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

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(Continued) Outcomes Illustrative comparative risks* (95% CI) Relative effect (95% CI) Efficacy: Total Failure (P. falciparum) Day 28 PCR adjusted Efficacy: Total Failure (P. falciparum) Day 28 PCR un adjusted- Vivax efficacy: P. vivax parasitaemia Transmission potential: Gametocyte carriage day 14 Harms: Serious adverse events (including deaths) Harms: Early vomiting Assumed risk Corresponding risk Amodiaquine plus sulfadoxinepyrimethamine Artesunate plus amodiaquine - - - 2346 (6) - - - 4220 (8) No of participants (studies) Quality of the evidence (GRADE) ⊕ very low 1,2,3,4,5 ⊕ very low 1,4,5,6,7,8 - - - - Not reported 38 per 1000 22 per 1000 (6 to 77) 17 per 1000 1 per 1000 (6 to 18) RR 0.57 (0.16 to 2.02) RR 0.61 (0.36 to 1.03) 894 (3) 4200 (7) ⊕ very low 4,9,10,11,12 ⊕⊕⊕ moderate 13,14,15 - - - - Not reported *The assumed risk is the mean risk from the studies included in this review, calculated as the number of patients in the control groups with the event divided by the total number of patients in control groups. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; RR: risk ratio GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate. Footnotes Artemisinin-based combination therapy for treating uncomplicated malaria (Review) Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. 262
1 Dorsey 2006 UGA; Faye 2003 SEN; Karema 2004 RWA; Kayentao 2006 MLI; Menard 2006 MDG; Yeka 2004 UGA. 2 No serious limitations: Allocation concealment was assessed as ’low risk of bias’ in two trials. Laboratory staff were blinded in 3 trials. 3 Serious inconsistency: Substantial heterogeneity (I 2 = 77%). In the three trials from east Africa AS+AQ tended to perform better that AQ+SP, but AQ+SP still performed well elsewhere. 4 Serious indirectness: Due to variability in resistance rates generalization of results is likely to be unreliable. 5 Very serious imprecision: Data not pooled due to high heterogeneity. The magnitude of effect is likely to vary between settings. 6 and Mutabingwa 2004 TZA and Staedke 2003 UGA. 7 No serious limitations: Allocation concealment was assessed as ’low risk of bias’ in four trials. Laboratory staff were blinded in four trials. 8 Serious inconsistency: Substantial heterogeneity (I 2 = 91%). In the five trials from east Africa AS+AQ tended to perform better than AQ+SP, but AQ+SP still performed well elsewhere. 9 Dorsey 2006 UGA; Faye 2003 SEN; Menard 2006 MDG. 10 No serious limitations: Allocation concealment was assessed as ’low risk of bias’ in two trials. 11 Very serious imprecision: The 95% CI is very wide including appreciable benefit and harm or each drug over the other. 12 Faye 2003 SEN found a significant reduction in gametocytaemia at day three with AS+AQ. Staedke 2003 UGA found a significant reduction in gametocyte development with AS+AQ. 13 No serious limitations. 14 No serious inconsistency: Heterogeneity is low. 15 Serious imprecision: The 95%CI of the pooled estimate includes appreciable benefit with AS+AQ over AQ+SP and crosses the line of no effect. W H A T ’ S N E W Last assessed as up-to-date: 25 March 2009. 12 August 2009 Amended Tables for treatment comparisons, search strategy, primary outcome measures, adverse events, anaemia, and summary of findings moved to appendices. H I S T O R Y Protocol first published: Issue 4, 2008 Review first published: Issue 3, 2009 Artemisinin-based combination therapy for treating uncomplicated malaria (Review) Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. 263
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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 10. Olliaro-Vaillant plot. D
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of findings tables’. For these ta
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References to studies excluded from
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Adjuik 2004 Adjuik M, Babiker A, Ga
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Tran 2002 VNM Methods Trial design:
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Van Vugt 1998 THA Methods Trial des
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D A T A A N D A N A L Y S E S Compa
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