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. |