Zare 2017.
| Methods | Prospective, randomised, non‐blinded, controlled trial to compare MAD to a control over a 2‐month period | |
| Participants | 66 adult participants aged 18 years or over, with drug‐resistant epilepsy (2 or more AEDs and 2 or more seizures per month). Study was conducted in Iran | |
| Interventions | Randomised into 1 of 2 groups; MAD (carbohydrates limited to 15 g per day; approximate macronutrient intakes as a percentage of total energy: 4% to 6% carbohydrate, 20% to 30% protein, 60% to 70% fat) and a control for a 2‐month period. | |
| Outcomes |
|
|
| Notes | At 2 months 12 participants dropped out of the MAD arm, all due to non‐compliance Exclusion criteria: prior use of the Atkins' diet or MAD for 1 week or more, use of KD within the last year, heart disease, renal disease, hypercholesterolaemia, coronary heart diease, cerebral vascular disease, peripheral vascular disease, atherosclerosis, myocardial infarction, pregnancy, BMI < 18.5 kg/m2, status epilepticus in last 6 months and 2‐week seizure‐free period in last 6 months The study was supported by the Plastic Surgery Research Centre, Isfahan University of Medical Sciences, Isfahan. |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Random number table |
| Allocation concealment (selection bias) | Unclear risk | Not stated |
| Blinding (performance bias and detection bias) All outcomes | High risk | Unblinded |
| Incomplete outcome data (attrition bias) | Low risk | Study attrition reported and ITT analysis carried out |
| Selective reporting (reporting bias) | Unclear risk | Protocol unavailable |
| Other bias | High risk | Numerical errors with the article. No power calculation stated. Low levels of urinary ketosis achieved, may impact efficacy data. Unknown if baseline period completed prior to commencing diet |
AED: antiepileptic drug; BMI: body mass index; Fast FD: fasting‐onset ketogenic diet; Grad KD: gradual‐onset ketogenic diet; ITT: intention‐to‐treat; KD: ketogenic diet; MAD: modified Atkins diet; MCT: medium‐chain triglyceride; QALYs: quality‐adjusted life years; SD: standard deviation; sMAD: simplified modified Atkins diet.