Artemisinin-based combination therapy for ... - The Cochrane Library

or those treated for P. vivax at baseline (one trial, 72 participants,
Analysis 10.5)
Gametocytes
Karunajeewa 2007 PNG reports no differences in gametocyte carriage
between the two groups during follow up (figures not reported).
Anaemia
Karunajeewa 2007 PNG reports no differences in mean
haemoglobin during follow up (figures not reported).
Adverse events
Two trials report on adverse events and no differences are noted
between the two groups (Karunajeewa 2007 PNG; Van den Broek
2004 ZAR). For a summary of adverse events see Appendix 4.
Early vomiting
Not reported.
Comparison 11. AL6 versus amodiaquine plus sulfadoxinepyrimethamine
We found seven trials (all in Africa) which assessed this comparison.
One trial was excluded from the primary analysis due to baseline
differences between groups. Of the remaining trials allocation
concealment was assessed as low risk of bias in two trials (Dorsey
2006 UGA; Zongo 2007 BFA) and laboratory staff were blinded
to treatment allocation in four trials.
Total failure
PCR adjusted treatment failure with AL6 was below 5% in all six
trials. The performance of AQ+SP was much more variable.
In East Africa, where treatment failure with AQ+SP was high, AL6
performed markedly better at day 28 (three trials, 1646 participants:
PCR unadjusted RR 0.35, 95% CI 0.30 to 0.41, Analysis
11.1; PCR adjusted RR 0.12, 95% CI 0.06 to 0.24, Analysis 11.2).
In contrast, in West Africa, where AQ+SP performed much better,
there were fewer PCR unadjusted treatment failures with AQ+SP
at both day 28 (three trials, 1130 participants: PCR unadjusted RR
2.88, 95% CI 1.86 to 4.47, Analysis 11.1) and day 42 (one trial,
345 participants: PCR unadjusted RR 2.64, 95% CI 1.66 to 4.21,
Analysis 11.3). There were no significant differences between the
two combinations after PCR adjustment (Analysis 11.2; Analysis
11.4).
P. vivax
Only one trial (Dorsey 2006 UGA) reported on P. vivax and there
were too few patients to draw a conclusion (AL6 8/202 at baseline
and 3/202 during follow up, AQ+SP 4/253 at baseline and 0
during follow up).
Gametocytes
The prevalence of gametocyte carriage was significantly lower with
AL6 at day three (three trials, 1331 participants: RR 0.43, 95%
CI 0.25 to 0.75, Analysis 11.5) and day seven (four trials,1538
participants: RR 0.32, 95% CI 0.18 to 0.54, Analysis 11.5). Zongo
2007 BFA found no significant difference in the development of
gametocytaemia in participants without detectable gametocytes at
baseline (one trial, 371 participants, Analysis 11.6).
Anaemia
Zongo 2005 BFA reports change in haemoglobin from baseline to
day 28; Zongo 2007 BFA reports mean haemoglobin at baseline
and day 42. Neither of these trials showed a clinically significant
difference (two trials, 893 participants, Analysis 11.7). Four other
trials assessed haematological recovery at shorter time points and
did not detect a difference (Dorsey 2006 UGA; Fanello 2004
RWA; Faye 2003 SEN; Mutabingwa 2004 TZA).
Adverse events
No difference has been shown in the frequency of serious adverse
events (five trials, 2684 participants, Analysis 11.8).
Dorsey 2006 UGA reports more anorexia (P < 0.05) and weakness
(P < 0.05) with AQ+SP (455 participants). Two trials report a
significant increase in pruritis (P < 0.05, P < 0.0001) with AQ+SP.
No further differences are noted. For a summary of adverse events
see Appendix 4.
Early vomiting
Artemisinin-based combination therapy for treating uncomplicated malaria (Review)
Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Two trials report on the number of participants excluded for persistent
vomiting on day 0. There were no differences between groups
(two trials, 893 participants, Analysis 11.9).
Question 4. How does artesunate plus amodiaquine
perform?
Comparison 12. AS+AQ versus artesunate plus sulfadoxinepyrimethamine
We found seven trials (all in Africa) which assessed this comparison.
Allocation concealment was judged as low risk of bias in only
one trial (Bonnet 2004 GIN) and unclear in four. Laboratory staff
were blinded to treatment allocation in two trials.
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