Abstract
Background/Objectives: Thread-embedding acupuncture (TEA) is widely used for cosmetic and therapeutic purposes; however, its safety profile, particularly in real-world clinical settings, remains under-researched. This study aimed to evaluate the safety profile of TEA through a prospective, observational analysis and confirm the feasibility of the study design for future studies involving larger patient populations. Methods: A multicenter, prospective observational study was conducted involving 100 patients who received TEA. Adverse events (AEs) were tracked, including incidence, severity, and duration during the 6-month post-treatment period. Bivariate analysis was used to assess factors influencing AE occurrence, including treatment site, depth, and patient-specific variables. Results: A total of 100 patients received 136 treatments during the study period. A total of 12 AEs were reported, most of which were mild and transient local reactions, including pain and bruising. More than half of the AEs occurred on the day of the procedure, with an average duration of 7 days. No serious AEs were observed, and all events resolved without any lasting effects. Patients undergoing multiple treatments showed no significantly higher AE rates than those receiving a single session. Conclusions: This study suggested that TEA generally has a favorable safety profile, with most AEs being mild and resolving without long-term effects. Further studies that evaluate the safety of TEA treatment across larger populations are recommended.