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Stakeholder advisory boards are recognized as an essential and useful part of patient-centered research. However, such engagement can involve exchanges of diverse individual experiences, multiple opinions, and strong feelings in the face of researchers limitations, deadlines, and agendas. Yet, little work examines how these potential tensions occur and are resolved in actual advisory board meetings. This perspective article describes and employs a communication framework for analyzing a patient advisory council (PAC) for a comparative effectiveness study on acupuncture and pain counseling for inpatients with cancer. The framework, Action-Implicative Discourse Analysis (AIDA), is an observational method that examines challenges through recorded and transcribed, naturally occurring interaction. Our analysis focused on two short excerpts from the first PAC meeting to demonstrate members navigation of advice-giving and advice-receiving-one in which advice was ultimately implemented by the study team and another in which it was deemed unfeasible. Although advice is inherent to the work of all PACs, it often emerges unannounced as negotiated moments, made up of seemingly minor conversation moves. As a recurring event, advice can and should be analyzed and discussed within PACs to improve communication and team dynamics.

PurposeStable angina is ischemic chest pain on exertion or with emotional stress. Despite guideline-directed therapy, up to 30% of patients have suboptimal pain relief. The aims of this study were to: (1) determine the feasibility and acceptability of a randomized controlled trial (RCT) of acupuncture; and (2) evaluate preliminary efficacy of acupuncture with respect to reduction of pain and increased functional status and health-related quality of life (HRQoL).MethodsParticipants with stable angina for ⩾1 month received either a standardized acupuncture protocol, twice per week for 5 weeks, or an attention control protocol. Measures included the McGill Pain Questionnaire (average pain intensity (API), pain now) and the Seattle Angina Questionnaire-7 (functional status, symptoms, and HRQoL). Feasibility was defined as ⩾80% recruitment, ⩾75% retention following enrollment, and ⩾80% completion. Descriptive statistics and mixed-effects linear regression were used for analysis.ResultsThe sample (n = 24) had a mean age of 59 ± 12 years, was predominantly female (63%), and represented minority groups (8% White, 52% Black, 33% Hispanic, and 8% Other). Feasibility was supported by 79% retention and 89% completion rates. The recruitment rate (68%) was slightly lower than expected. Acceptability scores were 87.9% for the acupuncture group and 51.7% for the control group. Outcomes were significantly better for the acupuncture versus control groups (API, b = -2.1 (1.1), p = 0.047; functional status, b = 27.6 (7.2), p

OBJECTIVE: The goal of this systematic review was to evaluate practice-based, real-world research of individualized complementary and integrative health (CIH) therapies for pain as provided in CIH outpatient clinics. METHODS: A systematic review was conducted on articles in PubMed, Ovid, Cochrane, Web of Science, Scopus, and Embase published through December 2020. The study was listed in the PROSPERO database (CRD42020159193). Major categories of variables extracted included study details and demographics, interventions, and outcomes. RESULTS: The literature search yielded 3,316 records, with 264 assessed for full-text review. Of those, 23 studies (including ∼8,464 patients) were specific to pain conditions as a main outcome. Studies included chiropractic, acupuncture, multimodal individualized intervention/programs, physiotherapy, and anthroposophic medicine therapy. Retention rates ranged from 53% to 91%, with studies offering monetary incentives showing the highest retention. The 0-10 numerical rating scale was the most common pain questionnaire (n = 10; 43% of studies), with an average percent improvement across all studies and time points of 32% (range: 18-60%). CONCLUSIONS: Findings from this systematic review of practice-based, real-word research indicate that CIH therapies exert positive effects on various pain outcomes. Although all studies reported beneficial impacts on one or more pain outcomes, the heterogeneous nature of the studies limits our overall understanding of CIH as provided in clinical settings. Accordingly, we present numerous recommendations to improve publication reporting and guide future research. Our call to action is that future practice-based CIH research is needed, but it should be more expansive and conducted in association with a CIH scientific society with academic and health care members.

BackgroundTo evaluate safety of acupuncture treatment by Korean Medicine Doctors (KMDs), a prospective, practice-based survey on adverse events (AEs) associated with acupuncture was conducted.MethodsFrom July 2016 to October 2017, KMDs were invited to participate in an online survey. Frequency was calculated as the number of AEs per 10,000 treatments; severity was assessed with the Common Terminology Criteria for Adverse Events Grading (Severity) Scale; and causality was evaluated using the World Health Organisation-Uppsala Monitoring Centre system for standardised case causality assessment. Associations between AE occurrence and KMDs' type of practice/clinical experience and patient age/gender/current medication(s) were analysed.ResultsData on 37,490 acupuncture treatments were collected from 222 KMDs. At least one AE was reported from 4,518 acupuncture treatments, giving a frequency rate of 1,205 per 10,000 acupuncture treatments; this increased to 4,768 treatments when administrative problems related to defective devices or medical negligence were added, for a rate of 1,272 per 10,000 acupuncture treatments. Commonly reported AEs were bleeding, needle site pain, and bruising. Approximately 72.9% of AEs/administrative problems were assessed as they certainly occurred by acupuncture treatment in causality assessment. Most AEs/administrative problems were considered mild in severity and two life-threatening AEs were resolved with no sequelae. Compared to males, female patients were more likely to experience AEs and KMDs' clinical experience was not associated with reported AE occurrence.ConclusionsAlthough acupuncture-associated AEs occur commonly, they are largely transient and mild. Acupuncture performed by qualified KMDs may serve as a reliable medical treatment with acceptable safety profiles.

Objectives: As part of a pragmatic effectiveness trial of integrative pain management among inpatients with cancer, the authors sought to understand the clinical context and adaptations to implementation of two study interventions, acupuncture and pain counseling (i.e., pain education and coping skills). Design: The larger study uses a 2 × 2 factorial design with inpatients randomized to: (1) usual care (UC), (2) UC with acupuncture, (3) UC with pain counseling, and (4) UC with acupuncture and pain counseling. The study is being conducted in two hospitals (one academic and one public) and three languages (Cantonese, English, and Spanish). The authors conducted a process evaluation by interviewing study interventionists. Analysis included deductive coding to describe context, intervention, implementation, and inductive thematic coding related to intervention delivery. Results: Interviewees included seven acupuncturists and four pain counselors. Qualitative themes covered adaptations and recognizing site-specific differences that affected implementation. Interventionists adhered closely to protocols and made patient-centered adaptations that were then standardized in broader implementation (e.g., including caregivers in pain counseling sessions; working in culturally nuanced ways with non-English-speaking patients). The public hospital included more patients with recent diagnoses and advanced disease, more ethnically and linguistically diverse patients, less continuity of staffing, and shared patient rooms. At the academic medical center, more patients were familiar with integrative therapies and all were located in single rooms. Providing acupuncture to hospital staff was a key strategy to establish trust, experientially explain the intervention, and create camaraderie and staff buy-in. Conclusions: Providing nonpharmacologic interventions for a pragmatic trial requires adapting to a range of clinical factors. Site-specific factors included greater coordination and resources needed for successful implementation in the public hospital. The authors conclude that adaptation to context and individual patient needs can be done without compromising intervention fidelity and that intervention design should apply principles such as centering at the margins to reduce participation barriers for diverse patient populations.

BACKGROUND: Cancer is the second leading cause of death before the age of 70. Improved cancer survival has put increasing demands on cancer care. Palliative care is the specialized multi-disciplinary care providing relief from the pain, symptoms, and stress of serious illness. The study aims to evaluate the adjunctive effect of acupuncture for advanced cancer patients in a collaborative model of palliative care. METHODS/DESIGN: This is a single-blinded, randomized, sham-controlled trial. One hundred twenty advanced cancer patients undergoing palliative care will be randomized in a ratio of 2:1:1 to manual acupuncture plus standard care group (ASC), sham acupuncture plus standard care group (SSC), and standard care group (SC). Patients in ASC and SSC will receive 9 sessions of acupuncture or sham acupuncture for 3 weeks, and will be followed up for 2 months. The primary measure is the change from baseline score of the Edmonton Symptom Assessment System at 3 weeks. The secondary measures include the Brief Fatigue Inventory, Hospital Anxiety and Depression Scale, Insomnia Severity Index, Numeric Rating Scale, and European Organization for Research and Treatment of Cancer Quality of Life 15 items Questionnaire for Palliative Care. DISCUSSION: The finding of this trial will provide high-quality evidence on the adjunctive effect of acupuncture to standard care on advanced cancer patients undergoing palliative care. TRIAL REGISTRATION: Clinicaltrials.gov, NCT04398875 (https://www.clinicaltrials.gov/ct2/show/NCT04398875), Registered on 21 May 2020.

BackgroundMany health care systems are beginning to encourage patients to use complementary and integrative health (CIH) therapies for pain management. Many clinicians have anecdotally reported that patients combining self-care CIH therapies with practitioner-delivered therapies report larger health improvements than do patients using practitioner-delivered or self-care CIH therapies alone. However, we are unaware of any trials in this area.DesignThe APPROACH Study (Assessing Pain, Patient-Reported Outcomes and Complementary and Integrative Health) assesses the value of veterans participating in practitioner-delivered CIH therapies alone or self-care CIH therapies alone compared with the combination of self-care and practitioner-delivered care. The study is being conducted in 18 Veterans Health Administration sites that received funding as part of the Comprehensive Addiction and Recovery Act to expand availability of CIH therapies. Practitioner-delivered therapies under study include chiropractic care, acupuncture, and therapeutic massage, and self-care therapies include tai chi/qi gong, yoga, and meditation. The primary outcome will be improvement on the Brief Pain Inventory 6 months after initiation of CIH as compared with baseline scores. Patients will enter treatment groups on the basis of the care they receive because randomizing patients to specific CIH therapies would require withholding therapies routinely offered at VA. We will address selection bias and confounding by using sites' variations in business practices and other encouragements to receive different types of CIH therapies as a surrogate for direct randomization by using instrumental variable econometrics methods.SummaryReal-world evidence about the value of combining self-care and practitioner-delivered CIH therapies from this pragmatic trial will help guide the VA and other health care systems in offering specific nonpharmacological approaches to manage patients' chronic pain.

ObjectiveInsomnia is a common, distressing, and impairing psychological outcome experienced by informal caregivers (ICs) of patients with cancer. Cognitive behavioral therapy for insomnia (CBT-I) and acupuncture both have known benefits for patients with cancer, but such benefits have yet to be evaluated among ICs. The purpose of the present study was to evaluate the feasibility, acceptability and preliminary effects of CBT-I and acupuncture among ICs with moderate or greater levels of insomnia.MethodParticipants were randomized to eight sessions of CBT-I or ten sessions of acupuncture.ResultsResults highlighted challenges of identifying interested and eligible ICs and the impact of perception of intervention on retention and likely ultimately outcome.Significance of the resultsFindings suggest preliminary support for non-pharmacological interventions to treat insomnia in ICs and emphasize the importance of matching treatment modality to the preferences and needs of ICs.

ObjectivesNonpharmacological options to treat pain are in demand, in part to address the opioid crisis. One such option is acupuncture. Battlefield acupuncture (BFA) is an auricular needling protocol currently used to treat pain in the Veterans Health Administration. We aimed to identify the advantages and disadvantages of BFA from providers' perspectives.MethodsWe rely on an inductive qualitative approach to explore provider perceptions through thematic analysis of semistructured interviews with 43 BFA providers across the nation.ResultsWe identified the following themes. Disadvantages included: (1) clinical guidelines are insufficient; (2) patients often request multiple BFA visits from providers; (3) BFA can be uncomfortable; (4) BFA may not be an effective treatment option unless it can be provided "on demand"; and (5) BFA can promote euphoria, which can have deleterious consequences for patient self-care. Perceived advantages included: (1) BFA can simultaneously effectively control pain while reducing opioid use; (2) BFA may alleviate the pain that has been unsuccessfully treated by conventional methods; (3) BFA gives providers a treatment option to offer patients with substance use disorder; (4) BFA helps build a trusting patient-provider relationship; (5) BFA can create the opportunity for hope.ConclusionsProviders perceive BFA to have many benefits, both clinical and relational, including ways in which it may have utility in addressing the current opioid crisis. BFA is easy to deliver and has potential clinical and relational utility. Efforts to better understand effectiveness are warranted.

ObjectivesVeterans Health Administration encourages auricular acupuncture (Battlefield Acupuncture/BFA) as a nonpharmacologic approach to pain management. Qualitative reports highlighted a "gateway hypothesis": providing BFA can lead to additional nonpharmacologic treatments. This analysis examines subsequent use of traditional acupuncture.Research designCohort study of Veterans treated with BFA and a propensity score matched comparison group with a 3-month follow-up period to identify subsequent use of traditional acupuncture. Matching variables included pain, comorbidity, and demographics, with further adjustment in multivariate regression analysis.SubjectsWe identified 41,234 patients who used BFA across 130 Veterans Health Administration medical facilities between October 1, 2016 and March 31, 2019. These patients were matched 2:1 on Veterans who used VA care but not BFA during the same period resulting in a population of 24,037 BFA users and a comparison cohort of 40,358 non-BFA users. Patients with prior use of traditional acupuncture were excluded.ResultsAmong Veterans receiving BFA, 9.5% subsequently used traditional acupuncture compared with 0.9% of non-BFA users (P

ObjectivesVeterans Health Administration (VHA) launched a national initiative to train providers in a specific, protocolized auricular acupuncture treatment (also called Battlefield Acupuncture or BFA) as a nonpharmacological approach to pain management. This evaluation assessed the real-world effectiveness of BFA on immediate pain relief and identified subgroups of patients for whom BFA is most effective.Research designIn a cross-sectional cohort study, electronic medical record data for 11,406 Veterans treated with BFA at 57 VHA medical centers between October 2016 and September 2018 was analyzed. The multivariate analysis incorporated data on pain history, change in pain level on an 11-point scale, complications, and demographic information.MethodsA total of 11,406 Veterans were treated with BFA at 57 VHA medical centers between October 2016 and September 2018 and had effectiveness data recorded in their electronic medical record.ResultsMore than 3 quarters experienced immediate decreases in pain following administration of BFA, with nearly 60% reported experiencing a minimal clinically important difference in pain intensity. The average decrease in pain intensity was -2.5 points (SD=2.2) at the initial BFA treatment, and -2.2 points (SD=2.0) at subsequent treatments. BFA was effective across a wide range of Veterans with many having preexisting chronic pain, or physical, or psychological comorbid conditions. Veterans with opioid use in the year before BFA experienced less improvement, with pain intensity scores improving more among Veterans who had not recently used opioids.ConclusionVHA's rapid expansion of training providers to offer BFA as a nonpharmacological approach to pain management has benefited many Veterans.

ObjectiveBecause hot flashes are a common symptom experienced by women with breast cancer, we sought to explore genetic predictors associated with response to acupuncture for the treatment of hot flashes.MethodsUsing data from our completed randomized controlled trial (Clinicaltrials.gov identifier: NCT01005108) on hot flashes among breast cancer survivors who provided biomarker collection (N = 108), we extracted and assayed DNA for single nucleotide polymorphisms in genes involved in neurotransmission, thermoregulation, and inflammation (ADORA1, COMT, TCL1A, and TRPV1). For our primary outcome we classified individuals with a 50% or more reduction in their hot flash composite score at the end of treatment as responders. We used Fisher exact test to identify individual and combined single nucleotide polymorphisms associated with treatment response.ResultsAmong women (N = 57) who received acupuncture treatment (electro or sham), we found that women who were carriers of at least one of these six genotypes (ADORA1 rs41264025-GA or rs16851029-GG or rs12744240-GT, COMT rs6269-GA, TCL1A rs2369049-GG, and TRPV1 rs8065080-TT) were more likely to respond to acupuncture for hot flashes than noncarriers (70.3% vs 37.5%, P = 0.035). These six genotypes were not associated with response in women (N = 51) who received pharmacological hot flash treatment (gabapentin or placebo pill; 37.5% vs 37.5%, P = 1.0).ConclusionsIn this exploratory, proof of concept study, we identified six genotypes that may predict response to acupuncture for hot flashes in breast cancer survivors. If confirmed by future studies, these findings may inform the development of personalized acupuncture for managing hot flashes.

Based on two separate randomized controlled trials (RCTs) on traditional Chinese medicine (TCM) moxibustion and 10.6-μm infrared laser moxibustion in treating knee osteoarthritis (OA), we did an indirect and preliminary comparison of the effects of the 10.6-μm laser moxibustion with the traditional moxibustion for knee osteoarthritis. The objective was to see whether the laser moxibustion is non-inferior to the traditional moxibustion in alleviating symptoms of knee osteoarthritis such as pain, stiffness, and joint dysfunction as well as improving quality of life for the patients with knee osteoarthritis, and whether a further RCT directly comparing the laser and traditional moxibustion is necessary. Pooled data from two RCTs in patients with knee osteoarthritis, trial ISRCTN68475405 and trial ISRCTN26065334, were used. In the two RCTs, the eligibility criteria were almost identical, the treatment procedure (i.e., sessions, duration, and points) were similar, and the outcome measurements (i.e., WOMAC for symptoms and SF-36 for quality of life) were the same. The double robustness method was used for the WOMAC scale and the SF-36 endpoints to detect the difference between traditional and laser moxibustion. The analysis comprised 55 patients from ISRCTN68475405 in real moxibustion arm (moxibustion group) and 88 patients from ISRCTN26065334 in real laser moxibustion arm (laser group). Demographic characteristics and course of disease were similar between the two groups. Causal inference, using the doubly robust estimating approach to correct for bias due to baseline differences, showed that there was no statistically significant difference in the WOMAC pain, stiffness, and physical function between the two treatments at midterm, end of treatment, and 4 weeks after the end of treatment (P > 0.05). The exception was that there was statistically significantly more benefit associated with laser moxibustion compared with traditional moxibustion in physical function at the follow-up of 4 weeks after the end of treatment (P=0.006). There was no statistically significant difference in most SF-36 endpoints (P > 0.05) except that physical functioning (PF), mental health (MH), and bodily pain (BP) were statistically significantly better in the laser group than in the traditional moxibustion group at the follow-up of 4 weeks after the end of treatment (P = 0.005, 0.034, 0.002). The benefits of 10.6-μm infrared laser moxibustion and the traditional moxibustion for knee osteoarthritis were comparable in pain, stiffness, physical dysfunction, and in most of the quality of life subdimensions. The laser moxibustion might be more beneficial in terms of physical function, body pain, and mental health in the long term. RCTs directly comparing 10.6-μm laser moxibustion with traditional moxibustion are warranted.

ObjectiveLike any therapy, acupuncture is effective for some patients, while not helpful for others. Understanding from a patients' perspective what makes one respond or not to acupuncture can help guide further intervention development. This study aimed to identify factors that influence the perception of acupuncture's therapeutic effect among cancer survivors with insomnia.MethodWe conducted post-treatment semi-structured interviews with cancer survivors who were randomized to the acupuncture group in a clinical trial for the treatment of insomnia. Survivors were categorized into Responders and Non-Responders to acupuncture treatment based on the change in the Insomnia Severity Index with a reduction of eight points or greater as the cut-off for the response. An integrated approach to data analysis was utilized by merging an a priori set of codes derived from the key ideas and a set of codes that emerged from the data through a grounded theory approach. Codes were examined for themes and patterns.ResultsAmong 28 cancer survivors interviewed, 18 (64%) were classified as Responders. Participants perceived the ability to respond to acupuncture as dependent on treatment that effectively: (1) alleviated co-morbidities contributing to insomnia, (2) supported sleep hygiene practices, and (3) provided a durable therapeutic effect. Acupuncture treatment that did not address one of these themes often detracted from positive treatment outcomes and diminished perceived benefit from acupuncture.Significance of resultsWe identified patient-perceived contributors to response to acupuncture, such as co-morbid medical conditions, adequate support for sleep hygiene practices, and temporary therapeutic relief. Addressing these factors may improve the overall effectiveness of acupuncture for insomnia.

BackgroundOpioid overdose mortality continues to increase in the United States despite significant investments to reverse the epidemic. The national response to-date has focused primarily on reducing opioid prescribing, yet reductions in prescribing have been associated with patients reporting uncontrolled pain, psychological distress, and transition to illicit substances. The aim of this study is to qualitatively explore chronic pain management experiences among PLWH with a history of illicit substance use after long-term opioid therapy reductions or discontinuations.MethodsWe analyzed 18 interviews, stopping upon reaching thematic saturation, with HIV-positive participants with a history of substance use who were enrolled in a longitudinal cohort study to assess the impact of prescribing changes among patients with chronic pain. Participants in this nested qualitative study had been reduced/discontinued from opioid pain relievers (OPRs) within the 12 months prior to interview. Interviews were audio-recorded and transcribed verbatim. Two analysts coded all interviews, interrater reliability was measured, and coding discrepancies discussed. The study took place in San Francisco, California in 2018.ResultsEleven participants were male with a mean age of 55; 8 were African American and 8 were White. All participants were HIV-positive, actively engaged in primary care, and had a lifetime history of illicit substance use. Twelve reported using illicit substances within the past year, including non-prescription opioids/heroin (10), and stimulant use (10). After being reduced/discontinued from their long-term opioid therapy, patients reported developing complex multimodal pain management systems that often included both nonpharmacological approaches and illicit substance use. Participants encountered a range of barriers to nonpharmacological therapies including issues related to accessibility and availability. Participants often reported attempts to replicate their prior OPR prescription by seeking out the same medication and dose from illicit sources and reported transitioning to heroin after exhausting other options.ConclusionAfter being reduced/discontinued from OPRs, HIV-positive patients with a history of substance use reported experimenting with a range of pain management modalities including nonpharmacological therapies and illicit substance use to manage symptoms of opioid withdrawal and pain. Providers should consider that any change to a patients' long-term opioid therapy may result in experimentation with pain management outside of the medical setting and may want to employ patient-centered, holistic approaches when managing patients' opioid prescriptions and chronic pain.

ObjectiveExisting pharmacologic approaches for painful diabetic neuropathy (PDN) are limited in efficacy and have side effects. We examined the feasibility, acceptability, and effects of group acupuncture for PDN.Design and settingWe randomized patients with PDN from a public safety net hospital to 1) usual care, 2) usual care plus 12 weeks of group acupuncture once weekly, or 3) usual care plus 12 weeks of group acupuncture twice weekly.MethodsThe primary outcome was change in weekly pain intensity (daily 0-10 numerical rating scale [NRS] averaged over seven days) from baseline to week 12. We also assessed health-related quality of life and related symptoms at baseline and weeks 6, 12, and 18.ResultsWe enrolled 40 patients with PDN (baseline pain = 5.3). Among participants randomized to acupuncture, 92% attended at least one treatment (mean treatments = 10.1). We observed no significant differences between once- vs twice-weekly acupuncture and combined those groups for the main analyses. Compared with usual care, participants randomized to acupuncture experienced greater decreases in pain during the 12-week intervention period (between-group differences from baseline = -2.06, 95% confidence interval [CI] = -3.01 to -1.10), but benefits were not maintained after acupuncture ended (baseline to week 18 = -0.61, 95% CI = -1.46 to 0.24). Quality of life improved for acupuncture participants (baseline to week 12 difference = 11.79, 95% CI = 1.92 to 21.66), but group differences were not significant compared with usual care (25.58, 95% CI = -3.90 to 55.06).ConclusionsGroup acupuncture is feasible and acceptable among linguistically and racially diverse safety net patients. Findings suggest clinically relevant reduction in pain from PDN and quality of life improvements associated with acupuncture, with no differences based on frequency.

Objective: To explore an interprofessional group of health care providers' perspectives on the facilitators and barriers to implementation of an inpatient acupuncture service for pain and symptom management. Design: Qualitative. Setting: An urban, academic, tertiary care health system. Subjects: Key interprofessional health care providers, including physicians, nurses, and administrators. Methods/interventions: We used interviews and focus group with questions guided by the Promoting Action on Research Implementation in Health Services framework to explore three domains of implementation-evidence, context, and facilitation. Data were analyzed using content analysis. Results: Thirty health professionals participated in 11 interviews and 1 focus group. We identified 12 codes or topics, grouped into 3 categories: (1) facilitators to implementation, (2) barriers to implementation, and (3) strategies to promote successful implementation. Health professionals' awareness of acupuncture was high, and the positive support was based on beliefs that acupuncture fills a biomedical gap in treatment and adds institutional value by enhancing the reputation of the health system. Many thought that to provide comprehensive care, acupuncture should be available to inpatients, but opinions varied on the appropriateness and timing of acupuncture in patients' disease or care trajectory. Concerns about inconsistencies in insurance coverage and resulting expenses patients may incur were noted. Strategies to overcome implementation challenges included ensuring buy-in, setting appropriate expectations of the benefits of acupuncture, and educating patients and providers. Conclusions: Our study finds clear support for acupuncture. These strong endorsements were the foundation of facilitating factors that can guide implementation of acupuncture in the inpatient setting. Although we also identified potential barriers to implementation that must be addressed, we also report a number of actionable steps to operationalize evidence-based acupuncture to patients who are inpatients.

OBJECTIVE:The purpose of this study was to evaluate the effect of acupuncture and massage on health-related quality of life (HR-QOL) among end stage renal disease (ESRD) patients. DESIGN:Pre-post test design. SETTING:A hemodialysis (HD) unit located in a university hospital. INTERVENTION:Participants were given the option to choose between 20 min sessions of massage or acupuncture therapy once a week for 8 weeks by licensed acupuncturists and massage therapists while undergoing their usual HD session in the University of California, San Diego Chronic HD unit. OUTCOME MEASURES:Participants were asked to complete pre- and postintervention surveys, which consisted of the Patient-Reported Outcomes Measurement Information System (PROMIS™) Global Health Short Form and a Generalized Anxiety Disorder 7-item Scale. RESULTS:A total of 101 patients were included in this study. The average age was 57.6 (standard deviation: 14.5) dialysis vintage 7.5 years, 58% patients were male and the most common etiology of ESRD was diabetic nephropathy (45%). Patients had multiple comorbidities as can be expected for this population with the most common being hypertension (94%), diabetes mellitus (53%), and cardiovascular disease (53%). In this brief intervention study, we were able to find a trend toward improvement in overall HR-QOL as determined by the PROMIS score (p = 0.08). PROMIS mental raw score improved with intervention, which was statistically significant (p = 0.034). CONCLUSION:Use of complementary therapies such as massage and acupuncture during HD may contribute toward improvement of HR-QOL and thus should be considered when addressing overall health status of these patients.

BACKGROUND: Many cancer patients seek traditional Chinese medicine (TCM), the prevalence varying with diagnosis, comorbidities, and demographics. Interventions sought include acupuncture, massage, herbs, diet, and exercise, usually combined with conventional therapies. It is not known what proportion of TCM practitioners care for cancer patients, their cancer specific training or caseload, what interventions they employ, their outcomes, and their communication patterns with conventional oncologists. METHODS: A survey was mailed to all 2213 licensed acupuncturists in the 9-county San Francisco Bay Area gathering descriptive statistics. RESULTS: A total of 472 (21%) responded by mail or web-based Research Electronic Data Capture (REDCap) tool. Most respondents (77%) reported caring for patients with cancer, with 29% reporting having 6 to 10 years of practice experience, and 44.2% having 0 to 20 hours of training specific to the needs of patients with cancer. Improving quality of life was reported by 94% as what their treatment offered cancer patients as well as the area where treatment was felt to have the greatest impact. The most useful TCM modalities were acupuncture (98%), herbs (79%), diet (72%), moxibustion (46%), and meditation instruction (44%). Absence of adverse reactions was noted by 95%. Ninety-one percent reported never or hardly ever having been contacted by patients oncologists to discuss treatment. CONCLUSIONS: Many acupuncturists seeing cancer patients have significant clinical experience and have sought specialized training. Improved communication is needed between TCM practitioners and oncologists sharing care of cancer patients.

Evaluate laser acupuncture (LA) as an adjuvant therapy in pain management during percutaneous kidney biopsy procedure in children and adolescents. This prospective, double-blinded, randomized controlled trial enrolled patients aged 7 to 26 years admitted to a children's hospital for percutaneous kidney biopsy. Patients received LA to treatment points (acupuncture group) or sham points (control group) before the procedure. The laser delivered a dose of 42 J/cm over 10 acupoints. Patients and parents rated the pain during and after the biopsy, and change in pain scores were calculated for each patient. Anxiety, vital signs, sedation medication, and patient's biopsy experience were secondary outcomes. Sixty-nine treatments (33 in the acupuncture group and 36 in the control group) were eligible for analysis. Patients in the acupuncture group reported a significantly improved change in the pain score after the biopsy compared with the controls (0.8 vs -0.5, P = 0.044). Patients in the acupuncture group had a statistically significant decrease in procedure vital signs including heart rate (-1.8 vs 5.6, P = 0.043) and respiratory rate (-2.4 vs 0.4, P = 0.045) when compared with controls. Parents also perceived a correspondingly greater improvement in their child's pain for those in the acupuncture group compared with the controls (2.3 vs 0.3, P = 0.04). Adjunctive LA significantly improved pain after pediatric percutaneous kidney biopsies.

ObjectiveTo determine if injection of vitamin K3 in an acupuncture point is optimal for the treatment of primary dysmenorrhoea, when compared with 2 other injection treatments.SettingA Menstrual Disorder Centre at a public hospital in Shanghai, China.ParticipantsChinese women aged 14-25 years with severe primary dysmenorrhoea for at least 6 months not relieved by any other treatment were recruited. Exclusion criteria were the use of oral contraceptives, intrauterine devices or anticoagulant drugs, pregnancy, history of abdominal surgery, participation in other therapies for pain and diagnosis of secondary dysmenorrhoea. Eighty patients with primary dysmenorrhoea, as defined on a 4-grade scale, completed the study. Two patients withdrew after randomisation.InterventionsA double-blind, double-dummy, randomised controlled trial compared vitamin K3 acupuncture point injection to saline acupuncture point injection and vitamin K3 deep muscle injection. Patients in each group received 3 injections at a single treatment visit.Primary and secondary outcome measuresThe primary outcome was the difference in subjective perception of pain as measured by an 11 unit Numeric Rating Scale (NRS). Secondary measurements were Cox Pain Intensity and Duration scales and the consumption of analgesic tablets before and after treatment and during 6 following cycles.ResultsPatients in all 3 groups experienced pain relief from the injection treatments. Differences in NRS measured mean pain scores between the 2 active control groups were less than 1 unit (-0.71, CI -1.37 to -0.05) and not significant, but the differences in average scores between the treatment hypothesised to be optimal and both active control groups (1.11, CI 0.45 to 1.78) and (1.82, CI 1.45 to 2.49) were statistically significant in adjusted mixed-effects models. Menstrual distress and use of analgesics were diminished for 6 months post-treatment.ConclusionsAcupuncture point injection of vitamin K3 relieves menstrual pain rapidly and is a useful treatment in an urban outpatient clinic.Trial registration numberNCT00104546; Results.

Objectives: To provide updated evidence from randomized controlled trials (RCTs) on the efficacy of intradermal acupuncture for insomnia.Methods: A search of relevant literatures was performed on major medical databases, including the Cochrane Library, PubMed, EMBASE, CBM, CNKI, VIP, Wanfang Data and so on. Risk of bias evaluation, meta-analysis, sensitivity analysis and evidence rating of all extracted information were also conducted.Results: A total of 508 studies were initially identified. However, only 45 studies were deemed eligible for the present review. Meta-analyses were conducted in three comparisons separately: intradermal versus acupuncture, Effective rate (RR = 0.08, 95% CI -0.02 to 0.19), Global scales score (points) (SMD = -0.52, 95% CI: -0.81,-0.24, P = 0.02); intradermal acupuncture versus non acupuncture, Effective rate(RR = 1.22, 95% CI 1.04 to 1.42), Global scales score (points) (SMD = -0.81, 95% CI: -1.23,-0.38, P < 0.00001); control group versus control add intradermal acupuncture. Effective rate(RR = 1.27, 95% CI 1.13 to 1.42), Global scales score (points) (SMD = -1.15, 95% CI: -1.46,-0.84, P < 0.00001). Although these results suggested benefits of intradermal acupuncture, the overall quality of evidence rated was low.Conclusions: The summary estimates indicate that it improved the clinical effective rate and lowered PSQI or other scales score, when compared to sham acupuncture or placebo/conventional medications/herbs.Also,it significantly improved the clinical effective rate and lowered PSQI or other scales score, when the control groups add intradermal acupuncture. However, the quality of the evidence is varied from very low to low due to the potential risk of bias and inconsistency among included trials. The more larger sample size and much more rigorous designed RCTs are still further studied. [ABSTRACT FROM AUTHOR]

Robust methods are needed to efficiently conduct large, multisite, randomized, controlled clinical trials of acupuncture protocols. The Southwest Oncology Group (SWOG) S1200 trial is a randomized, controlled (i.e., sham-controlled and waitlist-controlled) trial of a standardized acupuncture protocol for treating aromatase inhibitor (AI)-associated arthralgias in early-stage breast cancer patients (n = 228). The primary objective of this study was to determine whether true acupuncture administered twice weekly for 6 weeks, as compared to sham acupuncture or a waitlist control, reduced AI-associated joint pain at 6 weeks as assessed by patient reports. The study was conducted at 11 institutions across the United States. The true acupuncture protocol was developed using a consensus-based process. The true acupuncture and the sham acupuncture protocols each consisted of 12 sessions administered for 6 weeks, followed by one weekly session for 6 weeks. The true acupuncture protocol used standardized protocol points, and the standardized acupoints were tailored to a patient's joint symptoms. The similarly standardized sham acupuncture protocol utilized superficial needling of nonacupoints. Standardized methods were developed to train and monitor acupuncturists and included online and in-person training, study manuals, monthly phone calls, and remote quality assurance monitoring throughout the study period. The research staff similarly received online and in-person training and monthly phone calls.

This study investigates whether visual deprivation influences participants' accuracy in differentiating between real and sham acupuncture needles. It also evaluates the relative contributions of tactile, visual, and auditory cues that participants use in their decision-making processes. In addition, a simple sensory decision-making model for research using acupuncture sham devices as comparative controls is proposed. Forty healthy individuals underwent two conditions (blindfolded and sighted) in random sequence. Four sham and four real needles were randomly applied to the participants' lower limb acupoints (ST32 to ST39). Participants responded which needle type was applied. Participants then verbally answered a questionnaire on which sensory cues influenced their decision-making. The proportion of correct judgments, P(C), was calculated to indicate the participants' accuracy in distinguishing between the needle types. Visual deprivation did not significantly influence the participants' discrimination accuracy. Tactile cues were the dominant sensory modality used in decision-making, followed by visual and auditory cues. Sharp and blunt sensations were associated with the real and sham needles, respectively, for both conditions. This study confirmed that tactile cues were the main sensory modalities used in participant decision-making during acupuncture administration. Also, short-term blindfolding of participants during procedures will unlikely influence blinding effectiveness. Not applicable. This study does not fall under the definition of a clinical trial under the ICMJE guidelines. [ABSTRACT FROM AUTHOR]

"A doctor of the highest caliber treats an illness before it happens," a seemingly antiquated doctrine in traditional Chinese medicine, is enjoying surging popularity among practitioners in urban China and the United States today. In this essay, I examine how the meanings and contours of traditional Chinese medicine have shifted in recent decades as it is molded into a "preventive medicine" through translocal encounters. From the 1960s and the early 1970s, the emphasis China's socialist health care placed on preventive health among the rural poor shaped the practice of Chinese herbal medicine and especially acupuncture. This version of preventive medicine was also exported to the Third World, which China strove to champion. Since the end of the Cold War and especially during the 1990s, as China strives to "get on track with the world" (specifically, affluent nation-states, especially in North America and the European Union), traditional Chinese medicine has been rapidly commodified and reinvented as a new kind of preventive medicine tailored for cosmopolitan, middle-class lifestyles. The emergence of this radically new preventive medicine resuscitates certain stories of antiquity and continuity, emphasizing that traditional Chinese medicine has always been "preventive" while obliterating recent memories of the proletariat world and its preventive medicine.