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

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...

Full description

Saved in:
Bibliographic Details
Published in:World journal of urology 2021-09, Vol.39 (9), p.3489-3495
Main Authors: Zhang, Kai, Guo, Run-Qi, Chen, Shan-Wen, Chen, Bin, Xue, Xin-Bo, Chen, Shan, Huang, Jian, Liu, Ming, Tian, Ye, Zuo, Li, Chen, Ming, Zhou, Li-Qun
Format: Article
Language:English
Subjects:
Adult
Adverse events
Antibiotics
Chronic pain
Clinical trials
Disease
Double-Blind Method
Double-blind studies
Drugs
Humans
Laboratories
Male
Medicine
Medicine & Public Health
Nephrology
Oncology
Original
Original Article
Pain
Patients
Placebos
Plant Extracts - adverse effects
Plant Extracts - therapeutic use
Population studies
Prostatitis
Serenoa - adverse effects
Serenoa repens
Standard deviation
Statistical analysis
Treatment Outcome
Urology
Variance analysis
Citations: Items that this one cites
Items that cite this one
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary: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  
ISSN:0724-4983
1433-8726
DOI:10.1007/s00345-020-03577-2