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ObjectiveHydrotherapy 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.MethodsRCTs 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.ConclusionAlthough 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 numberCRD42021237611.

Complementary and integrative medical procedures (CIM) are commonly used in Germany, including for the treatment of mental health conditions. The aim of the study was to investigate how CIM is used and perceived in outpatient mental healthcare settings. This qualitative interview study was conducted as part of the PSYKIM cross-sectional project. Twenty participants (15 women, 5 men; mean age 37.5 years, range 19-64) were recruited from a larger survey sample. Semi-structured telephone interviews were used to explore participants' experiences with CIM therapies in the context of mental healthcare. Interview data was analyzed using qualitative content analysis within a constructivist paradigm. The most frequently used CIM therapies were yoga, acupuncture, meditation, art therapy, and progressive muscle relaxation (PMR). Thematic analysis identified four overarching experiential dimensions across therapies: (1) emotional regulation and inner calm, (2) individual prerequisites and ambivalent effects, (3) creative expression and emotional processing, and (4) the influence of therapeutic setting. CIM therapies were experienced in highly heterogeneous ways. While many interviewed participants reported symptom relief, improved wellbeing, and enhanced self-awareness through CIM therapies, others described frustration, emotional distress, or a lack of effect. Overall, experiences were highly individualized and influenced by factors such as personal readiness, the therapeutic environment, and group dynamics. The highly heterogeneous ways in which patients with mental health conditions experience CIM therapies underscore the need for individualized implementation, professional guidance, and open communication about both benefits and potential risks. Future research should investigate how multimodal interventions that combine CIM with conventional treatments can be individually tailored and contextually adapted to improve mental health outcomes. This study has been registered in the German Clinical Trial Registry with trial ID DRKS00032426 on 08.08.2023.

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

Background Many studies have shown that sociodemographic variables significantly predict the use of complementary and alternative medicine (CAM), although these predictions were not particularly strong. A multitude of predictors of the use or approval of CAM have been investigated in the field of personal values and worldviews, but the effects were small or doubtful due to non-representative samples. More recent psychological research has linked positive attitudes towards CAM with intuitive thinking, paranormal beliefs, ontological confusions and magical health beliefs, suggesting a common thinking style behind all these variables. The aim of this study is to identify the most important predictors of the use and approval of CAM. Methods We performed a canonical correlation analysis on all 3480 records from the 2012 German General Social Survey (ALLBUS) with the lifetime use and opinion of CAM as the dependent variables. Results Approval of paranormal practices such as fortune-telling, dowsing or spiritualism explained 32% of the variance in the dependent canonical variate “approval of CAM”, while sociodemographic variables explained only 2%. Experience with paranormal practices explained 17% of the variance in the dependent canonical variate “experience with CAM”, and sociodemographic variables explained 10% of the variance. Traditional religiosity, attitudes towards science and post-materialist values showed no relevant correlations with the dependent canonical variates. Conclusions Paranormal beliefs and related measures are the most important known predictors of the use and approval of CAM. Experience with paranormal practices not only indicates paranormal beliefs but also explains experience with CAM that cannot be explained by approval of CAM. Female gender and higher socioeconomic status predict experience with CAM without predicting approval of CAM, but their influence should not be overstated.

Background: During the COVID-19 pandemic people are facing risks of adverse health effects due to the restrictions implemented such as quarantine measures, reduced social contact, and self-isolation. In this qualitative review, we collected data on potential preventive and therapeutic health benefits of Complementary and Integrative Medicine (CIM) that might be useful during the COVID-19 pandemic. We have reviewed the scientific literature to summarize CIM practices that could be beneficial for improving physical and mental health and well-being of the population under the current pandemic circumstances. It must be noted that this review is not SARS-CoV-2 specific and we explicitly do not intend to make any SARS-CoV-2 specific health claims in this article. Methods and Findings: A qualitative, non-systematic literature review was conducted in Medline to identify literature describing preventive and therapeutic CIM approaches for strengthening mental and physical health. For a variety of CIM approaches clinical evidence was identified, indicating beneficial effects. CIM approaches include specific dietary measures and selected micronutrients, physical activity, techniques from Mind-Body Medicine, single botanicals or botanical compounds, and spending time in nature among others. The effects of CIM measures on conditions like obesity and hypertension are of special relevance here, as these conditions are considered as risk factors for a severe course of COVID-19. Moreover, a possibly direct effect of CIM approaches on immune functions and clinical parameters in respiratory tract infections, such as influenza, were identified. The findings of this review could be helpful for clinicians, patients, and the general population during the current pandemic when discussing and/or considering CIM options. Conclusions: CIM offers a variety of preventive and therapeutic options for strengthening physical and mental resilience, which could also be useful in the current COVID-19 pandemic. The evidence of CIM approaches with a potential benefit in the COVID-19 pandemic in different areas is worth to be analyzed. While this qualitative review has several obvious limitations, it might serve as useful starting point for further research on this topic.

Non-pharmacological interventions for restless legs syndrome (RLS) are frequently used, although scientific evidence remains limited. The study aimed to investigate the feasibility and effects of self-applied hydrotherapy and self-applied acupressure in patients with RLS. In a three-armed randomized single-center open exploratory pilot study, adults with moderate to severe RLS were randomly allocated to 6 weeks of daily hydrotherapy plus routine care (HT group), acupressure plus routine care (AP group), or routine care alone (RC group). Outcome measures included RLS symptom severity (IRLS), disease-specific quality of life (RLSQoL), the impression of change (PGI-C), health-related quality of life (SF-12), psychological outcomes (SGW-B, HADS, and GSE), and adherence and adverse events (AEs) after 6 and 12 weeks. Fifty-four adults (mean age 57.5 ± 11.4 years, 63% women) were included. The study showed good feasibility with an 83% retention rate. After 6 weeks, baseline-adjusted mean IRLS scores were 19.8 (95% [16.4, 23.2]) for HT, 22.9 (19.2, 26.6) for AP, and 24.0 (20.8, 27.2) for RC. RLSQoL adjusted means were 65.3 (59.7, 70.9) for HT, 68.3 (62.3, 74.3) for AP, and 56.2 (50.9, 61.5) for RC, after 6 weeks. Both interventions were safe, with high adherence rates. Self-applied hydrotherapy and acupressure appear to be feasible and safe interventions for patients with RLS. This exploratory pilot study suggests potential benefits, though larger, well-designed confirmatory studies are needed to validate these findings. This study was registered in the German Clinical Trials Register (number DRKS00029960) on August 09, 2022. https://drks.de/search/de/trial/DRKS00029960.

Background The aim of the trial was to investigate the effect of a hypnotherapeutic group program in healthy persons with increased levels of perceived stress. Methods In a randomized controlled multicenter trial participants with a self-assessed subjective stress level ≥ 40 mm on a visual analogue scale (0–100 mm; VAS) for the previous week and a stable state of health were randomized to either 5 weekly sessions of 120-min duration of a hypnotherapeutic group program for stress reduction and improved stress coping plus 5 hypnosis audiorecords for individual practice at home plus an educational booklet for stress coping (hypnosis group) versus an educational booklet only (control group). The primary outcome parameter was the VAS stress level for the previous week after 5 weeks. Secondary outcome parameters included the VAS stress level after 12 weeks, perceived stress (CPSS), depression (ADS-K), self efficacy (SWE) and quality of life (SF 36) after 5 weeks and 12 weeks. Analysis of covariance with a significance level of 5% using the full analysis set was used for analysis; the model included treatment (fixed effect), VAS baseline value (fixed covariate), and center (random effect). Results A total of 95 participants were randomized; 47 (40 female, 45 ± 13.4 years of age) were allocated to the hypnosis group, and 48 (41 female, 46.9 ± 14.3 years) were allocated to the control group. Regarding VAS stress level after 5 weeks, the adjusted VAS mean in the hypnosis group was 41.8 mm [95% confidence interval (CI): 35.2; 48.4] compared to 62.9 mm [56.2; 69.7] in the control group, and the group difference was − 21.2 mm [− 30.1; − 12.2] ( P  < 0.001). After 12 weeks, the stress intensity on the VAS showed a between-group difference of − 14.7 mm [− 25.1; − 4.4] ( P  = 0.006), and the adjusted means were 41.1 mm [33.4; 48.8] in the hypnosis group and 55.9 mm [48.4; 63.5] in the control group. Improvements were also reported for CPSS, SF-36, SWE and ADS-K after 5 and 12 weeks. Conclusion Compared to the control group, the hypnosis group showed reduced perceived stress after 5 and 12 weeks. Trial registration ClinicalTrials.gov NCT03525093 ; date of registration: May 15, 2018.

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.

The specific clinical benefit of the homeopathic consultation and of homeopathic remedies in patients with depression has not yet been investigated. To investigate the 1) specific effect of individualized homeopathic Q-potencies compared to placebo and 2) the effect of an extensive homeopathic case taking (case history I) compared to a shorter, rather conventional one (case history II) in the treatment of acute major depression (moderate episode) after six weeks. A randomized, partially double-blind, placebo-controlled, four-armed trial using a 2×2 factorial design with a six-week study duration per patient was performed. A total of 44 from 228 planned patients were randomized (2∶1∶2∶1 randomization: 16 homeopathic Q-potencies/case history I, 7 placebo/case history I, 14 homeopathic Q-potencies/case history II, 7 placebo/case history II). Because of recruitment problems, the study was terminated prior to full recruitment, and was underpowered for the preplanned confirmatory hypothesis testing. Exploratory data analyses showed heterogeneous and inconclusive results with large variance in the sample. The mean difference for the Hamilton-D after 6 weeks was 2.0 (95%CI -1.2;5.2) for Q-potencies vs. placebo and -3.1 (-5.9;-0.2) for case history I vs. case history II. Overall, no consistent or clinically relevant results across all outcomes between homeopathic Q-potencies versus placebo and homeopathic versus conventional case taking were observed. The frequency of adverse events was comparable for all groups. Although our results are inconclusive, given that recruitment into this trial was very difficult and we had to terminate early, we cannot recommend undertaking a further trial addressing this question in a similar setting. Prof. Dr. Claudia Witt had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. clinicaltrials.gov identifier NCT01178255. Protocol publication: http://www.trialsjournal.com/content/12/1/43.

Older adults often use complementary medicine; however, very few interventional studies have focused on them. The aim of this study was to evaluate the feasibility and to obtain preliminary data on effectiveness of an Integrative Medicine (IM) program compared to usual medical care. The study consisted of older adults living in shared apartment communities including caregiving. The shared apartments were cluster-randomized to the IM program or Usual Care (UC). IM consisted of additional lifestyle modification (exercise and diet), external naturopathic applications, homeopathic treatment, and modification of conventional drug therapy for 12 months. The UC group received conventional care alone. The following outcomes were used: Nurses Observation Scale for Geriatric Patients (NOSGER); Assessment of Motor and Process Skills; Barthel Index; Qualidem; Profile of Wellbeing; and Mini-mental State Examination. Exploratory effect sizes (Cohen's d, means adjusted for differences of baseline values) were calculated to analyze group differences. A total of eight shared apartment communities were included; four were allocated to IM (29 patients, median seven patients; [mean ± standard deviation] 82.7 ± 8.6 years) and four to UC (29 patients, median eight patients; 76.0 ± 12.8 years of age). After 12 months, effect sizes ≥0.3 were observed for activities of daily living on the NOSGER-Activities of Daily Living subscale (0.53), Barthel Index (0.30), Qualidem total sum score (0.39), Profile of Wellbeing (0.36), NOSGER-Impaired Social Behavior (0.47), and NOSGER-Depressed Mood subscales (0.40). Smaller or no effects were observed for all other outcomes. The intervention itself was found to be feasible, but elaborate and time consuming. This exploratory pilot study showed that for a full-scale trial, the outcomes of Activities of Daily Living and Quality of Life seem to be the most promising. The results have to be interpreted with care; larger confirmatory trials are necessary to validate the effects.