Murat Faik Erdoğan1, Özgür Demir1, Reyhan Ünlü Ersoy2, Kamile Gül2, Berna İmge Aydoğan1, Ziynet Alphan Üç3, Türkan Mete4, Sibel Ertek5, Uğur Ünlütürk1, Bekir Çakır2, Yalçın Aral3, Serdar Güler4, Sevim Güllü1, Demet Çorapçıoğlu1, Selçuk Dağdelen6, Gürbüz Erdoğan5. 1. Department of Endocrinology and Metabolic Diseases, Ankara University Medical Faculty, Ankara, Turkey. 2. Department of Endocrinology and Metabolic Diseases, Yıldırım Beyazıt University Medical Faculty, Ankara, Turkey. 3. Department of Endocrinology and Metabolic Diseases, Ankara Training and Research Hospital, Ankara, Turkey. 4. Endocrinology and Metabolic Diseases, Ankara Numune Training and Research Hospital, Ankara, Turkey. 5. Department of Endocrinology and Metabolic Diseases, Ufuk University Medical Faculty, Ankara, Turkey. 6. Department of Endocrinology and Metabolic Diseases, Hacettepe University Medical Faculty, Ankara, Turkey.
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).
RCT Entities:
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).
Entities:
Keywords:
Antithyroid treatment; Graves’ orbitopathy; Total thyroidectomy
Authors: L Bartalena; C Marcocci; F Bogazzi; L Manetti; M L Tanda; E Dell'Unto; G Bruno-Bossio; M Nardi; M P Bartolomei; A Lepri; G Rossi; E Martino; A Pinchera Journal: N Engl J Med Date: 1998-01-08 Impact factor: 91.245