Luo Daosheng, Guo Jintao, Chen Tongwen, Liu Guihua, Luo Peng, Deng Zhiquan, Tang Yu Xin, Liao Yongbin, Deng Chunhua
Department of Urology, Dongguan People's Hospital, Dongguan 523000, China.
Reproductive Medicine Centre, The Sixth Affiliated Hospital, Sun Yat-Sen University, Guangzhou 510000, China.
Sex Med. 2025 May 13;13(2):qfaf024. doi: 10.1093/sexmed/qfaf024. eCollection 2025 Apr.
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.
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.
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.
The primary endpoint was the reduction in NIH-CPSI pain domain scores from baseline to week 4.
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, = 0.043; week 4, MD -3.57 ± 3.50 vs. -1.07 ± 2.94, = 0.009). Notably, combination therapy achieved greater IIEF-5 score enhancements compared to NMT alone ( 0.05) and higher responder rates than either sildenafil or NMT monotherapy ( 0.05). No significant differences were found among the three arms concerning EHS. No adverse events were reported.
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 include a prospective randomized design, which is well controlled. Limitations encompass the absence of placebo control and long-term follow-up.
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.
The study protocol was reviewed and approved by the institutional ethics committee and was registered at ClinicalTrials.gov (NCT06064448).
慢性前列腺炎/慢性盆腔疼痛综合征（CP/CPPS）男性患者中很大一部分伴有勃起功能障碍（ED）合并症，但针对该患者群体的循证治疗干预措施在临床试验中仍未得到充分研究。
评估口服中药制剂宁泌泰胶囊（NMT）联合西地那非与单一疗法相比，在缓解一组CP/CPPS合并ED参与者症状方面的疗效。
2019年3月至2022年12月在中国六家三级医院进行了一项多中心随机临床试验。总共214名被诊断为CP/CPPS和ED的参与者按1:2:2随机分组，口服西地那非（25毫克，每晚一次）、NMT（0.38克×4粒胶囊，每日三次）或两者联合用药，为期4周。在基线、第2周和第4周时，使用经过验证的中文版美国国立卫生研究院慢性前列腺炎症状指数（NIH-CPSI）、国际勃起功能指数-5（IIEF-5）和勃起硬度评分（EHS）问卷进行评估。
所有治疗组在2周内NIH-CPSI总分、疼痛、排尿和生活质量（QoL）领域评分均有统计学意义的下降，且改善持续至治疗结束。联合治疗组在两个时间点的疼痛评分降低均优于西地那非单一疗法（第2周：平均差值[MD]-2.82±3.27对-1.26±3.45，P=0.043；第4周，MD-3.57±3.50对-1.07±2.94，P=0.009）。值得注意的是，联合治疗与单独使用NMT相比，IIEF-5评分提高幅度更大（P<0.05）且应答率高于西地那非或NMT单一疗法（P<0.05）。三组在EHS方面未发现显著差异。未报告不良事件。
NMT-西地那非联合治疗可能是CP/CPPS-ED患者基于α受体阻滞剂方案的可行替代方案，可能规避与同时使用磷酸二酯酶5抑制剂（PDE5i）和α受体阻滞剂相关的体位性低血压风险。
优点包括前瞻性随机设计且控制良好。局限性包括缺乏安慰剂对照和长期随访。
与单一疗法相比,NMT-西地那非联合治疗在改善CP/CPPS合并ED男性的疼痛症状和勃起功能方面具有显著更大的益处，且耐受性良好。
该研究方案经机构伦理委员会审查并批准，并在ClinicalTrials.gov（NCT06064448）注册。
