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Hamre H.J.,Institute for Applied Epistemology and Medical Methodology | Witt C.M.,Charité - Medical University of Berlin | Kienle G.S.,Institute for Applied Epistemology and Medical Methodology | Meinecke C.,Community Hospital Havelhohe | And 4 more authors.
International Journal of General Medicine | Year: 2010

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. © 2010 Hamre et al, publisher and licensee Dove Medical Press Ltd.


Kienle G.S.,Institute for Applied Epistemology and Medical Methodology | Albonico H.-U.,Union of Associations of Swiss Physicians for Complementary Medicine | Albonico H.-U.,Regional Hospital Emmental | Fischer L.,University of Bern | And 6 more authors.
Explore: The Journal of Science and Healing | Year: 2011

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 artifical 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. © 2011 Elsevier Inc. All rights reserved.


Kienle G.S.,Institute for Applied Epistemology and Medical Methodology | Kiene H.,Institute for Applied Epistemology and Medical Methodology
Integrative Cancer Therapies | Year: 2010

Objective. To evaluate controlled clinical studies on the efficacy and effectiveness of Viscum album for quality of life (QoL) in cancer. Materials and methods. The authors conducted a search of 7 electronic databases and reference lists and had extensive consultations with experts. They carried out a criteria-based assessment of methodological study quality. Results. The authors identified 26 randomized controlled trials (RCTs) and 10 non-RCTs that investigated the influence of V album extracts (VAEs) on QoL in malignant diseases; 26 studies assessed patient-reported QoL. Questionnaires were mostly well established and validated. Half of the studies investigated VAEs concomitant with chemotherapy, radiotherapy, or surgery. Some studies were well designed, whereas others had minor or major methodological weaknesses. Among the 26 RCTs, 22 reported a QoL benefit, 3 indicated no difference, and 1 did not report any result. All the non-RCTs reported a QoL benefit. Of the studies with higher methodological quality, most reported a benefit, whereas 1 found no difference. Improvements were mainly in regard to coping, fatigue, sleep, exhaustion, energy, nausea, vomiting, appetite, depression, anxiety, ability to work, and emotional and functional well-being in general and, less consistently, in regard to pain, diarrhea, general performance, and side effects of conventional treatments. VAEs were well tolerated. Conclusions. VAEs seem to have an impact on QoL and reduction of side effects of conventional therapies (chemotherapy, radiation) in experimental trials as well as in routine daily application. The influence on fatigue especially should be investigated further. © The Author(s) 2010.


Kienle G.S.,Institute for Applied Epistemology and Medical Methodology | Kiene H.,Institute for Applied Epistemology and Medical Methodology
Journal of Evaluation in Clinical Practice | Year: 2011

Objectives Clinical judgment is a central element of the medical profession, essential for the performance of the doctor, and potentially generating information also for other clinicians and for scientists and health care managers. The recently renewed interest in clinical judgement is primarily engaged with its role in communication, diagnosis and decision making. Beyond this issue, the present article highlights the interrelations between clinical judgement, therapy assessment and medical professionalism. Methods Literature review and theory development. Results The article presents different methodological approaches to causality assessment in clinical studies and in clinical judgement, and offers criteria for clinical single case causality. The article outlines models of medical professionalism such as technical rationality and practice epistemology, and characterizes features of professional expertise such as tacit knowledge, reflection in action, and gestalt cognition. Conclusions Consequences of a methodological and logistical advancement of clinical judgment are discussed, both in regard to medical progress and to the renewel of the cognitive basis of the medical profession. © 2010 Blackwell Publishing Ltd.


Hamre H.J.,Institute for Applied Epistemology and Medical Methodology | Witt C.M.,Charité - Medical University of Berlin | Glockmann A.,Institute for Applied Epistemology and Medical Methodology | Ziegler R.,Society for Cancer Research | And 3 more authors.
European Journal of Health Economics | Year: 2010

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 €7,129, €4,371, and €3,532 in the pre-study year (P = 0.008); €6,029, €3,522, and €3,353 in the first year (P = 0.083); and €4,929, €3,792, and €4,031 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.


PubMed | Institute for Applied Epistemology and Medical Methodology
Type: Journal Article | Journal: Explore (New York, N.Y.) | Year: 2011

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 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.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.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.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.


PubMed | Institute for Applied Epistemology and Medical Methodology
Type: | Journal: Drug target insights | Year: 2011

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.A prospective four-week observational cohort study was conducted in 21 primary care practices in Europe and the U.S.A. The cohort comprised 715 consecutive outpatients aged 1 month, treated by anthroposophic physicians for acute otitis and respiratory infections. Physicians prescription data and patient reports of adverse events were analyzed. Main outcome measures were use of AMED and ADR to AMED.two patients had confirmed ADR to AMED: 1) swelling and redness at the injection site after subcutaneous injections of Prunus spinosa 5%, 2) sleeplessness after intake of Pneumodoron() 2 liquid. These ADR lasted one and two days respectively; both subsided after dose reduction; none were unexpected; none were serious. The frequency of confirmed ADR to AMED was 0.61% (2/327) of all different AMED used, 0.28% (2/715) of patients, and 0.004% (3/73,443) of applications.In this prospective study, anthroposophic medications used by primary care patients with acute respiratory or ear infections were well tolerated.


PubMed | Institute for Applied Epistemology and Medical Methodology
Type: | Journal: Journal of asthma and allergy | Year: 2011

Anthroposophic treatment for asthma includes special artistic and physical therapies and special medications.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.Ninety patients (54 adults, 36 children) were included. Anthroposophic treatment modalities used were medications (88% of patients, n = 79/90); eurythmy therapy (22%); art therapy (10%); and rhythmical massage therapy (1%). Median number of eurythmy/art/massage sessions was 12 (interquartile range 10-20), median therapy duration was 120 days (84-184). From baseline to 12-month follow-up, all outcomes improved significantly (P < 0.001 for all comparisons). Average improvements were: average asthma severity 2.61 points (95% confidence interval CI: 1.90-3.32); cough 0.93 (95% CI: 0.60-1.25); dyspnea 0.92 (95% CI: 0.56-1.28); exertion-induced symptoms 0.95 (95% CI: 0.64-1.25); frequency of asthma attacks 0.78 (95% CI: 0.41-1.14); awakening from asthma 0.90 (95% CI: 0.58-1.21); AQLQ overall score 1.44 (95% CI: 0.97-1.92); and KINDL asthma module 14.74 (95% CI: 9.70-19.78). All improvements were maintained until last follow-up after 24 months.Patients with asthma under anthroposophic treatment had long-term improvements of symptoms and quality of life.


PubMed | Institute for Applied Epistemology and Medical Methodology
Type: | Journal: Journal of pain research | Year: 2011

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. We conducted a two-year follow-up analysis of the anthroposophic therapy group with a larger sample size.Seventy-five consecutive adult outpatients in Germany, starting anthroposophic treatment for discogenic or non-specific LBP of 6 weeks duration participated in a prospective cohort study. Main outcomes were Hanover Functional Ability Questionnaire (HFAQ; 0-100), LBP Rating Scale Pain Score (LBPRS; 0-100), Symptom Score (0-10), and SF-36 after 24 months.Eighty-five percent of patients were women. Mean age was 49.0 years. From baseline to 24-month follow-up all outcomes improved significantly; average improvements were: HFAQ 11.1 points (95% confidence interval [CI]: 5.5-16.6; p < 0.001), LBPRS 8.7 (95% CI: 4.4-13.0; p < 0.001), Symptom Score 2.0 (95% CI: 1.3-2.8; p < 0.001), SF-36 Physical Component Summary 6.0 (95% CI: 2.9-9.1; p < 0.001), and SF-36 Mental Component Summary 4.0 (95% CI: 1.1-6.8; p = 0.007).Patients with chronic LBP receiving anthroposophic treatment had sustained improvements of symptoms, back function, and quality of life, suggesting that larger multicenter rigorous studies may be worthwhile.

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