Clinical Study Of Qingxin Wendan Decoction In The Treatment Of Intractable Epilepsy

ObjectiveTo study the clinical efficacy and safety of Qingxin Wendan Decoction in the treatment of intractable epilepsy(IE),in order to provide new ideas for the treatment of IE,and provide evidence for clinical treatment of Chinese medicine standard.MethodAccording to the diagnostic criteria and exclusion criteria,a total of 94 patients with IE were enrolled from January 2016 to August 2016 from epilepsy center of Guangdong Province Traditional Chinese Medical Hospital,which were randomly divided into treatment group(TG)and control group(CG)with 47 cases in each group by random number method.The type and dose of Anti-Epileptic Drugs(AEDs)used of the TG were invariable,but Qingxin Wendan Decoction added.On the basis of the original regimen,the CG was treated with the addition of third drugs or the replacement of new drugs in accordance with the western medicine treatment of IE.Two groups were followed up every 1 months for 6 times.The curative effect of Qingxin Wendan Decoction in the treatment of IE was evaluate by comparing the different time points after treatment and baseline period,different time points within groups and between groups,through the monthly seizure frequency,severity score(NHS3 scale),quality of life score(QOLIE 31 scale),EEG and other indicators.The TCM Syndromes applicative to Qingxin Wendan Decoction were judged through the comparison of the curative effect between different TCM Syndromes within groups and between groups.The safety of Qingxin Wendan Decoction was judged by the observation of adverse reactions.ResultsAfter the treatment,the seizure frequency of the two groups decreased,and the severity score(QOL score)of each group was lower(higher)than that of the baseline period,the differences were statistically significant(P<0.05).In the frequency of seizure,seizure severity score,quality of life score,the situation of the TG every month(every two months)compared with the month before(two months before),the differences were statistically significant(P<0.05);In the first 3 months of the CG,the number of seizure frequency per month was lower than before,the differences were statistically significant(P<0.05);and the difference was not statistically significant from the fourth months(P>0.05).In the seizure frequency and quality of life score,the first 2 scores were lower(higher)than before,the differences were statistically significant(P<0.05),and the difference was not statistically significant from the third score(P>0.05).In the comparison of the 3 evaluation indexes above between the 2 groups of the same time points,the TG is better than the CG and the differences were statistically significant(P<0.05).The EEG of the two groups after treatment was better than before,and the TG was more obvious(P<0.05).In the case of TCM syndromes,the TG was superior to the CG in seizure frequency among the following three TCM Syndromes:wind-phlegm(WP),phlegm-fire disturbing brain(PFDB),blood stagnant in cerebral venation(BSICV),and the difference was statistically significant(P<0.05).There were no significant differences between the other 3 syndromes.ConclusionQingxin Wendan Decoction combined with AEDs are better than pure AEDs in treatment of IE,in the respects of lessening the severity and frequency of seizures,improve the quality of life and improve the EEG,and the longer treatment time,the more obvious effect.Among the 6 types of TCM syndromes,WP,PFDB and BSICV were effective,and may be WP and PFDB were at the best effect.In a word,Qingxin Wendan Decoction is safe and effective in the treatment of IE.A new way to combine traditional Chinese medicine and Western medicine in the treatment of IE has been opened up and the standard for traditional Chinese medicine clinical medication has been provided.