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).
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).
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.
SRE was effective, safe, and clinically superior to placebo for the treatment of CP/CPPS. ChiCTR-IPR-16010196, December 21, 2016 retrospectively registered.
World journal of urology. 2021 Jan 16 [Epub ahead of print]
Kai Zhang, Run-Qi Guo, Shan-Wen Chen, Bin Chen, Xin-Bo Xue, Shan Chen, Jian Huang, Ming Liu, Ye Tian, Li Zuo, Ming Chen, Li-Qun Zhou
Department of Urology, Peking University First Hospital, The Institute of Urology, Peking University, National Urological Cancer Center, Beijing, 100034, China., Minimally Invasive Tumor Therapies Center, Beijing Hospital, National Center of Gerontology, Beijing, China., Department of Urology, Huashan Hospital of Fudan University, Shanghai, China., Department of Urology, Renji Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China., Department of Urology, The Second Affiliated Hospital, Soochow University, Suzhou, China., Department of Urology, Beijing Tongren Hospital, Capital Medical University, Beijing, China., Department of Urology, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, Guangdong, China., Department of Urology, Beijing Hospital, Beijing, China., Department of Urology, Beijing Friendship Hospital, Capital Medical University, Beijing, China., Department of Urology, Changzhou No. 2 People's Hospital Affiliated to Nanjing Medical University, Changzhou, Jiangsu, China., Department of Urology, Zhongda Hospital, Southeast University, Nanjing, 210000, Jiangsu, China. ., Department of Urology, Peking University First Hospital, The Institute of Urology, Peking University, National Urological Cancer Center, Beijing, 100034, China. .