Abstract
BackgroundThe 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.MethodsThis 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.DiscussionThe 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 registrationAcupuncture-Moxibustion Clinical Trial Registry AMCTR-IOR-19000308 (ChiCTR1900026830). Registered on 23 October 2019.
Highlights
The incidence rate of Hashimoto thyroiditis (HT) has gradually increased in recent years
It was found that HT patients with normal thyroid function may suffer from various clinical symptoms which reduce the quality of life and this may be positively correlated with high thyroid antibody concentrations [11, 12]
The current treatment of HT focuses mainly on the symptom of hypothyroidism that occurs in the later stage of the disease via orally-taken LT4 in a long-term
Summary
The incidence rate of Hashimoto thyroiditis (HT) has gradually increased in recent years. 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. Hashimoto’s thyroiditis (HT), known as chronic lymphocytic thyroiditis, has become one of the most common endocrine disorders and the most common leading cause of hypothyroidism in recent years, as a result of its gradually increasing incidence rate. It was found that HT patients with normal thyroid function may suffer from various clinical symptoms which reduce the quality of life and this may be positively correlated with high thyroid antibody concentrations [11, 12]
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