Reviewed: He L, Chen X, Zhou M, et al. Radix/rhizoma notoginseng extract (Sanchitongshu) for ischemic stroke: a randomized controlled study. Phytomed. 2011;18(6):437-442.
Ischemic stroke is the leading cause of long-term disability. Acute treatment of stroke may help restore blood flow in the brain and limit damage caused by ischemia, but better strategies are needed to reduce disability following a stroke. Sanchi (aka Tienchi) ginseng root (Panax notoginseng, Araliaceae) is used in China to treat ischemic stroke. The main active components in sanchi are saponins. Animal and human trials have shown that these saponins inhibit platelet aggregation and have anti-inflammatory and neuroprotective effects. The purpose of this randomized, double-blind, placebo-controlled trial was to investigate the effects of aspirin plus a sanchi product on outcomes in people with mild-to-moderate ischemic stroke.
The trial was conducted at 4 unidentified clinical sites in China by researchers from the West China Hospital of Sichuan University. Subjects were eligible for the trial if they were 18-75 years of age, were diagnosed with an ischemic stroke in the anterior cerebral circulation, and had the stroke within 30 days of enrolling in the trial. Those with brain tumors, Parkinson’s disease, dementia, psychiatric disorders, or other types of strokes were excluded from the trial.
Eligible subjects were randomly assigned to receive either standardized P. notoginseng root extract, (Sanchitongshu; Chengdu Hoist Inc. Ltd.; Chengdu, China) or a matching placebo. (The article refers to the sanchi extract as “a new Chinese patent medicine,” although sanchi preparations have been relatively popular in traditional Chinese medicine for many years; the claimed novelty of this extract is presumably based on its standardization parameters.) Each capsule of Sanchitongshu contained 100 mg panaxatriol saponin from an ethanolic root extract, standardized to provide 50 mg ginsenoside Rg1, 11 mg notoginsenoside R1, and 6 mg ginsenoside Re. Subjects took 1 capsule 3 times per day for 28 days. All subjects received 50 mg aspirin 1 time per day as part of their medical care. Subjects were examined at baseline and after 28 days, and follow-up lasted for up to 180 days. Neurological function was evaluated using the European Stroke Scale (ESS), and activities of daily living were evaluated using the Barthel Index (BI).
The trial enrolled 145 subjects, and 140 were randomized to the aspirin plus Sanchitongshu group or aspirin plus placebo group. The subjects included 70 men and 70 women ranging in age from 41 to 75 years. The Sanchitongshu group had higher ESS and BI scores at baseline compared to the placebo group, but all other characteristics were similar between the groups. Of the 140 subjects, 137 completed the 28-day treatment and follow-up examinations.
Neurological function as measured by ESS improved significantly in both groups (P<0.0001). Mean improvement in ESS score in the Sanchitongshu group was significantly greater than the placebo group after 28 days (P<0.0001). More subjects in the Sanchitongshu group had marked improvement in neurological function than in the placebo group (P<0.0001). The 8 ESS items evaluating limb movement showed the greatest improvement. Activities of daily living as measured by BI improved significantly in both groups (P<0.0001). The mean improvement in BI score was significantly better in the Sanchitongshu group (P=0.0178) than in the placebo group. Adverse events were similar in both groups and included nausea and other gastrointestinal symptoms.
The authors conclude that the combination of aspirin plus Sanchitongshu improves outcomes better than aspirin alone in people with a recent mild or moderate stroke. The most prominent improvements in neurological function were seen in limb movement. The combination of aspirin and Sanchitongshu does not appear to increase the risk of bleeding or hemorrhage. The authors point out that the aspirin dose of 50 mg used in this trial is 50% lower than what is typically recommended for stroke patients (100 mg). The safety and effectiveness of adding Sanchitongshu to higher doses of aspirin are unknown. The authors also state that improvements seen in patients with mild-to-moderate stroke may not apply to patients with more severe strokes.
The authors report changes in ESS and BI scores from baseline to the end of the 28-day treatment period. Although the trial included follow-up for 90-180 days, the authors provide no data from the longer follow-up period. It is not clear why the data were not provided and why the authors did not comment on this. It would be important to determine if the better outcomes observed in the Sanchitongshu group persisted over time.
—Heather S. Oliff, PhD