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Abstract Title:

Efficacy and Safety of Serenoa repens Extract Among Patients with Benign Prostatic Hyperplasia in China: A Multicenter, Randomized, Double-blind, Placebo-controlled Trial.

Abstract Source:

Urology. 2019 Mar 14. Epub 2019 Mar 14. PMID: 30880074

Abstract Author(s):

Zhangqun Ye, Jian Huang, Liqun Zhou, Shan Chen, Zengjun Wang, Lulin Ma, Dongfang Wang, Gongxian Wang, Shusheng Wang, Chaozhao Liang, Shaopeng Qiu, Xiaojian Gu, Jianhe Liu, Zhiliang Weng, Changli Wu, Qiang Wei, Liping Xie, Weizhen Wu, Yue Cheng, Jingqian Hu, Zhixian Wang, Xiaoyong Zeng

Article Affiliation:

Zhangqun Ye

Abstract:

OBJECTIVE: To evaluate the efficacy and safety of Serenoa repens among patients with benign prostatic hyperplasia (lower urinary tract symptoms/benign prostatic hyperplasia [LUTS/BPH]) in China.

METHODS: We conducted a double blind, placebo-controlled study of 354 patients with LUTS/BPH from 19 institutions, to evaluate the efficacy and safety of Serenoa repens. Participants were randomly assigned (1:1) into the Serenoa repens extract (320 mg) or placebo groups for 24 weeks. Primary efficacy parameters were changes in International Prostate Symptom Score and peak urinary flow from baseline to each assessment. Secondary efficacy parameters included improvement of storage symptom and voiding symptom scores, prostate volume, urinary frequency, and total prostate-specific antigen level. Other parameters assessed were quality of life score, a four-item male sexual function questionnaire score, and International Index of Erectile Function score across the consecutive double-blind visits.

RESULTS: Statistically significant improvement in the peak urinary flow, International Prostate Symptom Score, scores of storage symptoms and voiding symptoms, quality of life score, four-item male sexual function questionnaire score, and International Index of Erectile Function score were observed in the Serenoa repens extract group compared with those in the placebo group (P<.05). Two (1.18%) of 169 patients in the placebo group and 3 (1.89) of 159 patients in the Serenoa repens extract group experienced 1 or more adverse events.

CONCLUSION: The Serenoa repens extract was effective, safe, well-tolerated, and clinically and statistically superior to placebo in the target LUTS/BPH population.

Study Type : Human Study

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Sayer Ji
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