Graves Disease Clinical Trial
Official title:
Prospective Randomized Clinical Trial of Total Thyroidectomy (Tx) Versus Thionamides (Anti-Thyroid Drugs) in Patients With Moderate-to-Severe Graves' Ophthalmopathy - a 1-year Follow-up
Introduction: Graves disease (GD) is characterized by thyrotoxicosis and goiter, arising
through circulating autoantibodies that bind to and stimulate the thyroid hormone receptor
(TSHR). Graves' ophthalmopathy (GO) is characterized by inflammation, expansion of the
extraocular muscles and an increase in retroorbital fat. There are currently three forms of
therapies offered: anti-thyroid drugs (ATD) (thionamides), radioactive iodine (RAI) and
total thyroidectomy (Tx). There is currently no consensus on the treatment of Grave's
disease and GO.
Objective: To examine the difference in the outcome of GO in patients with
moderate-to-severe GO, who receive Tx versus further ATD after suffering their first relapse
of GO or in which GO stays the same following the initial decrease in ATD therapy after 6
months.
Methods: This prospective randomized clinical trial with observer blinded analysis will
analyze 60 patients with moderate-to-severe GO who receive Tx versus ATD without surgery.
Main outcome variables include: muscle index measurements via ultrasound and thyroid
antibody levels. Additional outcome variables include: CAScore/NOSPECS score, superonasal
index measurements via ultrasound and quality of life score.
Introduction: Graves disease (GD) is characterized by thyrotoxicosis and goiter, arising
through circulating autoantibodies that bind to and stimulate the thyroid hormone receptor
(TSHR). Graves' ophthalmopathy (GO) is characterized by inflammation, expansion of the
extraocular muscles and an increase in retroorbital fat. There are currently three forms of
therapies offered: anti-thyroid drugs (ATD) (thionamides), radioactive iodine (RAI) and
total thyroidectomy (Tx). There is currently no consensus on the treatment of Grave's
disease and GO.
Objective: To examine the difference in the outcome of GO in patients with
moderate-to-severe GO, who receive Tx versus further ATD after suffering their first relapse
of GO or in which GO stays the same following the initial decrease in ATD therapy after 6
months.
Methods: This prospective randomized clinical trial with observer blinded analysis will
analyze 60 patients with moderate-to-severe GO who receive Tx versus ATD without surgery.
Main outcome variables include: muscle index measurements via ultrasound and thyroid
antibody levels. Additional outcome variables include: CAScore/NOSPECS score, superonasal
index measurements via ultrasound and quality of life score.
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