CH
Han
Department of Urology, Ewha Womans University, School of Medicine, Seoul, Republic of Korea.
Bong Suk
BS
Shim
Department of Urology, St. Mary's Hospital, The Catholic University of Korea, College of Medicine, Seoul, Republic of Korea.
Yong-Hyun
YH
Cho
D000328:Adult; D002908:Chronic Disease / Q000188:drug therapy*; D002939:Ciprofloxacin / Q000627:therapeutic use*; D004008:Diclofenac / Q000031:analogs & derivatives* / Q000627:therapeutic use; D006801:Humans; D008297:Male; D017699:Pelvic Pain / Q000188:drug therapy*; D010865:Pilot Projects; D011446:Prospective Studies; D011472:Prostatitis / Q000188:drug therapy*; D015575:Roxithromycin / Q000627:therapeutic use*; D016896:Treatment Outcome; D055815:Young Adult
D004008:Diclofenac; D015575:Roxithromycin; D002939:Ciprofloxacin; C056498:aceclofenac
Chronic pelvic pain syndrome; Chronic prostatitis; Immunomodulation; Macrolide; Roxithromycin