A Randomized Controlled Clinical Trial Study Of Sishun Decoction In The Treatment Of Migraine In The Remission Period

ObjectiveThrough the observation of the clinical effect of Sishun Decoction on migraine in remission period,our research verified the theory of the traditional Chinese medicine method of harmonizing ying and wei in the treatment of migraine in remission period,evaluated the efficacy and safety of Sishun Decoction in the treatment of migraine in remission period,thus providing clinical evaluation evidence for new drug development and efficacy evaluation.MethodOur research was a randomized controlled clinical trial of Sishun Decoction in the treatment of migraine in remission period.Patients who met the inclusion criteria were recruited into the group through outpatient service.After entering the group,the patients were treated with Sishun decoction or placebo for 3 months,and were followed up once when the drug was stopped for 1 month.Our main efficacy observation indexes were the frequency of headache attack reduced by half,the secondary efficacy observation indexes were headache attack frequency,headache attack degree,headache attack days and reduced by half,headache attack duration,number and number of painkillers used,TCM syndrome change of Tou feng disease,migraine outcome evaluation based on patient report(pro scale),etc.All of the above indicators are statistically analyzed on the two data sets,the pro protocol set(PPS)and the intention-to-treat population(ITT).ResultThe results showed that Sishun Decoction had a certain effect on improving the clinicalmanifestations of migraine and the attack of migraine after the withdrawal of medicine,and there was a certain effect on reducing the score of depression syndrome,and there was no obvious adverse reaction.The results of the study showed that Sishun Decoction could be used to treat migraine in remission period safely and effectively by adjusting the method of harmonizing ying and wei,which had the value of clinical treatment of migraine.The effects of Sishun Decoction on the therapeutic indexes in this study are as follows:1.Sishun Decoction can increase the frequency of headache reducing by halfdecreased.The frequency of of headache reducing by halfdecreased is an important index to evaluate the curative effect of medicine on migraine,and it is the main outcome of this research.In our research,it was considered that there was a difference between the two groups in the frequency of headache reducing by halfdecreased.in 2-3 months,suggesting that the treatment of Sishun Decoction was effective.2.Sishun Decoction can improve migraine attackHeadache attack conditions include:headache attack frequency,headache attack degree,headache attack days and the percentage of attack days reducing by halfdecreased,headache attack duration and times of using painkillers.In this study,we comprehensively analyzed the data in ITT and PPS.From 3 months of treatment to follow-up period,taking Sishun Decoction reduced the number of headache attacks,VAS score(the degree of headache attacks)and the number of painkillers;from 2-3 months to follow-up period,taking Sishun Decoction reduced the number of headache attack days and the percentage of attack days reducing by halfdecreased;from 1-2 months to follow-up period,taking Sishun Decoction reduced the duration of headache attacks Reduce.The above data show that there was a certain effect of Sishun Decoction on the improvement of headache attack.3.Sishun Decoction can reduce part of the score of migraine Patient Report Outcome(PRO scale)PRO scale is a kind of migraine evaluation scale which emphasizes the subjective feelings of migraine patients.It is of great significance to evaluate the condition of migraine patients.The PRO scale consists of 12 items,which are divided into four evaluation dimensions:headache situation,physical symptoms,mental state and functional state.The self-evaluation of patients is introduced into the clinical efficacy evaluation system of migraine,which has good performance verified by a number of clinical studies.In this study,the migraine of patients was evaluated by PRO scale.After analyzing the data in ITT and PPS,it was considered that in the later period of treatment(mainly from the treatment of 3 months or follow-up),taking Sishun Decoction reduced the physical symptoms,functional state scores and the total scores of PRO scale,because of the uneven baseline of psycho mental state scores According to the data description and comparison among the groups,it can be seen that taking Sishun Decoction did not reduce the mental state score.In conclusion,Sishun Decoction reduced the scores of most dimensions of PRO scale,suggesting that it is effective for migraine treatment.4.Sishun Decoction has some influence on the classification and diagnosis of syndrome of Toufeng diseaseAccording to the diagnosis standard of syndrome of Toufeng disease,the common syndrome types of migraine can be divided into 9 types,including syndrome of wind,syndrome of fire and heat,syndrome of phlegm and dampness,syndrome of depression and syndrome of blood stasis,syndrome of deficiency:deficiency of Qi,syndrome of blood,syndrome of yin and syndrome of Yang.Each syndrome can be mixed with each other and influence each other,resulting in the mixture of deficiency and reality,which can not be cured for a long time.In this study,The imbalance between Ying and Wei was regarded as the basic pathogenesis of migraine.Based on the analysis of classification and diagnosis scores of syndrome of Toufeng disease,the influence of the Sishun Decoction on the above nine syndrome types was studied,based on the basic pathogenesis of Ying Wei maladjustment.After analyzing the data in ITT and PPS,it was considered that the treatment of Sishun Decoction might only reduce the score of depression syndrome,but it has no effect on the improvement of syndromes of other syndrome types.Conclusion1.The method of harmonizing Ying and Wei can improve migraine attack.The method of harmonizing Ying has practical significance in clinical diagnosis and treatment of migraine;2.Sishun Decoction has a certain effect on improving the clinical manifestations of migraine and improving the attack of migraine and physical symptoms after drug withdrawal,and may have a certain effect on improving the syndromes of traditional Chinese medicine.3.Sishun Decoction has no obvious adverse reactions in the treatment of migraine and is highly feasible in clinical application.