| Objective: Using flunarizine hydrochloride capsules as a positive control drug and TCM syndrome score,Dizziness Handicap Inventory(DHI)and Headache Symptom Score Scale of vestibular migraine as an outcome the outcome indicators,the efficacy and safety of the method of warming Tanyin(Huayinzhixuan Decoction)in the treatment of vestibular migraine of Tanyin syndrome were evaluated by a randomized,controlled clinical trial observed,providing certain evidence-based medical evidence for its clinical applications for further promotion.Methods: From May 2020 to September 2021,a total of 64 patients who fulfilled the diagnosis of vestibular migraine of Tanyin syndrome were recorded in the outpatient department of Neurology of the Affiliated Hospital of Jiangxi University of Chinese Medicine,and 61 patients were finally enrolled according to the inclusion and exclusion criteria.According to the principle of an open clinical controlled trial,all patients were randomly assigned to the Huayinzhixuan decoction group(observation group)or the flunarizine hydrochloride capsule group(control group).The patients’ general data(gender,age,etc.),pre-treatment data,post-treatment data,and data at the end of week 12 were recorded,as well as TCM syndrome score,Dizziness Handicap Inventory,headache symptom score,etc.The adverse events that occurred during the treatment were also observed.SPSS25.0 statistical software was used for statistical analysis of the data.The Overall clinical efficacy is the main efficacy indicator.The overall clinical efficacy index was the reduction rate of TCM syndrome score,which was classified as effective if the reduction rate of TCM syndrome score was ≥ 30% according to the prescribed criteria,and invalid if the opposite was the case;the secondary observational indexes were the Dizziness Handicap Inventory and the Headache Rating Scale;after compiling and analyzing the clinical trial data,this was used to evaluate the therapeutic efficacy of the method of Warming Tanyin(Huayinzhixuan decoction)in the treatment of vestibular migraine of Tanyin syndrome;the safety of the treatment was evaluated by laboratory indicators(blood routine examination,liver and kidney function)and adverse reactions before and after the treatment.Results:1.A total of 64 Patients were put one’s name down in this research process and 61 cases were finally completed,with 2 cases falling in the observation group and 1 Case in the control group,for an overall rate of 4.68%.A total of 64 patients were enrolled in this study and 61 cases were finally completed,with 2 cases falling in the observation group and 1 case in the control group,for an overall rate of 4.68%.2.Before enrollment,there was no statistically significant difference between the observation group and the control group in terms of gender,age,disease duration,TCM syndrome score,DHI score,and headache score(P > 0.05),and the clinical data were comparable.3.TCM syndrome scores:(1)Comparison within groups: After 4 weeks of treatment and at the follow-up after 12 weeks,TCM syndrome scores decreased in both the observation group and the control group compared with those before treatment,and there was a statistically significant difference(P < 0.01);during the follow-up period from the cessation of treatment after 4 weeks to the 12-week enrollment,the TCM syndrome scores of the observation group showed no statistically significant changes(P > 0.05),while the control group showed statistically significant changes(P < 0.05).(2)Comparison between groups: At the follow-up after 4 weeks of treatment and 12 weeks after enrollment,there were differences between the observation group and the control group based on the statistical comparison of TCM syndrome scores(P < 0.05).4.DHI scores:(1)Intra-group comparison: after 4 weeks of treatment and at the follow-up after 12 weeks of enrollment,the DHI scores of both the observation group and the control group decreased compared with those before treatment and showed statistically significant differences(P < 0.01).During the follow-up from 4 weeks after the end of treatment to 12 weeks after enrollment,the DHI scores of the observation group did not show statistically significant changes(P > 0.05),while the control group showed statistically significant changes(P < 0.05).(2)Comparison between groups: Statistically significant differences were found between the DHI scores of the observation group and the control group after 4weeks of treatment and at follow-up 12 weeks after enrollment(P <0.01).5.Headache symptom scores:(1)Intra-group comparison: after 4weeks of treatment and at the follow-up examination at 12 weeks after enrollment,the headache scores in both the observation group and the control group decreased compared with those before treatment,and there was a statistically significant difference(P < 0.01).During the follow-up period from 4 weeks after treatment to 12 weeks after enrollment,the headache scores of the observation group showed no statistically significant change(P > 0.05),whereas the control group showed a statistically significant change(P < 0.05).(2)Comparison between groups: At follow-up after 4 weeks of treatment and 12 weeks after enrollment,there was a statistically significant difference between the headache scores of the observation group and the control group(P < 0.01).6.Overall clinical efficacy: After 4 weeks of treatment,the overall efficacy rate of the observation group(80.00%)was better than that of the control group(61.29%),and the difference between the two groups was statistically significant(P < 0.05).7.safety evaluation: no serious adverse events occurred in both groups during this study,and only one patient in the control group had a minor adverse reaction in the form of drowsiness.the blood routine examination and liver and kidney functions of patients in both groups did not show any significant abnormalities before and after treatment.Conclusion:1.The overall clinical efficacy of the treatment of patients with vestibular migraine of Tanyin syndrome treated with the method of warming Tanyin(Huayinzhixuan Decoction)was significantly better than that of the flunarizine hydrochloride capsule group;the Huayinzhixuan Decoction group was able to reduce the TCM syndrome score of patients with vestibular migraine of Tanyin syndrome more significantly than the flunarizine hydrochloride group.2.Based on the method of warming Tanyin,the Huayinzhixuan decoction group performed better than the flunarizine hydrochloride group in improving the Dizziness Handicap Inventory(DHI)and headache symptom score of patients with vestibular migraine of Tanyin syndrome,which effectively improved the patients’ dizziness and migraine symptoms and their quality of life.3.The efficacy and safety of the method of warming Tanyin(Huayinzhixuan decoction)in the treatment of vestibular migraine of Tanyin syndrome are promising,and it is worthy of wide clinical application. |
PDF Full Text Request