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

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(Continued) 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 1 Please note that due to its longer half-life, treatment failure with AS+MQ may be underestimated at this timepoint. 2 Faye 2003 SEN. 3 Serious limitations: Allocation concealment was assessed as ’high risk of bias’ and no blinding is described. 4 Serious indirectness: Only one trial from Senegal reported this outcome. Extrapolation of this result to other countries is likely to be unreliable. 5 Children aged < 1 year and pregnant or lactating women were excluded. 6 Very serious imprecision: No PCR adjusted treatment failures were recorded in either treatment group. 7 Very serious imprecision: The 95% CI is wide including appreciable benefit and harm with each drug over the other. 8 No serious imprecision: Both limits of the 95% CI imply appreciable benefit with AS+MQ. At day 14 there were no participants with detectable gametocytes in either group. 9 Very serious imprecision: No serious adverse events were recorded in this trial. A trial of this size would be unlikely to detect rare but important adverse events. Is Artemether-lumefantrine superior to Artesunate plus amodiaquine for treating uncomplicated malaria? Patient or population: Patients with uncomplicated malaria Settings: Africa Intervention: Artemether-lumefantrine Comparison: Artesunate plus amodiaquine Outcomes Illustrative comparative risks* (95% CI) Relative effect (95% CI) Efficacy: Total Failure (P. falciparum) Day 28 PCR adjusted Assumed risk Corresponding risk Artesunate plus amodiaquine Artemetherlumefantrine Artemisinin-based combination therapy for treating uncomplicated malaria (Review) Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. No of participants (studies) Quality of the evidence (GRADE) 254
(Continued) Efficacy: Total Failure (P. falciparum) Day 28 PCR adjusted Efficacy: Total Failure (P. falciparum) Day 28 PCR unadjusted Vivax efficacy: P. vivax parasitaemia Transmission potential: Gametocyte carriage day 14 Harms: Serious adverse events (including deaths) Harms: Early vomiting 19 per 1000 31 per 1000 (18 to 55) RR 1.65 (0.95 to 2.87) 1729 (8) - - - 2617 (5) ⊕⊕⊕ moderate 1,2,3,4,5,6 ⊕ very low 2,5,7,8,9 - - - - Not reported 10 - - - 718 (2) 13 per 1000 14 per 1000 (8 to 27) 83 per 1000 72 per 1000 (49 to 109) RR 1.11 (0.59 to 2.08) RR 0.87 (0.59 to 1.31) 2617 (5) 1097 (5) ⊕ very low 11,12,13,14 ⊕⊕ low 3,4,5,15 ⊕ very low 4,15,16 *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 1 Please note that due to its long half-life PCR adjusted treatment failure with AL6 may be underestimated at this time point. 2 Adjei 2006 GHA, Bukirwa 2005 UGA, Dorsey 2006 UGA, Falade 2005 NGA, Faye 2003 SEN, Guthmann 2004 AGO, Kobbe 2007 GHA and Owusu-Agyei 2006 GHA (and Mutabingwa 2004 TZA for PCR unadjusted only). 3 No serious limitations: Allocation concealment was assessed as ’low risk of bias’ in four trials. Sensitivity analysis removing the trials with inadequate allocation concealment did not substantially alter the result. 4 No serious inconsistency: Heterogeneity was low. Artemisinin-based combination therapy for treating uncomplicated malaria (Review) Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. 255
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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 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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Fanello 2004 RWA Methods Trial desi
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Faye 2003 SEN (Continued) Outcomes
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Grande 2005 PER (Continued) Allocat
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Guthmann 2004 AGO (Continued) All d
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Hasugian 2005 IDN Methods Trial des
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Martensson 2003 TZA Methods Trial d
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Sagara 2005b MLI (Continued) • 25
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Stohrer 2003 LAO Methods Trial desi
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Tran 2002 VNM Methods Trial design:
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Van den Broek 2003a BGD (Continued)
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Van Vugt 1998 THA Methods Trial des
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Yeka 2004 UGA (Continued) Risk of b
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Yeka 2007 UGA (Continued) Free of o
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Zongo 2007 BFA (Continued) Novartis
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(Continued) Fofana 2005 Conference
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D A T A A N D A N A L Y S E S Compa
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2.2 Asia 1 317 Risk Ratio (M-H, Fix
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Comparison 5. Dihydroartemisinin-pi
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Comparison 8. Artesunate plus meflo
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Comparison 10. Artemether-lumefantr
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Comparison 12. Artesunate plus amod
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5.2 DHA-P 3 doses 3 1116 Risk Ratio
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Comparison 21. How does Artesunate
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(... Continued) Study or subgroup D
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Analysis 1.12. Comparison 1 Dihydro
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Analysis 9.2. Comparison 9 Artemeth
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Analysis 14.2. Comparison 14 Dihydr
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