Graves Ophthalmopathy
Conditions
Keywords
Graves ophthalmopathy, Exophthalmos, Proptosis, Quality of life
Brief summary
Autoimmune ophthalmopathy is clinically evident in one third of Graves' disease cases. In most cases it is mild; however, in 3 to 5% of cases it has a severe presentation. At present, the treatment is directed to identify vision threatening which requires aggressive intervention, usually with glucocorticoids. For mild cases the treatment is limited to the normalization of hyperthyroidism and support measures. Preliminary data show that pentoxifylline and bromocriptine may have a favorable effect in the course of ophthalmopathy by inhibition of the synthesis of TNF-α, VEGF, glycosaminoglycan production, and lymphocyte infiltration. Therefore, the aims of this study were to evaluate the effect of bromocriptine and pentoxifylline on the clinical course and quality of life of patients with mild to moderate ophthalmopathy associated to Graves´disease. Methods. Patients with mild to moderate ophthalmopathy, with less than one year of evolution, and naive to treatment were randomized to receive treatment during 12 months with either 1) bromocriptine (5 mg twice a day) + methimazole (30 mg/day), 2) pentoxifylline (400 mg twice a day) + methimazole (30 mg/day), or 3) methimazole only (30 mg/day). They completed 10 visits to evaluate proptosis and clinical activity score (CAS). In addition, in the first and last visit the quality of life questionnaire specific for Graves' ophthalmopathy(GO-QOL) was applied.
Interventions
Sponsors
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Women or men * Between 18 and 45 years * Autoimmune hyperthyroidism with one year or less of evolution * No previous treatment * Mild to moderate ophthalmopathy
Exclusion criteria
* Smoking * Severe ophthalmopathy * Steroid treatment * Asthma * Diabetes or other significant disease * Creatine \>1.5 mg/dl * Women with child bearing potential not using a birth control method * Opthalmologic diseases * Uncontrolled hypertension * History of ischemic cardiopathy * History of stroke * History of gastrointestinal bleeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proptosis | One year | Left and right eye proptosis by exophthalmometry |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical activity score | One year | Clinical activity score for Graves' ophthalmopathy |
| Quality of life | One year | Quality of life assessed with the quality of life questionnaire specific for Graves' ophthalmopathy (GO-QOL) |
Countries
Mexico
Outcome results
None listed