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Selected AbstractsThe clinical effectiveness of length of bed rest for patients recovering from trans-femoral diagnostic cardiac catheterisationINTERNATIONAL JOURNAL OF EVIDENCE BASED HEALTHCARE, Issue 4 2008Sek Ying Chair RN MBA PhD Background, Cardiac catheterisation plays a vital role in the diagnosis and evaluation of cardiac conditions. The goal of management of patients after cardiac catheterisation is to reduce the risk of development of any local or prolonged vascular complications, in particular bleeding and haematoma formation at the puncture site. Bed rest and immobilisation of the affected leg are recommended practices to ensure adequate haemostasis at the femoral arterial puncture site and prevent complications. Objectives, The objective of this review was to present the best available evidence for the optimal length of bed rest after trans-femoral diagnostic cardiac catheterisation. The main outcome of interest was the incidence of bleeding and haematoma formation following varying periods of bed rest. Search strategy, We searched the following databases: CINAHL, Medline, Cochrane Library, Current Contents, EBSCO, Web of Science, Embase, British Nursing Index, Controlled clinical trials database, Google Scholar. Reference lists of relevant articles and conference proceedings were searched. We also contacted key organisations and researchers in the field. Selection criteria, All randomised and quasi-randomised controlled trials that compared the effects of different lengths of bed rest following trans-femoral diagnostic cardiac catheterisation on patient outcomes were considered for inclusion in the review. Data collection and analysis, Eligibility of the trials for inclusion in the review, details of eligible trials and the methodological quality of the trials were assessed independently by two reviewers. Odds ratios (OR) for dichotomous data and a weighted mean difference for continuous data were calculated with 95% confidence intervals (CI). Where synthesis was inappropriate, trials were considered separately. Main results, Eighteen trials involving a total of 4294 participants were included in the review. One trial included three treatment groups. In seven trials among 747 people there was no significant difference in the incidence of bleeding following six or less than 6 h of bed rest (OR 1.47; 95% CI 0.60, 3.64). Likewise, there was no significant difference in the incidence of bleeding following bed rest at other time periods. In eight trials involving 2272 patients there was no significant difference in the incidence of haematoma formation following 6 or less than 6 h of bed rest (OR 0.82; 95% CI 0.59, 1.16). Significantly fewer patients randomised to less than 6 h of bed rest complained of back pain. The odds of developing back pain at 4 (OR 24.60; 95% CI 1.29, 469) and 24 h (OR 2.47; 95% CI 1.16, 5.23) following coronary catheterisation was significantly higher among patients randomised to 6 compared with 3 h of bed rest. Authors' conclusions, There is evidence of no benefit relating to bleeding and haematoma formation in patients who have more than 3 h of bed rest following trans-femoral diagnostic cardiac catheterisation. However, there is evidence of benefit relating to decreased incidence and severity of back pain and cost-effectiveness following 3 h of bed rest. There is suggestive but inconclusive evidence of a benefit from bed rest for 2 h following trans-femoral cardiac catheterisation. Clinicians should consider a balance between avoiding increased risk of haematoma formation following 2,2.5 h of bed rest and circumventing back pain following more than 4 h of bed rest. [source] Elements of a neurobiological theory of hippocampal function: the role of synaptic plasticity, synaptic tagging and schemasEUROPEAN JOURNAL OF NEUROSCIENCE, Issue 11 2006R. G. M. MorrisArticle first published online: 8 JUN 200 Abstract The 2004 EJN Lecture was an attempt to lay out further aspects of a developing neurobiological theory of hippocampal function [Morris, R.G.M., Moser, E.I., Riedel, G., Martin, S.J., Sandin, J., Day, M. & O'Carroll, C. (2003) Phil. Trans. R. Soc. Lond. B Biol. Sci., 358, 773,786.] These are that (i) activity-dependent synaptic plasticity plays a key role in the automatic encoding and initial storage of attended experience; (ii) the persistence of hippocampal synaptic potentiation over time can be influenced by other independent neural events happening closely in time, an idea with behavioural implications for memory; and (iii) that systems-level consolidation of memory traces within neocortex is guided both by hippocampal traces that have been subject to cellular consolidation and by the presence of organized schema in neocortex into which relevant newly encoded information might be stored. Hippocampal memory is associative and, to study it more effectively than with previous paradigms, a new learning task is described which is unusual in requiring the incidental encoding of flavour,place paired associates, with the readout of successful storage being successful recall of a place given the flavour with which it was paired. NMDA receptor-dependent synaptic plasticity is shown to be critical for the encoding and intermediate storage of memory traces in this task, while AMPA receptor-mediated fast synaptic transmission is necessary for memory retrieval. Typically, these rapidly encoded traces decay quite rapidly over time. Synaptic potentiation also decays rapidly, but can be rendered more persistent by a process of cellular consolidation in which synaptic tagging and capture play a key part in determining whether or not it will be persistent. Synaptic tags set at the time of an event, even many trivial events, can capture the products of the synthesis of plasticity proteins set in train by events before, during or even after an event to be remembered. Tag,protein interactions stabilize synaptic potentiation and, by implication, memory. The behavioural implications of tagging are explored. Finally, using a different protocol for flavour,place paired associate learning, it is shown that rats can develop a spatial schema which represents the relative locations of several different flavours of food hidden at places within a familiar space. This schema is learned gradually but, once acquired, enables new paired associates to be encoded and stored in one trial. Their incorporation into the schema prevents rapid forgetting and suggests that schema play a key and hitherto unappreciated role in systems-level memory consolidation. The elements of what may eventually mature into a more formal neurobiological theory of hippocampal memory are laid out as specific propositions with detailed conceptual discussion and reference to recent data. [source] Effectiveness of general practice nurse interventions in cardiac risk factor reduction among adultsINTERNATIONAL JOURNAL OF EVIDENCE BASED HEALTHCARE, Issue 3 2007Elizabeth Halcomb RN BN(Hons) Grad Cert. Abstract Background, Cardiovascular disease is the leading cause of death for adults in Australia. In recent years there has been a shift in health service delivery from institutional to community-based care for chronic conditions, including cardiovascular disease. The general practice setting is seen to offer greater flexibility, higher levels of efficiency and more client focused healthcare delivery than is possible in the acute care sector. It has been suggested that practice nurses represent a useful adjunct to current models of cardiovascular disease management. To date, significant descriptive research has been conducted exploring the demographics, roles, educational needs and issues facing practice nurses. However, there is a need to evaluate the effectiveness of practice nurse interventions in terms of patient outcomes, clinician satisfaction and cost-effectiveness. Objectives, This review seeks to present the best available evidence regarding the efficacy of general practice nurse interventions for cardiac risk factor reduction in healthy adults, as well as those with established cardiovascular disease or known cardiac risk factors. Search Strategy, A systematic literature search was performed using Medline (1966 , 2005), CINAHL (1982 ,2005), Cochrane Controlled Trials Register (Issue 4, 2005) and the Joanna Briggs Institute Evidence Library. In addition, the reference lists of retrieved papers, conference proceedings and the Internet, were scrutinised for additional trials. Selection Criteria, This review considered any English language randomised trials that investigated interventions conducted by the practice nurse for cardiovascular disease management or reduction of cardiac risk factors. Interventions conducted by specialist cardiac nurses in general practice were excluded. Outcomes measured included blood pressure, smoking cessation, total cholesterol, exercise, body weight/body mass index and cost-effectiveness. Results, Eighteen trials, reported in 33 papers, were included in the review. Ten trials investigated multifaceted interventions, while the remaining eight trials reported targeted interventions. Of the trials that reported multifaceted interventions, three trials investigated risk reduction in those with established cardiovascular disease, four trials focused on those with known cardiovascular disease risk factors and three trials included the general community. The eight trials which examined the efficacy of targeted interventions focused upon dietary intake (two trials), smoking cessation (three trials), weight reduction (one trial) and physical activity (two trials). The effect of both the multifaceted and targeted interventions on patient outcomes was variable. However, both the multifaceted and targeted interventions demonstrated similar outcome trends for specific variables. Improvements were demonstrated by most studies in blood pressure, cholesterol level, dietary intake and physical activity. The variation in outcome measures and contradictory findings between some studies makes it difficult to draw definitive conclusions. Conclusions, While interventions to reduce cardiovascular disease risk factors have produced variable results, they offer significant potential to assist patients in modifying their personal risk profile and should be developed. The public health importance of these changes is dependant upon the sustainability of the change and its effect on the health outcomes of these individuals. Further well-designed research is required to establish the effectiveness of practice nurse interventions for cardiovascular disease management and risk factor reduction in terms of patient outcomes and cost-effectiveness. [source] Regular or "Super-Aspirins"?JOURNAL OF AMERICAN GERIATRICS SOCIETY, Issue 4 2001A Review of Thienopyridines or Aspirin to Prevent Stroke PURPOSE: To review the evidence for the effectiveness and safety of the thienopyridines (ticlopidine and clopidogrel) compared with aspirin for the prevention of vascular events among patients at high risk of vascular disease. BACKGROUND: Atherosclerosis and resultant cardiovascular disease are important causes of morbidity and mortality in older people. In particular, atherosclerosis of the cerebral arteries can lead to transient ischemic attacks (TIAs) and stroke. Stroke ranks as the third-leading cause of death in the United States and in 1997 was responsible for over 150,000 fatalities.1 In addition to the mortality associated with this disease, stroke is also a leading source of long-term disability in survivors. Nearly 4.5 million stroke survivors are alive today,1 highlighting the fact that primary, but also secondary, prevention are extremely important for minimizing the complications of this illness. DATA SOURCES: Specialized trial registers of the Cochrane Stroke Group and the Antithrombotic Trialist's Collaboration, MEDLINE, and Embase were searched. Additional unpublished information and data were sought from Sanofi, the pharmaceutical company that developed and manufactures ticlopidine and clopidogrel, as well as the principal investigators of the Clopidogrel versus Aspirin in Patients at Risk of Ischemic Events (CAPRIE) trial,7 the largest of the trials identified. STUDY SELECTION CRITERIA: All unconfounded randomized trials comparing either ticlopidine or clopidogrel with aspirin among patients at high risk of vascular disease (those with symptoms of ischemia of the cerebral, coronary, or peripheral circulations) who were followed for at least 1 month for the recurrence of vascular events were included. DATA EXTRACTION: Data were extracted from four completed randomized trials completed in the past 20 years, which included 22,656 patients.7,10 Two authors independently extracted the data from these trials for the following information: the types of patients enrolled; the entry and exclusion criteria; the randomization method; the number of patients originally allocated to the treatment and control groups; the method and duration of follow-up; the number of patients in each group lost to follow-up; information on compliance with the treatment allocated; the definitions of outcome events; the number of outcome events in each treatment group; and any method used for blinding patients, treating clinicians, and outcome assessors to treatment allocation. MAIN RESULTS: Four completed trials involving a total of 22,656 patients were identified. Aspirin was compared with ticlopidine in three trials (3,471 patients)8,10 and with clopidogrel in one trial (19,185 patients).7 A recent TIA or ischemic stroke was the qualifying event in 9,840 patients, a recent myocardial infarction in 6,302 patients, and symptomatic peripheral arterial disease in 6,514 patients. The average age of the patients was approximately 63, with approximately two-thirds of the patients being male and white. The duration of follow-up ranged from 12 to 40 months. CONCLUSIONS: This systematic review demonstrates that, compared with aspirin, thienopyridines are only modestly more effective in preventing serious vascular events in high-risk patients. For patients who are intolerant of, or allergic to aspirin, the available safety and efficacy data suggest that clopidogrel is an appropriate, but more-expensive, alternative antiplatelet drug. It appears safer than ticlopidine and as safe as aspirin but it should not replace aspirin as the first-choice antiplatelet agent for all patients. Further studies are necessary to determine which, if any, particular types of patients would benefit most and least from clopidogrel instead of aspirin. [source] Systematic review on the effectiveness of caffeine abstinence on the quality of sleepJOURNAL OF CLINICAL NURSING, Issue 1 2009Celia WM Sin Aim., The aim of the present study is to review the effects of caffeine abstinence on the quality of sleep. Background., Insomnia is a common problem and abstinence from caffeine is the most popular component in sleep hygiene advice. However, there have been inconsistent results relating to the effectiveness of caffeine abstinence in improving sleep. Design., Systematic review. Methods., We browsed several electronic databases and reference lists of articles about the correlation of caffeine consumption and sleep deprivation. We selected the articles according to predefined inclusion and exclusion criteria. Two reviewers assessed the quality of trials, which were selected according to the Jadad quality assessment scale. We included the trials scoring three or above in the systematic review and extracted their data. We assessed the heterogeneity of the studies before we considered whether or not to combine the studies' results. Results., Three randomised control trials fulfilled the selection criteria among which two trials scored ,3 on the Jadad scale. We included these two trials in our systematic review. The designs and outcome measurements of these two trials were not homogeneous, therefore, we did not combine their results. Instead, we conducted a critical appraisal. In one trial, caffeine abstinence was associated with significant lengthening of sleep duration (p < 0·01) and better sleep quality (p < 0·05). In another trial, subjects had less difficulty falling asleep on days when they drank decaffeinated coffee (p < 0·05). Conclusions., The results showed that caffeine abstinence for a whole day could improve sleep quality. Thus, health practitioners were recommended to include caffeine abstinence in the instructions for sleep hygiene. Relevance to clinical practice., This study demonstrates the effectiveness of caffeine abstinence in improving sleep quality. It provides evidence for the practice of including caffeine abstinence in sleep hygiene advice. [source] Effect of phosphate fertilization on crop yield and soil phosphorus status,JOURNAL OF PLANT NUTRITION AND SOIL SCIENCE, Issue 5 2003Anne Gallet Abstract To evaluate the effect of three phosphorus (P) fertilization regimes (no P, P input equivalent to P off-take by crops, P input higher than P off-take) on crop yield, P uptake, and soil P availability, seven field experiments (six in crop rotations, one under permanent grassland) were conducted in Switzerland during nine years (six trials) or 27 years (one trial). Soil total P (Pt), inorganic P (Pi), organic P (Po), and the amount of isotopically exchangeable soil P were measured in the 0,20,cm and 30,50,cm layers of the arable soils and in the 0,10,cm layer of the permanent grassland soil. Omitting P fertilization resulted in significant yield decreases only in one field crop trial as the amount of P isotopically exchangeable within one minute (E1min) reached values lower than 5 mg P (kg soil),1. In the absence of P fertilization Pi decreased on average from 470 to 410 mg P (kg soil),1 in the upper horizon of 6 sites while Po decreased only at two sites (from 510 to 466 mg P (kg soil),1 on average). In all the treatments of the trials started in 1989 the E1min values of the upper horizon decreased on average from 15.6 to 7.4 mg P (kg soil),1 between 1989 and 1998. These decreases were also observed when P inputs were higher than crops needs, showing that in these soils the highest P inputs were not sufficient to maintain the high initial available P levels. Finally for the six arable trials the values of the isotopic exchange kinetics parameters (R/r1, n, CP) and P exchangeable within 1 minute (E1min) at the end of the experiment could be estimated from the values measured at the beginning of trial and the cumulated P balance. Der Einfluss der Phosphordüngung auf den Pflanzenertrag und den Phosphorstatus des Bodens Die Begrenzung der Düngung mit Phosphat (P) bei Böden, die bereits hohe Gehalte an verfügbarem P aufweisen, kann zur Verringerung der P-Verluste in Oberflächen- und Grundwasser beitragen. Sieben Feldversuche (6 Versuche mit Ackerkulturen, 1 Versuch mit Dauerwiese) wurden während 9 Jahren (6 Versuche) resp. 27 Jahren (1 Versuch) durchgeführt mit dem Ziel, den Einfluss von drei Düngungsraten (keine P-Gabe, P-Gabe entsprechend dem P-Entzug durch die Pflanzen und P-Gabe höher als der P-Entzug durch die Pflanzen) auf Pflanzenertrag, P-Aufnahme und P-Verfügbarkeit zu studieren. Die Gehalte an anorganischem P (Pi) und organischem P (Po), sowie deren Summe (Pt) und die Gehalte an isotopisch austauschbarem P wurden in den Bodentiefen von 0,20,cm und 30,50,cm der ackerbaulichen Versuche und in einer Bodentiefe von 0,10,cm in der Dauerwiese gemessen. Der Verzicht auf P-Düngung führte nur in einem der ackerbaulichen Versuche zu einer signifikanten Abnahme des Pflanzenertrags, wobei der Gehalt an isotopisch austauschbarem P (E1min) unter 5 mg P (kg Boden),1 fiel. Pi sank bei Verzicht auf P-Düngung im oberen Horizont von 6 Böden durchschnittlich von 470 auf 410 mg P (kg Boden),1, während Po nur in 2 Böden absank (durchschnittlich von 510 auf 466 mg P (kg Boden),1). Ueber alle Düngungsverfahren jener Versuche, die 1989 begonnen hatten, sank E1min im oberen Horizont von 1989 bis 1998 durchschnittlich von 15.6 auf 7.4 mg P (kg Boden),1. Die Abnahme wurde auch beobachtet, wenn die P-Gabe höher war als der P-Entzug durch die Pflanzen, was zeigt, dass in diesen Böden selbst die höchste P-Gabe nicht genügte, um den ursprünglich hohen Gehalt an verfügbarem P aufrecht zu erhalten. Schließlich wurden in den 6 ackerbaulichen Versuchen die Parameter der Isotopenaustauschkinetik (R/r1, n, CP) und E1min am Ende des Versuches mit den ursprünglichen Werten zu Beginn des Versuchs verglichen. Es ergaben sich signifikante Beziehungen zwischen den Werten am Ende des Versuchs einerseits und den ursprünglichen Werten und der P-Bilanz andererseits. [source] Evaluation of the meaningfulness of health-related quality of life improvements as assessed by the SF-36 and the EQ-5D VAS in patients with active Crohn's diseaseALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 9 2009G. COTEUR Summary Background, Crohn's disease (CD) is a chronic inflammatory illness characterized by episodic abdominal pain, diarrhoea, fever, bleeding and obstruction. While the Crohn's Disease Activity Index (CDAI) remains the most commonly accepted measure for assessing the disease status in clinical trials, patient-reported outcome (PRO) instruments are being utilized more frequently to provide information about health-related quality of life (HRQOL). To facilitate interpretation of results, it is common to identify a meaningful unit of PRO score change, such as a minimal clinically important difference (MCID). Aim, To define and apply MCID estimates for the SF-36 and EuroQol-5D visual analogue scale (EQ-5D VAS) for use in CD treatment evaluation. Methods, Data from two phase III randomized controlled trials of certolizumab pegol were utilized. MCID estimates were computed from one trial using anchor-based and distribution-based methods. These estimates were applied to data from the other trial. Results, SF-36 PCS and MCS MCID estimates ranged from 1.6 to 7.0 and 2.3 to 8.7 respectively, depending on approach. EQ-5D VAS MCID estimates ranged from 4.2 to 14.8. Conclusions, For the first time, the MCID values provided interpretation guidelines for PRO results in CD. This research demonstrates that patients treated with certolizumab pegol benefit from meaningful and sustained HRQOL improvements. [source] The pharmacological treatment for uremic restless legs syndrome: Evidence-based review,MOVEMENT DISORDERS, Issue 10 2010Márcio Moysés de Oliveira MD Abstract Restless legs syndrome (RLS) is a common and often misdiagnosed entity among the general population and it may be more common among dialysis patients, with an estimated prevalence of 6.6 to 21.5%. The treatment for uremic RLS has been controversial and therefore a systematic synthesis of the evidence is needed in order to evaluate the effectiveness and safety of treatments for uremic RLS. This was a systematic review of randomized or quasi-randomized double-blind trials on treatments for uremic RLS. The outcomes considered were relief of RLS symptoms marked on a validated scale, subjective sleep quality, sleep quality measured using night polysomnography and actigraphy, quality of life measured subjectively, and adverse events associated with these treatments. Six eligible clinical trials were included. The results from subjective analyses in these studies were divergent, although objective analyses in one trial showed that there was a statistically significant improvement in periodic leg movement while asleep in the treatment group. No combined analysis (meta-analysis) was performed. The most common adverse event seen was gastrointestinal symptoms. Only a few therapeutic trials on patients with uremia with RLS have been published, and there is insufficient scientific evidence to favor any specific therapeutic regimen for uremic-associated RLS. Therapy using levodopa, dopaminergic agonists, anticonvulsants, and clonidine tend to be effective, but further studies are needed. © 2010 Movement Disorder Society [source] Herbal medicines for treatment of fungal infections: a systematic review of controlled clinical trialsMYCOSES, Issue 3-4 2004Karen W. Martin Antimykotische Chemotherapie; Phytomedizin Summary Traditional medicine has made use of many different plant extracts for treatment of fungal infections and some of these have been tested for in vitro antifungal activity. This systematic review evaluates antifungal herbal preparations that have been tested in controlled clinical trials. Four electronic databases were searched for controlled clinical trials of antifungal herbal medicines. Data were extracted in a standardized manner by two independent reviewers and are reviewed narratively. Seven clinical trials met our inclusion criteria. Tea tree oil preparations were tested in four randomized clinical trials and some positive outcomes were attributed to the intervention in all trials. Solanum species (two trials) and oil of bitter orange preparations (one trial) were compared with conventional treatments. In all cases encouraging results were reported. There are few controlled clinical trials of herbal antifungal medicines. The most thoroughly clinically tested is tea tree oil, which holds some promise. All herbal remedies require further investigation in rigorous clinical trials. Zusammenfassung Die traditionelle Medizin nutzt eine Vielzahl unterschiedlicher Pflanzenextrakte zur Behandlung von Pilzinfektionen, die teilweise auf antimyzetische Wirksamkeit in vitro untersucht wurden. Dieser Überblick bewertet diejenigen antimyzetischen Zubereitungen pflanzlichen Ursprungs, die in kontrollierten klinischen Studien geprüft worden sind. Zu diesem Zweck wurden vier elektronische Datenbanken gesichtet. Die Daten wurden mit einer standardisierten Methode von zwei unabhängigen Gutachtern erhoben und werden im Folgenden bewertend dargestellt. Sieben klinische Studien erfüllten unsere Einschlusskriterien. Teebaumöl-Zubereitungen wurden in vier randomisierten klinischen Studien getestet, und einige positive Ergebnisse wurden in allen Studien auf den Wirkstoff zurückgeführt. Zubereitungen von Solanum -Arten (zwei Studien) und Orangenbitteröl wurden mit konventionellen Behandlungsmethoden verglichen. In allen Studien wurden ermutigende Resultate erzielt. Diese wenigen kontrollierten klinischen Studien mit antimyzetischen Zubereitungen pflanzlichen Ursprungs ergaben, dass Teebaumöl am vielversprechendsten ist. Alle pflanzlichen Zubereitungen erfordern jedoch weitere Studien unter kritischen klinischen Versuchbedingungen. [source] Micronutrients and Adverse Pregnancy Outcomes in the Context of HIV InfectionNUTRITION REVIEWS, Issue 7 2004Dr.P.H., Wafaie Fawzi M.B. HIV infection is a global public health problem, particularly in Africa. Concurrently, micronutrient deficiencies and adverse pregnancy outcomes are prevalent in the same settings. Supplements containing B complex and vitamins C and E were efficacious in reducing adverse pregnancy outcomes, including fetal loss, low birth weight, and prematurity among HIV-infected women; the generalizability of this finding to uninfected women is being examined. There is little encouragement from published studies to provide prenatal vitamin A supplements in HIV infection, particularly in light of significantly higher risk of mother-to-child transmission observed in one trial. The efficacy and safety of prenatal zinc and selenium supplements on these outcomes need to be examined in randomized trials. [source] Latest news and product developmentsPRESCRIBER, Issue 5 2008Article first published online: 3 APR 200 Newer antidepressants no better than placebo? A new meta-analysis suggests that newer antidepressants are no superior to placebo in most patients with depression , the exception being those with very severe depression, who can expect a small benefit. Writing in the online-only open access journal PLoS Medicine (5:e45.doi:10.1371/ journal.pmed.0050045), researchers from Hull and the US analysed published and unpublished trials submitted to the Food and Drug Administration in marketing applications for fluoxetine, paroxetine, venlafaxine (Efexor) and nefazodone (no longer available). Using the Hamilton Rating Scale for Depression (HRSD) score as an endpoint, meta-analysis of 35 trials involving 5133 patients and lasting six to eight weeks showed that mean HRSD score improved by 9.6 points with drug treatment and 7.8 with placebo. The authors say the difference of 1.8 was statistically significant but below the criterion for clinical significance (3.0) set by NICE in its clinical guideline on depression. A review of the study by the NHS Knowledge Service (www.nhs.uk) points out that it omits trials published after the drugs were licensed (1999) and those not sponsored by the pharmaceutical industry. It did not include any patients with severe depression and only one trial in patients with moderate depression. An earlier US study of data submitted to the FDA (N Eng J Med 2008;358:25260) showed that published trials of antidepressants were more likely to be positive (37/38) than unpublished ones (3/25). Further, FDA analysts concluded that 51 per cent of trials (published and unpublished) demonstrated positive findings compared with 94 per cent of those that were published. Audit reveals variations in hospital psoriasis care There are unacceptably large variations in the quality of care for patients with psoriasis in UK hospitals, a report by the British Association of Dermatologists and the Royal College of Physicians reveals. The audit of 100 hospital units found that 39 per cent restricted access to biological therapies because of cost, and over one-third of pharmacies could not supply ,specials' such as topical coal tar preparations. More positively, the units are adequately resourced to provide timely communication with GPs. RCGP responds to Public Accounts Committee The Royal College of General Practitioners has agreed with the Commons Public Accounts Committee that drug package labelling should include the cost of the medication. The suggestion was made by the Committee in its report Prescribing Costs in Primary Care. While recognising the importance of generic prescribing, the RCGP cautions against frequent medication switches because it may unsettle patients. ,Any changes must be carried out for sound clinical reasons with good communication between GPs and their patients,' it adds. Statins for patients with kidney disease? Statins reduce cardiovascular risk in people with chronic kidney disease, a new study suggests, but their effects on renal function remain unclear (BMJ 2008; published online doi: 10.1136/bmj. 39472.580984.AE). The meta-analysis of 50 trials involving a total of 30 144 patients found that statins reduced lipids and cardiovascular events regardless of the severity of kidney disease. However, all-cause mortality was unaffected and, although proteinuria improved slightly, there was no change in the rate of decline of glomerular filtration rate. An accompanying editorial (BMJ 2008; published online doi:10.1136/ bmj.39483.665139.80) suggests that the indications for statin therapy to reduce cardiovascular risk in patients with chronic kidney disease should be the same as for those with normal renal function. New NICE guidance New clinical guidelines from NICE (see New from NICE, pages 14,15) include the diagnosis and management of irritable bowel syndrome in adults in primary care, the care and management of osteoarthritis in adults, and the diagnosis and treatment of prostate cancer. In a public health guideline on smoking cessation services, NICE endorses the use of nicotine replacement patches for 12,17 year olds. Suspect additives in children's medicines The Food Commission (www.foodcomm.org.uk) has drawn attention to the presence in children's medicines of food additives it says are linked with hyperactivity. The Commission, a national nonprofit organisation campaigning for ,the right to safe, wholesome food', says that seven common additives (including tartrazine, sodium benzoate and Ponceau 4R) are associated with hyperactivity in susceptible children. Checking the SPCs, it found that 28 of 70 children's medicines , including formulations of paracetamol, ibuprofen, amoxicillin, erythromycin and codeine phosphate throat linctus , contain at least one suspect additive. Digoxin may increase mortality in AF patients An observational study has suggested that digoxin may increase deaths in patients with atrial fibrillation (Heart 2008;94:191,6). The study was a planned subgroup analysis of a trial evaluating anticoagulant therapy in 7329 patients with atrial fibrillation. Of these, 53 per cent were treated with digoxin. Mortality was significantly higher among digoxin users than nonusers (4.22 vs 2.66 per cent per year); myocardial infarction and other vascular deaths (but not stroke, systemic embolic episodes and major bleeding events) were significantly more frequent with digoxin. Poor communications cause readmission Elderly hospital patients are often discharged with inadequate information or arrangements for care, causing almost three-quarters to be readmitted within a week, say investigators from Nottingham (Qual Safety Health Care 2008;17:71,5). Retrospective review of records for 108 consecutive patients aged over 75 found that readmission was related to medication in 38 per cent and, of these, 61 per cent were considered avoidable. Almost two-thirds had no discharge letter or were readmitted before the letter was typed; two-thirds of discharge letters had incomplete documentation of medication changes. Copyright © 2008 Wiley Interface Ltd [source] Evaluation of fungal antagonists for grey mould management in early growth of pot rosesANNALS OF APPLIED BIOLOGY, Issue 1 2004D S YOHALEM Summary Several filamentous fungi can reduce disease incidence and suppress sporulation of Botrytis cinerea during early establishment and vegetative growth of pot roses. Two isolates of Ulocladium atrum were the most successful of those fungi tested, were consistently more effective than the fungicide, iprodione and not different from each other. Tween 80, added as a dispersant, had no effect on the efficacy of U. atrum. An isolate of Clonostachys rosea also gave better disease control than iprodione, although not to the levels given by isolates of U. atrum, nor was its behaviour consistent across experiments. Another isolate of C. rosea performed well in one trial, had no discernible effect in a second and was excluded from the third due to poor inoculum quality. Commercial Trichoderma harzianum preparations (Trichodex and Supresivit) failed to reduce disease incidence under the high disease pressure of these experiments, but did reduce sporulation of the pathogen relative to untreated controls. [source] Impact of the predatory mite Anystis baccarum (Prostigmata: Anystidae) on apple rust mite Aculus schlechtendali (Prostigmata: Eriophyidae) populations in Northern Ireland Bramley orchardsANNALS OF APPLIED BIOLOGY, Issue 1 2003A G S CUTHBERTSON Summary Anystis baccarum is a common predatory mite in Northern Ireland Bramley orchards. To determine its effect on Aculus schlechtendali populations, sticky traps and sprays of demeton-S-methyl were used to exclude A. baccarum from branches. Out of four trials, exclusion of A. baccarum by sticky traps alone resulted in significantly greater numbers of A. schlechtendali in one trial. In the other trials where A. schlechtendali numbers were lower, there was either no effect, or possible evidence of fewer A. schlechtendali. The combination of demeton-S-methyl treatments and sticky traps to exclude A. baccarum resulted in significantly more A. schlechtendali in two trials out of three in 1998. It seems likely that this resulted from the dual effects of stimulation of A. schlechtendali reproduction by the acaricide and the absence of predation by A. baccarum, because acaricide treatment alone in 1999 resulted in significant reductions in A. schlechtendali numbers at the end of the season. This effect could have resulted from A. baccarum re-invading the treatment branches after the effects of the acaricide had worn off. It is recommended that growers are encouraged to conserve A. baccarum within their orchards. [source] Efficacy of bird-baited traps placed at different heights for collecting ornithophilic mosquitoes in eastern Queensland, AustraliaAUSTRALIAN JOURNAL OF ENTOMOLOGY, Issue 1 2009Cassie C Jansen Abstract To compare the efficacy of bird-baited traps with standard CO2 -baited Centers for Disease Control (CDC) light traps for collecting ornithophilic mosquito species, seven Latin square trials were conducted at six urban sites in Cairns and Brisbane, Australia. Traps were placed 1 m above ground level and 5,10 m according to tree canopy height. CO2 -baited CDC traps consistently collected more mosquitoes of all species than the bird-baited traps at all locations. In Brisbane, CO2 -baited CDC traps placed at ground level collected significantly more Culex annulirostris Skuse than those at canopy height during two trials, and more Aedes vigilax (Skuse) and Ae. procax (Skuse) during one trial each. Conversely, in Cairns, CO2 -baited CDC traps placed in the tree canopy collected significantly more Cx. squamosus (Taylor) during two trials, and significantly more Aedeomyia catasticta Knab and Cx. cubiculi Marks during one trial each. Consistently low yields of ornithophilic species including Cx. australicus Dobrotworsky & Drummond and Cx. quinquefasciatus Say in all traps tested suggests the need to employ alternative trapping measures to target these species in urban areas. [source] Antenatal Perineal Massage for Reducing Perineal TraumaBIRTH, Issue 2 2006M.M. Beckmann Background:, Perineal trauma following vaginal birth can be associated with significant short- and long-term morbidity. Antenatal perineal massage has been proposed as one method of decreasing the incidence of perineal trauma. Objectives:, To assess the effect of antenatal perineal massage on the incidence of perineal trauma at birth and subsequent morbidity. Search strategy:, We searched the Cochrane Pregnancy and Childbirth Group Trials Register (30 January 2005), the Cochrane Central Register of Controlled Trials (The Cochrane Library, Issue 1, 2005), PubMed (1966 to January 2005), EMBASE (1980 to January 2005) and reference lists of relevant articles. Selection criteria:, Randomised and quasi-randomised controlled trials evaluating any described method of antenatal perineal massage undertaken for at least the last four weeks of pregnancy. Data collection and analysis:, Both review authors independently applied the selection criteria, extracted data from the included studies and assessed study quality. We contacted study authors for additional information. Main results:, Three trials (2434 women) comparing digital perineal massage with control were included. All were of good quality. Antenatal perineal massage was associated with an overall reduction in the incidence of trauma requiring suturing (three trials, 2417 women, relative risk (RR) 0.91 (95% confidence interval (CI) 0.86 to 0.96), number needed to treat (NNT) 16 (10 to 39)). This reduction was statistically significant for women without previous vaginal birth only (three trials, 1925 women, RR 0.90 (95% CI 0.84 to 0.96), NNT 14 (9 to 35)). Women who practised perineal massage were less likely to have an episiotomy (three trials, 2417 women, RR 0.85 (95% CI 0.75 to 0.97), NNT 23 (13 to 111)). Again this reduction was statistically significant for women without previous vaginal birth only (three trials, 1925 women, RR 0.85 (95% CI 0.74 to 0.97), NNT 20 (11 to 110)). No differences were seen in the incidence of 1st or 2nd degree perineal tears or 3rd/4th degree perineal trauma. Only women who have previously birthed vaginally reported a statistically significant reduction in the incidence of pain at three months postpartum (one trial, 376 women, RR 0.68 (95% CI 0.50 to 0.91) NNT 13 (7 to 60)). No significant differences were observed in the incidence of instrumental deliveries, sexual satisfaction, or incontinence of urine, faeces or flatus for any women who practised perineal massage compared with those who did not massage. Authors' conclusions:, Antenatal perineal massage reduces the likelihood of perineal trauma (mainly episiotomies) and the reporting of ongoing perineal pain and is generally well accepted by women. As such, women should be made aware of the likely benefit of perineal massage and provided with information on how to massage. *** The preceding report is an Abstract of a regularly updated, systematic review prepared and maintained by the Cochrane Collaboration. The full text of the review is available in The Cochrane Library (ISSN 1464,780X). The Cochrane Database of Systematic Reviews 2006 Issue 1. Copyright © 2006 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. [source] Impact of fesoterodine on quality of life: pooled data from two randomized trialsBJU INTERNATIONAL, Issue 1 2008Con J. Kelleher OBJECTIVE To evaluate the effect of fesoterodine on health-related quality of life (HRQoL) in patients with overactive bladder (OAB) syndrome. PATIENTS AND METHODS Pooled data from two randomized placebo-controlled phase III studies were analysed. Eligible patients with frequency and urgency or urgency urinary incontinence were randomized to placebo or fesoterodine 4 or 8 mg for 12 weeks; one trial also included tolterodine extended release (tolterodine-ER) 4 mg. HRQoL was assessed using the King's Health Questionnaire (KHQ), International Consultation on Incontinence Questionnaire,Short Form (ICIQ-SF), a six-point Likert scale measuring the severity of bladder-related problems, and treatment response. RESULTS By the end of treatment, all active-treatment groups had significantly improved HRQoL compared with those on placebo, as shown by an improvement in the KHQ and ICIQ-SF scores, treatment response rate, and a major improvement in self-reported bladder-related problems. The fesoterodine 8-mg group had statistically significant improvements over placebo in eight of nine KHQ domains. Fesoterodine 4 mg and tolterodine-ER produced statistically significant improvements in seven of nine KHQ domains. Fesoterodine 8 mg gave better results than 4 mg in two domains; Emotions and Symptom Severity (P < 0.05). A major improvement (,2 points) in bladder-related problems was reported by 33% of patients on fesoterodine 4 mg, 38% on fesoterodine 8 mg, and 34% on tolterodine-ER, vs 21% on placebo (P < 0.001). CONCLUSIONS Fesoterodine significantly improved HRQoL in patients with OAB. Both fesoterodine 4 and 8 mg produced significant improvements on most KHQ domains, the ICIQ-SF, treatment response rate, and a Likert scale measuring bladder-related problems. [source] A systematic review of phase-II trials of thalidomide monotherapy in patients with relapsed or refractory multiple myelomaBRITISH JOURNAL OF HAEMATOLOGY, Issue 5 2006Axel Glasmacher Summary The activity of thalidomide in relapsed or refractory multiple myeloma is widely accepted but not yet demonstrated in a randomised-controlled trial. A systematic review of the published clinical trials of these patients could reduce the possible bias of single phase-II studies. A systematic search identified 42 communications reporting on 1674 patients. Thirty-two trials used an escalating dosing regimen and four a fixed dose regimen (one dose with 50 mg/d, three doses with 200 mg/d). The target dose in the dose escalating trials was 800 mg/d in 17 trials, 400,600 mg/d in 10 and 200 mg/d in one trial. The intention-to-treat population for efficacy was 1629 patients with a median age of 62 years. The complete and partial (>50% reduction in monoclonal protein) response rate was 29·4% (95%-confidence interval, 27,32%). The rates for minor responses or stable disease were 13·8% (12,16%) and 11·0% (9,13%). Progressive disease was reported in 9·9% (8,11%). The median overall survival from all trials was reported at 14 months. Severe adverse events (grade III,IV) included somnolence 11%, constipation 16%, neuropathy 6%, rash 3%, thrombo-embolism 3%, cardiac 2%. In conclusion, thalidomide monotherapy achieved complete and partial responses in 29·4% of patients with relapsed or refractory multiple myeloma. [source] Utilization of catheterization and revascularization procedures in patients with non-ST segment elevation acute coronary syndrome over the last decadeCATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, Issue 2 2005Glenn N. Levine MD Abstract The degree to which catheterization and revascularization procedures are utilized in patients with non-ST segment elevation acute coronary syndrome (NSTE-ACS) during hospitalization has broad implications with respect to initial pharmacotherapeutic decisions (upfront therapies), treatment and hospital transfer protocols, guideline recommendations, and allocation of training, material, and financial resources. Analysis of data from multiple trials and registries of patients with NSTE-ACS has the potential to assess more broadly utilization of invasive and revascularization procedures and provide a wide angle or bird's-eye view of the management of such patients, complementing the data obtained from any one trial or registry. We therefore undertook a systematic overview of all large trials and registries of patients with NSTE-ACS conducted over the last decade that were deemed appropriate to provide information on catheterization and revascularization procedures. Although not unexpectedly the percentage of patients with NSTE-ACS managed with cardiac catheterization, percutaneous coronary intervention (PCI), and coronary artery bypass grafting varies in different clinical trials and registries, general findings and trends were still discernable from these studies. During the initial treatment period, the majority of patients were ultimately treated with medical therapy alone (e.g., without revascularization). The percentage of those NSTE-ACS patients undergoing diagnostic cardiac catheterization who were then managed with PCI increased over the last decade and now stands at approximately 50%. Of NSTE-ACS patients who undergo revascularization, the percentage of those patients who are revascularized via PCI similarly increased, and PCI is currently the revascularization procedure utilized in approximately three-fourths of patients undergoing revascularization. The percentages of patients undergoing invasive and revascularization procedures were consistently higher in the U.S. cohorts of study subjects when compared to non-U.S. cohorts of study subjects. © 2005 Wiley-Liss, Inc. [source] Azathioprine for atopic dermatitisCLINICAL & EXPERIMENTAL DERMATOLOGY, Issue 5 2001S. J. Meggitt For adults with atopic dermatitis (AD) refractory to topical treatment, the choices of second-line therapy are limited. Furthermore, there are concerns about the long-term safety of treatments such as cyclosporin. Limited open studies suggest that azathioprine may be effective, although controlled trial data is lacking. Nevertheless, many UK dermatologists use azathioprine to treat patients with severe AD, despite the potential risk of serious toxicity. Azathioprine myelotoxicity and drug efficacy are now known to be related to the activity of a key enzyme in azathioprine metabolism, thiopurinemethyltransferase (TPMT). Recently, the facility for TPMT measurement has become more widely available, providing the possibility to optimize the therapeutic effect of azathioprine, yet minimise the risk of toxicity. We review the evidence concerning the use of azathioprine for AD, and have identified 128 cases in eight open studies, including our own prospective trial. Improvement in the majority was noted in seven studies, although objective measures of disease activity were used in only one trial. Measurements of TPMT activity were performed in the two most recent studies only. These data underscore the requirement for a prospective randomised controlled trial, and highlight the need to further investigate the role of TPMT measurement in azathioprine usage. [source] Nasal continuous positive airway pressure versus nasal intermittent positive pressure ventilation for preterm neonates: a systematic review and meta-analysisACTA PAEDIATRICA, Issue 1 2003AG De Paoli Aim: To determine whether nasal intermittent positive pressure ventilation (NIPPV) is more effective in preterm infants than nasal continuous positive airway pressure (NCPAP) in reducing the rate of extubation failure following mechanical ventilation, and reducing the frequency of apnoea of prematurity and subsequent need for endotracheal intubation. Methods: Randomized trials of NIPPV versus NCPAP were sought and their data extracted and analysed independently by the authors using the methodology of the Cochrane Collaboration. The analysis used relative risk (RR), risk difference (RD) and number needed to treat (NNT) with 95% confidence intervals. Results: The three studies identified, comparing NIPPV with NCPAP in the postextubation period, all used synchronized NIPPV (SNIPPV), which was more effective than NCPAP in preventing failure of extubation [RR 0.21 (0.10, 0.45), RD -0.32 (-0.45, -0.20), NNT 3 (2, 5)]. Two studies compared NIPPV versus NCPAP for the treatment of apnoea of prematurity. Although meta-analysis was not possible one trial showed a reduction in apnoea frequency with NIPPV and the other a trend favouring NIPPV. Conclusion: SNIPPV is an effective method of augmenting the beneficial effects of NCPAP in preterm infants in the postextubation period. Further research is required to delineate the role of NIPPV in the management of apnoea of prematurity. [source] | |||||||||||||