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

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Martensson 2003 TZA (Continued) Allocation concealment? No None described Blinding? All outcomes Incomplete outcome data addressed? All outcomes No No blinding is described. 10% of malaria films were cross-checked by an independaent examiner in a central laboratory Yes Low losses to follow up (1.5% AL6 vs 1% AS+AQ) Free of selective reporting? Yes All WHO outcomes reported Free of other bias? No Due to different inclusion criteria for the 2 groups, participants in the AL6 group were, on average, older and heavier at baseline Mayxay 2003 LAO Methods Trial design: A 3-arm, open label randomized controlled trial Follow up: Temperature was measured every 6 hours and patient reviewed daily until fever and parasites cleared then weekly until day 42 or any time they felt unwell. At each visit a malaria film and haematocrit measurement was taken. Adverse event monitoring: Potential side effects were recorded at each visit Participants Number: 220 randomized into included treatment arms Inclusion criteria: Age > 1 yr, axillary temp > 37.5 ºC or history of fever in previous 3 days, P. falciparum parasitaemia 5000 to 200,000/µl, likely to stay in hospital until fever cleared and complete 42 days follow up, informed consent Exclusion criteria: Pregnancy or lactation, signs of severe malaria, history of allergy or contraindication to the study drugs, a full course of antimalarials in the previous 3 days Interventions 1. Artemether-lumefantrine, fixed dose combination, 20 mg/120 mg tablets (Coartem: Novartis) • < 15 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 • > 35 kg 4 tablets twice daily for 3 days • Advised to take with fatty food 2. Artesunate plus mefloquine, loose combination (artesunate: Guilan, Lariam: Roche) • AS 4 mg/kg once daily for 3 days • MQ 15 mg/kg on day 1 and 10 mg/kg on day 2 All doses supervized Outcomes 1. Cure rates at day 42, PCR adjusted and unadjusted 2. P. vivax parasitaemia during follow up 3. Gametocyte development 4. Mean haematocrit after treatment 5. Adverse events Not included in the review: Artemisinin-based combination therapy for treating uncomplicated malaria (Review) Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. 76
Mayxay 2003 LAO (Continued) 1. Fever clearance time 2. Parasite clearance time Notes Country: Lao People’s Democratic Republic Setting: District clinic Transmission: Not stated Resistance: CQ and SP resistance Dates: June to Oct in 2002 and 2003 Funding: Wellcome Trust of Great Britain Risk of bias Item Authors’ judgement Description Adequate sequence generation? Unclear ’Randomized in blocks of 15’. No further details given. Allocation concealment? Yes ’The treatment choice was kept in a sealed opaque envelope that was opened only after the decision to recruit had been made’ 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 (2.7% AL6 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 may underestimate treatment failure with AS+MQ. Free of other bias? Yes No other sources of bias identified Mayxay 2004 LAO Methods Trial design: An open label randomized controlled trial Follow up: Temperature was measured every 6 hours and patient reviewed daily until fever and parasites cleared then weekly until day 42 or anytime they felt unwell. At each visit a malaria film and haematocrit measurement was taken. Adverse event monitoring: Potential adverse events were recorded at each visit Participants Number: 220 randomized Inclusion criteria: Age > 1 year, axillary temp > 37.5 ºC or history of fever in the previous 3 days, P. falciparum mono-infection 1000 to 200,00/µl, were likely to stay in hospital until parasite clearance and complete 42 days follow up, informed consent Exclusion criteria: Pregnancy or lactation, signs of severe malaria, antimalarials in the previous 3 days, contraindications to the study drugs Artemisinin-based combination therapy for treating uncomplicated malaria (Review) Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. 77
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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 9.8. 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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(Continued) Zongo 2005 BFA (521 par
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(Continued) Faye 2003 SEN (521 part
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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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