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

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Kobbe 2007 GHA (Continued) Free of selective reporting? Yes All WHO outcomes reported Free of other bias? Yes No other sources of bias identified Koram 2003 GHA Methods Trial design: A 4-arm, open-label randomized controlled trial Follow up: Examination, symptoms recorded, temperature and pulse and malaria film on days 0, 1, 2, 3, 7, 14, 21 and 28 and any other day they felt unwell. Full blood count and haemoglobin measured at days 14 and 28. Adverse event monitoring: None Participants Number: 105 randomized into included treatment arms Inclusion criteria: Age 6 to 59 months, signs and symptoms of uncomplicated malaria including axillary temp > 37.5 ºC, P. falciparum mono-infection of 2000 to 200,000/µl, informed consent Exclusion criteria: Signs and symptoms of severe malaria, other diseases requiring drugs with antimalarial or antihistaminic activities, Hb < 5 g/dl Interventions 1. Artemether-lumefantrine, fixed dose combination, 20 mg/120 mg tablets (Coartem: Novartis) • Twice daily for 3 days based on weight 2. Artesunate plus amodiaquine, loose combination • AS 4 mg/kg/day for 3 days • AQ 10 mg/kg on days 0 and 1 and 5 mg/kg on day 2 All doses supervized Outcomes 1. ACPR at day 28, PCR adjusted and unadjusted (excluded from primary analysis due to baseline differences) 2. Gametocyte carriage on days 0, 7, and 14 3. Mean haemoglobin on days 0, 14, and 28 Not included in the review: 1. Fever clearance time 2. Parasite clearance time Notes Country: Ghana Setting: Hohoe District Hospital and Navrongo War Memorial Hospital Transmission: High transmission and markedly seasonal Resistance: CQ and SP resistance Dates: June 2003 to Aug 2003 Funding: Multilateral Initiative on Malaria, UNICEF/UNDP/World Bank/WHO Special Program for Research & Training in Tropical Diseases Risk of bias Item Authors’ judgement Description Artemisinin-based combination therapy for treating uncomplicated malaria (Review) Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. 72
Koram 2003 GHA (Continued) Adequate sequence generation? Yes ’Computer generated random list based on a simple random selection procedure’ Allocation concealment? No None described Blinding? All outcomes Incomplete outcome data addressed? All outcomes No An open-label trial. No comment on blinding of laboratory staff No ’Patients who showed signs/symptoms of severe malaria, had serious adverse events or required blood transfusion were withdrawn from the study’. These events after enrolment would represent treatment failure and should not be withdrawn. Free of selective reporting? Yes 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? No Participants in the AL6 group were significantly older and had a higher Hb at baseline. This is due to differing inclusion criteria for the 2 groups and is likely to affect the result. Lefevre 1999 THA Methods Trial design: An open-label clinical and pharmacokinetic randomized controlled trial Follow up: Monitored 3 times daily until parasites and fever cleared. Then follow up at days 1, 2, 3, 7, 14, 21, and 28 for temp and malaria film. P. vivax during follow up was treated with CQ and primaquine and continued in follow up Adverse event monitoring: Assessed at each visit. ECG monitoring and laboratory tests (including FBC liver and renal function tests) at baseline and each day of follow up. Participants Number: 219 randomized Inclusion criteria: Age > 12 yrs, weight > 35 kg, microscopically confirmed P. falciparum, informed consent Exclusion criteria: Signs or symptoms of severe malaria, heart disease or significant ECG abnormalities, psychiatric disorders, severe renal or hepatic impairment, history of drug hypersensitivity or allergy Interventions 1. Artemether-lumefantrine, fixed dose combination, 20 mg/120 mg tablets (Coartem: Novartis) • 4 tablets twice daily for 3 days 2. Artesunate plus mefloquine, loose combination (Artesunate: Guilan, Lariam: Hoffman-La Roche) • AS 4 mg/kg once daily for 3 days Artemisinin-based combination therapy for treating uncomplicated malaria (Review) Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. 73
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Artemisinin-based combination thera
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Analysis 2.2. Comparison 2 Dihydroa
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Analysis 10.5. Comparison 10 Arteme
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[Intervention Review] Artemisinin-b
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B A C K G R O U N D Malaria is a di
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drugs and the treatment comparisons
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this analysis into participants who
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Figure 1. Methodological quality su
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confidence intervals of the estimat
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Anaemia Hasugian 2005 IDN found tha
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Three trials report significantly m
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or those treated for P. vivax at ba
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Early vomiting Not reported. D I S
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Comparison 21. How does Artesunate
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Analysis 1.12. Comparison 1 Dihydro
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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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(Continued) Sensitivity analysis 1
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(Continued) Smithuis 2004 MMR (652
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PCR = polymerase chain reaction PCV
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(Continued) Efficacy: Total Failure
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Footnotes 1 Data were also availabl
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8 Very serious imprecision: There w
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(Continued) justed Vivax efficacy:
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(Continued) Harms: Serious adverse
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(Continued) Harms: Early vomiting -
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1 Dorsey 2006 UGA; Faye 2003 SEN; K
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