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. 2020 Jun 24;2020(6):CD001903. doi: 10.1002/14651858.CD001903.pub5

Zare 2017.

Study characteristics
Methods Prospective, randomised, non‐blinded, controlled trial to compare MAD to usual care 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;

  • 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.

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 usual care for a 2‐month period.
Outcomes
  • Seizure reduction;

  • Adverse effects.

Notes
  • At 2 months 12 participants dropped out of the MAD arm, all due to non‐compliance;

  • 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 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) 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.