Early Initiation of Thyroid Hormone Therapy Versus Watchful Waiting or Delayed Treatment or no Treatment in Subclinical Hypothyroidism: A Systematic Review and Meta-analysis Protocol.

Q2 Pharmacology, Toxicology and Pharmaceutics

F1000Research Pub Date : 2026-09-29 eCollection Date: 2026-01-01 DOI:10.12688/f1000research.179360.3

Aravind P Gandhi, Kalyani P Deshmukh, Anupriya Kaliyappan, Akash Bang, Neha Gangane

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引用次数: 0

Abstract

Background: The prevalence of subclinical hypothyroidism (SCH) in the general population is notably high, ranging from 4% to 20%, and varies according to sex and age. SCH has been reported to be associated with multiple adverse pregnancy outcomes in pregnant women. While the therapeutic decision for overt hypothyroidism is fairly straightforward, treatment of SCH, especially the timing of the initiation of therapy, has been a point of discussion.

Objective: To assess the effect of early initiation of treatment (thyroid hormone therapy) compared to watchful waiting, delayed initiation, or no treatment on progression to overt hypothyroidism, prevention of complications, and associated adverse outcomes through a "systematic review and meta-analysis (SRMA)".

Methods: The SRMA protocol adhered to the "Preferred Reporting Items for Systematic reviews and Meta-Analyses Protocols (PRISMA-P 2015)" guidelines. Only "randomized controlled trials (RCTs)" will be included. The databases "PubMed, Scopus, EMBASE, and the Cochrane Library" will be searched from inception until 30.12.2025. Two stages (title abstract followed by full-text review) and two-pass screening (two authors independently) with a third reviewer adjudication of conflicts will be adopted. Data will be extracted, and the risk of bias will be assessed independently by two authors using a process to resolve differences. The risk of bias for RCTs will be assessed using Cochrane ROB 2.0. Pooled estimates will be calculated for meta-analysis. Subgroup analysis and meta-regression will be performed if heterogeneity was present. The certainty of the evidence will be ascertained through "GRADE (Grading of Recommendations, Assessment, Development, and Evaluation)".

Intended outcomes: The SRMA can inform the framing of clinical guidelines for SCH management for all population groups and also intends to bring out gaps in the existing literature for future studies.PROSPERO ID: CRD420251270021 (Date: 08 February 2026).

查看原文本刊更多论文

早期开始甲状腺激素治疗与观察等待或延迟治疗或不治疗亚临床甲状腺功能减退：一项系统回顾和荟萃分析方案

背景：亚临床甲状腺功能减退症（SCH）在普通人群中的患病率非常高，从4%到20%不等，并因性别和年龄而异。据报道，SCH与孕妇的多种不良妊娠结局有关。虽然显性甲状腺功能减退症的治疗决定相当简单，但SCH的治疗，特别是开始治疗的时机，一直是讨论的焦点。目的：通过一项“系统回顾和荟萃分析（SRMA）”，评估早期开始治疗（甲状腺激素治疗）与观察等待、延迟开始治疗或不治疗对进展为明显甲状腺功能减退、并发症预防和相关不良结局的影响。方法：SRMA方案遵循“系统评价和荟萃分析方案的首选报告项目（PRISMA-P 2015）”指南。只包括“随机对照试验（RCTs）”。数据库“PubMed, Scopus， EMBASE和Cochrane Library”将从成立到2025年12月30日进行检索。采用两阶段（标题摘要后全文审查）和两阶段筛选（两名作者独立），并由第三审稿人对冲突进行评审。数据将被提取，偏倚风险将由两位作者使用解决差异的程序独立评估。随机对照试验的偏倚风险将使用Cochrane ROB 2.0进行评估。汇总估计将用于元分析。如果异质性存在，将进行亚组分析和meta回归。证据的确定性将通过“GRADE（建议、评估、发展和评估的分级）”来确定。预期结果：SRMA可以为所有人群的SCH管理的临床指南框架提供信息，也可以为未来的研究提出现有文献中的空白。普洛斯彼罗ID: CRD420251270021（日期：2026年2月8日）。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

F1000Research Pharmacology, Toxicology and Pharmaceutics-Pharmacology, Toxicology and Pharmaceutics (all)

CiteScore

5.00

自引率

0.00%

发文量

1646

审稿时长

1 weeks

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