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

Van den Broek 2004 ZAR (Continued)
Outcomes 1. Recurrent parasitaemia at day 28, PCR adjusted and unadjusted
2. Gametocyte carriage at days 0 and 28
3. Changes in haemoglobin during follow up
4. Adverse events
Not included in the review:
1. Fever clearance
2. Parasite clearance
Notes Country: Republic of Congo
Setting: Health centre
Transmission: Holoendemic with a peak in the rainy seasons
Resistance: CQ, SP, and AQ resistance
Dates: May 2004 to Oct 2004
Funding: Médecins sans Frontières (Holland)
Risk of bias
Item Authors’ judgement Description
Adequate sequence generation? Yes ’Randomized to the three treatments by a
random number list’ (information from author)
Allocation concealment? No Allocation was not concealed (information
from author)
Blinding?
All outcomes
Incomplete outcome data addressed?
All outcomes
No An open label trial. 10% of malaria films
were cross-checked by external laboratories.
Yes Low losses to follow up in all groups (5.7%
AL6 vs 4% AS+AQ vs 6.6% AS+SP). A
significant number of PCR samples were
indeterminate or missing which may affect
the result.
Free of selective reporting? Yes The WHO recommends 42 days follow up
in studies of AL6. Day 28 outcomes may
underestimate the failure rate with AL6.
Free of other bias? No Due to differing inclusion criteria for the 3
arms children in the AL6 group were older,
heavier and had higher Hb levels at baseline.
This may improve outcome in this
group and consequently the AL6 arm was
excluded from this review.
Artemisinin-based combination therapy for treating uncomplicated malaria (Review)
Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
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