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. 2014 Jan 20;2014(1):CD010927. doi: 10.1002/14651858.CD010927
Dihydroartemisinin‐piperaquine compared to Artemether‐lumefantrine for uncomplicated P. falciparum malaria
Patient or population: Patients with uncomplicated P. falciparum malaria
 Settings: Malaria endemic areas
 Intervention: Dihydroartemisinin‐piperaquine (DHA‐P)
 Comparison: Artemether‐lumefantrine (AL6)
Outcomes Number of participants having adverse events (95% CI) No of participants 
 (trials) Quality of the evidence 
 (GRADE)
AL6 DHA‐P
Serious adverse events (including deaths) 6 per 1000 10 per 1000 
 (6 to 17) 7022
 (8 trials) moderate1,2,3,4
Gastroenterological Early vomiting 2 per 100 3 per 100 
 (2 to 5) 2695
 (3 trials) moderate2,3,5,6
Vomiting 9 per 100 9 per 100 
 (8 to 11) 6761
 (9 trials) moderate2,3,5,6
Nausea 2 per 100 2 per 100 
 (1 to 7) 547
 (2 trials) low2,3,5,7
Diarrhoea 12 per 100 12 per 100 
 (10 to 14) 4889
 (7 trials) moderate2,3,5,6
Abdominal pain 19 per 100 16 per 100 
 (12 to 20) 911
 (5 trials) low2,3,5,8
Anorexia 15 per 100 14 per 100 
 (12 to 17) 3834
 (5 trials) moderate2,3,5,6
Neuro‐psychiatric Headache 27 per 100 33 per 100 
 (25 to 44) 309
 (2 trials) low2,3,5,8
Sleeplessness 1 per 100 3 per 100 
 (1 to 9) 547
 (2 trials) low2,3,5,7
Dizziness 3 per 100 4 per 100 
 (2 to 11) 547
 (2 trials) low3,5,7
Sleepiness 0 per 100 0 per 100 
 (0 to 0) 384
 (1 trial) low2,3,5,7
Weakness 17 per 100 18 per 100 
 (15 to 21) 1812
 (5 trials) moderate2,3,5,6
Cardio‐respiratory Cough 42 per 100 42 per 100 
 (40 to 45) 4342
 (5 trials) moderate2,3,5,6
Coryza 68 per 100 66 per 100 
 (60 to 72) 832
 (2 trials) low1,2,3,8
Prolonged QT interval 
 (adverse event) 3 per 100 2 per 100 
 (1 to 5) 1548
 (1 trial) low8,10,11
Prolonged QT interval 
 (Bazett's correction) 7 per 100 9 per 100 
 (6 to 11) 1548
 (1 trial) low5,8,11
Prolonged QT interval 
 (Fridericia's correction) 0 per 100 0 per 100 
 (0 to 2) 1548
 (1 trial) low5,8,11
Musculoskeletal/ 
 dermatological Pruritis 2 per 100 4 per 100 
 (2 to 6) 2033
 (5 trials) moderate2,3,5,6
Facial oedema 0 per 100 0 per 100 
 (0 to 0) 384
 (1 trial) low2,3,5,7
*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: All but one of the trials are open label. However, we did not down grade 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, with few trials in Asia or in adults.
 4 Downgraded by 1 for serious imprecision: No statistically significant difference was detected between treatments. However the current sample size does not exclude the possibility of rare but clinically important differences.
 5 Downgraded by 1 for risk of bias: The majority of trials are open label.
 6 No serious imprecision: The finding is of no effect and the CIs around the absolute effect excludes clinically important differences.
 7 Downgraded by 1 for serious imprecision: There are limited data.
8 Downgraded by 1 for serious imprecision: The result does not reach statistical significance.
 9 No serious imprecision: The total number of participants is high and findings are precise.
 10 Downgraded by 1 for serious risk of bias: This trial is unblinded. Only a few of the recorded prolonged QT intervals were registered as adverse events which removed the statistical significance. The reasons for this are unclear.
 11 No serious indirectness: This single trial was conducted in children in Uganda, Kenya, Mozambique, Zambia, and Burkina Faso.