Methods | Open‐label, head‐to‐head controlled, parallel study. Two treatment arms: one TGB, one TPM. Participants were randomly assigned using non‐random component Duration of screening period: eight weeks, followed by a titration phase of three months and a maintenance period of three months | |
Participants | No information regarding study sites or countries 41 participants with drug‐resistant partial epilepsy randomly assigned. Baseline data reported for only 30 participants who completed the whole study Participants already taking one to three background AEDs |
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Interventions | Group one: TGB at least 20 mg/d; mean 32 mg/d Group two: TPM at least 200 mg/d; mean 335 mg/d |
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Outcomes |
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Notes | Non‐accurate baseline data reported. Four participants excluded from ITT analysis for seizure reduction outcome | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | Non‐randomisation component employed in the sequence generation process. Sequence generated by odd versus even number of week in which participant was seen |
Allocation concealment (selection bias) | High risk | No concealment used |
Blinding (performance bias and detection bias) All outcomes | High risk | Study was open‐label |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Attrition rates reported and intention‐to‐treat analysis employed |
Selective reporting (reporting bias) | Unclear risk | All outcomes reported in methods section were reported in text; however, no protocol was available for comparison of outcomes. Participant characteristics reported for only 30 participants who completed the whole study of the 41 randomly assigned |