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

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Ashley 2003b THA Methods Trial design: A randomized controlled trial Follow up: Temperature and blood smears daily until clearance of fever and parasites, then weekly attendance until day 63 Adverse event monitoring: Adverse events defined as signs or symptoms that occurred or became more severe after treatment started. A subset of 55 patients in the DHA-P group had full blood counts, urea, electrolyte, creatinine and liver function tests at days 0 and 7. 32 patients from the DHA-P group also had ECG monitoring before and after treatment. Participants Number: 355 randomized into included treatment arms Inclusion criteria: Age 1 to 65 yrs, symptomatic 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 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 Outcomes 1. Cure rate at day 63, PCR adjusted and unadjusted 2. P. vivax during follow up, and mean time to reappearance 3. Gametocyte development during follow up 4. Mean haematocrit at days 0 and 7 5. Adverse events Not included in this review: 1. Fever clearance time 2. Parasite clearance time Notes Country: Thailand Setting: 4 clinics on the Thai-Myanmar border Transmission: Unstable low and seasonal transmission Resistance: Multiple-drug resistance Dates: Jul 2002 to Apr 2003 Funding: 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 9. Artemisinin-based combination therapy for treating uncomplicated malaria (Review) Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. 40
Ashley 2003b THA (Continued) 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 losses to follow up in all groups (12.8% DHA-P vs 13.6% AS+MQ) Free of selective reporting? Yes All WHO outcomes reported Free of other bias? Yes No other sources of bias identified Ashley 2004 THA Methods Trial design: A 3-arm randomized controlled trial Follow up: Temperature and blood smears daily until clearance of fever and parasites, then weekly attendance for examination, symptom enquiry, malaria smear and haematocrit until day 63 Adverse event monitoring: Adverse events defined as signs or symptoms that occurred or became more severe after treatment started. Symptoms were screened at each visit Participants Number: 499 randomized Inclusion criteria: Age 1 to 65 yrs, symptomatic P. falciparum mono-infection or mixed infections, informed consent Exclusion criteria: Pregnancy or lactation, signs or symptoms of severe malaria, > 4% of red blood cells parasitized, treatment with mefloquine in the previous 60 days Interventions 1. Dihydroartemisinin-piperaquine, fixed dose combination (Artekin: Holleykin) • Total dose: 6.4 mg/kg DHA and 51.2 mg/kg P in 4 divided doses at 0, 8, 24, and 48 hours 2. Dihydroartemisinin-piperaquine, fixed dose combination (Artekin: Holleykin) • Total dose: 6.4 mg/kg DHA and 51.2 mg/kg P in 3 divided doses at 0, 24, and 48 hours 3. 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 Outcomes 1. Cure rate at days 63, 42, and 28, PCR adjusted and unadjusted 2. P. vivax during follow up, and median time to reappearance 3. Gametocyte development during follow up 4. Mean haematocrit during follow up 5. Adverse events Not included in this review: 1. Fever clearance Artemisinin-based combination therapy for treating uncomplicated malaria (Review) Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. 41
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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 6.6. Comparison 6 Artesuna
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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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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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