The efficacy and safety of Serenoa repens extract for the treatment of patients with chronic prostatitis/chronic pelvic pain syndrome: a multicenter, randomized, double-blind, placebo-controlled trial
单位：[1]Department of Urology, Peking University First Hospital, The Institute of Urology, Peking University, National Urological Cancer Center, Beijing 100034, China [2]Beijing Key Laboratory of Urogenital Diseases (Male) Molecular Diagnosis and Treatment Center, Beijing, China [3]Minimally Invasive Tumor Therapies Center, Beijing Hospital, National Center of Gerontology, Beijing, China [4]Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing, China [5]Department of Urology, Huashan Hospital of Fudan University, Shanghai, China [6]Department of Urology, Renji Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China [7]Department of Urology, The Second Affiliated Hospital, Soochow University, Suzhou, China 苏州大学附属第二医院[8]Department of Urology, Beijing Tongren Hospital, Capital Medical University, Beijing, China 首都医科大学附属同仁医院[9]Department of Urology, Sun Yat‑Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, Guangdong, China 中山大学附属第二医院[10] Department of Urology, Beijing Hospital, Beijing, China [11]Department of Urology, Beijing Friendship Hospital, Capital Medical University, Beijing, China 临床科室泌尿外科泌尿外科首都医科大学附属北京友谊医院[12]Department of Urology, Changzhou No. 2 People’s Hospital Affiliated to Nanjing Medical University, Changzhou, Jiangsu, China [13]Department of Urology, Zhongda Hospital, Southeast University, Nanjing 210000, Jiangsu, China
Purpose To perform a placebo-controlled trial to evaluate the efficacy and safety of Serenoa repens extract (SRE) for the treatment of chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS). Methods We conducted a double-blind, randomized, placebo-controlled, multicenter, clinical phase 4 study of 221 patients with CP/CPPS across 11 centers. Participants were randomly assigned in a 2:1 ratio to receive SRE or placebo for 12 weeks. The primary efficacy endpoint was the change in total score on the National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI). Secondary efficacy endpoints included improvements within each domain of NIH-CPSI, clinical response rate, and International Index of Erectile Function 5 items (IIEF-5). Results In total, 226 patients were enrolled and randomized between January 2017 and June 2018. Of these 221 patients were included in the intent-to-treat analysis: 148 in the SRE group and 73 patients in the placebo group. Compared to the placebo, SRE led to statistically significant improvements in the NIH-CPSI total score and sub-scores. The significant improvements of NIH-CPSI scores were established after 2 weeks from the first dose, and continued to the end of the treatment. Furthermore, a significantly higher rate of patients achieved a clinical response in the SRE group compared with that in the placebo group (73.0% vs 32.9%, P < 0.0001). Only minor adverse events were observed across the entire study population. Conclusions SRE was effective, safe, and clinically superior to placebo for the treatment of CP/CPPS. ChiCTR-IPR-16010196, December 21, 2016 retrospectively registered
第一作者单位：[1]Department of Urology, Peking University First Hospital, The Institute of Urology, Peking University, National Urological Cancer Center, Beijing 100034, China [2]Beijing Key Laboratory of Urogenital Diseases (Male) Molecular Diagnosis and Treatment Center, Beijing, China
共同第一作者：
通讯作者：
通讯机构：[1]Department of Urology, Peking University First Hospital, The Institute of Urology, Peking University, National Urological Cancer Center, Beijing 100034, China [2]Beijing Key Laboratory of Urogenital Diseases (Male) Molecular Diagnosis and Treatment Center, Beijing, China
推荐引用方式(GB/T 7714)：
Kai Zhang,Run‑Qi Guo,Shan‑Wen Chen,et al.The efficacy and safety of Serenoa repens extract for the treatment of patients with chronic prostatitis/chronic pelvic pain syndrome: a multicenter, randomized, double-blind, placebo-controlled trial[J].WORLD JOURNAL of UROLOGY.2021,39(9):3489-3495.doi:10.1007/s00345-020-03577-2.
APA：
Kai Zhang,Run‑Qi Guo,Shan‑Wen Chen,Bin Chen,Xin‑Bo Xue...&Li‑Qun Zhou.(2021).The efficacy and safety of Serenoa repens extract for the treatment of patients with chronic prostatitis/chronic pelvic pain syndrome: a multicenter, randomized, double-blind, placebo-controlled trial.WORLD JOURNAL of UROLOGY,39,(9)
MLA：
Kai Zhang,et al."The efficacy and safety of Serenoa repens extract for the treatment of patients with chronic prostatitis/chronic pelvic pain syndrome: a multicenter, randomized, double-blind, placebo-controlled trial".WORLD JOURNAL of UROLOGY 39..9(2021):3489-3495
