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

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Smithuis 2004 MMR
(652 participants)
Tangpukdee 2005 THA
(180 participants)
Tran 2002 VNM
(243 participants)
Symptom questionnaire at days
0, 1, 2, 3 and 7. Only adverse
events occurring in the first 7
days are reported.
Inpatient monitoring until day
28. Assessed using non-suggestive
questioning.
Review at days 0, 2 and 7
LFTs on days 3, 7 and 28. Further
follow-up is unclear.
Dihydroartemisinin-piperaquine vs Artemether-lumefantrine
Study ID Adverse event monitoring Blinding Adverse events
Kamya 2006 UGA
(421 participants)
Karunajeewa 2007 PNG
(250 participants)
Assessed daily until day 3
then weekly until day 42.
A standardized history, physical
exam, including neurological
assessment at each visit.
Haemoglobin was checked at
baseline and last day of follow
up.
Standardized follow up on days
0, 1, 2, 3, 7, 14, 28, and 42. Ad-
Artemisinin-based combination therapy for treating uncomplicated malaria (Review)
Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
< 0.001, 0.02), abdominal pain and diarrhoea not
significantly different
CNS: More dizziness, sleep disturbance, nightmares,
headache and weakness with AS+MQ (P =
< 0.001, 0.02, 0.003, 0.001, 0.009)
CVS/RS: More palpitations and dyspnoea with
AS+MQ (P = 0.002, 0.04)
Open label SAE: No serious adverse events reported in the first
7 days
GI: More nausea with AS+MQ but only significant
in the group having supervised treatment (P = 0.05),
diarrhoea, vomiting, and abdominal pain were not
significantly different
CNS: More dizziness with AS+MQ but only significant
in the group having unsupervised treatment
(P = 0.03), no other symptoms reported
Open label SAE: No serious adverse events observed
Other: Reported as minor. No differences between
groups reported
Open label SAE: 12 events (10 vomiting, 2 dizziness) described
as significant in AS+MQ group and none
with DHA-P (P = 0.002)
Biochemical: No significant differences
Other: All other adverse events described as minor
with no differences between groups reported
Double-blind SAE: four with DHA-P, 2 with AL, all judged to
be unrelated to study meds (3 febrile convulsions,
otitis media, asthma attack, pyomyositis)
GI: No difference in vomiting, diarrhoea, abdominal
pain, or anorexia
CNS: No differences presented
CVS/RS: No difference in cough
Open label Overall comment: No treatment withdrawals
were attributable to adverse events related to a
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