| Objective:The object of this study was to observe the clinical efficacy of Toushuning granules in treating migraine without aura(Wind-Phlegm-Stasis syndrome),to preliminary evaluate the clinical application value and safety of Toushuning granules,and to provide a safe and effective treatment of the prophylactic treatment for migraine without aura.Methods:In strict accordance with the inclusion and exclusion criteria of the subject,collected 86 migraine patients and divided into a treatment group and a control group according to random number table method.The control group was treated with flunarizine hydrochloride capsules,and the treatment group was treated with Toushuning granules on the basis of the control group.After 4 weeks of treatment,the headache scores,visual analogue scale(VAS)scores,TCM syndrome scores,and migraine specific quality of life questionnaire(MSQ)scores were observed and analyzed before and after treatment,and follow-up for 1 month after treatment.At the same time,the adverse events during the clinical trial were detailed recorded and the safety indicators were evaluated,to comprehensively evaluate the clinical efficacy and safety of Toushuning granules for the prophylactic treatment of migraine without aura.Results:1 In this clinical trail,42 cases were actually studied in the treatment group and41 cases in the control group.2 The comparison of TCM syndrome efficacy: the total effective rate of the treatment group was about 95.24%,that of the control group was about 73.17%,and the treatment group was better than the control group(P <0.05).3 The headache scores,VAS scores,TCM syndrome scores,and MSQ scores after treatment in the two groups were all lower than those before treatment.The treatment group was better than the control group,and the difference was statistically significant(P <0.05).4 The number of attacks,degree,duration,and accompanying symptoms of the two groups were reduced compared with before treatment.The treatment group was better than the control group in reducing the number,degree,and accompanying symptoms of attacks(P<0.05).There was no significant difference in the reduction duration between the both groups(P>0.05).5 The comparison of clinical efficacy: the total effective rate of the treatment group was about 92.86%,that of the control group was about 75.61%,and the treatment group was better than the control group(P<0.05).6 Follow-up results: the treatment group has a stable effect,better than the control group(P<0.05).7 In terms of safety: no adverse events occurred in both groups.Conclusion:Toushuning granules have significant clinical effect in the prophylactic treatment of migraine without aura(Wind-Phlegm-Stasis syndrome),which can significantly reduce the number,degree,duration and accompanying symptoms of acute migraine attacks,and effectively improve TCM syndrome symptoms and the quality of life.And it has the advantages of stable efficacy and high safety. |