the First clinical medical college, Beijing University of Chinese Medicine, Beijing 100029, China.
Department of Neurology, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing 100700, China.
J Tradit Chin Med. 2022 Feb;42(1):83-89. doi: 10.19852/j.cnki.jtcm.20211214.001.
To evaluate the effectiveness and safety of Ginkgo biloba extract (GBE50) in the treatment of dizziness caused by cerebral arteriosclerosis.
This was a multi-center, double-blind, double-dummy, positive-controlled, parallel randomized controlled clinical trial with 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.
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).
The treatment of dizziness caused by cerebral arteriosclerosis with GBE50 is effective, safe and reliable.
评价银杏叶提取物（GBE50）治疗脑动脉硬化性眩晕的有效性和安全性。
这是一项多中心、双盲、双模拟、阳性对照、平行随机对照临床试验，采用 1：1 分配。我们在中国 10 家医院招募了 404 例脑动脉硬化性眩晕（血瘀证型）患者。GBE50 组给予 GBE50 和模拟剂脑心清片（NXQ），对照组给予 NXQ 和模拟剂 GBE50。主要结局是治疗 6 周后血瘀证中医证候积分的变化。次要结局是眩晕残障程度评定量表（DHI）评分、眩晕视觉模拟量表（VAS）评分、加利福尼亚大学眩晕问卷（UCLA-DQ）评分以及中医单项症状评分从基线到 2、4 和 6 周的变化。安全性指标包括不良事件、严重不良事件以及包括血常规、肝功能、肾功能等在内的实验室检查的发生率。
治疗 6 周后，GBE50 组中医证候积分总有效率高于对照组，差异有统计学意义（92.67%比 83.07%，P = 0.004）。与对照组相比，不良反应发生率差异无统计学意义（9.95%比 14.85%，P = 0.136）。
GBE50 治疗脑动脉硬化性眩晕有效、安全、可靠。
