Boas 1996.
| Methods | Randomized, double‐blind, cross‐over study. Two treatment arms: 1 placebo, 1 lamotrigine. Five phases: baseline period = 12 weeks; treatment I = 12 weeks; washout I = 4 weeks; treatment II = 12 weeks; washout II = 4 weeks. |
|
| Participants |
|
|
| Interventions | Lamotrigine or placebo was added to the patients' existing AEDs. The dose of lamotrigine varied from 75 to 400 mg. Participants on valproate received lower doses. | |
| Outcomes | (1) 50% responder rates. (2) Withdrawal from study for any reason. (3) Adverse effects. | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer‐generated random permuted blocks. |
| Allocation concealment (selection bias) | Low risk | Partcipants were allocated sequentially‐numbered, sealed packages containing either lamotrigine or placebo. |
| Blinding (performance bias and detection bias) All outcomes | Unclear risk | No details provided regarding blinding of participants, study personnel, and outcome assessors. All treatments (tablets) and packaging were identical. Prepacked coded medication was dispensed by pharmacy. |
| Incomplete outcome data (attrition bias) | Low risk | No participants were excluded from analysis. 10 participants withdrew from the study; 8 randomised to lamotrigine and 2 to placebo. The reasons for exclusion were reported. |
| Selective reporting (reporting bias) | Low risk | All outcomes stated in methods section of paper were reported in the results. There was no protocol available to check a priori outcomes. |
| Other bias | Unclear risk | This study was sponsored by GlaxoSmithKline, the manufactures of LTG. |