Garcia 2004.
Methods | Randomized controlled trial Duration: recruitment between January 1997 and March 1999. Follow up for 6 months. |
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Participants | Number: 120 enrolled (61 male, 59 female) Inclusion criteria: adults with fewer than 20 viable parenchymal cysts plus 1 or more seizures in the previous 6 months Exclusion criteria: primary generalized seizures, history of antiparasitic treatment, evidence on CT of other diseases, moderate or severe intracranial hypertension, status epilepticus, focal neurological deficits, unstable vital signs, impending risk of death, or pregnancy. Type of lesion: viable |
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Interventions | Group 1. Albendazole: 400 mg every 12 hours and 2 mg dexamethasone every 8 hours for 10 days Group 2. Placebos | |
Outcomes | Included in the review: recurrence of seizures during months 2 to 30; partial seizures in month 1, months 2 to 12 and months 13 to 30, and following tapering of anti‐epileptic drugs; seizures with generalization in month 1, months 2 to 12 and months 13 to 30, and following tapering of anti‐epileptic drugs; number of cysts at baseline and 6 months; persistence of seizures at 6 months; adverse events associated with treatment | |
Notes | Location: Peru Source of funding: not stated |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Adequate sequence generation? | Low risk | Random assignment in blocks of 6 according to a pre‐established list taken from a random‐numbers table |
Allocation concealment? | Low risk | Randomization performed from remote site by a statistician not otherwise involved in the study. All drugs and placebos were administered by the study personnel, who received them in sealed, opaque, sequentially numbered envelopes |
Blinding? All outcomes | Low risk | Blinded all study participants and personnel |
Incomplete outcome data addressed? All outcomes | Low risk | 120 randomized, 116 received study medication, 2 were excluded from the analysis, 14 lost to follow up (100/120 = 83%). The reasons for all withdrawals were clearly documented. |
Free of selective reporting? | Low risk | No evidence of selective reporting |
Free of other bias? | Low risk | No evidence of other bias |