Objective: To investigate the efficacy and safety of the early addition of Haizao Yuhu Decoction (HYD) with methimazole (MMI) versus the monotherapy of MMI in treating Graves’ disease (GD). Methods: This was a prospective observational study. A total of 198 patients with GD were assigned to either the HYD combined with MMI group or the MMI monotherapy group according to clinical judgment and patient preference. To minimize confounding bias, propensity score matching (PSM) was performed to balance baseline characteristics between the two groups. Primary (thyroid function, MMI dose) and secondary outcomes (general conditions, thyrotrophin receptor antibody TRAb, thyroid size, peak systolic velocity of the superior thyroid artery STA-PSV, the Thyroid-related Patient-Reported Outcome 39 ThyPRO39 scores, traditional Chinese medicine TCM syndrome scores, and safety) were measured at 0 (V 1 ), 4 (V 2 ), 8 (V 3 ) and 12 weeks of treatment (V 4 ). Results: Each group consisted of 54 GD patients after a 1:1 PSM. A greater decline in free thyroxine (FT4) (16.67 7.64, 24.43 pmol/L vs 9.82 3.49, 19.02 pmol/L, P = 0.018) and free triiodothyronine (FT3) (5.32 3.10, 10.33 pmol/L vs 3.46 1.16, 7.63 pmol/L, P = 0.043) was observed at V 2 in the combination group than in the MMI group. The cumulative dose of MMI during the 12-week treatment was significantly lower in the combination group than in the MMI group (814.20 600.00, 1050.00 mg vs 1007.10 782.10, 1125.00 mg, P = 0.004). The combination group showed more pronounced reductions in the STA-PSV, TCM syndrome scores, and ThyPRO scores ( P = 0.032, 0.010, and 0.044, respectively). The cumulative incidence of adverse events in the combination group was significantly lower than that in the MMI group (5.56% 3/54 vs 18.52% 10/54, P = 0.038). Conclusion: The combination of HYD and MMI serves as an effective and safe treatment of GD, accelerating thyroid function recovery, reducing thyroid hormone levels and ATD dosage, alleviating hyperthyroid symptoms, and lowering the risk of adverse events. Keywords: Haizao Yuhu decoction, Graves’ disease, methimazole, thyroid function, antithyroid drugs
Huang et al. (Wed,) studied this question.