Effects of Yangxue Qingnao Granules on chronic cerebral circulation insufficiency: A randomized, double-blind, double-dummy, controlled multicentre trial

摘要

Background: There is a great deal of interest in traditional Chinese medicine as a treatment for chronic cerebral circulation insufficiency (CCCI). In the present study, we evaluated the efficacy and safety of Yangxue Qingnao Granules (YXQNG) as a monotherapy in patients with CCCI. Methods: From July 2007 to May 2010, 273 patients with CCCI at nine centres in China were randomly assigned to receive either YXQNG with nimodipine placebo (n= 140, 12g/day) or nimodipine with YXQNG placebo (n= 133, 30mg/day) for 8weeks. The primary end points after 8weeks of treatment were changes from baseline in severity of headache, heavy-headed feeling, dizziness and sleep disorder. Results: The mean baseline levels of headache, heavy-headed feeling, dizziness and sleep disorder were comparable between the two groups. Both therapies significantly improved these symptoms after 8weeks of treatment (P < 0.001). Compared with nimodipine therapy, YXQNG resulted in similar reductions in these symptoms. No adverse effects were observed in the YXQNG group. Conclusions: These data demonstrate that YXQNG as a monotherapy were as effective as nimodipine monotherapy in improving the symptoms of CCCI. It is well-tolerated and may have an important place in the management of this condition. Whether a combination of these two medicines will increase therapeutic efficacy deserves further clinical investigation.