Meta AnalysisID 1412
L-鸟氨酸-L-天冬氨酸治疗肝硬化合并肝性脑病患者 [Cochrane方案]
CRD42017055017
To assess the beneficial and harmful effects of L-ornithine L-aspartate versus placebo, no intervention, or other active interventions for people with cirrhosis and hepatic encephalopathy.
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Record Fields
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- Meta Analysis Id
- 1412
- Evidence Id
- 9970
- Core Evidence Id
- 9970
- Source Meta Analysis Id
- 1367
- Herb2 Meta Analysis Id
- HBMA001367
- Crd Id
- CRD42017055017
- Title
- L-ornithine L-aspartate for people with cirrhosis and hepatic encephalopathy [Cochrane Protocol]
- Review Question
- To assess the beneficial and harmful effects of L-ornithine L-aspartate versus placebo, no intervention, or other active interventions for people with cirrhosis and hepatic encephalopathy.
- Study Type Included
- We will include randomised clinical trials (RCTs) regardless of their publication status, language, or blinding in our primary analyses. If, during the selection of trials, we identify observational studies (i.e. quasi-randomised studies; cohort studies; or patient reports) that report adverse events caused by or associated with the interventions in our review, we will include these studies for a review of the adverse events. We will not specifically search for observational studies for inclusion in this review, which is a known limitation of our systematic review.
- Condition Being Studied
- The Cochrane Hepato-Biliary Group
- Participant
- We will include participants with cirrhosis who have overt or minimal hepatic encephalopathy or who are at risk of developing hepatic encephalopathy. We will include participants in our primary analyses regardless of sex, age, aetiology of the underlying liver disease or precipitating factors. We will exclude data on people with acute liver failure.
- Animal
- Human Disease Modelled
- Intervention
- We will compare: i) L-ornithine L-aspartate versus placebo or no intervention; and ii) L-ornithine L-aspartate versus nonabsorbable disaccharides, antibiotics, probiotics, or branched-chain amino acids. We will include trials irrespective of the doses, treatment durations, or mode of administration. We will allow co-interventions administered equally to allocation arms. We do not plan to include analyses of glycerol phenylbutyrate, ornithine phenylacetate, or spherical carbon adsorbents (AST-120), which will be evaluated in a separate review (Morgan 2016).
- Comparator Control
- i) L-ornithine L-aspartate versus placebo or no intervention; ii) L-ornithine L-aspartate versus nonabsorbable disaccharides, antibiotics, probiotics, or branched-chain amino acids.
- Main Outcome
- <ol> Mortality (all-cause). Hepatic encephalopathy. We will assess the outcome using the primary investigators' overall assessment of: i) number of participants who developed hepatic encephalopathy; and ii) number of participants without a clinically-relevant improvement in hepatic encephalopathy. Serious adverse events: defined as any untoward medical occurrence that led to death, was life threatening or required hospitalisation or prolongation of hospitalisation (ICH-GCP 1997). We will analyse serious adverse events as a composite outcome (Gluud 2016).</ol>
- Outcome Measure
- Additional Outcome
- <ol> Quality of life. Liver-related mortality. Non-serious adverse events (all adverse events that do no fulfil the criteria listed under serious adverse events). </ol>Exploratory outcomes<ol> Number connection test. Portal hepatic encephalopathy score. Blood ammonia concentrations. Electroencephalography.</ol>
- Study Method
- Intervention, Systematic review
- Keyword
- MeSH headings have not been applied to this record.
- Contact
- Lise Lotte Gluud [email protected]
- Organisational Affiliation
- The Cochrane Collaboration http://www.cochrane.org/
- Funding Source
- None specified
- Other Selection Criteria
- Final Publication
- Same Topic Review
- Published Protocol
- Review Type
- Language
- English
- Country
- England, Denmark
- Review Stage
- Review Ongoing
- First Submission Date
- 2017-01-11
- Registration Date
- 2017-12-11
- Anticipated Start Date
- 2016-10-15
- Anticipated Completion Date
- 2017-06-09
- Title Cn
- L-鸟氨酸-L-天冬氨酸治疗肝硬化合并肝性脑病患者 [Cochrane方案]
- Title En
- L-ornithine L-aspartate for people with cirrhosis and hepatic encephalopathy [Cochrane Protocol]
- Bilingual Status
- complete