Page 171 - 80 guidelines for the treatment of malaria_opt

ANNEX 8. Treatment of severe Plasmodium falciparum malaria

No serious limitations: this large RCT was open label although allocation concealment was classified as adequate; of the 10 patients discharged from hospital with residual neurological sequelae,
Serious indirectness: one large trial enrolled both adults and children and one trial enrolled only children; 1259 out of 1533 participants were adults but it was not reported how many adults had
five had psychiatric sequelae, four had persisting problems with balance (one of whom had psychiatric sequelae and tremor) and two had hemiparesis; it was felt that these adverse events were
No serious indirectness: four trials enrolled adults only, one trial enrolled only children and one large trial enrolled children and adults; in a total of 1938 participants, 1664 were adults and 274
were children; a sub-group analysis of trials which only enrolled adults did not affect the significance of this result and it was, therefore, decided not to downgrade this outcome on the basis of
Serious indirectness: one trial enrolled only adults and one trial enrolled only children; 85 participants were adults and 72 were children, but it was not reported how many adults had data for
No serious limitations: two out of six trials had inadequate allocation concealment; however, the panel chose not to downgrade for this as a sub-group, analysis excluding these trials did not

Intravenous artesunate is more effective at reducing deaths in severe malaria (high quality evidence).
Very serious imprecision: the 95% CI of the pooled estimate includes appreciable benefit with both artesunate and quinine.

No difference was shown in the rate of neurological sequelae (very low quality evidence).

Serious limitations: one of the two trials used inadequate allocation concealment and was open label.
minimally subjective and it was, therefore, decided not to downgrade due to absence of blinding.
Very serious limitations: this trial used inadequate allocation concealment and was open label.
data for this outcome; adults are less likely to develop neurological sequelae than children.
Artesunate may result in less hypoglycaemia (low quality evidence).
There is very little evidence of artesunate versus quinine in children.

affect the significance of the result or the absolute magnitude of the effect.

A8

panel comment: panel conclusion: indirectness. Not applicable: only one trial. this outcome.

3.
7.
9.
8.
4.
1.
2.
6.
5.

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