Singhi 2003.
| Methods | Randomised controlled trial. Single centre in India. Total duration of trial 2‐3 years in both comparison groups. |
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| Participants | Children with NCC. Diagnostic criteria based on CT Scan findings, only single lesions included. 55 children treated with AEDs for 1 year as group A, 51 children treated for 2 years as group B. Age range: 3 to 14 years, 61 boys, 45 girls. Demographically comparable groups. Inclusion criteria: children with seizures and CT scan diagnosis of NCC. Exclusion criteria: children with multiple or calcified CT lesions, static or progressive neurological disorder, any systemic or chronic illness, any clinical or ancillary evidence of tuberculosis; 55% also received albendazole within 3 months of presentation. Follow‐up: 12 months after drug withdrawal. |
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| Interventions | AEDs for 12 months in group A and 24 months in group B. All children received monotherapy. 80% received carbamazepine, 18% received dilantin. Formulations, dosage, group‐wise distribution not stated. |
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| Outcomes | Seizure recurrence during and after drug withdrawal. Association of seizure recurrence with clinical variables (type and frequency of seizures). Association of seizure recurrence with CT and EEG abnormalities. |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Random sequence tables used for randomisation Demographic variables of children in both groups comparable Type and frequency of seizures, AEDs given, EEG and CT Scan observations detailed and comparable |
| Allocation concealment (selection bias) | Unclear risk | Not stated |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants and personnel were not blinded to the intervention. Hence, we assume here that they were also not blinded to short or long duration treatment arms. |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not stated |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Withdrawals and reasons not stated |
| Selective reporting (reporting bias) | Low risk | Study protocol not available, all expected outcomes suitably detailed in the results section |
| Other bias | High risk | Dosage of AEDs given not stated |