Objective: To observe the clinical efficacy of Si-Miao-Yong-An decoction (SMYAD) in the treatment of post-stroke epilepsy. Methods: 112 patients with post-stroke epilepsy were randomly assigned to either the control or the treatment group (56 subjects in each group). Patients in the control group received oral levetiracetam (LEV) combined with other conventional Western medicine treatment (s), while the treatment group received SMYAD only. Outcome measures were the duration for seizure remission, remission rates at one year, changes in electroencephalogram (EEG), scores of National Institutes of Health Stroke Scale (NIHSS), and adverse events in the two groups. Results: The numbers of patients who completed treatment were 41 and 55 in the LEV group and SMYAD group, respectively (P<0.01). After 12 months of treatment, epilepsy was controlled in 35 patients in LEV group and 47 in SMYAD group (P=0.990). Seizure remission was achieved in 15.1 days in LEV group and 8.7 days in SMYAD group (P<0.01). Relapse of epilepsy was observed in 19 cases in the LEV group and 11 in SMYAD group (P<0.01). Abnormal EEG patterns persisted in 32 patients in LEV group and 29 patients in SMYAD group (P<0.01). The NIHSS score decreased from 12.2 to 9.4 in LEV group, and from 12.5 to 5.8 in SMYAD group (P<0.01). Adverse effects of treatment were observed in 28 cases in LEV group and 6 patients in SMYAD group (P<0.01). The most common adverse events reported were rash, fatigue, somnolence, headache, and dizziness in LEV group, and diarrhea in SMYAD group. Adverse effects caused withdrawal of 8 patients from LEV group but none from SMYAD group (P<0.01). Conclusion: SMYAD is an effective and well tolerated remedy for post-stroke epilepsy. Further large scale randomized controlled trials are needed to establish the efficacy and tolerability.
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