Background/Objectives: Medical therapies that apply biodegradable materials, such as polydioxanone, are widely used to treat various disorders. Thread-embedding acupuncture (TEA) is a unique form of acupuncture that exerts long-lasting therapeutic effects by inserting absorbable threads at specific acupuncture points, and is widely used to treat various diseases. However, there is currently a lack of research regarding the safety of TEA. This prospective observational trial aims to evaluate the safety of TEA by collecting and analyzing data related to adverse events in patients receiving TEA in actual practice. Methods: A total of 350 eligible participants who undergo TEA at one of three university-affiliated hospitals and two traditional Korean medicine clinics will be systemically observed for post-treatment adverse reactions. The patients will be monitored at three time points: 1 week, 1 month, and 3 months post-treatment. Safety evaluations will assess the incidence of adverse events and treatment discontinuation rates during the 3-month post-treatment period. Conclusions: This study will evaluate the safety of TEA and provide information for decision-making in clinical practice as well as basic data for future large-scale research.

Jinyeong Hong, In-Hwa Park, Min-Jeong Kim. Journal of Acupuncture Research 2024;41:209-15. https://doi.org/10.13045/jar.24.0024

Background/Objectives: Thread-embedding acupuncture (TEA) involves the implantation of suture threads into therapeutic points for sustained stimulation; however, its safety evidence remains limited. This systematic review and meta-analysis evaluated adverse events (AEs) associated with TEA to establish its safety profile. Methods: Ten databases were searched up to April 5, 2026 for randomized controlled trials (RCTs) of TEA. Reported AEs were standardized using MedDRA terminology, WHO-UMC causality criteria, and CTCAE version 5.0. Pooled incidence proportions were estimated using generalized linear mixed models, and risk ratios (RRs) were pooled using random-effects models with 95% confidence intervals (CIs). Results: Of the 90 RCTs included, most were conducted in China (81, 90.0%). For TEA monotherapy, pooled AE incidence proportion was 3% (95% CI: 2–7%; I² = 53.7%). Local AEs were most common (111, 5.9%), followed by systemic (5, 0.3%) and other AEs (2, 0.1%). Among 118 participants with AEs, most were classified as Grade 1 (95, 80.5%), with Grade 2 (8, 6.8%) and unassessable cases (15, 12.7%). In comparative analyses, TEA showed no significant increase in AE risk versus sham TEA (RR: 1.15, 95% CI: 0.83–1.60), acupuncture (RR: 0.97, 95% CI: 0.64–1.49), or conventional medicine (RR: 0.28, 95% CI: 0.18–0.45). Only one serious TEA-related AE was reported among 1697 participants (0.06%); the withdrawal rate due to TEA-related AEs was 0.36% (9/2524). Conclusions: TEA demonstrated a favorable safety profile when used alone or as an add-on therapy, with most AEs mild and transient. However, inconsistencies in AE definitions and reporting highlight the need for standardized terminology and more rigorous safety evaluation in future studies.

Jinyeong Hong, Bo-In Kwon, Joo-Hee Kim. Journal of Acupuncture Research 2026;43:232-7. https://doi.org/10.13045/jar.26.0005