[Integrative Oncology for Women with Breast Cancer]. / Integrative Onkologie in der Behandlung von Frauen mit Brustkrebs.

Integrative Oncology for Women with Breast Cancer Abstract. Integrative oncology is a patient-centered, evidence-informed field of cancer care, used worldwide to complement standard cancer care and is actively sought by patients. It is also well established in Switzerland. A wide range of procedures are used, such as mind body medicine, art therapies, exercise, nutrition, herbal medicines, nursing measures and specific complementary medical procedures. They support patients to regain health, improve their quality of life and enable them to take an active role in their health care management. An evidence-based guideline for integrative breast cancer treatment has been published by the Society of Integrative Oncology and implemented by the American Society of Clinical Oncology. Mistletoe therapy is a widely used herbal remedy to support cancer treatment and to improve quality of life. Its mode of action, safety and efficacy are being intensively investigated. The central focus of integrative oncology is a trusting and appreciative consultation on eye-level, so that a patient-centered and safe treatment concept can be designed.

Refugees in Conflict: Creating a Bridge Between Traditional and Conventional Health Belief Models.

The recent wave of migration from Middle Eastern countries to Europe presents significant challenges to the European health profession. These include the inevitable communication gap created by differences in health care beliefs between European oncologists, health care practitioners, and refugee patients. This article presents the conclusions of a workshop attended by a group of clinicians and researchers affiliated with the Middle East Cancer Consortium, as well as four European-based health-related organizations. Workshop participants included leading clinicians and medical educators from the field of integrative medicine and supportive cancer care from Italy, Germany, Turkey, Israel, Palestine, Iran, Lebanon, Jordan, Egypt, and Sudan. The workshop illustrated the need for creating a dialogue between European health care professionals and the refugee population in order to overcome the communication barriers to create healing process. The affinity for complementary and traditional medicine (CTM) among many refugee populations was also addressed, directing participants to the mediating role that integrative medicine serves between CTM and conventional medicine health belief models. This is especially relevant to the use of herbal medicine among oncology patients, for whom an open and nonjudgmental (yet evidence-based) dialogue is of utmost importance. The workshop concluded with a recommendation for the creation of a comprehensive health care model, to include bio-psycho-social and cultural-spiritual elements, addressing both acute and chronic medical conditions. These models need to be codesigned by European and Middle Eastern clinicians and researchers, internalizing a culturally sensitive approach and ethical commitment to the refugee population, as well as indigenous groups originating from Middle Eastern and north African countries. IMPLICATIONS FOR PRACTICE: European oncologists face a communication gap with refugee patients who have recently immigrated from Middle Eastern and northern African countries, with their different health belief models and affinity for traditional and herbal medicine. A culturally sensitive approach to care will foster doctor-refugee communication, through the integration of evidence-based medicine within a nonjudgmental, bio-psycho-social-cultural-spiritual agenda, addressing patients' expectation within a supportive and palliative care context. Integrative physicians, who are conventional doctors trained in traditional/complementary medicine, can mediate between conventional and traditional/herbal paradigms of care, facilitating doctor-patient communication through education and by providing clinical consultations within conventional oncology centers.

Eurythmy Therapy in anxiety.

Anxiety is a highly frequent condition; many patients seek complementary treatment. One of these is anthroposophic medicine (AM) using therapeutic approaches that are based on a distinct concept of the human organism, illness, and healing. AM is applied in anxiety; however, little is known about underlying therapeutic concepts, the effectiveness, and the modalities of clinical reasoning and judgment. Presented is a 21-year-old woman who had suffered from severe and increasing anxiety for 6 months, which had led to social isolation and complete sick leave from work. She had attended an AM health care center and counseling at a psychiatric hospital but had not improved significantly after 6 months. Eurythmy therapy (EYT) was then applied for 8 weeks. Within the AM pathophysiological context, the patient was diagnosed as having stress-induced anxiety based on a juvenile disturbance of the rhythmical system. Associated symptoms were specific anomalies in the patient's eurythmy movement pattern, a "breathed-in-upwards syndrome." In the EYT sessions, clear interconnections between EYT-exercises and symptom-relief were observable, paralleled by a substantial relief of the patient's anxiety. EYT might have some impact on anxiety syndrome and should be investigated in more detail.

CARE for COVID-19: A Checklist for Documentation of Coronavirus Disease 2019 Case Reports and Case Series.

Coronavirus disease 2019 (COVID-19) is a new, rapidly spreading pandemic that can lead to a life-threatening disease. Accurate and transparent COVID-19 case reports provide systematic clinical observations supporting researchers designing clinical trials and clinicians delivering health care. The checklist described here is designed to systematically and accurately capture data from case reports and case series for documentation on COVID-19. It is aligned with the CARE guidelines, available from the EQUATOR (Enhancing the QUAlity and Transparency Of health Research) Network.

Clinical research in anthroposophic medicine.

Anthroposophic medicine includes special medications and special artistic and physical therapies. More than 200 clinical studies of varying design and quality have been conducted on anthroposophic treatment. Half of these studies concern anthroposophic mistletoe therapy for cancer. Clinical effects of mistletoe products include improvement of quality of life, reduction of side effects from chemotherapy and radiation, and possibly increased survival. Apart from cancer therapy, the largest studies of anthroposophic treatment have been 2 naturalistic system evaluations: In German outpatients with mental, musculoskeletal, respiratory, and other chronic conditions, anthroposophic treatment was followed by sustained improvements of symptoms and quality of life. In primary care patients from 4 European countries and the United States treated for acute respiratory and ear infections by anthroposophic or conventional physicians, anthroposophic treatment was associated with reduced use of antibiotics and antipyretics, quicker recovery, and fewer adverse reactions; these differences remained after adjustment for relevant baseline differences.

Durable clinical remission of a skull metastasis under intralesional Viscum album extract therapy: Case report.

BACKGROUND: Skull metastases are rare, they can eventually cause pain, and can invade the brain. Viscum album extracts (VAEs) are used as an adjuvant treatment in cancer. METHODS AND RESULTS: A 68-year-old patient with rectal cancer presented with lung metastases, and metastases to multiple bone sites, the chest wall, and the liver were later identified. Histological examination of one of the bone lesions revealed an additional thyroid carcinoma. An osteolytic parietal bone lesion progressed to a painful metastasis of the skull despite radiotherapy and chemotherapy. The VAEs were applied weekly into the metastasis, followed by pain relief and softening of the lesion. The lesion partially regressed (>50%) after 8 months of continued VAE treatment and remained stable for 2 years. CONCLUSION: This case shows a durable clinical remission of a skull metastasis under VAE. Further investigations of intratumoral VAE treatment seem worthwhile-especially in symptomatic skull metastases not responding to radiotherapy or systemic therapies.

Investigations on the constitutional types under consideration of anthropometric data, autonomic regulation and immunological parameters.

OBJECTIVES: Over time different systems were developed for the characterization of individuals according to their physical and psycho-vegetative traits which until today play a role in complementary medicine. This pilot study aimed at investigating if the concepts of polar constitutional types of anthroposophic medicine and according to Kretschmer can be further clarified using empirical method. METHODS: 96 participants, preselected by two polar body mass index (BMI) ranges (17-19.5 kg/m2 and 27-31 kg/m2), were categorized using both classification systems. Anthropometrical measurements were carried out and differences in the autonomic regulation were assessed using a questionnaire. From 12 participants showing a pronounced polar constitutional type, production of reactive oxygen species, proliferation, autophagy, and glucose uptake by lymphocytes, monocytes and granulocytes were measured in vitro. RESULTS: Correlations between the BMI and the strength of constitutional classification were found for both classification systems. Additionally, a strong correlation between the two systems themselves could be seen. Analysis of the overall questionnaire score of autonomic regulation did not yield significant correlations. However, using a modified 11 item score, reliability (Cronbach α = 0.656) and a differentiation of polar constitutional types was demonstrated (p < 0.001). Regarding the immune function slightly varying levels of reactive oxygen species, autophagy in granulocytes and differences in the strength of inhibition of lymphocyte proliferation by dexamethasone and cyclosporine A were detected. However, most of these in vitro results did not reach significance. CONCLUSION: This study represents a first empirical approach toward the classification of anthroposophic constitutional types.

Long-term tumor-free survival in a metastatic pancreatic carcinoma patient with FOLFIRINOX/Mitomycin, high-dose, fever inducing Viscum album extracts and subsequent R0 resection: A case report.

RATIONALE: Metastatic pancreatic cancer has a dismal prognosis. Many patients seek integrative care as an add-on to their conventional cancer treatment. Viscum album extracts (VAE)-widely used as an adjunct to cancer treatment-have cytotoxic, apoptogenic, and immune stimulatory properties. A statistically significant survival benefit has been demonstrated for VAE in advanced pancreatic cancer. PATIENT CONCERNS AND DIAGNOSIS: A 28-year old patient presented with painless jaundice and was subsequently diagnosed as pancreatic adenocarcinoma with liver metastases. INTERVENTIONS: He was treated with FOLFIRINOX/Mitomycin, hyperthermia and fever-inducing VAE. OUTCOMES: Subsequently, the liver metastases regressed. Surgical intervention involved successful R0-resection of the primary tumor, as well as an atypical liver resection. A relapse was again treated with FOLFIRINOX/Mitomycin and hyperthermia. As of publication of this report, 49 months after initial diagnosis, the patient exhibits good condition, and is unrestricted in quality of life (till publication). LESSONS: This case demonstrates the favorable outcome of a patient with metastatic pancreatic cancer following treatment with chemotherapy, integrative medicine, and surgical excision. As other positive outcomes in pancreatic cancer patients are related to inflammatory events, we presume the immunologic effects of VAE to have contributed to the favorable outcome here. Based on this case, and the other positive results of VAE use in pancreatic cancer, further investigations seem highly worthwhile.

Viscum album neutralizes tumor-induced immunosuppression in a human in vitro cell model.

Tumor cells have the capacity to secrete immunosuppressive substances in order to diminish dendritic cell (DC) activity and thereby escape from immune responses. The impact of mistletoe (Viscum album) extracts (VAE), which are frequently used as an additive anti-cancer therapy to stimulate the immune response, is still unknown. Using a human cellular system, the impact of two different VAE (VAEA + VAEI) on the maturation of human dendritic cells and on T cell function has been investigated using flow cytometry, automated fluorescence microscopy and cytokine bead array assays. Furthermore, we examined whether VAEI was able to counteract tumor-induced immunosuppression within this cellular system using a renal cancer cell model. The role of mistletoe lectin (ML) was analyzed using ML-specific antibodies and ML-depleted VAEI. VAEI and VAEA augmented the maturation of dendritic cells. VAEI abrogated tumor-induced immunosuppression of dendritic cells and both processes were partially mediated by ML since ML-depleted VAEI and ML-specific antibodies almost neutralized the rehabilitative effects of VAEI on DC maturation. Using these settings, co-culture experiments with purified CD4+ T cells had no influence on T cell proliferation and activation but did have an impact on IFN-γ secretion. The study provides a potential mode-of-action of VAE as an additive cancer therapy based on immunomodulatory effects. However, the impact on the in vivo situation has to be evaluated in further studies.

A General Pediatrics and Integrative Medicine Approach to Pervasive Refusal Syndrome: A Case Report.

INTRODUCTION: Pervasive refusal syndrome (PRS) describes children with social withdrawal who become unable to walk, eat, or care for themselves. This case report examines whether an integrative medicine approach is useful for treating PRS. CASE PRESENTATION: A seven-year-old girl with symptoms most consistent with PRS and depression was admitted to a pediatric ward in Germany that integrates conventional pediatric and psychosomatic care with anthroposophic medicine. She was integrated into the structured activities of the ward and received massages, movement therapy, and color light therapy. Her parents were fully integrated into her care. After four weeks, she talked again, showed increased appetite, and supported herself when moved passively. She made a full recovery within four weeks after hospital discharge. DISCUSSION: Integration of parents and an integrative medicine approach providing a variety of comforting sensory experiences was helpful for this patient with PRS.

Tumour response following high-dose intratumoural application of Viscum album on a patient with adenoid cystic carcinoma.

Adenoid cystic carcinoma (ACC) is a rare type of cancer that typically originates in the salivary glands. Surgical removal can lead to functional loss and psychological distress. Viscum album extract (VAE) is a herbal remedy with dose-dependent cytotoxic, apoptogenic and immunological effects. In some case reports, tumour regression has been observed following high-dose local applications of VAE. An active 88-year-old man with fast-growing ACC of the hard palate refused surgical removal and received high-dose intratumoural injections of VAE (alone) over a 10-month period. The tumour decreased in size, softened and loosened from its surroundings. A biopsy during the course showed inflammation. The patient remained well and without functional limitations during the therapy and follow-up period (5 months). VAE produced no reported side effects. This aged patient exemplifies a satisfying course of ACC under VAE resulting in good quality of life and partial tumour regression.

Overview of the Publications From the Anthroposophic Medicine Outcomes Study (AMOS): A Whole System Evaluation Study.

Anthroposophic medicine is a physician-provided complementary therapy system that was founded by Rudolf Steiner and Ita Wegman. Anthroposophic therapy includes special medicinal products, artistic therapies, eurythmy movement exercises, and special physical therapies. The Anthroposophic Medicine Outcomes Study (AMOS) was a prospective observational multicenter study of 1631 outpatients starting anthroposophic therapy for anxiety disorders, asthma, attention deficit hyperactivity disorder, depression, low back pain, migraine, and other chronic indications under routine conditions in Germany. AMOS INCORPORATED TWO FEATURES PROPOSED FOR THE EVALUATION OF INTEGRATIVE THERAPY SYSTEMS: (1) a sequential approach, starting with the whole therapy system (use, safety, outcomes, perceived benefit), addressing comparative effectiveness and proceeding to the major system components (physician counseling, anthroposophic medicinal products, art therapy, eurythmy therapy, rhythmical massage therapy) and (2) a mix of different research methods to build an information synthesis, including pre-post analyses, prospective comparative analyses, economic analyses, and safety analyses of individual patient data. AMOS fostered two methodological innovations for the analysis of single-arm therapy studies (combined bias suppression, systematic outcome comparison with corresponding cohorts in other studies) and the first depression cost analysis worldwide comparing primary care patients treated for depression vs depressed patients treated for another disorder vs nondepressed patients. A total of 21 peer-reviewed publications from AMOS have resulted. This article provides an overview of the main research questions, methods, and findings from these publications: anthroposophic treatment was safe and was associated with clinically relevant improvements in symptoms and quality of life without cost increase; improvements were found in all age, diagnosis, and therapy modality groups and were retained at 48-month follow-up; nonrespondent bias, natural recovery, regression to the mean, and adjunctive therapies together could explain a maximum of 37% of the improvement.

La medicina antroposófica es un sistema terapéutico complementario proporcionado por el médico que fue fundada por Rudolf Steiner e Ita Wegman. La terapia antroposófica incluye productos medicinales especiales, terapias artísticas, ejercicios de movimiento eurítmico y terapias físicas especiales. El estudio de los resultados de la medicina antroposófica (Anthroposophic Medicine Outcomes Study, AMOS) consistió en un estudio prospectivo observacional multicéntrico de 1631 pacientes ambulatorios que comenzaban la terapia antroposófica para trastornos de ansiedad, asma, trastorno de hiperactividad y déficit de atención, depresión, dolor lumbar, migraña y otras indicaciones crónicas bajo condiciones rutinarias en Alemania.AMOS incorporaba dos características propuestas para la evaluación de sistemas terapéuticos integrales: (1) un enfoque secuencial, comenzando con el sistema terapéutico completo (uso, seguridad, resultados, ventaja percibida), que aborda la eficacia comparativa y continúa con los componentes principales del sistema (asesoramiento del médico, productos medicinales antroposóficos, terapia artística, terapia eurítmica, terapia de masaje rítmico) y (2) una combinación de diferentes métodos de investigación para crear una síntesis de información, que incluye análisis previos y posteriores, análisis comparativos prospectivos, análisis económicos y análisis de la seguridad de los datos del paciente individual. AMOS fomentaba dos innovaciones metodológicas para el análisis de los estudios terapéuticos de un grupo único (supresión del sesgo combinado, comparación sistemática de resultados con las cohortes correspondientes en otros estudios) y el primer análisis a nivel mundial del coste de la depresión comparando pacientes de atención primaria tratados de depresión frente a pacientes deprimidos tratados por otro trastorno frente a pacientes no deprimidos.Ha resultado en un total de 21 publicaciones revisadas por expertos de AMOS. Este artículo proporciona una visión general de las principales cuestiones de investigación, métodos y los resultados de estas publicaciones: el tratamiento antroposófico era seguro y se asociaba a mejoras clínicamente relevantes en los síntomas y la calidad de vida sin aumento de los costes; se observaron mejoras en todos los grupos de edad, diagnóstico y modalidad de terapia y se mantuvieron en el seguimiento de 48 meses; el sesgo ajeno a los entrevistados, la recuperación natural, la regresión a la media y las terapias adyuvantes juntos podían explicar un máximo del 37 % de la mejoría.

Durable response of cutaneous squamous cell carcinoma following high-dose peri-lesional injections of Viscum album extracts--a case report.

BACKGROUND: Cutaneous squamous cell carcinoma (CSCC) is a common locally invasive skin cancer which rarely metastasises. First-line treatment is surgical excision, which is curative in most cases. Viscum album extract (VAE) is a widely used herbal cancer treatment with cytotoxic, apoptogenic and immunological effects, but has not been investigated in CSCC. CASE PRESENTATION: A 78-year-old patient with histologically diagnosed CSCC refused surgical excision and was treated with peri-lesional high-dose VAE. After 10 months of treatment the CSCC had disappeared clinically. The patient has been recurrence-free for 4 years. CONCLUSION: The presented case shows clinical response of a CSCC to high-dose peri-lesional VAE injections. Further research on VAE in CSCC is warranted.

Long-term outcomes of anthroposophic treatment for chronic disease: a four-year follow-up analysis of 1510 patients from a prospective observational study in routine outpatient settings.

BACKGROUND: Anthroposophic treatment includes special artistic and physical therapies and special medications. We here report an update to a previously published study of anthroposophic treatment for chronic diseases, including more patients and a longer follow up. The Anthroposophic Medicine Outcomes Study (AMOS) was a prospective observational cohort study of anthroposophic treatment for chronic indications in routine outpatient settings in Germany. Anthroposophic treatment was associated with improvements of symptoms and quality of life. Previous follow-up-analyses have been performed after 24 months or, in subgroups of patients enrolled in the period 1999-2001, after 48 months. We conducted a 48-month follow-up analysis of all patients enrolled in AMOS in the period 1999-2005. METHODS: 1,510 outpatients aged 1-75 years, starting anthroposophic treatment for chronic conditions in routine German outpatient settings, participated in a prospective cohort study. Main outcomes were Symptom Score (primary outcome, mean symptom severity on numerical rating scales), SF-36 Physical and Mental Component scores in adults, and disease-specific outcomes in the six most common diagnosis groups: asthma, anxiety disorders and migraine (numerical rating scales), depression (Center for Epidemiological Studies Depression Scale), attention deficit hyperactivity symptoms (FBB-HKS Total score), and low back pain (Hanover Functional Ability Questionnaire, Low Back Pain Rating Scale). RESULTS: Median disease duration at baseline was 3.5 years. From baseline to 48-month follow-up all ten outcomes improved significantly (p < 0.001 for all pre-post comparisons). Standardised Response Mean effect sizes were large (range 0.84-1.24 standard deviations) for seven comparisons, medium for two comparisons (SF-36 Mental Component: 0.60, Low Back Pain Rating Scale: 0.55), and small for one comparison (SF-36 Physical Component: 0.39). Symptom Score improved significantly with large effect sizes in adults and children, and in the four main anthroposophic therapy modality groups (art therapy, eurythmy therapy, rhythmical massage therapy, medical therapy). CONCLUSIONS: This 48-month follow-up analysis confirmed previous analyses from the AMOS study. Outpatients receiving anthroposophic treatment for chronic indications had sustained, clinically relevant improvements of symptoms and quality of life.

[Clinical research on anthroposophic medicine:update of a health technology assessment report and status quo]. / Klinische Forschung zur Anthroposophischen Medizin - update eines «Health Technology Assessment¼-Berichts und status quo.

BACKGROUND AND OBJECTIVE: In 2005 a Health Technology Assessment (HTA) report analyzed efficacy, effectiveness, safety, utilization and costs of Anthroposophic Medicine (AM). After a recent referendum of the 'Swiss Population pro Complementary Medicine' (May 2009) this HTA report was updated. DESIGN: Update of the HTA report by a systematic review. METHODS: Methods corresponded to the existing HTA report and the guidelines of the Swiss Federal Office of Public Health. For clinical studies four databases and a specialized journal were searched, and extensive expert consultations were used. Studies were selected according to predefined inclusion criteria, data were extracted, and methodological quality was assessed individually. RESULTS: 70 new clinical studies were found. Altogether, 265 clinical studies investigated efficacy and effectiveness of AM: 38 randomized controlled trials, 36 prospective and 49 retrospective non-randomized controlled trials as well as 90 prospective and 52 retrospective trials without control groups. They investigated a wide spectrum of AM treatments in a multitude of diseases; the whole AM system in 38 trials, non-pharmacological therapies in 10 trials, AM mistletoe products in cancer therapy in 133 trials, and other AM medication treatments in 84 trials. Most studies showed a positive result for AM. Methodological quality differed substantially; some studies showed major limitations, others were reasonably well conducted. Trials with better quality still showed a positive result. External validity was usually high. Side effects or other risks were rare and usually described to be mild or moderate. Studies regarding safety showed a good tolerability altogether. CONCLUSION: Trials of varying design and quality in a variety of diseases predominantly describe good clinical outcomes for AM, only marginal side effects, high satisfaction of patients with regard to results and safety and presumably slightly less costs. Further high-quality evaluations are desirable.

Complementary therapy systems and their integrative evaluation.

Complementary and alternative medicine (CAM) is becoming an integral part of modern medicine. Complementary and alternative medicine therapy systems include natural medicinal products, nonpharmacological treatments, and counselling on health and lifestyle issues. Complementary and alternative medicine concepts are often elaborate, transcending biophysical models and employing the principles of salutogenesis. Evaluations of CAM therapy systems need to be integrative and cover the dimensions of: (1) therapeutic professionalism; (2) patient perspective and public demand; (3) conceptuality; (4) safety, effectiveness, and costs. Complex research strategies are required, which reverse the phases of conventional drug assessment. The predominant use of randomized trials would introduce structural bias and create an artificial picture. Important are evaluations of the whole system in real-world conditions, and surveys on component evaluations. Systemic CAM assessments should consist of a broad array of high-quality research methods: well-conducted randomized and nonrandomized studies, cohort studies, qualitative research, high-quality case reports and case series, studies on patient perspective, safety analyses, economic analyses, etc. Good clinical judgement, a core epistemic element of medicine based on nonstochastic principles, should also be integrated and could reflect routine patient care.