Harald J. Hamre
Witten/Herdecke University
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Global advances in health and medicine : improving healthcare outcomes worldwide | 2013
Gunver S. Kienle; Hans-Ulrich Albonico; Erik Baars; Harald J. Hamre; Peter Zimmermann; Helmut Kiene
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.
Explore-the Journal of Science and Healing | 2011
Gunver S. Kienle; Hans-Ulrich Albonico; Lorenz Fischer; Martin Frei-Erb; Harald J. Hamre; Peter Heusser; Peter F. Matthiessen; Adrian Renfer; Helmut Kiene
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.
BMC Psychiatry | 2006
Harald J. Hamre; Claudia M. Witt; Anja Glockmann; Renatus Ziegler; Stefan N. Willich; Helmut Kiene
BackgroundDepressive 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.Methods97 outpatients from 42 medical practices in Germany participated in a prospective cohort study. Patients were aged 20–69 years and were referred to anthroposophic therapies (art, eurythmy movement exercises, or rhythmical massage) or started physician-provided anthroposophic therapy (counselling, medication) for depression: depressed mood, at least two of six further depressive symptoms, minimum duration six months, Center for Epidemiological Studies Depression Scale, German version (CES-D, range 0–60 points) of at least 24 points. Outcomes were CES-D (primary outcome) and SF-36 after 3, 6, 12, 18, 24, and 48 months. Data were collected from July 1998 to March 2005.ResultsMedian number of art/eurythmy/massage sessions was 14 (interquartile range 12–22), median therapy duration was 137 (91–212) days. All outcomes improved significantly between baseline and all subsequent follow-ups. Improvements from baseline to 12 months were: CES-D from mean (standard deviation) 34.77 (8.21) to 19.55 (13.12) (p < 0.001), SF-36 Mental Component Summary from 26.11 (7.98) to 39.15 (12.08) (p < 0.001), and SF-36 Physical Component Summary from 43.78 (9.46) to 48.79 (9.00) (p < 0.001). All these improvements were maintained until last follow-up. At 12-month follow-up and later, 52%–56% of evaluable patients (35%–42% of all patients) were improved by at least 50% of baseline CES-D scores. CES-D improved similarly in patients not using antidepressants or psychotherapy during the first six study months (55% of patients).ConclusionIn outpatients with chronic depression, anthroposophic therapies were followed by long-term clinical improvement. Although the pre-post design of the present study does not allow for conclusions about comparative effectiveness, study findings suggest that the anthroposophic approach, with its recourse to non-verbal and artistic exercising therapies can be useful for patients motivated for such therapies.
BMC Health Services Research | 2006
Harald J. Hamre; Claudia M. Witt; Anja Glockmann; Renatus Ziegler; Stefan N. Willich; Helmut Kiene
BackgroundAnthroposophic therapies (counselling, special medication, art, eurythmy movement, and rhythmical massage) aim to stimulate long-term self-healing processes, which theoretically could lead to a reduction of healthcare use. In a prospective two-year cohort study, anthroposophic therapies were followed by a reduction of chronic disease symptoms and improvement of quality of life. The purpose of this analysis was to describe health costs in users of anthroposophic therapies.Methods717 consecutive outpatients from 134 medical practices in Germany, starting anthroposophic therapies for chronic diseases, participated in a prospective cohort study. We analysed direct health costs (anthroposophic therapies, physician and dentist consultations, psychotherapy, medication, physiotherapy, ergotherapy, hospital treatment, rehabilitation) and indirect costs (sick leave compensation) in the pre-study year and the first two study years. Costs were calculated from resource utilisation, documented by patient self-reporting. Data were collected from January 1999 to April 2003.ResultsTotal health costs in the first study year (bootstrap mean 3,297 Euro; 95% confidence interval 95%-CI 3,157 Euro to 3,923 Euro) did not differ significantly from the pre-study year (3,186 Euro; 95%-CI 3,037 Euro to 3,711 Euro), whereas in the second year, costs (2,771 Euro; 95%-CI 2,647 Euro to 3,256 Euro) were significantly reduced by 416 Euro (95%-CI 264 Euro to 960 Euro) compared to the pre-study year. In each period hospitalisation and sick-leave together amounted to more than half of the total health costs. Anthroposophic therapies and medication amounted to 3%, 15%, and 8% of total health costs in the pre-study year, first year, and second study year, respectively. The cost reduction in the second year was largely accounted for by a decrease of inpatient hospitalisation, leading to a hospital cost reduction of 519 Euro (95%-CI 377 Euro to 904 Euro) compared to the pre-study year.ConclusionIn patients starting anthroposophic therapies for chronic disease, total health costs did not increase in the first year, and were reduced in the second year. This reduction was largely explained by a decrease of inpatient hospitalisation. Within the limits of a pre-post design, study findings suggest that anthroposophic therapies are not associated with a relevant increase in total health costs.
Drug Safety | 2006
Harald J. Hamre; Claudia M. Witt; Anja Glockmann; Wilfried Tröger; Stefan N. Willich; Helmut Kiene
AbstractBackground and objective: Anthroposophic medications (AMED) are prescribed by physicians in 56 countries worldwide and are used for the treatment of a variety of conditions. However, safety data on long-term use of AMED from large prospective studies are sparse. The objective of this analysis was to determine the frequency of patient-reported and physician-assessed adverse drug reactions (ADRs) to AMED in outpatients using AMED for chronic diseases over a 2-year period. Methods: We conducted a prospective observational cohort study involving 131 medical practices in Germany. In total, 662 consecutive outpatients aged 1–75 years were enrolled in the study. The patients were using AMED for mental (primarily depression and fatigue), musculoskeletal, respiratory, neurological and other chronic diseases. Main outcome measures were use of AMED and ADRs to AMED. Results: Throughout the 2-year follow-up, patients used 949 different AMED for a total of 11 487 patient-months. The origin of AMED was mineral (8.1%, 77 of 949 AMED), botanical (41.8%), zoological (7.8%), chemically defined (10.5%) and mixed (31.7%). Most frequently used AMED ingredients were Viscum album (11.5%, 76 of 662 patients), Bryophyllum (9.4%), Arnica (7.9%) and Silicea (7.7%). Non-AMED products were used by 94.2% of patients for a total of 11 202 patient-months; 45.2% of this use was accounted for by medication for the CNS, the cardiovascular system and the alimentary tract and metabolism.A total of 1861 adverse events (AEs) were documented. The most frequent AEs were non-specific symptoms, signs and findings (International Classification of Diseases [10th Edition] R00-R99: 27.6%, 513 of 1861 AEs), musculoskeletal (M00-M99: 16.9%), respiratory (J00-J99: 8.2%) and digestive diseases (K00-K93: 6.6%). No serious AEs attributable to any medication occurred. Out of the 1861 reported AEs, 284 (15.3%) AEs were suspected by the physician or the patient to be an adverse reaction to non-medication therapy (n = 42 AEs), non-AMED (n = 187) or AMED (n = 55 AEs in 29 patients). Twenty of these 29 patients had confirmed ADRs to 21 AMED. These ADRs were local reactions to topical application (n = 6 patients), systemic hypersensitivity (n = 1) and aggravation of pre-existing symptoms (n = 13). In ten patients, AMED was stopped due to ADRs; two patients had ADRs of severe intensity. Median number of days with ADRs was 7 (range 1–39 days). All ADRs subsided, none were serious. The frequency of confirmed ADRs to AMED was 2.2% (21 of 949) of all different AMED used, 3.0% (20 of 662) of AMED users and one ADR per 382 patient-months of AMED use. Conclusion: In this 2-year prospective study, AMED therapy was generally well tolerated.
Global advances in health and medicine : improving healthcare outcomes worldwide | 2013
Helmut Kiene; Harald J. Hamre; Gunver S. Kienle
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.
Breast Cancer: Basic and Clinical Research | 2009
Wilfried Tröger; Svetlana Jezdić; Zdravko Ždrale; nevena Tišma; Harald J. Hamre; Miodrag Matijašević
Background Chemotherapy for breast cancer often deteriorates quality of life, augments fatigue, and induces neutropenia. Mistletoe preparations are frequently used by cancer patients in Central Europe. Physicians have reported better quality of life in breast cancer patients additionally treated with mistletoe preparations during chemotherapy. Mistletoe preparations also have immunostimulant properties and might therefore have protective effects against chemotherapy-induced neutropenia. Patients and Methods We conducted a prospective randomized open label pilot study with 95 patients randomized into three groups. Two groups received Iscador® M special (IMS) or a different mistletoe preparation, respectively, additionally to chemotherapy with six cycles of cyclophosphamide, adriamycin, and 5-fluoro-uracil (CAF). A control group received CAF with no additional therapy. Here we report the comparison IMS (n = 30) vs. control (n = 31). Quality of life including fatigue was assessed with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30). Neutropenia was defined as neutrophil counts < 1,000/μl and assessed at baseline and one day before each CAF cycle. Results In the descriptive analysis all 15 scores of the EORTC-QLQ-C30 showed better quality of life in the IMS group compared to the control group. In 12 scores the differences were significant (p < 0.02) and nine scores showed a clinically relevant and significant difference of at least 5 points. Neutropenia occurred in 3/30 IMS patients and in 8/31 control patients (p = 0.182). Conclusions This pilot study showed an improvement of quality of life by treating breast cancer patients with IMS additionally to CAF. CAF-induced neutropenia showed a trend to lower frequency in the IMS group.
Journal of Evaluation in Clinical Practice | 2008
Harald J. Hamre; Anja Glockmann; Gunver S. Kienle; Helmut Kiene
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. Method We present a procedure for combined suppression of several bias factors, using two methods: sample restriction to patients unaffected by bias, and score adjustment. The procedure was used for a secondary analysis of disease score (doctors’ global rating, 0–10) in a cohort of patients receiving anthroposophic therapies for chronic diseases. Four bias factors were suppressed stepwise: attrition bias (by replacing missing values with the baseline value carried forward), bias from natural recovery (by sample restriction to patients with disease duration of ≥12 months), regression to the mean due to symptom-driven self-selection (by replacing baseline scores with scores three months before enrolment) and bias from adjunctive therapies (by sample restriction to patients not using adjunctive therapies). Results In the cohort analysed, these four bias factors could together explain a maximum of 37% of the 0- to 6-month improvement of disease score. Conclusion Combined bias suppression, using sample restriction and score adjustment, is a transparent procedure to minimize bias in single-arm therapy studies. Further applicability of the procedure should be tested in future studies.
Complementary Medicine Research | 2011
Gunver S. Kienle; Anja Glockmann; Renate Grugel; Harald J. Hamre; Helmut Kiene
Hintergrund und Fragestellung: 2005 wurde ein «Health Technology Assessment»(HTA)-Bericht zu Wirksamkeit, Sicherheit, Wirtschaftlichkeit und Bedarf der Anthroposophischen Medizin (AM) erstellt. Im Kontext des «Schweizer Volksvotums pro Komplementärmedizin» (Mai 2009) erfolgte ein Update des HTA-Berichts. Design: Update des HTA-Berichts durch eine systematische Übersichtsarbeit. Methoden: Das Update wurde in Anlehnung an den bereits vorhandenen HTA-Bericht sowie entsprechend den Vorgaben des Schweizer Bundesamtes für Gesundheit durchgeführt. Nach klinischen Studien wurde systematisch in vier Datenbanken, in einer spezialisierten Zeitschrift und mit Hilfe umfassender Expertenkontakte gesucht. Studien wurden nach vorab definierten Kriterien ausgewählt, die Daten extrahiert und die Qualität individuell überprüft. Ergebnisse: 70 neue klinische Studien zur Wirksamkeit wurden gefunden. Damit liegen derzeit insgesamt 265 klinische Studien zur AM vor: 38 randomisierte Studien, 36 prospektive und 49 retrospektive, nichtrandomisierte, vergleichende Studien sowie 90 prospektive und 52 retrospektive Studien ohne Kontrollgruppe. Die Studien untersuchten ein weites Spektrum an AM-Therapien bei einer Vielzahl von Erkrankungen; das Gesamtsystem der AM untersuchten 38 Studien, in 10 Studien ging es um nichtpharmakologische Therapien, 133 befassten sich mit Misteltherapie bei Krebs und 84 untersuchten sonstige AM-Arzneitherapien. Die Studien zeigten in der Mehrzahl ein positives Ergebnis für AM. Die methodische Qualität der Studien variierte sehr; einige wiesen erhebliche Schwächen auf, andere waren sorgfältig durchgeführt. Die Praxisrelevanz war überwiegend hoch. Bei Beschränkung auf die qualitativ besseren Studien ergab sich ein positives Ergebnis für die AM. Nebenwirkungen und Risiken waren selten und im Schweregrad meist mild oder mäßig. Studien zur Sicherheit zeigten eine insgesamt gute Verträglichkeit. Schlussfolgerung: Studien unterschiedlichen Designs und unterschiedlicher Qualität beschreiben bei einer Vielzahl von Erkrankungen ein für die AM medizinisch gutes und für die Patienten zufriedenstellendes, sicheres und vermutlich auch kostengünstiges Behandlungsergebnis. Weiterführende qualitativ hochwertige Evaluationen sind wünschenswert.
Journal of Pain Research | 2009
Harald J. Hamre; Claudia M. Witt; Gunver S. Kienle; Anja Glockmann; Renatus Ziegler; Stefan N. Willich; Helmut Kiene
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. We conducted a two-year follow-up analysis of the anthroposophic therapy group with a larger sample size. Methods 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. Results 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). Conclusion 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.