Design paper: The CapOpus trial: a randomized, parallel-group, observer-blinded clinical trial of specialized addiction treatment versus treatment as usual for young patients with cannabis abuse and psychosis.

Background: A number of studies indicate a link between cannabis-use and psychosis as well as more severe psychosis in those with existing psychotic disorders. There is currently insufficient evidence to decide the optimal way to treat cannabis abuse among patients with psychosis.

Objectives: The major objective for the CapOpus trial is to evaluate the additional effect on cannabis abuse of a specialized addiction treatment program adding group treatment and motivational interviewing to treatment as usual.

Hospital-based comprehensive cardiac rehabilitation versus usual care among patients with congestive heart failure, ischemic heart disease, or high risk of ischemic heart disease: 12-month results of a randomized clinical trial.

Background: Current guidelines broadly recommend comprehensive cardiac rehabilitation (CCR), although evidence for this is still limited. We investigated the 12-month effect of hospital-based CCR versus usual care (UC) for a broadly defined group of cardiac patients within the modern therapeutic era of cardiology.

Methods: We conducted a centrally randomized single-center clinical trial with blinded assessment of the primary outcome: registry-based composite of total mortality, myocardial infarction, or acute first-time readmission due to heart disease.

Clarithromycin for 2 weeks for stable coronary heart disease: 6-year follow-up of the CLARICOR randomized trial and updated meta-analysis of antibiotics for coronary heart disease.

Objectives: We have reported increased 2.6-year mortality in clarithromycin- versus placebo-exposed stable coronary heart disease patients, but meta-analysis of randomized trials in coronary heart disease patients showed no significant effect of antibiotics on mortality. Here we report the 6-year mortality of clarithromycin- versus placebo-exposed patients and updated meta-analyses.

Antioxidant supplements for prevention of mortality in healthy participants and patients with various diseases.

Background: Animal and physiological research as well as observational studies suggest that antioxidant supplements may improve survival.

Objectives: To assess the effect of antioxidant supplements on mortality in primary or secondary prevention randomised clinical trials.

Search Strategy: We searched The Cochrane Library (Issue 3, 2005), MEDLINE (1966 to October 2005), EMBASE (1985 to October 2005), and the Science Citation Index Expanded (1945 to October 2005).

Intra-articular sodium hyaluronate 2 mL versus physiological saline 20 mL versus physiological saline 2 mL for painful knee osteoarthritis: a randomized clinical trial.

Objective: Methodological constraints weaken previous evidence on intra-articular viscosupplementation and physiological saline distention for osteoarthritis. We conducted a randomized, patient- and observer-blind trial to evaluate these interventions in patients with painful knee osteoarthritis.

Methods: We centrally randomized 251 patients with knee osteoarthritis to four weekly intra-articular injections of sodium hyaluronate 2 mL (Hyalgan 10.

Trial sequential analysis reveals insufficient information size and potentially false positive results in many meta-analyses.

Objectives: To evaluate meta-analyses with trial sequential analysis (TSA). TSA adjusts for random error risk and provides the required number of participants (information size) in a meta-analysis. Meta-analyses not reaching information size are analyzed with trial sequential monitoring boundaries analogous to interim monitoring boundaries in a single trial.

Systematic review: glucocorticosteroids for alcoholic hepatitis--a Cochrane Hepato-Biliary Group systematic review with meta-analyses and trial sequential analyses of randomized clinical trials.

Background: Glucocorticosteroids versus placebo or no intervention for patients with alcoholic hepatitis have been evaluated for more than 35 years. However, the results of randomized trials and meta-analyses differ substantially.

Aim: To review all randomized clinical trials of glucocorticosteroids vs.

Empirical evidence of bias in treatment effect estimates in controlled trials with different interventions and outcomes: meta-epidemiological study.

Objective: To examine whether the association of inadequate or unclear allocation concealment and lack of blinding with biased estimates of intervention effects varies with the nature of the intervention or outcome.

Design: Combined analysis of data from three meta-epidemiological studies based on collections of meta-analyses.

Data Sources: 146 meta-analyses including 1346 trials examining a wide range of interventions and outcomes.

Trial sequential analysis may establish when firm evidence is reached in cumulative meta-analysis.

Background And Objective: Cumulative meta-analyses are prone to produce spurious P<0.05 because of repeated testing of significance as trial data accumulate. Information size in a meta-analysis should at least equal the sample size of an adequately powered trial.

Banding ligation versus beta-blockers as primary prophylaxis in esophageal varices: systematic review of randomized trials.

Objective: To compare banding ligation versus beta-blockers as primary prophylaxis in patients with esophageal varices and no previous bleeding.

Methods: Randomized trials were identified through electronic databases, reference lists in relevant articles, and correspondence with experts. Three authors extracted data.

The ExStroke Pilot Trial: rationale, design, and baseline data of a randomized multicenter trial comparing physical training versus usual care after an ischemic stroke.

Introduction: A high level of physical activity is associated with a decreased risk of first stroke and physical activity modifies recognized stroke risk factors and is recommended for stroke survivors. Available research shows that stroke patients can increase their level of physical performance over a short period. When the intervention period is over, physical performance often declines towards baseline level.

Milk thistle for alcoholic and/or hepatitis B or C virus liver diseases.

Background: Alcohol and hepatotoxic viruses cause the majority of liver diseases. Randomised clinical trials have assessed whether extracts of milk thistle, Silybum marianum (L) Gaertneri, have any effect in patients with alcoholic and/or hepatitis B or C virus liver diseases.

Objectives: To assess the beneficial and harmful effects of milk thistle or milk thistle constituents versus placebo or no intervention in patients with alcoholic liver disease and/or viral liver diseases (hepatitis B and hepatitis C).

Bile acids for viral hepatitis.

Background: Trials have assessed bile acids for patients with viral hepatitis, but no consensus has been reached regarding their usefulness.

Objectives: To assess the beneficial and harmful effects of bile acids for viral hepatitis.

Search Strategy: Searches were performed in The Cochrane Hepato-Biliary Group Controlled Trials Register (July 2007), The Cochrane Library (Issue 1, 2007), MEDLINE (July 2007), EMBASE (July 2007), Science Citation Index Expanded (July 2007), and Chinese Biomedical Database (July 2007).

Agreement between Cochrane Neonatal reviews and clinical practice guidelines for newborns in Denmark: a cross-sectional study.

Objective: To assess agreement between Cochrane Neonatal Group reviews and clinical practice guidelines in Denmark.

Design: Retrospective analysis of clinical guidelines for newborn infants.

Materials: All Cochrane neonatal reviews and Danish clinical guidelines for newborn infants.

Azathioprine for primary biliary cirrhosis.

Background: Azathioprine is used for patients with primary biliary cirrhosis, but the therapeutic responses in randomised clinical trials have been conflicting.

Objectives: To assess the benefits and harms of azathioprine for patients with primary biliary cirrhosis.

Search Strategy: Randomised clinical trials were identified by searching The Cochrane Hepato-Biliary Group Controlled Trials Register, the Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library, MEDLINE, EMBASE, Science Citation Index Expanded, The Chinese Biomedical Database, and LILACS, and manual searches of bibliographies to September 2005.

Cyclosporin A for primary biliary cirrhosis.

Background: Cyclosporin A has been used for patients with primary biliary cirrhosis, but the therapeutic responses in randomised clinical trials have been heterogeneous.

Objectives: To assess the beneficial and harmful effects of cyclosporin A for patients with primary biliary cirrhosis.

Search Strategy: Relevant randomised clinical trials were identified by searching The Cochrane Hepato-Biliary Group Controlled Trials Register, the Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library, MEDLINE, EMBASE, Science Citation Index Expanded, The Chinese Biomedical Database, and LILACS, and manual searches of bibliographies to June 2006.

WITHDRAWN: Ribavirin with or without alpha interferon for chronic hepatitis C.

Background: Hepatitis C is a major cause of liver-related morbidity and mortality. Ribavirin plus interferon combination therapy is presently considered the optimal treatment of interferon naive patients with chronic hepatitis C, but its role in relapsers and non-responders to previous interferon therapy is not established.

Objectives: To assess the efficacy and safety of ribavirin alone or in combination with alpha interferon in interferon naive patients, relapsers, and non-responders with chronic hepatitis C.

Ursodeoxycholic acid for patients with primary biliary cirrhosis: an updated systematic review and meta-analysis of randomized clinical trials using Bayesian approach as sensitivity analyses.

Objectives: Ursodeoxycholic acid (UDCA) is used for primary biliary cirrhosis (PBC), but the beneficial effects remain controversial.

Methods: We performed an updated systematic review to evaluate the benefits and harms of UDCA in patients with PBC. We included randomized clinical trials evaluating UDCA versus placebo or no intervention in patients with PBC.

Cochrane systematic review: pegylated interferon plus ribavirin vs. interferon plus ribavirin for chronic hepatitis C.

Background: About 170 million patients worldwide have chronic hepatitis C. Pegylated interferon plus ribavirin is currently the recommended therapy.

Aim: To evaluate the beneficial and harmful effects of pegylated interferon plus ribavirin vs.

Mortality in randomized trials of antioxidant supplements for primary and secondary prevention: systematic review and meta-analysis.

Context: Antioxidant supplements are used for prevention of several diseases.

Objective: To assess the effect of antioxidant supplements on mortality in randomized primary and secondary prevention trials. DATA SOURCES AND TRIAL SELECTION: We searched electronic databases and bibliographies published by October 2005.

Likely country of origin in publications on randomised controlled trials and controlled clinical trials during the last 60 years.

Background: The number of publications on clinical trials is unknown as well as the countries publishing most trial reports. To try to examine these questions we performed an ecological study.

Methods: We searched the 454,449 records on publications in The Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library, Issue 3, 2005 (CD-ROM version) for possible country of origin.

Hepatology may have problems with putative surrogate outcome measures.

A surrogate outcome measure is a laboratory measurement, a physical sign, or another intermediate substitute that is able to predict an intervention's effect on a clinically meaningful outcome. A clinical outcome detects how a patient feels, functions, or survives. Surrogate outcome measures occur faster or more often, are cheaper, and/or are less invasively achieved than the clinical outcome.

Systematic review and meta-analysis: D-Penicillamine vs. placebo/no intervention in patients with primary biliary cirrhosis--Cochrane Hepato-Biliary Group.

Background: D-Penicillamine is used for patients with primary biliary cirrhosis due to its ability to decrease hepatic copper and modulate the immune response. The results on effects of D--penicillamine in randomized-clinical trials of primary biliary cirrhosis patients are inconsistent.

Aim: To systematically evaluate the benefits and harms of D-penicillamine for patients with primary biliary cirrhosis.