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Acupuncture for Hashimoto thyroiditis: study protocol for a randomized controlled trial

BACKGROUND: The incidence rate of Hashimoto thyroiditis (HT) has gradually increased in recent years. There has been no specific etiological treatment for HT. Even though with normal level of thyroid hormone, the patients may still suffer from various clinical symptoms, such as anterior neck discomf...

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Autores principales: Wang, Shanze, Zhao, Jiping, Zeng, Weimei, Du, Wanqing, Zhong, Tenghui, Gao, Hui, Xiao, Yi, Yang, Chao
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7818748/
https://www.ncbi.nlm.nih.gov/pubmed/33478571
http://dx.doi.org/10.1186/s13063-021-05036-8
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author Wang, Shanze
Zhao, Jiping
Zeng, Weimei
Du, Wanqing
Zhong, Tenghui
Gao, Hui
Xiao, Yi
Yang, Chao
author_facet Wang, Shanze
Zhao, Jiping
Zeng, Weimei
Du, Wanqing
Zhong, Tenghui
Gao, Hui
Xiao, Yi
Yang, Chao
author_sort Wang, Shanze
collection PubMed
description BACKGROUND: The incidence rate of Hashimoto thyroiditis (HT) has gradually increased in recent years. There has been no specific etiological treatment for HT. Even though with normal level of thyroid hormone, the patients may still suffer from various clinical symptoms, such as anterior neck discomfort, fatigue, and mood swings, which seriously impair their quality of life. Acupuncture has long been used in the treatment of thyroid diseases, but there has been no related standardized clinical study as of today. This study aims to assess the feasibility, efficacy, and safety of acupuncture for HT. METHODS: This is a randomized, black-controlled assessor-blinded pilot trial. A total of 60 patients will be recruited and divided into the experimental group (n = 30) or the control group (n = 30). The experimental group will undergo acupuncture therapy (penetration needling of Hand-Yangming meridian, PNHM) for 16 weeks, followed by a 16-week follow-up period, and the control group will first go through an observation period for 16 weeks, followed by a 16-week compensation PNHM therapy. The primary outcome will be the change of the concentrations of anti-thyroperoxidase antibodies (TPOAb), antithyroglobulin antibodies (TgAb), and thyroid hormone, including total thyroxine (FT(4)), free thyroxine (FT(3)), and thyroid-stimulating hormone (TSH). The secondary outcome measurements include the thyroid-related quality of life questionnaire short-form (ThyPRO-39), The Mos 36-item Short Form Health Survey (SF-36), and Hospital Anxiety and Depression Scale (HAD). Data collection will be performed before the start of the study (the baseline assessment) and at weeks 8, 16, 24, and 32. DISCUSSION: The study is designed to assess the feasibility and effectiveness of PNHM in reducing the thyroid antibody level and improving the quality of life of HT patients with hypothyroidism or subclinical hypothyroidism. Results of this trial will assist further analyses on whether the acupuncture treatment can alleviate symptoms for patients with HT. TRIAL REGISTRATION: Acupuncture-Moxibustion Clinical Trial Registry AMCTR-IOR-19000308 (ChiCTR1900026830). Registered on 23 October 2019.
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spelling pubmed-78187482021-01-22 Acupuncture for Hashimoto thyroiditis: study protocol for a randomized controlled trial Wang, Shanze Zhao, Jiping Zeng, Weimei Du, Wanqing Zhong, Tenghui Gao, Hui Xiao, Yi Yang, Chao Trials Study Protocol BACKGROUND: The incidence rate of Hashimoto thyroiditis (HT) has gradually increased in recent years. There has been no specific etiological treatment for HT. Even though with normal level of thyroid hormone, the patients may still suffer from various clinical symptoms, such as anterior neck discomfort, fatigue, and mood swings, which seriously impair their quality of life. Acupuncture has long been used in the treatment of thyroid diseases, but there has been no related standardized clinical study as of today. This study aims to assess the feasibility, efficacy, and safety of acupuncture for HT. METHODS: This is a randomized, black-controlled assessor-blinded pilot trial. A total of 60 patients will be recruited and divided into the experimental group (n = 30) or the control group (n = 30). The experimental group will undergo acupuncture therapy (penetration needling of Hand-Yangming meridian, PNHM) for 16 weeks, followed by a 16-week follow-up period, and the control group will first go through an observation period for 16 weeks, followed by a 16-week compensation PNHM therapy. The primary outcome will be the change of the concentrations of anti-thyroperoxidase antibodies (TPOAb), antithyroglobulin antibodies (TgAb), and thyroid hormone, including total thyroxine (FT(4)), free thyroxine (FT(3)), and thyroid-stimulating hormone (TSH). The secondary outcome measurements include the thyroid-related quality of life questionnaire short-form (ThyPRO-39), The Mos 36-item Short Form Health Survey (SF-36), and Hospital Anxiety and Depression Scale (HAD). Data collection will be performed before the start of the study (the baseline assessment) and at weeks 8, 16, 24, and 32. DISCUSSION: The study is designed to assess the feasibility and effectiveness of PNHM in reducing the thyroid antibody level and improving the quality of life of HT patients with hypothyroidism or subclinical hypothyroidism. Results of this trial will assist further analyses on whether the acupuncture treatment can alleviate symptoms for patients with HT. TRIAL REGISTRATION: Acupuncture-Moxibustion Clinical Trial Registry AMCTR-IOR-19000308 (ChiCTR1900026830). Registered on 23 October 2019. BioMed Central 2021-01-21 /pmc/articles/PMC7818748/ /pubmed/33478571 http://dx.doi.org/10.1186/s13063-021-05036-8 Text en © The Author(s) 2021 Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Study Protocol
Wang, Shanze
Zhao, Jiping
Zeng, Weimei
Du, Wanqing
Zhong, Tenghui
Gao, Hui
Xiao, Yi
Yang, Chao
Acupuncture for Hashimoto thyroiditis: study protocol for a randomized controlled trial
title Acupuncture for Hashimoto thyroiditis: study protocol for a randomized controlled trial
title_full Acupuncture for Hashimoto thyroiditis: study protocol for a randomized controlled trial
title_fullStr Acupuncture for Hashimoto thyroiditis: study protocol for a randomized controlled trial
title_full_unstemmed Acupuncture for Hashimoto thyroiditis: study protocol for a randomized controlled trial
title_short Acupuncture for Hashimoto thyroiditis: study protocol for a randomized controlled trial
title_sort acupuncture for hashimoto thyroiditis: study protocol for a randomized controlled trial
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7818748/
https://www.ncbi.nlm.nih.gov/pubmed/33478571
http://dx.doi.org/10.1186/s13063-021-05036-8
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