Antiamoebic drugs for treating amoebic colitis - The Cochrane Library

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Mansour-Ghanaei 2003 Methods Generation of allocation sequence: unclear Allocation concealment: unclear Blinding: double (participants, care providers, and outcome assessors - from personal communication with primary author) Inclusion of all randomized participants: 94.7% (54/57)) Participants Number: 57 enrolled; 54 analysed; 3 noncompliant participants (2 from the group without Saccharomyces boulardii and 1 from the group with S. boulardii) were excluded from analysis Inclusion criteria: amoebic dysentery presenting with mucous bloody diarrhoea, fever, and abdominal pain; stool specimens positive for haematophagous trophozoites of E. histolytica; laboratory diagnostic method was not specified Exclusion criteria: pregnant women; those on maintenance haemodialysis, steroids, or chemotherapy Interventions 1. Metronidazole, iodoquinol, and placebo: metronidazole 750 mg and iodoquinol 650 mg given thrice daily orally with placebo tablets for 10 days 2. Metronidazole, iodoquinol, and S. boulardii: 750 mg and iodoquinol 650 mg thrice daily orally for 10 days plus lyophilized S. boulardii 250 mg orally thrice daily for 10 days S. boulardii and placebo were identical in appearance Outcomes 1. Parasitological failure: persistence of amoebic cysts in stool examinations at 4 weeks after treatment Not included in this review: mean duration of diarrhoea, abdominal pain, fever, and headache from start of treatment to resolution of symptoms Notes Location: Shahid Beheshti Educational and Therapeutic Center in Shiraz, Iran Date: 21 March 1995 to 21 March 1996 Source of funding: not stated The author was contacted and kindly provided data on method of blinding; however, no response was obtained regarding method of allocation concealment despite several follow-up communications Mathur 1976 Methods Generation of allocation sequence: unclear Allocation concealment: unclear Blinding: open Inclusion of all randomized participants: 100% Participants Number: 60 enrolled and 60 analysed Inclusion criteria: adults and adolescents with clinical symptoms of intestinal amoebiasis and stool specimens positive for trophozoites or cysts of E. histolytica; laboratory diagnostic method was not specified Exclusion criteria: received antiamoebic treatment in the previous 1 month; pregnant women; dehydrated patients; and those with hepatic, renal, hematologic or EKG abnormalities Interventions 1. Tinidazole: 600 mg twice daily orally for 5 days 2. Metronidazole: 400 mg thrice daily orally for 5 days (for acute amoebic dysentery)or 800 mg thrice daily for 5 days (for other cases) Treatment period was extended to 10 days in both groups when 5 days treatment was inadequate to relieve symptoms or clear the stools of E. histolytica Antiamoebic drugs for treating amoebic colitis (Review) Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. 41
Mathur 1976 (Continued) Outcomes 1. Parasitological cure: eradication of E. histolytica from stools on day 30 after start of treatment 2. Clinical cure: relief of presenting clinical signs and symptoms and healing of ulcers on sigmoidoscopy, when carried out 3. Adverse events: voluntary reporting of clinical adverse events by participants; laboratory tests monitored before and after treatment including haemogram, urinalysis, serum bilirubin, transaminases (SGOT, SGPT), alkaline phosphatase, and blood urea Notes Location: India Date: 1976 (date of publication only; actual study period not reported) Source of funding: not stated Tinidazole tablets (Fasigyn) were supplied by Pfizer Ltd. Misra 1974 Methods Generation of allocation sequence: unclear Allocation concealment: unclear Blinding: unclear; reported as “single blind”, but it was not stated who among the participants, care provider, or outcome assessor was blinded Inclusion of all randomized participants: 100% Participants Number: 60 enrolled and analysed Inclusion criteria: adults and children with clinical symptoms of intestinal amoebiasis and stool specimens positive for trophozoites or cysts of E. histolytica by direct smear or concentration method Exclusion criteria: antiamoebic treatment in the preceding 1 month before enrolment; pregnant women; severe anaemia Interventions 1. Tinidazole: 600 mg twice daily orally for 5 days 2. Metronidazole: 400 mg thrice daily orally for 5 days (for acute amoebic dysentery)or 800 mg thrice daily orally for 5 days (for chronic intestinal amoebiases if symptoms were more than 15 days duration) Treatment period was extended to 10 days in both groups when 5 days treatment was inadequate to relieve symptoms or clear the stools of E. histolytica Outcomes 1. Parasitological cure: eradication of E. histolytica on follow-up stool examinations on day 30 after start of treatment 2. Clinical cure: disappearance of presenting clinical symptoms and healing of ulcers on sigmoidoscopy on day 30 after start of treatment 3. Adverse events: clinical adverse events monitored during treatment; laboratory tests monitored before and after treatment including complete blood count and platelet count, urinalysis, electrocardiogram, blood urea, serum bilirubin, alkaline phosphatase, and liver transaminases (SGOT, SGPT) Notes Location: Medical College Hospital in Bhopal, India Date: 1974 (date of publication only; actual study period not reported) Source of funding: Pfizer Ltd. for support and for supply of study drugs tinidazole (Fasigyn) and metronidazole (Flagyl) Antiamoebic drugs for treating amoebic colitis (Review) Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. 42
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
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Page 17 and 18: ness or nausea. No abnormalities in
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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
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Page 49 and 50: Nnochiri 1967 (Continued) haemoglob
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Analysis 7.2. Comparison 7 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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Antiamoebic drugs for treating amoebic colitis - The Cochrane Library

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