| BackgroundMigraine, an idiopathic headache, which is caused by vasomotor dysfunction, is characterized with recurrent headache attacks in clinic. Its high morbidity, procrastinating, and refractory, seriously affects people’s health and quality of life, and a large number of labor loss caused by migraine brings heavy burden to the family and society. Prevention and treatment of migraine attacks, and improving patient’s quality of life have become the common responsibility of Chinese and western medicine physicians. Currently the modern medicine have not clearly understood the etiology and pathogenesis of migraine, and lack of safe and effective therapeutic drugs restrict the application of people to some extent and then affect the therapeutic effect of migraine. In recent years, the literature and clinical reports found that traditional Chinese medicine (TCM) has achieved relatively satisfactory curative effect in prevention and treatment of migraine. But most of these studies, with simple research methods and relatively single therapeutic evaluation and unclear specific stages for migraine, would not better to guide the clinical practice. How to embody the connotation of TCM syndrome differentiation and the standardization of the evaluation of curative effect, and how to improve the reliability and repeatability of the curative effect of TCM, have always attracted TCM clinical researchers’broad attention.The study, as the part of 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, discussed the traits of therapeutic effect of Chuanxiong Ding Tong Herbal Formula Granule in the treatment of migraine patients with the Syndrome of Liver Wind and Blood Stasis at different time points by analyzing128migraine patients’ data in order to provide strong evidence for clinical application of TCM syndrome differentiation and lay a foundation for TCM clinical research and curative effect evaluation of migraine remission stage.ObjectiveTo probe into the characteristics of therapeutic effect of Chuanxiong Ding Tong Herbal Formula Granule in the treatment of migraine patients with the Syndrome of Liver Wind and Blood Stasis by analyzing the headache attack situation, TCM syndrome, quality of life sleep condition and other indexs of128migraine patients (Syndrome of Liver Wind and Blood Stasis), and then to provide sufficient evidence for clinical application.Method128migraine patients (Syndrome of Liver Wind and Blood Stasis) were selected with the treatment group (n=86) taking Chuanxiong Ding Tong Herbal Formula Granule and the control group (n=42) taking placebo,the study course of both groups include12weeks’ treatment and1follow-up after4weeks’stopping medication. Based on the patients’ headache diary, and refer to Pittsburgh sleep quality index (PSQI) scale, quality of life index (QLI) scale and Head wind disease standard syndromes, the study comprehensively evaluated the two groups’curative effect at different treatment period and the follow-up period from migraine attack numbers, migraine days, degree, and accompanying symptoms, sleep and life quality, TCM syndrome elements and other aspects so on.ResultThe main outcome measures of migraine:the treatment group and control group all had statistical differences compared with before treatment respectively; at week12of treatment and follow-up period, the treatment group showed significant reduction in migraine numbers from baseline compared with the placebo group (P value were respectively0.043,0.033); there were statistical differences in migraine days compared with the baseline of difference between groups at week12and follow-up period (P value were0.033,0.042respectively); and there was significant difference in the proportion of responders between the treatment group and control group which accounted for83.7%and64.3%respectively at follow-up period (P=0.014); at week12of treatment and follow-up period the treatment group was better than the control group in improving the headache extent (P values were0.037,0.037respectively), and the Visual Analogue Scale (VAS) scores showed significant differences between the groups (P=0.005) at follow-up period.Other outcome measures of migraine:the analgesic usage of the two groups had a downward trend, but no statistical difference during the treatment time, among them the treatment group’s analgesicusage showed persistently decline while the control group’s had the trend of rebound; the total scores of accompanied symptoms had significant differences between the two groups at week12of treatment and follow-up period (P value were0.008,0.025respectively); at week12of treatment period the two groups of Pittsburgh sleep quality index (PISQ) total integral scores compared with the baseline difference between groups had statistical significance (P=0.048), among the components of PISQ the sleep quality integral had statistical difference compared with baseline difference between groups in the treatment of4weeks,12weeks (P value were0.032,0.047respectively), and it was positively correlated with the changes of migraine numbers (R=0.215, P=0.215), there was statistical differences in daytime dysfunction component at week12compared with baseline difference between the groups (P=0.048); after12weeks’treatment the quality of life index (QLI) integral of two groups had statistical difference (P=0.049), but no statistical significance compared with the baseline difference, among of QLI the future clause has statistically difference between groups comparison (P=0.001), and it shows negative correlation with the changes of migraine numbers (R=0.213, P=0.213); the treatment group showed a downward trend in the TCM wind syndrome and blood stasis syndrome integral, but no statistical difference compared with the control group.Conclusion Chuanxiong Ding Tong Herbal Formula Granule had certain clinical curative effect in the treatment and prophylactic of Migraine patients with Syndrome of Liver Wind and Blood Stasis in remission period, especially in reducing migraine numbers and migraine days and alleviation of migraine extent being better than placebo group, and it had certain preventive effect. Meanwhile the herbal could also improve the accompanying symptoms, quality of life, and sleep quality to a certain extent, then the study had certain practical significance for clinical application of Chuanxiong Ding Tong Herbal Formula Granule in prevention and treatment of remission migraine. |
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