Multimodal Treatment of Patients with Mental Symptom Load: A Pre-Post Comparison.

The Traditional Chinese Medicine (TCM) Hospital in Bad Kötzting, Germany, is treating chronically ill patients, covering a broad range of indications. The aim of this study was to prove the efficacy of a multimodal intervention combining mainstream medicine with TCM treatments on the severity of psychopathological symptoms. Out of 966 patients with chronic psychosomatic disease treated 2017 at the TCM Hospital, we selected 759 patients according to specific criteria and analyzed the outcomes after multimodal intervention. The patients completed a validated questionnaire (International Statistical Classification of Diseases (ICD) Symptom-Rating-(ISR)) at admission, discharge, and follow-up. The most frequent ICD-10 diagnoses were "diseases of the musculoskeletal system and connective tissue" (28.5%), "mental and behavioral disorders" (23.7%), and "diseases of the nervous system" (13.8%). Regarding ISR symptom load, "depressive syndrome" and "anxiety syndrome" were the leading burdens showing remissions of about 40%-60% with moderate (0.588) to strong (1.115) effect sizes (Cohen's d) after treatment. ISR total scores at discharge and follow-up were remarkably lower after intervention (0.64 and 0.75, respectively) compared to 1.02 at admission with moderate to strong effect sizes (0.512-0.815). These findings indicate a clinically relevant relief from mental symptom load after intervention with lasting clinical effects for at least six months.

Therapeutic Effects of Curcumin-From Traditional Past to Present and Future Clinical Applications.

The efficacy of the plant-derived polyphenol curcumin, in various aspects of health and wellbeing, are a 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, whose work is scientifically sound and evidence is based 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.

The TALENT II study: a randomized controlled trial assessing the impact of an individual health management (IHM) on stress reduction.

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).

The Role of Curcumin in Prevention and Management of Metastatic Disease.

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.

Introduction of a web portal for an Individual Health Management and observational health data sciences.

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.

Herbal Traditional Chinese Medicine and suspected liver injury: A prospective study.

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.

High and Low Responders in a Comprehensive Lifestyle Program for Weight Loss - Secondary Analysis of a Randomized Controlled Trial.

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: <7.5%) were compared in terms of sociodemographic data, baseline values, and pre-post changes of various risk and protective factors. A logistic regression was performed to identify potential predictors of weight loss. 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.

Effects of a tailored lifestyle self-management intervention (TALENT) study on weight reduction: a randomized controlled trial.

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<0.001) was confirmed by various sensitivity analyses. Body mass index, waist circumference, high-density lipid cholesterol, body fat, and the ratio of fat and body cell mass improved to a significantly higher degree in the IHM group. CONCLUSION: IHM proved to be superior to UC in weight reduction after 1 year. With a mean loss of about 10% of the baseline weight, a clinically high relevant risk reduction for cardio-metabolic diseases is achievable.

[Complementary and Alternative Medicine in Oncology - What Makes Sense?] / Komplementärmedizin in der Onkologie ­ was ist sinnvoll?

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.

New Analytical Monographs on TCM Herbal Drugs for Quality Proof.

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.

Quality Control and Complication Screening Programme of Chinese Medicinal Drugs at the First German Hospital of Traditional Chinese Medicine - A Retrospective Analysis.

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.

Quality Profiling at the TCM Hospital Bad Kötzting - Examples from an Ongoing Systematic Patient Documentation.

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.

Individual Health Management - A Comprehensive Lifestyle Counselling Programme for Health Promotion, Disease Prevention and Patient Education.

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.

Traditional Chinese Medicine (TCM) and Herbal Hepatotoxicity: RUCAM and the Role of Novel Diagnostic Biomarkers Such as MicroRNAs.

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.

The talent study: a multicentre randomized controlled trial assessing the impact of a 'tailored lifestyle self-management intervention' (talent) on weight reduction.

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).