Abstract
OBJECTIVES: This study assesses the efficacy of Jie Yu Xiao Yin (JYXY), a Traditional Chinese Medicine (TCM) formulation, on Hashimoto's Thyroiditis (HT). METHODS: Ninety HT patients (2020-2022) were randomized to JYXY + levothyroxine (n = 45) or levothyroxine alone (n = 45) for 12 weeks. JYXY (300 mL/day) and levothyroxine (12.5-25 µg/day) were provided. Thyroid hormones (thyroid stimulating hormone (TSH), free thyroxine (FT4), free triiodothyronine (FT3)), antibodies (thyroid peroxidase (TPOAb), thyroglobulin (TGAb)), interleukin (IL 6, 10, 12, 17), transforming growth factor-beta (TGF-β), and TCM scores were measured at baseline and in weeks 4, 8, and 12. The final study included 86 patients (44 treatment and 42 control). RESULTS: Baseline parameters were comparable (P > 0.05). At week 12, the treatment group showed greater reductions in TSH (3.06 ± 0.59 vs. 4.89 ± 0.71; P < 0.001), TPOAb (165.37 ± 8.55 vs. 199.28 ± 13.81 IU/mL; P < 0.001), and TGAb (159.77 ± 9.37 vs. 178.26 ± 13.04 IU/mL; P < 0.001). Pro-inflammatory cytokines decreased significantly in the JYXY group: IL-6 (16.02 ± 6.34 vs. 19.84 ± 5.21), IL-17 (21.07 ± 8.95 vs. 30.45 ± 10.12), and TGF-β (18.91 ± 6.12 vs. 22.34 ± 5.67) (all P < 0.001). IL-10 and IL-12 remained unchanged (P > 0.05). TCM scores improved markedly (3.70 ± 0.90 vs. 7.42 ± 4.38; P < 0.001), with higher clinical efficacy (87.63% vs. 69.05%; P < 0.001). CONCLUSIONS: JYXY coupled with levothyroxine improves thyroid function, decreases autoantibodies and pro-inflammatory cytokines (IL-6, IL-17, TGF-β), and alleviates symptoms in HT patients, outperforming levothyroxine alone.