| Study characteristics |
| Methods |
Open‐label, single‐centre, parallel‐group, randomised controlled trial, to compare the MAD to a usual care group over a 3‐month period. Authors noted the study design to be similar to that of Neal 2008. There was a 4‐week baseline of seizure frequency. |
| Participants |
102 children aged 2‐14 years with drug‐resistant epilepsy and 2‐14 daily seizures, having previously tried 3 AEDs. Study conducted in India; Exclusion criteria: known or suspected inborn errors of metabolism, systemic illness or motivational issues the family that would prelude compliance; Epilepsy syndromes included: West syndrome (9 participants in the MAD group and 10 participants in usual care group) and myoclonic astatic epilepsy (2 participants in the MAD group and 3 participants in usual care group). |
| Interventions |
Randomised into 1 of 2 groups; MAD (50 participants) or a normal diet (52 participants) for a period of 3 months. |
| Outcomes |
Seizure frequency; Tolerability; Adverse effects. |
| Notes |
4 children reported to have dropped out of the trial. 2 secondary to lower respiratory tract infections, 1 secondary to hyperammonaemic encephalopathy and 1 as the child and family found the diet too restrictive. In the usual care group, 3 participants were lost to follow‐up; The lead author (Sharma) was financially supported as a Senior Research Associate in the “Scientists pool scheme” of the Council for Scientific and Industrial Research (CSIR), Government. of India, for this study. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Randomisation sequence was computer generated. |
| Allocation concealment (selection bias) |
Low risk |
Opaque sealed envelopes were used to conceal allocation. |
| Blinding of participants and personnel (performance bias)
All outcomes |
High risk |
Open‐label study meaning participants and personnel were not blinded. |
| Blinding of outcome assessment (detection bias)
All outcomes |
High risk |
Open‐label study meaning outcome assessors were not blinded. |
| Incomplete outcome data (attrition bias) |
Low risk |
Study attrition reported and ITT analysis carried out. |
| Selective reporting (reporting bias) |
Low risk |
Protocol available 15 August 2015 (NCT00836836). |
| Other bias |
High risk |
Excluded participants where motivational issues within the family were noted. |
