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

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Tangpukdee 2005 THA (Continued) Interventions 1. Dihydroartemisinin-piperaquine, fixed dose combination, 40 mg/320 mg tablets (Artekin: Holleykin) • Total dose: DHA 6 mg/kg + P 45 mg/kg in 3 divided doses, given once daily for 3 days 2. Artesunate plus mefloquine, loose combination • 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 28. PCR analysis not performed as all patients hospitalised for duration of follow up, so all recurrent parasitaemias presumed to be recrudescence 2. Adverse events Not included in the review: 1. Fever clearance time 2. Parasite clearance time Notes Country: Thailand Setting: Bangkok Hospital for Tropical Diseases Transmission: Low Resistance: Multiple-drug resistance Dates: Not given Funding: Mahidol University Research Grant, Artekin supplied by Holleykin Pharmaceuticals Risk of bias Item Authors’ judgement Description Adequate sequence generation? Unclear ’Randomly treated at a ratio of 1:2’. No further details given. 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. Yes Losses to follow up were low and similar between groups (10.8% DHA-P vs 10% AS+MQ) Free of selective reporting? Yes Day 28 outcomes may overestimate the efficacy of drugs with long half-lives such as AS+MQ and DHA-P Free of other bias? Yes No other sources of bias identified Artemisinin-based combination therapy for treating uncomplicated malaria (Review) Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. 94
Tran 2002 VNM Methods Trial design: An open label randomized controlled trial Follow up: Malaria film on days 0, 2, and 7. Participants followed up to day 56 but further details not described Adverse event monitoring: Not described Participants Number: 243 randomized to included treatment arms Inclusion criteria: Age > 2 yrs, microscopically confirmed uncomplicated P. falciparum malaria Exclusion criteria: Pregnancy, evidence of organ dysfunction, unable to tolerate oral medication, unable to return for follow up, resident in Dac O for > 2 years Interventions 1. Dihydroartemisinin-piperaquine, fixed dose combination, 40 mg/320 mg tablets (Artekin: Holleykin) • Adults: 2 tablets at 0, 6, 24, and 48 hrs • Children < 15 yrs: 1 tablet at 0, 6, 24, and 48 hrs 2. 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 2 divided doses 6 hours apart on day 3 Outcomes 1. Parasitological failure at days 42 and 28, PCR adjusted and unadjusted 2. Adverse events Not included in this review: 1. Fever clearance 2. Parasite clearance Notes Country: Vietnam Setting: Health station Transmission: Low and seasonal Resistance: Multiple-drug resistance Dates: Nov 2001 to Mar 2002 Funding: Wellcome Trust of Great Britain Risk of bias Item Authors’ judgement Description Adequate sequence generation? Unclear ’Patients were randomly allocated one of three treatments in a ratio of 2:2:1’. No further details given. Allocation concealment? Unclear ’Drugs were kept in identically numbered opaque 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 ’There were no losses to follow-up’ 95
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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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(... 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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