| Methods | Randomised, double‐blind cross‐over trial with three 21‐day treatment periods and 2‐week washout period (regular medications used) conducted in a single centre in Newcastle, Indiana, United States Three treatment arms: carbamazepine, phenytoin and phenobarbitone Dates conducted: Not stated |
|
| Participants | Institutionalised adults with uncontrolled seizures on current medication Number randomised: PHT = 45, CBZ = 45 41 participants (91%) with partial epilepsy. 28 (62%) men. Age range: 18 to 51 years Study duration 13 weeks (3 x 21‐day treatment periods plus 2 x 2‐week washout periods) |
|
| Interventions | Monotherapy with PHT or CBZ Daily dose: PHT = 300 mg/day, or CBZ = 1200 mg/day | |
| Outcomes | Behaviour outcomes Adverse effects Seizure frequency Time to treatment withdrawal due to poor seizure control |
|
| Notes | Outcomes chosen for this review were not reported due to cross‐over design Funding: Supported in part by an NIH research contract Conflicts of interest: None stated |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Randomisation of groups from random number tables (confirmed by author) |
| Allocation concealment (selection bias) | Unclear risk | No information provided |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | No information provided |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No information provided |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Withdrawal rates reported, no further information provided |
| Selective reporting (reporting bias) | Low risk | All efficacy and tolerability outcomes specified in the Methods sections reported well in the Results section. No protocol available, outcomes for this review not available due to trial cross‐over design |
| Other bias | High risk | Cross‐over design may not be appropriate for monotherapy designs, likely carry‐over effects from 1 period to another, so the comparison may not be entirely monotherapy |