| Methods |
RCT, cross‐over |
| Participants |
Total randomised: 14
Age range = 4.2 to 15.7 years. All patients had Lennox‐Gastaut syndrome, although the article does not make specific mention of the level of intellectual disability in this population |
| Interventions |
Felbamate versus placebo in presence of valproic acid |
| Outcomes |
Primary variable not stated. However, the measures include: (1) the % change in total seizure frequency after FBM/placebo add‐on compared with baseline (baseline = VPA monotherapy)
Seizures were determined by either (a) video‐EEG counts; (b) family seizure records; (c) electrographic seizures without a clinical correlate viewed on the video‐EEG tapes |
| Notes |
Numbers used in data analysis = 13 |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Insufficient information about how randomisation was achieved |
| Allocation concealment (selection bias) |
Unclear risk |
Insufficient information |
| Blinding of participants and personnel (performance bias)
All outcomes |
Unclear risk |
Unclear how blinding was achieved |
| Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
Unclear how blinding was achieved |
| Incomplete outcome data (attrition bias)
All outcomes |
Unclear risk |
1 participant withdrew but reasons not given |
| Selective reporting (reporting bias) |
Low risk |
All outcomes discussed were reported. There is no evidence to suggest outcomes were selectively reported |
| Other bias |
Unclear risk |
No information about how trial was funded and no other evidence to suggest unclear risk of bias |
