RESUMEN
Objective: To evaluate the efficacy and safety of Ningmitai Capsule in the treatment towards type III prostatitis. Methods A randomized, double-blind, placebo-control clinical trial was conducted. A total of 50 patients diagnosed as type III prostatitis were divided into two groups with the ratio of 1:1. Patients of the trial group were treated with Ningmitai Capsule at the dose of four grain tid for 4 weeks, and patients of the control group were given placebo in the same way. The efficacy was evaluated by the NIH chronic prostatitis symptom index (NIH-CPSI) while safety-evaluation was evaluated by adverse events, results of urine routine examinations and hepatorenal-function tests. Results:After 4-week treatment, NIH-CPSI total scores were 23.96 ± 1.30 before treatment, and reduced to 16.04 ± 1.66 (P < 0.001). To the contrary, for all these scores, no significant statistical differences exist in placebo-control group. Pain-symptom scores, micturition-symptom scores and QOL scores were all statistically reduced in the trial group. No significant adverse events occurred in all patients who completed the study. Conclusion:Ningmitai Capsule is effective and safe in the treatment of type III prostatitis.
RESUMEN
Objective@#To study the safety and efficacy of Bushen Daozhuo Granules (BDG) in the treatment of type Ⅲ prostatitis.@*METHODS@#This multicenter randomized controlled clinical trial included 478 patients with type Ⅲ prostatitis, 290 in the trial group and 188 as controls, the former treated with BDG at 200 ml bid and the latter with tamsulosin hydrochloride sustainedrelease capsules at 0.2 mg qd, both for 4 weeks. Before treatment, after 4 weeks of medication, and at 4 weeks after drug withdrawal, we obtained the NIH Chronic Prostatitis Symptom Index (NIHCPSI) scores and compared the safety and effectiveness rate between the two groups of patients.@*RESULTS@#Compared with the baseline, the NIHCPSI score was markedly decreased in the control group after 4 weeks of medication (21.42 ± 4.02 vs 15.67 ± 3.65, P 0.05), while the NIHCPSI score in the trial group was remarkably lower than the baseline both after 4 weeks of medication and at 4 weeks after drug withdrawal (10.92 ± 2.06 and 12.91 ± 2.64 vs 21.58 ± 3.67, P < 0.05). The trial group exhibited both a higher rate of total effectiveness and safety than the control (P < 0.05).@*CONCLUSIONS@#BDG is safe and effective for the treatment of type Ⅲ prostatitis.