The efficacy of combination therapy with Ningmitai capsule and sildenafil in men with chronic prostatitis/chronic pelvic pain syndrome and erectile dysfunction: a prospective, multicenter, randomized controlled trial
Abstract
BACKGROUND: A high proportion of men with chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) present with comorbid erectile dysfunction (ED), but evidence-based therapeutic interventions specifically targeting this patient population remain understudied in clinical trials.
AIM: To assess the efficacy of Ningmitai capsule (NMT), an oral traditional Chinese herbal formulation, combined with sildenafil versus monotherapy in alleviating symptoms among a cohort of participants with CP/CPPS and ED.
METHODS: A multi-center, randomized clinical trial was conducted from March 2019 to December 2022 at six tertiary hospitals in China. A total of 214 participants diagnosed with CP/CPPS and ED were randomized 1:2:2 to receive orally sildenafil (25 mg, q.n.), NMT (0.38 g × 4 capsules, t.i.d.), or a combination of both for 4 weeks. Validated Chinese version of the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI), the International Index of Erectile Function-5 (IIEF-5) and the Erection Hardness Score (EHS) questionnaires were administered at baseline, week 2, and week 4.
OUTCOMES: The primary endpoint was the reduction in NIH-CPSI pain domain scores from baseline to week 4.
RESULTS: All treatment groups exhibited statistically significant decreases in NIH-CPSI total, pain, urinary and quality of life (QoL) domain scores within 2 weeks, with improvements sustained until the end of the treatment. The combination group demonstrated superior pain score…
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: 214 participants or records.
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