Anh 1995.
| Methods | Study design: An open label randomized controlled trial Study dates: Jul 1992 to May 1995 |
|
| Participants | Number: 190 enrolled Inclusion criteria: adults 15 to 65 yr with cerebral malaria (asexual P. falciparum parasitaemia and clinical signs of cerebral malaria alone or associated with other visceral complications) Exclusion criteria: associated P. vivax parasitaemia, pregnancy, and concomitant diseases such as diabetes mellitus, stroke, meningitis, head trauma, pulmonary tuberculosis, or AIDS |
|
| Interventions | 1. Artesunate: 60 mg intravenous (IV) at 0, 4, 24, and 48 h
2. Quinine: 10 mg/kg IV over 4 h at 0 h then 10 mg/kg IV every 8 h until able to swallow then quinine by mouth at similar doses every 8 h until day 7 Additional antimalarials: artesunate treatment arm given one dose of mefloquine by mouth 15 mg/kg at day 7; quinine none |
|
| Outcomes | 1. Death within 24 h
2. Death after 24 h
3. Coma recovery time
4. Fever clearance time
5. Parasite clearance time of 50%
6. Parasite clearance time of 95%
7. Parasite clearance time of 100% Not included in the review: 8. Time to sit 9. Time to take oral by self medication |
|
| Notes | Location: Vietnamese clinical research centre Transmission: not specified Funding: World Health Organization |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Personal communication with author: Central randomization |
| Allocation concealment (selection bias) | Low risk | Personal communication with author: Central randomization |
| 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 are recorded |
| Selective reporting (reporting bias) | Low risk | No evidence of selective reporting |
| Other bias | Low risk | No other bias identified |