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Search Results: 1 - 10 of 324953 matches for " Gunver S Kienle "
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Safety of higher dosages of Viscum album L. in animals and humans - systematic review of immune changes and safety parameters
Gunver S Kienle, Renate Grugel, Helmut Kiene
BMC Complementary and Alternative Medicine , 2011, DOI: 10.1186/1472-6882-11-72
Abstract: Systematic review of all experiments and clinical studies investigating higher dosages of VAE in animals and humans (Viscum album > 1 mg in humans corresponding to > 0.02 mg/kg in animals or ML > 1 ng/kg) and assessing immune parameters or infections or adverse drug reactions.69 clinical studies and 48 animal experiments reported application of higher doses of VAE or ML and had assessed immune changes and/or harm. In these studies, Viscum album was applied in dosages up to 1500 mg in humans and 1400 mg/kg in animals, ML was applied up to 6.4 μg/kg in humans and in animals up to 14 μg/kg subcutaneously, 50 μg/kg nasally and 500 μg/kg orally. A variety of immune parameters showed fluctuating or rising outcomes, but no immunosuppressive effect. Side effects consisted mainly of dose-dependent flu-like symptoms (FLS), fever, local reactions at the injection site and various mild unspecific effects. Occasionally, allergic reactions were reported. After application of high doses of recombinant ML, reversible hepatotoxicity was observed in some cases.Application of higher dosages of VAE or ML is not accompanied by immunosuppression; altogether VAE seems to exhibit low risk but should be monitored by clinicians when applied in high dosages.Complementary cancer treatment is utilised by 15-73% of all cancer patients in Europe, in addition to well established oncological treatments [1]. Most of these complementary treatments are herbal remedies and among these, Viscum album L extracts (VAE, European mistletoe, a hemiparasitic shrub, not to be confused with the Phoradendron species or "American mistletoe") are frequently used [1]. Physicians in Germany consider VAE to have a relevant therapeutic benefit [2].VAE contains a variety of biologically active compounds. Of these, mistletoe lectins (ML I, II and III) have been most thoroughly investigated. ML consist of two polypeptide chains: a carbohydrate-binding B-chain that can bind to cell surface receptors and thus enable the pro
Viscum album L. extracts in breast and gynaecological cancers: a systematic review of clinical and preclinical research
Gunver S Kienle, Anja Glockmann, Michael Schink, Helmut Kiene
Journal of Experimental & Clinical Cancer Research , 2009, DOI: 10.1186/1756-9966-28-79
Abstract: Systematic review to evaluate clinical studies and preclinical research on the therapeutic effectiveness and biological effects of VAE on gynaecological and breast cancer. Search of databases, reference lists and expert consultations. Criteria-based assessment of methodological study quality.19 randomized (RCT), 16 non-randomized (non-RCT) controlled studies, and 11 single-arm cohort studies were identified that investigated VAE treatment of breast or gynaecological cancer. They included 2420, 6399 and 1130 patients respectively. 8 RCTs and 8 non-RCTs were embedded in the same large epidemiological cohort study. 9 RCTs and 13 non-RCTs assessed survival; 12 reported a statistically significant benefit, the others either a trend or no difference. 3 RCTs and 6 non-RCTs assessed tumour behaviour (remission or time to relapse); 3 reported statistically significant benefit, the others either a trend, no difference or mixed results. Quality of life (QoL) and tolerability of chemotherapy, radiotherapy or surgery was assessed in 15 RCTs and 9 non-RCTs. 21 reported a statistically significant positive result, the others either a trend, no difference, or mixed results. Methodological quality of the studies differed substantially; some had major limitations, especially RCTs on survival and tumour behaviour had very small sample sizes. Some recent studies, however, especially on QoL were reasonably well conducted. Single-arm cohort studies investigated tumour behaviour, QoL, pharmacokinetics and safety of VAE. Tumour remission was observed after high dosage and local application. VAE application was well tolerated. 34 animal experiments investigated VAE and isolated or recombinant compounds in various breast and gynaecological cancer models in mice and rats. VAE showed increase of survival and tumour remission especially in mice, while application in rats as well as application of VAE compounds had mixed results. In vitro VAE and its compounds have strong cytotoxic effects on ca
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
Harald J Hamre, Claudia M Witt, Gunver S Kienle, Anja Glockmann, Stefan N Willich, Helmut Kiene
BMC Research Notes , 2010, DOI: 10.1186/1756-0500-3-218
Abstract: 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,
Assessing the order of magnitude of outcomes in single-arm cohorts through systematic comparison with corresponding cohorts: An example from the AMOS study
Harald J Hamre, Anja Glockmann, Wilfried Tr?ger, Gunver S Kienle, Helmut Kiene
BMC Medical Research Methodology , 2008, DOI: 10.1186/1471-2288-8-11
Abstract: The therapy to be compared (anthroposophic medicine, a complementary therapy system) had been evaluated in one single-arm cohort study: the Anthroposophic Medicine Outcomes Study (AMOS). The five largest AMOS diagnosis groups (A-cohorts: asthma, depression, low back pain, migraine, neck pain) were compared to all retrievable corresponding cohorts (C-cohorts) receiving other therapies with identical outcomes (SF-36 scales or summary measures) and identical follow-up periods (3, 6 or 12 months). Between-group differences (pre-post difference in an A-cohort minus pre-post difference in the respective C-cohort) were divided with the standard deviation (SD) of the baseline score of the A-cohort.A-cohorts (5 cohorts with 392 patients) were similar to C-cohorts (84 cohorts with 16,167 patients) regarding age, disease duration, baseline affection and follow-up rates. A-cohorts had ≥ 0.50 SD larger improvements than C-cohorts in 13.5% (70/517) of comparisons; improvements of the same order of magnitude (small or minimal differences: -0.49 to 0.49 SD) were found in 80.1% of comparisons; and C-cohorts had ≥ 0.50 SD larger improvements than A-cohorts in 6.4% of comparisons. Analyses stratified by diagnosis had similar results. Sensitivity analyses, restricting the comparisons to C-cohorts with similar study design (observational studies), setting (primary care) or interventions (drugs, physical therapies, mixed), or restricting comparisons to SF-36 scales with small baseline differences between A- and C-cohorts (-0.49 to 0.49 SD) also had similar results.In this descriptive analysis, anthroposophic therapy was associated with SF-36 improvements largely of the same order of magnitude as improvements following other treatments. Although these non-concurrent comparisons cannot assess comparative effectiveness, they suggest that improvements in health status following anthroposophic therapy can be clinically meaningful. The analysis also demonstrates the value of a systematic appro
Outcome of anthroposophic medication therapy in chronic disease: A 12-month prospective cohort study
Harald J Hamre, Claudia M Witt, Anja Glockmann, Renatus Ziegler, Gunver S Kienle et al
Drug Design, Development and Therapy , 2008, DOI: http://dx.doi.org/10.2147/DDDT.S
Abstract: tcome of anthroposophic medication therapy in chronic disease: A 12-month prospective cohort study (3530) Total Article Views Authors: Harald J Hamre, Claudia M Witt, Anja Glockmann, Renatus Ziegler, Gunver S Kienle et al Published Date January 2008 Volume 2008:2 Pages 25 - 37 DOI: http://dx.doi.org/10.2147/DDDT.S Harald J Hamre1, Claudia M Witt2, Anja Glockmann1, Renatus Ziegler3, Gunver S Kienle1, Stefan N Willich2, Helmut Kiene1 1Institute for Applied Epistemology and Medical Methodology, Freiburg, Germany; 2Institute of Social Medicine, Epidemiology, and Health Economics, Charité University Medical Center, Berlin, Germany; 3Society for Cancer Research, Arlesheim, Switzerland 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.
Anthroposophic therapy for attention deficit hyperactivity: A two-year prospective study in outpatients
Harald J Hamre, Claudia M Witt, Gunver S Kienle, et al
International Journal of General Medicine , 2010, DOI: http://dx.doi.org/10.2147/IJGM.S11725
Abstract: nthroposophic therapy for attention deficit hyperactivity: A two-year prospective study in outpatients Original Research (3843) Total Article Views Authors: Harald J Hamre, Claudia M Witt, Gunver S Kienle, et al Published Date August 2010 Volume 2010:3 Pages 239 - 253 DOI: http://dx.doi.org/10.2147/IJGM.S11725 Harald J Hamre1, Claudia M Witt2, Gunver S Kienle1, Christoph Meinecke3, Anja Glockmann1, Renatus Ziegler4, Stefan N Willich2, Helmut Kiene1 1Institute for Applied Epistemology and Medical Methodology, Freiburg, Germany; 2Institute of Social Medicine, Epidemiology, and Health Economics, Charité University Medical Center, Berlin, Germany; 3Pediatric Consultant, Community Hospital Havelh he, Berlin, Germany; 4Society for Cancer Research, Arlesheim, Switzerland 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.
Long-term outcomes of anthroposophic therapy for chronic low back pain: A two-year follow-up analysis
Harald J Hamre, Claudia M Witt, Gunver S Kienle, Anja Glockmann, et al.
Journal of Pain Research , 2009, DOI: http://dx.doi.org/10.2147/JPR.S5922
Abstract: ng-term outcomes of anthroposophic therapy for chronic low back pain: A two-year follow-up analysis Original Research (5274) Total Article Views Authors: Harald J Hamre, Claudia M Witt, Gunver S Kienle, Anja Glockmann, et al. Published Date June 2009 Volume 2009:2 Pages 75 - 85 DOI: http://dx.doi.org/10.2147/JPR.S5922 Harald J Hamre1, Claudia M Witt2, Gunver S Kienle1, Anja Glockmann1, Renatus Ziegler3, Stefan N Willich2, Helmut Kiene1 1Institute for Applied Epistemology and Medical Methodology, Freiburg, Germany; 2Institute of Social Medicine, Epidemiology, and Health Economics, Charité University Medical Center, Berlin, Germany; 3Society for Cancer Research, Arlesheim, Switzerland 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.
Anthroposophic therapy for asthma: A two-year prospective cohort study in routine outpatient settings
Harald J Hamre, Claudia M Witt, Gunver S Kienle, et al
Journal of Asthma and Allergy , 2009, DOI: http://dx.doi.org/10.2147/JAA.S7184
Abstract: nthroposophic therapy for asthma: A two-year prospective cohort study in routine outpatient settings Original Research (5763) Total Article Views Authors: Harald J Hamre, Claudia M Witt, Gunver S Kienle, et al Published Date November 2009 Volume 2009:2 Pages 111 - 128 DOI: http://dx.doi.org/10.2147/JAA.S7184 Harald J Hamre1, Claudia M Witt2, Gunver S Kienle1, Christof Schnürer3, Anja Glockmann1, Renatus Ziegler4, Stefan N Willich2, Helmut Kiene1 1Institute for Applied Epistemology and Medical Methodology, Freiburg, Germany; 2Institute of Social Medicine, Epidemiology, and Health Economics, Charité University Medical Center, Berlin, Germany; 3Internal Medicine Practice, A Fraenkel Centrum, Badenweiler, Germany; 4Society for Cancer Research, Arlesheim, Switzerland 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. Results: 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. Conclusions: Patients with asthma under anthroposophic treatment had long-term improvements of symptoms and quality of life.
Anthroposophic therapy for attention deficit hyperactivity: A two-year prospective study in outpatients
Harald J Hamre,Claudia M Witt,Gunver S Kienle,et al
International Journal of General Medicine , 2010,
Abstract: Harald J Hamre1, Claudia M Witt2, Gunver S Kienle1, Christoph Meinecke3, Anja Glockmann1, Renatus Ziegler4, Stefan N Willich2, Helmut Kiene11Institute for Applied Epistemology and Medical Methodology, Freiburg, Germany; 2Institute of Social Medicine, Epidemiology, and Health Economics, Charité University Medical Center, Berlin, Germany; 3Pediatric Consultant, Community Hospital Havelh he, Berlin, Germany; 4Society for Cancer Research, Arlesheim, SwitzerlandBackground: 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.Keywords: anthroposophy, attention deficit disorder with hyperactivity, combined modality therapy, prospective studies, quality of life
Anthroposophic therapy for asthma: A two-year prospective cohort study in routine outpatient settings
Harald J Hamre,Claudia M Witt,Gunver S Kienle,et al
Journal of Asthma and Allergy , 2009,
Abstract: Harald J Hamre1, Claudia M Witt2, Gunver S Kienle1, Christof Schnürer3, Anja Glockmann1, Renatus Ziegler4, Stefan N Willich2, Helmut Kiene11Institute for Applied Epistemology and Medical Methodology, Freiburg, Germany; 2Institute of Social Medicine, Epidemiology, and Health Economics, Charité University Medical Center, Berlin, Germany; 3Internal Medicine Practice, A Fraenkel Centrum, Badenweiler, Germany; 4Society for Cancer Research, Arlesheim, SwitzerlandBackground: 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.Results: 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.Conclusions: Patients with asthma under anthroposophic treatment had long-term improvements of symptoms and quality of life.Keywords: anthroposophy, art therapy, asthma, combined modality therapy, drug therapy, eurythmy therapy, prospective studies, quality of life
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