Clinical Study And Efficacy Analysis On The Treatment Of Migraine With Chuanxiong Oil Soft Capsule

Background:Headache is a common clinical disorder,we have had almost everyone experiences a headache.Particularly the most common migraine.Migraine is a recurrent primary headache was unilateral or bilateral pain accompanied by nausea, vomiting,the authors made a small number of typical visual pre-attack,such as sensory and motor aura,and family history,According to the Centers for Disease Control show that the prevalence rate of migraine there is an upward trend.In addition to migraine pain in many individuals,a more serious impact on society.But its pathogenesis are complex,have yet to understand.Western medicine diagnosis and treatment of the status quo can not be optimistic about treatment,the acute phase of drug commonly used to control migraine pain,but long-term use in patients with pain medication will lead to serious side effects,and ultimately can lead to drug dependence headache.World Health Organization will be a serious migraine for refractory disease,the diagnosis and treatment of migraine has been the program in return for medical treatment.Of ancient Chinese medicine has a long history of headaches,back in "Neijing" there are records of a headache.A large number of ancient literature,the use of unilateral Chuanxiong the efficacy of this disease better.Chuanxiong in the compound-based drugs,it is too numerous to mention.Based on these clinical practice,physicians Jinyuan Li Dongyuan that "shall be Chuanxiong headache." Modern clinical reports,and Chuanxiong Chuanxiong extract effective in treating migraine.Chuanxiong only contained in the "after" was ranked the top grade,formerly Xiongqiong.Weixin of temperature,for the perennial herb Chuanxiong Umbelliferae Ligusticum chuanxiong Hort.Rhizome dry.Its greatest strength and expertise to treat migraine headaches and blood stasis.Produced by modern technology('huanxiong oil soft capsule to Chuanxiong for raw materials,chuanxiong volatile oil extracted as the main components,retains the original huoxuehuayu Chuanxiong,the effect of pain Tongluo.This study for the treatment of migraine and blood stasis.The study was conducted in pre-clinical pharmacological and toxicological tests,Ⅰclinical trials,Ⅱclinical trials conducted on the basis of the Chuanxiong oil soft capsule stageⅢclinical trials.The test was from Sichuan Pharmaceutical Wo are organized.Objective:Further evaluation of Chuanxiong oil soft capsule in treating migraine(blood stasis) the effectiveness and safety.Methods:Experimental Design:A randomized,controlled,double-blind experiment, divided into test group and control group.Select Case Method:including diagnostic criteria and standards into the case, exclusion criteria and exclusion,and suspended off the standard tests.Diagnostic criteria which refer to the 2003 International Headache Society(International Headache Society) has developed aura and migraine without aura diagnostic criteria of Western medicine;At the same time,the standard combination of TCM.Medication and treatment:oral test group sooner or later each Chuanxiong oil soft capsule 2,2 times a day;oral placebo control group each morning and evening 2, 2 times a day.Study medication for 12 weeks,every four-week follow-up 1.Drug provisions of the merger:the merger shall not be applied during the drug may have role in the prevention of headache episodes drugs.In medication during the attack if it were unbearable headache,you can take pain medication to alleviate temporary headache,if the merger for more than 10 days,the case is null and void effect.Observation:including demographic data affecting the efficacy of factors, general physical examination and laboratory tests.Efficacy criteria:criteria for efficacy included headache syndromes and efficacy of Chinese medicine to determine standard.Adverse events observed Methods:In clinical studies covering the period of observation were emerging and it will also affect the health of any subjects syndromes,symptoms,syndrome or disease or deterioration of the appearance. Adverse events may be a new disease;the treatment of the state of deterioration of symptoms or signs;or accompanied by the deterioration of the disease;the role of drug control;and to participate in the trial has nothing to do;one or a combination of a number of factors.Therefore,the "adverse events" and the term does not mean that a causal relationship between drug tests.Data Processing:Data SPSS13.0 statistical software application for processing. Headache medication before and after the number of days,the extent of the data using repeated measures analysis of variance,the time factor alone was used to analyze the effect of repeated measure analysis of variance;grouping factors separate the effect of the use of homogeneity of variance Indepentent-Samples T Test,each group multiple comparisons between the use of LSD testing;variance arrhythmia used Welch method similar to analysis of variance.The above test to P＜0.05 as statistically significant difference.Efficacy of TCM Syndrome 2 test,when TχAnalysis of the use of fourfold table information＜5 s use of the Fisher information on the exact probability method.Results:Views on the impact of migraine:drug delivery between the different time points before and after each group were statistically significant differences(F= 19.370,P = 0.000),the experimental group F = 45.006,P = 0.000,control group F = 2.621,P = 0.083,indicating that the experimental group gradually reduce the number of headaches per month,the monthly headache frequency of the control group no significant change.Headache frequency in each group were statistically significant differences between(F = 6.281,P = 0.014),from the point in time,the medication before taking a month,taking two of each group on the number of headache was no significant difference(t value -0.691,0.137,- 1.864,P values were 0.492,0.892,0.069), taking three months after the headache frequency of each group were statistically significant differences(t =- 5.624,P= 0.000),showed that taking time headache for more than 3 months a better therapeutic effect.Taking a panoramic view of the above test group and control group the number of headaches that affect the data can be Chuanxiong oil soft capsule to improve the number of headache role.Each group and time between drug interaction(F = 7.428,P = 0.000),and in front of each group at different time points the results of the comparison between the analysis of multi-match,indicating that the pilot group and the control group on the number of migraine patients with headache to drugs affect the time trend of growth.Patients with migraine headache days per month the impact of:before and after administration at different time points the difference between the groups were statistically significant(F = 27.482,P = 0.000),test group and control group F were 58.001,3.966,P 0.000,0.013 respectively,show that the test group and control group the number of days headache per month were reduced gradually.Headache days in each group there was no significant difference between the(F = 3.397,P= 0.069), from the point in time,the medication before taking a month,taking on two headache frequency in each group the difference was not statistically significant(t values were 1.026,-0.297,-1.944,P values were 0.308,0.767,0.055),taking three months after the number of days in each group headache statistically significant difference(t =- 5.686, P = 0.000),showed that taking time headache for more than 3 months a better therapeutic effect.Taking a panoramic view of the above test group and control group the number of days of headache data illustrate the impact of oil soft capsule of Chuanxiong headache improvement in the role of the number of days.Each group and time between drug interaction(F = 7.530,P = 0.000),and in front of each group at different time points the results of the comparison between the analysis of multi-match,indicating that the pilot group and the control group of patients with migraine headache as the number of days to drugs affect the time trend of growth.Chuanxiong oil soft capsules taken before and after a month of migraine headache in patients with the extent of the impact of:before and after administration at different time points the difference between the groups were statistically significant (F = 37.849,P = 0.000),test group and control group,respectively,F for 89.459,3.784, P values were 0.000,0.015,show that the test group and control group the degree of headache per month were reduced gradually.Headache between the groups were statistically significant differences(F = 10.783,P = 0.002),from the time point of view,taking 2 months,3 months after the head of each group were statistically significant differences(t = -2.637,-5.306,P value 0.010,0000 respectively),and the remaining time points were not statistically significant,indicating that taking the time two months or more in the extent of the treatment of headache better.Taking a panoramic view of the above test group and control group on the extent of the impact of headache data Chuanxiong oil soft capsule description of the degree of improvement in the role of a headache.Each group and time between drug interaction (F = 14.289,P = 0.000),and in front of each group at different time points the results of the comparison between the analysis of multi-match,indicating that the pilot group and the control group of patients with migraine headache as the extent to drugs affect the time trend of growth.Chuanxiong oil soft capsule on the efficacy of TCM Syndrome impact:test group and control group in the efficacy of TCM Syndrome efficient statistical significance(P = 0.000).Show that the use of Chuanxiong oil soft capsule on migraine efficacy of TCM Syndrome affect efficient than the placebo group.The test case there are four types of adverse events,including skin allergies, ALT increased,menstrual period,urine leukocyte increased.Adverse events were considered mild,asymptomatic,after mitigation,the possibility of drug-related and not.Discussion:79 cases of subjects and to determine the efficacy of TCM Syndrome Analysis, from the patients with migraine headache frequency,number of days,headache extent, the test group and control group in general are a few more significant that Chuanxiong oil soft capsule for the treatment of migraine is superior to the placebo group;test group and control group at different time points the number of days a headache and the degree of improvement in both statistical significance,the role that the psychological impact of migraine,psychological therapy can improve balance in migraine.In addition to the degree of headache after 2 months in the treatment group and placebo group were significantly different,the headache frequency and the number of days in the three months after the treatment group and placebo group were significantly different,but also describes the treatment of migraine prevention in three months or more.Test group and control group in the efficacy of TCM Syndrome efficient statistical significance.Show that the use of Chuanxiong oil soft capsules in the treatment of migraine efficacy of TCM Syndrome efficiency is superior to the placebo group.Chuanxiong oil soft capsule compared with the headache side effect of migraine treatment analysis:60 cases from taking Chuanxiong oil soft capsule group and 100 cases of patients taking the headache side TCM can be seen in both performance characteristics for a variety of syndromes,not a single blood stasis. Chuanxiong headache side with the contrast of oil soft capsule of Chinese medicine treatment of migraine symptoms the results were statistically significant effects(P = 0.027),Treatment of migraine headache is better than oil soft capsule group Chuanxiong.Chuanxiong single treatment that contains a variety of traditional Chinese medicine blood stasis syndrome of migraine headaches have a therapeutic effect,but the TCM treatment of migraine is superior to single Chuanxiong.Taking a panoramic view of the above conclusions,the Treatment is better than from a single administration of the syndrome.Head more blood,more than his head wet,windy head,but also has a special note of headache pathogenesis.