| Methods |
RCT, cross‐over |
| Participants |
Total randomised: 21
Age range = 6 to 38. Mean = 24.9. All patients had intellectual disabilities
Most patients on 1 to 3 other AEDs, except 2 patients who were not taking concomitant AEDs
Baseline period = 8 weeks. Each cross‐over leg = 10 weeks |
| Interventions |
Carbamazepine versus slow‐release carbamazepine |
| Outcomes |
Primary efficacy variables not stated. The study aims state (a) to carry out a 24‐hour pharmacokinetic trial comparing slow‐release CBZ and conventional CBZ at different dosing frequencies; (b) to look at the effect the reduction in dosing frequency of CBZ has on seizure control, that is the difference between slow‐release and conventional CBZ |
| Notes |
Numbers used in data analysis = 20 |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
High risk |
Study states that randomisation was achieved according to order participants were recruited to study |
| Allocation concealment (selection bias) |
Low risk |
Pharmacist‐controlled allocation |
| Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
Participants and study personnel blinded |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
Study personnel blinded |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Only 1 participant dropped out and reasons for dropout unlikely to affect study outcome |
| 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 |
