Introduction: despite administration of numerous combinations of epileptic drugs, nearly 15% of childhood seizures are resistant to treatment and it is still a problem in pediatric practice. In traditional medicine, Nigella sativa was known to have anticonvulsant effects. Recent studies also have shown its anticonvulsant effects. Most of the properties of N. sativa or its extracts are mainly attributed to thymoquinone. It has been shown that thymoquinone has several therapeutic effects and no evidence of toxicity or side effects is reported.
Materials and methods: in this pilot, double-blinded crossover clinical trial study on children with refractory epilepsy, thymoquinone with dose of 1mg/kg was administered as an adjunctive therapy and its effects on frequency of seizures were compared with those of a placebo. Twenty-two patients entered in the study. They were assigned in two groups and received either thymoquinone or placebo for a period of four weeks, and then during the two weeks of wash out period, they received only their pre-existing anti-epileptic drugs; then, after cross-overing, they received thymoquinone or placebo for a period of four weeks again. During these periods their effects on seizure frequency were investigated.
Results: the reduction of frequency of seizures at the end of first period in comparison with the same period before the study demonstrated a significant difference between two groups (thymoquinone and placebo) (P=0.04). Also reduction of frequency of seizure has shown significant difference between two groups at the end of second period in comparison with end of first period (P=0.02). The parental satisfaction showed significant difference between the two groups at the end of the first period (P=0.03).
Conclusion: it can be concluded that thymoquinone has anti-epileptic effects in children with refractory seizures.
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