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

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Janssens 2003 KHM (Continued) blood cells parasitized, a history of convulsions or neuropsychiatric disorder, treatment with mefloquine in the past 60 days Interventions 1. Dihydroartemisinin-piperaquine, fixed dose combination, 40 mg/320 mg tablets (Artekin: Holleykin) • Adult total dose: 6 mg/kg DHA and 48 mg/kg P in 4 divided doses, given at 0, 8, 24, and 48 hours • Children total dose: 6.4 mg/kg DHA + 51.2 mg/kg P in 4 divided doses, given at 0, 8, 24, 48 hours 2. Artesunate plus mefloquine, loose combination (Artesunate: Guilin, Mefloquine: Mepha) • Adults: 100 mg AS plus 500 mg MQ twice daily on day 0, then 200 mg AS once daily on day 1 and day 2 • Children: AS 4 mg/kg once daily for 3 days plus 25 mg/kg MQ split into 2 doses on day 0 All doses supervized Outcomes 1. Cure rate at days 63, 42, and 28, PCR adjusted and unadjusted 2. P. vivax parasitaemia during follow up 3. Mean haematocrit at day 0 and 63 4. Adverse effects Not included in the review: 1. Fever clearance 2. Parasite clearance Notes Country: Cambodia Setting: Rural health centres and outreach malaria clinics Transmission: Low and seasonal Resistance: Multiple-drug resistance Dates: Oct 2002 to March 2003 Funding: Médecins sans Frontières Risk of bias Item Authors’ judgement Description Adequate sequence generation? Yes ’Computer generated randomisation (STATA version 8, Statacorp)’ Allocation concealment? Unclear ’Treatment allocations were concealed in sealed envelopes’. No further details. Blinding? All outcomes Incomplete outcome data addressed? All outcomes Artemisinin-based combination therapy for treating uncomplicated malaria (Review) Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. No An open-label trial. No comment on blinding of laboratory staff. Yes Losses to follow up balanced and low in both groups (9.3% DHA-P vs 10% AS+MQ) 64
Janssens 2003 KHM (Continued) Free of selective reporting? Yes All WHO outcomes reported Free of other bias? Yes No other sources of bias identified Kamya 2006 UGA Methods Trial design: A single blind (outcome assessors) randomized controlled trial Follow up: Standardized history and examination and malaria film on days 0, 1, 2, 3, 7, 14, 21, 28, 35, 42 and any other day they felt unwell. Haemoglobin measured at day 0 and day 42 or day of failure. Anaemia was treated with ferrous sulphate and anthelminthics according to IMCI guidelines. Adverse event monitoring: Assessed for any new or worsening event at each visit. An adverse event defined as any untoward medical occurrence, irrespective of its suspected relationship to the study medications. Participants Number: 509 randomized Inclusion criteria: Age 6 m to 10 yrs, weight > 5 kg, axillary temp > 37.5 ºC or history of fever in the past 24 hours, P. falciparum mono-infection 2000 to 200,000/µl, informed consent Exclusion criteria: Danger signs or signs of severe malaria, evidence of concomitant febrile illness, history of serious side effects to study medication Interventions 1. Artemether-lumefantrine, fixed dose combination, 20 mg/120 mg tablets (Coartem: Novartis) • 5 to 14 kg 1 tablet twice daily for 3 days • 15 to 24 kg 2 tablets twice daily for 3 days • 25 to 34 kg 3 tablets twice daily for 3 days • > 35 kg 4 tablets twice daily for 3 days 2. Dihydroartemisinin-piperaquine, fixed dose combination, 40 mg/320 mg tablets ( Duocotexin: HolleyPharm) • Total dose: DHA 6.4 mg/kg + P 51.2 mg/kg in 3 divided doses, given once daily for 3 days • Plus placebo tablet in the evening to simulate twice daily dosing All doses supervized. All participants received a glass of milk after each dose Outcomes 1. Risk of treatment failure at day 42, PCR adjusted and unadjusted 2. Non falciparum species during follow up 3. Gametocyte development during follow up 4. Mean increase in haemoglobin at last day of follow up 5. Adverse events Not included in the review: 1. Fever clearance 2. Parasite clearance Notes Country: Uganda Setting: Rural health centre Transmission: Perennial holoendemic malaria with very high transmission intensity Resistance: Not reported Artemisinin-based combination therapy for treating uncomplicated malaria (Review) Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. 65
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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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Comparison 8. Artesunate plus meflo
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Comparison 12. Artesunate plus amod
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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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(... Continued) Study or subgroup D
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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 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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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) Proportion with anaemia
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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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