These authors contributed equally to this work.
Ginsenoside-Rd improves outcome of acute ischaemic stroke – a randomized, double-blind, placebo-controlled, multicenter trial
Article first published online: 10 JAN 2012
© 2012 The Author(s). European Journal of Neurology © 2012 EFNS
European Journal of Neurology
Volume 19, Issue 6, pages 855–863, June 2012
How to Cite
Liu, X., Wang, L., Wen, A., Yang, J., Yan, Y., Song, Y., Liu, X., Ren, H., Wu, Y., Li, Z., Chen, W., Xu, Y., Li, L., Xia, J. and Zhao, G. (2012), Ginsenoside-Rd improves outcome of acute ischaemic stroke – a randomized, double-blind, placebo-controlled, multicenter trial. European Journal of Neurology, 19: 855–863. doi: 10.1111/j.1468-1331.2011.03634.x
See editorial by Kaste, on page 797.
- Issue published online: 12 MAY 2012
- Article first published online: 10 JAN 2012
- Received 14 October 2011 Accepted 23 November 2011
- ischaemic stroke;
- randomized trial
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.