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

2019-03-14
Urology 129
- 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

PubMed: 30880074
DOI: 10.1016/j.urology.2019.02.030

Study Design

Type: Randomized Controlled Trial (RCT)
Sample size: n = 354
Population: 354 patients with LUTS/BPH from 19 institutions
Methods: double blind, placebo-controlled study; participants randomly assigned (1:1) into the Serenoa repens extract (320 mg) or placebo groups for 24 weeks
Blinding: Double-blind
Duration: 24 weeks
Funding: Unclear

Large Human Trial

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.

Research Insights

Saw Palmetto→Improved Erectile Function
Statistically significant improvement in the ... International Index of Erectile Function score were observed in the Serenoa repens extract group compared with those in the placebo group (P <.05).
Effect
Beneficial
Effect size
Moderate
Dose
320 mg
Saw Palmetto→Improved International Prostate Symptom Score
Statistically significant improvement in the peak urinary flow, International Prostate Symptom Score, ... were observed in the Serenoa repens extract group compared with those in the placebo group (P <.05).
Effect
Beneficial
Effect size
Moderate
Dose
320 mg
Saw Palmetto→Improved Male Sexual Function Score
Statistically significant improvement in the ... four-item male sexual function questionnaire score, ... were observed in the Serenoa repens extract group compared with those in the placebo group (P <.05).
Effect
Beneficial
Effect size
Moderate
Dose
320 mg
Saw Palmetto→Improved Peak Urinary Flow
Statistically significant improvement in the peak urinary flow, International Prostate Symptom Score, ... were observed in the Serenoa repens extract group compared with those in the placebo group (P <.05).
Effect
Beneficial
Effect size
Moderate
Dose
320 mg
Saw Palmetto→Improved Quality of Life Score
Statistically significant improvement in the ... quality of life score, ... were observed in the Serenoa repens extract group compared with those in the placebo group (P <.05).
Effect
Beneficial
Effect size
Moderate
Dose
320 mg
Saw Palmetto→Improved Storage Symptom Score
Statistically significant improvement in the ... scores of storage symptoms ... were observed in the Serenoa repens extract group compared with those in the placebo group (P <.05).
Effect
Beneficial
Effect size
Moderate
Dose
320 mg
Saw Palmetto→Improved Voiding Symptom Score
Statistically significant improvement in the ... scores of ... voiding symptoms ... were observed in the Serenoa repens extract group compared with those in the placebo group (P <.05).
Effect
Beneficial
Effect size
Moderate
Dose
320 mg
Saw Palmetto→Reduced Prostate Volume
Secondary efficacy parameters included improvement of ... prostate volume, urinary frequency, and total prostate-specific antigen level.
Effect
Neutral
Effect size
Small
Dose
320 mg
Saw Palmetto→Reduced Total Prostate-Specific Antigen Level
Secondary efficacy parameters included improvement of ... and total prostate-specific antigen level.
Effect
Neutral
Effect size
Small
Dose
320 mg
Saw Palmetto→Reduced Urinary Frequency
Secondary efficacy parameters included improvement of ... urinary frequency, and total prostate-specific antigen level.
Effect
Neutral
Effect size
Small
Dose
320 mg

Adverse Events Reported

Saw Palmetto→Overall tolerability
The Serenoa repens extract was effective, safe, well-tolerated, and clinically and statistically superior to placebo in the target LUTS/BPH population.
Finding
Reported
Saw Palmetto→adverse events
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.
Finding
Reported
Magnitude
2 (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