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 Data are also available for treatment failure at day 28 but provide no further useful information. 3 Kamya 2006 UGA, Yeka 2007 UGA and Zongo 2007 BFA. 4 No serious limitations: Allocation concealment was assessed as ’low risk of bias’ in all trials. Laboratory staff were blinded in two trials. 5 No serious inconsistency: Heterogeneity was low. 6 No serious indirectness: Trials were conducted in Africa (Uganda and Burkina Faso) in areas of high and moderate transmission. Children aged < six months and pregnant or lactating women were excluded. 7 No serious imprecision: Both limits of the 95% CI of the pooled estimate imply appreciable benefit with DHA-P. 8 Serious inconsistency: Heterogeneity was high (I 2 = 91%) reflecting differences in the magnitude of effect but not the direction. 9 No serious imprecision: The 95% CI of the pooled estimate includes appreciable benefit and non-appreciable benefit with DHA-P over AL6 but does not cross the line of no effect. 10 Ratcliff 2005 IDN. 11 Serious limitations: Allocation concealment was assessed as ’low risk of bias’ in this trial. At day 42 loss to follow-up was high: > 20% in both groups. 12 Serious indirectness: Only one trial from Asia. 13 Serious imprecision: The 95% CI is very wide including appreciable benefit or harm with each drug over the other. 14 No serious imprecision: The 95% CI includes appreciable benefit with DHA-P and crosses the line of no effect but does not include appreciable benefit with AS+AQ. 15 Allocation concealment was assessed as ’low risk of bias’ in three out of four trials. Laboratory staff were blinded in 4 trials. 16 No serious indirectness: Although the strongest data are from Asia (Ratcliff 2005 IDN and Karunajeewa 2007 PNG) these are consistent with the data from Africa. 17 No serious limitations: Allocation concealment was assessed as ’low risk of bias’ in two out of four trials. Laboratory staff were blinded in three trials. 18 Very serious inconsistency: Heterogeneity was high (I 2 = 76%) with two trials (Kamya 2006 UGA; Yeka 2007 UGA) favouring DHA-P and two (Mens 2007 KEN; Zongo 2007 BFA) favouring AL6. 19 Very serious imprecision: Data not pooled. 20 No serious limitations: Allocation concealment was assessed as ’low risk of bias’ in four trials. 21 Very serious imprecision: The 95% CI of the pooled estimate is wide including appreciable benefit and harm with each drug over the other. 22 Serious limitations: Allocation concealment was assessed as ’low risk of bias’ in both trials. Both trials were unblinded. Is Dihydroartemisinin-piperaquine as effective as Artesunate plus amodiaquine for treating uncomplicated malaria? Patient or population: Patients with uncomplicated malaria Settings: Endemic areas worldwide Intervention: Dihydroartemisinin-piperaquine Comparison: Artesunate plus amodiaquine Artemisinin-based combination therapy for treating uncomplicated malaria (Review) Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. 244
(Continued) Outcomes Illustrative comparative risks* (95% CI) Relative effect (95% CI) Efficacy: Total Failure (P. falciparum) Day 28 PCR adjusted Efficacy: Total Failure (P. falciparum) Day 28 PCR unadjusted Vivax efficacy: P. vivax parasitaemia by day 42 Transmission potential: Gametocyte carriage Harms: Serious adverse events (including deaths) Harms: Early vomiting Assumed risk Corresponding risk Artesunate plus amodiaquine Dihydroartemisininpiperaquine 73 per 1000 34 per 1000 (17 to 69) 161 per 1000 85 per 1000 (56 to 130) 175 per 1000 44 per 1000 (16 to 130) RR 0.47 (0.23 to 0.94) RR 0.53 (0.35 to 0.81) RR 0.25 (0.09 to 0.74) No of participants (studies) 629 (2) 679 (2) 170 (1) - - - 881 (2) 18 per 1000 3 per 1000 (0 to 49) 78 per 1000 41 per 1000 (17 to 101) RR 0.14 (0.01 to 2.71) RR 0.53 (0.22 to 1.3) 334 (1) 334 (1) Quality of the evidence (GRADE) ⊕⊕⊕ moderate 1,2,3,4,5,6,7,8 ⊕⊕⊕ moderate 2,3,4,5,6,7,8 ⊕⊕⊕ moderate 9,10,11 - 12 ⊕ very low 9,10,13 ⊕ very low 10,13,14 *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. Artemisinin-based combination therapy for treating uncomplicated malaria (Review) Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. 245
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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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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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Faye 2003 SEN (Continued) Outcomes
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Guthmann 2004 AGO (Continued) All d
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Martensson 2003 TZA Methods Trial d
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Mens 2007 KEN (Continued) Risk of b
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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 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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