Purpose: To determine the efficacy, adverse effects and tolerability of MAD in intractable epilepsy of children of different types in our country.
Method: This was a randomized controlled trial done from July 2016 to December 2017. This study was carried out in the OPD of Paediatric Neurology, National Institute of Neurosciences, (NINS) Dhaka, BSMMU, Dhaka, Dhaka Shishu Hospital. At each of the study sites intractable epilepsy cases aged 3 to 18 years having at least 3 seizures per week who intended to be enrolled were randomized either as in study group (MAD treatment group) and control group (getting normal family diet). Children were evaluated thereafter through detail history and clinical examination, lab test were obtained. Subsequently cases were randomized by lottery method. The standard anticonvulsant medications were continued to both the group as per requirement. After one month observation period MAD was given to the study group and 3 follow up visit at an interval of one month was made. Parents checked urine ketones by reagent test sticks daily throughout 3 month.
Results: Age and sex of both the group is comparable.Phenytoin,valproate,Carbamazepine were the common AED for study group whereas valproate,levitiracetum,carbamazepine and phenobarbitone were the common AED for the control group to treat intractable epilepsy in present study. The primary outcome of this study at the endpoint of 3rd follow-up, 71 % children had at least 50% or more seizure reduction and 25.7 % children had a ≥ 90% seizure reduction. 8 children in MAD group developed constipation,and other adverse effects were vomiting, skin rash, abdominal pain and abdominal distention.
Conclusion: Results of the study documented that MAD was found to be effective in reducing seizure burden in children with refractory epilepsy, well tolerated in the studied children and only few adverse effects were observed during study period