A new pilot study on Salvia miltiorrhiza vs saw palmetto for urinary symptoms in men: reading it carefully

Lower urinary tract symptoms (LUTS) are common in aging men. Most people associate them with benign prostatic hyperplasia (BPH), but the picture is broader than that. Symptoms like nighttime urination (nocturia), urgency, weak stream, and incomplete emptying are driven by a mix of prostate enlargement, smooth muscle tone, low-grade inflammation, autonomic nervous system patterns, metabolic factors, and even sleep architecture. Treatment options range from prescription alpha blockers and 5-alpha reductase inhibitors to surgical procedures to botanical supplements, with saw palmetto (Serenoa repens) being the most familiar herbal option. A new small randomized pilot study from Korea tested a different botanical (a Salvia miltiorrhiza extract called SAGX) head to head against saw palmetto. The result is promising, but a careful read matters.

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What the research found

This was a 12-week, randomized, double-blind, parallel-group pilot study published in Nutrients in 2026 [1]. Thirty men with LUTS were randomized to either 400 mg of SAGX (a standardized Salvia miltiorrhiza extract) or 320 mg of saw palmetto extract, once daily, for 12 weeks. The primary outcome was change in the International Prostate Symptom Score (IPSS) and the LUTS-related quality of life score. The IPSS is a 35-point scale where higher numbers mean worse symptoms; clinicians commonly use it to grade BPH-related LUTS as mild, moderate, or severe. Secondary outcomes included erectile function (IIEF) and adverse events.

The SAGX group had a significantly greater reduction in total IPSS than the saw palmetto group (P = 0.031), with notable improvements in storage-related symptoms (urgency, frequency, nocturia; P = 0.003) and in quality of life (P = 0.035). Erectile function (IIEF) also improved significantly in the SAGX group (P = 0.005). All adverse events were mild and transient. The authors describe this as a "pilot study with a limited cohort" and call the findings "preliminary." Three of the authors are employees of Curome Biosciences, the manufacturer of the SAGX extract.

Two things to hold in mind right away. First, the trial had 30 participants, with no placebo arm. Second, the comparator was saw palmetto, which gives the result a different meaning depending on what you think saw palmetto actually does.

The bigger picture

This is where the broader literature changes how you read this pilot. The 2023 Cochrane systematic review of Serenoa repens for LUTS/BPH (27 trials, 4,656 participants) concluded with high-certainty evidence that saw palmetto alone results in "little to no difference" in urologic symptoms or quality of life compared with placebo at both short-term and long-term follow-up [2]. If saw palmetto by itself is roughly equivalent to placebo, then a botanical that "beats saw palmetto" in a 30-person pilot may simply be performing like an active intervention against a near-inactive comparator. That does not mean SAGX does not work. It means this trial cannot tell us whether SAGX beats placebo. That question requires a different trial.

There is one important caveat about saw palmetto itself. The hexanic extract of Serenoa repens (commercial name Permixon) has its own meta-analysis showing nocturia reduction and improvement in urinary flow comparable to tamsulosin [3], and a 2025 multicenter trial showed that adding hexanic saw palmetto extract to alfuzosin gave better LUTS improvement than alfuzosin alone [4]. Not all saw palmetto products are the same. The form, extraction method, and standardization matter, and the Cochrane review and the hexanic-extract literature reach different conclusions partly because they are studying somewhat different molecules in the bottle.

That nuance applies to the new SAGX study too. The trial did not specify which saw palmetto extract was used as the comparator, only the dose (320 mg, which matches Permixon's standard dose). Without that detail, the comparison is hard to interpret cleanly.

The naturopathic lens

Urinary symptoms in midlife and beyond rarely have a single driver. The picture I see most often in clinic includes some combination of prostate enlargement, chronic low-grade prostate inflammation, metabolic syndrome features (insulin resistance, central adiposity, hypertension), poor sleep architecture, evening fluid and caffeine patterns, alcohol intake, pelvic floor tension, and autonomic nervous system dysregulation. Botanical and supplement options are one piece of that picture, never the whole picture.

Salvia miltiorrhiza (Dan Shen in Traditional Chinese Medicine) has a long history of use as an anti-inflammatory and circulation-supporting herb, with documented effects on inflammatory pathways relevant to prostate tissue. That biology is plausible. Whether a specific commercial extract delivered at a specific dose for 12 weeks improves clinically meaningful LUTS outcomes in a way that holds up against placebo and across populations remains an open question. The SAGX pilot is a reasonable first step in that direction, not a final answer.

For a man dealing with LUTS, the more important questions are usually upstream of the supplement choice. How is sleep? Are there metabolic patterns to address (blood sugar, weight, blood pressure)? What does evening fluid and alcohol intake look like? Is there a chronic prostatitis or pelvic floor component that has been missed? Has a urologist evaluated prostate size, post-void residual, and ruled out other contributors? Once those pieces are mapped, a botanical option (whether saw palmetto, pygeum, beta-sitosterol, pumpkin seed, stinging nettle, or something like Salvia miltiorrhiza) has a clearer role to play, alongside whatever conventional therapy is also part of the plan.

How to apply this in your own life

A few practical reads if you or someone you care about is navigating LUTS:

1. Get evaluated. LUTS can come from BPH, but it can also come from prostatitis, overactive bladder, neurogenic causes, medication side effects, or (rarely) prostate cancer. A clinical workup gives any supplement or lifestyle plan something accurate to work with.

2. The Cochrane review is the highest-certainty evidence on saw palmetto alone for BPH-related LUTS, and it found little to no benefit over placebo. The hexanic Permixon literature reads differently. If you decide to try a saw palmetto product, the extract form and standardization matter, and even with the best form, the evidence is mixed.

3. SAGX is interesting but very preliminary. Thirty patients, no placebo, industry-affiliated authors. A pilot study like this earns a follow-up trial; it does not yet earn a recommendation.

4. Look upstream. Sleep, metabolic health, evening fluid and caffeine patterns, alcohol, and pelvic floor work all move LUTS in ways that no botanical can match by itself.

5. If you are already on a prescription medication for BPH (an alpha blocker or 5-alpha reductase inhibitor), adding a botanical is a conversation to have with your prescriber. Drug-herb interactions and overlapping effects on blood pressure or sexual function need a clinician in the loop.

References

1. Kim EY, Lee EJ, Chang JY, Im SJ, Park YH, Kim HY. 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. 2026;18(11):1752. PMID: 42280395. DOI: 10.3390/nu18111752.

2. Franco JV, Trivisonno L, Sgarbossa NJ, et al. Serenoa repens for the treatment of lower urinary tract symptoms due to benign prostatic enlargement. Cochrane Database Syst Rev. 2023;6(6):CD001423. PMID: 37345871. DOI: 10.1002/14651858.CD001423.pub4.

3. Vela-Navarrete R, Alcaraz A, Rodríguez-Antolín A, et al. Efficacy and safety of a hexanic extract of Serenoa repens (Permixon) for the treatment of lower urinary tract symptoms associated with benign prostatic hyperplasia (LUTS/BPH): systematic review and meta-analysis of randomised controlled trials and observational studies. BJU Int. 2018;122(6):1049-1065. PMID: 29694707. DOI: 10.1111/bju.14362.

4. Bevilacqua G, Carino D, Salciccia S, et al. Efficacy of Serenoa repens Extract Combined With Alfuzosin Versus Alfuzosin Alone in Men With Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia: A Multicenter Randomized Study. Prostate. 2025;86(2):204-218. PMID: 41098072. DOI: 10.1002/pros.70071.

This information is educational and is not medical advice. Lower urinary tract symptoms warrant clinical evaluation. Specific supplement and medication decisions should be made with a qualified healthcare provider who knows your full medical history and current prescriptions.

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If this resonates with what you're experiencing and you'd like to explore a naturopathic approach, book a consultation with our clinic.