OBJECTIVE: To assess the safety and efficacy of gabapentin in treatment of refractory epilepsy. METHODS:Sixty-six patients with refractory epilepsy were treated with gabapentin 200 mg/d and 72 patients with placebo, totally 138 patients in five hospitals in different cities in China. Double-blind study was performed to observe the times of seizure, and Mini-Mental State Examination (MMSE) and Activities of Daily Life (ADL) assessment were conducted every 4 weeks. RESULTS: In comparison with the control group, the seizure times at any time point in the GB group all decreased with significant differences at the 12th and 20th weeks. The significant efficacy rates, with the seizure times decreasing by more than 75%, in the gabapentin group were higher than those in the control group, with significant differences in the 4, 8, 16, and 20th weeks. Both the MMSE scores of the 2 groups were raised with a significant difference between the 2 groups at the 16 weeks. There was no significant difference in ADL between these 2 groups. No serious side effect was found in these 2 groups. CONCLUSION:Gabapentin at a dosage of 1200 mg/d is safe and effective in treatment of epilepsy.
RCT Entities:
OBJECTIVE: To assess the safety and efficacy of gabapentin in treatment of refractory epilepsy. METHODS: Sixty-six patients with refractory epilepsy were treated with gabapentin 200 mg/d and 72 patients with placebo, totally 138 patients in five hospitals in different cities in China. Double-blind study was performed to observe the times of seizure, and Mini-Mental State Examination (MMSE) and Activities of Daily Life (ADL) assessment were conducted every 4 weeks. RESULTS: In comparison with the control group, the seizure times at any time point in the GB group all decreased with significant differences at the 12th and 20th weeks. The significant efficacy rates, with the seizure times decreasing by more than 75%, in the gabapentin group were higher than those in the control group, with significant differences in the 4, 8, 16, and 20th weeks. Both the MMSE scores of the 2 groups were raised with a significant difference between the 2 groups at the 16 weeks. There was no significant difference in ADL between these 2 groups. No serious side effect was found in these 2 groups. CONCLUSION:Gabapentin at a dosage of 1200 mg/d is safe and effective in treatment of epilepsy.