A meta-ethnography investigating relational influences on mental health and cancer-related health care interventions for racially minoritised people in the UK.

OBJECTIVE: Despite calls to increase the 'cultural competence' of health care providers, racially minoritised people continue to experience a range of problems when it comes to health care, including discrimination. While relevant qualitative meta-syntheses have suggested better ways forward for health care for racialised minorities, many have lacked conceptual depth, and none have specifically investigated the relational dimensions involved in care. We set out to investigate the social and cultural influences on health care interventions, focusing on psychological approaches and/or cancer care to inform the trial of a new psychological therapy for those living with or beyond cancer. METHOD: A meta-ethnography approach was used to examine the relevant qualitative studies, following Noblit and Hare, and guided by patient involvement throughout. Papers were analysed between September 2018 and February 2023, with some interruptions caused by the Covid pandemic. The following databases were searched: Ovid MEDLINE, EBSCO CINAHL, Ovid Embase, EBSCO PsycINFO, Proquest Sociology Collection (including Applied Social Sciences Index & Abstracts (ASSIA), Sociological Abstracts and Sociology Database), EBSCO SocINDEX, Ovid AMED, and Web of Science. The systematic review protocol was registered with the International Prospective Register of Systematic Reviews (PROSPERO) (ID: CRD42018107695), and reporting follows the eMERGe Reporting Guidance for meta-ethnographies (France et al. 2019). RESULTS: Twenty-nine journal papers were included in the final review. Themes (third-order constructs) developed in the paper include the centrality of the patient-practitioner relationship; how participants give meaning to their illness in connection to others; how families (rather than individuals) may make health decisions; how links with a higher power and spiritual/religious others can play a role in coping; and the ways in which a hierarchy of help-seeking develops, frequently with the first port of call being the resources of oneself. Participants in studies had a need to avoid being 'othered' in their care, valuing practitioners that connected with them, and who were able to recognise them as whole and complex (sometimes described in relational languages like 'love'). Complex family-based health decision-making and/or the importance of relations with non-human interactants (e.g. God, spiritual beings) were frequently uncovered, not to mention the profoundly emergent nature of stigma, whereby families could be relatively safe havens for containing and dealing with health challenges. A conceptual framework of 'animated via (frequently hidden) affective relationality' emerged in the final synthesis, bringing all themes together, and drawing attention to the emergent nature of the salient issues facing minoritised patients in health care interactions. CONCLUSION: Our analysis is important because it sheds light on the hitherto buried relational forces animating and producing the specific issues facing racially minoritised patients, which study participants thought were largely overlooked, but to which professionals can readily relate (given the universal nature of human relations). Thus, training around the affective relationality of consultations could be a fruitful avenue to explore to improve care of diverse patients.

Coriolus (Trametes) versicolor mushroom to reduce adverse effects from chemotherapy or radiotherapy in people with colorectal cancer.

BACKGROUND: Radiotherapy and chemotherapy are used to improve survival in colorectal cancer but adverse effects can be a problem. Severe adverse effects may result in dose reduction or cessation of treatment, which have an impact on survival. Coriolus versicolor (Trametes versicolor or 'Turkey Tail') mushroom and its extracts have been used by cancer patients to help with adverse effects. OBJECTIVES: To assess the effects of adjunctive Coriolus versicolor (Trametes versicolor) and its extracts on adverse effects and on survival during colorectal cancer treatment (chemotherapy and radiotherapy) compared with no adjunctive treatment. SEARCH METHODS: We searched databases including CENTRAL, MEDLINE, Embase, AMED and CINAHL, Chinese and Japanese databases, and trials registers to 12th April 2022 without restriction of language or publication status. We screened reference lists and attempted to contact researchers in the field to identify additional studies. SELECTION CRITERIA: We included randomised controlled trials (RCTs) investigating the efficacy and safety of Coriolus versicolor and its extracts in adult participants with a confirmed diagnosis of colorectal cancer, in addition to conventional treatment. Interventions included any preparation of Coriolus versicolor (raw, decoction, capsule, tablet, tincture, extract, injection), any part of the fungus (cap, stem, mycelium or whole), in any dose or regimen. Outcomes included adverse events rates, survival, disease progression and recurrence, response rates and quality of life. DATA COLLECTION AND ANALYSIS: Two review authors independently screened and selected studies, extracted outcome data, and assessed risk of bias. We evaluated the overall certainty of evidence using the GRADE approach. MAIN RESULTS: We included seven parallel RCTs (1569 participants). Six studies (1516 participants) were conducted in Japan and one study (53 participants) in China. Studies included both male and female participants with colorectal cancer (five studies), colon cancer (one study) or rectal cancer (one study). Participants were diagnosed with cancer ranging from stage II to stage IV. Coriolus was used in the form of an extract in all seven studies and was generally used after curative resection, although in one study it was used preoperatively. Duration of treatment with the extract varied between four weeks and three years. Chemotherapeutic regimens in six studies consisted of an oral fluoropyrimidine which was preceded by weekly intravenous 5-Fluorouracil (5-FU) in one study, by mitomycin C in two studies, and which was combined with folinic acid (Leucovorin) in two studies and with radiotherapy preoperatively in one study. XELOX (oxaliplatin intravenous infusion and capecitabine) was used in the remaining study. We found very low-certainty evidence of little to no effect of adjunctive treatment with Coriolus (in the form of an extract, polysaccharide-Krestin, PSK) on withdrawal from treatment due to adverse events  (risk ratio (RR) 1.03, 95% confidence interval (CI) 0.45 to 2.34; 703 participants; 3 studies;). We are uncertain whether adjunctive Coriolus versicolor and its extracts compared to usual care alone resulted in a difference in adverse events including neutropenia (RR 0.41, 95% CI 0.24 to 0.71; 133 participants; 3 studies; very low certainty), oral cavity disorders such as oral dryness and mucositis (RR 0.37, 95% CI 0.13 to 1.03; 1022 participants; 5 studies; very low certainty), nausea (RR 0.73, 95% CI 0.44 to 1.22; 969 participants; 4 studies; very low certainty), diarrhoea (RR 0.77, 95% CI 0.32 to 1.86; 1022 participants; 5 studies; very low certainty), and fatigue (RR 0.76; 95% CI 0.33 to 1.78; 133 participants; 3 studies; very low certainty). We found low-certainty evidence of a small effect of adjunctive Coriolus on improved survival at five years compared with no adjunctive care (RR 1.08, 95% CI 1.01 to 1.15; 1094 participants; 3 studies; number needed to benefit (NNTB) = 16 (95% Cl 9 to 70). The effect at earlier time points was unclear. AUTHORS' CONCLUSIONS: Due to the very low certainty of evidence, we were uncertain about the effect of adjunctive Coriolus (in the form of an extract PSK) on adverse events resulting from conventional chemotherapy for colorectal cancer. This includes effects on withdrawal of treatment due to adverse events and on specific adverse outcomes such as neutropenia and nausea. The uncertainty in the evidence also means that it was unclear whether any adverse events were due to the chemotherapy or to the extract itself. While there was low-certainty evidence of a small effect on overall survival at five years, the influence of reduced adverse effects on this could not be determined. In addition, chemotherapy regimens used in assessing this outcome do not reflect current preferred practice.

Yoga for chronic non-specific low back pain.

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.

Systematic Reviews and Quality Appraisal of In Vitro Cancer Studies: Investigation of Current Practice.

BACKGROUND/AIM: To assess the quantity and quality of systematic reviews of in vitro cancer studies. MATERIALS AND METHODS: PubMed, MEDLINE, Embase, Web of Knowledge and PROSPERO databases were searched. Articles described as systematic reviews of in vitro studies, focused on or relevant to cancer and published in English were selected and appraised using an adapted version of AMSTAR 2 'critical domains'. RESULTS: From 4,021 records, 41 reviews described as systematic and cancer-related were identified. Publication dates indicate increasing frequency of systematic review conduct. Mean number of databases searched was three (range=1-8). Thirty-six reviews (88%) reported search methods, 35 (85%) specified inclusion criteria, 26 (63%) reported study selection methods, and 21 (51%) used reporting guidelines. Only 13 reviews (32%) involved formal quality assessment. CONCLUSION: Detailed investigation of reviews of cancer-relevant in vitro studies indicates need for further development and use of robust search strategies, appropriate quality assessment tools, and researchers with relevant skills.

Towards More Predictive, Physiological and Animal-free In Vitro Models: Advances in Cell and Tissue Culture 2020 Conference Proceedings.

Experimental systems that faithfully replicate human physiology at cellular, tissue and organ level are crucial to the development of efficacious and safe therapies with high success rates and low cost. The development of such systems is challenging and requires skills, expertise and inputs from a diverse range of experts, such as biologists, physicists, engineers, clinicians and regulatory bodies. Kirkstall Limited, a biotechnology company based in York, UK, organised the annual conference, Advances in Cell and Tissue Culture (ACTC), which brought together people having a variety of expertise and interests, to present and discuss the latest developments in the field of cell and tissue culture and in vitro modelling. The conference has also been influential in engaging animal welfare organisations in the promotion of research, collaborative projects and funding opportunities. This report describes the proceedings of the latest ACTC conference, which was held virtually on 30th September and 1st October 2020, and included sessions on in vitro models in the following areas: advanced skin and respiratory models, neurological disease, cancer research, advanced models including 3-D, fluid flow and co-cultures, diabetes and other age-related disorders, and animal-free research. The roundtable session on the second day was very interactive and drew huge interest, with intriguing discussion taking place among all participants on the theme of replacement of animal models of disease.

A relational analysis of an invisible illness: A meta-ethnography of people with chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME) and their support needs.

Chronic fatigue syndrome (CFS)/myalgic encephalomyelitis (ME) is indicated by prolonged, medically unexplained fatigue (amongst other symptoms), not alleviated by rest, and causing substantial disability. There are limited treatments on offer, which may not be effective and/or acceptable for all people, and treatment views are polarised. We, thus, aimed to take a step back from this debate, to explore more broadly preferences for formal and informal support among people with CFS/ME. We used a meta-ethnography approach to examine the substantial qualitative literature available. Using the process outlined by Noblit and Hare, and guided by patient involvement throughout, 47 studies were analysed. Our synthesis suggested that to understand people with CFS/ME (such as their invisibility, loss of self, and fraught clinical encounters), it was useful to shift focus to a 'relational goods' framework. Emotions and tensions encountered in CFS/ME care and support only emerge via 'sui generis' real life interactions, influenced by how social networks and health consultations unfold, as well as structures like disability support. This relational paradigm reveals the hidden forces at work producing the specific problems of CFS/ME, and offers a 'no blame' framework going forward.

A Systematic Approach to Review of in vitro Methods in Brain Tumour Research (SAToRI-BTR): Development of a Preliminary Checklist for Evaluating Quality and Human Relevance.

BACKGROUND: A wide range of human in vitro methods have been developed and there is considerable interest in the potential of these studies to address questions related to clinical (human) use of drugs, and the pathobiology of tumours. This requires agreement on how to assess the strength of evidence available (i.e., quality and quantity) and the human-relevance of such studies. The SAToRI-BTR (Systematic Approach To Review of in vitro methods in Brain Tumour Research) project seeks to identify relevant appraisal criteria to aid planning and/or evaluation of brain tumour studies using in vitro methods. OBJECTIVES: To identify criteria for evaluation of quality and human relevance of in vitro brain tumour studies; to assess the general acceptability of such criteria to senior scientists working within the field. METHODS: Stage one involved identification of potential criteria for evaluation of in vitro studies through: (1) an international survey of brain tumour researchers; (2) interviews with scientists, clinicians, regulators, and journal editors; (3) analysis of relevant reports, documents, and published studies. Through content analysis of findings, an initial list of criteria for quality appraisal of in vitro studies of brain tumours was developed. Stage two involved review of the criteria by an expert panel (Delphi process). RESULTS: Results of stage one indicated that methods for and quality of review of in vitro studies are highly variable, and that improved reporting standards are needed. 129 preliminary criteria were identified; duplicate and highly context-specific items were removed, resulting in 48 criteria for review by the expert (Delphi) panel. 37 criteria reached agreement, resulting in a provisional checklist for appraisal of in vitro studies in brain tumour research. CONCLUSION: Through a systematic process of collating assessment criteria and subjecting these to expert review, SAToRI-BTR has resulted in preliminary guidance for appraisal of in vitro brain tumour studies. Further development of this guidance, including investigating strategies for adaptation and dissemination across different sub-fields of brain tumour research, as well as the wider in vitro field, is planned.

Self-care for anxiety and depression: a comparison of evidence from Cochrane reviews and practice to inform decision-making and priority-setting.

BACKGROUND: Self-care refers to a range of activities and approaches undertaken by an individual to maintain health and manage ill-health which may include various complementary or alternative approaches. The purpose of this study was to identify the self-care approaches used by the general public for depression and anxiety, assess the usefulness of Cochrane reviews for informing decisions on self-care and highlight any gaps in the evidence. METHODS: Searches were carried out for surveys of self-care for anxiety and/or depression and for Cochrane reviews and protocols of interventions with potential for use in self-care. Data was extracted from each review and Plain Language Summaries assessed for content, consistency and readability. Interventions reported in surveys and in Cochrane reviews were compared and effectiveness of each assessed. RESULTS: Surveys from 10 countries reported a variety of self-care interventions, 17 of which appeared in 2 or more surveys and which included dietary supplements, herbal medicines, mind-body therapies and various forms of exercise. Twenty-two reviews and 5 protocols on potential self-care interventions were identified, the majority in depression. Twelve interventions were judged effective or promising, most with small effect sizes. Readability of summaries was highly variable: half were written at college/university level. Several commonly used approaches were not covered by Cochrane reviews. CONCLUSIONS: This study has revealed the interventions currently used by the general public which are judged effective or promising based on Cochrane reviews. Some disparity is highlighted between interventions used in practice and the availability of reliable evidence, and in the presentation of effectiveness and safety. Being able to direct patients to reliable, accessible information is a positive step in ensuring effective patient-centered, evidence-informed care. Addressing gaps, ensuring consistency and increasing usability of evidence intended for the general public will support this goal.

Non-invasive techniques for stimulating urine production in non-toilet trained children: a systematic review.

BACKGROUND: Urinary tract infection requires collection of a sterile urine specimen for diagnosis, which is difficult and time consuming in pre-continent children. This systematic review summarises evidence of the effectiveness of bladder stimulation techniques on urine collection in pre-continent children, compared with standard techniques. METHODS: MEDLINE, PubMed, EMBASE and CINAHL were searched to May 2019. Selection, data extraction, risk of bias and quality assessment were undertaken by two independent reviewers. Inclusion: (1) all study designs; (2) pre-continent, age <3 years receiving bladder stimulation techniques; (3) outcomes including time to urine collection or contamination rates; (4) English-language articles. Exclusion: coexisting neurological disorders. RESULTS: Three randomised controlled trials (RCTs) were identified using three techniques in 568 participants aged 1 day to 35 months. Two RCTs demonstrated an increased success in voiding within 5 min, one using a finger tapping and lumbar paravertebral massage technique and the other cold saline-soaked gauze rubbed over the suprapubic region, compared with no active intervention. A third RCT using a mechanical vibration device demonstrated no difference in time to voiding from advice alone. Non-randomised studies compared different temperatures for the gauze intervention and tapping alone versus urine bags. Six uncontrolled studies tested the finger tapping and massage technique. Risk of bias was low for one RCT and unclear for two RCTs with the other studies rated poor to fair quality. Overall, the evidence on success rates was graded low for tapping plus massage and moderate for the gauze rubbing intervention. Adverse effects included crying and mild distress. DISCUSSION: The results suggest a positive effect of stimulation techniquesbut lack of replication in rigorous RCTs and heterogeneity of techniques and outcomes assessed prevent conclusive recommendations being made. Further RCTs are required comparing non-invasive stimulation methods and assessing time to successful collection, contamination rates, adverse effects, caregiver and clinical staff acceptability.

Yoga practice in the UK: a cross-sectional survey of motivation, health benefits and behaviours.

OBJECTIVES: Despite the popularity of yoga and evidence of its positive effects on physical and mental health, little is known about yoga practice in the UK. This study investigated the characteristics of people who practise yoga, reasons for initiating and maintaining practice, and perceived impact of yoga on health and well-being. DESIGN, SETTING AND PARTICIPANTS: A cross-sectional online anonymous survey distributed through UK-based yoga organisations, studios and events, through email invites and flyers. 2434 yoga practitioners completed the survey, including 903 yoga teachers: 87% were women, 91% white and 71% degree educated; mean age was 48.7 years. MAIN OUTCOME MEASURES: Perceived impact of yoga on health conditions, health outcomes and injuries. Relationships between yoga practice and measures of health, lifestyle, stress and well-being. RESULTS: In comparison with national population norms, participants reported significantly higher well-being but also higher anxiety; lower perceived stress, body mass index and incidence of obesity, and higher rates of positive health behaviours. 47% reported changing their motivations to practise yoga, with general wellness and fitness key to initial uptake, and stress management and spirituality important to current practice. 16% of participants reported starting yoga to manage a physical or mental health condition. Respondents reported the value of yoga for a wide range of health conditions, most notably for musculoskeletal and mental health conditions. 20.7% reported at least one yoga-related injury over their lifetime. Controlling for demographic factors, frequency of yoga practice accounted for small but significant variance in health-related regression models (p<0.001). CONCLUSION: The findings of this first detailed UK survey were consistent with surveys in other Western countries. Yoga was perceived to have a positive impact on physical and mental health conditions and was linked to positive health behaviours. Further investigation of yoga's role in self-care could inform health-related challenges faced by many countries.

Associations of yoga practice, health status, and health behavior among yoga practitioners in Germany-Results of a national cross-sectional survey.

BACKGROUND: While yoga can improve health-related variables and health behavior, different yoga styles and practice components appear to be associated with specific health outcomes. The aim of this study was to explore the connection between yoga use, health, and health behaviors across different yoga styles. METHODS: A cross-sectional anonymous online survey (n = 1,702; 88.9% female; 93.3% German nationality; mean age 47.2 ± 10.8 years; 58.2% yoga teachers) assessed yoga practice characteristics, health-related variables and health behavior. The survey was distributed in Germany only but not limited to German participants. RESULTS: Ashtanga yoga (15.7%), Hatha yoga (14.2%), and Sivananda yoga (22.4%) were the most commonly practiced yoga styles; participants practiced for a mean of 12.7 ± 10.0 years. Most participants had good to excellent (96.1%) overall health; 87.7% reported improved health since starting yoga. Controlling for sociodemographic and clinical factors, health-related variables were mainly associated with frequency of yoga postures practice (p < 0.05), health behaviors also with yoga philosophy study (p < 0.05). The various yoga styles were associated with specific health-related variables (p < 0.05). CONCLUSION: Yoga practitioners generally have a good overall health and a healthy lifestyle. While health variables are mainly associated with practice of yoga postures, health behaviors are also associated with the study of yoga philosophy. Yoga interventions targeting prevention or health promotion should include yoga philosophy to modify health behaviors. The specific yoga style employed may also influence health outcomes.

Yoga for anxiety: A systematic review and meta-analysis of randomized controlled trials.

Yoga has become a popular approach to improve emotional health. The aim of this review was to systematically assess and meta-analyze the effectiveness and safety of yoga for anxiety. Medline/PubMed, Scopus, the Cochrane Library, PsycINFO, and IndMED were searched through October 2016 for randomized controlled trials (RCTs) of yoga for individuals with anxiety disorders or elevated levels of anxiety. The primary outcomes were anxiety and remission rates, and secondary outcomes were depression, quality of life, and safety. Risk of bias was assessed using the Cochrane tool. Eight RCTs with 319 participants (mean age: 30.0-38.5 years) were included. Risk of selection bias was unclear for most RCTs. Meta-analyses revealed evidence for small short-term effects of yoga on anxiety compared to no treatment (standardized mean difference [SMD] = -0.43; 95% confidence interval [CI] = -0.74, -0.11; P = .008), and large effects compared to active comparators (SMD = -0.86; 95% CI = -1.56, -0.15; P = .02). Small effects on depression were found compared to no treatment (SMD = -0.35; 95% CI = -0.66, -0.04; P = .03). Effects were robust against potential methodological bias. No effects were found for patients with anxiety disorders diagnosed by Diagnostic and Statistical Manual criteria, only for patients diagnosed by other methods, and for individuals with elevated levels of anxiety without a formal diagnosis. Only three RCTs reported safety-related data but these indicated that yoga was not associated with increased injuries. In conclusion, yoga might be an effective and safe intervention for individuals with elevated levels of anxiety. There was inconclusive evidence for effects of yoga in anxiety disorders. More high-quality studies are needed and are warranted given these preliminary findings and plausible mechanisms of action.

Searching for Real-World Effectiveness of Health Care Innovations: Scoping Study of Social Prescribing for Diabetes.

BACKGROUND: Social prescribing is a process whereby primary care patients are linked or referred to nonmedical sources of support in the community and voluntary sector. It is a concept that has arisen in practice and implemented widely in the United Kingdom and has been evaluated by various organizations. OBJECTIVE: The aim of our study was to characterize, collate, and analyze the evidence from evaluation of social prescribing for type 2 diabetes in the United Kingdom and Ireland, comparing information available on publicly available websites with the published literature. METHODS: We used a broad, pragmatic definition of social prescribing and conducted Web-based searches for websites of organizations providing potentially relevant services. We also explored linked information. In parallel, we searched Medline, PubMed, Cochrane Library, Google Scholar, and reference lists for relevant studies published in peer-reviewed journals. We extracted the data systematically on the characteristics, any reported evaluation, outcomes measured and results, and terminology used to describe each service. RESULTS: We identified 40 UK- or Ireland-based projects that referred people with type 2 diabetes and prediabetes to nonmedical interventions or services provided in the community. We located evaluations of 24 projects; 11 as published papers, 12 as Web-based reports, and 1 as both a paper and a Web-based report. The interventions and services identified included structured group educational programs, exercise referral schemes, and individualized advice and support with signposting of health-related activities in the community. Although specific interventions such as community-based group educational programs and exercise referral have been evaluated in randomized controlled trials, evaluation of individualized social prescribing services involving people with type 2 diabetes has, in most cases, used pre-post and mixed methods approaches. These evaluations report generic improvement in a broad range of outcomes and provide an insight into the criteria for the success of social prescribing services. CONCLUSIONS: Our study revealed the varied models of social prescribing and nonmedical, community-based services available to people with type 2 diabetes and the extent of evaluation of these, which would not have been achieved by searching databases alone. The findings of this scoping study do not prove that social prescribing is an effective measure for people with type 2 diabetes in the United Kingdom, but can be used to inform future evaluation and contribute to the development of the evidence base for social prescribing. Accessing Web-based information provides a potential method for investigating how specific innovative health concepts, such as social prescribing, have been translated, implemented, and evaluated in practice. Several challenges were encountered including defining the concept, focusing on process plus intervention, and searching diverse, evolving Web-based sources. Further exploration of this approach will inform future research on the application of innovative health care concepts into practice.

Yoga treatment for chronic non-specific low back pain.

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.

Quality of reporting in systematic reviews of adverse events: systematic review.

OBJECTIVES: To examine the quality of reporting of harms in systematic reviews, and to determine the need for a reporting guideline specific for reviews of harms. DESIGN: Systematic review. DATA SOURCES: Cochrane Database of Systematic Reviews (CDSR) and Database of Abstracts of Reviews of Effects (DARE). REVIEW METHODS: Databases were searched for systematic reviews having an adverse event as the main outcome, published from January 2008 to April 2011. Adverse events included an adverse reaction, harms, or complications associated with any healthcare intervention. Articles with a primary aim to investigate the complete safety profile of an intervention were also included. We developed a list of 37 items to measure the quality of reporting on harms in each review; data were collected as dichotomous outcomes ("yes" or "no" for each item). RESULTS: Of 4644 reviews identified, 309 were systematic reviews or meta-analyses primarily assessing harms (13 from CDSR; 296 from DARE). Despite a short time interval, the comparison between the years of 2008 and 2010-11 showed no difference on the quality of reporting over time (P=0.079). Titles in fewer than half the reviews (proportion of reviews 0.46 (95% confidence interval 0.40 to 0.52)) did not mention any harm related terms. Almost one third of DARE reviews (0.26 (0.22 to 0.31)) did not clearly define the adverse events reviewed, nor did they specify the study designs selected for inclusion in their methods section. Almost half of reviews (n=170) did not consider patient risk factors or length of follow-up when reviewing harms of an intervention. Of 67 reviews of complications related to surgery or other procedures, only four (0.05 (0.01 to 0.14)) reported professional qualifications of the individuals involved. The overall, unweighted, proportion of reviews with good reporting was 0.56 (0.55 to 0.57); corresponding proportions were 0.55 (0.53 to 0.57) in 2008, 0.55 (0.54 to 0.57) in 2009, and 0.57 (0.55 to 0.58) in 2010-11. CONCLUSION: Systematic reviews compound the poor reporting of harms data in primary studies by failing to report on harms or doing so inadequately. Improving reporting of adverse events in systematic reviews is an important step towards a balanced assessment of an intervention.

Acupuncture therapy for psychiatric illness.

Acupuncture has traditionally been used for problems including anxiety, insomnia, stress, and depression in China and other East Asian countries. A range of different neurobiological responses to acupuncture have been investigated including modulation of serotonergic, noradrenergic, and dopaminergic systems; effects on GABA and the hypothalamic-pituitary-adrenal axis; and inflammatory responses. Interpretation of the findings is challenging because the neurobiology of psychiatric disorders has yet to be fully elucidated. Limitations also arise from the use of animal models and the selection of appropriate control treatments. Further complexity is added by acupuncture treatment being nonstandardized with acupuncture points often selected on the basis on traditional practice and theory. Potentially promising findings require further investigation and substantiation.

Chinese herbal medicine and depression: the research evidence.

Background. Alternative approaches for managing depression are often sought and herbal mixtures are widely used in China. The aim of this paper was to provide an overall picture of the current evidence by analysing published systematic reviews and presenting a supplementary systematic review of trials in Western databases. Methods. Searches were conducted using AMED, Cochrane Library, EMBASE, MEDLINE/PubMed, PsycINFO, and trial registers. Results were screened and selected trials were evaluated by two reviewers working independently. Systematic reviews were identified and assessed using key criteria. Results. Five systematic reviews were located addressing the Chinese literature, adjunctive use of Chinese herbs, and the formulae Chaihu-Shugan-San, Xiao Yao San, and Free and Easy Wanderer Plus. The supplementary review located 8 trials, 3 of which were not included in previous reviews. Positive results were reported: no significant differences from medication, greater effect than medication or placebo, reduced adverse event rates when combined or compared with antidepressants. However, limitations in methodology and reporting were revealed. Conclusions. Despite promising results, particularly for Xiao Yao San and its modifications, the effectiveness of Chinese herbal medicine in depression could not be fully substantiated based on current evidence. Further well-designed, well-reported trials that reflect practice may be worth pursuing.