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

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Adjei 2006 GHA (Continued) Item Authors’ judgement Description Adequate sequence generation? Yes ’A computer generated randomisation scheme was prepared in advance’ Allocation concealment? Yes ’Allocated treatments were kept in sealed opaque envelopes’ Blinding? All outcomes Incomplete outcome data addressed? All outcomes Yes ’All study personnel (except project nurses) were unaware of the assigned treatments’ Yes Low losses to follow up in both groups (7.2% AL6 vs 7.8% AS+AQ) Free of selective reporting? Yes All WHO outcomes reported. The WHO recommends 42 days follow up in studies of AL6. Day 28 outcomes may under estimate treatment failure with AL6. Free of other bias? Yes No other sources of bias identified Ashley 2003a THA Methods Trial design: A 3-arm randomized controlled trial Follow up: All patients admitted to hospital for 28 days, oral temperature taken every 6 hours, parasite counts 12-hourly until negative then daily for 28 days Adverse event monitoring: Adverse events defined as signs or symptoms that occurred or became more severe after treatment started. All patients had full blood counts, urea, electrolytes, creatinine, and liver function tests at days 0 and 7. Participants Number: 134 randomized into included treatment arms Inclusion criteria: Age > 14 yrs, weight > 40 kg, symptoms of malaria, P. falciparum parasitaemia, informed consent Exclusion criteria: Pregnancy or lactation, signs or symptoms of severe malaria, > 4% of red blood cells parasitized, contraindication to mefloquine, treatment with mefloquine in the previous 60 days, sulphonamides or 4-aminoquinolones present in urine on admission Interventions 1. Dihydroartemisinin-piperaquine, fixed dose combination (Artekin: Holleykin) • Total dose: 6 mg/kg DHA and 48 mg/kg P in 4 divided doses at 0, 8, 24 and 48 hours 2. Artesunate plus mefloquine, loose combination (Artesunate: Guilin, Mequin: Atlantic) • AS 4 mg/kg once daily for 3 days • MQ 8 mg/kg once daily for 3 days All doses supervized Artemisinin-based combination therapy for treating uncomplicated malaria (Review) Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. 38
Ashley 2003a THA (Continued) Outcomes 1. Cure rate at day 28, all reappearances of parasites presumed to be recrudescences as patients hospitalized for duration 2. Adverse events Not included in this review: 1. Fever clearance time 2. Parasite clearance time Notes Country: Thailand Setting: Bangkok Hospital for Tropical Diseases Transmission: Low transmission Resistance: Multiple-drug resistance Dates: Jul 2002 to Apr 2003 Funding: Mahidol University, Tak Malaria Initiative Project, supported by Bill and Melinda Gates Foundation, Wellcome Trust of Great Britain Risk of bias Item Authors’ judgement Description Adequate sequence generation? Yes ’The randomisation was computer generated (STATA; version 7; Statacorp)’. Randomized in blocks of 6 Allocation concealment? Yes ’The treatment allocation was concealed in sealed envelopes labelled with the study code’ Blinding? All outcomes Incomplete outcome data addressed? All outcomes No ’Laboratory staff reading the blood smears had no knowledge of the treatment received’. No other blinding described Yes Similar loss to follow up in all groups (10.6% DHA-P vs 11.9% AS+MQ) Free of selective reporting? Yes The WHO recommends 63 days follow up in studies of AS+MQ. Day 28 outcomes are likely to underestimate treatment failure with AS+MQ and DHA-P. 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. 39
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D A T A A N D A N A L Y S E S Compa
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2.2 Asia 1 317 Risk Ratio (M-H, Fix
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Comparison 5. Dihydroartemisinin-pi
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5.2 DHA-P 3 doses 3 1116 Risk Ratio
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Comparison 21. How does Artesunate
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Analysis 1.3. Comparison 1 Dihydroa
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Analysis 9.2. Comparison 9 Artemeth
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Analysis 12.2. Comparison 12 Artesu
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Analysis 14.2. Comparison 14 Dihydr
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Analysis 20.1. Comparison 20 How do
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Analysis 21.1. Comparison 21 How do
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(Continued) 2. How does artesunate
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(Continued) Sensitivity analysis 1
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(Continued) Smithuis 2004 MMR (652
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Dihydroartemisinin-piperaquine vs A
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PCR = polymerase chain reaction PCV
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Footnotes 1 Data were also availabl
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(Continued) justed Vivax efficacy:
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1 Dorsey 2006 UGA; Faye 2003 SEN; K
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