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

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

Tran 2002 VNM (Continued) Free of selective reporting? Unclear It is unclear from the paper whether it is only clinical failure that is being reported Free of other bias? Yes No other sources of bias identified Van den Broek 2003a BGD Methods Trial design: A 3-arm, open label randomized controlled trial Follow up: Clinical assessment and malaria film on days 0, 1, 2, 3, 7, 14, 21, 28, 35, and 42 and any other day when feeling ill P. vivax or P. malariae during follow up were treated with CQ and continued in follow up Adverse event monitoring: Possible side effects assessed at each visit Participants Number: 242 randomized to included treatment arms Inclusion criteria: Age > 1 yr, history of fever, P. falciparum mono-infection 1000 to 100,000/µl, informed consent Exclusion criteria: Pregnancy, signs of severe malaria, signs of another febrile illness or severe illness requiring treatment, Hb < 6 g/dl Interventions 1. Artemether-lumefantrine, fixed dose combination, 20 mg/120 mg tablets (Coartem: Novartis) • 2 doses per day for 3 days according to weight (no further details). • Taken with 250 ml of sweetened milk 2. Artesunate plus mefloquine, loose combination • AS 4 mg/kg once daily for 3 days • MQ 15 mg/kg on day 0 and 10 mg/kg on day 1 All doses supervized Outcomes 1. ACPR at day 42, PCR adjusted and unadjusted 2. P. vivax parasitaemia during follow up 3. Gametocyte prevalence at days 0, 3, 7, and 14 4. Adverse events Notes Country: Bangladesh Setting: Outpatient clinics Transmission: High endemicity with a clear seasonal pattern Resistance: Multiple-drug resistance Dates: May 2003 to Sept 2003 Funding: Médecins sans Frontières (Holland) Risk of bias Item Authors’ judgement Description Adequate sequence generation? Yes ’Randomisation was done in blocks of 30 by drawing a card from a box’ Artemisinin-based combination therapy for treating uncomplicated malaria (Review) Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. 96
Van den Broek 2003a BGD (Continued) Allocation concealment? No ’Treatment allocation was done by drawing a card from a box containing three types of cards coding for treatments’ Blinding? All outcomes Incomplete outcome data addressed? All outcomes No An open label trial. No comment on blinding of laboratory staff. 10% of slides were cross-checked. Yes Low losses to follow up (1.6% AL6 vs 5.8% 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 Van den Broek 2004 ZAR Methods Trial design: A 3-arm, open label randomized controlled trial Follow up: Clinical assessment and malaria film on days 0, 1, 2, 3, 7, 14, 21, and 28. Haemoglobin measured at days 0, 14, and 28 Adverse event monitoring: Possible side effects as passively reported to the examiner were recorded at each visit Participants Number: 298 randomized Inclusion criteria: Age 6 to 59 months, weight > 5 kg for AS+AQ and AS+SP groups and > 10 kg for AL6, fever > 37.5 ºC or history of fever in the previous 24 hrs, P. falciparum mono-infection 2000 to 200,000/µl, lives within 2 hours walking distance, informed consent Exclusion criteria: Signs of severe or complicated malaria, any danger sign, a serious concomitant illness, malnutrition, known hypersensitivity to the study drugs Interventions 1. Artemether-lumefantrine, fixed dose combination, 20 mg/120 mg tablets (Coartem: Novartis) • Twice daily for 3 days, weight based as per manufacturers guidance • Given with fatty food or a glass of milk 2. Artesunate plus amodiaquine, loose combination (Arsumax: Sanofi-Aventis, Camoquin: Parke-Davis) • AS 4 mg/kg once daily for 3 days • AQ 10 mg/kg once daily for 3 days 3. Artesunate plus sulphadoxine-pyrimethamine, loose combination (Arsumax: Sanofi- Aventis, Fansidar: La Roche) • AS 4 mg/kg once daily for 3 days • SP 25/1.25 mg/kg on day 1 All doses supervized Artemisinin-based combination therapy for treating uncomplicated malaria (Review) Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. 97
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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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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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