Mercury, silver and selenium in serum before and after removal of amalgam restorations: results from a prospective cohort study in Norway.

OBJECTIVE: A prospective cohort study on changes of health complaints after removal of amalgam restorations was carried out at the request of the Norwegian Directorate of Health. The aim was to provide and evaluate experimental treatment to patients with health complaints attributed to dental amalgam fillings. METHODS: Patients (n = 32) with medically unexplained physical symptoms (MUPS), which were attributed to dental amalgam restorations had all their amalgam restorations removed and replaced with other dental restorative materials. Samples of blood were collected before and 1 year after removal of the fillings, and concentration of inorganic mercury (I-Hg), methylmercury (MeHg), silver (Ag) and selenium (Se) in serum was determined by inductively coupled plasma-sector field mass spectrometry. The comparison groups (one with MUPS but without attribution to amalgam [n = 28] and one group of healthy individuals [n = 19]) received no treatment. The participants responded to questionnaires at baseline and at follow-up after 1 and 5 years. RESULTS: Concentration of I-Hg and Ag in serum decreased significantly after removal of all amalgam restorations. Concentration of MeHg and Se in serum were not changed. Intensity of health complaints was significantly reduced after amalgam removal, but there were no statistically significant correlations between exposure indicators and health complaints. CONCLUSIONS: Removal of all amalgam restorations is followed by a decrease of concentration of I-Hg and Ag in serum. The results support the hypothesis that exposure to amalgam fillings causes an increase of the daily dose of both I-Hg and Ag. Even though intensity of health complaints decreased after removal of all amalgam restorations there was no clear evidence of a direct relationship between exposure and health complaints. Trial registration: The project is registered at Clinicaltrials.gov (NCT01682278).

Is amalgam removal in patients with medically unexplained physical symptoms cost-effective? A prospective cohort and decision modelling study in Norway.

There are many patients in general practice with health complaints that cannot be medically explained. Some of these patients attribute their health complaints to dental amalgam restorations. This study examined the cost-effectiveness of the removal of amalgam restorations in patients with medically unexplained physical symptoms (MUPS) attributed to amalgam fillings compared to usual care, based on a prospective cohort study in Norway. Costs were determined using a micro-costing approach at the individual level. Health outcomes were documented at baseline and approximately two years later for both the intervention and the usual care using EQ-5D-5L. Quality adjusted life year (QALY) was used as a main outcome measure. A decision analytical model was developed to estimate the incremental cost-effectiveness of the intervention. Both probabilistic and one-way sensitivity analyses were conducted to assess the impact of uncertainty in costs and effectiveness. In patients who attribute health complaints to dental amalgam restorations and fulfil the inclusion and exclusion criteria, amalgam removal is associated with modest increase in costs at societal level as well as improved health outcomes. In the base-case analysis, the mean incremental cost per patient in the amalgam group was NOK 19 416 compared to the MUPS group, while mean incremental QALY was 0.119 with a time horizon of two years. Thus, the incremental costs per QALY of the intervention was NOK 162 680, which is usually considered cost effective in Norway. The estimated incremental cost per QALY decreased with increasing time horizon, and amalgam removal was found to be cost saving over both 5 and 10 years. This study provides insight into the costs and health outcomes associated with the removal of amalgam restorations in patients who attribute health complaints to dental amalgam fillings, which are appropriate instruments to inform health care priorities.

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.

Validity and responsiveness of GHC-index in patients with amalgam-attributed health complaints.

OBJECTIVE: Many patients have medically unexplained physical symptoms (MUPS); some of them attribute their health complaints to dental amalgam fillings. The aim of this study was to assess the validity and responsiveness of General Health Complaints index (GHC-index) for measuring the symptom load in MUPS patients compared to the widely used symptom outcome measure, Giessen Subjective Complaints List (GBB-24). METHODS: Three outcome measures - GHC-index, GBB-24, and Munich Amalgam Scale (MAS) - were administered at baseline and 12 months after removal of all dental amalgam restorations. The validity and responsiveness of these symptom measures were tested against external anchors: bodily distress syndrome (BDS), SF-36 vitality, and visual analogue scale (VAS). We tested both convergent and known group validities. We also examined the predictive validity and responsiveness to changes for each instrument. RESULTS: All the main outcome measures showed evidence of convergent and known group validities. The GHC-index, GBB-24 and MAS were all able to detect the anticipated differences in BDS and Energy. But the GBB-24 was more efficient in discriminating the BDS compared with the GHC-index (relative efficiency: RE = 0.69; 95% CI: 0.41-0.96) and MAS (RE = 0.59; 95% CI: 0.32-0.86). Each main outcome variable revealed good predictive validity for vitality (standardized coefficient: b ≈ 0.71 and R2 ≈ 0.50). Moderate to high sensitivity to change over time was demonstrated, with GHC-index performing better. CONCLUSION: The GHC-index is a valid and responsive instrument for assessing symptom load in MUPS patients attributing their health complaints to amalgam fillings and undergoing amalgam removal.

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. For each ADR, information about the patient, outcome, causality and AMP was retrieved. Primary outcome was the frequency of reported ADRs relative to MDADs sold. RESULTS: In the period 2010-2017, a total of 5506 ADRs were reported that had occurred in 2765 different patients, comprising 370 different AMPs. A total of 104 ADRs (1.9%) were classified as serious. The frequency of ADRs for all AMPs was 1.50 per million MDADs. For serious ADRs the frequency was 0.03 per million MDADs. ADRs were more frequently reported with parenteral AMP administration (injections) than with oral or local administration (18.85 vs. 0.59 vs. 1.61 ADRs per million MDADs, respectively; p < 0.0001). The large majority of users (91.9%) had recovered or were recovering from the ADRs and there were no reports with a fatal outcome. Most frequently reported ADR symptom was injection site inflammation for parenteral AMPs (4.66 ADRs per million MDADs), nausea for oral AMPs (0.03 ADRs per million MDADs), and eye irritation for locally administered AMPs (0.23 ADRs per million MDADs). CONCLUSIONS: In this retrolective safety analysis of pharmacovigilance data, the frequency of ADRs to AMPs was 1.50 per million MDADs. Notably, the ADR frequency in this study based on spontaneous reporting is not directly comparable to frequencies in prospective clinical studies nor to frequencies based on other measures of patient exposure than MDADs.

Validity and responsiveness of EQ-5D-5L and SF-6D in patients with health complaints attributed to their amalgam fillings: a prospective cohort study of patients undergoing amalgam removal.

BACKGROUND: Evidence of health utility changes in patients who suffer from longstanding health complaints attributed to dental amalgam fillings are limited. The change in health utility outcomes enables calculating quality-adjusted life-year (QALY) and facilitates the comparison with other health conditions. The purpose of this study was to estimate the validity and responsiveness of the EQ-5D-5L and SF-6D utilities following removal of dental amalgam fillings in patients with health complaints attributed to their amalgam fillings, and examine the ability of these instruments to detect minimally important changes over time. METHODS: Patients with medically unexplained physical symptoms, which they attributed to dental amalgam restorations, were recruited to a prospective cohort study in Norway. Two health state utility instruments, EQ-5D-5L and SF-6D, as well as self-reported general health complaints (GHC-index) and visual analogue scale (EQ-VAS) were administered to all patients (n = 32) at baseline and at follow-up. The last two were used as criteria measures. Concurrent and predictive validities were examined using correlation coefficients. Responsiveness was assessed by the effect size (ES), standardized response mean (SRM), and relative efficiency. Minimally important change (MIC) was examined by distribution and anchor-based approaches. RESULTS: Concurrent validity of the EQ-5D-5L was similar to that of SF-6D utility. EQ-5D-5L was more responsive than SF-6D: the ES were 0.73 and 0.58 for EQ-5D-5L and SF-6D, respectively; SRM were 0.76 and 0.67, respectively. EQ-5D-5L was more efficient than SF-6D in detecting changes, but both were less efficient compared to criteria-based measures. The estimated MIC of EQ-5D-5L value set was 0.108 and 0.118 based on distribution and anchor-based approaches, respectively. The corresponding values for SF-6D were 0.048 and 0.064, respectively. CONCLUSIONS: In patients with health complaints attributed to dental amalgam undergoing amalgam removal, both EQ-5D-5L and SF-6D showed reasonable concurrent and predictive validity and acceptable responsiveness. The EQ-5D-5L utility appears to be more responsive compared to SF-6D. Trial registration The research was registered at ClinicalTrials.gov., NCT01682278. Registered 10 September 2012, https://clinicaltrials.gov/ct2/show/NCT01682278 .

Removal of dental amalgam restorations in patients with health complaints attributed to amalgam: A prospective cohort study.

BACKGROUND: The Norwegian Ministry of Health and Care Services initiated a project including experimental treatment for patients with health complaints attributed to amalgam restorations. OBJECTIVE: The aim was to evaluate changes of general health complaints in patients who participated in the project and had all amalgam restorations removed. METHODS: The project was designed as a prospective cohort study and organised by the Dental Biomaterials Adverse Reaction Unit in Bergen, Norway. The dental treatment was provided by the patient's local dentist. The main target group consisted of patients with medically unexplained physical symptoms, attributed to dental amalgam restorations (Amalgam cohort). The primary comparison group consisted of patients with medically unexplained physical symptoms without attribution to dental amalgam restorations (MUPS cohort). Primary outcome was self-reported general health complaints (GHC index) at follow-up 12-months after completed amalgam removal. RESULTS: In the Amalgam cohort, a significant reduction of GHC index from 43.3 (SD 17.8) at baseline to 30.5 (SD 14.4) at follow-up (mean reduction 12.8, SD 15.9; n = 32; P < .001) was observed. The change scores for GHC index indicated that the reduction of complaints was significantly higher (P = .004) in the Amalgam cohort compared with the MUPS cohort (mean reduction 1.2, SD 12.3, n = 28). After adjustment for age, gender, education and baseline GHC index, the mean adjusted difference was -8.0 (95% confidence interval from -15.4 to -0.5; P = .036). CONCLUSION: In a group of patients with medically unexplained physical symptoms, which they attributed to dental amalgam restorations, removal of amalgam restorations was followed by a significant reduction of health complaints.

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.

A 4-year non-randomized comparative phase-IV study of early rheumatoid arthritis: integrative anthroposophic medicine for patients with preference against DMARDs versus conventional therapy including DMARDs for patients without preference.

BACKGROUND: While disease-modifying antirheumatic drugs (DMARDs) are a mainstay of therapy for rheumatoid arthritis (RA), some patients with early RA refuse DMARDs. In anthroposophic medicine (AM), a treatment strategy for early RA without DMARDs has been developed. Preliminary data suggest that RA symptoms and inflammatory markers can be reduced under AM, without DMARDs. PATIENTS AND METHODS: Two hundred and fifty-one self-selected patients aged 16-70 years, starting treatment for RA of <3 years duration, without prior DMARD therapy, participated in a prospective, non-randomized, comparative Phase IV study. C-patients were treated in clinics offering conventional therapy including DMARDs, while A-patients had chosen treatment in anthroposophic clinics, without DMARDs. Both groups received corticosteroids and nonsteroidal anti-inflammatory drugs (NSAIDs). Primary outcomes were intensity of RA symptoms measured by self-rating on visual analog scales, C-reactive protein, radiological progression, study withdrawals, serious adverse events (SAE), and adverse drug reactions in months 0-48. RESULTS: The groups were similar in most baseline characteristics, while A-patients had longer disease duration (mean 15.1 vs 10.8 months, p<0.0001), slightly more bone destruction, and a much higher proportion of women (94.6% vs 69.7%, p<0.0001). In months 0-12, corticosteroids were used by 45.7% and 81.6% (p<0.0001) and NSAIDs by 52.8% and 68.5% (p=0.0191) of A- and C-patients, respectively. During follow-up, both groups not only had marked reduction of RA symptoms and C-reactive protein, but also some radiological disease progression. Also, 6.2% of A-patients needed DMARDs. Apart from adverse drug reactions (50.4% and 69.7% of A- and C-patients, respectively, p=0.0020), none of the primary outcomes showed any significant between-group difference. CONCLUSION: Study results suggest that for most patients preferring anthroposophic treatment, satisfactory results can be achieved without use of DMARDs and with less use of corticosteroids and NSAIDs than in conventional care. LIMITATION: Because of the non-randomized study design, with A-patients choosing anthroposophic treatment, one cannot infer how this treatment would have worked for C-patients.

Whole Medical Systems versus the System of Conventional Biomedicine: A Critical, Narrative Review of Similarities, Differences, and Factors That Promote the Integration Process.

BACKGROUND: There is an increasing need for a worldwide professional integration of conventional medicine and traditional/complementary whole medical systems (WMSs). However, the integration is perceived by conventional medicine as problematic or unacceptable, because of a supposed lack of evidence for specific effects of WMSs therapies and supposed prescientific or unscientific paradigms of WMSs. OBJECTIVES: To review the literature on the features of WMSs, similarities and differences between conventional medicine and WMSs, and scientific and clinical practice issues that should be dealt with in order to promote the integration process. METHODS: A critical, narrative review of the literature on six WMSs. RESULTS AND CONCLUSIONS: Key factors for the integration of WMSs and conventional medicine are as follows: legal frameworks, quality standards, high-quality research on safety and efficacy of WMS interventions, infrastructure, and financial resources. For scientific assessment of WMSs, there are unresolved ontological, epistemological, and methodological issues and issues of diagnostics, therapy delivery, and outcome assessment in clinical practice. Future research not only should be directed at quality assurance and generating the necessary data on safety and efficacy/effectiveness but also should address more fundamental (ontological, epistemological, and methodological) issues, in order to overcome the differences between WMSs and conventional medicine.

Use of complementary and alternative medicine in patients with health complaints attributed to former dental amalgam fillings.

BACKGROUND: The dental filling material amalgam is generally well tolerated. However, a small proportion of dental patients experience health complaints which they attribute to amalgam. The symptom pattern is often similar to patients with medically unexplained physical symptoms (MUPS) and the health complaints may persist after amalgam removal. Among patients with MUPS, the use of complementary and alternative medicine (CAM) seems to be high. The aim of this survey was to describe the prevalence and range of CAM use among people with health complaints attributed to dental amalgam fillings in which the health problems persist after the removal of all amalgam fillings. Specific attention was paid to (1) self-reported effects of CAM, (2) differences in CAM use dependent on self-reported health, and (3) gender differences in self-reported CAM use. METHODS: A survey was distributed to all members of The Norwegian dental patient association (NDPA) (n = 999), the response rate was 36.4%. The anonymous questionnaire asked for socio-demographic data, health complaints related to former amalgam fillings, subjectively perceived health status, symptoms, and experience with therapeutic interventions, mostly from the spectrum of CAM. Only participants who had all their fillings removed, which was the vast majority, were analysed. RESULTS: A total of 88.9% of included respondents had used at least one CAM modality, with a higher proportion of men (95.7%) compared to women (86.2%, p = 0.015). The most frequently used therapies were dietary supplements, vitamins and minerals recommended by a therapist (used by 66.7%) followed by self-prescribed dietary supplements, vitamins and minerals (59.0%), homeopathy (54.0%), acupuncture (48.8%) and special diets (47.5%). Use of CAM was similar for participants reporting normal to good health compared to participants reporting poor health. For all but two CAM modalities, the self-reported treatment effect was better in the group reporting normal to good health compared to the group reporting poor health. CONCLUSIONS: CAM was widely used by participants in our study, a finding similar to findings from studies of MUPS patients. To date, health problems associated with the use of dental amalgam is not an accepted diagnosis in the healthcare system. Consequently, people suffering from such complaints experience a lack of adequate treatment and support within conventional health care, which might have contributed to the high number of CAM users in this 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.

In support of clinical case reports: a system of causality assessment.

The usefulness of clinical research depends on an assessment of causality. This assessment determines what constitutes clinical evidence. Case reports are an example of evidence that is frequently overlooked because it is believed they cannot address causal links between treatment and outcomes. This may be a mistake. Clarity on the topic of causality and its assessment will be of benefit for researchers and clinicians. This article outlines an overall system of causality and causality assessment. The system proposed involves two dimensions: horizontal and vertical; each of these dimensions consists of three different types of causality and three corresponding types of causality assessment. Included in this system are diverse forms of case causality illustrated with examples from everyday life and clinical medicine. Assessing case causality can complement conventional clinical research in an era of personalized medicine.

La utilidad de la investigación clínica depende de una evaluación de la causalidad. Esta evaluación determina qué constituyen pruebas clínicas. Los informes de caso son un ejemplo de pruebas que suele pasarse por alto con frecuencia, ya que se cree que no pueden resolver las relaciones causales entre tratamiento y resultados. Esto puede ser un error. La claridad en el tema de la causalidad y su evaluación será beneficiosa para investigadores y personal clínico.Este artículo esboza un sistema global de causalidad y evaluación de la causalidad. El sistema propuesto implica dos dimensiones: horizontal y vertical, cada una de las cuales consiste en tres tipos diferentes de causalidad y tres tipos de evaluación de la causalidad correspondientes. En este sistema, se incluyen diversas formas de causalidad de casos ilustradas con ejemplos de la vida diaria y de la medicina clínica. La evaluación de la causalidad de los casos puede complementar la investigación clínica tradicional en una era de medicina personalizada.

Anthroposophic medicine: an integrative medical system originating in europe.

Anthroposophic medicine is an integrative multimodal treatment system based on a holistic understanding of man and nature and of disease and treatment. It builds on a concept of four levels of formative forces and on the model of a three-fold human constitution. Anthroposophic medicine is integrated with conventional medicine in large hospitals and medical practices. It applies medicines derived from plants, minerals, and animals; art therapy, eurythmy therapy, and rhythmical massage; counseling; psychotherapy; and specific nursing techniques such as external embrocation. Anthroposophic healthcare is provided by medical doctors, therapists, and nurses. A Health-Technology Assessment Report and its recent update identified 265 clinical studies on the efficacy and effectiveness of anthroposophic medicine. The outcomes were described as predominantly positive. These studies as well as a variety of specific safety studies found no major risk but good tolerability. Economic analyses found a favorable cost structure. Patients report high satisfaction with anthroposophic healthcare.

La medicina antroposófica es un sistema de tratamiento multimodal integrador que se basa en un entendimiento holístico del hombre y la naturaleza, así como de la enfermedad y del tratamiento. Se desarrolla sobre un concepto de cuatro niveles de fuerzas formativas y sobre el modelo de una constitución humana en tres partes. La medicina antroposófica se integra con la medicina convencional en grandes hospitales y en consultorios médicos. Aplica medicamentos de origen vegetal, mineral y animal; terapias artísticas, euritmia curativa y masaje rítmico; orientación, psicoterapia y técnicas de enfermería específicas, tales como la frotación externa. La atención sanitaria antroposófica es realizada por médicos, terapeutas y personal de enfermería. En un informe de evaluación de la tecnología sanitaria y en su reciente actualización se identificaron 265 estudios clínicos sobre la eficacia y la efectividad de la medicina antroposófica. Los resultados se describieron como predominantemente positivos. Estos estudios, así como diversos estudios de seguridad específicos, no encontraron ningún riesgo importante y sí una buena tolerabilidad. Los análisis económicos revelaron una estructura de costes favorable. Los pacientes indican una alta satisfacción con la atención sanitaria antroposófica.

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.

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). RESULTS: A total of 67% of patients fulfilled the DSM-IV criteria for ADHD, 15% had an exclusion diagnosis such as pervasive developmental disorders, while 18% did not fulfill ADHD criteria for another reason. Anthroposophic treatment modalities used were eurythmy therapy (in 56% of patients), art therapy (20%), rhythmical massage therapy (8%), and medications (51%). From baseline to six-month follow-up, all outcomes improved significantly; average improvements were FBB-HKS total score 0.30 points (95% confidence interval [CI]: 0.18-0.43; P < 0.001), FBB-HKS inattention 0.36 (95% CI: 0.21-0.50; P < 0.001), FBB-HKS hyperactivity 0.29 (95% CI: 0.14-0.44; P < 0.001), FBB-HKS impulsivity 0.22 (95% CI: 0.03-0.40; P < 0.001), disease score 2.33 (95% CI: 1.84-2.82; P < 0.001), symptom score 1.66 (95% CI: 1.17-2.16; P < 0.001), and KINDL 5.37 (95% CI: 2.27-8.47; P = 0.001). Improvements were similar in patients not using stimulants (90% of patients at months 0-6) and were maintained until last follow-up after 24 months. CONCLUSION: Children with ADHD symptoms receiving anthroposophic treatment had long-term improvement of symptoms and quality of life.

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. Patients were starting anthroposophic treatment for mental (30.4% of patients, n = 278/913), musculoskeletal (20.2%), neurological (7.6%), genitourinary (7.4%) or respiratory disorders (7.2%) or other chronic indications. Stepwise multiple linear regression analysis was performed with the improvement of Symptom Score (patients' assessment, 0: not present, 10: worst possible) after 6 and 12 months as dependent variables. 61 independent variables pertaining to socio-demographics, life style, disease status, co-morbidity, health status (SF-36), depression, and therapy factors were analysed. RESULTS: Compared to baseline, Symptom Score improved by average 2.53 points (95% confidence interval 2.39-2.68, p < 0.001) after six months and by 2.49 points (2.32-2.65, p < 0.001) after 12 months. The strongest predictor for improvement after six months was baseline Symptom Score, which alone accounted for 25% of the variance (total model 32%). Improvement after six months was also positively predicted by better physical function, better general health, shorter disease duration, higher education level, a diagnosis of respiratory disorders, and by a higher therapy goal documented by the physician at baseline; and negatively predicted by the number of physiotherapy sessions in the pre-study year and by a diagnosis of genitourinary disorders. Seven of these nine variables (not the two diagnoses) also predicted improvement after 12 months. When repeating the 0-6 month analysis on two random subsamples of the original sample, three variables (baseline Symptom Score, physical function, general health) remained significant predictors in both analyses, and three further variables (education level, respiratory disorders, therapy goal) were significant in one analysis. CONCLUSION: In adult outpatients receiving anthroposophic treatment for chronic diseases, symptom improvement after 6 and 12 months was predicted by baseline symptoms, health status, disease duration, education, and therapy goal. Other variables were not associated with the outcome. This secondary predictor analysis of data from a pre-post study does not allow for causal conclusions; the results are hypothesis generating and need verification in subsequent studies.

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. RESULTS: The anthroposophic treatment modalities used were medications (67% of patients), eurythmy therapy (38%), art therapy (18%), and rhythmical massage therapy (13%). Median therapy duration was 105 days. In months 0-6, conventional prophylactic antimigraine medications were used by 14% (n=5/36) of evaluable patients. From baseline to six-month follow-up, physician-rated Average Migraine Severity improved by 3.14 points (95% confidence interval 2.40-3.87, p<0.001); patient-rated Average Migraine Severity improved by 2.82 points (2.05-3.64, p<0.001); and Symptom Score improved by 2.32 points (1.68-2.95, p<0.001). In addition, three SF-36 scales (Social Functioning, Bodily Pain, Vitality), the SF-36 Physical Component summary measure, and the SF-36 Health Change item improved significantly. All improvements were maintained at last follow-up after 24 months. Patients not using conventional prophylactic antimigraine medications had improvements similar to the whole cohort. CONCLUSIONS: Patients with migraine under anthroposophic treatment had long-term improvement of symptoms and quality of life. Although the pre-post design of the present study does not allow for conclusions about comparative effectiveness, study findings suggest that anthroposophic therapies may be useful in the long-term care of patients with migraine.

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 = 0.008); euro6,029, euro3,522, and euro3,353 in the first year (P = 0.083); and euro4,929, euro3,792, and euro4,031 in the second year (P = 0.460). In the 2nd year, costs were significantly reduced in Group 1. This study underlines the importance of depression for health costs, and suggests that treatment of depression could be associated with long-term cost reductions.

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. SETTING: 110 medical practices in Germany. PARTICIPANTS: 665 consecutive outpatients aged 1-71 years, prescribed AMED for mental, respiratory, musculoskeletal, neurological, genitourinary, and other chronic diseases. MAIN OUTCOMES: Disease and Symptom Scores (physicians' and patients' assessment, 0-10) and SF-36. RESULTS: During the first six months, an average of 1.5 AMED per patient was used, in total 652 different AMED. Origin of AMED was mineral (8.0% of 652 AMED), botanical (39.0%), zoological (7.2%), chemically defined (13.0%), and mixed (33.0%). From baseline to six-month-follow-up, all outcomes improved significantly: Disease Score improved by mean 3.15 points (95% confidence interval 2.97-3.34, p < 0.001), Symptom Score by 2.43 points (2.23-2.63, p < 0.001), SF-36 Physical Component Summary by 3.04 points (2.16-3.91, p < 0.001), and SF-36 Mental Component Summary by 5.75 points (4.59-6.92, p < 0.001). All improvements were maintained at 12-month follow-up. Improvements were similar in adult men and women, in children, and in patients not using adjunctive therapies. CONCLUSION: Outpatients using AMED for chronic disease had long-term reduction of disease severity and improvement of quality of life.