| Study characteristics |
| Methods |
Prospective, randomised controlled trial comparing MAD (up to 16 g carbohydrate per day, excluding fibre) to a usual care over a three‐month period. |
| Participants |
75 adult participants aged 16 years or over, with focal or multifocal epilepsy, at least three countable seizures per month, tried at least three AEDs, BMI > 18.5kg/m2, motivated and capable of adhering to the diet, with assistance if required. Participants were referred from across Norway;
Exclusion criteria: pregnancy, previous use of KD in past 12 months, change of AED treatment, non‐epileptic seizures, status epilepticus in past six months, resective surgery or vagal nerve stimulation in past 12 months or comorbidities that contraindicate use of the KD.
|
| Interventions |
MAD (up to 16 g carbohydrate per day, excluding fibre; 37 participants) compared to usual care (38 participants) over a three‐month period. |
| Outcomes |
|
| Notes |
13 participants dropped out from the treatment arm; 9 did not receive the diet and 4 were lost to follow‐up. In the usual care arm 6 participants dropped out; 3 did not start the treatment period, 1 was excluded as commenced diet during the control period and 2 were lost to follow‐up.
No funding was received for this study.
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Manual random allocation sequence. |
| Allocation concealment (selection bias) |
Low risk |
Researcher not involved in study. |
| Blinding of participants and personnel (performance bias)
All outcomes |
High risk |
Blinding was not discussed in this paper, but considering the design of the study, blinding of participants and study personnel does not seem possible. |
| Blinding of outcome assessment (detection bias)
All outcomes |
High risk |
Blinding was not discussed in this paper, but considering the design of the study, blinding of outcome assessors does not seem possible. |
| Incomplete outcome data (attrition bias) |
Unclear risk |
Unclear if ITT used. |
| Selective reporting (reporting bias) |
Low risk |
Protocol received. No evidence to suggest selective reporting. |
| Other bias |
High risk |
Study discontinued after 6 years due to limited recruitment; initial study powered to 92 participants (75 were recruited). Female dominant intervention group at baseline. |