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. 2017 Jun 29;2017(6):CD011412. doi: 10.1002/14651858.CD011412.pub2
Methods Parallel‐design RCT conducted in Meerut, India
2 treatment arms: PHT and VPS
Participants Participants with at least 2 partial or generalised tonic‐clonic seizures per month
Unclear if participants were newly diagnosed
Number randomised: PHT = 45; VPS = 49
70 male participants (74%)
27 participants with partial epilepsy (29%)
Age range: PHT: 12‐42 years; VPS: 8‐52 years
Interventions Monotherapy with PHT or VPS
Average daily dose achieved: PHT: 5.6 mg/kg/d, VPS: 18.8 mg/kg/d
Participants were evaluated after 4, 12 and 24 weeks of treatment
No information on range of follow‐up
Outcomes Reduction in frequency of seizures:
  • excellent (100% reduction);

  • good (75%‐99% reduction);

  • fair (50%‐74% reduction);

  • poor (< 50% reduction)


Adverse effects
Seizure control
Notes Outcomes chosen for this review were not reported. IPD not available
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Participants "randomly allocated irrespective of seizure type," no further information provided
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 Frequency of seizures reported for all randomised participants, no information provided on withdrawal rates/attrition rates etc
Selective reporting (reporting bias) Low risk Frequency of seizures during treatment well reported, most common adverse events reported
No protocol available to compare with a priori analysis plan, outcomes for this review not reported
Other bias Low risk None identified