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

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5 No serious indirectness: Trials were conducted in a variety of African countries with variable transmission and resistance patterns. Children aged < four months and pregnant or lactating women were excluded. 6 Serious imprecision: The 95% CI of the pooled estimate includes appreciable benefit with ASAQ over AL6 and crosses the line of no effect. 7 No serious limitations: Allocation concealment was assessed as ’low risk of bias’ in five trials. Sensitivity analysis removing the trials with inadequate allocation concealment did not substantially alter the result. 8 Very serious inconsistency: Heterogeneity was high so data were not pooled. This heterogeneity seemed to be related to region (with trials from East Africa favouring AL6 and trials from West Africa favouring ASAQ) and transmission intensity (with two trials experiencing very high rates of new infections). 9 Very serious imprecision: Data were not pooled due to heterogeneity. The effect estimate is likely to vary between settings. 10 Only one trial reported P. vivax and there were too few events to draw a conclusion. 11 Dorsey 2006 UGA had adequate allocation concealment and blinding. In Faye 2003 SEN no allocation concealment or blinding was described. 12 Very serious inconsistency: Heterogeneity was high so data were not pooled. 13 Trials were conducted in Senegal (moderate transmission) and Uganda (mesoendemic). 14 Very serious imprecision: The two trials reporting this outcome had very different results. 15 Very serious imprecision: The 95% CI of the pooled estimate includes appreciable benefit and harm with each drug over the other. 16 Serious limitations: Four out of five trials were unblinded. Is Artemether-lumefantrine superior to Artesunate plus sulfadoxine-pyrimethamine for treating uncomplicated malaria? Patient or population: Patients with uncomplicated malaria Settings: Endemic areas worldwide Intervention: Artemether-lumefantrine Comparison: Artesunate plus sulfadoxine-pyrimethamine Outcomes Illustrative comparative risks* (95% CI) Relative effect (95% CI) Efficacy: Total Failure (P. falciparum) Day 42 PCR adjusted Efficacy: Total Failure (P. falciparum) Day 42 PCR unad- Assumed risk Corresponding risk Artesunate plus sulfadoxinepyrimethamine Artemetherlumefantrine 202 per 1000 67 per 1000 (26 to 174) 380 per 1000 369 per 1000 (258 to 517) RR 0.33 (0.13 to 0.86) RR 0.97 (0.68 to 1.36) Artemisinin-based combination therapy for treating uncomplicated malaria (Review) Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. No of participants (studies) 158 (1) 217 (1) Quality of the evidence (GRADE) ⊕ very low 1,2,3,4,5 ⊕ very low 2,3,4,6 256
(Continued) justed Vivax efficacy: P. vivax parasitaemia by Day 42 Transmission potential: Gametocyte carriage Harms: Serious adverse events (including deaths) Harms: Early vomiting 667 per 1000 700 per 1000 (507 to 954) RR 1.05 (0.76 to 1.43) 72 (1) - - - 158 (1) - - - 197 (1) ⊕ very low 2,3,7,8 - 9 ⊕ very low 10,11 - - - - 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 Please note that due to its longer half-life, PCR adjusted treatment failure with AL6 may be underestimated at this time point. 2 Karunajeewa 2007 PNG. 3 Serious limitations: Allocation concealment was assessed as ’high risk of bias’ in this trial. Only microscopists were blinded to treatment allocation. 4 Very serious indirectness: Data are only available from one country (Papua New Guinea). One other trial from Sudan with high risk of bias (Mukhtar 2005 SDN) reports data for day 28 and did not find a difference. 5 No serious imprecision: The 95% CI includes appreciable and non-appreciable benefit with AL6 over AS+SP but does not cross the line of no effect. 6 Very serious imprecision: The 95% CI is very wide including appreciable benefit and harm with each drug over the other. 7 Serious indirectness: Data are only available from one country (Papua New Guinea). This outcome is for participants with P. vivax ± P. falciparum at baseline. 8 Serious imprecision: The 95% CI includes appreciable benefit with AS+SP and crosses the line of no effect. 9 Karunajeewa 2007 PNG reports no differences in gametocyte carriage between the two groups during follow up (figures not given). Artemisinin-based combination therapy for treating uncomplicated malaria (Review) Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. 257
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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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drugs and the treatment comparisons
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this analysis into participants who
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confidence intervals of the estimat
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Anaemia Hasugian 2005 IDN found tha
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or those treated for P. vivax at ba
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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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