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Biomedical subjects

J Mau

Publications and source records attributed to J Mau.

At least 19 recordsLinked to original sources
PubMed2005

Myocardial perfusion/metabolism mismatch and ventricular arrhythmias in the chronic post infarction state.

AIM: Ventricular arrhythmias have been shown to originate in the myocardial peri-infarct region due to irregular heterotopic conduction. Hypoperfused but viable myocardium is often localised in those areas and may be involved in the pathogenesis of arrhythmias. We tested the hypothesis that these myocardial perfusion/metabolism mismatches (MM) are significantly associated with ventricular arrhythmias in the chronic post infarction state. PATIENTS, METHODS: 47 post infarction patients were included in the study. 33 suffered from ventricular arrhythmia whereas 14 did not. All patients underwent (99m)Tc tetrofosmin SPECT and (18)F-FDG PET. A region-of-interest(ROI)-analysis was used to assess viable myocardium based on predefined MM-criteria. Univariate analyses as well as a logistic regression model for the multivariate analysis were carried out. RESULTS: 94% of the arrhythmic patients displayed at least one MM-segment as compared to 64% of the non-arrhythmic patients. MM-segments and arrhythmia showed a statistically significant relation (p = 0.018). The logistic regression model predicted the occurrence or absence of arrhythmia in 85% of all cases. Multivariate analysis gave consistent results, after adjusting for symptomatic chronic heart failure (CHF), aneurysms and age. CONCLUSION: Our results support the hypothesis that hypoperfused but viable myocardium represents an arrhythmogenic substrate and is a relevant risk factor for developing ventricular arrhythmias following myocardial infarction. Therefore, the detection of MM-segments allows the identification of patients with a higher risk for future cardiac events.

Coronary Disease↗
PubMed2004

Designing an acupuncture study to meet evidence-based medical criteria: methodological considerations for logistic design and development of treatment interventions arising from the German randomized controlled acupuncture trial on chronic shoulder pain (GRASP).

The results from studies on potential treatment effects of acupuncture are often limited due to serious difficulties in methodology. Randomized controlled trials on acupuncture should test a widely accepted treatment strategy of verum and sham acupuncture. However, in clinical practice various patterns of acupuncture techniques are employed, and up to now no generally accepted guidelines on how to perform a reliable verum or sham treatment have been established. Another limitation is that in most studies the study populations are too small to obtain reliable data and to detect subtle differences between the unspecific needling of sham acupuncture and specific needling of verum acupuncture with sufficient statistical power. Moreover, only a multicenter trial in an outpatient setting would guarantee a naturalistic environment in which acupuncture is used in clinical practice. In the present report we discuss such methodological aspects in detail and summarize some practical considerations for planning an acupuncture trial that fulfills evidence-based medical criteria. The largest German study on the treatment effects of acupuncture in patients with chronic shoulder pain (recruited patients n = 452), might serve as an example for such a well-designed study. Before we could conduct our study, clear definitions and protocols for the verum and sham acupuncture treatments as well as adequate endpoints had to be developed. For this we used a combination of a comprehensive study of the literature and structured interviews with experienced physicians followed by an expert panel. A total of 41 physicians had to be trained to achieve a homogeneously high quality of acupuncture treatment. The latter represents a prerequisite for reproducibility, constituting a critical component of rigorous efficacy trials in scientific acupuncture research.

Acupuncture Therapy↗
PubMed2001

Antimicrobial effect of extracts from Chinese chive, cinnamon, and corni fructus.

Extracts were prepared from Chinese chive (Allium tuberosum), cinnamon (Cinnamomum cassia), and corni fructus (Cornus officinalis) and used to evaluate their antimicrobial activity on common foodborne microorganisms, alone and in combination. The mixed extract, consisting of three extracts in equal volumes, showed an entire antimicrobial spectrum and had excellent stability to heat, pH, and storage. The mixed extract exhibited better inhibition on growth of Escherichia coli than potassium sorbate at 2-5 mg/mL. The mixed extract inhibited the growth of Pichia membranaefaciens at levels as low as 2 mg/mL. When the mixed extract was used in foods, the expected antimicrobial effect in orange juice, pork, and milk was observed. After gel filtration chromatography, each extract was partially purified into fractions, and one fraction in each extract showed enhanced antimicrobial activity. Overall, the mixed extract was of promising potential for incorporation into various food products for which a natural antimicrobial additive is desired.

Allium↗
PubMed2001

Recovery of motor functions following hemiparetic stroke: a clinical and magnetic resonance-morphometric study.

Predictors for the degree of clinical recovery after stroke are still poorly defined. In this study we tried to assess the predictive value of clinical data and of lesion size for motor recovery after ischemic stroke. In 52 hemiparetic patients we monitored the course of clinical recovery by a dedicated score of sensorimotor hand function after their first stroke. The course of the lesion size was measured in proton density magnetic resonance images. Three groups of patients were identified. Patients with moderate initial motor deficit recovered almost completely within 9 days (17/17, group 1). From the patients with severe initial motor deficit, about equal numbers recovered (16/35, group 2) or remained severely impaired during the entire observation period of more than 6 months (19/35, group 3). There was no correlation between changes of lesion size and motor deficit. Logistic regression of probability of good clinical outcome on initial lesion size, initial motor score and subcortical versus cortical location of lesion showed that only the initial motor score was predictive (p = 0.006). A relative improvement of the initial motor score of about 20% in the first 4 weeks after stroke appeared to be a relevant cut point for good outcome. The data indicate that patients with mild initial motor deficits recover well, whereas severely affected patients may differ in outcome. Since lesion size was not correlated with outcome the amount of spared residual function appeared as major determinant for the capacity for motor recovery.

Activities of Daily Living↗
PubMed1998

Gastrointestinal tolerability of meloxicam compared to diclofenac in osteoarthritis patients. International MELISSA Study Group. Meloxicam Large-scale International Study Safety Assessment.

Although widely used, non-steroidal anti-inflammatory drugs (NSAIDs) are associated with a high incidence of gastrointestinal (GI) side-effects. Inhibition of the cyclooxygenase (COX) enzyme is the basis for both the efficacy and toxicity of NSAIDs. The discovery of two COX isoforms, constitutive COX-1 and inducible COX-2, has led to the hypothesis that selective inhibition of COX-2 will minimize the potential for GI toxicity without compromising efficacy. The Meloxicam Large-scale International Study Safety Assessment (MELISSA) trial reported here was therefore set up to investigate the tolerability of meloxicam, a preferential inhibitor of COX-2, compared to diclofenac. MELISSA was a large-scale, double-blind, randomized, international, prospective trial, conducted over 28 days in patients with symptomatic osteoarthritis. Patients received either meloxicam 7.5 mg or diclofenac 100 mg slow release, the recommended doses for the treatment of osteoarthritis. Evaluation of the profile of adverse events was the main aim of the trial, together with assessment of efficacy. A total of 9323 patients received treatment (4635 and 4688 in the meloxicam and diclofenac groups, respectively). Significantly fewer adverse events were reported by patients receiving meloxicam. This was attributable to fewer GI adverse events (13%) compared to diclofenac (19%; P < 0.001). Of the most common GI adverse events, there was significantly less dyspepsia (P < 0.001), nausea and vomiting (P < 0.05), abdominal pain (P < 0.001) and diarrhoea (P < 0.001) with meloxicam compared to diclofenac. Five patients on meloxicam experienced a perforation, ulcer or bleed vs seven on diclofenac (not significant). No endoscopically verified ulcer complication was detected in the meloxicam group compared to four with diclofenac. There were five patient days of hospitalization in patients on meloxicam compared to 121 with diclofenac. Adverse events caused withdrawal from the study in 254 patients receiving meloxicam (5.48%) compared to 373 (7.96%) on diclofenac (P < 0.001). These differences were attributable to differences in reported GI adverse events (3.02% on meloxicam vs 6.14% on diclofenac; P < 0.001). Differences in efficacy, as assessed by visual analogue scales, consistently favoured diclofenac. In all instances, 95% confidence intervals did not cross zero, suggesting a statistically significant effect. However, differences were small (4.5-9.01% difference) and did not reach pre-determined levels of clinical significance. Nevertheless, significantly more patients discontinued meloxicam because of lack of efficacy (80 out of 4635 vs 49 out of 4688; P < 0.01). The MELISSA trial confirms earlier studies suggesting that meloxicam has a significantly improved GI tolerability profile in comparison with other NSAIDs, including diclofenac. These results may in part reflect the preferential COX-2 selectivity of meloxicam, although the dose and other aspects of tolerability may be important. These results may provide support for the hypothesis that selective inhibition of COX-2 relative to COX-1 might be an effective approach towards improved NSAID therapy.

Aged↗
PubMed1998

Improvement in gastrointestinal tolerability of the selective cyclooxygenase (COX)-2 inhibitor, meloxicam, compared with piroxicam: results of the Safety and Efficacy Large-scale Evaluation of COX-inhibiting Therapies (SELECT) trial in osteoarthritis.

SELECT is a large-scale, prospective, international, multicentre, double-blind, double-dummy, randomized, parallel-group trial. Patients with exacerbation of osteoarthritis were treated with the recommended dose of meloxicam (7.5 mg) or piroxicam (20 mg) once daily for 28 days; 4320 patients were administered meloxicam and 4336 piroxicam. The incidence of adverse events was significantly lower in the meloxicam group (22.5%) compared with the piroxicam group (27.9%; P < 0.001), mainly due to the significantly lower incidence of gastrointestinal (GI) adverse events in the meloxicam than in the piroxicam group (10.3% vs 15.4%,; P < 0.001), while the efficacy of both drugs was equivalent. Individual GI events occurred significantly less often with meloxicam than piroxicam: dyspepsia (3.4% vs 5.8%; P < 0.001), nausea/vomiting (2.5% vs 3.4%; P < 0.05) and abdominal pain (2.1% vs 3.6%; P < 0.001). There were 16 patients with perforations, ulcerations or bleeding (PUBs) of the upper GI tract in the piroxicam group compared with seven in the meloxicam group (relative risk piroxicam:meloxicam = 1.4). Four PUBs were complicated (perforations or bleedings); none of these occurred in the meloxicam group (relative risk piroxicam:meloxicam = 1.9). The outcome of SELECT is consistent with that of the large-scale clinical trial of similar design and size which compared 7.5 mg meloxicam with 100 mg diclofenac in patients with osteoarthritis, and with a previous global analysis of the safety of meloxicam. It adds further data to the proposed relationship between selective inhibition of cyclooxygenase-2 and improved GI tolerability of non-steroidal anti-inflammatory drugs.

Aged↗
PubMed1993

On statistics of success and loss for dental implants.

Assessments of implantation success have mainly been based on incorrect statistical methods: the binomial approach of percentage of implants not failed-to-date over inserted implants. The survival or life-table approach, instead, adjusts individually for duration of exposure (from insertion until explantation or last recall examination). If published failure percentages are adjusted for mean time of follow-up, which is reported in at least some papers, and a lower 95 per cent-confidence bound on the failure rate is calculated, considerably lower probabilities of one, two or more years of survival will be obtained in many cases. An analysis of 2,292 implants yielded a pre-prosthetic 6-months survival probability between 87 and 91 per cent. The post-prosthetic 2-years survival for pillar-shaped (n = 314 with single tooth replacements) and screw implants (n = 150 with edentulous jaws and one implant, randomly chosen, per patient) may be between 79 and 89 per cent and 79 to 96 per cent, respectively (95 per cent-confidence intervals). In pillar-shaped implants, there is preliminary evidence that ceramic implants and male patients carry a larger risk of failure than metal implants and female patients. With screw implants, only high patient age at implantation may be a risk factor.

Analysis of Variance↗
PubMed1989

[Risk factors for three-unit bonded bridges].

Statistical methods of survival-analysis were applied to investigate the effects of anatomical factors and clinical procedures which determine the "life-time" of 3-unit adhesive bridges. Their influences were analyzed until the first loss of retention after insertion. Besides the therapist effect, increased mobility and macromechanical preparation of the abutments could be identified as significant variables. Bridges bonded to one non-mobile and one hypermobile abutment tooth were found to be especially threatened. Extensive macromechanical preparation of the hard tissues reduces the hazard of debonding remarkably; this effect may be replaced by improved retentive mechanism of retainers.

Acid Etching, Dental↗
PubMed1988

A statistical assessment of clinical equivalence.

An observed confidence distribution is proposed as a measure of strength of evidence for practically equivalent efficacies of two treatments. The concept is independent of prior opinions about relevant sizes of a difference in efficacy. It also avoids retrospective power calculations for trials with missed recruitment goals and allows combination of the confidence from independent experiments.

Bayes Theorem↗
PubMed1988

[Therapy of common cold with a homeopathic combination preparation in comparison with acetylsalicylic acid. A controlled, randomized double-blind study].

A clinical test was carried out on 170 West German army soldiers suffering from common cold. The test was conducted on a monocentric, randomized, non-sequential, and inter-individual basis; the research workers were kept blind on the identity of the medication. The purpose of testing was to compare the effectiveness of a combination homeopathic preparation (Gripp-Heel) with that of acetylsalicylic acid. On the 4th and 10th treatment days, no significant difference was determined with respect to changes in clinical findings, subjectively assessed complaints, or length of time the patients were unable to work. Thus the two preparations possess comparative effectiveness in the treatment of the common cold.

Adolescent↗
PubMed1986

[Significance of clinical and laboratory chemical parameters for the course and prognosis of non-Hodgkin's lymphomas].

Using a regression model, the prognostic significance of clinical and biochemical parameters as well as of histology was analyzed in a group of 336 patients with Non-Hodgkin's lymphoma. A stochastic process model was used for evaluation of the course of disease. With respect to overall survival, serum-LDH-activity, performance status, and the histologically defined grade of malignancy were found to be the most important prognostic parameters, as well as age, though that to a lesser extent. In the course of disease, stage was the most relevant factor for achievement of a complete remission. In patients without remission, survival was determined mainly by histology and serum-LDH-activity; the latter was also of importance for duration of remission. Our study shows that histology is not the only prognostic factor in NHL but that other parameters, mainly serum-LDH-activity and performance status, also have to be considered in comparing different groups of patients.

Age Factors↗
PubMed1983

Bayesian approach to bioequivalence assessment: an example.

The statistical methods required for a Bayesian analysis of bioequivalence are outlined and numerically illustrated. The analysis consists of the calculation of the posterior probability, given the experimental results, that the ratio of true means of a new and a standard formulation of a drug with respect to some biological response lies in a given interval. Nomograms helpful for the calculation of these probabilities are provided.

Bayes Theorem↗
PubMed1981

Comparison of different methods for decision-making in bioequivalence assessment.

If the regulatory requirements are symmetrical, the use of symmetrical confidence intervals as a decision rule for bioequivalence assessment leads, as shown by simulations, to better level properties and an inferior power compared to a rule based on shortest confidence intervals. A choice between these two approaches will have to depend on a loss function. For asymmetric regulatory requirements, symmetrical confidence intervals should not be used; however, a decision can still be based on posterior probabilities, pr (theta epsilon [r1, r2]/x), or shortest confidence intervals. For purposes of inference, presentation and interpretation of results, we think that the use of symmetrical confidence intervals alone can be misleading and we therefore recommend that the posterior probabilities and densities, or at least the shortest confidence intervals, be given.

Bayes Theorem↗