Perspectives on Integrative Medicine

Protocol

Study Protocol for a Systematic Review of the Methods and Reliability of Sham Electroacupuncture in Randomized Controlled Trials: Sung Min Lim; Perspect Integr Med. 2025;4(1):62-64. Published online February 21, 2025; DOI: https://doi.org/10.56986/pim.2025.02.008

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Abstract PDF: Background
Electroacupuncture (traditional acupuncture combined with electrical stimulation) is used to treat various medical conditions. However, the lack of standardized sham electroacupuncture options (placebo controls) poses a challenge in ensuring the validity of the results gained from randomized controlled trials (RCTs). This study presents a protocol for a systematic review to evaluate the methods and validity of sham electroacupuncture used in RCTs.
Methods
To provide evidence for establishing an optimal control model for sham electroacupuncture, a systematic review will be conducted by searching major English language electronic databases (including PubMed, EMBASE, and the Cochrane Central Register of Controlled Trials) for studies published up to May 2024. RCTs that utilized sham electroacupuncture as a control group will be included. Two independent reviewers will screen the studies and extract the data, and the quality of the selected studies will be assessed using the Cochrane Risk of Bias Tool 2. Frequency analysis will be conducted, and to assess blinding in RCTs the Blinding Index will be reported. This systematic review protocol is registered with PROSPERO (no.: CRD42024542514).
Results
/Conclusion: This systematic review will provide a comprehensive analysis of the methods and reliability of sham electroacupuncture in RCTs and thus help identify current practices and gaps. The findings may contribute to the development of standardized sham electroacupuncture controls and improve the design RCT in the future which will facilitate treatment validation of electroacupuncture.

Short Communication

Robust Evidence in Integrative Medicine: Innovations, Challenges, and Future Directions: Ye-Seul Lee, Myeong Soo Lee, David Moher, In-Hyuk Ha, Jian-Ping Liu, Terje Alræk, Stephen Birch, Tae-Hun Kim, Yoon Jae Lee, Juan V.A. Franco, Jeremy Y. Ng, Holger Cramer; Perspect Integr Med. 2024;3(3):162-167. Published online October 23, 2024; DOI: https://doi.org/10.56986/pim.2024.10.005

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Graphical Abstract Abstract PDF: Integrative Medicine (IM), which includes therapies such as acupuncture, herbal medicine, yoga, and meditation, is gaining attention for managing chronic pain conditions. However, concerns about the quality of evidence supporting the use of these interventions persist. The 5th Annual Jaseng Academic conference 2024, in Seoul, South Korea, themed "Robust Evidence in Integrative Medicine: Innovations, Challenges, and Future Directions," addressed these concerns by focusing on advancements in study design, evidence synthesis, and open science practices. This conference proceeding summarizes key insights from the conference, emphasizing the role of pragmatic randomized controlled trials (pRCTs) in evaluating real-world effectiveness, and addressing the complexities involved in IM research such as sham controls. The integration of IM therapies into comprehensive pain management strategies (particularly in Korea), supported by government-backed research and policy initiatives was also discussed. Advancements in methodologies were addressed, such as bibliometric analysis, evidence mapping, and the development of clinical practice guidelines (CPGs) for integrative therapies. These methodologies offer valuable insights but face challenges due to the heterogeneity of IM interventions, and potential synergistic or antagonistic effects when combined with conventional medicine. Finally, the potential of open science to enhance transparency, reporting, and reproducibility in IM was explored, emphasizing the increased role of adherence to reporting guidelines (CONSORT and PRISMA). The future of IM research is built upon the continued efforts of refined study designs, rigorous evidence synthesis, and the integration of open science principles, for a robust and more credible evidence base.

Protocol

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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Abstract PDF

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

Citations to this article as recorded by

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

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