Anh 1989.
Methods | Study design: An open label randomized controlled trial Study dates: Feb to Dec 1989 |
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Participants | Number: 41 enrolled Inclusion criteria: adults > 16 yr old with cerebral malaria (P. falciparum parasitaemia > 1000/mm3 and Glasgow Coma Scale of 14 or less not attributable to any cause other than malaria) Exclusions: not specified |
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Interventions | 1. Artesunate: 60 mg intravenous (IV) at 0, 4, 24, and 48 h
2. Quinine: 20 mg/kg IV loading dose over 4 h at 0 h then 10 mg/kg IV every 8 h until able to swallow then 10 mg/kg by mouth every 8 h until day 7 Additional antimalarials: none reported |
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Outcomes | 1. Death 2. Coma recovery time 3. Parasite clearance time of 50% 4. Parasite clearance time of 95% | |
Notes | Location: Vietnamese hospital Transmission: not specified Funding: Roche Asian Research Foundation supplied artesunate (personal communication from author) |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Personal communication with author: Random numbers table |
Allocation concealment (selection bias) | High risk | Comment: Not done |
Blinding (performance bias and detection bias) Objective outcomes: Death | Low risk | Comment: An open‐label trial is unlikely to bias an objective outcome like death |
Blinding (performance bias and detection bias) Subjective outcomes: Others | High risk | Comment: An open label trial. No attempt was made to blind participants, providers or outcome assessors |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No losses to follow‐up occurred |
Selective reporting (reporting bias) | Low risk | No evidence of selective reporting |
Other bias | Low risk | No other bias identified |