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Christian Gluud

Publications and source records attributed to Christian Gluud.

At least 37 records · Page 2Linked to original sources
PubMed2005

Milk thistle for alcoholic and/or hepatitis B or C liver diseases--a systematic cochrane hepato-biliary group review with meta-analyses of randomized clinical trials.

OBJECTIVES: Our objectives were to assess the beneficial and harmful effects of milk thistle (MT) or MT constituents versus placebo or no intervention in patients with alcoholic liver disease and/or hepatitis B and/or C liver diseases. METHODS: Randomized clinical trials studying patients with alcoholic and/or hepatitis B or C liver diseases were included (December 2003). The randomized clinical trials were evaluated by components of methodological quality. RESULTS: Thirteen randomized clinical trials assessed MT in 915 patients with alcoholic and/or hepatitis B or C liver diseases. The methodological quality was low: only 23% of the trials reported adequate allocation concealment and only 46% were considered double blind. MT versus placebo or no intervention for a median duration of 6 months had no significant effects on all-cause mortality (relative risk (RR) 0.78, 95% confidence interval (CI) 0.53-1.15), complications of liver disease, or liver histology. Liver-related mortality was significantly reduced by MT in all trials (RR 0.50, 95% CI 0.29-0.88), but not in high-quality trials (RR 0.57, 95% CI 0.28-1.19). MT was not associated with a significantly increased risk of adverse events. CONCLUSIONS: Based on high-quality trials, MT does not seem to significantly influence the course of patients with alcoholic and/or hepatitis B or C liver diseases. MT could potentially affect liver injury. Adequately conducted randomized clinical trials on MT versus placebo may be needed.

Cause of Death↗
PubMed2005

The journal impact factor as a predictor of trial quality and outcomes: cohort study of hepatobiliary randomized clinical trials.

OBJECTIVES: To examine the association between the impact factor and characteristics of hepatobiliary randomized clinical trials. METHODS: A cohort study of 530 hepatobiliary randomized clinical trials was performed. The journal impact factor was extracted from Science Citation Index. For each trial, we extracted the sample size, the quality of randomization and blinding methods, and the statistical significance of the primary outcome measure. RESULTS: The median sample size was 45 participants (interquartile range 25-88). The allocation sequence generation was adequate in 273 trials (52%). Allocation concealment was adequate in 178 trials (34%). The primary outcome measure was statistically significant in 374 (71%) trials. Nonparametric analyses for trend indicated that the impact factor was significantly associated with the sample size (p < 0.01) and the proportion of trials with adequate allocation sequence generation (p < 0.01) or allocation concealment (p= 0.02). The impact factor was not significantly associated with the study outcome (p= 0.28). CONCLUSIONS: The present study supports the use of the impact factor as a rough quality indicator. However, even trials in high impact journals may be small or may have inadequate quality. Critical appraisal of individual trials is always necessary, irrespective of the place of publication.

Bibliometrics↗
PubMed2005

Colchicine for primary biliary cirrhosis: a Cochrane Hepato-Biliary Group systematic review of randomized clinical trials.

OBJECTIVES: Colchicine is used for patients with primary biliary cirrhosis due to its immunomodulatory and antifibrotic potential. The results from randomized clinical trials have, however, been inconsistent. We conducted a systematical review to evaluate the effect of colchicine for primary biliary cirrhosis. METHODS: We identified randomized clinical trials comparing colchicine with placebo/no intervention. We analyzed effects by fixed and random effects model. We investigated heterogeneity by subgroup and sensitivity analyses. RESULTS: We included 10 trials involving 631 patients, four of which were high-quality trials. No significant differences were detected between colchicine and placebo/no intervention regarding mortality (relative risk (RR), 1.21; 95% confidence interval (CI), 0.71-2.06), mortality or liver transplantation (RR = 1.00; 95% CI, 0.67-1.49), liver complications, liver biochemical variables, liver histology, or adverse events. Regarding mortality, an extreme case analysis favoring colchicine did not demonstrate beneficial effects of colchicine, whereas an extreme case analysis favoring placebo/no intervention demonstrated a detrimental effect of colchicine (RR = 2.28; 95% CI, 1.17-4.44). The number of patients without improvement of pruritus significantly decreased in the colchicine group (RR = 0.75; 95% CI, 0.65-0.87). However, this estimate was based on only 156 patients from three trials. CONCLUSIONS: There is insufficient evidence to support the use of colchicine for patients with primary biliary cirrhosis. As we are unable to exclude a risk of increased mortality, we recommend to use colchicine only in randomized clinical trials.

Colchicine↗
PubMed2004

Non-absorbable disaccharides for hepatic encephalopathy: systematic review of randomised trials.

OBJECTIVE: To assess the effects of non-absorbable disaccharides (lactulose and lactitol) in patients with hepatic encephalopathy. DATA SOURCES: Cochrane Hepato-Biliary Group controlled trials register, Cochrane Library, Medline, and Embase until March 2003; reference lists of relevant articles; authors and pharmaceutical companies. REVIEW METHODS: Randomised trials that compared non-absorbable disaccharides with placebo, no intervention, or antibiotics for hepatic encephalopathy were included. The primary outcome measures were no improvement of hepatic encephalopathy and all cause mortality. RESULTS: 22 trials were included. Compared with placebo or no intervention, non-absorbable disaccharides seemed to reduce the risk of no improvement in patients with hepatic encephalopathy (relative risk 0.62, 95% confidence interval 0.46 to 0.84, six trials). However, high quality trials found no significant effect (0.92, 0.42 to 2.04, two trials). Compared with placebo or no intervention, non-absorbable disaccharides had no significant effect on mortality (0.41, 0.02 to 8.68, four trials). Non-absorbable disaccharides were inferior to antibiotics in reducing the risk of no improvement (1.24, 1.02 to 1.50, 10 trials) and lowering blood ammonia concentration (weighted mean difference 2.35 micromol/l, 0.06 micromol/l to 13.45 micromol/l, 10 trials). There was no significant difference in mortality (0.90, 0.48 to 1.67, five trials). CONCLUSIONS: There is insufficient evidence to support or refute the use of non-absorbable disaccharides for hepatic encephalopathy. Antibiotics were superior to non-absorbable disaccharides in improving hepatic encephalopathy, but it is unclear whether this difference is clinically important. Non-absorbable disaccharides should not serve as comparator in randomised trials on hepatic encephalopathy.

Anti-Infective Agents↗
PubMed2004

The Diabetic Postoperative Mortality and Morbidity (DIPOM) trial: rationale and design of a multicenter, randomized, placebo-controlled, clinical trial of metoprolol for patients with diabetes mellitus who are undergoing major noncardiac surgery.

BACKGROUND: Recent trials suggest that perioperative beta-blockade reduces the risk of cardiac events in patients with a risk of myocardial ischemia who are undergoing noncardiac surgery. Patients with diabetes mellitus are at a high-risk for postoperative cardiac morbidity and mortality. They may, therefore, benefit from perioperative beta-blockade. METHODS: The Diabetic Postoperative Mortality and Morbidity (DIPOM) trial is an investigator-initiated and -controlled, centrally randomized, double-blind, placebo-controlled, multicenter trial. We compared the effect of metoprolol with placebo on mortality and cardiovascular morbidity rates in patients with diabetes mellitus who were beta-blocker naive, >or=40 years old, and undergoing noncardiac surgery. The study drug was given during hospitalization for a maximum of 7 days beginning the evening before surgery. The primary outcome measure is the composite of all-cause mortality, acute myocardial infarction, unstable angina, or congestive heart failure leading to hospitalization or discovered or aggravated during hospitalization. Follow-up involves re-examination of patients at 6 months and collection of mortality and morbidity data via linkage to public databases. The study was powered on the basis of an estimated 30% 1-year event rate in the placebo arm and a 33% relative risk reduction in the metoprolol arm. The median follow-up period was 18 months. RESULTS: Enrollment started in July 2000 and ended in June 2002. A total of 921 patients were randomized, and 54% of these patients had known cardiac disease, hypertension, or both. CONCLUSION: The results of this study may have implications for reduction of perioperative and postoperative risk in patients with diabetes mellitus who are undergoing major noncardiac surgery.

Adrenergic beta-Antagonists↗
PubMed2004

Chinese herbal medicine for severe acute respiratory syndrome: a systematic review and meta-analysis.

OBJECTIVES: To review randomized controlled trials (RCTs) evaluating the effects of Chinese herbal medicine for treating severe acute respiratory syndrome (SARS) systematically. DESIGN: Electronic and manual searches identified RCTs comparing Chinese medicine integrated to conventional medicine versus conventional medicine alone. Methodological quality of trials was assessed by generation of allocation sequence, allocation concealment, blinding, and intention-to-treat. RESULTS: Eight RCTs (488 patients with SARS) were included. The methodological quality was generally low. The combined therapy showed significant reduction of mortality (relative risk 0.32 [95% confidence interval {CI} 0.12 to 0.91]), shortened duration of fever, symptom relief, reductions in chest radiograph abnormalities, and reductions in secondary fungal infections among patients receiving glucocorticoids. There were no significant effects on quality of life or glucocorticoid dosage. CONCLUSION: Chinese herbal medicine combined with conventional medicine may have beneficial effects in patients with SARS. The evidence is insufficient because of the low methodological quality of the included trials.

Drug Therapy, Combination↗
PubMed2004

Sexuality after total vs. subtotal hysterectomy.

BACKGROUND: The effect of hysterectomy on sexuality is not fully elucidated and until recently total and subtotal hysterectomies have only been compared in observational studies. AIMS: To compare total abdominal hysterectomy (TAH) to subtotal abdominal hysterectomy (SAH) regarding effects on sexuality. METHODS: In a Danish multicenter trial 319 women were randomized to TAH (n = 158) or SAH (n = 161); 185 women had self-selected TAH (n = 80) or SAH (n = 105) in a simultaneously conducted observational study. Women were followed for 1 year by strict data collection procedures, including postal questionnaires. Results were analyzed by intention to treat (ITT) analyses. RESULTS: No significant differences were observed between TAH and SAH at 1-year follow-up in both the randomized trial and the observational study regarding women's desire for sex, frequency of intercourse, frequency of orgasm, quality of orgasm, localization of orgasm, satisfaction with sexual life, and dyspareunia. None of these sexual variables changed significantly from entry to the 1-year follow-up, apart from dyspareunia, which was significantly (p = 0.009) reduced in both intervention groups. Significant (p < 0.05) predictors for satisfaction with sexual life after hysterectomy were the preoperative satisfaction with sexual life [odds ratio (OR) 32, 95% confidence interval (CI) 10-125], good relationship with partner (OR 50, 95% CI 9-354), physical well-being (OR 0.30, 95% CI 0.09-0.88) and hormone replacement therapy (OR 0.23, 95% CI 0.06-0.78). CONCLUSIONS: Both TAH and SAH significantly reduce dyspareunia without having a negative effect on sexual function. The shift toward SAH seems unwarranted.

Cervix Uteri↗
PubMed2004

Hospital doctors' self-rated skills in and use of evidence-based medicine - a questionnaire survey.

RATIONALE, AIMS AND OBJECTIVES: Problems in understanding basic aspects of evidence-based medicine (EBM) may form barriers to its implementation into clinical practice. We examined hospital doctors' skills in EBM terms and related these skills to their use of information sources, critical appraisal, and implementation of EBM into clinical practice. METHODS: A self-administered questionnaire was sent to all hospital doctors (n = 376) at a university hospital in Denmark, including 12 questions on methodological terms frequently used in evidence-based literature plus one non-existing dummy term. Furthermore, participants were asked about their use of various information sources, self-rated skills of critical appraisal of standard scientific literature, and level of implementation of evidence-based principles in daily clinical settings. Based on the answers to the 12 evidence-based methodological terms, we calculated a familiarity score. RESULTS: Proportion of responding was 60% (n = 225), but representative for all hospital doctors regarding background data. Ten doctors (4.4%) could define and explain all 12 methodological terms. The majority of all doctors showed interest in knowing more about the terms. Fifty-six per cent knew the dummy term. Doctors mainly consulted traditional and possibly insufficient sources (textbooks, colleagues, scientific journals) when searching for clinical evidence. The Cochrane Library was the least consulted information source and had never been consulted by 49%. Only 18% always practised EBM. More reliance on PubMed and The Cochrane Library as information sources, more competence of critical appraisal, and more frequent practise of EBM were significantly (P < 0.001) associated with a higher familiarity score. Compared to seldom or never users of The Cochrane Library, frequent users had significantly higher academic degree (P = 0.01), familiarity score (P < 0.001), and use of PubMed (P = 0.0004). DISCUSSION AND CONCLUSIONS: Most hospital doctors seem to lack knowledge of key methodological evidence-based medicine terms. This may form a barrier when consulting EBM sources and to the implementation of EBM into clinical practice.

Adult↗
PubMed2003

Association of funding and conclusions in randomized drug trials: a reflection of treatment effect or adverse events?

CONTEXT: Previous studies indicate that industry-sponsored trials tend to draw proindustry conclusions. OBJECTIVE: To explore whether the association between funding and conclusions in randomized drug trials reflects treatment effects or adverse events. DESIGN: Observational study of 370 randomized drug trials included in meta-analyses from Cochrane reviews selected from the Cochrane Library, May 2001. From a random sample of 167 Cochrane reviews, 25 contained eligible meta-analyses (assessed a binary outcome; pooled at least 5 full-paper trials of which at least 1 reported adequate and 1 reported inadequate allocation concealment). The primary binary outcome from each meta-analysis was considered the primary outcome for all trials included in each meta-analysis. The association between funding and conclusions was analyzed by logistic regression with adjustment for treatment effect, adverse events, and additional confounding factors (methodological quality, control intervention, sample size, publication year, and place of publication). MAIN OUTCOME MEASURE: Conclusions in trials, classified into whether the experimental drug was recommended as the treatment of choice or not. RESULTS: The experimental drug was recommended as treatment of choice in 16% of trials funded by nonprofit organizations, 30% of trials not reporting funding, 35% of trials funded by both nonprofit and for-profit organizations, and 51% of trials funded by for-profit organizations (P<.001; chi2 test). Logistic regression analyses indicated that funding, treatment effect, and double blinding were the only significant predictors of conclusions. Adjusted analyses showed that trials funded by for-profit organizations were significantly more likely to recommend the experimental drug as treatment of choice (odds ratio, 5.3; 95% confidence interval, 2.0-14.4) compared with trials funded by nonprofit organizations. This association did not appear to reflect treatment effect or adverse events. CONCLUSIONS: Conclusions in trials funded by for-profit organizations may be more positive due to biased interpretation of trial results. Readers should carefully evaluate whether conclusions in randomized trials are supported by data.

Bias↗
PubMed2003

Artificial and bioartificial support systems for acute and acute-on-chronic liver failure: a systematic review.

CONTEXT: Artificial and bioartificial support systems may provide a "bridge" for patients with severe liver disease to recovery or transplantation. OBJECTIVE: To evaluate the effect of artificial and bioartificial support systems for acute and acute-on-chronic liver failure. DATA SOURCES: Randomized trials on any support system vs standard medical therapy were included irrespective of publication status or language. Nonrandomized studies were included in explorative analyses. Trials were identified through electronic searches (Cochrane Hepato-Biliary Group Controlled Trials Register, Cochrane Library, MEDLINE, EMBASE, and the Chinese Medical Database), bibliographies, and contact with experts. Searches were conducted of the entire databases through September 2002. STUDY SELECTION: Of 528 references identified, 12 randomized trials with 483 patients were included. Eight nonrandomized studies were included in explorative analyses. DATA EXTRACTION: Data were extracted and trial quality was assessed independently by 3 reviewers (L.L.K., J.L., B.A-N.). The primary outcome measure was all-cause mortality. Results were combined on the risk ratio (RR) scale. Random-effects models were used. Sources of heterogeneity were explored through meta-regression and stratified meta-analyses. DATA SYNTHESIS: Of the 12 trials included, 10 assessed artificial systems for acute or acute-on-chronic liver failure and 2 assessed bioartificial systems for acute liver failure. Overall, support systems had no significant effect on mortality compared with standard medical therapy (RR, 0.86; 95% confidence interval [CI], 0.65-1.12). Meta-regression indicated that the effect of support systems depended on the type of liver failure (P =.03). In stratified meta-analyses, support systems appeared to reduce mortality by 33% in acute-on-chronic liver failure (RR, 0.67; 95% CI, 0.51-0.90), but not in acute liver failure (RR, 0.95; 95% CI, 0.71-1.29). Compared with randomized trials, nonrandomized studies produced significantly larger estimates of intervention effects (P =.01). CONCLUSION: This review suggests that artificial support systems reduce mortality in acute-on-chronic liver failure compared with standard medical therapy. Artificial and bioartificial support systems did not appear to affect mortality in acute liver failure.

Chronic Disease↗
PubMed2003

Medicinal herbs for hepatitis C virus infection: a Cochrane hepatobiliary systematic review of randomized trials.

OBJECTIVE: The aim of this study was to assess beneficial and harmful effects of medicinal herbs for hepatitis C virus (HCV) infection. METHODS: The databases of the Cochrane Collaboration, MEDLINE, EMBASE, and BIOSIS were searched combined with manual searches of five Chinese and one Japanese journals. We included randomized trials comparing medicinal herbs with placebo, no intervention, nonspecific treatment, other herbs, or interferon and/or ribavirin. Trials of herbs with or without other drug(s) were included. Methodological quality of the trials was evaluated by randomization, double blinding, and the Jadad scale. RESULTS: Thirteen randomized trials (n = 818) evaluated 14 medicinal herbs. Four trials had adequate methodology. Compared with placebo, none of the herbs showed effects on HCV RNA or liver enzyme, except for silybin, which showed a significant reduction of serum AST and gamma-glutamyltranspeptidase levels in one trial. Oxymatrine showed effects on clearance of HCV RNA (relative risk = 9.20, 95% CI = 1.26-67.35) compared with vitamins. The herbal mixture Bing Gan Tang plus interferon-alpha showed better effects on clearance of HCV RNA (relative risk = 2.54, 95% CI = 1.43-4.49) and on normalization of serum ALT (relative risk = 2.54, 95% CI = 1.43-4.49) than interferon-alpha alone. The herbal mixture Yi Zhu decoction showed better effects on clearance of HCV RNA and normalization of ALT compared with glycyrrhizin plus ribavirin. Yi Er Gan Tang showed effects on normalizing serum ALT compared with silymarin plus glucurolactone. The herbs were associated with adverse events. CONCLUSIONS: There is no firm evidence supporting medicinal herbs for HCV infection, and further randomized trials are justified.

Hepacivirus↗
PubMed2003

Randomised controlled trial of total compared with subtotal hysterectomy with one-year follow up results.

OBJECTIVE: To compare total abdominal hysterectomy and subtotal abdominal hysterectomy performed for benign uterine diseases. DESIGN: Randomised, controlled, unblinded trial with central, computer-generated randomisation. SETTING: Danish trial performed in 11 departments of gynaecology. POPULATION: Women referred for benign uterine diseases were randomised to total abdominal hysterectomy (n = 158) or subtotal abdominal hysterectomy (n = 161). One-year follow up questionnaires had a response rate of 87%. METHODS: Patients were followed by strict data collection procedures, including postal questionnaires. The results after one year of follow up were analysed by intention-to-treat analyses. MAIN OUTCOME MEASURES: (1) Primary: urinary incontinence and (2) secondary: post-operative complications, quality of life (SF-36), constipation, prolapse of the vaginal vault/cervical stump, satisfaction with sexual life, pelvic pain and vaginal bleeding. RESULTS: A significantly (P = 0.043) smaller proportion of women had urinary incontinence one year after total abdominal hysterectomy compared with subtotal abdominal hysterectomy [9% vs 18% (OR 2.08, 95% CI 1.01-4.29)]. The lower proportion of incontinent women in the total abdominal hysterectomy group was a result of a higher proportion of symptom relief (total abdominal hysterectomy: 20/140, subtotal abdominal hysterectomy: 14/136) as well as a lower proportion of women with new symptoms (total abdominal hysterectomy: 3/140, subtotal abdominal hysterectomy: 10/137). Twenty-seven women (20%) from the subtotal abdominal hysterectomy group had vaginal bleeding and two of them had to have their cervix removed. No other clinically important differences were found between the two hysterectomy methods. CONCLUSIONS: A smaller proportion of women suffered from urinary incontinence after total abdominal hysterectomy than after subtotal abdominal hysterectomy one year post-operatively.

Female↗
PubMed2002

Citation bias of hepato-biliary randomized clinical trials.

The objective of this study was to assess whether trials with a positive (i.e., statistically significant) outcome are cited more often than negative trials. We reviewed 530 randomized clinical trials on hepato-biliary diseases published in 11 English-language journals indexed in MEDLINE from 1985-1996. From each trial, we extracted the statistical significance of the primary study outcome (positive or negative), the disease area, and methodological quality (randomization and double blinding). The number of citations during two calendar years after publication was obtained from Science Citation Index. There was a significant positive association between a statistically significant study outcome and the citation frequency (beta, 0.55, 95% confidence interval, 0.39-0.72). The disease area and adequate generation of the allocation sequence were also significant predictors of the citation frequency. We concluded that positive trials are cited significantly more often than negative trials. The association was not explained by disease area or methodological quality.

Bias↗
PubMed2002

Artificial and bioartificial support systems for liver failure: a Cochrane Hepato-Biliary Group Protocol.

AIMS/BACKGROUND: Liver support systems may bridge patients to liver transplantation or recovery from liver failure. This review is to evaluate the beneficial and harmful effects of artificial and bioartificial support systems for acute and acute-on-chronic liver failure. DATA SOURCES: Randomized trials on any support system versus standard medical therapy will be included irrespective of publication status or language. Non-randomized studies are included in explorative analyses. Trials will be identified through bibliographies, correspondence with original investigators, and electronic searches (Cochrane Hepato-Biliary Group Controlled Trials Register, Cochrane Controlled Trials Register, MEDLINE, EMBASE, and The Chinese Biomedical Database). METHODS OF THE REVIEW: The extracted data will include characteristics of trials, patients, interventions, and all outcome measures. Methodological quality will be assessed by the randomization, follow up, and blinding. The RevMan and STATA will be used for statistical analyses. Sources of heterogeneity and methodological quality in the assessment of the primary outcome will be explored by sensitivity analyses and meta-regression.

Chronic Disease↗
PubMed2002

Validity of randomized clinical trials in gastroenterology from 1964-2000.

BACKGROUND & AIMS: The internal validity of clinical trials depends on the adequacy of the reported methodological quality. We assessed the methodological quality of all 383 randomized clinical trials published in GASTROENTEROLOGY as original articles from 1964 to 2000. METHODS: The methodological quality (randomization and blinding), sample size, publication year, and disease area were extracted from each trial. Changes during the study period were analyzed by analysis of variance with adjustments for potential confounders. RESULTS: Forty-two percent of all trials reported adequate generation of the allocation sequence, 39% reported adequate allocation concealment, and 62% were double blind. The reported methodological quality improved significantly in the mid-1990s. CONCLUSIONS: The present study shows a positive development, but the reported methodological quality of trials can still be improved.

Gastroenterology↗