A prospective clinical controlled trial of curative effect and prognosis evaluation of methimazole combination with levo-thyroxine for treatment of Graves' disease

Abstract

To assess and compare the curative effect and replase rates of methimazole alone vs in combination with levo-thyroxine for the treatment of Graves' disease. 540 patients with newly diagnosed, and previously untreated Graves' disease, were randomly divided into combined therapy group and monotherapy group. Combined therapy group were given methimazole and levo-thyroxine; on the contrary, monotherapy group only methimazole was given. Then thyroid stimulating hormone receptor(TRAb), thyroid volume, and thyroid function were measured to evaluate curative effect and prognosis. Compared with monotherapy group, levels of TRAb and the sizes of thyroid glands in combined therapy group were significantly decreased. In 2, 4, 6, 8, 10, 12 months after discontinuation of combined drugs, hyperthyroidism recurrence rates, were 5.7%, 6.1%, 4.9%, 3.8%, 3.8%, and 2.7% respectively, the overall recurrence rate of 12 months was 27.0%, while in monotherapy group, the recurrence rates were 6.5%, 5.8%, 5.4%, 5.1%, 4.3%, and 4.3% respectively, the total recurrence rate was 31.4%, and the difference between combined group and monotherapy group was not significant(P>0.05). The conclusion is: comparing with monotherapy group, methimazole combined with levo-thyroxine in the treatment of hyperthyroidism reduces the levels of TRAb and thyroid volumes, decreases the incidence of drug-induced hypothyroidism, but does not decrease recurrence rate within one year. (Chin J Endocrinol Metab, 2016, 32: 763-766) Key words: Thyroid stimulating hormone receptor; Thyroid volume; Replase rate; Hyperthyroidism; Methimazole; Levo-thyroxine