Short-term Prednisone to Treat STA Study(SPTSS)

Army Medical University of People's Liberation Army

Status and phase: Completed; Phase 4

Conditions: Subacute Thyroiditis

Treatments: Drug: Prednisone 1 week; Drug: Prednisone 6 weeks

Study type: Interventional

Funder types: Other

Identifiers

NCT01837433

XinqiaoH-001

Details and patient eligibility

About

Efficiency and Safety Study of Short-term Prednisone to Treat Moderate and Severe Subacute Thyroiditis

The investigators hypothesize that less adverse reactions will be observed, comparing with the guidelines recommend. The recurrence rate, adrenal insufficiency, temporary and permanent hypothyroidism aren't significant difference.

Full description

Comparing with the guidelines recommend, short-term (one week)prednisone and nsaids following up next week to treat moderate and severe subacute thyroiditis will be assessed.

The patients in wards will be assessed from temperature,erythrocyte sedimentation rate,C-reactive protein,local pain and goiter.The random treatment will be executed in moderate and severe SAT after informed consent be signed.

Subjects will be monitored once every 2 weeks.If patients complained of pain in their neck or if the erythrocyte sedimentation rate is still high,after discontinuation of prednisone, prednisone treatment will be resumed in moderate and severe subject and non-steroidal anti-inflammatory drugs will be used in mild subject.Anti-ulcer drugs will be administered to all patients.

The endpoint of the study are efficiency and safety of short-term prednisone treating. The investigators will assess adrenal insufficiency (such as anorexia, nausea, vomiting, abdominal pain),steroid withdrawal syndrome, recurrence rate and hypothyroidism. The investigators will observe erythrocyte sedimentation rate,pain,steroid level and thyroid function.

Enrollment: 40 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18-70 years patients with Moderate and severe subacute thyroiditis

Exclusion criteria

• adrenal cortical dysfunction,
• use of corticosteroids in nearly three months,
• mild subacute thyroiditis,
• non-onset STA,
• family history of diabetes,
• gastric ulcer,
• the special medication history,
• heart，liver and renal insufficiency,
• tumors,
• tuberculosis and
• poor compliance.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Prednisone 1 week

Experimental group

Description:

Prednisone 1 week 30mg/day and Celecoxib 400mg in first day, and then 200mg bid in the remaining next week, total 2 weeks.

Treatment:

Drug: Prednisone 1 week

Prednisone 6 weeks

Active Comparator group

Description:

Oral 30 mg/day of prednisone will be administered as the initial dose for the treatment of SAT in first week,then tapered by 5mg every 1 week,the duration of prednisone will be 6 weeks.

Treatment:

Drug: Prednisone 6 weeks