Longitudinal Care Patterns and Utilization Among Patients With New-Onset Neck Pain by Initial Provider Specialty.

STUDY DESIGN: Retrospective cohort study. OBJECTIVE: To compare utilization patterns for patients with new-onset neck pain by initial provider specialty. SUMMARY OF BACKGROUND DATA: Initial provider specialty has been associated with distinct care patterns among patients with acute back pain; little is known about care patterns among patients with acute neck pain. METHODS: De-identified administrative claims and electronic health record data were derived from the Optum Labs Data Warehouse, which contains longitudinal health information on over 200M enrollees and patients representing a mixture of ages and geographical regions across the United States. Patients had outpatient visits for new-onset neck pain from October 1, 2016 to September 30, 2019, classified by initial provider specialty. Utilization was assessed during a 180-day follow-up period, including subsequent neck pain visits, diagnostic imaging, and therapeutic interventions. RESULTS: The cohort included 770,326 patients with new-onset neck pain visits. The most common initial provider specialty was chiropractor (45.2%), followed by primary care (33.4%). Initial provider specialty was strongly associated with the receipt of subsequent neck pain visits with the same provider specialty. Rates and types of diagnostic imaging and therapeutic interventions during follow-up also varied widely by initial provider specialty. While uncommon after initial visits with chiropractors (≤2%), CT, or MRI scans occurred in over 30% of patients with initial visits with emergency physicians, orthopedists, or neurologists. Similarly, 6.8% and 3.4% of patients initially seen by orthopedists received therapeutic injections and major surgery, respectively, compared with 0.4% and 0.1% of patients initially seen by a chiropractor. CONCLUSION: Within a large national cohort, chiropractors were the initial provider for a plurality of patients with new-onset neck pain. Compared with patients initially seen by physician providers, patients treated initially by chiropractors or therapists received fewer and less costly imaging services and were less likely to receive invasive therapeutic interventions during follow-up. LEVEL OF EVIDENCE: 3.

Determining the safety and effectiveness of Tai Chi: a critical overview of 210 systematic reviews of controlled clinical trials.

BACKGROUND: This overview summarizes the best available systematic review (SR) evidence on the health effects of Tai Chi. METHODS: Nine databases (PubMed, Cochrane Library, EMBASE, Medline, Web of Science, China National Knowledge Infrastructure (CNKI), Chinese Scientific Journal Database (VIP), Sino-Med, and Wanfang Database) were searched for SRs of controlled clinical trials of Tai Chi interventions published between Jan 2010 and Dec 2020 in any language. Effect estimates were extracted from the most recent, comprehensive, highest-quality SR for each population, condition, and outcome. SR quality was appraised with AMSTAR 2 and overall certainty of effect estimates with the GRADE method. RESULTS: Of the 210 included SRs, 193 only included randomized controlled trials, one only included non-randomized studies of interventions, and 16 included both. Common conditions were neurological (18.6%), falls/balance (14.7%), cardiovascular (14.7%), musculoskeletal (11.0%), cancer (7.1%), and diabetes mellitus (6.7%). Except for stroke, no evidence for disease prevention was found; however, multiple proxy-outcomes/risks factors were evaluated. One hundred and fourteen effect estimates were extracted from 37 SRs (2 high, 6 moderate, 18 low, and 11 critically low quality), representing 59,306 adults. Compared to active and/or inactive controls, 66 of the 114 effect estimates reported clinically important benefits from Tai Chi, 53 reported an equivalent or marginal benefit, and 6 an equivalent risk of adverse events. Eight of the 114 effect estimates (7.0%) were rated as high, 43 (37.7%) moderate, 36 (31.6%) low, and 27 (23.7%) very low certainty evidence due to concerns with risk of bias (92/114, 80.7%), imprecision (43/114, 37.7%), inconsistency (37/114, 32.5%), and publication bias (3/114, 2.6%). SR quality was often limited by the search strategies, language bias, inadequate consideration of clinical, methodological, and statistical heterogeneity, poor reporting standards, and/or no registered SR protocol. CONCLUSIONS: The findings suggest Tai Chi has multidimensional effects, including physical, psychological and quality of life benefits for a wide range of conditions, as well as multimorbidity. Clinically important benefits were most consistently reported for Parkinson's disease, falls risk, knee osteoarthritis, low back pain, cerebrovascular, and cardiovascular diseases including hypertension. For most conditions, higher-quality SRs with rigorous primary studies are required. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42021225708.

Qigong Training Positively Impacts Both Posture and Mood in Breast Cancer Survivors With Persistent Post-surgical Pain: Support for an Embodied Cognition Paradigm.

Theories of embodied cognition hypothesize interdependencies between psychological well-being and physical posture. The purpose of this study was to assess the feasibility of objectively measuring posture, and to explore the relationship between posture and affect and other patient centered outcomes in breast cancer survivors (BCS) with persistent postsurgical pain (PPSP) over a 12-week course of therapeutic Qigong mind-body training. Twenty-one BCS with PPSP attended group Qigong training. Clinical outcomes were pain, fatigue, self-esteem, anxiety, depression, stress and exercise self-efficacy. Posture outcomes were vertical spine and vertical head angles in the sagittal plane, measured with a 3D motion capture system in three conditions: eyes open (EO), eyes open relaxed (EOR) and eyes closed (EC). Assessments were made before and after the Qigong training. The association between categorical variables (angle and mood) was measured by Cramer's V. In the EO condition, most participants who improved in fatigue and anxiety scales also had better vertical head values. For the EOR condition, a moderate correlation was observed between changes in vertical head angle and changes in fatigue scale. In the EC condition, most of the participants who improved in measures of fatigue also improved vertical head angle. Additionally, pain severity decreased while vertical spine angle improved. These preliminary findings support that emotion and other patient centered outcomes should be considered within an embodied framework, and that Qigong may be a promising intervention for addressing biopsychosocially complex interventions such as PPSP in BCSs.

Tai Chi for health and well-being: A bibliometric analysis of published clinical studies between 2010 and 2020.

The objective of this bibliometric review was to identify the volume, breadth, and characteristics of clinical studies evaluating Tai Chi published between January 2010 and January 2020. Five English and four Chinese language databases were searched. Following independent screening, 1018 eligible publications representing 987 studies were identified, which was a three-fold increase from the previous decade. Most common were randomized controlled trials (548/987, 55.5 %), followed by systematic reviews (157/987, 15.9 %), non-randomized controlled clinical studies (152/987, 15.4 %), case series (127/987, 12.9 %) and case reports (3/987, 0.3 %) that were conducted in China (730/987, 74.0 %), followed by the United States of America (123/987, 12.5 %) and South Korea (20/987, 2.0 %). Study participants were mostly in the adult (55.2 %) and/or older adult (72.0 %) age groups. The top ten diseases/conditions were hypertension, chronic obstructive pulmonary disease, diabetes, knee osteoarthritis, heart failure, depression, osteoporosis/osteopenia, breast cancer, coronary heart disease and insomnia. A quarter of the studies enrolled healthy participants to evaluate the effects of Tai Chi on health promotion/preservation, balance/falls, and physiological/biomechanical outcomes. Yang style Tai Chi was the most popular, followed by Chen and Sun style. Tai Chi was mostly commonly delivered face-to-face by a Tai Chi instructor in group settings for 60 min, three times a week, for 12 weeks. Most studies (93.8 %) reported at least one outcome in favor of Tai Chi. Adverse events were underreported (7.2 %). Over half fell short of expected intervention reporting standards, signalling the need for Tai Chi extensions to existing guidelines.

Factors Influencing Preference for Intervention in a Comparative Effectiveness Trial of Mindfulness-Based Cancer Recovery and Tai Chi/Qigong in Cancer Survivors.

Introduction: An important gap between randomized efficacy research and real-world implementation of complementary therapies is the role of patient preferences in influencing engagement and outcome. Several studies have highlighted the benefits of patient preference on health outcomes, but few have investigated the factors associated with preference for interventions, which may be critical to assure the success of program implementation. The current study sought to explore the factors associated with patient preference in an ongoing randomized preference-based trial of Mindfulness-Based Cancer Recovery (MBCR) versus Tai Chi/qigong (TCQ) (the Mindfulness and Tai Chi/qigong in Cancer Health [MATCH] study). Materials and Methods: A multi-method study design was used. A subsample of participants were purposely selected from the ongoing MATCH study to have representation from both intervention arms and from both men and women across different age groups. Open-ended, semi-structured qualitative interviews were conducted to explore the factors influencing initial patient preference. Interviews were transcribed verbatim and analyzed by using inductive thematic analysis. The treatment acceptability and preference measure was administered to determine patients' ratings of acceptability and credibility of both preferred and nonpreferred interventions. Results: A total of 13 participants were interviewed prior to program attendance, with 8 (62%) preferring TCQ and 5 (38%) choosing MBCR. Major themes related to patients' preference for intervention included: (1) expectations about the preferred intervention; (2) knowledge of the intervention; (3) past experiences with the intervention; and (4) self-efficacy. Participants' mean treatment acceptability scores were higher for their preferred program than their nonpreferred program. Conclusion: Understanding the factors that influence cancer survivors' preference for mind-body interventions can augment health care providers' knowledge of the barriers and facilitators for successful implementation of interventions in clinical settings, as well as help patients make informed treatment decisions and improve satisfaction and outcomes. Clinical trial registration no.: NCT03641222.

Qigong mind-body program for caregivers of cancer patients: design of a pilot three-arm randomized clinical trial.

BACKGROUND: Informal caregivers, often family and friends, experience significant psychological and physical distress leading to reductions in health and quality of life (QOL). Mind-body interventions focused on caregivers are often limited and do not address multiple barriers, including caregivers' economic, geographic, and time constraints. Translation of in-person, community-based interventions to Internet-based delivery may offer greater accessibility for caregivers, leading to increased adherence. METHODS: Caring for Caregivers with Mind-Body implements a three-arm, pilot, randomized controlled trial to evaluate the feasibility of delivering a Qigong intervention (Eight Brocades) to cancer caregivers. A total of 54 cancer caregivers will be randomized into one of three 12-week programs: (1) community-based Qigong, (2) Internet-based Qigong, or (3) a self-care control group. Study-specific aims include (1) modify intervention content for online delivery, (2) evaluate the feasibility of recruiting and retaining cancer caregivers into a 12-week clinical trial, and (3) evaluate the feasibility of collecting and managing data, and the suitability of questionnaires for this population. Several outcomes will be assessed, including caregiver QOL, caregiver burden, caregiver distress, perceived social support, physical function, and cognitive function. A 6-month follow-up will also assess longer-term changes in QOL and psychosocial well-being. DISCUSSION: Findings will be used to inform the design and conduct of a large-scale comparative effectiveness trial evaluating caregivers who received Qigong training delivered through community-based vs Internet-based programs. A finding that either or both programs are effective would inform care and options for caregivers. TRIAL REGISTRATION: NCT04019301 ; registered on July 15, 2019; clinicaltrials.gov.

"Making Peace with Our Bodies": A Qualitative Analysis of Breast Cancer Survivors' Experiences with Qigong Mind-Body Exercise.

Objectives: Breast cancer treatment leaves breast cancer survivors (BCS) with an array of lasting side effects, including persistent postsurgical pain (PPSP). In this study, we explored the perceptions of BCS with PPSP as they learned Qigong mind-body exercise (QMBE), a multimodal practice rooted in Traditional Chinese Medicine. Methods: Participants included 18 female BCS treated for stage 0-III breast cancer and experiencing PPSP. Participants were taught QMBE over 12 weeks. Semi-structured interviews were conducted before and after the intervention. Results: BCS disclosed a disconnect between mind and body that emerged during treatment. They perceived QMBE as moving meditation, which enabled them to reconnect mind and body, lessen their pain, and make peace with their bodies. Conclusion: These women's experiences both inform the promise of integrating QMBE and related mind-body exercise into PPSP clinical practice guidelines and suggest new areas of research regarding the role of multimodal interventions for holistic healing in BCS.

Qigong Mind-Body Exercise as a Biopsychosocial Therapy for Persistent Post-Surgical Pain in Breast Cancer: A Pilot Study.

Purpose: To assess the feasibility, safety, and preliminary effectiveness of a 12-week multimodal Qigong Mind-Body Exercise (QMBE) program for breast cancer survivors with persistent post-surgical pain (PPSP). Methods: This was a single-arm mixed-methods pilot study. Primary outcome measures were feasibility (recruitment, adherence) and safety. Validated self-report questionnaires were used to evaluate a constellation of interdependent symptoms, including pain, fatigue, mood, exercise, interoceptive awareness, and health-related quality of life at baseline and 12 weeks. A subset of the instruments was administered 6 months postintervention. Shoulder range of motion and grip strength were objectively assessed at baseline and 12 weeks. Qualitative interviews were conducted at baseline and 12 weeks. Results: Twenty-one participants were enrolled; 18 and 17 participants, respectively, completed the 12-week and 6-month outcome assessment. No serious adverse events were reported. Statistically significant improvements were observed at 12 weeks in pain severity and interference, fatigue, anxiety, depression, perceived stress, self-esteem, pain catastrophizing, and several subdomains of quality of life, interoceptive awareness, and shoulder range of motion. Changes in pain, fatigue, pain catastrophizing, anxiety, depression, and quality of life were clinically meaningful. Postintervention effects were sustained at 6 months. Conclusions: QMBE is a safe and gentle multimodal intervention that shows promise in conferring a broad range of psychosocial and physical benefits for breast cancer survivors with PPSP. Results support the value of future studies evaluating the impact of QMBE on multiple outcomes relevant to breast cancer survivors with PPSP.

Cost-Effectiveness of a Team-Based Integrative Medicine Approach to the Treatment of Back Pain.

OBJECTIVES: To report the results of health economic analyses comparing two treatment approaches for chronic low back pain (CLBP). DESIGN: Observational prospective cohort study comparing effectiveness and cost-effectiveness of CLBP care provided at an integrative care clinic with that provided in other clinics within the same hospital. CLBP-related medical utilization, function, quality of life, and days of work incapacity were self-reported at baseline, 3, 6, and 12 months. SETTINGS/LOCATION: Osher Clinical Center (OCC) based at a tertiary academic hospital (Brigham and Women's Hospital [BWH]) and other clinics at BWH. SUBJECTS: CLBP patients seeking care at OCC or non-OCC BWH clinics. INTERVENTIONS: Integrative or conventional care for CLBP as prescribed by the treating clinician(s). OUTCOME MEASURES: Quality-adjusted life years (QALYs) were estimated per treatment approach based on the SF-12. Cost per QALY gained was evaluated using an incremental cost-effectiveness ratio (ICER). ICERs based on CLBP-specific effectiveness measures (Roland Disability Questionnaire [RDQ] and bothersomeness of pain [BOP]) were exploratory outcomes. RESULTS: Total adjusted annual CLBP-related costs per patient were greater in the OCC versus non-OCC group ($11,526.73 vs. $6,810.63). Between group differences in QALYs were small and ICER estimate of cost per QALY gained was high ($436,676). However, unadjusted mean direct costs per patient decreased over time in the OCC group. Savings in direct costs of $391 (95% confidence interval: -1,078 to 1,861) were observed in the OCC group for the 6- to 12-month period, driven primarily by reduced medication usage. ICERs based on adjusted RDQ and BOP group differences showed cost of $2,073 and $4,203 for a one-point reduction per respective scale. CONCLUSIONS: When adjusted for baseline differences, self-reported costs were higher in the OCC group with only small effects on QALYs. However, trends toward decreased direct expenditures and medication usage over time warrant further investigation. Future studies evaluating potential benefits of integrative care models for the management of CLBP should employ randomized designs, longer observational periods, and explore multiple metrics of cost-effectiveness.

COMT and Alpha-Tocopherol Effects in Cancer Prevention: Gene-Supplement Interactions in Two Randomized Clinical Trials.

BACKGROUND: Vitamins are among the most frequently used supplements (48% of US adults). However, little is known about contributions of genetic variation to their efficacy and safety. Multiple pathways link catechol-O-methyltransferase (COMT) to the vitamin E supplement, alpha-tocopherol, and cancer. METHODS: Here we determined if COMT exerted pharmacogenetic effects on cancer prevention in two randomized trials of alpha-tocopherol supplementation. Pharmacogenetic effects of common COMT rs4680 (val158met), which encodes a nonsynonymous valine-to-methionine substitution, were examined in the trial plus a 10-year post-trial follow-up (overall) period of The Women's Genome Health Study (WGHS, N = 23 294), a 10-year alpha-tocopherol and aspirin trial with 10 years post-trial follow-up. Results were validated in a case/control (N = 2396/2235) subset of the Alpha-Tocopherol Beta-Carotene Cancer Prevention Study (ATBC, N = 29 133). The primary outcome was total cancers. Rates of cancer types prevalent in women (colorectal, breast, lung, uterine, and lymphoma/leukemia) were also examined. All statistical tests were two-sided. RESULTS: Random-effects meta-analysis of rs4680 genotype strata, in WGHS and ATBC overall periods, revealed differential alpha-tocopherol effects compared with placebo: met/met (hazard ratio [HR] = 0.88; 95% confidence interval [CI] = 0.80 to 0.97; P = .01), val/met (HR = 0.99; 95% CI = 0.92 to 1.06; P = .74), and val/val (HR = 1.18; 95% CI = 1.06 to 1.31; P = .002) with a statistically significant COMT by alpha-tocopherol interaction (Pinteraction <.001). Timing of effects differed, with stronger effects in WGHS trial and ATBC post-trial. CONCLUSION: Pharmacogenetic analysis of COMT and cancer prevention in two large randomized trials revealed statistically significant COMT by alpha-tocopherol interaction, such that alpha-tocopherol was beneficial among rs4680 met-allele (28.0%), but not val-allele (22.8%) homozygotes. These effects indicate the need for additional studies of genetic variation as a determinant of the benefits and possible harms of over-the-counter supplements, like alpha-tocopherol, used for health promotion.

Tai Chi and Qigong for cancer-related symptoms and quality of life: a systematic review and meta-analysis.

PURPOSE: This study aims to summarize and critically evaluate the effects of Tai Chi and Qigong (TCQ) mind-body exercises on symptoms and quality of life (QOL) in cancer survivors. METHODS: A systematic search in four electronic databases targeted randomized and non-randomized clinical studies evaluating TCQ for fatigue, sleep difficulty, depression, pain, and QOL in cancer patients, published through August 2016. Meta-analysis was used to estimate effect sizes (ES, Hedges' g) and publication bias for randomized controlled trials (RCTs). Methodological bias in RCTs was assessed. RESULTS: Our search identified 22 studies, including 15 RCTs that evaluated 1283 participants in total, 75% women. RCTs evaluated breast (n = 7), prostate (n = 2), lymphoma (n = 1), lung (n = 1), or combined (n = 4) cancers. RCT comparison groups included active intervention (n = 7), usual care (n = 5), or both (n = 3). Duration of TCQ training ranged from 3 to 12 weeks. Methodological bias was low in 12 studies and high in 3 studies. TCQ was associated with significant improvement in fatigue (ES = - 0.53, p < 0.001), sleep difficulty (ES = - 0.49, p = 0.018), depression (ES = - 0.27, p = 0.001), and overall QOL (ES = 0.33, p = 0.004); a statistically non-significant trend was observed for pain (ES = - 0.38, p = 0.136). Random effects models were used for meta-analysis based on Q test and I 2 criteria. Funnel plots suggest some degree of publication bias. Findings in non-randomized studies largely paralleled meta-analysis results. CONCLUSIONS: Larger and methodologically sound trials with longer follow-up periods and appropriate comparison groups are needed before definitive conclusions can be drawn, and cancer- and symptom-specific recommendations can be made. IMPLICATIONS FOR CANCER SURVIVORS: TCQ shows promise in addressing cancer-related symptoms and QOL in cancer survivors.

Protocol for the MATCH study (Mindfulness and Tai Chi for cancer health): A preference-based multi-site randomized comparative effectiveness trial (CET) of Mindfulness-Based Cancer Recovery (MBCR) vs. Tai Chi/Qigong (TCQ) for cancer survivors.

PURPOSE: A growing number of cancer survivors suffer high levels of distress, depression and stress, as well as sleep disturbance, pain and fatigue. Two different mind-body interventions helpful for treating these problems are Mindfulness-Based Cancer Recovery (MBCR) and Tai Chi/Qigong (TCQ). However, while both interventions show efficacy compared to usual care, they have never been evaluated in the same study or directly compared. This study will be the first to incorporate innovative design features including patient choice while evaluating two interventions to treat distressed cancer survivors. It will also allow for secondary analyses of which program best targets specific symptoms in particular groups of survivors, based on preferences and baseline characteristics. METHODS AND SIGNIFICANCE: The design is a preference-based multi-site randomized comparative effectiveness trial. Participants (N=600) with a preference for either MBCR or TCQ will receive their preferred intervention; while those without a preference will be randomized into either intervention. Further, within the preference and non-preference groups, participants will be randomized into immediate intervention or wait-list control. Total mood disturbance on the Profile of mood states (POMS) post-intervention is the primary outcome. Other measures taken pre- and post-intervention and at 6-month follow-up include quality of life, psychological functioning, cancer-related symptoms and physical functioning. Exploratory analyses investigate biomarkers (cortisol, cytokines, blood pressure/Heart Rate Variability, telomere length, gene expression), which may uncover potentially important effects on key biological regulatory and antineoplastic functions. Health economic measures will determine potential savings to the health system.

Publication Trends in Acupuncture Research: A 20-Year Bibliometric Analysis Based on PubMed.

OBJECTIVE: Acupuncture has become popular and widely practiced in many countries around the world. Despite the large amount of acupuncture-related literature that has been published, broader trends in the prevalence and scope of acupuncture research remain underexplored. The current study quantitatively analyzes trends in acupuncture research publications in the past 20 years. METHODS: A bibliometric approach was used to search PubMed for all acupuncture-related research articles including clinical and animal studies. Inclusion criteria were articles published between 1995 and 2014 with sufficient information for bibliometric analyses. Rates and patterns of acupuncture publication within the 20 year observational period were estimated, and compared with broader publication rates in biomedicine. Identified eligible publications were further analyzed with respect to study type/design, clinical condition addressed, country of origin, and journal impact factor. RESULTS: A total of 13,320 acupuncture-related publications were identified using our search strategy and eligibility criteria. Regression analyses indicated an exponential growth in publications over the past two decades, with a mean annual growth rate of 10.7%. This compares to a mean annual growth rate of 4.5% in biomedicine. A striking trend was an observed increase in the proportion of randomized clinical trials (RCTs), from 7.4% in 1995 to 20.3% in 2014, exceeding the 4.5% proportional growth of RCTs in biomedicine. Over the 20 year period, pain was consistently the most common focus of acupuncture research (37.9% of publications). Other top rankings with respect to medical focus were arthritis, neoplasms/cancer, pregnancy or labor, mood disorders, stroke, nausea/vomiting, sleep, and paralysis/palsy. Acupuncture research was conducted in 60 countries, with the top 3 contributors being China (47.4%), United States (17.5%), and United Kingdom (8.2%). Retrieved articles were published mostly in complementary and alternative medicine (CAM) journals with impact factors ranging between 0.7 and 2.8 in the top 20 journals, followed by journals specializing in neuroscience, pain, anesthesia/analgesia, internal medicine and comprehensive fields. CONCLUSION: Acupuncture research has grown markedly in the past two decades, with a 2-fold higher growth rate than for biomedical research overall. Both the increases in the proportion of RCTs and the impact factor of journals support that the quality of published research has improved. While pain was a consistently dominant research focus, other topics gained more attention during this time period. These findings provide a context for analyzing strengths and gaps in the current state of acupuncture research, and for informing a comprehensive strategy for further advancing the field.

Acupuncture for Chemoradiation Therapy-Related Dysphagia in Head and Neck Cancer: A Pilot Randomized Sham-Controlled Trial.

INTRODUCTION: Dysphagia is common in head and neck cancer patients after concurrent chemoradiation therapy (CRT). This study evaluated the feasibility of conducting a randomized sham-controlled trial and collected preliminary data on safety and efficacy of acupuncture. PATIENTS AND METHODS: Head and neck cancer (HNC) patients with stage III-IV squamous cell carcinoma were randomized to 12 sessions of either active acupuncture (AA) or sham acupuncture (SA) during and following CRT. Patients were blinded to treatment assignment. Swallowing-related quality of life (QOL) was assessed using the MD Anderson Dysphagia Inventory (MDADI) total and subscale scores. RESULTS: Multiple aspects of trial feasibility were confirmed. Forty-two of 196 patients screened (21%) were enrolled and randomized to receive AA (n = 21) or SA (n = 21); 79% completed at least 10 of 12 planned acupuncture sessions; 81% completed the study follow-ups. The majority of patients reported uncertainty regarding their treatment assignment, with no difference between the AA and SA groups. Audits confirmed both AA and SA treatments were delivered with high fidelity. No serious acupuncture-related side effects were observed. MDADI total scores significantly improved from baseline to 12 months post-CRT in both groups (AA: +7.9; SA +13.9; p = .044, p < .001). Similar patterns were observed for the MDADI global subscale (AA: +25.0; SA +22.7; p = .001, p = .002). Intent-to-treat analyses suggested no difference between the treatment groups (p = .17, p = .76 for MDADI total and global scores, respectively). CONCLUSION: A sham-controlled randomized trial evaluating acupuncture in dysphagia-related QOL in HNC found the procedure to be feasible and safe. Further investigation is required to evaluate efficacy. IMPLICATIONS FOR PRACTICE: Dysphagia or swallowing difficulty is an important and common condition after concurrent chemoradiation therapy in head and neck cancer patients. In addition to current available supportive care, acupuncture may offer potential for treating dysphagia. This study demonstrated that both active acupuncture and sham acupuncture are safe and were associated with improved dysphagia-related quality of life from baseline to 12 months after concurrent chemoradiation therapy. This study was not designed to inform underlying specific versus nonspecific effects. Future larger-scale pragmatic clinical trials evaluating the effectiveness of acupuncture versus standard of care are warranted, and further mechanistic research is needed to understand how active versus purportedly sham acupuncture procedures affect dysphagia-related symptoms.

Evidence base of clinical studies on Tai Chi: a bibliometric analysis.

BACKGROUND: The safety and health benefits of Tai Chi mind-body exercise has been documented in a large number of clinical studies focused on specific diseases and health conditions. The objective of this systematic review is to more comprehensively summarize the evidence base of clinical studies of Tai Chi for healthcare. METHODS AND FINDINGS: We searched for all types of clinical studies on Tai chi in PubMed, the Cochrane Library and four major Chinese electronic databases from their inception to July 2013. Data were analyzed using SPSS17.0 software. A total of 507 studies published between 1958 and 2013 were identified, including 43 (8.3%) systematic reviews of clinical studies, 255 (50.3%) randomized clinical trials, 90 (17.8%) non-randomized controlled clinical studies, 115 (22.7%) case series and 4 (0.8%) case reports. The top 10 diseases/conditions was hypertension, diabetes, osteoarthritis, osteoporosis or osteopenia, breast cancer, heart failure, chronic obstructive pulmonary disease, coronary heart disease, schizophrenia, and depression. Many healthy participants practiced Tai Chi for the purpose of health promotion or preservation. Yang style Tai Chi was the most popular, and Tai Chi was frequently practiced two to three 1-hour sessions per week for 12 weeks. Tai Chi was used alone in more than half of the studies (58.6%), while in other studies Tai Chi was applied in combination with other therapies including medications, health education and other physical therapies. The majority of studies (94.1%) reported positive effects of Tai Chi, 5.1% studies reported uncertain effects and 0.8% studies reported negative effects. No serious adverse events related to Tai Chi were reported. CONCLUSIONS: The quantity and evidence base of clinical studies on Tai Chi is substantial. However, there is a wide variation in Tai Chi intervention studied and the reporting of Tai Chi intervention needs to be improved. Further well-designed and reported studies are recommended to confirm the effects of Tai Chi for the frequently reported diseases/conditions.

Acupuncture for dysphagia after chemoradiation in head and neck cancer: rationale and design of a randomized, sham-controlled trial.

INTRODUCTION: Dysphagia is a common side effect following chemoradiation therapy (CRT) in head and neck cancer (HNC) patients. Current dysphagia management includes swallowing therapy and dilation procedures, but these treatments have limitations. While acupuncture has been reported to positively impact swallowing function and quality of life (QOL) in patients with dysphagia, current evidence is inconclusive. MATERIAL AND METHODS: In an ongoing trial, 42 squamous cell carcinoma HNC patients, who are receiving platinum-based CRT with curative intent, are being recruited from a comprehensive cancer center. They are randomized to 12 sessions of either active acupuncture or to sham acupuncture during and following CRT over a 24-week period. Blinded research staff assesses outcomes at baseline, 20 weeks post-CRT (end of acupuncture), and 12 months after baseline (6-month follow-up). The primary outcome is change in M.D. Anderson Dysphagia Inventory score from baseline to 12 months. Secondary outcomes include QOL measures pertaining to HNC patients. In addition, a subset of study patients are tested for salivary flow rates and cytokines, including plasma transforming growth factor-ß1 and interleukin 6 (n=10 per arm), to preliminarily explore the biological mechanisms of acupuncture for dysphagia. DISCUSSION: This paper addresses unique challenges related to study design in nonpharmacological, sham-controlled acupuncture trials including development of evidence-based credible verum and sham treatment protocols, blinding, and assuring fidelity of treatment. Results of this study will inform the feasibility of conducting a large scale trial and will provide preliminary evidence regarding the value of acupuncture for dysphagia in HNC patients.

Electrodermal measures of Jing-Well points and their clinical relevance in endometriosis-related chronic pelvic pain.

OBJECTIVES: To determine whether electrodermal measures at Jing-Well acupuncture points, "indicator" points located at the tips of fingers and toes are associated with clinical measures in adolescent women with chronic pelvic pain. DESIGN: The design of this study was a randomized sham-controlled trial. Analyses of electrodermal measures were based on longitudinal, multivariable analyses using generalized estimating equations. SUBJECTS AND SETTING: The subjects were 14 young women (ages 14-22) with laparoscopically diagnosed endometriosis and chronic pelvic pain. Subjects were randomized to sham acupuncture or Japanese-style active acupuncture. Sixteen (16) treatments were administered over 8 weeks. OUTCOME MEASURES: Using a Hibiki-7 device, electrodermal impedance measures were obtained at all 24 Jing-Well points for each treatment visit. From these readings, measures of "imbalance" were determined by calculating statistical dispersion (statistical deviation and Gini coefficient) and level of asymmetry (left-right, top-bottom, and yin-yang). Clinical outcome measures were obtained at baseline, week 4, and week 8 and included level of pelvic pain, Endometriosis Health Profile, Pediatric Quality of Life, perceived stress, and inflammatory cytokine levels (interleukin-6 and tumor necrosis factor-alpha). RESULTS: Participants designated to the acupuncture group had, on average, a substantial decrease in statistical dispersion and asymmetry of Hibiki-7 values over the course of treatment compared to the sham group. Electrodermal asymmetry variables, specifically either yin-yang or left-right measure, were significantly associated with pelvic pain, Endometriosis Health Profile, Pediatric Quality of Life, and Perceived Stress even after adjusting for treatment designation. No associations between electrodermal balance measures and inflammatory cytokines were found. CONCLUSIONS: Electrodermal measures may be significantly associated with clinical outcome and acupuncture treatments in adolescent women with chronic pelvic pain.

Acupuncture for chemotherapy-induced neutropenia in patients with gynecologic malignancies: a pilot randomized, sham-controlled clinical trial.

OBJECTIVES: The objective of this study was to investigate the effect of acupuncture administered during myelosuppressive chemotherapy on white blood cell (WBC) count and absolute neutrophil count (ANC) in patients with ovarian cancer. DESIGN: This study is a pilot, randomized, sham-controlled clinical trial. Patients received active acupuncture versus sham acupuncture while undergoing chemotherapy. A standardized acupuncture protocol was employed with manual and electrostimulation. The frequency of treatment was 2-3 times per week for a total of 10 sessions, starting 1 week before the second cycle of chemotherapy. SETTING: The setting was two outpatient academic centers for patients with cancer. SUBJECTS: Twenty-one (21) newly diagnosed and recurrent ovarian cancer patients were the subjects. OUTCOME MEASURES: WBC count, ANC, and plasma granulocyte colony-stimulating factor (G-CSF ) were assessed weekly. RESULTS: The median leukocyte value in the acupuncture arm at the first day of the third cycle of chemotherapy was significantly higher than in the control arm after adjusting for baseline value (8600 cells/microL, range: 4800-12,000 versus 4400 cell/microL, range: 2300-10,000) (p = 0.046). The incidence of grade 2-4 leukopenia was less in the acupuncture arm than in the sham arm (30% versus 90%; p = 0.02). However, the median leukocyte nadir, neutrophil nadir, and recovering ANC were all higher but not statistically significantly different (p = 0.116-0.16), after adjusting for baseline differences. There were no statistically significant differences in plasma G-CSF between the two groups. CONCLUSIONS: We observed clinically relevant trends of higher WBC values during one cycle of chemotherapy in patients with ovarian cancer, which suggests a potential myeloprotective effect of acupuncture. A larger trial is warranted to more definitively determine the efficacy of acupuncture on clinically important outcomes of chemotherapy-induced neutropenia.