RESUMO
Despite a wide range of medications available to control epilepsy, seizures in more than 30 % of patients remain uncontrolled. However, in traditional medicine, Paeonia officinalis (P. officinalis), a native perennial herb of Southern Europe and Western Asia, has been used for an anticonvulsant effect for over 2000 years globally. In an open-label pilot study implemented on 30 children with intractable epilepsy aged 1-14 years, the hydroalcoholic extract of P. officinalis was administered. This study's purpose was to assess the efficacy and tolerability of the P. officinalis extract as an adjunct therapy to a patient's antiseizure medications in reducing the frequency and duration of the seizures in childhood intractable epilepsy. The mean frequency of seizures decreased significantly during treatment with the P. officinalis extract (P < 0.05). At the end of the intervention, 62.5 % and 36.7 % of the patients showed a≥50 % and a≥75 % reduction in seizure frequency, respectively. Regarding safety and tolerability, no serious adverse events occurred during the trial, although restlessness was reported in one child and the other children who experienced constipation, stopped treatment. The results show that the P. officinalis root extract was well tolerated and has contributed to a significant improvement in seizure control in children with medically intractable epilepsy. This trial was registered with the Iranian Registry of Clinical Trials (www.irct.ir; registration number: IRCT20131125015533N2.