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Introduction The introduction of a screening programme for cervical carcinoma in Germany has led to a significant reduction in incidence of the disease. To date, however, diagnosis in Germany has been based solely on cervical cytology, which has been criticised because of a low sensitivity and consequently high rate of false negative results. Because an infection with the human papillomavirus (HPV) previously was found to be a necessary aetiological factor in the development of cervical cancer, there has been some discussion that HPV testing should be included in cervical cancer screening. Objectives How do HPV tests compare to cytological tests in terms of sensitivity and specificity, and what are the effects of screening for cervical carcinoma in Germany? Is there health economic evidence that may foster an inclusion of HPV testing into national screening programms? Methods A systematic literature review was performed, including studies that compared the HPV test to cervical cytology in terms of sensitivity and specificity in the diagnosis of CIN 2+ (CIN=Cervical Intraepithelial Neoplasia). In addition, a systematic review of the relevant health economic literature was performed to analyze cost-effectiveness in the German setting. Results A total of 24 studies fulfilled the inclusion criteria. One study consisted of three substudies. Hence, results of 26 comparisons of HPV and cytology are reported. In 25 of these, the HPV test was more sensitive than cytology, whereas cytology had better specificity in 21 studies. The combination of HPV test and cytology increased sensitivity. Variability in results was considerably larger for cytology than for HPV testing. Results of the economic meta-analysis suggest that in health care settings with already established PAP screening programms, cost-effectiveness strongly depends on screening intervals. In analyses comparing HPV screening to conventional PAP screening with two-yearly intervals, only 25% of the HPV strategies were found to be cost-effective, whereas in comparison with one-, three-, and five-yearly PAP screening, the percentage of overall cost-effective HPV strategies was 83%, 55%, and 92%, respectively. Results for annual screening intervals are based on the assumption of complete screening compliance, which has to be further evaluated in decision analyses in the future adapting to the German health care setting. Discussion Including HPV testing in screening procedures for cervical carcinoma could lead to a reduction in false positive results. Doing so would involve one of the following approaches: a) combining the HPV test with cytology, or b) using cytology as triage in HPV-positive women. The most appropriate interval between screening tests and the best age to start or stop screening remains to be determined. At this point a formal health economic decision analyses may help in resolving those questions, additionally incorporating compliance and adherence within different screening scenarios. Conclusion Considering medical evidence weighing the question whether HPV testing should be implemented into screening routine may not be if but how to do so. Open questions remain in setting the length of optimal screening intervals, the age range in which to screen, and the combination or sequence of existing cytology and HPV testing. Answers to those questions will be gathered in the very near future through large international clinical trials. Cost-effectiveness of implementing HPV testing is likely to exist in the management of borderline or unclear smears in triage treatment as well as in certain scenarios of primary screening within the German health care setting.

Stroke is one of the leading causes of death globally. Awareness of stroke risk factors and warning signs are important for stroke prevention and seeking care. The purpose of this systematic review was to review existing literature that assessed the knowledge of stroke risk factors and warning signs and allowed separate gender analysis. We conducted a systematic review of all published studies (to August 2008) examining knowledge of stroke risk factors and warning signs that included women and provided results separated by gender. Two reviewers selected studies for inclusion, assessed quality, and extracted data. The database search identified 2158 references for screening and 158 were selected for possible inclusion. Twenty-two studies were reviewed including 20 cross-sectional and two pretest–posttest design surveys. Overall, better stroke knowledge was observed in women compared with men in the majority of the studies although there is a general lack of knowledge in both genders. Four out of 18 studies reported better risk factor knowledge and eight out of 15 studies reported better knowledge in stroke warning signs in women compared with men. Women tended to know more evidence-based stroke risk factors than men. Stroke knowledge also appeared to be related to country of study origin, age, education, and medical history. Stroke knowledge among different populations and both in men and women is suboptimal. More research is necessary to further investigate gender differences in stroke knowledge with specific focus on how to use these differences to improve public health campaigns.

Vor dem Hintergrund einer sich verscharfenden Finanzierungsproblematik im deutschen Gesundheitswesen werden Erkenntnisse der gesundheitsokonomischen Forschung zukunftig weiter an Relevanz gewinnen. Dabei stellt sich die Frage, aus welchen Datenquellen solche Erkenntnisse generiert werden konnen? In den letzten Jahren richtete sich der Fokus insbesondere in der Versorgungsforschung zunehmend auf die Nutzung von Sekundardaten, insbesondere der gesetzlichen Krankenversicherungen. Dabei wird immer wieder auf die grundsatzlichen Vorteile solcher Daten hingewiesen: die Abbildung des Versorgungsalltags, die schnelle und kostengunstige Datenverfugbarkeit sowie hohe Fallzahlen. Der vorliegende Artikel soll das Potenzial und die Einschrankungen von Sekundardaten zur Beantwortung gesundheitsokonomischer Fragstellungen exemplarisch aufzuzeigen. Im Fokus stehen dabei die Nutzungsmoglichkeiten routinemasig erhobener Datensatze der gesetzlichen Krankenversicherungssysteme (GKV). Dabei erweisen sich Sekundardaten der GKV in der Gesundheitsokonomie als sinnvolle Moglichkeit zur Durchfuhrung von Krankheitskostenstudien und Kosten-Minimierungsanalysen sowie als zusatzliche Datenbasis fur Kosten-Nutzen- bzw. Kosten-Effektivitatsanalysen. Die Moglichkeit zur Durchfuhrung von Patientenflussanalysen bietet zudem die Moglichkeit zur Validierung gesundheitsokonomischer Modelle. Als problematisch erweist sich bei der Nutzung von Sekundardaten aber in besonderer Hinsicht die Gefahr des Confounding und der damit verbundenen Fehlinterpretation gesundheitsokonomischer Ergebnisse. Hier muss mit speziellen Masnahmen (z. B. Datenvalidierung, Plausibilitatsprufungen, Nutzung von Propensity Scores) eine Kontrolle moglicher Storgrosen erfolgen. Dennoch sind Krankenkassendaten grundsatzlich zur Durchfuhrung von gesundheitsokonomischen Sekundardatenanalysen geeignet und bieten an dieser Stelle in besonderer Weise unterstutzendes Potenzial zur Entscheidungsfindung im Gesundheitswesen. Facing an increasingly difficult financial situation in the German health care system, the relevance of health economic research will become more and more important. A main question is on which data sources such analyses can be based on? Particularly in the field of health services research, the use of secondary data, especially from sickness funds, gained more attention during the last years. As advantages of such data were pointed out: the reflection of routine care, the rapid and cost-effective availability of the data as well as large numbers of cases. The present article aims to illustrate and summarize the applicapability and the limitations of secondary data for answering health-economic questions and is focusing on the usage of routinely documented data from German statutory health insurance systems (SHI). As a main result it can be stated that secondary data are applicable as a useful way to carry out cost-of-illness studies as well as comparative cost-minimization analyses. The possibilities to implement patient flow analysis additionally offer the opportunity to support respectively validate health economic models to conduct cost-utility, cost-effectiveness or cost-benefit-analyses. A major limitation could arise from the increased risk of confounding, which is related with every use of secondary data. Thus, the control of possible confounders, using special instruments like data validation, plausibility checks or the use of propensity scores, should be kept in mind. However, health insurance data are generally suitable for the implementation in health economic research and could be a useful tool for supporting decision making processes in health care also in the German health care system.

Background It is controversial whether the onset of myocardial infarction occurs randomly or is precipitated by identifiable stimuli. Previous studies have suggested a higher risk of cardiac events in association with exertion. Methods Consecutive patients with acute myocardial infarction were identified by recording all admissions to our hospital in Berlin and by monitoring a general population of 330,000 residents in Augsburg, Germany. Information on the circumstances of each infarction was obtained by means of standardized interviews. The data analysis included a comparison of patients with matched controls and a case-crossover comparison (one in which each patient serves as his or her own control) of the patient's usual frequency of exertion with the last episode of exertion before the onset of myocardial infarction. Results From January 1989 through December 1991, 1194 patients (74 percent of whom were men; mean age [±SD], 61 ±9 years) completed the interview 13 ±6 days after infarction. We found tha...

Study design Randomized controlled trial. Objective To evaluate whether qigong is more effective than no treatment and not inferior to exercise therapy. Summary of background data Lifetime prevalence of chronic neck pain is close to 50%. Qigong is often used by patients, although, the evidence is still unclear. Methods Patients (aged 20-60 years) with chronic neck pain (visual analog scale, VAS ≥ 40 mm) were randomized to 1) qigong or 2) exercise therapy (18 sessions over 6 months) or 3) waiting list (no treatment). At baseline and after 3 and 6 months, patients completed standardized questionnaires assessing neck pain (VAS), neck pain and disability, and quality of life (Short Form SF-36 questionnaire, SF-36). The primary endpoint was average pain in the last 7 days on VAS at 6-month follow-up. Statistical analysis included generalized estimation equation models adjusted for baseline values and patient expectation. Results A total of 123 patients (aged 46 ± 11 years, 88% women) suffering from chronic neck pain for 3.2 (SD ± 1.6) years were included. After 6 months, a significant difference was seen between the qigong and waiting list control groups (VAS mean difference: -14 mm [95%CI = -23.1 to -5.4], P = 0.002). Mean improvements in the exercise group were comparable to those in the qigong group (difference between groups -0.7 mm [CI = -9.1 to 7.7]) but failed to show statistical significance (P = 0.092). Neck pain and disability, and SF-36 results also yielded superiority of qigong over no treatment and similar results in the qigong and exercise therapy groups. Conclusion Qigong was more effective than no treatment in patients with chronic neck pain. Further studies could be designed without waiting list control and should use a larger sample to clarify the value of qigong compared to exercise therapy.

Background Homeopathy is often sought by patients with depression. In classical homeopathy, the treatment consists of two main elements: the case history and the prescription of an individually selected homeopathic remedy. Previous data suggest that individualized homeopathic Q-potencies were not inferior to the antidepressant fluoxetine in a sample of patients with moderate to severe depression. However, the question remains whether individualized homeopathic Q-potencies and/or the type of the homeopathic case history have a specific therapeutical effect in acute depression as this has not yet been investigated. The study aims to assess the two components of individualized homeopathic treatment for acute depression, i.e., to investigate the specific effect of individualized Q-potencies versus placebo and to investigate the effect of different approaches to the homeopathic case history. Methods/Design A randomized, partially double-blind, placebo-controlled, four-armed trial using a 2 × 2 factorial design with a six-week study duration per patient will be performed. 228 patients diagnosed with major depression (moderate episode) by a psychiatrist will be included. The primary endpoint is the total score on the 17-item Hamilton Depression Rating Scale after six weeks. Secondary end points are: Hamilton Depression Rating Scale total score after two and four weeks; response and remission rates, Beck Depression inventory total score, quality of life and safety at two, four and six weeks. Statistical analyses will be by intention-to-treat. The main endpoint will be analysed by a two-factorial analysis of covariance. Within this model generalized estimation equations will be used to estimate differences between verum and placebo, and between both types of case history. Discussion For the first time this study evaluates both the specific effect of homeopathic medicines and of a homeopathic case taking in patients with depression. It is an attempt to deal with the challenges of homeopathic research and the results might be useful information in the current discussion about the evidence on homeopathy Trial registration ClinicalTrials.gov: NCT01178255

Dietary supplements have been suggested in the prevention of the common cold, but previous investigations have been inconsistent. The present study was designed to determine the preventive effect of a dietary supplement from fruits and vegetables on common cold symptoms. In a randomised, double-blind, placebo-controlled trial, healthcare professionals (mainly nursing staff aged 18–65 years) from a university hospital in Berlin, Germany, were randomised to four capsules of dietary supplement (Juice Plus+®) or matching placebo daily for 8 months, including a 2-month run-in period. The number of days with moderate or severe common cold symptoms within 6 months (primary outcome) was assessed by diary self-reports. We determined means and 95 % CI, and differences between the two groups were analysed by ANOVA. A total of 529 subjects were included into the primary analysis (Juice Plus+®: 263, placebo: 266). The mean age of the participants was 39·9 (sd 10·3) years, and 80 % of the participants were female. The mean number of days with moderate or severe common cold symptoms was 7·6 (95 % CI 6·5, 8·8) in the Juice Plus+® group and 9·5 (8·4, 10·6) in the placebo group (P = 0·023). The mean number of total days with any common cold symptoms was similar in the Juice Plus+® and in the placebo groups (29·4 (25·8, 33·0) v. 30·7 (27·1, 34·3), P = 0·616). Intake of a dietary supplement from fruits and vegetables was associated with a 20 % reduction of moderate or severe common cold symptom days in healthcare professionals particularly exposed to patient contact.

To evaluate point-of-decision prompts in the promotion of stair use in Germany, motivational posters were placed at three underground stations in Berlin. The proportion of passengers using stairs or stairways was counted before, during installation, and two weeks after removal of posters. In total, 5,467 passersby were counted. Stair use increased significantly in women, but not in men. The present pilot study thereby shows that the use of point-of-decision prompts is also feasible in Germany and it provides some evidence of effectiveness. Methodologically rigorous studies are warranted to confirm these findings.

Background Anthroposophic medicine is a physician-provided complementary therapy system involving counselling, artistic and physical therapies, and special medications. The purpose of this analysis was to identify predictors of symptom improvement in patients receiving anthroposophic treatment for chronic diseases. Methods 913 adult outpatients from Germany participated in a prospective cohort study. Patients were starting anthroposophic treatment for mental (30.4% of patients, n = 278/913), musculoskeletal (20.2%), neurological (7.6%), genitourinary (7.4%) or respiratory disorders (7.2%) or other chronic indications. Stepwise multiple linear regression analysis was performed with the improvement of Symptom Score (patients' assessment, 0: not present, 10: worst possible) after 6 and 12 months as dependent variables. 61 independent variables pertaining to socio-demographics, life style, disease status, co-morbidity, health status (SF-36), depression, and therapy factors were analysed. Results Compared to baseline, Symptom Score improved by average 2.53 points (95% confidence interval 2.39-2.68, p < 0.001) after six months and by 2.49 points (2.32-2.65, p < 0.001) after 12 months. The strongest predictor for improvement after six months was baseline Symptom Score, which alone accounted for 25% of the variance (total model 32%). Improvement after six months was also positively predicted by better physical function, better general health, shorter disease duration, higher education level, a diagnosis of respiratory disorders, and by a higher therapy goal documented by the physician at baseline; and negatively predicted by the number of physiotherapy sessions in the pre-study year and by a diagnosis of genitourinary disorders. Seven of these nine variables (not the two diagnoses) also predicted improvement after 12 months. When repeating the 0-6 month analysis on two random subsamples of the original sample, three variables (baseline Symptom Score, physical function, general health) remained significant predictors in both analyses, and three further variables (education level, respiratory disorders, therapy goal) were significant in one analysis. Conclusion In adult outpatients receiving anthroposophic treatment for chronic diseases, symptom improvement after 6 and 12 months was predicted by baseline symptoms, health status, disease duration, education, and therapy goal. Other variables were not associated with the outcome. This secondary predictor analysis of data from a pre-post study does not allow for causal conclusions; the results are hypothesis generating and need verification in subsequent studies.

Background: A recent meta-analysis of randomized trials revealed that antiepileptic drugs (AEDs) as a class increase the risk of suicidal thoughts and behavior. We conducted an observational study with data from the United Kingdom General Practice Research Database to investigate if an increase in risk for different groups of AEDs is also evident in clinical practice. Methods: This was a nested case-control study in a cohort of 44,300 patients with epilepsy who were treated with AEDs. Patients with self-harm or suicidal behavior were identified by predefined codes. We included 453 cases and 8,962 age-matched and sex-matched controls. AEDs were classified into 4 groups: barbiturates, conventional AEDs, and newer AEDs with low (lamotrigine, gabapentin, pregabalin, oxcarbazepine) or high (levetiracetam, tiagabine, topiramate, vigabatrin) potential of causing depression. Adjusted odds ratios (OR) were calculated using conditional logistic regression. Results: Current use of newer AEDs with a high potential of causing depression was associated with a 3-fold increased risk of self-harm/suicidal behavior (OR = 3.08; 95% [CI] 1.22–7.77) as compared with no use of AEDs during the last year. Use of barbiturates (OR = 0.66; 95% CI 0.25–1.73), conventional AEDs (OR = 0.74; 95% CI 0.53–1.03), or low-risk newer AEDs (OR = 0.87; 95% CI 0.47–1.59) was not associated with an increased risk. Conclusions: Newer AEDs with a rather high frequency of depressive symptoms in clinical trials may also increase the risk of self-harm or suicidal behavior in clinical practice. For the most commonly used other groups of AEDs, no increase in risk was observed.

There is still debate about whether the quality of long-term efficacy of lithium in patients with bipolar disorders is influenced by atypical features. Extended Cox regression models allow for the use of all follow-up data on diseases with multiple episodes. The aim of the present analysis was to apply the best suited of these models to analyze the influence of atypical features on the widely used outcome measure of time to recurrence in a large multicenter cohort of lithium responders established by the International Group for the Study of Lithium Treated Patients.A conditional extended Cox model with a random frailty term was applied to the data of 336 bipolar I and II disorder patients, all of whom were responders to lithium with treatment for up to 30 years.Differences were found in the long-term outcome, even in patients who have demonstrated a relatively good response to lithium treatment. The hazard for recurrence was negatively influenced by the presence of atypical features, mainly mood-incongruent psychotic symptoms, interepisodic residual symptomatology, and rapid cycling.As a result of the findings, physicians should regularly reassess the quality of response in bipolar disorder patients with atypical features and, if necessary, modify treatment. Extended Cox regression models are well suited for evaluating long-term outcome and should be used more extensively to analyze treatment outcome in psychiatric and somatic disorders.

BACKGROUND: The results of a survey of decision makers (directors of clinical departments, along with research and education institutes) at German medical schools in 1997 demonstrated that although most respondents were in favour of integrating complementary and alternative medicine (CAM) into medical school curricula, only a minority had implemented these into their medical schools. The aims of this study were to evaluate the current opinions on CAM from decision makers at medical schools in three German-speaking countries and the present extent to which it has been integrated. METHODS: In 2004 we sent a standardised questionnaire to 1,017 department directors at medical schools in Austria (A, n = 75), Germany (G, n = 873) and Switzerland (CH, n = 69). RESULTS: 487 questionnaires (overall response rate: 48%, country-specific response rate: A 39%; G 49%; S 42%) were returned. 40% of respondents had a positive opinion on CAM, whereas 28% had a neutral and 29% a negative opinion and 3% were unsure with a significant difference between Germany (44% positive opinion) in favour for CAM vs. Switzerland (22%; p = 0,021). The CAM therapies rated most positively were acupuncture (53%), osteopathy (52%) and naturopathy (38%) with no statistical differences between the countries. Naturopathy (39%) and herbal medicine (34%) were viewed more positively in Germany compared to Austria (4%, p = 0.001 and 8%, p = 0.01), but not to Switzerland (27%, p = 0.289 and 24%, p = 0.353). The majority of respondents favoured the integration of CAM into the medical system (research 85%, teaching 84% and treatment 60%). However, only 162 respondents (34%) indicated that CAM therapies had already been integrated into the curriculum at their medical schools (treatment 26%, research 19% and education 18%) with no significant differences between the countries. Respondents of Switzerland indicated lower activity of CAM integration (treatment 10% and research 10%) compared to Austria (28%, p = 0.016 and 28%, p = 0.016) and Germany (27%, p = 0.01 and 20%, p = 0.174). CONCLUSIONS: The majority of respondents favoured the integration of CAM into the medical system. However, this integration remains limited and does not reflect the high usage of CAM in the population.

Aim– We aimed at developing a prioritized set of quality indicators for schizophrenia care to be used for continuous quality monitoring. They should be evidence-based and rely on routine data.Methods– A systematic literature search was performed to identify papers on validated quality indicators published between 1990 to April 2008 in MEDLINE, the Cochrane databases, EMBASE and PsycINFO. Databases of relevant national and international organizations were searched. Indicators were described with respect to meaningfulness, feasibility and actionability. A workshop with relevant stakeholders evaluated the measures through a structured consensus process.Results– We identified 78 indicators through literature search and selected 22 quality indicators. Furthermore, 12 structural and case-mix indicators were choosen. Only five quality indicators were rated “essential indicators” (priority 1), 14 were rated “additional first choice” (priority 2), and three were rated as “additional second choice” (priority 3). Only four indicators assessed outcome quality. In the majority of indicators the evidence base supporting the indicator recommendation was weak. None of the selected indicators was validated in experimental studies.Conclusions– Evidence and validation base played only a subordinate role for indicator prioritisation by stakeholders indicating that there are discrepancies between clinical questions and requirements in schizophrenia care and scientific research.Declaration of Interest: Stefan Weinmann and Thomas Becker received an unrestricted grant from the Federal Association of Local Health Funds (AOK-BV) for the whole project. Christiane Roick is an employee of the AOK-BV. All authors declare that there are no other financing arrangements or payments that might be considered a conflict of interests related to the present paper.

Cytology-based screening for cervical cancer has been criticised because of its high percentage of false-negative results. Considering HPV testing as an integral part of the screening process has been discussed as a way to address this issue in Germany. The aim of our study was to review trials comparing HPV testing with cytology in cervical cancer screening. Based on a systematic literature review, 14 studies with 85,820 women could be included. Generally HPV testing was more sensitive, but less specific than cytology. Based on the pooled data, sensitivity and specificity for HPV testing were 91% and 90%, respectively, whereas sensitivity and specificity for cytology amounted to 66% and 96%, respectively. Based on these results, including HPV testing in primary cervical cancer screening might lead to a reduction of false-negative results. Due the lower specificity false-positive test results would increase though.

The objective of this study was to evaluate treatment details and possible effects of an individualized homeopathic treatment in patients with migraine in usual care.This was a prospective multicenter observational study. Consecutive patients beginning homeopathic treatment in primary care practices were evaluated over 2 years using standardized questionnaires. The data recorded included diagnoses (International Classification of Diseases, Ninth Revision) and current complaints, including their severity (numeric rating scale = 0-10), health-related quality of life (QoL, 36-item Short-Form Health Survey), medical history, consultations, homeopathic and conventional treatments, as well as other health service use.Two hundred and twelve (212) adults (89.2% women), mean age 39.4 +/- 10.7 years were treated by 67 physicians. Patients had suffered from migraine for a period of 15.2 +/- 10.9 years. Most patients (90.0%) were conventionally pretreated. The physician workload included taking the initial patient history (120 +/- 45 minutes), case analysis (40 +/- 47 minutes), and follow-ups (7.3 +/- 7.0, totaling 165.6 +/- 118.8 minutes). Patients received 6.2 +/- 4.6 homeopathic prescriptions. Migraine severity showed marked improvement with a large effect size (Cohen's d = 1.48 after 3 months and 2.28 after 24 months. QoL improved accordingly (Mental Component Score and Physical Component Score after 24 months: 0.42 and 0.45). The use of conventional treatment and health services decreased markedly.In this observational study, patients seeking homeopathic treatment for migraine showed relevant improvements that persisted for the observed 24 month period. Due to the design of this study, however, it does not answer the question as to whether the effects are treatment specific or not.

Background The benefit of Ginkgo biloba has been discussed controversially. The aim of this review was to assess the effects of Ginkgo biloba in Alzheimer's disease as well as vascular and mixed dementia covering a variety of outcome domains. Methods We searched MEDLINE, EMBASE, the Cochrane databases, CINAHL and PsycINFO for controlled trials of ginkgo for Alzheimer's, vascular or mixed dementia. Studies had to be of a minimum of 12 weeks duration with at least ten participants per group. Clinical characteristics and outcomes were extracted. Meta-analysis results were expressed as risk ratios or standardized mean differences (SMD) in scores. Results Nine trials using the standardized extract EGb761® met our inclusion criteria. Trials were of 12 to 52 weeks duration and included 2372 patients in total. In the meta-analysis, the SMDs in change scores for cognition were in favor of ginkgo compared to placebo (-0.58, 95% confidence interval [CI] -1.14; -0.01, p = 0.04), but did not show a statistically significant difference from placebo for activities in daily living (ADLs) (SMD = -0.32, 95% CI -0.66; 0.03, p = 0.08). Heterogeneity among studies was high. For the Alzheimer subgroup, the SMDs for ADLs and cognition outcomes were larger than for the whole group of dementias with statistical superiority for ginkgo also for ADL outcomes (SMD = -0.44, 95% CI -0.77; -0.12, p = 0.008). Drop-out rates and side effects did not differ between ginkgo and placebo. No consistent results were available for quality of life and neuropsychiatric symptoms, possibly due to the heterogeneity of the study populations. Conclusions Ginkgo biloba appears more effective than placebo. Effect sizes were moderate, while clinical relevance is, similar to other dementia drugs, difficult to determine.

Case reports indicate that antipsychotics can cause priapism, a persistent penile erection possibly leading to erectile dysfunction. The mechanism of antipsychotic-induced priapism is thought to be related to blockade of alpha1 adrenergic receptors, but clinical data supporting this hypothesis are lacking. The aim of this study was to investigate if the presence of safety signals for antipsychotics and priapism is associated with their alpha1 affinity. Spontaneous reports of adverse drug reactions contained in the US Adverse Event Reporting System database were used to calculate reporting odds ratios (RORs) of priapism for antipsychotics. In total, 426 cases of priapism with 144 of them attributed to antipsychotics were identified. For antipsychotics with high alpha1 affinity, the adjusted ROR was markedly elevated (ROR = 9.9; 95% CI, 7.9-12.4), whereas a weaker signal was observed for antipsychotics with low/medium alpha1 affinity (ROR = 3.6; 95% CI, 2.4-5.2). Signals were present for chlorpromazine, quetiapine, risperidone, ziprasidone, and aripiprazole. After restricting the analysis to cases with medical intervention or disability, the safety signal remained evident only for antipsychotics with high but not for those with low/medium affinity. The observed pattern of signals indicates a relationship between alpha1 affinities of antipsychotics and the occurrence of priapism.

Background: Health economic parameters are increasingly considered as variables in health care decisions, but decision makers are interested in country-specific evaluations. However, a large number of studies are performed in foreign countries or in a multinational setting, which limits the transferability to a single nation’s context. Objective: The present analysis summarises several of the most common international methods for generating health economic analyses based on clinical studies from different settings. Methods: A narrative literature review was performed to identify potential reasons for limited transferability of health economic evaluation results from one country to another. Based on these results, we searched the methodological literature for analytic approaches to handle the restrictions. Additionally we describe the possibility of transferring foreign economic study results to the country of interest by matching trial data with routine data of national databases. Results: The main factors for limited transferability of health economic findings were found in country-specific differences in resource consumption and the resulting costs. These differences are affected by a number of influencing cofactors (demography, epidemiology and individual patient’s factors) and the overall health care system structures (e.g. payment systems, health provider incentives). However, despite the limitations country-specific health economic assessments could be realised using the pooled/ split analyses approach, some statistical approaches and modelling approaches. Conclusion: A variety of methods for identifying and adjusting country-specific differences in costs, effects and cost-effectiveness was established during the past decades. Multinational studies will continue to play a crucial role in the evaluation of cost-effectiveness at national levels. It seems likely that the growing interest in multinational studies will lead to continued developments in adaptation methods.

Aim: To summarize the current evidence with regard to the effectiveness of nonpharmacological secondary prevention strategies of coronary heart disease (CHD) and to investigate the comparative effectiveness of interventions of different categories, specific intervention components and the effectiveness in patient subgroups. Methods: A structured search of databases and manual search were conducted. Clinical trials and meta-analyses published between January 2003 and September 2008 were included if they targeted adults with CHD, had a follow-up of at least 12 months, and reported mortality, cardiac events or quality of life. Two researchers assessed eligibility and methodological quality, in which appropriate, pooled effect estimates were calculated and tested in sensitivity analyses. Results: Of 4798 publications 43 met the inclusion criteria. Overall study quality was satisfactory, but only about half of the studies reported mortality. Follow-up duration varied between 12 and 120 months. Despite substantial heterogeneity, there was strong evidence of intervention effectiveness overall. The evidence for exercise and multimodal interventions was more conclusive for reducing mortality, whereas psychosocial interventions seemed to be more effective in improving the quality of life. Rigorous studies investigating dietary and smoking cessation interventions, specific intervention components and important patient subgroups, were scarce. Conclusion: Nonpharmacological secondary prevention is safe and effective, with exercise and multimodal interventions reducing mortality most substantially. There is a lack of studies concerning dietary and smoking cessation interventions. In addition, intervention effectiveness in patient subgroups and of intervention components could not be evaluated conclusively. Future research should investigate these issues in rigorous studies with appropriate follow-up duration to improve the current poor risk factor control of CHD patients. © 2010 The European Society of Cardiology.

Background Pharmacotherapy in the older adult is a complex field involving several different medical professionals. The evidence base for pharmacotherapy in elderly patients in primary care relies on only a few clinical trials, thus documentation must be improved, particularly in the field of complementary and alternative medicine (CAM) like phytotherapy, homoeopathy, and anthroposophic medicine. This study describes diagnoses and therapies observed in elderly patients treated with anthroposophic medicine in usual care. Methods Twenty-nine primary care physicians in Germany participated in this prospective, multicenter observational study on prescribing patterns. Prescriptions and diagnoses were reported for each consecutive patient. Data were included if patients were at least 60 years of age. Multiple logistic regression analysis was used to determine factors associated with anthroposophic prescriptions. Results In 2005, a total of 12 314 prescriptions for 3076 patients (68.1% female) were included. The most frequent diagnoses were hypertension (11.1%), breast cancer (3.5%), and heart failure (3.0%). In total, 30.5% of the prescriptions were classified as CAM remedies alone, 54.4% as conventional pharmaceuticals alone, and 15.1% as a combination of both. CAM remedies accounted for 41.7% of all medications prescribed (35.5% anthroposophic). The adjusted odds ratio (AOR) for receiving an anthroposophic remedy was significantly higher for the first consultation (AOR = 1.65; CI: 1.52-1.79), treatment by an internist (AOR = 1.49; CI: 1.40-1.58), female patients (AOR = 1.35; CI: 1.27-1.43), cancer (AOR = 4.54; CI: 4.12-4.99), arthropathies (AOR = 1.36; CI: 1.19-1.55), or dorsopathies (AOR = 1.34; CI: 1.16-1.55) and it decreased with patient age (AOR = 0.97; CI: 0.97-0.98). The likelihood of being prescribed an anthroposophic remedy was especially low for patients with hypertensive diseases (AOR = 0.36; CI: 0.32-0.39), diabetes mellitus (AOR = 0.17; CI: 0.14-0.22), or metabolic disorders (AOR = 0.17; CI: 0.13-0.22). Conclusion The present study is the first to provide a systematic overview of everyday anthroposophic medical practice in primary care for elderly patients. Practitioners of anthroposophic medicine prescribe both conventional and complementary treatments. Our study may facilitate further CAM-research on indications of, for example, dementia or adverse drug reactions in the elderly.

The article profiles former physician George Wolff, who was born on April 9, 1886 in Germany and died in Washington, D.C. on September 16, 1952. A discussion of Wolff's research on medical topics and social medicine, and of his relationship with his mentor, academician and social medicine advocate Alfred Grotjahn, is presented.

Background The distribution and clustering of cardiovascular risk factors among German adolescents is only poorly understood. Objectives To describe the prevalence of major modifiable cardiovascular disease (CVD) risk factors and the clustering of risk factors in German adolescents aged 11-17 years. Design Cross-sectional study. Methods The German Health Interview and Examination Survey for Children and Adolescents was conducted between 2003 and 2006. The prevalence of major CVD risk factors (smoking, obesity, physical inactivity, hypertension, dyslipidaemia and diabetes) and their clustering among 6813 11-17 year old adolescents was calculated according to age and sex. Associations with sociodemographic variables were investigated in multivariate logistic regression analysis. Results The prevalence of all risk factors apart from diabetes and obesity increased significantly across age groups. At the age of 17 years smoking and physical inactivity were the most frequent risk factors. In addition to age, most consistent and strongest associations were observed between socioeconomic status and CVD risk factors. Although the age of 11 years the majority of boys and girls were free of CVD risk factors, at age 17 years more than three-quarters were exposed to at least one risk factor. Conclusion Results indicate that the prevalence of CVD risk factors is increasing rapidly across age groups from 11 to 17 years. In late adolescence the majority of boys and girls are exposed to one or more CVD risk factor. Preventive actions will have to be expanded substantially to reduce the future burden of CVD.

Background The management of hypertension is a key challenge in modern health systems. This study aimed to investigate hypertension treatment strategies among physicians specialized in complementary and alternative medicine (CAM) in Germany by analysing prescribing patterns and comparing these to the current treatment guidelines issued by the German Hypertension Society. Methods In this prospective, multicentre observational study, which included 25 primary care physicians specialized in CAM treatment, prescriptions and diagnoses were analysed for each consecutive hypertensive patient using routine electronic data. Data analysis was performed using univariate statistical tests (Chi square test, Cochran-Armitage trend test). Multiple logistic regression was used to determine factors associated with antihypertensive medication. Results In the year 2005, 1320 patients with 3278 prescriptions were included (mean age = 64.2 years (SD = 14.5), 63.5% women). Most patients were treated with conventional antihypertensive monotherapies (n = 838, 63.5%). Beta-blockers were the most commonly prescribed monotherapy (30.7%), followed by ACE inhibitors (24.0%). Combination treatment usually consisted of two antihypertensive drugs administered either as separate agents or as a coformulation. The most common combination was a diuretic plus an ACE inhibitor (31.2% of dual therapies). Patient gender, age, and comorbidities significantly influenced which treatment was prescribed. 187 patients (14.2%) received one or more CAM remedies, most of which were administered in addition to classic monotherapies (n = 104). Men (OR = 0.66; 95% CI: 0.54-0.80) and patients with diabetes (OR = 0.55; 95% CI: 0.42-0.0.73), hypercholesterolaemia (OR = 0.59; 95% CI: 0.47-0.75), obesity (OR = 0.74; 95% CI: 0.57-0.97), stroke (OR = 0.54; 95% CI: 0.40-0.74), or prior myocardial infarction (OR = 0.37; 95% CI: 0.17-0.81) were less likely to receive CAM treatment. Conclusions The large majority of antihypertensive treatments prescribed by CAM physicians in the present study complied with the current German Hypertension Society treatment guidelines. Deviations from the guidelines were observed in one of every seven patients receiving some form of CAM treatment.

Background: We report on the study design and protocol of a randomised controlled trial (Acupuncture in Seasonal Allergic Rhinitis, ACUSAR) that investigates the efficacy of acupuncture in the treatment of seasonal allergic rhinitis (SAR). Objective: To investigate whether acupuncture is non-inferior or superior to (a) penetrating sham acupuncture and (b) rescue medication in the treatment of SAR. Design: 3-armed, randomised controlled multi-centre trial with a total follow-up time of 16 weeks in the 1st year and 8 weeks in the 2nd year. Setting: 41 physicians in 37 out-patient units in Germany specialised in acupuncture treatment. Patients: 400 seasonal allergic rhinitis patients with clinical symptoms and test-positive (skin-prick test and/or specific IgE) to both birch and grass pollen. Interventions: Patients will be randomised in a 2:1:1 ratio to one of three groups: (a) semi-standardised acupuncture plus rescue medication (cetirizine); (b) penetrating sham acupuncture at non-acupuncture points plus rescue medication; or (c) rescue medication alone for 8 weeks (standard treatment group). Acupuncture and sham acupuncture will consist of 12 treatments per patient over 8 weeks. Main Outcome Measures: Average means of the Rhinitis Quality of Life Questionnaire (RQLQ) overall score and the Rescue Medication Score (RMS) between weeks 6 and 8 in the first year, adjusted for baseline values. Outlook: The results of this trial available in 2011 will have a major impact on the decision of whether acupuncture should be considered as a therapeutic option in the treatment of SAR.

Introduction This is a report of a cross-sectional study on paraphilia-associated sexual arousal patterns (PASAP) among men in a metropolitan city in Germany, EU. Aim To determine the prevalence of PASAP during sexual fantasies, fantasies accompanying masturbation, and real-life sociosexual behavior. Methods In a cross-sectional study, self-reported sexual history data were collected by questionnaire from 367 volunteers recruited from a community sample of 1,915 men aged 40–79 years. Main Outcome Measures The Derogatis Symptom Checklist—Revised (SCL-90–R) and the Life Satisfaction Questionnaire (LSQ; German original, Fragebogen zur Lebenszufriedenheit , [FLZ]) were administered to obtain a general subjective health measure and a measure of general as well as sex life satisfaction. The Questionnaire on Sexual Experiences and Behaviour was administered to comprehensively assess all relevant sexo-medical data. Results The percent of men that reported at least one PASAP was 62.4%. In 1.7% of cases, PASAP were reported to have caused distress. The presence of PASAP was associated with a higher likelihood of being single (odds ratio [OR] 2.6; 95%; confidence interval [CI] 1.047–6.640), masturbating at least once per week (OR 4.4; 95%; CI 1.773–10.914), or having a low general subjective health score (OR 11.9; 95%; CI 2.601–54.553). Pedophilic PASAP in sexual fantasies and in real-life sociosexual behavior was reported by 9.5% and 3.8% of participants, respectively. Conclusion The findings suggest that paraphilia-related experience can not be regarded as unusual from a normative perspective. At the same time, many men experience PASAP without accompanying problem awareness or distress, even when PASAP contents are associated with potentially causing harm to others. In view of the relevance for sex life and relationship satisfaction, presence of PASAP should be assessed in all sexual medicine consultations. Future research should focus on conditions in which PASAP reach clinical significance in the sense of mental disorders. Ahlers CJ, Schaefer GA, Mundt IA, Roll S, Englert H, Willich SN, and Beier KM. How unusual are the contents of paraphilias? Paraphilia-associated sexual arousal patterns in a community-based sample of men.

Harald J Hamre1, Claudia M Witt2, GunverS Kienle1, Christof Schnürer3, Anja Glockmann1, Renatus Ziegler4, StefanN Willich2, Helmut Kiene11Institute for Applied Epistemology and Medical Methodology, Freiburg, Germany; 2Institute of Social Medicine, Epidemiology, and Health Economics, Charité University Medical Center, Berlin, Germany; 3Internal Medicine Practice, A Fraenkel Centrum, Badenweiler, Germany; 4Society for Cancer Research, Arlesheim, SwitzerlandBackground: Anthroposophic treatment for asthma includes special artistic and physical therapies and special medications.Methods: We studied consecutive outpatients starting anthroposophic treatment for asthma under routine conditions in Germany. Main outcomes were average asthma severity (0–10, primary outcome); symptoms (1–4); and asthma-related quality of life at 12-month follow-up (Asthma Quality of Life Questionnaire [AQLQ] overall score, 1–7, for adults; KINDL Questionnaire for Measuring Health-Related Quality of Life in Children and Adolescents, asthma module, 0–100, for children) at 12-month follow-up.Results: Ninety patients (54 adults, 36 children) were included. Anthroposophic treatment modalities used were medications (88% of patients, n = 79/90); eurythmy therapy (22%); art therapy (10%); and rhythmical massage therapy (1%). Median number of eurythmy/art/massage sessions was 12 (interquartile range 10–20), median therapy duration was 120 days (84–184). From baseline to 12-month follow-up, all outcomes improved significantly (P < 0.001 for all comparisons). Average improvements were: average asthma severity 2.61 points (95% confidence interval CI: 1.90–3.32); cough 0.93 (95% CI: 0.60–1.25); dyspnea 0.92 (95% CI: 0.56–1.28); exertion-induced symptoms 0.95 (95% CI: 0.64–1.25); frequency of asthma attacks 0.78 (95% CI:0.41–1.14); awakening from asthma 0.90 (95% CI: 0.58–1.21); AQLQ overall score 1.44 (95% CI:0.97–1.92); and KINDL asthma module 14.74 (95% CI: 9.70–19.78). All improvements were maintained until last follow-up after 24 months.Conclusions: Patients with asthma under anthroposophic treatment had long-term improvements of symptoms and quality of life.Keywords: anthroposophy, art therapy, asthma, combined modality therapy, drug therapy, eurythmy therapy, prospective studies, quality of life

Medicinal plants are the primary ingredients of Tibetan medicinal formulae. The aim of the present study was to evaluate the spectrum of medical complaints treated by a Tibetan doctor in Sikkim and Nepal, and to determine which plants the doctor used most frequently to treat these complaints.Two prospective observational studies were carried out at two locations (Sikkim and Nepal). Patients who visited the participating Tibetan doctor were included consecutively. Medical symptoms, Tibetan syndrome diagnoses, and treatments were documented. The most frequently used plants were identified retrospectively.A total of 238 patients were included (Sikkim: n = 135, 62.2% women, mean age 33.9 3.4 years; Nepal: n = 103, 54.4% men, mean age 42.9 2.4 years). The most frequent medical complaint was pain (Sikkim: 46% of patients; Nepal: 51% of patients). The most frequent Tibetan syndrome diagnosis was Bad-kan in Sikkim (20.7% of patients; a cold disorder affecting the lower body) and a combination of Bad-kan and mKhris-pa in Nepal (28.2%; a mixed cold/hot disorder affecting the lower and middle body). A total of 71 different Tibetan medicines were prescribed, including 138 different plants. Of these 138 plants, 81 typically grow at high and medium altitudes, and 57 grow in tropical and subtropical areas. Nevertheless, most (93%) of the prescribed formulae contained high-altitude plants.For the first time, information on medical complaints and treatments has been evaluated systematically for patients receiving treatment from a Tibetan doctor. These data provide a good foundation for further research on Tibetan medicine. Further studies should go a step farther and include follow-up data and information about the effectiveness and safety of Tibetan medicines.

Background In patients with acute stroke, systemic thrombolysis needs to be administered within 3 hours of symptom onset. The aim of the present study was to reduce prehospital delays in a population-based intervention. Methods We performed a cluster-randomized trial with 48 zip code areas as cluster units in the catchment area of 3 inner-city hospitals in Berlin, Germany. The primary end point was time between symptom onset and hospital admission. The intervention consisted of an educational letter indicating stroke symptoms and emphasizing the importance of calling the emergency medical services. We additionally included a bookmark and sticker with the emergency medical services’ telephone number. We fitted a series of log-normal survival regression models (time to admission) with frailty terms shared by inhabitants of the same zip code area. Results A total of 75 720 inhabitants received the intervention. Between 2004 and 2005, 741 patients with cerebrovascular events were admitted from the control areas (n = 24) and 647 from the intervention areas (n = 24). A prehospital time of 2 hours or less and 3 hours or less was achieved by 22% and 28% of patients, respectively, in the control group compared with 26% and 34%, respectively, in the intervention group. In the log-normal model, time to hospital was reduced by 27% in the intervention group in women (acceleration factor, 0.73; 95% confidence interval, 0.58-0.94), while no significant effect was found in men. Conclusions The population-based intervention was effective in reducing prehospital delays in women but not in men. Future research should focus on the potential transferability of the intervention, its sustainability, and sex-specific impact. Trial Registration clinicaltrials.gov Identifier:NCT00744029

Details and effects of individualised homeopathic treatment of headache (ICD-9: 784.0) in usual care have not yet been investigated.Prospective multi-centre observational study. Consecutive primary-care patients beginning homeopathic treatment were followed for 2 years, keeping regular records of complaint severity, health-related quality of life (QoL), and medication use.230 adults (77.0% women), age 38.2 +/- 11.3 years, and 74 children (10.4 +/- 3.2 years, 55.4% girls) treated by 73 physicians were included. Patients suffered from headaches (average duration: adults 9.3 +/- 9.5 years, children 2.7 +/- 2.6 years) and other chronic diseases. Most patients (adults 90.0%, children 70.8%) had been pre-treated (usually with conventional treatment). Severity of diagnoses and complaints showed marked improvements in the first 3 months, continuing on until the end of the study. For headache, standardised effects (mean change divided by standard deviation at baseline) in adults reached 1.63 (95% CI 1.78-1.49), 2.27 (2.45-2.09), and 2.44 (2.63-2.25) at 3, 12, and 24 months, respectively. In children, the standardised effects at these time points were 1.67 (1.91-1.44), 2.55 (2.82-2.28), and 2.74 (3.03-2.46), respectively. Whilst the QoL among adults improved over time, this trend was not observed in children. Use of conventional treatment and health services decreased markedly.This observational study of patients seeking homeopathic treatment because of headache showed consistent improvements over the 24-month period. The observational and uncontrolled character of the study design does not allow conclusions on a specific relationship between treatment and the observed effects.

We read the important article on the epidemiology of heart failure in Germany with great interest. The conclusions resulting from figures 1 to 3 and the discussion with regard to how the risk of morbidity and mortality differ by sex are misleading, however (1). The data source used by the authors (2) reveals that for almost all categories themorbidity and mortality rates are higher in men than in women up to a very old age. Up to the age of 70, women have a 50–56% lower risk of death or hospitalization than men. This difference evens out slowly by about the age of 90. Women are slightly more affected only at an older age. The reason for the apparent discrepancy in findings is that the use of the standard population of Germany 1987 for age standardization leads to different reference groups for men and women: The age standardized rates for men derived from federal health monitoring data (2) were applied to the male population of 1987 and the female rates to the female population of 1987 (3). The rates for men and women are therefore suitable for comparisons within the sexes (for example, between federal states or over time) but not between them. A correct analysis of sex differences would therefore require the use of a standard population with identical age structure in men and women (for example, the Old European Standard Population). Alternatively, it is possible to use the same reference population for both sexes. Correct age standardization reveals that the standardized death and hospitalization rates of women, shown by the authors in figures 1 to 3, are not higher but lower than those in men.

Objectives To evaluate the details and effects of an individualized homeopathic treatment in patients with chronic low back pain in usual care. Methods Prospective multicenter observational study. Consecutive patients beginning homeopathic treatment in primary care practices were evaluated over 2 years by using standardized questionnaires. Diagnoses (ICD-9) and symptoms with severity, health-related quality of life (QoL), medical history, consultations, homeopathic and conventional treatments, and other health service use were recorded. Results One hundred twenty-nine adults (64.3% women, mean age 43.6 +/- 12.7 y) were treated by 48 physicians. The patients mainly had chronic low back pain (average duration 9.6 +/- 9.0 y) and other chronic diseases. Nearly all the patients (91.3%) had been pretreated. The initial case-taking took 113 +/- 36, and the case analysis took 31 +/- 38 minutes. The 7.4 +/- 8.1 subsequent consultations (duration: 23.7 +/- 15.2 min) cumulated to 204.5 +/- 184.6 minutes. The patients received an average of 6.8 +/- 6.3 homeopathic prescriptions. The severity of the diagnoses and complaints showed marked and sustained improvements with large effect sizes (Cohen's d from 1.67 to 2.55) and QoL improved accordingly (SF-36 physical component scale d = 0.33; mental component scale d = 0.54). The use of conventional treatment and health services decreased markedly: the number of patients using low back pain-related drugs was half of the baseline. Discussion Classic homeopathic treatment represents an effective treatment for low back pain and other diagnoses. It improves health-related QoL and reduces the use of other healthcare services.

Background Recent studies have shown that adverse drug reactions (ADRs) are underreported. This may be particularly true of ADRs associated with complementary and alternative medicine (CAM). Data on CAM-related ADRs, however, are sparse. Objective was to evaluate the impact of an educational intervention and monitoring programme designed to improve physician reporting of ADRs in a primary care setting. Methods A prospective multicentre study with 38 primary care practitioners specialized in CAM was conducted from January 2004 through June 2007. After 21 month all physicians received an educational intervention in terms of face-to-face training to assist them in classifying and reporting ADRs. The study centre monitored the quantity and quality of ADR reports and analysed the results. To measure changes in the ADR reporting rate, the median number of ADR reports and interquartile range (IQR) were calculated before and after the educational intervention. The pre-intervention and post-intervention quality of the reports was assessed in terms of changes in the completeness of data provided for obligatory items. Interrater reliability between the physicians and the study centre was calculated using Cohen's kappa with a 95% confidence interval (CI). We used Mann Whitney U-test for testing continuous data and chi-square test was used for categorical data. The level of statistical significance was set at P < 0.05. Results A total of 404 ADRs were reported during the complete study period. An initial 148% increase (P = 0.001) in the number of ADR reports was observed after the educational intervention. Compared to baseline the postinterventional number of ADR reportings was statistically significant higher (P < 0.005) through the first 16 months after the intervention but not significant in the last 4-month period (median: 8.00 (IQR [2.75; 8.75]; P = 0.605). The completeness of the ADR reports increased from 80.3% before to 90.7% after the intervention. The completeness of the item for classifying ADRs as serious or non-serious increased significantly (P < 0.001) after the educational intervention. The quality of ADR reports increased from kappa 0.15 (95% CI: 0.08; 0.29) before to 0.43 (95% CI: 0.23; 0.63) after the intervention. Conclusion The results of the present study demonstrate that an educational intervention can increase physician awareness of ADRs. Participating physicians were able to incorporate the knowledge they had gained from face-to-face training into their daily clinical practice. However, the effects of the intervention were temporary.

Background Very little is known about the range of diagnoses, course of treatment and long-term outcome in elderly patients who choose to receive homeopathic medical treatment. We investigated homeopathic practice in an industrialised country under everyday conditions. The aim of the study was to determine the spectrum of diagnoses and treatments, as well as to describe the course of illness over time among older patients who chose to receive homeopathic treatment. Methods In this subgroup analysis of a prospective, multicentre cohort study totally including 3981 patients treated by homeopathic physicians in primary care practices in Germany and Switzerland, data was analysed from all patients > 70 years consulting the physician for the first time. The main outcome measures were: assessment by patient of the severity of complaints (numeric rating scales) and quality of life (SF-36) and by the physician of the severity of diagnoses (numeric rating scales) at baseline, and after 3, 12, and 24 months. Results A total of 83 patients were included in the subgroup analysis (41% men, mean age 73.2 ± (SD) 3.1 years; 59% women, 74.3 ± 3.8 years). 98.6 percent of all diagnoses were chronic with an average duration of 11.5 ± 11.5 years. 82 percent of the patients were taking medication at baseline. The most frequent diagnoses were hypertension (20.5%, 11.1 ± 7.5 years) and sleep disturbances (15.7%, 22.1 ± 25.8 years). The severity of complaints decreased significantly between baseline and 24 months in both patients (from 6.3 (95%CI: 5.7-6.8) to 4.6 (4.0-5.1), p < 0.001) and physicians' assessments (from 6.6 (6.0-7.1) to 3.7 (3.2-4.3), p < 0.001); quality of life (SF 36) and the number of medicines taken did not significantly change. Conclusion The severity of disease showed marked and sustained improvements under homeopathic treatment, but this did not lead to an improvement of quality of life. Our findings might indicate that homeopathic medical therapy may play a beneficial role in the long-term care of older adults with chronic diseases and studies on comparative effectiveness are needed to evaluate this hypothesis.

The aim of this paper was to quantify the influence of the physician's training and experience in the field of acupuncture on the outcome in patients with chronic pain. Patients visiting their physician because of chronic low back pain, headache, pain due to osteoarthritis of the knee or hip, or neck pain, were included in 4 multicenter, randomized, controlled studies. All patients received routine care; patients in the acupuncture groups received additional acupuncture treatment (on average 10 sessions). The data was pooled, and the 3-month change from baseline of the SF-36 bodily pain subscale as the main outcome defined. A total of 9,990 patients (mean age 49.6 ± 13.6 years, 68% female) treated by 2,781 physicians (mean age 46.3 ± 7 years, 37% female) were analyzed. The physicians had 7.3 ± 5.2 (mean ± sd) years of experience in acupuncture and their mean duration of formal acupuncture training had been 287 ± 321 hours. The outcome was markedly improved in the acupuncture group. We identified only 1 physician characteristic with a significant influence on the outcome: Internists performed better (odds ratio OR = 1.49, confidence interval CI: 1.01;2.18; P = .043); orthopedists worse (OR = .79, CI: .62;1; P = .043) than the average physician. Neither the duration of training nor the duration of experience had any impact on the extent of the acupuncture effect. Perspective In this analysis, physician characteristics such as training did not influence patients' outcome after acupuncture, suggesting that formal training parameters have only a limited influence on treatment effect. Other skills such as the therapeutic relationship, which are difficult to measure, may probably play a more important role and should be taken into consideration.

Background Many children with chronic disease use complementary therapies. Anthroposophic treatment for paediatric chronic disease is provided by physicians and differs from conventional treatment in the use of special therapies (art therapy, eurythmy movement exercises, rhythmical massage therapy) and special medications. We studied clinical outcomes in children with chronic diseases under anthroposophic treatment in routine outpatient settings. Methods In conjunction with a health benefit program, consecutive outpatients starting anthroposophic treatment for any chronic disease participated in a prospective cohort study. Main outcome was disease severity (Disease and Symptom Scores, physicians' and caregivers' assessment on numerical rating scales 0–10). Disease Score was documented after 0, 6, and 12 months, Symptom Score after 0, 3, 6, 12, 18, and 24 months. Results A total of 435 patients were included. Mean age was 8.2 years (standard deviation 3.3, range 1.0–16.9 years). Most common indications were mental disorders (46.2% of patients; primarily hyperkinetic, emotional, and developmental disorders), respiratory disorders (14.0%), and neurological disorders (5.7%). Median disease duration at baseline was 3.0 years (interquartile range 1.0–5.0 years). The anthroposophic treatment modalities used were medications (69.2% of patients), eurythmy therapy (54.7%), art therapy (11.3%), and rhythmical massage therapy (6.7%). Median number of eurythmy/art/massage therapy sessions was 12 (interquartile range 10–20), median therapy duration was 118 days (interquartile range 78–189 days). From baseline to six-month follow-up, Disease Score improved by average 3.00 points (95% confidence interval 2.76–3.24 points, p < 0.001) and Symptom Score improved by 2.41 points (95% confidence interval 2.16–2.66 points, p < 0.001). These improvements were maintained until the last follow-up. Symptom Score improved similarly in patients not using adjunctive non-anthroposophic therapies within the first six study months. Conclusion Children under anthroposophic treatment had long-term improvement of chronic disease symptoms. Although the pre-post design of the present study does not allow for conclusions about comparative effectiveness, study findings suggest that anthroposophic therapies may play a beneficial role in the long-term care of children with chronic illness.

Background and objectives: An important component of efficient and high-quality treatment of patients under DRG conditions is the control of patients' length of stay in hospitals. Medical processes need to be structured in such a way that unnecessary extensions of the length of stay are avoided, thus achieving an economically and qualitatively optimal result. The study presented here examines the question of whether the introduction of length-of-stay-oriented case management can optimize the duration of patients' hospital stays. Methods: In total, 168 inpatient cases and their matched control cases from the cardiology and urology stations of a maximum care hospital are examined in this study. Results: The result of the t-test for the difference of means indicates that the average length of stay of the intervention cases (5.79 days) was significantly shorter than the average length of stay of the control cases (7.34 days). With respect to the re-admission rate, a statistically significant dependence could not be determined. Discussion and conclusion: The operationalization of case management in daily clinical routines was tested by a comprehensive survey. Length-of-stay-oriented case management provides transparency of the entire treatment process and integrates procedures to an optimal extent. However, the doctor's sovereignty over therapy is not affected by the introduction of length-of-stay-oriented case management. Hence, the form of case management presented here serves as a new and innovative control and monitoring system for hospitals, as it makes institutions that implement such a system more competitive through the improvement of economical aspects as well as through the introduction of higher process efficiency.

This article does not have an abstract.

Background: One of five children visiting a homoeopathic physician is suffering from atopic eczema. Objective: To examine the effectiveness, safety and costs of homoeopathic versus conventional treatment in usual care. Methods: In a prospective multicentre comparative observational non-randomised study, 135 children (homoeopathy n = 48 vs. conventional n = 87) with mild to moderate atopic eczema were included. The primary outcome was the SCORAD (Scoring Atopic Dermatitis) at 6 months. Further outcomes at 6 and 12 months also included quality of life of parents and children, use of conventional medicine, treatment safety and disease-related costs. Results: The adjusted SCORAD showed no significant differences between the groups at both 6 months (homoeopathy 22.49 ± 3.02 [mean ± SE] vs. conventional 18.20 ± 2.31, p = 0.290) and 12 months (17.41 ± 3.01 vs. 17.29 ± 2.31, p = 0.974). Adjusted costs were higher in the homoeopathic than in the conventional group: for the first 6 months EUR 935.02 vs. EUR 514.44, p = 0.026, and for 12 months EUR 1,524.23 vs. EUR 721.21, p = 0.001. Quality of life was not significantly different between both groups. Conclusion: Taking patient preferences into account, homoeopathic treatment was not superior to conventional treatment for children with mild to moderate atopic eczema.

Background: Sudden cardiac death exhibits a circadian variation and predominantly occurs during morning hours. Beta-adrenergic antagonists have shown to blunt this morning peak. However, previous reports studying the effects of beta blockers on the circadian variation did not analyze the underlying cause of sudden cardiac death. It thus remains unclear whether ventricular tachyarrhythmias are influenced by beta-blocker therapy. Hypothesis: This study tested the hypothesis that beta-blocking agents blunt the morning peak of life-threatening ventricular tachyarrhythmias. Methods: In 87 patients who were treated and monitored with an implantable cardioverter defibrillator, the circadian distribution of ventricular tachyarrhythmias terminated by appropriate shocks was analyzed and compared in those receiving beta blockers versus those not receiving beta-blocker therapy. Results: Tachyarrhythmic episodes in the absence of beta-blocker therapy (n = 344) exhibited a circadian variation with a distinct morning peak (16, 38, 28, and 18% of episodes at 0–6, 6–12, 12–18, and 18–24 h, respectively, p