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Efficacy and Safety of Ningmitai Capsule in Patients With Chronic Prostatitis/Chronic Pelvic Pain Syndrome: A Multicenter, Randomized, Double-blind, Placebo-controlled Trial.

Authors :
Zhang, Kai
Liu, Yuexin
Yang, Wenbo
Wang, Jiaji
Yang, Jianlin
Zhang, Guangyin
Bai, Wenjun
Chen, Shan
Source :
Urology. Jul2021, Vol. 153, p264-269. 6p.
Publication Year :
2021

Abstract

<bold>Objective: </bold>To validate the efficacy and safety of Ningmitai capsule (NMT) in the patients with chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS).<bold>Methods: </bold>We conducted a multicenter, randomized, double-blind, placebo-controlled trial in 120 men with CP/CPPS to evaluate the efficacy and safety of NMT. Participants were randomly assigned (1:1) to NMT or placebo treatment for 4 weeks at 3 centres. The patients were evaluated by the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) at baseline, the end of 2 and 4 weeks of treatment. The primary endpoints were the changes of the NIH-CPSI pain scores from baseline to the end of 2 and 4 weeks of the treatment. The secondary endpoints include the changes of the NIH-CPSI total scores, urinary symptoms scores and the quality of life (QoL) as well as the responder rate.<bold>Results: </bold>After 2 and 4 weeks of treatment, the mean decreases of the NIH-CPSI pain scores, total scores and QoL in the NMT group were all significantly superior to those in the placebo group. The responder rate was significantly higher in the NMT group than that in the placebo group at both 2 and 4 weeks. No adverse events were reported during the treatment.<bold>Conclusion: </bold>NMT could significantly improve the pain symptoms and QoL in the patients with CP/CPPS as early as in 2 weeks, and the efficacy enhanced at the end of the 4-week treatment. The safety of NMT was confirmed in this trial. [ABSTRACT FROM AUTHOR]

Details

Language :
English
ISSN :
00904295
Volume :
153
Database :
Academic Search Index
Journal :
Urology
Publication Type :
Academic Journal
Accession number :
151555517
Full Text :
https://doi.org/10.1016/j.urology.2021.01.018