Efficacy of Yangyin Yiqi Huoxue Granule in Treatment of Ischemic Stroke Patients with Qi-Yin Deficiency and Blood Stasis Syndrome: A Randomized, Double-Blind, Multicenter, Phase-2 Clinical Trial

Objective: To evaluate the efficacy and safety of Yangyin Yiqi Huoxue Granule (........, YYHG) in the treatment of ischemic stroke (IS) patients with qi-yin defificiency and blood stasis syndrome (QYDBSS), and to explore its effective dosage. Methods: The total of 288 patients were randomly assigned to the YYHG high-dose, YYHG low-dose, positive control (administered Xiaoshuantong Granule, XSTG,.....), or placebo control (administered inert granule) groups (72 cases per group) by software-drived competitive block randomization. The trial was conducted for a 28-day period, with a 180-day follow-up period. The primary outcome was the comprehensive curative evaluation, and secondary outcomes were the National Institute of Health Stroke Scale ( NIHSS) score, Barthel activities of daily living (ADL) index score, the quality of life index (QLI) score, and the Chinese medicine syndrome (CMS) score. All analyses were done on an intention-to-treat basis. The clinical safety was also assessed. Results: The total of 288 participants were recruited between June 1, 2008 and September 30, 2009, and 287 patients received intervention; the treatment groups were well balanced at baseline. The comprehensive cure rates of YYHG high-dose, low-dose, positive and placebo control groups were 63.38%, 31.94%, 36.11% and 6.14%, respectively; there was a statistical difference between the two groups ( P< 0.01), while the high-dose YYHG treatment group was signifificantly higher than the other 3 groups (P< 0.01). The improvement of NIHSS, ADL, QLI and CMS scores of the YYHG high-dose and low-dose groups was signifificantly better than that of the positive control group and the placebo control group ( P< 0.05). In terms of improving the classifification of the NIHSS scale and the assessment of the ADL scale, the YYHG high-dose group was signifificantly better than the other three groups (P< 0.05), and the YYHG low-dose group was better than the placebo control group (P< 0.01). At the same time, except for the QLI score, the high-dose group was better than the low-dose group ( P< 0.05). In terms of safety, adverse reactions after YYHG treatment were generally mild (3.78%), and no serious adverse reactions have been reported. Conclusion: YYHG is safe and effective in the treatment of IS patients with QYDBSS. KEYWORDS stroke, qi-yin defificiency and blood stasis syndrome, Chinese medicine, randomized controlled trial