{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,11,1]],"date-time":"2025-11-01T12:58:25Z","timestamp":1762001905945,"version":"3.37.3"},"reference-count":36,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2021,1,21]],"date-time":"2021-01-21T00:00:00Z","timestamp":1611187200000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2021,1,21]],"date-time":"2021-01-21T00:00:00Z","timestamp":1611187200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100004846","name":"Beijing University of Traditional Chinese Medicine","doi-asserted-by":"crossref","award":["2019-JYB-XS-150"],"award-info":[{"award-number":["2019-JYB-XS-150"]}],"id":[{"id":"10.13039\/501100004846","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Trials"],"published-print":{"date-parts":[[2021,12]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec>\n                <jats:title>Background<\/jats:title>\n                <jats:p>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.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>This is a randomized, black-controlled assessor-blinded pilot trial. A total of 60 patients will be recruited and divided into the experimental group (<jats:italic>n<\/jats:italic>\u2009=\u200930) or the control group (<jats:italic>n<\/jats:italic>\u2009=\u200930). The experimental group will undergo acupuncture therapy (penetration needling of Hand-Yangming meridian, PNHM) for 16\u2009weeks, followed by a 16-week follow-up period, and the control group will first go through an observation period for 16\u2009weeks, 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<jats:sub>4<\/jats:sub>), free thyroxine (FT<jats:sub>3<\/jats:sub>), 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.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Discussion<\/jats:title>\n                <jats:p>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.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Trial registration<\/jats:title>\n                <jats:p>Acupuncture-Moxibustion Clinical Trial Registry AMCTR-IOR-19000308 (<jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"http:\/\/www.chictr.org.cn\/showproj.aspx?proj=44826\">ChiCTR1900026830<\/jats:ext-link>). Registered on 23 October 2019.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1186\/s13063-021-05036-8","type":"journal-article","created":{"date-parts":[[2021,1,21]],"date-time":"2021-01-21T08:03:06Z","timestamp":1611216186000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["Acupuncture for Hashimoto thyroiditis: study protocol for a randomized controlled trial"],"prefix":"10.1186","volume":"22","author":[{"given":"Shanze","family":"Wang","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jiping","family":"Zhao","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Weimei","family":"Zeng","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Wanqing","family":"Du","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tenghui","family":"Zhong","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hui","family":"Gao","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yi","family":"Xiao","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5076-4354","authenticated-orcid":false,"given":"Chao","family":"Yang","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2021,1,21]]},"reference":[{"key":"5036_CR1","doi-asserted-by":"publisher","first-page":"943","DOI":"10.1530\/EJE-10-1041","volume":"164","author":"X Teng","year":"2011","unstructured":"Teng X, Shan Z, Chen Y, Lai Y, Yu J, Shan L, et al. More than adequate iodine intake may increase subclinical hypothyroidism and autoimmune thyroiditis: a cross-sectional study based on two Chinese communities with different iodine intake levels. Eur J Endocrinol. 2011;164:943\u201350.","journal-title":"Eur J Endocrinol"},{"key":"5036_CR2","doi-asserted-by":"publisher","first-page":"489","DOI":"10.1210\/jcem.87.2.8182","volume":"87","author":"JG Hollowell","year":"2002","unstructured":"Hollowell JG, Staehling NW, Flanders WD, Hannon WH, Gunter EW, Spencer CA, et al. Serum TSH, T (4), and thyroid antibodies in the United States population (1988 to 1994): National Health and Nutrition Examination Survey (NHANES III). J Clin Endocrinol Metab. 2002;87:489\u201399.","journal-title":"J Clin Endocrinol Metab"},{"key":"5036_CR3","doi-asserted-by":"publisher","first-page":"55","DOI":"10.1111\/j.1365-2265.1995.tb01894.x","volume":"43","author":"MP Vanderpump","year":"1995","unstructured":"Vanderpump MP, Tunbridge WM, French JM, Appleton D, Bates D, Clark F, et al. The incidence of thyroid disorders in the community: a twenty-year follow-up of the Whickham Survey. Clin Endocrinol. 1995;43:55\u201368.","journal-title":"Clin Endocrinol"},{"key":"5036_CR4","doi-asserted-by":"publisher","first-page":"97","DOI":"10.1111\/j.1365-2265.2005.02424.x","volume":"64","author":"PC O'Leary","year":"2006","unstructured":"O'Leary PC, Feddema PH, Michelangeli VP, Leedman PJ, Chew GT, Knuiman M, et al. Investigations of thyroid hormones and antibodies based on a community health survey: the Busselton thyroid study. Clin Endocrinol (Oxf). 2006;64:97\u2013104.","journal-title":"Clin Endocrinol (Oxf)"},{"key":"5036_CR5","first-page":"3611","volume":"18","author":"YH Dong","year":"2014","unstructured":"Dong YH, Fu DG. Autoimmune thyroid disease: mechanism, genetics and current knowledge. Eur Rev Med Pharmacol Sci. 2014;18:3611\u20138.","journal-title":"Eur Rev Med Pharmacol Sci"},{"key":"5036_CR6","doi-asserted-by":"publisher","first-page":"359","DOI":"10.1111\/ans.13943","volume":"88","author":"K Heggie","year":"2018","unstructured":"Heggie K, Yeung M, Grodski S, Lee J, Serpell J. Total thyroidectomy for pressure symptoms in patients with Hashimoto's thyroiditis. ANZ J Surg. 2018;88:359\u201362.","journal-title":"ANZ J Surg"},{"key":"5036_CR7","doi-asserted-by":"publisher","first-page":"261","DOI":"10.1016\/j.bbi.2014.03.008","volume":"41","author":"T Leyhe","year":"2014","unstructured":"Leyhe T, M\u00fcssig K. Cognitive and affective dysfunctions in autoimmune thyroiditis. Brain Behav Immun. 2014;41:261\u20136.","journal-title":"Brain Behav Immun"},{"key":"5036_CR8","doi-asserted-by":"publisher","first-page":"279","DOI":"10.1007\/s12020-013-0065-1","volume":"46","author":"M Asik","year":"2014","unstructured":"Asik M, Gunes F, Binnetoglu E, Eroglu M, Bozkurt N, Sen H, et al. Decrease in TSH levels after lactose restriction in Hashimoto's thyroiditis patients with lactose intolerance. Endocrine. 2014;46:279\u201384.","journal-title":"Endocrine."},{"key":"5036_CR9","doi-asserted-by":"publisher","first-page":"526","DOI":"10.1001\/archinte.160.4.526","volume":"160","author":"GJ Canaris","year":"2000","unstructured":"Canaris GJ, Manowitz NR, Mayor G, Ridgway EC. The Colorado thyroid disease prevalence study. Arch Intern Med. 2000;160:526\u201334.","journal-title":"Arch Intern Med"},{"doi-asserted-by":"crossref","unstructured":"Sun X, Hou N, Wang H, Ma L, Sun J, Liu Y. A meta-analysis of pregnancy outcomes with levothyroxine treatment in euthyroid women with thyroid autoimmunity. J Clin Endocrinol Metab. 2020;105(4):dgz217.","key":"5036_CR10","DOI":"10.1210\/clinem\/dgz217"},{"key":"5036_CR11","doi-asserted-by":"publisher","first-page":"427","DOI":"10.1016\/j.kjms.2016.06.006","volume":"32","author":"UH Bektas","year":"2016","unstructured":"Bektas UH, Ayhan M. Autoimmunity affects health-related quality of life in patients with Hashimoto\u2019s thyroiditis. Kaohsiung J Med Sci. 2016;32:427\u201333.","journal-title":"Kaohsiung J Med Sci"},{"key":"5036_CR12","doi-asserted-by":"publisher","first-page":"425","DOI":"10.1507\/endocrj.EJ16-0418","volume":"64","author":"MM Yalcin","year":"2017","unstructured":"Yalcin MM, Altinova AE, Cavnar B, Bolayir B, Akturk M, Arslan E, et al. Is thyroid autoimmunity itself associated with psychological well-being in euthyroid Hashimoto\u2019s thyroiditis? Endocr J. 2017;64:425\u20139.","journal-title":"Endocr J"},{"key":"5036_CR13","doi-asserted-by":"publisher","first-page":"34","DOI":"10.1017\/S0029665118001192","volume":"78","author":"MP Rayman","year":"2019","unstructured":"Rayman MP. Multiple nutritional factors and thyroid disease, with particular reference to autoimmune thyroid disease. Proc Nutr Soc. 2019;78:34\u201344.","journal-title":"Proc Nutr Soc"},{"key":"5036_CR14","doi-asserted-by":"publisher","first-page":"609","DOI":"10.1089\/thy.2007.0040","volume":"17","author":"EE Mazokopakis","year":"2007","unstructured":"Mazokopakis EE, Papadakis JA, Papadomanolaki MG, Batistakis AG, Giannakopoulos TG, Protopapadakis EE, et al. Effects of 12 months treatment with L-selenomethionine on serum anti-TPO levels in patients with Hashimoto\u2019s thyroiditis. Thyroid. 2007;17:609\u201312.","journal-title":"Thyroid."},{"key":"5036_CR15","doi-asserted-by":"publisher","first-page":"1263","DOI":"10.1210\/jc.2006-1821","volume":"92","author":"R Negro","year":"2007","unstructured":"Negro R, Greco G, Mangieri T, Pezzarossa A, Dazzi D, Hassan H. The influence of selenium supplementation on postpartum thyroid status in pregnant women with thyroid peroxidase autoantibodies. J Clin Endocrinol Metab. 2007;92:1263\u20138.","journal-title":"J Clin Endocrinol Metab"},{"key":"5036_CR16","doi-asserted-by":"publisher","first-page":"378","DOI":"10.1111\/j.1742-1241.2011.02879.x","volume":"66","author":"ADA","year":"2012","unstructured":"ADA, KAT, PN, DGG, LK, RMV, et al. Selenomethionine treatment in patients with autoimmune thyroiditis: a prospective, quasi-randomised trial. Int J Clin Pract. 2012;66:378\u201383.","journal-title":"Int J Clin Pract"},{"key":"5036_CR17","doi-asserted-by":"publisher","first-page":"7","DOI":"10.1089\/thy.2007.0127","volume":"18","author":"G Karanikas","year":"2008","unstructured":"Karanikas G, Schuetz M, Kontur S, Duan H, Kommata S, Schoen R, et al. No immunological benefit of selenium in consecutive patients with autoimmune thyroiditis. Thyroid. 2008;18:7\u201312.","journal-title":"Thyroid."},{"key":"5036_CR18","doi-asserted-by":"publisher","first-page":"83","DOI":"10.1007\/s40618-016-0535-4","volume":"40","author":"D Esposito","year":"2017","unstructured":"Esposito D, Rotondi M, Accardo G, Vallone G, Conzo G, Docimo G, et al. Influence of short-term selenium supplementation on the natural course of Hashimoto\u2019s thyroiditis: clinical results of a blinded placebo-controlled randomized prospective trial. J Endocrinol Investig. 2017;40:83\u20139.","journal-title":"J Endocrinol Investig"},{"key":"5036_CR19","doi-asserted-by":"publisher","first-page":"145","DOI":"10.1210\/jc.2005-1775","volume":"91","author":"R Jorde","year":"2006","unstructured":"Jorde R, Waterloo K, Storhaug H, Nyrnes A, Sundsfjord J, Jenssen TG. Neuropsychological function and symptoms in subjects with subclinical hypothyroidism and the effect of thyroxine treatment. J Clin Endocrinol Metab. 2006;91:145\u201353.","journal-title":"J Clin Endocrinol Metab"},{"key":"5036_CR20","first-page":"359","volume":"34","author":"Q Zhan","year":"2014","unstructured":"Zhan Q, Chen HD. Study on rules of acupoints selection for vertigo in ancient acupuncture. Zhongguo Zhen Jiu. 2014;34:359\u201362.","journal-title":"Zhongguo Zhen Jiu"},{"key":"5036_CR21","doi-asserted-by":"publisher","first-page":"375","DOI":"10.1016\/j.joim.2018.09.002","volume":"16","author":"FK Cheng","year":"2018","unstructured":"Cheng FK. An overview of the contribution of acupuncture to thyroid disorders. J Integr Med. 2018;16:375\u201383.","journal-title":"J Integr Med"},{"doi-asserted-by":"crossref","unstructured":"Caturegli P, De Remigis A, Rose NR. Hashimoto thyroiditis: clinical and diagnostic criteria. Autoimmun Rev. 2014;13(4-5):391\u20137.","key":"5036_CR22","DOI":"10.1016\/j.autrev.2014.01.007"},{"unstructured":"Chinese Society of Endocrinology. Chinese thyroid disease diagnosis and treatment guidelines-thyroiditis. Chin J Intern Med. 2008;47:784\u20138.","key":"5036_CR23"},{"key":"5036_CR24","doi-asserted-by":"publisher","first-page":"287","DOI":"10.1002\/pst.185","volume":"4","author":"SA Julious","year":"2010","unstructured":"Julious SA. Sample size of 12 per group rule of thumb for a pilot study. Pharmaceutical Stats. 2010;4:287\u201391.","journal-title":"Pharmaceutical Stats"},{"unstructured":"State Administration for Market Regulation. Provisions for Drug Registration (Bureau No. 28). The State Council of s\/b China. 2007;38\u201339.","key":"5036_CR25"},{"key":"5036_CR26","volume-title":"WHO Standard Acupuncture Point Locations in the Western Pacific Region","author":"LX Huang","year":"2010","unstructured":"Huang LX. WHO Standard Acupuncture Point Locations in the Western Pacific Region. Beijing: People's Medical Publishing House; 2010."},{"key":"5036_CR27","doi-asserted-by":"publisher","first-page":"2177","DOI":"10.1007\/s11136-018-1857-9","volume":"27","author":"C Wong","year":"2018","unstructured":"Wong C, Choi E, Woo YC, Lang B. Measurement properties of ThyPRO short-form (ThyPRO-39) for use in Chinese patients with benign thyroid diseases. Qual Life Res. 2018;27:2177\u201387.","journal-title":"Qual Life Res"},{"key":"5036_CR28","first-page":"2111","volume":"20","author":"X Xue","year":"2017","unstructured":"Xue X, Xu XJ, Gu ZF, et al. Reliability and validity of the Chinese version of short version of Thyroid-specific Patient Reported Outcome (ThyPRO39). Chinese General Pract. 2017;20:2111\u20137 2122.","journal-title":"Chinese General Pract"},{"key":"5036_CR29","doi-asserted-by":"publisher","first-page":"1437","DOI":"10.1136\/bmj.306.6890.1437","volume":"306","author":"C Jenkinson","year":"1993","unstructured":"Jenkinson C, Coulter A, Wright L. Short form 36 (SF36) health survey questionnaire: normative data for adults of working age. BMJ. 1993;306:1437\u201340.","journal-title":"BMJ."},{"key":"5036_CR30","first-page":"109","volume":"36","author":"L Li","year":"2002","unstructured":"Li L, Wang H, Shen Y. Development and psychometric tests of a Chinese version of the SF-36 Health Survey Scales. Zhonghua Yu Fang Yi Xue Za Zhi. 2002;36:109\u201313.","journal-title":"Zhonghua Yu Fang Yi Xue Za Zhi"},{"key":"5036_CR31","doi-asserted-by":"publisher","first-page":"579","DOI":"10.1016\/S0022-3999(00)00102-1","volume":"48","author":"M Johnston","year":"2000","unstructured":"Johnston M, Pollard B, Hennessey P. Construct validation of the hospital anxiety and depression scale with clinical populations. J Psychosom Res. 2000;48:579\u201384.","journal-title":"J Psychosom Res"},{"key":"5036_CR32","first-page":"747","volume":"43","author":"SG Yu","year":"2018","unstructured":"Yu SG, Jing XH, Tang Y, Wu QF, Yin HY, Xie LS, et al. Acupuncture and Moxibustion and immunity: the actuality and future. Zhen Ci Yan Jiu. 2018;43:747\u201353.","journal-title":"Zhen Ci Yan Jiu"},{"key":"5036_CR33","first-page":"939","volume":"77","author":"R Paschke","year":"1993","unstructured":"Paschke R, Vogg M, Swillens S, Usadel KH. Correlation of microsomal antibodies with the intensity of the intrathyroidal autoimmune process in Graves\u2019 disease. J Clin Endocrinol Metab. 1993;77:939\u201343.","journal-title":"J Clin Endocrinol Metab"},{"key":"5036_CR34","doi-asserted-by":"publisher","first-page":"63","DOI":"10.1002\/dc.10235","volume":"28","author":"AA Pandit","year":"2003","unstructured":"Pandit AA, Vijay WM, Menon PS. Correlation of number of intrathyroid lymphocytes with antimicrosomal antibody titer in Hashimoto\u2019s thyroiditis. Diagn Cytopathol. 2003;28:63\u20135.","journal-title":"Diagn Cytopathol"},{"key":"5036_CR35","doi-asserted-by":"publisher","first-page":"403","DOI":"10.1016\/S0254-6272(13)60187-9","volume":"33","author":"W He","year":"2013","unstructured":"He W, Tong Y, Zhao Y, Zhang L, Ben H, Qin Q, et al. Review of controlled clinical trials on acupuncture versus sham acupuncture in Germany. J Tradit Chin Med. 2013;33:403\u20137.","journal-title":"J Tradit Chin Med"},{"key":"5036_CR36","doi-asserted-by":"publisher","first-page":"733","DOI":"10.1016\/S0140-6736(00)04176-3","volume":"357","author":"C Van Weel","year":"2001","unstructured":"Van Weel C. Examination of context of medicine. Lancet. 2001;357:733\u20134.","journal-title":"Lancet"}],"container-title":["Trials"],"original-title":[],"language":"en","link":[{"URL":"http:\/\/link.springer.com\/content\/pdf\/10.1186\/s13063-021-05036-8.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"http:\/\/link.springer.com\/article\/10.1186\/s13063-021-05036-8\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"http:\/\/link.springer.com\/content\/pdf\/10.1186\/s13063-021-05036-8.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2021,1,21]],"date-time":"2021-01-21T08:09:34Z","timestamp":1611216574000},"score":1,"resource":{"primary":{"URL":"https:\/\/trialsjournal.biomedcentral.com\/articles\/10.1186\/s13063-021-05036-8"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,1,21]]},"references-count":36,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2021,12]]}},"alternative-id":["5036"],"URL":"https:\/\/doi.org\/10.1186\/s13063-021-05036-8","relation":{},"ISSN":["1745-6215"],"issn-type":[{"type":"electronic","value":"1745-6215"}],"subject":[],"published":{"date-parts":[[2021,1,21]]},"assertion":[{"value":"18 April 2020","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"9 January 2021","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"21 January 2021","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"Ethics approval for this trial has been granted by the Institutional Review Boards of Dongzhimen Hospital, Beijing University of Traditional Chinese Medicine (Approval No. DZMEC-KY-2019-33). This study was registered with Acupuncture-Moxibustion Clinical Trial Registry, AMCTR-IOR-19000308 (ChiCTR1900026830). The implementation follows the principles of the Declaration of Helsinki (Version Edinburgh 2000). Any modifications can only be implemented after the approval of the ethics committee. The outcomes of the trial will be disseminated through peer-reviewed journals and presented at a relevant conference.","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"All named authors adhere to the authorship guidelines of Trials. All authors have agreed to publication.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"The authors declare that they have no competing interests.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"74"}}