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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
- Source :
- World Journal of Urology
- Publication Year :
- 2021
- Publisher :
- Springer Science and Business Media LLC, 2021.
-
Abstract
- 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 Conclusions SRE was effective, safe, and clinically superior to placebo for the treatment of CP/CPPS. ChiCTR-IPR-16010196, December 21, 2016 retrospectively registered
- Subjects :
- Response rate (survey)
Nephrology
medicine.medical_specialty
Efficacy
business.industry
Urology
030232 urology & nephrology
Placebo-controlled study
Prostatitis
Placebo
medicine.disease
Chronic pelvic pain syndrome
03 medical and health sciences
Chronic prostatitis
0302 clinical medicine
Chronic prostatitis/chronic pelvic pain syndrome
030220 oncology & carcinogenesis
Internal medicine
medicine
Population study
Original Article
Serenoa repens
Safety
Adverse effect
business
Subjects
Details
- ISSN :
- 14338726 and 07244983
- Volume :
- 39
- Database :
- OpenAIRE
- Journal :
- World Journal of Urology
- Accession number :
- edsair.doi.dedup.....ceee6644c7094b22a8deb4b394d238bc