Comparison of Early Total Thyroidectomy with Antithyroid Treatment in Patients with Moderate-Severe Graves' Orbitopathy: A Randomized Prospective Trial

Abstract

Background: The optimal therapeutic choice for Graves' hyperthyroidism in the presence of moderate-severe Graves' orbitopathy (GO) remains controversial. Objectives: We aimed to compare GO course in patients with moderate-severe GO treated with early total thyroidectomy (TTx) versus antithyroid drug (ATD) regimens, in a prospective, randomized manner. Methods: Forty-two patients with moderate-severe GO were enrolled. A total of 4.5 g of pulse corticosteroids were given intravenously to all patients before randomization. Patients in the first group were given TTx, whereas patients in the second group were treated with ATDs. TSH was kept between 0.4 and 1 mIU/l. The clinical course of GO was evaluated with proptosis, lid aperture, clinical activity score (CAS), and diplopia. Results: Eighteen and 24 patients were randomized to the TTx and ATD groups, respectively. Thyroid autoantibodies decreased significantly, and there were significant improvements in proptosis, lid aperture, and CAS in the TTx group. While in the ATD group the decrement in thyroid autoantibodies was not significant, there were significant improvements in proptosis and CAS. When the TTx group was compared with the ATD group, anti-TPO, anti-Tg, and TSH-receptor antibodies were significantly decreased in the TTx group (p < 0.01), but there was no significant difference with respect to proptosis, lid aperture, CAS, and diplopia between the two groups during a median (min.-max.) follow-up period of 60 months (36-72). Conclusion: Although no definitive conclusions could be drawn from the study, mainly due to limited power, early TTx and the ATD treatment regimens, followed by intravenous pulse corticosteroid therapy, seemed to be equally effective on the course of GO in this relatively small group of patients with moderate-severe GO during a median (min.-max.) follow-up period of 60 months (36-72).

Current concepts regarding Graves’ orbitopathy

“…Long-term ATD treatment-associated gradual decrease in serum TSHR-Ab levels may be beneficial for GO. A small RCT [270] and a retrospective case study [271] reported that early thyroidectomy may result in a more favorable outcome of immunosuppressive therapy. As discussed, RAI bears a small but definite risk for GO [90,91,97], preventable by steroid prophylaxis [80].…”

TSH receptor autoantibody levels post-total thyroidectomy in Graves’ ophthalmopathy: a meta-analysis

“…The characteristics of all 14 studies included in the review are summarized in Table 1 . Most studies were conducted in European population groups while Catz et al examined North American patients, Erdogan et al and Nart et al examined Turkish patients [ 7 , 23 ]. Most studies included predominately adult patients and sample sizes varied from 32 to 200 patients.…”

“…The RCT of 200 patients comparing TTx to STx by Barcyznski et al was the only RCT that was double-blinded as both investigators and ophthalmologists were masked to the group assignment [ 15 ]. The RCT of 42 patients by Erdogan et al did not account for blinding in their analysis [ 23 ]. However, this study was not included in our meta-analysis since it did not have comparable GO data.…”

“…All studies included in the review showed a decline in TRAb levels post-TTx, and a statistically significant decline was documented by seven studies [ 7 , 9 , 18 , 19 , 21 – 23 ]. Five studies (four RCTs and one cohort study) that had a comparison group and also made qualitative assessments in regard to the normalization of TRAbs were included in our meta-analysis [ 14 – 18 ].…”

Α Case of Severe Thyroid Eye Disease Treated with Tocilizumab

“…Sy et al (10) reported two cases of sight-threatening TED who received iv tocilizumab after orbital decompression. Tocilizumab improved the signs of TED although the previous decompressions did not have the desired effects.…”