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

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Smithuis 2004 MMR Methods Trial design: A 4-arm open-label randomized controlled trial Follow up: A symptom questionnaire, malaria film, and gametocyte count on days 0, 1, 2, 3, 7, 14, 21, 28, 35, and 42. Haemoglobin was measured on days 0 and 28. Adverse event monitoring: A symptom questionnaire at each visit Participants Number: 652 randomized Inclusion criteria: Age > 1 year, axillary temperature > 37.5 ºC or history of fever in the previous 48 hrs, P. falciparum mono-infection 500 to 100,000 parasites/µl or coinfection with P. vivax, informed consent Exclusion criteria: Pregnancy, signs of severe malaria, signs or symptoms of other diseases, history of taking mefloquine in the previous 2 months or any other antimalarial in the previous 48 hrs, history of psychiatric disease 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 • Supervized 2. 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 • Unsupervized 3. Artesunate plus mefloquine, loose combination (artesunate: Guilin, Lariam: Hoffman- La Roche) • AS 4 mg/kg once daily for 3 days • MQ 25 mg base/kg as a single dose on day 0 • Supervized 4. Artesunate plus mefloquine, loose combination (artesunate: Guilin, Lariam: Hoffman- La Roche) • AS 4 mg/kg once daily for 3 days • MQ 25 mg base/kg as a single dose on day 0 • Unsupervized Outcomes 1. Failure Rate at days 42 and 28, 42 PCR unadjusted and PCR adjusted 2. P. vivax during follow up and median time to appearance 3. Gametocyte carriage at days 0, 7, 14, 21, and 28 4. Mean change in haemoglobin from day 0 to day 28 5. Adverse events Not included in the review: 1. Fever clearance 2. Parasite clearance 3. New gametocyte appearance at day 7 and day 14 Notes Country: Myanmar Setting: Rural village tracts Transmission: Seasonal with peaks in the monsoon season Nov to Jan and sometimes in the early monsoon, May to June Resistance: Very high rates of CQ and SP resistance Artemisinin-based combination therapy for treating uncomplicated malaria (Review) Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. 88
Smithuis 2004 MMR (Continued) Risk of bias Dates: Nov 2003 to Feb 2004 Funding: Médecins sans Frontières (Holland) Item Authors’ judgement Description Adequate sequence generation? Yes Unmarked and sealed envelopes, containing the treatment allocation were drawn from a box Allocation concealment? Unclear ’Unmarked and sealed envelopes’. No further details given. Blinding? All outcomes Incomplete outcome data addressed? All outcomes No An open label trial. No comment on blinding of laboratory staff. Yes Very low losses to follow up in both groups 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 Staedke 2003 UGA Methods Trial design: An open label randomized controlled trial Follow up: A standardized history and examination and malaria film on days 1, 2, 3, 7, 14, 21, and 28 or other times if they were unwell. Haemoglobin was measured on days 0, 7, and 28. Adverse event monitoring: Assessed at each visit. Neurological assessment on days 0, 7, 14, and 28. Complete blood count, creatinine, and alanine transferase on days 0, 7, and 28. Participants Number: 278 randomized into included treatment arms Inclusion criteria: Age 6 months to 10 yrs, tympanic temp > 38.0 ºC or febrile symptoms in previous 48 hrs, P. falciparum mono-infection 500 to 200,000/µl, willingness to participate in 28 day follow up, informed consent Exclusion criteria: Danger signs, severe malaria, alternative diagnosis for febrile illness, antifolate use in the previous 4 weeks, history of serious side effects to any of the study drugs, severe anaemia (Hb < 5 g/dl) Interventions 1. Amodiaquine plus sulfadoxine-pyrimethamine, loose combination • AQ 10 mg/kg on days 0 and 1 and 5 mg/kg on day 2 • SP 25/1.25 mg/kg once on day 0 Artemisinin-based combination therapy for treating uncomplicated malaria (Review) Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. 89
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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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Figure 4. Olliaro-Vaillant plot. Da
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Figure 10. Olliaro-Vaillant plot. D
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of findings tables’. For these ta
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Huambo and Bie provinces, central A
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References to studies excluded from
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Adjuik 2004 Adjuik M, Babiker A, Ga
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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 9.8. 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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(... Continued) Study or subgroup D
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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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(Continued) Mayxay 2003 LAO (220 pa
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Artesunate plus mefloquine vs Amodi
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(Continued) Faye 2003 SEN (509 part
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Artemether-lumefantrine vs Artesuna
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(Continued) Zongo 2005 BFA (521 par
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(Continued) Faye 2003 SEN (521 part
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PCR = polymerase chain reaction PCV
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(Continued) Proportion with anaemia
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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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