Prevention Relapse of Graves' Disease by Intrathyroid Injection of Dexamethasone

Sponsor

Xiao-Ming Mao (Other)

Overall Status

Completed

CT.gov ID

NCT00917241

Collaborator

(none)

218

Enrollment

Arms

Duration (Months)

Study Details

Study Description

Brief Summary

Antithyroid drugs are widely used in treatment of Graves' disease (GD), but after therapy withdrawal, relapse rate is very high. The aim this trail is to evaluate the effects of intrathyroid injection of dexamethasone combined with antithyroid drugs on patients with newly diagnosed GD.

Condition or Disease	Intervention/Treatment	Phase
Graves' Disease	Drug: MMI combined with IID Drug: MMI	Phase 4

Detailed Description

The morbility of GD is nearly 0.5% and the underlying cause of 50 to 80% of cases of hyperthyroidism.Recently,anti-thyroid drugs are still the main therapy for Graves'hyperthyroidism in a lot of districts, but the relapse rate is very high (51~68%) after withdrawal of anti-thyroid treatment.In order to reduce the relapse rate, some studies tried to prescribe replacement thyroxine, either with the anti-thyroid drug treatment, or after this was completed, but there is no clear evidence in favour of giving thyroid hormone supplementation following the initial treatment of Graves' thyrotoxicosis with anti-thyroid medication. Therefore, the optimal medical therapy for Graves' hyperthyroidism remains a subject of debate.

It is well known that glucocorticoids have anti-inflammatory, immunomodulation and immunosuppression effects and they has long been used to treat GO, and is one of the most effective medicine ,it can decrease some cytokines and reduce inflammatory status ,and improve some thyroid specific antibody, like as thyrotropin receptor antibodies (TRAb), antithyroperoxidase antibodies (TPOAb) and antithyroglobulin antibodies (TGAb).These studies suggested that glucocorticoids might affect autoimmune process and have some benefit effects on GD. Moreover glucocorticoids have been used to treat GD in several early reports, in which serum free triiodothyronine (FT3) and thyroxine (FT4) or total T3(TT3) and TT4 levels decreased after 8 days or three weeks treatment with glucocorticoids . But in those studies, the number of selected patients is small, and the duration of the therapy is relatively short, so that might not confirm the effects of glucocorticoids on GD.

Study Design

Study Type:

Interventional

Actual Enrollment :

218 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Prevention Relapse of Graves' Disease by Treatment With Intrathyroid Injection of Dexamethasone

Study Start Date :

Jun 1, 2004

Actual Primary Completion Date :

Dec 1, 2008

Actual Study Completion Date :

Mar 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: MMI+IID group MMI,methimazole；IID,intrathyroid injection of dexamethasone	Drug: MMI combined with IID MMI titration regimen for 18 months,initial dosage of MMI was 20 mg/d,which combined with IID for 3 months.Dexamethasone was injected into the two side of thyroid, the dose of dexamethasone was 5 mg by every side, twice a week. The treatment strategy was changed to once a week at the second month and twice a month at the third month, the dose of dexamethasone was the same as the first month. Other Names: methimazole,tapazole;dexamethasone,hexadecadrol
Active Comparator: MMI Group MMI,methimazole	Drug: MMI MMI treatment with titration regimen for 18 months, initial dosage was 20 mg/d.

Arm

Intervention/Treatment

Experimental: MMI+IID group

MMI,methimazole；IID,intrathyroid injection of dexamethasone

Drug: MMI combined with IID

MMI titration regimen for 18 months,initial dosage of MMI was 20 mg/d,which combined with IID for 3 months.Dexamethasone was injected into the two side of thyroid, the dose of dexamethasone was 5 mg by every side, twice a week. The treatment strategy was changed to once a week at the second month and twice a month at the third month, the dose of dexamethasone was the same as the first month.

Other Names:

methimazole,tapazole;dexamethasone,hexadecadrol

Active Comparator: MMI Group

MMI,methimazole

Drug: MMI

MMI treatment with titration regimen for 18 months, initial dosage was 20 mg/d.

Outcome Measures

Primary Outcome Measures

relapse of hyperthyroidism [4.5 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Newly diagnosed of Graves' Disease

Exclusion Criteria:

Pregnancy
Allergy to ATD, Alanine aminotransferase (ALT) or asparate aminotransferase (AST) above 2 times of upper normal range
Non-compliance because of psychiatric or other serious diseases, or unwillingness to participate in the study.