Artemisinin-based combination therapy for ... - The Cochrane Library
Artemisinin-based combination therapy for ... - The Cochrane Library
Artemisinin-based combination therapy for ... - The Cochrane Library
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Ratcliff 2005 IDN (Continued)<br />
Risk of bias<br />
Item Authors’ judgement Description<br />
Adequate sequence generation? Yes ’A randomisation list was generated in<br />
blocks of 20 patients by an independent<br />
statistician’<br />
Allocation concealment? Yes ’With each treatment allocation concealed<br />
in an opaque sealed envelope’. No further<br />
details given.<br />
Blinding?<br />
All outcomes<br />
Incomplete outcome data addressed?<br />
All outcomes<br />
No An open label trial. <strong>The</strong> microscopists were<br />
blinded to treatment allocation.<br />
No <strong>The</strong> primary outcome data are unpublished<br />
data including only participants with P.<br />
falciparum mono or co-infection at baseline.<br />
Losses to follow up were high in both<br />
groups at day 42 (28.4 % DHA-P vs 25.6 %<br />
AL6) and moderate at day 28 (19% DHA-<br />
P vs 17.6% AL6).<br />
Free of selective reporting? Yes All WHO outcomes reported. Day 42<br />
outcomes may underestimate failure with<br />
DHA-P due to its long half-life.<br />
Free of other bias? Yes No other sources of bias identified<br />
Sagara 2005b MLI<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, 28, and any day<br />
they felt unwell. Haemoglobin on days 0, 14, and 28.<br />
Adverse event monitoring: CBC, ALT, and creatinine on 20% of participants on days 0<br />
and 14<br />
Participants Number: 470 randomized<br />
Inclusion criteria: Age > 1 yr, weight >10 kg, axillary temperature > 37.5 ºC, P.falciparum<br />
mono-infection 2000 to 200,000, resident at study site, able to take oral medication,<br />
in<strong>for</strong>med consent<br />
Exclusion criteria: Pregnancy, severe malaria, a serious underlying disease, an allergy to<br />
1 or more study drugs, use of study drugs within 28 days<br />
Interventions 1. Artemether-lumefantrine, fixed dose <strong>combination</strong>, 20 mg/120 mg tablets (Coartem:<br />
Novartis)<br />
• 5 to 14 kg 1 tablet twice daily <strong>for</strong> 3 days<br />
• 15 to 24 kg 2 tablets twice daily <strong>for</strong> 3 days<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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