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

Mutabingwa 2004 TZA (Continued)
• AS 4 mg/kg/day for 3 days
• AQ 10 mg/kg on days 0 and 1 and 5 mg/kg on day 2
3. Amodiaquine plus sulfadoxine-pyrimethamine, loose combination (Sanofi, Roche)
• AQ 10 mg/kg on days 0 and 1 and 5 mg/kg on day 2
• SP 25/1.25 mg/kg on day 0
All doses unsupervized
Outcomes 1. Parasitological failure at day 28 PCR unadjusted
2. Mean change in haemoglobin from baseline day 14
3. Adverse events
Not included in the review:
1. PCR corrected data (only conducted for 1 year of the trial and we were unable to
adequately extract attrition data)
2. Gametocytes during follow up (no baseline data)
Notes Country: Tanzania
Setting: Maternal and child health clinic
Transmission: Very high
Resistance: High level CQ and SP resistance
Dates: Sept 2002 to Oct 2004
Funding: Gates Malaria Partnership. AS+AQ donated by Sanofi. AL6 donated by WHO
Risk of bias
Item Authors’ judgement Description
Adequate sequence generation? Yes ’Randomization was done by computer
(Stata Version 6), with blocks of variable
sizes’
Allocation concealment? Yes ’Treatment allocations were put into
opaque, sealed and countersigned, sequentially
numbered envelopes’
Blinding?
All outcomes
Incomplete outcome data addressed?
All outcomes
No Malaria films were read by 2 different laboratories
unaware of treatment allocation.
No other blinding is reported.
Yes Losses to follow up were low in all groups
(6.5% AL6 vs 8.3% AS+AQ vs 8.7%
AQ+SP)
Free of selective reporting? No No baseline data is given on gametocytes.
PCR data is only given for 1 year of the
trial. It is not possible to calculate attrition
for this period.
Free of other bias? Yes No other sources of bias identified
Artemisinin-based combination therapy for treating uncomplicated malaria (Review)
Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
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