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PubMed2002

Interventional radiology in the treatment of hepatic metastases.

Recent technical developments have enabled the development of a range of non-surgical interventions for liver metastases. These include cryotherapy, chemoembolisation, and radiofrequency, laser or microwave ablation. These techniques are reviewed and their role in the management of liver metastases discussed. Chemoembolization does not reliably achieve destruction of hepatic metastases. Cryotherapy and radiofrequency treatment can ablate metastases in 50-90% of cases and are relatively safe compared to hepatic resection. There has been no randomised comparison to show that either cryotherapy or radiofrequency treatment alter long-term survival compared with chemotherapy alone. However, this may be related to the fact that most patients being referred for ablative treatment are considered unsuitable for hepatic resection. Randomised trials to accurately define the place of these innovative techniques are needed.

Catheter Ablation↗
PubMed2006

Acute peri-operative beta blockade in intermediate-risk patients.

Peri-operative beta-blockade has been shown to reduce the incidence of postoperative cardio- vascular complications including cardiac death in high-risk non-cardiac surgical patients. However, the recent analysis by Lindenauer et al. suggests that it is inappropriate to administer beta-blockers blindly to all surgical patients. In an attempt to determine the appropriateness of peri-operative beta-blocker administration across patients with a spectrum of cardiovascular risks, we have examined studies of intermediate-risk patient groups (that is those undergoing intermediate risk surgery or those with a Lee Revised Cardiac Risk Score of < or =2). We analysed data from randomised prospective studies of the effects of acute peri-operative beta-blockade on the incidence of peri-operative myocardial ischaemia. By examining the demographics and surgical interventions in these patients, we have compared these studies with other studies of peri-operative silent myocardial ischaemia representing patients of similar risk. We thus estimated the expected long-term postoperative cardiovascular complication rate associated with myocardial ischaemia in these patients in terms of number needed to treat for ischaemia prevention and for prevention of major cardiovascular complications. Prevention of peri-operative myocardial ischaemia with acute beta-blockade in non-cardiac surgical patients with 1-2 RCRI clinical risk factors can be achieved with a number needed to treat of 10. It is not associated with a significant increase in drug associated side-effects. However, acute beta-blockade shows no real benefit in the prevention of major cardiovascular complications in intermediate risk non-vascular surgical patients with a number-needed-to-treat of 833. Vascular surgical patients undergoing intermediate-risk surgery may benefit from the protective effects of acute peri-operative beta-blockade, however, with a number-needed-to-treat of 68 it would require a randomised clinical trial of over 24,000 patients to prove their efficacy.

Adrenergic beta-Antagonists↗
PubMed1999

Double blind, randomised, placebo controlled, crossover, multicentre study to determine the efficacy of a 0.1% (w/v) sodium hyaluronate solution (Fermavisc) in the treatment of dry eye syndrome.

BACKGROUND/AIMS: Hyaluronan (sodium hyaluronate) has been shown to confer objective and subjective improvement in patients with dry eye syndrome. This study compared the efficacy and safety of a 0.1% solution of hyaluronan with 0.9% saline, when administered topically to the eye, in the treatment of symptoms of severe dry eye syndrome. METHODS: A randomised, double blind, crossover clinical trial in which subjects were randomised to receive either hyaluronan or saline, applied as one or two drops to the eye, three or four times a day or as required. After 28 days' treatment, subjects crossed over to the other study medication for a further 28 days' treatment. RESULTS: 70 subjects were included in the analyses of efficacy and significant improvements in Schirmer's score (p=0.0006) and rose bengal staining score (p=0.0001) were observed during treatment with hyaluronan. In a subjective assessment of the effectiveness of two treatments, a majority of subjects felt that hyaluronan was more effective than saline in alleviating the symptoms of burning and grittiness (p<0.001). No adverse events attributable to hyaluronan treatment were reported. CONCLUSION: The study demonstrates a clear benefit of hyaluronan over saline, in both subjective and objective assessments of dry eye syndrome. Hyaluronan was shown to be well tolerated.

Adult↗
PubMed2004

Pharmacotherapy for excessive daytime sleepiness.

Excessive daytime sleepiness (EDS) has recognized detrimental consequences such as road traffic accidents, impaired psychological functioning and reduced work performance. EDS can result from multiple causes such as sleep deprivation, sleep fragmentation, neurological, psychiatric and circadian rhythm disorders. Treating the underlying cause of EDS remains the mainstay of therapy but in those who continue to be excessively sleepy, further treatment may be warranted. Traditionally, the amphetamine derivatives, methylphenidate and pemoline (collectively sympathomimetic) psychostimulants were the commonest form of therapy for EDS, particularly in conditions such as narcolepsy. More recently, the advent of modafinil has broadened the range of therapeutic options. Modafinil has a safer side-effect profile and as a result, interest in this drug for the management of EDS in other disorders, as well as narcolepsy, has increased considerably. There is a growing school of thought that modafinil may have a role to play in other indications such as obstructive sleep apnea/hypopnea syndrome already treated by nasal continuous positive airway pressure but persisting EDS, shift work sleep disorders, neurological causes of sleepiness, and healthy adults performing sustained operations, particularly those in the military. However, until adequately powered randomised-controlled trials confirm long-term efficacy and safety, the recommendation of wakefulness promoters in healthy adults cannot be justified.

Amphetamines↗
PubMed2002

Systematic review and meta-analysis of evidence for increasing numbers of drugs in antiretroviral combination therapy.

OBJECTIVE: To assess the evidence for the effectiveness of increasing numbers of drugs in antiretroviral combination therapy. DESIGN: Systematic review, meta-analysis, and meta-regression of fully reported randomised controlled trials. All studies included compared quadruple versus triple therapy, triple versus double therapy, double versus monotherapy, or monotherapy versus placebo or no treatment. PARTICIPANTS: Patients with any stage of HIV infection who had not received antiretroviral therapy. MAIN OUTCOME MEASURES: Changes in disease progression or death (clinical outcomes); CD4 count and plasma viral load (surrogate markers). SEARCH STRATEGY: Six electronic databases, including Medline, Embase, and the Cochrane Library, searched up to February 2001. RESULTS: 54 randomised controlled trials, most of good quality, with 66 comparison groups were included in the analysis. For both the clinical outcomes and surrogate markers, combinations with up to and including three (triple therapy) were progressively and significantly more effective. The odds ratio for disease progression or death for triple therapy compared with double therapy was 0.6 (95% confidence interval 0.5 to 0.8). Heterogeneity in effect sizes was present in many outcomes but was largely related to the drugs used and trial quality. CONCLUSIONS: Evidence from randomised controlled trials supports the use of triple therapy. Research is needed on the effectiveness of quadruple therapies and the relative effectiveness of specific combinations of drugs.

Anti-HIV Agents↗
PubMed2002

The role of adjuvant therapy for pancreatic cancer.

Patients with pancreatic cancer have a very poor outlook. There have been major advances in the standard surgical treatment of this disease, resulting in decreased post-operative mortality and morbidity. The use of chemotherapy and radiotherapy has been developed to increase long-term patient survival following potentially curative resection. The standard chemotherapeutic agent is 5-fluorouracil (5-FU), although newer cytotoxic agents are in clinical trials for advanced cancer. Initial studies of adjuvant therapy have been based on small numbers of patients, but recently two large European randomised controlled trials of adjuvant therapy (EORTC and ESPAC-1) have been completed. These suggest that adjuvant chemotherapy has a significant survival advantage over resection alone but chemoradiotherapy does not. Promising new agents are being developed and tested mainly in clinical trials of advanced pancreatic cancer. The results of large-scale randomised controlled trials to assess adjuvant therapies for pancreatic cancer demonstrate the great surgical and oncological progress that has been made over the past decade.

Chemotherapy, Adjuvant↗
PubMed2004

Pneumococcal vaccination for the elderly in The Netherlands? Assessment of the quality and content of available comparative studies.

BACKGROUND: A question that is currently topical in the Netherlands is whether it makes sense to introduce on a national scale vaccination against pneumococcal infections for elderly people who are at present receiving the influenza vaccination. We recently studied the scientific literature on the subject in an attempt to answer this question. METHODS: We searched for systematic reviews (SRs), randomised clinical trials (RCTs) and cohort studies in MEDLINE, EMBASE, the Cochrane Library, Current Controlled Trials and via Google (period 1966 to June 2002). The SRs and RCTs were assessed with a methodological checklist. RESULTS: We identified four SRs, two trials (of which one was pseudo-random) and one retrospective cohort study. The methodological quality of the SRs was reasonable and in this respect differed little among themselves. The SRs differed strongly with regard to subgroups, outcome measures, valency of vaccines, duration of follow-up and combination with influenza vaccination. The SRs showed that vaccination has more effect in low-risk groups, does not appear to be effective in high-risk patients and the elderly and is more effective in nonindustrialised countries. The outcomes based on the various outcome measures showed major differences. The three studies into the effectiveness of the pneumococcal vaccination in the elderly all showed major methodological shortcomings. For the majority of outcome measures the outcomes were negative. CONCLUSION: There is insufficient convincing evidence in favour of the introduction of the pneumococcal vaccination as a supplement to influenza vaccination for the elderly. It seems as if (international) opinion had already been fully formed before published studies and systematic reviews become available in the last few years. It is perhaps worth considering setting up a prospective trial in the elderly Dutch population.

Aged↗
PubMed2000

Cost-effectiveness analysis of topical calcipotriol versus short-contact dithranol. In the treatment of mild to moderate plaque psoriasis.

OBJECTIVE: To examine the relative cost effectiveness of topical calcipotriol and short-contact dithranol in the treatment of mild to moderate plaque psoriasis. DESIGN AND SETTING: This was a modelling study from the perspective of the UK National Health Service as payer. METHODS: The interventions were compared using 2 decision-analytic models: one using a short term horizon (12 weeks) and the other using a longer term horizon (up to 1 year). Clinical success of treatment and relapse rates were obtained from the results of randomised controlled trials. MAIN OUTCOME MEASURES AND RESULTS: The outcome measure used was the degree of improvement in psoriasis as judged by the patient. In the short term comparison, calcipotriol was the most effective treatment (60.8% success), but it was also the most expensive (96.03 Pounds; 2000 values). The incremental cost per success was 577.50 Pounds using a 12-week course of calcipotriol compared with short-contact dithranol. Over the long term horizon, first-line treatment with calcipotriol still had the highest expected cost per successful treatment (164.91 Pounds), but the incremental cost using this strategy was 38.66 Pounds compared with short-contact dithranol. In terms of cost per successful day's treatment (i.e. the cost for a day in which the patient reported a marked improvement or cleared lesions), the cost of each additional successful day's treatment was 19.93 Pounds when using calcipotriol as first-line treatment rather than short-contact dithranol. CONCLUSION: The combination of differences in drug acquisition costs and relapse rates can lead to large differences in the comparative cost effectiveness of topical treatments for plaque psoriasis. From the perspective of the prescriber, the results of this analysis suggest that selecting short-contact dithranol as first-line treatment was the most cost-effective strategy.

Administration, Topical↗
PubMed1999

Evaluating the outcomes of low vision rehabilitation.

The requirement for those providing healthcare to measure outcomes raises the fundamental question of how these should be measured. Both the scale of the low vision population and the different models of care proposed make it a pressing need to determine outcomes using valid and reliable measures. In this study we describe the development and piloting of a questionnaire designed to meet this requirement. The questionnaire was piloted on 56 subjects with age-related macular degeneration (ARMD). Test-retest reliability of the questionnaire was estimated using a further sample of 28 subjects with ARMD. Pilot testing confirmed the feasibility of administering the questionnaire to an elderly population with ARMD. A total of 87% of the sample reported using an LVA (65% on a daily basis), predominantly for a reading task. The number of tasks an LVA was used for, its frequency of use, length of continuous use and ease of use are significantly associated with the rating of an LVA as important/less important (P < 0.0001), but the acuity achieved with the device is not significantly associated with rated importance (P = 0.11), reinforcing doubt about the validity of visual function outcomes. The limitations of this pilot study and earlier case series in describing the outcomes of low vision care are discussed and a randomised controlled trial using a broad range of outcomes is proposed in order to fully describe the effectiveness of low vision rehabilitation and inform the debate about models of care.

Aged↗
PubMed2005

Do citation classics in rhinology reflect utility rather than quality?

Citation rates have been suggested to be more of an indicator of utility than quality. The aim of this study was to apply measures of utility and quality to articles identified as citation classics in rhinology/anterior skull base surgery. There were 14 articles analysed in the study. The assessment of quality was performed by combining factors from previous publications on quality assessment and the various elements were categorised into four groups; quality of written article and publication, quality of research, quality of evidence-based methodology and quality of outcome. This study revealed that citation classics in rhinology/anterior skull base surgery were well-written and satisfied peer review in reputable journals in the specialty. Quality is satisfied by clarity of exposition and patient numbers. The research was generally asking an important question and the methodology overall was adequate and appropriate for the type of study performed. A good quality of research and outcome was demonstrated with a definite historical importance, and reports that stimulated further research and enquiry. Quality is not satisfied by the lack of randomised controlled trials, appropriate statistical analysis or patient criteria. In conclusion citation rates when considered as an individual measure, reflect utility rather than quality.

Bibliometrics↗
PubMed2006

The effects of a team-based continuous quality improvement intervention on the management of primary care: a randomised controlled trial.

AIM: To study the effects of a team-based model for continuous quality improvement (CQI) on primary care practice management. DESIGN OF STUDY: Randomised controlled trial. SETTING: Twenty-six intervention and 23 control primary care practices in the Netherlands. METHOD: Practices interested in taking part in the CQI project were, after assessment of their practice organisation, randomly assigned to the intervention or control groups. During a total of five meetings, a facilitator helped the teams in the intervention group select suitable topics for quality improvement and follow a structured approach to achieve improvement objectives. Checklists completed by an outreach visitor, questionnaires for the GPs, staff and patients were used to assemble data on the number and quality of improvement activities undertaken and on practice management prior to the start of the intervention and 1 year later. RESULTS: Pre-test and post-test data were compared for the 26 intervention and 23 control practices. A significant intervention effect was found for the number of improvement objectives actually defined (93 versus 54, P<0.001) and successfully completed (80 versus 69% of the projects, P<0.001). The intervention group also improved on more aspects of practice management, as measured by our practice visit method, than the control group but none of these differences proved statistically significant. CONCLUSION: The intervention exerted a significant effect on the number and quality of improvement projects undertaken and self-defined objectives met. Failure of the effects of the intervention on the other dimensions of practice management to achieve significance may be due to the topics selected for some of the improvement projects being only partly covered by the assessment instrument.

Family Practice↗
PubMed2002

Antibiotics for trachoma.

BACKGROUND: Trachoma is the world's leading cause of preventable blindness. In 1997 the World Health Organization launched an initiative on trachoma control based on the 'SAFE' strategy (surgery, antibiotics, facial cleanliness and environmental improvement). OBJECTIVES: The aim of this review is to assess the evidence supporting the antibiotic arm of the SAFE strategy by assessing the effects of antibiotics on both active trachoma (primary objective) and on Chlamydia trachomatis infection of the conjunctiva (secondary objective). SEARCH STRATEGY: We searched The Cochrane Controlled Trials Register - CENTRAL/CCTR, which contains the Cochrane Eyes and Vision Group specialised register (Cochrane Library Issue 3, 2001), MEDLINE (1966 to August 2001), and EMBASE (1980 to September 2001). We used the Science Citation Index to look for articles that cited the included studies. We searched the reference lists of identified articles and we contacted authors and experts for details of further relevant studies. SELECTION CRITERIA: We included only randomised trials that satisfied either of two criteria: (a) trials in which topical or oral administration of an antibiotic was compared to placebo or no treatment in people with trachoma, (b) trials in which a topical antibiotic was compared with an oral antibiotic in people with trachoma. A subdivision of particular interest was of trials in which topical tetracycline/chlortetracycline was compared with oral azithromycin, as these are the two World Health Organization recommended treatments. DATA COLLECTION AND ANALYSIS: Two reviewers independently assessed trial quality and extracted data. We contacted investigators for missing data. MAIN RESULTS: We found 15 studies that randomised a total of 8678 participants. For both outcomes (active trachoma and laboratory evidence of infection) the results of the chi-square tests suggested that there was significant statistical heterogeneity among the trials. There was also marked clinical heterogeneity. No summary statistics were calculated and we therefore present a narrative summary of the results. For the comparisons of oral or topical antibiotic against placebo/no treatment, the data are consistent with there being no effect of antibiotics but are suggestive of a lowering of the point prevalence of relative risk of both active disease and laboratory evidence of infection at three and 12 months after treatment. For the comparison of oral against topical antibiotics the results suggest that oral treatment is neither more nor less effective than topical treatment. REVIEWER'S CONCLUSIONS: There is some evidence that antibiotics reduce active trachoma but results are not consistent and cannot be pooled.

Anti-Bacterial Agents↗
PubMed1982

Controlled trial of terlipressin ('Glypressin') versus vasopressin in the early treatment of oesophageal varices.

In a randomised controlled trial the effect of intermittent bolus injection of triglycyl lysine vasopressin (terlipressin 'Glypressin') (2 mg that 6-hourly), an analogue of vasopressin, was compared with that of a constant peripheral intravenous infusion of vasopressin (0.4 units/Min) in the initial management of bleeding oesophageal varices in nineteen patients. Failure of vasopressin therapy was defined as continued bleeding of sufficient severity to necessitate the passage of a Sengstaken tube. Bleeding was controlled in 70% of patients treated with glypressin but in only 9% of patients given vasopressin. The glypressin group required significantly less blood after randomisation than the vasopressin group. Because of its efficacy, lack of side-effects, and ease of administration, glypressin appears to be valuable in the management of bleeding varices.

Adult↗
PubMed2004

Vitamin C supplementation for asthma.

BACKGROUND: Vitamin C is one of the key antioxidant vitamins which is abundant in the extracellular fluid lining the lung and low vitamin C intake has been associated with pulmonary dysfunction. OBJECTIVES: To evaluate the evidence for the efficacy of vitamin C in the treatment of asthma. SEARCH STRATEGY: The Cochrane Airways Review Group asthma register was searched and bibliographies of studies identified were also checked for further trials. This review has been updated by searches to January 2004. SELECTION CRITERIA: Only randomised controlled trials were eligible for inclusion. Studies were considered for inclusion if they dealt with the treatment of asthma using vitamin C supplementation. Two independent reviewers identified potentially relevant studies using pre-defined criteria and selected studies for inclusion. DATA COLLECTION AND ANALYSIS: Data were abstracted independently by two reviewers. Information on patients, methods, interventions, outcomes and results was extracted using standard forms. MAIN RESULTS: A total of 71 abstracts and titles were identified. Sixteen studies were selected for potential inclusion, eight met the inclusion criteria. All included studies were placebo-controlled and randomised. Only four provided data in a form that permitted further analysis and none could be aggregated in a meta analysis. The individual studies did not show a significant effect on any asthma outcome. The 2004 update for this review includes a large study in 201 adults on inhaled corticosteroids in which important benefit from the addition of vitamin C was excluded by the narrow confidence intervals of the lung function results. REVIEWERS' CONCLUSIONS: At present, evidence from randomised-controlled trials is insufficient to recommend a specific role for vitamin C in the treatment of asthma. Further methodologically strong and large-scale randomised controlled trials are warranted in order to address the question of the effectiveness of vitamin C in children with asthma.

Antioxidants↗
PubMed2002

Ursodeoxycholic acid and/or antibiotics for prevention of biliary stent occlusion.

BACKGROUND: Malignant biliary obstruction, which requires endoscopic stenting as palliative therapy, is often complicated by clogging of the stent with subsequent jaundice and/or cholangitis. Stent clogging may be caused by microbiological adhesion and biliary stasis. Therefore, antibiotics and choleretic agents like ursodeoxycholic acid (UDCA) have been investigated to see whether they prolong stent patency. OBJECTIVES: To evaluate if UDCA and/or antibiotics may prolong stent patency and survival in patients with strictures of the biliary tract and endoscopically inserted stents. SEARCH STRATEGY: The Trials Register of The Cochrane Hepato-Biliary Group, The Cochrane Library, MEDLINE, Current Contents, EMBASE, and CancerLit were searched until June 2001. Reference lists of the identified articles were checked for further trials. SELECTION CRITERIA: All randomised or quasi-randomised clinical trials investigating UDCA and/or antibiotics in patients with biliary stents were considered for inclusion, regardless of blinding, language, and publication status. DATA COLLECTION AND ANALYSIS: Trial inclusion, quality assessment, and data extraction were performed independently by two reviewers. Principal investigators were contacted for further information. Survival data were combined by using hazard ratios (with 95% confidence interval (95% CI)). MAIN RESULTS: Five non-blinded randomised trials with 258 patients with malignant strictures treated with polyethylene stents were included. Three trials, including 152 patients, investigated a combination of UDCA and antibiotics versus no treatment. The meta-analysis of these three trials does not show a significant treatment effect on the duration of stent patency (hazard ratio (random effects model) 0.58, 95% CI 0.22 to 1.54) or mortality (hazard ratio (fixed effect model) 0.99, 95% CI 0.68 to 1.43). Two trials with 106 patients compared antibiotics with no treatment, one of these trials used a combination of antibiotics and rowachol (an 'alternative' drug of the 'mint' family). The pooled results of these two trials do not show significant effects of antibiotics on the duration of stent patency (hazard ratio (fixed effect model) 0.69 (95% CI 0.37 to 1.30)) or mortality (hazard ratio (fixed effect model) 1.23 (95% CI 0.72 to 2.08). Data concerning duration of hospital stay, frequency of cholangitis, and rate of infectious complications due to selection of antibiotic resistant bacteria strains were not available. REVIEWER'S CONCLUSIONS: Treatment with UDCA and/or antibiotics to prevent clogging of biliary stents in patients with malignant stricture of the biliary tract cannot be recommended routinely on the basis of the existing randomised clinical trials. Further trials are needed with rigorous methodology and sufficient statistical power.

Anti-Bacterial Agents↗