Methods | Randomised, double‐blind cross‐over trial with 3, 21‐day treatment periods and a 2‐week washout period (regular medications used) 3 treatment arms: CBZ, phenytoin, and PB |
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Participants | Institutionalised adult participants with uncontrolled seizures on current medication Number randomised: PB = 45, CBZ = 45 41 participants (91%) with partial epilepsy 28 (62%) male participants Age range: 18 to 51 years Study duration: 13 weeks (3 x 21‐day treatment periods plus 2 x 2‐week washout periods) |
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Interventions | Monotherapy with PB or CBZ Daily dose: PB = 300 mg/day or CBZ = 1200 mg/day | |
Outcomes |
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Notes | The outcomes chosen for this review were not reported due to the cross‐over design of the trial. | |
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 on blinding. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No information provided on blinding. |
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 carryover effects from one period to another so the comparison may not be entirely monotherapy. |