A Randomized Controlled Trial Of The Auricular Thumb-tack Needles Therapy In The Treatment Of Migraine

Objective:Through A randomized controlled trial,Preliminary study on the effect of the auricular thumb-tack needles treatment on the degree of symptom relief in migraine patients,including the VAS score of headaches,the number of occurrences,the degree of headache,etc.To provide clinical evidence for the treatment of migraine with auricular acupuncture,and to lay the foundation for further study on the application of auricular acupuncture in migraine.Methods:A randomized,placebo-controlled,three-blind study method was used.A total of 78 patients were randomized into an auricular thumb-tack needle therapy group and an auricular shame thumb-tack needle therapy group.The auricular points were the first Acupoint group（shenmen（TF4）,jiaogan（AH6）,pizhixia（AT4））and the second acupoint group（neifenmi（CO18）,gan（CO20）,shen（CO10）,xin（CO15））in the two groups.The two points groups on both sides were used alternatively.The treatment was given twice a week,and the consecutive 4 weeks courses of treatment were required.The effectiveness evaluation indicators included visual analog scale（VAS）of headache before,4,8,12,and 16 weeks after entering the group,current pain intensity assessment（PPI）,number of headaches,and pain in both groups.Graded index（PRI）,ear-related safety assessment and auricular acupuncture therapy can still be evaluated.Results:1.At the end of the 4-week treatment period and the 8th week of the treatment,the ITT analysis set and the statistical analysis of the PP analysis set showed that the treatment group of the VAS score was lower than that of the control group.The statistical analysis between the two groups showed that at 12 and 16 weeks of enrollment,there was no difference between the two groups in the headache VAS scores of the treatment group and the VAS scores of the control group.The headache VAS scores of the treatment group were different from the pre-treatment VAS scores(P₄<0.01,P₈<0.01,P₁₂=0.041<0.05,P₁₆=0.049<0.05).The control group only had differences at the end of 4 weeks of treatment and the 8th week of enrollment.2.At the end of the 4-week treatment period,the number of headaches was reduced in both groups,and the difference was not statistically significant（P₄>0.05）.During the5th week of enrollment and the 9th week of enrollment,the reduction of the number of headaches in the treatment group were different from the control group.(P₈、P₁₂<0.05).At the 13th to 16th week of enrollment,there was no statistical.(P₁₆>0.05).3.The statistical analysis of the ITT analysis set and the PP analysis set showed that the existing headache intensity of the two groups of patients at the end of treatment and the8th week of enrollment was improved,and the treatment group was superior to the control group.At the 12th and 16th week of enrollment,there was no significant improvement between the two groups in the current headache intensity(P₁₂>0.05,P₁₆>0.05).4.At the 4th week,patients in the treatment group were superior to the control group in terms of PRI in terms of sensory,emotional,and total scores after receiving acupuncture at the auricular acupuncture point;in the 8th week of enrollment,the emotional item and total score were superior.The control group（P<0.05）;at the 12th week of enrollment,the PP set only showed that the emotional item of the treatment group were different from the control group（P<0.05）;and at the 16th week,there was no difference in the PRI（P>0.05）.5.Six months after the end of the study,patients were followed up to evaluate the patient’s acceptance of auricular thumb-tack needles therapy.The patients in the treatment group were better than the False thumb-tack needle auricular control group,and P=0.045<0.05.Conclusion:The auricular thumb-tack needles treatment has clinical therapeutic significance for improving the VAS score of pain symptoms in migraine patients,reducing the patient’s current headache intensity,and the safety of this treatment plan is good,and it is recognized and accepted by the subjects.This program is worthy of clinical promotion.