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

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15 Only one trial reported on P. vivax and there were too few events to draw a conclusion. 16 Data were also available for day seven where gametocyte carriage was significantly lower with AL6. 17 Serious limitations: Only one of the four trials had adequate allocation concealment. 18 Serious imprecision: The 95% CI of the pooled estimate includes appreciable benefit with AL6 and crosses the line of no effect. 19 No serious limitations: Allocation concealment was assessed as ’low risk of bias’ in three trials. 20 Two trials reported vomiting of medication on day 0 (as an exclusion criteria not an outcome) and found no difference. Is Artesunate plus amodiaquine superior to Artesunate plus sulfadoxine-pyrimethamine for treating uncomplicated malaria? Patient or population: Patients with uncomplicated malaria Settings: Endemic areas worldwide Intervention: Artesunate plus amodiaquine Comparison: Artesunate 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: Gametocyte carriage day 14 Harms: Serious adverse events (including deaths) Assumed risk Corresponding risk Artesunate plus sulfadoxinepyrimethamine Artesunate plus amodiaquine 44 per 1000 28 per 1000 (16 to 48) RR 0.64 (0.37 to 1.08) No of participants (studies) 1419 (7) - - - 1614 (7) Quality of the evidence (GRADE) ⊕⊕ low 1,2,3,4,5 ⊕ very low 1,2,4,6,7 - - - - Not reported 91 per 1000 81 per 1000 (46 to 140) 2 per 1000 2 per 1000 (0 to 14) RR 0.89 (0.51 to 1.54) RR 0.99 (0.14 to 7.02) Artemisinin-based combination therapy for treating uncomplicated malaria (Review) Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. 520 (3) 1108 (4) ⊕ very low 8,9,10,11 ⊕ very low 9,10,11 260
(Continued) Harms: Early vomiting - - - - 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 1 Bonnet 2004 GIN; Djimde 2004 MLI; Guthmann 2003 AGO; Hamour 2003 SDN; Kayentao 2006 MLI; Swarthout 2004 ZAR; Van den Broek 2004 ZAR. 2 Serious limitations: Allocation concealment was assessed as ’low risk of bias’ in only one trial. Only one trial had adequate blinding of laboratory staff. 3 No serious inconsistency: Heterogeneity was low. 4 Trials were conducted in a variety of African countries (Guinea, Mali, Angola, DRC) and transmission intensities in children aged 6 to 59 months. 5 Serious imprecision: The 95% CI of the pooled estimate includes appreciable benefit with ASAQ and crosses the line of no effect. 6 Very serious inconsistency: Heterogeneity was high (I 2 = 88%) with some trials showing benefit with AS+AQ and some with AS+SP. 7 Very serious imprecision: Data were not pooled due to high heterogeneity. 8 No difference was shown in gametocyte carriage at day three or seven. 9 Serious limitations: No trial adequately described an allocation concealment procedure. 10 No serious inconsistency: Heterogeneity was low. 11 Very serious imprecision: The 95% CI of the pooled estimate is wide including appreciable benefit or harm of each drug over the other. Is Artesunate plus amodiaquine superior to Amodiaquine plus sulfadoxine-pyrimethamine for treating uncomplicated malaria? Patient or population: Patients with uncomplicated malaria Settings: Africa Intervention: Artesunate plus amodiaquine Comparison: Amodiaquine plus sulfadoxine-pyrimethamine Artemisinin-based combination therapy for treating uncomplicated malaria (Review) Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. 261
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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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Bonnet 2004 GIN (Continued) Item Au
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Bukirwa 2005 UGA Methods Trial desi
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Dorsey 2006 UGA (Continued) Item Au
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Faye 2003 SEN (Continued) Outcomes
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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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(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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