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Comparative effectiveness research (CER) is defined by the Institute of Medicine as "the generation and synthesis of evidence that compares the benefits and harms of alternative methods to prevent, diagnose, treat, and monitor a clinical condition or to im

Cancer pain impairs the quality of life of cancer patients, but opioid intervention can cause significant side effects that further decrease quality of life. Although electroacupuncture (EA) has been used to treat cancer pain, its mechanisms are largely unknown. To examine its effects and underlying mechanisms on cancer pain, we injected AT-3.1 prostate cancer cells into the tibia to induce bone cancer in the male Copenhagen rat. The resulting pain was treated with 10Hz/2mA/0.4ms pulse EA for 30min daily at the point equivalent to the human acupoint GB30 (Huantiao) between days 14 and 18 after the injection. For sham control, EA needles were inserted into GB30 without stimulation. Thermal hyperalgesia, a decrease in paw withdrawal latency (PWL) to a noxious thermal stimulus, and mechanical hyperalgesia, a decrease in paw withdrawal pressure threshold (PWPT), was measured at baseline and 20min after the EA treatment. Preprodynorphin mRNA and dynorphin were determined by RT-PCR and immunohistochemistry, respectively. Thermal and mechanical hyperalgesia developed ipsilaterally between days 12 and 18 after cancer cell inoculation. EA significantly (P<0.05) attenuated this hyperalgesia, as shown by increased PWL and PWPT, and inhibited up-regulation of preprodynorphin mRNA and dynorphin compared to sham control. Intrathecal injection of antiserum against dynorphin A (1-17) also significantly inhibited the cancer-induced hyperalgesia. These results suggest that EA alleviates bone cancer pain at least in part by suppressing dynorphin expression, and they support the clinical use of EA in the treatment of cancer pain. [ABSTRACT FROM AUTHOR]

This purpose of this article is to contrast the analgesic efficacy of acupuncture following dental surgery with the analgesic effects based on the expectation of benefit in two independently conducted placebo-controlled trials evaluating acupuncture as an adjunctive therapy for dental surgery. Both trials used pain following dental surgery as the outcome variable, and both included a blinding check to ascertain patients' beliefs regarding which treatment they were receiving. Although no statistically significant analgesic effect was observed between the acupuncture and placebo groups, participants in both experiments who believed they received real acupuncture reported significantly less pain than patients who believed that they received a placebo. Patients' beliefs regarding the receipt of acupuncture bore a stronger relationship to pain than any specific action possessed by acupuncture. These results also support the importance of both employing credible controls for the placebo effect in clinical trials and evaluating the credibility of those controls. [ABSTRACT FROM AUTHOR]

Background: Evidence on the efficacy of acupuncture for reducing the pain and dysfunction of osteoarthritis is equivocal.Objective: To determine whether acupuncture provides greater pain relief and improved function compared with sham acupuncture or education in patients with osteoarthritis of the knee.Design: Randomized, controlled trial.Setting: Two outpatient clinics (an integrative medicine facility and a rheumatology facility) located in academic teaching hospitals and 1 clinical trials facility.Patients: 570 patients with osteoarthritis of the knee (mean age [+/-SD], 65.5 +/- 8.4 years).Intervention: 23 true acupuncture sessions over 26 weeks. Controls received 6 two-hour sessions over 12 weeks or 23 sham acupuncture sessions over 26 weeks.Measurements: Primary outcomes were changes in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain and function scores at 8 and 26 weeks. Secondary outcomes were patient global assessment, 6-minute walk distance, and physical health scores of the 36-Item Short-Form Health Survey (SF-36).Results: Participants in the true acupuncture group experienced greater improvement in WOMAC function scores than the sham acupuncture group at 8 weeks (mean difference, -2.9 [95% CI, -5.0 to -0.8]; P = 0.01) but not in WOMAC pain score (mean difference, -0.5 [CI, -1.2 to 0.2]; P = 0.18) or the patient global assessment (mean difference, 0.16 [CI, -0.02 to 0.34]; P > 0.2). At 26 weeks, the true acupuncture group experienced significantly greater improvement than the sham group in the WOMAC function score (mean difference, -2.5 [CI, -4.7 to -0.4]; P = 0.01), WOMAC pain score (mean difference, -0.87 [CI, -1.58 to -0.16];P = 0.003), and patient global assessment (mean difference, 0.26 [CI, 0.07 to 0.45]; P = 0.02).Limitations: At 26 weeks, 43% of the participants in the education group and 25% in each of the true and sham acupuncture groups were not available for analysis.Conclusions: Acupuncture seems to provide improvement in function and pain relief as an adjunctive therapy for osteoarthritis of the knee when compared with credible sham acupuncture and education control groups. [ABSTRACT FROM AUTHOR]

Osteoarthritis is the most common form of arthritis, affecting millions of people in the United States. It is a complex disease whose etiology bridges biomechanics and biochemistry. Evidence is growing for the role of systemic factors, such as genetics, diet, estrogen use, and bone density, and local biomechanical factors, such as muscle weakness, obesity, and joint laxity. These risk factors are particularly important in the weight-bearing joints, and modifying them may help prevent osteoarthritis-related pain and disability. Major advances in management to reduce pain and disability are yielding a panoply of available treatments ranging from nutriceuticals to chondrocyte transplantation, new oral anti-inflammatory medications, and health education. This article is part 2 of a two-part summary of a National Institutes of Health conference that brought together experts in osteoarthritis from diverse backgrounds and provided a multidisciplinary and comprehensive summary of recent advances in the prevention of osteoarthritis onset, progression, and disability. Part 2 focuses on treatment approaches; evidence for the efficacy of commonly used oral therapies is reviewed and information on alternative therapies, including nutriceuticals and acupuncture, is presented. Biomechanical interventions, such as exercise and bracing, and behavioral interventions directed toward enhancing self-management are reviewed. Current surgical approaches are described and probable future biotechnology-oriented approaches to treatment are suggested. [ABSTRACT FROM AUTHOR]

BACKGROUND: Studies show that electroacupuncture (EA) has beneficial effects in patients with inflammatory diseases. This study investigated the mechanisms of EA anti-inflammation, using a rat model of complete Freund's adjuvant (CFA)-induced hind paw inflammation and hyperalgesia. DESIGN: Four experiments were conducted on male Sprague-Dawley rats (n = 6-7/per group). Inflammation was induced by injecting CFA into the plantar surface of one hind paw. Experiment 1 examined whether EA increases plasma adrenocorticotropic hormone (ACTH) levels. Experiments 2 and 3 studied the effects of the ACTH and corticotropin-releasing hormone (CRH) receptor antagonists, ACTH(11-24) and astressin, on the EA anti-edema. Experiment 4 determined whether EA activates CRH neurons in the paraventricular nucleus of the hypothalammus. EA treatment, 10 Hz at 3 mA and 0.1 ms pulse width, was given twice for 20 min each, once immediately post and again 2 hr post-CFA. Plasma ACTH levels, paw thickness, and paw withdrawal latency to a noxious thermal stimulus were measured 2 h and 5 h after the CFA. RESULTS: EA significantly increased ACTH levels 5 h (2 folds) after CFA compared to sham EA control, but EA alone in naive rats and CFA alone did not induce significant increases in ACTH. ACTH(11-24) and astressin blocked EA anti-edema but not EA anti-hyperalgesia. EA induced phosphorylation of NR1, an essential subunit of the N-methyl-D-aspartic acid (NMDA) receptor, in CRH-containing neurons of the paraventricular nucleus. CONCLUSION: The data demonstrate that EA activates CRH neurons to significantly increase plasma ACTH levels and suppress edema through CRH and ACTH receptors in a rat model of inflammation. [ABSTRACT FROM AUTHOR]

Acupuncture, a component of the health care system of China that can be traced back at least 2500 years, describes a family of procedures involving stimulation of anatomical locations on the skin by a variety of techniques. In November 1997, the National Institutes of Health conducted a consensus conference during which a panel of experts convened to discuss the scientific evidence regarding acupuncture. The panel concluded that acupuncture is an effective treatment for several medical conditions and described biochemical and physiologic mechanisms that begin to explain these effects. This presentation summarizes the evidence of the clinical efficacy of acupuncture and is divided into three segments. The first segment presents an overview of evidence-based medicine, the second segment summarizes the current evidence from systematic reviews of acupuncture, and the third segment looks to the future by proposing a stepwise method for designing phase I, II, and III acupuncture clinical trials. [ABSTRACT FROM AUTHOR]

This presentation provides an overview of studies that are of sound methodological quality and that contribute to the understanding of acupuncture. It is difficult to design an appropriate control group for acupuncture because acupuncture is an invasive, physical modality. No single control group can answer all of the research questions. Therefore, many types of control groups, each with advantages and disadvantages, have been used, depending on the specific questions being asked. Examples are taken from the different categories of control groups (e.g., acupuncture versus standard medical care). A model for future acupuncture research, which is simultaneously comprehensive and cost effective, is described. [ABSTRACT FROM AUTHOR]

During the past decade, the Cochrane Collaboration has been an increasingly important source of information on complementary and alternative medicine (CAM) therapies. From 2007 to 2008, the Cochrane CAM Field developed a topics list that allowed us to categorize all 396 Cochrane reviews related to CAM (as of The Cochrane Library, Issue 4, 2009). This topics list is an advance in making Cochrane reviews on CAM topics accessible to the public. In this article, we discuss challenges in developing the topics list, including developing an operational efinition of CAM, deciding which reviews should be included within the CAM Field's scope, developing the structured list of CAM Field-specific topics, and determining where in the topics list the reviews should be placed. Although aspects of our operational definition of CAM are open to revision, a standardized definition provides us with an objective, reproducible, and systematic method for defining and classifying CAM therapies. [ABSTRACT FROM AUTHOR]

Objective: The greater acceptance of acupuncture by healthcare professionals and the public has increased the importance of addressing public concern about its safety. Of particular concern has been the potential for transmission of infectious disease and organ and tissue injury, as well as the training and professional standards of acupuncture practitioners. This paper, therefore, addresses the following question: What is the frequency and severity of adverse complications and events in acupuncture treatment?Data Sources: All first-hand case reports of complications and adverse effects of acupuncture that could be identified in the English language literature were reviewed and classified according to type of complication or adverse effect, circumstances of the event, credentials of the acupuncturist, country of occurrence, and long-term patient outcome.Study Selection: The case reports were selected by a search of 9 databases and covered the years between 1965-1999.Data Extraction: Relevant papers were collected and analyzed by 2 reviewers. Over the 35 years, 202 incidents were identified in 98 relevant papers reported from 22 countries.Results: Types of complications included infections (primarily hepatitis from a few practitioners), and organ, tissue, and nerve injury. Adverse effects included cutaneous disorders, hypotension, fainting, and vomiting. There is a trend toward fewer reported serious complications after 1988.Conclusions: Declines in adverse reports may suggest that recent practices, such as clean needle techniques and more rigorous acupuncturist training requirements, have reduced the risks associated with the procedure. Therefore, acupuncture performed by trained practitioners using clean needle techniques is a generally safe procedure. [ABSTRACT FROM AUTHOR]

Human flourishing, the state of optimal functioning and well-being across all aspects of an individual's life, has been a topic of philosophical and theological discussion for centuries. In the mid-20th century, social psychologists and health scientists began exploring the concept of flourishing in the context of health and high-level wellness. However, it is only in recent years, in part due to the USD 43 million Global Flourishing Study including 22 countries, that flourishing has entered the mainstream discourse. Here, we explore this history and the rapid acceleration of research into human flourishing, defined as "the relative attainment of a state in which all aspects of a person's life are good" by the Harvard University's Flourishing Program. We also explore the construct of "vitality", which refers to a sense of aliveness, energy, and motivation; we contend that this has been neglected in the flourishing movement. We explore why incorporating measures of vitality, together with a broader biopsychosocial approach, considers all dimensions of the environment across time (the total exposome), which will greatly advance research, policies, and actions to achieve human flourishing.

Background: Non-specific low back pain is a common, potentially disabling condition usually treated with self-care and non-prescription medication. For chronic low back pain, current guidelines recommend exercise therapy. Yoga is a mind-body exercise sometimes used for non-specific low back pain., Objectives: To evaluate the benefits and harms of yoga for treating chronic non-specific low back pain in adults compared to sham yoga, no specific treatment, a minimal intervention (e.g. education), or another active treatment, focusing on pain, function, quality of life, and adverse events., Search Methods: We used standard, extensive Cochrane search methods. The latest search date was 31 August 2021 without language or publication status restrictions., Selection Criteria: We included randomized controlled trials of yoga compared to sham yoga, no intervention, any other intervention and yoga added to other therapies., Data Collection and Analysis: We followed standard Cochrane methods. Our major outcomes were 1. back-specific function, 2. pain, 3. clinical improvement, 4. mental and physical quality of life, 5. depression, and 6., Adverse Events: Our minor outcome was 1. work disability. We used GRADE to assess certainty of evidence for the major outcomes., Main Results: We included 21 trials (2223 participants) from the USA, India, the UK, Croatia, Germany, Sweden, and Turkey. Participants were recruited from both clinical and community settings. Most were women in their 40s or 50s. Most trials used iyengar, hatha, or viniyoga yoga. Trials compared yoga to a non-exercise control including waiting list, usual care, or education (10 trials); back-focused exercise such as physical therapy (five trials); both exercise and non-exercise controls (four trials); both non-exercise and another mind-body exercise (qigong) (one trial); and yoga plus exercise to exercise alone (one trial). One trial comparing yoga to exercise was an intensive residential one-week program, and we analyzed this trial separately. All trials were at high risk of performance and detection bias because participants and providers were not blinded to treatment, and outcomes were self-assessed. We found no trials comparing yoga to sham yoga. Low-certainty evidence from 11 trials showed that there may be a small clinically unimportant improvement in back-specific function with yoga (mean difference [MD] -1.69, 95% confidence interval [CI] -2.73 to -0.65 on the 0- to 24-point Roland-Morris Disability Questionnaire [RMDQ], lower = better, minimal clinically important difference [MCID] 5 points; 1155 participants) and moderate-certainty evidence from nine trials showed a clinically unimportant improvement in pain (MD -4.53, 95% CI -6.61 to -2.46 on a 0 to 100 scale, 0 no pain, MCID 15 points; 946 participants) compared to no exercise at three months. Low-certainty evidence from four trials showed that there may be a clinical improvement with yoga (risk ratio [RR] 2.33, 95% CI 1.46 to 3.71; assessed as participant rating that back pain was improved or resolved; 353 participants). Moderate-certainty evidence from six trials showed that there is probably a small improvement in physical and mental quality of life (physical: MD 1.80, 95% CI 0.27 to 3.33 on the 36-item Short Form [SF-36] physical health scale, higher = better; mental: MD 2.38, 95% CI 0.60 to 4.17 on the SF-36 mental health scale, higher = better; both 686 participants). Low-certainty evidence from three trials showed little to no improvement in depression (MD -1.25, 95% CI -2.90 to 0.46 on the Beck Depression Inventory, lower = better; 241 participants). There was low-certainty evidence from eight trials that yoga increased the risk of adverse events, primarily increased back pain, at six to 12 months (RR 4.76, 95% CI 2.08 to 10.89; 43/1000 with yoga and 9/1000 with no exercise; 1037 participants). For yoga compared to back-focused exercise controls (8 trials, 912 participants) at three months, we found moderate-certainty evidence from four trials for little or no difference in back-specific function (MD -0.38, 95% CI -1.33 to 0.62 on the RMDQ, lower = better; 575 participants) and very low-certainty evidence from two trials for little or no difference in pain (MD 2.68, 95% CI -2.01 to 7.36 on a 0 to 100 scale, lower = better; 326 participants). We found very low-certainty evidence from three trials for no difference in clinical improvement assessed as participant rating that back pain was improved or resolved (RR 0.97, 95% CI 0.72 to 1.31; 433 participants) and very low-certainty evidence from one trial for little or no difference in physical and mental quality of life (physical: MD 1.30, 95% CI -0.95 to 3.55 on the SF-36 physical health scale, higher = better; mental: MD 1.90, 95% CI -1.17 to 4.97 on the SF-36 mental health scale, higher = better; both 237 participants). No studies reported depression. Low-certainty evidence from five trials showed that there was little or no difference between yoga and exercise in the risk of adverse events at six to 12 months (RR 0.93, 95% CI 0.56 to 1.53; 84/1000 with yoga and 91/1000 with non-yoga exercise; 640 participants)., Authors' Conclusions: There is low- to moderate-certainty evidence that yoga compared to no exercise results in small and clinically unimportant improvements in back-related function and pain. There is probably little or no difference between yoga and other back-related exercise for back-related function at three months, although it remains uncertain whether there is any difference between yoga and other exercise for pain and quality of life. Yoga is associated with more adverse events than no exercise, but may have the same risk of adverse events as other exercise. In light of these results, decisions to use yoga instead of no exercise or another exercise may depend on availability, cost, and participant or provider preference. Since all studies were unblinded and at high risk of performance and detection bias, it is unlikely that blinded comparisons would find a clinically important benefit., (Copyright © 2022 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.)

Introduction: Culinary medicine training combining evidence-based nutrition instruction with experiential cooking application has improved nutrition knowledge, skills, and attitudes in the professional and personal lives of medical students. However, interprofessional culinary training remains largely unstudied among professional students who will be involved in collaborative patient care. The goal of this study was to evaluate the feasibility and effectiveness of an elective interprofessional culinary medicine course for students in the medical, pharmacy, social work, nursing, law, and dentistry schools at the University of Maryland, Baltimore. Methods: The interprofessional culinary medicine course was offered in-person at the teaching kitchen of the Nova Institute for Health in 2020 and virtually in 2021 during the COVID pandemic. The training featured five workshops combining instruction in a variety of popular diets, cooking a meal inspired by the diet in focus, and group discussion. Paired t tests were utilized to evaluate changes in pre-/post-training nutrition and interprofessional experience outcomes. Linear regression models were constructed to compare outcomes between in-person and virtual delivery. Results: A total of 62 students participated in the culinary medicine training. Confidence in all nutrition knowledge, skills, and attitudes, as well as interprofessional experience outcomes, improved after the training ( p  < 0.05). Similar improvements were noted in most outcomes with in-person and virtual delivery in linear regression modeling. Discussion: Interprofessional culinary medicine training is feasible, and virtual delivery may help enhance replicability in other settings.

Bold new approaches are urgently needed to overcome global health challenges. The proposed Advanced Research Projects Agency for Health (ARPA-H) is intended to provide rapid health breakthroughs. While new technologies for earlier disease detection and more effective treatment are critical, we urge equal attention be given to the wider (physical, emotional, social, political, and economic) environmental ecosystems driving the non-communicable disease (NCD) crisis in the first place. This requires an integrated, cross-sectoral vision that spans the interwoven connections affecting health across the scales of people, places, and planet. This wider "exposome" perspective considers biopsychosocial factors that promote resilience and reduce vulnerabilities of individuals and communities over time-the many variables driving health disparities. Since life course health is strongly determined by early life environments, early interventions should be prioritized as a matter of effectiveness and social justice. Here, we explore the origins of the Advanced Research Project Agency and point to its potential to build integrated solutions, with wisdom and ethical value systems as a compass. Since the planned ARPA-H is anticipated to spawn international collaborations, the imagined concept is of relevance to a broad audience of researchers. With appropriate input, the quest for health equity through personalized, precision medicine while deconstructing unacceptable structural inequities may be accelerated.

Objectives: Acceptance and Commitment Therapy (ACT) is an empirically supported treatment which aims to enhance self-acceptance and a commitment to core values. The present study examined the effectiveness of the Choice Point model of ACT in a residential substance use disorder (SUD) setting. Choice Point is a contemporary approach to ACT and targets transdiagnostic processes. Methods: This uncontrolled quasi-experimental design assessed 47 participants taking part in Choice Point for Substances (CHOPS) in order to investigate its influence on psychological inflexibility, values-based action, and self-compassion over time. The study additionally assessed for sleeper effects and associations between transdiagnostic processes and warning signs of relapse. Results: Findings demonstrated a decrease in psychological inflexibility and increases in values-based action and self-compassion over time. Gains were maintained at follow-up, and sleeper effects were observed for psychological inflexibility and mindfulness. Correlational analysis suggested that all transdiagnostic processes were related to warning signs of relapse at follow-up. Conclusion: These results provide preliminary evidence for the feasibility, acceptability, and effectiveness of CHOPS for SUD. Observed sleeper effects in psychological inflexibility and mindfulness indicate that CHOPS may provide longer-term benefits critical to a population where relapse is common. While encouraging, these findings should be interpreted with caution. Future research should utilize comparison groups when investigating CHOPS., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2021 Berman and Kurlancheek.)

Background: Elective culinary medicine education has become popular to help fill important gaps in physician nutrition training. The implementation and outcomes among the inaugural cohort of medical students who received culinary medicine training as a required component of medical school curriculum at the University of Maryland School of Medicine are described. Methods: Following a series of elective pilot sessions, culinary medicine training was provided to all first-year medical students in the 2019-2020 academic year. The 3-hour training included evidence-based nutrition lecture, cooking simple recipes, and group discussion of the application to personal and patient care. Pre-/postsession questionnaires assessed nutrition knowledge, skills, and attitudes as well as nutritional counseling confidence. Paired t -tests estimated mean differences in outcomes pre- and posttraining. Qualitative data were subjected to thematic analysis. Results: Overall, 119 of 125 (95.2%) students provided pre- and posttraining outcomes data. All nutritional and patient counseling outcomes improved ( P < .05). Themes of being better prepared to address healthy eating barriers in patient care and personal ability to make healthy dietary changes were noted in qualitative analysis. Conclusion: One session of culinary medicine training in core medical student curriculum was feasible and improved medical student nutrition knowledge, skills, and attitudes and confidence in patient nutrition counseling., Competing Interests: The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article., (© 2021 The Author(s).)

Vegetable intake is far below recommendations among African-American adolescents living in economically-underserved urban areas. While the National School Lunch Program (NSLP) helps overcome access barriers, vegetable intake remains challenging and novel interventions are required. A two-year, multi-phase, school-based intervention was conducted at an urban, economically-underserved, and predominantly African-American high school in Baltimore, Maryland to determine whether stakeholder-informed addition of spices and herbs to NSLP vegetables would increase intake. The stakeholder engagement phase included assessment of NSLP vegetable attitudes/preferences among 43 school stakeholders and subsequent student sensory testing. The second phase was conducted in the school cafeteria and consisted of eight weeks comparing student intake of typical vegetable recipes versus otherwise-identical recipes with spices and herbs. 4,570 student lunch plates were included in the vegetable intake comparison. Vegetable intake was measured by lunch tray plate waste. Willingness to try vegetables was assessed by the difference between plate waste and estimated mean vegetable served weight. Intake of typical vegetable recipes and vegetable recipes with spices and herbs was compared with student's t-test. Chi-square test was used to compare willingness to try vegetables. Total vegetable intake was 18.2% higher (8.22 grams per meal, p<0.0001) with spices and herbs than with typical recipes. There were no differences in trying vegetables with spices and herbs, although student-led advocacy was associated with increased trying vegetables with spices and herbs (78.8% with advocacy, 67.5% without advocacy, p<0.0001). The addition of spices and herbs to vegetables in the NSLP was feasible and associated with small increases in vegetable intake at an urban, economically-underserved, and predominantly African-American high school., Competing Interests: Declarations of interest: none

Background: Given the large number of obesity-focused studies conducted in schools, there is a surprising lack of data regarding teacher workplace health behaviors in the United States., Objective: To determine the feasibility and effectiveness of an onsite fitness facility with a structured integrative wellness program to improve health-related outcomes among teachers and staff at an urban elementary/middle school., Methods: A 2-year mixed-methods analysis using Patient-Reported Outcomes Measurement Information System (PROMIS) measures and qualitative interviews included 39 teachers and staff employed at an urban elementary/middle school in Baltimore, Maryland. The fitness facility was dedicated exclusively to teachers and staff and the integrative wellness program included group exercise classes, yoga, mindfulness, and nutrition competitions. T tests were used to compare quantitative outcomes at baseline, the end of year 1, and the end of year 2., Results: Compared to baseline, at year 1, there was a significant improvement in the PROMIS Sleep Disturbance score. From baseline to end of year 2, there were significant increases in the PROMIS Global Physical Health as well as significant decreases in Sleep Disturbances, Fatigue, and Social Isolation. Qualitative interviews conducted at the end of year 1 indicated that teachers who used the facility felt that it improved their mood, increased their energy, motivated them to eat healthily, and gave them opportunities to socialize with their colleagues in new ways. This impact was further enhanced in year 2., Conclusions: An onsite fitness facility with an integrative wellness program may improve health-related outcomes among urban elementary school teachers and staff, with the greatest benefits seen after 2 years of implementation.

Rheumatoid arthritis (RA) is a chronic, debilitating illness characterized by painful swelling of the joints, inflammation of the synovial lining of the joints, and damage to cartilage and bone. Several anti-inflammatory and disease-modifying drugs are available for RA therapy. However, the prolonged use of these drugs is associated with severe side effects. Furthermore, these drugs are effective only in a proportion of RA patients. Hence, there is a need to search for new therapeutic agents that are effective yet safe. Interestingly, a variety of herbs and other natural products offer a vast resource for such anti-arthritic agents. We discuss here the basic features of RA pathogenesis; the commonly used animal models of RA; the mainstream drugs used for RA; the use of well-characterized natural products possessing anti-arthritic activity; the application of nanoparticles for efficient delivery of such products; and the interplay between dietary products and the host microbiome for maintenance of health and disease induction. We believe that with several advances in the past decade in the characterization and functional studies of natural products, the stage is set for widespread clinical testing and/or use of these products for the treatment of RA and other diseases.

Background: Hip osteoarthritis (OA) is a major cause of pain and functional limitation. Few hip OA treatments have been evaluated for safety and effectiveness. Acupuncture is a traditional Chinese medical therapy which aims to treat disease by inserting very thin needles at specific points on the body., Objectives: To assess the benefits and harms of acupuncture in patients with hip OA., Search Methods: We searched Cochrane CENTRAL, MEDLINE, and Embase all through March 2018., Selection Criteria: We included randomized controlled trials (RCTs) that compared acupuncture with sham acupuncture, another active treatment, or no specific treatment; and RCTs that evaluated acupuncture as an addition to another treatment. Major outcomes were pain and function at the short term (i.e. < 3 months after randomization) and adverse events., Data Collection and Analysis: We used standard methodological procedures expected by Cochrane., Main Results: Six RCTs with 413 participants were included. Four RCTs included only people with OA of the hip, and two included a mix of people with OA of the hip and knee. All RCTs included primarily older participants, with a mean age range from 61 to 67 years, and a mean duration of hip OA pain from two to eight years. Approximately two-thirds of participants were women. Two RCTs compared acupuncture versus sham acupuncture; the other four RCTs were not blinded. All results were evaluated at short term (i.e. four to nine weeks after randomization).In the two RCTs that compared acupuncture to sham acupuncture, the sham acupuncture control interventions were judged believable, but each sham acupuncture intervention was also judged to have a risk of weak acupuncture-specific effects, due to placement of non-penetrating needles at the correct acupuncture points in one RCT, and the use of penetrating needles not inserted at the correct points in the other RCT. For these two sham-controlled RCTs, the risk of bias was low for all outcomes.The combined analysis of two sham-controlled RCTs gave moderate quality evidence of little or no effect in reduction in pain for acupuncture relative to sham acupuncture. Due to the small sample sizes in the studies, the confidence interval includes both the possibility of moderate benefit and the possibility of no effect of acupuncture (120 participants; Standardized Mean Difference (SMD) -0.13, (95% Confidence Interval (CI) -0.49 to 0.22); 2.1 points greater improvement with acupuncture compared to sham acupuncture on 100 point scale (i.e., absolute percent change -2.1% (95% CI -7.9% to 3.6%)); relative percent change -4.1% (95% CI -15.6% to 7.0%)). Estimates of effect were similar for function (120 participants; SMD -0.15, (95% CI -0.51 to 0.21)). No pooled estimate, representative of the two sham-controlled RCTs, could be calculated or reported for the quality of life outcome.The four other RCTs were unblinded comparative effectiveness RCTs, which compared (additional) acupuncture to four different active control treatments.There was low quality evidence that addition of acupuncture to the routine primary care that RCT participants were receiving from their physicians was associated with statistically significant and clinically relevant benefits, compared to the routine primary physician care alone, in pain (1 RCT; 137 participants; mean percent difference -22.9% (95% CI -29.2% to -16.6%); relative percent difference -46.5% (95% CI -59.3% to -33.7%)) and function (mean percent difference -19.0% (95% CI -24.41 to -13.59); relative percent difference -38.6% (95% CI -49.6% to -27.6%)). There was no statistically significant difference for mental quality of life and acupuncture showed a small, significant benefit for physical quality of life.The effects of acupuncture compared with either advice plus exercise or NSAIDs are uncertain.We are also uncertain whether acupuncture plus patient education improves pain, function, and quality of life, when compared to patient education alone.In general, the overall quality of the evidence for the four comparative effectiveness RCTs was low to very low, mainly due to the potential for biased reporting of patient-assessed outcomes due to lack of blinding and sparse data.Information on safety was reported in four RCTs. Two RCTs reported minor side effects of acupuncture, which were primarily minor bruising, bleeding, or pain at needle insertion sites. Four RCTs reported on adverse events, and none reported any serious adverse events attributed to acupuncture., Authors' Conclusions: Acupuncture probably has little or no effect in reducing pain or improving function relative to sham acupuncture in people with hip osteoarthritis. Due to the small sample size in the studies, the confidence intervals include both the possibility of moderate benefits and the possibility of no effect of acupuncture. One unblinded trial found that acupuncture as an addition to routine primary physician care was associated with benefits on pain and function. However, these reported benefits are likely due at least partially to RCT participants' greater expectations of benefit from acupuncture. Possible side effects associated with acupuncture treatment were minor.

Background: Current medical treatments for chemotherapy-induced pain (CIP) are either ineffective or have adverse side effects. Acupuncture may alleviate CIP, but its effectiveness against this condition has not been studied. Paclitaxel causes neuropathic pain in cancer patients., Methods: We evaluated the effects of electroacupuncture (EA) on paclitaxel-induced CIP in a rat model. Paclitaxel (2 mg/kg) or vehicle was injected (i.p.) on alternate days of 0-6. The resulting pain was treated with 10 Hz/2 mA/0.4 ms pulse EA for 30 min at the equivalent of human acupoint GB30 (Huantiao) once every other day between days 14 and 26. For sham control, EA needles were inserted into GB30 without stimulation. Von Frey filaments with bending forces of 2-8 g and 15 g were used to assess mechanical allodynia and hyperalgesia, respectively, on day 13 and once every other day between 14-26 days and then for 2-3 weeks after EA treatment., Results: Compared to sham control, EA significantly alleviated paclitaxel-induced mechanical allodynia and hyperalgesia, as shown by less frequent withdrawal responses to the filaments. The alleviation of allodynia/hyperalgesia lasted up to 3 weeks after the EA treatment. EA significantly inhibited phosphorylation of Ca 2+ /calmodulin-dependent protein kinase II (CaMKII) in the spinal cord. KN-93, a selective inhibitor of p-CaMKII, inhibited mechanical allodynia/hyperalgesia and p-CaMKII. 5-HT1A receptor antagonist blocked EA inhibition of allodynia/hyperalgesia and p-CaMKII., Conclusions: Electroacupuncture activates 5-HT 1A receptors in the spinal cord and inhibits p-CaMKII to alleviate both allodynia and hyperalgesia. The data support acupuncture/EA as a complementary therapy for CIP., Significance: Electroacupuncture (EA) activates spinal 5-HT1A receptors to inhibit p-CaMKII to alleviate paclitaxel-induced pain. Acupuncture/EA may be used as a complementary therapy for CIP., (© 2017 European Pain Federation - EFIC®.)

Context: Physical inactivity, poor nutrition, and chronic stress threaten the health of African-American youth in urban environments. Conditions often worsen in summer with diminished access to healthy foods and safe venues for physical activity., Objective: A public-private partnership was formed to develop and evaluate an integrative health intervention entitled "Mission Thrive Summer" (MTS)., Methods: The MTS setting was an urban farm and adjacent school in a low-income community in Baltimore, Maryland. The intervention included farming, nutrition education, cooking, physical activity, yoga, mindfulness, and employment. Mixed-methods outcomes evaluation was conducted. Quantitative measures included accelerometry and self-reported health behaviors, using the Child and Adolescent Mindfulness Measure, Perceived Stress Scale, Physical Activity Questionnaire for Adolescents (PAQA), CDC Youth Risk Behavior Survey, and Block Kids Food Screener (BKFS). Outcomes were compared pre- and post-intervention using paired t-tests. Qualitative evaluation was based on participant and parent interviews., Participants: In total, 36 African-American 9th- and 10th-grade students joined MTS (17 in 2013, 26 in 2014, and 7 participating both years)., Results: In total, 88% of participants completed MTS. Accelerometry revealed that participants took 7158 steps and burned 544 calories per day during MTS. Participants experienced statistically significant improvements in self-reported physical activity (PAQA) and dietary habits (BKFS). Surveys did not detect changes in stress or mindfulness (P > .05). Qualitative data demonstrated new knowledge and skills, increased self-efficacy, health behavior change, and program enjoyment., Conclusions: MTS was feasible among African-American high school students in Baltimore. Mixed-methods outcomes evaluation provided preliminary evidence of health behavior change during the summer and at follow-up., (Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.)

Background and Objective: Randomized trials may be designed to provide evidence more strongly related to efficacy or effectiveness of an intervention. When systematic reviews are used to inform clinical or policy decisions, it is important to know the efficacy-effectiveness nature of the included trials. The objective of this study was to develop a tool to characterize randomized trials included in a systematic review on an efficacy-effectiveness continuum., Methods: We extracted rating domains and descriptors from existing tools and used a modified Delphi procedure to condense the domains and develop a new tool. The feasibility and interrater reliability of the tool was tested on trials from four systematic reviews., Results: The Rating of Included Trials on the Efficacy-Effectiveness Spectrum (RITES) tool rates clinical trials on a five-point Likert scale in four domains: (1) participant characteristics, (2) trial setting, (3) flexibility of interventions, and (4) clinical relevance of interventions. When RITES was piloted on trials from three reviews by unaffiliated raters, ratings were variable (intraclass correlation coefficient [ICC] 0.25-0.66 for the four domains); but, when RITES was used on one review by the review authors with expertise on the topic, the ratings were consistent (ICCs > 0.80., Conclusion: RITES may help to characterize the efficacy-effectiveness nature of trials included in systematic reviews., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Background: Non-specific low back pain is a common, potentially disabling condition usually treated with self-care and non-prescription medication. For chronic low back pain, current guidelines state that exercise therapy may be beneficial. Yoga is a mind-body exercise sometimes used for non-specific low back pain., Objectives: To assess the effects of yoga for treating chronic non-specific low back pain, compared to no specific treatment, a minimal intervention (e.g. education), or another active treatment, with a focus on pain, function, and adverse events., Search Methods: We searched CENTRAL, MEDLINE, Embase, five other databases and four trials registers to 11 March 2016 without restriction of language or publication status. We screened reference lists and contacted experts in the field to identify additional studies., Selection Criteria: We included randomized controlled trials of yoga treatment in people with chronic non-specific low back pain. We included studies comparing yoga to any other intervention or to no intervention. We also included studies comparing yoga as an adjunct to other therapies, versus those other therapies alone., Data Collection and Analysis: Two authors independently screened and selected studies, extracted outcome data, and assessed risk of bias. We contacted study authors to obtain missing or unclear information. We evaluated the overall certainty of evidence using the GRADE approach., Main Results: We included 12 trials (1080 participants) carried out in the USA (seven trials), India (three trials), and the UK (two trials). Studies were unfunded (one trial), funded by a yoga institution (one trial), funded by non-profit or government sources (seven trials), or did not report on funding (three trials). Most trials used Iyengar, Hatha, or Viniyoga forms of yoga. The trials compared yoga to no intervention or a non-exercise intervention such as education (seven trials), an exercise intervention (three trials), or both exercise and non-exercise interventions (two trials). All trials were at high risk of performance and detection bias because participants and providers were not blinded to treatment assignment, and outcomes were self-assessed. Therefore, we downgraded all outcomes to 'moderate' certainty evidence because of risk of bias, and when there was additional serious risk of bias, unexplained heterogeneity between studies, or the analyses were imprecise, we downgraded the certainty of the evidence further.For yoga compared to non-exercise controls (9 trials; 810 participants), there was low-certainty evidence that yoga produced small to moderate improvements in back-related function at three to four months (standardized mean difference (SMD) -0.40, 95% confidence interval (CI) -0.66 to -0.14; corresponding to a change in the Roland-Morris Disability Questionnaire of mean difference (MD) -2.18, 95% -3.60 to -0.76), moderate-certainty evidence for small to moderate improvements at six months (SMD -0.44, 95% CI -0.66 to -0.22; corresponding to a change in the Roland-Morris Disability Questionnaire of MD -2.15, 95% -3.23 to -1.08), and low-certainty evidence for small improvements at 12 months (SMD -0.26, 95% CI -0.46 to -0.05; corresponding to a change in the Roland-Morris Disability Questionnaire of MD -1.36, 95% -2.41 to -0.26). On a 0-100 scale there was very low- to moderate-certainty evidence that yoga was slightly better for pain at three to four months (MD -4.55, 95% CI -7.04 to -2.06), six months (MD -7.81, 95% CI -13.37 to -2.25), and 12 months (MD -5.40, 95% CI -14.50 to -3.70), however we pre-defined clinically significant changes in pain as 15 points or greater and this threshold was not met. Based on information from six trials, there was moderate-certainty evidence that the risk of adverse events, primarily increased back pain, was higher in yoga than in non-exercise controls (risk difference (RD) 5%, 95% CI 2% to 8%).For yoga compared to non-yoga exercise controls (4 trials; 394 participants), there was very-low-certainty evidence for little or no difference in back-related function at three months (SMD -0.22, 95% CI -0.65 to 0.20; corresponding to a change in the Roland-Morris Disability Questionnaire of MD -0.99, 95% -2.87 to 0.90) and six months (SMD -0.20, 95% CI -0.59 to 0.19; corresponding to a change in the Roland-Morris Disability Questionnaire of MD -0.90, 95% -2.61 to 0.81), and no information on back-related function after six months. There was very low-certainty evidence for lower pain on a 0-100 scale at seven months (MD -20.40, 95% CI -25.48 to -15.32), and no information on pain at three months or after seven months. Based on information from three trials, there was low-certainty evidence for no difference in the risk of adverse events between yoga and non-yoga exercise controls (RD 1%, 95% CI -4% to 6%).For yoga added to exercise compared to exercise alone (1 trial; 24 participants), there was very-low-certainty evidence for little or no difference at 10 weeks in back-related function (SMD -0.60, 95% CI -1.42 to 0.22; corresponding to a change in the Oswestry Disability Index of MD -17.05, 95% -22.96 to 11.14) or pain on a 0-100 scale (MD -3.20, 95% CI -13.76 to 7.36). There was no information on outcomes at other time points. There was no information on adverse events.Studies provided limited evidence on risk of clinical improvement, measures of quality of life, and depression. There was no evidence on work-related disability., Authors' Conclusions: There is low- to moderate-certainty evidence that yoga compared to non-exercise controls results in small to moderate improvements in back-related function at three and six months. Yoga may also be slightly more effective for pain at three and six months, however the effect size did not meet predefined levels of minimum clinical importance. It is uncertain whether there is any difference between yoga and other exercise for back-related function or pain, or whether yoga added to exercise is more effective than exercise alone. Yoga is associated with more adverse events than non-exercise controls, but may have the same risk of adverse events as other back-focused exercise. Yoga is not associated with serious adverse events. There is a need for additional high-quality research to improve confidence in estimates of effect, to evaluate long-term outcomes, and to provide additional information on comparisons between yoga and other exercise for chronic non-specific low back pain., Competing Interests: DECLARATIONS OF INTEREST No known conflicts of interest. RV is a volunteer researcher with Yoga Sangeeta, a non-profit organization which promotes music for meditation and healing.

Purpose: To determine whether an experiential nutrition education intervention focusing on spices and herbs ("Spice MyPlate") is feasible and improves diet quality and healthy eating attitudes among an urban and predominantly African-American sample of adolescents more than standard nutrition education alone., Design: A nonrandomized controlled trial compared standard nutrition education in U.S. Department of Agriculture MyPlate guidelines (control group) with standard nutrition education plus adjuvant Spice MyPlate curriculum (intervention group). Data were collected at baseline and after 3, 6, and 10 weeks., Setting: Study setting was two public high schools in Baltimore, Maryland., Subjects: A total of 110 students in grades 9 to 12 participated., Intervention: The 6-week school-based intervention conducted during health class focused on cooking using spices and herbs to eat healthier diets according to MyPlate., Measures: Dietary intake reported on 3-day food records and healthy eating attitudes questionnaires was analyzed., Analysis: Differences in diet quality and healthy eating attitudes between study groups were estimated by t-tests, Wilcoxon-Mann-Whitney tests, and covariate-adjusted regression models., Results: Spice MyPlate was feasible and there were modest but significant improvements (p ≤ .05) in the Spice MyPlate group compared with control in whole grains (31.2 g/wk) and protein foods (13.2 ounces per week) intake, and attitudes toward eating vegetables, whole grains, lean protein, and low-fat dairy., Conclusions: Although randomized trials are needed, experiential nutrition education focusing on spices and herbs may help urban and predominantly African-American adolescent populations eat healthier diets., (© The Author(s) 2016.)

Study Design: Systematic review of randomized controlled trials (RCTs)., Objectives: To determine the effectiveness of herbal medicine for nonspecific low back pain (LBP)., Summary of Background Data: Many people with chronic LBP use complementary and alternative medicine (CAM), visit CAM practitioners, or both. Several herbal medicines have been purported for use in treating people with LBP. This is an update of a Cochrane Review first published in 2006., Methods: We searched numerous electronic databases up to September 2014; checked reference lists in review articles, guidelines and retrieved trials; and personally contacted individuals with expertise in this area. We included RCTs examining adults (over 18 years of age) suffering from acute, sub-acute, or chronic nonspecific LBP. The interventions were herbal medicines that we defined as plants used for medicinal purposes in any form. Primary outcome measures were pain and function. Two review authors assessed risk of bias, GRADE criteria (GRADE 2004), and CONSORT compliance and a random subset were compared with assessments by a third individual. Two review authors assessed clinical relevance and resolved any disagreements by consensus., Results: Fourteen RCTs (2050 participants) were included. Capsicum frutescens (cayenne) reduces pain more than placebo. Although Harpagophytum procumbens (devil's claw), Salix alba (white willow bark), Symphytum officinale L. (comfrey), Solidago chilensis (Brazilian arnica), and lavender essential oil also seem to reduce pain more than placebo, evidence for these substances was of moderate quality at best. No significant adverse events were noted within the included trials., Conclusions: Additional well-designed large trials are needed to test these herbal medicines against standard treatments. In general, the completeness of reporting in these trials was poor. Trialists should refer to the CONSORT statement extension for reporting trials of herbal medicine interventions., Level of Evidence: N/A.

Purpose: The rapidly increasing incidence of Lyme disease has become a serious public health problem. Persistent symptoms of Lyme disease occur in over 40% of the 300,000 new cases diagnosed annually in the United States and often include debilitating musculoskeletal pain, fatigue, and poor health-related quality of life. No clinical practice guidelines for Lyme disease currently include resistance exercise partly because of concern over its safety and feasibility in this population. The goal of this pilot study was to evaluate the feasibility and preliminary efficacy of a supervised, low-intensity resistance exercise program in a sample of patients with persistent symptoms of Lyme disease., Methods: An uncontrolled resistance exercise intervention was conducted under the supervision of an exercise professional. Participants performed three exercise sessions per week for 4 wk. Each exercise session consisted of one set of varying repetitions of the leg press, seated row, vertical chest press, standing heel raise, and supine abdominal crunch. Outcomes were assessed at baseline and the end of each week of intervention and included musculoskeletal pain, fatigue, health-related quality of life, vitality, and exercise performance. ANOVA and t-tests were performed to assess changes in the study outcomes., Results: Eight patients participated in the exercise intervention. All participants successfully completed the intervention, and there were no adverse events related to exercise. Statistically significant improvements (P ≤ 0.05) were noted in exercise performance and in the number of days out of the past 30 d feeling healthy and full of energy (0.6 at baseline and 4.5 at end of intervention)., Conclusions: Although larger and controlled studies are necessary, supervised resistance exercise was feasible and may benefit patients with persistent symptoms of Lyme disease.

Background: Low-back pain (LBP) is a common condition and imposes a substantial economic burden upon people living in industrialized societies. A large proportion of people with chronic LBP use complementary and alternative medicine (CAM), visit CAM practitioners, or both. Several herbal medicines have been purported for use in treating people with LBP. This is an update of a Cochrane Review first published in 2006., Objectives: To determine the effectiveness of herbal medicine for non-specific LBP., Search Methods: We searched the following electronic databases up to September 2014: MEDLINE, EMBASE, CENTRAL, CINAHL, Clinical Trials.gov, World Health Organization International Clinical Trials Registry Portal and PubMed; checked reference lists in review articles, guidelines and retrieved trials; and personally contacted individuals with expertise in this area., Selection Criteria: We included randomized controlled trials (RCTs) examining adults (over 18 years of age) suffering from acute, sub-acute, or chronic non-specific LBP. The interventions were herbal medicines which we defined as plants used for medicinal purposes in any form. Primary outcome measures were pain and function., Data Collection and Analysis: A library scientist with the Cochrane Back Review Group conducted the database searches. One review author contacted content experts and acquired relevant citations. We downloaded full references and abstracts of the identified studies and retrieved a hard copy of each study for final inclusion decisions. Two review authors assessed risk of bias, GRADE criteria (GRADE 2004), and CONSORT compliance and a random subset were compared to assessments by a third individual. Two review authors assessed clinical relevance and resolved any disagreements by consensus., Main Results: We included 14 RCTs (2050 participants) in this review. One trial on Solidago chilensis M. (Brazilian arnica) (20 participants) found very low quality evidence of reduction in perception of pain and improved flexibility with application of Brazilian arnica-containing gel twice daily as compared to placebo gel. Capsicum frutescens cream or plaster probably produces more favourable results than placebo in people with chronic LBP (three trials, 755 participants, moderate quality evidence). Based on current evidence, it is not clear whether topical capsicum cream is more beneficial for treating people with acute LBP compared to placebo (one trial, 40 participants, low quality evidence). Another trial found equivalence of C. frutescens cream to a homeopathic ointment (one trial, 161 participants, very low quality evidence). Daily doses of Harpagophytum procumbens (devil's claw), standardized to 50 mg or 100 mg harpagoside, may be better than placebo for short-term improvements in pain and may reduce use of rescue medication (two trials, 315 participants, low quality evidence). Another H. procumbens trial demonstrated relative equivalence to 12.5 mg per day of rofecoxib (Vioxx®) but was of very low quality (one trial, 88 participants, very low quality). Daily doses of Salix alba (white willow bark), standardized to 120 mg or 240 mg salicin, are probably better than placebo for short-term improvements in pain and rescue medication (two trials, 261 participants, moderate quality evidence). An additional trial demonstrated relative equivalence to 12.5 mg per day of rofecoxib (one trial, 228 participants) but was graded as very low quality evidence. S. alba minimally affected platelet thrombosis versus a cardioprotective dose of acetylsalicylate (one trial, 51 participants). One trial (120 participants) examining Symphytum officinale L. (comfrey root extract) found low quality evidence that a Kytta-Salbe comfrey extract ointment is better than placebo ointment for short-term improvements in pain as assessed by VAS. Aromatic lavender essential oil applied by acupressure may reduce subjective pain intensity and improve lateral spine flexion and walking time compared to untreated participants (one trial, 61 participants,very low quality evidence). No significant adverse events were noted within the included trials., Authors' Conclusions: C. frutescens (Cayenne) reduces pain more than placebo. Although H. procumbens, S. alba, S. officinale L., S. chilensis, and lavender essential oil also seem to reduce pain more than placebo, evidence for these substances was of moderate quality at best. Additional well-designed large trials are needed to test these herbal medicines against standard treatments. In general, the completeness of reporting in these trials was poor. Trialists should refer to the CONSORT statement extension for reporting trials of herbal medicine interventions.

The interest in Comparative Effectiveness Research (CER) in the international community is growing. A panel titled "What Can Comparative Effectiveness Research Contribute to Integrative Health in International Perspective?" took place at the 3rd International Research Congress on Integrative Medicine and Health in Portland, Oregon, in 2012. The presentations at this panel highlighted different perspectives on CER, including the funders' and the stakeholders' perspectives from the United States, as well as experiences with economic evaluations from Australia and pragmatic trials in Europe. The funders' perspective emphasized the need for innovation and controlling costs in large-scale studies. The stakeholder's perspective stressed the need to gather the input of stakeholders in shaping the framework for more informative, more decision-maker-driven research. Several examples of cost-effectiveness analyses were offered from Australia. The importance of balancing rigor and pragmatism was also discussed in a presentation of the efficacy-effectiveness continuum. A wide-ranging discussion explored additional questions concerning the translation of evidence into practice; the effect of pragmatic trials on funding or policy; evidentiary distinctions between and among pragmatic trials and traditional randomized clinical trials; and the multiple roles of stakeholders, particularly in generating new information and knowledge. The presentations and discussions showed that more development of methods is needed. This includes developments on study design and statistical approaches, as well as methods for stakeholder involvement and mechanisms to bring these results into practice.

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