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This case report indicates a complication of a footbath with herbs, self-applied by a patient at home. A 60 year old female patient presented herself at the TCM (Traditional Chinese Medicine) hospital, Bad Kötzting, Germany with the main symptoms of persistent coughing fits and disturbing smells especially during meals. At admission, she was administered a high dose Chinese herbal therapy complementary to her already prescribed pharmaceuticals. During her sojourn in the hospital she started suffering from numbness in both feet, preferred on the dorsum, and up to and including the toes, accompanied with a sensation of cold. Therefore TCM herbal footbaths containing 5g Psoraleae fructus semen (Buguzhi) were administered, twice a day, for 2 weeks, during the hospital stay without any complications. One week after discharge from the hospital she went on with her footbaths, prescribed for outpatient treatment. Buguzhi is suspected to cause phototoxic reactions under sunlight. Unfortunately, the patient applied the prescription-based footbath under a parasol in her garden. This seems to be the reason, why the patient developed an erythema bullosa grade three. She was treated with antibiotics for 10 days and ointment bandages until remission. To avoid similar adverse events in future, patients have to be informed to not expose their skin to solar irradiation during or after footbaths containing Buguzhi. Alternatively it has to be considered to omit Buguzhi for the use of footbaths applied as outpatient treatment.

Dieter Melchart,1,2 Axel Eustachi,1 Stephan Gronwald,3 Erich Wühr,3 Kristina Wifling,1 Beatrice E Bachmeier1,4 1Competence Centre for Complementary Medicine and Naturopathy, Klinikum Rechts der Isar, Technische Universität München, Munich, Germany; 2Institute for Complementary and Integrative Medicine, University Hospital Zurich and University of Zurich, Zurich, Switzerland; 3Applied Health Care Science, Deggendorf Institute of Technology, Deggendorf, Germany; 4Institute of Laboratory Medicine, Ludwig-Maximilians-University, Munich, Germany Background: There is a global trend to a stronger active involvement of persons in the maintenance and restoring of health. The Competence Centre for Complementary Medicine and Naturopathy (CoCoNat) of the Technical University of Munich (TUM) has developed a lifestyle concept to enable each individual to manage his or her health – Individual Health Management (IHM) – and a web-based health portal named Virtual Tool for Education, Reporting, Information and Outcomes (VITERIO®), which addresses these needs for practice and research. Objectives: The objectives of this study were to establish a core set of questionnaires for a self-assessment program on certain risk indications and comprehensive protection factors of health and to develop and enhance 1) tools for individual feedback, longitudinal self-monitoring, self-assessment, and (self-)care-planning; 2) training packages; 3) open notes and records for provider and patient; and 4) tools for monitoring groups and single participants in various indicators for individual coaching and scientific evaluation. Methods: The CoCoNat of TUM, Faculty for Applied Health Science of Technische Hochschule Deggendorf, VITERIO® company, IHM campus network, and Erich Rothenfußer Foundation, Munich, provide a consortium responsible for content, research strategy, technical production and implication, postgraduate education for IHM coaches, implementation of IHM in various settings, and funding resources. Results: A data set of indicators for health screening and self-monitoring of findings, symptoms, health behavior, and attitudes are integrated into a web-based health portal named VITERIO®. The article introduces some implemented graphical solutions of developed tools and gives examples for daily use. Conclusion: Behavioral change and adaptation in attitudes and personal values are difficult issues of health education and lifestyle medicine. To address this problem best, the implementation of a patient-centric, performance measures-based program including open records and a blended learning concept were elaborated. The combination of an individual web-based health portal with personal coaching allows the implementation of IHM in everyday practice. Keywords: lifestyle program, Individual Health Management, IHM, blended learning, performance measures, web-based health portal, adherence

The basis of any complementary therapy should be the recommendation of a healthy lifestyle (diet, nutrition, exercise, stress-reduction), and appropriate self-help techniques (e. g. thermotherapy, herbal OTC-products) aimed at releasing the patients’ most debilitating symptoms. For therapy-resistant or strong symptoms, more invasive interventions or medical treatments with an acceptable evidence base can be used (e. g. acupuncture for cancer pain, herbal prescriptions). The effects of any complementary intervention should be controlled for a period of six weeks after its administration. Patients should be advised not to use products or methods with possibly harmful side effects or negative interactions with conventional medications.

The efficacy of the plant-derived polyphenol curcumin, in various aspects of health and wellbeing, is matter of public interest. An internet search of the term “Curcumin” displays about 12 million hits. Among the multitudinous information presented on partly doubtful websites, there are reports attracting the reader with promises ranging from eternal youth to cures for incurable diseases. Unfortunately, many of these reports are not based on scientific evidence, but they feed the desideratum of the reader for a “miracle cure”. This circumstance makes it very difficult for researchers, who work in a scientifically sound and evidence-based manner on the therapeutic benefits (or side effects) of curcumin, to demarcate their results from sensational reports that circulate in the web and in other media. This is only one of many obstacles making it difficult to pave curcumin’s way into clinical application; others are its nonpatentability and low economic usability. A further impediment comes from scientists who never worked with curcumin or any other natural plant-derived compound in their own labs. They have never tested these compounds in any scientific assay, neither in vitro nor in vivo; however, they claim, in a sometimes polemic manner, that everything that has so far been published on curcumin’s molecular effects is based on artefacts. The here presented Special Issue comprises a collection of five scientifically sound articles and nine reviews reporting on the therapeutic benefits and the molecular mechanisms of curcumin or of chemically modified curcumin in various diseases ranging from malignant tumors to chronic diseases, microbial infection, and even neurodegenerative diseases. The excellent results of the scientific projects that underlie the five original papers give reason to hope that curcumin will be part of novel treatment strategies in the near future—either as monotherapy or in combination with other drugs or therapeutic applications.

Background Unfavorable lifestyle factors influence the risk of stress disorders. For risk reduction, lifestyle modifications, such as regular physical activity, balanced nutrition and competence in stress management, are a means of choice. The clinical study examines the efficacy of an intensive lifestyle intervention, named Individual Health Management (IHM), − with regard to a reduction of perceived stress. The study is supported by the major regional health insurance, which conducts, in cooperation with the Traditional Chinese Medicine (TCM) hospital, Bad Kötzting, a local model project offering insurants the IHM program as prevention measure against stress and related aftermath. Methods The study is a controlled, randomized, monocentric trial with a 12-months intervention phase. Feasible persons are checked according to inclusion and exclusion criteria and assigned to the intervention or control group. Randomization ratio is 1:1. (A) Participants of the intervention group receive the lifestyle program IHM, have access to a web-based health portal (www.viterio.de), and join 3 full-day and 10 two-hour training sessions during the first 3 months. During the remaining 9 months, 4 training sessions and a weekly monitoring are performed with remote assistance. Besides measurement of perceived stress, examinations include burnout symptoms, heart rate variability, laboratory and physical findings. Further patient reported outcomes are documented (e.g. well-being, life satisfaction, severity of mood state, sense of coherence, psycho-vegetative test, cardio-metabolic risk factors, hypertension and diabetes risk. (B) Participants in the control group have access to the intensive lifestyle intervention IHM after a waiting period of at least 6 months. Examinations are conducted at baseline, after 3 and 6 months and in the intervention group additionally after 9 and 12 months. The confirmatory analysis examines the differences between the two groups with regard to changes in perceived stress after 6 months compared to the initial value. Discussion In order to enhance adherence, avoid attrition and to insure data quality, different measures will be implemented in the study. Based on a blended learning concept including a web-based e-health tool named VITERIO®, the program promises to achieve sustainable effects in perceived stress. Trial registration German Clinical Trial Register Freiburg (DRKS): DRKS00013040 (date registered 2017–10-1). Electronic supplementary material The online version of this article (10.1186/s12889-018-5756-3) contains supplementary material, which is available to authorized users.

Background: The use of drugs derived from plants is a cornerstone of Traditional Chinese Medicine (TCM). Yet, too little is known about risk and safety of Chinese medicinal drugs (CMD). Therefore, the TCM hospital Bad Kötzting has developed a quality control and complication screening programme in order to ensure a safe administration of TCM drugs to their patients. Methods: All Chinese medicinal drugs delivered to the hospital between September 1, 2012 and December 31, 2013 entered the quality control program and were screened for microbial contamination, aflatoxin, pesticides and heavy metals. A routinely applied complication screening programme monitored liver enzymes in all patients. Case causality assessment by CIOMS scale and identification of admitted herbs were conducted. Additionally, side effects of patients were identified by a routinely performed web-based documentation system. Results: In 5 of 23 investigated samples (21.7%) the initial testing showed microbial contamination (2), pesticide (2) and heavy metals (1). The drugs were tested for authenticity and adulterations, respectively. All 994 patients (mean age 52.6 years; 72.6% female) admitted were available for analysis. 448 (45.1%) of all patients reported having perceived at least one side effect of treatment. They experienced mainly gastrointestinal symptoms (13.6%), neurovegetative symptoms (10.8 %), temporary deteriorations of pain (8.8%), diarrhoea (5.9%), nausea (1.6%) and vomiting (0.5%). Further, 6 patients with a more than 2-fold elevation (compared to maximum normal value or elevated admission values) of ALT were found in the systematic laboratory control with a non-conclusive causality assessment for TCM-drugs. Conclusion: Approximate incidence rates and analysed drugs associated with liver damage revealed a low rate of liver injury. Patients should be informed of the gastrointestinal symptoms caused by and potential hepatotoxicity of TCM herbs.

Tumorpatienten sind im Verlauf ihrer Erkrankung haufig mit therapieresistenten Beschwerden und schlechter Lebensqualitat konfrontiert. Mehr als die Halfte der Betroffenen nimmt daher Methoden oder Produkte in Anspruch, die nicht Teil der konventionellen medizinischen Versorgung sind, deren wissenschaftlicher Evidenzgrad oft unklar ist und die teilweise mit Risiken verbunden sind. Lebensstilmasnahmen (Ernahrung, Bewegung, Entspannung) und viele Selbsthilfetechniken konnen die Lebensqualitat stabilisieren, sind risikolos und stellen daher die Basis einer begleitenden Behandlung dar. Fur die arztliche Behandlung von Symptomen liegen insbesondere fur die Akupunktur sowie fur einige Naturstoffe (Medizinalkrauter, Pflanzenextrakte, Vitamine, Spurenelemente) ausreichende Hinweise aus der Forschung vor, die diese Methoden im Sinne einer vertretbaren Komplementarmedizin akzeptabel und moglicherweise sinnvoll erscheinen lassen.

Bei haufigen Tumorentitaten (z. B. Mamma-, Prostata- oder Kolonkarzinom) nehmen 75−80 % der Betroffenen naturheilkundliche Methoden in Anspruch 6 , 18 , 20 . Patienten in der aktiven Behandlungsphase (Operation, Chemotherapie, Strahlentherapie u. a.) verfolgen mit der Anwendung von Naturheilkunde und Komplementarmedizin haufig die Reduktion von Nebenwirkungen der konventionellen Tumortherapie, aber auch eine aktive Starkung der Gesundheit 10 , 17 . Menschen, die die aktive Tumortherapie abgeschlossen haben, interessieren sich besonders fur Moglichkeiten der Rezidivprophylaxe 19 . Dieser Nachfrage von Tumorpatienten entspricht das naturheilkundliche Tumorbegleitprogramm des Kompetenzzentrums fur Komplementarmedizin und Naturheilkunde (KoKoNat) des Klinikums rechts der Isar der Technischen Universitat Munchen. Die Einzelkomponenten des Patientenkompetenz-Programms werden beschrieben.

AIM To analyze liver tests before and following treatment with herbal Traditional Chinese Medicine (TCM) in order to evaluate the frequency of newly detected liver injury. METHODS Patients with normal values of alanine aminotransferase (ALT) as a diagnostic marker for ruling out pre-existing liver disease were enrolled in a prospective study of a safety program carried out at the First German Hospital of TCM from 1994 to 2015. All patients received herbal products, and their ALT values were reassessed 1-3 d prior to discharge. To verify or exclude causality for suspected TCM herbs, the Roussel Uclaf Causality Assessment Method (RUCAM) was used. RESULTS This report presents for the first time liver injury data derived from a prospective, hospital-based and large-scale study of 21470 patients who had no liver disease prior to treatment with herbal TCM. Among these, ALT ranged from 1 × to < 5 × upper limit normal (ULN) in 844 patients (3.93%) and suggested mild or moderate liver adaptive abnormalities. However, 26 patients (0.12%) experienced higher ALT values of ≥ 5 × ULN (300.0 ± 172.9 U/L, mean ± SD). Causality for TCM herbs was RUCAM-based probable in 8/26 patients, possible in 16/26, and excluded in 2/26 cases. Bupleuri radix and Scutellariae radix were the two TCM herbs most commonly implicated. CONCLUSION In 26 (0.12%) of 21470 patients treated with herbal TCM, liver injury with ALT values of ≥ 5 × ULN was found, which normalized shortly following treatment cessation, also substantiating causality.

Dieter Melchart,1,2 Peter Löw,3 Erich Wühr,4 Victoria Kehl,5 Wolfgang Weidenhammer1 1Competence Center for Complementary Medicine and Naturopathy, Klinikum Rechts der Isar, Technische Universität München, Munich, Germany; 2Institute for Complementary and Integrative Medicine, University Hospital Zurich, University of Zurich, Zurich, Switzerland; 3Medical Practice for Internal Medicine, Treuchtlingen, 4Faculty for Applied Health Care Science, Deggendorf Institute of Technology, Deggendorf, 5Institute for Medical Statistics and Epidemiology, Munich Trial Centre, Klinikum Rechts der Isar, Technische Universität München, Munich, Germany Objective: Overweight and obesity are globally increasing risk factors for diseases in the context of metabolic syndrome. A randomized controlled trial was conducted to investigate whether there are any existing differences between two lifestyle intervention strategies with respect to weight reduction after 1 year.Subjects and methods: A total of 166 subjects with a body mass index of 28–35 kg/m2 were enrolled in this trial at seven study centers; 109 were randomly allocated to the intervention group (comprehensive lifestyle modification program: web-based Individual Health Management [IHM]) with 3-month reduction phase plus 9-month maintenance phase, and 57 were allocated to the control group (written information with advice for healthy food habits: usual care [UC]). Body weight, waist circumference, blood pressure, laboratory findings, and bioimpedance analysis used to determine body composition were measured at baseline and after 3, 6, 9, and 12 months. The primary outcome parameter was body weight at month 12 compared to baseline.Results: With respect to baseline status there were no statistically significant differences between the groups. Based on the intent-to-treat population, body weight showed a mean decrease of 8.7 kg (SD 6.1) in the intervention group (IHM) and 4.2 kg (SD 5) in the control group (UC) at month 12. This statistically significant difference (P

Background/Objectives: Unhealthy lifestyle is often related to overweight and obesity and thus to chronic diseases. Web-based programs might be an option for a comprehensive approach to improving long-term weight management. Data from a randomized controlled trial (RCT) evaluating the impact of a lifestyle program on weight reduction were used for a secondary analysis. The objectives were (a) to identify potential predictors for marked weight loss, (b) to explore associations of weight reduction with changes in health-related variables, and (c) to evaluate whether self-monitoring of the daily lifestyle is associated with weight loss. Methods: 67 subjects with a body mass index of 28-35 who underwent the 1-year ‘Individual Health Management' (IHM) program were included in the analysis (mean age 49.8 years, 79% female). Two subgroups (high response: ≥7.5% weight reduction vs. low response: Results: 70% of the subjects fulfilled the criterion of high response. There were no statistically significant differences between the two subgroups with respect to sociodemographic and baseline data. Regression analysis failed to identify any predictors for the amount of weight reduction. Subjects with high response showed a more distinct improvement in life satisfaction and neurovegetative stability. The findings indicated an association between the level of self-monitoring and weight loss. Conclusions: More research is needed to establish optimal strategies for maximizing the longer-term maintenance of weight loss and prevention effects. For weight reduction, support strategies like feedback learning through self-monitoring, reporting systems, and self-performance measurement with questionnaires might ameliorate high-intensity lifestyle modification programs.

International audience; Background: Traditional Chinese Medicine (TCM) with its focus on herbal use is popular and appreciated worldwide with increased tendency, although its therapeutic efficacy is poorly established for most herbal TCM products. Treatment was perceived as fairly safe but discussions emerged more recently as to whether herb induced liver injury (HILI) from herbal TCM is a major issue; Methods: To analyze clinical and case characteristics of HILI caused by herbal TCM, we undertook a selective literature search in the PubMed database with the search items Traditional Chinese Medicine, TCM, alone and combined with the terms herbal hepatotoxicity or herb induced liver injury; Results: HILI caused by herbal TCM is rare and similarly to drugs can be caused by an unpredictable idiosyncratic or a predictable intrinsic reaction. Clinical features of liver injury from herbal TCM products are variable, and specific diagnostic biomarkers such as microsomal epoxide hydrolase, pyrrole-protein adducts, metabolomics, and microRNAs are available for only a few TCM herbs. The diagnosis is ascertained if alternative causes are validly excluded and causality levels of probable or highly probable are achieved applying the liver specific RUCAM (Roussel Uclaf Causality Assessment Method) as the most commonly used diagnostic tool worldwide. Case evaluation may be confounded by inappropriate or lacking causality assessment, poor herbal product quality, insufficiently documented cases, and failing to exclude alternative causes such as infections by hepatotropic viruses including hepatitis E virus infections; Conclusion: Suspected cases of liver injury from herbal TCM represent major challenges that deserve special clinical and regulatory attention to improve the quality of case evaluations and ascertain patients' safety and benefit.

Regardless of specific national drug regulations there is an international consensus that all TCM drugs must meet stipulated high quality standards focusing on authentication, identification and chemical composition. In addition, safety of all TCM drugs prescribed by physicians has to be guaranteed. During the 25 years history of the TCM hospital Bad Kötzting, 171 TCM drugs underwent an analytical quality proof including thin layer as well as high pressure liquid chromatography. As from now mass spectroscopy will also be available as analytical tool. The findings are compiled and already published in three volumes of analytical monographs. One more volume will be published shortly, and a fifth volume is in preparation. The main issues of the analytical procedure in TCM drugs like authenticity, botanical nomenclature, variability of plant species and parts as well as processing are pointed out and possible ways to overcome them are sketched.

Background: Quality profiling is practiced at the TCM hospital Bad Kötzting since its establishment 25 years ago. The profiling comprises assessment of treatment effectiveness andsafety, structural features, staff qualification as well as diagnostic and therapeutic processes. Findings regarding patients, intervention and outcome profiles are presented by appropriate examples. Methods: Data of each in-patient were systematically collected by physicians and via self-reports at admission, discharge and follow-up. Over the years the system was adjusted several times resulting in a data pool of about 19,000 in-patients by end of 2014. Results: Patients are 52 years old on average, 70% are female, and suffering from the main complaint since 7 years (median). The diagnostic spectrum changed over the years according to the development towards a psychosomatic focus. For TCM acupuncture therapy 222 different acupoints were used in 7.7 different localisations on average per individual treatment. The mean intensity of the main complaint decreased clinically relevant (Cohen's d = 1.11 at discharge and 0.93 at follow-up). After the hospital stay the number of days of sick leave declined from 51.3 days by 40% per patient and year. Depressive disorders as most common mental illness decreased significantly decreased significantly at discharge (ICD symptom rating; Cohen's d = -1.01). 29.8% of patients met the criteria for a metabolic syndrome diagnosis according to the International Diabetes Federation (IDF). In this group of cases, triglycerides, cholesterol and blood glucose improved markedly at discharge. Discussion: The presented quality control measures clearly contribute to an enhanced transparency in terms of a comprehensive quality profile. The findings from various outcome parameters indicate that patients benefit from the treatment.

Background: Epidemiological data shows globally increasing numbers of obesity and stress-related diseases. In this article, a comprehensive medical lifestyle modification programme - called Individual Health Management (IHM) - is described in detail and discussed as a promising tool to individually manage and reverse such negative health trends in patients. Methods: The IHM programme is based on a blended learning concept. It comprises a 12-week basic training phase, followed by a 9-month maintenance phase, and includes the following key features: 1) web-based and physician-led health screenings; 2) a structured 12-week basic training with a core curriculum providing tuition in behavioural self-management strategies for weight loss and stress reduction; 3) weekly supervised group sessions during the core curriculum; 4) tailoring of materials, strategies and lifestyle goals; 5) continuous self-monitoring and feedback of the achieved progress; 6) regular contact with physicians or health professionals based on either face-to-face or distant lifestyle counselling; 7) recurrent one-day health seminars to ensure the sustainability of obtained results. Conclusions: IHM is a multi-component lifestyle intervention programme to increase physical activity, to reduce calorie intake and to practice both self and stress management. Individual care, group support and a tailored web-based programme blend to achieve the desired goals. A randomised control study to evaluate IHM's effects on weight control is currently being conducted.

This systematic review aims to summarize the available randomized trials of multifactorial lifestyle interventions in the primary and secondary prevention of coronary heart disease and type 2 diabetes mellitus. Randomized trials investigating the effects of lifestyle interventions including the elements of diet, physical activity, and stress management in people at increased risk for or with manifest coronary heart disease or type 2 diabetes mellitus were searched for in five electronic database and by citation tracking. Quality was assessed using the Cochrane Collaboration's risk of bias tool. Exploratory effect size calculations were performed for a variety of laboratory and clinical outcome measures. Twenty-five trials including a total of 7,703 participants met the inclusion criteria. Fifteen trials were in patients with coronary heart disease, seven in patients with type 2 diabetes mellitus, and three on primary prevention. The interventions varied greatly regarding concept, intensity, and providers. Compared to participants in "usual care" control groups, there were no consistent effects on lipid levels and blood pressure and small effects on body mass index and glycated hemoglobin (HbA1c). Composite cardiac event rates were significantly less in the intervention groups of the few trials reporting these outcomes. Mortality was also lower in the intervention groups, but the difference was not statistically significant, and confidence intervals were wide. The evidence base for multifactorial lifestyle interventions is weak. Effects on surrogate measures seem minor, but there may be clinically relevant effects on major clinical endpoints.

OBJECTIVE: We aimed to investigate (1) to which extent headache diary variables correlate among each other; (2) to which extent they correlate with generic measures of quality of life and disability; (3) and whether correlations vary over time. METHODS: We performed a secondary analysis of data from 301 patients suffering from migraine and 270 patients suffering from tension-type headache collected in 2 randomized trials of acupuncture. We calculated product-moment correlation coefficients. RESULTS: Correlations between diary parameters varied to a great extent. Attack frequency, a measure recommended by the International Headache Society as a primary outcome measure for migraine prophylaxis trials, correlated only moderately with other diary outcomes. At baseline the parameters measured in the headache diary correlated only weakly with the generic outcome measures. After 12 weeks these correlations had increased considerably. CONCLUSION: Our findings suggest that participants in headache trials "learn" to fill in diaries and generic instruments in a more consistent manner during the course of the study.

Objective: to assess the use of, knowledge about, and the demand for information concerning complementary and alternative medicine (CAM) in cancer patients. Methods: A cross-sectional survey was performed on consecutive patients visiting the outpatient tumor treatment center of a university hospital at Munich, Germany. The authors used a questionnaire with questions on sociodemographics, tumor diagnosis and treatment, current symptoms, previous use of CAM, and expectations and attitudes with respect to CAM. Results: 52% used at least 1 CAM method, 24% did not use CAM but asked for consultation, and 24% neither used CAM nor were interested; 59% rated CAM treatment as personally important; 76% and 34% described themselves as well informed about conventional treatment and CAM, respectively. Current CAM use was associated with higher degrees of information and subjective importance, and not suffering from lymphatic cancer and metastases. Conclusions: CAM is a relevant topic for the care of cancer patients.

Hintergrund und Fragestellung: Die Zungenbeurteilung ist ein zentrales diagnostisches Verfahren der traditionellen chinesischen Medizin. In der vorliegenden Studienserie wurde untersucht, inwieweit unterschiedliche Beurteiler bei der morphologischen Beschreibung von Zungenmerkmalen übereinstimmen. Methoden: In zwei Pilotstudien (jeweils n = 15 Patienten) und einer größeren Untersuchung (Hauptstudie; n = 101) wurden Digitalfotografien der Zungenbefunde von Klinikpatienten durch zwei bzw. drei erfahrene Beurteiler mithilfe von Formularen verblindet bewertet. Das wichtigste Zielkriterium war die Übereinstimmung über die erwartete zufällige Übereinstimmung hinaus (Cohens Kappa). Ergebnisse: In der ersten Pilotstudie wurden in hohem Maße variable Kappa-Werte beobachtet (–0,15 bis 0,76). Bei zahlreichen Merkmalen zeigten sich jedoch nur geringe bis mäßige Übereinstimmungen. In der zweiten, mit einer verbesserten Methode durchgeführten Pilotstudie zeigten sich zwar wiederum in hohem Maße variable Kappa-Werte (–0,10 bis 1,00), bei 7 der 18 erhobenen Merkmale war die überzufällige Übereinstimmung jedoch sehr gut (Kappa ≥0,75). In der Hauptstudie lagen die Kappa-Werte zwischen 0,15 und 0,83. Diskussion: In den vorliegenden Studien wurden erste Schritte hin zu einer systematischen Untersuchung der Reliabilität der Zungendiagnose im Rahmen der traditionellen chinesischen Medizin unternommen. Die Ergebnisse deuten darauf hin, dass die Beurteilung morphologischer Merkmale eine befriedigende Reliabilität haben dürfte.

Zusammenfassung Hintergrund Die wissenschaftlichen Studien im Rahmen des Modellvorhabens Akupunktur der Ersatzkassen verfolgten das Ziel, die Wirksamkeit und Therapiesicherheit der Akupunktur bei chronischen Kopfschmerzen, Schmerzen der Lendenwirbelsaule und Arthroseschmerzen unter kontrollierten und unter Alltagsbedingungen zu untersuchen. Das Behandlungsergebnis dient als Kriterium fur eine qualitativ gute Akupunktur. Aus der Koppelung einer Beobachtungsstudie mit Daten einer Arztbefragung liesen sich gewisse Hinweise in Bezug auf Patienten-, Behandlungs- und Behandlermerkmale ableiten. Ziel Uberprufung der bereits publizierten Zusammenhange an einer homogenen Indikationsgruppe. Methodik Zusammenfuhrung der Patientendaten einer prospektiven Beobachtungsstudie mit den Daten der behandelnden Akupunkteure aus einer Praxisbefragung. Von den Patienten lagen Messwerte vor bezuglich Schmerzstarke, Funktionalitat im Alltag, Lebensqualitat und Anzahl Schmerztage bei Akupunkturbeginn und sechs Monate danach. Nach Therapie wurden eine globale Erfolgsbeurteilung, das Auftreten von Nebenwirkungen sowie die Patientenzufriedenheit erhoben. Seitens der Akupunkteure wurden untersucht: Fachrichtung, Akupunkturqualifikation, Anteil akupunktierter Patienten in der Praxis, Anwendung weiterer komplementarmedizinischer Verfahren. Ergebnisse 1.727 Patienten mit chronischen LWS-Schmerzen (mittleres Alter 58 Jahre, 79 % weiblich), behandelt von 1.061 Akupunkturarzten, gingen in die Analysen ein. Bezuglich des Behandlungsergebnisses wurden zwei Extremgruppen (445 Non-Responder und 261 Best-Responder) verglichen. Es zeigte sich bei Patienten von Akupunkteuren mit kurzerer (A-Diplom) oder langerer (B-Diplom) Ausbildung kein unterschiedlicher Behandlungserfolg. Von Orthopaden behandelte Patienten waren seltener in der Gruppe der besonders erfolgreich behandelten Patienten vertreten. Patienten von Arzten mit hoherem Akupunkturanteil in der Praxis sowie von Arzten, die in ihrer Praxis auch weitere naturheilkundliche Verfahren anboten, wiesen haufiger ein gutes Therapieergebnis auf. Hinweise ergaben sich, dass bei Arzten mit langerer Akupunkturausbildungszeit und Erfahrung die Patienten seltener uber Nebenwirkungen berichteten. Unabhangig von ihrem Geschlecht waren Patienten zufriedener mit der Akupunkturbehandlung, wenn die Behandlung von einer Arztin durchgefuhrt wurde. Mannliche Orthopaden wiesen eine auffallend niedrigere durchschnittliche Dauer des Arzt-Patienten-Kontaktes wahrend der Akupunktur auf. Schlussfolgerungen Trotz einiger methodischer Einschrankungen ergaben sich Hinweise fur den Stellenwert einzelner Arztmerkmale als „Qualitatsmerkmal”, die fur eine Verbesserung der Versorgungspraxis mit Akupunktur nutzbar sind.

Zusammenfassung Hintergrund und Ziel Im Rahmen des Modellvorhabens der Ersatzkassen wurden Wirksamkeit und Vertraglichkeit der Akupunktur bei der Behandlung von Patienten mit chronischen Schmerzen untersucht. In der vorliegenden Arbeit berichten wir uber die Ergebnisse einer grosen Beobachtungsstudie im Rahmen des Modellvorhabens zur Sicherheit und Vertraglichkeit. Methoden Aspekte der Sicherheit und Vertraglichkeit wurden auf dreierlei Weise untersucht: Bei allen 503.397 zwischen Juli 2001 und Juni 2003 dokumentierten Behandlungsfallen sollten die Arzte eine globale Vertraglichkeitsbewertung abgeben und aufgetretene unerwunschte Wirkungen benennen. Schwerwiegende unerwunschte Wirkungen sollten bis Ende 2004 der begleitenden Forschungseinrichtung gemeldet werden. Auserdem wurden 6.140 Patienten direkt zu Nebenwirkungen befragt. Ergebnisse Die Arzte berichteten in 7,8% der Falle uber unerwunschte Wirkungen; die am haufigsten genannte unerwunschte Wirkung war Nadelungsschmerz. Insgesamt 17 Falle von schwerwiegenden unerwunschten Wirkungen wurden gemeldet; das am haufigsten genannte Ereignis war hierbei ein Pneumothorax (5 Falle). 9,3% der Patienten bejahten die Frage nach Nebenwirkungen; in einem Viertel der Falle wurden diese als stark beeintrachtigend bewertet. Die von Patienten am haufigsten genannten Nebenwirkungen waren Schmerzen, Mudigkeit und Kreislaufbeschwerden. Schlussfolgerung Schwerwiegende unerwunschte Wirkungen der Akupunktur sind sehr selten, leichtere Nebenwirkungen werden dagegen haufig von Patienten angegeben. Insgesamt ist Akupunktur bei arztlicher Anwendung als vergleichsweise sichere Methode anzusehen.

Objective. To investigate the suitability of measurements of mercury (Hg) concentration as a means of identifying patients with health complaints attributed to dental amalgam. Methods. Hg in erythrocytes, plasma, urine, and saliva was determined in 27 patients complaining about health problems attributed to amalgam, 27 healthy volunteers with amalgam fillings, and 27 healthy amalgam-free volunteers. Results. Concentrations of inorganic mercury in blood and of total mercury in urine and saliva differed significantly between individuals with amalgam fillings and amalgam-free volunteers, but not between symptomatic patients and healthy volunteers with amalgam fillings. Urine Hg levels tended to be better correlated with blood than with saliva data. Levels of organic Hg were equal in all groups. Conclusion. Concentrations of total and inorganic mercury in body fluids do not distinguish between asymptomatic amalgam bearers and those who suffer from a poorly defined syndrome of multiple nonspecific symptoms.

Summary Objectives To investigate which patients receive acupuncture in the framework of statutory health insurance in Germany, how treatment was carried out, and what results were achieved. Design Basic documentation (carried out by physician) within a prospective observational study. Setting 454,920 patients with at least one of the three chronic pain conditions including headache, low back pain and osteoarthritis treated by 8727 medical acupuncturists (panel doctors) within the scope of a reimbursement program. Results Fifty-three percent of the patients were treated by general practitioners, 19% by orthopaedists and 9% by internists. Eighty percent of patients were female, mean age was 53.6 (S.D. = 15.7) years. Primary indication for acupuncture was low back pain (45%), headache (36%), and osteoarthritis (12%). Median time since the initial diagnosis was 3 years. 8.4 (S.D. = 3.0) acupuncture sessions (body acupuncture) were administered on average. In 28% a concomitant treatment was reported. Effectiveness of acupuncture was rated by physicians in 22% of the patients as marked, in 54% as moderate, in 16% as minimal and in 4% as poor (unchanged). In 8% of the patients mild adverse reactions were reported, severe side effects occurred in 13 patients (0.003%). Orthopaedists rated the effectiveness of acupuncture lower, showing shortest time for face-to-face contact with the patient. More acupuncture training did not correspond to better therapeutic effect assessed by physicians. Conclusions Acupuncture proved a highly demanded treatment option for chronic pain conditions within the German research program. Results indicate that acupuncture provided by qualified therapists is safe, and patients benefited from the treatment.

Summary Objective The aim of this paper is to describe the treatment and physician characteristics in a randomised trial of acupuncture for osteoarthritis of the knee. Design Three-armed, randomised, controlled multicentre trial with 1-year follow-up. Setting Twenty-eight outpatient centres in Germany. Interventions A total of 294 patients with osteoarthritis of the knee were randomised to 12 sessions of semi-standardised acupuncture (at least 6 local and 2 distant points needled per affected knee from a selection of predefined points, but individual choice of additional body or ear acupuncture points possible), 12 sessions of minimal acupuncture (superficial needling of at least 8 of 10 predefined, bilateral, distant non-acupuncture points) or a waiting list control (2 months no acupuncture). Outcome Participating trial physicians and interventions. Results Forty-seven physicians specialised in acupuncture (mean age 43 ± 8 years, 26 females) provided study interventions in 28 outpatient centres in Germany. The median duration of acupuncture training completed by participating physicians was 350 h (range 140–2508). The total number of needles used was 17.4 ± 4.8 in the acupuncture group compared to 12.9 ± 3.3 in the minimal acupuncture group. In total, 39 physicians (83%) stated that they would have treated patients in either a similar or in exactly the same way outside of the trial, whereas 7 (15%) stated that they would have treated patients differently (1 missing). Conclusions Our documentation of the trial interventions shows that semi-standardised acupuncture strategy represents an acceptable compromise for efficacy studies. However, a substantial minority of participating trial physicians stated that they would have treated patients differently outside of the trial.

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.

Objective To compare patient characteristics and outcomes between a randomized controlled trial (RCT) and an observational study (OS) of acupuncture treatment in patients with migraine. Study Design and Setting Within the framework of a research program for acupuncture for chronic pain, both an RCT and an OS of routine care were performed in patients with migraine. One hundred forty-five patients received acupuncture in the RCT and 732 in the OS. All patients completed a pain questionnaire, including instruments evaluating disability, quality of life, and depression, at baseline and at 6-month follow-up. Results At baseline, patients participating in the RCT had a significantly longer history of complaints and more headache days but better quality of life and fewer depressive symptoms than patients participating in the OS. In unadjusted analyses, improvements after 6 months were more pronounced in the OS than in the RCT. After adjustment for potential confounders, the differences decreased but were still significant for several outcomes. Conclusion Participants of the RCT were probably not representative of migraine patients undergoing acupuncture treatment in routine care under current regulations in Germany. However, changes after treatment were similar in the RCT and the OS of routine care.

Objective: We aimed to investigate whether the Prognos® device might be a useful tool in the diagnosis of disorders suspected to be due to dental amalgam fillings. Participants and Methods: A diagnostic case-control study was performed in 27 patients who complained about health problems attributed to amalgam (cases), 27 healthy volunteers with amalgam fillings (controls I), and 27 healthy amalgamfree volunteers (controls II). All participants were tested before and after application of 300 mg DMPS (2.3-dimercapto- 1-propanesulfonic acid) with Prognos®, a diagnostic device for the energetic measurement of Traditional Chinese Medicine meridians. In addition, mercury was measured in blood, urine, and saliva, and a lymphocyte transformation test (LTT) was performed. Results: Diagnoses derived from the first and second Prognos® testing did not agree above chance (Cohen’s Kappa = -0.11, 95% confidence interval -0.33 to 0.10; p = 0.30). Agreement for secondary outcome measures was poor, too. Prognos® measurements did not differ between cases and controls. Correlations with measurements in urine, blood and saliva were low. Conclusion: In this study Prognos® could not be shown to be a useful tool in the diagnosis of disorders suspected to be due to dental amalgam fillings.

To present a patient care evaluation program exemplified by a rehabilitation clinic for complementary and alternative medicine (CAM) with focus on aspects of structure quality, steps of quality assurance and interventions administered. Methods: Assessment of previously defined criteria of structure (general characteristics of the facility, staff, medical equipment and constructional features, medical concept, continuing care, internal communication) and measures of quality assurance with the aid of a questionnaire filled in by the management of the hospital. Development of internal guidelines for diagnostics and therapy with respect to relevant diseases. Results: The clinic’s structure profile describes the indications and contraindications in effect, the quantity and qualification structure of staff, and the constructional and medical equipment details. Based on a multidimensional bio-psycho-social concept the general objectives of rehabilitation are derived. According to the medical concept the corresponding diagnostic and therapeutic methods are presented. Guidelines for treatment were exemplified by patients with migraine. Conclusion: The structural features do not fully meet the preconditions valid for the various indications in rehabilitation. As CAM hospitals define themselves by the methods of intervention they apply rather than by the indications to be treated they demand for an exceptional position.

Background Overweight is considered an important risk factor for diseases in the context of metabolic syndrome. Lifestyle modifications are the means of choice to reduce weight in persons with a Body Mass Index of 28 to 35. The study examines whether there are any differences between two intervention strategies regarding weight reduction in overweight persons. Methods/Design The study is a multicentre randomized controlled trial with observation duration of 12 months. Eight study centres are involved to include a minimal sample size of 150 participants. Randomization ratio is 2:1. Feasible persons are checked according to inclusion and exclusion criteria and after given informed consent are assigned randomly to one of two intervention programs: A) intervention group: comprehensive lifestyle modification program (Individual Health Management IHM) with 3 months reduction phase plus 9 months maintaining phase, B) control group: written information with advice for healthy food habits (Usual care UC). Participants of the IHM group have access to a web-based health portal and join 3 full-day and 10 two-hour training sessions during the first 3 months. During the remaining 9 months four refresh trainings will be performed. There are 3 different diet strategies (fasting, two-day diet, meal replacement) for free choice. Participants of the control group are provided with acknowledged rules for healthy food according to the German Nutrition Society (DGE). Examinations are conducted at baseline, after 3, 6, 9 and 12 months. They include body weight, waist circumference, blood pressure, laboratory findings and a bio-impedance analysis to measure body composition. Statistical analysis of the primary outcome ‘change of body weight after 12 months’ is based on ITT population including analysis of variance of the weight differences between month 0 and 12 with the factors ‘group’, ‘baseline value’ and ‘study centre’. Secondary outcomes will be analyzed exploratively. Discussion The monitoring of the study will implement different measures to enhance compliance, avoid attrition and ensure data quality. Based on a blended learning concept and using web-based e-health tools the program promises to achieve sustainable effects in weight reduction. Trial registration German Clinical Trials Register Freiburg (DRKS): DRKS00006736 (date registered 20/09/2014). Electronic supplementary material The online version of this article (doi:10.1186/s40608-015-0069-x) contains supplementary material, which is available to authorized users.

OBJECTIVE: Descriptions of the interventions used in acupuncture studies are often incomplete. The aim of this paper is to describe participating trial physicians and interventions in a randomised trial of acupuncture for low back pain. DESIGN: Three-armed, randomized, controlled multicenter trial with 1-year follow-up. A total of 301 patients with low-back pain were randomized to 12 sessions of semistandardized acupuncture (at least six local and two distant points needled bilaterally from a selection of predefined points, but individual choice of additional body or ear acupuncture points possible), minimal acupuncture (superficial needling of at least 6 of 10 predefined, bilateral, distant nonacupuncture points), or a waiting list control (2 months no acupuncture followed by semistandardised acupuncture described above). OUTCOME MEASURES: Participating trial physicians and interventions. RESULTS: Forty-five (45) physicians specializing in acupuncture (mean age 44 +/- 7.8 years, 23 (51%) female) in 30 outpatient centers in Germany provided the interventions. The median duration of acupuncture training of trial physicians was 350 hours (range 140-2508). The most frequently reported Chinese diagnosis was Kidney deficiency (39%), followed by qi and Blood stagnation (24%), and bi syndrome (20%). The total number of needles used was 17.3 +/- 4.2 in the acupuncture group compared to 12.3 +/- 1.2 in the minimal acupuncture group. In total, 40 physicians (89%) stated that they would have treated patients similarly or in exactly the same way outside of the trial, whereas 5 (11%) stated that they would have treated patients differently. CONCLUSIONS: For most trial physicians, the semistandardized acupuncture strategy used in this trial was an acceptable compromise for an efficacy study. However, a relevant minority of participating trial physicians stated that they would have treated patients differently outside of the trial.

To investigate whether a combination of acupuncture and acupressure is effective for reducing chemotherapy-induced nausea and vomiting. In a randomised cross-over trial, 28 patients receiving moderately or highly emetogenic chemotherapy and conventional standard antiemesis were treated for one chemotherapy cycle with a combination of acupuncture and acupressure at point P6 and for one cycle at a close sham point. The main outcome measure was a nausea score derived from daily intensity rating. There was no difference between combined acupuncture and acupressure treatment at P6 and at the sham point for the nausea score, but the level of nausea was very low in both phases. The mean nausea score was 6.2 (standard deviation 9.0) for treatment at P6 and 6.3 (9.1) for treatment at the sham point (mean difference −0.1, 95% confidence interval −3.9 to 3.7; p=0.96). Seventeen of 21 participants completing the study would desire acupuncture and acupressure for future chemotherapy cycles, but there was no clear preference for either point. In this small pilot study a significant difference between treatment at P6 and a close sham point could not be detected. However, it cannot be ruled out that an existing difference was missed due to the small sample size.

Zusammenfassung Ziel Beschreibung der am Modellvorhaben Akupunktur der Ersatzkassen teilnehmenden Arzte bzw. Arztpraxen hinsichtlich Merkmalen zur Struktur- und allgemeinen Prozessqualitat. Methodik Schriftliche Befragung der Arzte sechs Monate nach dem Start des Modellvorhabens mit Erfassung von demographischen Daten, Niederlassungsdauer, Praxisgrose, Akupunkturqualifikation und Indikations- und Methodenschwerpunkten im Zeitraum eines Jahres vor der Befragung. Die Daten wurden fur das Gesamtkollektiv und stratifiziert nach Akupunkturqualifikation (A- bzw. B-Diplom) und Facharztgruppe (Allgemein-/Praktische Arzte, Orthopaden, Sonstige) analysiert. Ergebnisse 5.217 (57 %) von 9.182 Arzten beantworteten den Fragebogen (Alter im Median 46 Jahre; 64 % mannlich; 28 % mit B-Diplom). Der Anteil von Allgemein-/Praktischen Arzten lag bei 51 %, der von Orthopaden bei 18 %. Akupunktur wurde im Median seit sieben Jahren eingesetzt, bei im Durchschnitt 5 % aller Praxis-Patienten; dafur wurde 10 % der Zeit der therapeutischen Tatigkeit aufgewendet. 87 % der Arzte nutzten auch Mikrosystemverfahren. B-Diplom-Trager setzten eine grosere Vielfalt an Akupunkturverfahren und haufiger auch klassische Naturheilverfahren, Homoopathie und chinesische Phytotherapie ein. Orthopaden unterschieden sich bezuglich der Qualifikation nicht von den anderen Facharztgruppen, verwendeten aber eine geringere Vielfalt an Akupunkturmethoden. Schlussfolgerung Die Stratifizierungen nach Akupunkturqualifikation bzw. Facharztgruppe zeigten erhebliche Unterschiede in Struktur- und Prozessmerkmalen.

OBJECTIVE: To investigate characteristics and outcomes of patients undergoing acupuncture treatment for osteoarthritic pain under conditions of routine care in the framework of statutory health insurance in Germany. METHODS: Patients with chronic pain due to osteoarthritis (ICD-10 diagnoses M15 to M19) treated with acupuncture as the leading form of therapy were included in an observational study. Detailed questionnaires including instruments to measure pain intensity (numerical rating scales from 0 to 10), disability (Pain Disability Index) and quality of life (SF-36) were filled in before treatment, after treatment and at 6 months. Patients suffering from osteoarthritis of the knee and hip also filled in the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index questionnaire. RESULTS: A total of 736 patients were included in the main analysis. Seventy (10%) patients and 278 (38%) patients, respectively, suffered exclusively from primary osteoarthritis of the hip or knee, 239 (33%) from another type of osteoarthritis and 149 (20%) had more than one affected joint. On average, patients received 8.7 +/- 3.1 acupuncture treatments. Statistically significant and clinically relevant improvements were seen in all subgroups both after treatment and at 6 months in all major outcome measures. In patients with osteoarthritis of the hip, the WOMAC sum score was 47.9 +/- 20.7 at baseline, 34.8 +/- 20.0 after treatment and 33.1 +/- 22.2 at 6 months. The respective values in patients with osteoarthritis of the knee were 51.7 +/- 20.9, 34.1 +/- 23.3 and 34.6 +/- 25.1. CONCLUSIONS: In this study, patients with chronic pain due to osteoarthritis reported clinically relevant improvements after acupuncture treatment. Due to the uncontrolled design and the high proportion of patients lost to follow-up, the study findings must be interpreted cautiously.

This paper describes the concept and realization of a nation-wide observational study which is part of the patient care evaluation programme on acupuncture as part of a model project of German statutory insurance bodies. The study aimed describing medical care with acupuncture to estimate the incidence of adverse reactions as well as the treatment effects of acupuncture in chronically ill patients with headache, low back pain or osteoarthritic pain. It was also intended to analyse relations between treatment effects and specialties of the treating acupuncturists. During the two-year period of report 9,918 acupuncturists took part in the study documenting 503,397 cases. A more comprehensive documentation is available for a sample of 10,366 patients with complete longitudinal data of 6,140 patients. The difficulties with data management and sampling technique are presented with reference to restricted capacities for monitoring. Furthermore the question of generalising of the results is discussed. There were differences in some respects (for example, frequencies of different indications) between the patient sample and the population of all patients included in the project. Patients also differed slightly with respect to the completeness of the longitudinal documentation. The results indicated that we cannot claim global representativeness for the sample-based findings, but there is no reason to assume a "positive" selection.

Objective : To investigate the effectiveness of a clinical treatment program with traditional Chinese medicine for migraine and tension-type headache. Methods : Ninety-one patients with migraine, episodic or chronic tension-type headache according to the criteria of the International Headache Society were randomised into an experimental or a waiting list control group. Patients in the experimental group were treated 4 weeks in a hospital for traditional Chinese medicine after a baseline period of one month. Patients in the waiting list group continued their previous headache treatment. Main outcome measure was the difference in the number of days with headache of at least moderate intensity during baseline (month 1) and month 7. Results : The difference in the number of days with headache of at least moderate intensity was 5.6 (S.D., 6.1) days in the experimental group and 1.2 (S.D., 4.5) days in the waiting list group ( P Conclusion : The results of this study indicate that treatment in the hospital for traditional Chinese medicine in Kotzting is associated with lasting improvements in the majority of patients.

Development of ‚Ordnungstherapie‚ due to Bircher-Benner in the Naturopathy of the 20th Century Background: The German term ‚Ordnungstherapie‚ is one of the five therapeutics which defines naturopathy in German-speaking countries. Objective: Who formed the term Ordnungstherapie in naturopathy and what does it mean? Material and Methods: Heuristics and criticism of literature of the 20th century as well as database research. Results: Nowadays in German-language medical books Ordnungstherpie belongs to the five therapeutics which define European naturopathy. Yet, the interpretation ranges from health education to body-orientated forms of psychotherapy. The term Ordnungstherapie is often related with the German priest and hydropath Sebastian Kneipp, however, term and definition have been founded by the Swiss physician Maximillian Bircher-Benner. In 1937 he defined Ordnungstherapie as a complex concept of natural healing. It is based upon the rather nosological idea that health is order/harmony in the human body (physically, psychologically), the environment and the daily course. Illness occurs if disorder appears in one of these fields. The therapeutic setting of Ordnungstherapy is defined by 9 rules of conduct to maintain order, which include nutrition, the skin as an organ (exposure to light, air, water), breathing, movement, rhythm of life, and psyche. For all these aspects Bircher-Benner himself uses the terms somatotherapy (dietotherapy, sun and light therapy, hydrotherapy, exercise therapy, breathing technique, order of the rhythm of live) and psychotherapy. He chose these complementary methods subjectively after learning them from 1897 onwards in an eclectic manner and after gaining therapeutic empiricism. Nevertheless his ideas of the Ordnungstherapie correlate with the socio-political context of the 1940ies. Conclusions: The term Ordnungstherapie was introduced by Bircher-Benner as an umbrella term in 1937 to describe a complex concept of naturopathic therapies. It comprises, with certain limitations for phytotherapy, the therapies which nowadays define European naturopathy. Yet, in European naturopathy today Ordnungstherapie is mostly considered as one out of 5 constituents of naturopathy (dietotherapy, hydrotherapy, exercise therapy, phytotherapy, Ordnungstherapie). The classification of Ordnungstherapie as one of the 5 pillars of the Kneipp therapy was only done by Kneipp physicians in the middle of the 20th century and needs to be thought over.

Background: In two hospitals we performed an open, prospective observational study on patients with chronic headache as a measure of internal quality assurance using identical methods. Available data were subordinately analysed in order to compare both studies. Questions: Are the patient samples of both hospitals comparable? If not, which form of statistical adjustment is recommended? Are there differences in the outcome measures of both facilities? Methods: The outcomes were defined as differences between baseline values and values at discharge from hospital, respectively 6 months after. Frequency of headache attacks, intensity of pain, intensity of general complaints as well as of concomitant symptoms, and quality of life were determined in advance as dependent variables. To compare both patient groups univariate analysis of variance without and with inclusion of covariates were used. For calculating propensity scores (conditional probability of belonging to one of two groups) a logistic regression with the same covariates serving as independent variables was performed. Patients: 426 patients with the main diagnosis ‘Migraine’ and complete data sets concerning the covariates were selected for analysis. 87% of patients are female, the mean age is 45.5 ± 11.7 years (range 14–73 yrs). Results: 4 out of 11 potential covariates show statistically significant differences between the patients of both hospitals. Correct classification of patients by means of the propensity score succeeds in 67%. Comparing the outcomes at discharge from hospital, significant differences between both groups exist which are, with one exception, not affected by controlling for covariates. 6 months after discharge two of the initial differences between both patient groups are no longer present. These findings are independent from the statistical technique of risk adjustment. Conclusions: Because of the observed differences between both patient groups it is recommended to adjust data by regression analysis in order to enhance comparability. The choice for one of the two proposed techniques is secondary. With respect to the analyses clear differences between both hospitals exist in short-term outcomes, disappearing 6 months later.

dients of Chinese medicinal drugs used for inpatient treatment. Responsible for this area of interest are Hildebert Wagner of the Center for Drug Research of the Ludwig-Maximilians-Universitat Munich and Rudolf Bauer of the Institute of Pharmaceutical Science, Department of Pharmacognosists of the Karl-Franzens-Universitat Graz. Especially in Germany, there is a long tradition of classifying active herbs and their chemical constituents. For this reason, the monographs on TCM drugs resulting from this work are important features of the scientific activities, as indicated in the cover of this issue and the article by Wagner et al. [3]. TCM is under increasing pressure to show therapeutic efficacy and lack of side effects as well as to improve clinical quality continuously. Therefore, a ‘complication screening program’ with an effective adverse event reporting system for all used methods in the clinic has been established. We especially stress the absence of toxins, contamination and adulteration in order to avoid risks for the patients. The article by Melchart et al. [4] describes a model of safety monitoring and risk management in TCM drugs, so that risks can be identified early. Both Eastern and Western medical systems will benefit from additional TCM approaches, modified according to modern scientific requirements – these objectives are shared by all members of the scientific board.

Background: We report on the study design and protocols of two randomized controlled trials (Acupuncture Randomized Trials = ART) that investigate the efficacy of acupuncture in the treatment of chronic low back pain and osteoarthritis of the knee, respectively. Objective: To investigate whether acupuncture is more efficacious than (a) no treatment or (b) minimal acupuncture in the treatment of low back pain and osteoarthritis. Design: Two randomized, controlled, multicenter trials with three treatment arms and a total follow-up time of 52 weeks. Setting: 30 practitioners and outpatient units in Germany specialized in acupuncture treatment. Patients: 300 patients will be included in each study. In the low back pain trial, patients will be included according to clinical diagnosis. In the osteoarthritis pain trial, patients will be included according to the American College of Rheumatology criteria. Interventions: Patients are randomly assigned to receive either (1) semi-standardized acupuncture (150 patients), (2) minimal acupuncture at non-acupuncture points (75 patients), or (3) no treatment for two months followed by semi-standardized acupuncture (75 patients, waiting list control). Acupuncture treatment consists of 12 sessions per patient over a period of 8 weeks. Main Outcome Measure: The main outcome measure is the difference between baseline and the end of the 8-week treatment period in the following parameters: pain intensity as measured by a visual analogue scale (VAS; 0–100 mm) in the low back pain trial and by the Western Ontario and McMaster Universities Osteoarthritis Score (WOMAC) in the osteoarthritis trial. Outlook: The results of these two studies (available in 2004) will provide health care providers and policy makers with the information needed to make scientifically sound assessments of acupuncture therapy.

Background and Objective: We report the design and essentials of the protocols of two Acupuncture Randomized Trials (ART) investigating whether acupuncture is more efficacious than no treatment and minimal acupuncture in the interval treatment of migraine and tension-type headache. Design: Randomized controlled multicenter trials with three treatment arms and a total observation period of 28 weeks. Setting: 30 practitioners and outpatient units in Germany specialized in acupuncture treatment. Patients: Per study 300 patients with migraine and episodic or chronic tension-type headache, respectively (diagnosis according to the criteria of the International Headache Society). Interventions: Patients are randomly assigned to receive either (1) semi-standardized acupuncture (150 patients), (2) standardized minimal acupuncture (75 patients), or (3) no interval treatment for 12 weeks followed by semi-standardized acupuncture (75 patients, waiting list control). Acupuncture treatment consists of 12 sessions per patient over a period of 8 weeks. Main Outcome Measure: Main outcome measure in the migraine trial is the difference between the number of days with headache of moderate or severe intensity during the 4 weeks before randomization and weeks 9 to 12 after randomization. In the study on tension-type headache the main outcome measure is similar to that described above, but for the number of headache days regardless of intensity. Outlook: The results of these two studies (available in 2004) will provide health care providers and policy makers with the information needed to make scientifically sound assessments of acupuncture therapy.

Einleitung: Es werden erste Zwischenergebnisse aus der Basisdokumentation einer Beobachtungsstudie zur Akupunktur bei chronischem Kopfschmerz, chronischen LWS-Beschwerden und chronischem Osteoarthroseschmerz berichtet. Die Studie ist eine Teilkomponente des wissenschaftlichen Begleitprogramms des Modellvorhabens der Ersatzkassen zur Akupunktur. Zielsetzung: Beschreibung der Versorgungspraxis mit Akupunktur bei den definierten Indikationen, durchgefuhrt von qualifizierten arztlichen Akupunkteuren im niedergelassenen Bereich; Abschatzung der Inzidenz von unerwunschten Ereignissen und Beschreibung der Behandlungseffekte der Akupunktur. Methodik: Offene, prospektive, multizentrische Beobachtungsstudie mit einer fur alle Patienten des Modellvorhabens verbindlichen Basisdokumentation durch den Arzt. Neben den allgemeinen Rahmenbedingungen des Modellvorhabens gibt es keine weiteren Vorgaben hinsichtlich der durchgefuhrten Akupunktur. Ergebnisse: Zum Stichtag 25.3.2002 steht die Basisdokumentation von 97 733 Fallen (80,5 % weiblich, Alter 55,1 ± 15,5 Jahre), behandelt von 7050 Akupunkteuren, zur Verfugung. Haufigste Indikation fur die Akupunktur sind LWS-Beschwerden (45,7 %). 35,2 % der Falle werden wegen chronischer Kopfschmerzen und 12,1 % wegen Arthroseschmerz behandelt. In 7 % liegen mehrere Indikationen gleichzeitig vor. Die Diagnose ist im Median seit 3 Jahren bekannt und meist facharztlich gesichert. 70,8 % der Patienten erhielten bislang noch keine Akupunktur. Pro Patient wurden durchschnittlich 7,9 Akupunktursitzungen dokumentiert. 34,3 % erhielten eine Begleitbehandlung. Die therapeutische Wirksamkeit wird von den Arzten abschliesend in 21,6 % der Falle als sehr gut, in 55,1 % als gut und in 16,8 % als gering beurteilt. 3,6 % der Falle werden als unverandert oder verschlechtert eingestuft. Eine unerwunschte Wirkung wurde in 7,1 % der Falle berichtet. Schwerwiegende Ereignisse wurden in 6 Fallen mitgeteilt, ihre Haufigkeit liegt unter 0,01 %. Ausblick: Fur die laufende Studie werden bis etwa 500 000 Behandlungsfalle erwartet. Derzeit werden die an einer Patientenstichprobe zusatzlich eingesetzten Patientenfragebogen ausgewertet. Eine elektronische Form der Dokumentation wird derzeit erprobt. Introduction: The German Social Law allows the health insurance companies to perform so called „Modellvorhaben” (trial phases) in order to investigate effectiveness and efficiency of health care interventions under real life conditions. We report preliminary results of a study representing one component of the concomitant research strategy of a Modellvorhaben on acupuncture by a group of German social health insurance companies. Objective: Description of the usage of acupuncture in routine care of out-patients, estimation of the incidence of adverse effects, description of the therapeutic effects of acupuncture. Methods: Open prospective multicenter observational study of patients suffering from chronic headache, low back pain and osteoarthritic pain. Acupuncture is performed by registered medical acupuncturists with at least 140 hours of acupuncture training. Results: By March, 25, 2002 data from 97 733 patients (80.5 % female; mean age 55.1 ± 15.5 yrs) treated by 7050 acupuncturists were available for analysis. The most frequent indication for acupuncture was low back pain (45.7 %). The relative frequency of chronic headache was 35.2 % and 12.1 % for osteoarthritic pain, respectively. Multiple indications were reported in 7 % of the patients. The median duration of complaints was 3 years. 70.8 % of the patients were treated with acupuncture for the first time. 7.9 acupuncture sessions were reported per patient on average. 34.3 % of the patients received concomitant treatment. The therapeutic effectiveness was judged by the physicians as very good in 21.6 % of the patients, as good in 55.1 %, and as minimal in 16.8 %. In 3.6 % complaints were rated as unchanged or worse. Adverse effects were reported in 7.1 % of all patients, whereas severe adverse effects were documented in 6 cases meaning a frequency of below 0.01 %. Outlook: About 500 000 patients are expected for this ongoing study. An electronic version of the documentation is currently being tested. At present, more detailed patient-based data obtained in a random sample of patients are analyzed.

In an open prospective study with matched historical controls we aimed to evaluate whether a polysaccharide fraction isolated from the herb Echinacea purpurea could counteract the undesired effects of chemotherapy. Fifteen patients with advanced gastric cancer undergoing palliative chemotherapy with etoposide, leucovorin and 5-fluorouracil (ELF) received for 10 days (beginning 3 days before chemotherapy) daily i.v. injections of 2 mg of a polysaccharide fraction isolated from Echinacea purpurea herb cell cultures (EPS-EPO VIIa). The median number of leukocytes 14-16 days after chemotherapy was 3630/microL (range 1470-5770) in the patients receiving EPS-EPO VIIa compared with 2370/microL (870-3950) in the patients of the historical control group (p = 0.015). EPS-EPO VIIa had no clinically relevant effects on phagocytic activity of granulocytes or on lymphocyte subpopulations. Sixty-eight adverse events including two deaths were observed, most likely due to chemotherapy and the general condition of the patients. However, an association with the test intervention cannot be ruled out completely. The results of this pilot study suggest that EPS-EPO VIIa might be effective in reducing chemotherapy-induced leukopenia. The efficacy and safety should be investigated in further studies.