Low inter-rater reliability and reproducibility of Neck Reflex / "Adler-Langer" Points in Neural Therapy Diagnostics but increased pressure-pain threshold after therapy - results of a randomized controlled observer-blind trial.

BACKGROUND: Neck reflex points or Adler-Langer Points are commonly used in neural therapy to detect so-called interference fields. Chronic irritations or inflammations in the sinuses, teeth, tonsils or ears are supposed to induce tension and tenderness of the soft tissues and short muscles in the upper cervical spine. The individual treatment strategy is based on the results of diagnostic Adler-Langer Points palpation. This study investigated the inter- and intra-rater reliability and explored treatment effects. METHODS: We performed a randomized-controlled trial with 104 inpatients (80.8% female, 51.812.74 yrs) of a German department for internal and integrative medicine. Patients were randomized to individual neural therapy according to the pathological findings (n=48) or no treatment (n=56). In each patient, three experienced raters (20-45y experience in neural therapy) and two novice raters (medical students) rated Adler-Langer Points rigidity on a standardized rating scale ("strong", "weak", "none"). The patients independently evaluated the tenderness on palpation of the eight points using the same scale. Pressure pain thresholds were assessed at the eight Adler-Langer Points. All patients were retested after 30 minutes. The five raters were blinded to treatment allocation and assessments of the other raters. Video recordings were obtained to assess the consistency of the areas tested by the different raters. RESULTS: Agreement between patients and raters (Cohen's Kappa=.161-.400) and inter-rater reliability were low (Fleiss-Kappa=.132-.150). Moreover, the individual agreement (pre-post comparisons in untreated patients) was similarly low even in experienced raters (Cohen's Kappa=.099-.173). Video documentation suggests that raters do not place their fingers in the correct segments (percentage of correct position 42.0-60.6%). Pressure pain thresholds at five of the eight Adler-Langer Points showed significant changes after treatment compared to none in the control group. CONCLUSION: Under this artificial experimental setting, this method of Adler-Langer Point palpation has not proven to be a reliable diagnostic tool. But it could be shown, that as claimed by the method, the tenderness in five of eight Adler-Langer Points decreased after neural therapy.

A systematic review and meta-analysis of mindfulness-based stress reduction for arterial hypertension.

Arterial hypertension is a major public health issue. Non-pharmacological approaches like Mindfulness-Based Stress Reduction (MBSR) might be a promising addition to conventional therapy. This systematic review and meta-analysis aim to evaluate the effects of MBSR on systolic (SBP) and diastolic blood pressure (DBP) among individuals with prehypertension or hypertension. We searched Medline/PubMed, Scopus and the Cochrane Central Register of Controlled Trials (CENTRAL) for randomized controlled trials (RCTs) from their inception until August 1st 2021. RCTs were included that compared MBSR to any control intervention in participants with diagnosed prehypertension (120-139/80-89 mmHg) or hypertension (≥140/≥90 mmHg). Mean differences (MD) and 95% confidence intervals (CI) were calculated. Risk of Bias was assessed using the Cochrane tool. Seven RCTs with 429 participants were included. Very low quality of evidence was found for positive effects of MBSR on SBP (MD = -11.26 mmHg, 95%CI = -20.24 to -2.29, p = 0.01) but no evidence for effects on DBP levels (MD = -3.62 mmHg, 95%CI = -8.52 to 1.29, p = 0.15) compared to waitlist control. Compared to active control, very low quality of evidence was found for positive effects on DBP (MD = -5.51 mmHg, 95%CI = -10.93 to -0.09, p = 0.05) but no effects on SBP levels (MD = -4.33 mmHg, 95%CI = -12.04 to 3.38, p = 0.27). Overall, the studies showed a high degree of heterogeneity. The effects found were robust against selection, detection, and attrition bias. Only one RCT reported safety data. MBSR may be an option for lowering blood pressure in people with prehypertension to hypertension. More and larger high-quality studies are needed to substantiate our findings.

A Randomized Controlled Trial of Fasting and Lifestyle Modification in Patients with Metabolic Syndrome: Effects on Patient-Reported Outcomes.

Lifestyle interventions can have a positive impact on quality of life and psychological parameters in patients with metabolic syndrome (MetS). In this randomized controlled trial, 145 participants with MetS (62.8% women; 59.7 ± 9.3 years) were randomized to (1) 5-day fasting followed by 10 weeks of lifestyle modification (F + LM; modified DASH diet, exercise, mindfulness; n = 73) or (2) 10 weeks of lifestyle modification only (LM; n = 72). Outcomes were assessed at weeks 0, 1, 12, and 24, and included quality of life (Short-Form 36 Health Survey Questionnaire, SF-36), anxiety/depression (Hospital Anxiety and Depression Scale, HADS), stress (Cohen Perceived Stress Scale, CPSS), mood (Profile of Mood States, POMS), self-efficacy (General Self-Efficacy Scale, GSE), mindfulness (Mindfulness Attention Awareness Scale, MAAS), and self-compassion (Self-Compassion Scale, SCS). At week 1, POMS depression and fatigue scores were significantly lower in F + LM compared to LM. At week 12, most self-report outcomes improved in both groups-only POMS vigor was significantly higher in F + LM than in LM. Most of the beneficial effects within the groups persisted at week 24. Fasting can induce mood-modulating effects in the short term. LM induced several positive effects on quality of life and psychological parameters in patients with MetS.

Effects of Fasting and Lifestyle Modification in Patients with Metabolic Syndrome: A Randomized Controlled Trial.

BACKGROUND: Lifestyle interventions, such as fasting, diet, and exercise, are increasingly used as a treatment option for patients with metabolic syndrome (MS). This study assesses the efficacy and safety of fasting followed by lifestyle modification in patients with MS compared to lifestyle modification only. METHODS: Single-blind, multicenter, parallel, randomized controlled trial in two German tertiary referral hospitals in metropolitan areas. INTERVENTIONS: (a) 5-day fasting followed by 10 weeks of lifestyle modification (modified DASH diet, exercise, mindfulness; n = 73); (b) 10 weeks of lifestyle modification only (n = 72). MAIN OUTCOMES AND MEASURES: Co-primary outcomes were ambulatory systolic blood pressure and the homeostasis model assessment (HOMA) index at week 12. Further outcomes included anthropometric, laboratory parameters, and the PROCAM score at weeks 1, 12, and 24. RESULTS: A total of 145 patients with metabolic syndrome (62.8% women; 59.7 ± 9.3 years) were included. No significant group differences occurred for the co-primary outcomes at week 12. However, compared to lifestyle modification only, fasting significantly reduced HOMA index (Δ = -0.8; 95% confidence interval [CI] = -1.7, -0.1), diastolic blood pressure (Δ = -4.8; 95% CI = -5.5, -4.1), BMI (Δ = -1.7; 95% CI = -2.0, -1.4), weight (Δ = -1.7; 95% CI = -2.0, -1.4), waist circumference (Δ = -2.6; 95% CI = -5.0, -0.2), glucose (Δ = -10.3; 95% CI = -19.0, -1.6), insulin (Δ = -2.9; 95% CI = -5.3, -0.4), HbA1c (Δ = -0.2; 95% CI = -0.4, -0.05;), triglycerides (Δ = -48.9; 95% CI = -81.0, -16.9), IL-6 (Δ = -1.2; 95% CI = -2.5, -0.005), and the 10-year risk of acute coronary events (Δ = -4.9; 95% CI = -9.5, -0.4) after week 1. Fasting increased uric acid levels (Δ = 1.0; 95% CI = 0.1, 1.9) and slightly reduced eGRF (Δ = -11.9; 95% CI = -21.8, -2.0). Group differences at week 24 were found for weight (Δ = -2, 7; 95% CI = -4.8, -0.5), BMI (Δ = -1.0; 95% CI = -1.8, -0.3), glucose (Δ = -7.7; 95% CI = -13.5, -1.8), HDL (Δ = 5.1; 95% CI = 1.5, 8.8), and CRP (Δ = 0.2; 95% CI = 0.03, 0.4). No serious adverse events occurred. CONCLUSIONS: A beneficial effect at week 24 was found on weight; fasting also induced various positive short-term effects in patients with MS. Fasting can thus be considered a treatment for initializing lifestyle modification for this patient group; however, it remains to be investigated whether and how the multilayered effects of fasting can be maintained in the medium and longer term.

Safety of acupuncture in oncology: A systematic review and meta-analysis of randomized controlled trials.

BACKGROUND: Acupuncture is frequently used to treat the side effects of cancer treatment, but the safety of this intervention remains uncertain. The current meta-analysis was conducted to assess the safety of acupuncture in oncological patients. METHODS: The PubMed, Cochrane Central Register of Controlled Trials, and Scopus databases were searched from their inception to August 7, 2020. Randomized controlled trials in oncological patients comparing invasive acupuncture with sham acupuncture, treatment as usual (TAU), or any other active control were eligible. Two reviewers independently extracted data on study characteristics and adverse events (AEs). Risk of bias was assessed using the Cochrane Risk of Bias Tool. RESULTS: Of 4590 screened articles, 65 were included in the analyses. The authors observed that acupuncture was not associated an with increased risk of intervention-related AEs, nonserious AEs, serious AEs, or dropout because of AEs compared with sham acupuncture and an active control. Compared with TAU, acupuncture was not associated with an increased risk of intervention-related AEs, serious AEs, or drop out because of AEs but was associated with an increased risk for nonserious AEs (odds ratio, 3.94; 95% confidence interval, 1.16-13.35; P = .03). However, the increased risk of nonserious AEs compared with TAU was not robust against selection bias. The meta-analyses may have been biased because of the insufficient reporting of AEs in the original randomized controlled trials. CONCLUSIONS: The current review indicates that acupuncture is as safe as sham acupuncture and active controls in oncological patients. The authors recommend researchers heed the CONSORT (Consolidated Standards of Reporting Trials) safety and harm extension for reporting to capture the side effects and better investigate the risk profile of acupuncture in oncology. LAY SUMMARY: According to this analysis, acupuncture is a safe therapy for the treatment of patients with cancer. Acupuncture seems to be safe compared with sham acupuncture and active controls.

Efficacy of Auricular Acupuncture and Lavender Oil Aromatherapy in Reducing Preinterventional Anxiety in Cardiovascular Patients: A Randomized Single-Blind Placebo-Controlled Trial.

Introduction: Auricular acupuncture at the "relaxation point" and lavender oil aromatherapy can reduce preoperative anxiety associated with increased mortality and morbidity. Data on the effect of combined auricular acupuncture and lavender oil aromatherapy in patients undergoing cardiovascular interventions with the use of local anesthesia or under conscious sedation are sparse. The authors sought to evaluate the efficacy of auricular acupuncture and lavender oil aromatherapy in reducing preinterventional anxiety in cardiovascular patients. Materials and Methods: Data of 80 consecutive patients undergoing diagnostic coronary angiography (n = 56) with or without percutaneous coronary intervention (n = 9) and right heart catheterization (n = 6), transcatheter aortic valve replacement (n = 17) and percutaneous mitral valve repair (MitraClip; n = 2) were analyzed. Patients were prospectively randomized to receive either preinterventional auricular acupuncture and lavender oil (Lavandula angustifolia) aromatherapy (verum group, n = 39) or combined sham auricular acupuncture and placebo oil aromatherapy (placebo group, n = 41). For the verum group bilateral auricular acupuncture was performed at the "relaxation point." State anxiety and blood pressure were assessed before and at 30 min after acupuncture and presternal oil application. State anxiety was defined as primary outcome measure and assessed using the Spielberger State Anxiety Inventory (STAI) for Adults form Y6. Intervention-specific anxiety was assessed by a 10-point numerical rating scale, and perceived treatment success by a single dichotomous question. Clinical blood pressure was further assessed. Results: After the intervention, the verum group had significantly decreased anxiety on the STAI compared with the placebo group (Δ = -4.18; 95% confidence interval = -8.31 to -0.05; p = 0.047). Significantly more patients reported subjective treatment success in the verum group (87.2%) than in the placebo group (65.9%, p = 0.035). No significant differences were observed regarding intervention-specific anxiety and blood pressure between the two groups. No serious adverse events occurred in any group. Conclusions: Combined auricular acupuncture and lavender oil aromatherapy can decrease preinterventional anxiety in cardiovascular patients and requires further investigation. German Clinical Trials Register (registration no. DRKS00023686).

Yoga for treating low back pain: a systematic review and meta-analysis.

ABSTRACT: Yoga is frequently used for back pain relief. However, the evidence was judged to be of only low to moderate certainty. To assess the efficacy and safety of yoga in patients with low back pain, a meta-analysis was performed. Therefore, MEDLINE/PubMed, Scopus, and the Cochrane Library were searched to May 26, 2020. Only randomized controlled trials comparing Yoga with passive control (usual care or wait list), or an active comparator, for patients with low back pain and that assessed pain intensity or pain-related disability as a primary outcome were considered to be eligible. Two reviewers independently extracted data on study characteristics, outcome measures, and results at short-term and long-term follow-up. Risk of bias was assessed using the Cochrane risk of bias tool. Thirty articles on 27 individual studies (2702 participants in total) proved eligible for review. Compared with passive control, yoga was associated with short-term improvements in pain intensity (15 RCTs; mean difference [MD] = -0.74 points on a numeric rating scale; 95% confidence interval [CI] = -1.04 to -0.44; standardized mean difference [SMD] = -0.37 95% CI = -0.52 to -0.22), pain-related disability (15 RCTs; MD = -2.28; 95% CI = -3.30 to -1.26; SMD = -0.38 95% CI = -0.55 to -0.21), mental health (7 RCTs; MD = 1.70; 95% CI = 0.20-3.20; SMD = 0.17 95% CI = 0.02-0.32), and physical functioning (9 RCTs; MD = 2.80; 95% CI = 1.00-4.70; SMD = 0.28 95% CI = 0.10-0.47). Except for mental health, all effects were sustained long-term. Compared with an active comparator, yoga was not associated with any significant differences in short-term or long-term outcomes.

Comprehensive Lifestyle Modification Influences Medium-Term and Artificially Induced Stress in Ulcerative Colitis-A Sub-Study within a Randomized Controlled Trial Using the Trier Social Stress Test.

OBJECTIVE: The present study presents long-term results of stress-related outcomes of a prospective RCT that evaluated effects of a ten-week comprehensive lifestyle-modification program (LSM) in patients with inactive ulcerative colitis (UC). In addition, exploratory results of a sub-study applying a laboratory stress protocol (Trier Social Stress Test; TSST) conducted within the RCT are reported. METHODS: Ninety-seven patients with inactive UC were randomized to LSM (n = 47; 50.28 ± 11.90 years; 72.3% female) or self-care (n = 50; 45.54 ± 12.49 years; 70% female). Patients' perceived stress, anxiety, flourishing and depression were assessed at week 0, 12, 24 and 48. After the respective intervention, 16 female patients (LSM: n = 8; 44.6 ± 14.3 years; Self-care: n = 8; 49.25 ± 4.30 years) additionally underwent the TSST. State anxiety, blood pressure, pulse, complete blood counts, adrenocorticotropic hormone (ACTH), cortisol, adrenalin and noradrenalin were measured at baseline (-15 min), stress (+10 min), recovery1 (+20 min) and recovery2 (+55 min). Statistical significance was set at p < 0.05; for the exploratory sub-study using the TSST, p-values < 0.10 were considered significant. RESULTS: Patients' perceived stress declined significantly after the LSM (p < 0.001) compared with control. This lasted until week 24 (p = 0.023) but did not persist until week 48 (p = 0.060). After 48 weeks, patients' flourishing was significantly increased compared with control (p = 0.006). In response to the TSST, significant group differences were evident for pulse (p = 0.015), adrenaline (p = 0.037) and anxiety (p = 0.066). After 55 min, group differences were found for ACTH (p = 0.067) and systolic blood pressure (p = 0.050). CONCLUSIONS: LSM has a medium-term positive effect on perceived stress. First indications show that it is promising to investigate these effects further under laboratory conditions. It is also desirable to find out how the effects of LSM can be maintained in the long term.

A systematic review and meta-analysis of acceptance- and mindfulness-based interventions for DSM-5 anxiety disorders.

This meta-analysis systematically reviewed the evidence on standardized acceptance-/mindfulness-based interventions in DSM-5 anxiety disorders. Randomized controlled trials examining Acceptance and Commitment Therapy (ACT), Mindfulness-Based Cognitive Therapy (MBCT), and Mindfulness-Based Stress Reduction (MBSR) were searched via PubMed, Central, PsycInfo, and Scopus until June 2021. Standardized mean differences (SMD) and 95% confidence intervals (CI) were calculated for primary outcomes (anxiety) and secondary ones (depression and quality of life). Risk of bias was assessed using the Cochrane tool. We found 23 studies, mostly of unclear risk of bias, including 1815 adults with different DSM-5 anxiety disorders. ACT, MBCT and MBSR led to short-term effects on clinician- and patient-rated anxiety in addition to treatment as usual (TAU) versus TAU alone. In comparison to Cognitive Behavioral Therapy (CBT), ACT and MBCT showed comparable effects on both anxiety outcomes, while MBSR showed significantly lower effects. Analyses up to 6 and 12 months did not reveal significant differences compared to TAU or CBT. Effects on depression and quality of life showed similar trends. Statistical heterogeneity was moderate to considerable. Adverse events were reported insufficiently. The evidence suggests short-term anxiolytic effects of acceptance- and mindfulness-based interventions. Specific treatment effects exceeding those of placebo mechanisms remain unclear. Protocol registry: Registered at Prospero on November 3rd, 2017 (CRD42017076810).

Efficacy and Safety of Auricular Acupuncture for the Treatment of Insomnia in Breast Cancer Survivors: A Randomized Controlled Trial.

Among women, breast cancer is the most commonly diagnosed cancer worldwide. Sleep problems impair 40-70% of breast cancer survivors. This randomized controlled trial evaluates the effect of auricular acupuncture on sleep quality in breast cancer survivors suffering from insomnia. Fifty-two female breast cancer survivors with insomnia (mean age 55.73 ± 8.10 years) were randomized either to 10 treatments of auricular acupuncture within five weeks (n = 26), or to a single session of psychoeducation plus an insomnia advice booklet (n = 26). The primary outcome was sleep quality (measured by the Pittsburgh Sleep Quality Index) at week 5. Secondary outcomes were inflammation parameter (interleukin-6), stress, anxiety, depression, quality of life, and fatigue at week 5, and sleep quality, stress, anxiety, depression, quality of life, and fatigue 17 and 29 weeks after randomization. Intention-to-treat analysis showed a significantly stronger increase in sleep quality in the auricular acupuncture group compared to the psychoeducation group (p = 0.031; η2p = 0.094) at week 5. Furthermore, auricular acupuncture improved stress (p = 0.030; η2p = 0.094), anxiety (p = 0.001; η2p = 0.192), and fatigue (p = 0.006; η2p = 0.148) at week 5 compared to psychoeducation. No significant group difference was found concerning the other outcomes at week 5, or in any outcome at week 17 or week 29. No serious adverse events occurred during the study period. In conclusion, a semi-standardized group auricular acupuncture might be an effective and safe intervention in treating insomnia in breast cancer survivors in the short term, and may reduce stress, anxiety, and fatigue as well. Long-term effects remain questionable.

Complementary medicine use and flu vaccination - A nationally representative survey of US adults.

BACKGROUND: Prior research presented inconsistent results with less, equal or higher vaccination rates among patients using complementary medicine. Given that complementary medicine includes a wide range of therapies, variable vaccination patterns may occur within consultations with different professions. This analysis aims to to evaluate differences between categories of complementary medicine regarding vaccination behavior among US adults. METHODS AND RESULTS: This analysis used data from the 2017 National Health Interview Survey (NHIS; n = 26,742; response rate 80.7%). Prevalences of flu vaccination, consultations with complementary medicine practitioners in the past 12 months and their potential interactions were examined. 42.7% of participants had received flu vaccination in the past 12 months, 32.4% had seen one or more complementary medicine practitioner. Users of any type of complementary medicine were as likely as non-users to have received a flu vaccination (44.8% users versus 41.7% non-users; p = 0,862; adjusted odds ratio [AOR] = 1.01, 95% confidence interval [CI] = 0.95-1.07). Regarding specific complementary medicine types, individuals consulting with naturopaths (p < 0.001; AOR = 0.67, 95 %CI = 0.54-0.82), homeopaths (p < 0.001; AOR = 0.55; 95 %CI = 0.44-0.69) and chiropractors (p = 0.016; AOR = 0.9, 95 %CI = 0.83-0.98) were less likely, while other complementary medicine approaches showed no significant association with flu vaccination behavior. Independent predictors for a flu shot were prior diabetes, cancer, current asthma, kidney disease, overweight and current pregnancy. As well, higher educational level, age, ethnicity, health insurance coverage and having seen a general physician or medical specialist in the past 12 months were also associated with a higher vaccination rate. CONCLUSIONS: Complementary medicine users were equally likely to receive an influenza vaccination compared with non-users. Different complementary therapies showed varied associations with vaccination behavior. Further analyses may be needed to distinguish influencing factors among patients' vaccination behavior.

Integrative pediatrics survey: Parents report high demand and willingness to self-pay for complementary and integrative medicine in German hospitals.

BACKGROUND: In Germany, there is hardly any institutionalization of pediatric complementary and integrative medicine (CIM) present, which is one reason why the statutory health insurance companies usually do not cover the costs. Which in turn serves as an obstacle for integrating CIM into routine pediatric care. Within the present study, we assessed existing demand for CIM methods in parents of children in clinical primary care and whether the parents would be willing to cover the costs privately. METHODS: Parents who visited the Pediatric Department of the Elisabeth Hospital, Essen, Germany and the Children's Hospital St. Marien, Landshut, Germany with their children in 2015 and 2016 were asked to take part in a paper-pencil survey. Both outpatients and inpatients were interviewed. RESULTS: 1323 parents took part in the survey. 40 % of them stated that they already use CIM for their children. Homeopathy was the most frequently mentioned with almost 60 %, followed by osteopathy and phytotherapy. More than 80 % of the participants endorsed the expansion of the CIM offers in respective hospitals. Homeopathy was the method most desired by the parents, followed by osteopathy, phytotherapy and massage therapies. The majority (88 %) of the parents stated that they would like to take advantage of an extended range of services, including extra services that they would have to pay privately for. CONCLUSION: Many parents are already using CIM for their children and are looking forward to CIM being incorporated in clinical primary care. They would also be willing to bear the costs themselves if the therapy in question is not covered by their insurance. pay for the costs themselves if the therapy is not covered by their insurance.

The INTREST registry: protocol of a multicenter prospective cohort study of predictors of women's response to integrative breast cancer treatment.

BACKGROUND: Cancer registries usually assess data of conventional treatments and/or patient survival. Beyond that, little is known about the influence of other predictors of treatment response related to the use of complementary therapies (CM) and lifestyle factors affecting patients' quality and quantity of life. METHODS: INTREST is a prospective cohort study collecting register data at multiple German certified cancer centers, which provide individualized, integrative, in- and outpatient breast cancer care. Patient-reported outcomes and clinical cancer data of anticipated N = 715 women with pTNM stage I-III breast cancer are collected using standardized case report forms at the time of diagnosis, after completing neo-/adjuvant chemotherapy, after completing adjuvant therapy (with the exception of endocrine therapy) as well as 1, 2, 5, and 10 years after baseline. Endpoints for multivariable prediction models are quality of life, fatigue, treatment adherence, and progression-based outcomes/survival. Predictors include the study center, sociodemographic characteristics, histologic cancer and comorbidity data, performance status, stress perception, depression, anxiety, sleep quality, spirituality, social support, physical activity, diet behavior, type of conventional treatments, use of and belief in CM treatments, and participation in a clinical trial. Safety is recorded following the Common Terminology Criteria for Adverse Events. DISCUSSION: This trial is currently recruiting participants. Future analyses will allow to identify predictors of short- and long-term response to integrative breast cancer treatment in women, which, in turn, may improve cancer care as well as quality and quantity of life with cancer. TRIAL REGISTRATION: German Clinical Trial Register DRKS00014852 . Retrospectively registered at July 4th, 2018.

Yoga in women with abdominal obesity - Do lifestyle factors mediate the effect? Secondary analysis of a RCT.

INTRODUCTION: The reduction of obesity is an important challenge for health policy. Although dietary interventions are widely available, patient adherence is usually low. A promising alternative is yoga. We hypothesized that weight reduction through yoga is mediated by aspects related to eating habits as well as physical aspects. METHODS: This is an exploratory secondary analysis of a randomized controlled trial comparing the effects of yoga to waiting list in women with abdominal obesity. Body mass index (BMI) and waist circumference were assessed as outcomes; physical exercise habits, physical activity habits at leisure time, physical activity habits at work time, daily fruit and vegetable intake, nutrition self-efficacy, and physical self-efficacy were captured as mediators. Measures were assessed at weeks 0 and 12. The original trial was conducted between April and August 2015. The secondary analysis was performed December 2019. RESULTS: Forty patients were randomized to the 12 weekly yoga sessions (48.5 ± 7.9 years) and 20 patients to the waitlist group (46.4 ± 8.9 years). Physical exercise habits fully mediated the effect of yoga on BMI (B=-0.26;CI[-.56;-.07]). Daily fruit and vegetable intake partially mediated the effect of yoga on BMI (B=-0.13;CI[-.38;-.01]). No further mediation effects were found. CONCLUSIONS: Yoga supports people with overweight in eating healthier and increasing their physical activity which in turn leads to a reduced BMI. Yoga's effects on waist circumference seem to be due to other mechanisms.

The use and benefits of Craniosacral Therapy in primary health care: A prospective cohort study.

BACKGROUND: Patients frequently use treatments complementary to standard primary care. This prospective cohort-study examined the use, benefits, and safety of Craniosacral Therapy (CST). METHODS: Consecutive out-patients utilizing CST from 2015 to 2019 were asked to provide anonymized data on symptom intensity, functional disability, and quality of life before and after treatment using an adapted 11-point numerical rating scale (NRS) version of the Measure Yourself Medical Outcome Profile (MYMOP). Treatment expectations were assessed as were concurrent therapies/medication and safety. Mean differences were analyzed using paired sample t-tests with 95 % confidence intervals (CI), predictors of treatment response using linear regression modelling. RESULTS: CST therapists submitted 220 patient records (71.4 % female) including 15.5 % infants and toddlers, 7.7 % children, and 76.8 % adolescents and adults. Patients received on average 7.0 ± 7.3 CST sessions to treat 114 different, acute and chronic conditions. Symptom intensity significantly decreased by -4.38 NRS (95 %CI=-4.69/-4.07), disability by -4.41 NRS (95 %CI=-4.78/-4.05), and quality of life improved by 2.94 NRS (95 %CI = 2.62/3.27). Furthermore, CST enhanced personal resources by 3.10 NRS (95 %CI = 1.99/4.21). Independent positive predictors of change in the adapted total MYMOP score included patients' expectations (p = .001) and therapists' CST experience (p = .013), negative predictors were symptom duration (p < .002) and patient age (p = .021); a final categorical predictor was CST type (p = .023). Minor but no serious adverse events occurred. CONCLUSIONS: In primary care, patients and parents of underage children use CST for preventive and therapeutic purposes. Considering the design limitations, CST appears to be overall effective and safe in infants, children, and adults.

Fasting alters the gut microbiome reducing blood pressure and body weight in metabolic syndrome patients.

Periods of fasting and refeeding may reduce cardiometabolic risk elevated by Western diet. Here we show in the substudy of NCT02099968, investigating the clinical parameters, the immunome and gut microbiome exploratory endpoints, that in hypertensive metabolic syndrome patients, a 5-day fast followed by a modified Dietary Approach to Stop Hypertension diet reduces systolic blood pressure, need for antihypertensive medications, body-mass index at three months post intervention compared to a modified Dietary Approach to Stop Hypertension diet alone. Fasting alters the gut microbiome, impacting bacterial taxa and gene modules associated with short-chain fatty acid production. Cross-system analyses reveal a positive correlation of circulating mucosa-associated invariant T cells, non-classical monocytes and CD4+ effector T cells with systolic blood pressure. Furthermore, regulatory T cells positively correlate with body-mass index and weight. Machine learning analysis of baseline immunome or microbiome data predicts sustained systolic blood pressure response within the fasting group, identifying CD8+ effector T cells, Th17 cells and regulatory T cells or Desulfovibrionaceae, Hydrogenoanaerobacterium, Akkermansia, and Ruminococcaceae as important contributors to the model. Here we report that the high-resolution multi-omics data highlight fasting as a promising non-pharmacological intervention for the treatment of high blood pressure in metabolic syndrome patients.

Effects of an Integrative Mind-Body-Medicine Group Program on Breast Cancer Patients During Chemotherapy: An Observational Study.

BACKGROUND: Breast cancer is one of the leading cancers in women in the Western world. Cancer treatment, especially chemotherapy, is often associated with physical and psychosocial side effects. OBJECTIVE: To improve the quality of life and manage side effects, a new integrative mind-body-medicine group concept for breast cancer patients receiving chemotherapy was developed and pilot tested. METHODS: Breast cancer patients participated in a 66 hours mind-body-medicine group program tailored to the needs of cancer patients during chemotherapy. The program was integrated into standard care encompassing mindfulness training, yoga, moderate exercise, nutrition, complementary self-help strategies, cognitive restructuring, and acupuncture. Quality of life (EORTC QLQ-C30), depression and anxiety (HADS), stress (PSS-10), and fatigue (BFI) were assessed before and after the program, as well as satisfaction and safety. Analyses were carried out on exploratory basis with paired samples t-tests. RESULTS: Fifty-seven female patients, aged 51.3±10.5 years, with breast cancer diagnoses were enrolled. After completing the program, global EORTC quality of life was improved (D=9.5; 95%-CI=[2.9|16.1]; p=.005), although the EORTC-symptom scales assessing fatigue (D=9.9; 95%-CI=[1|18.8]; p=.030), nausea (D=7.1; 95%- CI=[0.6|13.6]; p=.031), and dyspnea (D=12.5; 95%-CI=[2.9|22.1]; p=.011) were found to be increased. Stress (D=-3.5; 95%-CI=[-5|-2.1]; p=.000), anxiety (D=-3.8; 95%-CI=[-4.9|-2.7]; p=.000) and depression (D=-3.9; 95%-CI=[-4.9|-2.8]; p=.000) were also found to be significantly reduced. Regarding the severity of (D=0.2; 95%- CI=[-0.8|0.5]; p=.644) and the impairment due to fatigue (D=0.1; 95%-CI=[-0.8|0.6]; p=.696), no significant worsening was observed. Patients were satisfied with the program. No serious adverse events were reported. CONCLUSION: Breast cancer patients benefit from an integrative mind-body-medicine group program during chemotherapy regarding the quality of life and psychological symptoms. Randomized controlled trials are warranted.

Comprehensive Lifestyle-Modification in Patients with Ulcerative Colitis-A Randomized Controlled Trial.

Patients with ulcerative colitis suffer from impaired health-related quality of life (HrQoL). Comprehensive lifestyle-modification might increase HrQoL and decrease disease activity. Ninety-seven patients in clinical remission with impaired HrQoL were randomly assigned to a 10 week comprehensive lifestyle-modification program (LSM; n = 47; 50.28 ± 11.90 years) or control (n = 50; 45.54 ± 12.49 years) that received a single workshop of intense training in naturopathic self-help strategies. Primary outcome was HrQoL (Inflammatory Bowel Disease Questionnaire; IBDQ) at week 12. Secondary outcomes included IBDQ subscales; generic HrQoL; disease activity and microbiome. Both groups showed improvement in HrQoL from baseline to post-treatment at week 12. The IBDQ sum score showed no significant group difference (p = 0.251). If patients attended more than 50% of the training sessions, a significant group effect (p = 0.034) was evident in favor of LSM. In addition, the SF-36 mental component summary (p = 0.002) was significantly different between the groups in favor of LSM. Disease activity microbiome and adverse events did not differ. Both a single workshop and a 10-week comprehensive lifestyle-modification program can improve HrQoL in patients with ulcerative colitis in remission with no apparent effects on clinical disease activity. A treatment difference was observed when examining a subsample of patients who attended ≥ 50% of sessions.

Comparative efficacy of different exercise interventions in chronic non-specific low back pain: protocol of a systematic review and network meta-analysis.

INTRODUCTION: Chronic non-specific low back pain is a major public health problem. Evidence supports the effectiveness of exercise as an intervention. Due to a paucity of direct comparisons of different exercise categories, medical guidelines were unable to make specific recommendations regarding the type of exercise working best in improving chronic low back pain. This network meta-analysis (NMA) of randomised controlled trials aims to investigate the comparative efficacy of different exercise interventions in patients with chronic non-specific low back pain. METHODS AND ANALYSIS: MEDLINE, Scopus, Cochrane Central Register of Controlled Trials, Physiotherapy Evidence Database, SPORTDiscus, Clinicaltrials.gov and the WHO International Clinical Trials Registry Platform search portal were searched on November 2019 and without language restrictions. The search will be updated after data analysis. Studies on adults with non-specific low back pain of at least 12 weeks duration comparing exercise to either no specific intervention (ie, no treatment, wait-list or usual care at the treating physician's discretion) and/or functionally inert interventions (ie, sham or attention control interventions) will be eligible. Pain intensity and back-specific disability are defined as primary outcomes. Secondary outcomes will include health-related physical and mental quality of life, work disability, frequency of analgesic use and adverse events. All outcomes will be analysed short-term, intermediate-term and long-term. Data will be extracted independently by two review authors. Risk of bias will be assessed using the recommendations by the Cochrane Back and Neck Group and be based on an adaptation of the Cochrane Risk of Bias tool. ETHICS AND DISSEMINATION: This NMA will be reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses_NMA checklist. The results will be presented in peer-reviewed journals, implemented in existing national and international guidelines and will be presented to health care providers and decision makers. The planned completion date of the study is 1 July 2021. PROSPERO REGISTRATION NUMBER: CRD42020151472.

Diagnostic Performance of Simultaneous [18F]-FDG PET/MR for Assessing Endoscopically Active Inflammation in Patients with Ulcerative Colitis: A Prospective Study.

Background: To investigate the diagnostic performance of simultaneous 18F-fluoro-deoxyglucose ([18F]-FDG) PET/MR enterography in assessing and grading endoscopically active inflammation in patients with ulcerative colitis. Methods: 50 patients underwent PET/MR 24 h before ileocolonoscopy. Inflammatory activities of bowel segments were evaluated with both Mayo endoscopic subscore and Nancy histologic index. MR, DWI (Diffusion-weighted imaging) and PET were utilized as qualitative parameters for detecting endoscopically active inflammation. SUVmaxQuot in each segment (maximum of standard uptake value relative to liver) was calculated to quantify inflammation. Results: In the study arm without bowel purgation, combined reading of PET and MR resulted in significantly increased specificity against each submodality alone (0.944 vs. 0.82 for MR and 0.843 for PET, p < 0.05) and highest overall accuracy. In the study arm with bowel purgation, the significantly lower specificity of PET (0.595) could be markedly improved by a combined reading of PET and MR. Metabolic conditions in bowel segments with both endoscopic and histological remission were significantly lower than in segments with endoscopic remission but persistent microscopic inflammation (SUVmaxQuot 0.719 vs. 0.947, p < 0.001). SUVmaxQuot correlated highly with Mayo endoscopic subscore (ρ = 0.718 and 0.606) and enabled grading of inflammatory activity. Conclusions: Simultaneous [18F]-FDG PET/MR may be considered as an alternative to endoscopy in clinical trials.