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

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Footnotes 1 Please note that due to its longer half-life, PCR adjusted treatment failure with DHA-P may be underestimated at this time point. 2 One trial (Hasugian 2005 IDN) also reported outcomes at day 42 but losses to follow up were very high (> 20%) at this time point. 3 Hasugian 2005 IDN and Karema 2004 RWA. 4 No serious limitations: Allocation concealment was assessed as ’low risk of bias’ in one trial and ’unclear’ in one trial. Laboratory staff were blinded in both trials. 5 No serious inconsistency: Heterogeneity was low. 6 One trial was conducted in Africa (Rwanda, transmission intensity not reported) and one in Asia (Indonesia, unstable transmission). Children aged < one year and pregnant or lactating women were excluded. 7 Serious indirectness: Due to variable resistance rates to amodiaquine extrapolation to other areas is likely to be unreliable. 8 No serious imprecision: The 95% CI of the pooled estimate includes appreciable and non-appreciable benefit with DHA-P over AS+AQ but does not cross the line of no effect. 9 No serious limitations: Allocation concealment was assessed as ’low risk of bias’ in this trial (Hasugian 2005 IDN). 10 Serious indirectness: Only one trial (Hasugian 2005 IDN) assessed this outcome. 11 No serious imprecision: Both limits of the 95% CI imply appreciable benefit with DHA-P over AS+AQ. 12 Both trials report no differences in gametocyte carriage but figures were not given. 13 Very serious imprecision: The 95% CI includes appreciable benefit or harm with each drugs over the other. 14 Serious limitations: This trial was open label. Is Dihydroartemisinin-piperaquine superior to Artesunate plus sulfadoxine-pyrimethamine for treating uncomplicated malaria? Patient or population: Patients with uncomplicated malaria Settings: Endemic areas excluding Southeast Asia Intervention: Dihydroartemisinin-piperaquine Comparison: Artesunate plus sulfadoxine-pyrimethamine Outcomes Illustrative comparative risks* (95% CI) Relative effect (95% CI) Efficacy: Total Failure Day 42 PCR adjusted Assumed risk Corresponding risk Artesunate plus sulfadoxinepyrimethamine Dihydroartemisinin - piperaquine 202 per 1000 156 per 1000 (79 to 305) RR 0.77 (0.39 to 1.51) Artemisinin-based combination therapy for treating uncomplicated malaria (Review) Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. No of participants (studies) 161 (1) Quality of the evidence (GRADE) ⊕ very low 1,2,3,4 246
(Continued) Efficacy: Total Failure Day 42 PCR unadjusted Vivax efficacy: P. vivax parasitaemia Day 42 Transmission potential: Gametocyte carriage Harms: Serious adverse events (including deaths) Harms: Early vomiting 380 per 1000 391 per 1000 (281 to 551) 596 per 1000 268 per 1000 (191 to 387) RR 1.03 (0.74 to 1.45) RR 0.45 (0.32 to 0.65) 215 (1) 194 (1) - - - 215 (1) ⊕ very low 1,2,3,4 ⊕⊕ low 1,2,3,5 - - - - Not reported - - - - Not reported *The assumed risk is the mean risk from the studies included in this review, calculated as the number of patients in the control groups with the event divided by the total number of patients in control groups. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; RR: risk ratio GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate. Footnotes 1 Karunajeewa 2007 PNG. 2 Serious limitations: No allocation concealment was described. Laboratory staff were blinded to treatment allocation. 3 Serious indirectness: Data only available from one country. 4 Very serious imprecision: The 95% CI includes appreciable benefit and harm of one drug over the other. 5 No serious imprecision: Both limits of the 95% CI suggest appreciable benefit with DHA-P. 6 Karunajeewa 2007 PNG reports that there were no differences in gametocyte carriage but no figures were given. Artemisinin-based combination therapy for treating uncomplicated malaria (Review) Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. - 6 247
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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 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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Martensson 2003 TZA Methods Trial d
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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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Analysis 6.6. Comparison 6 Artesuna
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Analysis 9.2. Comparison 9 Artemeth
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Analysis 12.2. Comparison 12 Artesu
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Analysis 12.4. Comparison 12 Artesu
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