The goal of this clinical trial is to compare the efficacy and safety of short-term versus 6-week prednisone in the treatment of moderate-to-severe subacute thyroiditis. The main questions it aims to answer are: Does the short-term medication regimen reduce glucocorticoid side effects while achieving similar efficacy as the guideline treatment group? Patients with moderate-to-severe symptoms were randomly assigned to receive either 30 mg/day prednisone for 1 week, followed by 1 week of nonsteroidal anti-inflammatory drugs, or the conventional 6-week prednisone therapy in the control group.
This is an open-label, randomized, controlled, and multicenter trial. Patients with moderate-to-severe symptoms were randomly assigned to receive either 20 and 10 mg prednisone in the morning and afternoon, respectively, daily for 1 week; in the second week, these participants received 400 mg celecoxib on day 1 and 200 mg twice daily for the remaining 6 days until celecoxib withdrawal or 20 and 10 mg prednisone in the morning and afternoon, respectively, daily in the first week, and then reduced by 5 mg/week from the second week until withdrawal in the sixth week. The primary endpoint was intergroup differences in treatment efficacy at the end of the treatment course. Secondary endpoints included between-group differences in post-withdrawal adverse effect parameters and thyroid function at weeks 6, 12, and 24.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
600
20 and 10 mg prednisone in the morning and afternoon, respectively, daily for 1 week; in the second week, these participants received 400 mg celecoxib (a type of nonsteroidal anti-inflammatory drug) on day 1 and 200 mg twice daily for the remaining 6 days until celecoxib withdrawal.
20 and 10 mg prednisone in the morning and afternoon, respectively, daily in the first week, and then reduced by 5 mg/week from the second week until withdrawal in the sixth week.
The difference in efficacy between the two groups at the completion.
Efficacy is defined as no pain in the thyroid region through palpation and pain assessment using visual analog scoring, and normalization of CRP level.
Time frame: The palpation and CRP will investigate at 2nd (experimental group) or 6th (control group) weeks.
Thyroid function
The differences in thyroid function (FT3, FT4, TSH) between the two groups at the end of treatment.
Time frame: Thyroid function will be measured at weeks 6, 12, and 24 after the initial treatment.
Total cholesterol (TC)
The differences in TC between the two groups at the end of treatment.
Time frame: TC will be measured at 2nd (experimental group) or 6th (control group) weeks.
Triglycerides (TG)
The differences in TG between the two groups at the end of treatment.
Time frame: TG will be measured at 2nd (experimental group) or 6th (control group) weeks.
Systolic blood pressure (SBP)
The differences in SBP between the two groups at the end of treatment.
Time frame: SBP will be measured at 2nd (experimental group) or 6th (control group) weeks.
Diastolic blood pressure (DBP)
The differences in DBP between the two groups at the end of treatment.
Time frame: DBP will be measured at 2nd (experimental group) or 6th (control group) weeks.
Parathyroid hormone (PTH)
The differences in PTH between the two groups at the end of treatment.
Time frame: PTH will be measured at 2nd (experimental group) or 6th (control group) weeks.
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