Bromocriptine and Pentoxifylline in Ophthalmopathy Autoimmune Treatment

Comparison of the Effect of Bromocriptine and Pentoxifylline in Mild to Moderate Autoimmune Ophthalmopathy. A Randomized, Controlled, Single Blind, Clinical Trial.

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.

Study Overview

• Status: Terminated
• Conditions: Graves Ophthalmopathy
• Intervention / Treatment: Drug: Pentoxifylline; Drug: Bromocriptine; Drug: Methimazole

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Mexico
  • Distrito Federal
    • Mexico City, Distrito Federal, Mexico, 14000
      • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: methimazole; methimazole 30 mg daily during one year	Drug: Methimazole
Active Comparator: methimazole, bromocriptine; methimazole 30 mg daily during one year, bromocriptine 5 mg twice a day during one year	Drug: Bromocriptine
Active Comparator: pentoxifylline; methimazol 30 mg daily and pentoxifylline 400 mg twice a day during one year	Drug: Pentoxifylline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proptosis	Left and right eye proptosis by exophthalmometry	One year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical activity score	Clinical activity score for Graves' ophthalmopathy	One year
Quality of life	Quality of life assessed with the quality of life questionnaire specific for Graves' ophthalmopathy (GO-QOL)	One year

Collaborators and Investigators

• Sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Study record dates

Study Major Dates

• Study Start: June 1, 2008
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: June 28, 2013
• First Submitted That Met QC Criteria: July 2, 2013
• First Posted (Estimate): July 9, 2013

Study Record Updates

• Last Update Posted (Estimate): July 9, 2013
• Last Update Submitted That Met QC Criteria: July 2, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Keywords: Quality of life; Proptosis; Graves ophthalmopathy; Exophthalmos
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Genetic Diseases, Inborn; Thyroid Diseases; Eye Diseases, Hereditary; Graves Disease; Exophthalmos; Orbital Diseases; Goiter; Hyperthyroidism; Eye Diseases; Graves Ophthalmopathy; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Enzyme Inhibitors; Platelet Aggregation Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Protective Agents; Dopamine Agonists; Dopamine Agents; Hormone Antagonists; Antioxidants; Phosphodiesterase Inhibitors; Free Radical Scavengers; Radiation-Protective Agents; Antiparkinson Agents; Anti-Dyskinesia Agents; Antithyroid Agents; Pentoxifylline; Bromocriptine; Methimazole
• Other Study ID Numbers: DIA19508091