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Simple Summary: Even today, we do not know from which point the chicken embryo is able to process and feel pain. This is of special interest as worldwide, millions of male embryos are killed before hatching. This work aimed to examine when during the development of the embryo the brain shows normal activity, based on EEG recordings. The data strongly suggest developmental day 13 as the earliest embryonal stage being able to process pain. These results may support legislative processes establishing updated laws on animal welfare. Chicken culling has been forbidden in Germany since 2022; male/female selection and male elimination must be brought to an embryonic status prior to the onset of nociception. The present study evaluated the ontogenetic point at which noxious stimuli could potentially be perceived/processed in the brain in ovo. EEG recordings from randomized hyperpallial brain sites were recorded in ovo and noxious stimuli were applied. Temporal and spectral analyses of the EEG were performed. The onset of physiological neuronal signals could be determined at developmental day 13. ERP/ERSP/ITC analysis did not reveal phase-locked nociceptive responses. Although no central nociceptive responses were documented, adequate EEG responses to noxious stimuli from other brain areas cannot be excluded. The extreme stress impact on the embryo during the recording may overwrite the perception of noniceptive stimuli. The results suggest developmental day 13 as the earliest embryonal stage being able to receive and process nociceptive stimuli. [ABSTRACT FROM AUTHOR]

Hand and forearm injuries are the most frequent reason for consultations in German emergency departments. Therefore, full recovery has a high social and economic relevance. In this study, data on surgically treated hand injuries in a regional German trauma centre between 01.01.2019 and 31.01.2021 were collected using the new German HandTraumaRegister of the German Society for Hand Surgery. These data were retrospectively analysed and correlated with mobility data of the Bavarian population, the 7-day incidence of Covid-19 infections in Germany and the number of elective hand surgeries. We found that a fall from standing height with consecutive distal radius fracture was the most common injury in women, whereas mechanism of injury and diagnosis were more diverse in men. The populations' mobility correlated well with the number of accidents, which in turn was reciprocal to the 7-day-incidence of Covid-19 infections. The number of elective hand surgeries expectedly dropped significantly during the state-imposed lockdowns. Knowing that mainly young men and elderly women suffer from hand injuries, tailored prevention measures may be elaborated. In order to reduce socioeconomic burden, care for hand injuries and elective hand surgeries must be guaranteed according to the frequency of their occurrence. [ABSTRACT FROM AUTHOR]

Simple Summary: Surgical castration of piglets is generally recognized as a painful procedure. Thus, for animal welfare reasons, the German Animal Welfare Act stipulates the use of effective anesthesia during castration. However, whether local anesthesia provides adequate analgesia has been an ongoing debate in Germany. In the present study, we compared the behavior of 178 piglets allocated to various test groups in an observation arena before any of the applied procedures, after administration of the local anesthetic, and 0, 2 and 24 h after surgical castration. The local anesthetic and the injection techniques were evaluated and optimized in three sequential study parts. Overall, the results revealed that when local anesthesia was used, piglets less frequently showed pain-associated behaviors—such as changes in tail position—than piglets of the control group that had been castrated without local anesthesia. Non-castrated piglets showed the fewest pain-associated behaviors in the observation arena. In several test groups, the piglets showed changes in tail position, tail wagging, or hunched-back posture on the day following the procedure. These behaviors differed significantly from those shown before the procedure. The administration of local anesthetics in the present study considerably reduced castration-related pain. However, because local anesthesia has a limited duration of effect, adverse effects due to castration-related pain were still observable one day after castration. Surgical castration of piglets is generally recognized as a painful procedure, but there is currently no gold standard for the assessment of pain behavior in piglets. However, pain assessment is essential for evaluating the effectiveness of local anesthetics. In this study, we investigated the efficacy of four local anesthetics in terms of pain relief during and after surgical castration in three sequential study parts. To do so, we filmed 178 piglets before the applied procedures, after injection of the local anesthetic, and up to 24 h after castration (five observation times in total) in an observation arena and compared their behavior before and after castration and between treatments and control groups. The results showed significant differences in the behavior of the piglets before and after castration and between the sham-castrated control group and the control group castrated without anesthesia. The different local anesthesia treatment groups showed diverging differences to the control groups. The most frequently shown pain-associated behaviors of the piglets were changes in tail position and hunched back posture. We observed a reduction but no complete elimination of the expressed pain-associated behaviors after local anesthesia. Several behavioral changes—such as changes in tail position, hunched back posture or tail wagging—persisted until the day after castration. Owing to the limited duration of the effects of the local anesthetics, local anesthesia did not influence long-term pain. [ABSTRACT FROM AUTHOR]

Background: Delirium is a common complication in critical care. The syndrome is often underestimated due to its potentially no less dangerous course as a hypoactive delirium. Therefore, current guidelines ask for a structured, regular and routine screening in all intensive care units. If delirium is diagnosed, symptomatic therapy should be initiated promptly.Objectives: The aim of the current study was to evaluate recent German anesthetists' strategies regarding delirium care compared to the German guidelines for sedation and delirium in intensive care.Methods: In an online survey German hospitals' senior anesthetists (n = 922) were interviewed anonymously between May and June 2015 regarding guideline use in delirium management in German intensive care units. In 33 direct questions the anesthetists were invited to answer items regarding the structure of their hospitals, intensive care and delirium therapy in order to review their knowledge of the German delirium guidelines that expired in 2014.Results: The 249 senior anesthetists who responded to the survey, can be associated with (or represent) a quarter of German intensive care beds and cases, respectively. In every tenth clinic that runs an intensive care unit the guideline was unknown. In three of four intensive care units physicians specified a preferred delirium score, the CAM-ICU (49.4 %) is used most frequently. With knowledge of the guidelines more often a recommended delirium score is used (p = 0.017). However, only 53.6 % of the respondents ascertain a score every eight hours and 36 % have no facility for standardized documentation in the records. At intensive care rounds, a possible diagnosis of delirium is an inherent part in only 34.9 % of the responders even with guideline knowledge. The particular gold standard for the therapy of delirium (alphaagonists for vegetative symptoms; 89.6 %, benzodiazepines for anxiety, 77.5 %; antipsychotics in 86.7 % for psychotic symptoms) is implemented more often with growing knowledge of the guidelines. The latter applies to the implementation of structured programs for delirium prophylaxis, cognition and therapy.Conclusion: For the first time, this study documents knowledge and implementation of the German S3 guidelines for delirium in intensive care. Overall, the guidelines for delirium care are less well executed than those for sedation. With growing knowledge of the guidelines, diagnosis and treatment of delirium fits the guidelines more frequently. The facility to document a delirium score in intensive records is insufficient. Especially a nursing-based delirium strategy could possibly improve implementation of the guidelines, claiming an eight-hour screening and documentation. However, the small number of hospitals that have integrated the guidelines into in-house standard operating procedures (40 %) shows urgent need for optimization. A re-evaluation involving all relevant caretakers could probably improve the implementation of guidelines in intensive care and perioperative medicine. [ABSTRACT FROM AUTHOR]

Background:The German Pegvisomant Observational Study (GPOS) was created immediately after marketing authorisation was received in Germany for Somavert®(pegvisomant) for the treatment of patients with acromegaly. In August 2006, the database underwent its fifth interim analysis of 263 patients, the vast majority of whom previously had insufficient disease control with other treatment modalities. The GPOS documents both safety and efficacy aspects of the treatment of patients with acromegaly by the first growth hormone-receptor antagonist, pegvisomant. This treatment led to normalization of disease activity in most patients, had favourable effects on glucose metabolism and improved signs and symptoms of the disorder. The safety profile indicates that pegvisomant treatment is well tolerated, and tumour growth is noted to occur at the same rate as for somatostatin analogue treatment. Transaminase elevations occurred in 16 of the 263 patients but spontaneously resolved in eight of them and promptly normalised in five patients who discontinued treatment. GPOS is presently the largest database of pegvisomant-treated patients, and it comprises more than 87% of all patients treated with pegvisomant in Germany. Conclusions: The GPOS database provides important information about treatment modalities, safety and efficacy of pegvisomant in patients with acromegaly. Copyright © 2007 S. Karger AG, Basel [ABSTRACT FROM AUTHOR]

Objective: The goal of the methodological approach of "quality profiling" for complementary and alternative medicine (CAM) is to offer an empirical database that would enable different participants in the health care system to evaluate the quality of a medical provider. Methods: Quality profiling is a structured way of describing quality on the levels of infra-structure, patients, medical interventions, outcomes, and quality assurance related to one specific provider. As part of a program called "quality management and research," this type of profiling constitutes one basic step for generating knowledge in terms of evidence-based medicine as well as confidence-based medicine. Quality profiling is exemplified by a hospital for Traditional Chinese Medicine in Germany. Within 1 year all in-patients were included in the database using questionnaires for physicians and patients at the time of admission, discharge from the hospital, and follow-up inquiries at intervals up to 1 year after discharge. The frequency of diagnostic and therapeutic interventions was recorded daily. Results: Data for 1036 patients (mean age 53 years old, 73% female) were analyzed. The most frequent diagnostic categories were musculoskeletal disorders (30%) and neurologic disorders (26%). Therapeutic effects were shown in various outcome measures such as reduced intensity of complaints, improved quality of life, increased satisfaction in lifestyle areas, and fewer days off work. In 6.5% of the subjects, adverse events (mostly of minor severity) were recorded. Conclusions: Quality profiles can serve as a basic tool for evaluating provider quality when the results are compared with either a predefined standard or with profiles of other providers who are offering similar medical services. [ABSTRACT FROM AUTHOR]

An exchange of information concerning a general tendency to increase prices infringes competition law.Companies which regularly meet to exchange information might have an agreement or concerted practices infringing Art. 101 TFEUIt can be illegal to exchange information which was (partly) published in the press as this information is generally deemed reliable by competitors. [ABSTRACT FROM PUBLISHER]

Simple Summary: More than 80 million male piglets are castrated every year within the first week of life mostly without pain relief in the EU. Castration is performed to prevent boar taint, to minimize aggressive and sexual behavior associated with intact males and to gain a constant quality of meat. It is an important animal welfare issue to eliminate pain caused by castration. Local anesthesia, meaning the sole injection of a local anesthetic into the testicles and in the surrounding tissue of conscious piglets, prior to castration is a currently discussed method in Germany. Thus, it was the aim of the present study to investigate the effect of four local anesthetics (procaine, lidocaine, bupivacaine and mepivacaine) on pain relief during surgical castration in conscious piglets. To assess pain, defensive behavior of piglets undergoing injection and castration was evaluated. In addition, attention was paid to possible side effects. Considering healing, bleeding and weight gain no negative impacts were observed, but impairments of locomotor activity occurred. The results indicate that lidocaine and mepivacaine are able to achieve significant pain relief during the castration procedure, whereas procaine and bupivacaine only during the severing of the spermatic cord. The aim of the present study was to investigate the effect of four local anesthetics on pain relief during surgical castration under standardized conditions in conscious piglets. Therefore, 71 male piglets (three to seven days) were distributed into control groups (handling, castration without anesthesia or analgesia) and local anesthetic trial groups (procaine, lidocaine, bupivacaine, mepivacaine). Then, 20 min prior to castration, animals of the treatment groups, except piglets in the handling group, received an injection of a local anesthetic or sodium chloride of 0.5 mL intratesticularly and 0.5 mL subscrotally. During injection and castration, defensive behavior was evaluated. Locomotor activity, as well as postoperative bleeding, wound healing and average daily weight gain were assessed to detect side effects. The injection caused increased defensive movements, significantly in the bupivacaine group. Lidocaine and mepivacaine significantly reduced defensive movements during castration, and procaine and bupivacaine only during severing of the spermatic cord. Impairments of locomotor activity were found in piglets injected with lidocaine, bupivacaine or sodium chloride. Considering healing, bleeding and weight gain, no negative impacts were observed. In conclusion, lidocaine and mepivacaine were able to achieve significant pain relief during the castration procedure, whereas procaine and bupivacaine only during the severing of the spermatic cord. Moreover, the injection of bupivacaine seemed to be painful itself. [ABSTRACT FROM AUTHOR]

Focuses on the convention organized by three medical disciplines of universities in Germany on research and clinical practice of obesity as of March 2000. Range of topics discussed by several scientists at the congress; Focus of the congress on interdisciplinary cooperation; Indications of the expansion of obesity research in the congress' discussions.

• One Health investigation of the first identified cluster of human infections with highly lethal Borna disease virus 1 (BoDV-1) in a small municipality in Bavaria, Germany. • BoDV-1 was detected only in the known reservoir, the bicoloured white-toothed shrew (Crocidura leucodon). • Two different phylogenetic subclades were detected circulating in parallel in the study area. • Despite a high probability of shrew contact and confirmed BoDV-1-presence in shrews, no oligo-/asymptomatic or additional clinically manifest human BoDV-1-infections were detected. • BoDV-1 was neither detected in ticks nor in any of the environmental samples. Zoonotic Borna disease virus 1 (BoDV-1) causes fatal encephalitis in humans and animals. Subsequent to the detection of two paediatric cases in a Bavarian municipality in Germany within three years, we conducted an interdisciplinary One Health investigation. We aimed to explore seroprevalence in a local human population with a risk for BoDV-1 exposure as well as viral presence in environmental samples from local sites and BoDV-1 prevalence within the local small mammal population and its natural reservoir, the bicoloured white-toothed shrew (Crocidura leucodon). The municipality's adult residents participated in an anonymised sero-epidemiological study. Potential risk factors and clinical symptoms were assessed by an electronic questionnaire. Small mammals, environmental samples and ticks from the municipality were tested for BoDV-1-RNA. Shrew-derived BoDV-1-sequences together with sequences of the two human cases were phylogenetically analysed. In total, 679 citizens participated (response: 41 %), of whom 38 % reported shrews in their living environment and 19 % direct shrew contact. No anti-BoDV-1 antibodies were detected in human samples. BoDV-1-RNA was also undetectable in 38 environmental samples and 336 ticks. Of 220 collected shrews, twelve of 40 C. leucodon (30%) tested BoDV-1-RNA-positive. BoDV-1-sequences from the previously diagnosed two paediatric patients belonged to two different subclades, that were also present in shrews from the municipality. Our data support the interpretation that human BoDV-1 infections are rare even in endemic areas and primarily manifest as severe encephalitis. Sequence analysis linked both previous paediatric human infections to the local shrew population, but indicated independent infection sources. The project was partly financed by funds of the German Federal Ministry of Education and Research (grant numbers: 01KI2005A, 01KI2005C, 01KI1722A, 01KI1722C, 01KI2002 to MaBe, DR, RGU, DT, BS) as well as by the ReForM-A programme of the University Hospital Regensburg (to MaBa) and by funds of the Bavarian State Ministry of Health, Care and Prevention, project "Zoonotic Bornavirus Focal Point Bavaria – ZooBoFo" (to MaBa, MaBe, BS, MMB, DR, PS, RGU). [ABSTRACT FROM AUTHOR]

Introduction: The demographic shift leads to a tremendous increase in age-related diseases, which are often chronic. Therefore, a focus of chronic disease management should be set on the maintenance or even improvement of the patients' quality of life (QoL). One indicator to objectively measure QoL is the EQ-5D questionnaire, which was validated in a disease- and world region-specific manner. The aim of this study was to conduct a systematic literature review and meta-analysis on the QoL across the most frequent chronic diseases that utilized the EQ-5D and performed a disease-specific meta-analysis for treatment-dependent QoL improvement., Materials and Methods: The most common chronic disease in Germany were identified by their ICD-10 codes, followed by a systematic literature review of these ICD-10 codes and the EQ-5D index values. Finally, out of 10,016 independently -screened studies by two persons, 538 studies were included in the systematic review and 216 studies in the meta-analysis, respectively., Results: We found significant medium to large effect sizes of treatment effects, i.e., effect size >0.5, in musculoskeletal conditions with the exception of fractures, for chronic depression and for stroke. The effect size did not differ significantly from zero for breast and lung cancer and were significantly negative for fractures., Conclusion: Our analysis showed a large variation between baseline and post-treatment scores on the EQ-5D health index, depending on the health condition. We found large gains in health-related quality of life mainly for interventions for musculoskeletal disease., Systematic Review Registration: https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42020150936, PROSPERO identifier CRD42020150936., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2024 Riecke, Bauer, Polzer, Baumbach, Neuerburg, Böcker, Grill and Saller.)

Postoperative delirium is common and has multiple adverse consequences. Guidelines recommend routine screening for postoperative delirium beginning in the post-anaesthesia care unit. The 4 A's test (4AT) is a widely used assessment tool for delirium but there are no studies evaluating its use in the post-anaesthesia care unit. We evaluated the performance of the 4AT in the post-anaesthesia care unit in a tertiary German medical centre. Adults who were able to provide informed consent, were not scheduled for postoperative intensive care, and who did not have dementia or severe neuropsychiatric disorders underwent screening by trained research staff with the Nurse Delirium Screening Scale and a new German translation of the 4AT in a random order at the point of discharge from the post-anaesthesia care unit. Reference standard assessment of delirium was psychiatric evaluation by experienced clinicians. Five hundred and forty-three patients (mean age (SD) 52 (18) years) were analysed; 22 (4.1%) patients developed delirium. The sensitivity and specificity of the 4AT were 95.5% (95%CI 77.2-99.9) and 99.2% (95%CI 98.1-99.8), respectively. The area under the receiver operator characteristic curve was 0.998 (95%CI 0.995-1.000). The Nursing Delirium Screening Scale had a sensitivity of 27.3% (95%CI 10.7-50.2) and specificity of 99.4% (95%CI 98.3-99.9), with an area under the curve of 0.761 (95%CI 0.629-0.894). These findings suggest that the 4AT is an effective and robust instrument for delirium detection in the post-anaesthesia care unit., (© 2019 Association of Anaesthetists.)

Introduction: Premedication of surgical patients with benzodiazepines has become questionable regarding risk-benefit ratio and lack of evidence. Though preoperative benzodiazepines might alleviate preoperative anxiety, a higher risk for adverse events is described, particularly for elderly patients (≥ 65 years). Several German hospitals already withhold benzodiazepine premedication from elderly patients, though evidence for this approach is lacking. The patient-centred outcome known as global postoperative patient satisfaction is recognised as a substantial quality indicator of anaesthesia care incorporated by the American Society of Anesthesiologists. Therefore, we aim to assess whether the postoperative patient satisfaction after premedication with placebo compared to the preoperative administration of 3.75 mg midazolam in elderly patients differs., Methods: This study is a multicentre, randomised, placebo-controlled, double-blinded, two-arm parallel, interventional trial, conducted in nine German hospitals. In total 614 patients (≥ 65-80 years of age) undergoing elective surgery with general anaesthesia will be randomised to receive either 3.75 mg midazolam or placebo. The primary outcome (global patient satisfaction) will be assessed with the validated EVAN-G questionnaire on the first postoperative day. Secondary outcomes will be assessed until the first postoperative day and then 30 days after surgery. They comprise among other things: functional and cognitive recovery, postoperative delirium, health-related quality of life assessment, and mortality or new onset of serious cardiac or pulmonary complications, acute stroke, or acute kidney injury. Analysis will adhere to the intention-to-treat principle. The primary outcome will be analysed with the use of mixed linear models including treatment effect and study centre as factors and random effects for blocks. Exploratory adjusted and subgroup analyses of the primary and secondary outcomes with regard to gender effects, frailty, pre-operative anxiety level, patient demographics, and surgery experience will also be performed., Discussion: This is, to the best of our knowledge, the first study analysing patient satisfaction after premedication with midazolam in elderly patients. In conclusion, this study will provide high-quality data for the decision-making process regarding premedication in elderly surgical patients., Trial Registration: ClinicalTrials.gov, NCT03052660 . Registered on 14 February 2017. EudraCT 2016-004555-79 .

Background: TAPP surgery can be considered as a gold standard in inguinal hernia repair. Patients benefit of a faster reconvalescence and less pain compared to other techniques. TAPP surgery in Germany is performed in an in-patient setting routinely. However, according to European guidelines, inguinal hernia surgery should be considered as day-case surgery whenever possible., Objectives: The safety of day-case surgery was examined in relation to postoperative pain, complications, comorbidities, recurrent inguinal hernia and bilateral procedures., Material and Methods: In a retrospective, monocentric study we analyzed 522 elective inguinal hernia repairs using TAPP technique in a specialized hernia center. Supplemental data from Herniamed registry is analyzed., Results: Parts of the procedures should be performed in an in-patient setting, whereas a much larger number of cases should be carried out as day-case surgeries. Logistic regression analyses show that "age", "bilateral procedures" and "comorbidities" affect the complication rate. "Age" and "recurrent inguinal hernia" are risk factors for an increased need for analgetic medication. Furthermore, we present an actual distribution of day-case vs. in-patient surgeries in inguinal hernia repair based on data from the Herniamed registry., Conclusion: A much larger part of procedures could safely be carried out as day-case surgeries. Based on a false incentive there is an incorrect steering in the German health system. These procedures cannot be carried out covering the costs as day-surgery cases. If there is no reevaluation of the proceeds of these procedures in a day-case surgery setting, the reasonable quality in treatment is compromised especially in inguinal hernia surgery.

The spreading of Tibetan Buddhism and with it the Tibetan medicine in the region east of Lake Baikal, goes back to the 17th century. At the beginning of the 18th century, German speaking scholars were among the first to undertake scientific expeditions through Siberia. As such they were amongst the first scientists of the modern era who encountered the traditions, concepts, and therapeutic methods of Tibetan medicine. The aim of this article is to describe and analyze these first encounters with Tibetan medicine by the example of selected men of science of the 18th and 19th century. This work is based on extensive studies of sources in archives and libraries in Russia and Switzerland. We found documents related to the following scientists: Daniel Gottlieb Messerschmidt (1685-1735), Johann Georg Gmelin (1709-1755), Erik Laxmann (1737-1796), Friedrich Adelung (1768-1843), and Joseph Rehmann (1779-1831). They mentioned the distribution of Tibetan medicine within Russia, the use of medicinal plants and formulas as well as therapeutic techniques. For the scientific community of the time these first encounters of Europeans with practitioners of Tibetan medicine could not lift Tibetan medicine out of other exotic context in the field of ethnography. For today's researchers, these encounters are an important evidence for more than 300 years of development of Tibetan medicine on the vast territory of Siberia. The practice and the scientific examination of Tibetan medicine in Siberia is an active endeavor until today. The present work shows that it is possible and rewarding to follow up the historic and cultural connections from Europe to Asia via the Siberian link., (Copyright © 2012 S. Karger AG, Basel.)

Clinical studies have demonstrated that traumatic brain injury (TBI) and aneurysmal subarachnoid hemorrhage (SAH) are frequent causes of long-term disturbances of hypothalamo-pituitary function. This study aimed to assess the prevalence and associated factors of post-traumatic hypopituitarism in a large national registry of patients with TBI and SAH. Data were collected from 14 centers in Germany and Austria treating patients for TBI or SAH and performing endocrine assessments. Data were collected using a structured, internet-based study sheet, obtaining information on clinical, radiological, and hormonal parameters. A total of 1242 patients (825 TBI, age 43.5±19.7 years; 417 SAH, age 49.7±11.8 years) were included. We studied the prevalence of hypopituitarism reported based on different definitions of laboratory values and stimulation tests. Stimulation tests for the corticotropic and somatotropic axes were performed in 26% and 22% of the patients, respectively. The prevalence of hypopituitarism in the chronic phase (at least 5 months after the event) by laboratory values, physician diagnoses, and stimulation tests, was 35%, 36%, and 70%, respectively. Hypopituitarism was less common in the acute phase. According to the frequency of endocrine dysfunction, pituitary hormone secretion was impaired in the following sequence: ACTH, LH/FSH, GH, and TSH. TBI patients with abnormal stimulation tests had suffered from more severe TBI than patients with normal stimulation tests. In conclusion, our data confirm that hypopituitarism is a common complication of TBI and SAH. It is possible that patients with a higher likelihood of hypopituitarism were selected for endocrine stimulation tests.

Pivotal studies have demonstrated that pharmacotherapy with pegvisomant (Somavert) is a highly effective treatment for acromegaly. Since clinical experience with the drug was very limited, the Pegvisomant Observational Study was launched in Germany immediately with the drug becoming commercially available to patients early in 2004. Its purpose was to record safety and efficacy data on as many patients as possible. As of 12th August 2008 a total of 371 patients (185 males, 186 females) had been included in the study. They were on pegvisomant therapy for an average of 118 weeks. Median and mean doses of pegvisomant were 15 and 16.4 mg/day respectively. Treatment efficacy was monitored by IGF1 levels and the patients symptoms were evaluated by completion of a questionnaire (patient-assessed acromegaly symptom questionnaire). Safety data included liver function tests, fasting glucose, HbA1c measurements, and tumor size monitoring by repeated magnetic resonance imaging. Normalization of IGF1 ranged from 55.7% of the 273 patients assessed after 6 months to 71.3% of 202 patients assessed after 24 months of treatment. It was 70.7% after 36 months (133 patients), 64.8% at 48 months (71 patients), and 58.4% after 60 months (24 patients). In 39 patients (10.9%) treatment was discontinued due to serious adverse events or adverse events with 25 (6.7%) of these patients having a potential causal relationship with the pegvisomant treatment. Liver function tests became abnormal in 20 patients and another three patients were recorded to have hepatobiliary disorders. Tumor size increase was reported in 20 patients, but only confirmed in nine patients by careful revision of all available images. Local injection site reactions were observed in 12 patients. In conclusion, in this large group of pegvisomant-treated patients, long-term data for up to 5 years of treatment are now available. In 71.3% of patients with previously not sufficiently treatable acromegaly, IGF1 levels were normalized by pegvisomant therapy. Elevated transaminases usually normalized after discontinuation but in half of the affected patients also despite continuation of treatment without dose alteration. Tumor progression was a rare event. It did not exceed the expected rate in patients with acromegaly not treated with pegvisomant. As from this presently largest database of acromegalic patients treated with pegvisomant, long-term results are encouraging. The German data are now merged into the global ACROSTUDY and will constitute a major portion of the international ACROSTUDY project as a continuing global web-based observational study.

Objective: Several studies documented metabolic and psychological benefits of GH substitution in deficient adults, most of them suffering from benign pituitary adenomas. Since GH substitution is considered to promote tumour regrowth, adequate treatment is performed with some reservation. Therefore, we aimed to elucidate the effect of GH replacement therapy on tumour recurrence following surgery., Methods: In patients with hormonally inactive pituitary adenomas undergoing tumour surgery, a retrospective case-control study was performed. Pre- and postoperative magnetic resonance (MR) images of GH-treated and untreated patients were matched for best fit by two independent observers. The treated patients were retrieved from the surveillance programme of the German KIMS database and the untreated from the database of the Department of Neurosurgery, University of Erlangen. A total of 55 matched pairs were followed for at least 5 years. Tumour recurrence and progression rates were determined according to the postoperative MR., Results: There were 16 tumour progressions in the treatment group and 12 in the control group. Statistical analysis revealed no significant increase in either recurrence (P = 0.317) or progression (P = 0.617) within the follow-up period of 5 years when GH was adequately replaced., Conclusions: This study provides further observational data of substitution therapy in GH-deficient adults with pituitary adenomas. Comparing long-term surgical results, we found no evidence that GH substitution should be withheld in deficient patients. Even residual tumour does not constitute a contraindication to GH replacement. However, since pituitary tumours are slow growing, an observational period of 5 years may not have been long enough to verify any absolute influence on recurrence potential.

Background: Practitioners and users of naturopathic therapies claim that one of the assumptions underlying their work is a holistic "view of man"., Objective: Does there exist one specific view of man in present naturopathy and what does this mean?, Material and Methods: Database and literature research of use and meaning of the term "view of man" and descriptive analysis., Results: The term "view of man" is neither timeless nor related to a specific subject area. Its meaning is connected with the state of knowledge of the respective epoch as well as its reception in science and society. The discourse concerning the term "view of man" in the 2nd half of the 20th century in German literature shows, that in different fields the argumentation about one specific view of man shifts towards a pluralistic understanding of man. This pluralistic view about man exists in medicine as well. On the one hand conventional medicine, a long time under influence of the reductionism of natural science, has widened its worldview due to methods and questions of different disciplines such as psychosomatics, psychotherapy or social medicine towards a more complex perception of man. On the other hand Traditional European Naturopathy (TEN) too, claims to respect aspects of the "body-mind-soul-unity" in its understanding of man; yet, in connection with its hardly ever explained "natural forces". Besides the findings in literature clinical experience with our patients reveals some aspects that are characteristic of today's pluralistic naturopathic understanding of man and could also be useful for conventional medicine: recognition of patients' expectations (e.g. subjective view of illness), participation in the therapy planning (e.g. construction of how to get healthy) and naturopathic modes of therapy (e.g. start of therapy at healthy parts of the body, too)., Conclusions: Despite some characteristics in naturopathy one finds variations of views or images of man, which originate from multiple subjective and socio-cultural perspectives of patients and therapists and which require, next to medical knowledge, on both sides openness and communication regarding aspects of health, illness and therapeutic settings.

Background: The German term 'Ordnungstherapie' is one of the five therapeutics which defines naturopathy in German-speaking countries., Objective: Who formed the term Ordnungstherapie in naturopathy and what does it mean?, Material and Methods: Heuristics and criticism of literature of the 20th century as well as database research., Results: Nowadays in German-language medical books Ordnungstherpie belongs to the five therapeutics which define European naturopathy. Yet, the interpretation ranges from health education to body-orientated forms of psychotherapy. The term Ordnungstherapie is often related with the German priest and hydropath Sebastian Kneipp, however, term and definition have been founded by the Swiss physician Maximillian Bircher-Benner. In 1937 he defined Ordnungstherapie as a complex concept of natural healing. It is based upon the rather nosological idea that health is order/harmony in the human body (physically, psychologically), the environment and the daily course. Illness occurs if disorder appears in one of these fields. The therapeutic setting of Ordnungstherapy is defined by 9 rules of conduct to maintain order, which include nutrition, the skin as an organ (exposure to light, air, water), breathing, movement, rhythm of life, and psyche. For all these aspects Bircher-Benner himself uses the terms somatotherapy (dietotherapy, sun and light therapy, hydrotherapy, exercise therapy, breathing technique, order of the rhythm of live) and psychotherapy. He chose these complementary methods subjectively after learning them from 1897 onwards in an eclectic manner and after gaining therapeutic empiricism. Nevertheless his ideas of the Ordnungstherapie correlate with the socio-political context of the 1940ies., Conclusions: The term Ordnungstherapie was introduced by Bircher-Benner as an umbrella term in 1937 to describe a complex concept of naturopathic therapies. It comprises, with certain limitations for phytotherapy, the therapies which nowadays define European naturopathy. Yet, in European naturopathy today Ordnungstherapie is mostly considered as one out of 5 constituents of naturopathy (dietotherapy, hydrotherapy, exercise therapy, phytotherapy, Ordnungstherapie). The classification of Ordnungstherapie as one of the 5 pillars of the Kneipp therapy was only done by Kneipp physicians in the middle of the 20th century and needs to be thought over.

Background and Objectives: Patient preferences play an important role when choosing between different treatment options and may have an influence on outcome. We performed a study to investigate (1) to what extent patients make use of the offer to receive acupuncture as a pretreatment for gastroscopy, (2) whether this is perceived as being as effective as sedation, and (3) whether characteristics and outcomes differ between patients giving consent to random allocation and patients choosing their pretreatment., Design: Partially randomized patient preference trial. Patients who gave consent to randomization were allocated randomly while patients who had a preference received the treatment of their choice., Patients: One hundred and six (106) inpatients of a district hospital in southern Germany undergoing gastroscopy for diagnostic purposes., Interventions: Pretreatment with a sedative (midazolam) or acupuncture., Main Outcome Measure: Patient's overall assessment on a visual analogue scale (VAS)., Results: Twenty-eight (28) patients (26%) agreed to be randomized, 21 (20%) chose acupuncture, 51 (47%) midazolam, and 8 (7%) did not want pretreatment. Patients receiving midazolam rated the examination as slightly less troublesome than those receiving acupuncture. Oxygen saturation, blood pressure, and heart rate were significantly lower in patients receiving midazolam. Characteristics and outcomes of randomized and nonrandomized patients did not differ significantly., Conclusions: Because of the low number of patients giving consent to random allocation conclusions on effectiveness are difficult to draw. The partially randomized patient preference design is recommended for use in future trials of acupuncture for gastroscopy. Such trials should be performed in an outpatient setting.

Background: Until today there existed no major studies about the wide range of currently utilized methods or potential sociodemographic and institutional influences on utilization despite an immense interest among nurses in alternative nursing methods (in this study referred to as home remedies)., Methods: In this study, from standardized questionnaires with a convenience sample of three different settings of nursing practice, i.e. acute-care, nursing homes, and home health care were analyzed using the statistical program SPSS., Results: Our analysis showed that a wide range of traditional home remedies is being utilized, e.g. application of heat and cold or herbal infusion (herbal teas). Furthermore, lay approaches such as aromatherapy were also commonly used. The statistical analysis revealed complex influences of age, duration of nursing practice and institutional setting in the utilization of home remedies., Conclusion: There is need for more systematic studies to further examine the alternative methods or home remedies so popular among nurses and their patients. Regarding a more consistent naming of the variety of different methods coming from naturopathy, folk and lay medicine, the authors suggest the term "integrative nursing care".

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

Increase preparations are being used with increasing frequency in Western medicine. In experimental investigations, an anti-inflammatory effect has been shown. Clinical observations relate to increase applications in rheumatoid arthritis, malignant brain tumors, inflammatory bowel diseases and asthma bronchiale. A relevant clinical effect of increase preparations has not been ascertained. In Germany, the registration of increase preparation H 15 as a drug has been withheld by the federal drug registration office (former "Bundesgesundheitsamt"). Health funds may reimburse costs for increase preparations in exceptional cases only.

We propose a structured assessment of private prescriptions presented to the German Health Funds for reimbursement. A flow chart is presented. Given a medical indication, prescriptions in the context of clinical studies and possible legal exclusions should be identified. The expert opinion may be directed by Medicine Guidelines, regional contracts and court rulings. The individual case assessment should be combined with structural advice.