Foyaca‐Sibat 2001.
Study characteristics | ||
Methods | Type of study: randomized controlled trial Duration: participants followed up for 1 month, enrolled over a 2‐year period, dates not stated |
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Participants | Number: 163 enrolled, data available for 143 after exclusions but before loss to follow‐up (65 male, 68 female) Inclusion criteria: uncontrolled epilepsy probably due to neurocysticercosis, active/chronic forms of neurocysticercosis after CT, without signs of raised intracranial pressure Exclusion criteria: previous history of neurological disease apart from epilepsy, metabolic disorders, cerebrovascular disease, meningoencephalitis, head injury, immunomodulatory agents received in the previous 6 months, alternative cause for intracranial calcification, suspicion of tuberculoma/pyogenic brain abscess/mycotic granuloma, primary or metastatic brain tumour, uncontrollable tonic‐clonic generalized motor seizures despite regular phenytoin 300 mg at night Types of lesion: viable or non‐viable cysts, or both Position of lesions: not stated Number of lesions: not stated |
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Interventions | Group 1. Praziquantel 100 mg/kg daily in 4 divided doses for 1 day with prednisolone 40 mg daily for 5 days Group 2. No praziquantel or prednisolone All groups: phenytoin 400 mg once at night for 5 days (all) |
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Outcomes | Included in meta‐analysis: none Included in narrative only: seizure recurrence, frequency of seizures |
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Notes | Location: South Africa Source of funding: not stated |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "...by block‐randomization procedure." |
Allocation concealment (selection bias) | Unclear risk | Not described |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "The study was designed as a double blind, randomized trial..." |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "The study was designed as a double blind, randomized trial..." |
Incomplete outcome data (attrition bias) All outcomes | High risk | 163 participants randomized: 34 lost to follow‐up, 129 (79%) included in the analysis. |
Selective reporting (reporting bias) | Low risk | No evidence of selective reporting |
Other bias | Low risk | No evidence of other bias |