Iwamura Hiromichi, Koie Takuya, Soma Osamu, Matsumoto Teppei, Imai Atsushi, Hatakeyama Shingo, Yoneyama Takahiro, Hashimoto Yasuhiro, Ohyama Chikara
Department of Urology, Hirosaki University Graduate School of Medicine, 5 Zaifucho, Hirosaki, Aomori, 036-8562, Japan.
BMC Urol. 2015 Dec 7;15:120. doi: 10.1186/s12894-015-0115-5.
Previously reported results of a prospective, randomized placebo-controlled study showed that the pollen extract (Cernilton) significantly improved total symptoms, pain, and quality of life in patients with inflammatory prostatitis/chronic pelvic pain syndrome (CP/CPPS) without severe side effects. A phytotherapeutic agent, Eviprostat, is reportedly effective in a rat model of nonbacterial prostatitis. The aim of the present study was to compare the efficacy and safety of Eviprostat to that of the pollen extract in the management of CP/CPPS.
The patients with category III CP/CPPS were randomized to receive either oral capsules of Eviprostat (two capsules, q 8 h) or the pollen extract (two capsules, q 8 h) for 8 weeks. The primary endpoint of the study was symptomatic improvement in the NIH Chronic Prostatitis Symptom Index (NIH-CPSI). Participants were evaluated using the NIH-CPSI and the International Prostate Symptom Score (IPSS) at baseline and after 4 and 8 weeks.
In the intention-to-treat analysis, 100 men were randomly allocated to Eviprostat (n = 50) or the pollen extract (n = 50). Response (defined as a decrease in the NIH-CPSI total score by at least 25 %) in the Eviprostat group and the pollen extract group was 88.2 and 78.1 %, respectively. There was no significant difference in the total, pain, urinary, and quality of life (QOL) scores of the NIH-CPSI between the two groups at 8 weeks. This was also the case with the total, voiding, and storage symptoms of the IPSS. There were no severe adverse events observed in any patients in this study.
Both the pollen extract and Eviprostat significantly reduced the symptoms of category III CP/CPPS without any adverse events. Eviprostat may have an identical effect on category III CP/CPPS compared the pollen extract.
The study was registered with the University Hospital Medical Information Network Clinical Trials Registry in Japan (UMIN000019618); registration date: 3 November 2015.
先前一项前瞻性、随机、安慰剂对照研究的结果显示，花粉提取物（舍尼通）能显著改善炎症性前列腺炎/慢性盆腔疼痛综合征（CP/CPPS）患者的总体症状、疼痛及生活质量，且无严重副作用。据报道，一种植物治疗剂爱普列特在非细菌性前列腺炎大鼠模型中有效。本研究的目的是比较爱普列特与花粉提取物在CP/CPPS治疗中的疗效和安全性。
III型CP/CPPS患者被随机分为两组，分别口服爱普列特胶囊（2粒，每8小时1次）或花粉提取物胶囊（2粒，每8小时1次），疗程8周。研究的主要终点是美国国立卫生研究院慢性前列腺炎症状指数（NIH-CPSI）的症状改善情况。在基线以及4周和8周后，使用NIH-CPSI和国际前列腺症状评分（IPSS）对参与者进行评估。
在意向性分析中，100名男性被随机分配至爱普列特组（n = 50）或花粉提取物组（n = 50）。爱普列特组和花粉提取物组的反应率（定义为NIH-CPSI总分至少降低25%）分别为88.2%和78.1%。8周时，两组NIH-CPSI的总体、疼痛、排尿及生活质量（QOL）评分无显著差异。IPSS的总体、排尿及储尿症状评分情况亦是如此。本研究中未观察到任何患者出现严重不良事件。
花粉提取物和爱普列特均能显著减轻III型CP/CPPS的症状，且无任何不良事件。与花粉提取物相比，爱普列特对III型CP/CPPS可能具有相同的疗效。
本研究在日本大学医院医学信息网络临床试验注册中心注册（UMIN000019618）；注册日期：2015年11月3日。
