Singhi 2003.
Methods | Randomized controlled trial Duration: recruitment from June 1999 to June 2000. Participants were followed up for 12 months. |
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Participants | Number: 147 randomized, 122 included in the analysis (68 male, 54 female) Inclusion criteria: children with seizures for less than 3 months and up to 3 small enhancing lesions in parenchyma Exclusion criteria: raised intracranial pressure, focal neurological deficit, neurodevelopmental delay, any chronic systemic disease, other lesions on imaging, evidence of tuberculosis Type of lesion: non‐viable |
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Interventions | Group 1. Oral prednisolone: 2 mg per kg once daily for 5 days plus 15 mg per kg per day albendazole for 4 weeks starting 2 days after prednisolone started Group 2. Oral prednisolone: 2 mg per kg once daily for 5 days plus 15 mg per kg per day albendazole for 1 week starting 2 days after prednisolone started | |
Outcomes | Included in the review: persistence of lesions at 1 month; recurrence of seizures within 12 months; epigastric discomfort with treatment Not included in the review: lesion size reduced at 6 months |
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Notes | Location: India Source of funding: not stated |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Adequate sequence generation? | Low risk | Quote: "...they were randomized according to random number tables..." Decision: done |
Allocation concealment? | Unclear risk | Not described Decision: unclear |
Blinding? All outcomes | Low risk | Quote: "None of the persons involved in the study (i.e. patient, investigators and neuroradiologist) was aware of this random allocation. The code was opened only after completion of the study" Decision: done |
Incomplete outcome data addressed? All outcomes | High risk | 147 randomized, 25 excluded due to poor compliance with treatment or inadequate follow up (83% included in the analysis). No discussion of the differences between participants included in the analysis and those excluded. |
Free of selective reporting? | Low risk | No evidence of selective reporting |
Free of other bias? | Low risk | No evidence of other bias |