| Objective: The aim of this non-inferiority study was to explore the efficacy and safety of low-dose(LD)prednisolone(PDN)at 15 mg one time per day as compared to the regular dose(RD)at 10 mg three times per day for treatment of subacute thyroiditis(SAT).Methods: The eligibility criteria of this randomized,open-label,non-inferiority trial included age > 18 years,recent diagnosis of SAT,and no contraindications to glucocorticoids.Participants were randomly allocated at a 1:1 ratio using the block randomization method to either the LD or RD group.The laboratory personnel were blinded to the study until after group assignment.The primary outcome was the time(days)required for PDN treatment.Non-inferiority was defined as a mean difference of7 days.Secondary outcomes included the percentages of participants experiencing relapse during and after treatment,drug compliance,time(days)required for symptoms to resolve,cumulative PDN dose(mg),and mean erythrocyte sedimentation rate(ESR)at 2 weeks and all adverse events.All analyses were performed using the“Full-analysis-set”,while safety analyses were based on the “Safety-analysis-set” of the actual treatment received by the participants.This study is registered with Chinese Clinical Trial Registry(Chi CTR2100051762).Results: The study cohort included 40 patients who were diagnosed with SAT between December 2020 and December 2021.The participants were randomly assigned to the LD group(n = 18)or RD group(n = 22).Two(11.1%)and two(9.1%)patients in the LD and RD groups,respectively,were not followed-up due to the coronavirus pandemic.There was no significant difference in the treatment duration between the LD and RD groups(48.31 ± 11.35 vs.60.30 ± 21.85 days,respectively,p = 0.41).The mean difference in the time required for PSL treatment between the LD and RD groups was-4.99(95% confidence interval =-16.53 to 6.56)days,which was within the non-inferiority margin of 7 days.There was a significant difference in the drug compliance rate between the LD and RD groups(5.94 ± 0.77 vs.5.25 ± 1.12,respectively,p = 0.037),but not in the incidences of neck pain(2.63 ± 0.94 vs.2.42± 0.85,respectively,p = 0.507)or tenderness around the thyroid gland(7.13 ± 1.17 vs.6.48 ± 1.34,respectively,p = 1.137).Also,there was a significant difference in the cumulative PDN dose between the LD and RD groups(447.34±156.74 vs.964.75±300.88,p < 0.0001).The erythrocyte sedimentation rate(ESR)at 2 weeks was statistically significant as compared to baseline values in both groups,with pre-treatment and post-treatment ESRs of 53.06 ± 26.80 and 18.63 ± 15.00/mm/h,respectively(p < 0.0001),in the LD group and 64.20 ± 22.06 and 17.00 ±8.94/mm/h,respectively(p < 0.0001)in the RD group,while there was no significant difference before and after treatment between the two groups.In the LD and RD groups,6(37.50%)and 9(45%)patients,respectively,experienced relapse(p = 0.65)during treatment,in addition to 2(12.50%)and 1(5.00%)(p = 0.57)after treatment discontinuation.Overall,adverse drug events occurred in 5(31.25%)and 9(45%)patients in the LD and RD groups,respectively.Conclusion: Low-dose PDN therapy for SAT shortened the treatment duration,improved patient compliance,and achieved more satisfactory results.In addition,the efficacy of low-dose PDN was not inferior to the standard dosage and with fewer adverse effects.Hence,low-dose steroid therapy may be sufficient to achieve complete recovery and better outcomes of SAT. |
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