Efficacy and Safety of Salvia miltiorrhiza Extract (SAGX) Compared with Saw Palmetto in Men with Lower Urinary Tract Symptoms: A 12-Week, Randomized, Double-Blind, Parallel-Group Pilot Study

Background: Lower urinary tract symptoms (LUTS) are prevalent among aging men and negatively affect quality of life. Salvia miltiorrhiza extract (SAGX), which exhibits anti-inflammatory and antioxidant properties, has been developed as a functional ingredient to improve LUTS. However, comparative clinical data against established standards, such as saw palmetto, are currently lacking. Objectives: To compare the efficacy and safety of SAGX with saw palmetto extract in men with LUTS. Methods: In this randomized, parallel-group pilot study, 30 men with LUTS were assigned to receive either 400 mg of SAGX or 320 mg of saw palmetto extract once daily for 12 weeks. The primary outcome was the change in the International Prostate Symptom Score (IPSS) and the LUTS-related quality-of-life (QoL) score. Secondary outcomes included changes in the erectile function assessed using the International Index of Erectile Function (IIEF). Safety was evaluated by monitoring adverse events. Results: SAGX supplementation resulted in a significantly greater reduction in total IPSS compared with the saw palmetto group (p = 0.031), with notable improvements in storage symptoms (p = 0.003) and QoL (p = 0.035). Erectile function also improved significantly in the SAGX group (p = 0.005). All adverse events were mild and transient, with treatment-related events occurring less frequently in the SAGX group. Conclusions: Although this study was a pilot study with a limited cohort, these findings provide preliminary evidence for the use of SAGX as a functional ingredient for supporting urinary health in men with LUTS.