Therapeutic Efficacy Of TouTong Mixture In Migraine Without Aura:A Randomized Controlled Trial

Objective: Our study was investigated whether Tou Tong Mixture has effective treatment on mild to moderate migraine without aura(MO),based on the observation of headache intensity,frequency,attack days,migraine associated symptoms,migraine disability assessment test(MIDAS)and headache impact test-6(HIT-6)between 3 months prior and after treatment respectively.The contribution of this study will not only demonstrated the therapeutic efficacy of Tou Tong Mixture in mild to moderate MO,but also provide clinical evidence to physicians and patients when they choose Tou Tong Mixture as an optional treatment approach in mild to moderate MO.Methods: This study was performed as a clinical randomized controlled trial.We had recruited total 80 participants and randomly divided them into experimental group and control group,each group contains 40 participants.In the experimental group,participants were only given Tou Tong Mixtrue during the trial,while the control group participants were taken Iboprofen when necessary,they could retake the pill with the same dosage if acute headache attack without relief after 4 hours,moreover,they were also given flunarizine to prevent migraine attack.The duration treatment of both group were 2 weeks.Subsequent following up period lasted to three months.The evaluation indicators including VAS,headache frequency,headache attack days,migraine associated symptoms,MIDAS and HIT-6.Finally,all the data were analysed by statistics in order to evaluate the therapeutic efficacy of Tou Tong Mixture objectively.Results: 1.Comparison of headache intensity: after the course of treatment,the VAS of both group were decreased compared with no treatment,the difference have statistically significant(p<0.01),while the difference between experimental group and control group have no statistically significant(p>0.05).2.comparison of headache frequency:after the course of treatment,the headache frequency of both group were decreased compared with no treatment,the difference have statistically significant(p<0.01),while the difference between experimental group and control group have no statistically significant(p>0.05).3.Comparison of headache attack days:after the course of treatment,the headache attack days of both group were decreased compared with no treatment,the difference have statistically significant(p<0.01),while the difference between experimental group and control group have no statistically significant(p>0.05).4.Comparison of migraine associated symptoms:after the course of treatment,the migraine associated symptoms which refers to nausea or vomit of both group were decreased compared with no treatment,while the decrease in experimental group is more significant than the control group,the difference between experimental group and control group have statistically significant(p<0.05).5.Comparison of migraine disability assessment test:after the course of treatment,the migraine disability assessment test of both group were improved compared with no treatment,while the improvement in experimental group is more significant than the control group,the difference between experimental group and control group have statistically significant(p<0.05).6.Comparison of headache impact test:after the course of treatment,the headache impact test of both group were improved compared with no treatment,while the improvement in experimental group is more significant than the control group,the difference between experimental group and control group have statistically significant(p<0.05).Conclusions: Tou Tong Mixtrue generates an effective treatment in mild to moderate MO,it produce the same effect as well as western medicine in terms of decreasing headache intensity,frequency and attack days.However,Tou Tong mixture shows an advantage in reducing migraine associated symptoms,MIDAS and HIT-6 when compare with western medicine.Taken together,Tou Tong mixture has a positive effect in mild to moderate MO with high safety as well,it may be a good option for patients who have gastrointestinal disorders and elder patients,.it is worth widely use in clinical treatment.