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

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Mayxay 2004 LAO (Continued) Interventions 1. Dihydroartemisinin-piperaquine, fixed dose combination, 40 mg/320 mg tablets (Artekin: Holleykin) • Total dose: DHA 6.3 mg/kg + P 50.4 mg/kg in 3 divided doses, given once daily for 3 days 2. Artesunate plus mefloquine, loose combination (Artesunate: Guilin, Lariam: Roche) • AS 4 mg/kg once daily for 3 days • MQ 15 mg base/kg on day 1 and 10 mg base/kg on day 2 All doses supervized Outcomes 1. Cure rate at day 42, PCR adjusted and unadjusted 2. P. vivax during follow up 3. Adverse events Not included in the review: 1. Fever clearance time 2. Parasite clearance time 3. Gametocyte carriage after treatment Notes Country: Lao People’s Democratic Republic (Laos) Setting: District clinic Transmission: Not reported Resistance: Not reported Dates: May 2004 to Sept 2004 Funding: Western Pacific Regional office of WHO, Wellcome Trust of Great Britain, Artekin provided by Holleykin Pharmaceuticals Risk of bias Item Authors’ judgement Description Adequate sequence generation? Unclear ’Randomized in blocks of 10’. No further details given. Allocation concealment? Yes ’The treatment choice was kept in a sealed opaque envelope, which was opened only after the decision to recruit’ Blinding? All outcomes Incomplete outcome data addressed? All outcomes No An open-label trial. No comment on blinding of laboratory staff. Yes Low losses to follow up in both groups (3.6% DHA-P vs 1.8% AS+MQ) Free of selective reporting? Yes The WHO recommends 63 days follow up in studies of AS+MQ. Day 42 outcomes are likely to overestimate the efficacy of the 2 drugs. 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. 78
Menard 2006 MDG Methods Trial design: A 5-arm single blind (outcome assessors) randomized controlled trial Follow up: Patients returned for malaria films on days 0, 1, 2, 3, 7, 14, 21, 28, and any other day they felt ill. Haemoglobin was assessed on days 0 and 28. Adverse event monitoring: Not described Participants Number: 166 randomized to included treatment arms Inclusion criteria: Age 6 months to 15 yrs, weight > 5 kg, axillary temp > 37.5 ºC, P. falciparum mono-infection 1000 to 200,000/µl, informed consent Exclusion criteria: Danger signs, severe or complicated malaria, febrile conditions other than malaria, severe malnutrition, severe anaemia (Hb < 5 g/dl), development of concomitant disease which could interfere with study outcome, known hypersensitivity to the study drugs, repeated vomiting of the first dose Interventions 1. Artesunate plus amodiaquine • AS 4 mg/kg once daily for 3 days • AQ 10 mg/kg once daily for 3 days 2. Amodiaquine plus sulfadoxine-pyrimethamine, loose combination • AQ 10 mg/kg once daily for 3 days • SP 25/1.25 mg/kg once on the first day All doses supervized Outcomes 1. ACPR at day 28, PCR adjusted and unadjusted 2. Gametocyte carriage at days 0, 7, 14, 21, and 28 3. Mean increase in haemoglobin by day 28 4. Adverse events Not included in the review: 1. Fever clearance 2. Parasite clearance Notes Country: Madagascar Setting: Primary health centres Transmission: Low and predominantly seasonal Resistance: CQ resistance Dates: Feb 2006 to June 2006 Funding: Natixis, the Global Fund to Fight AIDS, Tuberculosis and Malaria, and the IAEA project Risk of bias Item Authors’ judgement Description Adequate sequence generation? Yes ’Randomization was in blocks of 5’. Drawing numbered papers from a box (additional detail from author). Allocation concealment? Yes ’Treatment regimens were allocated by an independent individual not involved in the analysis of the study’ Artemisinin-based combination therapy for treating uncomplicated malaria (Review) Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. 79
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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 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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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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