| BackgroundMigraine is one of the primary headache in neurology disease. Its morbidity is rather high, according to research the female morbidity is about17.1%,and the male morbidity is about5.6%; migraine can induce cardiovascular disease and other neurological disease in the recent clinical study. It seriously affects the patients’living quality,and increases their economic burden, according to epidemiological survey data shows that migraine sufferers are often prone to comorbidity. Anxiety-depression and sleep disorder is the most general. Some studies show that migraine sufferers are easier and higher than the normal person to anxiety-depression and sleep disorder, migraine sufferers often have anxiety-depression and sleep disorder,the phenomenon shows three diseases’ relationship is rather complicated. Owing to migraine sufferers often with sleep disorder,in order to further understanding the impact factors between migraine and sleep quality. And for the treatment of migraine and sleep disorder offer more evidence and theoretical support.So we analyze the sleep of haemorrheological nature blood stasis type of migraine patients who is treated with Nao Tong Li Ting Formula.The study is based on the "Eleventh Five-year Plan" of China State Science and Technology Ministry migraine syndrome differentiation and treatment scheme and curative effect evaluation system research", which being a multi-center, randomized, double-blind, placebo-controlled, prospective study, we analyze the data of78cases migraine sufferers with statistical approach,discussed the traits of therapeutic effect and the relation of sleep about Nao Tong Li Ting Formula Granule in the treatment of haemorrheological nature blood stasis type of migraine patients,for the clinic application of syndrome differentiation of traditional chinese medicine to provide powerful evidence. At the same time it can lay the foundation of treatment evaluation that chinese medicine cures migraine in the clinic research.ObjectiveBased on the78cases migraine patients (haemorrheological nature blood stasis type) we analyze their headache state,living quality,sleep quality,and TCM syndrome in the statistical method. So as to migraine treatment of chinese medicine offer more evidence.MethodIn the selection there are78cases migraine sufferers (haemorrheological nature blood stasis type),treatment group with51cases, matched group27cases,rejected0cases,exited13cases, of which8cases are from treatment group and other are from matched group. Finally65cases are set into the validity analysis,in which43cases are from treatment group and other are from matched group. Treatment group taking Nao Tong Li Ting formula granule, the matched group taking placebo. All patients will be treated12weeks. Follow-up visiting after taking medicine every four weeks, meantime every patient will write a headache diary as the basis,With reference to the Pittsburgh sleep fares,the quality of life index scale,"the head wind disease syndrome diagnostic criteria" Respectively in the treatment group and the placebo group in the treatment of different points and the number of follow-up of headache days, attack, and degree of pain headache related indicators, and the curative effect of comprehensive evaluation on the aspects of sleep situation.ResultFeatures12weeks of treatment efficacy studies of migraine pain, haemorrheological nature blood stasis type of migraine, sleep disorder treatment group and the comparison points8and12weeks into the group phase when, during four weeks without statistical p value of0.323meaning,8and12weeks when p values were0.018,0.004.There are significant differences in treatment outcome effects visible; the control group at4weeks into the group of comparison with the p value of1.000, there is no difference;8and12weeks with the sleep disorder integration into the group when comparing p values were0.035,0.016but showed no significant treatment group. Different time points the difference between sleep disorders comparison p value greater than0.05, it is not statistically significant;no significant differences between groups at different time points sleep disorders. Based on headache main efficacy index:the treatment group and placebo group in reducing the frequency of migraine days, times,and the degree of headache,there was no significant difference in such aspects (p>0.05). in the aspect of earlier reducing medicine and the degree of headache,treatment group is better than placebo group, finding no obvious adverse reactions. Specific is as follows:before and after the treatment group and the placebo group in the treatment of headache is not statistically significant,in terms of its attack days before and after the treatment group is also not statistically different. Contrast the effect between twelfth week treatment to the follow-up visit,there is also not statistically difference on times of headache and baseline comparison between the difference of groups,follow-up in the treatment group and the placebo group in the headache days response rate (with baseline than cut in half or more) respectively85.7%,81.0%,no statistically significant difference between groups. Contrast the twelfth weeks of treatment to follow-up treatment group in improving the degree of headache is better than the placebo group,but there is still no statistically significant results,Through follow-up pain score significantly compared differences between groups. Other the curative effect of treatment period of treatment group and the placebo group analgesic usage has a downward trend, the use of two groups of analgesics are on the decline, but treatment group downward trend is more obvious.ConclusionThe treatment group and placebo group Sleeping area by the Pittsburgh Sleep Index comparison found the treatment group and the control group were improved sleep, clinical observation points to improve sleep disorders, sleep efficiency points, there is a certain improvement in sleep time, more significant improvement in the treatment group, but statistical results no difference between the two groups. In reducing frequency of migraine days,attack times,and degree of headache, there is no significant difference in such aspects. It is earlier to reduce pain relievers used times and a degree of headache,the treatment group compared with placebo. And the result is obvious,and there is no untoward reaction. |
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