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

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Stohrer 2003 LAO (Continued)<br />

Allocation concealment? Unclear ’A sealed envelope was opened which assigned<br />

patients to one of the two treatment<br />

arms’. No further details given.<br />

Blinding?<br />

All outcomes<br />

Incomplete outcome data addressed?<br />

All outcomes<br />

No An open label trial. No comment on blinding<br />

of laboratory staff, quality control was<br />

conducted by rechecking malaria films by<br />

expert microscopists.<br />

Yes Disproportionate losses to follow up<br />

(11.3% AL6 vs 3.6% AS+MQ) but unlikely<br />

to have affected the overall result<br />

Free of selective reporting? Yes <strong>The</strong> WHO recommends 63 days follow up<br />

in studies of AS+MQ. Day 42 outcomes<br />

may overestimate the efficacy of AS+MQ.<br />

Free of other bias? Yes No other sources of bias identified<br />

Swarthout 2004 ZAR<br />

Methods Trial design: An open label randomized controlled trial<br />

Follow up: Examination and malaria film on days 0, 1, 2, 3, 7, 14, 21, and 28, or other<br />

times if they were unwell<br />

Adverse event monitoring: Parents and guardians were asked about tolerability and potential<br />

side effects of the drugs<br />

Participants Number: 180 randomized<br />

Inclusion criteria: Age 6 to 59 months, symptoms suggestive of malaria, P. falciparum<br />

mono-infection 2000 to 200,000/µl, able to take the study drugs orally, able to attend<br />

follow up, in<strong>for</strong>med consent<br />

Exclusion criteria: Severe or complicated malaria, concomitant disease that could mask<br />

response to antimalarial treatment, known hypersensitivity to any of the study drugs<br />

Interventions 1. Artesunate plus amodiaquine<br />

• No dosing details given<br />

2. Artesunate plus sulfadoxine-pyrimethamine<br />

• No dosing details given<br />

All doses supervized<br />

Outcomes 1. Failure rate at day 28, PCR adjusted and unadjusted<br />

2. Gametocytaemia during follow up<br />

3. <strong>The</strong> percentage of participants with mild and moderate anaemia during follow up<br />

4. Adverse events<br />

Not included in the review:<br />

1. Fever clearance<br />

2. Parasite clearance<br />

<strong>Artemisinin</strong>-<strong>based</strong> <strong>combination</strong> <strong>therapy</strong> <strong>for</strong> treating uncomplicated malaria (Review)<br />

Copyright © 2009 <strong>The</strong> <strong>Cochrane</strong> Collaboration. Published by John Wiley & Sons, Ltd.<br />

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