Subacute Thyroiditis
Conditions
Keywords
Short-Term Prednisone, Subacute Thyroiditis, Open-label, Randomized, Controlled, and Multicenter
Brief summary
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.
Detailed description
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.
Interventions
DRUG1-week predisone+1-week celecoxib
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.
DRUG6-weeks predisone
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.
Sponsors
Xinqiao Hospital of Chongqing
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prednisone
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* We enrolled adult patients (age 18-70) with Subacute Thyroiditis (SAT) scores ≥3 points. SAT was diagnosed on the basis of diagnostic criteria. The severity of SAT was scored as follows: fever - none, \<38℃, and \>38℃ (0, 1, and 2 points, respectively); tenderness - none, mild, and severe (0, 1, and 2 points, respectively); goiter by ultrasonography or palpation - none and yes (0 and 1 point, respectively); and ESR - normal, 25-60 mm/h, and \>60 mm/h (0, 1, and 2 points, respectively).
Exclusion criteria
* Patients who were diagnosed with diabetes, an active peptic ulcer, benign and malignant tumors, hepatic dysfunction, recurrent SAT, and already on glucocorticoid therapy were excluded within 3 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The difference in efficacy between the two groups at the completion. | The palpation and CRP will investigate at 2nd (experimental group) or 6th (control group) weeks. | Efficacy is defined as no pain in the thyroid region through palpation and pain assessment using visual analog scoring, and normalization of CRP level. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total cholesterol (TC) | TC will be measured at 2nd (experimental group) or 6th (control group) weeks. | The differences in TC between the two groups at the end of treatment. |
| Triglycerides (TG) | TG will be measured at 2nd (experimental group) or 6th (control group) weeks. | The differences in TG between the two groups at the end of treatment. |
| Thyroid function | Thyroid function will be measured at weeks 6, 12, and 24 after the initial treatment. | The differences in thyroid function (FT3, FT4, TSH) between the two groups at the end of treatment. |
| Diastolic blood pressure (DBP) | DBP will be measured at 2nd (experimental group) or 6th (control group) weeks. | The differences in DBP between the two groups at the end of treatment. |
| Parathyroid hormone (PTH) | PTH will be measured at 2nd (experimental group) or 6th (control group) weeks. | The differences in PTH between the two groups at the end of treatment. |
| Systolic blood pressure (SBP) | SBP will be measured at 2nd (experimental group) or 6th (control group) weeks. | The differences in SBP between the two groups at the end of treatment. |
Outcome results
None listed