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.
- 2021-01-16
- World journal of urology 39(9)
- 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
- PubMed: 33452912
- DOI: 10.1007/s00345-020-03577-2
Study Design
- Type
- Randomized Controlled Trial (RCT)
- Sample size
- n = 226
- Population
- 221 patients with CP/CPPS
- Methods
- Double-blind, randomized, placebo-controlled, multicenter, clinical phase 4 study; participants randomly assigned in a 2:1 ratio to receive SRE or placebo for 12 weeks
- Blinding
- Double-blind
- Duration
- 12 weeks
- Funding
- Unclear
- Large Human 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 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 < 0.0001). Only minor adverse events were observed across the entire study population.Conclusions
SRE was effective, safe, and clinically superior to placebo for the treatment of CP/CPPS. ChiCTR-IPR-16010196, December 21, 2016 retrospectively registered.Research Insights
Compared to the placebo, SRE led to statistically significant improvements in the NIH-CPSI total score and sub-scores.
- Effect
- Beneficial
- Effect size
- Moderate
Compared to the placebo, SRE led to statistically significant improvements in the NIH-CPSI total score and sub-scores.
- Effect
- Beneficial
- Effect size
- Moderate
Compared to the placebo, SRE led to statistically significant improvements in the NIH-CPSI total score and sub-scores.
- Effect
- Beneficial
- Effect size
- Moderate
Secondary efficacy endpoints included improvements within each domain of NIH-CPSI, clinical response rate, and International Index of Erectile Function 5 items (IIEF-5).
- Effect
- Neutral
- Effect size
- Small
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).
- Effect
- Beneficial
- Effect size
- Large
Adverse Events Reported
Only minor adverse events were observed across the entire study population.
- Finding
- Reported