Page 155 - 80 guidelines for the treatment of malaria_opt

ANNEX 7. Uncomplicated Plasmodium falciparum malaria

Trials were conducted in Uganda (mesoendemic), Rwanda (transmission not reported) and Senegal (moderate transmission). Children aged <6 months and pregnant or lactating women were
No serious limitations: allocation concealment was assessed as “low risk of bias” in two of the three trials; sensitivity analysis removing the trial with unclear concealment did not change the

Very serious indirectness: the treatment failure rate with AQ+SP seems to be unusually low in Burkina Faso; this result should not be extrapolated to other countries.
In most areas where it has been studied, AL is more effective than AQ+SP at treating P. falciparum malaria (moderate quality evidence).

Serious limitations: two of the four trials had inadequate allocation concealment; removing these trials shifted the result significantly in favour of AL6.
Data from individual trials showed that failure rates with AQ+SP exceeded the WHO standard of 10% in two out of five trials.
Serious indirectness: there is considerable variability in the efficacy of AQ+SP, which makes extrapolation of results to other settings unreliable.
No serious limitations: allocation concealment was assessed as “low risk of bias” in one trial and unclear in the other; one trial was blinded.
Very serious imprecision: the 95%CI of the pooled estimate is wide including appreciable benefit and harm with each drug over the other.
Serious imprecision: the 95% CI of the pooled estimate includes appreciable benefit with AL6 and no difference between the two drugs.

No serious imprecision: both limits of the 95% CI of the pooled estimate imply appreciable benefit with AQ+SP over AL6.
No serious imprecision: both limits of the 95% CI of the pooled estimate imply appreciable benefit with AL6 over AQ+SP.
Two trials reported vomiting of medication on day 0 (as an exclusion criteria not an outcome) and found no difference.
No difference has been shown in the incidence of serious adverse events (low quality evidence).
Please note due to its longer half-life treatment, failure with AL6 may be underestimated at this point in time.

No serious limitations: allocation concealment was assessed as “low risk of bias” in three trials.
AL is more effective on gametocytes than AQ+SP (low quality evidence).
Data was also available for day 7 where gametocyte carriage was significantly lower with AL6.

A7

Rwanda (5), Senegal (4) and Uganda (6). Only one trial had adequate blinding. No serious inconsistency: heterogeneity was low. Data was also available from one trial from Burkina Faso at day 42.

panel comment: panel conclusion: result substantially. excluded. Burkina Faso (2,7).

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