Objective:This study was conducted to objectively evaluate the clinical efficacy and safety of Chaiqi Xiaoying Tang in the treatment of Hashimoto’s thyroiditis in the hypothyroid phase(liver-depression and spleen-deficiency evidence),and to provide a new diagnostic basis for the treatment of this disease in Chinese medicine.Methods:Seventy patients attending our outpatient clinic with evidence of liver depression and spleen deficiency in the hypothyroid phase of Hashimoto’s thyroiditis were selected and randomly divided into a control group and a treatment group of 35 cases each(65 cases were actually included,2 cases fell off in the treatment group and 3 cases in the control group).Both groups were given basic treatment: mood regulation and regular work and rest.The control group was treated with levothyroxine sodium tablets,and the treatment group was treated with Chaiqi Xiaoying Tang on the basis of the control group for 8 weeks.The clinical efficacy of Chaiqi Xiaoying Tang was evaluated by observing the changes of TCM syndrome score,thyroid function(TSH,FT3,FT4)and thyroid autoantibodies(TPOAb,TGAb)before and after treatment in both groups and analyzing the data with statistical software.Results:1.Comparison of TCM efficacy:(1)The total effective rate of TCM symptoms in the treatment group was 84.85%,and the total effective rate of TCM symptoms in the control group was 62.5%,and the treatment group was better than the control group,and the difference was statistically significant(P<0.05).(2)The total TCM evidence points of both groups decreased after treatment compared with those before treatment,and the difference was statistically significant(P<0.05);the improvement of the total TCM evidence points of the treatment group was better than that of the control group after treatment,and the difference was statistically significant(P<0.05).(3)After treatment,the TCM symptom scores of the treatment group decreased compared with those before treatment,and the difference was statistically significant(P<0.05);after treatment,the TCM symptom scores of the control group decreased compared with those before treatment,except for the symptom of anterior neck enlargement,and the difference was statistically significant(P<0.05),and the improvement of the TCM symptom scores of the treatment group was better than that of the control group after treatment,and the difference was statistically significant(P<0.05).P<0.05).2.Comparison of thyroid function:TSH,FT3 and FT4 in both groups improved significantly after 4 and 8weeks of treatment compared with those before treatment,and the difference was statistically significant(P<0.05);compared between groups after treatment,the improvement of TSH,FT3 and FT4 in the treatment group at 4and 8 weeks was better than that in the control group,and the difference was statistically significant(P<0.05).3.Comparison of thyroid autoantibodies:TPOAb and TGAb in the treatment group decreased significantly after treatment compared with those before treatment,and the difference was statistically significant(P<0.05);TPOAb and TGAb in the control group were not statistically significant after treatment compared with those before treatment(P>0.05);the treatment group was better than the control group after treatment compared between groups,and the difference was statistically significant(P<0.05).4.Safety indexes:During the subject observation period,there were no significant abnormalities in blood,urine and stool routine,liver and kidney function and standard electrocardiogram indexes in both groups.Conclusion:1.Chaiqi Xiaoyin Tang combined with Levothyroxine Sodium Tablets can effectively reduce the TCM evidence score and better relieve the clinical symptoms of patients with Hashimoto’s thyroiditis in the hypothyroid phase(liver-depression and spleen-deficiency evidence).2.The combination of Chaiqi Xiaoyin Tang and Levothyroxine Sodium Tablets was more advantageous in improving thyroid function and down-regulating thyroid autoantibody titers in patients with Hashimoto’s thyroiditis in the hypothyroid phase(liver-depression and spleen-deficiency evidence). |