The clinical outcome of adjuvant therapy with black seed oil on intractable paediatric seizures: a pilot study

Abstract

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. Conclusion.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.

Review on Clinical Trials of Black Seed (Nigella sativa ) and Its Active Constituent, Thymoquinone

“…A similar clinical trial done by the same author had similar outcomes, although TQ (1 mg/kg) was administered as an add-on therapy instead of water extract of black seed [81]. On the other hand, another study conducted by Shawki et al had a different result; after administration of 40 – 80 mg/kg/day of black seed oil as an adjuvant therapy for 4 weeks, no beneficial effects on the frequency and severity of seizures in intractable epileptic children were observed [82]. …”

“…In contrast, some authors have reached results that conflict with the traditional beliefs about NS. Actually, the evidence for the positive effects of NS in the treatment of osteopenic postmenopausal women and intractable epileptic children is conflicting [40, 82, 105]. Therefore, more studies should be planned in these situations.…”

Preclinical and clinical effects of Nigella sativa and its constituent, thymoquinone: A review

“…Although the oxidative stress markers were higher in intractable epileptic children compared with healthy children, N. sativa oil supplementation could not improve it, but no side effects were reported during the study (Shawki et al, 2013). However, in another similarly planned study, administration of TQ (the main constituents of the plant) showed antiepileptic effects in children with intractable epilepsy.…”

Phyllathin From Phyllanthus Amarus Ameliorates Epileptic Convulsion and Kindling Associated Post-Ictal Depression in Mice via Inhibition of NF-κB/TLR-4 Pathway

“…A double-blind study conducted in epileptic patients treated with Nigella sativa showed a marked reduction in seizure frequency, and it was well tolerated. 36,45 A recent study conducted by George et al (2019) showed that a standardized extract of P. amarus (PHYLLPRO™) containing phyllanthin and hypophyllanthin as an active phytoconstituents ameliorates inflammation and intoxication via inhibition of pro-inflammatory cytokines in hangover populations without serious adverse events. 15 Thus, P. amarus can be considered as a potential herbal therapeutic remedy for the management of epileptic seizures.…”