The effect of a fermented soy beverage among patients with localized prostate cancer prior to radical prostatectomy.

BACKGROUND: Fermented soy products have shown to possess inhibitory effects on prostate cancer (PCa). We evaluated the effect of a fermented soy beverage (Q-Can®), containing medium-chain triglycerides, ketones and soy isoflavones, among men with localized PCa prior to radical prostatectomy. METHODS: We conducted a placebo-controlled, double-blind randomized trial of Q-Can®. Stratified randomization (Cancer of the Prostate Risk Assessment (CAPRA) score at diagnosis) was used to assign patients to receive Q-Can® or placebo for 2-5 weeks before RP. Primary endpoint was change in serum PSA from baseline to end-of-study. We assessed changes in other clinical and pathologic endpoints. The primary ITT analysis compared PSA at end-of-study between randomization arms using repeated measures linear mixed model incorporating baseline CAPRA risk strata. RESULTS: We randomized 19 patients, 16 were eligible for analysis of the primary outcome. Mean age at enrollment was 61, 9(56.2%) were classified as low and intermediate risk, and 7(43.8%) high CAPRA risk. Among patients who received Q-Can®, mean PSA at baseline and end-of-study was 8.98(standard deviation, SD 4.07) and 8.02ng/mL(SD 3.99) compared with 8.66(SD 2.71) to 9.53ng/mL(SD 3.03), respectively, (Difference baseline - end-of-study, p = 0.36). There were no significant differences in Gleason score, clinical stage, surgical margin status, or CAPRA score between treatment arms (p > 0.05), and no significant differences between treatment arms in end-of-study or change in lipids, testosterone and FACT-P scores (p > 0.05). CONCLUSIONS: Short exposure to Q-Can® among patients with localized PCa was not associated with changes in PSA levels, PCa characteristics including grade and stage or serum testosterone. Due to early termination from inability to recruit, study power, was not achieved.

Exploring the impact of energy consumption on poverty in Pakistan: evidence from the asymmetric ARDL approach.

This research work contributes to the literature by examining the role of energy consumption in mitigating poverty via decomposing energy consumption into its positive and negative components, covering the period spanning from 1985 to 2017. To accomplish this objective, this study employs the nonlinear autoregressive distributed lag (NARDL) approach recently popularized by Shin et al., (2014). The NARDL approach is well-suited to our study becuase of its capability to delineate hidden asymmetries. The empirical findings reveal the prevalence of long-run associations among the studied variables. The outcomes show that an increase (decrease) in energy consumption combats (augments) poverty in Pakistan. The empirical findings underscore that the decreasing effect of energy consumption on poverty is found to be more promising than its increasing effect, both in the long and short run. Based on the empirical outcomes, we suggest that the policymakers, and other stakeholders should consider the asymmetric or nonlinear behavior of the studied variables for better poverty policy-making in Pakistan.

Role of renewable and non-renewable energy consumption in environmental quality and their subsequent effects on average temperature: an assessment of sustainable development goals in South Korea.

Environmental quality is a global concern, and an accurate assessment of environmental progress has emerged as a key element in achieving sustainable development goals. The study offers a two-pronged contribution by analyzing the interplay between renewable energy consumption, traditional energy consumption, and urbanization on environmental quality while simultaneously testing the impact of environmental quality on average temperature. Distinguishing itself from prior research, the study employs both carbon emissions and ecological footprint to ensure an intricate and reliable analysis. Current study analyzes data from 1970 to 2022 from South Korea to indicate that energy-environment association is influenced by energy consumption, urbanization, and economic growth, while renewable energy consumption is key in long-term environmental sustainability. Our extensive econometric analysis allows us to suggest that South Korea need to prioritize renewable energy, and green growth is prioritized so that economic growth and green agenda are synchronized to overcome environmental challenges. Addictingly, there is need to devise long-term environmental policies to strengthen the role of environmental innovation in energy productivity and boost renewable energy consumption.

Fermented Soy Drink (Q-CAN® PLUS) Induces Apoptosis and Reduces Viability of Cancer Cells.

This study tested the ability of a fermented soy product to induce tumor cell toxicity and to assess if this was due to fermentation of soy, and to the genistein content. Four cancer cell lines were cultured without additive, with fermented soy (Q-CAN® PLUS), nonfermented soy, or genistein, and cell viability was examined at 24 h, 48 h, and 72 h. The sensitivity of the cell lines to apoptosis by Q-CAN PLUS was tested with the Annexin V assay. All cell lines demonstrated a dose and time response reduction in tumor cell viability with exposure to Q-CAN PLUS (IC50 at 24 h 3.8 mg/mL to 9 mg/mL). Unfermented soy did not show reduction in viability of any cell line within the same concentration range. The IC50 of genistein for each of the cell lines was significantly greater than for Q-CAN PLUS. All four tumor cell lines demonstrated apoptosis in response to Q-CAN PLUS. Q-CAN PLUS reduces viability and increases apoptosis of cancer cells in a concentration- and fermentation-dependent manner. Taking into consideration the IC50 of genistein and the concentration of genistein in Q-CAN PLUS, the genistein content of Q-CAN PLUS is not responsible for the majority reduction in tumor cell viability. This suggests that fermentation of soy results in the production of metabolites that reduce cancer cell viability and induce cellular apoptosis, and play a major role in addition to any effects produced by their genistein content.

Flood risk perception and communication: The role of hazard proximity.

Climate change-induced extreme events have increased worldwide, including riverine flooding in rural areas. Risk communication is an effective mechanism that affects risk perception and can significantly reduce flood risk. This study quantifies risk perception and communication in flood-prone rural areas of District Dera Ghazi Khan, Pakistan. The rural communities were divided into two zones based on the distance from rivers, i.e., Zone 1 (households within 0-3 km) and Zone 2 (households within 3-6 km). After a thorough literature review, indicators measured on the Likert scale were selected for risk perception and communication. Using Yamane's sampling, 420 samples were collected using a household survey. Chi-square and t-tests were used to identify differences between the two zones. Linear regression was performed to identify the socioeconomic determinants of risk communication and perception. Results showed that the people living away from the river had higher risk perception and received better risk communication than their peers. The main reason was attributed to their past flood experiences. The study also found a strong correlation between flood risk perception and risk communication. Hazard proximity was also found to affect risk perception and communication. People with higher risk perception are likely to seek risk communication information and engage in flood preparedness and mitigation measures. This study provides an insight into the need for risk communication for improving the effectiveness of flood risk reduction.

Asymmetric relationship of environmental degradation and economic growth with tourism demand in Pakistan: evidence from non-linear ARDL and causality estimation.

The purpose of this study is to assess the asymmetric associations of environmental degradation and economic growth with Pakistan's tourism demand. To fulfil this purpose, "non-linear autoregressive distributed lag" (NARDL) modelling was performed on the time series data collected from Pakistan for 26 years. The unit root test, co-integration test, long-run estimation and NARDL estimations were applied to the data to generate findings. The present study revealed that there exist the significant asymmetric associations between environmental degradation and tourism demand. It has also indicated that there exist the significant asymmetric associations between economic growth and tourism demand. It is found through the non-linear ARDL estimation results that the increase or decrease in economic growth leads towards the increase of the tourism demand of Pakistan. It means that any change (either positive or negative) in economic growth is followed by the increase of the tourism demand. Results further indicate that the increase in environmental degradation in Pakistan causes its tourism demand to reduce while the negative change in the environmental degradation does not cause any significant effect on tourism demand. However, this relationship becomes significant in the long run as the negative change in environmental degradation caused significant inverse effect on tourism demand in long run. The current study tends to be theoretically significant and practically beneficial for Pakistan's policymakers. It will help them realize the role of economic growth of the country and environmental degradation in shaping Pakistan's tourism demand and thus help them develop and implement better policies for the growth of the tourism sector.

The fermented soy beverage Q-CAN® plus induces beneficial changes in the oral and intestinal microbiome.

BACKGROUND: Soy products are associated with many beneficial health consequences, but their effects on the human intestinal microbiome are poorly characterized. OBJECTIVES: To identify the changes in the oral and fecal microbiome in lean and obese participants due to consumption of Q-CAN®, and to assess the expected consequences of these changes based on the published literature. METHODS: Prospective study of lean (10) and obese (9) participants consuming Q-CAN® twice daily for 4 weeks with 8 weeks follow-up. Microbial DNA was extracted from saliva and stool samples, amplified against the V4 region of the 16S ribosomal RNA gene and data analyzed using QIIME 1.9.1 bioinformatics. Four hundred forty-four samples were collected in total, 424 of which were productive and yielded good quality data. RESULTS: STOOL. In the lean population Bifidobacteria and Blautia show a significant increase while taking Q-CAN®, and there was a trend for this in the obese population. ORAL. There were relatively fewer major changes in the oral microbiome with an increase in the family Veillonellaceae in the lean population while on Q-CAN®. CONCLUSION: Q-CAN® consumption induced a number of significant changes in the fecal and oral microbiome. Most notably an increase in the stool microbiome of Bifidobacteria and Blautia, both of which are associated with positive health benefits, and in the saliva an increase in Veillonellaceae. TRIAL REGISTRATION: This trial was registered with Clinicaltrials.gov on January 14th 2016. ClinicalTrials.gov Identifier: NCT02656056.

Mindfulnes-Based Stress Reduction for Older Couples with Metabolic Syndrome: a Pilot Randomized Controlled Trial.

OBJECTIVE: We examined the feasibility and explored the physical, psychological, relational, and biological effects of Mindfulness-Based Stress Reduction (MBSR), an 8-week standardized mindfulness program, involving older married couples (60 years or older) with metabolic syndrome (one or both partners had metabolic syndrome). We also explored gender differences. METHODS: A pilot randomized controlled trial (RCT) compared MBSR to a Wait List Control (WLC) arm at baseline, post-intervention, and 3-month follow-up clinic visits. Twenty-two spouses (11 couples) self-reported stress, physical and mental functioning, mindfulness, and relationship satisfaction at each time point. Fasting glucose, cholesterol, triglycerides, blood pressure, weight, and waist circumference were measured. MBSR couples answered questions about partner influences on participation, adherence, and practice at the post-intervention visit. RESULTS: In terms of adherence to MBSR sessions, four of the six couples attended all 10 sessions; one couple attended 7; and one wife attended 6 and her husband attended 5 sessions. In terms of efficacy, there were no significant intervention effects; however, there were significant gender by intervention effects. Pre- to post-intervention, MBSR wives displayed greater increases in physical functioning (ß = 1.18, t(36) = 3.17, p = .003) and relationship satisfaction (ß = .72, t(36) = 2.81, p = .007) than WLC wives. Effects for husbands were not significant. Qualitatively, participants reported encouragement and increased relationship closeness. CONCLUSIONS: Engaging in MBSR as a couple to address symptoms of metabolic syndrome was well-received and feasible. Preliminary effects suggest more benefits for wives than husbands in terms of physical functioning and relational well-being.

Fermented Soy Beverage Q-CAN Plus Consumption Improves Serum Cholesterol and Cytokines.

Soy-based beverages are well recognized for their rich nutritional contents and positive health benefits. However, there is little information regarding the composition of various commercially available soy-based beverages and uncertainty among patients regarding the utility of fermented soy products. Current study evaluates the health benefits of QCAN® Plus-an easily available fermented soy drink. This study was performed in lean (n = 10) and obese (n = 10) subjects. The subjects were observed during pre-soy (weeks -2, -1, and 0), on-soy (weeks 1, 2, 3, and 4), and post-soy (weeks 6, 8, 10, and 12) periods. The serum samples during these visits were subjected to lipid profile analysis and multiplex assay for cytokines. The results revealed that total cholesterol and low-density lipoprotein (LDL) cholesterol levels were significantly reduced in both lean and obese individuals during on-soy (P ≤ .05). Furthermore, cytokines such as platelet-derived growth factor (PDGF) AA and AB/BB were significantly lowered on-soy compared with pre-soy (P ≤ .05) in lean subjects and PDGF AA, IL-1RA, and GMCSF were significantly reduced on-soy (P ≤ .05) in obese subjects. In addition, a qualitative and quantitative analysis of the Q-CAN Plus by a third-party laboratory confirmed its chemical and microbial safety. Our preliminary study on Q-CAN Plus ensures its safety for consumption and highlights its hypolipidemic and suppressive effect on certain cytokines. These observations and relevant studies in future might guide clinicians in future to consider Q-CAN Plus as a therapeutic nutritional supplement.

Efficacy and Safety of Massage for Osteoarthritis of the Knee: a Randomized Clinical Trial.

BACKGROUND: Current treatment options for knee osteoarthritis have limited effectiveness and potentially adverse side effects. Massage may offer a safe and effective complement to the management of knee osteoarthritis. OBJECTIVE: Examine effects of whole-body massage on knee osteoarthritis, compared to active control (light-touch) and usual care. DESIGN: Multisite RCT assessing the efficacy of massage compared to light-touch and usual care in adults with knee osteoarthritis, with assessments at baseline and weeks 8, 16, 24, 36, and 52. Subjects in massage or light-touch groups received eight weekly treatments, then were randomized to biweekly intervention or usual care to week 52. The original usual care group continued to week 24. Analysis was performed on an intention-to-treat basis. PARTICIPANTS: Five hundred fifty-one screened for eligibility, 222 adults with knee osteoarthritis enrolled, 200 completed 8-week assessments, and 175 completed 52-week assessments. INTERVENTION: Sixty minutes of protocolized full-body massage or light-touch. MAIN MEASURES: Primary: Western Ontario and McMaster Universities Arthritis Index. Secondary: visual analog pain scale, PROMIS Pain Interference, knee range of motion, and timed 50-ft walk. KEY RESULTS: At 8 weeks, massage significantly improved WOMAC Global scores compared to light-touch (- 8.16, 95% CI = - 13.50 to - 2.81) and usual care (- 9.55, 95% CI = - 14.66 to - 4.45). Additionally, massage improved pain, stiffness, and physical function WOMAC subscale scores compared to light-touch (p < 0.001; p = 0.04; p = 0.02, respectively) and usual care (p < 0.001; p = 0.002; p = 0.002; respectively). At 52 weeks, the omnibus test of any group difference in the change in WOMAC Global from baseline to 52 weeks was not significant (p = 0.707, df = 3), indicating no significant difference in change across groups. Adverse events were minimal. CONCLUSIONS: Efficacy of symptom relief and safety of weekly massage make it an attractive short-term treatment option for knee osteoarthritis. Longer-term biweekly dose maintained improvement, but did not provide additional benefit beyond usual care post 8-week treatment. TRIAL REGISTRATION: clinicaltrials.gov NCT01537484.

A leukocyte activation test identifies food items which induce release of DNA by innate immune peripheral blood leucocytes.

BACKGROUND: Leukocyte activation (LA) testing identifies food items that induce a patient specific cellular response in the immune system, and has recently been shown in a randomized double blinded prospective study to reduce symptoms in patients with irritable bowel syndrome (IBS). We hypothesized that test reactivity to particular food items, and the systemic immune response initiated by these food items, is due to the release of cellular DNA from blood immune cells. METHODS: We tested this by quantifying total DNA concentration in the cellular supernatant of immune cells exposed to positive and negative foods from 20 healthy volunteers. To establish if the DNA release by positive samples is a specific phenomenon, we quantified myeloperoxidase (MPO) in cellular supernatants. We further assessed if a particular immune cell population (neutrophils, eosinophils, and basophils) was activated by the positive food items by flow cytometry analysis. To identify the signaling pathways that are required for DNA release we tested if specific inhibitors of key signaling pathways could block DNA release. RESULTS: Foods with a positive LA test result gave a higher supernatant DNA content when compared to foods with a negative result. This was specific as MPO levels were not increased by foods with a positive LA test. Protein kinase C (PKC) inhibitors resulted in inhibition of positive food stimulated DNA release. Positive foods resulted in CD63 levels greater than negative foods in eosinophils in 76.5% of tests. CONCLUSION: LA test identifies food items that result in release of DNA and activation of peripheral blood innate immune cells in a PKC dependent manner, suggesting that this LA test identifies food items that result in release of inflammatory markers and activation of innate immune cells. This may be the basis for the improvement in symptoms in IBS patients who followed an LA test guided diet.

Efficacy of individualised diets in patients with irritable bowel syndrome: a randomised controlled trial.

BACKGROUND: Patients with irritable bowel syndrome (IBS) are often placed on diets guided by food intolerance assays, although these have not been validated. We assessed the effects of individualised diets in patients with IBS guided by a leucocyte activation test. METHODS: This is a parallel-group, double-blind, randomised controlled trial of 58 adults with IBS seen at an academic health centre in Northeast USA. Peripheral venous blood was analysed using a leucocyte activation test; individual foods were reported to produce positive or negative results. Participants were randomised to a 4-week diet with either individualised guidance to eliminate foods with positive assay results and allow foods with negative assay results (intervention), or with individualised guidance, matched in rigour and complexity, to eliminate foods with negative assay results and allow foods with positive assay results (comparison). The primary outcome was between-group differences in the IBS Global Improvement Scale (GIS). Secondary outcomes included reductions in IBS Symptom Severity Scale (SSS) scores and increases in IBS Adequate Relief (AR) and Quality of Life (QOL) scores. An aptamer-based proteomic analysis was conducted in strong responders. RESULTS: The intervention group had significantly greater increases in mean GIS score after 4 weeks (0.86 vs comparison; 95% CI 0.05 to 1.67; p=0.04) and 8 weeks (1.22 vs comparison; 95% CI 0.22 to 2.22; p=0.02). The intervention group also had significantly greater reductions in mean SSS score at 4 weeks (-61.78 vs comparison; 95% CI -4.43 to -119.14; p=0.04) and 8 weeks (-66.42 vs comparison; 95% CI -5.75 to -127.09; p=0.03). There were no significant differences between intervention and comparison groups in mean AR or QOL scores. A reduction in neutrophil elastase concentration was associated with reduced symptoms. CONCLUSIONS: Elimination diets guided by leucocyte activation tests reduced symptoms. These findings could lead to insights into the pathophysiology of IBS. TRIAL REGISTRATION NUMBER: NCT02186743.

Attention to Individuals: Mixed Methods for N-of-1 Health Care Interventions.

In several ways, randomized controlled trials represent a high standard of rigor in clinical biomedical research. Randomized controlled trials fail, however, to yield knowledge applicable to specific individuals. This article presents a methodological rationale for a mixed methods approach to n-of-1 clinical studies that attends to the preferences and concerns of individuals while attaining high standards of qualitative and quantitative rigor. An illustrative research design involving a hypothetical music therapy intervention for a quality of life outcome is examined in some detail and a concluding argument is made that the proposed mixed methods approach is especially appropriate for early-stage research interventions intended to generate explanatory hypotheses.

Mindfulness-Based Stress Reduction for Adolescents with Functional Somatic Syndromes: A Pilot Cohort Study.

OBJECTIVE: To assess the feasibility of a mindfulness-based stress reduction (MBSR) program for adolescents with widespread chronic pain and other functional somatic symptoms and to make preliminary assessments of its clinical utility. STUDY DESIGN: Three cohorts of subjects completed an 8-week MBSR program. Child- and parent-completed measures were collected at baseline and 8 and 12 weeks later. Measures included the Functional Disability Inventory (FDI), the Fibromyalgia/Symptom Impact Questionnaire-Revised (FIQR/SIQR), the Pediatric Quality of Life Inventory, the Multidimensional Anxiety Scale (MASC2), and the Perceived Stress Scale. Subjects and parents were interviewed following the program to assess feasibility. RESULTS: Fifteen of 18 subjects (83%) completed the 8-week program. No adverse events occurred. Compared with baseline scores, significant changes were found in mean scores on the FDI (33% improvement, P = .026), FIQR/SIQR (26% improvement, P = .03), and MASC2 (child: 12% improvement, P = .02; parent report: 17% improvement, P = .03) at 8 weeks. MASC2 scores (child and parent) and Perceived Stress Scale scores were significantly improved at 12 weeks. More time spent doing home practice was associated with better outcomes in the FDI and FIQR/SIQR (44% and 26% improvement, respectively). Qualitative interviews indicated that subjects and parents reported social support as a benefit of the MBSR class, as well as a positive impact of MBSR on activities of daily living, and on pain and anxiety. CONCLUSIONS: MBSR is a feasible and acceptable intervention in adolescents with functional somatic syndromes and has preliminary evidence for improving functional disability, symptom impact, and anxiety, with consistency between parent and child measures. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02190474.

Massage Therapy and Quality of Life in Osteoarthritis of the Knee: A Qualitative Study.

Objective: We hypothesized that participants receiving Swedish massage would experience benefits such as stress reduction and enhanced quality of life, in addition to the osteoarthritis-specific effects assessed in a randomized controlled clinical trial. Design: Qualitative methods were used to explore a deeper contextual understanding of participants' experiences with massage and osteoarthritis, in addition to the quantitative data collected from primary and secondary outcome measures of the dose-finding study. Setting: Two community hospitals affiliated with academic health centers in Connecticut and New Jersey. Subjects: Eighteen adults who previously participated in a dose-finding clinical trial of massage therapy for osteoarthritis of the knee. Methods: Face-to-face and telephone interviews using a standardized interview guide. Triangulation of qualitative and quantitative data allowed for a more thorough understanding of the effects of massage therapy. Results: Three salient themes emerged from our analysis. Participants discussed 1) relaxation effects, 2) improved quality of life associated with receiving massage therapy, and 3) the accessibility of massage therapy in treating osteoarthritis. Conclusions: Participant responses noted empowerment with an improved ability to perform activities of daily living after experiencing massage therapy. The majority of statements were consistent with their quantitative changes on standard osteoarthritis measures. Future research in pain conditions should include health-related quality of life assessments as well as outcomes related to perceived well-being, along with greater exploration of the concept of salutogenic side effects of an intervention in the context of complementary and integrative therapies.

Integrative Medicine in Preventive Medicine Education: Competency and Curriculum Development for Preventive Medicine and Other Specialty Residency Programs.

During 2012, the USDHHS's Health Resources and Services Administration funded 12 accredited preventive medicine residencies to incorporate an evidence-based integrative medicine curriculum into their training programs. It also funded a national coordinating center at the American College of Preventive Medicine, known as the Integrative Medicine in Preventive Medicine Education (IMPriME) Center, to provide technical assistance to the 12 grantees. To help with this task, the IMPriME Center established a multidisciplinary steering committee, versed in integrative medicine, whose primary aim was to develop integrative medicine core competencies for incorporation into preventive medicine graduate medical education training. The competency development process was informed by central integrative medicine definitions and principles, preventive medicine's dual role in clinical and population-based prevention, and the burgeoning evidence base of integrative medicine. The steering committee considered an interdisciplinary integrative medicine contextual framework guided by several themes related to workforce development and population health. A list of nine competencies, mapped to the six general domains of competence approved by the Accreditation Council of Graduate Medical Education, was operationalized through an iterative exercise with the 12 grantees in a process that included mapping each site's competency and curriculum products to the core competencies. The competencies, along with central curricular components informed by grantees' work presented elsewhere in this supplement, are outlined as a roadmap for residency programs aiming to incorporate integrative medicine content into their curricula. This set of competencies adds to the larger efforts of the IMPriME initiative to facilitate and enhance further curriculum development and implementation by not only the current grantees but other stakeholders in graduate medical education around integrative medicine training.

Disease Prevention and Health Promotion: How Integrative Medicine Fits.

As a discipline, preventive medicine has traditionally been described to encompass primary, secondary, and tertiary prevention. The fields of preventive medicine and public health share the objectives of promoting general health, preventing disease, and applying epidemiologic techniques to these goals. This paper discusses a conceptual approach between the overlap and potential synergies of integrative medicine principles and practices with preventive medicine in the context of these levels of prevention, acknowledging the relative deficiency of research on the effectiveness of practice-based integrative care. One goal of integrative medicine is to make the widest array of appropriate options available to patients, ultimately blurring the boundaries between conventional and complementary medicine. Both disciplines should be subject to rigorous scientific inquiry so that interventions that are efficacious and effective are systematically distinguished from those that are not. Furthermore, principles of preventive medicine can be infused into prevalent practices in complementary and integrative medicine, promoting public health in the context of more responsible practices. The case is made that an integrative preventive approach involves the responsible use of science with responsiveness to the needs of patients that persist when conclusive data are exhausted, providing a framework to make clinical decisions among integrative therapies.

Project ASPIRE: Incorporating Integrative Medicine Into Residency Training.

Griffin Hospital, a community hospital affiliated with Yale School of Public Health and Yale School of Medicine, received Health Resources and Services Administration funding to strengthen and improve its combined internal medicine and general preventive medicine residency program by incorporating an integrative medicine curriculum. The purpose of project ASPIRE (Advancing Skills of Preventive medicine residents through Integrative medicine Education, Research and Evaluation) was to create, implement, and evaluate a needs-based, innovative training curriculum in integrative medicine. Through this robust new training, the authors aimed to produce preventive medicine-trained physicians with competencies in integrative medicine to collaboratively work with other integrative medicine practitioners in interdisciplinary teams to provide holistic, patient-centered care. The multifaceted collaborative curriculum was composed of didactics, grand rounds, journal club, objective structured clinical examinations, and two new practicum rotations in integrative medicine. The new practicum rotations included block rotations at the Integrative Medicine Center at Griffin Hospital and the Yale Stress Center. Between 2012 and 2014, three cohorts participated in the curriculum; two of these cohorts included three advanced preventive medicine residents each and the fourth included four residents. Project faculty conducted 14 lectures and journal clubs, and two grand rounds. Six of the ten participating residents (60%) completed integrative medicine clinical rotations. Residents' attitudes toward integrative medicine were evaluated through self-assessment using the Complementary, Alternative, and Integrative Medicine Attitudes Questionnaire; data were analyzed in 2015. This article describes the results of this prospective observational study based on single-institution experience over the course of the 2-year project period.

Perceptions of Massage Therapists Participating in a Randomized Controlled Trial.

BACKGROUND: Clinical practice and randomized trials often have disparate aims, despite involving similar interventions. Attitudes and expectancies of practitioners influence patient outcomes, and there is growing emphasis on optimizing provider-patient relationships. In this study, we evaluated the experiences of licensed massage therapists involved in a randomized controlled clinical trial using qualitative methodology. METHODS: Seven massage therapists who were interventionists in a randomized controlled trial participated in structured interviews approximately 30 minutes in length. Interviews focused on their experiences and perceptions regarding aspects of the clinical trial, as well as recommendations for future trials. Transcribed interviews were analyzed for emergent topics and themes using standard qualitative methods. RESULTS: Six themes emerged. Therapists discussed 1) promoting the profession of massage therapy through research, 2) mixed views on using standardized protocols, 3) challenges of sham interventions, 4) participant response to the sham intervention, 5) views on scheduling and compensation, and 6) unanticipated benefits of participating in research. CONCLUSIONS: Therapists largely appreciated the opportunity to promote massage through research. They demonstrated insight and understanding of the rationale for a clinical trial adhering to a standardized protocol. Evaluating the experiences and ideas of complementary and alternative medicine practitioners provides valuable insight that is relevant for the implementation and design of randomized trials.

Fibromyalgia Impact and Mindfulness Characteristics in 4986 People with Fibromyalgia.

CONTEXT AND OBJECTIVE: A growing body of literature suggests that mindfulness techniques may be beneficial in fibromyalgia. A recent systematic review and meta-analysis of six trials indicated improvement in depressive symptoms and quality of life, calling for increased rigor and use of standardized measures in future trials. The purpose of the study was to examine the relationship between mindfulness [as measured by the Five Facet Mindfulness Questionnaire (FFMQ)] and fibromyalgia impact [as measured by the Revised Fibromyalgia Impact Questionnaire (FIQR)]. DESIGN, SETTING, AND PARTICIPANTS: A cross-sectional survey was conducted with adults diagnosed with fibromyalgia from a national fibromyalgia advocacy foundation e-mail list. RESULTS: A total of 4986 respondents represented all 50 states in the United States and 30 countries. FIQR scores demonstrated moderate to severe fibromyalgia with the majority of subjects (59%) scoring ≤60. Scores on the FFMQ subscales ranged from 20.8 to 27.3, with highest scores for the observe subscale. All subscale correlations were small to moderate and indicated that more severe fibromyalgia impact was associated with less mindfulness except in the observe scale (r = .15, P > .000). No clinical or demographics explained as much variance in the FIQR total as any of the mindfulness subscales. CONCLUSIONS: Fibromyalgia patients experience symptoms that may be alleviated by mindfulness interventions. Baseline values for the observe subscale of the FFMQ were unexpectedly high. Further research is needed to know if this may be due to non-mindful observations and should be noted when the FFMQ is used in fibromyalgia clinical trials.