Summary of findings for the main comparison. Artemisinin‐naphthoquine versus AL for treating uncomplicated P. falciparum malaria.
| Artemisinin‐naphthoquine versus AL for treating uncomplicated P. falciparum malaria | |||||
| Patient or population: Adults and children with uncomplicated P. falciparum malaria Settings: Malaria endemic settings Intervention: Artemisinin‐naphthoquine (ART‐NQ) (one or three‐day course) Comparison: Artemether‐lumefantrine (AL) (three‐day course) | |||||
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect (95% CI) | No of participants (trials) | Quality of the evidence (GRADE) | |
| Assumed risk | Corresponding risk | ||||
| AL | ART‐NQ | ||||
| Treatment failure at day 28 | PCR‐unadjusted | RR 1.02 (0.24 to 4.37) | 487 (3 trials) | ⊕⊕⊝⊝ low1,2,3,4 | |
| 1 per 100 | 1 per 100 (0 to 4) | ||||
| PCR‐adjusted | RR 1.03 (0.15 to 7.07) | 485 (3 trials) | ⊕⊕⊝⊝ low1,2,3,4 | ||
| 0 per 100 | 0 per 100 (0 to 0) | ||||
| Treatment failure at day 42 | PCR‐unadjusted |
RR 0.09 (0.00 to 1.59) |
186 (1 trial) |
⊕⊝⊝⊝ very low5,6,7 | |
| 5 per 100 | 0 per 100 (0 to 8) | ||||
| PCR‐adjusted |
RR 0.33 (0.01 to 7.91) |
186 (1 trial) |
⊕⊝⊝⊝ very low5,6,7 | ||
| 1 per 100 | 0 per 100 (0 to 8) | ||||
| The basis for the assumed risk is the mean control group risk across included studies. 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: Two studies adequately concealed allocation to be at low risk of selection bias. In the other study the process of randomization and allocation concealment was unclear. 2 No serious inconsistency: Statistical heterogeneity was low. 3 Downgraded by 1 for serious indirectness: Three studies have now evaluated this comparison, but only one used a three‐day regimen as recommended by the WHO. The three studies are from Benin, Côte d'Ivoire, and Papua New Guinea, and the level of treatment failure with both artemisinin‐naphthoquine and AL was very low, lower than seen in many trials of AL. Further studies from additional settings are required before this result can be generalized to elsewhere. 4 Downgraded by 1 for serious imprecision: to demonstrate non‐inferiority at 95% efficacy requires a sample size of 472. These trials are individually significantly underpowered, and the number of events is too low to have full confidence in this result. 5 No serious risk of bias: This study adequately concealed allocation to be at low risk of selection bias. 6 Downgraded by 1 for serious indirectness: This single study is from Papua New Guinea. Further studies from additional settings are required before this result can be generalized to elsewhere. 7 Downgraded by 2 for very serious imprecision: This trial is significantly underpowered to demonstrate non‐inferiority.