title: The clinical outcome of adjuvant therapy with black seed oil on intractable paediatric seizures: a pilot study.
abstract: OBJECTIVE
  To evaluate the effect of black seed oil, as add-on treatment to antiepileptic drugs (AEDs), on seizure frequency and severity as well as oxidative stress in intractable epilepsy patients.
  
  
  METHODS
  A prospective, randomised, single-blinded, controlled, crossover pilot study. Five healthy children were included as controls. Thirty intractable epileptic children were randomly assigned to either Group I or II. Group I received placebo for four weeks, followed by a two-week washout period, and subsequently black seed oil for four weeks. Group II received the same intervention but in the reverse order. All patients received AEDs throughout the study period. Prior to allocation, all patients underwent a neurological assessment and evaluation of oxidative stress markers; total antioxidant capacity (TAC) and malondialehyde (MDA). Patients were assessed at Weeks 4 and 10 for oxidative stress markers and seizure frequency and severity.
  
  
  RESULTS
  At baseline, both groups (I, II) had significantly lower serum TAC levels relative to healthy controls (p=0.007), while MDA levels were unchanged. After the 4-week period of black seed oil administration, there was no significant difference between the two groups with regards to seizure frequency, severity, or oxidative stress markers (TAC and MDA; p>0.05). Eight patients had >50% reduction in seizure frequency/severity after black seed oil versus placebo.
  
  
  CONCLUSIONS
  Children with intractable epilepsy show evidence of oxidative stress. Administration of 40-80 mg/kg/day of black seed oil as add-on therapy did not alter either oxidative stress markers or seizure frequency or severity in intractable epileptic patients.
authors: Department of Clinical Pharmacy, Faculty of Pharmacy.
authors: May
authors: M
authors: Shawki
authors: Lamia
authors: L
authors: El Wakeel
authors: Rania
authors: R
authors: Shatla
authors: Gamila
authors: G
authors: El-Saeed
authors: Samira
authors: S
authors: Ibrahim
authors: Osama
authors: O
authors: Badary
mesh_terms: D000293:Adolescent; D017668:Age of Onset; D000975:Antioxidants / Q000378:metabolism; D015415:Biomarkers; D017024:Chemotherapy, Adjuvant; D002648:Child; D002675:Child, Preschool; D004351:Drug Resistance; D005260:Female; D006801:Humans; D008297:Male; D008315:Malondialdehyde / Q000097:blood; D009460:Neurologic Examination; D031881:Nigella sativa; D018384:Oxidative Stress / Q000187:drug effects; D010938:Plant Oils / Q000627:therapeutic use*; D011446:Prospective Studies; D012640:Seizures / Q000188:drug therapy*; D016896:Treatment Outcome
chemical_list: D000975:Antioxidants; D015415:Biomarkers; D010938:Plant Oils; D008315:Malondialdehyde