Serenoa repens for the Treatment of Lower Urinary Tract Symptoms Due to Benign Prostatic Enlargement: An Updated Cochrane Review.

Purpose: To assess the effects of Serenoa repens in the treatment of men with lower urinary tract symptoms (LUTS) consistent with benign prostatic hyperplasia (BPH).

Materials and methods: We performed a comprehensive search using multiple databases up to September 2022 with no language or publication status restrictions. We included parallel-group randomized controlled trials of participants with BPH who were treated with Serenoa repens or placebo/no treatment. We used standard Cochrane methods, including a GRADE assessment of the certainty of the evidence (CoE).

Results: We included 27 studies involving a total of 4,656 participants. Serenoa repens results in little to no difference in urologic symptoms at short-term follow-up (International Prostate Symptom Score [IPSS]: mean difference [MD] -0.90, 95% confidence interval [CI] -1.74 to -0.07; I²=68%; 9 studies, 1,681 participants; high CoE). Serenoa repens results in little to no difference in the quality of life at short-term follow-up (high CoE). Serenoa repens probably results in little to no difference in adverse events (moderate CoE). Different phytotherapeutic agents that include Serenoa repens may result in little to no difference in urologic symptoms compared to placebo at short-term follow-up (IPSS: MD -2.41, 95% CI -4.54 to -0.29; I²=67%; 4 studies, 460 participants; low CoE). We are very uncertain about the effects of these agents on quality of life (very low CoE). These agents may result in little to no difference in the occurrence of adverse events (low CoE).

Conclusions: Serenoa repens alone provides little to no benefits for men with LUTS due to benign prostatic enlargement. There is more uncertainty about the role of Serenoa repens in combination with other phytotherapeutic agents.