Acupuncture (AT) has accumulated an extensive clinical evidence base, yet its efficacy remains controversial, partly because of sham acupuncture in randomized controlled trials testing the specific effects of acupuncture. The aim of this overview is to critically review the assumption that sham acupuncture is inert, examine the methodological implications of sham needle design, and evaluate whether the sham needling points affects clinical outcomes. We argue that sham acupuncture cannot be considered a valid placebo treatment because it activates the somatosensory system through tactile stimulation, which is a component of the mechanism of acupuncture. We also discuss evidence showing that the use of sham-devices in the sham and verum arms of acupuncture trials results in a suboptimal representation of verum acupuncture as practiced clinically. Meanwhile, the location of the points selected for sham acupuncture is highly relevant. Comparisons across multiple clinical conditions show no significant difference between ‘verum acupuncture and sham needling at real acupuncture points’ [Sham AT (verum)], however sham AT (verum) produces significantly greater pain relief than ‘sham needling at non-acupoints’ [Sham AT (sham)] in chronic low back pain. The reporting quality of sham needle characteristics has not improved over time, which presents an obstacle to the full understanding of sham interventions. We conclude that sham acupuncture is an active intervention that leads to underestimation of acupuncture efficacy. Researchers should carefully consider control design, adhere to the ACURATE reporting guideline, and interpret the results of sham-controlled trials appropriately.

Background Evidence regarding the effectiveness of acupuncture for cancer-related fatigue (CRF) in breast cancer survivors (BCS) remains inconsistent, warranting large pragmatic randomized controlled trials (RCTs). Methods The AcuBreast trial was a pragmatic, two-arm RCT comparing acupuncture plus usual care versus usual care alone. Inclusion criteria required CRF lasting 6 months post-treatment, written informed consent, and sufficient Norwegian proficiency. Exclusion criteria included conditions known to contribute to fatigue, ongoing acupuncture, pregnancy, and bleeding disorders. The acupuncture group received 10–12 treatments over 8–12 weeks alongside usual care. Control group received usual care only. The primary outcome was CRF measured by the Chalder Fatigue Questionnaire (CFQ14/11). Secondary outcomes included fatigue severity (FSS), adverse events, and quality-adjusted life years (QALYs). Results Of 221 randomized survivors (acupuncture n=112, control n=109; mean age 52.5 years [SD=8.9]), retention at 3 months was 106 versus 85, and at 6 months was 102 versus 83. At 3 months, CFQ14 scores were significantly lower in the acupuncture group (mean difference: −6.9, 95% CI: −8.8 to −4.9, p0.001), sustained at 6 months (−3.5, 95% CI: −5.5 to −1.6, p0.001). FSS scores were also significantly lower at 3 months (−4.2, 95% CI: −7.2 to −1.3, p=0.005) and 6 months (−4.2, 95% CI: −7.1 to −1.2, p=0.006). Adverse events were mild and self-limiting. Conclusions Acupuncture significantly reduces CRF in BCS with effect sizes exceeding minimal clinically important differences for both CFQ14/11 and FSS. Treatment is safe with only mild, transient adverse events. Trial registration ClinicalTrials.gov Identifier: NCT04418115.

INTRODUCTION:Functional constipation (FC) is prevalent among children and often persists despite standard pharmacological treatment with oral laxatives. Many parents turn to complementary therapies, including acupuncture, which has been shown to relieve symptoms in adults with FC. However, studies in children with FC are scarce and have important limitations. This study will evaluate the feasibility, safety and potential efficacy of acupuncture for children with FC. METHODS AND ANALYSIS:Prospective, non-randomised, open-label pilot study in children with FC (6-18 years). Participants will undergo eight acupuncture sessions over 10 weeks. Concurrent pharmacological treatment with polyethylene glycol (≥0.2 g/kg/day) will continue as initiated prior to enrolment. The primary endpoint is feasibility, defined by an attrition rate of ≥70%. Secondary feasibility endpoints include consent rate, patient/parent satisfaction and personnel requirements. Safety will be assessed by systematic monitoring of adverse events. Efficacy endpoints include treatment success, defined as no longer meeting the Rome IV criteria for FC at the end of the intervention period, as well as defecation frequency, stool consistency, painful defecation, faecal incontinence frequency, abdominal pain, medication use and quality of life, based on a previously published core outcome set. ETHICS AND DISSEMINATION:Ethical approval was provided by the Medical Ethics Committee of Amsterdam UMC (Netherlands; NL87083.018.24). Results will be published in peer-reviewed journals and presented to scientific and consumer audiences. TRIAL REGISTRATION NUMBERS:NCT06836362 and NL-OMON57236.

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.

Case reports represent the earliest form of scientific literature to identify and describe adverse events (AEs) associated with medical interventions, and they still represent important educational resources for ensuring the safe practice of such interventions. Although case reports on AEs related to acupuncture continue to be published, detailed information about the acupuncture procedure is often insufficiently reported in these studies, which may introduce an overstatement or exaggeration of the harm of acupuncture. Consequently, these reports fall short of evaluating causality and achieving the educational purpose of preventing future AEs. To help address these limitations, we developed the "REporting guidelines for aCupuncture-related AdverSe Event case reports" (RECASE) based on the CARE (CAse REports) reporting guidelines for case reports using the expert Delphi methodology. This guideline contains essential items for case reports on acupuncture-related AEs. We anticipate that this reporting guideline will encourage greater transparency, fairness, and comprehensiveness in future case reports on acupuncture-related AEs.

Objective: In sham acupuncture-controlled acupuncture clinical trials, although sham acupuncture techniques are different from those of verum acupuncture, the same acupuncture points are often used for verum and sham acupuncture, raising the question of whether sham acupuncture is an appropriate placebo. We aimed to examine the effects of sham and verum acupuncture according to the points needled (same or different between verum and sham acupuncture) in knee osteoarthritis. Methods: Ten databases were searched to find randomized controlled clinical trials (RCTs) assessing the effects of verum acupuncture with sham acupuncture or waiting lists on knee osteoarthritis. Sham acupuncture was classified as using the same acupuncture points as those in verum acupuncture (SATV) or using sham points (SATS). A frequentist network meta-analysis (NMA) was conducted, and the certainty of evidence was evaluated. Results: A total of 10 RCTs involving 1628 participants were included. Verum acupuncture was significantly superior to SATS but not different from SATV in terms of pain reduction. Additionally, SATV was significantly superior to the waiting list. For physical function, no difference were found between verum acupuncture, SATV, and SATS. The certainty of evidence was low to moderate. Conclusion: For knee osteoarthritis, the pain reduction effect of acupuncture may differ according to the needling points of sham acupuncture, and the control group should be established according to the specific aim of the study design and treatment mechanism.

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.

Perspectives on Integrative Medicine (Perspect Integr Med: PIM) is the official, open access journal of Jaseng Medical Foundation, a non-profit medical organization dedicated to academic research and philanthropy. The journal is a triannual, peer-reviewed publication of high-quality academic, pre-clinical, and clinical research on complementary and integrative medicine and related therapies.

Introduction Fatigue is a common symptom observed in post-cancer treatment, yet its underlying mechanisms remain poorly understood. Acupuncture has been employed to alleviate cancer-related fatigue (CRF); however, its effectiveness in addressing associated comorbidities that may influence fatigue is also poorly understood. This study represents the first investigation to use acupuncture as an intervention for fatigue in breast cancer survivors within a Norwegian cohort. The study will employ questionnaires to evaluate various facets of fatigue. As a pragmatic trial, it statistically assesses its clinical relevance, documents adverse events and evaluates the cost-effectiveness of the acupuncture treatment.Methods and analysis This assessor-blinded, pragmatic, randomised, mixed method, controlled trial with two parallel arms aims to evaluate the effectiveness, safety and cost-effectiveness of acupuncture. It will recruit 250 participants presented with CRF for 6 months or longer. Patients will be randomly allocated either to acupuncture and usual care (n=125) or to usual care alone (n=125). Acupuncture treatments (12 in total) are to be given within 12 weeks. The statistician who will analyse the data will be blinded to group allocation. The primary outcome will be changes in CRF measured by the Chalder fatigue scale. Measurements will be taken 12 weeks and 6 months after randomisation. The secondary outcomes include patient-reported outcomes of pain, anxiety, depression, hot flashes, insomnia and sleepiness. Health-related quality of life and economic evaluation will also be conducted 12 weeks and 6 months after randomisation. Nested within this randomised controlled trial are two qualitative studies and one sub-study measuring biomarkers (C-reactive protein, interleukin (IL)-1, IL-6, tumour necrosis factor alpha (TNF-α) and aPL in addition to the current genotype genes TNF-308 and IL-6–174) from blood samples (n=80). Such biomarkers can potentially address changes in CRF.Ethics and dissemination Ethical approval of this study has been granted by the Regional Committees for Medical and Health Research Ethics (REC southeast ID number: 112285). Written informed consent will be obtained from all participants. The outcomes of the trial will be disseminated through peer-reviewed publications.Trial registration number NCT04418115.

Various acupuncture clinical trials have been conducted on migraine; however, the conclusions remain controversial especially when acupuncture was compared with sham acupuncture. Sham acupuncture is sometimes performed at the same acupuncture points used for verum acupuncture despite the evidence on acupuncture point specificity. Four databases were searched for sham acupuncture or waiting list-controlled acupuncture trials for migraine on December 25, 2023. Sham acupuncture was classified according to the needling points: sham acupuncture therapy at verum points (SATV) or at sham points (SATS). Network meta-analysis was performed based on the frequentist framework for headache pain intensity and response rate. A total of 18 studies involving 1936 participants were analyzed. Headache pain intensity and response rate were significantly improved in verum acupuncture compared with SATS. However, there was no significant difference between SATV and verum acupuncture. When comparing SATS and SATV, there was no significant difference in headache pain intensity and response rate; however, the results were in favor of SATV. The effect of the risk of bias on the certainty of evidence between verum and sham acupunctures was judged to be generally low. SATV should not be misused as a placebo control to evaluate the efficacy of acupuncture.

Journal Article Methods matters: comments on the currently published article in Pain Medicine, “Effect of sham acupuncture on chronic pain: a Bayesian network meta-analysis” Get access Tae-Hun Kim, KMD, PhD, Tae-Hun Kim, KMD, PhD Korean Medicine Clinical Trial Center, Korean Medicine Hospital, Kyung Hee University, Seoul 02447, Republic of Korea https://orcid.org/0000-0002-8448-3219 Search for other works by this author on: Oxford Academic PubMed Google Scholar Myeong Soo Lee, PhD, Myeong Soo Lee, PhD KM Science Research Division, Korea Institute of Oriental Medicine, Daejeon 34054, Republic of Korea https://orcid.org/0000-0001-6651-7641 Search for other works by this author on: Oxford Academic PubMed Google Scholar Boram Lee, KMD, PhD, Boram Lee, KMD, PhD KM Science Research Division, Korea Institute of Oriental Medicine, Daejeon 34054, Republic of Korea Search for other works by this author on: Oxford Academic PubMed Google Scholar Stephen Birch, PhD, Stephen Birch, PhD School of Health Sciences, Kristiania University College, Oslo 0107, Norway Corresponding author: Stephen Birch, PhD, School of Health Sciences, Kristiania University College, Oslo 0107, Norway. Email: sjbirch@gmail.com Search for other works by this author on: Oxford Academic PubMed Google Scholar Terje Alraek, PhD Terje Alraek, PhD School of Health Sciences, Kristiania University College, Oslo 0107, NorwayNAFKAM, National Research Center in Complementary and Alternative Medicine, Department of Community Medicine, Faculty of Medicine, UiT The Arctic University of Norway, Tromso 9037, Norway Search for other works by this author on: Oxford Academic PubMed Google Scholar Pain Medicine, Volume 24, Issue 4, April 2023, Pages 468–469, https://doi.org/10.1093/pm/pnad023 Published: 03 March 2023 Article history Received: 13 September 2022 Revision received: 17 February 2023 Accepted: 17 February 2023 Published: 03 March 2023 Corrected and typeset: 14 March 2023

Introduction: Case reports on acupuncture-related adverse events (AEs) have been consistently published in the literature. This review aims to assess the current publication status of case reports on acupuncture-related AEs and evaluate their reporting quality in order to identify areas for improvement. Methods: This study is a systematic review (SR) of case reports. Studies describing cases for acupuncture-related AEs between 2010 and 2023 (until July) were searched in PubMed, Embase, and local databases (China and Korea), as well as by hand-searching references included in published relevant SRs. A bibliometric analysis was conducted to examine the publication trends of the included literature. The appropriateness of the acupuncture described in the cases, the causality assessment between AEs and acupuncture treatment, and the presence of necessary items from the CAse REport guidelines (CARE) checklist were narratively analyzed. Results: A total of 169 case reports were included in this review. Over the past decade, an average of 12 case reports on acupuncture-related AEs were published annually. However, only 38.2% of the articles provided sufficient information to determine the appropriateness of the acupuncture treatment used in the reported cases, and considerable numbers of the included case reports did not suggest enough information for the assessment of a causal relationship. The majority of cases did not report the timeline (n = 164), patient perspectives (n = 157), and informed consent (n = 121) items from the CARE checklist. Discussion: Acupuncture-related AEs persist in being frequently reported in the literature. Nonetheless, the information concerning acupuncture and causality assessment within these publications is still found to be insufficient. The development of reporting guidelines for future case reports on acupuncture-related AEs is anticipated to promote an academic environment conducive to more comprehensive reporting.

Objectives Although many trials have assessed the effect of acupuncture on knee osteoarthritis (KOA), its efficacy remains controversial. Sham acupuncture techniques are regarded as representative control interventions in acupuncture trials and sometimes incorporate the use of sham devices (base units) to support a non-penetrating needle. To achieve successful blinding, these trials also use acupuncture base units in the verum acupuncture group. Base units are not used in real-world clinical settings. We aimed to assess the effect sizes of verum and sham acupuncture for KOA in sham-controlled trials with or without base units. Methods A total of 10 electronic databases for randomized controlled trials (RCTs) comparing the efficacy of verum manual acupuncture and sham acupuncture for the treatment of KOA were searched for articles published before April 12, 2022. The primary outcome was pain intensity, and the secondary outcomes included physical function. The first assessment after the end of treatment was chosen for analysis. Effect sizes are reported as standardized mean differences (SMDs) with 95% confidence intervals (95% CIs). The risk of bias was assessed using the Cochrane risk of bias tool, and publication bias was evaluated using a funnel plot and Egger’s test. The quality of evidence for estimates was evaluated using the Grading of Recommendations, Assessment, Development, and Evaluations (GRADE) approach. Results Fifteen RCTs were included. There was generally a low risk of bias except for the difficulty in blinding acupuncture therapists (performance bias). Compared to verum acupuncture in sham-controlled trials using base units, verum acupuncture in sham-controlled trials without base units was more effective for improving pain (SMD −0.56, 95% CI −1.09 to −0.03) and function (SMD −0.73, 95% CI −1.36 to −0.10) in KOA. The quality of evidence for network estimates was moderate to low due to the risk of bias and imprecision. Conclusion These findings suggest that verum acupuncture in different types of sham-controlled trials has different effect sizes for KOA. Because base units are not used in clinical settings, the results of verum acupuncture in sham-controlled trials with base units need to be interpreted carefully. Systematic review registration https://www.researchregistry.com/browse-the-registry#registryofsystematicreviewsmeta-analyses/registryofsystematicreviewsmeta-analysesdetails/6269f962606c5e001fd8790c/ , identifier reviewregistry1351.