Artemisinin-based combination therapy for ... - The Cochrane Library

Bonnet 2004 GIN (Continued)
Item Authors’ judgement Description
Adequate sequence generation? Yes ’A randomization list with a block size
of 20 was electronically generated by the
methodological center (Epicentre, Paris)’
Allocation concealment? Yes ’Sealed opaque envelopes corresponding to
each inclusion number, and containing the
name of the allocated treatment regimen,
were prepared before the study started.’ (
Additional information from authors)
Blinding?
All outcomes
Incomplete outcome data addressed?
All outcomes
No No comment on blinding. A random sample
of 92 slides were cross-checked by an
independent technician.
Yes Low loss to follow up in both groups (2.7%
AS+AQ vs 3.6% AS+SP)
Free of selective reporting? Yes All WHO outcomes reported
Free of other bias? Yes No other sources of bias identified
Bousema 2004 KEN
Methods Trial design: A 3-arm, single blind (outcome assessors) randomized controlled trial
Follow up: Days 0, 1, 2, 3, 7, 14, and 28 or any other day they became ill
Adverse event monitoring: None described
Participants Number: 376 randomized to included treatment arms
Inclusion criteria: Age 6 months to 10 yrs, temp > 37.5 ºC or history of fever, P. falciparum
mono-infection > 500/µl. Additionally for AL group: weight > 10 kg and living < 5 km
from the clinic.
Exclusion criteria: Signs of severe malaria, inability to take meds orally, evidence of
chronic disease or an acute infection other than malaria, known hypersensitivity to any of
the study drugs, reported treatment with antimalarials in the previous 2 weeks, resident
outside of study area
Interventions 1. Artemether-lumefantrine, fixed dose combination, 20 mg/120 mg tablets (Coartem:
Novartis)
• 1/2 tablet per 5 kg bodyweight twice daily for 3 days
2. Artesunate plus sulfadoxine-pyrimethamine, loose combination (Arsumax: Sanofi-
Aventis, Fansidar: Roche)
• AS 4 mg/kg once daily for 3 days
• SP 25/1.25 mg/kg as a single dose
3. Amodiaquine plus sulfadoxine-pyrimethamine, loose combination (Camoquine:
Pfizer, Fansidar: Roche)
• AQ 10 mg/kg once daily for 3 days
Artemisinin-based combination therapy for treating uncomplicated malaria (Review)
Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
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