Perspectives on Integrative Medicine

Protocols

A Study Protocol for Developing a Consensus-Based Reporting Guideline for Case Reports on Acupuncture-Related Adverse Events: Tae-Hun Kim, Ye-Seul Lee, Jung-Won Kang, Myeong Soo Lee, Lin Ang, Jeremy Y. Ng, Stephen Birch, Terje Alræk, Lin Yu, Yuting Duan, Zhirui Xu; Perspect Integr Med. 2025;4(2):117-120. Published online June 23, 2025; DOI: https://doi.org/10.56986/pim.2025.06.007

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Graphical Abstract Abstract PDF Supplementary Material: Case reports play a crucial role in identifying safety concerns related to new or rare complications and adverse events (AEs) associated with therapeutic interventions. Although acupuncture is generally considered safe when performed by trained professionals, the increasing number of case reports reporting acupuncture-related AEs has raised public safety concerns. A recent systematic review of case reports from 2010 to 2023 determined that many reports lacked the essential details necessary for assessing AE causality, treatment appropriateness, and contributing risk factors. These omissions may result in misinformation, and exaggerate the potential harm of acupuncture. The CAse REport guidelines (13 items) provide general guidance to improve the clarity, completeness, and transparency of case report findings, but they do not address the unique clinical features and factors specific to acupuncture-related AEs such as defective needles, practitioner malpractice, or patient-related factors. These limitations may hinder the educational value of such reports in preventing acupuncture-related AEs. To address this gap, a consensus-based reporting guideline tailored to acupuncture-related AEs is necessary to enhance the quality, transparency, and reliability of case reports, which will ultimately contribute to improved patient care. This article outlines a protocol, and approaches, for developing a reporting guideline for acupuncture-related AEs in case reports.

Validation of a New Sham Acupuncture Needle for Double-Blind Trials: A Study Protocol: Sung Min Lim; Perspect Integr Med. 2024;3(1):57-60. Published online February 22, 2024; DOI: https://doi.org/10.56986/pim.2024.02.008

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Background
To establish efficacy in acupuncture treatment, rigorous randomized controlled trials (RCT) are needed. Non-invasive sham acupuncture needles are an effective tool for practitioner/participant blinding. This study presents a protocol for the validation of a newly developed sham acupuncture needle.
Methods
A double-blind RCT will be conducted on 66 healthy adults who will be randomly assigned (using computer-generated random numbers) to either the verum (n = 33) or sham (n = 33) acupuncture needle group. The needles will be inserted at 2 acupuncture points: LI4 (upper limb) and ST36 (lower limb). The primary outcome measure is the practitioner/participants belief that they received verum or sham acupuncture. The secondary outcome measures are participant-rated sensations (penetration, pain, and de qi). Adverse events will be recorded with detailed explanations, categorizing occurrences according to related or unrelated to acupuncture. As the newly developed sham acupuncture has not been studied before, an exploratory approach has been adopted. Descriptive statistics, t test, and χ² test will be applied appropriately.
Results
This study is intended to provide a protocol for the validation of a sham acupuncture needle by using a double-blind RCT setting, and the results will hopefully contribute to the standardization of the needles used for sham acupuncture. The outcomes aim to determine the reliability of practitioner/participant blinding, participant experience of sensations, and lay groundwork for a standardized control group for clinical trials in the future. The newly developed non-invasive sham acupuncture needle may reduce bias and improve reliability in the size effect of acupuncture treatment.

Citations

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Designing an Attention Control Condition for a Randomized Controlled Trial Using TED Talks
Karen A. Nelson, Sahereh Mirzaei, Judith M. Schlaeger, Hongjin Li, Larisa Burke, Peter Cabezas, Monya Meinel, Lauren Rountree, Sofie Su, Holli A. DeVon
Western Journal of Nursing Research.2025; 47(8): 764. CrossRef
Introducing a novel sham acupuncture method for double-blind trials: A validation study
Sung Min Lim, Eunji Go, Jungsup Lee, Go Eun Lee, Chihyoung Son
Complementary Therapies in Medicine.2025; 92: 103198. CrossRef
A Protocol for the Validation of Novel Sham Acupuncture in Patients Who Have Had a Stroke
Sung Min Lim
Perspectives on Integrative Medicine.2024; 3(3): 168. CrossRef

Systematic Review Protocol for Sham Acupuncture Validation Research: Sung Min Lim; Perspect Integr Med. 2023;2(2):131-133. Published online June 23, 2023; DOI: https://doi.org/10.56986/pim.2023.06.008

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Graphical Abstract Abstract PDF

Background
Streitberger and Park sham needles have been developed and used as non-penetrating sham acupuncture needles that can be blinded in randomized controlled clinical trials assessing the efficacy of acupuncture. Ideal sham acupuncture should not be distinguishable from an actual acupuncture treatment provided to the experimental group to ensure patient blinding; additionally, it should not have any physiological or biological effect. Providing evidence for such sophisticated sham acupuncture devices is critical, as control settings in clinical studies are based on research verifying their validity.
Methods
Three core electronic databases - PubMed, EMBASE, and the Cochrane Central Register of Controlled Trials - will be used to search for validity verification studies of sham acupuncture devices. Clinical studies that verify the validity of non-penetrating sham acupuncture devices will be included in the review.
Results
The study design, participant information, experimental and control groups, study population’s experience with acupuncture, outcome variables, and results of studies that verify the validity of sham acupuncture devices will be systematically reviewed.
Conclusion
This systematic review of validity verification studies of sham acupuncture devices is expected to help the development of more sophisticated sham acupuncture, as well as the design of studies verifying its validity in the future.

Citations

Citations to this article as recorded by

A systematic review of sham acupuncture validation studies
Sung Min Lim, Eunji Go
BMC Complementary Medicine and Therapies.2024;[Epub] CrossRef

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