Therapy In Germany Research Articles

Patterns of pharmaceutical therapy in advanced melanoma.

e20014 Background: Since 2011, two therapies that provide novel approaches to the treatment of advanced (unresectable or metastatic) melanoma have been introduced to the market: ipilimumab for second line and vemurafenib for BRAF mutation-positive melanoma. It is not known how the new drugs influence treatment; this study investigated current treatment patterns in advanced melanoma. Methods: A clinician-validated, web-based survey was administered between August and November 2012 to clinicians who treat advanced melanoma in France, Germany, Italy, Spain, and the UK. Respondents were asked about their treatment of patients in the previous 12 months, including treatment modalities and pharmaceutical therapies used, and factors that affect treatment choice. Results: 150 oncologists and dermatologists completed the survey, 30 in each country. Pharmaceutical therapy was more commonly used than other treatment modalities and varied by stage of disease. A high proportion of patients with late stage of disease were treated with pharmaceutical therapy in Germany (85% in M1B) and France (83% in M1C). Among the countries, 51% (Italy) to 87% (France) of respondents test BRAF mutation status. In patients with wild-type BRAF tumors, dacarbazine, which has not been shown to provide any overall survival benefit, was the most commonly used drug for first-line therapy in all countries. In mutated BRAF tumors, vemurafenib was the most commonly used drug in first line therapy in 3 of 5 countries. There was no standard of care in second line for either patients with wild-type or mutated-BRAFtumors; therapies used included fotemustine, temozolomide, interferon, paclitaxel, and ipilimumab. Conclusions: Treatment options for patients with advanced melanoma are limited, particularly for patients with wild-type BRAF disease. In second line, there does not appear to be an established standard of care: a range of treatments are used, including several not indicated for melanoma.

Stand der Pubertätsentwicklung bei Kindern und Jugendlichen während der kieferorthopädischen Therapie

Most orthodontic therapy in Germany takes place during puberty. However, since boys and girls experience puberty very differently, we can expect differences in their pubertal status when undergoing orthodontic therapy. In this study we addressed the stages of pubertal development in male and female children and adolescents undergoing orthodontic treatment. A total of 1011 individuals were randomly selected from a population-based representative sample of school students aged 10-18 years in the German city of Halle/Saale. This cohort was evaluated for the prevalence of orthodontic treatment and--using a modified German version of the Pubertal Development Scale--for pubertal status. An orthodontic subgroup of these boys and girls was analyzed for age distribution and pubertal stage (χ(2) test). The orthodontic subgroup included 296 boys and girls (accounting for 29.3% of the total sample), 50% of whom (n=148) had already attained advanced stages of pubertal development. Broken down by gender, we observed advanced stages in 60% of the girls versus 38% of the boys (p<0.001). However, this gender-specific difference was not reflected in the orthodontic subgroup's age distribution (p>0.05). Irrespective of gender, most subjects undergoing orthodontic treatment were 12 or 13 years old. Boys and girls in Germany undergo orthodontic treatment at the same age. Given the delayed onset of puberty in boys, most are still pre-pubertal, whereas most girls have reached an advanced stage of puberty by the time they undergo treatment--a discrepancy that could have therapeutic implications.

Immunological changes in psoriasis patients under long-term treatment with fumaric acid esters: risk of Kaposi sarcoma occurrence?

Psoriasis is a chronic skin disorder. The most frequently used systemic anti-psoriatic therapy in Germany is fumaric acid esters (FAE). We aimed to characterize immunological changes in psoriasis patients under FAE treatment. Over 200 flow-cytometry analyses of blood from 27 psoriasis patients and histological, molecular, and serological analyses of samples from a patient who developed Kaposi sarcoma (KS) during FAE therapy were performed. The patients receiving FAE showed decreased CD8+ T cell counts, in particular during the first six months. The CD4+ T cell decline was less pronounced and delayed in time. In a patient with KS, we found a profound CD4 and CD8 lymphocytopenia, as well as a NK cell number reduction, although leukocyte and lymphocyte counts were within the recommended limits. The patient was HIV negative, but positive for HHV8. After cessation of FAE therapy, KS regressed. HHV8 infection and iatrogenic T cell reduction, prominently of CD8+ T cells, could have contributed to KS development in this patient. Therefore, we suggest a control of CD4+ and CD8+ T cell counts in addition to the commonly-used differential blood counts in patients with a higher HHV8 prevalence or at high risk of other latent viral infections.

Development of Family Therapy and Systemic Therapy in Germany

The roots of systemic therapy in Germany date back to the sixties. Systemic therapy is one of the most widely applied forms of psychotherapy and counseling in Germany. The majority of therapists and counselors in child guidance centers, couples therapy counseling centers and youth protective services have been trained in systemic therapy. A high number of clinical psychologists, social workers and medical doctors have received training in this model of therapy. In the beginning, multigenerational, experiential, as well as structural-strategic and Milan systemic approaches were popular. Today, the post-modern systems concepts, solution-oriented and narrative approaches and self-organization theory appear to be predominant. Some centers provide research and training in behavioral and psychodynamic family and couples therapy. However, systemic approaches are clearly leading the field with over 10,000 people who have received systemic training and about 150 training institutes across the country. The critical attitude shared by many leading figures towards empirical research has limited its success in university programs. In addition, training is usually provided in the form of post-graduate courses rather than at academic institutions. Currently, three journals and one online-journal publish articles on various systemic topics. Many publishing houses have a series of books on systemic therapy and one publishing house specializes exclusively on systems oriented books. In 2008, systemic therapy gained recognition as an evidence-based treatment. Four years later, the appropriate authorities have not initiated the process of assessing it as a treatment paid for by public health insurances. In consequence, systemic therapy is not available on a large scale in the public outpatient psychotherapy system. Some additional remarks are provided on the history and current situation of systemic therapy in Austria and Switzerland.

P397 Quality of life of Crohn's disease patients under immunosuppressive therapy in Germany – preliminary results of the DaLi study

P397 Quality of life of Crohn’s disease patients under immunosuppressive therapy in Germany preliminary results of the DaLi study M. Reinshagen1 *, B. Bokemeyer2, T. Krummenerl3, M.R. Mross4, P. Nurwakagari5, M. Schwarz5, B.M. Wittig5. 1Klinikum Braunschweig, Dep. of Medicine I, Braunschweig, Germany, 2Gastroenterology Practice, Minden, Germany, 3Gastroenterology Center at Germania Campus, Muenster, Germany, 4Gastroenterology Practice, Berlin, Germany, 5Abbott GmbH & Co. KG, Medical Department, Wiesbaden, Germany

The German Health System and Heilpraktiker: integration of TCM and natural therapies in Germany

The German Health System and Heilpraktiker: integration of TCM and natural therapies in Germany

P01.18. Triterpene acid containing Viscum album L. extracts mediate apoptosis in paediatric solid cancer cells

Purpose Paediatric solid cancers such as osteosarcoma, Ewing s sarcoma, rhabdomyosarcoma and neuroblastoma are the most common cancers in children besides leukemia. These cancers have a poor prognosis, are highly metastatic and often resistant to current therapeutic approaches. Viscum album L. (mistletoe) is one of the most widely used complementary cancer therapies in Germany but little is known about its actual effects on paediatric solid cancers. Approved Viscum album L. extracts (VAE) basically contain water soluble compounds of the plant (lectins, viscotoxins). However, mistletoe also contains triterpene acids (mainly oleanolicand betulinic acid) that are water-insoluble. The antitumorigenic properties of these solubilized triterpene acids are the subject of ongoing research. The aim of this study is to determine the effects of different VAE containing either lectins (viscum), triterpene acids (TT) or a combination thereof (viscum TT) on solid tumor models in vitro and in vivo.

Peptide receptor radionuclide therapy for neuroendocrine tumors in Germany: Initial results of a multiinstitutional cancer registry.

e14513 Background: Peptide receptor radionuclide therapy is an effective treatment option for patients with well differentiated somatostatin receptor expressing neuroendocrine tumors. However, published data results mainly from retrospective monocentric studies. Methods: We initiated a multi-institutional, prospective and board reviewed registry for patients treated with Peptide receptor radionuclide therapy in Germany in 2009. Results: In five centers, 297 patients were registered. Primary tumors were mainly derived from pancreas (117/297), small intestine (80/297) whereas 56 were of unknown primary. Most tumors were well differentiated with a median Ki67 proliferation rate of 5% (range 0.9 to 70). Peptide receptor radionuclide therapy was performed using mainly Yttrium-90 and/or Lutetium-177 as radionuclides in 1-8 cycles. Mean overall survival was estimated at 213 months with a follow up between 1 and 230 months after initial diagnosis and 87 months with a follow up between 1 and 92 months after start of Peptide receptor radionuclide therapy. Median overall survival was not yet reached. Subgroup analysis demonstrated that best results were obtained in neuroendocrine tumors with a proliferation rate below 20%. Conclusions: Our results indicate that Peptide receptor radionuclide therapy is an effective treatment well and moderately differentiated neuroendocrine tumors irrespective of previous therapies and should be regarded a one of the primary treatment options for patients with neuroendocrine tumors.

Treatment of infantile Pompe s disease with enzyme replacement therapy in Germany and Austria

Aims: Enzyme replacement therapy (ERT) has been shown to improve the outcome in infantile Pompe disease, but information about mortality and morbidity of patients treated outside clinical trials is still limited.

Time Trends in Systemic Thrombolysis in a Large Hospital-Based Stroke Registry

Background: Systemic thrombolysis for acute stroke was approved by German authorities in 2002. While recombinant tissue plasminogen activator (rtPA) use first remained low, systemic thrombolysis is nowadays an established part of common stroke care. The purpose of this study was to determine changes in systemic thrombolysis rates within an observation period of 7 years following the approval of rtPA therapy in Germany in a large state-wide stroke data set. Methods: We analyzed a prospective hospital-based stroke registry covering the entire federal state of Hesse, Germany. All hospitals providing stroke care in Hesse (neurology hospitals and hospitals for internal medicine) are obligated to register all inpatients. All cases admitted between 2003 and 2009 with a final diagnosis of ischemic stroke (ICD-10: I63) were selected. We analyzed the relationship between thrombolysis rates, onset-to-admission time (hospital arrival ≤3 and >3 h after symptom onset), patient age (quartiles and dichotomized in ≤80 and >80 years) and disability at admission (assessed by the Rankin Scale). A one-way ANOVA with Bonferroni correction for multiple comparisons was performed to test for significant changes during the observation period. Results: 88,340 patients with ischemic stroke were identified. Thrombolysis rates increased continuously from 2.5% in 2003 to 8.4% in 2009. In patients admitted within 3 h after symptom onset, the thrombolysis rate was 2.5-fold higher in 2009 (25.4%) as compared to 2003 (10.5%). The mean age (±SD) of thrombolyzed patients increased from 68.7 (±11.5) years in 2003 to 70.7 (±13.4) years in 2009 (p for trend = 0.014), but remained stable in the entire cohort. 20.1% of all systemic thrombolytic treatments were performed in patients >80 years old. Disability at admission decreased more pronouncedly in rtPA-treated patients (Rankin Scale score 0-2: 15.2% in 2003 and 24.5% in 2009; p for trend <0.001) as compared to the entire cohort (34.5% in 2003 and 41.5% in 2009; p for trend <0.001). Conclusions: Thrombolytic therapy is increasingly used in acute stroke, particularly in patients admitted within the 3-hour time window. Higher treatment rates are at least partially explained by spreading rtPA application, including older and less severely affected patients. Approximately one fifth of all rtPA treatments were given to the very old (>80 years), which is outside the age limit for rtPA approval. In the light of upcoming demographic changes, the proportion of very aged stroke patients will increase substantially, further tightening the current discussion of an upper age limit for thrombolytic therapy.

Abstract 2905: Changes Of Systemic Thrombolysis Rates In A Large Hospital-based Stroke Registry

Objectives: This analysis determines changes in systemic thrombolysis rates in a large state-wide stroke data set covering an observation period of 7 years following the approval of rtPA therapy in Germany. Methods: A prospective hospital-based stroke registry covering the entire Federal State of Hesse, Germany was analyzed. All patients admitted between 2003 and 2009 with a final diagnosis of ischemic stroke (ICD-10: I63) were selected. The relationship between thrombolysis rates, onset-to-admission time, patient age, and initial stroke severity (assessed by the Modified Rankin Scale (MRS)) was analyzed. One-way ANOVA was performed to test for significant changes during the observation period. Results: We identified 88.340 patients with ischemic stroke. Thrombolysis rates increased continuously from 2.5% in 2003 to 8.4% in 2009. In patients admitted within 3h after symptom onset, thrombolysis rate was 2.5 fold higher in 2009 (25.4%) as compared to 2003 (10.5%). Mean age (+/-SD) of thrombolyzed patients increased from 68.7 (+/-11.5) years in 2003 to 70.7 (+/-13.4) years in 2009 (p=0.014 for trend), but remained stable in the entire cohort. In contrast, stroke severity decreased both in rtPA treated patients (initial mean MRS score 3.9 in 2003 and 3.5 in 2009 (p&lt;0.001 for trend)), and in the entire cohort (3.1 (2003); 2.9 (2009), p&lt;0.001 for trend). Conclusions: Thrombolytic therapy is increasingly used in acute ischemic stroke, particularly in patients admitted within the 3h time window. Several factors as improved clinical pathways, increasing personal experience and financial incentives may contribute to this development. In addition, our data suggest that higher treatment rates are at least partially explained by spreading rtPA application towards older and less severely affected patients.

Augmentation von Antidepressiva mit atypischen Antipsychotika bei Nonresponse auf eine Antidepressiva-Monotherapie

Objective Augmentation of antidepressants with atypical antipsychotics is used in depressive patients with non-response to antidepressants. We investigated the utility of this strategy.Methods Systematic computer-based search in the online library Pubmed for randomized placebo-controlled double-blind trials (RCT) from the years 1990 to 2011.Results We found 14 RCT about augmentation of antidepressants with atypical antipsychotics in depressive patients with non-response to antidepressants. Trials examined olanzapine, risperidone, quetiapine and aripiprazole.Conclusions Augmentation of antidepressants with atypical antipsychotics is an alternative to the augmentation with lithium in unipolar depressive patients with non-response to antidepressants. But treatment with atypical antipsychotics as opposed to placebo increases the risk of non-compliance due to side-effects of medication. Augmentation of antidepressants with atypical antipsychotics in unipolar depression is an off-label therapy in Germany except for the augmentation with extended-release quetiapine. Knowledge about treatment strategies regarding augmentation of antidepressants with atypical antipsychotics can increase the chance of a successful treatment, but interactions and side-effects should be considered.

Current state of evidence on ‘off-label’ therapeutic options for systemic lupus erythematosus, including biological immunosuppressive agents, in Germany, Austria and Switzerland – a consensus report

Systemic lupus erythematosus (SLE) can be a severe and potentially life-threatening disease that often represents a therapeutic challenge because of its heterogeneous organ manifestations. Only glucocorticoids, chloroquine and hydroxychloroquine, azathioprine, cyclophosphamide and very recently belimumab have been approved for SLE therapy in Germany, Austria and Switzerland. Dependence on glucocorticoids and resistance to the approved therapeutic agents, as well as substantial toxicity, are frequent. Therefore, treatment considerations will include 'off-label' use of medication approved for other indications. In this consensus approach, an effort has been undertaken to delineate the limits of the current evidence on therapeutic options for SLE organ disease, and to agree on common practice. This has been based on the best available evidence obtained by a rigorous literature review and the authors' own experience with available drugs derived under very similar health care conditions. Preparation of this consensus document included an initial meeting to agree upon the core agenda, a systematic literature review with subsequent formulation of a consensus and determination of the evidence level followed by collecting the level of agreement from the panel members. In addition to overarching principles, the panel have focused on the treatment of major SLE organ manifestations (lupus nephritis, arthritis, lung disease, neuropsychiatric and haematological manifestations, antiphospholipid syndrome and serositis). This consensus report is intended to support clinicians involved in the care of patients with difficult courses of SLE not responding to standard therapies by providing up-to-date information on the best available evidence.

The Effectiveness of couple therapy in Germany: A Replication Study

The utility of couple therapy has been investigated in a number of controlled clinical efficacy investigations, demonstrating the superiority of most forms of couple therapy relative to control groups. Despite its widespread use, the effectiveness of couple therapy in field settings is largely unknown. In 1997, Hahlweg and Klann published an effectiveness study of couple therapy as practiced in German and Austrian marital counseling agencies. The purpose of the current investigation was to replicate their earlier findings in a similar setting with identical measures. The findings demonstrate that the results are remarkably similar across the two studies and that couple therapy in these applied settings helps to alleviate relationship distress as well as individuals' depression.

Diuretics for hypertension – an inconsistency in primary care prescribing behaviour

Objective:Internationally there is an ongoing debate on diuretics as first-line therapy for most patients with hypertension. In spite of many arguments against them in antihypertensive monotherapy, the authors of the present study perceived them to be regularly prescribed in combination therapy in Germany. The study objective was to look for this discrepancy in prescribing reality as a contribution from clinical practice to an academic debate.Methods:A descriptive cross-sectional study in a yearly contact group (YCG; 1.7.2007–31.06.2008) was conducted based on data from a scientific network of 22 general practitioners in Germany. All patients with hypertension as diagnosed by their general practitioner were included. Antihypertensives were grouped according to the ATC classification. To assess for potential design effects by the given two-level setting, 95% confidence intervals (CI) were adjusted for clustering.Results:Hypertension had been diagnosed in 9.3% of the 58 852 patients. Of these, 21.6% received no antihypertensives. Of those who were treated, 30.6% (CI [28.6–32.6]) had monotherapy. In monotherapy, 8.6% (CI [7.1–10.2]) were prescribed some diuretic, 1.5% (CI [0.5–3.0]) received hydrochlorothiazide (HCT). Combination therapy was prescribed to 69.4% (CI [67.2–71.6]). These patients received some diuretic in 79.0% (CI [76.9–81.0]) of the cases, of which 80.8% (CI [78.5–83.1]) had a combination with HCT. HCT was prescribed in 76.2% (CI [73.5–78.9]) in fixed-dose formulations.Conclusion:In spite to the many arguments against them, leading to their almost complete disregard in monotherapy, thiazide-diuretics seem to be standard in combination therapy in Germany. This inconsistency can not be explained by the arguments of the current debate. Key limitations of the present study include the lack of ability to tell whether a given monotherapy is the first-line medication, the small sample size and the possible selection bias.

Das Deutsche Herzschrittmacher-Register

The German Pacemaker Register represents the oldest, still existing registry for cardiac rhythm devices worldwide and with nearly 1 million datasets also the largest register. It was founded by the Arbeitsgemeinschaft Herzschrittmacher e.V., and the first annual report presented data from 1982. Data were sent on a voluntary basis to the"Deutsches Zentralregister Herzschrittmacher" (German Central Register for Pacemakers) in Giessen, Germany, and were analyzed and published by Prof. Dr. Ing. Werner Irnich and his coworkers through 1999. Since the year 2000, the German Pacemaker Register represents the result of a cooperation between the German Cardiac Society, the"Bundesgeschäftsstelle Qualitätssicherung" (BQS, National Institute for Quality and Patient Safety; through 2009) and the AQUA Institute (since 2010), respectively. Since 2002, the German Pacemaker Register uses data from healthcare performance measurements. A new law is the basis of this data collection; thus, data collection is nearly 100%, which contributes to the improved data quality compared to the early years of the register. Although some targets still have not been reached, the German Pacemaker Register has contributed to a more comprehensive overview of pacemaker therapy in Germany by continuously publishing annual reports for roughly three decades. Many people have contributed to this tremendous work and they deserve our deepest respect and thanks.

ドイツにおけるダンス・セラピーおよびダンス・セラピスト養成の現状

ドイツにおけるダンス・セラピーおよびダンス・セラピスト養成の現状

Langenbeck’s archives and the early development of vascular surgery in Germany

Langenbeck's Archives of Surgery and its predecessor Archiv für Klinische Chirurgie have addressed vascular surgical problems from the early beginning. In 1860, Bernhard von Langenbeck published a review on venous injuries during tumor surgery, and in 1907, Erich Lexer heralded the era of vascular reconstructive therapy in Germany when he treated an axillary aneurysm by use of a segment of the longer saphenous vein. The Archiv für Klinische Chirurgie has significantly promoted the development of vascular surgery in Germany especially at the end of the nineteenth and first decades of the twentieth century.

The Person-Centered Approach in Germany: To Cut a Long Story Short / Der Personzentrierte Ansatz in Deutschland—um es kurz zu machen / El enfoque centrado en la persona en Alemania: Resumiendo una larga historia / Une courte histoire de l'approche centrée sur la personne en Allemagne / A Abordagem Centrada na Pessoa na Alemanha: Breve resenha /

This article outlines the history and development of client-centered therapy in Germany against the background of the evolving professionalization of psychotherapeutic care. Representatives of the approach had neglected to assert their interests in health policies for years. As a consequence, client-centered therapy (CCT) failed to achieve a secure position within the German medical care system, which de facto led to the exclusion of CCT until now. The resulting practical consequences for client-centered psychotherapists and training activities are exemplified. Finally a critical analysis investigates if traits inherent to the person-centered approach have provoked the described situation. Proposals for the future of CCT in Germany are discussed.

Outcomes of couples with infidelity in a community-based sample of couple therapy.

Infidelity is an often cited problem for couples seeking therapy, but the research literature to date is very limited on couple therapy outcomes when infidelity is a problem. The current study is a secondary analysis of a community-based sample of couple therapy in Germany and Austria. Outcomes for 145 couples who reported infidelity as a problem in their relationship were compared with 385 couples who sought therapy for other reasons. Analyses based on hierarchical linear modeling revealed that infidelity couples were significantly more distressed and reported more depressive symptoms at the start of therapy but continued improving through the end of therapy and to 6 months posttherapy. At the follow-up assessment, infidelity couples were not statistically distinguishable from non-infidelity couples, replicating previous research. Sexual dissatisfaction did not depend on infidelity status. Although there was substantial missing data, sensitivity analyses suggested that the primary findings were not due to missing data. The current findings based on a large community sample replicated previous work from an efficacy trial and show generally optimistic results for couples in which there has been an affair.