Effectiveness, safety and tolerability of a complex homeopathic medicinal product in the prevention of recurrent acute upper respiratory tract infections in children: a multicenter, open, comparative, randomized, controlled clinical trial

Background: The present study was initiated to investigate the effectiveness, safety and tolerability of complex homeopathic CalSuli-4-02 tablets on prevention of recurrent acute upper respiratory tract infections (URTIs) in children, in comparison to another complex homeopathic product. Methods: The study was designed as a prospective, multicenter, randomized, open, clinical trial with two parallel treatment groups at four outpatient pediatric clinics in Russia. Children aged <= 6 years with susceptibility to acute URTIs (>= three occasions during the last 6 months) were randomized to receive either CalSuli-4-02 or a comparator homeopathic product (control group) for 3 weeks. Primary outcome was the frequency of acute URTIs after 3 and 6 months post-treatment follow-up. Secondary endpoints were changes in complaints and symptoms (total and individual scores), treatment satisfaction, antibiotic use, safety and tolerability. Results: The intention-to-treat analysis involved 200 children (CalSuli-4-02: N = 99, Control: N = 101). In both treatment groups, the median number of acute URTIs was one for 3 months and two, respectively, for the full 6 months post-treatment (Relative Risk: 0.86 (95 %-CI: 0.72-1.03), p = 0.1099). Seasons had no influence on the outcome. At the end of study, CalSuli-4-02 had overall higher odds of getting lower complaints severity total score (Odds ratio: 1.99 (95 %-CI: 1.31-3.02), p = 0.0012) and showing symptom improvement (Odds ratio: 1.93 (95 %-CI: 1.25-3.00), p = 0.0033). Specifically, the complaint "appetite disorder" and the symptom "child's activities" significantly improved more in the CalSuli-4-02 group (p = 0.0135 and p = 0.0063, respectively). Antibiotic use was decreased in both treatment groups at the study end. Overall assessment for satisfaction with and tolerability of treatment was higher with CalSuli-4-02. A low number of non-serious adverse drug reactions was reported (CalSuli-4-02: N = 4, Control: N = 1). Conclusions: Both complex homeopathic products led to a comparable reduction of URTIs. In the CalSuli-4-02 group, significantly less URTI-related complaints and symptoms and higher treatment satisfaction and tolerability were detected. The observation that the use of antibiotics was reduced upon treatment with the complex homeopathic medications, without the occurrence of complications, is interesting and warrants further investigations on the potential of CalSuli-4-02 as an antibiotic sparing option

Attitudes toward integrative paediatrics: a national survey among youth health are physicians in the Netherlands

<p>Abstract</p> <p>Background</p> <p>Integrative Medicine (IM) is an emerging field in paediatrics, especially in the USA. The purpose of the present study was to assess the attitudes and beliefs of Youth Health Care (YHC) physicians in the Netherlands toward IM in paediatrics.</p> <p>Methods</p> <p>In October 2010, a link to an anonymous, self-reporting, 30-item web-based questionnaire was mailed to all members of the Dutch Organisation of YHC physicians. The questionnaire included questions on familiarity with IM, attitudes towards Integrative Paediatrics (IP), use and knowledge of Complementary and Alternative Medicine (CAM), demographic and practice characteristics.</p> <p>Results</p> <p>A total of 276 YHC physicians (response rate of 27%) responded to the survey. Of the respondents, 52% was familiar with IM and 56% had used some kind of CAM therapy during the past 2 years, of which self-medicated herbal and/or homeopathic remedies (61%) and supplements (50%) were most frequently mentioned. Most of the YHC physicians (62%) seldom asked parents of clients about CAM use. One third of the YHC physicians recommended CAM to their clients. In general, about 50% or more of the respondents had little knowledge of CAM therapies. Predictors for a positive attitude towards IP were familiarity with IM, own CAM use, asking their clients about CAM use and practising one or more forms of CAM therapy. Logistic regression analysis showed that the following factors were associated with a higher recommendation to CAM therapies: own CAM use (odds ratio (OR) = 3.8; 95% confidence interval (CI) = 2.1-6.9, <it>p </it>= 0.001) and practising CAM (OR 4.4; 95% CI = 1.6-11.7, <it>p </it>= 0.003).</p> <p>Conclusions</p> <p>In general Dutch YHC physicians have a relative positive attitude towards IP; more than half of the respondents used one or more forms of CAM and one third recommended CAM therapies. However, the majority of YHC physicians did not ask their clients about CAM use and seemed to have a lack of knowledge regarding CAM.</p

Physical Activity Characteristics across GOLD Quadrants Depend on the Questionnaire Used

BACKGROUND:The GOLD multidimensional classification of COPD severity combines the exacerbation risk with the symptom experience, for which 3 different questionnaires are permitted. This study investigated differences in physical activity (PA) in the different GOLD quadrants and patient's distribution in relation to the questionnaire used. METHODS:136 COPD patients (58±21% FEV1 predicted, 34F/102M) completed COPD assessment test (CAT), clinical COPD questionnaire (CCQ) and modified Medical Research Council (mMRC) questionnaire. Exacerbation history, spirometry and 6MWD were collected. PA was objectively measured for 2 periods of 1 week, 6 months apart, in 5 European centres; to minimise seasonal and clinical variation the average of these two periods was used for analysis. RESULTS:GOLD quadrants C+D had reduced PA compared with A+B (3824 [2976] vs. 5508 [4671] steps.d-1, p<0.0001). The choice of questionnaire yielded different patient distributions (agreement mMRC-CAT κ = 0.57; CCQ-mMRC κ = 0.71; CCQ-CAT κ = 0.72) with different clinical characteristics. PA was notably lower in patients with an mMRC score ≥2 (3430 [2537] vs. 5443 [3776] steps.d-1, p <0.001) in both the low and high risk quadrants. CONCLUSIONS:Using different questionnaires changes the patient distribution and results in different clinical characteristics. Therefore, standardization of the questionnaire used for classification is critical to allow comparison of different studies using this as an entry criterion. CLINICAL TRIAL REGISTRATION:ClinicalTrials.gov NCT01388218

Effectiveness of motivational interviewing and physical activity on prescription on leisure exercise time in subjects suffering from mild to moderate hypertension

<p>Abstract</p> <p>Background</p> <p>Physical inactivity is considered to be the strongest individual risk factor for poor health in Sweden. It has been shown that increased physical activity can reduce hypertension and the risk of developing cardiovascular diseases. The objective of the present pilot study was to investigate whether a combination of Motivational Interviewing (MI) and Physical Activity on Prescription (PAP) would increase leisure exercise time and subsequently improve health-related variables.</p> <p>Methods</p> <p>This pilot study was of a repeated measures design, with a 15 months intervention in 31 patients with mild to moderate hypertension. Primary outcome parameter was leisure exercise time and secondary outcome parameters were changes in blood pressure, Body Mass Index (BMI), waist circumference, lipid status, glycosylated haemoglobin (HbA1c) and maximal oxygen uptake (VO_{2 max}). Assessments of the outcome parameters were made at baseline and after 3, 9 and 15 months.</p> <p>Results</p> <p>Leisure exercise time improved significantly from < 60 min/week at baseline to a mean activity level of 300 (± 165) minutes/week at 15 months follow up. Furthermore, statistically significant improvements (p < 0.05) were observed in systolic (-14,5 ± 8.3 mmHg) and diastolic blood pressure (-5,1 ± 5.8 mmHg), heart rate (-4.9 ± 8.7 beats/min, weight (-1.2 ± 3.4 kg) BMI -0.6 ± 1.2 kg/m²), waist circumference (-3.5 ± 4.1 cm) as well as in VO_{2 max}(2.94 ± 3.8 ml/kg and 0.23, ± 0.34 lit/min) upon intervention as compared to baseline.</p> <p>Conclusions</p> <p>A 15 month intervention period with MI, in combination with PAP, significantly increased leisure exercise time and improved health-related variables in hypertensive patients. This outcome warrants further research to investigate the efficacy of MI and PAP in the treatment of mild to moderate hypertension.</p

Supporting Personal Growth in Childhood, Adolescent and Young-Adult Cancer Survivors Through Challenges in Nature — A Qualitative Study of WAYA Wilderness Programme Participation

Background: Childhood, adolescent and young-adult (AYA) cancer survivors often experience health problems due to late or long-term effects of their cancer or the treatment thereof. The general population gains health benefits from immersion in nature, and nature-based programmes seem to be an intervention that can promote health among childhood and AYA cancer survivors. Objective: To explore the impact of the WAYA wilderness programme on the health of childhood and AYA cancer survivors. Methods: The study had a qualitative approach, with data from individual interviews (n = 18) 3 months after completion of the WAYA programme. In addition, case report data was collected during follow-up talks (1, 2 and 12 months after the programme) (n = 19). The WAYA programme consisted of an 8-day expedition, followed 3 months later by a 4-day base camp. The programme included activities such as hiking, backpacking, kayaking, rock climbing, bushcraft and mindfulness. Data was analysed according to a qualitative content analysis. The consolidated criteria for reporting qualitative research (COREQ) were followed. Results: An overarching theme was identified: “Personal growth from challenges in nature supported by deep connections with others”. In 4 additional themes, participants’ experiences describe how deep personal connections arose, as they developed a feeling of being able and competent in nature. Nature provided a space that supported relaxation and respite from everyday challenges and stimuli, which also led to an experience of being more connected to nature. Conclusion: The WAYA programme was experienced as being of support to childhood and AYA cancer survivors. The programme provided them with skills and tools to be safe in nature. When connected to nature, the participants developed trust and self-confidence, personal growth, relaxation and recovery from stress. Their engagement in outdoor activities continued after completion of the programme, when they returned to everyday life at home

Patients’ experiences of the caring encounter in health promotion practice : a qualitative study in Swedish primary health care

Background: Previous 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. Aim: To 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. Methods: A 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. Results: The 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’. Conclusion: The 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.

Feasibility and Effects of Touch Massage and Nurse Led Sleep Counselling in the Treatment of Primary Insomnia

Cognitive Behavioral Therapy (CBT) is basically the only evidence based treatment both in short- as well as long term treatment of insomnia. Previous studies suggest that massage may have a role in initiating sleep and relaxation. This pilot study investigated the feasibility and effects of tactile massage (TM) and nurse led sleep counselling (SC) in the treatment of primary insomnia. Method: Thirty women with primary insomnia were randomized into three different groups: TM, SC or ‘care as usual’ (CAU) followed by a six weeks intervention period. Sleep quality was assessed with sleep diary and polysomnography. The results show that it is feasible to treat primary insomnia with TM. ‘Within’ group analysis showed that the TM group experienced significant improvements in measures of subjective sleep, SC and CAU had no improvements. No significant differences were found in the ‘between’ group analysis. Conclusion: On the basis of the findings, we can conclude that it is feasible to use the methods of TM and SC in the treatment of primary insomnia. Especially TM shows preliminary improvements in subjective measures of sleep, results which needs confirmation in full scale research. Based on the observed effects the research protocol/design is recommended to be simplified and also to combine TM and SC as intervention in future studies

Mapping the concept, content and outcome of wilderness therapy for childhood cancer survivors : protocol for a scoping review

Introduction: Long-term childhood cancer survivors are at risk for frailty and have significant health-related issues in adulthood. Various health promotion interventions have been proposed to enhance quality of life including wilderness therapy, which applies the impact of nature on health in a therapeutic context. Previous studies have described positive outcomes linked with various wilderness-related therapies for cancer survivors. However, there is no clarity on the role these therapies play in childhood cancer. The current scoping review aims to systematically map the concept, content and outcome of wilderness therapy for childhood cancer survivors. Methods and analysis: This review will be guided by the Joanna Briggs Institute Reviewers’ manual for scoping reviews. A systematic literature search using medical subject headings (MeSH) and text words related to wilderness therapy and childhood cancer survivors will be performed in EMBASE, ERIC, Medline, Psycinfo, CINAHL, Scopus, Web of Science, SPORTDiscus and Svemed+, Sociological Abstracts, supplemented by grey literature searches. Eligible quantitative and qualitative studies will be screened, included, assessed for quality and extracted for data by two reviewers independently. Results will be described in a narrative style, reported in extraction tables and diagrams, and where appropriate in themes and text. Ethics and dissemination: This study describes a protocol for a scoping review that will undertake secondary analysis of data already published in literature and is therefore exempt from medical ethical review. The scoping review will inform understanding of the benefits and risks of wilderness therapy for childhood cancer survivors, their families, practitioners, clinicians and researchers, and will help elucidate the steps necessary for building its evidence base going forward. Results will be published in a peer-reviewed scientific journal