We randomized 100 patients diagnosed Category III A/III B prostatitis. 80 patients completed 12 weeks of follow-up and had primary and secondary outcomes ascertained. Flow chart of this study was presented in Fig. 1. In Eviprostat group, 7 patients were lost to follow-up and 2 patients declined to participate the study. In pollen extract group, 8 patients were lost to follow up and 3 patients declined to participate the study.
In Eviprostat group, there were 26 category IIIA patients and 15 category IIIB patients. In pollen extract group, there were 20 category IIIA patients and 19 category IIIB patients. There were no differences from baseline in the number of leukocytes in the prostatic secretion between the two groups.
The baseline characteristics of each study group are presented in Table 1. In the Quality of Life (QOL) domain of NIH-CPSI, there were significant differences between two groups. (p=0.014) Except for QOL domain, there were no significant differences between the two groups at the start of this study.
Response (defined as a decrease in the NIH-CPSI total score by at least 25 %) in the Eviprostat group and the pollen extract group at 4 week was 68.3 and 61.5 %, respectively. Response in the Eviprostat group and the pollen extract group was 88.2 and 78.1 %, respectively. There were no severe adverse events observed in any patients in this study (Table 2). There was no significant difference in the total, pain, urinary, and the QOL scores of the NIH-CPSI between the two groups at 4 weeks and 8 weeks (Fig. 2). There were no significant differences about the total, voiding, and storage symptoms of the IPSS between two groups (Fig. 3). There were no severe adverse events observed in any patients in this study.
Mean change from baseline in the NIH-CPSI total score and in the sub-score after 4 and 8 week of treatment with Cernilton group or Eviprostat group. a NIH-CPSI total score. b NIH-CPSI pain domain score. c NIH-CPSI urinary domain score. d NIH-CPSI QOL domain score
Mean change from baseline in the IPSS total score and in the sub-score after 4 and 8 week of treatment with Cernilton group or Eviprostat group. a IPSS total score. b IPSS storage score. c IPSS voiding score
BMC Urol. 2015;15(120) © 2015 BioMed Central, Ltd.