A prospective randomized controlled clinical trial of Pingmu Decoction combined with acupuncture in the treatment of non-active thyroid-related ophthalmopathy

BACKGROUND: Thyroid eye disease of orbital disease first, it is main and clinical expression with exophthalmos, visual impairment, serious influence patient's quality of life and beautiful, especially for the non-active Graves’ ophthalmopathy, there is no effective treatment methods at home and abroad, for the non-active thyroid eye disease only recommended surgery, but the procedure pain, poor curative effect, postoperative recurrence, most patients are difficult to accept. Pingmu Decoction can effectively reduce the degree of exophthalmus and TCM syndrome integral, and The combination therapy with acupuncture and moxibustion on the basis of Pingmu Decoction has achieved remarkable clinical effect, but the lack of rigorous evidence of evidence-based medicine (ebm). The test is designed to further evaluate flat mesh in active soup combined with acupuncture treatment of thyroid related ophthalmopathy card belongs to the yang qi-deficiency, phlegm and blood stasis block syndrome in patients with clinical efficacy and safety. METHODS/DESIGN: A prospective, randomized controlled clinical trial will be conducted to evaluate the efficacy and safety of Pingmu Decoction combined with acupuncture in the treatment of non-active thyroid-related eye disease in patients with Yang qi deficiency and phlegm-blood stasis syndrome. A total of 120 patients with non-active thyroid-related eye disease, namely deficiency of Yang qi and blockage of phlegm and blood stasis, are randomly divided into 3 groups and treated for 12 weeks. All three groups will maintain basic western medicine treatment. The primary outcomes are to observe the degree of prominence of eyes, and the TCM syndrome scores. The secondary result is clinical efficacy. Free triiodothyronine (FT3), free thyroxine (FT4), thyroid stimulating hormone (TSH), and thyroid stimulating hormone receptor antibody (TRAb)will be used as the observation indicators in this study. In addition, adverse reactions will be observed and recorded as safety indicators. DISCUSSION: The results of this trial will provide convincing evidence for the efficacy and safety of Pingmu Decoction combined with acupuncture in the treatment of patients with non-active thyroid-associated eye disease with deficiency of Yang qi and phlegm and blood stasis block, and it will expand the treatment options for patients with non-active thyroid-related eye disease. TRIAL REGISTRATION: Clinical Trials.gov ID: ChiCTR2000039626. Registered on 3 November 2020.