Health Condition 1: null- Patients of Gravesâ?? disease with eye symptoms suggestive of Thyroid associated orbitopathy
Conditions
Interventions
Intervention1: GROUP-A Patients receiving intravenous pulse methylprednisolone: Patients receiving monthly iv. methylprednisolone (0.5gm for 3 consecutive days in a month for 4 months
total dose 6gm
Control Intervention1: Group-B Patients receiving oral prednisolone: Patients receiving oral prednisolone (starting with 1mg/kg/day for 6 weeks then tapered gradually and stopped over
Sponsors
Department of Endocrinology and Metabolism
Eligibility
Inclusion criteria
Inclusion criteria: Patients of moderately severe Thyroid associated orbitopathy (TAO) with moderate activity (Clinical activity score >2)were included. Moderate to severe TAO was defined as marked soft tissue swelling (2c by NOSPECS), and/or proptosis (>=18mm in females; >=20mm in males; 3a or more by NOSPECS), and/or inconstant/constant diplopia in primary or reading position (4b by NOSPECS), and/or punctuate staining of cornea, without any optic nerve involvement, as suggested by European Group on Gravesâ?? Orbitopathy
Exclusion criteria
Exclusion criteria: Patients with mild TAO, dysthyroid optic neuropathy (DON) and severe sight-threatening TAO were excluded.Patients were excluded who had received steroids, radiotherapy, immunosuppressive therapy or surgery for TAO. Patients with comorbidities making glucocorticoid administration difficult (uncontrolled hypertension, uncontrolled diabetes, tuberculosis, immune-compromised state, chronic liver disease, viral hepatitis, tuberculosis) were excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment outcomes will be assessed in terms of major response criteria (MRC) and Minor Response Criteria (MiRC. MRC include decrease in CAS score by â?¥3 points or improvement in diplopia. MiRC include decrease in lid retraction by â?¥2mm, decrease in proptosis by 2mm, decrease in CAS score by â?¥2 points or improvement in grade of soft tissue swelling. Responders (R) were defined as improvement in â?¥1 major criteria or â?¥2 minor criteria.Timepoint: Patients will be followed up 3 monthly for the duration of study | — |
Secondary
| Measure | Time frame |
|---|---|
| NILTimepoint: NIL | — |
Countries
India
Contacts
Public ContactDr Deep Dutta
IPGMER and SSKM Hospital
Outcome results
None listed