Bromocriptine and Pentoxifylline in Ophthalmopathy Autoimmune Treatment

Sponsor

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran (Other)

Overall Status

Terminated

CT.gov ID

NCT01893450

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Graves Ophthalmopathy	Drug: Methimazole Drug: Bromocriptine Drug: Pentoxifylline	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

31 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Care Provider)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jun 1, 2008

Actual Primary Completion Date :

Jun 1, 2013

Actual Study Completion Date :

Jun 1, 2013

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Proptosis [One year]
Left and right eye proptosis by exophthalmometry

Secondary Outcome Measures

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)