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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
  • 34 View
  • 4 Download
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.
Original Article
Acupuncture Needles and the Risk of Lymphedema After Breast Cancer Surgery: A Retrospective National Cohort Study
Ye-Seul Lee, Yucheol Lim, Jiyoon Yeo
Perspect Integr Med. 2024;3(1):29-36.   Published online February 22, 2024
DOI: https://doi.org/10.56986/pim.2024.02.004
  • 88 View
  • 8 Download
Graphical AbstractGraphical Abstract AbstractAbstract PDFSupplementary Material
Background
Controversies remain over the impact of using needles on breast cancer patients after surgery due to risk of breast cancer-related lymphedema (BCRL). While recent literature suggests that vascular access during the postsurgical stage does not affect the risk of BCRL, the impact of acupuncture on the risk of BCRL during the postsurgical stage has not been studied.
Methods
This study included 35,153 patients from 2011 to 2013 who were newly diagnosed with breast cancer in a population-based cohort from the Korean National Health Insurance Service database. All patients received breast surgery, and the treatment group received acupuncture for more than 3 sessions in the 3-6 months post-surgery. The control group did not receive acupuncture. The incidence rate ratio, Kaplan-Meier curve, and Cox proportional hazards models were used to compare the risk of BCRL, and death between groups.
Results
About 5.8% of the study population received acupuncture during the 3-6 months post-surgery treatment window. After propensity score matching, the acupuncture treatment group did not show an increased risk of BCRL (IRR 1.017, 95% CI 0.868-1.193; unadjusted HR 1.018, 95% CI 0.868-1.193). This risk was robust in all multivariate Cox proportional hazards models.
Conclusion
An association of BCRL with acupuncture was not observed. Patients who received acupuncture to manage symptoms such as pain during the 3-6 months postsurgical stage did not have a higher risk of developing BCRL. Breast cancer patients who seek acupuncture to alleviate post-surgery symptoms such as pain, can receive acupuncture without concerns for potential risk of BCRL.
Editorial
A Pilot Trial of Integrative Medicine for Stroke Rehabilitation: Expert Recommendations for the Development and Sustainability of Integrative Medicine
Chihyoung Son, Go-Eun Lee, Joo-Hee Seo, Inae Youn, Jin-Won Kim
Perspect Integr Med. 2024;3(1):1-6.   Published online February 22, 2024
DOI: https://doi.org/10.56986/pim.2024.02.001
  • 66 View
  • 7 Download
Graphical AbstractGraphical Abstract AbstractAbstract PDF
Background
Strategies towards development and sustainability of integrative treatment in stroke rehabilitation medicine are needed. National expert recommendations based on the implementation of Integrative Medicine (IM) in stroke rehabilitation and IM outcomes would be invaluable.
Methods
A pilot study was performed and the effectiveness of combining Korean traditional medicine and Western conventional medicine in post-stroke patients (ischemic stroke n = 15 and hemorrhagic stroke n = 4) was evaluated, and recommendations were developed through consensus with physicians in national centers of rehabilitative medicine. Outcome measures [Korean Modified Barthel Index (K-MBI), Korean Mini Mental State Examination (K-MMSE), Modified Rankin Scale (mRS), and EuroQol 5-dimension 5-level (EQ-5D-5L) assessment were used at baseline, 4, 8 (K-MBI, K-MMSE, mRS, and EQ-5D-5L) and 12 weeks post treatment (EQ-5D-5L and mRS).
Results
Improvements were observed in functional and cognitive abilities at 8 weeks (K-MBI score p = 0.0062; K-MMSE score p = 0.046). Quality of life improvements (EQ-5D-5L) were observed but were not statistically significant. The disability assessment (mRS) indicated a gradual improvement from baseline to 12 weeks. No adverse events were reported. For effective, patient-centered IM treatment: (1) build a strong evidence base for IM as compared with Western medicine alone or traditional medicine alone; (2) active expert collaboration; (3) IM promotion in public medical institutions; and (4) continued government support.
Conclusion
Functional and cognitive abilities of stroke patients statistically significantly improved following 8 weeks of IM treatment. Strategies have been suggested towards the development and sustainability of IM treatment in stroke rehabilitation medicine.
Letter
Does the Chinese Literature Indicate Larger Effect Sizes? This Might Indeed be the Case
Tae-Hun Kim, Jung Won Kang
Perspect Integr Med. 2023;2(3):202-203.   Published online October 23, 2023
DOI: https://doi.org/10.56986/pim.2023.10.009
  • 289 View
  • 17 Download
AbstractAbstract PDF
This letter discusses concerns in a currently published meta-epidemiological study on commonly observed large effect sizes in the Chinese literature, focusing on potential selection bias and analysis methods. Researchers should be cautious when conducting systematic reviews that include the literature from specific countries or regions. Regardless of the country, the key issue is to enhance future research quality.
Protocol
Acupuncture for Rectal Cancer Patients with Low Anterior Resection Syndrome: A Mixed Method Pilot Study Protocol
Ming Yang, Honglin Jiang, Lin Xu, Qiaoli Zhang, Xun Li, Liu Han, Yudong Bao, Lu Yang, Mi Zhang, Lihua Zheng, Ningyuan Liu, Jianping Liu, Jinchang Huang
Perspect Integr Med. 2023;2(3):195-201.   Published online October 23, 2023
DOI: https://doi.org/10.56986/pim.2023.10.008
  • 361 View
  • 10 Download
AbstractAbstract PDF
Background
This protocol aims to facilitate the evaluation of acupuncture in the treatment of low anterior resection syndrome (LARS) on the bowel in rectal cancer patients.
Methods
This pragmatic pilot study was designed using a convergent parallel mixed methods design combining a single-arm trial and semi-structured qualitative interview.
Results
Sixty patients with LARS will be recruited from out/inpatient departments. For evaluation of efficacy, the single-arm objective performance criteria will be used in the pilot study in which all eligible participants will receive electroacupuncture mainly on Baliao acupoints three times a week for four weeks. The LARS scale, Memorial Sloan Kettering Cancer Centre Bowel Function Index, and anorectal manometry will be used to assess symptoms and pressure changes. The European Quality of Life Five Dimensions Questionnaire and the European Organization for Research and Treatment of Cancer-Quality of Life Questionnaire-Core 30 will be used to evaluate quality of life. Semi-structured interviews will be conducted among twenty participants to understand their experience and feelings. The qualitative and quantitative data will be analyzed and summarized before comparative analysis. Qualitative themes derived from qualitative analysis will be ranked with the variables of quantitative statistics. Finally, we will answer the research question from multiple perspectives by comparing different types of evidence for the same dimension.
Conclusion
This mixed method study design will potentially evaluate the feasibility and effects of electroacupuncture for LARS and gain an in-depth understanding of the attitudes, experiences, feelings, and acceptance among patients with LARS.
Short Communication
Perspectives and Ideas to Advance Integrative Medicine and Healthcare: Proceedings of the 4th Annual Jaseng Academic Conference
Andrew Jang, Jinho Lee, Catherine Donahue, David Coggin-Carr, Mike Cummings, Kien Trinh, Myeong Soo Lee, Susan Wieland, Christopher Zaslawski, Lawrence Prokop, Joon Shik Shin
Perspect Integr Med. 2023;2(3):190-194.   Published online October 23, 2023
DOI: https://doi.org/10.56986/pim.2023.10.007
  • 304 View
  • 16 Download
AbstractAbstract PDF
The 4th Annual Jaseng Academic conference (August 13, 2023) in Seoul, South Korea, was a pivotal event in the realm of integrative medicine. Cohosted by Jaseng Hospital of Korean Medicine and Michigan State University College of Osteopathic Medicine, over 500 professionals including Korean medicine doctors, medical doctors, doctors of osteopathic medicine, acupuncturists, researchers, and students gathered at the conference. The theme, “Perspectives on Integrative Medicine,” marked a departure from previous conference themes and embraced a multidisciplinary approach to healthcare. The event highlighted the importance of holistic patient care and cross-disciplinary collaboration within healthcare. It offered a comprehensive overview of the current state of integrative medicine approaches in manual medicine, evidence-based acupuncture treatment, and acupuncture research. The Annual Jaseng Academic conference continues to serve as a platform for healthcare professionals to exchange ideas and perspectives, and bridges the gap between diverse medical systems to promote improved patient outcome and wellbeing.
Editorial
Best Evidence for Best Care
Nicola Robinson
Perspect Integr Med. 2023;2(3):139-141.   Published online October 23, 2023
DOI: https://doi.org/10.56986/pim.2023.10.001
  • 634 View
  • 30 Download
Graphical AbstractGraphical Abstract PDF
Protocol
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
  • 508 View
  • 6 Download
Graphical AbstractGraphical Abstract AbstractAbstract 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.
Short Communication
The Mazzanti AcuOsteo Method®: Pathology and Treatment with Acupuncture and Osteopathy of the Musculoskeletal Pain of The Upper and Lower Limbs
Umberto Mazzanti
Perspect Integr Med. 2023;2(2):126-130.   Published online June 23, 2023
DOI: https://doi.org/10.56986/pim.2023.06.007
  • 1,260 View
  • 86 Download
Graphical AbstractGraphical Abstract AbstractAbstract PDF
Musculoskeletal pain is one of the most frequent reasons for consultations in my clinic. In my experience of 35 years, acupuncture, and osteopathy are effective techniques in the treatment of musculoskeletal pain of the upper and lower limbs. Pain reported by the patient often affects a widespread area around the joint and is usually associated with some stiffness. The aim of acupuncture is to restore the local circulation of Qì and Blood, inducing an analgesic and anti-inflammatory effect, along with myofascial detensioning. The aim of the osteopathic manipulative treatment is to return joints to their normal position and restore restricted joint motion. The Mazzanti AcuOsteo Method is a newly patented method which uses the synergistic combination of using points for acupuncture, cupping or bleeding, and osteopathy to maximize effectiveness of treatment for musculoskeletal pain.
Guideline
ACURATE: A Guide for Reporting Sham Controls in Trials Using Acupuncture
Ye-Seul Lee, Song-Yi Kim, Hyangsook Lee, Younbyoung Chae, Myeong Soo Lee
Perspect Integr Med. 2023;2(2):100-106.   Published online June 23, 2023
DOI: https://doi.org/10.56986/pim.2023.06.004
  • 965 View
  • 18 Download
AbstractAbstract PDF
This paper presents the Acupuncture Controls gUideline for Reporting humAn Trials and Experiments (ACURATE) checklist, an extension of The Consolidated Standards for Reporting of Trials (CONSORT) and to be used along with STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA) when both real and sham acupuncture needles are used in the study. This checklist focuses on a clear depiction of sham needling procedures to enhance replicability and enable a precise appraisal. We encourage researchers to use ACURATE in trials and reviews involving sham acupuncture to assist reporting of sham acupuncture procedures and the related components.
Review Article
A Scoping Review of Clinical Research on Motion Style Acupuncture Treatment
Doori Kim, Yoon Jae Lee, In-Hyuk Ha
Perspect Integr Med. 2023;2(2):65-76.   Published online June 23, 2023
DOI: https://doi.org/10.56986/pim.2023.06.001
  • 665 View
  • 33 Download
  • 1 Citations
Graphical AbstractGraphical Abstract AbstractAbstract PDF
This scoping review was conducted to examine the concept of Motion style acupuncture treatment (MSAT), use in clinical practice, its effectiveness, and safety. A literature review of clinical study treatment methods combining acupuncture and movement therapy was performed using PubMed. Of 2,096 studies retrieved, 22 were included in this review. There were 12 randomized controlled trials, and all 22 studies were published in China and Korea, mostly, within the last 3 years. There were five studies concerning local acupoints and 17 studies regarding needling at distal acupoints, and the level of risk of the procedure was “high” in eight studies and “moderate” in 14 studies. The study participants were patients with musculoskeletal pain, and many studies reported significant improvements in pain and functional disability outcomes following treatment using MSAT. For conclusion, MSAT refers to a treatment method in which a patient performs active/passive movements under the supervision of a physician with the acupuncture needle retained at the insertion site. However, there are a limited number of MSAT studies, and various treatment types and related terms are mixed. Further studies, classification of the types of MSAT using a well-established classification system, and a clearer definition of the MSAT concept are needed.

Citations

Citations to this article as recorded by  
  • Effectiveness and Safety of Progressive Loading–Motion Style Acupuncture Treatment for Acute Low Back Pain after Traffic Accidents: A Randomized Controlled Trial
    Seung-Yoon Hwangbo, Young-Jun Kim, Dong Guk Shin, Sang-Joon An, Hyunjin Choi, Yeonsun Lee, Yoon Jae Lee, Ju Yeon Kim, In-Hyuk Ha
    Healthcare.2023; 11(22): 2939.     CrossRef
Original Article
An Observational Study on the Anatomical Characteristics of Acupoint CV23 (Lianquan) with Ultrasonography
Hongmin Chu, Seongjun Park, Jaehyo Kim, Wonbae Ha, Seung Bum Yang, Kyungho Kang, Jongho Kim, Jungtae Leem, Sanghun Lee
Perspect Integr Med. 2023;2(1):49-55.   Published online February 21, 2023
DOI: https://doi.org/10.56986/pim.2023.02.007
  • 944 View
  • 30 Download
Graphical AbstractGraphical Abstract AbstractAbstract PDF
Background
Acupoint CV23 is one of the most commonly used acupoints for the treatment of post-stroke dysphagia and tongue pain. However, care must be taken during the procedure to consider the position of glands and blood vessels in the subcutaneous space of the acupoint. Needling depths to the geniohyoid muscle reportedly range from 0.4 to 3.3 cm. Using ultrasound imaging, we aimed to observe the anatomical characteristics around acupoint CV23 to derive a safe needling depth.
Methods
Ultrasound images of acupoint CV23 accessed from the Standard Ultrasound Image of Acupoint database were retrospectively analyzed for 30 participants aged in their 20s and 30s (15 male, 15 female), and the depth from the skin to the geniohyoid muscle was measured. Correlations between the needling depth and anthropometric factors (such as neck circumference) were analyzed.
Results
The average needling depth to the geniohyoid muscle was 1.59 ± 0.49 cm (male; 1.43 ± 0.52 cm, female, 1.75 ± 0.42 cm, p = 0.03). The geniohyoid muscle, anterior digastric muscles, and genioglossus muscle were observed in the subcutaneous area of acupoint CV23, and a risk of sublingual gland damage needs to be considered for oblique insertion of the acupuncture needle. No statistically significant correlations between the needling depth and anthropometric factors were observed.
Conclusion
Acupoint CV23 has a relatively shallow needling depth, and considering the presence of blood vessels and glands in the sublingual space, visualizing the surrounding anatomical structures using ultrasound was helpful to ensure safe needling practice.
Review Articles
Trends in the Development of Sham Acupuncture-Related Technologies Focused on Patents Applied for in South Korea
Sung Min Lim
Perspect Integr Med. 2023;2(1):36-41.   Published online February 21, 2023
DOI: https://doi.org/10.56986/pim.2023.02.005
  • 881 View
  • 20 Download
  • 1 Citations
Graphical AbstractGraphical Abstract AbstractAbstract PDF
Background
This study aimed to analyze the trends in Korean patents for sham acupuncture.
Methods
The electronic database of the Korea Intellectual Property Rights Information Service was searched for Korean patents for sham acupuncture from inception till September 2020. Patents, which were not related to sham acupuncture, were excluded. The applicant, application date, International Patent Classification, and technological content of sham acupuncture were analyzed.
Results
This study included eight patents. Application analysis identified the following sham acupuncture types: four (50%), two (25%), and two (25%) patents were for non-penetrating sham acupuncture, electronic sham acupuncture, and patch sham acupuncture, respectively. All patents aimed to use sham acupuncture as a control for rigorous double-blind clinical trials to verify the efficacy of real acupuncture treatment.
Conclusion
The present findings suggest that technological advances were focused on developing various types of sham acupuncture methods for double-blind studies. Further large-scale studies using rigorous designs are needed to investigate new sham acupuncture applications.

Citations

Citations to this article as recorded by  
  • Systematic Review Protocol for Sham Acupuncture Validation Research
    Sung Min Lim
    Perspectives on Integrative Medicine.2023; 2(2): 131.     CrossRef
Proposal of a Case Reporting Draft Guideline for Pharmacopuncture: Literature Review of Pharmacopuncture Case Reports
Soohyun Jeong, Chaeyeon Son, Hyunjin Kim, Gapsik Yang, Hongmin Chu, Jungtae Leem
Perspect Integr Med. 2023;2(1):24-35.   Published online February 21, 2023
DOI: https://doi.org/10.56986/pim.2023.02.004
  • 1,149 View
  • 37 Download
Graphical AbstractGraphical Abstract AbstractAbstract PDFSupplementary Material
Pharmacopuncture is a popular treatment that combines the advantages of both herbal medicine and acupuncture. However, pharmacopuncture care reporting guidelines have not yet been developed. This study aimed to propose a reporting guideline draft for pharmacopuncture case reports. Pharmacopuncture case reports were retrieved from 4 databases (KCI, RISS, ScienceON, OASIS) to analyze the items reported and their fidelity. We analyzed 5 existing reporting guidelines related to Korean medicine case reporting to identify the items to be included in the extension of pharmacopuncture reporting guidelines. From 3,684 studies, 29 case reports were included and 4 items were identified as not reported in enough detail: “direction and depth of pharmacopuncture” (89.5%); “method of manufacturing the syringe needle” (82.8%); “posture of the patient during the therapy” (75.9%); and “pharmacopuncture recipe” (69.5%). As a result of analyzing moxibustion and acupuncture clinical trial reporting guidelines, it was determined that detailed reporting guidelines on the type of pharmacopuncture, manufacturing method, and treatment method were required and we propose that a pharmacopuncture reporting guideline draft should include these details. Further investigations are warranted using the Delphi technique to reach agreement with clinical practitioners and clinical research experts.
Editorial
Integration of Acupuncture into UK Healthcare - A NICE Perspective: Why is Acupuncture Now Recommended for Chronic Pain but not for Back Pain or Osteoarthritis
Mike Cummings
Perspect Integr Med. 2023;2(1):3-7.   Published online February 21, 2023
DOI: https://doi.org/10.56986/pim.2023.02.002
  • 1,615 View
  • 33 Download
  • 1 Citations
AbstractAbstract PDF
In April 2021, the National Institute for Health and Care Excellence (NICE) published a guideline on chronic pain (NG193) with a recommendation to consider a single course of acupuncture treatment in patients with chronic primary pain. This positive recommendation came after the NICE guideline on low back pain and sciatica (NG59) announced in November 2016, that acupuncture treatment did not work for back pain, having previously recommended it in 2009 (CG88). This article attempts to explain this apparent contradiction in recommendations by tracing the history of acupuncture debates in the NICE guidelines over the last 2 decades.

Citations

Citations to this article as recorded by  
  • 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

Perspect Integr Med : Perspectives on Integrative Medicine