Meta AnalysisID 7180

联合T4和T3治疗对比标准T4单药治疗以及干甲状腺制剂对比标准T4单药治疗甲状腺功能减退症的有效性评估：一项系统评价与Meta分析

CRD42023486957

For Combined T4 and T3 Therapy vs. Standard T4 Monotherapy: Population: patients with hypothyroidism included in the studies Intervention: Combined T4 and T3 therapy Comparison: standard T4 monotherapy Outcomes: thyroid

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Meta Analysis Id: 7180
Evidence Id: 15738
Core Evidence Id: 15738
Source Meta Analysis Id: 7167
Herb2 Meta Analysis Id: HBMA007167
Crd Id: CRD42023486957
Title: Evaluating the Effectiveness of Combined T4 and T3 Therapy Versus Standard T4 Monotherapy and Desiccated Thyroid Versus Standard T4 Monotherapy in the Treatment of Hypothyroidism: A Systematic Review and Meta-Analysis
Review Question: For Combined T4 and T3 Therapy vs. Standard T4 Monotherapy: Population: patients with hypothyroidism included in the studies Intervention: Combined T4 and T3 therapy Comparison: standard T4 monotherapy Outcomes: thyroid hormone levels, symptom improvement, quality of life Study Design: randomized controlled trials, observational studies For Desiccated Thyroid vs. Standard T4 Monotherapy: Population: patients with hypothyroidism Intervention: desiccated thyroid treatment Comparison: standard T4 monotherapy Outcomes: thyroid function tests, patient-reported outcomes, adverse effects Study Design: randomized controlled trials, observational studies.
Study Type Included: Randomized Controlled Trials (RCTs): These are considered the gold standard in clinical research and provide the highest level of evidence regarding the efficacy and safety of interventions. Cohort Studies: Both prospective and retrospective cohort studies can be included, as they can provide valuable data on long-term outcomes and real-world effectiveness. Case-Control Studies: Useful for understanding the associations and outcomes, especially in situations where RCTs are limited. Cross-Sectional Studies: These can be included if they provide relevant data on the interventions' effects or patient-reported outcomes. Quasi-Experimental Studies: Studies with non-randomized designs can be considered if they offer significant insights into the interventions' impacts.
Condition Being Studied: The condition being studied in your systematic review is hypothyroidism, a common endocrine disorder where the thyroid gland does not produce enough thyroid hormone. This hormone is crucial for regulating metabolism, heart rate, body temperature, and various other bodily functions. Hypothyroidism can lead to a variety of symptoms, including fatigue, weight gain, cold intolerance, depression, and slowed heart rate, among others. The disease can be primary, originating from the thyroid gland itself, or secondary, due to insufficient stimulation of the thyroid gland by the pituitary hormone TSH (thyroid-stimulating hormone). The standard treatment for hypothyroidism is hormone replacement therapy, primarily using levothyroxine (T4). However, some patients continue to experience symptoms despite normalizing their TSH levels with T4 alone, leading to alternative treatment strategies like combined T4 and T3 therapy, or the use of desiccated thyroid extract. Your review will explore these alternative treatment strategies, comparing their efficacy and safety with standard T4 monotherapy. This is particularly relevant as there is ongoing debate and variability in clinical practice regarding the optimal treatment approach for hypothyroidism, especially in patients who have persistent symptoms despite achieving biochemical euthyroidism with standard therapy.
Participant: Inclusion Criteria: Diagnosis: Individuals diagnosed with hypothyroidism, as confirmed by clinical and biochemical criteria (e.g., elevated TSH and low T4 levels). Age Groups: Include studies involving adults (aged 18 and above). Consider if you want to include pediatric populations or focus solely on adults. Treatment Types: Participants receiving either combined T4 and T3 therapy, desiccated thyroid, or standard T4 monotherapy. Study Types: Randomized controlled trials, observational studies, cohort studies, and case-control studies that provide data on the specified treatments. Health Status: Both newly diagnosed patients and those with long-term hypothyroidism, unless a specific subgroup is targeted. Exclusion Criteria: Other Thyroid Disorders: Exclude studies focusing on participants with hyperthyroidism, thyroid cancer, or non-thyroidal illness syndrome. Pregnancy: Exclude studies exclusively focusing on pregnant women, as thyroid hormone requirements and management differ significantly in this group. Short-term Studies: Exclude studies with very short follow-up periods (e.g., less than 3 months) as they may not adequately capture the efficacy and safety of the treatments. Secondary Hypothyroidism: Exclude studies focusing on hypothyroidism due to pituitary or hypothalamic disease unless your review specifically aims to include this subgroup. Incomplete Data: Studies with incomplete outcome data or those lacking key information relevant to your review's objectives.
Animal
Human Disease Modelled
Intervention: Combined T4 and T3 Therapy: Description: A regimen combining Levothyroxine (T4) and Liothyronine (T3) in various ratios. Dosage and Administration: Include studies with varying dosages and administration routes (oral, intravenous, etc.), as long as they are clearly defined and used for the treatment of hypothyroidism. Desiccated Thyroid: Description: Treatment involving natural desiccated thyroid extract, usually derived from porcine or bovine sources, containing both T4 and T3. Dosage and Administration: Studies should specify the dosage, frequency, and method of administration.
Comparator Control: Standard T4 Monotherapy: Description: Treatment exclusively using Levothyroxine (T4). Dosage and Administration: Studies with varying dosages and administration methods are included, provided they adhere to standard treatment guidelines for hypothyroidism.
Main Outcome: Thyroid Function Tests: Definition: Measures including serum levels of Thyroid-Stimulating Hormone (TSH), Free T4 (FT4), and Free T3 (FT3). Measurement: Blood tests to be conducted at baseline, and at specified intervals during and after the treatment (e.g., 3 months, 6 months, 1 year). Symptom Improvement: Definition: Reduction or resolution of hypothyroid symptoms such as fatigue, weight gain, cold intolerance, and others. Measurement: Utilizing validated symptom questionnaires or scales, recorded at baseline and at regular follow-up intervals. Quality of Life (QoL): Definition: Assessment of the patient's overall well-being and functionality, considering the impact of hypothyroidism and its treatment. Measurement: Using standardized Quality of Life questionnaires like the ThyPRO (Thyroid Patient-Reported Outcome) or SF-36 (Short Form Health Survey) at baseline and during follow-up. Adverse Effects: Definition: Any negative side effects or complications arising from the treatment. Measurement: Documented through patient reports, clinical examinations, and laboratory tests, noted at each follow-up appointment. Cardiovascular Outcomes: Definition: Impact on cardiovascular health, including changes in heart rate, blood pressure, and cholesterol levels. Measurement: Clinical assessments and laboratory tests conducted at baseline and at regular intervals during follow-up. Changes in Body Weight: Definition: Variation in body weight as a result of the treatment. Measurement: Weight measured at baseline and at subsequent follow-up visits.
Outcome Measure
Additional Outcome: Serum Lipid Profile: Definition: Assessment of changes in lipid levels, including total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides. Measurement: Blood tests to be conducted at baseline and at specified follow-up intervals (e.g., 6 months, 1 year). Cognitive Function: Definition: Evaluation of any changes in cognitive abilities or mood, which can be affected by thyroid hormone levels. Measurement: Using cognitive assessment tools or standardized questionnaires, measured at baseline and during follow-up. Bone Mineral Density: Definition: Assessment of the impact of thyroid hormone therapy on bone health, particularly relevant in postmenopausal women and older adults. Measurement: Bone density scans (DEXA scans) at baseline and at specified intervals. TSH Normalization Time: Definition: The duration it takes for serum TSH levels to normalize after the initiation of treatment. Measurement: Regular monitoring of TSH levels from the start of treatment until normalization is achieved. Patient Satisfaction: Definition: The degree of patient satisfaction with the treatment, considering factors like ease of use, perceived effectiveness, and side effects. Measurement: Conducted using patient satisfaction surveys or questionnaires at various points during the treatment course.
Study Method: Meta-analysis, Systematic review
Keyword: MeSH headings have not been applied to this record
Contact: Mahmoud Nassar [email protected]
Organisational Affiliation: Department of Medicine, Division of Endocrinology, Diabetes and Metabolism, Jacobs School of Medicine and Biomedical Sciences, University of Buffalo, NY
Funding Source
Other Selection Criteria
Final Publication
Same Topic Review
Published Protocol
Review Type
Language: English
Country: United States of America
Review Stage: Review Ongoing
First Submission Date: 2023-11-26
Registration Date: 2023-12-07
Anticipated Start Date: 2023-12-09
Anticipated Completion Date: 2024-02-29
Title Cn: 联合T4和T3治疗对比标准T4单药治疗以及干甲状腺制剂对比标准T4单药治疗甲状腺功能减退症的有效性评估：一项系统评价与Meta分析
Title En: Evaluating the Effectiveness of Combined T4 and T3 Therapy Versus Standard T4 Monotherapy and Desiccated Thyroid Versus Standard T4 Monotherapy in the Treatment of Hypothyroidism: A Systematic Review and Meta-Analysis
Bilingual Status: complete