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

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(Continued) Van den Broek 2003a BGD (242 participants) Van Vugt 1998 THA (200 participants) Routine follow up on days 0, 1, 2, 3, 7, 14, 21, 28, 35, and 42 and any other day when feeling ill Possible side effects assessed at each visit Routine follow up daily until fever and parasites cleared then weekly to day 28 A questionnaire for adverse effects was completed at each visit. Full neurological examination on days 0, 3, 7, and 28. Complete haematology and biochemistry (at one centre) on days 0, 3, 7, and 28. Artesunate plus mefloquine vs Artesunate plus amodiaquine Study ID Adverse event monitoring Blinding Adverse events Faye 2003 SEN (505 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 Artemisinin-based combination therapy for treating uncomplicated malaria (Review) Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Open label SAE: None observed During the first 3 days headache, vomiting, nausea, and dizziness were significantly more common with AS+MQ (P < 0.05) Other complaints were: sleeplessness, pruritis/ rash, epigastric pain, sweating with AS+MQ; blurred vision and anorexia with AL Open label SAE: 1 with AL: coma lasting 4 days 12 days after treatment, 1 with AS+MQ; generalized urticaria on day 1 Vomiting of medication: 4/150 AL vs 5/50 ASMQ (P = 0.045) GI: Anorexia, vomiting, nausea, abdominal pain, hepatomegaly less common with AL (12.7% AL vs 26% AS+MQ, P = 0.043) CVS: No electrocardiographic changes CNS: CNS symptoms (dizziness, sleep disorder, headache) less common with AL (6% AL vs 34% AS+MQ, P < 0.0001). One case of tremor and 2 cases of numbness with AL. Overall: Possible drug related adverse events less common with AL (33/150 AL vs 23/50 ASMQ, P = 0.002) 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 226
Artesunate plus mefloquine vs Amodiquine plus sulfadoxine-pyrimethamine Study ID Adverse event monitoring Blinding Adverse events Faye 2003 SEN (306 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 Artemether-lumefantrine vs Artesunate plus amodiaquine 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 Study ID Adverse event monitoring Blinding Adverse events Adjei 2006 GHA (227 participants) Assessed at each follow-up visit (days 0, 1, 2, 3, 7, 14, and 28), including neurological assessment Audiological assessment on days 0, 3, 7, and 28 Total and differential WBC counts and liver enzymes on days 0, 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. Single blind (outcome assessors) SAE: 1 patient treated with AS+AQ had severe anaemia on day 14 GI: No significant difference in nausea and vomiting between groups CNS: No significant difference in dizziness, fatigue, or excessive sleepiness between groups. Nystagmus was observed in 1 patient in each group, both cases had potential explanations from the past medical history. A positive Romberg’s test was observed in 1 child treated with AL, again with a possible alternative diagnosis. Audiology: Hearing thresholds were significantly elevated in treated subjects as days 0, 3, 7, and 28 but no differences between participants and controls after 9 months Haematological: The mean neutrophil count was lower than baseline in both 227
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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 6.6. Comparison 6 Artesuna
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Analysis 9.8. Comparison 9 Artemeth
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