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

El‐Rashidy 2013.

Study characteristics
Methods Single‐centre randomised controlled trial to comparing two different dietary interventions (MAD and classic KD in form of 4:1 liquid diet) and a control group (AED polytherapy).
Participants
  • 40 children aged 12‐36 months (mean 27.13, SD 6.63) with symptomatic intractable epilepsy. Study undertaken in Egypt;

  • Exclusion criteria: children < 1 year, diagnosed with idiopathic epilepsy or with other systemic chronic conditions;

  • Two children in the classic group had infantile spasms and one child in the classic group had myoclonic encephalopathy.

Interventions
  • Participants were randomised into 1 of 3 groups; MAD (15 participants), KD (10 participants) and control (polytherapy) (15 participants);

  • 4:1 refers to 4 g fat to 1 g of carbohydrate and protein combined.

Outcomes
  • Reduction in seizure frequency;

  • Adverse effects;

  • Attrition rate.


Data were collected at 3 and 6 months.
Notes
  • 2 participants in the MAD group dropped out of the trial as they could not accept the diet and experienced weight loss. From the results, it could be inferred that these participants dropped out between the 3‐ and 6‐month reviews. 2 participants from the classic KD group dropped out due to intolerance; however, it was unclear when these participants dropped out;

  • No external funding support was received for this study beyond the treating hospital (Children's hospital, Faculty of Medicine, Ain Shams University).

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Although the paper stated that participants were 'randomly assigned', there was no information regarding how the randomisation sequence was generated.
Allocation concealment (selection bias) Unclear risk There was no information suggesting whether allocation was concealed or not.
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) High risk Study attrition was reported but ITT analysis was not carried out. Reasons for drop outs were likely to be related to interventions.
Selective reporting (reporting bias) Unclear risk Emailed author regarding protocol, awaiting response from co‐authors. Protocol currently unavailable.
Other bias High risk No measure of seizure frequency reported at baseline. 20% of participants in the classic KD group had infantile spasms.