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. 2014 Jan 20;2014(1):CD010927. doi: 10.1002/14651858.CD010927
Dihydroartemisinin‐piperaquine compared to Artesunate plus amodiaquine for uncomplicated P. falciparum malaria
Patient or population: Patients with uncomplicated P. falciparum malaria
 Settings: Malaria endemic areas
 Intervention: Dihydroartemisinin‐piperaquine (DHA‐P)
 Comparison: Artesunate plus amodiaquine (AS+AQ)
Outcomes Number of participants having adverse events (95% CI) No of participants 
 (trials) Quality of the evidence 
 (GRADE)
AS+AQ DHA‐P
Serious adverse events (including deaths) 2 per 100 1 per 100 
 (0 to 1) 2805
 (2 trials) moderate1,2,3,4
Gastrointestinal Early vomiting 6 per 100 5 per 100 
 (3 to 10) 650
 (2 trials) low3,5,6,7
Vomiting 11 per 100 8 per 100 
 (7 to 11) 2471
 (1 trial) moderate7,8,9,10
Nausea 17 per 100 17 per 100 
 (11 to 28) 316
 (1 trial) moderate5,9,11,12
Diarrhoea 11 per 100 11 per 100 
 (9 to 14) 2787
 (2 trials) moderate2,3,12,13
Abdominal pain 13 per 100 12 per 100 
 (7 to 21) 316
 (1 trial) low5,7,9,11
Anorexia 11 per 100 10 per 100 
 (8 to 12) 2787
 (2 trials) low2,3,7,13
Neuro‐psychiatric Headache 1 per 100 1 per 100 
 (0 to 9) 316
 (1 trial) low5,9,11,14
Sleeplessness 14 per 100 11 per 100 
 (6 to 20) 316
 (1 trial) low5,7,9,11
Cardio‐respiratory Cough 31 per 100 32 per 100 
 (28 to 36) 2471
 (1 trial) moderate7,8,9,10
Palpitations 23 per 100 20 per 100 
 (13 to 30) 316
 (1 trial) low5,7,9,11
*The basis for the assumed risk (for example, the median control group risk across trials) is provided in footnotes. The corresponding risk (and its 95% CI) 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.
1 No serious risk of bias: Only one of the two trials was blinded. However, we did not downgrade for this outcome.
 2 No serious inconsistency: The finding is consistent across all trials. Statistical heterogeneity is low.
 3 No serious indirectness: Trials were mainly conducted in children in Africa and Asia, with few Asian adults.
 4 Downgraded by 1 for serious imprecision: The number of events is low despite the findings reaching statistical significance and the total number of participants being high.
 5 Downgraded by 1 for risk of bias: The trial that reported this finding was open‐label
 6 No serious inconsistency: The finding is consistent across all trials. Statistical heterogeneity can be explained by difference in definition of early vomiting.
 7 Downgraded by 1 for serious imprecision: The result does not reach statistical significance.
 8 No serious risk of bias: The trial that reported this outcome had low risk of bias for blinding of adverse events.
 9 No serious inconsistency: This outcome was only reported in one trial.
 10 No serious indirectness: This trial was mainly conducted in children in Africa.
 11 No serious indirectness: The trial was mainly conducted in children and adults in Asia.
 12 No serious imprecision: The finding is of no effect but the CIs around the absolute effect excludes clinically important differences.
 13 Downgraded by 1 for risk of bias: Only one trial was blinded for adverse events.
 14 Downgraded by 1 for serious imprecision: There are limited data and the 95% CI is wide.