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

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Fanello 2004 RWA (Continued) Allocation concealment? Unclear ’Allocation of treatment was concealed from both the doctor and the patient, until final recruitment of the patient’. Method not described. Blinding? All outcomes Incomplete outcome data addressed? All outcomes No An open-label trial. ’Laboratory technicians reading malaria slides did not know the treatment received by individual patients’ Yes Low losses to follow up (2% AL6 vs 0.8% AQ+SP) Free of selective reporting? Yes The WHO recommends 42 days follow up in studies of AL6. Day 28 outcomes may overestimate the efficacy of AL6. Free of other bias? Yes No other sources of bias identified Faye 2003 SEN Methods Trial design: A 5-arm, open-label randomized controlled trial Follow up: Days 0, 1, 2, 7, 14, 21, and 28 for a clinical examination and malaria film Adverse event monitoring: All side effects were monitored actively and passively during the study. 25% randomly selected for blood counts, liver, and renal function tests at days 0, 14, and 28. Participants Number: 815 randomized into included treatment arms Inclusion criteria: ’as per WHO 2002 protocol’ Exclusion criteria: ’as per WHO 2002 protocol’ Interventions 1. Artemether-lumefantrine, fixed dose combination, 20 mg/120 mg tablets (Coartem: Novartis) • Twice daily dosing for 3 days • Exact dosing regimen not specified 2. Artesunate plus mefloquine, co-blistered (Artequine: Mepha) • Adults: AS 200 mg/day plus MQ 250 mg/day for 3 days • Children: AS 100 mg/day plus MQ 125 mg/day for 3 days 3. Artesunate plus amodiaquine, co-blistered (Arsucam: Sanofi-Aventis) • AS 4 mg/kg/day for 3 days • AQ 10 mg/kg/day for 3 days 4. Amodiaquine plus sufadoxine-pyrimethamine (Pharmacie Nationale d’Approvisionnement d Senegal) • AQ 10 mg/kg/day for 3 days • Plus half a tablet of SP per 10 kg as a single dose All doses supervized Artemisinin-based combination therapy for treating uncomplicated malaria (Review) Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. 54
Faye 2003 SEN (Continued) Outcomes 1. Day 28 ACPR PCR adjusted and unadjusted 2. Gametocyte carriage at days 0, 7, 14, 28 3. Anaemia (Hb < 12) days 0, 14 4. Adverse events Notes Country: Senegal Setting: Healthcare centres Transmission: Moderate with a peak in the rainy season Resistance: High levels of chloroquine resistance Dates: The transmission periods of 2002 and 2003 Funding: Study drugs supplied by Sanofi-Aventis, Mepha, and Novartis Risk of bias Item Authors’ judgement Description Adequate sequence generation? Unclear Not described. Only described as ’randomized’ Allocation concealment? No None described Blinding? All outcomes Incomplete outcome data addressed? All outcomes No An open label trial. No comment on blinding of lab staff Yes Losses to follow up were not reported in the original paper and figures were only given as percentages. Unpublished data reveal loss to follow up as low in all groups (3.1% AS+AQ, 0.7% AS+MQ, 1.3% AL6, 3.1% AQ+SP). Free of selective reporting? Yes The WHO recommend 42 days follow up for studies involving AL6 and 63 days for AS+MQ. Day 28 outcomes may underestimate treatment failure with AL6 and AS+MQ. 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. 55
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Analysis 2.2. Comparison 2 Dihydroa
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Analysis 10.5. Comparison 10 Arteme
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[Intervention Review] Artemisinin-b
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Analysis 20.1. Comparison 20 How do
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PCR = polymerase chain reaction PCV
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(Continued) justed Vivax efficacy:
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1 Dorsey 2006 UGA; Faye 2003 SEN; K
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