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

Abstract

To validate the efficacy and safety of Ningmitai capsule (NMT) in the patients with chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS). 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. 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. 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.