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Efficacy of Injections with Disci/Rhus Toxicodendron Compositum for Chronic Low Back Pain – A Randomized Placebo-Controlled Trial
Daniel Pach, Benno Brinkhaus, Stephanie Roll, Karl Wegscheider, Katja Icke, Stefan N. Willich, Claudia M. Witt
PLOS ONE , 2011, DOI: 10.1371/journal.pone.0026166
Abstract: Background The effectiveness of injection therapy for low-back pain is still debatable. We compared the efficacy of local injections of the homeopathic preparation Disci/Rhus toxicodendron compositum (verum) with placebo injections and with no treatment in patients with chronic low back pain. Methodology/Principal Findings In a randomized controlled partly double blind multicenter trial patients with chronic low back pain from 9 German outpatient clinics were enrolled and randomly allocated in a 1:1:1 ratio to receive subcutaneous injections (verum or placebo) into painful sites on the lower back over 12 treatment sessions within eight weeks, or no treatment (rescue pain medication with paracetamol or NSAIDs). All trial personnel and participants were masked to treatment allocation. The primary outcome measure was the average pain intensity over the last seven days on a visual analogue scale (0–100 mm, 0 = no pain, 100 = worst imaginable pain) after eight weeks. Follow-up was 26 weeks. Primary analysis was by intention to treat. Between August 2007 and June 2008, 150 patients were randomly allocated to three groups (51 verum, 48 placebo and 51 no treatment). The mean baseline-adjusted low back pain intensity at week eight was: verum group 37.0 mm (97.5% CI 25.3;48.8), no treatment group 53.0 (41.8;64.2), and placebo group 41.8 (30.1;53.6). The verum was significantly superior to no treatment (P = 0.001), but not to placebo (P = 0.350). No significant side effects were reported. Conclusions/Significance The homeopathic preparation was not superior to placebo. Compared to no treatment injections resulted in significant and clinical relevant chronic back pain relief. Trial Registration ClinicalTrials.gov NCT00567736
Management of high-risk patients with hypertension and left ventricular hypertrophy in Germany: differences between cardiac specialists in the inpatient and outpatient setting
Heinz V?ller, Frank J Sonntag, Joachim Thiery, Karl Wegscheider, Friedrich C Luft, Kurt Bestehorn
BMC Public Health , 2006, DOI: 10.1186/1471-2458-6-256
Abstract: Prospective cross-sectional study in patients with hypertension and LVH who were referred to either inpatient care (rehabilitation hospitals) or to outpatient care (cardiology practices).A total of 6358 inpatients (59.6% males; mean age 66.6 years) and 2246 outpatients (59.5% males; mean age 63.2 years) were followed up for a mean of 23 vs. 52 days, respectively. Inpatients compared to outpatients had a significantly higher prevalence of coronary heart disease, history of stroke, renal failure or diabetes. Mean blood pressure of inpatients compared to outpatients was significantly lower both at entry (150/84 vs. 161/93 mmHg) and at end of follow-up (129/75 vs. 139/83 mmHg). After adjustment for baseline blood pressure and a propensity score, differences between out- and inpatients at end of follow-up were 8.0/5.1 mmHg in favour of inpatients. Blood pressure goals as specified by guidelines were not met by 32% of inpatients and 55% of outpatients.Inpatients had a higher rate of comorbidities and more advanced atherosclerotic disease than outpatients. Control of hypertension of inpatients was already better on admission than in outpatients, and treatment intensity in this group was also higher during the observation period. While blood pressure lowering was substantial in both groups, there were still a high proportion of patients who did not achieve treatment goals at discharge.Cardiovascular (CV) diseases such as coronary heart disease, heart failure and stroke are the leading causes of death in industrialized nations[1,2]. From a public health perspective, it is imperative to address CV risk factors that are amenable to treatment such as life-style adjustments (smoking, obesity), arterial hypertension, lipid disorders, and diabetes mellitus [3]. In recent years, left ventricular hypertrophy (LVH) has emerged as further important risk factor because it indicates target organ damage. Numerous clinical trials have shown that blood pressure reduction to predefined targ
Immediate versus conditional treatment of uncomplicated urinary tract infection - a randomized-controlled comparative effectiveness study in general practices
Ildiko Gagyor, Eva Hummers-Pradier, Michael M Kochen, Guido Schmiemann, Karl Wegscheider, Jutta Bleidorn
BMC Infectious Diseases , 2012, DOI: 10.1186/1471-2334-12-146
Abstract: This is a randomized-controlled, double-blind, double dummy multicentre trial assessing the comparative effectiveness of immediate vs. conditional antibiotic therapy in uncomplicated UTI. Women?>?18 and?<?65?years, presenting at general practices with at least one of the typical symptoms dysuria or frequency/urgency of micturition, will be screened and enrolled into the trial. During an 18- months recruitment period, a total of 494 patients will have to be recruited in 45 general practices in Lower Saxony. Participating patients receive either immediate antibiotic therapy with fosfomycin-trometamol 1x3g or initial symptomatic treatment with ibuprofen 3x400mg for 3?days. The ibuprofen group will be provided with antibiotic therapy only if needed, i.e. for persistent or worsening symptoms. For a combined primary endpoint, we choose the number of all antibiotic prescriptions regardless of the medical indication day 0–28 and the “disease burden”, defined as a weighted sum of the daily total symptom scores from day 0 to day 7. The study is considered positive if superiority of conditional antibiotic treatment with respect to the first primary endpoint and non-inferiority of conditional antibiotic treatment with respect to the second primary endpoint is proven.This study aims at investigating whether the use of antibiotics for uncomplicated UTI could be reduced by initial treatment with ibuprofen. The comparative effectiveness design was chosen to prove the effectiveness of two therapeutic strategies instead of the pure drug efficacy.Clinicaltrials.Gov: NCT01488955
Symptomatic treatment (ibuprofen) or antibiotics (ciprofloxacin) for uncomplicated urinary tract infection? - Results of a randomized controlled pilot trial
Jutta Bleidorn, Ildikó Gágyor, Michael M Kochen, Karl Wegscheider, Eva Hummers-Pradier
BMC Medicine , 2010, DOI: 10.1186/1741-7015-8-30
Abstract: This pilot study was set out 1) to make a rough estimate of the equivalence of ibuprofen and ciprofloxacin for uncomplicated urinary tract infection with regard to symptom resolution, and 2) to demonstrate the feasibility of a double-blind, randomized controlled drug trial in German general practices.We performed a double-blind, randomized controlled pilot trial in 29 German general practices. Eighty otherwise healthy women aged 18 to 85 years, presenting with at least one of the main UTI symptoms dysuria and frequency and without any complicating factors, were randomly assigned to receive either ibuprofen 3 × 400 mg oral or ciprofloxacin 2 × 250 mg (+1 placebo) oral, both for three days.Intensity of main symptoms - dysuria, frequency, low abdominal pain - was recorded at inclusion and after 4, 7 and 28 days, scoring each symptom from 0 (none) to 4 (very strong). The primary endpoint was symptom resolution on Day 4. Secondary outcomes were the burden of symptoms on Days 4 and 7 (based on the sum score of all symptoms), symptom resolution on Day 7 and frequency of relapses. Equivalence margins for symptom burden on Day 4 were pre-specified as +/- 0.5 sum score points. Data analysis was done by intention to treat and per protocol. Randomization was carried out on patient level by computer programme in blocks of six.Seventy-nine patients were analyzed (ibuprofen n = 40, ciprofloxacin n = 39). On Day 4, 21/36 (58.3%) of patients in the ibuprofen-group were symptom-free versus 17/33 (51.5%) in the ciprofloxacin-group. On Day 4, ibuprofen patients reported fewer symptoms in terms of total sum score (1; SD 1,42) than ciprofloxacin patients (1,3; SD 1,9), difference -0,33 (95% CI (-1,13 to +0,47)), PP (per protocol) analysis. During Days 0 and 9, 12/36 (33%) of patients in the ibuprofen-group received secondary antibiotic treatment due to ongoing or worsening symptoms, compared to 6/33 (18%) in the ciprofloxacin-group (non significant). A total of 58 non-serious adverse eve
Practices, patients and (im)perfect data - feasibility of a randomised controlled clinical drug trial in German general practices
Ildikó Gágyor, Jutta Bleidorn, Karl Wegscheider, Eva Hummers-Pradier, Michael M Kochen
Trials , 2011, DOI: 10.1186/1745-6215-12-91
Abstract: This report is based on the experience of the HWI-01 study conducted in 29 German general practices. Feasibility was defined by 1) successful practice recruitment, 2) sufficient patient recruitment, 3) complete and accurate data collection and 4) appropriate protection of patient safety.The final practice recruitment rate was 18%. In these practices, 79 of 195 screened UTI patients were enrolled. Recruitment differed strongly between practices (range 0-12, mean 2.8 patients per practice) and was below the recruitment goal of approximately 100 patients. As anticipated, practice nurses became the key figures in the screening und recruitment of patients. Clinical trial demands, in particular for completing symptom questionnaires, documentation of source data and reporting of adverse events, did not agree well with GPs' documentation habits and required support from study nurses. In many cases, GPs and practice staff seemed to be overwhelmed by the amount of information and regulations. No sudden unexpected serious adverse reactions (SUSARs) were observed during the trial.To enable drug trials in general practice, it is necessary to adapt the setup of clinical research infrastructure to the needs of GPs and their practice staff. Risk adaption of clinical trial regulations is necessary to facilitate non-commercial comparative effectiveness trials in primary health care.Trial registration number: ISRCTN00470468Randomised controlled clinical (drug) trials (RCTs) provide high-quality evidence for therapeutic decisions in all fields of medicine. For primary care research, drug RCTs, especially without commercial interests, are of particular relevance for two reasons:First, primary care health conditions and their treatment should be investigated in their specific setting, since evidence from specialised structures with selected patients cannot necessarily be transferred without being re-evaluated. Second, compared with drug studies in specialised settings, research questions
In-vivo-validation of a cardiovascular risk prediction tool: the arriba-pro study
Diener Annette,Celemín-Heinrich Salomé,Wegscheider Karl,Kolpatzik Kai
BMC Family Practice , 2013, DOI: 10.1186/1471-2296-14-13
Abstract: Background Calculation of individual risk is the cornerstone of effective cardiovascular prevention. arriba is a software to estimate the individual risk to suffer a cardiovascular event in 10 years. Prognosis and the absolute effects of pharmacological and lifestyle interventions help the patient make a well-informed decision. The risk calculation algorithm currently used in arriba is based on the Framingham risk algorithm calibrated to the German setting. The objective of this study is to evaluate and adapt the algorithm for the target population in primary care in Germany. Methods/design arriba-pro will be conducted within the primary care scheme provided by a large health care insurer in Baden-Württemberg, Germany. Patients who are counseled with arriba by their general practitioners (GPs) will be included in the arriba-pro cohort. Exposure data from the consultation with arriba such as demographic data and risk factors will be recorded automatically by the practice software and transferred to the study centre. Information on relevant prescription drugs (effect modifiers) and cardiovascular events (outcomes) will be derived from administrative sources. Discussion The study is unique in simulating a therapy na ve cohort, matching exactly research and application setting, using a robust administrative data base, and, finally, including patients with known cardiovascular disease who have been excluded from previous studies. Trial registration The study is registered with Deutsches Register Klinischer Studien (DRKS00004633).
Semiconductor-Superlattice Parametric Oscillator as a Subterahertz and Possible Terahertz Radiation Source
Karl F. Renk,Andreas Rogl,Benjamin I. Stahl,Matthias Muthmann,Helmut Appel,Manish Jain,Anatoly Glukhovskoy,Dieter Schuh,Werner Wegscheider
Advances in OptoElectronics , 2007, DOI: 10.1155/2007/54042
Abstract: We describe the operation of a semiconductor-superlattice parametric oscillator (SPO) at a subterahertz frequency (near 300 GHz). The oscillator is driven by a microwave source (frequency near 100 GHz). We also present an analysis indicating that operation at frequencies above 1 THz should be possible. The SPO is based on the ability of conduction electrons in a superlattice to perform Bloch oscillations. Broadband tunability as well as the monochromacy of a driving microwave field are transferred to the SPO.
Prevalence of mental disorders, psychosocial distress and need for psychosocial support in cancer patients – study protocol of an epidemiological multi-center study
Anja Mehnert, Uwe Koch, Holger Schulz, Karl Wegscheider, Joachim Weis, Hermann Faller, Monika Keller, Elmar Br?hler, Martin H?rter
BMC Psychiatry , 2012, DOI: 10.1186/1471-244x-12-70
Abstract: In this multicenter, epidemiological cross-sectional study, cancer patients across all major tumor entities will be enrolled from acute care hospitals, outpatient cancer care facilities, and rehabilitation centers in five major study centers in Germany: Freiburg, Hamburg, Heidelberg, Leipzig and Würzburg. A proportional stratified random sample based on the nationwide incidence of all cancer diagnoses in Germany is used. Patients are consecutively recruited in all centers. On the basis of a depression screener (PHQ-9) 50% of the participants that score below the cutoff point of 9 and all patients scoring above are assessed using the Composite International Diagnostic Interview for Oncology (CIDI-O). In addition, all patients complete validated questionnaires measuring emotional distress, information and psychosocial support needs as well as quality of life.Epidemiological data on the prevalence of mental disorders and distress provide detailed and valid information for the estimation of the demands for the type and extent of psychosocial support interventions. The data will provide information about specific demographic, functional, cancer- and treatment-related risk factors for mental comorbidity and psychosocial distress, specific supportive care needs and use of psychosocial support offers.Cancer is one of the leading causes of morbidity and mortality worldwide [1,2]. An estimated 3.2 million new cancer cases were diagnosed in Europe in 2008 [1]. The most frequent forms of cancer were colorectal cancers (13.6% of all cancer cases), breast cancer (13.1%), lung cancer (12.2%) and prostate cancer (11.9%). In Germany, recent epidemiological estimates indicate a projected annual incidence rate for 2010 of about 450,000 cancer cases [3]. Cancer incidence statistics show an enhanced 5-year survival rate up to 62% for women and 57% for men, including all cancer stages. The average age of onset of cancer is 69?years for both genders. For the population of 82 million peopl
Patterns of ambulatory medical care utilization in elderly patients with special reference to chronic diseases and multimorbidity - Results from a claims data based observational study in Germany
Hendrik van den Bussche, Gerhard Sch?n, Tina Kolonko, Heike Hansen, Karl Wegscheider, Gerd Glaeske, Daniela Koller
BMC Geriatrics , 2011, DOI: 10.1186/1471-2318-11-54
Abstract: Claims data of the year 2004 from 123,224 patients aged 65 years and over which are members of one nationwide operating statutory insurance company in Germany were studied. Multimorbidity was defined as the presence of 3 or more chronic conditions of a list of 46 most prevalent chronic conditions based on ICD 10 diagnoses. Utilization was analyzed by the number of contacts with practices of physicians working in the ambulatory medical care sector and by the number of different physicians contacted for every single chronic condition and their most frequent triadic combinations. Main statistical analyses were multidimensional frequency counts with standard deviations and confidence intervals, and multivariable linear regression analyses.Multimorbid patients had more than twice as many contacts per year with physicians than those without multimorbidity (36 vs. 16). These contact frequencies were associated with visits to 5.7 different physicians per year in case of multimorbidity vs. 3.5 when multimorbidity was not present. The number of contacts and of physicians contacted increased steadily with the number of chronic conditions. The number of contacts varied between 35 and 54 per year and the number of contacted physicians varied between 5 to 7, depending on the presence of individual chronic diseases and/or their triadic combinations. The influence of gender or age on utilization was small and clinically almost irrelevant. The most important factor influencing physician contact was the presence of nursing dependency due to disability.In absolute terms, we found a very high rate of utilization of ambulatory medical care by the elderly in Germany, when multimorbidity and especially nursing dependency were present. The extent of utilization by the elderly was related both to the number of chronic conditions and to the individual multimorbidity patterns, but not to gender and almost not to age.The increase in the number of elderly people in industrialized countries is g
A complex regional intervention to implement advance care planning in one town's nursing homes: Protocol of a controlled inter-regional study
Jürgen in der Schmitten, Sonja Roth?rmel, Christine Mellert, Stephan Rixen, Bernard J Hammes, Linda Briggs, Karl Wegscheider, Georg Marckmann
BMC Health Services Research , 2011, DOI: 10.1186/1472-6963-11-14
Abstract: In a longitudinal controlled study, we compare 1 intervention region (4 nursing homes [n/hs], altogether 421 residents) with 2 control regions (10 n/hs, altogether 985 residents). Inclusion went from 01.02.09 to 30.06.09, observation lasted until 30.06.10. Primary endpoint is the prevalence of ADs at follow-up, 17 (12) months after the first (last) possible inclusion. Secondary endpoints compare relevance and validity of ADs, process quality, the rate of life-sustaining interventions and, in deceased residents, location of death and intensity of treatment before death. The regional multifaceted intervention on the basis of the US program Respecting Choices? comprises training of n/h staff as facilitators, training of General Practitioners, education of hospital and ambulance staff, and development of eligible tools, including Physician Orders for Life-Sustaining Treatment in case of Emergency (POLST-E).Participation data: Of 1406 residents reported to live in the 14 n/hs plus an estimated turnover of 176 residents until the last possible inclusion date, 645 (41%) were willing to participate. Response rates were 38% in the intervention region and 42% in the control region. Non-responder analysis shows an equal distribution of sex and age but a bias towards dependency on nursing care in the responder group. Outcome analysis of this study will become available in the course of 2011.Implementing an ACP program for the n/hs and related health care providers of a region requires a complex community intervention with the effect of nothing less than a cultural shift in this health care sector. This study is to our knowledge the first to develop a strategy for regional implementation of ACP, and to evaluate its feasibility in a controlled design.ISRCTN: ISRCTN99887420Decisions about life-sustaining treatment in patients unable to consent often pose difficult medical, legal and ethical questions, and may implicate emotional burdens for all actors involved, namely the patient
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