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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | Participants in the experimental group received 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. |
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| Control group | Active Comparator | Participants in the control group received 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1-week predisone+1-week celecoxib | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Total cholesterol (TC) |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33471681 | Background | 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. | |
| 18535733 | Background | 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. |
| Label | URL |
|---|---|
| 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 | View source |
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| ID | Term |
|---|---|
| D013968 | Thyroiditis, Subacute |
| ID | Term |
|---|---|
| D013966 | Thyroiditis |
| D013959 | Thyroid Diseases |
| D004700 | Endocrine System Diseases |
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Prednisone
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| 6-weeks predisone | Drug | 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. |
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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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 17923793 | Background | 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. |
| 23227861 | Background | 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. |
| 28404617 | Background | 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. |
| 25844620 | Background | 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. |
| 26789102 | Background | 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. |
| 12826640 | Background | 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. |