Abstract
PurposeTo 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).MethodsWe 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).ResultsIn 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.ConclusionsSRE was effective, safe, and clinically superior to placebo for the treatment of CP/CPPS. ChiCTR-IPR-16010196, December 21, 2016 retrospectively registered
Highlights
The prostatitis category III, as classified by the National Institutes of Health (NIH), and named as chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS), is a commonKai Zhang and Run-Qi Guo contributed to this work
At the start of the screening phase, we evaluated all patients by taking a detailed medical history, and assessing patients using both NIH-CPSI [11] and International Index of Erectile Function 5 (IIEF-5) [12] questionnaires
Two patients did not satisfy the criteria after re-evaluation and two patients withdrew consent for difficulty to comply with the study medication in the Serenoa repens extract (SRE) group, whereas one patient was lost to follow-up from the first visit in the placebo group; 221 patients were included in the intention-to-treat analysis (148 in the SRE group and 73 in the placebo group; SFigure1)
Summary
This multicenter, randomized, double-blind, placebo-controlled study describes a clinical phase 4 trial conducted in 11 Chinese urologic centers between January 2017 and June 2018. The study protocol was approved by the Ethics Committee of Peking University First Hospital (Institutional Review Board Approval Number: 2016-038). This trial was reported based on the Consolidated Standards for Reporting Trials statement. The exclusion criteria were as follows: urinary tract infection, acute epididymitis, or suspected prostate cancer; genital herpes; diseases that affected micturition; trauma or surgery that might affect the evaluation of drug efficacy; severe cardiovascular disease, sexually transmitted diseases, malignant tumors, peptic ulcers, or hemorrhage disease; current use of antibiotics, non-steroidal anti-inflammatory drugs, α-adrenergic blockers, bioflavonoids, Chinese patent medicines, plant drugs for prostatitis, or drugs that affected bladder function or sexual activity; liver or kidney insufficiency, or levels of aspartate transaminase or alanine transaminase that exceeded 1.5 times the upper limit of the normal range, or levels of creatinine that exceeded the upper limit of the normal range and were considered clinically significant; allergy to the study drug or similar drugs
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