Gupta 2004a.

Methods	Randomized, double‐blind, parallel, placebo‐controlled trial
Participants	Inclusion criteria: children of either sex, aged 3‐12 years, carbamazepine monotherapy, confirmed diagnosis of epilepsy according to the International Classification of Epileptic Seizures, seizure‐free for ≥ 6 months Exclusion criteria: children with a history of psychiatric or other progressive neurological disorder, or a chronic haematological, cardiac, hepatic, renal, or thyroid disorder N: 31 (3 lost to follow‐up) M: 21; F: 7 Type of seizures: complex partial seizures (19); generalized tonic‐clonic seizures (6); simple partial seizures (3) Concurrent AED treatment: carbamazepine monotherapy Seizure frequency: all participants were seizure free for ≥ 6 months Duration of the trial (including follow‐up): 8 weeks
Interventions	Melatonin (fast release) compared with placebo (see text for more details)
Outcomes	Seizure freedom: participants were followed up clinically for 8 weeks during which all participants remained seizure free Adverse events: authors stated that "no adverse event warranting discontinuation of the therapy was observed" Quality of life: not evaluated systematically. Sleep quality after add‐on melatonin administration was assessed by a parental questionnaire, the SBQ
Notes	Reasons for lost to follow‐up (3 participants) were reported
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Randomization code list prepared by a statistician, not connected to the study. Computer‐generated permutation of code numbers for the treatment groups
Allocation concealment (selection bias)	Low risk	Placebo and melatonin tablets were identical in shape, size, colour, and packaging
Blinding (performance bias and detection bias) All outcomes	Unclear risk	Blinding not explicitly reported (insufficient information to permit judgement)
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Missing to follow‐up reported (the reason for 2 lost to follow‐up not reported). No intention‐to‐treat analysis
Selective reporting (reporting bias)	High risk	Each participant had a daily diary to record any adverse events or unusual symptoms observed immediately. In results section, authors only stated that "no adverse event warranting discontinuation of the therapy was observed"
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Blinding not explicitly reported (insufficient information to permit judgement)
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Blinding not explicitly reported (insufficient information to permit judgement)