Study Comparing Routine and Intensive Methimazole Treatment for Graves Disease and Its Effect on Recurrence After Two Years of Stopping Medication

What this Trial Is About

Researchers are evaluating the effects of conventional therapy versus intensive therapy on the regulation and recurrence of Graves disease after stopping medication. This phase IV clinical trial, conducted by the First Affiliated Hospital of Nanjing Medical University, aims to understand how different methimazole dosing strategies affect the cumulative recurrence of Graves hyperthyroidism two years after drug withdrawal. The study also examines changes in immune markers and inflammatory factors during treatment. Participants receive methimazole with doses adjusted based on thyroid function. In the conventional group, doses are lowered according to thyroid hormone levels over about 24 months. The intensive group uses a fixed middle dose of methimazole plus levothyroxine when hypothyroidism occurs, continuing treatment until thyroid antibodies become negative, followed by gradual dose reductions. Thyroid function and antibodies are monitored every four weeks during treatment. During the study, participants undergo regular thyroid function tests and antibody measurements to assess treatment effects. Researchers track the cumulative recurrence rate of hyperthyroidism up to two years after stopping drugs, as well as adverse reactions during treatment. Secondary outcomes include changes in thyroid volume, thyroid autoantibody levels, and cytokines. The total participation includes the treatment period and up to two years of follow-up after drug withdrawal to evaluate long-term outcomes.

Effects of Different Treatment Schemes on the Regulation and Recurrence of Graves' Disease