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

Smithuis 2004 MMR (Continued)
Risk of bias
Dates: Nov 2003 to Feb 2004
Funding: Médecins sans Frontières (Holland)
Item Authors’ judgement Description
Adequate sequence generation? Yes Unmarked and sealed envelopes, containing
the treatment allocation were drawn
from a box
Allocation concealment? Unclear ’Unmarked and sealed envelopes’. No further
details given.
Blinding?
All outcomes
Incomplete outcome data addressed?
All outcomes
No An open label trial. No comment on blinding
of laboratory staff.
Yes Very low losses to follow up in both groups
Free of selective reporting? Yes The WHO recommends 63 days follow up
in studies of AS+MQ. Day 42 outcomes
are likely to overestimate the efficacy of the
2 drugs.
Free of other bias? Yes No other sources of bias identified
Staedke 2003 UGA
Methods Trial design: An open label randomized controlled trial
Follow up: A standardized history and examination and malaria film on days 1, 2, 3, 7,
14, 21, and 28 or other times if they were unwell. Haemoglobin was measured on days
0, 7, and 28.
Adverse event monitoring: Assessed at each visit. Neurological assessment on days 0, 7,
14, and 28. Complete blood count, creatinine, and alanine transferase on days 0, 7, and
28.
Participants Number: 278 randomized into included treatment arms
Inclusion criteria: Age 6 months to 10 yrs, tympanic temp > 38.0 ºC or febrile symptoms
in previous 48 hrs, P. falciparum mono-infection 500 to 200,000/µl, willingness to
participate in 28 day follow up, informed consent
Exclusion criteria: Danger signs, severe malaria, alternative diagnosis for febrile illness,
antifolate use in the previous 4 weeks, history of serious side effects to any of the study
drugs, severe anaemia (Hb < 5 g/dl)
Interventions 1. Amodiaquine plus sulfadoxine-pyrimethamine, loose combination
• AQ 10 mg/kg on days 0 and 1 and 5 mg/kg on day 2
• SP 25/1.25 mg/kg once on day 0
Artemisinin-based combination therapy for treating uncomplicated malaria (Review)
Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
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