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

Artesunate plus mefloquine vs Amodiquine plus sulfadoxine-pyrimethamine
Study ID Adverse event monitoring Blinding Adverse events
Faye 2003 SEN
(306 participants)
All side effects were monitored
actively (days 0, 1, 2, 7, 14, 21,
and 28) and passively during
the study
25% were randomly selected for
blood counts, liver, and renal
function tests at days 0, 14, and
28
Artemether-lumefantrine vs Artesunate plus amodiaquine
Open label SAE: No serious adverse events
Overall comment: The side effects observed with
each treatment combination were minor, mainly
gastralgia, dizziness, pruritis, asthenia, and vomiting
Biochemical: No severe alterations in renal or hepatic
function were observed
Study ID Adverse event monitoring Blinding Adverse events
Adjei 2006 GHA
(227 participants)
Assessed at each follow-up visit
(days 0, 1, 2, 3, 7, 14, and
28), including neurological assessment
Audiological assessment on
days 0, 3, 7, and 28
Total and differential WBC
counts and liver enzymes on
days 0, 3, 7, 14, and 28
Artemisinin-based combination therapy for treating uncomplicated malaria (Review)
Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Single blind (outcome assessors)
SAE: 1 patient treated with
AS+AQ had severe anaemia on
day 14
GI: No significant difference in
nausea and vomiting between
groups
CNS: No significant difference
in dizziness, fatigue, or excessive
sleepiness between groups. Nystagmus
was observed in 1 patient
in each group, both cases
had potential explanations from
the past medical history. A positive
Romberg’s test was observed
in 1 child treated with
AL, again with a possible alternative
diagnosis.
Audiology: Hearing thresholds
were significantly elevated in
treated subjects as days 0, 3, 7,
and 28 but no differences between
participants and controls
after 9 months
Haematological:
The mean neutrophil count
was lower than baseline in both
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