Morgia Giuseppe, Russo Giorgio Ivan, Urzì Daniele, Privitera Salvatore, Castelli Tommaso, Favilla Vincenzo, Cimino Sebastiano
Urology section, Department of Surgery, University of Catania.
Arch Ital Urol Androl. 2017 Jun 30;89(2):110-113. doi: 10.4081/aiua.2017.2.110.
The management of chronic prostatitis/ chronic pelvic pain syndrome type III (CP/CPPS) has been always considered complex due to several biopsychological factors underling the disease. In this clinical study, we aimed to evaluate the efficacy of the treatment with Curcumin and Calendula extract in patients with CP/CPPS III.
From June 2015 to January 2016 we enrolled 60 consecutive patients affected by CP/CPPS III in our institution. Patients between 20 and 50 year of age with symptoms of pelvic pain for 3 months or more before study, a total National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) score ≥ 15 point and diagnosed with NIH category III. Patients were then allocated to receive placebo (Group A) or treatment (Group B). Treatment consisted of rectal suppositories of Curcumin extract 350 mg (95%) and Calendula extract 80 mg (1 suppository/die for 1 month). Patients of Group B received 1 suppository/die for 1 month of placebo. The primary endpoint of the study was the reduction of NIH-CPSI. The secondary outcomes were the change of peak flow, IIEF-5, VAS score and of premature ejaculation diagnostic tool (PEDT).
A total of 48 patients concluded the study protocol. The median age of the all cohort was 32.0 years, the median NIH-CPSI was 20.5, the median IIEF-5 was 18.5, the median PEDT was 11.0, the median VAS score was 7.5 and the median peak flow was 14.0. After 3 months of therapy in group A we observed a significant improvement of NIH-CPSI (-5.5; p < 0.01), IIEF-5 (+ 3.5; p < 0.01), PEDT (-6.5; p < 0.01), peak flow (+2.8; p < 0.01) and VAS (-6.5; p < 0.01) with significant differences over placebo group (all p-value significant).
In this phase II clinical trial we showed the clinical efficacy of the treatment with Curcumin and Calendula in patients with CP/CPPS III. The benefits of this treatment could be related to the reduction of inflammatory cytokines and of inflammatory cells. These results should be confirmed in further studies with greater sample size.
由于慢性前列腺炎/III型慢性盆腔疼痛综合征（CP/CPPS）存在多种生物心理因素，其管理一直被认为很复杂。在这项临床研究中，我们旨在评估姜黄素和金盏花提取物治疗CP/CPPS III型患者的疗效。
2015年6月至2016年1月，我们在本机构连续招募了60例受CP/CPPS III影响的患者。年龄在20至50岁之间，在研究前有盆腔疼痛症状3个月或更长时间，美国国立卫生研究院慢性前列腺炎症状指数（NIH-CPSI）总分≥15分且诊断为NIH III类。然后将患者分配接受安慰剂（A组）或治疗（B组）。治疗包括350毫克（95%）姜黄素提取物和80毫克金盏花提取物的直肠栓剂（每天1粒，共1个月）。B组患者接受1个月的安慰剂栓剂（每天1粒）。研究的主要终点是NIH-CPSI的降低。次要结果是峰值流速、国际勃起功能指数-5（IIEF-5）、视觉模拟评分（VAS）和早泄诊断工具（PEDT）的变化。
共有48例患者完成了研究方案。所有队列的中位年龄为32.0岁，中位NIH-CPSI为20.5，中位IIEF-5为18.5，中位PEDT为11.0，中位VAS评分为7.5，中位峰值流速为14.0。A组治疗3个月后，我们观察到NIH-CPSI（-5.5；p<0.01）、IIEF-5（+3.5；p<0.01）、PEDT（-6.5；p<0.01）、峰值流速（+2.8；p<0.01）和VAS（-6.5；p<0.01）有显著改善，与安慰剂组相比有显著差异（所有p值均显著）。
在这项II期临床试验中，我们展示了姜黄素和金盏花治疗CP/CPPS III型患者的临床疗效。这种治疗的益处可能与炎症细胞因子和炎症细胞的减少有关。这些结果应在更大样本量的进一步研究中得到证实。
