Safety of Anthroposophic Medicinal Products: An Analysis of Adverse Drug Reactions from German Pharmacovigilance Databases.

Background: Anthroposophic medicinal products (AMPs) are widely used in Europe and world-wide.

Objective: To determine the frequency of reported adverse drug reactions (ADRs) from all AMPs on the market, in absolute numbers and relative to the maximum daily administration doses (MDADs).

Patients And Methods: Retrolective safety analysis of AMP-related ADRs in pharmacovigilance databases of four AMP Marketing Authorisation Holders in Germany.

Mapping Physicians' Experiences with Medicinal Products from Whole Medical Systems: A Descriptive Analysis of the Vademecum of Anthroposophic Medicines.

Background: Therapy in whole medical systems involves a large number of medicinal products. One source of knowledge of clinical properties of such products is the experience of therapy providers. A systematic approach to documentation, assessment, and aggregation of physicians' experiences with anthroposophic medicinal products (AMPs) has been developed: the Vademecum of Anthroposophic Medicines.

Use and Safety of Anthroposophic Medicinal Products: An Analysis of 44,662 Patients from the EvaMed Pharmacovigilance Network.

Background: There is a need for data on the clinical safety of anthroposophic medicinal products (AMPs).

Objectives: The main objective of this analysis was to determine the frequency of adverse drug reactions (ADRs) to AMPs, relative to the number of AMP prescriptions.

Methods: EvaMed (Evaluation of Anthroposophic Medicine) was a prospective pharmacovigilance study with the patients of 38 physicians in outpatient care in Germany.

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.

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.

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.

[Clinical research on anthroposophic medicine:update of a health technology assessment report and 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.

Pulpa dentis D30 for acute reversible pulpitis: A prospective cohort study in routine dental practice.

Background: Pulpa dentis D30 (PD: dental pulp of the calf, prepared in a homeopathic D30 potency) has been used in acute reversible pulpitis for pain relief and to avoid or postpone invasive dental treatment.

Primary Study Objective: To study short-term clinical outcomes of PD therapy for acute reversible pulpitis in routine dental practice.

Methods/design: Prospective, observational, open-label, single-arm cohort study.

Anthroposophic therapy for attention deficit hyperactivity: a two-year prospective study in outpatients.

Background: Anthroposophic treatment for attention deficit hyperactivity disorder (ADHD) includes special artistic and physical therapies and special medications.

Methods: We studied 61 consecutive children starting anthroposophic treatment for ADHD symptoms under routine outpatient conditions. Primary outcome was FBB-HKS (a parents' questionnaire for ADHD core symptoms, 0-3), and secondary outcomes were disease and symptom scores (physicians' and parents' assessment, 0-10) and quality of life (KINDL(®) total score, 0-100).

Predictors of outcome after 6 and 12 months following anthroposophic therapy for adult outpatients with chronic disease: a secondary analysis from a prospective observational study.

Background: Anthroposophic medicine is a physician-provided complementary therapy system involving counselling, artistic and physical therapies, and special medications. The purpose of this analysis was to identify predictors of symptom improvement in patients receiving anthroposophic treatment for chronic diseases.

Methods: 913 adult outpatients from Germany participated in a prospective cohort study.

Anthroposophic therapy for migraine: a two-year prospective cohort study in routine outpatient settings.

Background And Methods: Anthroposophic treatment for migraine is provided by physicians and includes special artistic and physical therapies and special medications. We conducted a prospective cohort study of 45 consecutive adult outpatients (89% women) starting anthroposophic treatment for migraine under routine conditions. Main outcomes were Average Migraine Severity (physician and patient ratings 0-10, primary outcome), Symptom Score (patient rating, 0-10), and quality of life (SF-36); main follow-up time point was after six months.

Outcome of anthroposophic medication therapy in chronic disease: a 12-month prospective cohort study.

Background: Anthroposophic medications (AMED) are prescribed in 56 countries.

Objective: To study clinical outcomes in patients prescribed AMED for chronic disease.

Design: Prospective cohort study.

Health costs in patients treated for depression, in patients with depressive symptoms treated for another chronic disorder, and in non-depressed patients: a two-year prospective cohort study in anthroposophic outpatient settings.

We studied costs of healthcare and productivity loss in 487 German outpatients starting anthroposophic treatment: Group 1 was treated for depression, Group 2 had depressive symptoms but were treated for another chronic disorder, while Group 3 did not have depressive symptoms. Costs were adjusted for socio-demographics, comorbidity, and baseline health status. Total costs in groups 1-3 averaged euro7,129, euro4,371, and euro3,532 in the pre-study year (P = 0.

Anthroposophic therapy for children with chronic disease: a two-year prospective cohort study in routine outpatient settings.

Background: Many children with chronic disease use complementary therapies. Anthroposophic treatment for paediatric chronic disease is provided by physicians and differs from conventional treatment in the use of special therapies (art therapy, eurythmy movement exercises, rhythmical massage therapy) and special medications. We studied clinical outcomes in children with chronic diseases under anthroposophic treatment in routine outpatient settings.

Viscum album L. extracts in breast and gynaecological cancers: a systematic review of clinical and preclinical research.

Background: Viscum album L. extracts (VAE, European mistletoe) are a widely used medicinal plant extract in gynaecological and breast-cancer treatment.

Methods: Systematic review to evaluate clinical studies and preclinical research on the therapeutic effectiveness and biological effects of VAE on gynaecological and breast cancer.

Anthroposophic therapy for asthma: A two-year prospective cohort study in routine outpatient settings.

Background: Anthroposophic treatment for asthma includes special artistic and physical therapies and special medications.

Methods: We studied consecutive outpatients starting anthroposophic treatment for asthma under routine conditions in Germany. Main outcomes were average asthma severity (0-10, primary outcome); symptoms (1-4); and asthma-related quality of life at 12-month follow-up (Asthma Quality of Life Questionnaire [AQLQ] overall score, 1-7, for adults; KINDL Questionnaire for Measuring Health-Related Quality of Life in Children and Adolescents, asthma module, 0-100, for children) at 12-month follow-up.

Long-term outcomes of anthroposophic therapy for chronic low back pain: A two-year follow-up analysis.

Background: Anthroposophic treatment for chronic low back pain (LBP) includes special artistic and physical therapies and special medications. In a previously published prospective cohort study, anthroposophic treatment for chronic LBP was associated with improvements of pain, back function, and quality of life at 12-month follow-up. These improvements were at least comparable to improvements in a control group receiving conventional care.

Combined bias suppression in single-arm therapy studies.

Rationale, Aims And Objectives: For therapy evaluation studies, control groups are sometimes not feasible. In single-arm studies, various bias factors apart from the test therapy can affect clinical outcomes. The objective of this analysis was to improve the methods to minimize bias in single-arm studies.

Assessing the order of magnitude of outcomes in single-arm cohorts through systematic comparison with corresponding cohorts: an example from the AMOS study.

Background: When a therapy has been evaluated in the first clinical study, the outcome is often compared descriptively to outcomes in corresponding cohorts receiving other treatments. Such comparisons are often limited to selected studies, and often mix different outcomes and follow-up periods. Here we give an example of a systematic comparison to all cohorts with identical outcomes and follow-up periods.

Rhythmical massage therapy in chronic disease: a 4-year prospective cohort study.

Objective: Rhythmical massage therapy is used in 24 countries but has not yet been studied in outpatient settings. The objective was to study clinical outcomes in patients receiving rhythmical massage therapy for chronic diseases.

Design: Prospective 4-year cohort study.

Anthroposophic art therapy in chronic disease: a four-year prospective cohort study.

Background: Anthroposophic art therapy (painting, clay modeling, music, and speech exercises) is used in 28 countries but has not yet been studied in primary care.

Objective: To study clinical outcomes in patients treated with anthroposophic art therapy for chronic diseases.

Design: Prospective cohort study.

Eurythmy therapy in chronic disease: a four-year prospective cohort study.

Background: Many patients with chronic diseases use complementary therapies, often provided by their physicians. In Germany, several physician-provided complementary therapies have been reimbursed by health insurance companies as part of health benefit programs. In most of these therapies, the patient has a predominantly passive role.

Anthroposophic medical therapy in chronic disease: a four-year prospective cohort study.

Background: The short consultation length in primary care is a source of concern, and the wish for more consultation time is a common reason for patients to seek complementary medicine. Physicians practicing anthroposophic medicine have prolonged consultations with their patients, taking an extended history, addressing constitutional, psychosocial, and biographic aspect of patients' illness, and selecting optimal therapy. In Germany, health benefit programs have included the reimbursement of this additional physician time.

Use and safety of anthroposophic medications for acute respiratory and ear infections: a prospective cohort study.

Objective: Anthroposophic medications (AMED) are widely used, but safety data on AMED from large prospective studies are sparse. The objective of this analysis was to determine the frequency of adverse drug reactions (ADR) to AMED in outpatients using AMED for acute respiratory and ear infections.

Methods: A prospective four-week observational cohort study was conducted in 21 primary care practices in Europe and the U.

Anthroposophic therapy for chronic depression: a four-year prospective cohort study.

Background: Depressive disorders are common, cause considerable disability, and do not always respond to standard therapy (psychotherapy, antidepressants). Anthroposophic treatment for depression differs from ordinary treatment in the use of artistic and physical therapies and special medication. We studied clinical outcomes of anthroposophic therapy for depression.