Crawford 2001.
| Methods | Open‐label, parallel RCT | |
| Participants | Total randomised: 83 All patients were 12 years and over. Age range = 15 to 59. All patients had intellectual disability All patients were taking 1 to 3 other AEDs Baseline period = 8 weeks. Titration period up to 14 weeks. Treatment period = minimum of 10 weeks | |
| Interventions | Gabapentin versus lamotrigine | |
| Outcomes | Primary efficacy = reduction in seizure frequency between baseline period and the last 8 weeks of the treatment period assessed using the R‐ratio=(T‐B)/(T+B) where T and B are the seizure frequencies per 28 days during treatment and baseline, respectively Secondary = responders (seizure frequency reduced by 50% or more. Non‐responders = seizure frequency reduced by less than 50% and those withdrawing Mood, behaviour and dependency were assessed |
|
| Notes | — | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | High risk | Participants were sequentially randomised in blocks |
| Allocation concealment (selection bias) | Unclear risk | Insufficient information |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants were unblinded |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Outcome assessment unblinded |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Although missing data and study attrition are unclear, an intention‐to‐treat analysis was carried out |
| 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 | Funded by a pharmaceutical company but no other evidence for other risk of bias |