Thinking action as a performative and participative mental awareness.

This paper seeks to evaluate experiential facets of thinking action using first-person phenomenological methods. We begin our considerations using a simple mathematical proof as a case study-and also employ phenomenological contrasts between different types of thinking. They reveal that thinking actions produce performative insights rather than dispositional or remembered knowledge. This distinction allows us to introduce a new mode of thinking that is different from most known types of thinking, namely pure thinking action. The performative nature of this pure thinking action is participative and receptive with respect to concepts and has the quality of being persistent and coherent during its episode of action. Moreover, it is the often unattended source of thinking everyday life.

Overview of the Publications From the Anthroposophic Medicine Outcomes Study (AMOS): A Whole System Evaluation Study.

Anthroposophic medicine is a physician-provided complementary therapy system that was founded by Rudolf Steiner and Ita Wegman. Anthroposophic therapy includes special medicinal products, artistic therapies, eurythmy movement exercises, and special physical therapies. The Anthroposophic Medicine Outcomes Study (AMOS) was a prospective observational multicenter study of 1631 outpatients starting anthroposophic therapy for anxiety disorders, asthma, attention deficit hyperactivity disorder, depression, low back pain, migraine, and other chronic indications under routine conditions in Germany. AMOS INCORPORATED TWO FEATURES PROPOSED FOR THE EVALUATION OF INTEGRATIVE THERAPY SYSTEMS: (1) a sequential approach, starting with the whole therapy system (use, safety, outcomes, perceived benefit), addressing comparative effectiveness and proceeding to the major system components (physician counseling, anthroposophic medicinal products, art therapy, eurythmy therapy, rhythmical massage therapy) and (2) a mix of different research methods to build an information synthesis, including pre-post analyses, prospective comparative analyses, economic analyses, and safety analyses of individual patient data. AMOS fostered two methodological innovations for the analysis of single-arm therapy studies (combined bias suppression, systematic outcome comparison with corresponding cohorts in other studies) and the first depression cost analysis worldwide comparing primary care patients treated for depression vs depressed patients treated for another disorder vs nondepressed patients. A total of 21 peer-reviewed publications from AMOS have resulted. This article provides an overview of the main research questions, methods, and findings from these publications: anthroposophic treatment was safe and was associated with clinically relevant improvements in symptoms and quality of life without cost increase; improvements were found in all age, diagnosis, and therapy modality groups and were retained at 48-month follow-up; nonrespondent bias, natural recovery, regression to the mean, and adjunctive therapies together could explain a maximum of 37% of the improvement.

La medicina antroposófica es un sistema terapéutico complementario proporcionado por el médico que fue fundada por Rudolf Steiner e Ita Wegman. La terapia antroposófica incluye productos medicinales especiales, terapias artísticas, ejercicios de movimiento eurítmico y terapias físicas especiales. El estudio de los resultados de la medicina antroposófica (Anthroposophic Medicine Outcomes Study, AMOS) consistió en un estudio prospectivo observacional multicéntrico de 1631 pacientes ambulatorios que comenzaban la terapia antroposófica para trastornos de ansiedad, asma, trastorno de hiperactividad y déficit de atención, depresión, dolor lumbar, migraña y otras indicaciones crónicas bajo condiciones rutinarias en Alemania.AMOS incorporaba dos características propuestas para la evaluación de sistemas terapéuticos integrales: (1) un enfoque secuencial, comenzando con el sistema terapéutico completo (uso, seguridad, resultados, ventaja percibida), que aborda la eficacia comparativa y continúa con los componentes principales del sistema (asesoramiento del médico, productos medicinales antroposóficos, terapia artística, terapia eurítmica, terapia de masaje rítmico) y (2) una combinación de diferentes métodos de investigación para crear una síntesis de información, que incluye análisis previos y posteriores, análisis comparativos prospectivos, análisis económicos y análisis de la seguridad de los datos del paciente individual. AMOS fomentaba dos innovaciones metodológicas para el análisis de los estudios terapéuticos de un grupo único (supresión del sesgo combinado, comparación sistemática de resultados con las cohortes correspondientes en otros estudios) y el primer análisis a nivel mundial del coste de la depresión comparando pacientes de atención primaria tratados de depresión frente a pacientes deprimidos tratados por otro trastorno frente a pacientes no deprimidos.Ha resultado en un total de 21 publicaciones revisadas por expertos de AMOS. Este artículo proporciona una visión general de las principales cuestiones de investigación, métodos y los resultados de estas publicaciones: el tratamiento antroposófico era seguro y se asociaba a mejoras clínicamente relevantes en los síntomas y la calidad de vida sin aumento de los costes; se observaron mejoras en todos los grupos de edad, diagnóstico y modalidad de terapia y se mantuvieron en el seguimiento de 48 meses; el sesgo ajeno a los entrevistados, la recuperación natural, la regresión a la media y las terapias adyuvantes juntos podían explicar un máximo del 37 % de la mejoría.

Long-term outcomes of anthroposophic treatment for chronic disease: a four-year follow-up analysis of 1510 patients from a prospective observational study in routine outpatient settings.

BACKGROUND: Anthroposophic treatment includes special artistic and physical therapies and special medications. We here report an update to a previously published study of anthroposophic treatment for chronic diseases, including more patients and a longer follow up. The Anthroposophic Medicine Outcomes Study (AMOS) was a prospective observational cohort study of anthroposophic treatment for chronic indications in routine outpatient settings in Germany. Anthroposophic treatment was associated with improvements of symptoms and quality of life. Previous follow-up-analyses have been performed after 24 months or, in subgroups of patients enrolled in the period 1999-2001, after 48 months. We conducted a 48-month follow-up analysis of all patients enrolled in AMOS in the period 1999-2005. METHODS: 1,510 outpatients aged 1-75 years, starting anthroposophic treatment for chronic conditions in routine German outpatient settings, participated in a prospective cohort study. Main outcomes were Symptom Score (primary outcome, mean symptom severity on numerical rating scales), SF-36 Physical and Mental Component scores in adults, and disease-specific outcomes in the six most common diagnosis groups: asthma, anxiety disorders and migraine (numerical rating scales), depression (Center for Epidemiological Studies Depression Scale), attention deficit hyperactivity symptoms (FBB-HKS Total score), and low back pain (Hanover Functional Ability Questionnaire, Low Back Pain Rating Scale). RESULTS: Median disease duration at baseline was 3.5 years. From baseline to 48-month follow-up all ten outcomes improved significantly (p < 0.001 for all pre-post comparisons). Standardised Response Mean effect sizes were large (range 0.84-1.24 standard deviations) for seven comparisons, medium for two comparisons (SF-36 Mental Component: 0.60, Low Back Pain Rating Scale: 0.55), and small for one comparison (SF-36 Physical Component: 0.39). Symptom Score improved significantly with large effect sizes in adults and children, and in the four main anthroposophic therapy modality groups (art therapy, eurythmy therapy, rhythmical massage therapy, medical therapy). CONCLUSIONS: This 48-month follow-up analysis confirmed previous analyses from the AMOS study. Outpatients receiving anthroposophic treatment for chronic indications had sustained, clinically relevant improvements of symptoms and quality of life.

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.

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.

Mistletoe Preparation Iscador: Are there Methodological Concerns with Respect to Controlled Clinical Trials?

In Europe many cancer patients use complementary therapies, particularly mistletoe. Only a few controlled clinical trials have been performed with the mistletoe preparation Iscador as a complementary treatment for cancer, many of them with medium to low quality due to methodological shortcomings. Reasons for some quality concerns, particularly discontinuation of treatment and/or participation and premature termination are analyzed. Analysis is based on controlled clinical trials dealing with Iscador. Data stem from the archive of published and ongoing research of the <> (Society for Cancer Research) in Arlesheim, Switzerland. Controlled clinical studies with cancer patients that were started after 01.01.1990 or were not completed by then have been evaluated. Fifty-six controlled studies are documented, 24 of them randomized and 32 non-randomized. Nine of the randomized studies were done by matched-pair design, the others by conventional parallel group design; six of the last were terminated prematurely primarily for slow recruitment due to patient preferences and compliance of physicians. Patient and physician preference seem to be important factors limiting recruitment for randomized trials and hence implementation. This adds to the overall unwillingness of participation by patients with serious diseases. A well-balanced mix of designs using different research methods and outcomes is suggested combined with analyses, in countries where mistletoe therapy in general or Iscador in particular is unknown or not available.

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

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

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

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

Randomized and non-randomized prospective controlled cohort studies in matched pair design for the long-term therapy of corpus uteri cancer patients with a mistletoe preparation (Iscador).

BACKGROUND: Mistletoe preparations such as Iscador are in common use as complementary/anthroposophic medications for many cancer indications, particularly for solid cancers. Efficacy of this complementary therapy is still discussed controversially. OBJECTIVE: Does the long-term therapy with Iscador show any effect on survival or psychosomatic self-regulation of patients with corpus uteri cancer? PATIENTS AND METHODS: Prospective recruitment and long-term follow-up in the following 4 controlled cohort studies. (1) Two randomized matched-pairs studies: corpus uteri cancer patients without (30 pairs) and with distant metastases (26 pairs) that never used any kind of mistletoe therapy were matched for prognostic factors. By pairwise random allocation, one of the patients was suggested mistletoe therapy to be applied by the attending physician. (2) Two non-randomized matched-pairs studies: corpus uteri cancer patients without (103 pairs) and with distant metastases (95 pairs) that already received mistletoe (Iscador) therapy were matched by the same criteria to control patients without Iscador therapy. RESULTS: Concerning overall survival in the randomized studies, a significant effect in favour of Iscador therapy was present only in the first study, the second showed no evidence for an effect: estimate of the hazard ratio and 95% confidence interval: 0.36 (0.16, 0.82) and 1.00 (0.46, 2.16) respectively. In the non-randomized studies, the results that adjusted for relevant prognostic variables were: 0.41 (0.26, 0.63), and 0.61 (0.39, 0.93). The effect of therapy with Iscador within 12 months on psychosomatic self-regulation as a measure of autonomous coping with the disease shows a significant rise in the Iscador group against the control group in the randomized as well as in the non-randomized study on patients with corpus uteri cancer without metastases: estimate of the median difference and 95% confidence interval: 0.40 (0.15, 0.70) and 0.70 (0.25, 1.15) respectively. CONCLUSION: The mistletoe preparation Iscador in these studies has the effect of prolonging overall survival of corpus uteri cancer patients. Psychosomatic self-regulation as a measure of autonomous coping with the disease, rises significantly more under Iscador therapy than under conventional therapy alone.

Prospective controlled cohort studies on long-term therapy of ovairian cancer patients with mistletoe (Viscum album L.) extracts iscador.

BACKGROUND: Mistletoe extracts such as Iscador are commonly used as complementary/anthroposophic medications for many cancer indications, particularly for solid cancers. The efficacy of this complementary therapy is still controversial. OBJECTIVE: Does long-term therapy with mistletoe extracts Iscador show any effect on survival and psychosomatic self-regulation of patients with ovarian cancer? PATIENTS AND METHODS: Prospective recruitment and long-term follow-up in controlled cohort studies. (1) Two randomized matched-pair studies: OvarRand (ovarian cancer patients without distant metastases; 21 pairs) and OvarMetRand (ovarian cancer patients with distant metastases; 20 pairs); patients having no mistletoe therapy were matched for prognostic factors. By paired random allocation, one of the patients of each pair was suggested therapy with mistletoe extracts Iscador to be applied by her attending physician. (2) Two non-randomized matched-pair studies: Ovar (ovarian cancer patients without distant metastases; 75 pairs) and OvarRand (ovarian cancer patients with distant metastases; 62 pairs); patients that already received therapy with mistletoe extracts Iscador were matched by the same criteria to control patients without therapy with mistletoe extracts Iscador. RESULTS: For overall survival in the randomized studies, the effect in favor of therapy with mistletoe extracts Iscador was significant in OvarMetRand but not in OvarRand; hazard ratio estimate and 95% confidence interval: 0.40 (0.15, 1.03) and 0.33 (0.12, 0.92), respectively. In the non-randomized studies Ovar and OvarMet, the results adjusted for relevant prognostic variables were 0.47 (0.31, 0.69) and 0.62 (0.37, 1.05). Psychosomatic self-regulation in the Iscador group increases significantly within 12 months on a scale from 1 to 6 compared with the control group in the randomized study OvarRand as well as in the non-randomized study Ovar on patients with ovarian cancer without distant metastases; estimate of the median difference and 95% confidence interval: 0.58 (0.30, 0.90) and 0.30 (0.05, 0.65), respectively. CONCLUSION: Mistletoe extracts Iscador might have the effect of prolonging overall survival of ovarian cancer patients. In the short term, psychosomatic self-regulation increases more markedly under Iscador therapy than under conventional therapy alone.

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

OBJECTIVE: Rhythmical massage therapy is used in 24 countries but has not yet been studied in outpatient settings. The objective was to study clinical outcomes in patients receiving rhythmical massage therapy for chronic diseases. DESIGN: Prospective 4-year cohort study. SETTING: Thirty-six (36) medical practices in Germany. PARTICIPANTS: Eighty-five (85) outpatients referred to rhythmical massage therapy. OUTCOME MEASURES: Disease and Symptom Scores (physicians' and patients' assessment, respectively, 0-10) and SF-36. Disease Score was measured after 6 and 12 months, and other outcomes after 3, 6, 12, 18, 24, and 48 months. RESULTS: Most common indications were musculoskeletal diseases (45% of patients; primarily back and neck pain) and mental disorders (18%, primarily depression and fatigue). Median disease duration at baseline was 2.0 years (interquartile range 0.5-6.0). Median number of rhythmical massage therapy sessions was 12 (interquartile range 9-12), and median therapy duration was 84 (49-119) days. All outcomes improved significantly between baseline and all subsequent follow-ups. From baseline to 12 months, Disease Score improved from (mean +/- standard deviation) 6.30 +/- 2.01 to 2.77 +/- 1.97 (p < 0.001), Symptom Score improved from 5.76 +/- 1.81 to 3.13 +/- 2.20 (p < 0.001), SF-36 Physical Component score improved from 39.55 +/- 9.91 to 45.17 +/- 9.88 (p < 0.001), and SF-36 Mental Component score improved from 39.27 +/- 13.61 to 43.78 +/- 12.32 (p = 0.028). All these improvements were maintained until the last follow-up. Adverse reactions to rhythmical massage therapy occurred in 4 (5%) patients; 2 patients stopped therapy because of adverse reactions. CONCLUSIONS: Patients receiving rhythmical massage therapy had long-term reduction of chronic disease symptoms and improvement of quality of life.

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

BACKGROUND: Anthroposophic art therapy (painting, clay modeling, music, and speech exercises) is used in 28 countries but has not yet been studied in primary care. OBJECTIVE: To study clinical outcomes in patients treated with anthroposophic art therapy for chronic diseases. DESIGN: Prospective cohort study. SETTING: Fifty-four medical practices in Germany. PARTICIPANTS AND INTERVENTIONS: One hundred sixty-one consecutive outpatients (primary care: n = 150), aged 5-71 years, were treated by 52 different art therapists. MAIN OUTCOME MEASURES: Disease and symptom scores (physician and patient assessment, respectively, 0-10) and quality of life (adults: SF-36 Health Survey, children: KINDL Questionnaire for Measuring Health-Related Quality of Life in Children and Adolescents). Outcomes were measured after 3, 6, 12, 18, and 24 months; SF-36 and symptom scores were also measured after 48 months. RESULTS: Most common indications were mental disorders (60.9% of patients, primarily depression, fatigue, and anxiety) and neurological diseases (6.8%). The median number of therapy sessions was 15; median therapy duration was 161 days. All outcomes except KINDL improved significantly between baseline and all subsequent follow-ups. Improvements from baseline to 12 months were: disease score from (mean +/- standard deviation) 6.69 +/- 1.72 to 2.46 +/- 1.90 (P < .001), symptom score from 5.99 +/- 1.69 to 3.40 +/- 2.08 (P < .001), SF-36 physical component summary measure from 44.12 +/- 10.03 to 48.68 +/- 9.47 (P < .001), and SF-36 mental component summary measure from 35.07 +/- 12.23 to 42.13 +/- 11.51 (P < .001). All these improvements were maintained until last follow-up. CONCLUSION: Patients receiving anthroposophic art therapy had long-term reduction of chronic disease symptoms and improvement of quality of life.

Prospective controlled cohort studies on long-term therapy of cervical cancer patients with a mistletoe preparation (Iscador).

BACKGROUND: Mistletoe preparations such as Iscador are commonly used in complementary medication for many cancer indications, particularly solid cancers. The efficacy of this complementary therapy is still controversial. OBJECTIVE: Does longterm therapy with Iscador show any effect on survival, tumor progression and psychosomatic self-regulation of patients with cervical cancer? PATIENTS AND METHODS: Prospective recruitment and long-term follow-up was carried out in 3 controlled cohort studies: In a randomized matched-pair study (19 pairs), cervical cancer patients with distant metastases and no mistletoe therapy were matched for prognostic factors. By paired random allocation, one of the patients was recommended mistletoe therapy by the attending physician. In 2 non-randomized matched-pair studies, cervical cancer patients without (102) and with (66) metastases, who already received mistletoe therapy, were matched with control patients without Iscador therapy. RESULTS: For survival, the non-randomized studies showed significant effects in favor of Iscador therapy: hazard ratio (HR) estimate and 95% confidence interval (CI): 0.23 (0.14-0.39) and 0.37 (0.17-0.80), respectively. An effect of long-term Iscador therapy on tumor progression was not seen. Psychosomatic self-regulation in the Iscador group improved significantly within 12 months compared with the control group in the randomized as well as in 1 non-randomized study (cervical cancer without metastases): estimate of the median difference and 95% CI: 0.70 (0.15-1.05) and 0.25 (0.15-0.35), respectively. CONCLUSION: Iscador may have the effect of prolonging overall survival of cervical cancer patients. In the short term, psychosomatic self-regulation increases more markedly under complementary Iscador therapy than under conventional therapy alone.

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

BACKGROUND: The short consultation length in primary care is a source of concern, and the wish for more consultation time is a common reason for patients to seek complementary medicine. Physicians practicing anthroposophic medicine have prolonged consultations with their patients, taking an extended history, addressing constitutional, psychosocial, and biographic aspect of patients' illness, and selecting optimal therapy. In Germany, health benefit programs have included the reimbursement of this additional physician time. The purpose of this study was to describe clinical outcomes in patients with chronic diseases treated by anthroposophic physicians after an initial prolonged consultation. METHODS: In conjunction with a health benefit program in Germany, 233 outpatients aged 1-74 years, treated by 72 anthroposophic physicians after a consultation of at least 30 min participated in a prospective cohort study. Main outcomes were disease severity (Disease and Symptom Scores, physicians' and patients' assessment on numerical rating scales 0-10) and quality of life (adults: SF-36, children aged 8-16: KINDL, children 1-7: KITA). Disease Score was documented after 0, 6 and 12 months, other outcomes after 0, 3, 6, 12, 18, 24, and (Symptom Score and SF-36) 48 months. RESULTS: Most common indications were mental disorders (17.6% of patients; primarily depression and fatigue), respiratory diseases (15.5%), and musculoskeletal diseases (11.6%). Median disease duration at baseline was 3.0 years (interquartile range 0.5-9.8 years). The consultation leading to study enrolment lasted 30-60 min in 51.5% (120/233) of patients and > 60 min in 48.5%. During the following year, patients had a median of 3.0 (interquartile range 1.0-7.0) prolonged consultations with their anthroposophic physicians, 86.1% (167/194) of patients used anthroposophic medication. All outcomes except KITA Daily Life subscale and KINDL showed significant improvement between baseline and all subsequent follow-ups. Improvements from baseline to 12 months were: Disease Score from mean (standard deviation) 5.95 (1.74) to 2.31 (2.29) (p < 0.001), Symptom Score from 5.74 (1.81) to 3.04 (2.16) (p < 0.001), SF-36 Physical Component Summary from 44.01 (10.92) to 47.99 (10.43) (p < 0.001), SF-36 Mental Component Summary from 42.34 (11.98) to 46.84 (10.47) (p < 0.001), and KITA Psychosoma subscale from 62.23 (19.76) to 76.44 (13.62) (p = 0.001). All these improvements were maintained until the last follow-up. Improvements were similar in patients not using diagnosis-related adjunctive therapies within the first six study months. CONCLUSION: Patients treated by anthroposophic physicians after an initial prolonged consultation had long-term reduction of chronic disease symptoms and improvement of quality of life. Although the pre-post design of the present study does not allow for conclusions about comparative effectiveness, study findings suggest that physician-provided anthroposophic therapy may play a beneficial role in the long-term care of patients with chronic diseases.

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

BACKGROUND: Many patients with chronic diseases use complementary therapies, often provided by their physicians. In Germany, several physician-provided complementary therapies have been reimbursed by health insurance companies as part of health benefit programs. In most of these therapies, the patient has a predominantly passive role. In eurythmy therapy, however, patients actively exercise specific movements with the hands, the feet or the whole body. The purpose of this study was to describe clinical outcomes in patients practising eurythmy therapy exercises for chronic diseases. METHODS: In conjunction with a health benefit program, 419 outpatients from 94 medical practices in Germany, referred to 118 eurythmy therapists, participated in a prospective cohort study. Main outcomes were disease severity (Disease and Symptom Scores, physicians' and patients' assessment on numerical rating scales 0-10) and quality of life (adults: SF-36, children aged 8-16: KINDL, children 1-7: KITA). Disease Score was documented after 0, 6 and 12 months, other outcomes after 0, 3, 6, 12, 18, 24, and (SF-36 and Symptom Score) 48 months. RESULTS: Most common indications were mental disorders (31.7% of patients; primarily depression, fatigue, and childhood emotional disorder) and musculoskeletal diseases (23.4%). Median disease duration at baseline was 3.0 years (interquartile range 1.0-8.5). Median number of eurythmy therapy sessions was 12 (interquartile range 10-19), median therapy duration was 119 days (84-188). All outcomes improved significantly between baseline and all subsequent follow-ups (exceptions: KITA Psychosoma in first three months and KINDL). Improvements from baseline to 12 months were: Disease Score from mean (standard deviation) 6.65 (1.81) to 3.19 (2.27) (p < 0.001), Symptom Score from 5.95 (1.75) to 3.49 (2.12) (p < 0.001), SF-36 Physical Component Summary from 43.13 (10.25) to 47.10 (9.78) (p < 0.001), SF-36 Mental Component Summary from 38.31 (11.67) to 45.01 (11.76) (p < 0.001), KITA Psychosoma from 69.53 (15.45) to 77.21 (13.60) (p = 0.001), and KITA Daily Life from 59.23 (21.78) to 68.14 (18.52) (p = 0.001). All these improvements were maintained until the last follow-up. Improvements were similar in patients not using diagnosis-related adjunctive therapies within the first six study months. Adverse reactions to eurythmy therapy occurred in 3.1% (13/419) of patients. No patient stopped eurythmy therapy due to adverse reactions. CONCLUSION: Patients practising eurythmy therapy exercises had long-term improvement of chronic disease 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 eurythmy therapy can be useful for patients motivated for this therapy.

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

BACKGROUND: Depressive disorders are common, cause considerable disability, and do not always respond to standard therapy (psychotherapy, antidepressants). Anthroposophic treatment for depression differs from ordinary treatment in the use of artistic and physical therapies and special medication. We studied clinical outcomes of anthroposophic therapy for depression. METHODS: 97 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. RESULTS: Median 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). CONCLUSION: In 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.

Randomised and non-randomised prospective controlled cohort studies in matched-pair design for the long-term therapy of breast cancer patients with a mistletoe preparation (Iscador): a re-analysis.

OBJECTIVE: Expanded presentation and re-analysis of previously published data of randomized and non-randomized studies on mistletoe therapy with breast cancer patients [3, 4]. The main question is: Does a re-analysis confirm the previously reported effects of prolonging the survival of patients with breast cancer under long-term application of a complementary/anthroposophic therapy with the European mistletoe preparation Iscador? DATA SOURCES: (1) Randomised matched-pairs study: Breast cancer patients with only lymphatic metastases (17 pairs) that had never used mistletoe therapy were matched for several prognostic factors. By paired random allocation, one patient of a pair received a suggestion of mistletoe therapy to be applied by the attending physician. (2) Non-randomised matched-pairs studies: Patients that had already received mistletoe (Iscador) therapy were matched to control patients from the same pool using the same prognostic criteria. Three groups were recruited by this procedure: breast cancer with local recurrences and no metastases (42 pairs), breast cancer with only lymphatic metastases (55 pairs), and breast cancer with distant metastases (83 pairs). ANALYSIS: Cox proportional hazard models and sensitivity analyses based on subsets of the original data sets according to strict or lose application of the matching criteria. RESULTS: The results of this re-analysis are consistent with the earlier results, even when comparing different methods and subsets. In the randomised study, the effect of long-term Iscador therapy on overall survival is significantly in favour of the Iscador therapy: Estimate of the median difference and 95 % confidence interval in years 2.5 (0.83, 4.50). The results for the non-randomised studies were also in favour of the Iscador therapy: Breast cancer with local recurrences and no metastases: estimate of hazard ratio and 95 % confidence interval 0.52 (0.23, 1.17); breast cancer with lymphatic metastases: 0.27 (0.15, 0.50); breast cancer with distant metastases: 0.53 (0.32, 0.88). As a short-term effect of this therapy, psychosomatic self-regulation noticeably increases within 3 months in the Iscador group in comparison to the control group in the randomised study: estimate of the median difference 0.90 (0, 1.75). CONCLUSION: The re-analysis demonstrates that the effects shown in the previously published data are consistent despite using different analytic methods and different subsets. Overall, the survival of patients receiving mistletoe treatment with Iscador is longer in these studies. In the short term, psychosomatic self-regulation, as a measure of autonomous coping with the disease, rises more under Iscador therapy than under conventional therapy alone.

Prospective controlled cohort studies on long-term therapy of breast cancer patients with a mistletoe preparation (Iscador).

BACKGROUND: Mistletoe preparations such as Iscador (Weleda, Schwäbisch Gmünd, Germany) are commonly used in complementary and alternative / anthroposophic medicine for many cancer indications, particularly for solid cancers. Efficacy of this complementary therapy is still controversial. OBJECTIVE: Does long-term therapy with Iscador show any effect on survival, tumor progression and psychosomatic self-regulation of patients with breast cancer? PATIENTS AND METHODS: Prospective recruitment and long-term follow-up of two controlled cohort studies: (1) Randomized matched-pair study (38 pairs): breast cancer patients without any recurrences or metastases and no mistletoe therapy were matched for prognostic factors. By pairwise random allocation, one of the patients was suggested mistletoe therapy to be applied by the attending physician. (2) Non-randomized matched-pair study (84 pairs): breast cancer patients without recurrences or metastases that already received mistletoe therapy were matched to control patients without Iscador therapy. RESULTS: For overall survival, the nonrandomized study shows significant effects in favor of Iscador therapy: hazard ratio HR estimate and 95% confidence interval CI: 0.43 (0.27-0.68). The effect of long-term Iscador therapy on tumor progression as measured by the time to local recurrences, lymphatic or distant metastases in breast cancer patients without any such events at first diagnosis, is in most cases significant in favor of the Iscador group, in the randomized as well as in the non-randomized study. Psychosomatic self-regulation in the Iscador group improves significantly within 12 months compared with the control group in the randomized as well as in the non-randomized study: estimate of the median difference and 95% CI: 0.35 (0.05-0.60), respectively 0.20 (0-0.35). CONCLUSION: Iscador shows a clinically relevant effect on breast tumor progression as measured by overall survival as well as by the time to recurrences, lymphatic or distant metastases. In the short term, psychosomatic self-regulation increases more markedly under complementary Iscador therapy than under conventional therapy alone.