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

Beobachtungsstudien im Rahmen eines naturheilkundlichen Klinikverbunds :Teil IV: Methodische Aspekte, Diskussion und Empfehlungen

Objective: Empirical investigation of the influence of patient self-selection during follow-up in a prospective observational study in 4 in-patient facilities for complementary medicine and discussion of further methodological problems. Methods: 2662 patients treated in the 4 hospitals and included in a prospective observational study had been sent follow-up questionnaires 2, 6, and 12 months after admission. Characteristics and therapeutic success at discharge were compared in patients responding and those not responding. Results: Patients not responding to the follow-up questionnaires tended to be older and to assess the benefit of the treatment less positive than patients who responded (hospital one: 56.2% of patients with a follow-up reported a good or very good response to therapy at discharge compared to 37.7% of the patients without a follow-up: hospital two: 63.7% vs. 54.6%; hospital three: 71.1% vs. 65.8%; hospital four: 78,3% vs. 70,9%). Interpretation: When interpreting the results of the observational study a certain degree of bias induced by selection during follow-up has to be taken into account. Discussion: Other methodological problems discussed narratively include spontaneous improvements, reliability of baseline measures, influence of effective cointerventions, side-effects, outcome measures, feasibility, and efficiency. Finally, recommendations for quality management programs in in-patient facilities for complementary medicine are provided

Systematic reviews of complementary therapies – an annotated bibliography. Part 3: Homeopathy

Background Complementary therapies are widespread but controversial. We aim to provide a comprehensive collection and a summary of systematic reviews of clinical trials in three major complementary therapies (acupuncture, herbal medicine, homeopathy). This article is dealing with homeopathy. Potentially relevant reviews were searched through the register of the Cochrane Complementary Medicine Field, the Cochrane Library, Medline, and bibliographies of articles and books. To be included articles had to review prospective clinical trials of homeopathy; had to describe review methods explicitly; had to be published; and had to focus on treatment effects. Information on conditions, interventions, methods, results and conclusions was extracted using a pretested form and summarized descriptively. Results Eighteen out of 22 potentially relevant reviews preselected in the screening process met the inclusion criteria. Six reviews addressed the question whether homeopathy is effective across conditions and interventions. The majority of available trials seem to report positive results but the evidence is not convincing. For isopathic nosodes for allergic conditions, oscillococcinum for influenza-like syndromes and galphimia for pollinosis the evidence is promising while in other areas reviewed the results are equivocal. Interpretation Reviews on homeopathy often address general questions. While the evidence is promising for some topics the findings of the available reviews are unlikely to end the controversy on this therapy

Beobachtungsstudien im Rahmen eines naturheilkundlichen Klinikverbunds :Teil III: Zwischenergebnisse der diagnosespezifischen Dokumentation Migräne in der Klinik für TraditionelleChinesische Medizin Kötzting

Objective: To evaluate the course of symtoms and quality of life of migraine patients after treatment with traditional Chinese medicine. Design: Prospective observational study with 12 months follow-up. Patients: 138 consecutive patients diagnosed by a neurologist to have migraine headaches. Intervention: Complex in-patient treatment with traditional Chinese medicine including acupuncture and Chinese drug therapy. Outcomes: Number of days with headaches per month, number, intensity and duration of migraine attacks, concomitant symptoms, quality of life, global assessment and days off work. Results: The number of days with headaches per month decreased from 9 (median) at baseline to 4 at discharge and was 3 at 12 months. Also, for the other outcomes a clear improvement was seen with a slight wash-out tendency in follow-up. Conclusion: The observed patients with long-lasting migraines had a marked benefit from an in-patient treatment with traditional Chinese medicine

Beobachtungsstudien im Rahmen eines naturheilkundlichen Klinikverbunds :Teil II: Detaillierte Ergebnisse der Klinik für Traditionelle ChinesischeMedizin Kötzting

Objective: To collect information on patients, interventions and outcomes in a hospital for traditional Chinese medicine in Germany. Design: Prospective observational study with 12 months followup. Patients: All 667 consecutive patients admitted for in-patient treatment in the hospital between December 1994 and July 1995 were documented. The follow-up rate after 12 months was 65.8%. Outcome Measures: Sociodemographic data, diagnoses, duration of complaints, type and frequency of diagnostic and therapeutic interventions, intensity of complaints, assessment of the therapeutic success and quality of life. Results: About two thirds of the patients suffered from chronic pain syndromes (the most frequent single diagnoses were migraine, lumbago, and neck pain/headaches). 72.3% of the patients were female; the median duration since the onset of the disease was 7 years. Almost all patients received acupuncture and treatment with traditional Chinese drugs. 50.3% assessed the therapeutic success as good or very good at discharge; after 12 months this rate was 55.6%. Both intensity of main complaints and psychic and physical aspects of quality of life improved after treatment. After 12 months the improvement was less distinct but still significant. Conclusions: The in-patient treatment provided a clear benefit to the patients. Without a valid comparison with an alternative treatment little can be concluded about comparative effectiveness and efficiency of a treatment in the hospital for traditional Chinese medicine

Acupuncture randomized trials (ART) in patients with chronic low back pain and osteoarthritis of the knee - Design and protocols

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

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

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

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 Kotzting, 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 (R), the program promises to achieve sustainable effects in perceived stress

Beobachtungsstudien im Rahmen eines naturheilkundlichen Klinikverbunds :Teil I: Methoden und Übersicht der Ergebnisse in den beteiligten Kliniken

Background: In Germany a considerable number of in-patient facilities offer complementary medicine in addition to conventional care. In this study we aimed to describe patient characteristics, diagnostics, therapy and outcomes of four such in-patient facilities. Methods: 2835 consecutive in-patients admitted to two private hospitals with an emphasis on complementary medical cart, one private hospital for traditional Chinese medicine, and the Department of Complementary Medicine of a public district hospital participated in a prospective observational (cohort) study with 12 months follow-up. Sociodemographic characteristics, diagnoses, duration of disease, type and frequency of therapeutic interventions, intensity of complaints, assessment of therapeutic success, and quality of life were documented. Results: Patients of the observed hospitals were mostly female (66%-80% in the four hospitals) and a high proportion was chronically ill (31%-62% with a disease history longer than 5 years). The frequency of single diagnoses varied strongly between the four hospitals, however, chronic pain syndromes were very frequent in all. Complementary care always included a large number of different therapeutic methods whose combination varied with different diagnoses and between the hospitals. At discharge, 57%-73% of patients rated the therapeutic success as good or very good, Follow-up rates were satisfactory only in two of the four hospitals. After 12 months 51%-64% of the responding patients still rated the success as good or very good. Conclusions: In the observed hospitals mainly chronically ill patients are treated with highly complex combinations of a large variety of complementary therapies. A majority of patients seems to be satisfied by the treatment. A major methodological problem in the interpretations of patient outcomes are the partly low followup rates