| ObjectiveTo observe clinical effects of Yinao’an capsule on cognitive function, seizure control and quality of life in epilepsy patients.MethodAccording to the diagnostic criteria, inclusion criteria and exclusion criteria,60 qualified subjects were chosen which were outpatient or inpatient of Epilepsy Center in Guangdong Provincial Hospital of TCM from January 2015 to January 2016. By means of the Doll’s clinical random table,60 patients were divided into two groups, the treatment group was with(add-on therapy with Yinao’an capsule, n=30) and the control group was with(AEDs only, n=30) were compared. The courses of treatment were 3 months. Before and after the treatment, the Montreal Cognitive Assessment scale(MoCA), Quality of Life in Epilepsy-31 scale and changes of seizure frequency would be assessed each time, then go on observing and analyzing the difference of treatment, at last, try to explore the effect of Yinao’an capsule about those.ResultsThe clinical study included 60 subjects, all of the patients were with good compliance, no shedding, were able to comply with the requirements of this study. During the trial, we had not found adverse drug reactions, worse seizure attacks than before, patients taking other interfering drugs, and other conditions. Routine blood tests showed that no significant abnormalities happened or the original basis of patients got no further increase. Though the comparative analysis of the two group on gender, age, disease duration, the difference between the two group was not statistically significant (P>0.05), showed that it is comparable in those aspects between the two group. The TCM symptoms of the two group were analysed by x2 test, and no significant differences were found statistically(P>0.05), suggesting that TCM symptoms of the two group were with comparability. Treatment group included general tonic clonic seizures(GTCS)3cases, complex partial seizures(CPS)16 cases, simple partial seizures (SPS) 13 cases, absence seizures (AS) 1 cases;while control group included general tonic clonic seizures(GTCS)2cases, complex partial seizures(CPS)17 cases, simple partial seizures(SPS)11 cases. Besides,in the treatment group,24 cases were treated with single antiepileptic drugs,6 cases were treated with two kinds of antiepileptic drugs;while in the control group,28 cases were treated with single antiepileptic drugs,2 cases were treated with two kinds of antiepileptic drugs.Montreal Cognitive Assessment scale(MoCA):Before the treatment, the scores of MoCA scale of two groups have no difference in statistics(P>0.05). After the treatment, the scores of MoCA scale of two groups were not improved(P>0.05), statistical differences were not found between two group(P>0.05), implying that the add-on therapy with Yinao’an capsule has no effects in improving cognitive function among epilepsy patients. Through the comparison of MoCA scale scores in the two group before and after the treatment, the results showed that the difference was not statistically significant(P>0.05).Quality of Life in Epilepsy-31 scale:Statistical differences were not found between two groups (P>0.05) before the treatment. After the treatment, the scores of QOLIE-31 scale of two groups were significantly improved(P<0.01), when compared with the control group, the influence of treatment group is similar(P>0.05). Through the comparison of QOLIE-31 scale scores in the two group before and after the treatment, the results showed that the difference was not statistically significant(P>0.05).Changes of seizure frequency:Before the treatment, the seizure frequencies of two groups have no differences in statistics(P>0.05). But the seizure frequencies of two groups reduced significantly after the treatment(P<0.01), statistical differences were not found between two group(P>0.05), prompting that both add-on therapy with Yinao’an capsule and the only-AEDs therapy have a good effect in the control about seizure attacks, besides,the curative effect of two groups is similar. Through the comparison of seizure frequency in the two group before and after the treatment, the results showed that the difference was not statistically significant(P>0.05).ConclusionThe add-on therapy with Yinao’ an capsule can significantly reduce the seizure attack frequency of epilepsy patients,but has no significant improvement in cognitive function, in other ways, it can improves the quality of life of epilepsy patients significantly, relatively the effect is similar to the control group. |
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