| Objective:To evaluate the clinical effectiveness and safety of gastrodm injection in the treatment of vertigo.Methods:A muti-center, single-blind randomized controlled trial was designed to study 240 vertigo patients who were randomly allocated into the treatment and the controls.patients in the treatment group were treated with gastrodin injection 600mg,intravenously guttae,daily for 7days,while those in the control group were treated with betahistin 30mg, intravenously guttae,daily for 7days. 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 chinical control rate and effective rates in the treatment group(n=117) were 71.19%and 90.60%,respectively,while 54.17% and 77.50% in the control group(n=120).A statistic significance difference was found between the two groupes(P=0.0050 and p=0.0049 forcontrol and effective rate respectively).According to the per-protocol population(PP) analysis, the chinical control rate and effective rates 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 difference was found between the two groups(P=0.0050 and P=0.0033 respectively). ITT and PP analysis revealed similar results.2)The clinical effect on vestibular function: the chinical 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 chinical control rates but was not found in the effctive 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 11.86% in the treatment group(n=118)and 17.50% in the control group(n=120), respectively. No statistic significance was found between the two groups (P=0.2197) .Conclusion : Gastrodin injection and betahistine injection are safe and effective drugs for vertigo; gastrodin injection is bettr than betahistine injection in releaving vertigo symptoms . |
