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PubMed2005

Efficacy of thrombolytic agents in the treatment of pulmonary embolism.

Recent guidelines recommend bolus-dose alteplase for treating massive pulmonary embolism (PE). However, the safest and most effective treatment is as yet unknown. In the present study, a meta-analysis of published studies of alteplase infusion, bolus-dose alteplase and streptokinase was performed. The outcome measures were as follows: objective assessment of thrombolysis; all-cause mortality; deaths due to initial PE, major bleeding episodes and recurrent PE; and morbidity. In total, 26 studies were identified; however, only two comparative studies of alteplase infusion versus either bolus-dose alteplase or streptokinase were found. Meta-analysis revealed no significant difference between the three regimens, but was compromised by a paucity of data. Crude analysis of summated data on thrombolytic efficacy from all studies revealed that alteplase infusion was more effective than bolus-dose alteplase (relative risk (RR): 1.95; 95% confidence interval (CI): 1.19-3.2), whereas streptokinase was more effective than alteplase infusion (RR: 1.27; 95% CI: 1.09-1.47). Alteplase infusion had a lower mortality due to the initial PE than both bolus-dose alteplase and streptokinase (RR: 0.16; 95% CI: 0.05-0.59 and RR: 0.13; 95% CI: 0.04-0.46, respectively). In conclusion, this evidence suggests that the three thrombolytic agents may vary in efficacy. However, large-scale randomised controlled trials are needed to confirm these results.

Fibrinolytic Agents↗
PubMed2004

Using different designs in wound healing research.

Wounds are common, expensive to treat and prevent patients from returning to their normal activities. Wound healing as a clinical specialty has only developed over the past 20 years, and this is an area of practice where there is a very strong impetus towards ensuring that, as far as possible, all health care is evidence based. Scientific wound healing research has a long history, but clinical research in this field is much more recent. Clinical wound healing research has particular challenges related to the nature of the patients and the interventions being studied. Wounds are a symptom, rather than a disease, and patients often present with multiple or complex pathology. Wound healing interventions typically include dressings, bandages and mattresses, all of which are highly visible to researchers and patients alike. This makes the design and execution of experimental studies challenging. For example, the 'blinding' of researchers, patients and staff to highly visible interventions is very difficult. In this article, Sue Bale discusses the use of four different designs that have been employed: case studies, non-comparative studies, quasi-experimental studies, and randomised controlled trials. The value and contribution of each is explored.

Evidence-Based Medicine↗
PubMed2005

Colchicine for alcoholic and non-alcoholic liver fibrosis and cirrhosis.

BACKGROUND: Alcohol and hepatotropic viruses cause the majority of liver cirrhosis cases in the Western World. Colchicine is an anti-inflammatory and anti-fibrotic medication. Several randomised clinical trials have addressed the question whether colchicine has any efficacy in patients with alcoholic or non-alcoholic fibrosis and cirrhosis. OBJECTIVES: To assess the beneficial and harmful effects of colchicine in patients with alcoholic or non-alcoholic fibrosis or cirrhosis, excluding primary biliary cirrhosis. SEARCH STRATEGY: The Cochrane Hepato-Biliary Group Controlled Trials Register, The Cochrane Controlled Trials Register on The Cochrane Library, MEDLINE, EMBASE, Web of Science, and full text searches were combined (September 2004). Manufacturers and researchers in the field were also contacted. SELECTION CRITERIA: We included randomised trials irrespective of blinding, language, or publication status comparing per oral colchicine with placebo or no intervention for patients with fibrosis or cirrhosis induced by either alcohol, virus, or unknown factors (cryptogenic). DATA COLLECTION AND ANALYSIS: The statistical package (RevMan Analyses) provided by The Cochrane Collaboration was used. The methodological quality of the randomised clinical trials was evaluated. MAIN RESULTS: We could include fifteen randomised clinical trials in which 1714 patients were randomised. We found no significant effects of colchicine on mortality (relative risks (RR) 1.00, 95% confidence interval (CI) 0.87 to 1.16), liver-related mortality (RR 1.08, 95% CI 0.88 to 1.33), complications (RR 1.01, 95% CI 0.74 to 1.38), liver biochemistry, liver histology, and alcohol consumption (RR 1.03, 95% CI 0.77 to 1.39). Colchicine was associated with a significantly increased risk of adverse events (RR 4.35, 95% CI 2.16 to 8.77). AUTHORS' CONCLUSIONS: Colchicine should not be used for alcoholic, viral, or cryptogenic liver fibrosis or liver cirrhosis outside randomised clinical trials.

Anti-Inflammatory Agents↗
PubMed2005

Psychological interventions for children with asthma.

BACKGROUND: Asthma is a chronic disease of inflammation and smooth muscle dysfunction, including bronchoconstriction. These symptoms are usually associated with widespread but variable airflow obstruction that is often reversible either spontaneously or with treatment. Psychological factors may influence the symptoms and management of asthma in children in many ways, for example, evidence suggests that emotional stress can either precipitate or exacerbate both acute and chronic asthma. OBJECTIVES: To assess the efficacy of psychological interventions in improving health and behavioural outcomes for children with asthma. SEARCH STRATEGY: The Cochrane Airways Group Specialised Register and PsycINFO were searched with pre-defined terms up until March 2005. SELECTION CRITERIA: Randomised controlled trials published in any language assessing the effects of a psychological intervention compared with a control intervention in children and adolescents with asthma were included in the review. Cross-over trials were considered inappropriate for studies using psychological interventions and were therefore excluded from this systematic review. DATA COLLECTION AND ANALYSIS: Two reviewers assessed the relevance of abstracts identified by electronic searching and retrieved agreed studies for further scrutiny. The studies that met the inclusion criteria were assembled and data extracted. MAIN RESULTS: Twelve studies (588 children) were included in the review. Study quality was poor and sample sizes were frequently small. A meta-analysis was possible on two studies only examining the effects of relaxation therapy on PEFR which favoured the treatment group (32 L/min, 95% CI 13 to 50 L/min). No other meta-analysis could be performed due to the diversity of interventions and the outcomes assessed. In addition, many studies reported insufficient data. AUTHORS' CONCLUSIONS: This review was unable to draw firm conclusions for the role of psychological interventions for children with asthma. This review demonstrates the absence of an adequate evidence base and highlights the need for well-conducted and reported randomised trials in this area.

Adolescent↗
PubMed2005

Methotrexate for primary biliary cirrhosis.

BACKGROUND: Methotrexate, a folic acid antagonist with immunosuppressive properties, has been used to treat patients with primary biliary cirrhosis. The therapeutic responses to methotrexate in randomised clinical trials have been heterogeneous. OBJECTIVES: To assess the beneficial and harmful effects of methotrexate for patients with primary biliary cirrhosis. SEARCH STRATEGY: Relevant randomised clinical trials were identified by searching The Cochrane Hepato-Biliary Group Controlled Trials Register (June 2004), The Cochrane Central Register of Controlled Trials on The Cochrane Library (Issue 2, 2004), MEDLINE (January 1966 to August 2004), EMBASE (January 1980 to August 2004), and manual searches of bibliographies. We contacted authors of trials and pharmaceutical companies. SELECTION CRITERIA: Randomised clinical trials comparing methotrexate with placebo, no intervention, or another drug were included irrespective of blinding, language, year of publication, and publication status. DATA COLLECTION AND ANALYSIS: Our primary outcomes were mortality and mortality or liver transplantation. Dichotomous outcomes were reported as relative risk (RR) and hazard ratio (HR) if applicable. Continuous outcomes were reported as weighted mean difference (WMD). We examined intervention effects by using both a random-effects model and a fixed-effect model. Heterogeneity was investigated by subgroup analyses and sensitivity analyses. MAIN RESULTS: We identified four trials (370 patients) that compared methotrexate with placebo with or without ursodeoxycholic acid as co-intervention. One additional trial (87 patients) compared methotrexate with colchicine without and later with ursodeoxycholic acid as co-intervention. The methodological quality of the trials was low. We did not find significant effects of methotrexate on pruritus, fatigue, liver complications, liver biochemistry, liver histology, or adverse events. The pruritus score (WMD - 0.68, 95% CI - 1.11 to - 0.25), the levels of serum alkaline phosphatases (WMD - 0.41, 95% CI - 0.70 to - 0.12) and plasma immunoglobulin M (WMD - 0.47, 95% CI - 0.74 to - 0.20) were significantly lower in the patients receiving methotrexate. AUTHORS' CONCLUSIONS: Methotrexate increased mortality in patients with primary biliary cirrhosis. We do not recommend methotrexate for patients with primary biliary cirrhosis outside randomised trials.

Folic Acid Antagonists↗
PubMed2004

Colchicine for primary biliary cirrhosis.

BACKGROUND: Colchicine has been used for patients with primary biliary cirrhosis because of its immunomodulatory and antifibrotic potential. The therapeutical responses to colchicine in randomised clinical trials were inconsistent. OBJECTIVES: To evaluate the beneficial and harmful effects of colchicine in patients with primary biliary cirrhosis. SEARCH STRATEGY: We identified trials through electronic searches of The Cochrane Hepato-Biliary Group Controlled Trials Register, The Cochrane Central Register of Controlled Trials on The Cochrane Library, MEDLINE, EMBASE (September 2003), and manual searches of bibliographies. We contacted authors of trials and pharmaceutical companies. SELECTION CRITERIA: Randomised clinical trials comparing colchicine with any kind of control therapy were included irrespective of language, year of publication, and publication status. DATA COLLECTION AND ANALYSIS: The primary outcomes were the number of deaths and the number of death and/or patients who underwent liver transplantation. Dichotomous outcomes were reported as relative risk (RR) with 95% confidence interval (CI). We examined intervention effects by using both a fixed effect model and a random effects model. Heterogeneity was investigated by subgroup analyses and sensitivity analyses. MAIN RESULTS: Eleven randomised clinical trials involving 716 patients with primary biliary cirrhosis fulfilled the inclusion criteria. No significant differences were detected between colchicine and placebo/no intervention on the number of deaths (RR 1.21, 95% CI 0.71 to 2.06), the number of deaths and/or patients who underwent liver transplantation (RR 1.00, 95% CI 0.67 to 1.49), liver complications, liver biochemical variables, liver histological measurements, and adverse events. Trial methodology was generally low and some trials had high drop-out rate. A best-worst-case-scenario analysis showed no significant effect of colchicine on mortality (RR 0.59, 95%CI 0.30 to 1.15), while a worst-best-case-scenario analysis showed a significant detrimental effect of colchicine on mortality (RR 2.28, 95% CI 1.17 to 4.44). Colchicine significantly decreased the number of patients without improvement of pruritus (RR 0.75, 95% CI 0.65 to 0.87). However, this estimate was based on only 156 patients from three trials. The effect of the combined treatment with ursodeoxycholic acid was not significantly different from that of colchicine alone. REVIEWERS' CONCLUSIONS: We did not find evidence either to support or refute the use of colchicine for patients with primary biliary cirrhosis. As we are not able to exclude a detrimental effect of colchicine, we suggest that it is only used in randomised clinical trials.

Cholagogues and Choleretics↗
PubMed2006

Early versus delayed laparoscopic cholecystectomy for acute cholecystitis.

BACKGROUND: Gallstones are present in about 10% to 15% of the adult western population. Between 1% and 4% become symptomatic in a year. Cholecystectomy for symptomatic gallstones is mainly performed after the acute cholecystitis episode settles because of the fear of higher morbidity and conversion from laparoscopic cholecystectomy to open cholecystectomy during acute cholecystitis. OBJECTIVES: The aim was to compare the early laparoscopic cholecystectomy (less than seven days of onset of symptoms) versus delayed laparoscopic cholecystectomy (more than six weeks after index admission) with regards to benefits and harms. SEARCH STRATEGY: We searched The Cochrane Hepato-Biliary Group Controlled Trials Register, the Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library, MEDLINE, EMBASE, and Science Citation IndexExpanded until November 2005. SELECTION CRITERIA: We considered for inclusion all randomised clinical trials comparing early versus delayed laparoscopic cholecystectomy for acute cholecystitis. DATA COLLECTION AND ANALYSIS: We collected the data on the characteristics of the trial, methodological quality of the trials, mortality, morbidity, conversion rate, operating time, and hospital stay from each trial. We analysed the data with both the fixed-effect and the random-effects models using RevMan Analysis. For each outcome we calculated the odds ratio (OR) with 95% confidence intervals (CI) based on intention-to-treat analysis. MAIN RESULTS: We included five trials with 451 patients randomised: 223 to the early group and 228 to the delayed group. Surgery was performed on 222 patients in the early group and on 216 patients in the delayed group. There was no mortality in any of the trials. Four of the five trials were of high methodological quality. There was no statistically significant difference between the two groups for any of the outcomes including bile duct injury (OR 0.63, 95% CI 0.15 to 2.70) and conversion to open cholecystectomy (OR 0.84, 95% CI 0.53 to 1.34). Various other analyses including 'available case analysis', risk difference, statistical methods to overcome the 'zero-event trials' showed no statistically significant difference between the two groups in any of the outcomes measured. A total of 40 patients (17.5%) from the delayed group had to undergo emergency laparoscopic cholecystectomy due to non-resolving or recurrent cholecystitis; 18 (45%) of these had to undergo conversion to open procedure. The total hospital stay was about three days shorter in the early group compared with the delayed group. AUTHORS' CONCLUSIONS: Early laparoscopic cholecystectomy during acute cholecystitis seems safe and shortens the total hospital stay. The majority of the outcomes occurred rarely; hence, the confidence intervals are wide. Therefore, further randomised trials on the issue are needed.

Adult↗
PubMed2002

Improving safety reporting from randomised trials.

Randomised clinical trials offer a unique opportunity for capturing safety information under a controlled setting that minimises biases in the comparison of different therapeutic options. Nevertheless, empirical evidence across diverse medical fields suggests that the reporting of safety information in clinical trials is largely neglected and receives less attention compared with efficacy outcomes. An analysis of 192 randomised trials has shown that reasons for withdrawals due to toxicity were specified per study arm in only 46% of the trial reports. Adequate reporting of clinical adverse effects and laboratory-determined toxicity occurred in only 39 and 29% of the trials, respectively, even with lenient definitions of what constitutes adequate reporting. The use of standardised scales for adverse effects is a prerequisite for improved reporting on safety in randomised trials. Safety data need to be collected and analysed in a systematic fashion and active surveillance for toxicity during the conduct of a randomised trial is preferable to passive surveillance. Standardised reporting of safety data does not necessarily require extensive space to accomplish. It is essential to provide numerical data per study arm on each type of adverse effect along with a categorisation of the severity of the adverse effects with an emphasis on severe and life-threatening reactions. The severity grading must be referred to well-known standardised scales and new scales need to be carefully defined. Information on withdrawals due to toxicity is also important to report, along with the specific reasons leading to discontinuation. Tabulation of information may be helpful and rare or not previously reported adverse effects should be described in detail. The availability of newer options such as electronic publication, publication of raw databases, large database research, meta-analytic approaches, and prospective registration of clinical trials and of their databases may further improve the safety insights we can gain from randomised clinical trials.

Adverse Drug Reaction Reporting Systems↗