Effect of acupuncture on IVF-related anxiety: a systematic review and meta-analysis.

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.

Acupuncture Augmentation of Lidocaine for Provoked, Localized Vulvodynia: A Feasibility and Acceptability Study.

OBJECTIVE: 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). MATERIALS AND METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

The State of 21st Century Acupuncture in the United States.

The term "acupuncture" commonly refers to a non-pharmacologic therapy that is increasingly employed by diverse segments of the population for a wide variety of complaints including pain, insomnia, anxiety, depression, frozen shoulder, and other issues. The term is also used as a short-hand for the wider medical system from which the placement of needles into the skin for therapeutic benefit and related techniques evolved. Thus "acupuncture" refers both to the therapeutic technique and the therapeutic system of Acupuncture and Herbal Medicine (AHM). The other modalities included within AHM include a wide variety of physical and mechanical manipulations, herbal medicines, dietary recommendations, and lifestyle modifications. Clinically, acupuncture is increasingly offered in a variety of conventional medical settings such as hospitals, medical school clinics, veterans' healthcare centers, oncology facilities, and rehabilitation centers, and its safety profile is excellent overall. Barriers to further incorporation of acupuncture into biomedical sites include insurance coverage of acupuncture, education of conventional medical practitioners and other stakeholders about the utility, efficacy, and evidence base of acupuncture. Acupuncturists in the United States are skilled practitioners who are highly educated in the complex therapeutic system from which acupuncture arose and in the technical aspects of its utility as a treatment modality. The training, certification, licensure, and regulation of acupuncturists is similar to that of conventional providers such has physician's assistants, advanced practice nurses, and medical and osteopathic doctors. While clinical use and acceptance of acupuncture continues to grow, there is to date no definitive composite document explaining the utility of acupuncture in various healthcare settings, the current understanding of how acupuncture works, and the training, professional regulation, and certification of acupuncture practitioners. This article will address these topics and strive to create a reference for practitioners, administrators, legislators, insurance providers, patients and their families, and other stakeholders.

Acupuncture refers to the placement of thin, sterile needles into the skin to stimulate healing effects, and, in the United States, it also refers to the medical system from which the technique of acupuncture evolved. That system, Acupuncture and Herbal Medicine (AHM), uses acupuncture, dietary and lifestyle advice, herbal medicines, and other therapies to facilitate health and healing. Acupuncture is increasingly being used for a wide variety of medical problems including pain, difficulty sleeping, mental health concerns, and other issues in a wide variety of settings and is supported by a growing scientific basis for understanding why and how it works. Training and licensure of acupuncturists are similar to many conventional practitioners, and the process is accredited and overseen by various governmental and regulatory bodies. This paper aims to provide an overview of the use of acupuncture in the United States, the scientific basis for acupuncture, the training and licensure of acupuncturists, and the ways in which acupuncture is and might be incorporated into conventional medical settings.

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<.05) with a mean gain of 6.5 versus a predicted gain of 3.4. 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.

SEAttle-based Research of Chinese Herbs for COVID-19 Study: A Whole Health Perspective on Chinese Herbal Medicine for Symptoms that may be Related to COVID-19.

INTRODUCTION: East Asian Medicine (EAM) is a Whole System medicine that includes Chinese herbal medicine (CHM). Chinese herbal medicine has been utilized to reduce symptom burden in infectious disease, with notable theoretical reformulations during pandemics of the 3rd, 13th, and 17th centuries. Today, Licensed Acupuncturists trained in CHM have utilized it to treat symptoms and sequelae of COVID-19. However, little is known about its use or efficacy by the public and health practitioners. Understanding and evaluating whole medicine systems of healthcare is inherently complex; there is international consensus for a descriptive, pragmatic approach. We are conducting a feasibility pilot study using a prospective, pragmatic, observational design using Whole Health and Whole Person perspectives. The complexity of COVID-19 reflects the impact on multiple homeoregulatory systems and provides a unique opportunity to assess the impact of interventions such as EAM on whole health. Observation of these EAM encounters will provide valuable qualitative and quantitative data on the interface of an extant Whole System medicine with a novel complex illness as a precursor to a randomized clinical trial. METHODS: This ongoing study observes a CHM clinic offering telehealth consultations to a diverse patient population since April, 2020. Patients who report symptoms potentially related to COVID-19 disease are consented for standardized collection and analysis of demographic and clinical data from each clinical encounter. RESULTS: To date, 61 patients engaged in 195 consultations (mean 3.3) with 49 reporting symptom resolution sufficient to complete treatment, and 4 withdrawals. Just over half (62%) were female, with an average age of 45.7 years. A wide variety of CHM formulas and EAM dietary and lifestyle modifications were provided. DISCUSSION: Adequate recruitment and retention suggest feasibility of the intervention and data collection. The rich dataset may facilitate the construction of Whole Health models of CHM's clinical impact, as well as integrative inquiry into CHM's effects on symptoms.

Paradoxes in acupuncture research: strategies for moving forward.

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.

Chinese Herbal Medicines During the Covid-19 Pandemic: A Role for Observational Studies.

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.

Overcoming Barriers in Clinical Acupuncture Research: Translating Clinical Practice into Fundamental Science.

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.

A treatment trial of acupuncture in IBS patients.

OBJECTIVES: This study aimed to compare the effects of true and sham acupuncture in relieving symptoms of irritable bowel syndrome (IBS). METHODS: A total of 230 adult IBS patients (75 % females, average age: 38.4 years) were randomly assigned to 3 weeks of true or sham acupuncture (6 treatments) after a 3-week "run-in" with sham acupuncture in an "augmented" or "limited" patient-practitioner interaction. A third arm of the study included a waitlist control group. The primary outcome was the IBS Global Improvement Scale (IBS-GIS) (range: 1 - 7); secondary outcomes included the IBS Symptom Severity Scale (IBS-SSS), the IBS Adequate Relief (IBS-AR), and the IBS Quality of Life (IBS-QOL). RESULTS: Although there was no statistically significant difference between acupuncture and sham acupuncture on the IBS-GIS (41 vs. 32 % , P = 0.25), both groups improved significantly compared with the waitlist control group (37 vs. 4 % , P = 0.001). Similarly, small differences that were not statistically significant favored acupuncture over the other three outcomes: IBS-AR(59 vs. 57 % , P = 0.83), IBS-SSS (31 vs. 21 % , P = 0.18), and IBS-QOL (17 vs. 13 % , P = 0.56). Eliminating responders during the run-in period did not substantively change the results. Side effects were generally mild and only slightly greater in the acupuncture group. CONCLUSIONS: This study did not find evidence to support the superiority of acupuncture compared with sham acupuncture in the treatment of IBS.

Experimental Studies of Inter-Rater Agreement in Traditional Chinese Medicine: A Systematic Review.

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.

Matrix Analysis of Traditional Chinese Medicine Differential Diagnoses in Gulf War Illness.

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.

Can Reliability of the Chinese Medicine Diagnostic Process Be Improved? Results of a Prospective Randomized Controlled Trial.

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.

Acupuncture for treatment of persistent arm pain due to repetitive use: a randomized controlled clinical trial.

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 4 wk) 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, predominantly 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.

Central mechanisms of real and sham electroacupuncture in the treatment of chronic low back pain: study protocol for a randomized, placebo-controlled clinical trial.

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.

Acupuncture for postmenopausal hot flashes.

OBJECTIVE: To determine whether individually tailored acupuncture is an effective treatment option for reducing postmenopausal hot flashes and improving quality of life. METHODS: In a randomized, placebo-controlled pilot study, 29 postmenopausal participants averaging at least seven moderate to severe hot flashes per 24h, with a baseline estradiol concentration of less than 50 pg/mL and a normal TSH level, were randomized to receive 7 weeks (nine treatment sessions) of either active acupuncture or placebo acupuncture (placebo needles that did not penetrate the skin at sham acupuncture points). Participants recorded hot flashes in logs that were reported daily. Global indices of the severity and frequency of hot flashes were derived from the participants' daily logs. RESULTS: Participants receiving the active treatment had a greater reduction in hot flash severity (24.5+/-30.7%) compared to those receiving placebo (4.4+/-17.1%, P=0.042). Within group repeated measures analyses of variance revealed a significant reduction in hot flash severity in the active (P=0.042), but not in the placebo treatment group (P=0.15). Although there was no significant group difference in the reduction of hot flash frequency between the active (42.4+/-32.2%) and placebo groups (32.0+/-26.5%; P>or=0.352), within group repeated measures analyses of variance revealed that the reduction was statistically significant in both groups (P

Experiences of acupuncturists in a placebo-controlled, randomized clinical trial.

BACKGROUND: This paper describes the experiences of 8 licensed acupuncturists in a placebo-controlled randomized clinical trial (RCT). This information is important to the design and conduct of high-quality trials. METHODS: We conducted a RCT (N=135) with a 2-week placebo run-in followed by 4 weeks of twice-weekly treatments comparing genuine to sham acupuncture (using the Streitberger placebo needle) in the treatment of arm pain caused by repetitive use. At the end of this study, we conducted written structured interviews with 8 participating acupuncturists. The acupuncturists were not aware of the study's results at the time of these interviews. The questions focused on their experiences in the study, adherence to study protocols, their thoughts about the technical and ethical issues involved in using a sham needling device, and their expectations of trial outcomes. The questions were motivated by expressions of concerns the acupuncturists raised in feedback groups during the course of the study, and our desire to improve further trials. RESULTS: The acupuncturists differed widely in their comfort levels with the research methods used, their adherence to the study protocol, and their expectations of trial outcomes. CONCLUSIONS: We conclude that careful monitoring of acupuncturists, including observation of treatments and frequent meetings to support them throughout the trial, is necessary to maintain a high degree of quality control.

Correlated change in upper limb function and motor cortex activation after verum and sham acupuncture in patients with chronic stroke.

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.

Sham acupuncture devices--practical advice for researchers.

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.

Integrating Acupuncture Within a Wellness Intervention for Women With Multiple Sclerosis.

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.