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. 2016 Dec 15;2016(12):CD001904. doi: 10.1002/14651858.CD001904.pub3
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
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)
Interventions Monotherapy with PB or CBZ Daily dose: PB = 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 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.