Ginsenoside-Rd improves outcome of acute ischaemic stroke - a randomized, double-blind, placebo-controlled, multicenter trial.

Abstract

BACKGROUND AND PURPOSE:

 Ginsenoside-Rd is a receptor-operated calcium channel antagonist and has shown promise as a neuroprotectant in our phase II study. As an extended work, we sought to confirm its efficacy and safety of Ginsenoside-Rd in patients with acute ischaemic stroke.

METHODS:

We conducted a randomized, double-blind, placebo-controlled trial involving 390 patients with acute ischaemic stroke in a 3:1 ratio to receive a 14-day intravenous infusion of Ginsenoside-Rd or placebo within 72 h after the onset of stroke. Our primary end-point was the distribution of disability scores on the modified Rankin scale (mRs) at 90 days.

RESULTS:

  The efficacy analysis was based on 386 patients (Ginsenoside-Rd group: 290; placebo group: 96). Ginsenoside-Rd significantly improved the overall distribution of scores on the mRs, as compared with the placebo (P = 0.02; odds ratios [OR], 1.74; 95% confidence interval [CI], 1.08-2.78). There were significant differences between the two groups when we categorized the scores into 0-1 vs. 2-5 (P = 0.01; OR, 2.32; 95% CI, 1.23-4.38; 66.8% vs. 53.1%). It also improved the National Institutes of Health Stroke Scale (NIHSS) at 15 days [P < 0.01; least squares mean (LSM), -0.77; 95% CI, -1.31 to -0.24]. Mortality and rates of adverse events were similar in the two groups.

CONCLUSIONS:

  Ginsenoside-Rd improved the primary outcome of acute ischaemic stroke and had an acceptable adverse-event profile.

• Authors: X Liu, L Wang, A Wen, J Yang, Y Yan, Y Song, X Liu, H Ren, Y Wu, Z Li, W Chen, Y Xu, L Li, J Xia, G Zhao
• Journal: European journal of neurology (Eur J Neurol) Vol. 19 Issue 6 Pg. 855-63 (Jun 2012) ISSN: 1468-1331 [Electronic] England
• PMID: 22233205 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: © 2012 The Author(s). European Journal of Neurology © 2012 EFNS.

Chemical References

• Ginsenosides
• Neuroprotective Agents
• ginsenoside Rd

Topics

• Adolescent
• Adult
• Aged
• Disability Evaluation
• Double-Blind Method
• Female
• Follow-Up Studies
• Ginsenosides (therapeutic use)
• Humans
• Infusions, Intravenous (methods)
• Magnetic Resonance Imaging
• Male
• Middle Aged
• Neuroprotective Agents (therapeutic use)
• Stroke (diagnostic imaging, drug therapy)
• Tomography, X-Ray Computed
• Treatment Outcome
• Young Adult