Written by Tabish Mehraj, PhD. In this study, Salvia miltiorrhiza extract (SAGX) led to a greater reduction in total IPSS scores compared with saw palmetto (p = 0.031). It also improved urinary storage symptoms (p = 0.003) and quality of life (p = 0.035). Erectile function improved significantly in the SAGX group (p = 0.005). All side effects were mild and temporary, and treatment-related side effects were less common with SAGX than with saw palmetto. 

Lower urinary tract symptoms (LUTS) are common in aging men and can substantially affect urinary function and quality of life. Lower urinary tract symptoms (LUTS) include frequent urination, waking up at night to urinate, sudden urges to urinate, weak urine flow, and difficulty fully emptying the bladder. These symptoms can interfere with daily activities, affect confidence, and reduce quality of life. Although LUTS can have several causes, benign prostatic hyperplasia (BPH) is one of the most common causes in older adults. Common treatments, such as α-blockers (e.g., tamsulosin and alfuzosin) and 5-α-reductase inhibitors (e.g., finasteride and dutasteride), can improve symptoms but may cause side effects. α-blockers may cause dizziness, low blood pressure, and problems with ejaculation, while 5-ARIs may reduce sexual desire, cause erectile dysfunction, and decrease ejaculate volume. Some studies have also reported sexual problems that may continue even after stopping treatment. Saw palmetto has traditionally been used for prostate and urinary health, while S. miltiorrhiza contains compounds with anti-inflammatory and antioxidant properties that may support prostate and urinary tract function. These potential benefits have led researchers to investigate whether these extracts can improve urinary symptoms and quality of life.

This 12-week single-site, randomized, double-blind, parallel-group pilot study evaluated the efficacy and safety of a standardized Salvia miltiorrhiza extract (SAGX) compared with saw palmetto extract in men with mild-to-moderate LUTS. Thirty men aged 40-80 years were randomized to receive either 400 mg/day of SAGX, standardized to contain at least 10% cryptotanshinone, or 320 mg/day of saw palmetto extract for 12 weeks. The primary outcomes were changes in the International Prostate Symptom Score (IPSS) and LUTS-related quality-of-life (QoL) score. Changes in erectile function were also assessed.

Results/ Key Findings

• SAGX significantly improved overall urinary symptoms, with IPSS decreasing by 4.6 points compared with 0.6 points with saw palmetto (p=0.031); the reduction exceeded the cited minimal clinically important difference of 3 points.

• Urinary frequency and the composite storage symptom score improved significantly more with SAGX than with saw palmetto (p=0.006 and p=0.003, respectively).

• LUTS-related quality of life improved significantly more with SAGX than with saw palmetto (p=0.035), while composite voiding scores and several individual symptoms did not differ significantly.

• SAGX significantly improved total IIEF score, erectile function, sexual desire, and intercourse satisfaction, whereas orgasmic function and overall satisfaction showed no significant between-group differences.

• Safety findings were generally favorable; adverse events were mostly mild, with no treatment-related hematologic or blood-chemistry abnormalities reported in the SAGX group.

The study has several methodological strengths. Randomization, double blinding, identical capsules, standardized product preparation, and validated IIEF and IPSS instruments helped strengthen the assessment of treatment effects. Participants were evaluated by a board-certified urologist, and structured safety monitoring was performed throughout the intervention. The comparison with a commonly used plant-based LUTS product also provides useful preliminary head-to-head data.

Important limitations should nevertheless be considered. The study included only 30 randomized participants: 13 in the SAGX arm and 12 in the saw palmetto arm; no formal sample-size calculation was performed. The study relied substantially on patient-reported outcomes, which may be influenced by individual variability in symptom perception. The 12-week duration is insufficient to establish long-term efficacy, safety, disease progression, or potential drug–herb interactions. The study also received funding from Curome Biosciences, with several authors employed by the sponsor, although the authors state that these employees had no role in study design, data collection, analysis, or interpretation.

Overall, this pilot study provides preliminary evidence that 12 weeks of SAGX supplementation was associated with statistically significant improvements in overall LUTS, urinary frequency, storage symptoms, QoL, and selected measures of erectile function compared with saw palmetto. Because of the small sample size, per-protocol analysis, absence of a placebo control, short follow-up, and limited generalizability, the findings require confirmation in larger, placebo-controlled, adequately powered trials with intention-to-treat analysis and longer-term safety assessment.

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Posted September 25, 2026.

Dr. Tabish Mehraj is a pharmaceutical scientist with expertise in pharmaceutics, drug delivery, and formulation development. She earned her PhD in Pharmaceutical Sciences from the University of Mississippi, where her research focused on the formulation, optimization, and characterization of lipid-based nanocarriers for targeted liver delivery of antimalarial therapeutics. Dr. Mehraj has also served as an ORISE Fellow at the U.S. Food and Drug Administration (FDA), where she evaluated the effects of formulation and process design on the quality and performance of intravaginal drug delivery systems and developed bio-relevant in vitro drug release testing methods. She has teaching experience in pharmaceutical and life sciences courses and has authored peer-reviewed publications, book chapters, and conference presentations. Dr. Mehraj is an active member of the American Association of Pharmaceutical Scientists and has been recognized by honor societies including Rho Chi and Gamma Beta Phi.

Reference:

1. Kim, E. Y., Lee, E. J., Chang, J. Y., Im, S. J., Park, Y. H., & Kim, H. Y. (2026). 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. Nutrients, 18(11), 1752.