Ningmitai Capsule in Patients with Chronic Prostatitis/Chronic Pelvic Pain Syndrome: A Multicenter, Prospective, Randomized, Parallel, Positive-controlled Study

Jingjing Gao¹Yao Zhang¹Junhua Du¹Qiang Liu²Yi Cheng³Wentao Yang⁴Daoyuan Wang⁵Wei Wang⁶Liang Zheng⁷Dong Wang⁸Lixin Wu⁹Xiaolei Jiang¹⁰Qunli Men¹¹Chaozhao Liang^1*Xiansheng Zhang^1*

• ¹Department of Urology, First Affiliated Hospital of Anhui Medical University, Hefei, China
• ²Department of Urology, 9 O 3 Hospital, Jiangyou, Sichuan Province, 621700, China
• ³Department of Andrology, First Affiliated Hospital of Anhui University of Traditional Chinese Medicine, Hefei, Anhui Province, 230031, China
• ⁴Department of Andrology, Ruikang Hospital Affiliated to Guangxi University of Chinese Medicine, Nanning, Guangxi Province, 530011, China
• ⁵Department of Urology, 989 Hospital of Joint Service Support Force of Chinese People's Liberation Army, Luoyang, Henan Province, 471032, China
• ⁶Department of Urology, Hefei Second People's Hospital, Hefei, Anhui Province, 230012, China
• ⁷Department of Urology, Second Affiliated Hospital of Xi'an Medical College, Xi'an, Shaanxi Province, 710005, China
• ⁸Department of Urology, Huantai Branch, Qilu Hospital, Zibo, Shandong Province, 256400, China
• ⁹Department of Urology, Hefei Third People's Hospital, Hefei, Anhui Province, 230022, China
• ¹⁰Department of Urology, Mianyang 404 Hospital, Mianyang, Sichuan Province, 621053, China
• ¹¹Department of Urology, Baoji Central Hospital, Baoji, Shaanxi Province, 721008, China

Background: CP/CPPS is characterized by pain, the primary symptom, which significantly affects QoL and disrupts lower urinary tract function. Conventional monotherapies are often ineffective, necessitating multimodal treatments targeting key symptoms. Methods: This multicenter, prospective, randomized, parallel, positive-controlled trial enrolled 323 men aged 18-60 years with CP/CPPS across 14 centers in China. Participants were randomly assigned to three groups: tamsulosin 0.2 mg daily, Ningmitai capsule (NMT) 1.52 g thrice daily, or a combination of both, for 8 weeks. The primary endpoint was the change in the total NIH-CPSI score from baseline to week 8. Secondary endpoints included changes in pain, urinary, QoL subdomains, the percentage of patients achieving a ≥25% reduction in NIH-CPSI total score, and pain scores. Safety was monitored through adverse events and liver function tests. Results: Of the 323 patients, 108 received tamsulosin, 109 NMT, and 106 combination therapy. After 8 weeks, both NMT and combination therapy demonstrated significantly greater reductions in total NIH-CPSI scores compared to tamsulosin (-11.44 vs. -8.58, P < 0.001; -11.94 vs. -8.58, P < 0.001). Combination therapy also significantly reduced pain (P = 0.001) and improved QoL (P < 0.001) compared to tamsulosin. The NMT group showed greater improvements in pain scores at both 4 and 8 weeks compared to tamsulosin (P < 0.001). At week 8, the percentage of patients achieving a ≥25% reduction in NIH-CPSI total score was significantly higher in the NMT (87.10% vs. 65.82%, P < 0.001) and combination groups (85.42% vs. 65.82%, P < 0.001). Subgroup analyses indicated that NMT was most effective in patients with mild to moderate CP/CPPS, younger age (18-34 years), and disease duration of <12 months. No serious adverse events occurred, and NMT was well-tolerated across all groups. Conclusions: NMT demonstrated superior efficacy over tamsulosin in reducing pain and improving QoL in CP/CPPS patients. Combination therapy provided enhanced symptom relief, particularly in micturition and QoL domains, supporting a multimodal approach for more effective CP/CPPS management. These findings validate NMT as a promising treatment, either alone or in combination, for CP/CPPS. Further long-term studies are needed to optimize its use.