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. 2017 Jun 29;2017(6):CD011412. doi: 10.1002/14651858.CD011412.pub2
Methods Randomised trial conducted in Republic of Korea
2 treatment arms: CBZ (controlled release) and LEV
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
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
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
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