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Objectives: It has been recommended that clinical trials of Traditional Chinese Medicine (TCM) would be more ecologically valid if its characteristic mode of diagnostic reasoning were integrated into their design. In that context, however, it is also widely held that demonstrating a high level of agreement on initial TCM diagnoses is necessary for the replicability that the biomedical paradigm requires for the conclusions from such trials. Our aim was to review, summarize, and critique quantitative experimental studies of inter-rater agreement in TCM, and some of their underlying assumptions. Design: Systematic electronic searches were conducted for articles that reported a quantitative measure of inter-rater agreement across a number of rating choices based on examinations of human subjects in person by TCM practitioners, and published in English language peer-reviewed journals. Publications in languages other than English were not included, nor those appearing in other than peer-reviewed journals. Predefined categories of information were extracted from full texts by two investigators working independently. Each article was scored for methodological quality. Outcome measures: Design features across all studies and levels of inter-rater agreement across studies that reported the same type of outcome statistic were compared. Results: Twenty-one articles met inclusion criteria. Fourteen assessed inter-rater agreement on TCM diagnoses, two on diagnostic signs found upon traditional TCM examination, and five on novel rating schemes derived from TCM theory and practice. Raters were students of TCM colleges or graduates of TCM training programs with 3 or more years experience and licensure. Type of outcome statistic varied. Mean rates of pairwise agreement averaged 57% (median 65, range 19–96) across the 9 studies reporting them. Mean Cohen's kappa averaged 0.34 (median 0.34, range 0.07–0.59) across the seven studies reporting them. Meta-analysis was not possible due to variations in study design and outcome statistics. High risks of bias and confounding, and deficits in statistical reporting were common. Conclusions: With a few exceptions, the levels of agreement were low to moderate. Most studies had significant deficits of both methodology and reporting. Results overall suggest a few design features that might contribute to higher levels of agreement. These should be studied further with better experimental controls and more thorough reporting of outcomes. In addition, methods of complex systems analysis should be explored to more adequately model the relationship between clinical outcomes, and the series of diagnoses and treatments that are the norm in actual TCM practice.

Background: The diagnostic framework and clinical reasoning process of Chinese medicine are central to the practice of acupuncture and other related disciplines. There is growing interest in integrating it into clinical trials of acupuncture and Chinese herbal medicine to guide individualized treatment protocols and evaluate outcomes. Strategies that enhance diagnostic reliability may contribute to this integration. Objectives: (1) To evaluate inter-rater reliability among practitioners of Traditional Chinese Medicine (TCM) when assessing women with dysmenorrhea using a structured assessment questionnaire (Traditional East Asian Medicine Structure Interview [TEAMSI]-TCM) compared to using a TCM questionnaire from routine clinical practice, not developed for research purposes (CONTROL); and (2) To evaluate the impact of training in the use of each approach on reliability. Design: Thirty-eight acupuncturists were asked to complete assessments of 10 subjects based on the viewing of a videotape of the initial assessment interview, a picture of the tongue, and a description of the pulse. Acupuncturists were randomized into one of four groups comparing the use of two questionnaires, TEAMSI-TCM versus CONTROL, and comparing training in the use of each versus no training. Analysis: The authors used Cohen's kappa to estimate agreement on TCM diagnostic categories relevant to dysmenorrhea between 2 practitioners with respect to questionnaires and training over all 10 patients and all 10 TCM diagnostic categories. For all analyses, the authors estimated kappa values for questionnaire, training, and experience level. Analysis of variance was used to test agreement among various groupings. Results: Regardless of the questionnaire used or training, analysis of inter-rater reliability indicated overall agreement to be low among practitioners (median 0.26). Kappa varied slightly by questionnaire and training, among 38 practitioners, but the difference was not statistically significant (p = 0.227 and p = 0.126, respectively). Conclusions: A structured assessment interview instrument designed for research purposes with or without training did not significantly improve reliability of TCM diagnosis of dysmenorrhea compared to a commonly used instrument. Challenges in assessing reliability in TCM remain.

The aim of the study was to assess the feasibility and acceptability of acupuncture's augmentation of lidocaine therapy in the treatment of provoked localized vulvodynia (PLV).For 12 weeks, women with moderate to severe PLV were randomized to either 18 sessions of traditional acupuncture (TA) or non-TA (NTA). All participants applied lidocaine 5% cream 4 times daily to the vestibule. Feasibility was assessed by recruitment, enrollment, assessment completion, and blinding. Acceptability was assessed by study visit attendance and satisfaction. The primary outcome was change in tampon test scores from baseline to week 12 and follow-up at week 24.Nineteen women enrolled and 14 completed the study. Five withdrew because of lidocaine reaction (n = 2), inability to insert tampon (n = 1), starting a new medication (n = 1), or change in vulvar diagnosis (n = 1). Participants in both groups reported pain reduction for 12 weeks. There was no statistically significant difference between groups. Women in the TA group (n = 7) experienced less pain from baseline to 12 weeks (mean difference [MD] = 42.4 ± 19.4 and MD = 35.7 ± 17.8 at week 24). In the non-TA group (n = 7), women experienced a within-group MD of 28.7 ± 28.5 at 12 weeks and an MD of 36.7 ± 17.7.In this early-phase research, acupuncture augmentation of lidocaine was acceptable. The study procedures, with modifications, may be feasible for future investigation. Both acupuncture techniques showed a favorable effect; however, the contribution to pain relief is undetermined.

Patients undergoing IVF experience high levels of IVF-related state anxiety. Non-pharmacological interventions such as acupuncture may provide support, but its effect on IVF-related anxiety is unclear. This was a systematic review and meta-analysis to examine the effect of acupuncture on IVF-related state anxiety. The primary outcome was state anxiety after embryo transfer or oocyte retrieval as assessed by the State-Trait Anxiety Inventory, Hamilton Anxiety Scale, visual analogue scale or Standard Form 36. Eight trials with 2253 participants were reviewed, and 1785 participants completed an anxiety assessment. Using the random effects model, the meta-analysis found small but significant effects on state anxiety with acupuncture versus any control (standardized mean difference -0.21, 95% confidence interval -0.39 to -0.04, representing very low certainty evidence). Evidence was limited by the moderate number of included studies of an intermediate median sample size (n = 191). There was also a high risk of performance bias and substantial heterogeneity across trials. Acupuncture is a drug-free and safe treatment that may benefit those who are burdened with IVF-related anxiety, but more investigation is needed for confirmation.

Background: The translation of clinical practice into research presents unique challenges. This is especially the case in evaluating the effect of interventions in the management of chronic conditions such as pain, mental health, substance misuse, and oncology care. Chronic complex conditions might respond to different strategies at different points in time and may require an interdisciplinary approach to treatment. Objectives: To define the key barriers to the design, implementation, and evaluation of clinical trials of acupuncture that derive from a unidirectional translational research strategy. Results: Critical challenges to the design, implementation, and evaluation of clinical trials of acupuncture center around four areas: (1) insufficient early phase research, (2) suboptimal treatment protocols, (3) inadequate research questions, and 4) a narrowed assessment of outcomes. Conclusions: By promoting research priorities that reflect the complex nature of chronic illness, we can more clearly articulate research questions that better reflect clinical practice, while evaluating the impact of acupuncture in patient care. Key priorities include phase I research funding opportunities, pragmatic trials that evaluate acupuncture embedded in interprofessional teams, and the inclusion of hypothesis-driven secondary outcomes.

Editor's Note: This column continues the JACM commentary series from the Society for Acupuncture Research (SAR). The authors, Claudia Citkovitz, PhD, LAc, from NYU Langone Hospital - Brooklyn and Rosa N. Schnyer, DAOM, LAc, from the University of Texas, are both licensed East Asian Medicine (EAM) clinicians as well as researchers. The dual roles inform this commentary. As clinicians, they respect development over the centuries of strategies toward epidemics by the Chinese and are intrigued by the high use of Chinese herbal medicine to treat COVID-19 in China. As researchers, they are aware of the robust exploration of integrative strategies in China and the dearth of such interest of exploration by most agencies in the West. In their column, Citkovitz and Schnyer highlight what self-respecting clinician researchers are doing to fill the knowledge gap. They provide background on three separate data gathering initiatives that have collaborated to keep their reporting structures comparable in order to "improve clinical practice in real time": one for detailed case reports, a second via a registry, and the third an observational study that provides quantitative and qualitative data regarding clinical reasoning and patient response. At JACM, we look forward to seeing the kinds of reports these initiatives can cast on the widespread patient experience with integrative and EAM COVID-19. -John Weeks, Editor-in-Chief, JACM.

Purpose: This pilot study explored change over time in symptom management, health promotion, and quality of life following exposure to a holistic intervention combining group acupuncture with group sessions about health promotion for women with multiple sclerosis. Design: This was a pre/post nonexperimental design. Method: Fourteen women (average age 54 years) attended eight classes designed to help participants build the skills necessary to improve their health and consequently their overall quality of life. Acupuncture was provided in a group setting either immediately before or after each class. Findings: Self-reported fatigue, stress, pain, depression, anxiety, and sleep interference decreased significantly, and overall health-promoting behaviors, self-efficacy for health promotion, social functioning, and quality of life increased significantly. In addition, focus groups held with the participants indicated that they responded positively to the combination of acupuncture with an efficacy-building health promotion intervention. Conclusions: The results of this pilot study add to the growing literature demonstrating that holistic health promotion interventions may have positive benefits for people with multiple sclerosis. Delivering acupuncture to a small group of individuals attending wellness classes appears to be feasible and was generally well received by the study participants.

Editor's Note: This column takes our series from the Society for Acupuncture Research (SAR) in a new direction. Recently, the U.S. government's Center for Medicare and Medicaid Services (CMS) issued a call for public comment related to the government's exploration of inclusion of acupuncture and licensed acupuncturists in federal payment schemes. The decision of SAR's research leaders to engage with policymakers is forward thinking, especially as much dialogue and many research needs related to acupuncture and other integrative health practices and practitioners are shifting toward implementation concerns. SAR's engagement in this arena is also reflected in the organization's 2019 conference June 27–29, 2019 in Burlington, Vermont: “Acupuncture Research, Health Care Policy, & Community Health…Closing the Loop.” The author team includes the entire SAR Board, led by president-elect Jun J. Mao, MD, and current copresidents Robert T. Davis, MS, LAc, and Richard Harris, PhD. This is also a moment to congratulate Harris on his selection to the U.S. National Institutes of Health National Advisory Council on Complementary and Integrative Health.—John Weeks, Editor-in-Chief

Background Chronic low back pain (CLBP) is the most common chronic pain condition and is often resistant to conventional treatments. Acupuncture is a popular alternative for treating CLBP but its mechanisms of action remain poorly understood. Evidence suggests that pain regulatory mechanisms (particularly the ascending and secondarily the descending pain modulatory pathways) and psychological mechanisms (e.g., expectations, pain catastrophizing and self-efficacy) may be involved in the pathogenesis of CLBP and its response to treatments. We will examine these mechanisms in the treatment of CLBP by electroacupuncture (EA). Methods We present the aims and methods of a placebo-controlled, participant-blinded and assessor-blinded mechanistic study. Adult patients with CLBP will be randomized to receiving 16 sessions of real (active) or sham (placebo) EA over the course of 8 weeks. The primary pain regulatory measure for which the study was powered is temporal summation (TS), which approximates ascending pain facilitation. Conditioned pain modulation (CPM), representing a descending pain modulatory pathway, will be our secondary pain regulatory measure. The primary psychological measure is expectations of benefit, and the secondary psychological measures are pain catastrophizing and self-efficacy in managing pain. Main clinical outcomes are back pain bothersomeness on a 0–100 visual analog scale (primary), Roland Morris Disability Questionnaire (secondary), and relevant items from the National Institutes of Health (NIH) Patient-Reported Outcome Measures Information System (secondary). We hypothesize that compared to sham, real EA will lead to greater reduction in TS after 8 treatment sessions (4 weeks); and that reduction in TS (and secondarily, increase in CPM) after 8 treatment sessions will mediate reduction in back pain bothersomeness from baseline to week 10 (clinical response) to EA. We also hypothesize that the three psychological factors are moderators of clinical response. With 100 treatment completers, the study is designed to have 80% power to detect a medium-sized between-group effect (d = 0.5) on temporal summation. Discussion To the best of our knowledge, this is the first appropriately powered, placebo-controlled clinical trial evaluating mechanisms of EA in the treatment of CLBP. Trial registration ClinicalTrials.gov, NCT02503475. Registered on 15 July 15 2015. Retrospectively registered. Electronic supplementary material The online version of this article (10.1186/s13063-018-3044-2) contains supplementary material, which is available to authorized users.

Objective: To qualitatively categorize Traditional Chinese Medicine (TCM) differential diagnoses in a sample of veterans with Gulf War Illness (GWI) pre- and postacupuncture treatment. Subjects and methods: The authors randomized 104 veterans diagnosed with GWI to a 6-month acupuncture intervention that consisted of either weekly or biweekly individualized acupuncture treatments. TCM differential diagnoses were recorded at baseline and at 6 months. These TCM diagnoses were evaluated using Matrix Analysis to determine co-occurring patterns of excess, deficiency, and channel imbalances. These diagnoses were examined within and between participants to determine patterns of change and to assess stability of TCM diagnoses over time. Results: Frequencies of diagnoses of excess, deficiency, and channel patterns were tabulated. Diagnoses of excess combined with deficiency decreased from 43% at baseline to 39% of the sample at 6 months. Excess+deficiency+channel imbalances decreased from 26% to 17%, while deficiency+channel imbalances decreased from 11% to 4% over the study duration. The authors observed a trend over time of decreased numbers of individuals presenting with all three types of differential diagnosis combinations. This may suggest that fewer people were diagnosed with concurrent excess, deficiency, and channel imbalances and perhaps a lessening in the complexity of their presentation. Conclusion: This is the first published article that organizes and defines TCM differential diagnoses using Matrix Analysis; currently, there are no TCM frameworks for GWI. These findings are preliminary given the sample size and the amount of missing data at 6 months. Characterization of the TCM clinical presentation of veterans suffering from GWI may help us better understand the potential role that East Asian medicine may play in managing veterans with GWI and the design of effective acupuncture treatments based on TCM. The development of a TCM manual for treating GWI is merited.

Research into acupuncture has had ripple effects beyond the field of acupuncture. This paper identifies five exemplars to illustrate that there is tangible evidence of the way insights gleaned from acupuncture research have informed biomedical research, practice, or policy. The first exemplar documents how early research into acupuncture analgesia has expanded into neuroimaging research, broadening physiologic understanding and treatment of chronic pain. The second describes how the acupuncture needle has become a tool to enhance biomedical knowledge of connective tissue. The third exemplar, which illustrates use of a modified acupuncture needle as a sham device, focuses on emergent understanding of placebo effects and, in turn, on insights into therapeutic encounters in treatments unrelated to acupuncture. The fourth exemplar documents that two medical devices now in widespread use were inspired by acupuncture: transcutaneous electrical nerve stimulators for pain control and antinausea wrist bands. The final exemplar describes how pragmatic clinical trial designs applied in acupuncture research have informed current general interest in comparative effectiveness research. In conclusion, these exemplars of unanticipated outcomes of acupuncture research comprise an additional rationale for continued support of basic and clinical research evaluating acupuncture and other under-researched therapies.

Background: The use of acupuncture for common pediatric conditions continues to grow. Three previous overviews have summarized the research literature. Objective: The aim of this article is to provide an updated narrative review of the literature on the use of acupuncture within the pediatric population. Methods: A systematic search was performed to identify clinical trials and reviews published through July 2015. Trials were excluded if they were not: (1) acupuncture-specific; (2) limited to pediatric patients; (3) published in English. The literature was assessed and synthesized into a narrative review and commentary. Results: Seventy-one publications were identified (59 clinical trials and 12 reviews) that represented 20 conditions. Since the prior overviews, 36 new publications (33 clinical trials) were identified and represented nine countries; the top three were China, Norway, and the United States. The top five areas of research at that timepoint were autism spectrum disorder, cerebral pal...

In the field of acupuncture research there is an implicit yet unexplored assumption that the evidence on manual and electrical stimulation techniques, derived from basic science studies, clinical trials, systematic reviews, and meta-analyses, is generally interchangeable. Such interchangeability would justify a bidirectional approach to acupuncture research, where basic science studies and clinical trials each inform the other. This article examines the validity of this fundamental assumption by critically reviewing the literature and comparing manual to electrical acupuncture in basic science studies, clinical trials, and meta-analyses. The evidence from this study does not support the assumption that these techniques are interchangeable. This article also identifies endemic methodologic limitations that have impaired progress in the field. For example, basic science studies have not matched the frequency and duration of manual needle stimulation to the frequency and duration of electrical stimulation. Further, most clinical trials purporting to compare the two types of stimulation have instead tested electroacupuncture as an adjunct to manual acupuncture. The current findings reveal fundamental gaps in the understanding of the mechanisms and relative effectiveness of manual versus electrical acupuncture. Finally, future research directions are suggested to better differentiate electrical from manual simulation, and implications for clinical practice are discussed.

This pilot study explored change over time in symptom management, health promotion, and quality of life following exposure to a holistic intervention combining group acupuncture with group sessions about health promotion for women with multiple sclerosis.This was a pre/post nonexperimental design.Fourteen women (average age 54 years) attended eight classes designed to help participants build the skills necessary to improve their health and consequently their overall quality of life. Acupuncture was provided in a group setting either immediately before or after each class.Self-reported fatigue, stress, pain, depression, anxiety, and sleep interference decreased significantly, and overall health-promoting behaviors, self-efficacy for health promotion, social functioning, and quality of life increased significantly. In addition, focus groups held with the participants indicated that they responded positively to the combination of acupuncture with an efficacy-building health promotion intervention.The results of this pilot study add to the growing literature demonstrating that holistic health promotion interventions may have positive benefits for people with multiple sclerosis. Delivering acupuncture to a small group of individuals attending wellness classes appears to be feasible and was generally well received by the study participants.

BACKGROUND:Gulf War Illness is a Complex Medical Illness characterized by multiple symptoms, including fatigue, sleep and mood disturbances, cognitive dysfunction, and musculoskeletal pain affecting veterans of the first Gulf War. No standard of care treatment exists. METHODS:This pragmatic Randomized Clinical Trial tested the effects of individualized acupuncture treatments offered in extant acupuncture practices in the community; practitioners had at least 5 years of experience plus additional training provided by the study. Veterans with diagnosed symptoms of Gulf War Illness were randomized to either six months of biweekly acupuncture treatments (group 1, n = 52) or 2 months of waitlist followed by weekly acupuncture treatments (group 2, n = 52). Measurements were taken at baseline, 2, 4 and 6 months. The primary outcome is the SF-36 physical component scale score (SF-36P) and the secondary outcome is the McGill Pain scale. RESULTS:Of the 104 subjects who underwent randomization, 85 completed the protocol (82%). A clinically and statistically significant average improvement of 9.4 points (p = 0.03) in the SF-36P was observed for group 1 at month 6 compared to group 2, adjusting for baseline pain. The secondary outcome of McGill pain index produced similar results; at 6 months, group 1 was estimated to experience a reduction of approximately 3.6 points (p = 0.04) compared to group 2. CONCLUSIONS:Individualized acupuncture treatment of sufficient dose appears to offer significant relief of physical disability and pain for veterans with Gulf War Illness. This work was supported by the Office of the Assistant Secretary of Defense for Health Affairs through the Gulf War Illness Research Program under Award No. W81XWH-09-2-0064. Opinions, interpretations, conclusions and recommendations are those of the author and are not necessarily endorsed by the Department of Defense. TRIAL REGISTRATION:ClinicalTrials.gov NCT01305811.

162 Background: The popularity of acupuncture among cancer patients highlights the need for studying its effectiveness for mitigating side effects of cancer treatments. Insomnia is prevalent among cancer patients and is associated with fatigue and reduced quality of life (QOL). It is also closely linked with depression, sleep apnea, and circadian disruption. Using data form an RCT of acupuncture for insomnia among breast cancer survivors, we examined depression, apnea and circadian factors as moderators of acupuncture effectiveness. Methods: 68 breast cancer survivors (54 years, SD = 9) experiencing insomnia symptoms were randomized to receive 12 sessions of acupuncture (N = 34) or sham (N = 34; using placebo needles). Measures included the Insomnia Severity Index, Brief Fatigue Inventory, and FACT—G, obtained at baseline, mid-treatment (3 weeks), end of treatment (6 weeks), and follow-up (10 weeks). Results: Although acupuncture produced significant improvements from baseline to follow-up in insomnia symptoms, fatigue, and QOL, these improvements did not differ from sham. Compared to sham, the acupuncture produced significantly greater improvements in: 1) insomnia severity (p = 0.03) and QOL (p = 0.02) among those with greater tendency for morning chronotype; 2) fatigue (p = 0.01) among those with lower apnea risk; and 3) QOL (p < 0.001) among those with lower depression scores at baseline. Conclusions: These findings suggest that acupuncture might be more effective among certain subgroups of patients. Moderators of insomnia, fatigue, and QOL include morningness tendency, lower risk for sleep apnea and lower depression scores, respectively. Our findings on depression are in line with prior research that has found that patients with less severe depression may have a greater capacity for acupuncture response perhaps due to higher availability of serotonin. Additional research is needed to test whether acupuncture is a viable treatment option for subgroups of cancer survivors with insomnia. Clinical trial information: NCT01162018.

e20572 Background: Acupuncture is widely used by cancer patients and survivors for management of side effects. However, the empirical evidence supporting the efficacy of acupuncture for these sympt...