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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.

Duncan B, Shen K, Zou L-P, Han T-L, Lu Z-L, Zheng H, Walsh M, Venker C, Su Y, Schnyer R, Caspi O. Evaluating intense rehabilitative therapies with and without acupuncture for children with cerebral palsy: a randomized controlled trial. Objective To compare the outcomes of conventional therapies (physical, occupational, and hydrotherapies) plus acupuncture with those without acupuncture when administered intensely in the management of children with spastic cerebral palsy (CP). Design Evaluation-blind, prospective randomized controlled trial. Setting Therapies and video-recorded assessments at a children's hospital in Beijing, China, and blind scoring and data analyses at a university in the United States. Participants Children (N=75), 12 to 72 months of age, with spastic CP. Interventions Intensely administered (5 times per week for 12wk) physical therapy, occupational therapy, and hydrotherapy either with acupuncture (group 1) or without acupuncture (group 2). To satisfy standard of care, group 2 subsequently received acupuncture (weeks 16–28). Main Outcome Measures The Gross Motor Function Measure (GMFM)-66 and the Pediatric Evaluation of Disability Inventory (PEDI) assessments at 0, 4, 8, 12, 16, and 28 weeks. Results At the end of 12 weeks, there was no statistically significant difference between the 2 groups, but when group 2 received acupuncture (16–28wk) there was a shift toward improvement in the GMFM-66 and the PEDI-Functional Skills Self-Care and Mobility domain. When groups were combined, statistically significant improvements after intense therapies occurred from baseline to 12 weeks for each outcome measure at each Gross Motor Function Classification System (GMFCS) level. After adjusting for expected normative maturational gains based on age, the GMFM gains for children with GMFCS II level was statistically significant ( P Conclusions Intense early administered rehabilitation improves function in children with spastic CP. The contribution from acupuncture was unclear. Children's response varied widely, suggesting the importance of defining clinical profiles that identify which children might benefit most. Further research should explore how this approach might apply in the U.S.

C R I a h p a m m b c c Background: There is interest from the community in the use of self-help and complementary therapies for depression. This review examined the currently available evidence supporting the use of acupuncture to treat depression. Objectives: To examine the effectiveness and adverse effects of acupuncture in the treatment for depression. Search Strategy: The following databases were searched: CCDAN-CTR, Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (1966 to Dec 2008), EMBASE (1980 to Dec 2008), PSYCINFO (1874 to Dec 2008), the Database of Abstracts of Reviews of Effectiveness (DARE), CINAHL (1980 to Dec 2008), Wan Fang database (to Dec 2008). The following terms were used: depression, depressive disorder, dysthymic disorder and acupuncture. Selection Criteria: Inclusion criteria included all published and unpublished randomized controlled trials comparing acupuncture with sham acupuncture, no treatment, pharmacological treatment, other structured psychotherapies (cognitive behavioral therapy, psychotherapy or counseling), or standard care. The follow

Very little research has been conducted in the West to evaluate the clinical efficacy of Japanese acupuncture (JA). The characteristics that define and differentiate JA from Chinese acupuncture styles add specific challenges to the operationalization of treatment protocols for use in clinical trials.To develop an ecologically valid and viable multimodal treatment intervention, including active and sham protocols, for use in a pilot randomized sham-controlled trial of a style of JA in treating endometriosis-related chronic pelvic pain in adolescents and young women.A focus group format was used to systematize the diagnostic framework, operationalize the intake, design the treatment protocols, and develop a viable and effective sham acupuncture intervention using the Streitberger device and sham moxibustion. Implementation of the treatment protocol employed the manualization process to provide flexibility of treatment while assuring replicability and standardization.The Japanese Acupuncture Department at the New England School of Acupuncture in Newton, MA.Completed study visit forms indicated good compliance of study practitioners with active and sham treatment protocols. The specific JA protocols used in our pilot study were well tolerated by the adolescent girls who participated in the trial. No serious adverse events were reported by any participants. Our protocols were successful in maintaining patient blinding and minimizing differences in outcome expectations between treatment groups.Manualization provided a viable method for conforming to the interactive nature of JA treatments, yet facilitated compliance with a replicable treatment protocol. Sham controls of complex, multicomponent JA interventions pose unique challenges. The modified Streitberger needle in conjunction with sham moxibustion showed promise as a viable control in clinical trails of JA; both components of this sham protocol require further validation.

Several validated sham acupuncture devices have recently become available. While some debate exists on whether such needles are the best placebo control for an RCT of acupuncture, practical advice based on research experience is missing from the literature. This paper shares our concrete experience using the most commonly used such sham needle (the ‘Streitberger needle’ and its paired verum needle) in a large RCT (n=135) which included a two-week run-in period. The placebo run-in gave us an opportunity to use the sham device on all participants, who were then re-randomised to receive genuine acupuncture or to continue treatment with the device. The blinding was successful both at the end of the run-in and at the conclusion of the trial despite the re-randomisation. We also report our experience with the sham needle in neuroimaging experiments where the magnetic machinery poses considerable challenges for acupuncture research.

Background: Acupuncture may improve motor function in patients with chronic hemiparetic stroke, yet the neural mechanisms underlying such an effect are unknown. As part of a sham-controlled, randomized clinical trial testing the efficacy of a 10-week acupuncture protocol in patients with chronic hemiparetic stroke, we examined the relationship between changes in function of the affected upper limb and brain activation using functional magnetic resonance imaging (fMRI). Methods: Seven (7) chronic hemiparetic stroke patients underwent fMRI and testing of function of the affected upper limb (spasticity and range-of-motion) before and after a 10-week period of verum (N � 4) or sham (N � 3) acupuncture. The correlation between changes in function of the affected upper limb and brain activation after treatment was tested across patients. Results: We found a significant positive correlation between changes in function of the affected upper limb (spasticity and range of motion) and activation in a region of the ipsilesional motor cortex. Patients treated with verum acupuncture showed a trend toward a greater maximum activation change in this motor cortical area as compared to those treated with sham acupuncture. Conclusions: Acupuncture may improve function of the affected upper limb in chronic hemiparetic stroke patients by increasing activity in the ipsilesional motor cortex.

Wayne PM, Krebs DE, Macklin EA, Schnyer R, Kaptchuk TJ, Parker SW, Scarborough DM, McGibbon CA, Schaechter JD, Stein J, Stason WB. Acupuncture for upper-extremity rehabilitation in chronic stroke: a randomized sham-controlled study. Objective To compare the effects of traditional Chinese acupuncture with sham acupuncture on upper-extremity (UE) function and quality of life (QOL) in patients with chronic hemiparesis from stroke. Design A prospective, sham-controlled, randomized controlled trial (RCT). Setting Patients recruited through a hospital stroke rehabilitation program. Participants Thirty-three subjects who incurred a stroke 0.8 to 24 years previously and had moderate to severe UE functional impairment. Interventions Active acupuncture tailored to traditional Chinese medicine diagnoses, including electroacupuncture, or sham acupuncture. Up to 20 treatment sessions (mean, 16.9) over a mean of 10.5 weeks. Main Outcome Measures UE motor function, spasticity, grip strength, range of motion (ROM), activities of daily living, QOL, and mood. All outcomes were measured at baseline and after treatment. Results Intention-to-treat (ITT) analyses found no statistically significant differences in outcomes between active and sham acupuncture groups. Analyses of protocol-compliant subjects revealed significant improvement in wrist spasticity ( P P P P =.09) and digit ROM ( P =.06). Conclusions Based on ITT analyses, we conclude that acupuncture does not improve UE function or QOL in patients with chronic stroke symptoms. However, gains in UE function observed in protocol-compliant subjects suggest traditional Chinese acupuncture may help patients with chronic stroke symptoms. These results must be interpreted cautiously because of small sample sizes and multiple, unadjusted, post hoc comparisons. A larger, more definitive RCT using a similar design is feasible and warranted.

Few medically acceptable treatments for depression during pregnancy are available. The aim of this randomized controlled pilot study was to determine whether acupuncture holds promise as a treatment for depression during pregnancy.Sixty-one pregnant women with major depressive disorder and a 17-item Hamilton Rating Scale for Depression (HRSD17) scoreor=14 were randomly assigned to one of three treatments, delivered over 8 weeks: an active acupuncture (SPEC, N=20), an active control acupuncture (NSPEC, N=21), and massage (MSSG, N=20). Acupuncture treatments were standardized, but individually tailored, and were provided in a double-blind fashion. Responders to acute phase treatment (HRSD17 score14 andor=50% reduction from baseline) continued the treatment they were initially randomized to until 10 weeks postpartum.Response rates at the end of the acute phase were statistically significantly higher for SPEC (69%) than for MSSG (32%), with an intermediate NSPEC response rate (47%). The SPEC group also exhibited a significantly higher average rate of reduction in BDI scores from baseline to the end of the first month of treatment than the MSSG group. Responders to the acute phase of all treatments combined had significantly lower depression scores at 10 weeks postpartum than nonresponders.Generalizability is limited by the small sample and its relative homogeneity.Acupuncture holds promise for the treatment of depression during pregnancy.

Severe depression is common during pregnancy. It is associated with more negative pregnancy outcome and is a risk factor for postpartum depression. Treatment options available for depressed women during pregnancy are limited. Preliminary data suggest acupuncture as an effective treatment for depression. This article presents a systematic and standardized approach to acupuncture treatment, and its implementation is demonstrated using two case reports selected from a larger pool of participants in an ongoing study testingthe efficacy of acupuncture in treating depression during pregnancy. Baseline characteristics and outcome are presented from the integrated perspective of Western psychiatry and Chinese medicine.

Objective To estimate the efficacy of acupuncture for depression during pregnancy in a randomized controlled trial. Methods A total of 150 pregnant women who met Diagnostic and Statistical Manual of Mental Disorders (Fourth Edition) criteria for major depressive disorder were randomized to receive either acupuncture specific for depression or one of two active controls: control acupuncture or massage. Treatments lasted 8 weeks (12 sessions). Junior acupuncturists, who were not told about treatment assignment, needled participants at points prescribed by senior acupuncturists. All treatments were standardized. The primary outcome was the Hamilton Rating Scale for Depression, administered by masked raters at baseline and after 4 and 8 weeks of treatment. Continuous data were analyzed using mixed effects models and by intent to treat. Results Fifty-two women were randomized to acupuncture specific for depression, 49 to control acupuncture, and 49 to massage. Women who received acupuncture specific for depression experienced a greater rate of decrease in symptom severity (P Conclusion The short acupuncture protocol demonstrated symptom reduction and a response rate comparable to those observed in standard depression treatments of similar length and could be a viable treatment option for depression during pregnancy. CLINICAL TRIAL REGISTRATION: Clinicaltrials.gov , www.clinicaltrials.gov , NCT00186654.

The effectiveness of acupuncture as a treatment for major depression was examined in 38 women, randomly assigned to one of three treatment groups. Specific treatment involved acupuncture treatments for symptoms of depression; nonspecific treatment involved acupuncture for symptoms that were not clearly part of depression; a wait-list condition involved waiting without treatment for 8 weeks. The nonspecific and wait-list conditions were followed by specific treatment. Five women terminated treatment prematurely, 4 prior to the completion of the first 8 weeks. Following treatments specifically designed to address depression, 64% of the women ( n = 33) experienced full remission. A comparison of the acute effect of the three 8-week treatment conditions ( n = 34) showed that patients receiving specific acupuncture treatments improved significantly more than those receiving the placebo-like nonspecific acupuncture treatments, and marginally more than those in the wait-list condition. Results from this small sample suggest that acupuncture can provide significant symptom relief in depression, at rates comparable to those of psychotherapy or pharmacotherapy. Acupuncture may hold sufficient promise to warrant a larger scale clinical trial.

Terminally ill patients experience negative symptoms at end of life (EOL) that hinder well-being and quality of life (QOL). Current intervention strategies are not always effective or feasible. A focused literature review to evaluate the use of biofield therapies (ie, Therapeutic Touch, Healing Touch, and Reiki) to manage the symptoms in EOL revealed no studies on the use these therapies, specifically in this population. Evidence from studies on relevant populations (patients with cancer, elderly patients, and patients experiencing chronic pain), which addressed the outcomes relevant to palliative and EOL care (EOLC; pain levels, changes in psychological symptoms, well-being, and QOL), supports the use of biofield therapies in relieving pain, improving QOL and well-being, and reducing psychological symptoms of stress. Further research to assess the use of biofield therapies in EOLC is clearly needed.

Background: There is a need for more Comparative Effectiveness Research (CER) on Chinese medicine (CM) to inform clinical and policy decision-making. This document aims to provide consensus advice for the design of CER trials on CM for researchers. It broadly aims to ensure more adequate design and optimal use of resources in generating evidence for CM to inform stakeholder decision-making. Methods: The Effectiveness Guidance Document (EGD) development was based on multiple consensus procedures (survey, written Delphi rounds, interactive consensus workshop, international expert review). To balance aspects of internal and external validity, multiple stakeholders, including patients, clinicians, researchers and payers were involved in creating this document. Results: Recommendations were developed for “using available data” and “future clinical studies”. The recommendations for future trials focus on randomized trials and cover the following areas: designing CER studies, treatments, expertise and setting, outcomes, study design and statistical analyses, economic evaluation, and publication. Conclusion: The present EGD provides the first systematic methodological guidance for future CER trials on CM and can be applied to single or multi-component treatments. While CONSORT statements provide guidelines for reporting studies, EGDs provide recommendations for the design of future studies and can contribute to a more strategic use of limited research resources, as well as greater consistency in trial design.

Background. Achieving reproducibility in research design is challenging when patient cohorts under study are inconsistently defined. Traditional Chinese medicine (TCM) diagnosis is one example where inconsistency between practitioners has been found. We hypothesise that the use of a validated instrument may improve consistency. Biochemical biomarkers may also be used enhance reliability.Methods. Twenty-seven participants with prediabetes were assessed by two TCM practitioners using a validated instrument (TEAMSI-TCM). Inter-rater reliability was summarised using percentage agreement and the kappa coefficient. One-way ANOVA and Tukey’s post hoc test were used to test links between TCM diagnosis and biomarkers.Results. The two practitioners agreed on primary diagnosis of 70% of participants. kappa = 0.56 (P<0.001). The three predominant TCM diagnostic patterns for people with prediabetes were Yin deficiency, Qi and Yin deficiency and Spleen qi deficiency. The Spleen Qi deficiency with Damp cohort had statistically significant higher fasting glucose, higher insulin, higher insulin resistance, higher HbA1c and lower HDL than those with Qi and Yin deficiency.Conclusions. Using the TEAMSI-TCM resulted in moderate interrater reliability between TCM practitioners. This study provides initial evidence of variation in the biomarkers of people with prediabetes according to the different TCM patterns which may suggest a route to further improving interrater reliability.

We discuss the emerging translational tools for the study of acupuncture analgesia with a focus on psychophysical methods. The gap between animal mechanistic studies and human clinical trials of acupuncture analgesia calls for effective translational tools that bridge neurophysiological data with meaningful clinical outcomes. Temporal summation (TS) and conditioned pain modulation (CPM) are two promising tools yet to be widely utilized. These psychophysical measures capture the state of the ascending facilitation and the descending inhibition of nociceptive transmission, respectively. We review the basic concepts and current methodologies underlying these measures in clinical pain research, and illustrate their application to research on acupuncture analgesia. Finally, we highlight the strengths and limitations of these research methods and make recommendations on future directions. The appropriate addition of TS and CPM to our current research armamentarium will facilitate our efforts to elucidate the central analgesic mechanisms of acupuncture in clinical populations.

While increasing numbers of patients are seeking acupuncture treatment for depression in recent years, there is limited evidence of the antidepressant (AD) effectiveness of acupuncture. Given the unsatisfactory response rates of many Food and Drug Administration- approved ADs, research on acupuncture remains of potential value. Therefore, we sought to review the efficacy and safety of acupuncture treatment for depression in clinical applications. We conducted a PubMed search for publications through 2011. We assessed the adequacy of each report and abstracted information on reported effectiveness or efficacy of acupuncture as monotherapy for major depressive disorder (MDD) and as augmentation of ADs. We also examined adverse events associated with acupuncture, and evidence for acupuncture as a means of reducing side effects of ADs. Published data suggest that acupuncture, including manual-, electrical-, and laser-based, is a generally beneficial, well-tolerated, and safe monotherapy for depression. However, acupuncture augmentation in AD partial responders and nonresponders is not as well studied as monotherapy; and available studies have only investigated MDD, but not other depressive spectrum disorders. Manual acupuncture reduced side effects of ADs in MDD. We found no data on depressive recurrence rates after recovery with acupuncture treatment. Acupuncture is a potential effective monotherapy for depression, and a safe, well-tolerated augmentation in AD partial responders and nonresponders. However, the body of evidence based on well-designed studies is limited, and further investigation is called for.

Introduction It can be challenging to study complex and novel health states within the parameters of a RCT. This report describes the use of an unblinded Phase II Clinical Trial design to investigate the effectiveness of acupuncture in the treatment of Gulf War Illness (GWI). GWI is a complex illness found among veterans of the first Gulf War, and is characterized by multiple symptoms, including fatigue, sleep and mood disturbances, cognitive dysfunction, and musculoskeletal pain. No published trials of acupuncture for the treatment of GWI exist. This trial is designed to both answer questions of the effectiveness of acupuncture for our entire sample, as well as subgroups with of individual presentations of GWI. Materials and methods Our primary outcome is quality of life as measured by the SF-36. In an effort to better understand this complex disease and its treatment, our multi-level measurement plan examines psychosocial variables, fatigue, sleep quality, pain, and biomarkers of inflammation and immune status. All of the measurement instruments used in this trial show good validity and reliability. Results This study is ongoing and clinical results are not available. We have achieved good feasibility of our recruitment, treatment, and data collection procedures. Conclusions Low constraint RCT designs are an appropriate choice when investigating conditions in which the causes and mechanisms of disease are poorly understood. This naturalistic RCT includes individualized protocols, a clinically supported length and dose of treatment, a wait list control arm, and the ethical benefit that all subjects receive treatment during the study.

In November 2007, the Society for Acupuncture Research (SAR) held an international symposium to mark the 10th anniversary of the 1997 NIH Consensus Development Conference on Acupuncture. The symposium presentations revealed the considerable maturation of the field of acupuncture research, yet two provocative paradoxes emerged. First, a number of well-designed clinical trials have reported that true acupuncture is superior to usual care, but does not significantly outperform sham acupuncture, findings apparently at odds with traditional theories regarding acupuncture point specificity. Second, although many studies using animal and human experimental models have reported physiological effects that vary as a function of needling parameters (e.g., mode of stimulation) the extent to which these parameters influence therapeutic outcomes in clinical trials is unclear. This White Paper, collaboratively written by the SAR Board of Directors, identifies gaps in knowledge underlying the paradoxes and proposes strategies for their resolution through translational research. We recommend that acupuncture treatments should be studied (1) “top down” as multi-component “whole-system” interventions and (2) “bottom up” as mechanistic studies that focus on understanding how individual treatment components interact and translate into clinical and physiological outcomes. Such a strategy, incorporating considerations of efficacy, effectiveness and qualitative measures, will strengthen the evidence base for such complex interventions as acupuncture.

SUMMARY. Conventional treatments for Major Depression, although reasonably effective, leave many without lasting relief. Alternative approaches would therefore be welcome for both short- and long-term treatment of depression. Thirty-eight women were randomized to one of three treatment conditions in a double-blind randomized controlled trial of acupuncture in depression. 1 All participants eventually received eight weeks of acupuncture treatment specifically for depression. From among the 33 women who completed treatment, 26 (79%) were interviewed at six-month follow-up. Relapse rates were comparable to those of established treatments, with four of the 17 women (24%) who achieved full remission at the conclusion of treatment experiencing a relapse six months later. Compared to other empirically validated treatments, acupuncture designed specifically to treat major depression produces results that are comparable in terms of rates of response and of relapse or recurrence. These results suggest a larger trial of acupuncture in the acute- and maintenance-phase treatment of depression is warranted. C ∞ 2002 Elsevier Science Ltd. All rights reserved.

Peter M. Wayne: We’re going to be discussing the workshop that we held at the North American Research Conference on Complementary and Integrative Medicine (NARCCIM) in May 2009. The workshop was designed to present the findings from a Society for Acupuncture Research (SAR) board retreat, which focused on ‘‘Paradoxes in Acupuncture Research: Strategies for Moving Forward.’’ The paradoxes, in turn, had emerged during the 2007 SAR International Conference that reviewed the progress in our field in the decade since the 1997 NIH Consensus Development Conference on Acupuncture. The conference was a great success, with more than 300 attendees and support from the National Institutes of Health (NIH), conventional medical schools, schools of acupuncture and Oriental medicine, and a variety of other national and international organizations. The conference concluded that the field of acupuncture research had made great progress since 1997. Many rigorous phase II and III randomized controlled trials were completed for acupuncture treatment of a wide variety of medical conditions, and some very strong basic research was performed with state-of-the-art tools to examine biochemical and physiologic correlates of acupuncture. Important progress was also made with respect to control procedures and other aspects of clinical research design. Summaries of the conference have been published in the Journal of Alternative and Complementary Medicine. But in putting together this work, we identified two paradoxes. Paradox One is that an increasing number of large clinical trials have reported that true acupuncture does not significantly outperform sham acupuncture, a finding apparently at odds with traditional theories regarding acupuncture point specificity and needling techniques. Paradox Two is that while many studies with animal and human experimental models have reported physiologic effects that vary as a function of needling parameters, the extent to which these parameters influence therapeutic outcomes in clinical trials is unclear. As the SAR board prepared a White Paper to highlight these paradoxes and discuss research directions to resolve them, the opportunity arose to present our thinking at the NARCCIM conference. Richard Hammerschlag: That gives us a good sense of where we’re at: How we came to focus on these paradoxes, our work in clarifying them, and the research we’re proposing as necessary to resolve them. Regarding the first paradox, many people, and especially practitioners, were quite disturbed after the 2007 SAR Conference by the conclusion, especially on the basis of the largescale German trials that were presented, that it either doesn’t matter where we place acupuncture needles or that something is amiss with the research design of such studies. As researchers, we need to be open to exploring both possibilities. For me, the question with regard to this paradox is twofold. First, sham needling is not inert and appears to produce a level of benefit that is procedure related. Second, inclusion of a sham-treatment arm in a randomized controlled trial may reduce the level of effectiveness of the active-treatment arm (by reducing patient expectancy of receiving an effective treatment from 100% to 50%). My concern is that by utilizing a control procedure that has treatment benefit and by following a research design that may decrease the effectiveness of a verum or active treatment, we’re generating type II errors and getting false-negative results. For example, sham needling—especially if it’s invasive—may induce microtrauma through local physiologic changes in microcirculation or cytokines that promote healing in the body. A recent review indicates that in acupuncture trials that have had both a sham arm and a nontreatment arm in addition to the active-treatment arm, the difference between the sham and nontreatment arms seems to have been greater than that between the placebo and nontreatment arms in conventional pharmaceutical trials. So this again raises a possibility that sham treatment is not inert, and that some

Study Objective To assess feasibility, and collect preliminary data for a subsequent randomized, sham-controlled trial to evaluate Japanese-style acupuncture for reducing chronic pelvic pain and improving health-related quality of life (HRQOL) in adolescents with endometriosis. Design Randomized, sham-controlled trial. Settings Tertiary-referral hospital. Participants Eighteen young women (13–22y) with laparoscopically-diagnosed endometriosis-related chronic pelvic pain. Interventions A Japanese style of acupuncture and a sham acupuncture control. Sixteen treatments were administered over 8 weeks. Main Outcome Measures Protocol feasibility, recruitment numbers, pain not associated with menses or intercourse, and multiple HRQOL instruments including Endometriosis Health Profile, Pediatric Quality of Life, Perceived Stress, and Activity Limitation. Results Fourteen participants (out of 18 randomized) completed the study per protocol. Participants in the active acupuncture group (n = 9) experienced an average 4.8 (SD = 2.4) point reduction on a 11 point scale (62%) in pain after 4 weeks, which differed significantly from the control group's (n = 5) average reduction of 1.4 (SD = 2.1) points ( P = 0.004). Reduction in pain in the active group persisted through a 6-month assessment; however, after 4 weeks, differences between the active and control group decreased and were not statistically significant. All HRQOL measures indicated greater improvements in the active acupuncture group compared to the control; however, the majority of these trends were not statistically significant. No serious adverse events were reported. Conclusion Preliminary estimates indicate that Japanese-style acupuncture may be an effective, safe, and well-tolerated adjunct therapy for endometriosis-related pelvic pain in adolescents. A more definitive trial evaluating Japanese-style acupuncture in this population is both feasible and warranted.

On November 8–9, 2007, the Society for Acupuncture Research (SAR) hosted an international conference to mark the tenth anniversary of the landmark National Institutes of Health Consensus Development Conference on Acupuncture. More than 300 acupuncture researchers, practitioners, students, funding agency personnel, and health policy analysts from 20 countries attended the SAR meeting held at the University of Maryland School of Medicine, Baltimore, MD. This paper summarizes important invited lectures in the area of clinical research. Specifically, included are: a review of the recently conducted German trials and observational studies on low-back pain (LBP), gonarthrosis, migraine, and tension-type headache (the Acupuncture Research Trials and the German Acupuncture Trials, plus observational studies); a systematic review of acupuncture treatment for knee osteoarthritis (OA); and an overview of acupuncture trials in neurologic conditions, LBP, women's health, psychiatric disorders, and functional bowel disorders. A summary of the use of acupuncture in cancer care is also provided. Researchers involved in the German trials concluded that acupuncture is effective for treating chronic pain, but the correct selection of acupuncture points seems to play a limited role; no conclusions could be drawn about the placebo aspect of acupuncture, due to the design of the studies. Overall, when compared to sham, acupuncture did not show a benefit in treating knee OA or LBP, but acupuncture was better than a wait-list control and standard of care, respectively. In women's health, acupuncture has been found to be beneficial for patients with premenstrual syndrome, dysmenorrhea, several pregnancy-related conditions, and nausea in females who have cancers. Evidence on moxibustion for breech presentation, induction of labor, and reduction of menopausal symptoms is still inconclusive. In mental health, evidence for acupuncture's efficacy in treating neurologic and functional bowel disorder is still inconclusive. For chronic cancer-related problems such as pain, acupuncture may work well in stand-alone clinics; however, for acute or treatment-related symptoms, integration of acupuncture care into a busy and complex clinical environment is unlikely, unless compelling evidence of a considerable patient benefit can be established.

Objective There is growing interest in the utility of nonpharmacologic treatments for mood symptoms, including mood elevation and depression associated with bipolar disorders. The purpose of this research was to provide preliminary data on the safety, effectiveness, and acceptability of adjunctive acupuncture in the acute treatment of hypomania and depression associated with bipolar disorder. Method Two randomized trials were conducted to assess the benefits of adjunctive acupuncture for symptoms of depression and hypomania in patients with bipolar disorder (DSM-IV criteria). For 20 patients experiencing symptoms of hypomania, targeted acupuncture (points specific to symptoms) was compared to acupuncture points off the acupuncture meridian over 12 weeks (from May 2000 through May 2003). For patients experiencing symptoms of depression (n = 26), targeted acupuncture was compared to acupuncture for nonpsychiatric health concerns over 8 weeks (from November 2001 through May 2003). Preexisting psychotropic medications were maintained at stable doses throughout study participation. Results Regardless of acupuncture assignment or symptom pattern at entry, all patients experienced improvement over the course of study participation. There was evidence that acupuncture treatment did target the symptom dimension of interest (mood elevation in Study I, depression in Study II). There were few negative side effects and no attrition directly associated with adjunctive acupuncture. Conclusions Novel methodologies are needed to assess the utility of acupuncture as adjunctive treatment of mood episodes associated with bipolar disorder. We observed similar benefits associated with "placebo" acupuncture experiences and active treatment. Further studies are warranted. TRIAL REGISTRATION (STUDY II): (ClinicalTrials.gov) Identifier: NCT00071669.

Objective: To compare true and sham acupuncture in their abilities to relieve arm pain and improve arm function in individuals with arm pain due to repetitive use. Methods: Participants with persistent arm pain (N = 123) were randomly assigned to true or sham acupuncture groups and received 8 treatments over 4 weeks. The primary outcome was intensity of pain (10-point scale) and secondary outcomes were arm symptoms, arm function, and grip strength. Outcomes were measured during treatment (at 2 and 4wk) and 1 month after treatment ended. Results: Arm pain scores improved in both groups during the treatment period, but improvements were significantly greater in the sham group than in the true acupuncture group. This difference disappeared by 1 month after treatment ended. The true acupuncture group experienced more side effects, predominately mild pain at time of treatments. Discussion: Sham acupuncture reduced arm pain more than true acupuncture during treatment, but the difference did not persist after 1 month. Mild side effects from true acupuncture may have blunted any positive treatment effects. Overall, this study did not find evidence to support the effectiveness of true acupuncture in treatment of persistent arm pain due to repetitive use.

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.