The effect of a mixture of Nigella sativa and Thymus vulgaris extracts in children with refractory epilepsies: A randomized trial

Abstract

More than 25% of seizures in children are refractory to anti-seizure medications and need other modalities to control. Recently, herbal agents with anticonvulsive effects on seizure models in animals have received significant attention, but studies that show their impact on seizures in children are scarce. In a randomized, double-blind placebo-controlled cross-over design, we tried to demonstrate the efficacy of a mixture of Nigella sativa and Thymus vulgaris extracts (Epistop) on seizures in a group of children with refractory epilepsies. Twenty-two children with refractory epilepsies were randomly assigned into two sequences to receive Epistop or placebo in a cross-over design. Neither Epistop nor placebo had effects on the seizure frequency and duration over the study period. Only four children experienced clinically substantial seizure frequency (more than 50%) reduction after Epistop administration. These results indicate that a mixture of Nigella sativa and Thymus vulgaris extracts does not affect the seizure frequency and duration in children with refractory seizures. However, a minority of highly selected children with refractory seizures might benefit from the effects of a mixture of these agents’ extracts.