| Objective:Evaluate the effectiveness and safety of Xiexia Zhitong Decoction in treating frequent episodic tension-type headache(FETTH)with phlegm and blood stasis syndrome by observing the changes of traditional Chinese medicine(TCM)syndrome score,headache index and relevant indexes of patients before and after treatment and 4 weeks after drug withdrawal.Methods:A Randomized Controlled Trial(RCT)research method was used.A total of 86 patients for FETTH with phlegm and blood stasis syndrome were enrolled and randomly assigned to the observation group and the control group.In the observation group,43 cases were treated with the TCM Xiexia Zhitong decoction,whie in the control group,43 cases were treated with Chinese patent medicine Tong Ning Capsule;both treatments lasted for one week;and the patients were followed up 4 weeks after drug withdrawal.By observing the changes of TCM syndrome score and headache index of two groups patients,and adopting the liver and kidney function,and electrocardiograph as safety indexes.Result:1.There were 86 cases enrolled in clinical research,in which 79 patients completed the clinical observation,including 4 patients was lost in the observation group and 3 patients was lost in the control group,and the total shedding rate was 8.14%.2.The comparison of gender,age,course of disease,education level,occupation,Hamilton Anxiety(HAMA)score,Hamilton Depression(HAMD)score,Visual Analogue Scale(VAS)score,headache duration score,headache index,single TCM symptom and TCM syndrome score between the two groups before treatment was not statistically significant(P>0.05).3.TCM syndrome score:(1)After 1 week of treatment,TCM symptom scores in both groups were significantly lower than those before treatment(P<0.01);TCM symptom score of the observation group decreased from 23(20,26)to 5(2,8),and the control group decreased from 23(20.25,25)to 9(7.25,12.75);there was a significant difference between the two groups(P<0.01),and the improvement effect of the former is better.(2)After 4 weeks of drug withdrawal,TCM symptom score in the observation group was 6(5,9)and that was 9(7,14.75)in the control group,there was a significant difference between groups(P<0.01).4.Headache index score:(1)After 1 week of treatment,VAS score,headache duration score and headache index score in the two groups were significantly lower than those before treatment(P<0.01).Among them,the headache index score in the observation group decreased from 16(12,18)to 2(1,6),and that in the control group decreased from 17(12,24)to4(2,12),the difference between groups was statistically significant(P<0.05).(2)After 4 weeks of drug withdrawal,headache index score in the observation group was 4(2,9)and that was8(4,12)in the control group,the difference between groups was statistically significant(P<0.05).5.Overall clinical efficacy:(1)After 1 week of treatment,the total effective rate of the observation group was 92.31%,while that of the control group was 80.00%,there was a significant difference between groups(P<0.01),and the clinical efficacy of the observation group was better than that of the control group.(2)After 4 weeks of drug withdrawal,the total effective rates of the observation group and the control group was 89.74% and 75.00%,respectively.The clinical efficacy of the two groups is statistically significant(P<0.01).6.Safety evaluation: No adverse events occurred during clinical observation.Before and after treatment,the changes of liver and kidney function indexes in the two groups were within the normal range,and the abnormality was not found in routine ECG examination.In addition,difference between the two groups was not statistically significant(P>0.05).Conclusion:1.The Xiexia Zhitong Decoction has obvious efficacy in the treatment of the frequent episodic tension-type headache with phlegm and blood stasis syndrome,the efficacy is especially more advantageous in the reduction of TCM symptom score and headache index score.2.No obvious adverse reactions were found during the treatment of the Xiexia Zhitong Decoction which demonstrated its safety. |
PDF Full Text Request