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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: 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.

In the last two decades, targeted therapies have enhanced tumor patient care and treatment success, however, metastatic growth still cannot be stopped efficiently and, therefore, mortality rates remain high. Prevention strategies against formation of metastases are the most promising approach we have, however, due to lack of clinical validation studies, they have not yet entered routine clinical care. In order to smooth the way for efficient prevention, further preclinical and large clinical studies are required. In this context, the underlying molecular mechanisms and factors that lead to metastatic growth have to be explored, and potential preventive agents have to be tested. Thereby, special attention has to be paid to natural bioactive compounds which do not exert major adverse effects, like the plant-derived polyphenol Curcumin, which is known to be a powerful antitumor agent. So far, most of the preclinical studies with Curcumin have focused on its effect on inhibiting tumor cell proliferation and invasion, although, it is known that it also inhibits metastatic spread in vivo. This review discusses the preventive potential of this natural compound not only against tumor onset, but also against formation of metastases.

In the last two decades, targeted therapies have enhanced tumor patient care and treatment success, however, metastatic growth still cannot be stopped efficiently and, therefore, mortality rates remain high. Prevention strategies against formation of metastases are the most promising approach we have, however, due to lack of clinical validation studies, they have not yet entered routine clinical care. In order to smooth the way for efficient prevention, further preclinical and large clinical studies are required. In this context, the underlying molecular mechanisms and factors that lead to metastatic growth have to be explored, and potential preventive agents have to be tested. Thereby, special attention has to be paid to natural bioactive compounds which do not exert major adverse effects, like the plant-derived polyphenol Curcumin, which is known to be a powerful antitumor agent. So far, most of the preclinical studies with Curcumin have focused on its effect on inhibiting tumor cell proliferation and invasion, although, it is known that it also inhibits metastatic spread in vivo. This review discusses the preventive potential of this natural compound not only against tumor onset, but also against formation of metastases.

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

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.

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.

Das Individuelle Gesundheits-Management (IGM) als Lebensstil-Programm kombiniert ein modernes webbasiertes Gesundheitsportal mit einer personlichen Gesundheitsbegleitung in Form von Beratung, Seminaren, Kursen und kurortlichen Gesundheitsaufenthalten („blended learning-Konzept“). Es zielt auf die Gesundheitsforderung, Krankheitspravention und Patientenschulung von Herz-Kreislauf- und Stoffwechselerkrankungen sowie Stressfolgeschaden und will den Einzelnen „zum Manager seiner eigenen Gesundheit“ machen. Primare Settings sind die Kommunen, Betriebe und das medizinische Versorgungsklientel. Das Vorhaben versteht sich als Demonstrationsprojekt zur Starkung einer proaktiven Versorgung der regionalen Bevolkerung. Das inhaltliche Konzept „prufen – planen – praktizieren“ umfasst ein 12-wochiges Basistraining mit einer mindestens 9-monatigen Aufbau- oder Erhaltungsphase.

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.