[Multimorbidity and successful aging: the population-based KORA-Age study]. / Multimorbidität und erfolgreiches Altern: Ein Blick auf die Bevölkerung im Rahmen der KORA-Age-Studie.

BACKGROUND: The objective of the KORA-Age research consortium is to assess the determinants and consequences of multimorbidity in the elderly and to look into reasons for successful aging in the general public. PATIENTS AND METHODS: In the KORA-Age cohort study 9,197 persons were included who where born in the year 1943 or before and participants of previous KORA cohort studies conducted between 1984 and 2001 (KORA: Cooperative Health Research in the Region of Augsburg). The randomized intervention study KORINNA (Coronary infarct follow-up treatment in the elderly) tested a nurse-based case management program with 338 patients with myocardial infarct and included an evaluation in health economics. RESULTS: A total of 2,734 deaths were registered, 4,565 participants submitted a postal health status questionnaire and 4,127 participants were interviewed by telephone (response 76.2% and 68.9% respectively). A gender and age-stratified random sample of the cohort consisting of 1,079 persons took part in a physical examination (response 53.8%). CONCLUSION: The KORA-Age consortium was able to collect data in a large population-based sample and is contributing to the understanding of multimorbidity and successful aging.

Treatment of health complaints attributed to amalgam.

The aim of the present study was to compare the reduction of subjective complaints by 3 treatment strategies in 90 "amalgam patients" whose complaints could not be explained by a medical or psychological disorder. The individuals were randomly assigned either to removal of dental amalgam only (removal group), or removal in combination with a "biological detoxification" therapy with high doses of vitamins and trace elements (removal-plus group), or participation in a health promotion program without removal of dental amalgam (no-removal group). Between baseline and month 12, the sum score of main complaints decreased by 3.5 (SD=2.2) points on average in the removal group as well as in the removal-plus group, and by 2.5 (SD=2.4) points in the no-removal group (p=0.152). Both removal groups showed a significant decrease in steady-state levels of inorganic mercury compared with the no-removal group. Thus, all 3 interventions were associated with clinically relevant improvements.

Acupuncture for chronic pain within the research program of 10 German Health Insurance Funds--basic results from an observational study.

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.

[Chronic fatigue in complementary rehabilitative medicine--predictors of the outcomes]. / Das chronische Erschöpfungssyndrom in der naturheilkundlichen Rehabilitation--Prädiktoren des Behandlungsergebnisses.

Chronic exhaustion and fatigue are increasingly important in rehabilitation medicine. Objectives of this study were (a) to describe the effects of in-patient rehabilitation on patients with chronic fatigue syndromes, (b) to identify predictors for treatment outcome, and (c) to analyze the impact of comprehensive diagnosing on these issues. A total of 171 patients with chronic exhaustion or fatigue (90 % female, mean age 55 +/- 10 yrs) from a rehabilitation hospital with a complementary medicine-based treatment concept were included in a prospective observational study. Within the longitudinal study patients were examined three times (on admission to hospital, at discharge as well as six months later). Participation rate of the postal inquiry was 69 %. Besides items constructed ad hoc, Patient questionnaires included the Symptom Checklist and assessment instruments for depression, quality of life, sense of coherence as well as for changes in experience and behaviour. Treatment outcome was defined as sum score of binary-coded response criteria. The pattern of complaints differed clearly between diagnostic subgroups (neurasthenia, affective disorders, adjustment disorders) before treatment. At discharge from hospital patients showed clinically relevant improvements lasting for six months after rehabilitation. Multiple regression analyses revealed a statistically significant relationship (R (mult) = 0.59) between predictors and outcome at discharge from hospital. A better result was associated with higher trust in treatment success, active information seeking on complementary medicine, healthier feeding habits, better somatic health and a decreased mental status, with regard to the status before treatment. The prediction of outcome after six months was comparably poorer (R (mult) = 0.42). Treatment success was higher in the absence of a diagnosis of neurasthenia, in patients accepting the group-oriented treatment concept and in patients not believing that their disease was due to their own way of living. Trust in the success of the treatment was a highly ranked predictor for longer lasting outcome, too. The results underline the importance of motivation aspects for treatment outcome indicating that individual expectations and attitudes should be considered in a more distinct way when allocating patients to rehabilitative programmes.

[Acupuncture for chronic pain patients. Treatment outcomes--the role of the acupuncturist]. / Akupunktur bei chronischen Schmerzpatienten. Behandlungsergebnisse--Rolle des Akupunkteurs.

These results are relevant to the choice of appropriate criteria for quality assessment of acupuncture and emphasize the role of patient satisfaction within quality assurance. Pre- and post-treatment differences in a set of pain related measurements were determined using a combination of data from an observational study and a survey of physicians. The following features of the physicians' study were investigated: specialisation, qualification in acupuncture, rate at which patients received acupuncture, use of further, complementary methods in the practice. The results were statistically adjusted according to different basic conditions (case-mix). A total of 4,084 patients with chronic headache, lower back pain or arthritic pain were treated by 1,838 acupuncturists. There were no differences in success for patients treated by physicians passing through shorter (A diploma) or longer (B diploma) training courses in acupuncture. Patients treated by orthopedists showed less improvement than those treated by physicians with other specialisations. However, these differences had disappeared 6 months after the onset of acupuncture.These longer term effects were more pronounced for physicians offering additional complementary methods in their practice. Improvement after acupuncture and patient satisfaction were positively correlated.

Acupuncture for osteoarthritic pain: an observational study in routine care.

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.

[Structure, realization and data synopsis of an observational study as part of the patient care evaluation programme on acupuncture (PEP-AC) drafted by German statutory insurance institutions]. / Aufbau, Realisierung und Datenübersicht einer Beobachtungsstudie im Rahmen des Programms zur Evaluation der Patientenversorgung mit Akupunktur (PEP-AK) des Modellvorhabens der Ersatzkassen.

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.

Treatment outcomes in patients with migraine: an ex-post-facto comparison of two in-patient facilities.

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.

Acupuncture Randomized Trials (ART) in patients with migraine or tension-type headache--design and protocols.

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.

Acupuncture versus placebo versus sumatriptan for early treatment of migraine attacks: a randomized controlled trial.

OBJECTIVES: To investigate whether acupuncture is superior to placebo and equivalent to sumatriptan for the early treatment of an acute migraine attack. DESIGN: Randomized, partly double-blind (sumatriptan versus placebo) trial. SETTING: Two hospitals in Germany (one specialized in traditional Chinese medicine and one in the treatment of headache). SUBJECTS: A total of 179 migraineurs experiencing the first symptoms of a developing migraine attack. INTERVENTIONS: Traditional Chinese acupuncture, sumatriptan (6 mg subcutaneously) or placebo injection. MAIN OUTCOME MEASURE: Number of patients in whom a full migraine attack (defined as severe migraine headache) within 48 h was prevented. In patients who developed a migraine attack in spite of early treatment, acupuncture and sumatriptan were applied a second time, whilst patients initially randomized to placebo received sumatriptan. RESULTS: A full migraine attack was prevented in 21 of 60 (35%) patients receiving acupuncture, 21 of 58 (36%) patients receiving sumatriptan and 11 of 61 (18%) patients receiving placebo (relative risk of having a full attack 0.79 (95% CI, 0.64-0.99) for acupuncture versus placebo, and 0.78 (95% CI, 0.62-0.98) for sumatriptan versus placebo). Response to the second intervention in patients who developed a full attack was better with sumatriptan (17/31 patients who received sumatriptan twice and 37/46 patients who had had placebo first) than with acupuncture (4/31). The number of patients reporting side-effects was 14 in the acupuncture group, 23 in the sumatriptan group and 10 in the placebo group. CONCLUSIONS: In this trial acupuncture and sumatriptan were more effective than a placebo injection in the early treatment of an acute migraine attack. When an attack could not be prevented, sumatriptan was more effective than acupuncture at relieving headache.

[Short-term therapeutic fasting in the treatment of chronic pain and fatigue syndromes--well-being and side effects with and without mineral supplements]. / Kurzzeitiges therapeutisches Fasten in der Behandlung von chronischen Schmerz- und Erschöpfungssyndromen - Verträglichkeit und Nebenwirkungen mit und ohne begleitende Mineralstoffergänzung.

BACKGROUND: Fasting followed by vegetarian diet has shown to be an effective treatment for rheumatoid arthritis, moreover fasting is frequently used as an adjunctive treatment in chronic pain and stress/exhaustion syndromes. Data on well-being and the frequency of side effects during fasting are mostly retrospective. Mineral supplements are frequently used in order to compensate for fasting-induced tissue acidosis and to reduce side effects. There are only limited data that support this practice. OBJECTIVE: To study the effects of oral mineral supplements on common side effects and well-being during short-term fasting. PATIENTS AND METHODS: 209 consecutive inpatients with chronic pain/exhaustion syndromes were recruited. In a controlled non-randomised study design all patients underwent fasting (250 kcal; 3 l fluid intake/day) over 7 days, in study phase 1 without (n = 103) and in study phase 2 with (n = 106) concomitant prescription of standardised oral mineral supplements (3 x 2 to 3 x 3 Bullrich's Vital). Weight, blood pressure and urinary pH were recorded daily. Well-being and mood as well as common side effects (i.e. fatigue, hunger, heart burn, headache) were assessed with standardised self-reports. RESULTS: Baseline characteristics of the 209 patients (mean age 54.7 +/- 10.5 years; 83.3% female) were balanced. Both groups showed a fasting-induced decrease of blood pressure, a slight decrease in mood and well-being on days 3 and 4 with consecutive increase and moderate hunger, i.e. in the evening. Side effects and general tolerability of fasting as well as well-being and mood were not different between the groups. There were no serious side effects in both groups. CONCLUSIONS: Short-term fasting in inpatients with pain and stress syndromes is safe and well tolerated, concomitant mineral supplements have no additive benefit.

[Quality of outcome in treating patients with chronic headache within a hospital specialized for migraine. A cohort study with one-year follow-up]. / Ergebnisqualität bei der Behandlung chronischer Kopfschmerzpatienten in einer Migräneklinik. Eine Kohortenstudie mit einjähriger Nachbeobachtung.

AIMS: To describe characteristics of in-patients with chronic headache syndromes being treated with complementary methods, short-term effects at time of discharge as well as long-term effects covering a catamnesis of 1 year. METHODS: The study was designed as a prospective cohort study with outcome measurements 2 months in advance of admission to the hospital, at admission, and at time of discharge, continued by follow-up queries 2, 6 and 12 months after discharge from the hospital. The parameters for describing the course of headache symptoms were registered by questionnaires and diaries. During the first 6 months in 1996, a total of 424 consecutive patients with migraine or tension-type headache at the 'Migräne-Klinik Königstein' were included. RESULTS: 82.9% of the patients were women, the mean age was 46.3 +/-13.0 years. The median of the duration of the disease was 23 years. At discharge from the hospital there was a marked improvement regarding frequency of headache attacks, intensity of headaches, and concomitant symptoms. 60.5% of the patients were classified as 'responders'. 67.5% responded to follow-up questionnaires. With exception of the duration of headache attacks, a significant improvement regarding the 6-month follow- up compared to base level was observed. Intake of drugs could be diminished and quality of life was improved. Patients suffering from tension-type headache showed smaller effects in general. CONCLUSIONS: Taking into account the mean duration of disease of more than 20 years the results suggest a clinically relevant success from the patients' view regarding the short-term as well as the long-term course. The problem of data loss with follow-up queries and missing comparative data reduce the conclusiveness of the results.

[Quality management and research. A pragmatic concept for evaluation and optimization of complementary medicine within the framework of hospital and practitioner relations]. / Qualitätsmanagement mit Forschungsbegleitung. Ein pragmatisches Konzept zur Evaluation und Optimierung von Naturheilverfahren im Rahmen eines Klinik- und Praxisverbundes.

Objective of the concept "Quality Management and Research" is to evaluate and optimize Complementary Medicine (CM) within everyday-practice in a network of hospitals and practitioners. In a step by step-strategy the concept should give information about quality on the levels of structure, process and outcome for and about patients and providers. Therefore special profiles of quality should be determined. In a next step preinterventionally defined goals of therapies have to be proofed for being achieved at admission or at the end of the intervention. To enable decision-making for patients, physicians and insurance companies profiles of quality should be compared within the specialized network and/or with mainstream providers. Asking for high evidence it is necessary to conduct randomized controlled trials (RCTs). A main interest of the program is to integrate the concept into routine practice of the network and to build up a data-collection-centre at the university in order to improve the providing system and to create new tools for practice-based medical research.

Why do patients seek treatment in hospitals of complementary medicine?

OBJECTIVE: This exploratory study evaluated patients' reasons for entering a complementary (alternative) medicine hospital by ranking 15 medical and psychosocial factors that were thought to influence this choice. SUBJECTS AND OUTCOME MEASURES: Two hundred patients (200) from two complementary hospitals, one focusing on Traditional Chinese Medicine and one on the Western type of complementary medicine, completed an extensive questionnaire at the beginning of their inpatient treatment. The questionnaire covered personal background; disease parameters; attitude towards conventional medicine; previous experience with, and knowledge of, complementary therapies; expectations concerning the forthcoming treatment; health-related habits; personality traits; and social support. RESULTS: Optimistic attitudes towards treatment and a positive appraisal of alternative doctors were frequently stated reasons (80%), as was the disease severity (long duration: 86%; acute progression or imminent surgery: 70%). Previous successes with complementary therapies, however, ranked relatively low (53%). Negative opinions concerning conventional therapies and conventional doctors' treatments were mentioned by 68% of the patients. Many patients felt themselves to be under considerable psychologic stress (74%). A majority (73%) was well informed about complementary therapies, and 65% were curious about the forthcoming therapies. Sixty-eight percent (68%) indicated good health behaviors. Fewer patients mentioned contemplative and/or religious attitudes (44%) or lack of social support (25%). Age primarily accounted for variations in the ranking weights of the two subgroups. The specific type of complementary medicine was of minor influence. In 14 out of 21 personality dimensions, the current patient group showed significant deviations from the healthy reference, which is in good agreement with findings from conventionally treated patients.

Monitoring of liver enzymes in patients treated with traditional Chinese drugs.

BACKGROUND: Use of traditional Chinese drug treatment is widespread. While cases of hepatotoxic effects have been reported, little is known about the frequency of such effects. OBJECTIVES: To investigate the frequency, magnitude and course of liver enzyme elevations in patients treated with traditional Chinese drugs. DESIGN: Retrospective study. SETTING: Hospital for traditional Chinese medicine in Germany. PATIENTS: All 1507 patients admitted for inpatient treatment between February 1994 and July 1995. MAIN OUTCOME MEASURE: Number of patients who presented at discharge with a more than 2-fold elevation of alanine amino transferase (ALT) levels (over maximum normal values or elevated admission values). RESULTS: A more than 2-fold elevation of ALT values was observed in 14 patients (0.9%). In 13 cases a causal relationship with Chinese drug therapy seemed possible and, for one patient, likely. However, all patients were also on non-Chinese drug treatment. Follow-up values of ALT within 8 weeks after discharge were normal in 11 patients (six of them had continued to take traditional Chinese drugs) and close to normal in the remaining three. In five patients there were indications for previous liver damage. CONCLUSIONS: In the population and setting studied, clinically relevant liver enzyme elevations occurred in about 1/100 patients treated with traditional Chinese drugs.

Use of traditional drugs in a hospital of Chinese medicine in Germany.

The frequency of use of traditional Chinese drugs was investigated in relation to Western and Chinese diagnostic classifications in a hospital for traditional Chinese medicine in Germany. All 1597 in-patients treated in the hospital between February 1992 and August 1993 entered a prospective observational study. About two thirds of the patients suffered from chronic pain syndromes, the most frequent single diagnosis being migraine (n=244). All patients were treated with at least one of four Chinese therapies (traditional Chinese drugs, acupuncture, Tuina-massage, Qi-gong). 95.1% of all patients received traditional Chinese drug treatment, prescribed in complex prescriptions including 3 to 12 single drugs from a total of 305. Drug patterns prescribed to patients with the same Western diagnosis tended to be similar, but could differ strongly for single drugs in subgroups with distinct Chinese diagnoses. Studies evaluating traditional Chinese treatment strategies in patients classified according to Western nosology should take into account possible diagnostic differences according to Chinese nosology. The development of a reliable coding system for Chinese diagnostic classifications is a precondition for further cross-cultural studies.