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.
Background Acupuncture and moxibustion have been widely applied in treating allergic rhinitis (AR). However, there is a lack of evidence-based guidelines for acupuncture and moxibustion for AR, thus we started a project on developing an international clinical practice guideline (CPG) for acupuncture and moxibustion for AR (WFASRP202001-SC05) approved by the World Federation of Acupuncture-Moxibustion Societies (WFAS). This study aims to formulate the clinical questions and important outcomes for this guideline. Methods Based on the principle of the WFAS standardization committee, multiple methods including the International PICO question survey, Delphi survey, and consensus conference of guideline development group (GDG) were applied. International PICO questionnaires widely gathered the demands from the target population. Then GDG selected clinical questions and important outcomes for the guideline via a mixed method of Delphi survey and consensus conference. Results 15 potential clinical questions and 10 sorts of outcomes were formulated under the supervision of a guideline steering group based on the analysis of 123 pieces of feedbacks from 17 countries of 5 continents. After 2 rounds of the Delphi survey, the consensus was reached in GDG that all of the potential questions were included. After 3 rounds of the Delphi survey, the consensus was reached that 9 of these outcomes were considered important outcomes. Conclusion 15 clinical questions and 9 important outcomes were selected for the CPG for acupuncture and moxibustion for AR. Since there has not established a standard method in formulating the clinical questions and important outcomes for CPGs in acupuncture and moxibustion, this one will be a useful reference.
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