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

机译：针灸针灸甲状腺炎：随机对照试验的研究方案

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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.
机译：背景技术近年来哈希莫氏菌炎（HT）的发病率逐渐增加。 HT没有具体的病因治疗。尽管甲状腺激素的正常水平，但患者仍可能患有各种临床症状，例如前颈不适，疲劳和情绪波动，这严重损害了他们的生活质量。针灸长期以来一直用于治疗甲状腺疾病，但截至今天没有相关的标准化临床研究。本研究旨在评估针灸的可行性，疗效和安全性。方法这是一个随机的黑色受控评估员盲化的试验试验。将招募60名患者并分为实验组（N？=？30）或对照组（N？=？30）。实验组将进行针灸治疗（手工阳光经络，PNHM渗透针，PNHM）16？周，其次进行16周的随访期，并将对照组将首先通过观察期16？周，其次是一个16周的补偿pnhm疗法。主要结果将是抗叔吡嗪酶抗体（TPOAB），抗替酯素抗体（TGAB）和甲状腺激素的浓度的变化，包括总甲状腺素（FT 4），游离甲状腺素（FT 3）和甲状腺刺激激素（ TSH）。次要结果测量包括甲状腺相关的生活质量问卷调查表短型（ThyPro-39），MOS 36-项目短型健康调查（SF-36）和医院焦虑和抑郁尺度（曾经）。数据收集将在研究开始前（基线评估）和第8周，16,24和32周。该研究旨在评估PNHM在减少甲状腺抗体水平和改善的情况下的可行性和有效性HT患者的生活质量甲状腺功能减退症或亚临床甲状腺功能亢进症。该试验的结果将有助于进一步分析针灸治疗是否可以减轻HT患者的症状。试验登记针灸 - 艾灸临床试验登记处AMCTR-IOR-19000308（CHICTR1900026830）。 2019年10月23日注册。

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