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

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Mukhtar 2005 SDN (Continued) Risk of bias Dates: Oct to Dec in 2004 and 2005 Funding: National Centre for Research, drugs provided by Novartis, Amipharma and the national Malaria Control Programme Item Authors’ judgement Description Adequate sequence generation? Unclear ’A simple random technique of a hat draw’ Allocation concealment? No None described Blinding? All outcomes Incomplete outcome data addressed? All outcomes No No details of blinding given. Malaria films were read by 2 independent microscopists. Yes Low losses to follow up in both groups (0% AL6 vs 3.8% AS+SP) Free of selective reporting? Yes The WHO recommends 42 days follow up in studies of AL6. Day 28 outcomes may under estimate the failure rate of AL6. Free of other bias? No In general details of the trial were limited. Very few baseline data given and no detail on drug regimens. Mutabingwa 2004 TZA Methods Trial design: A 4-arm, randomized controlled trial Follow up: Participants were assessed clinically and by malaria film on days 0, 14, and 28 or any other day they were unwell Adverse event monitoring: Parents or guardians were asked to report on side effects, tolerability, and usefulness of the treatment Participants Number: 1541 randomized into included treatment arms Inclusion criteria: Age 4 to 59 months, symptoms suggestive of malaria, P. falciparum > 2000/µl, able to take oral meds, able to attend clinic for follow up, informed consent Exclusion criteria: Mixed infections, severe or complicated malaria, concomitant disease masking assessment of the response to treatment, intake of antimalarials other than CQ within the past 7 days, known hypersensitivity to any of the study drugs Interventions 1. Artemether-lumefantrine, fixed dose combination, 20 mg/120 mg tablets (Coartem: Novartis) • 10 to 15 kg 1 tablet twice daily for 3 days • 15 to 25 kg 2 tablets twice daily for 3 days • 25 to 35 kg 3 tablets twice daily for 3 days • > 35 kg 4 tablets twice daily for 3 days 2. Artesunate plus amodiaquine, co-blistered/loose (Sanofi) Artemisinin-based combination therapy for treating uncomplicated malaria (Review) Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. 82
Mutabingwa 2004 TZA (Continued) • AS 4 mg/kg/day for 3 days • AQ 10 mg/kg on days 0 and 1 and 5 mg/kg on day 2 3. Amodiaquine plus sulfadoxine-pyrimethamine, loose combination (Sanofi, Roche) • AQ 10 mg/kg on days 0 and 1 and 5 mg/kg on day 2 • SP 25/1.25 mg/kg on day 0 All doses unsupervized Outcomes 1. Parasitological failure at day 28 PCR unadjusted 2. Mean change in haemoglobin from baseline day 14 3. Adverse events Not included in the review: 1. PCR corrected data (only conducted for 1 year of the trial and we were unable to adequately extract attrition data) 2. Gametocytes during follow up (no baseline data) Notes Country: Tanzania Setting: Maternal and child health clinic Transmission: Very high Resistance: High level CQ and SP resistance Dates: Sept 2002 to Oct 2004 Funding: Gates Malaria Partnership. AS+AQ donated by Sanofi. AL6 donated by WHO Risk of bias Item Authors’ judgement Description Adequate sequence generation? Yes ’Randomization was done by computer (Stata Version 6), with blocks of variable sizes’ Allocation concealment? Yes ’Treatment allocations were put into opaque, sealed and countersigned, sequentially numbered envelopes’ Blinding? All outcomes Incomplete outcome data addressed? All outcomes No Malaria films were read by 2 different laboratories unaware of treatment allocation. No other blinding is reported. Yes Losses to follow up were low in all groups (6.5% AL6 vs 8.3% AS+AQ vs 8.7% AQ+SP) Free of selective reporting? No No baseline data is given on gametocytes. PCR data is only given for 1 year of the trial. It is not possible to calculate attrition for this period. 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. 83
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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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of findings tables’. For these ta
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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) Mayxay 2003 LAO (220 pa
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Artesunate plus mefloquine vs Amodi
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(Continued) Faye 2003 SEN (509 part
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Artemether-lumefantrine vs Artesuna
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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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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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