Safety Profile of Thread-Embedding Acupuncture: A Systematic Review and Meta-Analysis of Randomized Controlled Trials
In brief
Thread-embedding acupuncture had a 3% adverse-event rate in trials
Across 90 randomized trials, the pooled adverse-event rate with thread-embedding acupuncture alone was 3%; most reported events were mild and local. One serious treatment-related event was reported among 1,697 participants, but inconsistent safety reporting and the concentration of trials in China limit how confidently these findings define risks in broader practice.
- Journal
- Biomedicines (Q1)
- Published
- 26 August 2026
- Study design
- Systematic review / meta-analysis of RCTs
- Evidence level
- Level 1, High (CEBM 1a)
- Authors
- Jinyeong Hong, Woo-Hyeon Noh, Jin-Woo Suh, Yeonju Woo, Felipe Fregni, Joo-Hee Kim
- PMID
- 42792644
- DOI
- 10.3390/biomedicines14091901
Why clinicians should know about it
- Picked for Complementary and Alternative Medicine (top studies of the week, 27 September 2026): Pooled AE incidence 3%, mostly mild, low serious risk
Abstract
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.
Abstract as published, via PubMed.
For healthcare professionals. The summary is generated by AI from the published abstract, and the evidence level is assigned automatically from the study design on the Oxford CEBM hierarchy. Neither is medical advice. Read the full paper before changing practice.