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

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Is Dihydroartemisinin-piperaquine superior to Amodiaquine plus sulfadoxine-pyrimethamine for treating uncomplicated malaria? Patient or population: Patients with uncomplicated malaria Settings: Africa Intervention: Dihydroartemisinin-piperaquine Comparison: Amodiaquine plus sulfadoxine-pyrimethamine 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 unadjusted Vivax efficacy: P. vivax parasitaemia Transmission potential: Gametocytedevelopment (in those negative at baseline) Harms: Serious adverse events (including deaths) Harms: Early vomiting Assumed risk Corresponding risk Amodiaquine plus sulfadoxinepyrimethamine Dihydroartemisininpiperaquine 114 per 1000 34 per 1000 (19 to 62) 181 per 1000 67 per 1000 (45 to 100) RR 0.3 (0.17 to 0.54) RR 0.37 (0.25 to 0.55) No of participants (studies) 802 (2) 848 (2) Quality of the evidence (GRADE) ⊕⊕⊕ moderate 1,2,3,4,5,6,7 ⊕⊕⊕ moderate 1,2,3,4,5,6,7 - - - - Not reported 55 per 1000 38 per 1000 (15 to 98) RR 0.7 (0.27 to 1.79) 367 (1) - - - 374 (1) ⊕ very low 5,8,9 ⊕ very low 8,10,11 - - - - Not reported 12 *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 Artemisinin-based combination therapy for treating uncomplicated malaria (Review) Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. 248
(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 due to DHA-P may be underestimated at this time point. One trial (Zongo 2007 BFA) also reported treatment failure at day 42 and did not show a difference. 2 Karema 2004 RWA and Zongo 2007 BFA. 3 No serious limitations: Allocation concealment was judged to be at ’low risk of bias’ in one trial and ’unclear’ in the other. Laboratory staff were blinded to treatment allocation in one trial. 4 No serious inconsistency: Heterogeneity was low. 5 Serious indirectness: Due to variable resistance rates to AQ and SP, extrapolation of results to other areas is likely to be unreliable. 6 Trials conducted in Rwanda (transmission not stated) and Burkina Faso (holoendemic). Children aged < 6 months and pregnant or lactating women were excluded. 7 No serious imprecision: Both limits of the 95% CI of the pooled estimate imply appreciable benefit with DHA-P over AQ+SP. 8 No serious limitations: Allocation concealment was judged to be ’low risk of bias’ in this trial (Zongo 2007 BFA). This trial was unblinded. 9 Very serious imprecision: The 95% CI of the pooled estimate is wide including appreciable benefit or harm with each drug over the other. 10 Serious indirectness. Only one trial (Zongo 2007 BFA) reported this outcome. 11 Very serious imprecision: No serious adverse events were recorded. It is unlikely that a trial of this size would detect rare but important adverse events. 12 One trial (Zongo 2007 BFA) reports vomiting medication on day 0 (as an exclusion criteria not an outcome) and found no difference. Is Artesunate plus mefloquine superior to Artemether-lumefantrine for treating uncomplicated malaria? Patient or population: Patients with uncomplicated malaria Settings: Endemic areas worldwide Intervention: Artesunate plus mefloquine Comparison: Artemether-lumefantrine Outcomes Illustrative comparative risks* (95% CI) Relative effect (95% CI) 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) 249
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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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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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Hutagalung 2002 THA (Continued) 5.
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Janssens 2003 KHM (Continued) Free
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Karema 2004 RWA (Continued) Interve
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Karunajeewa 2007 PNG (Continued) Ri
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Kobbe 2007 GHA (Continued) Exclusio
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Koram 2003 GHA (Continued) Adequate
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Martensson 2003 TZA Methods Trial d
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Mayxay 2003 LAO (Continued) 1. Feve
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Menard 2006 MDG Methods Trial desig
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Mens 2007 KEN (Continued) Risk of b
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Mutabingwa 2004 TZA (Continued) •
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Owusu-Agyei 2006 GHA (Continued) Fr
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Sagara 2005b MLI (Continued) • 25
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Smithuis 2004 MMR (Continued) Risk
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Stohrer 2003 LAO Methods Trial desi
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Swarthout 2004 ZAR (Continued) Note
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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 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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