Immunostimulation in chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS): a one-year prospective, double-blind, placebo-controlled study.
OBJECTIVE
Inflammation/immunological dysfunction are discussed etiological causes of chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS). OM-89 is an orally immunostimulating agent. We performed a phase three multicentre, randomized, double-blind, placebo-controlled, long-term (12 months) study with OM-89 produced with a different lysis process in patients with moderate-to-severe CP/CPPS type III.


METHODS
Patients were randomized to OM-89 or placebo. Primary efficacy variable was difference of responders at the end of treatment (month 9) in patients receiving OM-89 versus placebo.


RESULTS
Two hundred and three patients were screened, 185 patients (47.8 ± 8.4 years) (90 % of CP/CPPS type IIIb) were enrolled in 30 centers and included in the safety set. Ninety-four were randomized to OM-89, 91 to placebo. One hundred and seventy-six patients were subjected to the full analysis (FAS), 150 to the per protocol set (PPS). Baseline NIH-CPSI score in FAS was 21.8 ± 3.8 (OM-89) and 23.0 ± 5.6 (placebo). At primary efficacy endpoint (month 9), in the OM-89 group, 67.0 % in FAS (PPS 72.7 %) and in the placebo group, 64.3 % in FAS (PPS 64.4 %) were responders [FAS: OR 1.19, p = 0.59; PPS: p = 0.19]. Mean relative decrease in NIH-CPSI was 40.5 and 44.0 % in the FAS. Treatment-related adverse events were low: 8.5 % with OM-89 and 5.5 % with placebo. Because of small numbers, no conclusion could be drawn regarding the potential benefit of OM-89 in CP/CPPS IIIa.


CONCLUSIONS
This placebo-controlled study evaluating OM-89 in patients with CP/CPPS showed a significant and long-lasting (12 months) favorable response with OM-89, but also with placebo. OM-89 was safe and well tolerated.
2007-004609-85.
Clinic for Urology, Pediatric Urology and Andrology, Justus-Liebig-University Giessen, Rudolf-Buchheim-Str. 7, 35385, Giessen, Germany, Wagenlehner@AOL.com.
Florian M E
FM
Wagenlehner
Stefania
S
Ballarini
Kurt G
KG
Naber
D000276:Adjuvants, Immunologic / Q000627:therapeutic use*; D000328:Adult; D000942:Antigens, Bacterial / Q000627:therapeutic use*; D059350:Chronic Pain / Q000188:drug therapy*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D006801:Humans; D008297:Male; D008875:Middle Aged; D017699:Pelvic Pain / Q000188:drug therapy*; D010865:Pilot Projects; D011472:Prostatitis / Q000188:drug therapy*; D016896:Treatment Outcome
D000276:Adjuvants, Immunologic; D000942:Antigens, Bacterial; C050501:OM 89