Ivy leaf dry extract EA 575 for the treatment of acute and chronic cough in pediatric patients: review and expert survey.

OBJECTIVES: EA 575 (Prospan) is a herbal medicine containing a dried extract of ivy leaves (drug extract ratio 5-7.5:1; extraction solvent, 30% ethanol). Although widely used for the treatment of cough, there remains a lack of clarity on the effects of EA 575 in children. This study aimed to evaluate the efficacy and tolerability of EA 575 in pediatric patients with cough, via a literature review and expert survey. METHODS: A MEDLINE/PubMed database search was performed to identify articles evaluating the efficacy and tolerability of EA 575 in pediatric patients with cough. An online survey of international pediatric cough experts was conducted to gather expert opinion regarding the use of EA 575 for pediatric cough. RESULTS: Ten controlled clinical trials and nine observational studies were identified. Controlled trials reported improvements in lung function and subjective cough symptoms with EA 575, while observational studies indicated overall favorable efficacy. EA 575 was generally well tolerated, with a low incidence of adverse events in children of all ages, including those aged <1 year. Survey responses from ten experts aligned with findings from the reviewed studies. Most experts agreed that EA 575 may improve quality of life, and highlighted its potential benefits on sleep. CONCLUSIONS: EA 575 has minimal side effects in pediatric patients with cough, as demonstrated by large, real-world studies. EA 575 may provide clinical benefits in pediatric patients; however, more robust clinical trials are needed to confirm its efficacy.

EA 575 (Prospan) is a medicine containing a dried extract of ivy leaves that is used to treat coughs. The aim of this review was to evaluate the available published information on the health benefits and side effects of EA 575 in children with coughs. We also conducted a survey of doctors who treat children with coughs. We found information from ten research trials that compared EA 575 with another cough medicine or a "dummy medicine". Although these studies included only a small number of children, the results suggested that children's breathing and cough symptoms may improve with EA 575 treatment. We also found nine studies that included children being treated in normal clinical situations and not in a research setting. Most of the children included in these studies and their doctors thought that EA 575 treatment was beneficial. A low number of side effects was reported in children of all ages, including in infants aged <1 year. Survey responses from ten doctors generally agreed with the findings from the research studies. Most of the doctors thought that EA 575 may improve quality of life. Improved sleep was commonly mentioned by doctors. Overall, our findings indicate that EA 575 has minimal side effects in children; we call for more research on the benefits of EA 575 on cough symptoms in children.

Perceptions of Health Professionals on the Implementation of Integrative and Complementary Practices at a University Pediatric Hospital in Brazil: A Qualitative Interview Study.

BACKGROUND: Despite an increase in use of pediatric complementary and integrative health (PCIH), many healthcare professionals still have an inadequate understanding of such practices and consider their use inappropriate, which might thwart implementation processes. In a qualitative interview study we examined the feedback of conventional healthcare professionals about the integrative practices provided to pediatric patients by an integrative team in a pediatric oncological hospital. METHODS: Fifteen semi-structured interviews were carried out with various conventional healthcare professionals in an university pediatric hospital in São Paulo, Brazil. The interviews were audio-recorded, transcribed and pseudonymized. DSCsoft® and MAXQDA® software assisted in a profound qualitative analysis using the collective subject discourse and thematic analysis method in order to display participants' perspectives on PCIH and the project in their hospital. RESULTS: Interviewees acknowledged their lack of knowledge about PCIH practices and reflected on the limits of their care as well as on new possibilities PCIH could offer. PCIH was perceived by interviewees as an effective supportive tool of care to promote patients' wellbeing, assist overall compliance, strengthen cooperation between professionals, children and their relatives and hence facilitated general patient care. Since PCIH was implemented in their clinic, perceptions led interviewees to wish for increased PCIH offering and a more profound integration of its therapists into the standard of care. DISCUSSION: The coexistence of integrative and conventional practices in the conventional healthcare setting is important to give visibility to the possibilities offered by the integrative pediatrics field. Regular and constant encounters with integrative practices, as well as information access seem crucial to reach a wider openness for PCIH and subsequently a broader application and dissemination of it.

"Like one part of a puzzle" - individualized aromatherapy for women with gynecological cancers in aftercare: results from a qualitative-focused mixed-methods study.

BACKGROUND: Gynecological cancer(s), including breast cancer patients in aftercare and survivors, need supportive strategies to cope with symptoms that are adapted to their individual needs and circumstances. Aromatherapy has potential to be such strategy, but (qualitative) empirical research taking users' own views into consideration about the potential and challenge of aromatherapy is lacking. PURPOSE: The purpose of the study is to gain insights from individualized aromatherapy as a supportive care treatment, regarding their use and evaluation by women with gynecological cancers in aftercare. METHODS: We conducted a study with a mixed-methods design, focused on qualitative research. Five essential oil products were given to 18 participants to apply individually over a 4-week period. After the intervention, qualitative semi-structured interviews were conducted. Further, we documented and assessed symptomatic burdens of the women (MYMOP2) before and after intervention quantitatively. RESULTS: Aromatherapy was customized by the participants according to their needs. It showed potential for relief of symptomatic burdens - especially nausea, peripheral neuropathy, pain, and sleep. Additionally, opportunities emerged to indirectly affect symptomatic burdens. These developed out of new coping strategies (e.g., sleep routines) or by combining with existing strategies (e.g., meditation). Furthermore, aromatherapy was successfully used to promote well-being and encourage mindfulness. CONCLUSION: Our findings demonstrated the potential of aromatherapy as a supportive treatment modality that can be used as a kind of toolbox. Challenges, such as individual odor aversions and intolerances, and limitations due to medication or illness should be considered in future aromatherapy research.

The implementation of an online mindfulness-based program for pediatric patients at a tertiary hospital in South America: a feasibility study protocol.

BACKGROUND: The prevalence of chronic and complex pediatric health conditions has quickly risen over the last decades. Chronic and complex health conditions make pediatric patients and their families more susceptible to many distressing events during their lifespan. Mindfulness-based interventions have become a popular intervention for individuals living with chronic illnesses and have been adapted for pediatric populations with good results, including online versions. This study intends to report an implementation protocol of an online mindfulness-based program for adolescents to address an important gap in stress relief and health promotion for pediatric patients. METHODS: In this article, we describe the rationale and design of an implementation study of an online mindfulness-based program for pediatric patients at a tertiary pediatric hospital in South America. Participants will be recruited during one year to participate in an eight-session online mindfulness-based program. To assess our primary aim of feasibility, we will exam recruitment, retention and participation rates. Participants will also complete a symptomatology evaluation (i.e., depression, anxiety, and stress symptoms) at baseline and immediately at post-treatment and fidelity will be evaluated by a structured questionnaire. DISCUSSION: This study will be the first known to assess the implementation of an online mindfulness-based program for a pediatric population at a tertiary pediatric center in South America under real-life conditions. This study will establish the feasibility of a novel intervention aimed at promoting mental health and positive coping strategies among pediatric patients with chronic and complex health conditions. Evidence from this study would be useful to patients, families, clinicians, and policymakers and will help to devise strategies of health promotion for the pediatric population, as well as serve as a model for a future trial to examine efficacy of the proposed intervention. TRIAL REGISTRATION: This research has been registered at Ensaiosclinicos.gov.br , identifier RBR-23trp87 . Registered 25 February 2022-retrospectively registered.

Mindfulness-Based Student Training Improves Vascular Variability Associated With Sustained Reductions in Physiological Stress Response.

In today's fast-paced society, chronic stress has become an increasing problem, as it can lead to psycho-physiological health problems. University students are also faced with stress due to the demands of many courses and exams. The positive effects of mindfulness-based stress reduction (MBSR) on stress management and self-regulation have already been studied. We have developed a new mindfulness intervention tailored for students-the Mindfulness-Based Student Training (MBST). In this study, we present longitudinal results of the MBST evaluation. Biosignal analysis methods, including pulse wave variability (PWV), heart rate variability, and respiratory activity, were used to assess participants' state of autonomic regulation during the 12-week intervention and at follow-up. The progress of the intervention group (IGR, N = 31) up to 3 months after the end of MBST was compared with that of a control group (CON, N = 34). In addition, the long-term effect for IGR up to 1 year after intervention was examined. The analysis showed significant positive changes in PWV exclusively for IGR. This positive effect, particularly on vascular function, persists 1 year after the end of MBST. These results suggest a physiologically reduced stress level in MBST participants and a beneficial preventive health care program for University students.

Health-Related Self-Care Strategies and Coping Resources During the COVID-19 Pandemic: An Online-Based Cross-Sectional Study.

Background: Complementary medicine (CM) is often used as an opportunity for preventive health measures and supportive self-care practices. This study aimed to explore the use of self-care practices and preventive health strategies and the aspects of the experienced emotions during the COVID-19 pandemic in a population with an affinity for CM. Methods: The authors conducted an exploratory cross-sectional study using an anonymous 41-item online survey in the German language. The survey respondents were recruited among adults with an affinity for CM (e.g., as targeted through their memberships in CM associations) from September 2020 to February 2021. A selection of self-care methods, mainly from CM, was presented in the questionnaire. Numerical rating scales (NRSs), ranging from 0 = minimum to 10 = maximum, were used to measure the intensity of different emotions experienced during the pandemic. Statistical analysis was carried out descriptively. Results: A total of 1605 participants (80.6% female; mean age: 55.4 ± 12.6 [SD] years; 43.9% holding a university degree) were included. The use of self-care methods for health promotion during the pandemic was reported by 86.8% of the respondents. Respondents favored staying in nature (85.6%), healthy nutrition (85.6%), and physical activities (83.6%). More than 60% of the respondents made use of vitamin C and/or D, herbal medicines, nutritional supplements, relaxation techniques, breathing exercises, homeopathy, or meditation for health promotion. The analysis of emotional status by NRS (0-10) revealed the lowest mean ± SD (standard deviation) for "feeling lonely" (2.6 ± 2.9) and "feeling anxious" (2.8 ± 2.6), and the highest mean for "feeling connected to others" (6.2 ± 2.5) and "well-being" (5.8 ± 2.4). Conclusions: Participants used a wide variety of self-care methods and prevention strategies to promote their health during the COVID-19 pandemic and showed, overall, a balanced emotional status. Further research should include a control group representative of the general population, to investigate the possible impact of self-care strategies. Clinical Trial Registration Number: "Deutsches Register Klinischer Studien" (German Clinical Trial Register); registration number: DRKS00022909.

Impact of Meditation-Based Lifestyle Modification on HRV in Outpatients With Mild to Moderate Depression: An Exploratory Study.

Background: The scientific evaluation of mind-body-interventions (MBI), including yoga and meditation, has increased significantly in recent decades. However, evidence of MBI's efficacy on biological parameters is still insufficient. Objectives: In this study, we used HRV analysis to evaluate a novel MBI as a treatment of outpatients with mild to moderate depressive disorder. The Meditation-Based Lifestyle Modification (MBLM) program incorporates all major elements of classical yoga, including ethical principles of yoga philosophy, breathing exercises, postural yoga, and meditation. Methods: In this exploratory randomized controlled trial, we compared the changes in HRV indices of a MBLM group (N = 22) and a minimal treatment group (MINIMAL, drugs only, N = 17) with those of a multimodal treatment-as-usual group (TAU, according to best clinical practice, N = 22). Electrocardiogram (ECG) recordings were derived from a Holter monitoring device, and HRV indices have been extracted from nearly stationary 20-min periods. Results: Short-term HRV analysis revealed statistically significant differences in the pre-to-post changes between MBLM and TAU. In particular, the vagal tone mediating RMSSD and the Rényi entropy of symbolic dynamics indicated HRV gains in MBLM participants compared with TAU. Almost no alterations were observed in the MINIMAL group. Conclusions: Our results suggest a benefit in selected HRV parameters for outpatients with mild to moderate depression participating in the MBLM program. For further investigations, we propose analysis of complete 24-h HRV recordings and additional continuous pulse wave or blood pressure analysis to assess long-term modulations and cardiovascular effects.

Integrative medicine during the intensive phase of chemotherapy in pediatric oncology in Germany: a randomized controlled trial with 5-year follow up.

BACKGROUND: Integrative medicine is used frequently alongside chemotherapy treatment in pediatric oncology, but little is known about the influence on toxicity. This German, multi-center, open-label, randomized controlled trial assessed the effects of complementary treatments on toxicity related to intensive-phase chemotherapy treatment in children aged 1-18 with the primary outcome of the toxicity sum score. Secondary outcomes were chemotherapy-related toxicity, overall and event-free survival after 5 years in study patients. METHODS: Intervention and control were given standard chemotherapy according to malignancy & tumor type. The intervention arm was provided with anthroposophic supportive treatment (AST); given as anthroposophic base medication (AMP), as a base medication for all patients and additional on-demand treatment tailored to the intervention malignancy groups. The control was given no AMP. The toxicity sum score (TSS) was assessed using NCI-CTC scales. RESULTS: Data of 288 patients could be analyzed. Analysis did not reveal any statistically significant differences between the AST and the control group for the primary endpoint or the toxicity measures (secondary endpoints). Furthermore, groups did not differ significantly in the five-year overall and event-free survival follow up. DISCUSSION: In this trial findings showed that AST was able to be safely administered in a clinical setting, although no beneficial effects of AST between group toxicity scores, overall or event-free survival were shown.

The Effect of Cold-Water Hydrotherapy According to Sebastian Kneipp for Immune Stimulation: A Nonrandomized, Controlled, Explorative, Mixed-Methods Clinical Study.

Highlights Home-based hydrotherapy leads to fewer missed kindergarten-days in total. In the application group, more fever days could be registered. Hydrotherapy, according to the hormesis principle by Sebastian Kneipp, aims to reduce infections of the lower respiratory tract. Parents participation motivated by increase in applicable health knowledge for their children. Objectives: This study investigates the effect of cold-water hydrotherapy stimulation according to the hormesis principle by Sebastian Kneipp on the number of missing kindergarten-days, fever days, and respiratory tract infections in children aged 3-6 years. Study design: A nonrandomized, controlled, explorative, mixed-methods clinical study. Intervention: The hydrotherapeutic intervention treated children aged 3-6 years with Kneipp arm affusions over 6 weeks. The control group received no intervention. Number of missed kindergarten-days, fever days, and respiratory tract infections were assessed by means of a digital diary. Through a self-developed structured questionnaire, sociodemographic data of both groups were compared and reason for participation in the study was recorded and qualitatively evaluated. Results: Twenty children participants and their parents in the intervention group and 18 in the control group were evaluated. The intervention was conducted at home by the parents. Statistical analysis revealed no significant differences between the groups but still showed intermediate effect sizes (indicating an underpowered study). These effect sizes point to a potentially lower proportion of children in the application group versus the control group with missed kindergarten-days in total (d = 0.67), days missed due to fever (d = 0.29), and infections of the lower respiratory tract (d = 0.60). In a future study, these parameters will thus serve as promising factors for evaluation. Parent's stated reasons for participation interest were to improve health, increase their own health knowledge, and because of their interest in alternative therapies and to support research. Conclusions: Cold-water hydrotherapy stimulation, according to the hormesis principle by Sebastian Kneipp, did reduce the number of days absent in kindergarten in total in the intervention group and lower respiratory tract infections occurred less frequently. Parent' participation interest demonstrated a desire to increase health literacy and implement this with their own children. Due to the small sample size, the results should be interpreted cautiously. Clinical Trial Registration Number: German Register of Clinical Trials (DRKS): ID 00017562.

Randomized Pilot Trial Using External Yarrow Liver Compress Applications With Metastatic Cancer Patients Suffering From Fatigue: Evaluation of Sympathetic Modulation by Heart Rate Variability Analysis.

BACKGROUND: Liver compresses are commonly applied in complementary medicine during cancer treatment and are believed to have an energizing effect. We conducted a pilot study to investigate the influence of external application of yarrow liver compresses on the autonomous nervous system by analyzing the heart rate variability (HRV) in metastatic cancer patients undergoing radiation therapy and suffering from cancer-related fatigue (CRF). METHODS: A randomized pilot trial was undertaken with patients suffering from CRF receiving palliative radiation therapy for bone or brain metastasis over 2 weeks. CRF patients were randomized into an intervention group receiving yarrow liver compresses and a control group receiving no external application. HRV was analyzed at the beginning (T1) and end (T2) period of the study during daytime (d) and nighttime (n) in both groups and quantified using time-, frequency-, and nonlinear dynamics domains. RESULTS: A total of 39 patients were randomized between September 2017 and August 2019 and a total of 20 patients (10 per group) were available for analysis. For both groups, significant differences in HRV analyses were found in the comparison over the timeline between the first and second measurement (T1d→T2d) during daytime. Specifically, the intervention group showed decreased HRV and complexity of heart rate regulation, indicating increased sympathetic activity at time T2d, whereas the control group showed increased HRV and complexity of heart rate regulation, indicating increased vagal activity at time T2d. Furthermore, the observed HRV analyses showed almost no significant differences between the 2 groups in a direct comparison at the beginning and the end of the study (exception: T2d). CONCLUSIONS: Yarrow liver compresses led to increased sympathetic activity during daytime in the intervention group, whereas in the control group, which did not receive any external application, increased parasympathetic activity was observed.

Quantification of Cardiovascular Regulation Applying Heart Rate Variability Analyses for Different Warm and Moist Chest Compresses in Healthy Subjects.

Background: In integrative medicine, complementary healing methods, such as external applications (massages, rhythmic rubs, and compresses), are part of the practice and clinical application and have proven their therapeutic effect in various fields. Objective: Aim of this exploratory, controlled, single-blinded study was to investigate the effects of three different warming chest compresses on cardiovascular regulation by analyzing heart rate variability (HRV) in healthy subjects. Methods: Over a period of 4 weeks, three different warming chest compresses (a hot water compress, a ginger powder compress, and a mustard flour compress) in 30 healthy subjects were analyzed. For all subjects, 48-h long-term electrocardiograms were recorded, and afterward, epochs of 5 min length extracted and analyzed by different linear and nonlinear HRV indices. Results: A moist chest compress did not result in any significant short- and long-term stimulation of the autonomic regulation, except for a short-term significant decrease in heart rate (meanNN, p < 0.05). Warm and moist chest compresses with ginger flour led to significantly increased HRV (sdNN, p < 0.05; symbolic dynamics2, p < 0.05) and its complexity (renyi4 entropy, p < 0.05) and a significant decrease in heart rate (meanNN, p < 0.00036), and thus to a short-term relaxation effect. In contrast, warm and moist chest compresses with mustard flour led to significantly decreased HRV and their complexity (time-, frequency-, and nonlinear dynamics domain, p < 0.00036), which can be interpreted as a stress reaction of the autonomous nervous system. Conclusions: The application of chest compresses led to short-term relaxation effects (ginger) as well as short-term stress effects (mustard) but not to any significant longer-term effect on HRV in healthy subjects.

Plant Fragrances Are Like Music for Our Senses: A Scoping Review of Aromatherapy in Gynecologic Cancers and Breast Cancer Care.

Introduction: Essential oil (EO) applications via inhalation and/or absorption through the skin-often referred to as aromatherapy-have particular relevance as complementary to cancer treatment and follow-up care. Aromatherapy is of particular interest for controlling symptoms and enhancing the general well-being of people with cancer. This is indicated by the increasing number of empirical studies on this topic. Although numerous reviews have summarized the extensive primary research about aromatherapy and cancer, no review on aromatherapy use targeting women with gynecologic and breast cancers currently exists. Our scoping review aims at giving an overview of the state of research about aromatherapy in this specific target group. By summarizing and describing study characteristics, based on methodological decisions and content, we intend to offer implications for future research, focused on the use of EO in women with gynecologic and breast cancers. Methods: A systematic scoping review was conducted, based on the literature, and using the extension of the PRISMA statement for scoping reviews (PRISMA-ScR). The databases PubMed and CINHAHL were searched in a multi-stage, iterative process taking the most relevant terms under consideration, given our research interest and Boolean operators. The included studies were analyzed and summarized through (1) a table matrix including categories of interest and (2) qualitative content analysis. Results: One hundred seventy studies were examined, and 10 were included in this review. They show high heterogeneity in how the term aromatherapy is defined, in content, research design, EO used, application, and outcomes. However, all 10 studies exclusively targeted women with breast cancer in different states of cancer treatment. Conclusions: Challenges of research within this field point to the heterogeneous use and classification of the term aromatherapy, the differentiation of the principle of action of EO, the lack of transparency in how EO are reported and described (e.g., botanical names, company, dosage, mixing ratios), and the need to include subjective perceptions. Ten implications for future research based on these challenges are given.

Association between ivy leaves dry extract EA 575 prescriptions and antibiotic use, sick leave duration, and repeated infections in adult patients.

OBJECTIVES: The present study aimed to analyze the association between the prescription of ivy leaf dry extract EA 575 (licensed under the trade name Prospan® in Germany) and the incidence of antibiotic use, incident bacterial complications, and days of sick leave in adult patients with cold diseases. METHODS: This retrospective cohort study was based on the IQVIA Disease Analyzer database and included adult patients from 1032 general practices in Germany with a documentation of common cold between 2017 and 2020 (index date) and prescription of either EA 575 or an antibiotic drug within 3 days after index date. 1:1 propensity score matching based on age, sex, index month, physician, health insurance status, and the Charlson Comorbidity Index was carried out. Univariable regression models were used to investigate the association between EA 575 prescription and defined outcomes. RESULTS: Data of 7034 patients treated with EA 575 and 7034 matched patients receiving an antibiotic were available. EA 575 prescription was associated with significantly lower odds of an antibiotic prescription in the time periods of 4-30 days (OR: 0.83; 95% CI: 0.72-0.96) and 31-365 days (OR: 0.44; 95% CI: 0.40-0.48) after the index date. EA 575 prescription was significantly associated with a lower rate of sick leave of more than 7 days (33.0% vs. 37.7%, OR: 0.81; 95% CI: 0.73-0.90) in patients with any sick leave, as well as with lower odds of a new cough diagnosis (OR: 0.91, 95% CI: 0.85-0.98) when compared to antibiotic prescription. CONCLUSION: Our study provides further evidence that the use of phytopharmaceuticals, in particular ivy leaf dry extract EA 575, could contribute to a reduction in the number of inappropriate antibiotic prescriptions for respiratory infection with cough symptoms.