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

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(Continued) Martensson 2003 TZA (407 participants) Mutabingwa 2004 TZA (1034 participants) Van den Broek 2004 ZAR (207 participants) Owusu-Agyei 2006 GHA (355 participants) Possible adverse events recorded at each visit (days 0, 1, 2, 3, 7, 14, 21, 28, 35, and 42) Differential white cell counts at days 0, 3, 7, 14, 21, and 28 An adverse event was defined as any undesirable medical occurrence regardless of whether it was related to the treatments Parents or guardians were asked to report on side effects, tolerability and usefulness of the treatment (days 0, 14, and 28) Possible side effects as passively reported to the examiner were recorded at each visit (days 0, 1, 2, 3, 7, 14, 21, and 28) Field workers visited their homes to solicit adverse events on days 0, 2, 3, 7, 14, and 28 Artemisinin-based combination therapy for treating uncomplicated malaria (Review) Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Unclear SAE: 9 severe adverse events (2/200 AL vs 7/208 AS+AQ) all associated with clinically suspected severe malaria and not attributed to study drugs Haematological: No significant differences in mean WBC or neutrophil count between groups Overall comment: Both regimens generally well tolerated Unclear SAE: 1 death in the group treated with AL No other reporting of AE Open label SAE: No severe adverse events judged to be related to the treatment given Overall comment: Common complaints were vomiting, diarrhoea, abdominal pain, and anorexia The frequency of potential adverse events was low (around 10%) and did not differ between groups. 1 case of urticaria occurred with AS+AQ Open label SAE: Not reported GI: No significant difference in diarrhoea, vomiting, nausea, anorexia, abdominal pain CNS: No significant difference in difficulty sleeping CVS/RS: No significant difference in cough, dyspnoea, palpitation Other: Body pain more common with AS+AQ. No difference in fever, runny nose, itching, joint pain, ulcers, yellow eyes 230
Artemether-lumefantrine vs Artesunate plus sulfadoxine-pyrimethamine Study ID Adverse event monitoring Blinding Adverse events Bousema 2004 KEN (249 participants) Karunajeewa 2007 PNG (249 participants) Mukhtar 2005 SDN (160 participants) Van den Broek 2004 ZAR (197 participants) Adverse event monitoring not described Adverse event monitoring not described Adverse event monitoring not described Possible side effects as passively reported to the examiner were recorded at each visit (days 0, 1, 2, 3, 7, 14, 21, and 28) Artemether-lumefantrine vs Amodiaquine plus sulfadoxine-pyrimethamine Single blind (outcome assessors) AE not reported Open label Overall comment: No treatment withdrawals were attributable to adverse events related to a study drug No other significant differences are noted between treatments Unclear AE not reported Open label SAE: No severe adverse events judged to be related to the treatment given Overall comment: Common complaints were vomiting, diarrhoea, abdominal pain and anorexia The frequency of potential adverse events was low (around 10%) and did not differ between groups. 1 case of urticaria occurred with AS+SP Study ID Adverse event monitoring Blinding Adverse events Dorsey 2006 UGA (455 participants) Assessed at each follow-up visit (days 0, 1, 2, 3, 7, 14, and 28) An adverse event defined as any untoward medical occurrence Complete blood count and liver enzymes on days 0 and 14 Artemisinin-based combination therapy for treating uncomplicated malaria (Review) Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Single blind (outcome assessors) SAE: 30 serious adverse events (14/202 AL vs 16 AQ+SP). Majority were seizures associated with fever. None considered probably or definitely related to study meds. GI: Anorexia more common with AQ+SP (P < 0.05). No significant difference in abdominal pain, vomiting, or diar- 231
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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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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 10.2. Comparison 10 Arteme
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