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.

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.

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.

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.

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.

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 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.

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.

Unanticipated Insights into Biomedicine from the Study of Acupuncture.

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.

Biofield therapies for symptom management in palliative and end-of-life care.

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.

Understanding central mechanisms of acupuncture analgesia using dynamic quantitative sensory testing: a review.

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.

Interrater reliability of chinese medicine diagnosis in people with prediabetes.

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.

Acupuncture for depression during pregnancy: a randomized controlled trial.

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<.05) compared with the combined controls (Cohen's d=0.39, 95% confidence interval [CI] 0.01-0.77) or control acupuncture alone (P<.05; Cohen's d=0.46, 95% CI 0.01-0.92). They also had significantly greater response rate (63.0%) than the combined controls (44.3%; P<.05; number needed to treat, 5.3; 95% CI 2.8-75.0) and control acupuncture alone (37.5%; P<.05: number needed to treat, 3.9; 95% CI 2.2-19.8). Symptom reduction and response rates did not differ significantly between controls (control acupuncture, 37.5%; massage, 50.0%). 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.