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Background Anthroposophic medicinal products (AMPs) are widely used in Europe and world-wide. Objective To determine the frequency of reported adverse drug reactions (ADRs) from all AMPs on the market, in absolute numbers and relative to the maximum daily administration doses (MDADs). Patients and Methods Retrolective safety analysis of AMP-related ADRs in pharmacovigilance databases of four AMP Marketing Authorisation Holders in Germany. For each ADR, information about the patient, outcome, causality and AMP was retrieved. Primary outcome was the frequency of reported ADRs relative to MDADs sold. Results In the period 2010–2017, a total of 5506 ADRs were reported that had occurred in 2765 different patients, comprising 370 different AMPs. A total of 104 ADRs (1.9%) were classified as serious. The frequency of ADRs for all AMPs was 1.50 per million MDADs. For serious ADRs the frequency was 0.03 per million MDADs. ADRs were more frequently reported with parenteral AMP administration (injections) than with oral or local administration (18.85 vs. 0.59 vs. 1.61 ADRs per million MDADs, respectively; p

Background The COVID-19 pandemic lockdown has had a profound impact on physical and mental well-being throughout the world. Previous studies have revealed that complementary and alternative medicine (CAM) is frequently used for, and can be potential beneficial for strengthening physical mental resilience. The aims of this study were therefore to determine the prevalence and reasons for use of CAM during the first wave of the COVID-19 pandemic among a representative sample of the Norwegian population, and further determine self-reported effects and adverse effects of the CAM modalities used. Methods Computer assisted telephone interviews using a COVID-adapted I-CAM-Q questionnaire were conducted with 1008 randomly selected Norwegians aged 16 and above using multistage sampling during April and May 2020 applying age and sex quotas for each area. Frequencies, Pearson’s chi-square tests, Fisher exact tests, and independent sample t-test were used to identify the users of CAM, what they used, why they used it and whether they experienced effect and/or adverse effects of the modalities used, and further to describe differences in sociodemographic factors associated with CAM use. Cronbach's alpha tests were used to test for internal consistency in the different groups of CAM. Significance level was set to p < 0.05. Results The study revealed that two thirds of the respondents (67%) had used CAM within the first 3 months of the COVID-19 pandemic, in particular CAM modalities that did not involve a provider. Most used were natural remedies and dietary supplement (57%, mainly vitamins and minerals), but self-help practices like yoga and meditation were also widely used (24%). Women used CAM modalities significantly more than men (77% vs. 58%). Most of the respondents found the modalities they used beneficial, and few reported adverse effects of the treatments. Conclusions A large proportion of the Norwegian population used CAM during the first wave of the COVID-19 pandemic with high satisfaction and few reported adverse effects. CAM was rarely used to prevent or treat COVID-19, but rather to treat a long-term health condition, and to improve well-being.

Detailed descriptions of theory, structure, and activities with causal links to specified outcomes of wilderness programs are lacking. Addressing this gap, the present qualitative study gives a thorough description of the development of the Wilderness programme for Adolescent and Young Adult (AYA) cancer survivors (WAYA). WAYA is adapted to the individual needs of AYA cancer survivors. It was conceived around Næss’s ecosophy and the Positive Health Model, and refined based on findings from a scoping review and patient/public involvement. Programme aims were to increase physical activity, self-confidence, personal growth, joy, safety within nature, meaningful relationships, and self-efficacy. The programme was an eight-day expedition followed three months later by a four-day base-camp. Activities included hiking, backpacking, kayaking, rock climbing, mindfulness and bushcrafting. Evaluation of the programme through focus group and individual interviews with 15 facilitators and 17 participants demonstrated that a diverse group of participants, challenging activities, and mindfulness-based practices were found to positively influence group bonding and the learning process. Furthermore, including an expedition and base-camp component was found to be beneficial in supporting the development of participants’ own personal outdoor practices. In conclusion, this study demonstrated that the WAYA programme is safe and well accepted by AYA cancer survivors.

Outdoor therapy and family-based therapy are suggested to be promising interventions for the treatment of mental health problems. The aim of the present scoping review was to systematically map the concept, content, and outcome of combining family- and outdoor-based therapy for children and adolescents with mental health problems. The Joanna Briggs Institute methodology and PRISMA guidelines were applied. Eligible qualitative and quantitative studies were screened, included, and extracted for data. Seven studies were included. Findings from these studies indicated that family-based outdoor therapy programs have a positive impact on family- and peer relationships, adolescent behavior, mental health, self-perceptions (self-concept), school success, social engagement, and delinquency rates. However, participant characteristics, study design, and content and mode of delivery of the interventions varied substantially, hence preventing detailed comparison of outcomes across studies. In addition, most of the studies included few participants and lacked population diversity and comparable control groups. Although important ethical concerns were raised, such as non-voluntary participation in some of the programs, there was a lack of reporting on safety. This review indicates that a combination of family- and outdoor-based therapy may benefit mental health among children and adolescents, but due to the limited number of studies eligible for inclusion and high levels of heterogeneity, it was difficult to draw firm conclusions. Thus, future theory-based studies using robust designs are warranted.

IntroductionThe majority of childhood, adolescent and young adult (AYA) cancer survivors suffer from long-term and late effects such as fatigue, psychological distress or comorbid diseases. Effective health promotion strategies are needed to support the health of this vulnerable group. This protocol provides a methodological description of a study that aims to examine the feasibility and safety of performing a randomised clinical trial (RCT) on a wilderness programme that is developed to support the health of AYA cancer survivors.Methods and analysisThe pilot RCT study has a mixed-method design, including quantitative and qualitative evaluations. Participants are AYAs, aged 16–39 years, that have been diagnosed with cancer during childhood, adolescence or young adulthood. A total of 40 participants will be randomly assigned to a wilderness programme (n=20) or a holiday programme (n=20). Both arms include participation in an 8-day summer programme, followed by a 4-day programme 3 months later. Primary outcomes are feasibility and safety parameters such as time to recruitment, willingness to be randomised, programme adherence and adverse effects. Secondary outcomes include self-reported health such as self-esteem, quality of life, self-efficacy and lived experiences. Descriptive statistics will be used to analyse outcomes and explore indications of differences between the programmes. Interviews are analysed by directed content analysis and hermeneutic phenomenology. A convergent parallel mixed-method analysis design will be applied to integrate quantitative and qualitative data. Results of this feasibility study will inform the preparation for a larger RCT with AYA cancer survivors.Ethics and disseminationThe study protocol is approved by the Swedish Ethical Review Authority (reference: 2020-00239). This study will be performed between January 2021 and December 2023. Results will be published in international peer-reviewed journals, presented at conferences and disseminated to participants, cancer societies, healthcare professionals and outdoor instructors.Trial registration numberNCT04761042.

Introduction Little is known about integration of Complementary and Alternative Medicine (CAM) in the Dutch healthcare system. The aim of the present study was to investigate how Integrative Medicine (IM) is practiced and how CAM is integrated with conventional medicine in curative and long-term healthcare centres in the Netherlands. Methods A mixed methodology was applied, including a systematic internet search, an online survey and focus groups among healthcare professionals. Results Most hospitals (92%) offered some form of CAM to treat anxiety (72%), restlessness (68%), pain (65%), sleeping problems (50%), stress (48%) and fatigue (36%). Mostly offered modalities were relaxation exercises (88%), art therapy (44%) and mindfulness (42%). Similar percentages of CAM use were found in other healthcare centres. Most CAM modalities were implemented without organizational vision, guidelines or protocols. Only 5% of implemented CAM was labelled as IM. Focus groups with health care professionals revealed the need to increase knowledge and to develop a vision for integration of CAM with conventional medicine, as well as to support effectiveness research in this area. Conclusions This study is the first in the Netherlands to quantitatively map the extent of CAM integration in conventional health care. The number of CAM interventions offered at conventional health care settings was surprisingly high. However, integration was fragmented. Guidelines, education and research programs are needed to further integration of CAM, preferably organised in a Dutch Consortium for IM.

BackgroundMany parents choose support such as Complementary and Alternative Medicine (CAM) for themselves and their children who have cancer. The aim of this paper is to describe, how parents who have children with cancer communicated with conventional health care providers about CAM, and what types and sources of information they would like to receive about CAM when the child was ill.MethodThis focused ethnography draws from in-depth, semi-structured interviews conducted with 22 families in Norway with 24 adult participants (two couples), including two individuals who had had cancer themselves. Four domains were explored in the data analysis: the use of CAM, advice from laypeople about CAM, communication with conventional health care providers about CAM, and parents’ information needs about CAM.ResultsMany of the participants had personal experiences with CAM before the child received the cancer diagnosis. The health care providers did not raise the question about CAM in the consultations. However, when the parents raised the question, they were mostly met in a positive way. The participants did not receive any information about CAM at the hospital, which they would have appreciated. Instead, they received recommendations about CAM from laypersons, which were mostly rejected, as the advice was not in line with their health values/philosophy.ConclusionThe reason participants did not disclose CAM use is that physicians did not ask them about it. However, positive communication about conventional treatment facilitated fruitful conversations about CAM. The participants wanted information about CAM from authoritative sources, primary from health care providers at the hospital and the Children’s Cancer Society. They demand information about risks and benefits when using CAM as well as whether CAM can improve the immune system, fight the cancer, and improve the quality of life of the family. An evidence-based decision aid is warranted to enable health care providers and parents of children with cancer to make well-informed decisions about CAM.

BackgroundThe present study was initiated to determine consultations with health care providers and use of self-management strategies such as herbal remedies, dietary supplements and self-help techniques for prevention and treatment of COVID-19 related symptoms in countries with a full lockdown (Norway), a partial (’intelligent’) lockdown (the Netherlands) and no lockdown (Sweden) during the first three months of the COVID-19 pandemic, and if such use correlates with worries of being infected by COVID-19 disease. MethodsData were collected in collaboration with the global marketing company Ipsos A/S in April-June 2020 during the first wave of the COVID-19 pandemic. An adapted version of the I-CAM-Q was used and the categories “for prevention of COVID-19” and “to treat COVID-19-related symptoms” added to the original “reasons for use” options. Data were collected among a representative sample in Norway, Sweden and the Netherlands using data assisted telephone interviews (Norway, n=990 and Sweden, n=500), and an online survey (the Netherlands, n=1004). Total response rate was 30%. ResultsOnly a very small number of people in any of the three countries consulted a health care provider with the intention to treat or prevent COVID-19 (1.2% and 1.0% respectively) with medical doctors mostly visited (1.0% and 0.9%). Similarly, the use of self-management strategies to prevent or treat COVID-19 was low (3.4% and 0.2% respectively); most commonly used were vitamins and minerals (2.8%) for prevention of COVID-19, primarily vitamin C (1.7%), vitamin D (0.9%), and multivitamins (0.5%). Consultations with health care providers and use of self-management strategies for prevention of COVID-19 were positively associated with worries of being infected with COVID-19. No such associations were found for worries about loved ones or the perception that COVID-19 is more dangerous than ordinary influenza. ConclusionsThe COVID-19 pandemic does not seem to have evoked a large-scale difference in behaviour related to consultations with health care providers or the use of self-management strategies such as dietary supplements and self-help techniques in any of the three countries, despite different containment and mitigation measures.

BackgroundDuring the Covid-19 pandemic the Dutch government implemented its so-called ‘intelligent lockdown’ in which people were urged to leave their homes as little as possible and work from home. This life changing event may have caused changes in lifestyle behaviour, an important factor in the onset and course of diseases. The overarching aim of this study is to determine life-style related changes during the first wave of the COVID-19 pandemic among a representative sample of the adult population in the Netherlands.MethodsLife-style related changes were studied among a random representative sample of the adult population in the Netherlands using an online survey conducted from 22 to 27 May 2020. Differences in COVID-19-related lifestyle changes between Complementary and Alternative Medicine (CAM) users and non-CAM users were determined. The survey included a modified version of the I-CAM-Q and 26 questions on lifestyle related measures, anxiety, and need for support to maintain lifestyle changes.Results1004 respondents were included in the study, aged between 18 and 88 years (50.7% females). Changes to a healthier lifestyle were observed in 19.3% of the population, mainly due to a change in diet habits, physical activity and relaxation, of whom 56.2% reported to be motivated to maintain this behaviour change in a post-COVID-19 era. Fewer respondents (12.3%) changed into an unhealthier lifestyle. Multivariable logistic regression analyses revealed that changing into a healthier lifestyle was positively associated with the variables ‘Worried/Anxious getting COVID-19’ (OR: 1.56, 95% C.I. 1.26–1.93), ‘CAM use’ (OR: 2.04, 95% C.I. 1.38–3.02) and ‘stress in relation to financial situation’ (OR: 1.89, 95% C.I. 1.30–2.74). ‘Age’ (OR 18–25: 1.00, OR 25–40: 0.55, 95% C.I. 0.31–0.96, OR 40–55:0.50 95% C.I. 0.28–0.87 OR 55+: 0.1095% C.I. 0.10–0.33), ‘stress in relation to health’ (OR: 2.52, 95% C.I. 1.64–3.86) and ‘stress in relation to the balance work and home’ (OR: 1.69, 95% C.I. 1.11–2.57) were found predicting the change into an unhealthier direction.ConclusionThese findings suggest that the coronavirus crisis resulted in a healthier lifestyle in one part and, to a lesser extent, in an unhealthier lifestyle in another part of the Dutch population. Further studies are warranted to see whether this behavioural change is maintained over time, and how different lifestyle factors can affect the susceptibility for and the course of COVID-19.

Background - Almost all health care interventions have the potential to be associated with risk to patient safety. Different terminologies are used to define treatment induced risk to patient safety and a common definition is the term adverse effect. Beyond the concept of adverse effect and specific to homeopathy is the concept of homeopathic aggravation. Homeopathic aggravation describes a transient worsening of the patients’ symptoms, which is not understood as an adverse effect. In order to ensure patient safety within a homeopathic treatment setting, it is important to identify adverse effects, as well as homeopathic aggravations, even though it may be challenging to distinguish between these two concepts. To date there is an obvious lack of systematic information on how adverse effects and homeopathic aggravations are reported in studies. This systematic review and meta-analysis focuses on observational studies, as a substantial amount of the research base for homeopathy are observational. Method - Eight electronic databases, central webpages and journals were searched for eligible studies. The searches were limited from the year 1995 to January 2020. The filters used were observational studies, human, English and German language. Adverse effects and homeopathic aggravations were identified and graded according to The Common Terminology Criteria for Adverse Effects (CTCAE). Meta-analysis was performed separately for adverse effects and homeopathic aggravations. Results - A total of 1,169 studies were identified, 41 were included in this review. Eighteen studies were included in a meta-analysis that made an overall comparison between homeopathy and control (conventional medicine and herbs). Eighty-seven percent (n = 35) of the studies reported adverse effects. They were graded as CTCAE 1, 2 or 3 and equally distributed between the intervention and control groups. Homeopathic aggravations were reported in 22,5% (n = 9) of the studies and graded as CTCAE 1 or 2. The frequency of adverse effects for control versus homeopathy was statistically significant (P < 0.0001). Analysis of sub-groups indicated that, compared to homeopathy, the number of adverse effects was significantly higher for conventional medicine (P = 0.0001), as well as other complementary therapies (P = 0.05). Conclusion - Adverse effects of homeopathic remedies are consistently reported in observational studies, while homeopathic aggravations are less documented. This meta-analysis revealed that the proportion of patients experiencing adverse effects was significantly higher when receiving conventional medicine and herbs, compared to patients receiving homeopathy. Nonetheless, the development and implementation of a standardized reporting system of adverse effects in homeopathic studies is warranted in order to facilitate future risk assessments.

BackgroundPrevious studies have reported that organizational structures and cultures in primary health care are obstacles to district nurses doing successful work in health promotion practice (HPP). Because organizational structures are not easily changed, Jean Watson’s Attending Nurse Caring Model (ANCM) was introduced and piloted at a primary health care center in Sweden, aiming to transform HPP so as to empower district nurses and increase their work satisfaction.AimTo investigate patients’ experiences of the caring encounter in HPP after introduction of the ANCM in Swedish primary health care, the aim being to explore the essential components of the caring encounter between patients and district nurses.MethodsA descriptive and qualitative research design was used. Data collection was performed using individual face-to-face interviews with twelve patients at risk for developing CVD. Data analysis consisted of both deductive content analysis, using a categorization matrix based on the ANCM and, subsequently, inductive latent content analysis.ResultsThe findings were abstracted into three themes: 1.‘Feeling the deepest essence of being cared for’: to be respected and being put at the center of the encounter; 2. ‘Feeling acceptance and worth’: being treated with openness and permissive attitudes, 3. ‘Being in a supportive atmosphere that promotes hope’: to feel trust and being trusted in the encounter, and being empowered by hope. The unifying main theme of the caring encounter was abstracted as ‘Experiencing human dignity’.ConclusionThe present study revealed that the essence of the caring encounter between patients and district nurses in HPP is to be unconditionally accepted in an environment that inspires hope and encouragement. The ANCM seems to be a promising model to use for strengthening the caring encounter and supporting CVD patients in making healthy lifestyle choices. However, further studies of qualitative and quantitative designs are needed to investigate what the ANCM can contribute to HPP in Swedish primary health care.

Background. Despite considerable efforts, health disparities between people with high and low socioeconomic status (SES) have not changed over the past decades in The Netherlands. To create a culture of health and an environment in which all people can flourish, a shift in focus is needed from disease management towards health promotion. The Bolk model for Positive Health and Living Environment was used as a tool to guide this shift. This study aimed to describe how this model was used and perceived by stakeholders in a case study on an integrated health promotion approach for residents with low SES. Methods. An instrumental case study was undertaken in Venserpolder, a neighborhood in Amsterdam South East of approximately 8500 residents. A participatory action approach was used that allowed continuous interaction between the residents, health care professionals, researchers, and other stakeholders. The Bolk model is a tool, based on the conceptual framework of positive health, that was developed to guide health promotion practice. Its use in the case study was evaluated by means of semistructured interviews with stakeholders, using qualitative directed content analyses. Results. The Bolk model was found to be a useful tool to identify and map the needs and strengths of residents with low SES. The model facilitated the development and implementation of eight health promotion pilots by transforming the needs and strengths of residents into concrete actions carried out by responsible actors in the neighborhood. Although the Bolk model seemed to be accepted by all stakeholders, the shift towards positive health thinking appeared to be more embodied by local professionals than by residents. Adjustments were proposed to enhance the applicability of the model in a multicultural setting, to increase its cultural sensitivity and to use language more familiar to residents. Conclusions. The Bolk model for positive health and living environment seems to be promising in the guidance of health promotion practices in Amsterdam South East. Further research and development are needed to improve its cultural sensitivity and to investigate its applicability in a broader range of public health settings.

Background: The Norwegian authorities decided in March 2020 to implement a nationwide lockdown to prevent spread of the COVID-19 virus. The lockdown had vast socioeconomic consequences for the society. The aim of this study was to investigate how COVID-19 affected Complementary and Alternative Medicine (CAM) providers' practice, financial situation, recommendations to patients, and how they perceived their future practice as CAM providers. Method: Data were collected in this cross-sectional survey using a self-administrated electronic questionnaire. A total of 581 CAM providers completed the questionnaire, which was designed to describe consequences for CAM providers and their clinical practice caused by the nationwide lockdown. Descriptive statistics were carried out using frequency analyses to describe the demographics and consequences of the lockdown. Between group differences (gender and age) were analyzed using Pearson chi-square tests and Fisher's exact tests for categorical variables, and ANOVA tests and t-tests for continuous variables. Significance level was defined as p < 0.05 without adjustment for multiple comparisons. Result: During the nationwide lockdown of Norway, 38.4% of the respondents were able to provide CAM treatment to their patients. Of those, the majority (96.4%) had reorganized their clinical practice in accordance with COVID-19 hygiene regulations, offered video consultations (57.4%) or telephone consultations (46.6%). To manage financially during the lockdown, half of the providers spent their savings (48.7%). More than one third (35.1%) was supported by their partner, and 26.7% received compensation from the Norwegian state. A total of 26.3% of the CAM providers had other paid work that provided them with income. Nearly a fifth (18.6%) borrowed money from friends and family, changed their loan terms, or took out new bank loans. More than half (62.7%) expressed uncertainty about the future of their practice. CAM providers who had reorganized their practice to online consultations were more optimistic. Conclusion: The impact of COVID-19 on CAM providers was considerable. It adversely affected their clinical practice, financial situation, and view on their future practice. To ensure that the health needs of the Norwegian population regarding CAM use are met during pandemic times like COVID-19, it is recommended to support and train CAM providers in the development of online CAM services, as well as efficient implementation of infection prevention and control measures.

Purpose To develop an evidence-based decision aid for parents of children with cancer and to help guide them in the use of complementary and alternative medicine (CAM) for cancer care. Methods This study had a mixed research design. The needs of parents were investigated by survey and focus group. A systematic review and meta-analysis were performed on the effectiveness of CAM using Grading of Recommendations Assessment, Development and Evaluation (GRADE). Clinical experts were interviewed and a decision aid on CAM treatment for pain was developed. Results Parents emphasized the importance of reliable information on CAM, focusing primarily on communication and a broad spectrum of complaints related to cancer treatment. The decision aid on CAM for pain included five modalities based on 11 randomized control trials (RCTs): hypnotherapy, mind-body techniques, massage, healing touch, and music therapy. Meta-analysis could be performed on hypnotherapy, which significantly reduced cancer-related procedural pain compared with standard care (MD, − 1.37; 95% CI, − 1.60, − 1.15; P

Objectives Systematic mapping of the concept, content, and outcome of wilderness programs for childhood cancer survivors. Design Scoping review. Search strategy Searches were performed in 13 databases and the grey literature. Included studies describe participation of childhood cancer survivors in wilderness programs where the role of nature had a contextual and therapeutic premise. At least two authors independently performed screening, data extraction and analysis. Results Database searches yielded 1848 articles, of which 15 met the inclusion criteria. The majority of programs (73%) employed adventure therapy. Five activity categories were identified as components of wilderness programs: challenge/risk, free time/leisure, experiential learning, physical activity and psychotherapeutic activities. A majority of the participating childhood cancer survivors were female, white, aged 8–40 years, with a wide range of cancer diagnoses. Reported outcomes included increased social involvement, self-esteem, self-confidence, self-efficacy, social support, and physical activity. Key gaps identified included the absence of randomized controlled trials (RCTs), lack of studies on long-term effects, lack of information on the multicultural aspects of programs, and missing information on engagement in nature activities after the program ended. Conclusions This scoping review guides childhood cancer survivors, their families, practitioners, clinicians and researchers in the development and optimization of wilderness programs for childhood cancer survivors. In addition, it informs the utilization of these programs, and identifies gaps in the evidence base of wilderness programs. It is recommended that future study reporting on wilderness programs include more detail and explicitly address the role of nature in the program. Performing RCTs on wilderness programs is challenging, as they occur in real-life contexts in which participants cannot be blinded. Creative solutions in the design of pragmatic trials and mixed method studies are thus needed for further investigation of the effectiveness and safety of wilderness programs in childhood cancer survivors.

Background Antibiotic-associated diarrhea (AAD) occurs in 2–25% of nursing home residents, which may lead to dehydration, malnutrition, severe complications and hospitalizations. Research shows that probiotics can be effective and safe in reducing AAD. However, probiotics are not routinely used in Dutch nursing homes. The objectives of this evaluation were to develop a procedure for the implementation of probiotics to prevent AAD in nursing homes, to evaluate effects on AAD occurrence, and to evaluate the implementation process of probiotics in daily care. Methods A pragmatic participatory evaluation (PPE) design was chosen, as it seemed a suitable approach for implementation of probiotics, as well as for evaluation of its effectiveness in daily nursing home practice. Probiotics administration was implemented in three nursing homes of the Rivas Zorggroep for residents with somatic and/or psychogeriatric conditions. Ninety-three residents provided data on 167 episodes of antibiotics use, of which 84 episodes that included supplementation with probiotics and 83 episodes with no probiotics supplementation. A multispecies probiotics was administered twice daily upon start of antibiotic treatment, up to 1 week after completing the antibiotics course. The occurrence of AAD was monitored and a process evaluation was conducted to assess facilitators and barriers of probiotics implementation. Results The number of episodes with AAD when using probiotics was significantly lower than when no probiotics was used (20% vs 36%; p = 0,022, Chi-square). No significant differences in the occurrence of AAD were found between the residents taking amoxicillin/clavulanic acid or ciprofloxacin. Reported facilitators for implementation were perceived benefits of probiotics and prescription by medical staff. Reported challenges were probiotics intake by residents and individual decision-making as to which resident would benefit from it. Conclusion Successful implementation of probiotics demonstrated the prevention of AAD in nursing home residents. Trial registration ISRCTN 94786163, retrospectively registered on 3 February 2020.

Premenstrual syndrome and premenstrual dysphoric disorder (PMS/PMDD) bother a substantial number of women. Homeopathy seems a promising treatment, but it needs investigation using reliable study designs. The feasibility of organizing an international randomized pragmatic trial on a homeopathic add-on treatment (usual care [UC] + HT) compared with UC alone was evaluated.A multicenter, randomized, controlled pragmatic trial with parallel groups.The study was organized in general and private homeopathic practices in the Netherlands and Sweden and in an outpatient university clinic in Germany.Women diagnosed as having PMS/PMDD, based on prospective daily rating by the daily record of severity of problems (DRSP) during a period of 2 months, were included and randomized.Women were to receive UC + HT or UC for 4 months. Homeopathic medicine selection was according to a previously tested prognostic questionnaire and electronic algorithm. Usual care was as provided by the women's general practitioner according to their preferences.Before and after treatment, the women completed diaries (DRSP), the measure yourself concerns and well-being, and other questionnaires. Intention-to-treat (ITT) and per protocol (PP) analyses were performed.In Germany, the study could not proceed because of legal limitations. In Sweden, recruitment proved extremely difficult. In the Netherlands and Sweden, 60 women were randomized (UC + HT: 28; UC: 32), data of 47/46 women were analyzed (ITT/PP). After 4 months, relative mean change of DRSP scores in the UC + HT group was significantly better than in the UC group (p = 0.03).With respect to recruitment and different legal status, it does not seem feasible to perform a larger, international, pragmatic randomized trial on (semi-)individualized homeopathy for PMS/PMDD. Since the added value of HT compared with UC was demonstrated by significant differences in symptom score changes, further studies are warranted.

Background: The comprehensive systematic review of randomised placebo-controlled trials (RCTs) in homeopathy requires examination of a study's model validity of homeopathic treatment (MVHT) as well as its risk of bias (extent of reliable evidence). Objective: To appraise MVHT in those RCTs of non-individualised homeopathy that an associated investigation had judged as ‘not at high risk of bias’. Design: Systematic review. Methods: An assessment of MVHT was ascribed to each of 26 eligible RCTs. Another 49 RCTs were ineligible due to their high risk of bias. Main outcome measures: MVHT and the prior risk of bias rating per trial were merged to obtain a single overall quality designation (‘high’, ‘moderate’, ‘low’), based on the GRADE principle of downgrading. Results: The trials were rated as ‘acceptable MVHT’ (N = 9), ‘uncertain MVHT’ (N = 10) and ‘inadequate MVHT’ (N = 7); and, previously, as ‘reliable evidence’ (N = 3) and ‘non-reliable evidence’ (N = 23). The 26 trials were designated overall as: ‘high quality’ (N = 1); ‘moderate quality’ (N = 18); ‘low quality’ (N = 7). Conclusion: Of the 26 RCTs of non-individualised homeopathy that were judged ‘not at high risk of bias’, nine have been rated ‘acceptable MVHT’. One of those nine studies was designated ‘high quality’ overall (‘acceptable MVHT’ and ‘reliable evidence’), and is thus currently the only reported RCT that represents best therapeutic practice as well as unbiased evidence in non-individualised homeopathy. As well as minimising risk of bias, new RCTs in this area must aim to maximise MVHT and clarity of reporting.

A significant number of medical students suffer from burnout symptoms and reduced empathy. This controlled, quasi-experimental study aimed to investigate whether a mind-body medicine (MBM) skills course could reduce perceived stress and increase empathy and self-reflection in medical and nursing students.The MBM course (consisting of experiential sessions of mind-body techniques and group reflections) was piloted among Dutch medical students and Swedish nursing students. Main outcome variables were perceived stress (PSS), empathy (IRI subscales perspective taking, fantasy, empathic concern, and personal distress), and self-reflection (GRAS). Participating and control students completed questionnaires at baseline, post-intervention, at 6 and 12 months follow-up.Seventy-four medical and 47 nursing students participated in the course. Participating medical students showed significantly increased empathic concern [1.42 (95% CI 0.05, 2.78), p = 0.042], increased fantasy [3.24 (95% CI 1.58, 4.90), p 0.001], and decreased personal distress [-1.73 (95% CI -3.04, -0.35), p = 0.010] compared to controls until 12 months follow-up. Participating nursing students showed significantly decreased levels of perceived stress [-5.09 (95% CI -8.37, -1.82), p = 0.002] and decreased personal distress [-5.01 (95% CI -6.97, -3.06), p 0.001] compared to controls until 12 months follow-up.This study demonstrated long-term beneficial effects of the MBM course on perceived stress and empathy in medical and nursing students.

Objective Health Promotion Practice (HPP) has the objective to promote a healthier lifestyle and reduce the risk of disease. The aim of this study was to examine district nurses׳ experiences of working with health preventive actions among patients with risk factors for cardiovascular disease (CVD), and to identify facilitators and obstacles in HPP. Design/Setting The study was carried out with a qualitative approach where individual semistructured interviews were performed with a total of 12 district nurses in primary care. Data transcripts were analyzed with a manifest content analysis. Findings Five categories were identified. Firstly, informants regarded HPP as the core essence of their work. Secondly, counseling and coaching were reported as crucial elements in working with HPP. Thirdly, informants identified tools such as motivational interviewing (MI) to facilitate HPP. In the fourth category facilitators and barriers of HPP appeared, consisting of both positive and negative attitudes and presence as well as lack of organizational culture and structure. Finally, some informants were dissatisfied with HPP and viewed it as compulsory or as a burden, while others were satisfied and experienced it as a stimulating challenge. Conclusion This study identified that HPP is the core of the district nurses׳ work to promote a healthier lifestyle in individuals with CVD. Organizational structures and culture need to be improved in order to support district nurses to successfully work with HPP. To optimize health promotion and strengthen patients׳ self-care, it is recommended that HPP include holistic elements of care.

Many children suffer from headaches. Since stress may trigger headaches, effective techniques to cope with stress are needed. We investigated the effectiveness of two mind-body techniques, transcendental meditation (TM) or hypnotherapy (HT), and compared them with progressive muscle relaxation (PMR) exercises (active control group). Children (9–18 years) suffering from primary headaches more than two times per month received either TM (N = 42), HT (N = 45) or PMR (N = 44) for 3 months. Primary outcomes were frequency of headaches and ≥ 50% reduction in headaches at 3 and 9 months. Secondary outcomes were adequate relief, pain coping, anxiety and depressive symptoms, somatisation and safety of treatment. Groups were comparable at baseline. Headache frequency was significantly reduced in all groups from 18.9 days per month to 12.5 and 10.5 at respectively 3 and 9 months (p < 0.001), with no significant differences between the groups. Clinically relevant headache reduction (≥ 50%) was observed in 41% and 47% of children at 3 and 9 months respectively, with no significant differences between the groups. No differences were observed in secondary outcome measures between the intervention groups. No adverse events were reported. Conclusion: All three techniques reduced primary headache in children and appeared to be safe. Trial registration: NTR 2955, 28 June 2011 (www.trialregister.nl) What is Known: • Stress may be an important trigger for both tension type headache and migraine in children. • Good data are lacking on the effect of transcendental meditation, hypnotherapy or progressive muscle relaxation as possible stress-reducing therapies in children with primary headaches. What is New: • Three non-pharmacological techniques, i.e., transcendental meditation, hypnotherapy and progressive muscle relaxation exercises, all result in a clinically significant reduction of headaches and use of pain medication. • No large differences between the three techniques were found, suggesting that children can choose either one of the three techniques based on personal preferences. This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/)

Needs and strengths of citizens in Amsterdam regarding improving their health and living environment

BackgroundPrimary care physicians are subjected to a high workload, which can lead to stress and a high incidence of burnout. A mindfulness training course was developed and implemented for primary care physicians to better cope with stress and improve job functioning.AimTo gain insight into the effects of the mindfulness training on perceived stress, self-compassion, and self-reflection of primary care physicians.Design & settingA pragmatic mixed-methods pre–post design in which physicians received 8 weeks of mindfulness training.MethodParticipants completed validated questionnaires on perceived stress (Perceived Stress Scale [PSS]), self-compassion (Self-Compassion Scale [SCS]), and self-reflection (Groningen Reflection Ability Scale [GRAS]) before the training, directly after, and 6 months later. Semi-structured interviews were conducted with six participants after the training and a content analysis was performed to gain in depth understanding of experiences.ResultsA total of 54 physicians participated in the study. PSS was reduced (mean difference [MD] -4.5, PPPP = 0.025) and SCS improved (MD = 0.7, PP = 0.120). Qualitative analysis revealed four themes: being more aware of their own feelings and thoughts; being better able to accept situations; experiencing more peacefulness; and having more openness to the self and others.ConclusionMindfulness training might be an effective approach for improving stress resilience, self-compassion, and self-reflection in primary care physicians.

An evidence-based decision aid on complementary medicine for parents of children with cancer

Health promotion through mindfulness training : a study among Dutch primary care physicians

This chapter describes the existing “core” of caring/nursing in the Nordic tradition and how that can be merged with the concepts of integrative nursing to form a vision and strategy for the future. Terms such as integrative nursing are unfamiliar among nurses in Sweden, but the concepts of holistic care and healing have been taught for a long time and are well integrated in education and legislation. This chapter discusses possible barriers, such as the level of decision-making in Swedish healthcare as well as the role and attitude towards legislation in the light of the dominant biomedical paradigm. Further discussion explores how integrative nursing may serve as a bridge between the caring, nursing, and biomedical perspectives in its effort to identify and construct evidence from the basis and understanding of complex interventions and complex systems science. Practical steps for progression are identified and suggested.