Abstract:
BACKGROUND:Reporting of all serious adverse events (SAEs) is a requirement for regulatory approval of a drug. Can equally rigorous reporting standards be expected in studies of non-drug treatments and how can underreporting, if any, be detected and proven? Using data from our large-scale prospective cohort study of acupuncture on outpatients, we examine the use of an internal standard, a principle taken from laboratory medicine, to quantify real event rates. METHODS:A total of 190,924 patients (68.6% women) seeking treatment for chronic pain (headache, low back pain, coxarthrosis or gonarthrosis) from 12,000 physicians in private practice in Germany were observed during a six-month period ending in May 2002. Most received ten sessions of body acupuncture. Mean treatment time was six weeks. All practitioners were certified in acupuncture and received written instructions on completing forms for basic patient data and SAE monitoring. They were also informed that payment by insurers would be made only upon return of the completed form. All SAEs occurring between start of the first acupuncture session and end of the last one were to be reported, whether causally related to the treatment or not. Multiple minor adverse events (AEs) per single patient were to be reported only once. As the internal standard we chose the expected number of deaths, based on the death rate for the German population, adjusted for age, sex distribution and mean observation time of our study patients. RESULTS:45 SAEs and 14,404 AEs were reported (i.e. 2.4 SAEs and 754 AEs per 10,000 patients). The number of reported deaths (9) was only 5% of the statistically expected number (180). Applying the resulting correction factor of 20 to all reported SAEs, resulted in 900 expected SAEs (versus 45 reported) or 47 per 10,000 patients. CONCLUSIONS:Without verifying the accuracy of a measurement, results remain speculative. Our internal standard for the first time provides a means of verifying the accuracy of the reported SAE rate and correcting it to the statistically expected SAE rate.
journal_name
Eur J Med Resjournal_title
European journal of medical researchauthors
Endres HG,Molsberger A,Lungenhausen M,Trampisch HJsubject
Has Abstractpub_date
2004-12-22 00:00:00pages
545-51issue
12eissn
0949-2321issn
2047-783Xjournal_volume
9pub_type
杂志文章abstract:BACKGROUND:Prostate cancer (PCa) originating from the prostate base may intrude into the urinary bladder and may be misdiagnosed as bladder cancer. In this retrospective study, we reviewed the clinic data on PCa cases which were initially misdiagnosed as bladder cancer in order to identify diagnostic methods that would...
journal_title:European journal of medical research
pub_type: 杂志文章
doi:10.1186/2047-783X-18-36
更新日期:2013-10-03 00:00:00
abstract::Among primary hepatic malignancies, sarcomas represent a minority of 2 %. Of those, primary hepatic angiosarcoma is the most common one. In the past its incidence has been related to the exposure of certain chemicals like thorotrast, vinyl-chloride or arsenic. - Patients suffering from this aggressive, highly vascular...
journal_title:European journal of medical research
pub_type: 杂志文章
doi:
更新日期:2007-12-14 00:00:00
abstract:OBJECTIVE:To compare two reduced dose indinavir (IDV) + ritonavir (RTV) combinations guided by therapeutic drug monitoring (TDM) in treatment-naive HIV1-infected patients. METHODS:HIV1-infected treatment naive patients were prospectively randomized to treatment with IDV 600 mg or 400 mg BID each in combination with RT...
journal_title:European journal of medical research
pub_type: 杂志文章,随机对照试验
doi:
更新日期:2007-07-26 00:00:00
abstract:AIM:The aim of the in vitro study was to examine the effect of estradiol and progesterone on the proliferation rate of human gingival fibroblasts (HGF) derived from a healthy and a diabetic (type II) individual. METHODS:In the first experiment, cells in the logarithmic proliferative phase were incubated with estradiol...
journal_title:European journal of medical research
pub_type: 杂志文章
doi:
更新日期:2003-12-09 00:00:00
abstract:BACKGROUND:Acute lung injury (ALI) is a serious clinical syndrome with a high rate of mortality. In this study, the effects of triptolide on lipopolysaccharide (LPS)-induced ALI in rats were investigated. METHODS:Sixty-five male Sprague Dawley rats(approved by ethics committee of the First Affiliated Hospital of Sooch...
journal_title:European journal of medical research
pub_type: 杂志文章,收录出版
doi:10.1186/2047-783X-18-58
更新日期:2013-12-17 00:00:00
abstract:BACKGROUND:Multiple severe trauma frequently leads to massive dysbalances of the human immune system. This phenomenon is known as "Systemic Inflammatory Response Syndrome (SIRS)". SIRS is connected to multiple organ failure and thereby entails higher morbidity and mortality in trauma patients. Pro- and anti-inflammator...
journal_title:European journal of medical research
pub_type: 杂志文章
doi:10.1186/2047-783x-14-7-284
更新日期:2009-07-22 00:00:00
abstract:INTRODUCTION:Carcinoma of the collecting ducts of Bellini of the kidney (CDC) is very rare but among the most aggressive urological entities. Standard therapy is not well defined with questionable efficacy. METHODS:We present two cases of male patients (49 and 66 years old) with pT3a pN2 CDC treated with a combination...
journal_title:European journal of medical research
pub_type: 杂志文章
doi:
更新日期:2008-11-24 00:00:00
abstract:BACKGROUND:Fingertip injuries treated with occlusive dressings (ODs) lead to nearly scar-free, functionally, and aesthetically pleasing results. We hypothesized that paracrine factors in the wound fluid (secretome) may influence migration and proliferation of mesenchymal stem cells (MSCs) and fibroblasts and modulate t...
journal_title:European journal of medical research
pub_type: 杂志文章
doi:10.1186/s40001-018-0357-2
更新日期:2018-12-26 00:00:00
abstract::The introduction of integrase inhibitors as a new drug class for treatment of HIV have added a very potent and extremely well tolerated new treatment option to the HIV-armentarium. Particularly in patients with previously developed drug resistance, the availability of new active drugs offers great hope. Moreover, the ...
journal_title:European journal of medical research
pub_type: 杂志文章,评审
doi:10.1186/2047-783x-14-s3-1
更新日期:2009-11-24 00:00:00
abstract::In the treatment of pulmonary diseases the inhalation of aerosols plays a key role - it is the preferred route of drug delivery in asthma, chronic obstructive pulmonary disease (COPD) and cystic fibrosis. But, in contrast to oral and intravenous administration drug delivery to the lungs is controlled by additional par...
journal_title:European journal of medical research
pub_type: 杂志文章,评审
doi:10.1186/2047-783x-14-s4-71
更新日期:2009-12-07 00:00:00
abstract::CMV infection is common in pediatric HIV-1 infected patients. We present a case report, to our knowledge the first pediatric patient, in which Addison-disease due to CMV was suspected during lifetime. We want to point out the importance of routine clinical and laboratory follow up once a HIV-1 infected child is shown ...
journal_title:European journal of medical research
pub_type: 杂志文章
doi:
更新日期:2000-06-20 00:00:00
abstract::The shared care paradigm is the current response to the crisis of industrial countries' health systems. The underlying information systems have to meet the shared care paradigm of communication and co-operation between all the partners involved in. This communication and co-operation must be provided in a secure way. ...
journal_title:European journal of medical research
pub_type: 杂志文章
doi:
更新日期:2000-08-18 00:00:00
abstract::We report the case of a 64-year old woman with severe attacks of allergic alveolitis occurring frequently independent of a concrete place. These attacks were regularely preceded by diarrhoe. Laboratory data showed marked leukopenia and circulating Candida albicans (C.a.)-antigen. Bronchoalveolar lavage revealed an inc...
journal_title:European journal of medical research
pub_type: 杂志文章
doi:
更新日期:2000-03-27 00:00:00
abstract::The influence of heparin on Polymorphonuclear (PMN s) leukocytes was investigated using a new whole-blood cytofluorometric method (patent granted for the test with the number P 4334935.8-41) with Candida albicans and Staphylococcus aureus as test microorganisms. After comparing the effect of equal volumes of two widel...
journal_title:European journal of medical research
pub_type: 杂志文章
doi:
更新日期:1997-12-31 00:00:00
abstract:BACKGROUND:Exacerbations of chronic obstructive pulmonary disease (COPD) are sporadic, acute worsening of symptoms. Identifying predictors of exacerbation frequency may facilitate medical interventions that reduce exacerbation frequency and severity. The objective of this study was to determine predictors of exacerbati...
journal_title:European journal of medical research
pub_type: 杂志文章
doi:10.1186/2047-783X-19-18
更新日期:2014-04-08 00:00:00
abstract:OBJECTIVE:Most industrialized countries experienced a change in dietary habits within the last 10 years. Growing obesity may result in an increased incidence of metabolic diseases as well as in a higher caries frequency. METHODS:In an interdisciplinary study, 842 elementary school children (414 girls and 428 boys, age...
journal_title:European journal of medical research
pub_type: 杂志文章
doi:
更新日期:2004-08-31 00:00:00
abstract:INTRODUCTION:Mitochondrial dysfunction plays a central role in the general pathogenesis of non-alcoholic fatty liver disease (NAFLD), increasing the risk of developing steatosis and subsequent hepatocellular inflammation. We aimed to assess hepatic mitochondrial function by a non-invasive (13)C-methionine breath test (...
journal_title:European journal of medical research
pub_type: 杂志文章
doi:10.1186/2047-783x-16-6-258
更新日期:2011-06-21 00:00:00
abstract::The prevalence of high plasmatic levels of homocysteine in hypertensive patients with mild renal dysfunction (MRD) defined by 2003 European Hypertension Society Guidelines (men plasmatic creatinine between 1.3 and 1.5; women plasmatic creatinine between 1.2 and 1.4 mg/dl) has not been previously reported. To evaluate ...
journal_title:European journal of medical research
pub_type: 杂志文章
doi:
更新日期:2008-05-26 00:00:00
abstract::Here we illustrate a 74-year-old patient presenting with clinical signs of slowly progressive motor neuron disease. After electromyography demonstrated myopathic changes, a skeletal muscle biopsy was performed showing histological signs of granulomatous myositis. In extensive diagnostic workup underlying primary granu...
journal_title:European journal of medical research
pub_type: 杂志文章
doi:
更新日期:2008-07-28 00:00:00
abstract::Nocturnal cardiac arrhythmias (NCA) were analyzed in patients with sleep apnea/hypopnea syndrome (SAHS) and controls. Occurrence and severity of NCA were compared in 33 SAHS patients and 16 control subjects, matched for cardiovascular risk factors. Continuous overnight polysomnography provided ECG, respiratory and sle...
journal_title:European journal of medical research
pub_type: 杂志文章
doi:10.1186/2047-783x-15-s2-193
更新日期:2010-11-04 00:00:00
abstract::Tooth-colored resin-based restoration materials have gained enormous significance in recent decades. Since the composites presently available still evidence various weaknesses, intensive research continues concerning them. In this study we tested the biocompatibility of six resin-based materials (Charisma, Solitaire, ...
journal_title:European journal of medical research
pub_type: 杂志文章
doi:
更新日期:1999-04-27 00:00:00
abstract:BACKGROUND:Resternotomy in cardiac surgery is considered a risk factor for postoperative complications. Previous studies have demonstrated an ambiguous relationship between resternotomy and clinical outcomes. Registry data from a mixed population of durable circulatory support devices suggest that history of cardiac su...
journal_title:European journal of medical research
pub_type: 杂志文章
doi:10.1186/s40001-017-0289-2
更新日期:2017-11-15 00:00:00
abstract:AIM:Antiseptics are commonly used in clinical practice to disinfect tissue and to avoid infections. However, topical antiseptics are assumed to have an influence on skin microcirculation, per se. Thus, the aim of the study was to analyse the influence of topically applied antiseptics on the microcirculation of intact s...
journal_title:European journal of medical research
pub_type: 杂志文章
doi:
更新日期:2004-09-29 00:00:00
abstract:BACKGROUND:The pathogenesis of central retinal artery occlusions (CRAO) varies, depending upon the underlying disease. An embolic origin of an occlusion often occurs. PATIENT AND METHODS:A 50-year-old man with an occlusion of the left internal carotid artery was examined because of a left central retinal artery occlus...
journal_title:European journal of medical research
pub_type: 杂志文章
doi:
更新日期:2000-04-19 00:00:00
abstract:BACKGROUND:It is hitherto still questionable which of the physical properties of the bile fluid influence the outcome of extracorporeal shock wave lithotripsy (ESWL). METHODS:In this study the influence of the density and viscosity of bile simulating fluid on ESWL was tested in vitro by applying CsCl solutions of dens...
journal_title:European journal of medical research
pub_type: 杂志文章
doi:
更新日期:1996-01-19 00:00:00
abstract::Among the 763 patients with ulcers and stomach cancer, including the control group of 586 blood donors, the search for a relationship between the spread of infection and the main blood groups was defined by the appearance of IgG against H. pylori in blood plasma (the ELISA test). The statistical analysis, however, did...
journal_title:European journal of medical research
pub_type: 杂志文章
doi:
更新日期:1996-03-19 00:00:00
abstract:OBJECTIVE:The aim of this study was to evaluate the efficacy and safety of composite extracts in reducing weight, as the main outcome measure. Secondary measures of the study were body composition change. DESIGN:Randomised, double blind, placebo-controlled clinical trial. SETTING:Tertiary university clinic. SUBJECTS...
journal_title:European journal of medical research
pub_type: 临床试验,杂志文章,随机对照试验
doi:
更新日期:2006-08-30 00:00:00
abstract::Right ventricle (RV) dysfunction is a key outcome determinant and a leading cause of death for patients with chronic thromboembolic pulmonary hypertension (CTEPH). In this report, we followed the 5-year clinical journey of a patient with CTEPH. The tricuspid pressure gradient was significantly increased in the early p...
journal_title:European journal of medical research
pub_type: 杂志文章
doi:10.1186/s40001-015-0112-x
更新日期:2015-03-02 00:00:00
abstract:OBJECTIVE:This study aims to discuss the correlation between serum inflammatory cytokines and neurogenic pulmonary edema (NPE) in children with severe hand-foot-mouth disease (HFMD). METHODS:A total of 89 patients with severe HFMD were enrolled into this study. These patients were divided into two groups, according to...
journal_title:European journal of medical research
pub_type: 杂志文章
doi:10.1186/s40001-018-0313-1
更新日期:2018-05-03 00:00:00
abstract:BACKGROUND:Systemic treatment of head and neck squamous cell carcinoma (HNSCC) includes a variety of antineoplastic drugs. However, drug-resistance interferes with the effectiveness of chemotherapy. Preclinical testing models are needed in order to develop approaches to overcome chemoresistance. - METHODS:Ten human ce...
journal_title:European journal of medical research
pub_type: 杂志文章
doi:10.1186/2047-783x-15-8-337
更新日期:2010-08-20 00:00:00