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

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Van Vugt 1998 THA (Continued) Blinding? All outcomes Incomplete outcome data addressed? All outcomes No An open label trial. No other comment on blinding. Yes Different losses to follow up in each group (11% AL6 vs 6% AS+MQ) but unlikely to affect the overall result Free of selective reporting? Yes The WHO recommends 63 days follow up in studies of AS+MQ, and 42 days with AL6. Day 28 outcomes may underestimate treatment failure with both drugs. Free of other bias? Yes No other sources of bias identified Yeka 2004 UGA Methods Trial design: A 3-arm single blind randomized controlled trial Follow up: Malaria film on days 0, 1, 2, 3, 7, 14, 21, 28 and any other day they were unwell. Haemoglobin on days 0 and 28 or the day of failure. Adverse event monitoring: Not described Participants Number: 1537 randomized to included treatment arms Inclusion criteria: Age > 6 months, axillary temp > 37.5 ºC or history of fever in the previous 24 hours, P. falciparum mono-infection 2000 to 200,000/µl, informed consent Exclusion criteria: Pregnancy, danger signs, signs of severe malaria, concomitant febrile illness, history of treatment with an antifolate or amodiaquine during the previous week, history of serious side effects to the study meds 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, plus placebo on days 1 and 2 2. Artesunate plus amodiaquine • AS 4 mg/kg once daily for 3 days • AQ 10 mg/kg on days 0 and 1 and 5 mg/kg on day 2 All doses supervized Outcomes 1. Risk of recurrent infection at day 28, PCR adjusted and unadjusted 2. Gametocytes during follow up 3. Mean increase in haemoglobin 4. Adverse events Not included in this review: 1. Fever clearance 2. Parasite clearance Notes Country: Uganda Setting: District health centres Transmission: 4 sites with medium-high to high endemicity Resistance: CQ and SP resistance Artemisinin-based combination therapy for treating uncomplicated malaria (Review) Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. 100
Yeka 2004 UGA (Continued) Risk of bias Dates: Nov 2002 to May 2004 Funding: CDC/Association of Schools of Public Health co-operative agreement, Malaria Surveillance and Control in Uganda, DfID Item Authors’ judgement Description Adequate sequence generation? Yes ’Randomisation codes were computer generated’ Allocation concealment? No Not described Blinding? All outcomes Incomplete outcome data addressed? All outcomes Yes ’All other study personnel (except study nurse) were blinded to the treatment assignments and participants were not informed of their treatment regimen’ Yes Low losses to follow up in both groups (3.4% AS+AQ vs 4.0% AQ+SP). High transmission with very high reinfection rates results in very high exclusions from primary analysis. Free of selective reporting? Yes Outcomes only presented as percentages. Additional data gained from authors. Free of other bias? Yes No other sources of bias identified Yeka 2007 UGA Methods Trial design: A single blind randomized controlled trial Follow up: Standardized history, physical exam, and malaria film on days 0, 1, 2, 3, 7, 14, 21, 28, 35, and 42 and any other day they were unwell. Haemoglobin on days 0 and 42 or the day of failure. Anaemia was treated with ferrous sulphate and antihelminthics according to IMCI guidelines. Adverse event monitoring: Assessed at each visit including neurological examination. Adverse events described as any untoward medical occurrence. Participants Number: 461 randomized Inclusion criteria: Age 6 months to 10 yrs, weight > 5 kg, axillary temp > 37.5 ºC or history of fever in the previous 24 hours, P. falciparum mono-infection 2000 to 200,000/ µl, informed consent Exclusion criteria: Danger signs or evidence of severe malaria, concomitant febrile illness, history of serious side effects to the study meds Interventions 1. Dihydroartemisinin-piperaquine, fixed dose combination, 40 mg/320 mg tablets ( Duocotexin: HolleyPharm) Artemisinin-based combination therapy for treating uncomplicated malaria (Review) Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. 101
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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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C H A R A C T E R I S T I C S O F S
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Ashley 2003a THA (Continued) Outcom
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Ashley 2003b THA (Continued) Alloca
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Ashley 2005 THA (Continued) Exclusi
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Bonnet 2004 GIN (Continued) Item Au
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Bukirwa 2005 UGA Methods Trial desi
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(... Continued) Study or subgroup A
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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) Vivax efficacy: P. viva
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(Continued) Efficacy: Total Failure
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(Continued) Outcomes Illustrative c
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(Continued) GRADE Working Group gra
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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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