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

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See: Characteristics of included studies; Characteristics of excluded studies. Results of the search The search was conducted on 12 August 2008 and repeated on 26 March 2009. In total 517 trials were identified. Full text copies were obtained for 85 trials. Fifty trials are included in this review and 35 were excluded. A further four trials (Bousema 2004 KEN; Koram 2003 GHA; Martensson 2003 TZA; Van den Broek 2004 ZAR) were excluded from the primary analysis due to baseline differences between groups which had the potential to severely bias the result. These trials were retained for their data on adverse events. Included studies Forty-six of the fifty included trials were conducted between 2003 and 2009. Thirty-one trials were conducted in Africa, 17 in Asia, one in South America (DHA-P versus AS+MQ) and one in Oceania (DHA-P versus AL6 versus AS+SP). There is obvious regional variability in which drugs are being studied. Trials from Asia mainly involve AS+MQ, AL6 and DHA-P (plus one trial from Indonesia with AS+AQ). Only two studies from Africa have evaluated AS+MQ. Pregnant and lactating women were excluded from all trials. The study population in Asian trials is older, with exclusion of children aged less than one year. African studies concentrated more on children and included those as young as six months. Three trials (Hasugian 2005 IDN; Karunajeewa 2007 PNG; Ratcliff 2005 IDN) included participants with P. vivax mono-infection at baseline. For our primary analysis we obtained data from the authors for only those participants who had P. falciparum or mixed infection (falciparum and vivax) at baseline. One trial (Dorsey 2006 UGA) had an unusual study design where participants were followed up for more than one episode of malaria. For our primary analysis we obtained data from the authors for first episodes of malaria only. The characteristics of the included studies are given in the ’ Characteristics of included studies’ table. Excluded studies Artemisinin-based combination therapy for treating uncomplicated malaria (Review) Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. The reasons for exclusion are given in the ’Characteristics of excluded studies’ table. The four additional studies excluded from the primary analysis had different inclusion criteria for different arms of the trial. Children aged less than one year were excluded from the AL6 treatment arm and reassigned to either AS+AQ or AS+SP. In these studies this led to significant baseline differences in age and weight, factors known to be associated with the outcomes. We explored the effects of including these trials in the largest meta-analysis (AL6 versus AS+AQ, Analysis 9.9; Analysis 9.10). Inclusion of the trials with this bias shifted the results from no difference detected to favouring AL6. In the light of this we decided to exclude all trials that had systematically reallocated patients after randomization. Risk of bias in included studies For a summary of the ’Risk of bias’ assessments please see Figure 1 and Figure 2. 8
Figure 1. Methodological quality summary: review authors’ judgements about each methodological quality item for each included study. Artemisinin-based combination therapy for treating uncomplicated malaria (Review) Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. 9
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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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5.2 DHA-P 3 doses 3 1116 Risk Ratio
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Comparison 21. How does Artesunate
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Analysis 1.3. Comparison 1 Dihydroa
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1 Dorsey 2006 UGA; Faye 2003 SEN; K
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