Clinical trial NCT06285617: Short-Term Versus 6-Week Prednisone in The Treatment of Subacute Thyroiditis
Official title: Short-Term Versus 6-Week Prednisone in The Treatment of Subacute Thyroiditis: An Open-label, Randomized, Controlled, and Multicenter Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Subacute Thyroiditis
Keywords: Short-Term Prednisone
Subacute Thyroiditis
Open-label, Randomized, Controlled, and Multicenter
Lead sponsor: Xinqiao Hospital of Chongqing
Sponsor class: OTHER
First posted: 2024-02-29
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prednisone
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The difference in efficacy between the two groups at the completion.
timeFrame: The palpation and CRP will investigate at 2nd (experimental group) or 6th (control group) weeks.
Secondary outcomes:
measure: Thyroid function
timeFrame: Thyroid function will be measured at weeks 6, 12, and 24 after the initial treatment.
measure: Total cholesterol (TC)
timeFrame: TC will be measured at 2nd (experimental group) or 6th (control group) weeks.
measure: Triglycerides (TG)
timeFrame: TG will be measured at 2nd (experimental group) or 6th (control group) weeks.
measure: Systolic blood pressure (SBP)
timeFrame: SBP will be measured at 2nd (experimental group) or 6th (control group) weeks.
measure: Diastolic blood pressure (DBP)
timeFrame: DBP will be measured at 2nd (experimental group) or 6th (control group) weeks.
measure: Parathyroid hormone (PTH)
timeFrame: PTH will be measured at 2nd (experimental group) or 6th (control group) weeks.
Other outcomes:
Locations:
Study officials:
References:
citation: Duan L, Feng X, Zhang R, Tan X, Xiang X, Shen R, Zheng H. Short-Term Versus 6-Week Prednisone In The Treatment Of Subacute Thyroiditis: A Randomized Controlled Trial. Endocr Pract. 2020 Aug;26(8):900-908. doi: 10.4158/EP-2020-0096.
citation: Alves C, Robazzi TC, Mendonca M. Withdrawal from glucocorticosteroid therapy: clinical practice recommendations. J Pediatr (Rio J). 2008 May-Jun;84(3):192-202. doi: 10.2223/JPED.1773.
citation: Benbassat CA, Olchovsky D, Tsvetov G, Shimon I. Subacute thyroiditis: clinical characteristics and treatment outcome in fifty-six consecutive patients diagnosed between 1999 and 2005. J Endocrinol Invest. 2007 Sep;30(8):631-5. doi: 10.1007/BF03347442.
citation: Kubota S, Nishihara E, Kudo T, Ito M, Amino N, Miyauchi A. Initial treatment with 15 mg of prednisolone daily is sufficient for most patients with subacute thyroiditis in Japan. Thyroid. 2013 Mar;23(3):269-72. doi: 10.1089/thy.2012.0459.
citation: Waljee AK, Rogers MA, Lin P, Singal AG, Stein JD, Marks RM, Ayanian JZ, Nallamothu BK. Short term use of oral corticosteroids and related harms among adults in the United States: population based cohort study. BMJ. 2017 Apr 12;357:j1415. doi: 10.1136/bmj.j1415.
citation: Broersen LH, Pereira AM, Jorgensen JO, Dekkers OM. Adrenal Insufficiency in Corticosteroids Use: Systematic Review and Meta-Analysis. J Clin Endocrinol Metab. 2015 Jun;100(6):2171-80. doi: 10.1210/jc.2015-1218. Epub 2015 Apr 6.
citation: Oray M, Abu Samra K, Ebrahimiadib N, Meese H, Foster CS. Long-term side effects of glucocorticoids. Expert Opin Drug Saf. 2016;15(4):457-65. doi: 10.1517/14740338.2016.1140743. Epub 2016 Feb 6.
citation: Pearce EN, Farwell AP, Braverman LE. Thyroiditis. N Engl J Med. 2003 Jun 26;348(26):2646-55. doi: 10.1056/NEJMra021194. No abstract available.