Meta AnalysisID 2955
β受体阻滞剂单用或联用单硝酸异山梨酯用于成人肝硬化食管胃静脉曲张的一级预防[Cochrane方案]
CRD42015026556
To assess the beneficial and harmful effects of beta-blockers alone or with isosorbide mononitrate versus placebo or no intervention for people with cirrhosis and gastro-oesophageal varices that have not bled.
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Record Fields
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- Meta Analysis Id
- 2955
- Evidence Id
- 11513
- Core Evidence Id
- 11513
- Source Meta Analysis Id
- 2904
- Herb2 Meta Analysis Id
- HBMA002904
- Crd Id
- CRD42015026556
- Title
- Beta-blockers alone or with isosorbide mononitrate for primary prevention in adults with cirrhosis and gastro-oesophageal varices [Cochrane Protocol]
- Review Question
- To assess the beneficial and harmful effects of beta-blockers alone or with isosorbide mononitrate versus placebo or no intervention for people with cirrhosis and gastro-oesophageal varices that have not bled.
- Study Type Included
- We will include randomised trials irrespective of blinding, language, year of publication, or publication status. In addition, we will include quasi-randomised studies and observational studies on our assessment of serious adverse events (Higgins 2011a).
- Condition Being Studied
- The Cochrane Hepato-Biliary Group
- Participant
- We will include people with cirrhosis and endoscopically verified gastro-oesophageal varices that have not bled (primary prevention), irrespective of the size (small or large varices) or the hepatic venous pressure gradient.
- Animal
- Human Disease Modelled
- Intervention
- We will include the following comparisons: beta-blockers versus placebo or no intervention; beta-blockers plus isosorbide mononitrate versus placebo or no intervention.</ul> We will include trials regardless of the dose of the interventions or treatment duration. We will exclude trials on carvedilol (a beta-blocker with alpha-blocking properties), which is included in another planned review. (Hobolth 2015) We will allow co-interventions such as endoscopic therapy (e.g., banding ligation) if administered equally to the intervention and control group.
- Comparator Control
- We will include the following comparisons: Beta-blockers versus placebo or no intervention; Beta-blockers plus isosorbide mononitrate versus placebo or no intervention. We will allow co-interventions such as endoscopic therapy (e.g., banding ligation) if administered equally to the intervention and control group.
- Main Outcome
- All-cause mortality. Upper gastrointestinal bleeding of any cause. Serious adverse events defined as any untoward medical occurrence that does not necessarily have a causal relationship with the treatment (ICH-GCP 1997). We will define serious adverse events as those that led to death, were life threatening, or required hospitalisation or prolongation of hospitalisation (ICH-GCP 1997). We will analyse adverse events separately (Loke 2011), and as a composite outcome (Gluud 2015). </ul>
- Outcome Measure
- Additional Outcome
- Bleeding from gastro-oesophageal varices. Non-serious adverse events defined as adverse events that did not fulfil the criteria for serious adverse events. Bleeding-related mortality. Quality of life. Portal venous pressure expressed as the hepatic venous pressure gradient. </ul>
- Study Method
- Keyword
- Adrenergic beta-Antagonists; Adult; Esophageal and Gastric Varices; Humans; Isosorbide; Dinitrate; isosorbide-5-mononitrate; Liver Cirrhosis; Primary Prevention
- Contact
- Nina Kimer [email protected]
- Organisational Affiliation
- The Cochrane Collaboration http://www.cochrane.org/
- Funding Source
- None, None
- Other Selection Criteria
- Final Publication
- Same Topic Review
- Published Protocol
- Review Type
- Language
- English
- Country
- Denmark
- Review Stage
- Review Ongoing
- First Submission Date
- Registration Date
- 2015-09-24
- Anticipated Start Date
- 2015-05-15
- Anticipated Completion Date
- 2017-02-02
- Title Cn
- β受体阻滞剂单用或联用单硝酸异山梨酯用于成人肝硬化食管胃静脉曲张的一级预防[Cochrane方案]
- Title En
- Beta-blockers alone or with isosorbide mononitrate for primary prevention in adults with cirrhosis and gastro-oesophageal varices [Cochrane Protocol]
- Bilingual Status
- complete