Effectiveness and safety of Ginkgo biloba extract(GBE50)in the treatment of dizziness caused by cerebral arteriosclerosis:a multi-center,double-blind,randomized controlled trial  

作　　者：SHA Rina TANG Lu DU Yawei WU Shengxian SHI Huawei ZOU Hongxin ZHANG Xuran DONG Xinglu ZHOU Li 

机构地区：[1]the First clinical medical college,Beijing University of Chinese Medicine,Beijing 100029,China [2]Department of Neurology,Dongzhimen Hospital,Beijing University of Chinese Medicine,Beijing 100700,China

出　　处：《Journal of Traditional Chinese Medicine》2022年第1期83-89,共7页中医杂志（英文版）

基　　金：Supported by National Major Scientific and Technological Special Project for"Significant New Drugs development"(No.2017ZX09304019);National Major Scientific and Technological Special Project for Clinical Evaluation Technology Platform of"Disease,Symptom Pattern and Symptom Correlation"of New Traditional Chinese Medicine。

摘　　要：OBJECTIVE:To evaluate the effectiveness and safety of Ginkgo biloba extract(GBE50)in the treatment of dizziness caused by cerebral arteriosclerosis.METHODS:This was a multi-center,double-blind,double-dummy,positive-controlled,parallel randomized controlled clinical trial with 1∶1 allocation.We recruited 404 patients with dizziness caused by cerebral arteriosclerosis(blood stasis symptom pattern)in 10 hospitals in China.GBE50 group received GBE50 and Naoxinqing tablet(NXQ)of mimetic agent,control group received NXQ and GBE50 of mimetic agent.The main outcome was Traditional Chinese Medicine(TCM)symptom pattern score of blood stasis after 6 weeks.The secondary outcomes were changes in the dizziness handicap inventory(DHI)score,vertigo visual analogue scale(VAS)score,the university of California vertigo questionnaire(UCLA-DQ)score and single-item symptom score of TCM from baseline to 2,4 and 6 weeks.Safety indicators included the incidence of adverse events,severe adverse events and laboratory examination including blood routine,liver function,renal function,and so forth.RESULTS:The total effective rate of TCM symptom pattern score in the GBE50 group after 6 weeks of treatment was higher than that in the control group,the difference in rate was statistically significant(92.67%vs 83.07%,P=0.004).Compared with the control group,there was no difference in the incidence of adverse reactions(9.95%vs 14.85%,P=0.136).CONCLUSION:The treatment of dizziness caused by cerebral arteriosclerosis with GBE50 is effective,safe and reliable.

关 键 词：Ginkgo biloba intracranial arteriosclerosis DIZZINESS treatment outcome randomized controlled trial 

分 类 号：R277.7[医药卫生—中医学]