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Journal of Traditional Chinese Medicine >

2022 , Vol. 42 >Issue 1: 83 - 89

DOI: https://doi.org/10.19852/j.cnki.jtcm.20211214.001

Research Articles

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

  • Rina SHA ,
  • Lu TANG ,
  • Yawei DU ,
  • Shengxian WU ,
  • Huawei SHI ,
  • Hongxin ZOU ,
  • Xuran ZHANG ,
  • Xinglu DONG ,
  • Li ZHOU
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  • 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
ZHOU Li, Department of Neurology, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing 100700, China. Zhouljk7211@163.com
DONG Xinglu, Department of Neurology, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing 100700, China. arthasdxl@163.com;

Received date: 2021-02-26

  Accepted date: 2021-05-20

  Online published: 2021-12-14

Supported by

National Major Scientific and Technological Special Project for "Significant New Drugs development"(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

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Abstract

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.

Key words： Ginkgo biloba; intracranial arteriosclerosis; dizziness; treatment outcome; randomized controlled trial

Cite this article

Rina SHA , Lu TANG , Yawei DU , Shengxian WU , Huawei SHI , Hongxin ZOU , Xuran ZHANG , Xinglu DONG , Li ZHOU . 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[J]. Journal of Traditional Chinese Medicine, 2022 , 42(1) : 83 -89 . DOI: 10.19852/j.cnki.jtcm.20211214.001

References

[1] Neuhauser H. The epidemiology of dizziness and vertigo. Handb Clin Neurol 2016;137:67-82.
[2] Karatas M. Vascular vertigo: epidemiology and clinical syndromes. Neurologist 2011;17:1-10.
[3] Yang X. Current status and countermeasures of vertigo diagnosis in domestic neurology. Zhong Yi Cu Zhong Za Zhi 2015;10:373-81.
[4] Xue H, Chong Y, Jiang ZD. Etiological analysis on patients with vertigo or dizziness. Zhong Hua Yi Xue Za Zhi 2018;98:1227-30.
[5] Flusty B, Havenon AD, Prabhakaran S, et al. Intracranial atherosclerosis treatment: past, present, and future. Stroke 2020;51:49-53.
[6] Murdin L, Hussain K, Schilder AGM. Betahistine for symptoms of vertigo. Cochrane Database Syst Rev 2016; 2016: CD010696.
[7] Huang Z, Hu YQ, Chen LM, et al. Research progress of Xuefu Zhuyu Decoction on vertigo. Shan Xi Zhong Yi 2020;41:1169-72.
[8] Wang XZ, Han QY, Guo XF, et al. Complete Book of Diagnosis and Treatment of Stroke and Encephalopathy. Beijing: China Medical Science Press, 2000: 334-5.
[9] The Minister of Health of the People's Republic of China. The second part of the Guiding Principle of Clinical Research on New Drugs of Chinese Medicine. Beijing: the Chinese Ministry of Public Health, 1995: 210-2.
[10] Zheng XY. Clinical research guidelines for new Chinese medicine. Beijing: Medical Science and Technology Press, 2002: 383-5.
[11] Lu WX. Cinical trial of Xingling granules for vertigo. Zhong Cheng Yao 1998;20(10):22-5.
[12] Li HM. Comparison of the curative effect of Xuesaitong soft capsule and ginkgo ketone ester dripping pills in the treatment of dizziness caused by Cerebral Arteriosclerosis. Zhong Guo Lao Nian Bao Jian Yi Xue 2018;16:105-6.
[13] Zhang J, Yang KP, Wei XX, et al. Efficacy of ginkgo ketone dripping pills in treating cerebral arteriosclerosis and vertigo. Zhong Hua Shi Yong Yi Xue 2014;9(22):143-4.
[14] Liu CY, Wang B, He DY, et al. Current status of Traditional Chinese and Western Medicine research on chronic cerebral insufficiency. Zhong Guo Lao Nian Xue Za Zhi 2014;34:1722-4.
[15] Gui SQ, Yu Z, Qu S, et al. Study on the academic thought of Renzhai Zhi Zhi Fang. Zhong Guo Zhong Yi Ji Chu Yi Xue Za Zhi 2016;22:744-7.
[16] Zhang ZJ. Treatise on Febrile Diseases. People’s Medical Publishing House Co., Ltd., 2005: 252.
[17] Zhang GQ, Chen L, Zhang LY. Study on TCM syndrome differentiation and syndrome factors of vascular headache based on data mining. Ya Tai Chuan Tong Yi Yao 2017;13:67-9.
[18] Li ZP, Zhao DS, Wang FY. A review on numbness in TCM syndrome. Zhong Guo Lin Chuang Yan Jiu 2015;7:144-6.
[19] Li D, Shao YY, Zhao M. Study on distribution law of TCM syndrome and syndrome element of insomnia based on literature. Huan Qiu Zhong Yi Yao 2020;13:384-8.
[20] Ekwall A, Lindberg A, Magnusson M. Dizzy-why not take a walk? Low level physical activity improves quality of life among elderly with dizziness. Gerontology 2009;55:652-9.
[21] Dros J, Maarsingh OR, Beem L, et al. Impact of dizziness on everyday life in older primary care patients: a cross-sectional study. Health Qual Life Outcomes 2011;9:44.
[22] Jacobson GP, Newman CW. The development of the dizziness handicap inventory. Arch Otolaryngol Head Neck Surg 1990;116:424-7.
[23] Honrubia V, Bell TS, Harris MR, et al. Quantitative evaluation of dizziness characteristics and impact on quality of life. Am J Otol 1996;17:595-602.
[24] Duracinsky M, Mosnier I, Bouccara D, et al. Literature review of questionnaires assessing vertigo and dizziness, and their impact on patients' quality of life. Value Health 2007;10:273-84.
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