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

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

Zongo 2005 BFA (Continued) Risk of bias Item Authors’ judgement Description Adequate sequence generation? Yes ’Computer-generated randomisation lists’ Allocation concealment? No None described Blinding? All outcomes Incomplete outcome data addressed? All outcomes Yes ’Investigators responsible for classification of treatment outcomes were unaware of treatment assignment’. Placebos were used and participants not informed of allocation. Yes Mildly disparate losses to follow up (6.1% AL6 vs 10.4% AQ+SP), unlikely to have affected overall result 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 and DHA-P. Free of other bias? Yes No other sources of bias identified Zongo 2007 BFA Methods Trial design: A 3-arm randomized controlled trial Follow up: A standardized history, examination, and malaria film on days 0, 1, 2, 3, 7, 14, 21, 28, 35, and 42. Haemoglobin measured on days 0 and 42 or day of clinical failure. Children with Hb < 10 g/dl were treated with ferrous sulphate and antihelminthic treatment. Adverse event monitoring: Assessed at each visit. Adverse events defined as untoward medical occurrences. Participants Number: 580 randomized Inclusion criteria: Age > 6 months, weight > 5 kg, axillary temp > 37.5 ºC or history of fever in the last 24 hours, P. falciparum mono-infection 2000 to 200,000/µl, the ability to participate in 42 days follow up, informed consent Exclusion criteria: Danger signs or signs of severe malaria, history of serious adverse effects related to study meds, evidence of concomitant febrile illness, antimalarial use other than chloroquine in previous 2 weeks, haemoglobin < 5 g/dl Interventions 1. Dihydroartemisinin-piperaquine, fixed dose combination, 40 mg/320 mg tablets ( Duocotexin: HolleyPharm) • Total dose: DHA 6.4 mg/kg + PQP 51.2 mg/kg in 3 divided doses, given once daily for 3 days 2. Artemether-lumefantrine, fixed dose combination, 20 mg/120 mg tablets (Coartem: Artemisinin-based combination therapy for treating uncomplicated malaria (Review) Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. 104
Zongo 2007 BFA (Continued) Novartis) • 5 to 14 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 3. Amodiaquine plus sulfadoxine-pyrimethamine, loose combination (Flavoquine: Aventis, Fansidar: Roche) • AQ 10 mg/kg once daily on days 0 and 1, then 5 mg/kg once on day 2 • SP 25/1.25 mg/kg on day 0 All doses supervized Outcomes 1. Risk of treatment failure at days 42 and 28, PCR adjusted and unadjusted 2. Gametocyte development during follow up 3. Hemoglobin (mean g/dl) on day 0 and last day of follow up 4. Adverse events Not included in this review: 1. Fever clearance 2. Parasite clearance Notes Country: Burkino Faso Setting: Health dispensaries Transmission: Holoendemic, transmission principally in the rainy season May to Oct Resistance: Not reported Dates: Not reported Funding: Doris Duke Charitable Foundation, Holley Cotec Pharmaceuticals, International Atomic Energy Agency, National Budget of the Institut de Recherche en Sciences de la Sante Risk of bias Item Authors’ judgement Description Adequate sequence generation? Yes ’Randomly assigned on the basis of a computer-generated code provided by an offsite investigator’ Allocation concealment? Yes ’Referred for treatment allocation by a study nurse not involved in enrolment or assessment of treatment outcomes’ Blinding? All outcomes Incomplete outcome data addressed? All outcomes No ’The study was not blinded’ Yes Low losses to follow up in all groups (8% DHA-P vs 6.4% AL6 vs 8.2% AQ+SP) Free of selective reporting? Yes All WHO outcomes reported. Day 42 outcomes may underestimate treatment failure with DHA-P due to its long half-life. Artemisinin-based combination therapy for treating uncomplicated malaria (Review) Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. 105
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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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References to studies excluded from
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Adjuik 2004 Adjuik M, Babiker A, Ga
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C H A R A C T E R I S T I C S O F S
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Ashley 2003a THA (Continued) Outcom
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Ashley 2003b THA (Continued) Alloca
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Ashley 2005 THA (Continued) Exclusi
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Bonnet 2004 GIN (Continued) Item Au
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Bukirwa 2005 UGA Methods Trial desi
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Djimde 2004 MLI (Continued) • AS
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Dorsey 2006 UGA (Continued) Item Au
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Analysis 5.7. Comparison 5 Dihydroa
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(... Continued) Study or subgroup 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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