Search

Introduction: The aim of this study was to explore the therapeutic process between contemporary spiritual healers and their clients in Germany., Methods: This prospective observational case study was supported by questionnaires and semi-structured interviews with clients and healers from the first encounter through a period of 6 months. The qualitative analysis is based on a directed content analysis with focus in this article on the results relating to the therapeutic process., Results: Seven healers and seven clients were included, and 22 interviews with healers and 20 interviews with clients were conducted. The first treatment session was perceived as laying a foundation for the therapeutic process and the relationship, which was seen as crucial for healing to take place. Healers perceived the therapeutic process as highly individualized and multi-layered, with the perceived effects of spiritual healing sessions layered upon each other. The capacities to connect and to trust were seen as key elements of the healing process. Trust and connection operate multidimensionally: to oneself, to others, and to a transcendent or spiritual source. Clients' spiritual attitudes were regarded as fundamental resources., Conclusion: The therapeutic process between spiritual healers and their clients was understood as a dynamic and individual activity, building up on a trustful relationship from the first encounter., (© 2022 The Author(s). Published by S. Karger AG, Basel.)

Background: Integrative Medicine (IM) training programs in oncology lacked standardized education core competencies to ensure the practical relevance of its learning content and objectives. In a previous international and interprofessional consensus procedure, core competencies were developed for health professionals working in Integrative Oncology (IO). However, the transferability of the developed core competencies to IO physicians working in Germany has not yet been verified. The overall aim of this survey study as part of the KOKON Project (Kompetenznetzwerk Komplementärmedizin in der Onkologie; Competence Network Complementary Medicine in Oncology) was to investigate if the international core competencies developed for IO for a broader group of health professionals are suitable for physicians in Germany., Material and Methods: Paper-pencil and digital questionnaires were distributed amongst various stakeholder groups (cancer patients and representatives; IO physicians; members of IM organization and IM researchers; multipliers of cancer support groups). The stakeholders were asked to rate the 37 core competencies developed according to their importance for the respective stakeholder group (not important, moderately, very important). Analyses were conducted using a 60% agreement threshold for medium to highly important competencies and 50% agreement threshold for highly important competencies., Results: We contacted different persons from various stakeholder groups (n > 370) with a survey response rate of 55.5-68.4% (n = 271) depending on the respective stakeholder group. Using the 50% agreement threshold, all competencies were accepted by the stakeholder groups. 27 competencies were considered very important by 60% of the survey participants. In particular, cancer patients and cancer support groups showed similar results., Conclusion: The list of developed international core competencies for IM health professionals seems to be suitable for physicians providing IO in Germany according to different stakeholder groups. The implementation of competencies can support the development of evidence-based, patient-centered training programs for physicians., (© 2022 The Author(s). Published by S. Karger AG, Basel.)

Aim: To explore the current practice of stakeholder engagement in clinical trials and its evaluation in North America (USA and Canada), DACH countries (Germany, Austria and Switzerland) and China. Participants & methods: We conducted a web-based, anonymous, international, cross-sectional online survey for clinical researchers. Data were analyzed using descriptive and explorative statistical analysis including analysis of variance and analysis of covariance. Results: Stakeholder engagement is more prominent and higher accepted among researchers in North America. Researchers in DACH countries have less knowledge of the stakeholder engagement method and are less likely to apply it. Conclusion: Stakeholder engagement is perceived very differently among participants from DACH countries, North America and China. For a broader acceptance and implementation institutional support and motivational conditions might be needed.

Background: A number of German statutory health insurance companies are offering integrated care contracts for homeopathy (ICCHs) that cover the reimbursement of homeopathic treatment. The effectiveness and cost-effectiveness of these contracts are highly debated., Methods: To evaluate the effectiveness and cost-effectiveness of treatment after an additional enrollment in an ICCH, a comparative, prospective, observational study was conducted in which participants in the ICCH (HOM group) were compared with matched (on diagnosis, sex and age) insured individuals (CON group) who received usual care alone. Those insured with either migraine or headache, allergic rhinitis, asthma, atopic dermatitis and depression were included. Primary effectiveness outcomes were the baseline adjusted scores of diagnosis-specific questionnaires (e.g. RQLQ, AQLQ, DLQI, BDI-II) after 6 months. Primary cost-effectiveness endpoints were the baseline adjusted total costs from an insurer perspective in relation to the achieved quality-adjusted life years (QALYs). Costs were derived from health claims data and QALYs were calculated based on SF-12 data., Results: Data from 2524 participants (1543 HOM group) were analyzed. The primary effectiveness outcomes after six months were statistically significant in favor of the HOM group for migraine or headache (Δ = difference between groups, days with headache: - 0.9, p = 0.042), asthma (Δ-AQLQ(S): + 0.4, p = 0.014), atopic dermatitis (Δ-DLQI: - 5.6, p ≤ 0.001) and depression (Δ-BDI-II: - 5.6, p ≤ 0.001). BDI-II differences reached the minimal clinically important difference. For all diagnoses, the adjusted mean total costs over 12 months were higher in the HOM group from an insurer perspective, with migraine or headache, atopic dermatitis and depression suggesting cost-effectiveness in terms of additional costs per QALY gained., Conclusion: After an additional enrollment in the ICCH, the treatment of participants with depression showed minimally clinically relevant improvements. From an insurer perspective, treatment with an ICCH enrollment resulted in higher costs over all diagnoses but seemed to be cost-effective for migraine or headache, atopic dermatitis and depression according to international used threshold values. Based on the study design and further limitations, our findings should be considered cautiously and no conclusions regarding the effectiveness of specific treatment components can be made. Further research is needed to overcome limitations of this study and to confirm our findings., Trial Registration: clinicaltrials.gov , NCT01854580. Registered 15 March 2013 - Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT01854580.

Background: The unmonitored use of complementary medicine in patients with cancer can be associated with an increased risk of safety-related issues, such as lower adherence to conventional cancer therapies. Training oncology physicians to advise their patients about the effectiveness and safety of these therapies could improve this situation., Methods: The objective of this study was to develop and pretest a consultation framework that has high potential to be widely implemented. The framework comprises: 1) a systematically developed and tested, manualized, guided consultation; and 2) blended learning training (e-learning and communication skills training workshop) to upskill oncology physicians in advising their patients on complementary and integrative medicine (CIM). For this implementation study, mixed methods were used to develop the manual (literature review, consensus procedure, pilot testing) and the training (questionnaires and interviews with oncology physicians and patients with cancer and an examination of the skills in a setting with standardized patients)., Results: The training was tested with 47 oncology physicians from across Germany. The manual-guided consultation (context: general information on the setting and communication techniques; inform: consultation duration and content; capture: previous CIM use; prioritize: focus on consultation; advise: evidence-based CIM recommendations; discuss, advise, accept, or advise against other CIM; concretize advice: summary and implementation; and monitor: documentation) was considered suitable. The structure and time frame (maximum, 20 minutes) of the consultation as well as the training were feasible and well accepted., Conclusions: The current study demonstrates that the KOKON-KTO framework (a German acronym for Competence Network for Complementary Medicine - Consultation Training for Oncology Physicians) is suitable for training oncology physicians. Its implementation can lead to better physician-patient communication about CIM in cancer., (© 2020 The Authors. Cancer published by Wiley Periodicals, Inc. on behalf of American Cancer Society.)

Background: Primary dysmenorrhea is a common condition in women of reproductive age. A previous app-based study undertaken by our group demonstrated that a smartphone app supporting self-acupressure introduced by a health care professional can reduce menstrual pain., Objective: This study aims to evaluate whether a specific smartphone app is effective in reducing menstrual pain in 18- to 34-year-old women with primary dysmenorrhea in a self-care setting. One group of women has access to the full-featured study app and will be compared with 2 control groups who have access to fewer app features. Here, we report the trial design, app development, user access, and engagement., Methods: On the basis of the practical implications of the previous app-based study, we revised and reengineered the study app and included the ResearchKit (Apple Inc) framework. Behavior change techniques (BCTs) were implemented in the app and validated by expert ratings. User access was estimated by assessing recruitment progress over time. User evolution and baseline survey respondent rate were assessed to evaluate user engagement., Results: The development of the study app for a 3-armed randomized controlled trial required a multidisciplinary team. The app is accessible for the target population free of charge via the Apple App Store. In Germany, within 9 months, the app was downloaded 1458 times and 328 study participants were recruited using it without external advertising. A total of 98.27% (5157/5248) of the app-based baseline questions were answered. The correct classification of BCTs used in the app required psychological expertise., Conclusions: Conducting an innovative app study requires multidisciplinary effort. Easy access and engagement with such an app can be achieved by recruitment via the App Store. Future research is needed to investigate the determinants of user engagement, optimal BCT application, and potential clinical and self-care scenarios for app use., Trial Registration: ClinicalTrials.gov NCT03432611; https://clinicaltrials.gov/ct2/show/NCT03432611 (Archived by WebCite at http://www.webcitation.org/75LLAcnCQ)., (©Jiani Wang, Alizé A Rogge, Mike Armour, Caroline A Smith, Christopher R D’Adamo, Claudia R Pischke, Hung-Rong Yen, Mei-Yao Wu, Ari Ojeda Ocampo Moré, Claudia M Witt, Daniel Pach. Originally published in JMIR mHealth and uHealth (http://mhealth.jmir.org), 11.02.2020.)

Background: The German Cancer Aid set up a priority research programme with the intention to generate high-quality information based on evidence and to make this information easily accessible for health-care professionals and advisors, researchers, patients, and the general public., Summary: The Kompetenznetz Komplementärmedizin in der Onkologie (KOKON) received 2 funding periods within this programme. During the first funding period, KOKON assessed patients' and health-care professionals' informational needs, developed a consulting manual for physicians, developed an education programme for self-help groups, set up a knowledge database, and developed a pilot information website for patients. Funding period 2 continues with work that allows cancer patients and health-care professionals to make informed decisions about complementary and alternative medicine (CAM). For this aim, KOKON evaluates training programmes for physicians (oncology physicians, paediatric oncologists, and general practitioners) and for self-help groups. All training programmes integrate results from an analysis of the ethical, psychological, and medical challenges of CAM in the medical encounter, and the knowledge database is being extended with issues related to CAM for supportive and palliative care. Key Message: A Germany-wide collaborative research project to identify needs, provide information, foster communication, and support decision-making about CAM in oncology is being set up., (© 2019 S. Karger AG, Basel.)

Background: Many cancer patients are interested in complementary and integrative medicine during and after regular cancer treatment. Given the high number of users it is important that physicians and patients engage in a dialog about useful complementary and integrative medicine therapies during cancer treatment. In a prospective, multi-center, cluster-randomized evaluation study we will develop, implement and evaluate a training program for oncology physicians advising their patients on complementary and integrative medicine. The main objective of the study is to evaluate whether training physicians in a blended-learning approach (e-learning + skills-training workshop) in providing advice to their cancer patients on complementary and integrative medicine, in addition to handing out an information leaflet about reputable websites, has different effects on the outcomes of patients, physicians, and their interaction level, compared to only giving out the information leaflet., Methods/design: Forty-eight oncology physicians will be included into a cluster-randomized trial to either participate or not in the blended-learning training. Physicians will then advise 10 cancer patients each, resulting in 480 patients participating in the trial. The blended learning consists of nine units of up to 45 min of e-learning and 18 units of up to 45 min of on-site skills-training workshop focusing. Outcomes will be measured on the physician, patient, and physician-patient-interaction level., Discussion: A blended-learning program for oncology physicians to advise their cancer patients in a systematic way and a reasonable time frame on complementary and integrative medicine will be evaluated in depth in a large cluster-randomized trial., Trial Registration: German Clinical Trials Register, ID: DRKS00012704 . Registered on 28 August 2017.

Background: The aims of this pilot study were to observe perceived outcomes of spiritual healing in Germany., Patients and Methods: In this prospective case study, we performed qualitative interviews with clients and healers about perceived outcomes of spiritual healing treatments. A directed qualitative content analysis was used. In addition, we applied questionnaires (WHOQOL-BREF, General Self-Efficacy Scale, Sense of Coherence 13, SpREUK-15, intensity of complaints on visual analogue scale) at baseline and after week 1, month 2 and month 6 which were analysed descriptively., Results: Seven healers and 7 clients participated, 42 interviews were analysed. In the interviews, the clients described positive body sensations, greater relaxation and well-being as short-term effects of healing treatments. Perceived longer-term effects were related to making significant life changes, creating new meanings, activating resources and improving social relationships. Patients in pain described a reduction of pain intensity. In the questionnaires, the clients reported improvements in quality of life and self-efficacy, to a smaller extent improvements of intensity of complaints and sense of coherence., Conclusion: The results from this pilot study could be useful to choose outcomes of future prospective studies with a larger sample: qualitative assessments combined with global and broad quantitative outcomes such as quality of life, self-efficacy and intensity of complaints could be applied., (© 2019 S. Karger AG, Basel.)

Objectives: The aim of this study was to compare the health care costs for patients using additional homeopathic treatment (homeopathy group) with the costs for those receiving usual care (control group)., Methods: Cost data provided by a large German statutory health insurance company were retrospectively analysed from the societal perspective (primary outcome) and from the statutory health insurance perspective. Patients in both groups were matched using a propensity score matching procedure based on socio-demographic variables as well as costs, number of hospital stays and sick leave days in the previous 12 months. Total cumulative costs over 18 months were compared between the groups with an analysis of covariance (adjusted for baseline costs) across diagnoses and for six specific diagnoses (depression, migraine, allergic rhinitis, asthma, atopic dermatitis, and headache)., Results: Data from 44,550 patients (67.3% females) were available for analysis. From the societal perspective, total costs after 18 months were higher in the homeopathy group (adj. mean: EUR 7,207.72 [95% CI 7,001.14-7,414.29]) than in the control group (EUR 5,857.56 [5,650.98-6,064.13]; p<0.0001) with the largest differences between groups for productivity loss (homeopathy EUR 3,698.00 [3,586.48-3,809.53] vs. control EUR 3,092.84 [2,981.31-3,204.37]) and outpatient care costs (homeopathy EUR 1,088.25 [1,073.90-1,102.59] vs. control EUR 867.87 [853.52-882.21]). Group differences decreased over time. For all diagnoses, costs were higher in the homeopathy group than in the control group, although this difference was not always statistically significant., Conclusion: Compared with usual care, additional homeopathic treatment was associated with significantly higher costs. These analyses did not confirm previously observed cost savings resulting from the use of homeopathy in the health care system.

Spiritual healers in contemporary Germany comprise a heterogeneous and growing group, yet little data exists about them. Therefore, one aim of this study was to learn about which biographical aspects and events were important to the process of becoming a healer and which biographical aspects drove clients to consult a healer. The study was based on semi-structured interviews combined with participant observations. All data were recorded digitally, transcribed, entered into the software program MAXQDA and analysed subjected to Content Analysis. In total, 15 healers (nine male, six female) and 16 clients (13 female, three male) were included. According to the healers, a talent for healing can be inborn, inherited or developed through life experiences. Most of the healers experienced a crisis, which prompted their transformation to healers (the wounded healer type). A smaller group became healers mainly out of interest without going through crisis and by focusing on the spiritual attitude itself (the healer by interest type). The basis of healing is seen as a connection to a transcendent reality, which enables an open, loving and empathetic attitude. The experience of crises and illnesses and the importance of spirituality are major biographical similarities between healers and clients. Near-death experiences as an extreme form of crisis were reported from a few healers and clients. The connections between healing talents and crises, including a deepened exploration of near-death experiences and questions regarding inclining towards spirituality could be of interest in further studies.

Background: Chronic low back pain (LBP) and neck pain (NP) are highly prevalent conditions resulting in high economic costs. Treatment guidelines recommend relaxation techniques, such as progressive muscle relaxation, as adjuvant therapies. Self-care interventions could have the potential to reduce costs in the health care system, but their effectiveness, especially in a usual care setting, is unclear. The aim of these two pragmatic randomized studies is to evaluate whether an additional app-delivered relaxation is more effective in the reduction of chronic LBP or NP than usual care alone., Methods/design: Each pragmatic randomized two-armed study aims to include a total of 220 patients aged 18 to 65 years with chronic (>12 weeks) LBP or NP and an average pain intensity of ≥ 4 on a numeric rating scale (NRS) in the 7 days before recruitment. The participants will be randomized into an intervention and a usual care group. The intervention group will be instructed to practice one of these 3 relaxation techniques on at least 5 days/week for 15 minutes/day over a period of 6 months starting on the day of randomization: autogenic training, mindfulness meditation, or guided imagery. Instructions and exercises will be provided using a smartphone app, baseline information will be collected using paper and pencil. Follow-up information (daily, weekly, and after 3 and 6 months) will be collected using electronic diaries and questionnaires included in the app. The primary outcome measure will be the mean LBP or NP intensity during the first 3 months of intervention based on daily pain intensity measurements on a NRS (0 = no pain, 10 = worst possible pain). The secondary outcome parameters will include the mean pain intensity during the first 6 months after randomization based on daily measurements, the mean pain intensity measured weekly as the average pain intensity of the previous 7 days over 3 and 6 months, pain acceptance, 'LBP- and NP-related' stress, sick leave days, pain medication intake, adherence, suspected adverse reaction, and serious adverse events., Discussion: The designed studies reflect a usual self-care setting and will provide evidence on a pragmatic self-care intervention that is easy to combine with care provided by medical professionals., Trial Registration: ClinicalTrials.gov identifier Relaxback NCT02019498, Relaxneck NCT02019134 registered on 18 December 2013.

In the aging population of Germany the consequences of Dementia for the society and the health care sector are complex and solutions require a multidisciplinary approach. The aim of the two-day interdisciplinary expert conference was to consider dementia from different perspectives, to identify dementia-related problems and to discuss integrative solutions under consideration of complementary therapies. In different working groups the experts developed solutions and recommendations with regards to political need, health care and future research priorities. The present recommendations profited very much from the interdisciplinary participants of the conference and brought together the expertise of different fields resulting in a comprehensive picture about dementia in Germany.

Background: Allergic rhinitis (AR) is a frequent allergic disorder with a significant economic effect on health care costs and productivity., Objective: To assess the cost-effectiveness of acupuncture for patients with seasonal AR (SAR) in Germany., Methods: The present analysis was part of the Acupuncture in Seasonal Allergic Rhinitis (ACUSAR) trial, a 3-arm randomized, controlled, multicenter trial in patients with SAR, comparing acupuncture plus rescue medication (RM), penetrating sham acupuncture plus RM, and a control group receiving RM alone. Measures for health economic analyses were costs and health-related quality of life. Incremental cost-effectiveness ratio was calculated for different scenarios on the duration of acupuncture effects and was expressed as costs per quality-adjusted life-year gained. The study was conducted from society's and from a third-party payer's perspective., Results: From 422 initially randomized patients, a total of 364 patients with complete data on costs and quality of life were included in the health economic evaluation. Patients receiving acupuncture or sham acupuncture caused higher costs than patients in the RM group. Patients in the acupuncture group gained significantly more quality-adjusted life-years compared with the RM group. Depending on different scenarios, the incremental cost-effectiveness ratio for acupuncture patients was between €31,241 (approximately US $38.569) and €118,889 (approximately US $146,777) from society's perspective and between €20,807 (approximately US $25,688) and €74,585 (approximately US $92.080) from a third-party payer's perspective., Conclusion: Acupuncture is an effective intervention that results in improved quality of life in patients with SAR. However, in times of limited resources for health care, acupuncture for AR may not be a cost-effective intervention., Trial Registration: clinicaltrials.gov Identifier: NCT00610584., (Copyright © 2013 American College of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.)

Background: Homeopathic drug proving is a basic concept in homeopathy. This study aimed to record symptoms produced by a homeopathic drug compared with placebo., Methods: This multicentre, randomised, double-blind, placebo-controlled phase 1 trial consisted of a 7-day run-in period, a 5-day intervention period and a 16-day post-intervention observation period. Subjects, investigators and statisticians were blinded for intervention groups and identity of the homeopathic drug. Subjects in the intervention group received Okoubaka aubrevillei (potency C12) and subjects in the placebo group received the optically identical sucrose globules. Dosage in both groups was five globules taken five times per day over a maximum period of 5 days. Subjects documented the symptoms they experienced in a semistructured online diary. The primary outcome parameter was the number of characteristic proving symptoms compared with placebo after a period of 3 weeks. Characteristic symptoms were categorised using content analysis. Secondary outcome parameters were the qualitative differences in profiles of characteristic and proving symptoms and the total number of all proving symptoms. The number of symptoms was quantitatively analysed on an intention-to-treat basis using analyses of covariance with the subject's expectation and baseline values as covariates., Results: Thirty-one subjects were included (19 Okoubaka and 12 placebo). Data for 29 participants could be analysed. No significant differences in number of characteristic symptoms in both groups were observed between Okoubaka (mean±standard deviation 5.4±6.0) and placebo (4.9±5.6). The odds ratio for observation of a characteristic symptom was 1.11 (95% confidence interval 0.4 to 3.05, P=0.843). Females and subjects expecting a higher number of symptoms at baseline or feeling more sensitive to homeopathic drugs experienced more characteristic symptoms regardless of allocation. The qualitative analysis showed an inter-coder reliability of 0.69 (95% confidence interval 0.62 to 0.76). The qualitative comparison of symptom profiles was inconclusive., Conclusions: Combined results of qualitative and quantitative methods did not result in a significant difference of characteristic proving symptoms between O. aubrevillei C12 and placebo. The qualitative comparison of the symptom profiles leaves some open questions. The nocebo effect might be a plausible explanation for most of the phenomena observed in this trial., Trial Registration: ClinicalTrials.gov: NCT01061229.

Background: In Germany the number of inhabitants with dementia is expected to increase from 1.2 million at present to 2.3 million in 2050. Our aim was to investigate which treatments complementary and alternative medicine (CAM) experts consider to be of therapeutic use in developing treatment strategies and hypotheses for further clinical studies., Methods: In a participatory group workshop the 'World Café' method was used. As questions we asked: 1) 'Based on your clinical experience, which CAM therapies are effective in the treatment of patients with dementia? 2) Based on your clinical experience, which CAM therapies are effective in the treatment of lay and professional caregivers of patients with dementia?, and 3) How should a CAM treatment program look like?' Further Delphi rounds were used to reach consensus and summarize the results., Results: The 2-day workshop took place in January 2012 in Berlin. A total of 17 experts participated. The most important subject in the treatment was the need to understand patients' biographies in order to individualize the therapy. Therapy itself consists of the therapeutic relationship, nonmedical therapies such as sports, massage, music and arts therapy as well as medical treatment such as herbal or homeopathic medicines. With regard to caregivers the most important aim is to prevent or reduce psychological distress, e.g., by mind-body programs. Instead of single treatments, more general elements such as understanding the patients' biographies, therapeutic relationships, individualizing, networking, and self-care emerged as main results., Discussion: An integrative treatment program should connect outpatient and inpatient care as well as all experts. CAM training courses should be offered to doctors, nurses, and caregivers. Future clinical studies should focus on complex intervention programs integrating these key elements., (© 2013 S. Karger GmbH, Freiburg.)

Background: Within recent years, the increasing popularity of complementary and alternative medicine (CAM) has led health care authorities to focus on the safety of these drugs. One reason for the low awareness of adverse drug reactions (ADRs) associated with CAM might be that users and physicians believe that there are no risks associated with CAM drugs. Recent studies have shown that ADRs are under-reported and are considered a leading cause of morbidity and mortality. The Evaluation of Anthroposophical Medicine (EvaMed) Pharmacovigilance Network was formed in 2004 at the Havelhoehe Research Institute in Berlin and is composed of 38 CAM physicians located in 12 of the 16 federal states in Germany for the purpose of using EvaMed data to evaluate the prescribing patterns, effectiveness, and safety of CAM therapies., Objective: To describe and quantify the volume and severity of ADRs for CAM and conventional (CON) drugs in a proprietary database created from prescriptions and patient data of primary care CAM physicians who participate in the EvaMed Network., Methods: This was a prospective, multicenter, observational study based on the ADR reports and electronic prescription data of 38 individual physicians (21 general practitioners, 9 pediatricians, 4 internists, 2 gynecologists, 1 dermatologist, and 1 neurologist) participating in the EvaMed Network. In addition to standard medical education, all physicians had 5 years practical experience and an additional qualification for anthroposophic medicine, which is a subcategory of CAM. All 38 physicians documented ADRs deemed serious, defined as life threatening or resulting in death, disability/incapacity, or inpatient hospital days. Due to the time-consuming nature of documenting ADRs, only a subgroup of 7 physicians (4 in general practice and 1 each in internal medicine, pediatrics, and gynecology) agreed to report both nonserious and serious ADRs. Therefore, the incidence and frequency of ADRs were evaluated in this subgroup. The study period was January 2004 through June 2009. ADRs were documented by the physicians using an electronic case report form in the EvaMed software, which was linked to the physicians' existing electronic medical record (EMR) systems and incorporated into their daily routines to avoid missing data or double entries. The participating physicians were compensated €15 (approximately US$20) for each ADR report. All ADR reports were monitored at the Havelhoehe Research Institute by 2 physicians who evaluated patient characteristics, present visit diagnosis, target drugs, associated drug classes and type of drugs, type of ADR, actions taken for the ADR, and outcome of the ADR., Results: There were 1,018,626 drugs (54.8% CAM) prescribed by the 38 physicians for 88,431 patients, and 412 ADRs reported for 389 patients; 124 (30.1%) ADRs were for CAM drugs. The majority were reported in children (69.2%, n = 285) and females (56.3%, n = 232). All serious ADRs (n = 14) were associated with CON drugs. In the subgroup of 7 physicians who agreed to report all ADRs, a total of 327 serious and nonserious ADRs were reported for 392,243 prescribed drugs (0.08%) and for 308 of 25,966 patients (1.2%). ADRs were reported for 241 of 16,032 children (aged 17 years or younger; 1.5%) versus 67 of 9,934 adults (0.7%). Of the 327 total ADRs, 10 (3.1%) were serious. There were 95 ADRs for 213,900 CAM prescriptions (4.4 per 10,000) versus 232 for 178,343 CON prescriptions (13.0 per 10,000). The CAM drug with the highest frequency of ADRs was Pelargonium sidoides root (0.21%, 4 of 1,940 prescriptions). The most frequently reported ingredient in CAM was ivy leaves with an ADR frequency of 0.17% (n = 11 of 6,575 prescriptions). The most reported drug connected with ADRs was amoxicillin (1.36%, n = 31 of 2,276 prescriptions). The most common ADR medical management was withdrawal of the drug (82.3% overall, 83.9% CAM, 81.6% CON)., Conclusions: A sample of 38 CAM physicians reported the occurrence of at least 1 ADR for 0.4% of treated patients in a 5.5-year study period. There were no serious ADRs reported for CAM drugs. In a subsample of 7 physicians who agreed to report all nonserious and serious ADRs, 1.2% of patients experienced at least 1 ADR; rates of ADRs per 10,000 prescriptions were 4.4 for CAM drugs and 13.0 for CON drugs.

Objectives: The aim of this study was to identify patients' characteristics that increase or decrease their benefit from acupuncture treatment of chronic pain., Methods: Patients with chronic low back pain, headache, neck pain, or pain due to osteoarthritis of the knee or hip, were included in 4 multicenter, randomized, controlled studies, all conducted in Germany. All patients received routine care; the patients randomized to the acupuncture group received additional acupuncture treatment. Data were pooled, and the main outcome was defined as the 3-month change from baseline of the SF-36 bodily pain subscale. To identify predictors for treatment effects and effect modifiers (ie, variables that interact with the form of treatment), patients' characteristics and their interaction with treatment were included in a mixed linear model to predict treatment outcome., Results: A total of 9,990 patients who were treated by 2,781 physicians were analyzed. The outcome was markedly improved in the acupuncture group (P < 0.001). Age, education, duration of illness, baseline pain, and some concomitant diseases predicted treatment outcome in both groups. Patients' characteristics that enlarged the acupuncture effect (ie, acted as effect modifiers) were being female (P = 0.028), living in a multi-person household (P = 0.002), failure of other therapies before the study (P = 0.049), and former positive acupuncture experience (P = 0.005)., Discussion: Future research to clarify the modifying effects with special focus on patients' expectations and other psychological variables is needed.

Objectives: The objective of this study was to identify the factors that make a good doctor, both from a patient and a physician perspective. Is there a connection between practicing homeopathy and being a good doctor?, Methods: This was a qualitative study of homeopathically trained physicians and their patients, using observation of patient-physician interactions (n = 29) and interviews with patients (n = 20) and with physicians (n = 4)., Results: Patients identified the availability of time, both in itself and as a prerequisite for other physician characteristics, as the single most important factor. Other factors include scope of diagnosis/holistic approach, patient-centeredness/empathy, and perceived competence/therapeutic success. Patients did not link these factors to the homeopathic orientation of their physician, while physicians clearly made this connection., Conclusions: The findings confirm other studies of patient satisfaction and physician characteristics. The availability of time, a holistic approach, and high physician empathy lead to high patient satisfaction. Homeopathic physicians probably are more likely to exhibit these characteristics., Practice Implications: Health care policy should create conditions that enable individual physicians to be "good doctors." For medical education, a stronger emphasis on interpersonal skills and practitioner empathy could lead to higher patient satisfaction and potentially better treatment outcomes. Homeopathy might provide a good role model for this type of education.

For more than 200 years, homeopathic doctors have been carrying out homeopathic drug provings (HDPs),which embodies the traditional self drug testing, an integral part of the homeopathic medical profession. However,according to national authorities, testing homeopathic drugs is a phase I clinical trial for which the German Federal Drug Law applies. Adapting a 200-year-old primary qualitative study design to modern drug law and Good Clinical Practice Guidelines generates several difficulties, in particular, blinding, informed consent and the classification of adverse events. In addition, in Germany naturopaths (German: ‘Heilpraktiker’) are excluded from leading HDP trials. The costs are climbing, and the organizational over heads for a HDP are enormous. Implications for the future are discussed., (Copyright © 2011 S. Karger AG, Basel.)

Background: The effectiveness of injection therapy for low-back pain is still debatable. We compared the efficacy of local injections of the homeopathic preparation Disci/Rhus toxicodendron compositum (verum) with placebo injections and with no treatment in patients with chronic low back pain., Methodology/principal Findings: In a randomized controlled partly double blind multicenter trial patients with chronic low back pain from 9 German outpatient clinics were enrolled and randomly allocated in a 1∶1∶1 ratio to receive subcutaneous injections (verum or placebo) into painful sites on the lower back over 12 treatment sessions within eight weeks, or no treatment (rescue pain medication with paracetamol or NSAIDs). All trial personnel and participants were masked to treatment allocation. The primary outcome measure was the average pain intensity over the last seven days on a visual analogue scale (0-100 mm, 0 = no pain, 100 = worst imaginable pain) after eight weeks. Follow-up was 26 weeks. Primary analysis was by intention to treat. Between August 2007 and June 2008, 150 patients were randomly allocated to three groups (51 verum, 48 placebo and 51 no treatment). The mean baseline-adjusted low back pain intensity at week eight was: verum group 37.0 mm (97.5% CI 25.3;48.8), no treatment group 53.0 (41.8;64.2), and placebo group 41.8 (30.1;53.6). The verum was significantly superior to no treatment (P = 0.001), but not to placebo (P = 0.350). No significant side effects were reported., Conclusions/significance: The homeopathic preparation was not superior to placebo. Compared to no treatment injections resulted in significant and clinical relevant chronic back pain relief., Trial Registration: ClinicalTrials.gov NCT00567736.

Background: The results of a survey of decision makers (directors of clinical departments, along with research and education institutes) at German medical schools in 1997 demonstrated that although most respondents were in favour of integrating complementary and alternative medicine (CAM) into medical school curricula, only a minority had implemented these into their medical schools. The aims of this study were to evaluate the current opinions on CAM from decision makers at medical schools in three German-speaking countries and the present extent to which it has been integrated., Methods: In 2004 we sent a standardised questionnaire to 1,017 department directors at medical schools in Austria (A, n = 75), Germany (G, n = 873) and Switzerland (CH, n = 69)., Results: 487 questionnaires (overall response rate: 48%, country-specific response rate: A 39%; G 49%; S 42%) were returned. 40% of respondents had a positive opinion on CAM, whereas 28% had a neutral and 29% a negative opinion and 3% were unsure with a significant difference between Germany (44% positive opinion) in favour for CAM vs. Switzerland (22%; p = 0,021). The CAM therapies rated most positively were acupuncture (53%), osteopathy (52%) and naturopathy (38%) with no statistical differences between the countries. Naturopathy (39%) and herbal medicine (34%) were viewed more positively in Germany compared to Austria (4%, p = 0.001 and 8%, p = 0.01), but not to Switzerland (27%, p = 0.289 and 24%, p = 0.353). The majority of respondents favoured the integration of CAM into the medical system (research 85%, teaching 84% and treatment 60%). However, only 162 respondents (34%) indicated that CAM therapies had already been integrated into the curriculum at their medical schools (treatment 26%, research 19% and education 18%) with no significant differences between the countries. Respondents of Switzerland indicated lower activity of CAM integration (treatment 10% and research 10%) compared to Austria (28%, p = 0.016 and 28%, p = 0.016) and Germany (27%, p = 0.01 and 20%, p = 0.174)., Conclusions: The majority of respondents favoured the integration of CAM into the medical system. However, this integration remains limited and does not reflect the high usage of CAM in the population.

Background: Very little is known about the range of diagnoses, course of treatment and long-term outcome in elderly patients who choose to receive homeopathic medical treatment. We investigated homeopathic practice in an industrialised country under everyday conditions.The aim of the study was to determine the spectrum of diagnoses and treatments, as well as to describe the course of illness over time among older patients who chose to receive homeopathic treatment., Methods: In this subgroup analysis of a prospective, multicentre cohort study totally including 3981 patients treated by homeopathic physicians in primary care practices in Germany and Switzerland, data was analysed from all patients > 70 years consulting the physician for the first time. The main outcome measures were: assessment by patient of the severity of complaints (numeric rating scales) and quality of life (SF-36) and by the physician of the severity of diagnoses (numeric rating scales) at baseline, and after 3, 12, and 24 months., Results: A total of 83 patients were included in the subgroup analysis (41% men, mean age 73.2 +/- (SD) 3.1 years; 59% women, 74.3 +/- 3.8 years).98.6 percent of all diagnoses were chronic with an average duration of 11.5 +/- 11.5 years. 82 percent of the patients were taking medication at baseline.The most frequent diagnoses were hypertension (20.5%, 11.1 +/- 7.5 years) and sleep disturbances (15.7%, 22.1 +/- 25.8 years).The severity of complaints decreased significantly between baseline and 24 months in both patients (from 6.3 (95%CI: 5.7-6.8) to 4.6 (4.0-5.1), p < 0.001) and physicians' assessments (from 6.6 (6.0-7.1) to 3.7 (3.2-4.3), p < 0.001); quality of life (SF 36) and the number of medicines taken did not significantly change., Conclusion: The severity of disease showed marked and sustained improvements under homeopathic treatment, but this did not lead to an improvement of quality of life. Our findings might indicate that homeopathic medical therapy may play a beneficial role in the long-term care of older adults with chronic diseases and studies on comparative effectiveness are needed to evaluate this hypothesis.

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.

Background: The management of hypertension is a key challenge in modern health systems. This study aimed to investigate hypertension treatment strategies among physicians specialized in complementary and alternative medicine (CAM) in Germany by analysing prescribing patterns and comparing these to the current treatment guidelines issued by the German Hypertension Society., Methods: In this prospective, multicentre observational study, which included 25 primary care physicians specialized in CAM treatment, prescriptions and diagnoses were analysed for each consecutive hypertensive patient using routine electronic data. Data analysis was performed using univariate statistical tests (Chi square test, Cochran-Armitage trend test). Multiple logistic regression was used to determine factors associated with antihypertensive medication., Results: In the year 2005, 1320 patients with 3278 prescriptions were included (mean age = 64.2 years (SD = 14.5), 63.5% women). Most patients were treated with conventional antihypertensive monotherapies (n = 838, 63.5%). Beta-blockers were the most commonly prescribed monotherapy (30.7%), followed by ACE inhibitors (24.0%). Combination treatment usually consisted of two antihypertensive drugs administered either as separate agents or as a coformulation. The most common combination was a diuretic plus an ACE inhibitor (31.2% of dual therapies). Patient gender, age, and comorbidities significantly influenced which treatment was prescribed. 187 patients (14.2%) received one or more CAM remedies, most of which were administered in addition to classic monotherapies (n = 104). Men (OR = 0.66; 95% CI: 0.54-0.80) and patients with diabetes (OR = 0.55; 95% CI: 0.42-0.0.73), hypercholesterolaemia (OR = 0.59; 95% CI: 0.47-0.75), obesity (OR = 0.74; 95% CI: 0.57-0.97), stroke (OR = 0.54; 95% CI: 0.40-0.74), or prior myocardial infarction (OR = 0.37; 95% CI: 0.17-0.81) were less likely to receive CAM treatment., Conclusions: The large majority of antihypertensive treatments prescribed by CAM physicians in the present study complied with the current German Hypertension Society treatment guidelines. Deviations from the guidelines were observed in one of every seven patients receiving some form of CAM treatment.

Quality management (QM) is an important tool for an effective and safe healthcare which also includes complementary and integrative medicine. Improving the three areas of quality (quality of structure, quality of process, and quality of results) is beneficial for patients and providers. Improvements of process, product and QM systems have a direct impact on time, quality, human resources, and costs. As a result, patient care improves and physicians and statutory sickness funds will benefit from increased efficiency. Several QM systems with different main focus exist. First publications about QM in complementary and alternative medicine (CAM) hospitals are from the 1990s. In order to increase the benefit and to avoid pitfalls, the implementation of a QM system should be planned systematically., (Copyright 2009 S. Karger AG, Basel.)

Objectives: To evaluate the details and effects of an individualized homeopathic treatment in patients with chronic low back pain in usual care., Methods: Prospective multicenter observational study. Consecutive patients beginning homeopathic treatment in primary care practices were evaluated over 2 years by using standardized questionnaires. Diagnoses (ICD-9) and symptoms with severity, health-related quality of life (QoL), medical history, consultations, homeopathic and conventional treatments, and other health service use were recorded., Results: One hundred twenty-nine adults (64.3% women, mean age 43.6 +/- 12.7 y) were treated by 48 physicians. The patients mainly had chronic low back pain (average duration 9.6 +/- 9.0 y) and other chronic diseases. Nearly all the patients (91.3%) had been pretreated. The initial case-taking took 113 +/- 36, and the case analysis took 31 +/- 38 minutes. The 7.4 +/- 8.1 subsequent consultations (duration: 23.7 +/- 15.2 min) cumulated to 204.5 +/- 184.6 minutes. The patients received an average of 6.8 +/- 6.3 homeopathic prescriptions. The severity of the diagnoses and complaints showed marked and sustained improvements with large effect sizes (Cohen's d from 1.67 to 2.55) and QoL improved accordingly (SF-36 physical component scale d = 0.33; mental component scale d = 0.54). The use of conventional treatment and health services decreased markedly: the number of patients using low back pain-related drugs was half of the baseline., Discussion: Classic homeopathic treatment represents an effective treatment for low back pain and other diagnoses. It improves health-related QoL and reduces the use of other healthcare services.

Background: The use of complementary therapies by patients has increased over the past 20 years, both in terms of self-medication and physician prescriptions. Among herbal medicines, those containing extracts of Asteraceae (Compositae), such as Echinacea spp., Arnica montana, Matricaria recutita and Calendula officinalis, are especially popular in the primary-care setting. However, there remains a gap between the growing acceptance of these remedies and the lack of data on their safety., Objective: The aim of this study was to analyse prescribing patterns and adverse drug reactions (ADRs) for Asteraceae-containing remedies in Germany., Methods: Primary-care physicians, all of whom were members of the German National Association of Anthroposophic Physicians were invited to participate in this prospective, multicentre, observational study. During the study period (September 2004 to September 2006), all prescriptions and suspected ADRs for both conventional and complementary therapies were documented using a web-based system. The study centre monitored all ADR reports and conducted a causality assessment according to Uppsala Monitoring Centre guidelines. Relative risks (RRs) and proportional reporting ratios (PRRs) were calculated., Results: Thirty-eight physicians, 55% of whom were general practitioners and 45% were specialists, fulfilled the technical requirements and were included in the investigation. Because documenting all ADRs (i.e. serious and nonserious) was time consuming, only a subgroup consisting of seven physicians agreed to report nonserious in addition to serious ADRs. During the study period, a total of 50 115 patients were evaluated and 344 ADRs for conventional and complementary remedies were reported. Altogether, 18 830 patients (58.0% female, 60.3% children) received 42 378 Asteraceae-containing remedies. The most frequently prescribed Asteraceae was Matricaria recutita (23%), followed by Calendula officinalis (20%) and Arnica montana (20%). No serious ADRs for Asteraceae-containing remedies were reported. In the analysis of the subgroup of seven physicians who also documented nonserious ADRs, 11 nonserious ADRs for Asteraceae-containing remedies occurred in 6961 patients, resulting in an RR of 0.13 (95% CI 0.07, 0.23). The majority of reported ADRs for Asteraceae-containing remedies were classified as uncommon. A subgroup analysis comparing phytotherapeutic and homoeopathic preparations did not reveal any relevant differences. The PRR for Asteraceae-containing remedies with respect to all other prescriptions was 1.7 (95% CI 1.0, 2.0) for the system organ class 'skin and subcutaneous tissue disorders' (six ADRs) and 1.0 (95% CI 0.3, 3.6) for 'gastrointestinal disorders' (three ADRs). Neither result was significant according to the PRR criteria developed by Evans et al., Conclusion: This is the first study to provide a systematic overview of prescribing patterns and ADRs for Asteraceae-containing remedies in the German primary-care sector. Asteraceae-containing remedies were used frequently in this context, especially among children. Our results indicate that treatment with Asteraceae-containing remedies is not associated with a high risk of ADRs.

Background: One of five children visiting a homoeopathic physician is suffering from atopic eczema., Objective: To examine the effectiveness, safety and costs of homoeopathic versus conventional treatment in usual care., Methods: In a prospective multicentre comparative observational non-randomised study, 135 children (homoeopathy n = 48 vs. conventional n = 87) with mild to moderate atopic eczema were included. The primary outcome was the SCORAD (Scoring Atopic Dermatitis) at 6 months. Further outcomes at 6 and 12 months also included quality of life of parents and children, use of conventional medicine, treatment safety and disease-related costs., Results: The adjusted SCORAD showed no significant differences between the groups at both 6 months (homoeopathy 22.49 + or - 3.02 [mean + or - SE] vs. conventional 18.20 + or - 2.31, p = 0.290) and 12 months (17.41 + or - 3.01 vs. 17.29 + or - 2.31, p = 0.974). Adjusted costs were higher in the homoeopathic than in the conventional group: for the first 6 months EUR 935.02 vs. EUR 514.44, p = 0.026, and for 12 months EUR 1,524.23 vs. EUR 721.21, p = 0.001. Quality of life was not significantly different between both groups., Conclusion: Taking patient preferences into account, homoeopathic treatment was not superior to conventional treatment for children with mild to moderate atopic eczema., (Copyright 2009 S. Karger AG, Basel.)

Background: Homeopathy is a highly debated but often used medical treatment. With this cohort study we aimed to evaluate health status changes under homeopathic treatment in routine care. Here we extend former results, now presenting data of an 8-year follow-up., Methods: In a prospective, multicentre cohort study with 103 homeopathic primary care practices in Germany and Switzerland, data from all patients (age >1 year) consulting the physician for the first time were observed. The main outcome measures were: The patients' perceived change in complaint severity (numeric rating scales from 0 = no complaint to 10 = maximal severity) and quality of life as measured by the SF-36 at baseline, and after 2 and 8 years., Results: A total of 3,709 patients were studied, 73% (2,722 adults, 72.8% female, age at baseline 41.0 +/- 12.3; 819 children, 48.4% female, age 6.5 +/- 4.0) contributed data to the 8-year follow-up. The most frequent diagnoses were allergic rhinitis and headache in adults, and atopic dermatitis and multiple recurrent infections in children. Disease severity decreased significantly (p < 0.001) between baseline, 2 and 8 years (adults from 6.2 +/- 1.7 to 2.9 +/- 2.2 and 2.7 +/- 2.1; children from 6.1 +/- 1.8 to 2.1 +/- 2.0 and 1.7 +/- 1.9). Physical and mental quality of life sores also increased considerably. Younger age, female gender and more severe disease at baseline were factors predictive of better therapeutic success., Conclusion: Patients who seek homeopathic treatment are likely to improve considerably. These effects persist for as long as 8 years.

To assess quality of life (QoL), costs, and cost-effectiveness of acupuncture treatment plus routine care versus routine care alone in osteoarthritis patients, a randomised, controlled trial was conducted in 255 general practices in Germany. Four hundred and eighty-nine patients with chronic pain due to osteoarthritis of the knee or hip were included to evaluated QoL and costs at baseline and after 3 months using health insurance funds data and standardized questionnaires. Patients receiving acupuncture had an improved QoL associated with significantly higher costs over the 3 months treatment period compared to routine care alone (mean cost-difference: 469.50 euros [95%CI 135.80-803.19 euros]). This increase in costs was primarily due to the costs of acupuncture. The overall ICER was 17,845 euros per QALY gained. The degree of cost-effectiveness was influenced by gender, with female patients achieving a better cost-effectiveness ratio than men. In conclusion, acupuncture was a cost-effective treatment strategy in patients with chronic osteoarthritis pain.

Objective: To investigate the clinical effectiveness and cost-effectiveness of acupuncture in patients with dysmenorrhea., Study Design: In a randomized controlled trial plus non-randomized cohort, patients with dysmenorrhea were randomized to acupuncture (15 sessions over three months) or to a control group (no acupuncture). Patients who declined randomization received acupuncture treatment. All subjects were allowed to receive usual medical care., Results: Of 649 women (mean age 36.1 +/- 7.1 years), 201 were randomized. After three months, the average pain intensity (NRS 0-10) was lower in the acupuncture compared to the control group: 3.1 (95% CI 2.7; 3.6) vs. 5.4 (4.9; 5.9), difference -2.3 (-2.9; -1.6); P<.001. The acupuncture group had better quality of life and higher costs. (overall ICER 3,011 euros per QALY)., Conclusion: Additional acupuncture in patients with dysmenorrhea was associated with improvements in pain and quality of life as compared to treatment with usual care alone and was cost-effective within usual thresholds.

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.

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.

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.

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.

In a pooled analysis of four randomized controlled trials of acupuncture in patients with migraine, tension-type headache, chronic low back pain, and osteoarthritis of the knee we investigated the influence of expectations on clinical outcome. The 864 patients included in the analysis received either 12 sessions of acupuncture or minimal (i.e. sham) acupuncture (superficial needling of non-acupuncture points) over an 8 week period. Patients were asked at baseline whether they considered acupuncture to be an effective therapy in general and what they personally expected from the treatment. After three acupuncture sessions patients were asked how confident they were that they would benefit from the treatment strategy they were receiving. Patients were classified as responders if the respective main outcome measure improved by at least fifty percent. Both univariate and multivariate analyses adjusted for potential confounders (such as condition, intervention group, age, sex, duration of complaints, etc.) consistently showed a significant influence of attitudes and expectations on outcome. After completion of treatment, the odds ratio for response between patients considering acupuncture an effective or highly effective therapy and patients who were more sceptical was 1.67 (95% confidence interval 1.20-2.32). For personal expectations and confidence after the third session, odds ratios were 2.03 (1.26-3.26) and 2.35 (1.68-3.30), respectively. Results from the 6-month follow-up were similar. In conclusion, in our trials a significant association was shown between better improvement and higher outcome expectations.

Background: The increasing utilization of complementary and alternative medicine (CAM) contrasts with a lack of CAM in medical school education. Therefore, CAM therapies were introduced to the Charité University Medical School (Berlin, Germany) reform curriculum., Methods and Results: Teaching concept: A CAM seminar provides basic knowledge about naturopathy, homeopathy, and Traditional Chinese medicine (TCM), plus their utilization, empirical research, and underlying philosophies. Experiential and dialogical didactic techniques are employed., Evaluation: Students evaluated one of the seminars using the 'Heidelberg Inventory for Educational EVALUATION' (Heidelberger Inventar zur Lehrveranstaltungs-EVALUATION, HILVE). Student participation and classroom atmosphere were rated as very good. All other categories were rated above average, except workload and excessive demands. Demand for Education: 69% of all 3rd- and 7th-semester students (n = 74) answered a questionnaire about their opinions on CAM, and the extent and sources of their knowledge. Acupuncture and homeopathy were the best-known methods, primarily from courses or seminars. Personal experience with CAM was reported by 44% of the students. Depending on the method 73-96% of the respondents supported the inclusion of CAM therapies into the medical school curriculum. Acknowledged advantages of CAM were its use as an alternative or additional treatment (73-82%), fewer side effects (44%), and cost reduction (37%)., Discussion: The presented concept helps medical students develop a reflected opinion on CAM. The students rated the quality of the seminar as above average. The high support for university CAM education reflects the students' desire for more knowledge. Interest in other philosophies of disease and therapy may prepare them for a more integrative and pluralistic approach to medicine.

Acupuncture is widely used by patients with neck pain, but there is a lack of information about its effectiveness in routine medical care. The aim was to investigate the effectiveness of acupuncture in addition to routine care in patients with chronic neck pain compared to treatment with routine care alone. We performed a randomized controlled multicentre trial plus non-randomized cohort in general practices in Germany. 14,161 patients with chronic neck pain (duration >6 months). Patients were randomly allocated to an acupuncture group or a control group receiving no acupuncture. Patients in the acupuncture group received up to 15 acupuncture sessions over three months. Patients who did not consent to randomization received acupuncture treatment. All subjects were allowed to receive usual medical care in addition to study treatment. Neck pain and disability (NPAD Scale by Wheeler) after three months. Of 14,161 patients (mean age 50.9+/-13.1 years, 68% female) 1880 were randomized to acupuncture and 1886 to control, and 10,395 included into the non-randomized acupuncture group. At three months, neck pain and disability improved by 16.2 (SE: 0.4) to 38.3 (SE: 0.4); and by 3.9 (SE: 0.4) to 50.5 (SE: 0.4), difference 12.3 (p<0.001) in the acupuncture and control group, respectively. Treatment success was essentially maintained through six months. Non-randomized patients had more severe symptoms at baseline and showed higher neck pain and disability improvement compared to randomized patients. Treatment with acupuncture added to routine care in patients with chronic neck pain was associated with improvements in neck pain and disability compared to treatment with routine care alone.

Acupuncture is increasingly used in patients with chronic pain, but there is a lack of evidence on the cost-benefit relationship of this treatment strategy. The objective of this study was to assess costs and cost-effectiveness of additional acupuncture treatment in patients with chronic neck pain compared to patients receiving routine care alone. A randomized controlled trial including patients (18 years of age) with chronic neck pain (>6 months) was carried out. We assessed the resource use and health related quality of life (SF-36) at baseline and after 3 months using complete social health insurance funds and standardized questionnaires, respectively. The main outcome parameters were direct and indirect cost differences during the 3 months study period and the incremental cost-effectiveness ratio (ICER) of acupuncture treatment. A total of 3,451 patients (1,753 acupuncture-group, 1,698 control-group) were randomized (31% men, age 53.5+/-12.9 years; 69% women, 49.2+/-12.7 years). Acupuncture treatment was associated with significantly higher costs over the 3 months study duration compared to routine care (925.53+/-1,551.06 euros vs. 648.06+/-1,459.13 euros; mean difference: 277.47 euros [95% CI: 175.71 euros-379.23 euros]). This cost increase was mainly due to costs of acupuncture (361.76+/-90.16 euros). The ICER was 12,469 euros per QALY gained and proved robust in additional sensitivity analyses. Since health insurance databases were used, private medical expenses such as over the counter medication were not included. Beyond the 3 months study duration, acupuncture might be associated with further health economic effects. According to international cost-effectiveness threshold values, acupuncture is a cost-effective treatment strategy in patients with chronic neck pain.

Background 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.

Background: On the range of diagnoses, course of treatment, and long-term outcome in patients who chose to receive homeopathic medical treatment very little is known. We investigated homeopathic practice in an industrialized country under everyday conditions., Methods: In a prospective, multicentre cohort study with 103 primary care practices with additional specialisation in homeopathy in Germany and Switzerland, data from all patients (age > 1 year) consulting the physician for the first time were observed. The main outcome measures were: Patient and physician assessments (numeric rating scales from 0 to 10) and quality of life at baseline, and after 3, 12, and 24 months., Results: A total of 3,981 patients were studied including 2,851 adults (29% men, mean age 42.5 +/- 13.1 years; 71% women, 39.9 +/- 12.4 years) and 1,130 children (52% boys, 6.5 +/- 3.9 years; 48% girls, 7.0 +/- 4.3 years). Ninety-seven percent of all diagnoses were chronic with an average duration of 8.8 +/- 8 years. The most frequent diagnoses were allergic rhinitis in men, headache in women, and atopic dermatitis in children. Disease severity decreased significantly (p < 0.001) between baseline and 24 months (adults from 6.2 +/- 1.7 to 3.0 +/- 2.2; children from 6.1 +/- 1.8 to 2.2 +/- 1.9). Physicians' assessments yielded similar results. For adults and young children, major improvements were observed for quality of life, whereas no changes were seen in adolescents. Younger age and more severe disease at baseline were factors predictive of better therapeutic success., Conclusion: Disease severity and quality of life demonstrated marked and sustained improvements following homeopathic treatment period. Our findings indicate that homeopathic medical therapy may play a beneficial role in the long-term care of patients with chronic diseases.