CHEN Jing 1 , LIU Shixi 1 , HU Guohua 2 , ZHANG Xueyuan 3 , XIA Yan 4
  • 1.Department of Otolayngology; West China Hospital; Sichuan Univercity; Chengdu 610041; China2.Department of Otolayngology; the First Affiliated Hospital; Chongqing University of Medical Science; Chongqing 4000163.Department of Otolayngology; Southwest Hospital; the Third Military Medical University; Chongqing 4000384.Department of Health Statistics; Huaxi School of Public Health; West China Center of Medical Sciences; Sichuan Univercity; Chengdu 610041; China;
Gastrodin injection; Betahistine injection; Vertigo; Randomized controlled trial
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Objective 　To evaluate the clinical effectiveness and safety of gastrodin injection in the treatment of vertigo.
Methods 　A multi-center, single-blind randomized controlled trial was designed to study 240 vertigo patients who were randomly allocated into the treatment and the control groups.Patients in the treatment group were treated with gastrodin injection 600 mg, intravenously guttae, daily for 7 days, while those in the control group were treated with betahistin 30 mg, intravenously guttae, daily for 7 days. All data were analyzed by SAS. CMH (Cochran’s and Mantel-Haenszel) method was used to compare the clinical effect between the two groups. Nonparametric statistics and t-test were used in baseline data analysis.
Results 　① The clinical effectivenes on vertigo: according to the intention-to-treat (ITT) analysis, the clinical control rate and effective rate in the treatment group (n=117) were 71.19% and 90.60%, respectively, while 54.17% and 77.50% were in the control group (n=120). A statistic significance difference was found between the two groups (P=0.005 and P=0.004 for control and effective rate respectively).According to the per-protocol population (PP) analysis, the clinical control rate and effective rate in the treatment group (n=116) were 72.41% and 91.38%, respectively, and were 54.70% and 77.78% in the control group (n=117). Statistic significance was found between the two groups (P=0.005 and P=0.004 respectively). ITT and PP analysis revealed similar results. ② The clinical effect on vestibular function: the clinical control rate and effective rate were 62.26% and 81.13% respectively in the treatment group (n=53), and were 42.37% and 76.27% in the control group (n=58). Statistic significance was found in the clinical control rate but was not found in the effective rates between the two groups (P=0.029 and P=0.504, respectively). ITT and PP analysis revealed the same results. ③ Adverse drug reactions (ADRs) were slight to moderate. ADRs rates were 8.33% in the treatment group (n=120) and 10.83% in the control group (n=120), respectively. No statistic significance was found between the two groups(P=0.538).
Conclusions 　Gastrodin injection and betahistine injection are safe and effective drugs for vertigo; gastrodin injection is better than betahistine injection in relieving vertigo symptoms.

Citation： CHEN Jing,LIU Shixi,HU Guohua,ZHANG Xueyuan,XIA Yan. Gastrodin Injection in the Treatment of Vertigo: A Multi-center Single-blind Randomized Controlled Trial. Chinese Journal of Evidence-Based Medicine, 2004, 04(12): 864-870. doi: Copy