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

More documents

Recommendations

Info

$Interventions for treating proximal humeral fractures in adults (Review)$

Ratcliff 2005 IDN (Continued) Risk of bias Item Authors’ judgement Description Adequate sequence generation? Yes ’A randomisation list was generated in blocks of 20 patients by an independent statistician’ Allocation concealment? Yes ’With each treatment allocation concealed in an opaque sealed envelope’. No further details given. Blinding? All outcomes Incomplete outcome data addressed? All outcomes No An open label trial. The microscopists were blinded to treatment allocation. No The primary outcome data are unpublished data including only participants with P. falciparum mono or co-infection at baseline. Losses to follow up were high in both groups at day 42 (28.4 % DHA-P vs 25.6 % AL6) and moderate at day 28 (19% DHA- P vs 17.6% AL6). Free of selective reporting? Yes All WHO outcomes reported. Day 42 outcomes may underestimate failure with DHA-P due to its long half-life. Free of other bias? Yes No other sources of bias identified Sagara 2005b MLI Methods Trial design: An open label randomized controlled trial Follow up: Examination and malaria film on days 0, 1, 2, 3, 7, 14, 21, 28, and any day they felt unwell. Haemoglobin on days 0, 14, and 28. Adverse event monitoring: CBC, ALT, and creatinine on 20% of participants on days 0 and 14 Participants Number: 470 randomized Inclusion criteria: Age > 1 yr, weight >10 kg, axillary temperature > 37.5 ºC, P.falciparum mono-infection 2000 to 200,000, resident at study site, able to take oral medication, informed consent Exclusion criteria: Pregnancy, severe malaria, a serious underlying disease, an allergy to 1 or more study drugs, use of study drugs within 28 days Interventions 1. Artemether-lumefantrine, fixed dose combination, 20 mg/120 mg tablets (Coartem: Novartis) • 5 to 14 kg 1 tablet twice daily for 3 days • 15 to 24 kg 2 tablets twice daily for 3 days Artemisinin-based combination therapy for treating uncomplicated malaria (Review) Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. 86
Sagara 2005b MLI (Continued) • 25 to 34 kg 3 tablets twice daily for 3 days • > 35 kg 4 tablets twice daily for 3 days 2. Artesunate plus mefloquine, co-blistered (Artequin: Mepha) • 10 to 14 kg AS 4 mg/kg and MQ 5 mg/kg once daily for 3 days • 15 to 30 kg AS 100 mg and MQ 150 mg once daily for 3 days • > 31 kg AS 200 mg and MQ 250 mg once daily for 3 days All doses supervized Outcomes 1. ACPR at day 28, PCR adjusted and unadjusted 2. Gametocyte carriage 3. Prevalence of anaemia on days 0, 28 4. Adverse events Not included in the review: 1. Fever clearance 2. Parasite clearance Notes Country: Mali Setting: Peri-urban Transmission: Hyperendemic with highly seasonal transmission Resistance: Not stated Dates: Aug 2004 to Feb 2005 Funding: Pharmatech Inc (also donated AS+MQ), and Mepha Ltd. Risk of bias Item Authors’ judgement Description Adequate sequence generation? Yes ’A bloc randomisation code with treatment arm was computer generated by the study statistician’ Allocation concealment? Yes ’Study codes were sealed in individual opaque and sequentially numbered envelopes’ Blinding? All outcomes Incomplete outcome data addressed? All outcomes No An open label trial. Microscopists were blinded to the treatment arm. Yes Losses to follow up were low in both groups (2.1% AS+MQ vs 1.7% AL6) Free of selective reporting? Yes The WHO recommends 42 days follow up in studies of AL6 and 63 days with AS+MQ. Day 28 outcomes may overestimate the efficacy of AL6 and AS+MQ. Free of other bias? Yes No other sources of bias identified Artemisinin-based combination therapy for treating uncomplicated malaria (Review) Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. 87
Page 1 and 2:
Artemisinin-based combination thera
Page 3 and 4:
Analysis 2.2. Comparison 2 Dihydroa
Page 5 and 6:
Analysis 10.5. Comparison 10 Arteme
Page 7 and 8:
[Intervention Review] Artemisinin-b
Page 9 and 10:
B A C K G R O U N D Malaria is a di
Page 11 and 12:
drugs and the treatment comparisons
Page 13 and 14:
this analysis into participants who
Page 15 and 16:
Figure 1. Methodological quality su
Page 17 and 18:
confidence intervals of the estimat
Page 19 and 20:
Anaemia Hasugian 2005 IDN found tha
Page 21 and 22:
Three trials report significantly m
Page 23 and 24:
or those treated for P. vivax at ba
Page 25 and 26:
Early vomiting Not reported. D I S
Page 27 and 28:
Figure 4. Olliaro-Vaillant plot. Da
Page 29 and 30:
Page 31 and 32:
Page 33 and 34:
Figure 10. Olliaro-Vaillant plot. D
Page 35 and 36:
of findings tables’. For these ta
Page 37 and 38:
Huambo and Bie provinces, central A
Page 39 and 40:
References to studies excluded from
Page 41 and 42: Adjuik 2004 Adjuik M, Babiker A, Ga
Page 43 and 44: C H A R A C T E R I S T I C S O F S
Page 45 and 46: Ashley 2003a THA (Continued) Outcom
Page 47 and 48: Ashley 2003b THA (Continued) Alloca
Page 49 and 50: Ashley 2005 THA (Continued) Exclusi
Page 51 and 52: Bonnet 2004 GIN (Continued) Item Au
Page 53 and 54: Bukirwa 2005 UGA Methods Trial desi
Page 55 and 56: Djimde 2004 MLI (Continued) • AS
Page 57 and 58: Dorsey 2006 UGA (Continued) Item Au
Page 59 and 60: Fanello 2004 RWA Methods Trial desi
Page 61 and 62: Faye 2003 SEN (Continued) Outcomes
Page 63 and 64: Grande 2005 PER (Continued) Allocat
Page 65 and 66: Guthmann 2004 AGO (Continued) All d
Page 67 and 68: Hasugian 2005 IDN Methods Trial des
Page 69 and 70: Hutagalung 2002 THA (Continued) 5.
Page 71 and 72: Janssens 2003 KHM (Continued) Free
Page 73 and 74: Karema 2004 RWA (Continued) Interve
Page 75 and 76: Karunajeewa 2007 PNG (Continued) Ri
Page 77 and 78: Kobbe 2007 GHA (Continued) Exclusio
Page 79 and 80: Koram 2003 GHA (Continued) Adequate
Page 81 and 82: Martensson 2003 TZA Methods Trial d
Page 83 and 84: Mayxay 2003 LAO (Continued) 1. Feve
Page 85 and 86: Menard 2006 MDG Methods Trial desig
Page 87 and 88: Mens 2007 KEN (Continued) Risk of b
Page 89 and 90: Mutabingwa 2004 TZA (Continued) •
Page 91: Owusu-Agyei 2006 GHA (Continued) Fr
Page 95 and 96: Smithuis 2004 MMR (Continued) Risk
Page 97 and 98: Stohrer 2003 LAO Methods Trial desi
Page 99 and 100: Swarthout 2004 ZAR (Continued) Note
Page 101 and 102: Tran 2002 VNM Methods Trial design:
Page 103 and 104: Van den Broek 2003a BGD (Continued)
Page 105 and 106: Van Vugt 1998 THA Methods Trial des
Page 107 and 108: Yeka 2004 UGA (Continued) Risk of b
Page 109 and 110: Yeka 2007 UGA (Continued) Free of o
Page 111 and 112: Zongo 2007 BFA (Continued) Novartis
Page 113 and 114: (Continued) Fofana 2005 Conference
Page 115 and 116: D A T A A N D A N A L Y S E S Compa
Page 117 and 118: 2.2 Asia 1 317 Risk Ratio (M-H, Fix
Page 119 and 120: Comparison 5. Dihydroartemisinin-pi
Page 121 and 122: Comparison 8. Artesunate plus meflo
Page 123 and 124: Comparison 10. Artemether-lumefantr
Page 125 and 126: Comparison 12. Artesunate plus amod
Page 127 and 128: 5.2 DHA-P 3 doses 3 1116 Risk Ratio
Page 129 and 130: Comparison 21. How does Artesunate
Page 131 and 132: Analysis 1.3. Comparison 1 Dihydroa
Page 137 and 138: (... Continued) Study or subgroup D
Page 139 and 140: Analysis 1.12. Comparison 1 Dihydro
Page 141 and 142: (... Continued) Study or subgroup D
Page 143 and 144:
Page 145 and 146:
Page 147 and 148:
Page 149 and 150:
Page 151 and 152:
Page 153 and 154:
Page 155 and 156:
Page 157 and 158:
Page 159 and 160:
Page 161 and 162:
Page 163 and 164:
(... Continued) Study or subgroup A
Page 165 and 166:
Analysis 6.6. Comparison 6 Artesuna
Page 167 and 168:
Page 169 and 170:
Page 171 and 172:
Page 173 and 174:
Analysis 9.2. Comparison 9 Artemeth
Page 175 and 176:
Page 177 and 178:
Analysis 9.8. Comparison 9 Artemeth
Page 179 and 180:
Page 181 and 182:
Page 183 and 184:
Page 185 and 186:
Page 187 and 188:
Page 189 and 190:
Page 191 and 192:
Page 193 and 194:
Page 195 and 196:
Page 197 and 198:
Analysis 12.2. Comparison 12 Artesu
Page 199 and 200:
Page 201 and 202:
Page 203 and 204:
Page 205 and 206:
Page 207 and 208:
Analysis 14.2. Comparison 14 Dihydr
Page 209 and 210:
Page 211 and 212:
Page 213 and 214:
Page 215 and 216:
Page 217 and 218:
(... Continued) Study or subgroup D
Page 219 and 220:
Analysis 20.1. Comparison 20 How do
Page 221 and 222:
Analysis 21.1. Comparison 21 How do
Page 223 and 224:
(Continued) 2. How does artesunate
Page 225 and 226:
(Continued) Sensitivity analysis 1
Page 227 and 228:
(Continued) Smithuis 2004 MMR (652
Page 229 and 230:
Dihydroartemisinin-piperaquine vs A
Page 231 and 232:
(Continued) Mayxay 2003 LAO (220 pa
Page 233 and 234:
Artesunate plus mefloquine vs Amodi
Page 235 and 236:
(Continued) Faye 2003 SEN (509 part
Page 237 and 238:
Artemether-lumefantrine vs Artesuna
Page 239 and 240:
(Continued) Zongo 2005 BFA (521 par
Page 241 and 242:
(Continued) Faye 2003 SEN (521 part
Page 243 and 244:
PCR = polymerase chain reaction PCV
Page 245 and 246:
(Continued) Proportion with anaemia
Page 247 and 248:
(Continued) Vivax efficacy: P. viva
Page 249 and 250:
(Continued) Efficacy: Total Failure
Page 251 and 252:
(Continued) Outcomes Illustrative c
Page 253 and 254:
Page 255 and 256:
(Continued) GRADE Working Group gra
Page 257 and 258:
Footnotes 1 Data were also availabl
Page 259 and 260:
8 Very serious imprecision: There w
Page 261 and 262:
Page 263 and 264:
(Continued) justed Vivax efficacy:
Page 265 and 266:
(Continued) Harms: Serious adverse
Page 267 and 268:
(Continued) Harms: Early vomiting -
Page 269 and 270:
1 Dorsey 2006 UGA; Faye 2003 SEN; K
show all

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

Create successful ePaper yourself

Delete template?

Save as template?