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ANNEX 7. Uncomplicated Plasmodium falciparum malaria
No serious limitations: allocation concealment was assessed as “low risk of bias” in three trials; removing the trials with inadequate concealment did not substantially alter the result; laboratory
The total failure rate (PCR corrected) with AQ+SP exceeded the WHO standard of 10% in three out of five trials but it was still performing well in Madagascar and Senegal.
No serious limitations: allocation concealment was assessed as “low risk of bias” in five trials; removal of the trials with inadequate concealment did not substantially alter the result; laboratory
Serious inconsistency: heterogeneity was high; AS+AQ performed better than AQ+SP in three trials, but AQ+SP was still performing well in Madagascar and Senegal.
No serious indirectness: trials were conducted in a variety of African countries. Children aged <6 months and pregnant or lactating women were excluded.
Serious imprecision: the 95% CI of the pooled estimate include appreciable benefit with AS+AQ over AQ+SP and no difference between the two drugs.
AS+AQ may be more effective at treating gametocytes than AQ+SP (at day 7 not day 14) (very low quality evidence).
No difference has been shown in the incidence of serious adverse events (low quality evidence).
This variability in performance is likely to reflect variation in resistance to its components.
Very serious imprecision: data were not pooled; treatment effect is likely to vary between settings.
A7
Madagascar (8), Rwanda (3), Senegal (4), Uganda (6,9). staff were blinded to allocation in four trials. staff were blinded to allocation in five trials. Serious inconsistency: heterogeneity was high and so data were not pooled. No serious limitations: allocation concealment was assessed as “low risk of bias” in two trials. No serious
panel comment: panel conclusion:
10.
7.
8.
9.
3.
2.
1.
6.
5.
4.
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