The efficacy and safety of Prostant ~(TM) in the treatment of chronic prostatitis: a multi-center,randomized,double-blind,placebo-controlled clinical trial
- VernacularTitle:前列安栓治疗慢性前列腺炎的安全性和有效性:随机双盲安慰剂对照试验
- Author:
Ningchen LI
;
Kai ZHANG
;
He XIAO
- Publication Type:Journal Article
- Keywords:
Prostatitis;
Therapeutics;
Clinical trial;
Prostant TM
- From:
Chinese Journal of Urology
2001;0(11):-
- CountryChina
- Language:Chinese
-
Abstract:
Objective To evaluate the efficacy and safety of Prostant TM and the patients’ compliance with the treatment of chronic prostatitis of different types. Methods A multi-central,randomized,double-blind,placebo-controlled clinical trial was conducted between June 2002 and December 2002.A total of 125 patients who had been diagnosed as chronic prostatitis and classified according to NIH classification system for prostatitis were divided into two groups: the trial group treated with Prostant TM anally one pill per night for 30 days and the control group given placebo in the same way.The efficacy was evaluated by the NIH chronic prostatitis symptom index (NIH-CPSI) and the WBC count in EPS after the treatment. Results Based on leukocyte and culture results,124 evaluable patients were stratified,with 48 cases of categories Ⅱ(38.7%),45 cases of Ⅲa(36.3%) and 31 cases of Ⅲb(25.0%)with chronic prostatitis.The overall NIH-CPSI scores were averagely reduced by 10.37 points in trial group and 6.65 in control group,and the symptom scores were averagely reduced by 7.34 in trial group and 4.72 in controll group,compared with pre-treatment.Significant differences of reduction were found between the two groups(P
