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

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Appendix 2. Detailed search strategy Search set CIDG SR a CENTRAL MEDLINE b EMBASE b LILACS b 1 malaria malaria malaria malaria malaria 2 arte* arte* arte* arte* arte* 3 dihydroarte* dihydroarte* dihydroarte* dihydroarte* dihydroarte* 4 amodiaq* amodiaq* amodiaq* amodiaq$ amodiaq$ 5 lumefantrine lumefantrine lumefantrine lumefantrine lumefantrine 6 Coartem* Coartem* Coartem* Coartem$ Coartem$ 7 mefloquine mefloquine mefloquine mefloquine mefloquine 8 2 or 3 2 or 3 2 or 3 2 or 3 2 or 3 9 4 or 5 or 6 or 7 4 or 5 or 6 or 7 4 or 5 or 6 or 7 4 or 5 or 6 or 7 4 or 5 or 6 or 7 10 1 and 8 and 9 1 and 8 and 9 1 and 8 and 9 1 and 8 and 9 1 and 8 and 9 11 - - Limit 10 to humans Limit 10 to human - Footnotes a Cochrane Infectious Diseases Group Specialized Register. b Search terms used in combination with the search strategy for retrieving trials developed by The Cochrane Collaboration (Lefebvre 2008); upper case: MeSH or EMTREE heading; lower case: free text term. Appendix 3. Primary outcome measure (Total Failure) and sensitivity analyses Analysis Participants PCR b -unadjusted PCR-adjusted Primary analysis Exclusions after enrolment Missing or indeterminate PCR Numerator Denominator Numerator Denominator Excluded c Excluded Excluded Excluded Included as failures Included Excluded Excluded New infections Included as failures Included Excluded Excluded Artemisinin-based combination therapy for treating uncomplicated malaria (Review) Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. 218
(Continued) Sensitivity analysis 1 d Sensitivity analysis 2 e Sensitivity analysis 3 f Sensitivity analysis 4 g Footnotes As ’Primary analysis’ except: missing or indeterminate PCR As ’Sensitivity analysis 1’ except: new infections As ’Sensitivity analysis 2’ except: exclusions after enrolment As ’Sensitivity analysis 2’ except: exclusions after enrolment - - Included as failures Included - - Included as successes Included Included as failures Included Included as failures Included Included as successes Included Included as successes Included a Note: participants who were found to not satisfy the inclusion criteria after randomization are removed from all calculations. b PCR: polymerase chain reaction. c ’Excluded’ means removed from the calculation. d To re-classify all indeterminate or missing PCR results as treatment failures in the PCR-adjusted analysis. e To re-classify all PCR-confirmed new infections as treatment successes in the PCR-adjusted analysis. (This analysis may overestimate efficacy as PCR is not wholly reliable and some recrudescences may be falsely classified as new infections. Also some participants may have gone on to develop a recrudescence after the new infection.) f To re-classify all exclusions after enrolment (losses to follow up, withdrawn consent, other antimalarial use, or failure to complete treatment) as treatment failures. For PCR-unadjusted total failure this represents a true worse-case scenario. g To re-classify all exclusions after enrolment (losses to follow up, withdrawn consent, other antimalarial use, or failure to complete treatment) as treatment successes. Appendix 4. Adverse event tables Dihydroartemisinin-piperaquine vs Artesunate plus mefloquine Study ID Adverse event monitoring Blinding Summary of adverse event findings Ashley 2003a THA (134 participants) Inpatient monitoring until day 28 FBC, U&E, LFT on days 0 and 7 Artemisinin-based combination therapy for treating uncomplicated malaria (Review) Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Open label SAE: No serious adverse events observed Biochemical: No evidence of toxicity observed Other: No differences between the groups reported 219
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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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Djimde 2004 MLI (Continued) • AS
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Dorsey 2006 UGA (Continued) Item Au
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Fanello 2004 RWA Methods Trial desi
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Faye 2003 SEN (Continued) Outcomes
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Grande 2005 PER (Continued) Allocat
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Guthmann 2004 AGO (Continued) All d
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Hasugian 2005 IDN Methods Trial des
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Hutagalung 2002 THA (Continued) 5.
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Janssens 2003 KHM (Continued) Free
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Karema 2004 RWA (Continued) Interve
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Karunajeewa 2007 PNG (Continued) Ri
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Kobbe 2007 GHA (Continued) Exclusio
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Koram 2003 GHA (Continued) Adequate
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Martensson 2003 TZA Methods Trial d
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Mayxay 2003 LAO (Continued) 1. Feve
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Menard 2006 MDG Methods Trial desig
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Mens 2007 KEN (Continued) Risk of b
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Mutabingwa 2004 TZA (Continued) •
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Owusu-Agyei 2006 GHA (Continued) Fr
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Sagara 2005b MLI (Continued) • 25
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Smithuis 2004 MMR (Continued) Risk
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Stohrer 2003 LAO Methods Trial desi
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Swarthout 2004 ZAR (Continued) Note
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Tran 2002 VNM Methods Trial design:
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Van den Broek 2003a BGD (Continued)
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Van Vugt 1998 THA Methods Trial des
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Yeka 2004 UGA (Continued) Risk of b
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Yeka 2007 UGA (Continued) Free of o
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Zongo 2007 BFA (Continued) Novartis
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(Continued) Fofana 2005 Conference
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D A T A A N D A N A L Y S E S Compa
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2.2 Asia 1 317 Risk Ratio (M-H, Fix
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Comparison 5. Dihydroartemisinin-pi
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Comparison 8. Artesunate plus meflo
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Comparison 10. Artemether-lumefantr
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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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(... Continued) Study or subgroup D
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(... Continued) Study or subgroup A
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Analysis 6.6. Comparison 6 Artesuna
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Page 173 and 174: Analysis 9.2. Comparison 9 Artemeth
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Page 243 and 244: PCR = polymerase chain reaction PCV
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