An open label trial of a standardized extract of cultured Lentinula edodes mycelia (ECLM) in children with refractory epilepsy

Objectives: This open-label trial was performed to assess the immune markers in a cohort of children with refractory epilepsy in order to identify diagnostic and therapeutic markers and to also investigate the effect of an immunologically active supplement derived from mushroom, a standardized extract of cultured Lentinula edodes mycelia (ECLM), on the clinical status and on the immunological markers in the subjects. Methods: Eighteen pediatric patients diagnosed with refractory epilepsy in which antiepileptic therapy was not effective were enrolled. All subjects were also treated with anticonvulsant medications for their seizures. Patients were administered 0.6 g/day (< 3 years old) or 1.2 g/day (≧ 3 years old) of ECLM (fine-granule equivalent) orally for one month. Immunological markers were assessed at baseline and after one month. Video electroencephalogram (EEG) was taken twice, once before the trials and once at the end of ECLM treatment. Seizure frequency and behavioral symptoms were measured by a questionnaire survey of the parents. A two-month follow-up was also performed for surveillance of secondary infections. Results: The subjects treated with ECLM showed significant elevation of several immune parameters including immunoglobulin G (IgG), CD3, CD4, and CD20 lymphocytes, and phagocytic index. Six of the 18 children on stable anticonvulsant drugs had fewer seizures reported during the ECLM treatment. The ECLM-treated patients also had less sharp and spike activity in the EEG measurement. At the two-month follow-up, the ECLM-treated subjects had developed fewer infections and viral syndromes compared to their condition before the trial. The children’s family reported other subjective behavioral improvements, leading to improved quality of life (QOL). Conclusion: ECLM administration to the pediatric patients with refractory epilepsy contributed to improvement of epileptic manifestation and decrease of epileptic seizure, possibly by suppressing the reactivation of herpes virus, as well as improvement of QOL. In addition, it was demonstrated that ECLM is a safe supplement for infants and children.