| Background Migraine is one of the most common diseases.In China,the prevalence of migraine is as high as 9.3% among adults aged 18-65 years.It is a heterogeneous condition that may produce a range of symptom profiles and various degrees of disability,which can be severe imposing a considerable health burden upon the sufferer and society.The purpose of the treatment of migraine is to terminate the attack as soon as possible,alleviate the concomitant symptoms,prevent recurrence and restore the normal life function of patients.For migraine treatment,the preventive treatment is as important as acute treatment.At present,the modern medicine is effective in the prevention and treatment of migraine,including: topiramate,sodium valproate,flunarizine and so on.But these modern medicines have more side effects.In contrast,the side effects of traditional Chinese medicine for migraine prevention were less.For the traditional medicine,there are many kinds of traditional Chinese medicine to prevent headache,and among the most suitable for Chinese migraine patients is DanZhen headache capsule.As a Chinese medicine,its main effect is to dispel wind and blood stasis.In China,DanZhen headache capsules for the prevention and treatment of headache has also been recommended by Chinese Guidelines for the Clinical Application of Essential Drugs.Compared with other drugs such as flunarizine,a better efficacy and tolerance of Danzhen headache capsule in migraine has since been evaluated in numerous clinical trials with small samples.Therefore,we could like to use a large sample of trial to evaluate its efficacy.What are the specific clinical manifestations of migraine patients in China? How is the tolerance of migraine patients to modern medicine? How is the efficacy and safety of Danzhen capsule in the prevention of migraine? In this study,these questions will be explored and revealed.Objectives1.To evaluate the tolerability of modern medicines in the prevention of migraine.2.The purpose of this study is to analysis the clinical features of migraine and to evaluate the efficacy of Danzhen headache capsule to prevent migraine in the real medical environment and to provide more evidence for clinical medicine.Strengths of this study1.In China,the Meta analysis for the tolerability of prophylactic drugs in migraine patients is less.2.This study may help to provide more evidences for traditional medicine about migraine prevention.3.It is the first time in our country that the real world study(RWS)is used to evaluate the efficacy of drugs in the prophylaxis of migraine.RWS can be likely to recruit to such research “real-world” patients who may be more representative of the migraine population at large.4.Headache diary APP,which is based on more portable devices,such as tablet computers and smartphones,is the first application to collect headache diary for headache study in China.Methods1.Meta analysis was used to assess tolerability of drug prophylaxis in migraine patients.Do statistical analysis by using Review Manager 5.3 software provided by Cochrane collaboration.2.This is a multicenter prospective-controlled real world study with a planned enrollment of 235 participants in each of two groups.Migraineurs will be consecutively recruited through the Outpatient department of Xiing Hospital and other centers.In the whole study,patients are asked to maintain a detailed headache diary via headache diary APP,also called SuiZhenTong,which is the electronic headache diaries(e-diaries)based on portable devices(iOS or Android tablet computers or smartphones).The primary efficacy end point is a 50% or greater reduction in headache days/month during the second treatment month relative to the month preceding initiation of treatment with one of the study drugs.Results1.There are four medicines that A class recommended in Guidelines for migraine prevention in China.And among them,the tolerance of patients on topiramate is the worst.There are fewer side effects of sodium valproate,but once appear,it will cause serious consequences to the patient.In this study,the number of included literature about flunarizine are less and the patients who participated in the trial were few.So a further research on the tolerance of patients with flunarizine need to be done.Propranolol has high incidence of adverse events,but migraine sufferers are well tolerated.2.A total of 57 patients with migraine were enrolled in this clinical trial and several results are obtained by analysis the trial data.People in 21-30 and 36-50 years of age,the 2 age groups,the prevalence of migraine is the highest.43 of the 57 patients were female,and the ratio of male to female was 1:3.07.There are 11 occupations in these patients,students and housewives constitute the highest proportion.Most patients have a migraine history of 3 to 15 years.The headache position of 39 migraine patients is the temporal region;There were 27 patients with unilateral headache,accounting for about 47.37% of the total.34 patients with throbbing headache,namely jump pain,accounting for about 59.65% of the total.During the trial,many patients appears nausea,vomiting,phonophobia symptoms.Some patients had premonitory symptoms,especially with visual aura.The most common inducements of migraine are fatigue,sleep disorders,or poor health condition.43.25% of patients,23 cases,had a family migraine history.There are 51 migraine patients involved in clinical medicine trials,topiramate group of 27 patients and 24 patients in Danzhen group.Before and after treatment,there were statistically significant differences in primary outcome measure(a 50% or greater reduction in headache days/month)between the two groups.However,there was no statistically significant difference between the secondary outcome measures.These 51 patients with good compliance did not terminate the trial because of side effects of drugs.9 cases of topiramate group and 2 cases of Danzhen group appear side effects(P<0.05).Conclusion1.Compared with other drugs,a better tolerance of sodium valproate and propranolol in migraine.2.Young and middle-aged women constitute the majority of migraine patients,most of them have a long migraine history.Most of the patients presented with unilateral temporal throbbing headache.Fatigue,mood and other factors can induce migraine attacks.And Some patients appear visual aura before the onset of headache.Nearly half of the patients have family migraine history.Danzhen headache capsule is effective in the prevention of migraine,although the effect is not as good as topiramate.But,in contrast,Danzhen headache capsule cause fewer side effects during the trial. |
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