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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

Year: 2025

Type: article

Study designs: Randomized Controlled Trial, Clinical 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 reductions versus sildenafil monotherapy at both timepoints (week 2: mean difference [MD] -2.82 ± 3.27 vs. -1.26 ± 3.45, P = 0.043; week 4, MD -3.57 ± 3.50 vs. -1.07 ± 2.94, P = 0.009). Notably, combination therapy achieved greater IIEF-5 score enhancements compared to NMT alone (P < 0.05) and higher responder rates than either sildenafil or NMT monotherapy (P < 0.05). No significant differences were found among the three arms concerning EHS. No adverse events were reported. Clinical Implications NMT-sildenafil combination therapy may serve as a viable alternative to α-blocker-based regimens for CP/CPPS-ED patients, potentially circumventing the orthostatic hypotension risk associated with the concurrent use of phosphodiesterase 5 inhibitors (PDE5i) and α-blockers. Strengths and Limitations Strengths include a prospective randomized design, which is well controlled. Limitations encompass the absence of placebo control and long-term follow-up. Conclusion NMT-sildenafil combination therapy demonstrates significantly greater benefits of ameliorating pain symptoms and improving erectile function in men with CP/CPPS and ED compared to either monotherapy, with favorable tolerability profiles. Registration The study protocol was reviewed and approved by the institutional ethics committee and was registered at ClinicalTrials.gov (NCT06064448).

Source: Sexual Medicine

DOI: 10.1093/sexmed/qfaf024