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Urology. 2019 Mar 14. pii: S0090-4295(19)30236-5. doi: 10.1016/j.urology.2019.02.030. [Epub ahead of print]

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

Author information

1
Department of Urology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China; Hubei Institute of Urology, Wuhan, China.
2
Department of Urology, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, China.
3
Department of Urology, Peking University First Hospital, Beijing, China.
4
Department of Urology, Beijing Tongren Hospital Capital Medical University, Beijing, China.
5
Department of Urology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China.
6
Department of Urology, Peking University Third Hospital, Beijing, China.
7
Department of Urology, The First Hospital of Shanxi Medical University, China.
8
Department of Urology, The First Affiliated Hospital of Nanchang University, Nanchang, China.
9
Department of Urology, Guangdong Provincial Hospital of Traditional Chinese Medicine, China.
10
Department of Urology, The First Affiliated Hospital of Anhui Medical University, Hefei, China.
11
Department of Urology, The First Affiliated Hospital of Sun Yat-Sen University, Guangzhou, China.
12
Department of Urology, Jiangsu Provincial Hospital of Traditional Chinese Medicine, Nanjing, China.
13
Department of Urology, The Second Affiliated Hospital of Kunming Medical University, Kunming, China.
14
Department of Urology, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, China.
15
Department of Urology, The Second Affiliated Hospital of Tianjin Medical University, Tianjin, China.
16
Department of Urology, West China Hospital, Sichuan University, Chengdu, China.
17
Department of Urology, The First Hospital, Zhejiang University, Hangzhou, China.
18
Department of Urology, Fuzhou General Hospital of Nanjing Military Command, Fuzhou, China.
19
Department of Urology, Ningbo First Hospital, Ningbo, China.
20
Department of anesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
21
Department of Urology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
22
Department of Urology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China; Hubei Institute of Urology, Wuhan, China. Electronic address: miwai@163.com.

Abstract

OBJECTIVE:

To evaluate the efficacy and safety of Serenoa repens among patients with 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 (IPSS) 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 (t-PSA) level. Other parameters assessed were quality of Life (QoL) score, a four-item male sexual function questionnaire MSF-4 score, and International Index of Erectile Function (IIEF) score across the consecutive double-blind visits.

RESULTS:

Statistically significant improvement in the peak urinary flow, IPSS, scores of storage symptoms and voiding symptoms, QoL score, MSF-4 score, and IIEF score were observed in the Serenoa repens extract group compared with those in the placebo group (P < 0.05). Two (1.18%) of 169 patients in the placebo group and 3 (1.89) of 159 patients in the Serenoa repens extract group experienced one 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.

KEYWORDS:

Benign prostatic hyperplasia; Clinical trial; Efficacy; Safety; Serenoa repens extract

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