| Background:Headache is a common clinical disease which almost everyone experiences in one’s life. Tension-type headache and migraine are the most popular ones. The prevalence rate of migraine is an upward trend accompanied by the development of social economy as well as the increase of overwhelming force. Approximately6-7%of men and up to20%of women worldwide are suffer from migraine, a chronic, recurrent, disabling, neurovascular and familial disorder. Around a third (31%) of these people report frequent migraines defined as three or more attacks a month. Migraine causes severe impairment or bed rest in more than half(53%) of affected people, markedly impairs quality of life both during and between attacks, More than half (53%) of migraineurs reported severe impairment in activity or the requirement for bed rest with severe headaches. Work or school productivity was reduced by at least50%among half (51%) of migraineurs. Increases absenteeism and reduces productivity at work, and is associated with increased healthcare costs. Most academics reckon on that migraine is a multi-genetic and factors condition associated with the interaction of various environmental and genetic factors, however a number of precipitating factors have been identified in85%sufferers including altered mood and weather, somnipathy and so forth. Western medical diagnosis and treatment can’t be optimistic. Recent pharmacologic treatment options are still far from optimum, leaving many patients with high recurrences or with unpleasant side effects, and ultimately can lead to drug dependence headache. WHO oriented the server migraine to the refractory one and which is referred to the TCM.The ancient Traditional Chinese Medicine has a long history of headaches, which is named " Brain wind, Head wind " cause by mind attacked by the wind. The items of Zhong Jing’s<treatise on febrile diseases> have the sun, Yang, Yang genre, less Yin headache,<Dong Yuan ten book> pointed that the causes were due to exogenous and internal injuries. There are typhoid headache, migraine headache, faint headache damp and hot inverse headache, etc according to different causes and symptoms, also added a little cloudy and the lunar headache. Thus the foundation of drugs with different types was laid. Zhang Jingyue points out that the diagnosis should identify the length of a headache, disease a list, evil is the actual and be dialectical therapy.In the research of Chinese medicine treatment by classification, with traditional Chinese medicine soup as the means, prolonging the treatment duration extension, follow-up times, reduce the recurrence rate in traditional Chinese medicine migraine validation, to solve the difficult problem of migraine management provide clinical evidence.Objective:This essay briefly attends to evaluate the clinical efficacy of treatment for migraine with syndrome differentiation classification of TCM further. Methods:Experimental design:a multi-center randomized controlled trials, divided into Live-yang hyperactivity Phlegm-damp stagnating and Blood stasis.Cases selected:including diagnosis criteria, involved standard, exclusion standard and eliminate fall off and to suspend the test standard. Diagnostic criteria refers to the2004IHS (International Headache Society) has developed without aura migraine and with aura migraine’s western medicine diagnosis standard, meanwhile combining with the Chinese medicine diagnosis and standards.Medication and treatment:Live-yang hyperactivity was treated with Lutong yin decoctions (12w), then Yangxueqingnao grains(4w),1bag once(4g),3times one-day; Phlegm-damp stagnating was treated with Banxiabaizhutianma decoctions (12w), then Erchen pills9g once2times one-day or Zheng tianwan6g once3times a day(4w); Blood stasis was treated with Taohongsiwu decoctions (12w), then Zheng tianwan6g once3times a day(4w).The treatment periods lasted16weeks, with a follow-Up after stop treatment12weeks and24weeks.Drug merger regulation:preventive drugs may not be merged applied during the test period, if subjects could not stand the attack, you can temporarily take painkillers to relieve the pain, if continuous10days or more, the cases for curative effect is invalid.Observation indexes, including demographic data, affecting curative factors, general physical examination and laboratory tests.Efficacy criteria:including headache determinant standard and curative effect of TCM syndrome outcome standards.Adverse events recording methods:covers any syndrome, symptoms or signs of deterioration syndrome affected the health of subjects during the research observation period; Or with the deterioration of the disease; Not related to the test; One or more combination of factors. So adverse events this term doesn’t mean to have a causality relationship with the experimental drugs.Data Processing:data applications SPSS13.0statistical software for processing. X2inspection or completely random design variance analysis was applied in comparison of the baseline clinical data among three groups; For the statistical analysis of attack frequency, headache days, duration times use of analgesics and headache accompanied symptoms:More related sample of parametric test (Friedman test) is used is to compare the difference in fixed group respectively up to the different time points; Comparison among groups:fixed all time points respectively, the completely random design of parametric Test (Kruskal-Wallis H Test) is applied, statistical list statistics and exact P value; grade material statistics are described with frequency, completely random between groups of design of parametric Test (Kruskal-Wallis H Test) are used in to compare groups; To adverse reactions and routine blood liver and kidney function are tested by descriptive statistical analysis. LSD for the follow-ups.Results:The impact on migraine headache frequency:before and after administration at various time points the differences among groups are statistically significant (P<0.000), the Liver-yang hyperactivity, Phlegm-damp stagnating, Blood stasis groups P was0.000respectively, show that the headache frequency per month reduced gradually. Throughout all data we can conclude that Liver-yang hyperactivity, treated with Lutongyin decoction, Phlegm-damp stagnating, treated with Banxiabaizhutianma Decoction, Blood stasis, treated with Taohongsiwu Decoction exerted satisfactory clinical effect in treating migraine for reducing the migraine attack frequency. The influence on migraine attack days before and after treatment:drug delivery between different time points before and after each group were statistically significant differences (P<0.000), the Liver-yang hyperactivity, Phlegm-damp stagnating, Blood stasis groups P was0.000respectively, show that the headache days per month reduced gradually. Throughout all data we can conclude that Liver-yang hyperactivity, treated with Lutongyin decoction, Phlegm-damp stagnating, treated with Banxiabaizhutianma Decoction, Blood stasis, treated with Taohongsiwu Decoction exerted satisfactory clinical effect in treating migraine for reducing the migraine attack days.Migraine attacks on the impact of the total duration times:before and after administration at various time points the differences among groups are statistically significant (P<=0.000), the Liver-yang hyperactivity, Phlegm-damp stagnating, Blood stasis groups P was0.000respectively, show that the headache duration times per month reduced gradually. Throughout all data we can conclude that Liver-yang hyperactivity, treated with Lutongyin decoction, Phlegm-dampstagnating, treated with Banxiabaizhutianma Decoction, Blood stasis, treated with Taohongsiwu Decoction exerted satisfactory clinical effect in treating migraine for reducing migraine duration times.The impact on analgetic taking times:before and after administration at various time points the differences among groups are statistically significant (P<0.000), phlegm-damp stagnating at various time points before and after treatment was no statistically significant differences(P=0.123), liver Yang card and blood stasis syndrome at different time points before and after treatment were statistically significant (P=0.000), show that the headache duration times per month reduced gradually in Liver-yang hyperactivity and Blood stasis groups, the reduction in Phlegm-damp group was no significant. Throughout all data we can conclude that Liver-yang hyperactivity, treated with Lutongyin decoction, Phlegm-damp stagnating, treated with Banxiabaizhutianma Decoction, Blood stasis, treated with Taohongsiwu Decoction exerted satisfactory clinical effect in treating migraine for reducing the application of.analgetic taking frequency.Scores of headache accompanied symptoms:before and after administration at various time points the differences among groups are statistically significant (P<0.000), phlegm-damp stagnating at various time points before and after treatment was no statistically significant differences(P=0.070), liver Yang card and blood stasis syndrome at different time points before and after treatment were statistically significant (P=0.000), show that the scores of headache accompanied symptoms per month reduced gradually in Liver-yang hyperactivity and Blood stasis groups, the reduction in Phlegm-damp group was no significant. Throughout all data we can conclude that Liver-yang hyperactivity, treated with Lutongyin decoction, Phlegm-damp stagnating, treated with Banxiabaizhutianma Decoction, Blood stasis, treated with Taohongsiwu Decoction exerted satisfactory clinical effect in treating migraine for improving the headache accompanied symptoms.The effect of Traditional Chinese Medical syndrome:the differences of three groups in the effect of TCM syndrome aren’t statistically significant (x2=1.940, P=0.379).Throughout all data we can conclude that Liver-yang hyperactivity, treated with Lutongyin decoction, Phlegm-damp stagnating, treated with Banxiabaizhutianma Decoction, Blood stasis, treated with Taohongsiwu Decoction exerted satisfactory clinical effect in treating migraine for improving Traditional Chinese Medical syndromes. There was no apparently difference among three groups.The influence on migraine curative after treatment:drug delivery between8w,12w,16w were statistically significant differences (P=0.037), show that Explain with the extension of time, the number of attacks three headache proportion more and more little. Throughout all data we can conclude that Liver-yang hyperactivity, treated with Lutongyin decoction, Phlegm-damp stagnating, treated with Banxiabaizhutianma Decoction, Blood stasis, treated with Taohongsiwu Decoction exerted satisfactory clinical effect in treating migraine for reducing the migraine attack days.Treatment for16weeks follow-up of12weeks follow-up at24weeks by LSD multiple comparison that the headache in attack frequency headache days of the attack, and liver Yang card follow-up of12weeks after treatment with16weeks statistical significance was found between1(P<0.05), the results show that the number of attacks from headaches and attack to see, days liver Yang card group have lower recurrence headache trend in headache attack last time analgesic use times and with symptom scores, liver Yang card and blood stasis syndrome in a group1there were no statistically significant difference (P>0.05), show that from headache attack last time analgesic use times and with symptom scores perspective, two groups are no recurrent headaches.There are4cases in this trial have adverse events:including2cases in liver Yang card,2cases in blood stasis syndrome,3cases of adverse events performance as nausea, dizzy, headache reaction, resulting in abandoning administration of TCM, and reserve to the western medicine, besides that,1case performance as defecate deformed, no special processing because of mild symptoms, spontaneously better2days later, thus did not affect the normal treatment, all56cases were associated with routine blood and liver and kidney function checked before and after treatment, the results are not apparently unusual.In conclusion, Live-yang hyperactivity syndrome been treated with Lutongyin decoctions, Phlegm-damp stagnating syndrome been treated with Banxiabaizhutianma decoctions, and Blood stasis syndrome been treated with Taohongsiwu decoctions are all effective in treating and preventing migraine clinically.Discussion:Through the assessment of therapeutic effects and TCM syndrome analysis of194subjects, During treatment in all three groups at headache is no longer hair shows that as the treatment period of extended, traditional Chinese medicine is better for migraine. The overall mean differences of the days of migraine attack, frequency of headache attacks, duration times from each group are statistically significant which suggest that three party all have therapeutic effects. The differences of three groups in the effect of TCM syndrome aren’t statistically significant which announce that there is a therapeutic effect in improving TCM syndromes, the efficacy are not apparently different. The follow-up period low recurrence rate three groups, the therapeutic indexes have no obvious trend recurrence. We can draw a conclude that flexibility is a rule to treat disease, along with differentiation classification can work according to the various syndromes. Which also shows that Traditional Chinese Medicine have certain preventive treatment effect on migraine, and the recurrence rate is low. |
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