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

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$Interventions for treating proximal humeral fractures in adults (Review)$

Owusu-Agyei 2006 GHA Methods Trial design: A 3-arm, randomized controlled trial Follow up: Participants were assessed for adverse events and by malaria film on days 0, 2, 3, 7, 14, and 28 or any other day they were unwell. Haemoglobin measured on days 1, 2, 3, 7, and 28. Anaemia was treated with iron according to national guidelines Adverse event monitoring: Field workers visited their homes to solicit adverse events on days 0, 2, 3, 7, 14, and 28 Participants Number: 355 randomized into included treatment arms Inclusion criteria: Age 6 months to 10 yrs, weight > 5 kg, axillary temp > 37.5 ºC or history of fever, parasitaemia 2000 to 200,000/µl, informed consent Exclusion criteria: Danger signs, signs of severe malaria, concomitant febrile illness, Hb < 7 g/dl Interventions 1. Artemether-lumefantrine, fixed dose combination, 20 mg/120 mg tablets (Coartem: Novartis) • Details not given 2. Artesunate plus amodiaquine, co-blistered (Arsucam: Sanofi-Aventis) • Details not given All doses supervized for 3 days Outcomes 1. Parasitological and clinical failure at day 28, PCR unadjusted and PCR adjusted 2. Gametocytaemia at day 7 3. Haemoglobin at day 28 4. Adverse events Notes Country: Ghana Setting: District hospital Transmission: Perennial, high with a peak July to August Resistance: Not stated Dates: June 2005 to May 2006 Funding: Gates Malaria Partnership of the London School of Hygiene and Tropical Medicine Risk of bias Item Authors’ judgement Description Adequate sequence generation? Yes ’Randomization was done using Microsoft Excel 2003 randomisation generator’ Allocation concealment? No None described Blinding? All outcomes Incomplete outcome data addressed? All outcomes Artemisinin-based combination therapy for treating uncomplicated malaria (Review) Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. No An open label trial. No comment on blinding of lab staff. Yes Moderate losses to follow up but similar in both groups (14% AL6 vs 15% AS+AQ) 84
Owusu-Agyei 2006 GHA (Continued) Free of selective reporting? Yes All WHO outcomes reported. Biochemical monitoring is stated although this outcome is not reported Free of other bias? Yes No other sources of bias identified Ratcliff 2005 IDN Methods Trial design: An open-label randomized controlled trial Follow up: A symptom questionnaire, physical examination, malaria film and haemoglobin measurement daily until fever and parasites cleared then weekly to day 42 Adverse event monitoring: A symptom questionnaire at each visit Participants Number: 774 randomized Inclusion criteria: Weight >10 kg, fever or a history of fever in the preceding 48 hours, slide confirmed malaria (P. falciparum, P. vivax or mixed infections) Exclusion criteria: Pregnancy or lactation, danger signs or signs of severity, parasitaemia > 4%, concomitant disease requiring hospital admission Interventions 1. Dihydroartemisinin-piperaquine, fixed dose combination, 40 mg/320 mg tablets (Artekin: Holleykin) • Total dose: DHA 6.75 mg/kg + P 54 mg/kg in 3 divided doses, given once daily for 3 days 2. 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 Only the first dose of each day was supervized. All participants advised to take each dose with a biscuit or milk. Outcomes 1. Parasitological failure at days 42 and 28, PCR adjusted and unadjusted 2. P. vivax during follow up 3. Gametocyte carriage after treatment 4. Anaemia during follow up 5. Adverse events Not included in the review: 1. Fever clearance 2. Parasite clearance Notes Country: Indonesia Setting: Rural outpatient clinics Transmission: Unstable Resistance: Multiple-drug resistance Dates: Jul 2004 to Jun 2005 Funding: Wellcome Trust UK and National Health and Medical Research Council Australia Artemisinin-based combination therapy for treating uncomplicated malaria (Review) Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. 85
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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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Figure 4. Olliaro-Vaillant plot. Da
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Figure 10. Olliaro-Vaillant plot. D
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of findings tables’. For these ta
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Huambo and Bie provinces, central A
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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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(... Continued) Study or subgroup D
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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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(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) Vivax efficacy: P. viva
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(Continued) Efficacy: Total Failure
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(Continued) Outcomes Illustrative c
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(Continued) GRADE Working Group gra
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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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