| Objective: To observe the clinical effect and safety of Flavored Chaihu Shugan Decoction on treating epilepsy with depressive disorder of the Liver qi stagnation and phlegm stasis syndrome.Methods: The research method of this topic is randomized and controlled.Selection of 65 cases of epilepsy with depressive disorder in the outpatient and Inpatient department of the First Affiliated Hospital of Guangxi University of Traditional Chinese medicine in accordance with diagnostic criteria andInclusion criteria.The patients were randomly divided into the treatmentgroup and the control group.Based on the original antiepileptic drugs,the patients in control group were given paroxetine hydrochloride,while the patients of treatment group were given Chinese medicine Flavored Chaihu Shugan Decoction,The clinical effect of two groups was observed for 12 weeks.Hamilton Deperssion scale(HAMD),the quality of life score(QOLIE-31)The traditional Chinese medicine(TCM)syndromes core,seizure frequency biochemical tests and physical examinations were applied to measure the effects Of two groups at both baseline and 6 weeks and12 weeks aftertreatment.By comparing the scores before and after,then collecting the data,using SPSS 22.0 softwareforstatisticalanalysis.Results:(1)The comparison of HAMD scores at 6 and 12 weeks after treatment in two groups of patients(treatment group : before treatment :27.33±2.94;6 weeks:22.87±2.62;12 weeks:17.13±2.97;control group:before treatment:28.17±3.64;6 weeks:26.03±3.96;12 weeks:20.63±3.59),all of them were significantly lower than those before treatment,and the difference was statistically significant(P < 0.05).The HAMD score of two drugs at 6 and 12 weeks(6weeks,treatment group :14.34±2.11,control group:15.53±1.98;12 weeks,treatment group:10.46±1.89,control group:11.84±2.73)the difference between the two groups were also statistically significant(P<0.05).(2)Comparison in epileptic seizures :After twelve weeks,the efficiency of antiepilepsy treatment in treatment group and control group were 83.3% and60.0% respectively,and the difference was statistically significant(P <0.05).(3)The quality of life scale(QOLIE-31)was compared:After treatment,the overall quality of life of the two groups had obvious improvement,scores of total health status in QOL-31 had statistics difference(P<0.05)between two groups after treating.Scores of Life Satisfaction,Attack of the concerns,Energy/Fatigue,Drug Influence of treatment group is higher significantly than control group(P<0.01).(4)Comparison of the curative effect of TCM Syndrome: After twelve weeks reatment,the curative effect of TCM Syndrome in treatment group and controlgroup were 90.0% and 63.3% respectively,and the difference was statistically significant(P <0.05).(5)Comparison in adverse reactions:there was no serious adverse drug event in two groups,the adverse reactions included dizziness(1patient)、gastrointestinal discomfort(2patients),lethargy(1patient),constipationin(1 patient)in the treatment group.the adverse reactions included dizziness(1patient)、gastrointestinal discomfort(3patients),lethargy(1 patient),constipationin(1 patient),thirst(1 patient)in the control group.The incidence of adverse events was 16.7%、23.3%,and the difference was no statistically significant(P>0.05).Conclusions:(1)The Flavored Chaihu Shugan Decoction has better clinical efficacy in treating epilepsy with depressive disorder which belong to of the Liver qi stagnation and phlegm stasis syndrome.Meanwhile,it also has a good safety.(2)In epilepsy patients with anxiety and depression,the use of tandospirone or paroxetine based on antiepileptic drugs could improve mood disorders and also suppress seizures. |
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