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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
  • 849 View
  • 40 Download
Graphical AbstractGraphical Abstract AbstractAbstract 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.
Protocols
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
  • 2,667 View
  • 19 Download
  • 1 Citations
AbstractAbstract 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
A Study Protocol for a Multicenter, Pragmatic, Randomized Controlled, Parallel-Grouped Pilot Clinical Trial: Effectiveness of Non-Pharmacological Versus Pharmacological Treatments for Non-Acute Lumbar Disc Herniation
Hui Yan Zhao, Purumea Jun, Chaewon Lee, In-Hyuk Ha, Chang-Hyun Han
Perspect Integr Med. 2023;2(1):59-64.   Published online February 21, 2023
DOI: https://doi.org/10.56986/pim.2023.02.009
  • 1,402 View
  • 32 Download
Graphical AbstractGraphical Abstract AbstractAbstract PDFSupplementary Material
Background
This study was the development of a protocol for the comparison between the efficacy of non-pharmacological and pharmacological treatment approaches for lumbar disc herniation in a pragmatic environment to obtain real-world based study data.
Methods
The protocol sets out a two-armed, parallel, multicenter pragmatic, randomized-controlled trial (RCT) which will be conducted in four spine specialist hospitals in Korea to determine cost-efficiency.
Results
The study will enroll 36 participants and allocate patients into either the non-pharmacological treatment group or the pharmacological treatment group in a 1:2 ratio. Patients must have evidence of disc-related disease diagnosed using MRI, as well as having lower back pain or radiating leg pain (numeric rating scale score ≥ 5). The treatment will last for 8 weeks with a 26-week follow-up. The primary outcome will be measured using the Oswestry Disability Index score from Week 9. Secondary outcomes related to lower back pain and radiating leg pain will be measured using the scores from the numeric rating scale, the visual analogue scale, the European Quality of Life 5 Dimensions 5 Level Version), the 12-item Short Form Survey, and the patient global impression of change.
Conclusion
This is the first protocol for a pragmatic RCT evaluating the efficacy, safety, and cost-efficiency of non-pharmacological and pharmacological treatment strategies in a clinical setting. Following the basis of this protocol, RCTs may play an important role in establishing guidelines for treating radiating leg pain and lower back pain and provide effective information to clinicians in practical settings.
Review Article
Shoulder Pain and the Potential Role of Acupuncture: A Narrative Review of Clinical Practice and Treatment Guidelines
Stephen Birch, Myeong Soo Lee, Tae-Hun Kim, Terje Alraek
Perspect Integr Med. 2022;1(1):3-9.   Published online September 22, 2022
DOI: https://doi.org/10.56986/pim.2022.09.002
  • 6,782 View
  • 154 Download
  • 4 Citations
AbstractAbstract PDFSupplementary Material
The potential use of acupuncture for shoulder pain of various etiologies and whether clinicians make recommendations about the use of acupuncture was examined. Shoulder pain is a common clinical problem. What is the level of evidence and how often is acupuncture recommended for shoulder pain? A manual and database (PubMed) search of review articles of related clinical trials and guidelines was performed. The evidence for effectiveness of acupuncture treatment of different types of shoulder pain was weak. However, there are some studies, with a weak to moderate level of evidence, on shoulder pain (across nine subtypes of shoulder pain). Acupuncture is safe and may be a cost-effective treatment for shoulder pain. There were 131 statements recommending the use of acupuncture for shoulder pain across 12 subtypes of shoulder pain. The most common statements were for non-specific ‘shoulder pain.’ There were 11 statements against the use of acupuncture for shoulder pain and three subtypes of shoulder pain. The level of evidence in studies of acupuncture treatment for shoulder pain is low, therefore, further research is needed. Recommendations for the use of acupuncture for shoulder pain are increasing but lag behind those for other pain problems such as low back pain.

Citations

Citations to this article as recorded by  
  • “Are we there yet?” – Green shoots of progress in acupuncture implementation in healthcare
    Sandro Graca, Matthias Huemer, Beverley de Valois, Bobbee Vang, Lara McClure
    European Journal of Integrative Medicine.2024; 69: 102371.     CrossRef
  • Health Care Utilization for Common Shoulder Disorders: Analysis of the 2010–2019 National Patient Sample Data from the Health Insurance Review and Assessment Service in Korea
    Jin-Young Kang, Doori Kim, Huijun Kim, In-Hyuk Ha, Yoon Jae Lee
    Medicina.2024; 60(5): 744.     CrossRef
  • Clinical effect analysis of timed strengthening moxibustion combined with continuing nursing on symptoms of qi deficiency and blood stasis type
    Fang Liu, Xuan Wang, Man Zhao, Qing Qin
    Medicine.2024; 103(52): e40886.     CrossRef
  • A Review of Key Research and Engagement in 2022
    John McDonald, Sandro Graca, Claudia Citkovitz, Lisa Taylor-Swanson
    Journal of Integrative and Complementary Medicine.2023; 29(8): 455.     CrossRef

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