To observe randomly and single-blindly the clinical efficacy of “Trinity Therapy” in the treatment of refractory goiter qi disease,and to provide reference for the treatment of refractory goiter qi disease.Methods:A total of 90 patients with refractory goiter qi disease admitted in Guizhou Hospital of Traditional Chinese Medicine from January 2015 to January 2016 and eligible for inclusion were selected as research subjects,and according to the order of treatment,they were randomly divided into observation group,control group 1 and control group 2,with 30 cases in each group.The 3 groups of patients were treated by 3 attending doctors of endocrinology respectively,and were only told the treatment plan of the group.According to the conventional methods of the Chinese Guidelines for Thyroid Diagnosis and Treatment,they were given basic treatment,with the control group 1 adding conventional treatment of traditional Chinese medicine(TCM),the control group 2 adding conventional western medicine treatment,and the treatment group adding “Trinity Therapy” treatment.The 3 groups of patients were treated for 2 years.The scores of main TCM symptoms and thyroid function indexes were compared before and after the treatment in the 3 groups.Reduction time and frequency of basic treatment in the 3 groups were counted.The efficacy on TCM syndromes was evaluated.Adverse drug reactions/toxic and side effects of the 2 groups were collected and compared during the treatment period.After 8 months of the treatment,follow-up visits were conducted to diagnose whether there was recurrence or not,and recurrence rates in the 3 groups were compared.Results:1）After 2 years of the treatment,the scores of adversion to heat,hyper appetite,palpitation,hyperhidrosis,irregular menstruation and thyroid morphology in the 3 groups were lower than those before the treatment,and the scores of adversion to heat,hyper appetite,palpitation,thyroid morphology and irregular menstruation in the observation group were lower than those in the control group 1 and the control group 2(P<0.05).There was no significant difference in symptom scores between the control group 1 and the control group 2(P>0.05).2）The curative effect rate of adversion to heat,hyper appetite,palpitation,thyroid morphology and menstrual disorders in the observation group was higher than that in the control group 1 and the control group 2(P<0.05).3）The serum FT4 levels of the control group 1 and the control group 2 were increased after 2 years of the treatment,and it was decreased in the observation group,compared with that before the treatment.After the treatment,the FT4 level of the observation group was significantly lower than that of the control group 1 and the control group 2(P<0.05); the positive rates of FT3 and TRAB in the 3 groups were significantly lower than those before the treatment,and the above indexes in the observation group were lower than those of the control group 1 and the control group 2(P<0.05).But there was no significant difference between the control group 1 and the control group 2(P>0.05).4）The reduction time and frequency and recurrence rate of the basic treatment in the observation group were lower than those in the control group 1 and the control group 2(P<0.05).5）No adverse reactions were found in the 3 groups during the treatment.Conclusion:Basic treatment combined with “Trinity Therapy” in the treatment of refractory goiter qi disease can treat the root and branch simultaneously,effectively improve the efficiency and quality of treatment,and enhance the safety of treatment,with high clinical value.