Summary of findings for the main comparison.
Mefloquine compared with sulfadoxine‐pyrimethamine for preventing malaria in pregnant women | ||||||
Patient or population: HIV‐uninfected pregnant women Setting: Benin, Gabon, Mozambique, and Tanzania Intervention: mefloquine Comparison: sulfadoxine‐pyrimethamine | ||||||
Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | Number of participants (trials) | Certainty of the evidence (GRADE) | Comments (compared with sulfadoxine‐pyrimethamine) | |
Risk with sulfadoxine‐pyrimethamine | Risk with mefloquine | |||||
Clinical malaria episodes during pregnancy | ‐ | ‐ | IRR 0.83 (0.65 to 1.05) | ‐ (2 RCTs) | ⊕⊕⊕⊝ HIGHa | Mefloquine results in little or no difference in the incidence of clinical malaria episodes during pregnancy |
Maternal peripheral parasitaemia at delivery | 43 per 1000 | 28 per 1000 (20 to 37) |
RR 0.65 (0.48 to 0.86) |
5455 (2 RCTs) |
⊕⊕⊕⊝ HIGHa | Mefloquine results in lower maternal peripheral parasitaemia at delivery |
Placental malaria | 52 per 1000 | 54 per 1000 (30 to 97) | RR 1.04 (0.58 to 1.86) | 4668 (2 RCTs) | ⊕⊕⊝⊝ LOWa,b,c Due to imprecision and heterogeneity |
Mefloquine may result in little or no difference in placental parasitaemia |
Maternal anaemia at delivery | 219 per 1000 | 184 per 1000 (166 to 206) | RR 0.84 (0.76 to 0.94) | 5469 (2 RCTs) | ⊕⊕⊕⊝ MODERATEa,d Due to imprecision |
Mefloquine probably results in fewer women anaemic at delivery |
Low birth weight | 117 per 1000 | 111 per 1000 (91 to 137) | RR 0.95 (0.78 to 1.17) | 5641 (2 RCTs) | ⊕⊕⊕⊝ HIGHa | Mefloquine results in little or no difference in low birth weight |
Stillbirths and abortions | 31 per 1000 | 37 per 1000 (28 to 49) | RR 1.20 (0.91 to 1.58) | 6219 (2 RCTs) | ⊕⊕⊕⊝ HIGHa | Mefloquine results in little or no difference in stillbirths or abortions |
AEs: vomiting | 82 per 1000 | 390 per 1000 (338 to 449) | RR 4.76 (4.13 to 5.49) | 6272 (2 RCTs) | ⊕⊕⊕⊕ HIGHa | Mefloquine results in a four‐fold increase in vomiting |
AEs: dizziness | 94 per 1000 | 396 per 1000 (316 to 496) | RR 4.21 (3.36 to 5.27) | 6272 (2 RCTs) | ⊕⊕⊕⊝ HIGHa,b | Mefloquine results in a four‐fold increase in dizziness |
*The risk in the intervention group (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). Abbreviations: CI: confidence interval; IRR: incidence rate ratio; RCT: randomized controlled trial; RR: risk ratio. | ||||||
GRADE Working Group grades of evidence. High certainty: we are very confident that the true effect lies close to that of the estimate of the effect. Moderate certainty: we are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. Low certainty: our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect. Very low certainty: we have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect. |
aAlthough one trial has serious risk of bias, the other is of high certainty and exclusion of the smaller trial has little effect on the estimate of effect. bDowngraded by 1 for imprecision: Confidence intervals range from considerable benefit to considerable harm. cDowngraded by 1 for heterogeneity: Substantive qualitative heterogeneity is evident in the meta‐analysis. dConfidence intervals include little or no important difference to a 24% reduction in anaemic women. The estimate of 16% is judged to be clinically important.