Antiamoebic drugs for treating amoebic colitis - The Cochrane Library

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Naoemar 1973 (Continued) Interventions 1. Ro 7-0207 (ornidazole) 2. Metronidazole Both drugs given as follows: 2 to 6 years of age - 125 mg daily in 3 divided doses for 7 days; 7 to 12 years of age - 250 mg daily in 3 divided doses for 7 days; adults - 1500 mg daily in 3 divided doses for 5 days Ro 7-0207 and metronidazole were identical in appearance (light yellow capsules) and kept in numbered bottles Outcomes 1. Parasitological response: clearance of E. histolytica from stools at the end of treatment and 1 month after end of treatment 2. Relapse: reappearance of E. histolytica in stools 1 month after end of treatment 3. Clinical cure: disappearance of symptoms at the end of treatment and at 1 month after end of treatment 4. Adverse events: clinical adverse events monitored during treatment; laboratory tests monitored before and after the end of treatment including complete blood counts, liver transaminase (SGPT), alkaline phosphatase, urinalysis, blood urea, and electrocardiogram Not included in this review: number of days from start of treatment to clearance of E. histolytica in stool specimens and disappearance of symptoms Notes Location: outpatient clinics in Jakarta, Indonesia Date: 1973 (date of publication only; actual study period not reported) Source of funding: Roche Far East Research Foundation for supply of drugs and support for the study Nnochiri 1967 Methods Generation of allocation sequence: unclear Allocation concealment: unclear Blinding: double (participants, care provider, and outcome assessors) Inclusion of all randomized participants: 100% at end of treatment; 96.7% (58/60) at 7 weeks after end of treatment Participants Number: 60 with acute amoebic dysentery enrolled; 60 analysed at end of treatment, and 58 (96.8%) analysed 7 weeks after end of treatment Inclusion criteria: military personnel and their families diagnosed with acute amoebic dysentery and stool specimens positive for E. histolytica examined by saline and iodine-stained smears Exclusion criteria: not stated Interventions 1. Diloxanide furoate, tetracycline hydrochloride, and chloroquine phosphate (per capsule): diloxanide furoate (187.5 mg), tetracycline hydrochloride (125 mg), and chloroquine phosphate (50 mg) given in 3 dosage regimens of 2 capsules 4 times a day for 5 days, 2 capsules 4 times a day for 7 days, or 2 capsules 4 times a day for 10 days 2. Diloxanide furoate and tetracycline hydrochloride (per capsule): diloxanide furoate (187.5 mg) and tetracycline hydrochloride (125 mg) given in 3 dosage regimens of 2 capsules 4 times a day for 5 days, 2 capsules 4 times a day for 7 days, or 2 capsules 4 times a day for 10 days The 2 drug combinations with and without chloroquine were identical in appearance Outcomes 1. Parasitological response: clearance of E. histolytica cysts and trophozoites at end of treatment, then on follow up 7 weeks from completion of treatment; patients whose stools remained negative 7 weeks after treatment were followed up 3 and 6 months from completion of treatment 2. Clinical response: recurrence of symptoms (results were not reported and could not be included in the metaanalysis) 3. Adverse events: clinical adverse events monitored during treatment and on follow up; laboratory tests monitored before and after treatment including urine cytology and presence of protein, blood examination for Antiamoebic drugs for treating amoebic colitis (Review) Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. 45
Nnochiri 1967 (Continued) haemoglobin, total erythrocyte and leucocyte counts and differential count Not included in this review: clearance of E. histolytica from stools of 36 asymptomatic cyst carriers Notes Location: Yaba Military Hospital in Lagos, Nigeria Date: August 1965 to July 1966 Source of funding: Messrs Boots Pure Drug Co., Ltd, Nottingham, England Padilla 2000 Methods Generation of allocation sequence: coin toss Allocation concealment: unclear Blinding: double blind (participants and outcome assessors for clinical and parasitological outcomes blinded; unclear if care provider (main investigator)who administered the medications was blinded) Inclusion of all randomized participants: 100% Participants Number: 239 enrolled and analysed Inclusion criteria: children with clinical symptoms of nondysenteric amoebic colitis with at least 1 of 3 stool specimens positive for E. histolytica cysts examined by direct smear using Faust concentration method Exclusion criteria: history of sensitivity to clioquinol or to metronidazole and its derivatives; children who had received antibacterial and/or antiparasitic drugs in the 15 days before their entry into the study; those with amoebic dysentery Interventions 1. Secnidazole: 30 mg/kg body weight orally in a single dose 2. Quinfamide: 4.3 mg/kg body weight orally in a single dose Outcomes 1. Parasitological response: clearance of E. histolytica cysts on days 5, 6, and 7 after administration of the drugs 2. Adverse events: clinical adverse events were solicited by the investigators through direct questioning for the presence of abdominal pain, nausea, vomiting, headache, diarrhoea, and unpleasant taste in the mouth Not included in this review: acceptability of taste Notes Location: 2 urban federal elementary schools in Celaya, Guanajuato, Mexico (Urban Federal Elementary schools ’Carmen Serdan’ and ’Juan Jesus de los Reyes’) Date: 2000 (date of publication only; actual study period not reported) Source of funding: not stated Pamba 1990 Methods Generation of allocation sequence: unclear Allocation concealment: unclear Blinding: single (only outcome assessor for parasitological response and rectosigmoidoscopy results were blinded; not stated if assessor for clinical response was blinded) Inclusion of all randomized participants: 88.5% (369/417) 15 days after start of treatment, 67.6% (282/417) 30 days after start of treatment, and 51.3% (214/417) 60 days after start of treatment Participants Number: 417 enrolled; 369/417 (88.5%) analysed 15 days after start of treatment, 282/417 (67.6%) analysed 30 days after start of treatment, and 214/417 (51.3%) analysed 60 days after start of treatment; recruitment to the etophamide plus aminosidine group was discontinued because of high incidence of diarrhoea; withdrawals not stated for the other groups Antiamoebic drugs for treating amoebic colitis (Review) Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. 46
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 and 46: Mathur 1976 (Continued) Outcomes 1.
Page 47: Misra 1978 (Continued) 3. Adverse e
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Page 55 and 56: Rossignol 2007 (Continued) Interven
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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
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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
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Page 83 and 84: Analysis 2.2. Comparison 2 Any anti
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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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