Abstract：
OBJECTIVE: The management of chronic prostatitis/ chronic pelvic pain syndrome type III (CP/CPPS) has been always considered complex due to several biopsychological factors underlying the disease. In this clinical study, we aimed to evaluate the efficacy of the treatment with Palmitoylethanolamide, Epilobium and Calendula extract in patients with CP/CPPS III.
METHODS: From June 2023 to July 2023, we enrolled 45 consecutive patients affected by CP/CPPS type III in three different institution. We included patients aged between 18 and 75 years with symptoms of pelvic pain for 3 months or more before the study, a total National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) score ≥ 12 point and diagnosed with NIH category III, according to 4-glass test Meares-Stamey test. Patients were then allocated to receive rectal suppositories of PEA, Epilobium and Calendula, 1 suppository/ die for 1 month. All patients have been tested with standard urinalysis in order to assess urinary leukocytes (U-WBC). The primary endpoint of the study was the reduction of NIHCPSI. The secondary outcomes were the change of peak flow, post-void residual (PVR), IIEF-5, VAS score, PSA and decrease of U-WBC.
RESULTS: A total of 45 patients concluded the study protocol. At baseline, the median age of all the patients included in the cohort was 49 years, the median PSA was 2.81 ng/ml, the median NIH-CPSI was 18.55, the median IIEF-5 was 18.27, the median U-WBC was 485.3/mmc, the median VAS score was 6.49, the median PVR was 26.5 ml and the median peak flow was 16.3 ml/s. After 1 month of therapy we observed a statistically significant improvement of NIH-CPSI, U-WBC, PSA, IIEF-5, peak flow, PVR and VAS.
CONCLUSIONS: In this observational study, we showed the clinical efficacy of the treatment with PEA, Epilobium and Calendula, 1 suppository/die for 1 month, in patients with CP/CPPS III. The benefits of this treatment could be related to the reduction of inflammatory cells in the urine that could imply a reduction of inflammatory cytokines. These results should be confirmed in further studies with greater sample size.
METHODS: From June 2023 to July 2023, we enrolled 45 consecutive patients affected by CP/CPPS type III in three different institution. We included patients aged between 18 and 75 years with symptoms of pelvic pain for 3 months or more before the study, a total National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) score ≥ 12 point and diagnosed with NIH category III, according to 4-glass test Meares-Stamey test. Patients were then allocated to receive rectal suppositories of PEA, Epilobium and Calendula, 1 suppository/ die for 1 month. All patients have been tested with standard urinalysis in order to assess urinary leukocytes (U-WBC). The primary endpoint of the study was the reduction of NIHCPSI. The secondary outcomes were the change of peak flow, post-void residual (PVR), IIEF-5, VAS score, PSA and decrease of U-WBC.
RESULTS: A total of 45 patients concluded the study protocol. At baseline, the median age of all the patients included in the cohort was 49 years, the median PSA was 2.81 ng/ml, the median NIH-CPSI was 18.55, the median IIEF-5 was 18.27, the median U-WBC was 485.3/mmc, the median VAS score was 6.49, the median PVR was 26.5 ml and the median peak flow was 16.3 ml/s. After 1 month of therapy we observed a statistically significant improvement of NIH-CPSI, U-WBC, PSA, IIEF-5, peak flow, PVR and VAS.
CONCLUSIONS: In this observational study, we showed the clinical efficacy of the treatment with PEA, Epilobium and Calendula, 1 suppository/die for 1 month, in patients with CP/CPPS III. The benefits of this treatment could be related to the reduction of inflammatory cells in the urine that could imply a reduction of inflammatory cytokines. These results should be confirmed in further studies with greater sample size.
摘要：
目的：慢性前列腺炎/慢性盆腔疼痛综合征III型（CP/CPPS）的治疗一直被认为是复杂的，原因是该疾病的多种生物心理学因素。在这项临床研究中，我们的目的是评估棕榈酰乙醇胺治疗的疗效，CP/CPPSIII患者的Epilobium和金盏花提取物。
方法：从2023年6月至2023年7月，我们在三个不同的机构中招募了45名受CP/CPPSIII型影响的连续患者。我们纳入了年龄在18至75岁之间的患者，在研究前出现3个月或更长时间的盆腔疼痛症状，美国国立卫生研究院慢性前列腺炎症状指数（NIH-CPSI）评分≥12分，诊断为NIHIII类，根据4玻璃测试Meares-Stamey测试。然后患者被分配接受PEA直肠栓剂，海马和金盏花，1栓剂/模具1个月。为了评估尿白细胞（U-WBC），所有患者都接受了标准尿液分析的测试。研究的主要终点是降低NIHCPSI。次要结果是峰值流量的变化，后空隙残留物(PVR)，IIEF-5VAS评分,PSA和U-WBC的减少。
结果：共有45名患者完成了研究方案。在基线,纳入队列的所有患者的中位年龄为49岁，PSA中位数为2.81ng/ml，NIH-CPSI中位数为18.55，IIEF-5中位数为18.27，U-WBC中位数为485.3/mmc，VAS评分中位数为6.49分,PVR中位数为26.5ml,流量峰值中位数为16.3ml/s.治疗1个月后，我们观察到NIH-CPSI有统计学意义的改善，U-WBC,PSA,IIEF-5峰值流量,PVR和VAS。
结论：在这项观察性研究中，我们显示了PEA治疗的临床疗效，海马和金盏花，1栓剂/模具1个月，CP/CPPSIII患者。这种治疗的益处可能与尿液中炎性细胞的减少有关，这可能意味着炎性细胞因子的减少。这些结果应在更大样本量的进一步研究中得到证实。
方法：从2023年6月至2023年7月，我们在三个不同的机构中招募了45名受CP/CPPSIII型影响的连续患者。我们纳入了年龄在18至75岁之间的患者，在研究前出现3个月或更长时间的盆腔疼痛症状，美国国立卫生研究院慢性前列腺炎症状指数（NIH-CPSI）评分≥12分，诊断为NIHIII类，根据4玻璃测试Meares-Stamey测试。然后患者被分配接受PEA直肠栓剂，海马和金盏花，1栓剂/模具1个月。为了评估尿白细胞（U-WBC），所有患者都接受了标准尿液分析的测试。研究的主要终点是降低NIHCPSI。次要结果是峰值流量的变化，后空隙残留物(PVR)，IIEF-5VAS评分,PSA和U-WBC的减少。
结果：共有45名患者完成了研究方案。在基线,纳入队列的所有患者的中位年龄为49岁，PSA中位数为2.81ng/ml，NIH-CPSI中位数为18.55，IIEF-5中位数为18.27，U-WBC中位数为485.3/mmc，VAS评分中位数为6.49分,PVR中位数为26.5ml,流量峰值中位数为16.3ml/s.治疗1个月后，我们观察到NIH-CPSI有统计学意义的改善，U-WBC,PSA,IIEF-5峰值流量,PVR和VAS。
结论：在这项观察性研究中，我们显示了PEA治疗的临床疗效，海马和金盏花，1栓剂/模具1个月，CP/CPPSIII患者。这种治疗的益处可能与尿液中炎性细胞的减少有关，这可能意味着炎性细胞因子的减少。这些结果应在更大样本量的进一步研究中得到证实。
