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Biomedical subjects

C Gluud

Publications and source records attributed to C Gluud.

At least 73 records · Page 4Linked to original sources

Beer, wine, spirits and subjective health.

STUDY OBJECTIVE: To examine the association between intake of different types of alcoholic beverages and self reported subjective health. DESIGN: Cross sectional health survey with assessment of intake of beer, wine and spirits (at last non-weekend day), smoking habits, social networks, physical activity, body mass index, educational level, presence of chronic disease, and self reported health. SETTING: WHO Copenhagen Healthy City Survey, Denmark. PARTICIPANTS: 4113 men and 7926 women aged 18 to 100 years. MAIN RESULTS: Of the 12,039 subjects, 8680 reported their health as optimal, and 3359 reported a suboptimal health. After controlling for the covariates, the relation between total alcohol intake and the proportion reporting suboptimal health was J shaped. Heavy drinkers of any of the three types of alcoholic beverages had a higher prevalence of suboptimal health than non-drinkers. However, only light (1-2 glasses of wine yesterday) and moderate (3-5) wine drinkers had significantly lower odds ratios for suboptimal health--0.72 (95% confidence limits; 0.56 to 0.92) and 0.65 (0.49 to 0.87), respectively--when compared with non-wine drinkers. Moderate beer or spirits drinkers did not differ significantly from non-drinkers of these beverages with regard to prevalence of suboptimal health. Consistently, beer preference drinkers had an odds ratio of 1.50 (1.25 to 1.80) for suboptimal health compared with wine preference drinkers. CONCLUSIONS: A light to moderate wine intake is related to good self perceived health, whereas this is not the case for beer and spirits. The causal relations creating this association are unknown and should be considered when interpreting the relation between different types of alcoholic beverages and subsequent morbidity and mortality.

Adolescent↗

Quality assessment of reports on clinical trials in the Journal of Hepatology.

BACKGROUND/AIMS: Electronic searches on databases for randomised clinical trials and controlled clinical trials do not identify as many trials as handsearches, and trial reporting may be flawed. The aims were to identify all fully reported randomised clinical trials in the Journal of Hepatology and to make a qualitative assessment of the reporting. METHODS: The publications were identified by systematically handsearching the full text of the journal and searching MEDLINE. Central dimensions of trial quality were used to assess the reporting quality of the trials. RESULTS: Randomised clinical trials represented 8.4% of the original articles (171/2028). Ten original articles (0.5%) could not be classified. A search on MEDLINE identified 81.3% of the randomised clinical trials, i.e., 139 out of the 171 identified by the handsearch. A total of 166 randomised clinical trials could be quality assessed. Forty-seven (28.3%) of them reported adequate generation of allocation sequence; 22 (13.3%) adequate allocation concealment; 95 (57.2%) allowed intention-to-treat analysis with only a few losses to follow-up; 50 (30.1%) were double-blind; 33 (19.9%) reported sample-size calculations; 13 trials (7.8%) employed the crossover design; and the median number of subjects per intervention arm in parallel group trials was 19 subjects (interquartile range: 11-31; range: 5-519). The quality of reporting was significantly better in regular issue articles than in supplement articles. CONCLUSIONS: Many important randomised clinical trials are published in the Journal of Hepatology, but there seems to be ample room for improvement of quality of reporting.

Controlled Clinical Trials as Topic↗

Organisation of a clinical trial unit--a proposal.

The urgent need for the performance of more, better designed, and better conducted randomised clinical trials is increasingly recognised. Based on structured interviews with leading persons of 43 outstanding organisations and units involved in clinical trials in Europe and North America during 1993, ways of organising and staffing clinical trial units were investigated. The present proposal is based on this experience from which an attempt to extract a composite set of minimal requirements has been made regarding pertinent objectives and aims, organisational aspects, staffing, and estimated costs of establishing a clinical trial unit. The core staff is suggested to consist of two chief physicians, one statistician, one data manager, one project coordinator, and two secretaries. In order to fulfil the minimal requirements for running such a unit, it is calculated that about GBP 450,000 per year is needed to cover investments, core staff, and running costs, but excluding housing costs and costs of randomised clinical trials that do not originate from trial coordination. In return, such a unit should be able to mount and launch 6-7 multicenter randomised clinical trials during a 5 year period, corresponding to a total cost for coordination per trial of about GBP 340,000. However, with a larger staff more studies may be coordinated possibly reducing the cost per trial depending on greater effectiveness in utilisation of the basic facilities.

Clinical Trials as Topic↗

Prevalence of alcohol problems in general practice: an experience from southern Italy.

The Michigan Alcoholism Screening Test (MAST) and the response to a question about heavy alcohol consumption were used to assess the prevalence of alcohol problems in consecutive patients (77 males and 46 females) consulting a general practitioner in an urban area in the South of Italy (Castellammare di Stabia). Alcohol problems, which were defined by a cut-off score of 5 on the MAST and/or by heavy alcohol consumption (corresponding to at least 60 g of ethanol daily for males and 36 g of ethanol daily for females for at least 2 years), were identified in 54 patients [43.9%; 95% confidence interval (CI) 35.0-53.1%], 45 males (58.4%; 95% CI 46.6-69.6%) and nine females (19.6%; 95% CI 9.4-33.9%). The prevalence of MAST positive patients was 32.5% (95% CI 24.4-41.6%) in the total patient sample, 45.5% (95% CI 34.1-57.2%) among males and 10.9% (95% CI 3.6-23.6%) among females. The question about heavy alcohol consumption had a predictive negative value of 97.2% (95% CI 90.2-99.7%) and a predictive positive value of 73.1% (95% CI 59.0-84.4%) in relation to MAST positive patients. It is suggested that general practitioners should incorporate this question about heavy alcohol consumption as a screening question in order to detect alcohol problems and give advice regarding reduction of alcohol consumption.

Adolescent↗

New developments in the conduct and management of multi-center trials: an international review of clinical trial units.

There is an urgent need for the performance of more, better designed, and better managed randomized clinical trials. After visits to 43 leading organizations and units involved in clinical trials in Europe and North America during 1993, the way of conducting randomized clinical trials was analyzed. By using a structured questionnaire, information on recent improvements in the way randomized clinical trials are performed was identified. These developments encompass human aspects (better information, collaboration, and communication) as well as non-human aspects (press button phone randomization and data management systems). By employing such developments, randomized clinical trials can run much more efficiently. This facilitates faster and better answers to the questions addressed by randomized clinical trials, thereby also making them more ethical.

Computer Communication Networks↗

Glucocorticoids are ineffective in alcoholic hepatitis: a meta-analysis adjusting for confounding variables.

The aim of this study was to perform a meta-analysis of controlled clinical trials of glucocorticoid treatment in clinical alcoholic hepatitis, adjusting for prognostic variables and their possible interaction with therapy, because these trials have given appreciably different results. Weighted logistic regression analysis was applied using the summarised descriptive data (for example, % with encephalopathy, mean bilirubin value) of the treatment and control groups of 12 controlled trials that gave this information. Despite evidence of publication bias favouring glucocorticoid treatment, its overall effect on mortality was not statistically significant (p = 0.20)--the relative risk (steroid/control) was 0.78 (95% confidence intervals 0.51, 1.18). There was indication of interaction between glucocorticoid therapy and gender, but not encephalopathy. Thus, the effect of glucocorticoid treatment may be different (beneficial or harmful) in special patient subgroups. These results do not support the routine use of glucocorticoids in patients with alcoholic hepatitis, including those with encephalopathy. Whether other subgroups may benefit needs further investigation using the individual patient data from the published trials and testing in new randomised trials.

Bilirubin↗

Prognostic markers for diet-induced weight loss in obese women.

OBJECTIVE: To identify prognostic metabolic and hormonal markers for long-term weight loss outcome in obese women. DESIGN: Dietary intervention consisting of 36 weeks treatment by a 4.2 MJ/d low-fat high carbohydrate diet, and follow-up 2 1/2 years after termination of treatment. SETTING: Outpatient clinic in Copenhagen. SUBJECTS: Forty consecutive female obese patients aged 15 to 62 years. MAIN OUTCOME MEASURE: Weight loss. RESULTS: The maximum weight loss (mean 16.2 kg, 95% CI 14.2-18.2) was positively associated to pre-treatment 24-h energy expenditure (P < 0.01), fat oxidation (%) (P < 0.02), plasma dihydrotestosterone (DHT) (P < 0.01), and to postprandial noradrenaline concentration (P < 0.04). Together these factors could explain 41% of the variation in maximum weight loss. Only 24-h EE and DHT had predictive power on weight loss after 36 weeks. Weight losses in upper and lower tertiles of DHT concentrations were 17.7 kg (14.1-21.4) and 9.8 kg (6.2-13.3) (P < 0.02). The adjusted relative risk of losing < 10 kg in the upper compared to the lower DHT tertile was 12% (4-32%). At 2 1/2 y follow-up 21 patients had maintained some of the weight loss (54%), while 14 patients had maintained > 5 kg weight loss (36%). High levels of pre-treatment DHT were also associated with better weight loss at 2 1/2 y follow-up. CONCLUSION: The study suggests that in particular DHT, but also 24-h EE, fat oxidation, and plasma noradrenaline, may be prognostic markers for weight loss outcome in obese women.

Adolescent↗

Prevalence of alcohol problems among adult somatic in-patients in Naples.

The aim of this cross-sectional study was to determine the prevalence of alcohol problems among adult somatic in-patients in urban hospitals of Naples. The patients were screened with a structured questionnaire regarding life style. After discharge, the patient records were examined and the hospital discharge diagnoses were registered. A patient was considered having an alcohol problem if one or more of the following criteria were fulfilled: (1) a Michigan Alcoholism Screening Test score at or above five; (2) a self-reported daily consumption for at least 2 years of at least 60 g of ethanol for males and 36 g for females; (3) an alcohol-related discharge diagnosis. The prevalence of patients with alcohol problems was significantly (P < 0.01) higher among male (43.8%, 95% confidence limits, 37.6-50.2%) than among female patients (14.8%, 95% confidence limits, 9.6-21.4%). There were no significant differences among the different types of somatic departments regarding the prevalence of alcohol problems when gender was considered. Patients with alcohol problems differed significantly from those without alcohol problems regarding a number of variables: the former drank significantly more alcohol, smoked for more years, and had a higher prevalence of alcohol problems in the family. It is concluded that alcohol problems among in-patients are as prevalent in Naples as in other industrialized countries, that it is often not registered among discharge diagnoses, and that the problems are more prevalent in males than in females, irrespective of the type of department.

Adolescent↗

The Mallory body: morphological, clinical and experimental studies (Part 1 of a literature survey).

To aid understanding of markers of disease and predictors of outcome in alcohol-exposed systems, we undertook a literature survey of more than 700 articles to view the morphological characteristics and the clinical and experimental epidemiology of the Mallory body. Mallory bodies are filaments of intermediate diameter that contain intermediate filament components (e.g., cytokeratins) observable by conventional light microscopy or immunohistochemical methods, identical in structure regardless of initiating factors or putative pathogenesis. Although three morphological types can be identified under electron microscopy (with fibrillar structure parallel, random or absent), they remain stereotypical manifestations of hepatocyte injury. A summary of the conditions associated with Mallory bodies in the literature and their validity and potential etiological relationships is presented and discussed, including estimates on the combined light microscopic and immunohistochemical prevalences and kinetics. Emphasis is placed on proper confounder control (in particular, alcohol history), which is highly essential but often inadequate. These conditions include (mean prevalence of Mallory bodies in parentheses): Indian childhood cirrhosis (73%), alcoholic hepatitis (65%), alcoholic cirrhosis (51%), Wilson's disease (25%), primary biliary cirrhosis (24%), nonalcoholic cirrhosis (24%), hepatocellular carcinoma (23%), morbid obesity (8%) and intestinal bypass surgery (6%). Studies in alcoholic hepatitis strongly suggest a hit-and-run effect of alcohol, whereas other chronic liver diseases show evidence of gradual increase in prevalence of Mallory bodies with severity of hepatic pathology. Mallory bodies in cirrhosis do not imply alcoholic pathogenesis. Obesity, however, is associated with alcoholism and diabetes, and Mallory bodies are only present in diabetic patients if alcoholism or obesity complicates the condition. In addition, case studies on diseases in which Mallory bodies have been identified, along with pharmacological side effects and experimental induction of Mallory bodies by various antimitotic and oncogenic chemicals, are presented. Mallory bodies occur only sporadically in abetalipoproteinemia, von Gierke's disease and focal nodular hyperplasia and during hepatitis due to calcium antagonists or perhexiline maleate. Other conditions and clinical drug side effects are still putative. Finally, a variety of experimental drugs have been developed that cause Mallory body formation, but markedly different cell dynamics and metabolic pathways may raise questions about the relevance of such animal models for human Mallory body formation. In conclusion, the Mallory body is indicative but not pathognomonic of alcohol involvement. A discussion on theories of development and pathological significance transcending the clinical frameworks will be presented in a future paper.

Abetalipoproteinemia↗

Sex hormone binding globulin phenotypes: their detection and distribution in healthy adults and in different clinical conditions.

Human sex hormone binding globulin (SHBG) is encoded by a normal and a variant allele. The resulting SHBG phenotypes (the homozygous normal SHBG, the heterozygous SHBG and the homozygous variant SHBG phenotype) can be distinguished by their electrophoretic patterns. We developed a novel detection system allowing us to distinguish between the different electrophoretic patterns in small amounts of plasma or serum (10 microliters). Small aliquots of Blue Sepharose were added to diluted sera or plasma samples for removal of albumin and the supernatants were subsequently applied to Western blotting. This method of detection was used to determine the distribution of SHBG phenotypes in healthy controls of both sexes and in five different pathological conditions characterized by changes in the SHBG level or endocrine disturbances (malignant and benign ovarian neoplasms, hirsutism, liver cirrhosis and alcoholism). The distribution of SHBG phenotypes was independent of such conditions and in agreement with the expected phenotype distribution of a bi-allelic gene in both healthy controls and patients (Hardy Weinberg law). An allele frequency of 0.13 was found for the SHBG variant allele based on the experimental values. Differences in SHBG phenotypes do not appear to have any clinical significance and no sex difference was found in the SHBG phenotype distribution.

Adolescent↗

A meta-analysis of HLA-antigen prevalences in alcoholics and alcoholic liver disease.

In the search for genetic factors influencing susceptibility to the development of alcoholism and alcoholic liver disease, 28 studies have been published analysing the distribution of human leucocyte antigens (HLA) in alcoholics compared to healthy controls. A number of HLA-phenotypes has been suspected of being associated with both alcoholism and alcoholic liver disease. In the present study a meta-analysis is carried out on the data from these studies, subdivided according to race and degree of liver injury. The conclusion is that none of the HLA-phenotypes so far investigated in Caucasians can be shown to be significantly more common in any of the studied patient categories than in controls, whereas the results of Japanese studies are less clear. The limitations of the data material and the design of the studies are discussed, as well as the strength and limitations of the method of meta-analysis.

Alcoholism↗

The validity of the Michigan Alcoholism Screening Test (MAST).

This review examines the validity of the Michigan Alcoholism Screening Test (MAST) as a screening instrument for alcohol problems. Studies that compare the MAST-questionnaire with other defined diagnostic criteria of alcohol problems were retrieved through MEDLINE and a cross-bibliographic check. A total of 20 validity studies were included. The studies varied considerably regarding the prevalence of alcohol problems, the diagnostic criteria, and the examined patient categories. The MAST compared with other diagnostic criteria of alcohol problems gave validity measures with the following span: predictive positive value (PVpos) 0.24-0.96, predictive negative value (PVneg) 0.78- approximately 1, sensitivity 0.36- approximately 1, and specificity 0.36-0.96. It appears that the PVneg are high. Except from one study, the sensitivities (0.57- approximately 1) are also high. The PVpos and the specificities show substantial variations. The variables that seem to have the largest influence on the PVpos seem to be the prevalence of alcohol problems, the diagnostic method against which the MAST-questionnaire is validated, and the populations on which the MAST is applied. The MAST should in the future be validated against internationally accepted diagnostic methods on populations with representative prevalences of alcohol problems.

Alcoholism↗

Prevalence of alcohol problems among adult somatic in-patients of a Copenhagen hospital.

The adult patients of somatic departments of a Copenhagen hospital were screened on a randomly selected day during a 14 day period by interviewers who examined them using a structured questionnaire regarding life-style. A patient was considered having an alcohol problem if one or more of the following criteria was fulfilled: (1) a self-reported daily alcohol consumption for at least 2 years of at least 60 g of ethanol in men and 36 g in women, (2) a Michigan Alcoholism Screening Test (MAST) score of or above 5, (3) an alcohol-related discharge diagnosis. In total, 692 patients fulfilled the entry criteria, but 181 patients (26.2%) had to be excluded owing to predefined exclusion criteria (terminal illness, dementia, etc.), and 74 patients (14.5%) refused to participate. Among the 437 interviewed patients, 125 patients (28.6%; 95%-confidence limits 24.4-33.1%) fulfilled one or more of the diagnostic criteria for an alcohol problem. Only 14 patients (3.2%; 95%-confidence limits 1.8-5.3%) had an alcohol-related discharge diagnosis. The prevalence of patients with alcohol problems was significantly (P < 0.05) higher among male patients (82 of 171 men (48.0%; 95%-confidence limits 40.3-55.7%)) than among female patients (43 of 266 women (16.2%; 95%-confidence limits 12.0-21.2%)). The prevalence of patients with alcohol problems was 32.4% (95%-confidence limits 25.5-39.8%) in internal medicine departments, 28.5% (95%-confidence limits 21.3-36.6%) in surgical departments, and of female patients 22.2% (95%-confidence limits 13.7-32.8%) in the department of gynaecology and obstetrics.

Adolescent↗