| Objective: In this study,we used Modfied Jiuwei Qianghuo Decoction to treat migraine patients with cold and blood stasis-type migraine.We observed the clinical symptoms and signs,visual analogue scale(VAS)and improvement of Chinese medicine symptoms to evaluate the effectiveness and safety of this formula in treating cold and blood stasis-type migraine and to provide evidence-based medical support for the future use of Modfied Jiuwei Qianghuo Decoction in treating migraine.Methods: Sixty patients with migraine(cold and blood stasis-type)who met the inclusion criteria were selected from the Department of Neurology,Affiliated Hospital of Jiangxi University of Chinese Medicine,and were divided into treatment group and control group by randomized control grouping,with 30 patients in each group.The treatment group was treated with Modfied Jiuwei Qianghuo Decoction,and the control group was treated with flunarizine capsule.The duration of treatment for both groups was 1 month,and the clinical symptom score,VAS score,TCM syndrome score and safety index were evaluated before and after treatment.Results: After a month of treatment,the number of cases that completed the whole clinical study was 57,and a total of 3 cases were shed,of which 1 case was shed in the treatment group because the patient interrupted herbal treatment;2 cases were shed in the control group,1 case was shed because the patient took other drugs privately during medication,and 1 case had poor compliance and incomplete data collection.Statistical analysis of the observed data for both groups of cases led to the following conclusions.1.Comparison of clinical symptom and sign scores: before treatment,the scores of the treatment and control groups were 13.72±3.39 and14.43±3.52,respectively;after treatment,the scores of the treatment and control groups were 6.69±1.39 and 8.50±2.50,respectively.within-group comparison before and after treatment,the clinical symptom and sign scores of patients in both groups were improved accordingly,and there were differences within-group comparison(P<0.05).In the comparison between groups after treatment,the treatment group showed more significant improvement and better efficacy than the control group,and there was a difference between groups(P<0.05).2.Comparison of separate clinical signs and symptoms scores:before treatment,the headache frequency,headache degree,duration,and concomitant symptoms sub-scores were 4.76±1.55,3.93±1.36,3.00±1.22,and 2.03±0.42,respectively,in the treatment group;in the control group,the sub-scores were 4.93±1.49,4.00±1.33,3.42±1.43,and 2.07±0.38,respectively.After treatment,the scores in the treatment group were 2.14±0.52,2.34±0.77,2.07±0.37,1.06±0.26,respectively;in the control group,the scores were2.71±0.98,3.00±1.39,2.21±0.63,1.21±0.42,respectively.The frequency of headache attacks,severity of headache,duration of pain,and concomitant symptoms were all relieved to some extent in both groups before and after treatment,and there was a difference in intragroup comparison(P<0.05).After treatment,the treatment group was more effective than the control group in reducing the number of headache attacks and relieving the degree of headache,and there was a difference between the groups(P<0.05);however,there was no significant difference between the two groups in shortening the headache duration and reducing the concomitant symptoms(P>0.05).3.Comparison of Visual Analogue Scale(VAS): before treatment,the VAS score was 5.84±1.53 in the treatment group and 6.17±1.48 in the control group;after treatment,the VAS score was 2.37±1.41 in the treatment group and 3.50±1.98 in the control group.There was a difference(P<0.05).In the comparison between groups after treatment,the reduction of VAS score in the treatment group was significantly greater than that in the control group,and there was a difference between groups(P<0.05).4.Comparison of total TCM syndrome points: before treatment,the total TCM syndrome points were 20.14±4.24 in the treatment group and19.50±4.61 in the control group;after treatment,the total TCM syndrome points were 7.24±6.21 in the treatment group and 10.46±6.59 in the control group.after the treatment,the total TCM syndrome points decreased significantly in both groups,and the TCM syndrome was improved There was a difference between the pre-and post-treatment comparisons within the groups(P<0.05).The improvement of TCM symptoms in the treatment group was better than that in the control group after treatment,and there was a difference between the groups(P<0.05).5.Comparison of the points of essential symptoms in Chinese medicine: before treatment,the points of three essential symptoms in the treatment group were 3.93±1.36,4.34±1.20 and 4.07±1.13 for Headache,Fear of wind and cold,and Tongue manifestations of blood stasis,respectively.And the points of the control group were3.92±1.27,4.07±1.27 and 4.00±1.22,respectively;after treatment,the points of After treatment,the degree of headache,Fear of wind and cold,and Tongue manifestations of blood stasis were all improved to some extent in the two groups,and there was a difference between the two groups(P<0.05).After treatment,the treatment group was better than the control group in terms of improving the degree of headache and the degree of fear of wind and cold,and there was a difference between the groups(P<0.05).In terms of improving tongue manifestations of blood stasis,there was no significant difference in the efficacy between the two groups,and there was no difference between the groups(P>0.05).6.Comparison of clinical efficacy of TCM symptoms: After treatment,the effective rate of the treatment group was 82.76%,and the effective rate of the control group was 71.43%.The difference in the efficacy between the two groups(P<0.05)indicated that Modfied Jiuwei Qianghuo Decoction had more advantages than flunarizine capsule in improving the TCM symptoms.7.No serious adverse events occurred during the treatment,and only one patient in the control group experienced slight weakness after oral administration of flunarizine capsules.Conclusion: The Modfied Jiuwei Qianghuo Decoction was effective in treating patients with cold and stasis type migraine,and was superior to the control group treated with flunarizine capsules in terms of improving clinical symptom scores,VAS scores,and TCM clinical signs and symptoms,and had a good safety profile. |
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