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Meta-Analysis
.2019 Jan 9;1(1):CD006085.
doi: 10.1002/14651858.CD006085.pub3.

Antiamoebic drugs for treating amoebic colitis

Affiliations
Meta-Analysis

Antiamoebic drugs for treating amoebic colitis

Maria Liza M Gonzales et al. Cochrane Database Syst Rev..

Abstract

Background: Infection with the protozoan Entamoeba histolytica is common in low- and middle-income countries, and up to 100,000 people with severe disease die every year. Adequate therapy for amoebic colitis is necessary to reduce illness, prevent development of complicated disease and extraintestinal spread, and decrease transmission.

Objectives: To evaluate antiamoebic drugs for treating amoebic colitis.

Search methods: We searched the available literature up to 22 March 2018. We searched the Cochrane Infectious Diseases Group Specialised Register, CENTRAL, MEDLINE, Embase, LILACS, mRCT, and conference proceedings. We contacted individual researchers, organizations, and pharmaceutical companies, and we checked reference lists.

Selection criteria: Randomized controlled trials of antiamoebic drugs given alone or in combination, compared with placebo or another antiamoebic drug, for treating adults and children with a diagnosis of amoebic colitis.

Data collection and analysis: Two review authors independently assessed the eligibility and methodological quality of trials and extracted and analysed the data. We calculated clinical and parasitological failure rates and rates of relapse and adverse events as risk ratios (RRs) with 95% confidence intervals (CIs), using a random-effects model. We determined statistical heterogeneity and explored possible sources of heterogeneity using subgroup analyses. We carried out sensitivity analysis by using trial quality to assess the robustness of reported results.

Main results: In total, 41 trials (4999 participants) met the inclusion criteria of this review. In this update, we added four trials to the 37 trials included in the first published review version. Thirty trials were published over 20 years ago. Only one trial used adequate methods of randomization and allocation concealment, was blinded, and analysed all randomized participants. Only one trial used an E histolytica stool antigen test, and two trials used amoebic culture.Tinidazole may be more effective than metronidazole for reducing clinical failure (RR 0.28, 95% CI 0.15 to 0.51; 477 participants, eight trials; low-certainty evidence) and is probably associated with fewer adverse events (RR 0.65, 95% CI 0.46 to 0.92; 477 participants, 8 trials; moderate-certainty evidence). Compared with metronidazole, combination therapy may result in fewer parasitological failures (RR 0.36, 95% CI 0.15 to 0.86; 720 participants, 3 trials; low-certainty evidence), but we are uncertain which combination is more effective than another. Evidence is insufficient to allow conclusions regarding the efficacy of other antiamoebic drugs.

Authors' conclusions: Compared with metronidazole, tinidazole may be more effective in reducing clinical failure and may be associated with fewer adverse events. Combination drug therapy may be more effective for reducing parasitological failure compared with metronidazole alone. However, these results are based mostly on small trials conducted over 20 years ago with a variety of poorly defined outcomes. Tests that detect E histolytica more accurately are needed, particularly in countries where concomitant infection with other bacteria and parasites is common.

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Conflict of interest statement

MLMG has no known conflicts of interest. LFD was an invited lecturer on a talk sponsored by Wyeth Nutrition. She has no other conflicts of interest to declare. JSA has no known conflicts of interest.

Figures

1
1
Study flow diagram.
2
2
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
3
3
Alternative drug versus metronidazole: clinical failure 15 to 60 days after end of treatment.
4
4
Alternative drug versus metronidazole: parasitological failure 15 to 60 days after end of treatment.
5
5
Combination regimen versus monotherapy: parasitological failure 1 to 14 days after end of treatment, subgrouped by intervention.
6
6
Funnel plot. Alternative drug versus metronidazole: parasitological failure 15 to 60 days after end of treatment.
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Doshi 1968 {published data only}
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dos Santos 1969 {published data only}
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el Mofti 1965 {published data only}
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Esquivel 1979 {published data only}
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Ey 1977 {published data only}
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Felix 1966 {published data only}
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Freeman 1990 {published data only}
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Gilman 1980 {published data only}
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Gorbea 1989 {published data only}
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Hatchuel 1975 {published data only}
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Hoekenga 1951 {published data only}
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Holz 1965 {published data only}
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Huggins 1965 {published data only}
    1. Huggins D. Treatment of amebiasis. Results obtained with diloxanide furoate [Tratamento da amebiase. Resultados obtidos com o furoato de diloxanida]. Revista do Instituto de Medicina Tropical de São Paulo 1965;7(2):110‐1. - PubMed
Huggins 1969 {published data only}
    1. Huggins D. Clinical trial of a new salt: ethyl chordiphene, in the treatment of chronic intestinal amebiasis [Ensaio clinico com um novo sal: etil clordifene, no tratamento da amebiase intestinal cronica]. Anais da Escola Nacional de Saude Publica e de Medicina Tropical 1969;3(1):93‐5. - PubMed
Huggins 1974 {published data only}
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Huggins 1977 {published data only}
    1. Huggins D. Clinical test with teclozan in the treatment of amebic dysentery with a dose of 24 hours [Ensaio clinico com teclozan no tratamento da colite amebiana nao desinterica na dose de 24 horas]. Anais do Instituto de Higiene e Medicina Tropical 1977‐1978;5(1‐4):329‐31. - PubMed
Huggins 1980 {published data only}
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Huggins 1981 {published data only}
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Irusen 1992 {published data only}
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Islam 1975 {published data only}
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Islam 1978a {published data only}
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Islam 1978b {published data only}
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Jain 1990 {published data only}
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Jayawickrema 1975 {published data only}
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Kaur 1972 {published data only}
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Khalil 1987 {published data only}
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Khokhani 1977 {published data only}
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Khokhani 1978 {published data only}
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Konar 1963 {published data only}
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Krishnaiah 2003 {published data only}
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Laham 1951 {published data only}
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Levy 1967 {published data only}
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Martinez 1969 {published data only}
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Masters 1979 {published data only}
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Mathur 1974 {published data only}
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McAuley 1992 {published data only}
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McLeod 2014 {published data only}
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Mendis 1984 {published data only}
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Misra 1976a {published data only}
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Misra 1976b {published data only}
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Montovani 2009 {published data only}
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Morales 1975 {published data only}
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Murray 1980 {published data only}
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Muzzafar 2006 {published data only}
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Nahrevanian 2008 {published data only}
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Naik 1968 {published data only}
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Nanavati 1965 {published data only}
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O'Holohan 1972 {published data only}
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Olaeta 1996 {published data only}
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Omrani 1995 {published data only}
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Orozco 1975 {published data only}
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Padilla 1995 {published data only}
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Padilla 1998 {published data only}
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Padilla 2002 {published data only}
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Pimparkar 1966 {published data only}
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Populaire 1980 {published data only}
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Powell 1965a {published data only}
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Powell 1965b {published data only}
    1. Powell SJ, Wilmot AJ, Macleod IN, Elsdon‐Dew R. A comparative trial of dehydroemetine, emetine hydrochloride and chloroquine in the treatment of amoebic liver abscess. Annals of Tropical Medicine and Parasitology 1965;59(4):496‐9. - PubMed
Powell 1965c {published data only}
    1. Powell SJ, Wilmot AJ, Macleod IN, Elsdon‐Dew R. Dehydroemetine in the treatment of amoebic liver abscess. Annals of Tropical Medicine and Parasitology 1965;59(2):208‐9. - PubMed
Powell 1965d {published data only}
    1. Powell SJ, MacLeod I, Wilmot AJ, Elsdon‐Dew R. Further drug trials in acute amoebic dysentery: demethylchlortetracycline, methacycline, ampicillin and chlorhydroxyquinoline. Transactions of the Royal Society of Tropical Medicine and Hygiene 1965;59(6):709‐11.
Powell 1966a {published data only}
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Powell 1966b {published data only}
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Powell 1966c {published data only}
    1. Powell SJ, Wilmot AJ, MacLeod I, Elsdon‐Dew R. The effect of a nitro‐thiazole derivative, Ciba 32,644‐Ba, in amebic dysentery and amebic liver abscess. American Journal of Tropical Medicine and Hygiene 1966;15(3):300‐2. - PubMed
Powell 1967 {published data only}
    1. Powell SJ, Wilmot AJ, Macleod IN, Elsdon‐Dew R. A comparative trial of dehydroemetine and emetine hydrochloride in identical dosage in amoebic liver abscess. Annals of Tropical Medicine and Parasitology 1967;61(1):26‐8. - PubMed
Powell 1968 {published data only}
    1. Powell SJ. Metronidazole in the treatment of amoebic dysentery. Indian Practitioner 1968;21:696‐700.
Powell 1969a {published data only}
    1. Powell SJ, Wilmot AJ, Elsdon‐Dew R. Single and low dosage regimens of metronidazole in amoebic dysentery and amoebic liver abscess. Annals of Tropical Medicine and Parasitology 1969;63(2):139‐42. - PubMed
Powell 1969b {published data only}
    1. Powell SJ, Wilmot AJ, Elsdon‐Dew R. The use of niridazole alone and in combination with other amoebicides in amoebic dysentery and amoebic liver abscess. Annals of the New York Academy of Science 1969;160(2):749‐54. - PubMed
Powell 1969c {published data only}
    1. Powell SJ. Drug trials in amoebiasis. Bulletin of the World Health Organization 1969;40(6):956‐8. - PMC - PubMed
Powell 1971a {published data only}
    1. Powell SJ, Elsdon‐Dew R. Evaluation of metronidazole and MK910 in invasive amebiasis. American Journal of Tropical Medicine and Hygiene 1971;20(6):839‐41. - PubMed
Powell 1971b {published data only}
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Powell 1972a {published data only}
    1. Powell SJ, Elsdon‐Dew R. Some new nitroimidazole derivatives. Clinical trials in amebic liver abscess. American Journal of Tropical Medicine and Hygiene 1972;21(5):518‐20. - PubMed
Powell 1972b {published data only}
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Powell 1973 {published data only}
    1. Powell SJ, Rubidge CJ, Elsdon‐Dew R. Clinical trials of benzoyl metronidazole suspension in amoebic dysentery and amoebic liver abscess. South African Medical Journal 1973;47(12):507‐8. - PubMed
Prakash 1974 {published data only}
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Qureshi 1994 {published data only}
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Qureshi 1997 {published data only}
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Rodrigues 1968 {published data only}
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Ruas 1973 {published data only}
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Ruchko 1978 {published data only}
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Saha 1966 {published data only}
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Saha 1970 {published data only}
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Salem 1964 {published data only}
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Salem 1967 {published data only}
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Sangiuolo 1969 {published data only}
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Sankale 1966 {published data only}
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Sankale 1969 {published data only}
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Schapiro 1967 {published data only}
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References to ongoing studies

NIAID 2016 {published data only}
    1. National Institute of Allergy and Infectious Diseases (NIAID). Phase IIa Randomized, Single‐blinded, Placebo‐controlled Clinical Trial of the Reprofiled Drug Auranofin for GI Protozoa.clinicaltrials.gov Last Update Posted: September 15, 2017. [ClinicalTrials.gov identifier: NCT02736968]
Pfizer 2016 {published data only}
    1. Drug Use Investigation of Paromomycin.clinicaltrials.gov Last update posted: March 6, 2018. [ClinicalTrials.gov identifier NCT02680665 ]

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