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

Janssens 2003 KHM (Continued)
blood cells parasitized, a history of convulsions or neuropsychiatric disorder, treatment
with mefloquine in the past 60 days
Interventions 1. Dihydroartemisinin-piperaquine, fixed dose combination, 40 mg/320 mg tablets
(Artekin: Holleykin)
• Adult total dose: 6 mg/kg DHA and 48 mg/kg P in 4 divided doses, given at 0, 8,
24, and 48 hours
• Children total dose: 6.4 mg/kg DHA + 51.2 mg/kg P in 4 divided doses, given at
0, 8, 24, 48 hours
2. Artesunate plus mefloquine, loose combination (Artesunate: Guilin, Mefloquine:
Mepha)
• Adults: 100 mg AS plus 500 mg MQ twice daily on day 0, then 200 mg AS once
daily on day 1 and day 2
• Children: AS 4 mg/kg once daily for 3 days plus 25 mg/kg MQ split into 2 doses
on day 0
All doses supervized
Outcomes 1. Cure rate at days 63, 42, and 28, PCR adjusted and unadjusted
2. P. vivax parasitaemia during follow up
3. Mean haematocrit at day 0 and 63
4. Adverse effects
Not included in the review:
1. Fever clearance
2. Parasite clearance
Notes Country: Cambodia
Setting: Rural health centres and outreach malaria clinics
Transmission: Low and seasonal
Resistance: Multiple-drug resistance
Dates: Oct 2002 to March 2003
Funding: Médecins sans Frontières
Risk of bias
Item Authors’ judgement Description
Adequate sequence generation? Yes ’Computer generated randomisation
(STATA version 8, Statacorp)’
Allocation concealment? Unclear ’Treatment allocations were concealed in
sealed envelopes’. No further details.
Blinding?
All outcomes
Incomplete outcome data addressed?
All outcomes
Artemisinin-based combination therapy for treating uncomplicated malaria (Review)
Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
No An open-label trial. No comment on blinding
of laboratory staff.
Yes Losses to follow up balanced and low
in both groups (9.3% DHA-P vs 10%
AS+MQ)
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