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. 2017 Feb 27;2017(2):CD001911. doi: 10.1002/14651858.CD001911.pub3
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