Objective To observe the clinical efficacy and safety of modified Chaibei Zhixian Decoction（ 柴贝止痫汤） in the adjuvant treatment of refractory epilepsy with phlegm qi stagnation syndrome. Methods A total of 70 patients with refractory epilepsy with phlegm qi stagnation syndrome were enrolled in the treatment group

and 70 patients were matched 1 ∶ 1 into the control group according to gender

age

disease duration and attack type. The control group kept the original anti-epileptic drugs unchanged

and the treatment group was additionally given the adjuvant treatment of Chaibei Zhixian Decoction. Both groups were treated for 12 weeks. The frequency of seizures

epilepsy scores（ for patients with generalized tonic-clonic seizures）

epilepsy accompanying symptom score

and electroencephalogram（ EEG） were compared between groups before treatment and after 4 weeks

8 weeks

and 12 weeks treatment. The drug retention and adverse reactions were recorded

and the clinical efficacy was evaluated. Results The 2 groups were eventually included in 66 cases respectively

including 37 matched groups with comprehensive tonic-clonic seizures. The frequency of seizures

epilepsy scores

and epilepsy accompanying symptom scores at different time points in the treatment group were decreased than those before treatment（ P < 0. 01 or P < 0. 05）

and the differences were statistically significant when compared with the control group（ P < 0. 01 or P < 0. 05）. After 4 weeks

8 weeks

and 12 weeks of treatment

the efficacy of the frequency of epileptic seizures

epilepsy scores

and epilepsy accompanying symptom score in the treatment group was superior to that of the control group

and the difference was statistically significant（ P < 0. 01 or P < 0. 05）. Electroencephalogram（ EEG） of only one patient in the treatment group changed from a moderate abnormality to a mild abnormality after treatment. The abnormalities of EEG in all other patients showed no significant changes after treatment. No serious adverse reactions were found in either group. There was no significant difference in drug retention rate between groups（ P > 0. 05）. Conclusion Modified Chaibei Zhixian Decoction can reduce the frequency of seizures and improve the symptoms associated with seizures in patients of refractory epilepsy with phlegm qi stagnation syndrome.