Ningmitai capsule in patients with chronic prostatitis/chronic pelvic pain syndrome: a multicenter, prospective, randomized, parallel, positive-controlled study
Abstract
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 P P = 0.001) and improved QoL (P P P 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…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 323 participants or records.
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