05/08/2026
A randomised, double blind, parallel-group clinical trial compared a proprietary Dan Shen (Salvia miltiorrhiza) root extract (SAGX) with standardised liposterolic saw palmetto extract in men aged 40 to 80 years with mild-to-moderate lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH). Thirty participants were randomised (15 per group), with 25 completing the 12-week study (13 SAGX, 12 saw palmetto).
Participants received two soft gel capsules daily containing either SAGX (400 mg/day of an ethanol root extract standardised to contain at least 10% cryptotanshinone) or saw palmetto extract (320 mg/day of berry extract standardised to a fatty acid profile containing a minimum of 220 mg/g lauric acid).
Unfortunately, the paper does not report the drug:extract ratio of the Dan Shen extract. Consequently, the amount of starting crude root cannot be calculated from the published information, but it would probably be between 2 and 4 g/day.
Compared with saw palmetto, SAGX (Dan Shen) produced significantly greater improvements in lower urinary tract symptoms. Total International Prostate Symptom Score (IPSS) decreased by 4.6 points compared with 0.6 points for saw palmetto (p=0.031), while bladder storage symptoms improved by 2.7 points versus 0.2 points (p=0.003). SAGX also produced significantly greater improvements in reducing urinary frequency (p=0.006), lower urinary tract symptom-related quality of life (p=0.035) and improving erectile function, with the total International Index of Erectile Function (IIEF) score increasing by 8.2 points compared with 1.1 points for saw palmetto (p=0.005). Importantly, the 4.6-point reduction in IPSS exceeded the accepted minimum clinically important target of 3 points change, indicating that the benefits were clinically meaningful as well as statistically significant. Both treatments were generally well tolerated.
This was a small pilot study, with only 30 participants randomised and 25 completing the trial, making the results vulnerable to random error and potentially exaggerated treatment effects. The authors appropriately described the trial as hypothesis-generating rather than confirmatory, and the primary analysis used a per-protocol rather than a full intention-to-treat approach, increasing the risk of attrition (dropout) bias. The treatment period of only 12 weeks is also relatively short for a BPH/LUTS trial, where the gold standard is 6 months. A further limitation is the absence of a placebo control, which makes it difficult to determine the absolute efficacy of SAGX. However, the use of a standardised saw palmetto extract as the comparator is also potentially a strength, as high-quality liposterolic saw palmetto extracts have demonstrated clinically meaningful benefits for LUTS in several systematic reviews and meta-analyses. On the other hand, if the saw palmetto extract was of poor quality, the trial results would not suggest the superiority of Dan Shen, only that it is clinically effective.
Dan Shen, originally a key heart herb, is developing a surprisingly broad clinical repertoire, and this trial suggests a useful new application for this important medicinal plant.
For more information see: https://pubmed.ncbi.nlm.nih.gov/42280395/
