Abstract The association observed between coronary heart disease (CHD) and Chlamydia ( Chlamydophila ) pneumoniae antibodies prompted, during the 1990s, several primary and secondary prevention ...trials with various antibiotics. In our CLARICOR trial, a randomized placebo-controlled trial in 4372 patients with stable CHD, a brief clarithromycin regimen was followed, unexpectedly, by increased long-term mortality. We now compare C. pneumoniae antibody levels at entry with population levels, with the patients' individual histories, and with their subsequent outcomes. IgG antibody levels were somewhat raised, but elevated IgA and IgG titers were unrelated to entry data (including prior acute myocardial infarction), except for an association with smoking and with not using statins. Hazards of mortality and of other outcomes tended to slightly increase with IgA and decrease with IgG titers, but the unfavorable clarithromycin effect was unrelated to antibody levels and remains unexplained. Smoking-related lung disease probably underlies the link between heart disease and increased IgG titers.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK
Artificial and bioartificial support systems may provide a "bridge" for patients with severe liver disease to recovery or transplantation. To evaluate the effect of artificial and bioartificial ...support systems for acute and acute-on-chronic liver failure. 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. Of 528 references identified, 12 randomized trials with 483 patients were included. Eight nonrandomized studies were included in explorative analyses. 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. 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). 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.
: 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.
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BFBNIB, DOBA, FZAB, GIS, IJS, IZUM, KILJ, NLZOH, NUK, OILJ, PILJ, PNG, SAZU, SBCE, SBMB, UILJ, UKNU, UL, UM, UPUK
Independent research should be supported Als-Nielsen, Bodil; Gluud, Christian; Gluud, Lise Lotte
Ugeskrift for læger,
2003-Oct-27, Volume:
165, Issue:
44
Journal Article
Abstract Objective: To assess the association between competing interests and authors' conclusions in randomised clinical trials. Design: Epidemiological study of randomised clinical trials published ...in the BMJ from January 1997 to June 2001. Financial competing interests were defined as funding by for profit organisations and other competing interests as personal, academic, or political. Studies: 159 trials from 12 medical specialties. Main outcome measures: Authors' conclusions defined as interpretation of extent to which overall results favoured experimental intervention. Conclusions appraised on 6 point scale; higher scores favour experimental intervention. Results: Authors' conclusions were significantly more positive towards the experimental intervention in trials funded by for profit organisations alone compared with trials without competing interests (mean difference 0.48 (SE 0.13), P=0.014), trials funded by both for profit and non-profit organisations (0.30 (SE 0.10), P=0.003), and trials with other competing interests (0.45 (SE 0.13), P=0.006). Other competing interests and funding from both for profit and non-profit organisations were not significantly associated with authors' conclusions. The association between financial competing interests and authors' conclusions was not explained by methodological quality, statistical power, type of experimental intervention (pharmacological or non-pharmacological), type of control intervention (for example, placebo or active drug), or medical specialty. Conclusions: Authors' conclusions in randomised clinical trials significantly favoured experimental interventions if financial competing interests were declared. Other competing interests were not significantly associated with authors' conclusions.
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BFBNIB, CMK, NMLJ, NUK, PNG, SAZU, UL, UM, UPUK
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