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, 12 g/day) or nimodipine with YXQNG placebo (n= 133, 30 mg/day) for 8 weeks. The primary end points after 8 weeks 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 8 weeks 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.
RCT Entities:
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, 12 g/day) or nimodipine with YXQNG placebo (n= 133, 30 mg/day) for 8 weeks. The primary end points after 8 weeks 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 8 weeks 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.
Authors: D Monzani; E Genovese; L A Pini; F Di Berardino; M Alicandri Ciufelli; G M Galeazzi; L Presutti Journal: Acta Otorhinolaryngol Ital Date: 2015-06 Impact factor: 2.124