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      The impact of levothyroxine therapy on the pregnancy, neonatal and childhood outcomes of subclinical hypothyroidism during pregnancy: An updated systematic review, meta-analysis and trial sequential analysis

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          Abstract

          Background

          Several systematic reviews and meta-analyses have investigated the effect of levothyroxine (LT4) therapy in pregnant women with subclinical hypothyroidism (SCH). However, all these studies have clinical or methodological problems (such as adopting the old 2011 American Thyroid Association [ATA] diagnostic criteria, directly combining randomized controlled trials [RCTs] and cohort studies for meta-analysis, and so on), and cannot provide accurate and satisfactory results. Thus, we performed this updated systematic review, meta-analysis and trial sequential analysis (TSA) to assess the effect of LT4 therapy in pregnant women with SCH, with the goal of providing more accurate and reliable evidence for clinical practice.

          Methods

          We searched nine databases from inception to February 2022. The search strategy targeted the RCTs and cohort studies on pregnancy, neonatal and childhood outcomes following LT4 treatment in pregnant women with SCH based on the new 2017 ATA diagnostic criteria. We performed meta-analyses of RCTs and cohort studies separately, and further performed meta-analyses by excluding studies with high risk of bias. TSA was performed to test whether the current evidence was sufficient, and the quality of evidence was evaluated using the GRADE method.

          Results

          A total of 9 RCTs and 13 cohort studies comprising 11273 pregnant women with SCH were included. There were no statistically significant differences between LT4 group and control group in all primary and secondary outcomes, such as preterm delivery (RR=0.46, 95%CI: 0.19-1.09, P=0.08, I 2 = 65%), miscarriage (RR=0.36, 95%CI: 0.13-1.03, P=0.06, I 2 = 38%), gestational hypertension (RR=0.91, 95%CI: 0.58-1.43, P=0.69, I 2 = 0%), preeclampsia (RR=1.10, 95%CI: 0.61-1.97, P=0.76, I 2 = 0%), gestational diabetes (RR=0.80, 95%CI: 0.51-1.25, P=0.32, I 2 = 34%), and so on. TSA showed that the results for all outcomes were insufficient and inconclusive. According to GRADE, the evidences for four outcomes (miscarriage, gestational hypertension, gestational diabetes, and small for gestational age) were rated as moderate quality, while the evidences for the other outcomes were rated as low or very low quality.

          Conclusion

          Unlike previous systematic reviews and meta-analyses, our study found no evidence of benefit of LT4 therapy on pregnancy, neonatal and childhood outcomes in pregnant women with SCH.

          Systematic Review Registration

          PROSPERO, https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42022321937, identifier CRD42022321937.

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          Most cited references39

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          RoB 2: a revised tool for assessing risk of bias in randomised trials

          Jonathan A C Sterne, Jelena Savović, Matthew J L Page … (2022)
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                Author and article information

                Contributors
                Journal
                Journal ID (nlm-ta): Front Endocrinol (Lausanne)
                Journal ID (iso-abbrev): Front Endocrinol (Lausanne)
                Journal ID (publisher-id): Front. Endocrinol.
                Title: Frontiers in Endocrinology
                Publisher: Frontiers Media S.A.
                ISSN (Electronic): 1664-2392
                Publication date (Electronic): 05 August 2022
                Publication date Collection: 2022
                Volume: 13
                Electronic Location Identifier: 964084
                Affiliations
                [1] 1 Department of Pharmacy, West China Second University Hospital, Sichuan University , Chengdu, China
                [2] 2 Evidence-Based Pharmacy Center, West China Second University Hospital, Sichuan University , Chengdu, China
                [3] 3 National Medical Products Administration (NMPA) Key Laboratory for Technical Research on Drug Products In Vitro and In Vivo Correlation , Chengdu, China
                [4] 4 Key Laboratory of Birth Defects and Related Diseases of Women and Children, Sichuan University, Ministry of Education , Chengdu, China
                [5] 5 West China School of Pharmacy, Sichuan University , Chengdu, China
                [6] 6 Department of Obstetrics and Gynecology, West China Second University Hospital, Sichuan University , Chengdu, China
                Author notes

                Edited by: Creswell John Eastman, The University of Sydney, Australia

                Reviewed by: Laura Giacomelli, Sapienza University of Rome, Italy; Inés Velasco, Hospital Germans Trias i Pujol, Spain

                *Correspondence: Lingli Zhang, zhanglingli@ 123456scu.edu.cn ; Li Zhang, zhangli_scu@ 123456scu.edu.cn

                †These authors have contributed equally to this work and share first authorship

                This article was submitted to Thyroid Endocrinology, a section of the journal Frontiers in Endocrinology

                Article
                DOI: 10.3389/fendo.2022.964084
                PMC ID: 9400061
                PubMed ID: 36034430
                SO-VID: df25af86-9b55-47f9-959b-7d80d76a8982
                Copyright © Copyright © 2022 Jiao, Zhang, Chen, Wei, Zeng, Liu, Zhang, Li, Zou, Zhang and Zhang
                License:

                This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

                History
                Date received : 08 June 2022
                Date accepted : 13 July 2022
                Page count
                Figures: 6, Tables: 3, Equations: 0, References: 41, Pages: 16, Words: 7973
                Categories
                Subject: Endocrinology
                Subject: Systematic Review

                ScienceOpen disciplines: Endocrinology & Diabetes
                Keywords: subclinical hypothyroidism during pregnancy,levothyroxine,pregnancy outcomes,neonatal outcomes,childhood outcomes
                Data availability:
                ScienceOpen disciplines: Endocrinology & Diabetes
                Keywords: subclinical hypothyroidism during pregnancy, levothyroxine, pregnancy outcomes, neonatal outcomes, childhood outcomes

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