Biofield Therapies: Guidelines for Reporting Clinical Trials.

Highlights Guidelines have been created to improve the reporting of clinical trials of biofield therapies, e.g. External Qigong, Healing Touch, Reiki, and Therapeutic Touch. Appropriate use of these guidelines is likely to strengthen the evidence base for biofield therapies as well as increase their usage as stand-alone practices and as complementary therapies within mainstream healthcare.

Biofield therapies: Guidelines for reporting clinical trials.

A set of guidelines has been developed to help improve reporting of clinical trials of biofield therapies. The need for enhanced transparency when reporting trials of this family of integrative health practices, e.g., External Qigong, Healing Touch, Reiki and Therapeutic Touch, has been advocated in systematic reviews of these studies. The guidelines, called Biofield Therapies: Reporting Evidence Guidelines (BiFi REGs), supplement CONSORT 2010 by including details of the intervention protocols relevant to biofield therapy trials. BiFi REGs evolved through a draft document created by a core group, two rounds of a Delphi process with an international group of subject matter experts and two panels, meeting via Zoom, which included editors of complementary and integrative medicine journals. BiFi REGs comprises a 15-item Intervention checklist. Modifications of two other CONSORT topic areas are also proposed to enhance their relevance to trials of biofield therapies. Included for each item are an explanation, and exemplars of reporting from peer-reviewed published reports of biofield therapy trials. When used in conjunction with all other items from CONSORT 2010, we anticipate that BiFi REGs will expedite the peer review process for biofield therapy trials, facilitate attempts at trial replication and help to inform decision-making in the clinical practice of biofield therapies.

Effectiveness of mind-body medicine for Hwa-Byung (a Korean cultural diagnosis of suppressed anger): A systematic review of interventional studies.

OBJECTIVE: This systematic review analysed the effectiveness of mind-body modalities (MBMs) in Hwa-byung (HB). METHODS: Ten electronic databases were searched. Intervention studies using MBMs for individuals with HB, published up to July 2023, were included. The methodological quality of the included studies was assessed using the Cochrane RoB and ROBINS-I tools. Meta-analysis of continuous variables was presented as mean differences (MDs) and their 95% confidence intervals (CIs). RESULTS: Nine studies including five randomized controlled clinical trials, were included. The MBM types were meditation, relaxation, biofield therapy, art therapy, and forest-based MBM, and comprehensive HB programs. Most studies used an MBM group, with 5-6 sessions delivered during an average of 4-5 weeks. As a result of the meta-analysis, art therapy showed a statistically significantly better effect on improving the Hwa-Byung Scale (HB-S) score compared to the waitlist control (MD = -7.74; 95% CI = -9.81 to -5.66). In the before-and-after comparison, MBMs were frequently reported to have significant benefits for improving the HB-S total score (7/7, 100%), depressive mood (4/5, 80%), and state anxiety (6/8, 75%). Some methodological flaws were identified in the included studies, including the reliability of diagnosis, non-implementation of assessor blinding, and inappropriate control groups. CONCLUSIONS: This review identified potentially promising MBMs that were not previously recommended in the current HB clinical practice guidelines. In the future, high-quality clinical studies that include the use of standardized HB diagnostic criteria, homogeneous interventions, appropriate control groups, standard assessment tools such as the HB-S, and assessor blinding are needed.

Mind-body therapies adjuvant to chemotherapy improve quality of life and fatigue in top cancers: A systematic review and meta-analysis.

BACKGROUND: Breast, lung and colorectal cancers are 3 of the top 4 most common cancers worldwide. Their treatment with chemotherapy often results in adverse effects on quality of life, fatigue and functional exercise capacity amongst patients. Mind-body therapies, including yoga, Tai chi and Qigong, are commonly used as complementary and alternative therapies in cancer. This meta-analysis evaluates the effects of yoga, Tai chi and Qigong in alleviating the adverse effects of chemotherapy. METHODS: Various databases were systematically interrogated using specific search terms, returning 1901 manuscripts. Removal of duplicates, irrelevant studies, those lacking available data and applying inclusion/exclusion criteria reduced this number to 9 manuscripts for inclusion in the final meta-analyses. Mean differences were calculated to determine pooled effect sizes using RStudio. RESULTS: This is the first systematic review and meta-analysis to demonstrate significant improvements in fatigue for colorectal cancer patients undergoing chemotherapy with a reduction of -1.40 (95 % CI: -2.24 to -0.56; p = 0.001) observed in mind-body therapy intervention groups. CONCLUSION: Yoga, Tai chi and Qigong could all be implemented alongside adjuvant therapies to alleviate the adverse effects on colorectal cancer patient fatigue during chemotherapy treatment. REVIEW REGISTRATION: This systematic review and meta-analysis is registered on InPlasy: registration number INPLASY202390035; doi: https://doi.org/10.37766/inplasy2023.9.0035.

Use of Complementary and Integrative Medicine for Alzheimer's Disease and Cognitive Decline.

Integrative medicine takes a holistic approach because it considers multiple aspects of the individual. This includes a person's physical, emotional, interpersonal, behavioral, nutritional, environmental, and spiritual dimensions of wellbeing that contribute to the Whole Person Health. There is increasing interest and popularity of integrative approaches to treating cognitive decline and dementia because of the multifactorial nature of aging and the limited pharmacological interventions available in treating cognitive decline and dementia, particularly Alzheimer's disease, the most common type of dementia. This review summarizes the existing evidence using complementary and integrative medicine therapies in cognitive decline and Alzheimer's disease. This includes the use of mind-body therapies, lifestyle interventions (nutritional, physical exercise, stress reduction), and other integrative modalities. Unfortunately, there are still limited studies available to guide clinicians despite the increasing popularity of integrative treatments.

Self-care strategies for medical students: an uncontrolled mixed-methods evaluation of a mind-body-medicine group course.

BACKGROUND: High stress during medical education and its detrimental effects on student health is well documented. This exploratory evaluation study assesses a 10-week Mind-Body-Medicine student course, created to promote student self-care at Charité Universitätsmedizin Berlin, Germany. METHODS: During 2012-2019, uncontrolled quantitative and qualitative data were gathered from 112 student participants. Outcomes including changes in perceived stress (PSS), mindfulness (FMI/MAAS), self-reflection (GRAS), self-efficacy (GSE), empathy (SPF), and health-related quality of life (SF-12) were measured between the first (T0) and last sessions (T1). Qualitative data were obtained in focus groups at course completion and triangulated with quantitative data. RESULTS: Quantitative outcomes showed decreases in perceived stress and increased self-efficacy, mindfulness, self-reflection, and empathy. In focus groups, students reported greater abilities to self-regulate stressful experiences, personal growth and new insights into integrative medicine. Triangulation grounded these effects of MBM practice in its social context, creating an interdependent dynamic between experiences of self and others. CONCLUSION: After completing an MBM course, students reported reduced perceived stress, increased self-efficacy, mindfulness, empathy and positive engagement with integrative concepts of doctor-patient relationships. Further research with larger randomized confirmatory studies is needed to validate these benefits.

Effects of traditional Chinese mind-body exercises for patients with chronic fatigue syndrome: A systematic review and meta-analysis.

Background: Chronic fatigue syndrome (CFS) is a global public health concern. We performed this systematic review of randomised controlled trials (RCTs) to evaluate the effects and safety of traditional Chinese mind-body exercises (TCME) for patients with CFS. Methods: We comprehensively searched MEDLINE, Embase, Web of Science, PsycINFO, Cochrane Library, CNKI, VIP databases, and Wanfang Data from inception to October 2022 for eligible RCTs of TCME for CFS management. We used Cochran's Q statistic and I2 to assess heterogeneity and conducted subgroup analyses based on different types of TCME, background therapy, and types of fatigue. We also assessed the quality of evidence using the Grading of Recommendations, Assessment, Development, and Evaluations (GRADE) approach. Results: We included 13 studies (n = 1187) with a maximal follow-up of 12 weeks. TCME included Qigong and Tai Chi. At the end of the treatment, compared with passive control, TCME probably reduces the severity of fatigue (standardised mean differences (SMD) = 0.85; 95% confidence interval (CI) = 0.64, 1.07, moderate certainty), depression (SMD = 0.53; 95% CI = 0.34, 0.72, moderate certainty), anxiety (SMD = 0.29; 95% CI = 0.11, 0.48, moderate certainty), sleep quality (SMD = 0.34; 95% CI = 0.10, 0.57, low certainty) and mental functioning (SMD = 0.90; 95% CI = 0.50, 1.29, low certainty). Compared with other active control therapies, TCME results in little to no difference in the severity of fatigue (SMD = 0.08; 95% CI = -0.18, 0.34, low certainty). For long-term outcomes, TCME may improve anxiety (SMD = 1.74; 95% CI = 0.44, 3.03, low certainty) compared to passive control. We did not identify TCME-related serious adverse events. Conclusions: In patients with CFS, TCME probably reduces post-intervention fatigue, depression, and anxiety and may improve sleep quality and mental function compared with passive control, but has limited long-term effects. These findings will help health professionals and patients with better clinical decision-making. Registration: PROSPERO: CRD42022329157.

Effects of exercise therapy on pain and disability in patients with non-specific neck pain: A systematic review and meta-analysis.

BACKGROUND: Existing systematic reviews and meta-analyses have only focused on patients with chronic non-specific neck pain (NNP), analyzing exercise therapy (ET) only as therapeutic exercise. Therefore, it is necessary to comprehensively review the effects of ET through a meta-analysis comprising a wide range of ETs that are not limited to therapeutic exercise. OBJECTIVES: This study aimed to investigate the effects of ET on pain and disability in patients with NNP. DESIGN: Systematic review and meta-analysis. METHOD: The studies selected for this study were based on the PICO-SD tool as follows: P (patient)-acute, subacute, and chronic NNP patents, I (intervention)-ET, C (comparison)-control and other therapy groups, O (outcome)-pain and disability, and SD (study design)-randomized controlled trial. RESULTS: Twenty-one studies were included. The effects of ET on pain and disability in patients with chronic NNP were significantly different (pain: SMD -1.47, 95% CI: -1.89 to -1.06, I2: 94%; disability: SMD -1.79, 95% CI: -2.31 to -1.27, I2: 94%). The effects of ET on pain (ET vs control: SMD: -1.60, 95% CI: -2.09 to -1.11, I2: 94%; ET vs sham therapy: SMD: -8.75, 95% CI: -10.71 to -6.79) and disability (ET vs control: SMD: -2.16, 95% CI: -2.80 to -1.52, I2: 94%; ET vs sham therapy: SMD: -1.73, 95% CI: -2.42 to -1.05) in NNP patients were significantly different. CONCLUSIONS: This study verified the efficacy of ET in improving pain and disability in patients with chronic NNP. However, evidence supporting the efficacy of ET in patients with acute and subacute NNP is still lacking.

[The benefits of corporal mediation in the psychic care of adolescents]. / Bienfaits des médiations corporelles dans le soin psychique chez les adolescents.

The actuation of the body and the bodily experience of each experience induce a continuous reshaping of the cerebral configuration of the human being, from birth to death. This ontogenetic dynamic is particularly important during adolescence. The young person's personality, still under construction, can be thrown off balance by traumatic experiences or repeated neglect. Adapted physical activity and psychomotricity, which focus on movement and the body, can help restore balance.

Do cancer curvivors and metavivors have distinct needs for stress management intervention? Retrospective analysis of a mind-body survivorship program.

PURPOSE: Cancer "curvivors" (completed initial curative intent treatment with surgery, radiation, chemotherapy, and/or other novel therapies) and "metavivors" (living with metastatic or chronic, incurable cancer) experience unique stressors, but it remains unknown whether these differences impact benefits from mind-body interventions. This study explored differences between curvivors and metavivors in distress (depression, anxiety, worry) and resiliency changes over the course of an 8-week group program, based in mind-body stress reduction, cognitive-behavioral therapy (CBT), and positive psychology. METHODS: From 2017-2021, 192 cancer survivors (83% curvivors; 17% metavivors) completed optional online surveys of resiliency (CES) and distress (PHQ-8, GAD-7, PSWQ-3) pre- and post- participation in an established clinical program. Mixed effect regression models explored curvivor-metavivor differences at baseline and in pre-post change. RESULTS: Compared to curvivors, metavivors began the program with significantly more resilient health behaviors (B = 0.99, 95% CI[0.12, 1.86], p = .03) and less depression (B = -2.42, 95%CI[-4.73, -0.12], p = .04), with no other significant differences. Curvivors experienced significantly greater reductions in depression (curvivor-metavivor difference in strength of change = 2.12, 95% CI [0.39, 3.83], p = .02) over the course of the program, with no other significant differences. Neither virtual delivery modality nor proportion of sessions attended significantly moderated strength of resiliency or distress change. CONCLUSION: Metavivors entering this mind-body program had relatively higher well-being than did curvivors, and both groups experienced statistically comparable change in all domains other than depression. Resiliency programming may thus benefit a variety of cancer survivors, including those living with incurable cancer.

Effects of mind-body exercise on cognitive performance in middle-aged and older adults with mild cognitive impairment: A meta-analysis study.

BACKGROUND: To systematically evaluate the clinical efficacy of physical and mental exercise on cognitive performance in middle-aged people with mild cognitive impairment (MCI). METHODS: Computer searches of PubMed, Web of science, Embase, Cochrane Library, China Biomedical Literature Service, Wanfang database, China Knowledge Network, and VIP full-text database of Veep journals were conducted to obtain clinical randomized controlled trials on physical and mental exercise interventions in middle-aged and elderly people with MCI. The literature was screened according to inclusion and exclusion criteria, and the final included literature was subjected to data extraction and risk of bias assessment. Meta-analysis was performed using Review Manager 5.4.1 software, and publication bias test was performed using stata17.0 software. RESULTS: A total of 27 publications with a total of 2565 cases of elderly people with MCI were included. The control group was conventional care, health education, or blank control, and the physical and mental exercise group was exercises including Tai Chi, dance, orthopraxia, and qigong for 30 to 90 minutes each time, 3 to 6 times per week, for a total duration of 8 to 36 weeks. Meta-analysis results showed that Montreal cognitive assessment scores (mean difference [MD] = 2.33, 95% CI [1.55, 3.10], P < .00001), the mini-mental state examination score (MD = 1.73, 95% CI [0.60, 2.86], P = .003), trail making test-A score (MD = -4.00, 95% CI [-6.75, -1.25], P = .004), trail making test-B score (MD = -18.46, 95% CI [-23.87, -13.06], P < .00001), global deterioration scale score (MD = -0.72, 95% CI [-1.09, -0.34], P = .0002), Wechsler Logical Memory Scale score (MD = 2.07, 95% CI [0.03, 4.10], P = .05), berg score (MD = -0.70, 95% CI [0.32, 1.07], P < .0003), cerebrospinal fluid Tau protein level (MD = -166.69, 95% CI [-196.93, -136.45], P < .00001), and cerebrospinal fluid levels of αß1-42 protein (MD = 180.39, 95% CI [134.24, 226.55], P < .00001). CONCLUSION: Mind-body exercise can improve cognitive performance, depressive status, and balance as well as increase αß1-42 protein levels and decrease Tau protein levels in middle-aged and older adults with mild cognitive impairment.

Mind-Body Approaches for Managing Distress in Cancer Care.

Symptoms of distress are common in people living with cancer. Evidence-based interventions for distress management in patients with cancer include mind-body approaches. Deep breathing, progressive muscle relaxation, and min.

A Group Intervention Combining Self-Hypnosis and Self-Care in Oncology: Implementation in Daily Life and Perceived Usefulness.

Multicomponent mind-body interventions are increasingly studied in oncology to improve patients' quality of life (QOL). However, the respective usefulness of each of their components or their long-term use by the participants are rarely assessed. In this study, 95 women with different cancer diagnoses participated in a self-hypnosis and self-care group. Different questionnaires were administrated before (T1), right after (T2), 3 to 4 months after (T3), and 1 year after (T4) the intervention. After the intervention, 97.5% of the participants regularly practiced any kind of relaxation (vs. 50% at baseline), especially hypnosis. The different components of the intervention (i.e., being in a group, hypnosis exercises during the sessions and at home, self-care tasks, and discussions during the group sessions) were all considered to be very useful (M = 6.91-7.75/10). One year after the intervention, the 10 most used techniques were mainly concrete activities to take care of oneself. This intervention seems very relevant for women who had cancer. Our results allow a first reflection about the mechanisms of action of our intervention.Registration: ClinicalTrials.gov (NCT03144154). Registered on the 1st of May 2017.

Effectiveness of Aromatherapy in Early Palliative Care for Oncology Patients: Blind Controlled Study.

BACKGROUND: Palliative care is the active holistic treatment of people of all ages who have serious health-related suffering as a result of severe illness, and especially of those who are close to the end of life. Palliative care is provided to cancer patients who experience serious suffering that cannot be relieved without professional intervention and that compromises physical, social, spiritual, and emotional functioning. A straightforward, low-risk, and affordable palliative care approach may be provided through aromatherapy, a type of complementary and alternative medicine. The study objective is to assess the comparative effectiveness of massage, aromatherapy massage, and massage combined with aromatherapy inhalation on cancer patients receiving palliative care. METHODS: A total of 100 participants who were divided into four groups at random. The first group, designated as the control group, received standard hospital nursing care, the second group received massage only (using the odorless almond carrier oil), the third group received massage with lavender oil, and the fourth group received combined (inhalation and massage) aromatherapy. The Rotterdam Symptom Checklist (RSCL), given two weeks after aromatherapy, was used to examine participants' perspectives of care. RESULTS: On the RSCL, combined aromatherapy performed best. In terms of reported physical symptoms, psychological symptoms, and activities, there were statistically significant differences between the scores of the control group and each of the experimental groups. Nonetheless, the total quality of life score showed no significant difference between the control group and the massage only group (t = 0.529, p = 0.60). CONCLUSIONS: When paired with aromatherapy inhalation, massage has a positive effect on physical, psychological symptoms, activities, and overall quality of life for cancer patients receiving early palliative care. Nurses and other healthcare providers are recommended to support programs that provide message therapy to reduce reported bodily symptoms, psychological problems, and limited activities among cancer patients.

Mind-body exercise interventions for prevention of post-traumatic stress disorder in trauma-exposed populations: a systematic review and meta-analysis.

OBJECTIVE: Mind-body exercise (MBE) interventions, such as yoga, are increasingly recognised as an adjunct treatment for trauma-related mental disorders but less is known about their efficacy as a preventative intervention. We aimed to systematically review if, and what type of, MBE interventions are effective at preventing the development of post-traumatic stress disorder (PTSD) or acute stress disorder (ASD) in trauma-exposed populations. DESIGN: Systematic review and meta-analysis. METHODS: A systematic search of MEDLINE, PsycINFO, EMBASE and CENTRAL databases was conducted to identify controlled trials of MBE interventions aimed at preventing the development of PTSD or ASD in high-risk populations. Risk of bias was assessed using the revised Cochrane risk-of-bias and ROBINS-I tools. Pooled effect sizes using Hedges' g and 95% CIs were calculated using random effects modelling for the main meta-analysis and planned subgroup and sensitivity analyses. RESULTS: Six studies (N analysed=399) were included in the final meta-analysis. Overall, there was a small effect for MBE interventions in preventing the development of PTSD (g=-0.25, 95% CI -0.56 to 0.06) among those with previous or ongoing exposure to trauma. Although a prespecified subgroup analyses comparing the different types of MBE intervention were conducted, meaningful conclusions could not be drawn due to the small number of studies. None of the included studies assessed ASD symptoms. CONCLUSION: Limited evidence was found for MBE interventions in reducing PTSD symptomology in the short term. Findings must be interpreted with caution due to the small number of studies and possible publication bias. PROSPERO REGISTRATION NUMBER: CRD42020180375.

Massage therapy significantly improves cancer-related fatigue in cancer patients: a meta-analysis of randomized controlled trials.

PURPOSE: This study was designed to investigate the effectiveness and safety of massage therapy in cancer-related fatigue (CRF) and to provide a reference for the future management of CRF. METHODS: Eight databases (PubMed, Embase, Cochrane Library, CINAHL, Sinomed, Chinese Scientific Journal database (VIP), Wanfang, and China National Knowledge Infrastructure (CNKI)) were systematically reviewed from inception to May 2022 for randomized controlled trials. Two reviewers critically and independently assessed the risk of bias using Cochrane Collaboration criteria and extracted correlated data using the designed form. The meta-analysis was performed using RevMan 5.3 to calculate the pooled effect sizes and 95% confidence intervals (CIs). Sensitivity analysis was performed to find the source of the heterogeneity. Publication bias was assessed via funnel plot analysis and the Egger test. RESULT: A total of 11 qualified studies that included 789 patients (massage therapy group: 389; control group: 400) were included in the meta-analysis. Massage therapy had a marked effect on fatigue in cancer patients [standardized mean difference (SMD) = - 1.69, 95% CI (- 2.46, - 0.93), P < 0.01], especially in breast cancer [SMD = - 1.62, 95% CI (- 2.18, - 1.05), P < 0.01]. Reflexology [SMD = - 2.71, 95% CI (- 4.65, - 0.77), P < 0.01] and Chinese massage [SMD = - 1.14, 95% CI (- 1.95, - 0.33), P < 0.01] can have a more significant effect on fatigue. Massage time is 20 to 40 min [SMD = - 2.39, 95% CI (- 4.13, - 0.66), P < 0.01], twice a week [SMD = - 3.46, 95% CI (- 5.47, - 1.45), P < 0.01] for 3-5 weeks [SMD = - 2.36, 95% CI (- 3.53, - 1.19), P < 0.01], which is more effective in relieving fatigue in cancer patients. Five studies described the occurrence of adverse events and only two studies had adverse events. CONCLUSION: Massage therapy can be effective in relieving fatigue in cancer patients. Current evidence suggests that reflexology is the most effective approach to relieve fatigue, particularly in the breast cancer patients. The optimal intervention frequency and cycle for massage therapy is twice a week for 3-5 weeks, and the optimal duration is 20-40 min.

[Complementary methods in the treatment of complex regional pain syndrome]. / Komplementäre Verfahren in der Behandlung des komplexen regionalen Schmerzsyndroms.

BACKGROUND: Complex regional pain syndrome (CRPS) affects 10-15% of patients following injuries (fractures, surgery) to the outer extremities and people after a stroke. The affected area hurts, is inflamed and lacks strength, while mobility and sensitivity are restricted. Complementary medicine as part of integrative medicine offers additional effective treatment options. RESEARCH QUESTION: Complementary therapies that extend the guideline recommendations, demonstrate clinical evidence and/or are plausible are presented. RESULTS: Mind-body medicine procedures (mindfulness, relaxation, yoga, Qi Gong, etc.) support the patient's self-efficacy and stimulate the vagus nerve as well as promoting the reduction of pain, depression and anxiety and improving quality of life. Phytotherapeutics such as turmeric or stinging nettle have an anti-inflammatory effect. Water treatments reduce pain, and acupuncture and neural therapy can be tried. CONCLUSIONS: Integrative, complementary medical therapy options support the CRPS patient in coping with their disease and the related pain. These options can play an important role in the multimodal, interdisciplinary treatment of this disease.