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

Mayxay 2004 LAO (Continued)
Interventions 1. Dihydroartemisinin-piperaquine, fixed dose combination, 40 mg/320 mg tablets
(Artekin: Holleykin)
• Total dose: DHA 6.3 mg/kg + P 50.4 mg/kg in 3 divided doses, given once daily
for 3 days
2. Artesunate plus mefloquine, loose combination (Artesunate: Guilin, Lariam: Roche)
• AS 4 mg/kg once daily for 3 days
• MQ 15 mg base/kg on day 1 and 10 mg base/kg on day 2
All doses supervized
Outcomes 1. Cure rate at day 42, PCR adjusted and unadjusted
2. P. vivax during follow up
3. Adverse events
Not included in the review:
1. Fever clearance time
2. Parasite clearance time
3. Gametocyte carriage after treatment
Notes Country: Lao People’s Democratic Republic (Laos)
Setting: District clinic
Transmission: Not reported
Resistance: Not reported
Dates: May 2004 to Sept 2004
Funding: Western Pacific Regional office of WHO, Wellcome Trust of Great Britain,
Artekin provided by Holleykin Pharmaceuticals
Risk of bias
Item Authors’ judgement Description
Adequate sequence generation? Unclear ’Randomized in blocks of 10’. No further
details given.
Allocation concealment? Yes ’The treatment choice was kept in a sealed
opaque envelope, which was opened only
after the decision to recruit’
Blinding?
All outcomes
Incomplete outcome data addressed?
All outcomes
No An open-label trial. No comment on blinding
of laboratory staff.
Yes Low losses to follow up in both groups
(3.6% DHA-P vs 1.8% AS+MQ)
Free of selective reporting? Yes The WHO recommends 63 days follow up
in studies of AS+MQ. Day 42 outcomes
are likely to overestimate the efficacy of the
2 drugs.
Free of other bias? Yes No other sources of bias identified
Artemisinin-based combination therapy for treating uncomplicated malaria (Review)
Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
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