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Efficacy and Safety of Panax notoginseng Saponins in the Treatment of Adults With Ischemic Stroke in China: A Randomized Clinical Trial.

  • 2023-06-20
  • JAMA network open 6(6)
    • Longfei Wu
    • Haiqing Song
    • Chi Zhang
    • Anxin Wang
    • Bowei Zhang
    • Chiyu Xiong
    • Xianbo Zhuang
    • Yingzhuo Zang
    • Chenghao Li
    • Qi Fang
    • Chuanqiang Qu
    • Lihua Wang
    • Mei Zhang
    • Hao Li
    • Xiaoli Wang
    • Yanan Li
    • Lei Xia
    • Zhigang Yao
    • Zhi Nie
    • Ying Gao
    • Xunming Ji

Study Design

Type
Randomized Controlled Trial (RCT)
Sample size
n = 1,488
Population
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%])
Methods
multicenter, double-blind, placebo-controlled randomized clinical trial; patients assigned within 14 days after symptom onset to receive either Xuesaitong soft capsules (120 mg orally twice daily) or placebo (120 mg orally twice daily) for 3 months
Blinding
Double-blind
Duration
3 months
  • Large Human Trial
  • Rigorous Journal

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.

Research Insights

    Adverse Events Reported

    • Notoginseng→Overall tolerability

      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).

      Finding
      No significant difference
      Severity
      Serious adverse event
      Magnitude
      15/1488 (1.0%) vs 16/1482 (1.1%)
      Significant
      No
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