| BackgroundMigraine is a common neurological-vascular dysfunction characterized by recurrent headache attacks and intermittent recurrent.The morbidity of the disease is high, with the ratio of female to male about 2-3:1.Migraine is often accompanied by other disorders,such as insomnia and anxiety, seriously affecting the patients’life,work and study,thereby affecting the quality of patients’life,and bring a heavy economic burden to society. Modern medicine is superior to traditional Chinese medicine in terms of alleviation of the pain of acute migraine attack, but because of its adverse effects,the application of modern medicine in preventive treatment of migraine is limited.In recent years, Chinese medicine in migraine prevention is becoming more and more important,and improving TCM syndromes has become its unique advantages.Migraine is usually induced by emotional uncomfortable, accompanying by insomnia,anxiety,the three diseases have a common syndrome foundation.Therefore,based on the common syndromes of different diseases,the same treatment method can aquire desirable effect.This study belongs to a part of the university research project "Evaluation of clinical medicine encephalopathy innovative team," Beijing University of Chinese Medicine.The study primarily through treating liver stagnation heat syndrome in migraine,insomnia and anxiety,observed the clinical efficacy of absolute and relative clinical efficacy,and further validate the TCM theory of treating different diseases with the same method.The study has been approved by the Beijing University of Chinese Medicine, Dongzhimen Hospital Ethics Committee (Approval document number:ECPJ-BDY-2013-28),and registered(registration number ChiCTR-TRC-14004469) in Chinese Clinical Trial Register.The clinical study Qinggan Jieyu Herbal Formula Granule in the treatment of migraine patients with the Syndrome of Heat Of Liver Stagnation is one part of the studies based on TCM syndromes.Through analyzing the stagnation heat syndrom in patients with migraine disease, as well as affect the quality of life of migraine patients,it will be a reference to the future clinical studies.ObjectiveIn order to see the therapeutic effects of Qinggan Jieyu Herbal Formula Granule in the treatment of migraine patients with the Syndrome of Heat Of Liver Stagnation,we analyze the migraine headache attacks, the TCM syndrome, the quality of life and patient-reported outcome (PRO) and other indicators to further explore the Qinggan Jieyu Herbal Formula Granule in the improvement of the disease and syndrome.MethodIn this study,we use a randomized controlled study methods,the SAS software is used to develop the random number table.Patients are mainly collected through clinics and advertising. All patients met the inclusion criteria need to sign the informed consent first,then they will take an examination, if the test results meet the criteria,then they will be included in accordance with the random number table strictly. The treatment group (n=29) taking Qinggan Jieyu Herbal Formula Granule and the control group (n=27) taking Tianshu Capsule,the study course of both groups include 4 weeks’treatment and 1 follow-up after 4 weeks’stopping medication.The SPSS20.0 statistical analysis software program is used to analyze data,and the Per-Protocol Set (PPS) is used.All statistical tests are two-sided test giving test statistics and its corresponding P values.If P≤0.05,there is a significant statistically significance;If P<≤0.01 there ia a highly significant statistically significance.The primary efficacy endpoint is the rate of halving the number of migraine attacks.The secondary outcome measures are the number of migraine days,the rate of halving the number of migraine days.the improvement of syndromes,patients reported outcomes(PRO) and quality of life.ResultThe primary efficacy endpoint:After four weeks,the rate of halving the number of migraine attacks between the two group was statistically significant.The secondary outcome measures: 1.There are statistical differences in the number of migraine attacks between the two groups at week 4 compared with the baseline(P value< 0.05);There were statistical differences in migraine days compared with the baseline between the two groups at week 4 (P value< 0.05); After four weeks’treatment,the rate of halving the number of migraine days between the two group was statistically significant.2.The total scores of the Syndrome of Heat Of Liver Stagnation has significant differences between the two groups at week 4 and follow-up period between the two groups(P value<0.05). The change rate of the total scores of the Syndrome of Heat Of Liver Stagnation at each time point has significant differences between the two groups.3.After 4 weeks’treatment, the difference was statistically significant between the two groups in PRO scores in physical symptoms, psychological status and total PRO scores. 4.After 4 weeks’of treatment,the quality of life in patients with both groups has improved compared with baseline.The treatment group improves much better.Among the components of SF-36,vitality(VT) had statistical difference compared with baseline between the two groups after the treatment of 4 weeks.Comparing the difference between the two groups,Mental Health(MH),Social Functioning(SF),Vitality(VT),General Health(GH) and MHC(Mental health content) has statistically significant difference before and after the treatment.Among the rate of change in each item of SF-36,MH, SF, VT and MHC has significant difference statistically.ConclusionQinggan Jieyu Herbal Formula Granule has a good effect in the treatment of migraine patients with the Syndrome of Heat Of Liver Stagnation,especially in reducing migraine attacks and migraine days compared with the control group.Also, it can reduce the integral scores of the Syndrome of Heat Of Liver Stagnation. Among the items of the Patient-Reported Outcome (PRO), the herbal can significantly improve the patients’ mental state and physical symptoms.Meanwhile the herbal could also improve the quality of life to a certain extent. |
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