Antiamoebic drugs for treating amoebic colitis - The Cochrane Library

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Misra 1977 Methods Generation of allocation sequence: unclear Allocation concealment: unclear Blinding: unclear Inclusion of all randomized participants: 100% Participants Number: 60 enrolled and analysed Inclusion criteria: adults with clinical symptoms of intestinal amoebiasis and stool specimens positive for trophozoites or cysts of E. histolytica by direct smear or formol-ether concentration technique, sigmoidoscopy for colonic ulcers, and parasitological examination of sigmoidoscopic scrapings Exclusion criteria: received antiamoebic treatment within the previous 4 weeks; pregnant women; dehydrated patients; evidence of hepatic, renal, hematologic, or EKG abnormalities Interventions 1. Tinidazole: 2 g single oral dose daily for 3 days 2. Metronidazole: 2 g single oral dose daily for 3 days Not stated if tinidazole and metronidazole were identical in appearance. Outcomes 1. Parasitological response: eradication of E. histolytica from stools on day 30 after start of treatment 2. Clinical response: disappearance of presenting clinical symptoms on day 30 after start of treatment 3. Adverse events: voluntary reporting of clinical adverse events by participants; laboratory tests monitored before and after treatment including urinalysis, complete blood count, serum bilirubin, alkaline phosphatase, liver transaminases (SGOT, SGPT), blood urea, and electrocardiogram Notes Location: hospital in Bhopal, India Date: 1977 (date of publication only; actual study period not reported) Source of funding: not stated Unclear if Misra 1977 and Misra 1978 reported the results for same group of participants Several attempts were made to contact the authors, but no response was obtained Misra 1978 Methods Generation of allocation sequence: unclear Allocation concealment: unclear Blinding: unclear Inclusion of all randomized participants: 98.3% (59/60) Participants Number: 60 enrolled; 59 analysed, 1 randomized to tinidazole group excluded because it was discovered later that he had a history of ulcerative colitis Inclusion criteria: adults with clinical symptoms of intestinal amoebiasis and stool specimens positive for trophozoites and cysts of E. histolytica by direct smear or formol-ether concentration technique, sigmoidoscopy for colonic pathology Exclusion criteria: received antiamoebic treatment in the previous 4 weeks before enrolment Interventions 1. Tinidazole: 2 g single oral dose daily for 3 days 2. Metronidazole: 2 g single oral dose daily for 3 days Not stated if tinidazole and metronidazole were identical in appearance Outcomes 1. Parasitological cure: eradication of E. histolytica from stools on day 30 after start of treatment 2. Clinical cure: disappearance of presenting clinical symptoms on day 30 after start of treatment Antiamoebic drugs for treating amoebic colitis (Review) Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. 43
Misra 1978 (Continued) 3. Adverse events: voluntary reporting of clinical adverse events by participants; laboratory monitoring done before and after treatment including complete blood count, urinalysis, and blood chemistry Notes Location: hospital in Bhopal, India Date: 1978 (date of publication only; actual study period not reported) Source of funding: not stated Unclear if Misra 1977 and Misra 1978 reported the results for same group of participants Several attempts were made to contact the author, but no response was obtained Mohammed 1998 Methods Generation of allocation sequence: random-numbers table Allocation concealment: unclear Blinding: open Inclusion of all randomized participants: 72.5% (50/69) Participants Number: 69 enrolled; 50 analysed; 19 lost to follow up (11 in the praziquantel group, 8 in the metronidazole group); 3 in praziquantel group withdrawn from treatment because of lack of response Inclusion criteria: adults with clinical symptoms of intestinal amoebiasis and stool specimens positive for vegetative trophozoite forms (acute amoebic dysentery)or cysts of E. histolytica; laboratory diagnostic method was not specified; those who were cyst passers were treated with praziquantel alone and were not included in the review Exclusion criteria: not stated Interventions 1. 1. Praziquantel: 40 mg/kg body weight divided into 2 doses orally and taken 4 to 6 hours apart 2. 2. Metronidazole: 800 mg thrice daily orally for 5 days Outcomes 1. Parasitological response: disappearance of E. histolytica from stools 1 week after treatment 2. Clinical response: disappearance of baseline clinical signs and symptoms at the end of treatment 3. Adverse events: voluntary reporting of clinical adverse events by participants only for praziquantel Notes Location: outpatients in Iraq Date: 1993 to 1995 Source of funding: not stated Naoemar 1973 Methods Generation of allocation sequence: unclear Allocation concealment: unclear Blinding: double (participants, care providers, and outcome assessors) Inclusion of all randomized participants: 100% at end of treatment; 96.7% at 7 weeks after end of treatment Participants Number: 20 enrolled, 20 analysed Inclusion criteria: adults and children with bloody diarrhoea and stools positive for motile haematophagous trophozoites of E. histolytica examined by eosin and iodine smears Exclusion criteria: anaemia or other diseases but exact conditions not stated Antiamoebic drugs for treating amoebic colitis (Review) Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. 44
Page 1 and 2: Antiamoebic drugs for treating amoe
Page 3 and 4: Analysis 6.4. Comparison 6 Subgroup
Page 5 and 6: Authors’ conclusions Tinidazole i
Page 7 and 8: parasite RNA and DNA (Haque 1995; H
Page 9 and 10: histopathology. We included individ
Page 11 and 12: sponsored trials were conducted wit
Page 13 and 14: (WHO 1969) where ’cure’ was def
Page 15 and 16: Figure 1. Alternative drug vs metro
Page 17 and 18: ness or nausea. No abnormalities in
Page 19 and 20: 4.1. Single-dose secnidazole versus
Page 21 and 22: with some activity against cysts in
Page 23 and 24: A U T H O R S ’ C O N C L U S I O
Page 25 and 26: suspension (two days dosage) in the
Page 27 and 28: el tratamiento de ninos con amibias
Page 29 and 30: Murray 1980 {published data only} M
Page 31 and 32: Sankale 1969 {published data only}
Page 33 and 34: Dans 2006 Dans L, Martinez E. Amoeb
Page 35 and 36: associated with increased expressio
Page 37 and 38: Awal 1979 (Continued) Participants
Page 39 and 40: Botero 1977 (Continued) Exclusion c
Page 41 and 42: Donckaster 1964 (Continued) and adu
Page 43 and 44: Kapadia 1968 Methods Generation of
Page 45: Mathur 1976 (Continued) Outcomes 1.
Page 49 and 50: Nnochiri 1967 (Continued) haemoglob
Page 51 and 52: Panggabean 1980 (Continued) Interve
Page 53 and 54: Prasad 1985 (Continued) years of ag
Page 55 and 56: Rossignol 2007 (Continued) Interven
Page 57 and 58: Singh 1977 (Continued) Outcomes 1.
Page 59 and 60: Swami 1977 (Continued) SGPT), and b
Page 61 and 62: (Continued) Baranski 1966 Not RCT B
Page 63 and 64: (Continued) Huggins 1969 Not RCT Hu
Page 65 and 66: (Continued) Padilla 2002 Interventi
Page 67 and 68: (Continued) Simjee 1985 Study popul
Page 69 and 70: Characteristics of studies awaiting
Page 71 and 72: 2 Parasitological failure: 1 to 14
Page 73 and 74: 2.3 Chlorhydroxyquinoline vs diiodo
Page 75 and 76: Comparison 9. Subgroup analyses: an
Page 77 and 78: (... Continued) Study or subgroup A
Page 79 and 80: Analysis 1.4. Comparison 1 Alternat
Page 81 and 82: Analysis 1.6. Comparison 1 Alternat
Page 83 and 84: Analysis 2.2. Comparison 2 Any anti
Page 85 and 86: Analysis 3.2. Comparison 3 Combinat
Page 87 and 88: Analysis 5.1. Comparison 5 Other an
Page 91 and 92: (... Continued) Study or subgroup A
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Analysis 8.1. Comparison 8 Subgroup
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Analysis 9.1. Comparison 9 Subgroup
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(Continued) 24 - - chloroquine oxyt
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(Continued) Department of Medicine,
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(Continued) Africa Egypt Rossignol
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(Continued) Stool microscopy plus s
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(Continued) 6. Not used, but mentio
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(Continued) Padilla 2000 Adequate U
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(Continued) Misra 1974 Malaise: tin
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(Continued) Pehrson 1984 ticipants)
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(Continued) ; metronidazole (4 part
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(Continued) Panidazole Botero 1977
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(Continued) Appendix 12. Adverse ev
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(Continued) Rossignol 2001 Rossigno
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(Continued) Secnidazole vs quinfami
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(Continued) idazole was encountered
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(Continued) Combinationtinidazole a
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(Continued) H I S T O R Y Protocol
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Sensitivity analyses We intended to
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