Cho 2011.
| Methods | Randomised trial conducted in Republic of Korea 2 treatment arms: CBZ (controlled release) and LEV |
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| Participants | Participants with newly diagnosed partial epilepsy who had their first seizure between 6 and 1 month prior to entry into the trial and had not taken any AEDs previously. Number completing the trial: CBZ = 15, LEV = 16 (number randomised not stated) 22 male participants (71%) 100% of participants had partial epilepsy Mean age (SD, range): CBZ = 29.8 (9.31, 15‐49), LEV = 31.4 (15.3, 15‐66) years |
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| Interventions | Monotherapy with CBZ or LEV Treatment regimens were CBZ = 400 mg/d and LEV = 1000 mg/d Trial duration 4‐6 weeks, range of follow‐up not stated |
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| Outcomes | Change in overnight PSG scores (sleep latency, REM sleep latency, total sleep time, sleep efficiency, percentage of each sleep stage, arousal index, and Wake time After Sleep Onset) from baseline after 4‐6 weeks of treatment Change in sleep questionnaires (sleep diaries, the Pittsburg Sleep Quality Index, the Korean version of the Epworth Sleepiness Scale, Beck’s depression inventory‐2 and the Hospital Anxiety Scale) and National Hospital Seizure Severity Scale (NHS3) from baseline after 4‐6 weeks of treatment |
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| Notes | IPD could not be provided for the trial due to concerns over institutional review board approval (information provided by corresponding author). Outcomes chosen for this review were not reported | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Trial described as randomised, 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 | Low risk | PSG scores were interpreted by a certified physician who was blinded to treatment |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Number randomised not stated, results provided only for those who completed the trial |
| Selective reporting (reporting bias) | Low risk | All sleep, efficacy, and tolerability outcomes specified in the methods sections were reported well in the results section. No protocol was available. Outcomes chosen for this review were not reported |
| Other bias | Low risk | None identified |