N-acetylcysteine for non-paracetamol drug-induced liver injury: a systematic review protocol

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dc.contributor.authorChughlay, Mohameden_ZA
dc.contributor.authorKramer, Nicoleen_ZA
dc.contributor.authorWerfalli, Mahmouden_ZA
dc.contributor.authorSpearman, Wendyen_ZA
dc.contributor.authorEngel, Mark Een_ZA
dc.contributor.authorCohen, Karenen_ZA
dc.date.accessioned2015-12-07T08:51:43Z
dc.date.available2015-12-07T08:51:43Z
dc.date.issued2015en_ZA
dc.description.abstractBACKGROUND: Drug-induced liver injury (DILI) refers to acute or chronic liver injury that may occur as a consequence of using drugs and herbal or dietary supplements. Specific therapies for DILI are limited. There is considerable evidence for efficacy and safety of N-acetylcysteine (NAC) in management of paracetamol-induced liver injury. More recently, research has explored the use of NAC in non-paracetamol drug-induced liver injury. It is important to summarise the evidence of NAC for non-paracetamol DILI to determine if NAC may be considered a therapeutic option in this condition.METHODS/DESIGN:We will conduct a systematic review of the benefit and harm of NAC in non-paracetamol drug-induced liver injury. Primary and secondary outcomes of interest are pre-specified. Primary outcomes include all-cause mortality, mortality due to DILI, time to normalisation of liver biochemistry (e.g. return of alanine transaminase to <100 U/l and/or international normalized ratio (INR) <1.5) and adverse events. Secondary outcomes include transplantation rate, time to transplantation, transplant-free survival and duration of hospitalisation. We will include randomized controlled trials (RCTs) and prospective cohort studies. RCTs will contribute to the evaluation of safety and efficacy of NAC, whereas, the cohort studies will contribute exclusively to the evaluation of safety. We will search several bibliographic databases (including PubMed, Scopus, CINAHL, CENTRAL), grey literature sources, conference proceedings and ongoing trials. Following data extraction and assessment of the risk of bias, we will conduct a meta-analysis if feasible, as well as subgroup analyses. We will assess and explore clinical and statistical heterogeneity.DISCUSSION:The aim of this review is to provide evidence on the effectiveness and safety of NAC in non-paracetamol DILI. We anticipate that the results could aid health care practitioners, researchers and policymakers in the decision-making regarding the use of NAC in patients with non-paracetamol DILI.SYSTEMATIC REVIEW REGISTRATION:PROSPERO CRD42014008771en_ZA
dc.identifier.apacitationChughlay, M., Kramer, N., Werfalli, M., Spearman, W., Engel, M. E., & Cohen, K. (2015). N-acetylcysteine for non-paracetamol drug-induced liver injury: a systematic review protocol. <i>Systematic Reviews</i>, http://hdl.handle.net/11427/15646en_ZA
dc.identifier.chicagocitationChughlay, Mohamed, Nicole Kramer, Mahmoud Werfalli, Wendy Spearman, Mark E Engel, and Karen Cohen "N-acetylcysteine for non-paracetamol drug-induced liver injury: a systematic review protocol." <i>Systematic Reviews</i> (2015) http://hdl.handle.net/11427/15646en_ZA
dc.identifier.citationChughlay, M. F., Kramer, N., Werfalli, M., Spearman, W., Engel, M. E., & Cohen, K. (2015). N-acetylcysteine for non-paracetamol drug-induced liver injury: a systematic review protocol. Systematic Reviews, 4(1), 81.en_ZA
dc.identifier.ris TY - Journal Article AU - Chughlay, Mohamed AU - Kramer, Nicole AU - Werfalli, Mahmoud AU - Spearman, Wendy AU - Engel, Mark E AU - Cohen, Karen AB - BACKGROUND: Drug-induced liver injury (DILI) refers to acute or chronic liver injury that may occur as a consequence of using drugs and herbal or dietary supplements. Specific therapies for DILI are limited. There is considerable evidence for efficacy and safety of N-acetylcysteine (NAC) in management of paracetamol-induced liver injury. More recently, research has explored the use of NAC in non-paracetamol drug-induced liver injury. It is important to summarise the evidence of NAC for non-paracetamol DILI to determine if NAC may be considered a therapeutic option in this condition.METHODS/DESIGN:We will conduct a systematic review of the benefit and harm of NAC in non-paracetamol drug-induced liver injury. Primary and secondary outcomes of interest are pre-specified. Primary outcomes include all-cause mortality, mortality due to DILI, time to normalisation of liver biochemistry (e.g. return of alanine transaminase to <100 U/l and/or international normalized ratio (INR) <1.5) and adverse events. Secondary outcomes include transplantation rate, time to transplantation, transplant-free survival and duration of hospitalisation. We will include randomized controlled trials (RCTs) and prospective cohort studies. RCTs will contribute to the evaluation of safety and efficacy of NAC, whereas, the cohort studies will contribute exclusively to the evaluation of safety. We will search several bibliographic databases (including PubMed, Scopus, CINAHL, CENTRAL), grey literature sources, conference proceedings and ongoing trials. Following data extraction and assessment of the risk of bias, we will conduct a meta-analysis if feasible, as well as subgroup analyses. We will assess and explore clinical and statistical heterogeneity.DISCUSSION:The aim of this review is to provide evidence on the effectiveness and safety of NAC in non-paracetamol DILI. We anticipate that the results could aid health care practitioners, researchers and policymakers in the decision-making regarding the use of NAC in patients with non-paracetamol DILI.SYSTEMATIC REVIEW REGISTRATION:PROSPERO CRD42014008771 DA - 2015 DB - OpenUCT DO - 10.1186/s13643-015-0075-6 DP - University of Cape Town J1 - Systematic Reviews LK - https://open.uct.ac.za PB - University of Cape Town PY - 2015 T1 - N-acetylcysteine for non-paracetamol drug-induced liver injury: a systematic review protocol TI - N-acetylcysteine for non-paracetamol drug-induced liver injury: a systematic review protocol UR - http://hdl.handle.net/11427/15646 ER - en_ZA
dc.identifier.urihttp://hdl.handle.net/11427/15646
dc.identifier.urihttp://dx.doi.org/10.1186/s13643-015-0075-6
dc.identifier.vancouvercitationChughlay M, Kramer N, Werfalli M, Spearman W, Engel ME, Cohen K. N-acetylcysteine for non-paracetamol drug-induced liver injury: a systematic review protocol. Systematic Reviews. 2015; http://hdl.handle.net/11427/15646.en_ZA
dc.language.isoengen_ZA
dc.publisherBioMed Central Ltden_ZA
dc.publisher.departmentDivision of Clinical Pharmacologyen_ZA
dc.publisher.facultyFaculty of Health Sciencesen_ZA
dc.publisher.institutionUniversity of Cape Town
dc.rightsThis is an Open Access article distributed under the terms of the Creative Commons Attribution Licenseen_ZA
dc.rights.holder2015 Chughlay et al.en_ZA
dc.rights.urihttp://creativecommons.org/licenses/by/4.0en_ZA
dc.sourceSystematic Reviewsen_ZA
dc.source.urihttp://www.systematicreviewsjournal.com/en_ZA
dc.subject.otherN-acetylcysteineen_ZA
dc.subject.otherAcetylcysteineen_ZA
dc.subject.otherDrug-induceden_ZA
dc.subject.otherHepatitisen_ZA
dc.subject.otherLiveren_ZA
dc.subject.otherLiver failureen_ZA
dc.subject.otherNon-paracetamolen_ZA
dc.subject.otherNon-acetaminophenen_ZA
dc.titleN-acetylcysteine for non-paracetamol drug-induced liver injury: a systematic review protocolen_ZA
dc.typeJournal Articleen_ZA
uct.type.filetypeText
uct.type.filetypeImage
uct.type.publicationResearchen_ZA
uct.type.resourceArticleen_ZA
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