Multidisciplinary study of the health and nutritional status of persons living in households at risk of poverty with children in Germany (MEGA_kids): Study design and methods.

Background: In Germany, the nutritional situation of adults and children living in households at risk of poverty has been insufficiently studied so far. Aim: The aim of the mixed-methods study MEGA_kids is to gain a deeper understanding of the nutritional situation including socioeconomic, behavioral, and attitudinal factors and health characteristics among persons living in families at risk of poverty. Method: MEGA_kids is a mixed-methods cross-sectional study consisting of four modules combining quantitative and qualitative methods. The first module (A) applies self-administered questionnaires to assess the individual's diet, household food insecurity, and several other factors among adults and children of 500 households. Cash receipts are used to assess household's food expenses. For the second module (B), a semistructured interview guide is used to identify factors influencing food security and nutritional quality from the perspective of a subsample of module A (n = 20). The third module (C) applies the participatory World Café technique to explore experiences and generate ideas for tailored support measures for a healthy diet from the perspective of 40 parents participating in module A. Finally, the fourth module (D) investigates the knowledge and usage of existing nutrition-related preventive measures among 200 parents at risk of poverty by using an online questionnaire. Conclusion: By providing a comprehensive picture of nutritional aspects of families living at risk of poverty, MEGA_kids will guide officials to target and prioritize public health nutrition measures, inform policy makers to implement and improve healthy policies and, finally, identify research gaps to be prioritized.

Case Reporting in Homeopathy-An Overview of Guidelines and Scientific Tools.

Case reports have been of central importance to the development of homeopathy over the past 200 years. With a special focus on homeopathy, we give an overview on guidelines and tools that may help to improve the quality of case reports. Reporting guidelines such as CARE (Case Report), HOM-CASE (Homeopathic Clinical Case Reports), and the WissHom Documentation Standard help to improve the quality of reporting and strengthen the scientific value of a case report. Additional scientific tools such as prospective outcome assessment, prognostic factor research, cognition-based medicine, and the Modified Naranjo Criteria for Homeopathy (MONARCH) score may be helpful in improving case documentation and evaluation.

Impact of a smoking cessation program on smoking prevalence and food security among food pantry users - a study protocol for a pragmatic cluster randomised controlled trial.

BACKGROUND: Among food pantry users there is a high prevalence of both smoking and food insecurity, which may be related to one another. This study aims to evaluate the impact of a smoking cessation program carried out in food pantries on the smoking status and the food security status of food pantry users. METHODS / DESIGN: Before starting the cluster randomised controlled trial, stakeholders will be engaged to adapt a behavioural group counselling program for smoking cessation to the needs of the food pantry users in a pre study. Food pantry users and workers as well as other experts, such as smoking cessation trainers, social workers, and psychologists, will be involved, using the world café technique and telephone interviews and a qualitative thematic analysis for data analysis to design the concept of the intervention program will be applied. In the second phase, the impact of the intervention on the smoking status and on food insecurity will be investigated by a cluster randomised controlled trial. A total of 416 food pantry users across 32 clusters (food pantries) in Berlin, Germany, should be recruited and randomly assigned to either the intervention group or the waiting list control group. The intervention will consist of a behavioural group counselling program for smoking cessation, specially tailored for food pantry users, as well as optional nicotine replacement therapy and the implementation of environmental smoking reduction measures in the food pantries. The primary outcomes 6 months after the treatment will be self-reported continuous smoking abstinence, validated by exhaled carbon monoxide (< 10 ppm of carbon monoxide), and increased food security level (the percentage of participants with an improved food security level). DISCUSSION: This study will be the first long-term investigation into the effect of a smoking cessation program on smoking status and food insecurity. The results of this study will inform the implementation of smoking cessation programs in food pantries throughout Germany. TRIAL REGISTRATION: Prospectively registered DRKS00020037 . Registered 29 April 2020.

Recommendations for Designing, Conducting and Reporting Observational Studies in Homeopathy.

BACKGROUND: Randomized placebo-controlled trials are considered to be the gold standard in clinical research and have the highest importance in the hierarchical system of evidence-based medicine. However, from the viewpoint of decision makers, due to lower external validity, practical results of efficacy research are often not in line with the huge investments made over decades. METHOD: We conducted a narrative review. With a special focus on homeopathy, we give an overview on cohort, comparative cohort, case-control and cross-sectional study designs and explain guidelines and tools that help to improve the quality of observational studies, such as the STROBE Statement, RECORD, GRACE and ENCePP Guide. RESULTS: Within the conventional medical research field, two types of arguments have been employed in favor of observational studies. First, observational studies allow for a more generalizable and robust estimation of effects in clinical practice, and if cohorts are large enough, there is no over-estimation of effect sizes, as is often feared. We argue that observational research is needed to balance the current over-emphasis on internal validity at the expense of external validity. Thus, observational research can be considered an important research tool to describe "real-world" care settings and can assist with the design and inform the results of randomised controlled trails. CONCLUSIONS: We present recommendations for designing, conducting and reporting observational studies in homeopathy and provide recommendations to complement the STROBE Statement for homeopathic observational studies.

The N-of-1 Clinical Trial: A Timely Research Opportunity in Homeopathy.

BACKGROUND: The randomised controlled trial (RCT) is considered the 'gold standard' for establishing treatment efficacy or effectiveness of an intervention, but its data do not infer response in an individual patient. Individualised clinical care, a fundamental principle in complementary and alternative medicine (CAM), including homeopathy, seems well disposed in principle to being researched by single-patient (N-of-1) study design. Guidelines for reporting N-of-1 trials have recently been developed. OBJECTIVE: To overview the current status in the literature of the N-of-1 method and its application in medicine, including CAM. To consider whether the N-of-1 trial design offers an opportunity for novel research in homeopathy. N-OF-1 TRIAL DESIGN: The N-of-1 trial applies the principles of the conventional crossover, blinded, RCT design. The treatment under study and the comparator are repeated in a randomised order, and with suitable washout time, over a defined period. N-of-1 design is constrained for use in chronic stable conditions, and for interventions that have quick onset and cessation of effect, with modest or negligible carryover. Outcome data can be aggregated and interpreted for the individual subject; they can also be pooled with data from several similar N-of-1 trials, enabling more generalisable conclusions. THE N-OF-1 TRIAL IN CAM: The typical individualisation of patient care can be accommodated in N-of-1 study design if the patient and the specific therapeutic intervention are selected within the constraints of the method. Application of the N-of-1 method in CAM has been advocated but has been mainly limited, in practice, to a small number of studies in herbal and traditional Chinese medicine. THE N-OF-1 TRIAL IN HOMEOPATHY: Individualised homeopathy can be accommodated for investigation within the same methodological constraints; less in-depth homeopathic approaches to prescribing are also amendable to investigation using the N-of-1 method. No such studies have been published. We identify three main targets in its ready applicability to homeopathy: (1) to optimise clinical care in an individual patient; (2) to investigate whether the outcomes of treatment using homeopathy differ from those of placebo; (3) to aggregate data from a series of N-of-1 trials to enable broader conclusions about a group of patients or intervention. CONCLUSION: The N-of-1 trial design offers important new investigative possibilities in homeopathy and should be explored as a means to optimise individualised health care or investigate effectiveness of the homeopathic intervention compared with placebo in individual subjects.

Scientific proving of ultra high dilutions on humans.

BACKGROUND: Homeopathic drug provings or pathogenetic trials (HPTs) are the pillar of homeopathy. This review summarizes the authors' findings and interpretations derived from a series of homeopathic drug proving between 1994 and 2015. It gives an overview over a series of attempts to use modern scientific experimental methodology to answer the question, whether such HPTs produce symptoms in healthy volunteers that can be distinguished from placebo symptoms. METHODS: Various experimental models were used: repeated crossover trials with categorical data collection, and a single-case, randomised study. Final models use diligent qualitative data-collection in experienced volunteers. In those, raters decide whether symptoms are typical for a remedy delivered or not. The design is triple-blind and placebo-controlled. RESULT: While previous attempts were inconclusive, this new model allowed to separate placebo symptoms from verum symptoms repeatedly in a series of two definitive studies following promising pilot studies. Results were statistically significant. Also, some signs of the purported non-local signature of homeopathic effects were visible, and the consequences for future methodology is discussed. CONCLUSION: Provided some cautionary notes are taken into account, HPTs can be used to separate out true specific symptoms from placebo symptoms. By the same token this is a road to experimental proof that homeopathic remedies are not just placebos. However, this needs to be taken forward by independent groups.

Biographical similarities between spiritual healers and their clients in Germany - a qualitative study.

Spiritual healers in contemporary Germany comprise a heterogeneous and growing group, yet little data exists about them. Therefore, one aim of this study was to learn about which biographical aspects and events were important to the process of becoming a healer and which biographical aspects drove clients to consult a healer. The study was based on semi-structured interviews combined with participant observations. All data were recorded digitally, transcribed, entered into the software program MAXQDA and analysed subjected to Content Analysis. In total, 15 healers (nine male, six female) and 16 clients (13 female, three male) were included. According to the healers, a talent for healing can be inborn, inherited or developed through life experiences. Most of the healers experienced a crisis, which prompted their transformation to healers (the wounded healer type). A smaller group became healers mainly out of interest without going through crisis and by focusing on the spiritual attitude itself (the healer by interest type). The basis of healing is seen as a connection to a transcendent reality, which enables an open, loving and empathetic attitude. The experience of crises and illnesses and the importance of spirituality are major biographical similarities between healers and clients. Near-death experiences as an extreme form of crisis were reported from a few healers and clients. The connections between healing talents and crises, including a deepened exploration of near-death experiences and questions regarding inclining towards spirituality could be of interest in further studies.

Use of complementary and alternative medicine by older adults--a cross-sectional survey.

BACKGROUND: Very little is known about complementary and alternative medicine (CAM) use by older adults in Germany. The aim of this study was to investigate the use of CAM and other health promoting substances (e.g., herbal teas) by older adults of at least 70 years of age. METHODS: A cross-sectional questionnaire study was conducted among persons of ≥70 years from metropolitan Berlin and rural parts of Brandenburg, Germany. Recorded were: demographics, current use of CAM, medical diagnoses, users' opinions and preferences. RESULTS: A total of 400 older adults, living as 'self-reliant' (n = 154), 'home care service user' (n = 97), or 'in nursing home' (n = 149), and with the legal status 'without guardian' (n = 355) or 'with guardian' (n = 45) were included (mean age 81.8 ± 7.4 years, 78.5% female). Any type of CAM used 61.3% of respondents (dietary supplements 35.5%, herbal medicines 33.3%, and external preparations 26.8%); 3.0% used drug-interaction causing preparations. Usage was based on recommendations (total 30.3%; in 20.0% by friends or family and 10.4% by pharmacists), own initiative (27.3%), and doctors' prescription (25.8%). Participants with legal guardian took almost solely prescribed dietary supplements. Of the others, only half (58.7%) informed their general practitioner (GP) of their CAM use. Participants expected significant (44.9%) or moderate (37.1%) improvement; half of them perceived a good effect (58.7%) and two-thirds (64.9%) generally preferred a combination of CAM and conventional medicine. More than half (57.9%) stated that they could neither assess whether their CAM preparations have side effects, nor assess what the side effects might be. Strongest predictors for CAM use were two treatment preferences (vs. 'conventional only': 'CAM only', OR = 3.98, p = 0.0042 and 'CAM + conventional', 3.02, 0.0028) and the type of health insurance ('statutory' vs. 'private', 3.57, 0.0356); against CAM use two subjective assessments predicted (vs. 'CAM causes no harm': 'CAM causes harmful drug interactions', 0.25, 0.0536 and 'I cannot assess side effects', 0.28, 0.0010). CONCLUSION: Older German adults frequently use CAM. They perceived it as an effective complement to conventional medicine, but are not sufficiently informed about risks and benefits.

Perceived outcomes of music therapy with Body Tambura in end of life care - a qualitative pilot study.

BACKGROUND: In recent years, music therapy is increasingly used in palliative care. The aim of this pilot study was to record and describe the subjective experiences of patients and their relatives undergoing music therapy with a Body Tambura in a German hospice and to develop hypotheses for future studies. METHODS: In a qualitative interview pilot study, data collection and analyses were performed according to the methodological framework of grounded theory. We included German-speaking patients, or relatives of patients, receiving end of life care in an inpatient hospice setting. RESULTS: 11 persons consisting of 8 patients (age range 51-82 years, 4 male and 4 female) and 3 relatives were treated and interviewed. All patients suffered from cancer in an advanced stage. The most often described subjective experiences were a relaxing and calming effect, sensations that the body feels lighter, and the generation of relaxing images and visualizations. Family members enjoyed listening to the music and felt more connected with the sick family member. CONCLUSION: Patient reported beneficial aspects. The small sample size could be seen as a limitation. Assessment instruments measuring relaxation, stress, quality of life and should be included in future quantitative studies.

Perceived outcomes of spiritual healing and explanations--a qualitative study on the perspectives of German healers and their clients.

BACKGROUND: Limited research has been conducted on contemporary spiritual healing in European countries. The aim of this article is to report how German healers and their clients experienced and perceived the outcomes of spiritual healing and which explanations they use to describe the perceived effects. METHODS: Semistructured interviews and participatory observation was used to collect data from spiritual healers and their clients. Analyses were based on the methodological concept of directed qualitative content analysis. Data was analyzed using MAXQDA software, discussed and reviewed by a multidisciplinary research team consisting of medical anthropologists, medical doctors and a religious studies scholar. RESULTS: In total 15 healers and 16 clients participated in this study, 24 interviews with healers, 20 interviews with clients and 8 participatory observations were analyzed. Healers and clients reported outcomes as positively perceived body sensations, increased well-being, positive emotions and symptomatic relief of medical complaints. Clients often described changes in their self-concepts and adapted life values. Explanations for perceived effects included connecting with transcendent sources, construction of meaning, as a result of the client-healer relationship, and as empowerment to make changes. Because the interviewed clients were recruited by the healers, a selection bias towards positive healing experiences is possible. CONCLUSION: We hypothesize that concepts of meaning construction, resource activation and the utilization of the clients' expectations help to explain the data. Grounded in the emic perspective, we propose to use the following outcomes for further prospective studies: positive body sensations, changes of self-concepts and values, changes of medical symptoms and complaints. From the etic perspective, physical, emotional, social and spiritual wellbeing, sense of coherence, meaningfulness of life, empowerment, resource activation, change and symptom control should be further explored as potential outcomes.

Complementary medicine in nursing homes--results of a mixed methods pilot study.

BACKGROUND: 'Kneipp Therapy' (KT) is a form of Complementary and Alternative Medicine (CAM) that includes a combination of hydrotherapy, herbal medicine, mind-body medicine, physical activities, and healthy eating. Since 2007, some nursing homes for older adults in Germany began to integrate CAM in the form of KT in care. The study investigated how KT is used in daily routine care and explored the health status of residents and caregivers involved in KT. METHODS: We performed a cross-sectional pilot study with a mixed methods approach that collected both quantitative and qualitative data in four German nursing homes in 2011. Assessments in the quantitative component included the Quality of Life in Dementia (QUALIDEM), the Short Form 12 Health Survey (SF-12), the Barthel-Index for residents and the Work Ability Index (WAI) and SF-12 for caregivers. The qualitative component addressed the residents' and caregivers' subjectively experienced changes after integration of KT. It was conceptualized as an ethnographic rapid appraisal by conducting participant observation and semi-structured interviews in two of the four nursing homes. RESULTS: The quantitative component included 64 residents (53 female, 83.2 ± 8.1 years (mean and SD)) and 29 caregivers (all female, 42.0 ± 11.7 years). Residents were multimorbid (8 ± 3 diagnoses), and activities of daily living were restricted (Barthel-Index 60.6 ± 24.4). The caregivers' results indicated good work ability (WAI 37.4 ± 5.1), health related quality of life was superior to the German sample (SF-12 physical CSS 49.2 ± 8.0; mental CSS 54.1 ± 6.6). Among both caregivers and residents, 89% considered KT to be positive for well-being.The qualitative analysis showed that caregivers perceived emotional and functional benefits from more content and calmer residents, a larger variety in basic care practices, and a more self-determined scope of action. Residents reported gains in attention and caring, and recognition of their lay knowledge. CONCLUSION: Residents showed typical characteristics of nursing home inhabitants. Caregivers demonstrated good work ability. Both reported to have benefits from KT. The results provide a good basis for future projects, e.g. controlled studies to evaluate the effects of CAM in nursing homes.

The relevance of outcome expectations in group hypnosis for stress reduction: a secondary analysis of a multicenter randomized controlled trial.

Background: There is evidence that patients' positive outcome expectations prior to study interventions are associated with better treatment outcomes. Nevertheless, to date, only few studies have investigated whether individual outcome expectations affect treatment outcomes in hypnosis. Objective: To examine whether outcome expectations to hypnosis prior to starting treatment were able to predict perceived stress, as measured on a visual analog scale (VAS), after 5 weeks. Methods: We performed a secondary data analysis of a multicenter randomized controlled trial of intervention group participants only. Study participants with stress symptoms were randomized to 5 weekly sessions of a group hypnosis program for stress reduction and improved stress coping, plus 5 hypnosis audio recordings for further individual practice at home, as well as an educational booklet on coping with stress. Perceived stress for the following week was measured at baseline and after 5 weeks using a visual analog scale (0-100 mm; VAS). Hypnosis outcome expectations were assessed at baseline only with the Expectations for Treatment Scale (ETS). Unadjusted and adjusted linear regressions were performed to examine the association between baseline expectations and perceived stress at 5 weeks. Results: Data from 47 participants (M = 45.02, SD = 13.40 years; 85.1% female) were analyzed. Unadjusted (B = 0.326, t = 0.239, p = 0.812, R2 = 0.001) and adjusted (B = 0.639, t = 0.470, p = 0.641, R2 = 0.168) linear regressions found that outcome expectations to hypnosis were not associated with a change in perceived stress between baseline and after 5 weeks in the intervention group. Conclusion: Our findings suggest that the beneficial effect of group hypnosis in distressed participants were not associated with outcome expectations. Other mechanisms of action may be more important for the effect of hypnosis, which should be explored in future research.Clinical trial registration: ClinicalTrials.gov, identifier NCT03525093.

[Dementia in Germany: results of an interdisciplinary expert workshop]. / Demenz in Deutschland--Ergebnisse eines interdisziplinären Expertenworkshops.

In the aging population of Germany the consequences of Dementia for the society and the health care sector are complex and solutions require a multidisciplinary approach. The aim of the two-day interdisciplinary expert conference was to consider dementia from different perspectives, to identify dementia-related problems and to discuss integrative solutions under consideration of complementary therapies. In different working groups the experts developed solutions and recommendations with regards to political need, health care and future research priorities. The present recommendations profited very much from the interdisciplinary participants of the conference and brought together the expertise of different fields resulting in a comprehensive picture about dementia in Germany.

The Therapeutic Process in Spiritual Healing: Qualitative Results of a Prospective Case Series.

INTRODUCTION: The aim of this study was to explore the therapeutic process between contemporary spiritual healers and their clients in Germany. METHODS: This prospective observational case study was supported by questionnaires and semi-structured interviews with clients and healers from the first encounter through a period of 6 months. The qualitative analysis is based on a directed content analysis with focus in this article on the results relating to the therapeutic process. RESULTS: Seven healers and seven clients were included, and 22 interviews with healers and 20 interviews with clients were conducted. The first treatment session was perceived as laying a foundation for the therapeutic process and the relationship, which was seen as crucial for healing to take place. Healers perceived the therapeutic process as highly individualized and multi-layered, with the perceived effects of spiritual healing sessions layered upon each other. The capacities to connect and to trust were seen as key elements of the healing process. Trust and connection operate multidimensionally: to oneself, to others, and to a transcendent or spiritual source. Clients' spiritual attitudes were regarded as fundamental resources. CONCLUSION: The therapeutic process between spiritual healers and their clients was understood as a dynamic and individual activity, building up on a trustful relationship from the first encounter.

Sense of coherence and religion/spirituality: A systematic review and meta-analysis based on a methodical classification of instruments measuring religion/spirituality.

The coherence hypothesis assumes that sense of coherence (SOC) explains the positive link between religion/spirituality (R/S) and mental health. The aim of our meta-analysis is to evaluate the evidence for the association between SOC (sensu Antonovsky) and different aspects of R/S and thus to contribute to the verification of the coherence hypothesis. Eighty-nine English- and German-language primarily cross-sectional studies with 67,913 participants met the inclusion criteria. The R/S scales of all included studies were subjected to item-by-item qualitative content analysis in order to determine whether scales do actually measure religion or spirituality and which R/S aspects dominated the instrument. Based on this classification, overall and subgroup meta-analyses were conducted using a random effects model. The adjusted effect size between SOC and all positive R/S measures was r+ = .120, 95% CI [.092, .149]. Particularly significant (r+ < -.180 or > .180) were correlations with negative R/S scales (r+ = -.405, 95% CI [-.476, -.333]), R/S instruments measuring primarily positive emotions (r+ = .212, 95% CI [.170, .253]) or meaning-making (r+ = .196, 95% CI [.126, .265]). Both sample characteristics (age, culture, gender, health status, religious affiliation) and study characteristics (e.g., publication year) had a moderating effect on the R/S-SOC connection. The correlation was particularly high in studies from Southern Asia (r+ = .226, 95% CI [.156, .297]), the African Islamic cultural value zone (r+ = .196, 95% CI [.106, .285]), and in a small subgroup of Iranian studies (r+ = .194, 95% CI [.117, .271]). The results confirm that R/S and SOC are clearly associated and suggest that there are different religious/spiritual pathways to a strong SOC. The strength of the associations presumably depends not only on individual differences, but also on cultural embeddedness and social plausibility of R/S. Trial registration. PROSPERO registration number: CRD42021240380. https://www.crd.york.ac.uk/prospero/display_record.php?ID = CRD42021240380.

Characteristics of Patients Presenting at a University Outpatient Department for Complementary and Integrative Medicine.

BACKGROUND: Complementary and integrative medicine (CIM) is increasingly provided at university outpatient departments (OPDs) in Germany, but its scientific evaluation is sparse. Therefore, we aimed to investigate and evaluate feasibility, patients' characteristics and complaints at a university's CIM-OPD. METHODS: A prospective evaluation included new patients without age restriction. At baseline, and after 6 and 12 months, patients filled out paper questionnaires. Patients rated their mean subjectively perceived severity of the main complaint within the last 7 days on a numerical rating scale (NRS) from 0 = no complaints to 10 = maximum complaints, their perceived resilience capacity in everyday life within the last 7 days (0 = not resilient to 10 = very resilient), and their contentment with the treatment (0 = not content to 10 = very content). Diagnoses were provided by physicians and coded according to the International Statistical Classification of Diseases and Related Health Problems, 10th revision. All data were analyzed descriptively. RESULTS: During two years, 536 new patients {72.6% response, age (mean ± standard deviation [SD] and range) 49.6 ± 15.8 and 1-86 years, 75.7% female} chose to participate. The most frequent diagnosis groups were neoplasms (C00-C97, n = 143, 18.6%) and musculoskeletal diseases (M00-M99, n = 137, 17.9%). In n = 165 patients (30.8%), more than one diagnosis was provided. In a subgroup of 187 patients, who returned the questionnaire after 6 months, we compared baseline to 6-month values: severity of main complaint (mean ± SD) 5.2 ± 2.6 changed to 3.9 ± 2.6; resilience capacity 5.1 ± 2.6 to 5.6 ± 2.4. After 6 months, respondents rated their contentment with the treatment with (mean ± SD) 7.7 ± 2.6. Data after 12 months (n = 113) are comparable to data after 6 months. CONCLUSION: Patients of our CIM-OPD had a broad age range, were predominantly female, and suffered mostly from oncologic-related complaints and musculoskeletal diseases. In the responding subgroup after 6 months, patients were content with the treatment. These results should be verified by further prospective evaluations.Komplementäre und integrative Medizin (CIM) wird in Deutschland zunehmend in Hochschulambulanzen (OPDs) angeboten, deren wissenschaftliche Evaluation ist jedoch unzureichend. Deshalb war es unser Ziel, die Durchführbarkeit einer Evaluation, die Charakteristika und die Beschwerden der Patienten und Patientinnen an einer CIM-ODP zu untersuchen.Eine prospektive Evaluation schloss neue Patienten und Patientinnen ohne Altersbeschränkung ein. Zu Baseline sowie nach sechs und 12 Monaten füllten die Patienten und Patientinnen Papierfragebögen aus. Die Patienten und Patientinnen bewerteten ihre mittlere subjektiv empfundene Schwere der Hauptbeschwerden in den letzten sieben Tagen auf einer numerischen Ratingskala (NRS) von 0 = keine Beschwerden bis 10 = maximale Beschwerden, ihre mittlere subjektiv empfundene Belastbarkeit im Alltag in den letzten sieben Tagen (0 = nicht belastbar bis 10 = sehr belastbar) und ihre Zufriedenheit mit der Behandlung (0 = nicht zufrieden bis 10 = sehr zufrieden). Die Diagnosen wurden von den Ärzten und Ärztinnen gestellt und nach der International Statistical Classification of Diseases and Related Health Problems, 10. Revision, kodiert. Die Daten wurden deskriptiv ausgewertet.Im Laufe von zwei Jahren nahmen 536 neue Patienten und Patientinnen (72.6% Rücklauf, Alter (Mittelwert ± SD und Range) 49.6 ± 15.8 und 1­86 Jahre, 75.7% weiblich) teil. Die häufigsten Diagnosen waren Neoplasmen (C00-C97, n = 143, 18.6%) und Erkrankungen des Bewegungsapparates (M00-M99, n = 137, 17.9%). Bei n = 165 (30.8%) Patienten und Patientinnen wurde mehr als eine Diagnose vergeben. In einer Subgruppe von 187 Patienten und Patientinnen, die den Fragebogen nach 6 Monaten zurücksendeten, verglichen wir die Ausgangs-und 6-Monats-Werte: Schweregrad der Hauptbeschwerden (Mittelwert±SD) 5.2 ± 2.6 veränderte sich zu 3.9 ± 2.6; Belastbarkeit 5.1 ± 2.6 zu 5.6 ± 2.4. Nach sechs Monaten bewerteten die Befragten ihre Zufriedenheit mit der Behandlung mit (Mittelwert±SD) 7.7 ± 2.6. Die Daten nach 12 Monaten (n = 113) sind mit den Daten nach 6 Monaten vergleichbar.Die Patienten und Patientinnen unserer CIM-OPD hatten eine breite Altersspanne, überwiegend weiblich und litten zumeist unter onkologisch bedingten Beschwerden und Erkrankungen des Bewegungsapparates. Patienten und Patientinnen der nach sechs Monaten antwortenden Subgruppe waren mit der Behandlung zufrieden. Die Ergebnisse sollten durch weitere prospektive Evaluationen verifiziert werden.

Hydrotherapy and acupressure in restless legs syndrome: A randomized, controlled, 3-armed, explorative clinical trial.

BACKGROUND: Restless legs syndrome (RLS) is a common neurological disease that has a significant impact on daily activities and quality of life, for which there is often no satisfactory therapy. Complementary medicine, such as acupressure and hydrotherapy, is used to treat patients with RLS; however, the clinical evidence is unclear. This study aims to investigate the effects and feasibility of self-administered hydrotherapy and acupressure in patients with RLS. METHODS: This is a randomized, controlled, open-label, exploratory, clinical study with 3 parallel arms, comparing both self-applied hydrotherapy (according to the German non-medical naturopath Sebastian Kneipp) and acupressure in addition to routine care in comparison to routine care alone (waiting list control) in patients with RLS. Fifty-one patients with at least moderate restless-legs syndrome will be randomized. Patients in the hydrotherapy group will be trained in the self-application of cold knee/lower leg affusions twice daily for 6 weeks. The acupressure group will be trained in the self-application of 6-point-acupressure therapy once daily for 6 weeks. Both interventions take approximately 20 minutes daily. The 6-week mandatory study intervention phase, which is in addition to the patient preexisting routine care treatment, is followed by a 6-week follow-up phase with optional interventions. The waitlist group will not receive any study intervention in addition to their routine care before the end of week 12. Outcome parameters including RLS-severity, disease and health-related quality of life (RLS-QoL, SF-12), Hospital Anxiety and Depression Score in German version, general self-efficacy scale, and study intervention safety will be measured at baseline and after 6 and 12 weeks. The statistical analyses will be descriptive and exploratory. CONCLUSION: In the case of clinically relevant therapeutic effects, feasibility, and therapeutic safety, the results will be the basis for planning a future confirmatory randomized trial and for helping to develop further RLS self-treatment concepts.

Clinical effects of Kneipp hydrotherapy: a systematic review of randomised controlled trials.

OBJECTIVE: Hydrotherapy is a traditional prevention and treatment strategy. This study's aim is to systematically review all available randomised controlled trials (RCTs) investigating clinical effects of hydrotherapy according to Kneipp which is characterised by cold water applications. METHODS: RCTs on disease therapy and prevention with Kneipp hydrotherapy were included. Study participants were patients and healthy volunteers of all age groups. MEDLINE (via PubMed), Scopus, Central, CAMbase, and opengrey.eu were systematically searched through April 2021 without language restrictions and updated by searching PubMed until April 6th 2023. Risk of bias was assessed using the Cochrane tool version 1.ResultsTwenty RCTs (N=4247) were included. Due to high heterogeneity of the RCTs, no meta-analysis was performed. Risk of bias was rated as unclear in most of the domains. Of 132 comparisons, 46 showed significant positive effects in favour of hydrotherapy on chronic venous insufficiency, menopausal symptoms, fever, cognition, emotional function and sickness absenteeism. However, 81 comparisons showed no differences between groups and 5 were in favour of the respective control group. Only half of the studies reported safety issues. CONCLUSION: Although RCTs on Kneipp hydrotherapy seem to show positive effects in some conditions and outcomes, it remains difficult to ascertain treatment effects due to the high risk of bias and heterogeneity of most of the considered studies. Further high-quality RCTs on Kneipp hydrotherapy are urgently warranted. PROSPERO REGISTRATION NUMBER: CRD42021237611.