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Ningmitai capsule in patients with chronic prostatitis/chronic pelvic pain syndrome: a multicenter, prospective,
Jingjing Gao1, Yao Zhang1, Junhua Du1
1Department of Urology, First Affiliated Hospital of Anhui Medical University, Hefei, Anhui, 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 < 0.05). At week 8, the percentage of patients achieving a ≥25% reduction in NIH-CPSI total score was significantly higher in the NMT (78.64% vs. 55.91%, P < 0.001) and combination groups (82.83% vs. 55.91%, 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.
Conclusion:
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.
Clinical Trial Registration:
ClinicalTrials.gov, identifier NCT05890235.
