Meta AnalysisID 2956

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出血的二级预防[Cochrane方案]

CRD42016045587

To assess the beneficial and harmful effects of beta-blockers alone or with isosorbide mononitrate versus placebo or no intervention for adults with cirrhosis and gastro-oesophageal varices that have bled.

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Record Fields

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Meta Analysis Id
2956
Evidence Id
11514
Core Evidence Id
11514
Source Meta Analysis Id
2905
Herb2 Meta Analysis Id
HBMA002905
Crd Id
CRD42016045587
Title
Beta-blockers alone or in combination with isosorbide mononitrate for secondary prevention of bleeding from gastro-esophageal varices 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 adults with cirrhosis and gastro-oesophageal varices that have 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 trials 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 bled (secondary prevention), irrespective of the size of the varices (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 in combination of 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), as it is included in another review (Hobolth 2015). We will only 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 in combination of isosorbide mononitrate versus placebo or no intervention.
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 lead 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 oesophageal varices. Bleeding-related mortality. Quality of life. Non-serious adverse events defined as all adverse events that do not fulfil the criteria for serious adverse events. Portal venous pressure expressed as the hepatic venous pressure gradient. </ul>
Study Method
Intervention, Systematic review
Keyword
Adrenergic beta-Antagonists; Adult; Drug Therapy; Drug Therapy, Combination; Esophageal and Gastric Varices; Hemorrhage; Humans; Isosorbide; Liver Cirrhosis; Secondary Prevention; Treatment Outcome
Contact
Lise Lotte Gluud [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
2016-08-09
Anticipated Start Date
2016-03-15
Anticipated Completion Date
2017-04-29
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出血的二级预防[Cochrane方案]
Title En
Beta-blockers alone or in combination with isosorbide mononitrate for secondary prevention of bleeding from gastro-esophageal varices in adults with cirrhosis and gastro-oesophageal varices [Cochrane Protocol]
Bilingual Status
complete