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

Abstract

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 (FT4), free thyroxine (FT3), 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.

Effect of acupuncture on Hashimoto thyroiditis: A systematic review and meta-analysis

“…[11] If thyroid ultrasound indicates diffuse enlargement of the thyroid and reduced echogenicity of glands in a patient with elevated serum thyroid-associated antibody, the clinical diagnosis of HT can be established. [12] Participants were diagnosed with Hashimoto thyroiditis, with or without hypothyroidism.…”

Acupuncture treatment for Hashimoto's thyroiditis: An exploratory randomized controlled trial

“…2017BL-076–01), registered in the Acupuncture Clinical Trial Registration Center (AMCTR-IOR-19,000,308, ChiCTR1,900,026,830), and published. 21 …”

“…This study is a preliminary study, so the sample size was not previously calculated. As stated in the published protocol, 21 considering the ethical requirements and feasibility, 30 subjects were recruited in each group. This study can serve as a reference for the calculation of sample size in subsequent studies.…”

“… 18 , 19 Among them, the application of penetration needling of the Hand Yangming Meridian is relatively common. 20 , 21 A clinical study carried out in Beijing showed that penetration needling of the Hand Yangming Meridian can reduce the size of thyroid nodules. 22 Although many Chinese physicians have used this method to treat different kinds of thyroid diseases, there is no randomized controlled trial (RCT) on the treatment of HT with penetrating acupuncture through the Hand Yangming Meridian, limiting the application of acupuncture in the treatment of thyroid diseases.…”

DataSheet1.PDF

“…The Heart Meridian connects with the heart directly, and the Lung Meridian indirectly associates with the heart. Both of these two meridians can be used for cardiovascular diseases in clinical practice [52]. 6a.2 Describe the rationale of the utilized TCM interventions with references.…”