Meta AnalysisID 1530
胆汁酸衍生物用于原发性硬化性胆管炎患者 [Cochrane方案]
CRD42016045492
To evaluate the benefits and harms of bile acid derivatives (such as obeticholic acid or nor-ursodeoxycholic acid) for the treatment of people with primary sclerosing cholangitis.
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Record Fields
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- Meta Analysis Id
- 1530
- Evidence Id
- 10088
- Core Evidence Id
- 10088
- Source Meta Analysis Id
- 1486
- Herb2 Meta Analysis Id
- HBMA001486
- Crd Id
- CRD42016045492
- Title
- Bile acid derivatives for people with primary sclerosing cholangitis [Cochrane Protocol]
- Review Question
- To evaluate the benefits and harms of bile acid derivatives (such as obeticholic acid or nor-ursodeoxycholic acid) for the treatment of people with primary sclerosing cholangitis.
- Study Type Included
- We will include all randomised clinical trials, irrespective of blinding, publication status, publication year, language, or sample size. For the assessment of harm, we will consider controlled clinical studies in which quasi-randomisation methods have been used, such as date of birth, day of the week, or medical record number, as well as observational studies.
- Condition Being Studied
- The Cochrane Hepato-Biliary Group
- Participant
- We will include hospital and community-based men and women (aged greater than 18 years), regardless of ethnicity if they have a confirmed diagnosis of primary sclerosing cholangitis or autoimmune overlap syndrome using the diagnostic criteria specified in the included trials (e.g., 1. elevated level of serum markers of cholestasis that cannot otherwise be explained; and 2. characteristic bile duct changes, demonstrated by magnetic resonance cholangiopancreatography or endoscopic cholangiopancreatography, i.e., multifocal strictures and segmental dilatations; or 3. liver biopsy showing features compatible with primary sclerosing cholangitis). People with a normal cholangiogram but typical clinical, biochemical, and histological findings are classified as small duct primary sclerosing cholangitis (EASL 2009). 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.</ul> 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 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). Colorectal cancer. </ul>
- Study Method
- Intervention, Systematic review
- Keyword
- Bile Acids and Salts; Cholangitis, Sclerosing; Humans; Treatment Outcome
- Contact
- Caroline S Stokes [email protected]
- Organisational Affiliation
- The Cochrane Collaboration http://www.cochrane.org/
- Funding Source
- None known, None known
- 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
- 2016-11-25
- Title Cn
- 胆汁酸衍生物用于原发性硬化性胆管炎患者 [Cochrane方案]
- Title En
- Bile acid derivatives for people with primary sclerosing cholangitis [Cochrane Protocol]
- Bilingual Status
- complete