Discussion
hypothyroidism, pain
ADVERSE REACTIONS, RECURRENCE, DISEASE COURSE, TRANSIENT HYPOTHYROIDISM, HYPOTHYROIDISM
This is the first multicenter RCT to evaluate the efficacy and safety of using a low initial dose of PSL for the treatment of moderate-to-severe SAT. The results demonstrate that the low initial dose (15 mg/d) of PSL was non-inferior to the standard initial dose of PSL (30 mg/d) in treatment duration, time to pain relief, or the prevalence of hypothyroidism, recurrence, and adverse reactions. Patients administered a low initial dose of PSL had a lower total dose of PSL compared to those receiving the standard dose of PSL.We have validated the conclusions of retrospective cohort studies which suggested that a low initial dose (15 mg/d) of PSL may achieve better outcomes compared to a high initial dose [In SAT patients, transient hypothyroidism may occur during the disease course, with 5%–26% of patients experiencing permanent hypothyroidism [Our study has four main limitations. Firstly, approximately 20% of patients dropped out during the treatment period or were lost to follow-up. However, most of the dropouts were due to personal reasons rather than poor treatment outcomes or adverse reactions. Multiple imputation method was utilized to fill in the missing values, and the per-protocol set was used to validate the stability of our results. Secondly, patients were followed up for only 6 months after withdrawal of PSL, which limited our ability to determine whether the prevalence of hypothyroidism was transient or permanent. However, we found that the proportion of patients with short-term hypothyroidism and a TSH level >10 mU/L was similar between the two groups. Hence, the initial dose of PSL may only have a slight effect on the risk of permanent hypothyroidism. Thirdly, no serious adverse reactions were reported during the treatment and follow-up period. We found that 13.33% of patients had mild adverse reactions, which is consistent with the findings of Li et al.’s study [