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open access

Vol 74, No 2 (2023)
Original paper
Submitted: 2022-10-21
Accepted: 2022-12-05
Published online: 2023-04-27
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Efficacy of two different dosages of prednisone for treatment of subacute thyroiditis: a single-centre, prospective, randomized, open-label, non-inferiority trial

Yiqi Xu1234, Shu Liu1, Xiaofan Zeng1, Qian Wu1, Yueping Chen1, Chunling He1, Qing Zhai1, Binhua Zhang1, Jialin Gao1234
DOI: 10.5603/EP.a2023.0023
·
Pubmed: 37155300
·
Endokrynol Pol 2023;74(2):168-175.
Affiliations
  1. Department of Endocrinology and Genetic Metabolism, The First Affiliated Hospital of Wannan Medical College (Yijishan Hospital of Wannan Medical College), Wuhu, China
  2. Institute of Endocrine and Metabolic Diseases, Department of Endocrinology and Genetic Metabolism, The First Affiliated Hospital of Wannan Medical College (Yijishan Hospital of Wannan Medical College), Wuhu, China
  3. Anhui Province Key Laboratory of Biological Macro-Molecules Research, Wannan Medical College, Wuhu, China
  4. Anhui Provincial College Key Laboratory of Non-coding RNA Transformation Research on Critical Diseases, Wannan Medical College, Wuhu, China

open access

Vol 74, No 2 (2023)
Original Paper
Submitted: 2022-10-21
Accepted: 2022-12-05
Published online: 2023-04-27

Abstract

Introduction: The study aimed to explore the efficacy and safety of low-dose (LD) and regular-dose (RD) prednisone (PDN) for the treatment of subacute thyroiditis (SAT).

Material and methods: Patients were randomly allocated using the block randomization method to the 2 groups. The primary outcome was the time required for PDN treatment. Secondary outcomes included percentages of relapse, mean score for the Morisky Medication Adherence Scale-8© (MMAS-8), time required for symptoms to resolve, cumulative PDN dose (mg), and mean erythrocyte sedimentation rate (ESR) at 2 weeks and at baseline.

Results: The study cohort included 77 patients, randomized 74 participants, and 68 completed the study. There was no significant difference in the treatment duration between the LD and RD groups (55.31 ± 14.05 vs. 61.25 ± 19.95 days, p = 0.053). The mean difference in the time required for PDN treatment between the LD and RD groups was –1.86 [95% confidence interval (CI) = –10.64 to 6.92] days, which was within the non-inferiority margin of 7 days. There was a significant difference in the mean score for MMAS-8 between the LD and RD groups (5.84 ± 0.88 vs. 5.33 ± 1.12, p = 0.031). Also, there was a significant difference in the cumulative PDN dose between the LD and RD groups (504.22 ± 236.86 vs. 1002.28 ± 309.86, p = 0.046). The ESR at 2 weeks was statistically significant compared to baseline values in both groups, with pre-treatment and post-treatment ESRs of 49.91 ± 24.95 and 17.91 ± 12.60/mm/h, (p < 0.0001) in the LD group and 65.08 ± 21.77 and 17.23 ± 13.61/mm/h (p < 0.0001) in the RD group.

Conclusion: Low-dose PDN therapy may be sufficient to achieve complete recovery and better outcomes for SAT. This study is registered with the Chinese Clinical Trial Registry (02/10/2021 ChiCTR2100051762).

Abstract

Introduction: The study aimed to explore the efficacy and safety of low-dose (LD) and regular-dose (RD) prednisone (PDN) for the treatment of subacute thyroiditis (SAT).

Material and methods: Patients were randomly allocated using the block randomization method to the 2 groups. The primary outcome was the time required for PDN treatment. Secondary outcomes included percentages of relapse, mean score for the Morisky Medication Adherence Scale-8© (MMAS-8), time required for symptoms to resolve, cumulative PDN dose (mg), and mean erythrocyte sedimentation rate (ESR) at 2 weeks and at baseline.

Results: The study cohort included 77 patients, randomized 74 participants, and 68 completed the study. There was no significant difference in the treatment duration between the LD and RD groups (55.31 ± 14.05 vs. 61.25 ± 19.95 days, p = 0.053). The mean difference in the time required for PDN treatment between the LD and RD groups was –1.86 [95% confidence interval (CI) = –10.64 to 6.92] days, which was within the non-inferiority margin of 7 days. There was a significant difference in the mean score for MMAS-8 between the LD and RD groups (5.84 ± 0.88 vs. 5.33 ± 1.12, p = 0.031). Also, there was a significant difference in the cumulative PDN dose between the LD and RD groups (504.22 ± 236.86 vs. 1002.28 ± 309.86, p = 0.046). The ESR at 2 weeks was statistically significant compared to baseline values in both groups, with pre-treatment and post-treatment ESRs of 49.91 ± 24.95 and 17.91 ± 12.60/mm/h, (p < 0.0001) in the LD group and 65.08 ± 21.77 and 17.23 ± 13.61/mm/h (p < 0.0001) in the RD group.

Conclusion: Low-dose PDN therapy may be sufficient to achieve complete recovery and better outcomes for SAT. This study is registered with the Chinese Clinical Trial Registry (02/10/2021 ChiCTR2100051762).

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Keywords

subacute thyroiditis; SAT; low dose; prednisone; non-inferiority

About this article
Title

Efficacy of two different dosages of prednisone for treatment of subacute thyroiditis: a single-centre, prospective, randomized, open-label, non-inferiority trial

Journal

Endokrynologia Polska

Issue

Vol 74, No 2 (2023)

Article type

Original paper

Pages

168-175

Published online

2023-04-27

Page views

2256

Article views/downloads

661

DOI

10.5603/EP.a2023.0023

Pubmed

37155300

Bibliographic record

Endokrynol Pol 2023;74(2):168-175.

Keywords

subacute thyroiditis
SAT
low dose
prednisone
non-inferiority

Authors

Yiqi Xu
Shu Liu
Xiaofan Zeng
Qian Wu
Yueping Chen
Chunling He
Qing Zhai
Binhua Zhang
Jialin Gao

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