Meta AnalysisID 1532
成人甲状腺功能亢进症的辅助性胆汁酸螯合剂治疗 [Cochrane方案]
CRD42016045966
To assess the effects of adjunctive bile acid sequestrant therapy for hyperthyroidism in adults.
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Record Fields
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- Meta Analysis Id
- 1532
- Evidence Id
- 10090
- Core Evidence Id
- 10090
- Source Meta Analysis Id
- 1488
- Herb2 Meta Analysis Id
- HBMA001488
- Crd Id
- CRD42016045966
- Title
- Adjunctive bile acid sequestrant therapy for hyperthyroidism in adults [Cochrane Protocol]
- Review Question
- To assess the effects of adjunctive bile acid sequestrant therapy for hyperthyroidism in adults.
- Study Type Included
- We will include randomised controlled clinical trials (RCTs).
- Condition Being Studied
- The Cochrane Metabolic and Endocrine Disorders Group
- Participant
- Adult persons, between 18 and 65 years old, with newly diagnosed hyperthyroidism. Diagnostic criteria for hyperthyroidism Participants should be diagnosed with hyperthyroidism as defined by: history of signs or symptoms of hyperthyroidism such as weight loss, heat intolerance, irritability, anxiety, palpitations, and tremor; laboratory findings such as elevated total thyroxine (T4) levels ( > 12.6 µg/dL ), elevated free T4 (FT4) levels ( > 1.8 ng/dL ), elevated total triiodothyronine (T3) levels ( > 180 ng/dL ), elevated free T3 (FT3) levels ( > 0.5 ng/dL ) or thyroid-stimulating hormone below the reference level ( < 0.4 mIU/L); and if necessary, we will use the trial authors' definition of hyperthyroidism.</ul> We plan to subject diagnostic criteria to a sensitivity analysis.
- Animal
- Human Disease Modelled
- Intervention
- We plan to investigate the following comparisons of intervention versus control/comparator. Intervention Bile acid sequestrant adjunctive therapy (i.e. standard therapy + bile acid sequestrants (BAS)).</ul> The available BAS include cholestyramine, colestipol, and colesevelam. Comparator Standard therapy + placebo.</ul> Concomitant interventions will have to be the same in both the intervention and comparator groups to establish fair comparisons. If multiple arms are included in a trial, we will include any arm that meets the inclusion criteria in the review. Minimum duration of intervention We will define trial duration according to the number of weeks over which the interventions have been conducted, and will only include trials in the analyses with interventions that lasted longer than four weeks. Follow-up, including duration of the intervention, should be at least eight weeks. Specific exclusion criteria Allergy or other adverse effects of BAS. Non-compliance because of a psychiatric or other serious disease.</ul>
- Comparator Control
- Comparator Standard therapy + placebo.</ul> Concomitant interventions will have to be the same in both the intervention and comparator groups to establish fair comparisons. If multiple arms are included in a trial, we will include any arm that meets the inclusion criteria in the review.
- Main Outcome
- Reduction of symptoms. Health-related quality of life. Adverse events. </ul> Measures of effect Method and timing of outcome measurement Reduction of symptoms; defined as the perception of participants that the hyperthyroidism symptoms improve. Symptoms include fatigue, heat intolerance, sweating, weight loss, shakiness, and anxiety. Palpitations of the heart, shortness of breath, and agitation can also be present. Poor sleep, thirst, nausea, and increased frequency of defecation are other common symptoms. Symptoms should be measured two and four weeks after initiation of the intervention. Ideally, all these symptoms should be measured using visual analogue scales (VAS). Health-related quality of life: measured with a validated instrument such as the SF-36 Health Survey and measured at least four weeks after the intervention (Ware 1992). Adverse events: for example, constipation, bloating, diarrhoea, and abdominal pain; measured any time during and after the intervention. All-cause mortality: defined as death from any cause; measured at any time during and after the intervention. Thyroid hormone levels: defined as serum T4 levels or serum T3 levels; measured at least two and four weeks after initiation of the intervention. Socioeconomic effects: such as reduced hospitalisation days, economic costs, and days of work disability leave; measured at least two and four weeks after initiation of the intervention. </ul>
- Outcome Measure
- Additional Outcome
- All-cause mortality. Thyroid hormone levels. Socioeconomic effects.</ul> Specification of key prognostic variables Degree of hyperthyroidism, measured according to serum FT4 concentrations: mild hyperthyroidism FT4 = 24 to 50 pmol/L, moderate hyperthyroidism FT4 = 51 to 100 pmol/L, and severe hyperthyroidism FT4 > 100 pmol/L (Iglesias 2010). Size of thyroid prior to treatment; an enlarged thyroid is associated with poor outcomes (Liu 2016). FT3 to FT4 ratio; an elevated FT3/FT4 ratio is associated with non-remission of hyperthyroidism (Liu 2016). Thyrotrophin receptor antibody levels; elevated levels of thyrotrophin receptor antibodies are associated with poor outcomes (Liu 2016).</ul> 'Summary of findings' table We will present a 'Summary of finding' table to report the following outcomes, listed according to priority.<ol> Reduction of symptoms. Adverse events. Health-related quality of life. All-cause mortality. Thyroid hormone levels. Socioeconomic effects.</ol> Measures of effect As above.
- Study Method
- Intervention, Systematic review
- Keyword
- Adult; Anticholesteremic Agents; Bile Acids and Salts; Combined Modality Therapy; Humans; Hyperthyroidism; Treatment Outcome
- Contact
- Carlos A Salazar [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
- Peru
- Review Stage
- Review Ongoing
- First Submission Date
- Registration Date
- 2016-08-15
- Anticipated Start Date
- 2016-06-15
- Anticipated Completion Date
- 2017-05-31
- Title Cn
- 成人甲状腺功能亢进症的辅助性胆汁酸螯合剂治疗 [Cochrane方案]
- Title En
- Adjunctive bile acid sequestrant therapy for hyperthyroidism in adults [Cochrane Protocol]
- Bilingual Status
- complete