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

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

10 Very serious limitations: The only trial which reports this outcome (Van den Broek 2004 ZAR) was excluded from the primary outcome due to baseline differences between groups. 11 Very serious imprecision: There were no serious adverse events in this trial. Trials of this size would be unlikely to detect rare but clinically important adverse events. Is Artemether-lumefantrine superior to Amodiaquine plus sulfadoxine-pyrimethamine for treating uncomplicated malaria? Patient or population: Patients with uncomplicated malaria Settings: Africa Intervention: Artemether-lumefantrine Comparison: Amodiaquine plus sulfadoxine-pyrimethamine Outcomes Illustrative comparative risks* (95% CI) Relative effect (95% CI) Efficacy: Total Failure (P. falciparum) Day 28 PCR adjusted - East Africa Efficacy: Total Failure (P. falciparum) Day 28 PCR unadjusted - East Africa Efficacy: Total Failure (P. falciparum) Day 28 PCR adjusted - West Africa Efficacy: Total Failure (P. falciparum) Day 28 PCR unadjusted - West Africa Vivax efficacy: P. vivax parasitaemia Transmission potential: Gametocyte carriage day 14 Assumed risk Corresponding risk Amodiaquine plus sulfadoxinepyrimethamine Artemetherlumefantrine 220 per 1000 26 per 1000 (13 to 53) 486 per 1000 170 per 1000 (146 to 199) 15 per 1000 21 per 1000 (8 to 52) 43 per 1000 124 per 1000 (80 to 192) RR 0.12 (0.06 to 0.24) RR 0.35 (0.3 to 0.41) RR 1.39 (0.55 to 3.47) RR 2.88 (1.86 to 4.47) No of participants (studies) 618 (2) 1646 (3) 1051 (3) 1130 (3) Quality of the evidence (GRADE) ⊕⊕⊕ moderate 1,2,3,4,5,6,7,8 ⊕⊕⊕ moderate 2,10,4,5,6,7,8,9 ⊕ very low 1,3,4,5,6,11,12,13 ⊕⊕⊕ moderate 3,5,6,11,12,14 - - - - Not reported 15 25 per 1000 11 per 1000 (5 to 25) RR 0.46 (0.21 to 1.01) Artemisinin-based combination therapy for treating uncomplicated malaria (Review) Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. 1536 (4) ⊕⊕ low 16,17,18 258
(Continued) Harms: Serious adverse events (including deaths) Harms: Early vomiting 13 per 1000 14 per 1000 (7 to 27) RR 1.08 (0.56 to 2.08) 2684 (5) ⊕⊕ low 5,13,19 - - - - Not reported 20 *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 due to its longer half-life, treatment failure with AL6 may be underestimated at this time point. 2 Dorsey 2006 UGA, Fanello 2004 RWA. 3 No serious limitations: Allocation concealment was assessed as ’low risk of bias’ in one of the trials. Sensitivity analysis removing the trials without adequate concealment did not substantially change the result. 4 Only one trial had adequate blinding. 5 No serious inconsistency: Heterogeneity was low. 6 Serious indirectness: There is considerable variability in the efficacy of AQSP which makes extrapolation of results to other settings unreliable. 7 Trials were conducted in Uganda (mesoendemic), Rwanda (transmission not reported). Children aged < six months and pregnant or lactating women were excluded. 8 No serious imprecision: Both limits of the 95% CI of the pooled estimate imply appreciable benefit with AL6 over AQ+SP. 9 No serious limitations: Allocation concealment was assessed as ’low risk of bias’ in two of the three trials. Sensitivity analysis removing the trial with unclear concealment did not substantially change the result. 10 and Mutabingwa 2004 TZA, Tanzania, very high transmission. 11 Zongo 2005 BFA, Zongo 2007 BFA and Faye 2003 SEN. 12 Trials conducted in Burkina Faso (holoendemic) and Senegal (moderate transmission). Children aged < six months and pregnant or lactating women were excluded. 13 Very serious imprecision: The 95% CI of the pooled estimate is wide including appreciable benefit and harm with each drug over the other. 14 No serious imprecision: Both limits of the 95% CI of the pooled estimate imply appreciable benefit with AQSP over AL6. Artemisinin-based combination therapy for treating uncomplicated malaria (Review) Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. 259
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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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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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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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Mutabingwa 2004 TZA (Continued) •
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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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(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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