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

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(Continued) Hamour 2003 SDN (161 participants) Kayentao 2006 MLI (265 participants) Swarthout 2004 ZAR (180 participants) Van den Broek 2004 ZAR (192 participants) Adverse event monitoring not described Adverse event monitoring not described Parents and guardians were asked about tolerability and potential side effects of the drugs (days 0, 1, 2, 3, 7, 14, 21, 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) Artesunate plus amodiaquine vs Amodiaquine plus sulfadoxine-pyrimethamine Open label SAE: No significant adverse events Overall comment: No significant adverse events were reported Single blind One death occurred at day 7 after treatment with AS+SP. The parasitaemia was reported as cleared and cause of death unknown. Other AE not reported Open label SAE: None reported Overall comment: There were no adverse side effects reported by parents and both regimens were well tolerated 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 (485 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: 31 serious adverse events (15/232 AS+AQ vs 16/253 AQSP). 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 abdomi- 234
(Continued) Faye 2003 SEN (521 participants) Karema 2004 RWA (510 participants) Kayentao 2006 MLI (265 participants) Menard 2006 MDG (166 participants) All side effects were monitored actively (days 0, 1, 2, 7, 14, 21, and 28) and passively during the study 25% were randomly selected for blood counts, liver and renal function tests at days 0, 14, and 28 Assessed at each follow-up visit (days 0, 1, 2, 3, 7, 14, 21, and 28) An adverse event defined as any unfavourable and unintended sign associated temporally with the use of the drug administered Differential WBC count (and liver function tests at one site only) assessed at days 0 and 14 Adverse event monitoring not described Adverse event monitoring not described Artemisinin-based combination therapy for treating uncomplicated malaria (Review) Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. nal pain, vomiting or diarrhoea. CVS/RS: No significant difference in cough CNS: Weakness more common with AQ+SP (P < 0.05). No other significant differences Biochemical: Elevated liver enzymes occurred in 7 patients, all were attributed to other causes (6 viral hepatitis and 1 Salmonella bacteraemia) Other: No significant difference in pruritis Open label SAE: No serious adverse events Overall comment: The side effects observed with each treatment combination were minor, mainly gastralgia, dizziness, pruritis, asthenia and vomiting Biochemical: No severe alterations in renal or hepatic function were observed Open label SAE: Not reported (one seizure with AS+AQ, one with AQ+SP) GI: No differences in nausea, vomiting, diarrhoea, abdominal pain, or anorexia CVS/RS: No difference in cough, angina, oedema CNS: No difference in seizures, headache, dizziness, drowsiness, or fatigue Biochemical: No differences in mean PCV or mean WBC. No hepatotoxicity observed (1 site only) Other: No difference in rash Single blind AE not reported Single blind (outcome assessors) SAE: ‘No severe side effects attributable to the study medication’ No other reporting of AE 235
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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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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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