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

Zongo 2005 BFA (Continued)
Risk of bias
Item Authors’ judgement Description
Adequate sequence generation? Yes ’Computer-generated randomisation lists’
Allocation concealment? No None described
Blinding?
All outcomes
Incomplete outcome data addressed?
All outcomes
Yes ’Investigators responsible for classification
of treatment outcomes were unaware of
treatment assignment’. Placebos were used
and participants not informed of allocation.
Yes Mildly disparate losses to follow up (6.1%
AL6 vs 10.4% AQ+SP), unlikely to have
affected overall result
Free of selective reporting? Yes The WHO recommends 42 days follow up
in studies of AL6. Day 28 outcomes may
under estimate treatment failure with AL6
and DHA-P.
Free of other bias? Yes No other sources of bias identified
Zongo 2007 BFA
Methods Trial design: A 3-arm randomized controlled trial
Follow up: A standardized history, examination, and malaria film on days 0, 1, 2, 3,
7, 14, 21, 28, 35, and 42. Haemoglobin measured on days 0 and 42 or day of clinical
failure. Children with Hb < 10 g/dl were treated with ferrous sulphate and antihelminthic
treatment.
Adverse event monitoring: Assessed at each visit. Adverse events defined as untoward
medical occurrences.
Participants Number: 580 randomized
Inclusion criteria: Age > 6 months, weight > 5 kg, axillary temp > 37.5 ºC or history of
fever in the last 24 hours, P. falciparum mono-infection 2000 to 200,000/µl, the ability
to participate in 42 days follow up, informed consent
Exclusion criteria: Danger signs or signs of severe malaria, history of serious adverse
effects related to study meds, evidence of concomitant febrile illness, antimalarial use
other than chloroquine in previous 2 weeks, haemoglobin < 5 g/dl
Interventions 1. Dihydroartemisinin-piperaquine, fixed dose combination, 40 mg/320 mg tablets (
Duocotexin: HolleyPharm)
• Total dose: DHA 6.4 mg/kg + PQP 51.2 mg/kg in 3 divided doses, given once
daily for 3 days
2. Artemether-lumefantrine, fixed dose combination, 20 mg/120 mg tablets (Coartem:
Artemisinin-based combination therapy for treating uncomplicated malaria (Review)
Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
104