Short-Term Versus 6-Week Prednisone in The Treatment of Subacute Thyroiditis

Subacute Thyroiditis Clinical Trial

— SAT  

Official title:

Short-Term Versus 6-Week Prednisone in The Treatment of Subacute Thyroiditis: An Open-label, Randomized, Controlled, and Multicenter Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06285617
• Other study ID #: 2022GDRC016
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: April 1, 2024
• Est. completion date: April 30, 2025

Study information

• Verified date: February 2024
• Source: Xinqiao Hospital of Chongqing
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 600
• Est. completion date: April 30, 2025
• Est. primary completion date: January 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Subacute Thyroiditis
• Thyroiditis

Intervention

Drug:
• 1-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.
• 6-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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Xinqiao Hospital of Chongqing

References & Publications (8)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. Erratum In: N Engl J Med. 2003 Aug 7;349(6):620. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	The palpation and CRP will investigate at 2nd (experimental group) or 6th (control group) weeks.
Secondary	Thyroid function	The differences in thyroid function (FT3, FT4, TSH) between the two groups at the end of treatment.	Thyroid function will be measured at weeks 6, 12, and 24 after the initial treatment.
Secondary	Total cholesterol (TC)	The differences in TC between the two groups at the end of treatment.	TC will be measured at 2nd (experimental group) or 6th (control group) weeks.
Secondary	Triglycerides (TG)	The differences in TG between the two groups at the end of treatment.	TG will be measured at 2nd (experimental group) or 6th (control group) weeks.
Secondary	Systolic blood pressure (SBP)	The differences in SBP between the two groups at the end of treatment.	SBP will be measured at 2nd (experimental group) or 6th (control group) weeks.
Secondary	Diastolic blood pressure (DBP)	The differences in DBP between the two groups at the end of treatment.	DBP will be measured at 2nd (experimental group) or 6th (control group) weeks.
Secondary	Parathyroid hormone (PTH)	The differences in PTH between the two groups at the end of treatment.	PTH will be measured at 2nd (experimental group) or 6th (control group) weeks.

External Links

•   This is the published small sample, single center, randomized controlled studies. Short-Term Versus 6-Week Prednisone In The Treatment Of Subacute Thyroiditis: A Randomized Controlled Trial