Meta AnalysisID 1531

胆汁酸衍生物用于原发性胆汁性胆管炎患者 [Cochrane方案]

CRD42016045493

To assess the benefits and harms of bile acid derivatives for people with primary biliary cholangitis.

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Meta Analysis Id: 1531
Evidence Id: 10089
Core Evidence Id: 10089
Source Meta Analysis Id: 1487
Herb2 Meta Analysis Id: HBMA001487
Crd Id: CRD42016045493
Title: Bile acid derivatives for people with primary biliary cholangitis [Cochrane Protocol]
Review Question: To assess the benefits and harms of bile acid derivatives for people with primary biliary cholangitis.
Study Type Included: We will include randomised clinical trials regardless of publication status or year of publication, sample size, presence of blinding or language. We will include quasi-randomised studies and observational studies in the assessment of adverse events.
Condition Being Studied: The Cochrane Hepato-Biliary Group
Participant: We will include both hospital and community-based men and women (aged over 18 years) from all ethnicities with confirmed diagnosis of primary biliary cholangitis or autoimmune overlap syndrome using the diagnostic criteria specified in included trials. For example; biochemical criteria consistent with cholestasis: elevated serum alkaline phosphatases, gamma-glutamyl transpeptidase, alanine aminotransferase, aspartate aminotransferase, raised serum bilirubin concentration, or a combination of these; positive anti-mitochondrial antibodies; liver biopsy showing features compatible with primary biliary cholangitis (EASL 2009; Lindor 2009).</ul> For autoimmune overlap syndrome, two of the following three diagnostic criteria must also be present: elevated serum alanine aminotransferase; elevated IgG concentrations; liver biopsy indicating moderate or severe periportal or periseptal lymphocytic piecemeal necrosis (EASL 2009).</ul> We will exclude randomised clinical trials evaluating participants who have undergone liver transplantation.
Animal
Human Disease Modelled
Intervention: We will evaluate the following experimental and control interventions. Experimental: bile acid derivatives such as obeticholic acid and nor-ursodeoxycholic acid administered at any dose, duration, and route of administration, given as monotherapy or in combination with ursodeoxycholic acid; Control: placebo, no intervention, or ursodeoxycholic acid. We will analyse randomised clinical trials evaluating placebo/no intervention and ursodeoxycholic acid separately.</ul> We will allow co-interventions if administered equally to the intervention and control group.
Comparator Control: Control: placebo, no intervention, or ursodeoxycholic acid. We will analyse randomised clinical trials evaluating placebo/no intervention and ursodeoxycholic acid separately.
Main Outcome: All-cause mortality. Serious adverse events: any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalisation or prolongation of existing hospitalisation, or resulted in persistent or significant disability or incapacity, or was a congenital anomaly/birth defect, or any medical event that might have jeopardised the person, or required intervention to prevent it (ICH-GCP 1997). We will conduct separate analyses of individual serious adverse events (e.g., mortality, variceal bleeding, hepatorenal syndrome, hepatic encephalopathy, ascites, and spontaneous bacterial peritonitis) and an analysis that combines all serious adverse events (Gluud 2015). Quality of life. We will consider all assessments of the quality of life including both disease-specific and generic scales. </ul>
Outcome Measure
Additional Outcome: Clinical symptoms: pruritus and fatigue. Non-serious adverse events. All adverse events that do not fulfil the criteria for serious adverse events. All malignancies (including malignancies other than cholangiocarcinoma and hepatocellular carcinoma). </ul> Exploratory outcomes Biochemical response (e.g., number of people without biochemical improvement). </ul>
Study Method: Intervention, Systematic review
Keyword: Bile Acids and Salts; Cholangitis; Humans; Treatment Outcome
Contact: Caroline S Stokes [email protected]
Organisational Affiliation: The Cochrane Collaboration http://www.cochrane.org/
Funding Source
Other Selection Criteria
Final Publication
Same Topic Review
Published Protocol
Review Type
Language: English
Country: Denmark, Germany
Review Stage: Review Ongoing
First Submission Date
Registration Date: 2016-08-08
Anticipated Start Date: 2016-01-15
Anticipated Completion Date: 2016-11-18
Title Cn: 胆汁酸衍生物用于原发性胆汁性胆管炎患者 [Cochrane方案]
Title En: Bile acid derivatives for people with primary biliary cholangitis [Cochrane Protocol]
Bilingual Status: complete