A Fundamental Question for Complementary Medicine: Are There Other Forces in the Natural World Besides the Physical Forces?

BACKGROUND: The integration of conventional and complementary medicine reflects the pluralism in science. Still, a critical issue is the conception of the natural world. Many complementary therapy systems seem to contradict the reductionist-atomistic paradigm that all of natural reality is essentially based on the physical interactions of atoms and molecules. Thus, a fundamental question about the natural world is: Do other than the physical forces exist? SUMMARY: The assumption that no other than physical forces exist and work in the natural world is not tenable. For example, the formation and maintenance of the functional Gestalt of organisms cannot possibly be explained by molecular processes (e.g., from DNA to RNA and further to amino acids and proteins). The processes on each structural level - from molecules, organelles, cells, organs up to the whole organism - are regulated in regard to the formation of the next higher level. Specific Gestalt-forming forces exist and can be systematically investigated. Their existence implies an extended conception of matter. The Gestalt-forming forces and the extended concept of matter may be relevant for the scientific assessment of complementary therapies. KEY MESSAGES: (i) In the natural world, specific Gestalt-forming forces exist in addition to the physical forces, and can be systematically investigated. (ii) The existence of these forces implies an extended conception of matter. (iii) These forces and this extended concept of matter may be relevant for the scientific assessment of complementary therapies, e.g., homeopathy.In der Integration von konventioneller und komplementärer Medizin spiegelt sich der Methodenpluralismus der Wissenschaft. Die Ontologien vieler komplementärmedizinisches Systeme liegen allerdings außerhalb der Erklärbarkeit durch die Kräfte der Physik. Eine zentrale Frage ist deshalb: Gibt es Kräfte in der Natur, die eine materielle Wirkung haben, deren Ursprung aber nicht in Atomen oder Molekülen und in diesem Sinne nicht in der Materie liegt?Die Annahme, dass in der Natur keine anderen als die mit Atomen und Molekülen assoziierten physikalischen Kräfte existent und wirksam seien, ist wissenschaftlich nicht begründet. Beispielsweise ist die Bildung und Erhaltung der funktionsfähigen Gestalt von Organismen nicht durch molekulare Prozesse (z.B. von der DNA zur RNA und weiter zu Aminosäuren und Proteinen) erklärbar. Die Prozesse auf jeder strukturellen Ebene ­ von den Molekülen, Organellen, Zellen, Organen bis hinauf zum Gesamtorganismus ­ sind in Hinblick auf die Bildung der funktionsfähigen Gestalt der jeweils nächsthöheren Ebene gesteuert. Für diese Gestaltbildung gibt es spezifische Kräfte, die systematisch erforscht werden können. Ihre Existenz impliziert eine erweiterte Konzeption von Materie. Diese Gestalt-bildenden Kräfte und dieses erweiterte Konzept von Materie sind relevant für die wissenschaftliche Erfassung komplementärmedizinischer Systeme.(i) In der Natur sind außer den physikalischen Kräften noch weitere spezifische Kräfte wirksam, beispielsweise bei der Bildung und Erhaltung der funktionsfähigen Gestalt von Organismen. Diese Kräfte können systematisch erforscht werden. (ii) Die Existenz dieser Kräfte impliziert eine erweitere Konzeption von Materie. (iii) Diese Kräfte und das erweiterte Materiekonzept sind relevant für die wissenschaftliche Erfassung komplementärmedizinischer Systeme, beispielsweise der Homöopathie.

Anthroposophic Medicinal Products: A Literature Review of Features, Similarities and Differences to Conventional Medicinal Products, Scientific and Regulatory Assessment.

Background: Regulatory assessment of anthroposophic medicinal products (AMPs) can be challenging due to their specific features. Objective: The aim of this paper is therefore to provide adequate scientific information on AMPs for regulatory purposes. Methods: A literature review was executed with database searches in PubMed, Cinahl, Merkurstab, Anthromedics, and https://iaap-pharma.org/. Search terms were: anthroposophic medicinal products, anthroposophic medicines, anthroposophic pharmacy. There was no language restriction; searches were executed from onset until June 11, 2020. In addition, experts were invited to suggest relevant literature. Results: Eighty-seven of 660 identified publications were included. The system of anthroposophic medicine (AM) with its conceptual background and various aspects of AMPs was described: definition, pharmaceutical properties, an example of AMP development, use in clinical practice, similarities with and differences to conventional medicinal products, societal aspects, scientific and regulatory assessment. Conclusion: AMPs are part of the integrative whole medical system of AM. AMPs are manufactured according to Good Manufacturing Practice and national drug regulations and have an excellent safety status; the limited available evidence suggests clinical benefits. Current drug regulation of AMPs in the EU and most European countries does not take the special properties of AMPs into account. Future research should focus on appropriate methodologies for the evaluation of effects of AMPs as part of the AM whole medical system, the scientific quality of its non-atomistic holistic ontological position, and the integration of AM and conventional medicine in clinical practice. Future policies should focus on appropriate ways of addressing regulatory challenges to AMPs.

Long-Term Survival of a Patient with Recurrent Dedifferentiated High-Grade Liposarcoma of the Retroperitoneum Under Adjuvant Treatment with Viscum album L. Extract: A Case Report.

CASE PRESENTATION: A 68-year-old male patient underwent a resection of a DDL (T2 N0 M0, FNCLCC grade 2, stage IIIA) in the retroperitoneum. Three months after this first surgery, a recurrence occurred, and was treated with neoadjuvant and adjuvant doxorubicin plus ifosfamide and surgery (resection). A second recurrence-11 months after the second surgery-was treated with surgery and radiotherapy. The patient then began to undergo VAE treatment (0.2 mg-2 mg, subcutaneously, thrice a week). After the VAE treatment was initiated, the patient reported improved quality of life. A third recurrence-12 months after the third surgery-was treated with surgery, radiotherapy, and with an increased dose of VAE (20 mg). Sixty-nine months (5.8 years) after the fourth surgery a fourth recurrence occurred. It was again treated with surgery, along with a month of intravenous VAE infusions and subsequent subcutaneous VAE (20 mg) treatment. Finally, a fifth recurrence-5 months after the fifth surgery-was treated with subcutaneous and intravenous VAE applications and eribulin. The patient died 11 months after the last recurrence; he received a total of 103 months (8.6 years) of VAE treatment and achieved 10.5 years of survival. CONCLUSION: The case presented herein shows a long-time survival and a prolonged recurrence-free interval in a patient with retroperitoneal DDL treated with surgery, chemotherapy, radiotherapy, and VAE injections. On the basis of the antitumoral and immunomodulating effects of VAE and on the reported prolonged survival of VAE-treated patients with other types of tumors, the adjunct VAE treatment is presumed to have contributed to the favorable outcome. Regarding the clinical relevance of VAE treatment, further investigations are needed.

Long-term survival of a patient with an inoperable thymic neuroendocrine tumor stage IIIa under sole treatment with Viscum album extract: A CARE compliant clinical case report.

RATIONALE: Thymic neuroendocrine tumor (TNET) is very rare and characterized by a tendency to invade adjacent structures, frequent metastasis, resistance to therapy, and a poor prognosis. Viscum album extracts (VAE) have shown immunological, apoptogenic, and cytotoxic properties. PATIENT CONCERNS: A 54-year-old Peruvian man was suffering from constant fatigue, cough, dyspnea, and fever for a couple of months. DIAGNOSES: He was diagnosed with TNET (12.8 cm × 10 cm × 7 cm) stage IIIa, G1. Due to the size and extensive invasiveness (vena cava superior, also obstructing 85% of its lumen, pericardium, and pleura), the TNET was inoperable. INTERVENTIONS: We report the case of this patient who declined chemotherapy and was treated instead with sole subcutaneous VAE 3 times per week for 85 months. No other tumor-specific intervention was applied. OUTCOMES: Quality of life (QoL) improved substantially. The patient returned to work, and the tumor remained stable for 71 months. Thereafter, the tumor progressed, and the patient died 90 months after initial diagnosis. Besides self-limited local skin reactions around the application site, no side effects occurred. LESSONS: This is an exceptionally good course of disease of an inoperable, large, obstructing, and invasive TNET with a reduced baseline condition (Karnofsky index: 50-60) due to pronounced symptoms. Given the considerable reduction of symptoms and improved QoL following the onset of VAE therapy and other reports describing long disease stability and improvement of the QoL using VAE in different cancer types, we presume that the VAE treatment was supportive in this case. As TNETs are rare and few trials are available, future treatments of TNETs using VAE should be carefully documented and published to help determine whether further investigation of the use of VAE in TNET treatment is worthwhile.

Bilateral Asynchronous Renal Cell Carcinoma With Lung Metastases: A Case Report of a Patient Treated Solely With High-dose Intravenous and Subcutaneous Viscum album Extract for a Second Renal Lesion.

BACKGROUND: Bilateral asynchronous renal cell carcinoma (RCC) is infrequent. Immunotherapy is the first-line treatment for advanced RCC not controlled by locoregional therapy. Viscum album extracts (VAE) have been shown to improve quality of life as well as immunological and antineoplastic properties in different types of cancers. CASE REPORT: A 67-year-old man was diagnosed with Fuhrman grade 3/4 RCC, stage pT1bN0M0 in the right kidney. During the subsequent 6 years, he underwent a right nephrectomy and two metastasectomies (lung). Then an RCC lesion of the left kidney was detected. The patient refused a second nephrectomy and was treated solely with high-dose intravenous and subsequent subcutaneous VAE. A central necrotic area and a peritumoral halo were seen on an ultrasound follow-up from month 7. The patient showed no further progression of RCC during the next 2.5 years. CONCLUSION: As far as we are aware of, this is the first report of a patient with metastatic RCC with an RCC lesion of the second kidney treated solely with high-dose intravenous and subcutaneous VAE, associated with 2.5 years of progression-free survival and a good quality of life. The use of VAE in RCC should be carefully documented and published to determine future research.

Intralesional and subcutaneous application of Viscum album L. (European mistletoe) extract in cervical carcinoma in situ: A CARE compliant case report.

RATIONALE: Carcinoma in situ (CIS) of the uterine cervix is a premalignant condition of squamous epithelium. The standard treatments are excision and ablation procedures; for women with positive margins, hysterectomy is recommended. PATIENT CONCERNS: A 47-year-old Peruvian woman with recurrent candidal vaginitis had been diagnosed with colpocervicitis and squamous metaplasia 8 years ago, which were not treated. DIAGNOSES: The patient was diagnosed with CIS after cervical conization procedure. She refused radical hysterectomy and opted for integrative medicine treatment. INTERVENTIONS: She was treated with intralesional and subcutaneous Viscum album L. extract (VAE) injections. VAE is a widely used herbal cancer treatment with cytotoxic, apoptogenic, and immunological effects, but it has not been investigated in cervical CIS. OUTCOMES: Ending month 5 of treatment, complete remission of cervical CIS was observed. The patient is still in remission after 30 months (until publication). LESSONS: This is the first report on complete remission of cervical CIS after intralesional and subcutaneous injection with VAE. Prospective studies should evaluate to what degree the treatment effect is reproducible.

The Subjective Dimension of Integrative Cancer Care: A Qualitative Study Exploring the Perspectives, Themes, and Observations of Experienced Doctors from the Area of Anthroposophic Medicine.

BACKGROUND: Integrative cancer care (ICC) is used by approximately 50% of cancer patients to complement oncologic treatments and to address unmet needs. One ICC practice is anthroposophic medicine, integrating conventional and complementary cancer care. It specifically provides mistletoe therapy (MT), but also intensive counselling, natural remedies, creative and movement therapies, nursing procedures, nutrition, and others. The objective of this study was to explore perceptions, themes, goals, procedures, and observations of experienced AM doctors with regard to the subjective dimensions of ICC. METHOD: A guideline-based qualitative interview study was conducted with 35 AM doctors working in hospitals and office-based practices in Germany and other countries. Structured qualitative content analysis was applied to examine the data. Triangulation was done with published studies investigating patients' perspectives on AM and MT. RESULTS: The interviewed doctors integrated conventional and holistic cancer concepts. Overarching therapeutic themes were: to enable patients to live with or overcome their disease, to find their own way through their disease, and to possibly reframe their situation. A broad variety of therapeutic goals were pursued, depending on the situation and priorities of the particular patient. Doctors described varying levels of patients' improved strength; increased vitality, thermal comfort, and recovery; relief from suffering, particularly in the areas of fatigue, appetite, sleep, pain, infections, and reactions to toxic anti-cancer therapies. The doctors also described how they perceived changes of patients' emotional level, their coping, autonomy, functional abilities, and finding their own way to deal with the disease. This is consistent with patients' perspectives described in published studies. CONCLUSION: Themes, goals, and described benefit of ICC from doctors' and patients' perspective may be an important complementation of conventional cancer care, as it meets important needs, distresses and conditions of patients which often stay unmet and unrelieved. Further research should investigate these goals and procedures.

On caring and sharing-Addressing psychological, biographical, and spiritual aspects in integrative cancer care: A qualitative interview study on physicians' perspectives.

BACKGROUND: Patients confronted with a cancer diagnosis experience a variety of existential needs encompassing emotional, psychological, and spiritual areas of being. A patient-centered care approach addressing such existential issues is recognized as an essential aspect of health care. The aim of this study is to explore what role psychological, biographical, and spiritual factors play for experienced doctors working in integrative cancer care. METHOD: The qualitative study was based on in-depth interviews with 35 purposively sampled doctors, all practicing integrative oncology in the field of anthroposophic medicine in hospitals and/or office-based practices in Germany and other countries. Data were analyzed using structured content analysis. RESULTS: Psychological, biographical, and spiritual factors are important issues in integrative cancer care. Prevailing themes identified in this study were enabling patients to participate in life, promoting autonomy and coping, stabilizing patients emotionally and cognitively, overcoming the disease, and-primarily if addressed by patients-integrating spiritual issues. Doctors offered conversation, counseling, and time, but also referred to art, music, literature, and nature, so that patients' ongoing emotional, psychological, and spiritual needs could be explored and addressed. Doctors' attitudes with regard to existential issues were seen as important, as was maintaining an attitude of openness towards existential issues. CONCLUSION: Doctors in integrative cancer care utilize different methods to explore the needs of patients and employ a variety of treatment methods that address not just patients' medical issues but their existential concerns as well.

An assessment of the scientific status of anthroposophic medicine, applying criteria from the philosophy of science.

OBJECTIVES: The objective was to evaluate the scientific status of anthroposophic medicine (AM) according to demarcation criteria proposed in contemporary philosophy of science. DESIGN: Criteria for what is science were retrieved from eight publications in the philosophy of science, focusing either on science in medicine or on the demarcation between science and pseudoscience or non-science. Criteria were combined, redundancies were excluded, and the final set of criteria was ordered in a logical sequence. The analysis yielded 11 demarcation criteria (community, domain, problems, goals, axiomatic basis, conceptual basis, quality of concepts, methodology, deontic basis, research products, tradition). RESULTS: Assessing the scientific status of AM according to the 11 criteria, all criteria were fulfilled by AM. DISCUSSION: AM is grounded on the notion that specific non-atomistic holistic formative forces exist and can be empirically and rationally assessed. From a position claiming that such holistic forces cannot possibly exist or cannot be empirically and rationally assessed, the axiomatic and conceptual basis of AM can be contested. However, such an a priori rejection is problematic in the presence of empirical evidence supporting the validity of holistic concepts, as discussed in the paper. Future research should therefore focus on the tenability of the ontological reductionist position in science and on the further validation of AM non-atomistic holistic concepts, methods and practices. CONCLUSION: In this analysis, using criteria from philosophy of science, AM fulfilled all 11 criteria for what is science.

CARE guidelines for case reports: explanation and elaboration document.

BACKGROUND: Well-written and transparent case reports (1) reveal early signals of potential benefits, harms, and information on the use of resources; (2) provide information for clinical research and clinical practice guidelines, and (3) inform medical education. High-quality case reports are more likely when authors follow reporting guidelines. During 2011-2012, a group of clinicians, researchers, and journal editors developed recommendations for the accurate reporting of information in case reports that resulted in the CARE (CAse REport) Statement and Checklist. They were presented at the 2013 International Congress on Peer Review and Biomedical Publication, have been endorsed by multiple medical journals, and translated into nine languages. OBJECTIVES: This explanation and elaboration document has the objective to increase the use and dissemination of the CARE Checklist in writing and publishing case reports. ARTICLE DESIGN AND SETTING: Each item from the CARE Checklist is explained and accompanied by published examples. The explanations and examples in this document are designed to support the writing of high-quality case reports by authors and their critical appraisal by editors, peer reviewers, and readers. RESULTS AND CONCLUSION: This article and the 2013 CARE Statement and Checklist, available from the CARE website [www.care-statement.org] and the EQUATOR Network [www.equator-network.org], are resources for improving the completeness and transparency of case reports.

Intravenous Mistletoe Treatment in Integrative Cancer Care: A Qualitative Study Exploring the Procedures, Concepts, and Observations of Expert Doctors.

Background. Mistletoe therapy (MT) is widely used in patient-centered integrative cancer care. The objective of this study was to explore the concepts, procedures, and observations of expert doctors, with a focus on intravenous MT. Method. A qualitative interview study was conducted with 35 highly experienced doctors specialized in integrative and anthroposophic medicine. Structured qualitative content analysis was applied. For triangulation, the results were compared with external evidence that was systematically collected, reviewed, and presented. Results. Doctors perform individualized patient assessments that lead to multimodal treatment approaches. The underlying goal is to help patients to live with and overcome disease. Mistletoe infusions are a means of accomplishing this goal. They are applied to stabilize disease, achieve responsiveness, induce fever, improve quality of life, and improve the tolerability of conventional cancer treatments. The doctors reported long-term disease stability and improvements in patients' general condition, vitality, strength, thermal comfort, appetite, sleep, pain from bone metastases, dyspnea in pulmonary lymphangitis carcinomatosa, fatigue, and cachexia; chemotherapy was better tolerated. Also patients' emotional and mental condition was reported to have improved. Conclusion. Individualized integrative cancer treatment including MT aims to help cancer patients to live well with their disease. Further research should investigate the reported observations.

Individualized Integrative Cancer Care in Anthroposophic Medicine: A Qualitative Study of the Concepts and Procedures of Expert Doctors.

Background Cancer patients widely seek integrative oncology which embraces a wide variety of treatments and system approaches. Objective To investigate the concepts, therapeutic goals, procedures, and working conditions of integrative oncology doctors in the field of anthroposophic medicine. Methods This qualitative study was based on in-depth interviews with 35 highly experienced doctors working in hospitals and office-based practices in Germany and other countries. Structured qualitative content analysis was applied to examine the data. Results The doctors integrated conventional and holistic cancer concepts. Their treatments aimed at both tumor and symptom control and at strengthening the patient on different levels: living with the disease, overcoming the disease, enabling emotional and cognitive development, and addressing spiritual or transcendental issues according to the patient's wishes and initiatives. Therapeutic procedures were conventional anticancer and symptom-relieving treatments, herbal and mineral remedies, mistletoe therapy, art therapies, massages and other external applications, nutrition and lifestyle advice, psychological support, and multiple forms of empowerment. The approach emphasised good patient-doctor relationships and sufficient time for patient encounters and decision-making. Individualization appeared in several dimensions and was interwoven with standards and mindlines. The doctors often worked in teams and cooperated with other cancer care-related specialists. Conclusion Integrative cancer care pursues an individualized and patient-centered approach, encompassing conventional and multimodal complementary interventions, and addressing, along with physical and functional needs, the emotional and spiritual needs of patients. This seems to be important for tumor and symptom control, and addresses major challenges and important goals of modern cancer care.

Improvement of Asthma and Gastroesophageal Reflux Disease With Oral Pulvis stomachicus cum Belladonna, a Combination of Matricaria recutita, Atropa belladonna, Bismuth, and Antimonite: A Pediatric Case Report.

The association between gastroesophageal reflux disease (GERD) and asthma, although well established in adults, is less strong in the pediatric age group. Benefits of proton pump therapy are limited across age ranges. While there is a growing body of literature on the use of complementary treatments for both asthma and GERD, few studies have focused on treatment benefits for the GERD-asthma association. We present the case of a 2-year-old boy with asthma and GERD who was not responding to inhaled, low-dose corticosteroids, beta-mimetic therapy, and a 6-week course of proton pump inhibitor treatment. We noted a gradual disappearance of symptoms when he was given an oral preparation of Pulvis stomachicus cum Belladonna, an anthroposophic medication containing Matricaria recutita, Atropa belladonna, bismuth, and antimonite. Matricaria recutita and bismuth have known gastric protective properties, and Atropa belladonna contains anticholinergic agents that have a bronchodilatory effect. These complementary medications appear promising in terms of relieving the symptoms of GERD-associated asthma.

La asociación entre la enfermedad por reflujo gastroesofágico (ERGE) y el asma, aunque está bien establecida en adultos, es menos fuerte en el grupo de niños. Los beneficios del tratamiento de bomba de protones está limitado entre rangos de edad. A pesar de que existe un aumento en el volumen de bibliografía acerca del uso de tratamientos complementarios tanto para el asma como para la ERGE, pocos estudios se han centrado en los beneficios terapéuticos para la asociación entre el asma y la ERGE. Presentamos el caso de un niño de 2 años con asma y ERGE que no responde al tratamiento betamimético con corticosteroides inhalados, a dosis baja y un curso de 6 semanas de tratamiento de inhibición de bomba de protones. Hemos advertido una desaparición gradual de los síntomas cuando se le administró una preparación por vía oral de Pulvis stomachicus con belladonna, un medicamento antroposófico que contiene Matricaria recutita, Atropa belladonna, bismuto y antimonita. La Matricaria recutita y el bismuto tienen propiedades gastroprotectoras conocidas y la Atropa belladonna contiene anticolinérgicos que tienen un efecto broncodilatador. Estos medicamentos complementarios parecen ser prometedores en términos de alivio sintomático del asma asociado a la ERGEreflERGE.

High-Dose Viscum album Extract Treatment in the Prevention of Recurrent Bladder Cancer: A Retrospective Case Series.

INTRODUCTION: Viscum album extract (European mistletoe), containing immuno-active compounds with dose-dependent cytotoxic activity, is being used as an adjuvant cancer treatment in Europe. Few studies have yet been done with high-dose, fever-inducing Viscum album treatment. OBJECTIVE: To explore whether subcutaneous injections of high-dose Viscum album have a preventive effect on risk of recurrence of bladder cancer. METHODS: We retrospectively analyzed the case records of patients with resectable bladder cancer who underwent initiation of high-dose Viscum album treatment at our clinic between January 2006 and December 2012. MAIN OUTCOME MEASURES: We calculated tumor recurrence and progression risk and explored case records to assess whether treatment had a likely, possible, or unlikely beneficial effect. RESULTS: Eight patients were identified, 7 of whom had nonmuscle-invasive bladder cancer and 1 with muscle-invasive cancer. Four patients had frequently recurring tumors before treatment. Among the 8 patients, 28 episodes of recurrence were observed. Median tumor-free follow-up duration was 48.5 months. High-dose Viscum album showed a possible beneficial effect in 5 of 8 patients, could not be assessed in 2 patients, and had an uncertain effect in 1 patient. No tumor progression was observed. Treatment was generally well tolerated and no patient stopped treatment because of side effects. CONCLUSION: High-dose Viscum album treatment may have interrupted frequently recurring tumors in individual patients with recurrent bladder cancer. Prospective studies are needed to assess whether this treatment offers an additional, bladder-sparing preventive option for patients with intermediate- to high-risk nonmuscle-invasive bladder cancer.. Treatment was generally well tolerated and no patient stopped treatment because of side effects.

Viscum Album in the Treatment of a Girl With Refractory Childhood Absence Epilepsy.

Viscum album (European mistletoe) extracts have known immunomodulatory effects but little data exist on anticonvulsant activity despite its usefulness having been reported for centuries. A 4½-year-old girl with childhood absence epilepsy and global developmental delay was treated with different antiepileptic drugs and ketogenic diet but failed to become seizure free over a 2-year period. She also received different herbal remedies as part of an integrative medicine approach. Initial improvement occurred on valproate-ethosuximide, a further improvement was seen after adding clobazam to valproate. Final cessation of absence activity occurred after a dose increase of V album. She was still seizure free at the 12-month follow-up. V album appears to have been a necessary adjunct treatment for this child to become seizure free. We call on physicians to report their experiences of V album in epilepsy and suggest further study.

Antibiotic Use in Children with Acute Respiratory or Ear Infections: Prospective Observational Comparison of Anthroposophic and Conventional Treatment under Routine Primary Care Conditions.

Children with acute respiratory or ear infections (RTI/OM) are often unnecessarily prescribed antibiotics. Antibiotic resistance is a major public health problem and antibiotic prescription for RTI/OM should be reduced. Anthroposophic treatment of RTI/OM includes anthroposophic medications, nonmedication therapy and if necessary also antibiotics. This secondary analysis from an observational study comprised 529 children <18 years from Europe (AT, DE, NL, and UK) or USA, whose caregivers had chosen to consult physicians offering anthroposophic (A-) or conventional (C-) treatment for RTI/OM. During the 28-day follow-up antibiotics were prescribed to 5.5% of A-patients and 25.6% of C-patients (P < 0.001); unadjusted odds ratio for nonprescription in A- versus C-patients 6.58 (95%-CI 3.45-12.56); after adjustment for demographics and morbidity 6.33 (3.17-12.64). Antibiotic prescription rates in recent observational studies with similar patients in similar settings, ranged from 31.0% to 84.1%. Compared to C-patients, A-patients also had much lower use of analgesics, somewhat quicker symptom resolution, and higher caregiver satisfaction. Adverse drug reactions were infrequent (2.3% in both groups) and not serious. Limitation was that results apply to children of caregivers who consult A-physicians. One cannot infer to what extent antibiotics might be avoided in children who usually receive C-treatment, if they were offered A-treatment.

Disappearance of an advanced adenomatous colon polyp after intratumoural injection with Viscum album (European mistletoe) extract: a case report.

BACKGROUND AND AIM: Extracts of Viscum album (European mistletoe) have immune-stimulatory and cytotoxic effects, with trials showing a well-established effect on the quality of life and prolonged survival in patients with advanced pancreatic cancer. Regression of tumours following intratumoural injection with Viscum album extract has been documented in individual cases. However, its influence on colon polyps has not been investigated. CASE PRESENTATION: We present the case of a 78-year-old Caucasian male who had undergone hemi-colectomy for a stage IIIC colon cancer but who refused adjuvant chemotherapy. Five years later a newly detected high-grade dysplasia colon adenoma was discovered; however, the adenoma could not be resected endoscopically and the patient did not consent to surgery. Intratumoural injections with Viscum album L extract (Quercus; Iscador®Qu) were administered twice in an attempt to limit tumour growth. Eight months after the second intratumoural injection the adenoma had disappeared and biopsy revealed no intraepithelial dysplasia or adenoma. CONCLUSIONS: This is the first report showing complete regression of a colon adenoma after intratumoural injection with Viscum album extract. Prospective studies should evaluate if the treatment effect is reproducible and if this approach could be a useful pre-operative measure for colon adenomas too large for endoscopic resection.

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.

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.