AI Article Synopsis
- Preclinical and clinical studies suggest that Panax notoginseng saponins, specifically Xuesaitong soft capsules, may have protective effects for patients with ischemic stroke, but concrete evidence in humans is limited.
- A randomized clinical trial conducted in China involved 2966 participants with ischemic stroke, assessing the effectiveness of Xuesaitong versus a placebo over three months.
- Results showed that 89.3% of patients in the Xuesaitong group achieved functional independence compared to 82.4% in the control group, indicating that Xuesaitong is a potentially safe and effective treatment alternative for ischemic stroke recovery.*
Article Abstract
Importance: Preclinical 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.
Objective: To assess the efficacy and safety of Xuesaitong soft capsules in patients with ischemic stroke.
Design, Setting, And Participants: This 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.
Interventions: Eligible 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 Measures: The primary outcome was functional independence at 3 months, defined as a modified Rankin Scale score of 0 to 2.
Results: Among 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 Relevance: In 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 Registration: Chinese Clinical Trial Registry Identifier: ChiCTR1800016363.
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|---|---|
| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC10282883 | PMC |
| http://dx.doi.org/10.1001/jamanetworkopen.2023.17574 | DOI Listing |
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