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

Anaemia
Hasugian 2005 IDN found that the prevalence of anaemia at day
seven (P = 0.02) and 28 (P = 0.006) was significantly higher with
AS+AQ (authors own figures); in this trial recurrence of parasitaemia
with both P. falciparum and P. vivax was higher in the
AS+AQ group. Karema 2004 RWA found no significant difference
in PCV between groups at days 0 or 14.
Adverse events
Hasugian 2005 IDN reports three serious adverse events with
AS+AQ (two patients with recurrent vomiting on day three, one
patient with bilateral cerebellar signs) (one trial, 334 participants,
Analysis 3.6). Karema 2004 RWA does not comment on serious
adverse events.
Hasugian 2005 IDN reports more nausea (P = 0.004), vomiting (P
= 0.02), and anorexia (P = 0.007) with AS+AQ (334 participants).
Karema 2004 RWA reports more vomiting (P = 0.007), anorexia (P
= 0.005) and fatigue (P = 0.001) with AS+AQ (504 participants).
For a summary of adverse event findings see Appendix 4.
Early vomiting
Hasugian 2005 IDN found no significant difference in the number
of participants who vomited at least one dose of medication (one
trial, 334 participants, Analysis 3.7).
Comparison 4. DHA-P versus artesunate plus sulfadoxinepyrimethamine
We found one trial (from Oceania) which assessed this comparison.
No attempt to conceal allocation was described. Laboratory
staff were blinded to treatment allocation.
Total failure
At day 42 PCR adjusted treatment failure was > 10% in both
groups.
There were no significant differences in treatment failure between
the two arms (one trial, 215 participants, Analysis 4.1; Analysis
4.2; Analysis 4.3; Analysis 4.4)
P. vivax
Compared to AS+SP, DHA-P significantly reduced the incidence
of P. vivax parasitaemia by day 42 in participants treated for P.
falciparum mono-infection at baseline (one trial, 194 participants:
RR 0.45, 95% CI 0.32 to 0.65, Analysis 4.5), or P. vivax ± P.
falciparum at baseline (one trial, 75 participants: RR 0.46, 95%
CI 0.27 to 0.79, Analysis 4.5).
Gametocytes
No significant differences in gametocyte carriage during follow up
are reported (figures not reported).
Anaemia
Haemoglobin levels were reported to remain similar in both groups
throughout follow up (figures not reported).
Adverse events
Monitoring for adverse events was undertaken but no differences
between the groups were reported (see Appendix 4).
Early vomiting
Not reported.
Comparison 5. DHA-P versus amodiaquine plus sulfadoxinepyrimethamine
We found two trials (both in Africa) which assessed this comparison.
Allocation concealment was assessed as low risk of bias in one
trial (Zongo 2007 BFA) and unclear in the other. Karema 2004
RWA blinded laboratory staff to treatment allocation. No other
blinding is described.
Total failure
PCR adjusted treatment failure with DHA-P was below 5% in
both trials. In Rwanda, PCR adjusted treatment failure with
AQ+SP was above 10%.
DHA-P performed significantly better than AQ+SP at 28 days
(two trials, 848 participants: PCR unadjusted RR 0.37, 95% CI
0.25 to 0.55, Analysis 5.1; PCR adjusted RR 0.30, 95% CI 0.17
to 0.54, Analysis 5.2). Zongo 2007 BFA did not show a difference
at day 42 with both drugs performing well at this site (one trial,
341 participants, Analysis 5.3; Analysis 5.4).
P. vivax
Not reported.
Gametocytes
Artemisinin-based combination therapy for treating uncomplicated malaria (Review)
Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Zongo 2007 BFA found no difference in the development of gametocytaemia
in participants who did not have detectable gametocytes
at baseline (one trial, 367 participants, Analysis 5.5). Karema
2004 RWA reported no significant difference in gametocyte carriage
during follow up but figures were not reported (one trial,
510 participants).
13