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

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Menard 2006 MDG (Continued) Blinding? All outcomes Incomplete outcome data addressed? All outcomes Yes ’All other study personnel were blinded to the treatment assignments, and patients not informed of their treatment regimen’ Yes Low losses to follow up in both groups (8.4% AS+AQ vs 4.8% AQ+SP) Free of selective reporting? Yes All WHO outcomes reported Free of other bias? Yes No other sources of bias identified Mens 2007 KEN Methods Trial design: An open label randomized controlled trial Follow up: Malaria film and haemoglobin level on days 0, 1, 2, 3, 7, 14, and 28, plus QT-NASBA for detection of sub-microscopic gametocytaemia Adverse event monitoring: Adverse events were recorded at each visit in the case record form. An adverse event defined as any unfavourable and unintended sign. Participants Number: 146 randomized Inclusion criteria: Age 6 months to 12 years, axillary temp > 37.5 ºC or history of fever, P. falciparum mono-infection 1000 to 200,000/µl, informed consent Exclusion criteria: Severe malaria, any other underlying illness Interventions 1. Dihydroartemisinin-piperaquine, fixed dose combination, 20 mg/160 mg tablets ( Sigma-Tau) • 4 to 7 kg 1/2 tablet once daily for 3 days • 7 to 13 kg 1 tablet once daily for 3 days • 13 to 24 kg 2 tablets once daily for 3 days • 24 to 35 kg 4 tablets once daily for 3 days 2. Artemether-lumefantrine, fixed dose combination, 20/120 mg tablets (Novartis) • 5 to 14 kg 1 tablet twice daily for 3 days • 15 to 24 kg 2 tablets twice daily for 3 days • 25 to 34 kg 3 tablets twice daily for 3 days All doses supervized and given with a glass of milk Outcomes 1. Recurrent parasitaemia at day 28, PCR adjusted and unadjusted 2. Gametocyte prevalence during follow up 3. Mean haemoglobin at day 28 4. Adverse events Not included in this review: 1. Fever clearance 2. Parasite clearance Notes Country: Kenya Setting: Health centre Transmission: High transmission Resistance: Not reported Artemisinin-based combination therapy for treating uncomplicated malaria (Review) Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. 80
Mens 2007 KEN (Continued) Risk of bias Dates: Apr 2007 to July 2007 Funding: The Knowledge and Innovation Fund, Koninklijk Instituut voor de Tropen/ Royal Tropical Institute. DHA-P provided free of charge by Sigma-Tau. Item Authors’ judgement Description Adequate sequence generation? Yes ’A computer generated randomisation list’ Allocation concealment? No None described Blinding? All outcomes Incomplete outcome data addressed? All outcomes No Microscopists were blinded to treatment allocation. No other blinding described. Yes Low losses to follow up in both groups (8.2% DHA-P vs 8.2% AL6) Free of selective reporting? Yes The WHO recommends 42 days follow up in studies of AL6. Day 28 outcomes may underestimate treatment failure with AL6 and DHA-P. Free of other bias? Yes No other sources of bias identified Mukhtar 2005 SDN Methods Trial design: A randomized controlled trial Follow up: On days 0, 1, 2, 3, 7, 14, 21, and 28. A malaria film taken at each visit Adverse event monitoring: None described Participants Number: 160 randomized Inclusion criteria: All age groups, as per WHO protocol 2003 Exclusion criteria: As per WHO protocol 2003 Interventions 1. Artemether-lumefantrine, fixed dose combination, 20 mg/120 mg tablets (Coartem: Novartis) • Dosing details not given 2. Artesunate plus sulfadoxine-pyrimethamine, loose combination • Dosing details not given Only first dose of each day was supervized Outcomes 1. ACPR at day 28, PCR adjusted and unadjusted Notes Country: Sudan Setting: 3 villages in eastern Sudan Transmission: Low endemicity Resistance: CQ and SP resistance Artemisinin-based combination therapy for treating uncomplicated malaria (Review) Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. 81
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Artemisinin-based combination thera
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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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B A C K G R O U N D Malaria is a di
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drugs and the treatment comparisons
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this analysis into participants who
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Figure 1. Methodological quality su
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confidence intervals of the estimat
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Anaemia Hasugian 2005 IDN found tha
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Three trials report significantly m
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or those treated for P. vivax at ba
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Early vomiting Not reported. D I S
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Analysis 1.12. Comparison 1 Dihydro
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Analysis 6.6. Comparison 6 Artesuna
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Analysis 9.2. Comparison 9 Artemeth
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Analysis 12.2. Comparison 12 Artesu
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Analysis 14.2. Comparison 14 Dihydr
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Analysis 20.1. Comparison 20 How do
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Analysis 21.1. Comparison 21 How do
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(Continued) 2. How does artesunate
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(Continued) Sensitivity analysis 1
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(Continued) Smithuis 2004 MMR (652
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Dihydroartemisinin-piperaquine vs A
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(Continued) Zongo 2005 BFA (521 par
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PCR = polymerase chain reaction PCV
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(Continued) Proportion with anaemia
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(Continued) Efficacy: Total Failure
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Footnotes 1 Data were also availabl
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8 Very serious imprecision: There w
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(Continued) justed Vivax efficacy:
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(Continued) Harms: Serious adverse
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(Continued) Harms: Early vomiting -
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1 Dorsey 2006 UGA; Faye 2003 SEN; K
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