Efficacy and Safety of Panax notoginseng Saponins in the Treatment of Adults With Ischemic Stroke in China

Abstract

ImportancePreclinical and clinical studies have suggested the neuroprotective effect of Panax notoginseng saponins (Xuesaitong soft capsules). However, robust evidence in patients with ischemic stroke is lacking.ObjectiveTo assess the efficacy and safety of Xuesaitong soft capsules in patients with ischemic stroke.Design, Setting, and ParticipantsThis multicenter, double-blind, placebo-controlled randomized clinical trial was conducted at 67 tertiary health centers in China from July 1, 2018, to June 30, 2020. Included patients were aged 18 to 75 years with a diagnosis of ischemic stroke and a National Institutes of Health Stroke Scale score between 4 and 15.InterventionsEligible patients were randomly assigned within 14 days after symptom onset to receive either treatment with Xuesaitong soft capsules (120 mg orally twice daily) or placebo (120 mg orally twice daily) for 3 months.Main Outcomes and MeasuresThe primary outcome was functional independence at 3 months, defined as a modified Rankin Scale score of 0 to 2.ResultsAmong 3072 eligible patients with ischemic stroke who were randomized, 2966 (96.5%) were included in the modified intention-to-treat cohort (median [IQR] age, 62 [55-68] years; 1982 male [66.8%]). The number of patients who achieved functional independence at 3 months was 1328 (89.3%) in the Xuesaitong group and 1218 (82.4%) in the control group (odds ratio, 1.95; 95% CI, 1.56-2.44; P < .001). In the safety cohort, serious adverse events occurred in 15 of 1488 patients (1.0%) in the Xuesaitong group and 16 of 1482 (1.1%) in the control group (P = .85).Conclusions and RelevanceIn this randomized clinical trial, Xuesaitong soft capsules significantly increased the likelihood of functional independence at 3 months in patients with ischemic stroke, indicating that this may be a safe and effective alternative therapy to improve prognosis in this population.Trial RegistrationChinese Clinical Trial Registry Identifier: ChiCTR1800016363

Efficacy and safety of Panax notoginseng saponins (Xuesaitong) for patients with acute ischemic stroke: a systematic review and meta-analysis of randomized controlled trials

“…Two studies ( Zhang et al, 2022 ; Wu et al, 2023 ) containing 3,162 cases reported all-cause mortality, whereas there was no significant difference between the XST group and the control group (RR = 0.43; 95% CI [0.06 to 2.93]; p = 0.39; I 2 = 0%) ( Figure 4 ). As such, no evidence was found to indicate that XST could reduce the all-cause mortality of AIS.…”

“…We identified the overall bias as “low risk of bias” in one study ( Wu et al, 2023 ) and judged the remaining 45 studies to have a “high risk of bias”, indicating the poor quality of the selected RCTs. The results of the assessment of bias risk are presented in Figure 2 and Supplementary Figure S1 .…”

“…For the long-term functional outcomes, two studies ( Zhang et al, 2022 ; Wu et al, 2023 ) comprising a total of 3,158 participants reported the grading or the proportion as per the mRS, and we were unable to synthesize the data. Patients in the XST group were more likely to have better long-term functional outcomes with lower mRS scores (MD = −0.67; 95% CI [−0.92 to −0.42]; p < 0.00001) or a higher proportion of functional independence (mRS ≤2) (RR = 1.08; 95% CI [1.05 to 1.12]; p < 0.00001) ( Figure 3 ).…”

Analysis of online prescription patterns in Chinese patients with sequelae of cerebral infarction: a real-world study

“…Notoginsenoside R1 has been found to alleviate neuronal injury induced by β-amyloid through the inhibition of reactive oxygen species and regulating MAPK activation 48 . Study has shown that Panax notoginseng saponins significantly increase the probability of functional independence at 3 months in patients with IS, suggesting that this may be a safe and effective alternative treatment to improve the prognosis of this population 49 .…”

The Optimization Design of Macrophage Membrane Camouflaging Liposomes for Alleviating Ischemic Stroke Injury through Intranasal Delivery

“…The panax notoginseng saponins (PNSs) are extracted from the roots of Panax notoginseng (Burk.) F. H. Chen , and their main active ingredients include five components: ginsenoside Rg1 (Rg1), ginsenoside Rb1 (Rb1), ginsenoside Rd (Rd), ginsenoside Re (Re), and notoginsenoside R1 (R1) [ 3 , 4 ]. Extensive scientific research has shown that PNS has pharmacological activity, such as anti-inflammatory effects, angiogenesis promotion, thrombosis inhibition, and antioxidant properties [ 5 , 6 , 7 ].…”