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

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Guthmann 2003 AGO (Continued) Risk of bias September to April Resistance: CQ and SP resistance Dates: March 2003 to July 2003 Funding: Médecins sans Frontières Item Authors’ judgement Description Adequate sequence generation? Unclear ’Randomly allocated in blocks of 20’. Due to technical problems randomization only started after the first 30 patients had been enrolled. Allocation concealment? No ’Without a concealment procedure’ Blinding? All outcomes Incomplete outcome data addressed? All outcomes No No comment on blinding. External quality control on a random sample of malaria films was conducted. No 3 times as many withdrawals in AS+AQ group vs AS+SP (12% vs 4%). Reasons for this disparity are not given. Free of selective reporting? Yes Only PCR adjusted results given, PCR unadjusted is unpublished data Free of other bias? Yes No other sources of bias identified Guthmann 2004 AGO Methods Trial design: A randomized controlled trial Follow up: Days 0, 1, 2, 3, 7, 14, 21, and 28, for a clinical assessment and malaria film. Haemoglobin and gametocyte measurement on days 0 and 28. Adverse event monitoring: Not described Participants Number: 137 randomized Inclusion criteria: Age 6 to 59 months, confirmed clinical P. falciparum malaria, informed consent Exclusion criteria: As per WHO 2003 protocol Interventions 1. Artemether-lumefantrine, fixed dose combination, 20 mg/120 mg tablets (Coartem: Novartis) • Twice daily for 3 days as per manufacturers guidance 2. Artesunate plus amodiaquine, loose combination (Arsumax: Sanofi-Aventis, Camoquin: Parke-Davis) • AS 4 mg/kg once daily for 3 days • AQ 10 mg/kg once daily for 3 days Artemisinin-based combination therapy for treating uncomplicated malaria (Review) Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. 58
Guthmann 2004 AGO (Continued) All doses supervized Outcomes 1. Recurrent parasitaemia at day 28, PCR adjusted and unadjusted 2. Prevalence of anaemia at days 0 and 28 3. Early vomiting Not included in the review: 1. Gametocytes on days 0 and 28 Notes Country: Angola Setting: Health centre Transmission: High transmission, mesoendemic Resistance: CQ and SP resistance Dates: Apr 2004 to Jul 2004 Funding: Médecins sans Frontières, The American Society of Tropical Medicine and Hygiene (ASTMH) and the American Committee on Clinical Tropical Medicine and Travelers’ Health (ACCTMTH) Risk of bias Item Authors’ judgement Description Adequate sequence generation? Unclear Described as ’randomized’ but no other details Allocation concealment? No None described Blinding? All outcomes Incomplete outcome data addressed? All outcomes No Blinding not mentioned. 100 malaria films were checked by an independent laboratory Yes Losses to follow up low in both groups (6.2% AL6 vs 7.2% AS+AQ) Free of selective reporting? Yes The WHO recommends 42 days follow up in studies of AL6. Day 28 outcomes may under estimate treatment failure with AL6. Free of other bias? Yes No other sources of bias identified Hamour 2003 SDN Methods Trial design: An open label randomized controlled trial Follow up: Reassessed clinically and parasitologically on days 0, 1, 2, 3, 7, 14, 21, and 28 Adverse event monitoring: Not described Participants Number: 161 randomized Inclusion criteria: Age 6 to 59 months, weight > 5 kg, axillary temp > 37.5 ºC, P. falciparum mono-infection 2000 to 200,000/µml, informed consent Exclusion criteria: Signs of severe malaria, concomitant febrile conditions except mild Artemisinin-based combination therapy for treating uncomplicated malaria (Review) Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. 59
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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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D A T A A N D A N A L Y S E S Compa
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2.2 Asia 1 317 Risk Ratio (M-H, Fix
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Comparison 5. Dihydroartemisinin-pi
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5.2 DHA-P 3 doses 3 1116 Risk Ratio
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Comparison 21. How does Artesunate
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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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Artemether-lumefantrine vs Artesuna
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(Continued) Faye 2003 SEN (521 part
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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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