Ginsenoside-Rd improves outcome of acute ischaemic stroke - a randomized, double-blind, placebo-controlled, multicenter trial
European Journal of Neurology, 05/08/2012
Liu X et al. – Ginsenoside–Rd improved the primary outcome of acute ischaemic stroke and had an acceptable adverse–event profile.Methods
- The authors 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.
- The primary end-point was the distribution of disability scores on the modified Rankin scale (mRs) at 90 days.
- 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 they 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.