Clinical Observation On The Effect Of Toutongning Capsule On Migraine With Blood Stasis Syndrome

Objective:To evaluate the effectiveness and safety of Toutongning Capsule in treating migraine with blood stasis block syndrome by observing the baseline changes in headache frequency,traditional Chinese medicine syndrome scores,and safety indicators after 8-12 weeks of treatment with Toutouning Capsule.Methods:This study adopts a single center,randomized,double-blind,placebo parallel controlled clinical trial.Select migraine patients who visited the Brain Disease Department of the Traditional Chinese Medicine Department of Enshi Tujia and Miao Autonomous Prefecture Central Hospital from December 2021 to December 2022.According to the inclusion criteria,the experimental group: control group=2:1,and the treatment course is 12 weeks.The experimental group received Toutouning capsules,while the control group received a placebo.Compare the changes in baseline changes in headache frequency,number of headache episodes,number of headache episodes,visual analog pain scale(VAS),migraine specific quality of life questionnaire(MSQ),and traditional Chinese medicine syndrome scores between 8 and 12 weeks after treatment.Results:(1)The change value of the number of headache attacks from 8 to 12 weeks after treatment compared with the baseline: the change value of the number of headache attacks from 8 to 12 weeks after treatment compared with the baseline was-1.51±2.12 in the control group and-2.73±2.26 in the test group.The difference between the two groups was statistically significant(P<0.05),indicating that Toutongning capsule can reduce the number of headache attacks.(2)The days of headache attack in 8-12 weeks after treatment:3.24±3.07 in the control group;The test group was 1.37±1.94,and the difference between the two groups was statistically significant(P<0.05).(3)After 8-12 weeks of treatment,the number of headache attacks in the control group was 2.51±2.12;The difference between the two groups was statistically significant(P<0.05).(4)Comparison of VAS after treatment: 3.76±2.65 in the control group after 12 weeks of treatment;The test group was 2.37±2.42,the difference between the two groups was statistically significant(P<0.05),indicating that Toutongning capsule can reduce the degree of headache.(5)Comparison of MSQ after treatment: after 12 weeks of treatment,the control group was 63.21±17.09,and the test group was75.11±10.80.The difference between the two groups was statistically significant(P<0.05),indicating that Toutongning capsule can improve the quality of life of migraine patients.(6)Comparison of TCM symptom scores after treatment: the control group was 10.09±6.15,and the test group was 6.39±4.79,the difference was statistically significant(P<0.05),indicating that Toutongning capsule can improve the clinical symptoms of TCM.(7)Analysis of curative effect of traditional Chinese medicine syndrome after treatment: in the control group,2 cases were cured,6 cases were markedly effective,and 10 cases were effective,with the total effective rate of51.43%;In the test group,2 cases were clinically cured,26 cases were markedly effective,and 28 cases were effective.The total effective rate was 84.85%.There was statistically significant difference between the groups(P<0.05).(8)There were7 adverse events in the control group,the incidence of adverse events was 20.00%,and there were no adverse reactions;There were 7 adverse events in the test group,the incidence of adverse events was 10.61%,and there were no adverse reactions.There was no statistically significant difference between the two groups(P>0.05).There was one serious adverse event in the control group,the incidence of serious adverse event was 2.86%,and there were no serious adverse reactions;There were no serious adverse events and adverse reactions in the test group,and there was no statistically significant difference between the two groups(P>0.05).Conclusion:Toutongning Capsules can effectively reduce the number of headache attacks,reduce the degree of headache attacks,shorten the duration of headache attacks,improve traditional Chinese medicine syndromes,and have no adverse reactions during use.In summary,Toutongning Capsule has good efficacy and safety in treating migraine(blood stasis syndrome)attacks.