Post 21: 3rd March 2006
Latest Systematic Reviews
Latest Reports
Evidence from Journals
Latest Questions to the Primary Care Question Answering Service
Hitting the Headlines - Evidence Behind the Press Stories
Document of the Week from the National Library for Health
Latest Systematic Reviews
Beach J, Rowe BH, Blitz S, Crumley E, Hooton N, Russell K, Spooner C, Klassen T. Evidence
Report/Technology Assessment No. 129. (Prepared by the University of Alberta Evidence-based Practice Center, under Contract No. 290-02-0023.) AHRQ Publication No. 06-E003-2. Rockville, MD: Agency for Healthcare Research and Quality. November 2005.
Latest Reports
Tackling child obesity: First steps: Report by the Comptroller General prepared jointly by the Audit Commission, The Healthcare Commission and the National Audit Office: HC 801 Session 2005-2006
Bourn J
National Audit Office; Audit Commission; Healthcare Commission
London : National Audit Office, 2006
Series: 59p.
The hidden heroes of the NHS: Time to recognise staff grade and associate specialist doctors
Johnson JN
British Medical Association
Imprint: London : BMA, 2006
50p.
Self-sufficiency in blood products in England and Wales: A chronology from 1973 to 1991
Department of Health
London : DoH, 2006
49p.
This report contains a chronology of events and an analysis of the key issues, including: developing understanding of the seriousness of the Hepatitis C virus; the evolving understanding of the viral risks associated with pooled blood products, both domestically produced and imported, and how this influenced policy; and more.
Sausage and mash and sustainability: a different type of food supplement
Purvis A
Department for Environment, Food and Rural Affairs
London : DEFRA, 2006
24p.
Managing personal change workbook
Cheshire and Merseyside SHA; Wellstead Associates
Stockton Heath : Cheshire and Merseyside SHA, 2005
55p.
Screening for breast cancer in England: past and future
Beral V
Advisory Committee on Breast Cancer Screening
Sheffield : NHS Cancer Screening Programmes, 2006
Description: 60p.
The purpose of the report is to review all available evidence on the benefits and risks associated with the NHS Breast Screening Programme and to draw firm conclusions about its effectiveness. The report estimates that the NHS Breast Screening Programme is saving 1,400 lives every year in England. The report also shows that women who attend for screening are not only less likely to die from breast cancer but are also less likely to be treated with a mastectomy than those who are not screened.
NHS Health Technology Assessment programme: Annual report 2005
National Coordinating Centre for Health Technology Assessment
Southampton : NCCHTA, 2006
This report, for clinicians, managers and users of the NHS and others interested in research, gives a brief outline of how the HTA programme works and the progress it has made in the past year. It includes information about the expanded role of the HTA programme in the new NHS R&D strategy, as well as details about the programme's new expert advisory panel on disease prevention.
Evaluating the activities of the Healthcare Commission
Healthcare Commission
London : Healthcare Commission, 2006
This paper sets out a high-level strategy for evaluating the impact of the Healthcare Commission’s activities over the next 12 to 18 months. A subsequent paper will cover other activities up to 2008. The primary aim of the evaluation is to assess the impact that the Healthcare Commission is having on the organisations that it assesses and inspects, and to assess how successful it is being in promoting improvements in healthcare for patients and the public.
Health equity audit: Learning from practice briefing
National Institute for Health and Clinical Excellence
London : NICE, 2006
32p.
The National Institute for Health and Clinical Excellence (NICE) has published Health equity audit : learning from practice briefing. This briefing provides a summary of learning from three workshops on HEA, and examples of completed or near-completed HEAs to illustrate these learning points.
Public service productivity: Health
Office for National Statistics
London : ONS, 2006
48p.
The Office of National Statistics (ONS) has published Public service productivity : health, which builds on the first health productivity publication in October 2004. The article discusses various methodologies and measures of quality improvements in the National Health Service. It estimates the change in productivity associated with public expenditure on health using National Accounts data from 1995 to 2004, in the context of wider information about health spending, output, outcomes and measurement issues. The main publication has a complementary technical article on sources and methods.
Sources and methods for public service productivity: Health
Supporting people with long term conditions to... self care: A guide to developing local strategies and good practice
Department of Health
London : DoH, 2006
56p.
The Department of Health has published a report on Supporting people with long term conditions to self care. The report is a guide for health and social care services to develop local strategies and good practice through an integrated package which includes information, self monitoring devices, self care skills, education and training and self care support networks.
The Intelligent Board
Wells W
Dr Foster Intelligence
London : Dr Foster Intelligence, 2006
46p.
The Intelligent Board proposes a basic set of criteria that Information Boards of acute and mental health trusts should have if they are to provide effective strategic leadership and monitoring of hospital performance.
The report highlights particular information challenges:
Action is required to avoid overloading Boards with excessive detail, and to present clear information on trends in performance and comparisons with others
Under payment by results, trust Boards need to pay much closer attention to cash-flow and the margins between revenues and costs on key areas of hospital activity
Trusts need a far better and more frequently updated understanding of how patients, their families and GPs feel about their experiences of the hospital
Bird flu (avian influenza): Public health advice for those going to or returning from Bird flu-affected areas: disease risk
Department of Health
London : DoH, 2006
4p.
This leaflet provides public health advice for those going to or returning from Bird flu-affected areas. It contaings information on this potentially serious disease and the precautions you should take to help protect yourself.
Travellers should be aware that cases of a severe form of bird flu are occurring in poultry and wild birds in some parts of the world.
Electronic prescription service
NHS Connecting for Health
Leeds : Connecting for Health, 2006
5p.
Connecting for Health (CfH) has published ‘The electronic prescription service’ (EPS), a leaflet which was distributed to healthcare professionals with last week’s Pharmaceutical Journal and Chemist and Druggist.
The leaflet explains the basis of how EPS works and discusses implementation of the system. Further information and resources are available from the link below, including a fact sheet on EPS.
Consultation on The Draft National Health Service (Functions of Strategic Health Authorities and Primary Care Trusts and Administration Arrangements) (England) (Amendment) Regulations 2005: Summary of Responses
Department of Health
London : Department of Health, 2006
6p.
Evidence from Journals
Mihalopoulos C, Kiropoulos L, Shih ST, Gunn J, Blashki G, Meadows G. (2005) Exploratory economic analyses of two primary care mental health projects: implications for sustainability. Med J Aust. 2005 Nov 21;183(10 Suppl):S73-6.
Thomas TR Rosemann , Katharina KJ Joest , Thorsten TK Koerner , Marc MH Heiderhoff , Rainer RS Schaefert and Joachim JS Szecsenyi (2006) How can the practice nurse be more involved in the care of the chronically ill? The perspectives of GPs, patients and practice nurses. BMC Family Practice 2006, 7:14
Background: A well established "midlevel" of patient care, such as nurse practitioners and/or physician assistants, exits in many countries like the US, Canada, and Australia. In Germany, however there is only one kind of profession assisting the physician in practices, the practice nurse. Little is known about the present involvement of practice nurses in patients' care in Germany and about the attitudes of GPs, assistants and patients concerning an increased involvement. The aim of our study was to get qualitative information on the extent to which practice nurses are currently involved in the treatment of patients and about possibilities of increased involvement as well as on barriers of increased involvement.
Methods: We performed qualitative, semi-structured interviews with 20 GPs, 20 practice nurses and 20 patients in the Heidelberg area. The interviews were digitally recorded, transcribed and content-analysed with ATLAS.ti.
Results: Practice nurses are only marginally involved in the treatment of patients. GPs as well as patients were very sceptical about increased involvement in care. Patients were sceptical about nurses' professional background and feared a worsening of the patient doctor relationship. GPs also complained about the nurses' deficient education concerning medical knowledge. They feared a lack of time as well as a missing reimbursement for the efforts of an increased involvement. Practice nurses were mostly willing to be more involved, regarding it as an appreciation of their role. Important barriers were lack of time, overload with administrative work, and a lack of professional knowledge.
Conclusions: Practice nurses were only little involved in patient care. GPs were more sceptical then patients regarding an increased involvement. One possible area, accepted by all interviewed groups, was patient education as for instance dietary counselling. New treatment approaches as the chronic care model will require a team approach which currently only marginally exists in the German health care system. Better medical education of practice nurses is indispensable, but also GPs have to accept that they can not fulfil the requirement of future care alone.
Rosemann T, Korner T, Wensing M, Gensichen J, Muth C, Joos S, Szecsenyi J. (2005)
Rationale, design and conduct of a comprehensive evaluation of a primary care based intervention to improve the quality of life of osteoarthritis patients. The PraxArt-project: a cluster randomized controlled trial. BMC Public Health. Jul 19;5:77.
BACKGROUND: Osteoarthritis (OA) has a high prevalence in primary care. Conservative, guideline orientated approaches aiming at improving pain treatment and increasing physical activity, have been proven to be effective in several contexts outside the primary care setting, as for instance the Arthritis Self management Programs (ASMPs). But it remains unclear if these comprehensive evidence based approaches can improve patients' quality of life if they are provided in a primary care setting.
METHODS/DESIGN: PraxArt is a cluster randomised controlled trial with GPs as the unit of randomisation. The aim of the study is to evaluate the impact of a comprehensive evidence based medical education of GPs on individual care and patients' quality of life. 75 GPs were randomised either to intervention group I or II or to a control group. Each GP will include 15 patients suffering from osteoarthritis according to the criteria of ACR.In intervention group I GPs will receive medical education and patient education leaflets including a physical exercise program. In intervention group II the same is provided, but in addition a practice nurse will be trained to monitor via monthly telephone calls adherence to GPs prescriptions and advices and ask about increasing pain and possible side effects of medication.In the control group no intervention will be applied at all. Main outcome measurement for patients' QoL is the GERMAN-AIMS2-SF questionnaire. In addition data about patients' satisfaction (using a modified EUROPEP-tool), medication, health care utilization, comorbidity, physical activity and depression (using PHQ-9) will be retrieved.Measurements (pre data collection) will take place in months I-III, starting in June 2005. Post data collection will be performed after 6 months.
DISCUSSION: Despite the high prevalence and increasing incidence, comprehensive and evidence based treatment approaches for OA in a primary care setting are neither established nor evaluated in Germany. If the evaluation of the presented approach reveals a clear benefit it is planned to provide this GP-centred interventions on a much larger scale.
Zillich AJ, et al. (2005) Hypertension outcomes through blood pressure monitoring and evaluation by pharmacists (HOME study). J Gen Intern Med. Dec;20(12):1091-6.
OBJECTIVE: To evaluate the effectiveness of a community pharmacist-based home blood pressure (BP) monitoring program.
DESIGN: Trial of a high-intensity (HI) versus low-intensity (LI) intervention randomized in 12 community pharmacies. The HI intervention comprised 4 face-to-face visits with a trained pharmacist. Pharmacists provided patient-specific education about hypertension. Following the first and third visits, patients were provided with a home BP monitoring device and instructed to measure their BP at least once daily for the next month. Home BP readings were used by the pharmacists to develop treatment recommendations for the patient's physician. Recommendations were discussed with the physician and, if approved, implemented by the pharmacist. In the LI intervention, pharmacists measured patients BP in the pharmacy and referred them to their physician for evaluation.
PARTICIPANTS: Patients with uncontrolled BP at baseline.
MEASUREMENTS: The main outcomes were the differences in systolic and diastolic BP (SBP and DBP) from baseline to follow-up between the HI and LI patients. RESULTS: The study enrolled 125 patients, 64 in the HI and 61 in the LI group. From baseline, SBP declined 13.4 mmHg in the HI group and 9.0 mmHg in the LI group. At the final visit, the difference in SBP/DBP change between the HI and LI group was -4.5/-3.2 mmHg (P=.12 for SBP and P=.03 for DBP).
CONCLUSIONS: The HI intervention achieved a lower DBP and this model could be a strategy for patients with hypertension.
Irwin, et al. (2006) Comparative meta-analysis of behavioral interventions for insomnia and their efficacy in middle-aged adults and in older adults 55+ years of age. Health Psychol. Jan;25(1):3-14.
Meta-analyses support the effectiveness of behavioral interventions for the treatment of insomnia, although few have systematically evaluated the relative efficacy of different treatment modalities or the relation of old age to sleep outcomes. In this meta-analysis of randomized controlled trials (k = 23), moderate to large effects of behavioral treatments on subjective sleep outcomes were found. Evaluation of the moderating effects of behavioral intervention type (i.e., cognitive-behavioral treatment, relaxation, behavioral only) revealed similar effects for the 3 treatment modalities. Both middle-aged adults and persons older than 55 years of age showed similar robust improvements in sleep quality, sleep latency, and wakening after sleep onset. A research agenda is recommended to examine the mechanisms of action of behavioral treatments on sleep with increased attention to the high prevalence of insomnia in older individuals.
Conen D, et al. (2006) Usefulness of B-type natriuretic Peptide and C-reactive protein in predicting the presence or absence of left ventricular hypertrophy in patients with systemic hypertension. Am J Cardiol. Jan 15;97(2):249-52. Epub 2005 Nov 21. |
The diagnosis of left ventricular (LV) hypertrophy, an independent predictor of death and cardiovascular events, is difficult without using echocardiography. This study tested the hypothesis whether C-reactive protein (CRP) and B-type natriuretic peptide (BNP) would be useful to exclude echocardiographic LV hypertrophy. Consecutive hypertensive outpatients were asked to participate. Exclusion criteria were overt heart failure, severe renal insufficiency or any other severe concomitant illness. A venous blood sample was taken to measure plasma CRP and BNP concentrations. Echocardiographic LV hypertrophy was defined as LV mass > or =125 g/m2 for men and > or =110 g/m2 for women. In total, 320 patients were studied, and 37 patients (12%) had echocardiographic LV hypertrophy. Patients with LV hypertrophy were significantly older and had higher CRP and BNP concentrations and higher systolic blood pressure than those without LV hypertrophy. The optimal cut-off points for the diagnosis of LV hypertrophy were 35 pg/ml for BNP (sensitivity 73%, specificity 72%) and 2.5 mg/L for CRP (sensitivity 68%, specificity 59%). Only 1 of 123 patients with values of BNP and CRP less than the optimal cut-off point had echocardiographic LV hypertrophy, resulting in a high negative predictive value of 99% for the 2 blood tests combined to exclude LV hypertrophy. In conclusion, in hypertensive patients, echocardiographic LV hypertrophy can be excluded on the basis of a single blood sample for the determination of BNP and CRP.
Wolfe J, et al. (2006) Formoterol, 24 microg bid, and serious asthma exacerbations: similar rates compared with formoterol, 12 microg bid, with and without extra doses taken on demand, and placebo. Chest. Jan;129(1):27-38.
STUDY OBJECTIVES: The primary objective was to determine whether high-dose formoterol, 24 mug bid, was associated with more asthma exacerbations compared with lower formoterol doses in patients with stable persistent asthma. Serious asthma exacerbations (life threatening or requiring hospitalization) were the primary end point. Secondary end points included significant exacerbations requiring systemic corticosteroids, all exacerbations, and changes in FEV1.
DESIGN: In a multicenter, placebo-controlled, parallel-group study, patients were randomized to 16 weeks of treatment with formoterol, 24 microg bid; formoterol, 12 microg bid, with up to two additional 12-microg doses daily on demand for worsening symptoms (12 microg bid plus on demand); formoterol, 12 microg bid; or placebo. The formoterol 12-microg-bid plus on-demand regimen was administered open label, while the other three regimens were double blind.
SETTING: Outpatient clinics.
PATIENTS: A total of 2,085 patients aged > or = 12 years with stable, persistent asthma were enrolled and treated; 65% (n = 1,347) received regular concomitant antiinflammatory therapy during the study.
MEASUREMENTS AND RESULTS: Nine patients had respiratory-related serious adverse events (SAEs) requiring hospitalization: two patients (0.4%) in the 24-microg-bid group; one patient (0.2%) in the 12-microg-bid plus on-demand group; five patients (0.9%) in the 12-microg-bid group; and one patient (0.2%) in the placebo group. All of these events were asthma related, except for two SAEs in the 12-microg-bid group that were later considered not to be asthma related by independent reviewers who were not associated with the conduct of the study. The proportions of patients with significant asthma exacerbations (requiring systemic corticosteroids) were similar in the 24-microg-bid group (6.3%, 33 of 527 patients), 12-microg-bid group (5.9%, 31 of 527 patients) and placebo group (8.8%, 45 of 514 patients) and lower in the 12-microg-bid plus on-demand group (4.4%, 23 of 517 patients; p = 0.0057 vs placebo). All treatments were well tolerated. All formoterol treatment regimens had a significant effect on FEV1 measured 2 h after dose during the study (p < 0.0001 vs placebo); and on predose trough FEV1 measured at all visits after baseline (p < 0.002 vs placebo).
CONCLUSIONS: Treatment with formoterol, 24 microg bid, was not associated with an increase in serious asthma exacerbations compared with the lower formoterol doses or placebo.
Hindley D, et al. (2006) A randomised study of ``wet wraps`` versus conventional treatment for atopic eczema. Arch Dis Child. 2006 Feb;91(2):164-8. Epub 2005 Nov 24.
AIMS: To compare two treatments in common usage for children with atopic eczema: "wet wrap" bandages versus conventional topically applied ointments. METHODS: A total of 50 children (age 4-27 months) with moderate to severe eczema were randomised to one or other treatment. Two research nurses supervised the study. The first gave advice and support, and the second, blinded to the treatment modality being used, scored the change in eczema severity over a period of four weeks using the SCORAD eczema severity scale.
RESULTS: Both treatments gave a benefit in overall SCORAD scores (mean change for wet wrap group was 53 to 24; for the conventional group, 41 to 17). There was no significant difference between the two groups in terms of overall improvement at four weeks or in the timescale of improvements. The amount of topical of topical steroid used was similar in both groups. The wet wrap group suffered significantly more skin infections requiring antibiotics. Carers reported that wet wraps were less easy to apply than conventional treatment.
Pompeii LA, et al. Physical exertion at work and the risk of preterm delivery and small-for-gestational-age birth. Obstet Gynecol. 2005 Dec;106(6):1279-88.
OBJECTIVE: To assess whether exposure to standing, lifting, night work, or long work hours during 3 periods of pregnancy are associated with an increased risk of preterm or small-for-gestational-age birth.
METHODS: The Pregnancy, Infection and Nutrition study is a prospective cohort with a nested case-control component that was conducted through clinic and hospital settings in Central North Carolina. A total of 1,908 women pregnant with a singleton gestation were recruited during prenatal visits from January 1995 through April 2000 and provided information during telephone and face-to-face interviews about physical exertion for the 2 longest-held jobs during pregnancy.
RESULTS: No significant elevations in preterm delivery were observed among women who lifted repeatedly or stood at least 30 hours per week, with no changes in risk estimates over the course of pregnancy. A 50% elevation in the risk of preterm delivery (relative risk 1.5, 95% confidence interval 1.0-2.0; first trimester) was observed among women who reported working at night (10:00 PM to 7:00 AM), whereas a 40% reduction in risk was observed among women working at least 46 hours per week (relative risk 0.6, 95% confidence interval 0.4-0.9; first trimester), regardless of period of exposure. No elevations in small-for-gestational-age birth were observed among women exposed to any of the 4 types of occupational exertion.
CONCLUSION: Physically demanding work does not seem to be associated with adverse pregnancy outcomes, whereas working at night during pregnancy may increase the risk of preterm delivery. Studies to examine the effect of shift work on uterine activity would help to clarify the possibility of a causal effect on preterm birth.
Hoepffner N, et al. Comparative evaluation of a new bedside faecal occult blood test in a prospective multicentre study. Aliment Pharmacol Ther. 2006 Jan 1;23(1):145-54.
BACKGROUND: Faecal occult blood testing is an established method of colorectal neoplasia screening. Guaiac-based tests are limited by poor patient compliance, low sensitivity, specificity and positive predictive value. Newer immunochemical-based tests, accurate but tedious, require a well-established laboratory set up. There is need for simpler immunochemical tests that can be performed at the out-patient clinic.
AIM: To compare the performance characteristics of a new bedside immunological test strip device with a sensitive Guaiac-based and established immunochemical test for detection of faecal occult blood in patients undergoing colonoscopy.
METHODS: A total of 389 consecutive patients from four centres who were referred for colonoscopy also provided the stool samples for detection of occult blood without dietary restrictions. Stool tests performed were (i) Guaiac-based, (ii) immunochemical enzyme-linked immunosorbent assay and (iii) bedside immunochemical strip test. RESULTS: At the optimal threshold level, the sensitivity and specificity of the beside immunochemical strip test for detection of significant colorectal neoplasia (adenomas >1.0 cm and carcinomas) were 60% and 95%, respectively.
CONCLUSIONS: This bedside immunochemical strip test proved to be a simple, convenient, non-cumbersome and accurate tool with similar performance characteristics for detection of any bleeding lesion including colorectal neoplasia when compared with an established immunochemical faecal occult blood test.
Latest Questions to the Primary Care Question Answering Service
Assessment and Diagnosis
1) Is there any evidence of benefit of using pulse oximeters in the assessment of patients with respiratory disorders (Pleuritic chest pains, asthma) in the general practice setting? 2) Also any evidence of positive or negative predictive values of normal and abnormal oxygen levels (detected by pulse oximetry) in disorders such as Pulm embolism etc?
A 26 year old patient wants to delay starting her family until she is 30 years old. Her mother had menopause at age 40yrs and sister at mid 30s. What is the likelyhood of her having premature menopause?
What causes a raised ESR and normal CRP?
What is the difference between central and peripheral vertigo?
What general factors influence the selection of an antibiotic regime
If a gap occurs between 1st and 2nd doses of Hepatitis B vaccine, at what point should consideration be given to restarting the vaccination course?
What evidence is there that too big a cuff will produce erroneous bp readings?
Is unilateral breast enlargement in an otherwise healthy and normally developed 18/12 old child simply a variant of normal or should it be investigated further?
I would like to ask about monitoring of patients on venlafaxine. When should we be checking BP - I presume we should check before treatment starts but how often during treatment. Also is it necessary to perform an ECG and if so why?
Where can I find predicted peak flow charts for adults and children online?
Cancer
Given that the evidence suggests that people older than 69 stand to significantly benefit from screening for colorectal cancer, why has the government chosen the cut-off 60-60 for the screening programme?
Causes, Risks and Prevention
Is it ok to give Depo Provera in the buttock in obese women?
Can saw palmetto be causing a man of 76 to develop abnormal LFTs, and if so how common/likely is this?
Is there any evidence that corticosteroids injection can cause shingles?
When giving 2 or more vaccinations into the same site, how far apart should they be given?
In a patient ages 38, complaining of severe tingling and pins and needles in her fingers, both feet, lower lip and tip of the tongue for one week, what investigations and management plan would be appropriate?
Does Betnovate RD produce less skin atrophy than Halciderm?
Can a 57 year old lady with OA and type 2 DM take glucosamine - are there any contraindications?
Is there evidence to support the concomitant use of cabergoline or bromocriptine for treating hyperprolactinaemia in patients on risperidone?
Can you prescribe HRT for someone with focal migraines. If not what can be tried for her flushes? Also would HRT be advisable to protect her bones?
Can raised uric acid or gout could cause tinnitus?
Child Health
In acute otitis media but should antibiotics be used in an acutely discharging ear post otitis media in children and if so how long after the discharge starts?
Infections Disease
Does the evidence support a patient's request for long term antibiotics to treat her multiple sclerosis?
Musculoskeletal Disease
Is there evidence that the once a month biphosphanate ibandronate is superior to the currently available daily or once a week currently available preparations in preventing osteoporotic fractures
Hitting the Headlines - Evidence Behind the Press Stories
'Arthritis painkiller could double the risk of heart attack'
The painkiller celecoxib, marketed under the name Celebrex, may double the risk of heart attacks, reported four newspapers on 1 March 2006.(1-4) The generally accurate reports were based on a well-conducted systematic review of randomised controlled trials, the findings of which appear reliable.(5)
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The painkiller celecoxib, one of a class of drugs called Cox-2 inhibitors, may double the risk of heart attacks, reported four newspapers on 1 March 2006.(1-4) All the reports included reference to the withdrawal of Vioxx, another Cox-2 inhibitor, from markets in 2004 after researchers found that it increased the risk of heart attacks and strokes.
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The newspaper articles were based on a well-conducted systematic review of randomised controlled trials that compared celecoxib with placebo, diclofenac, ibuprofen or paracetamol, involving 12,780 participants.(5)
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The review authors concluded that there was an increased risk of myocardial infarction with celecoxib therapy, consistent with a class effect for COX-2 specific inhibitors. The newspapers accurately reported these findings, which appear reliable.
Evaluation of the evidence base for heart attack risk of celecoxib
Where does the evidence come from?
The evidence comes from research conducted at the Medical Research Institute of New Zealand, led by Brent Caldwell. The research was funded by a bequest of the Estate of Beverley Liddington.
What were the authors' objectives?
The objective was to examine the risk of cardiovascular events associated with the use of celecoxib.
What was the nature of the evidence?
The study was a systematic review of double-blind randomised controlled trials of celecoxib compared with placebo, paracetamol or a non-steroidal anti-inflammatory drug (NSAID). Six trials, with a total of 12,780 participants were included in the review.
What interventions were examined in the research?
Studies of at least six weeks' duration that randomised patients to celecoxib or placebo, paracetamol or an NSAID, and reported serious cardiovascular thromboembolic events were eligible for inclusion in the review. Estimates of the odds ratios for risk of cardiovascular events with celecoxib compared with the comparator treatment were calculated. The main outcome measure was myocardial infarction.
What were the findings?
There was a statistically significant increase in the risk of myocardial infarction with celecoxib (1.13% patients) compared with placebo (0.41% patients) based on three studies. There was no statistically significant increase in composite cardiovascular events, cardiovascular deaths or stroke.
There was a statistically significant increase in the risk of myocardial infarction with celecoxib (0.83% patients) compared with placebo, diclofenac, ibuprofen or paracetamol (0.38% patients) based on five studies. There was no statistically significant increase in composite cardiovascular events, cardiovascular deaths or stroke.
It was not possible to investigate the effect of different dosages and duration of treatment owing to the small number of studies included.
What were the authors' conclusions?
The authors concluded that the available data indicate an increased risk of myocardial infarction with celecoxib therapy, consistent with a class effect for COX-2 specific inhibitors.
How reliable are the conclusions?
This was a well conducted systematic review and the conclusions are likely to be reliable.
The inclusion criteria for the review were well defined and a thorough search strategy was used to identify relevant trials, including contacting the manufacturer of celecoxib. Selection of studies and data extraction were carried out independently by two reviewers, which helps reduce the potential for bias and error. The methods used to pool studies appear to have been appropriate. The included studies were primarily designed to determine the efficacy of celecoxib and risk of gastrointestinal adverse events, therefore, each of the individual studies was underpowered to identify the risk of myocardial infarction. The quality of the included studies does not appear to have been systematically assessed, however, only double-blind randomised controlled trials were included.
Systematic reviews
Information staff at CRD searched for systematic reviews relevant to this topic. Systematic reviews are valuable sources of evidence as they locate, appraise and synthesize all available evidence on a particular topic.
There were no related systematic reviews identified on the Cochrane Database of Systematic Reviews (CDSR) or on the Database of Abstracts of Reviews of Effects (DARE).
References and resources
1. Painkiller 'may double risk of heart attacks'. Daily Telegraph, 1 March 2006, p7.
2. Arthritis painkiller could double the risk of a heart attack. Daily Mail, 1 March 2006, p15.
3. Heart attack risk of painkiller used by 600,000 people. Daily Express, 1 March 2006, p28.
4. Warning over painkiller issued. Independent, 1 March 2006, p8.
Consumer information
Previous Hitting the Headlines summaries on this topic
Anti-inflammatory drugs and risk of heart attack. Hitting the Headlines archive, 16th June 2005.
New pill for arthritis. Hitting the Headlines archive, 20th August 2004.
Melatonin for the treatment of tinnitus
Melatonin, a drug used for jet lag, could help sufferers of tinnitus, reported the Daily Mail on 28 February 2006 (1). The report was based on a small uncontrolled trial, whose findings would need to be confirmed in a larger placebo-controlled trial. The newspaper's brief report was generally accurate.
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The Daily Mail (1) reported that melatonin, a hormone naturally produced by the pineal gland that helps to control the body's sleep-wake cycle, could help sufferers of tinnitus. However, they also quote the chairman of the British Tinnitus Association as stating that patients probably felt better because they were sleeping better, rather than melatonin actually having a direct effect on the condition itself.
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The research (2) was a very small uncontrolled trial involving 20 patients with tinnitus. The authors' conclusions that melatonin use is associated with improvements in tinnitus and sleep would need to be confirmed in a larger, placebo-controlled trial, before any recommendations can be made for its use in the treatment of tinnitus.
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The newspaper report was generally accurate, although the headline overstated the improvement in tinnitus symptoms found in the trial, which was not clinically significant.
Evaluation of the evidence base for treatment of tinnitus
Where does the evidence come from?
The evidence comes from research conducted at the Clinical Outcomes Research Office, Department of Otolaryngology-Head and Neck Surgery, Washington University School of Medicine, led by Uchechukwu Megwalu.
What were the authors' objectives?
The objective was to determine whether melatonin improves tinnitus in patients with idiopathic nonpulsatile tinnitus and if the improvement is related to improvement in sleep.
What was the nature of the evidence?
The study was a small uncontrolled trial involving 20 adult patients who had idiopathic, troublesome, unilateral or bilateral, nonpulsatile tinnitus of at least 6 months' duration. Patients had to score 25 or more, out of a possible 100, on the Tinnitus Handicap Inventory to be eligible for inclusion in the study. Patients with tinnitus related to cochlear implantation, retrocochlear lesion or other known anatomic and structural lesions of the ear and temporal bone were not eligible for the study.
What interventions were examined in the research?
Patients were asked to take a 3 mg melatonin pill every night, one to two hours before going to bed, for four weeks, followed by 4 weeks of observation. Patients were asked to complete the Tinnitus Handicap Inventory and the Pittsburgh Sleep Quality Index questionnaires at the beginning of the study and at two weeks, four weeks, six weeks and eight weeks. The authors predefined a drop of 10 points in the Tinnitus Handicap Inventory to be a minimally important difference and a change of 2.5 points, out of a possible 21 points, on the Pittsburgh Sleep Quality Index to be clinically significant.
What were the findings?
Of 20 patients who enrolled in the study, two dropped out after four weeks due to loss of interest. No adverse effects of melatonin were reported by any of the patients.
There was a statistically significant, but not clinically significant, decrease in the Tinnitus Handicap Inventory score between the beginning of the study and the end of treatment (p=0.02) and between the beginning of the study and four weeks after the end of treatment (p=0.006).
There was a statistically significant and clinically significant decrease in the Pittsburgh Sleep Quality Index score between the beginning of the study and the end of treatment (p<0.0001)>
There was a statistically significant association between the change in the Pittsburgh Sleep Quality Index and the change in the Tinnitus Handicap Inventory between the beginning of the study and the end of treatment, but not between the beginning of the study and four weeks after the end of treatment.
What were the authors' conclusions?
The authors concluded that melatonin use is associated with improvement in tinnitus and sleep and that there was an association between the amount of improvement in sleep and tinnitus.
How reliable are the conclusions?
This was a very small, uncontrolled trial. The outcomes measured appear to have been appropriate and the authors used validated tinnitus and sleep quality scales. However, 15% of the included patients had pulsatile tinnitus; the inclusion criteria stated that patients had to have nonpulsatile tinnitus, therefore, these patients did not meet the trial's inclusion criteria. No assessment of patient compliance with medication was made.
The authors' conclusions are supported by the findings of the trial. However, the findings need to be confirmed in a larger, placebo-controlled trial. The authors state that they are currently planning a large prospective randomised placebo-controlled trial to study the therapeutic efficacy of melatonin in the treatment of tinnitus. The authors refer to a previous placebo controlled trial of melatonin for tinnitus which found an improvement in tinnitus with melatonin and with placebo, but no difference in improvement between the two groups (3).
Systematic reviews
Information staff at CRD searched for systematic reviews relevant to this topic. Systematic reviews are valuable sources of evidence as they locate, appraise and synthesize all available evidence on a particular topic.
There were no related systematic reviews identified on the Cochrane Database of Systematic Reviews (CDSR) or on the Database of Abstracts of Reviews of Effects (DARE).
References and resources
1. Jet-lag drug can end misery of tinnitus. Daily Mail, 28 February 2006, p50.
3. Rosenberg SI, Silverstein H, Rowan PT, Olds MJ. Effect of melatonin on tinnitus. Laryngoscope 1998;103(3):305-10.
Consumer information
NHS Direct Online Health Encyclopaedia - Tinnitus
RNID Information and Resources for Tinnitus
Previous Hitting the Headlines summaries on this topic
Effectiveness of Ginkgo biloba in treating tinnitus. Hitting the Headlines archive, 25 January 2001.
Viagra 'could be a remedy' for Crohn's disease
Viagra could be a remedy for Crohn's disease, reported The Guardian (1). The newspaper accurately reported the findings of a study investigating the causes of Crohn's disease. A clinical trial is needed before the usefulness of Viagra in the treatment of Crohn's disease is known.
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Viagra could be used as a treatment for Crohn's disease, reported The Guardian (1).
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The story was based on an experimental study which was primarily an investigation into the causes of Crohn's disease (2). Researchers studied the immune response to killed bacteria and acute trauma caused by biopsy of the bowel in individuals with Crohn's disease, ulcerative colitis, and non-inflammatory bowel disease. After injection with killed bacteria, patients with Crohn's disease showed an abnormally low increase in bloodflow at the site of the injection. Ten individuals with Crohn's disease and five healthy individuals were given 50mg Viagra either 24 or 48 hours after bacterial injection. Most patients showed a significant increase in blood flow after taking Viagra. The authors concluded that vasodilatatory drugs such as Viagra may be useful in healing or preventing lesions in Crohn's disease. The results are preliminary and a clinical trial is needed before the effectiveness of Viagra in the treatment of Crohn's disease is known.
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The newspaper accurately reported the findings of the study, and noted the researchers' intention to carry out a clinical trial to determine whether Viagra, or a similar drug, could actually aid healing in the gut of people with Crohn's disease.
Systematic reviews
Information staff at CRD searched for systematic reviews relevant to this topic. Systematic reviews are valuable sources of evidence as they locate, appraise and synthesize all available evidence on a particular topic.
There were no related systematic reviews identified on the Cochrane Database of Systematic Reviews (CDSR) or on the Database of Abstracts of Reviews of Effects (DARE).
References and resources
1. Bowel disease researchers find Viagra could be a remedy.The Guardian, 24 February 2006, p24.
Consumer information
The National Association for Colitis and Crohn's Disease (NACC)
CORE - Digestive Disorders Foundation
Previous Hitting the Headlines summaries on this topic
New drug gives hope to Crohn's sufferers? Hitting the Headlines archive, 27 March 2001.
Document of the Week from the National Library for Health
"Demonstrating Excellence in Practice-based Teaching for Public Health"
The aim of this report, published by the Association of Schools of Public Health, is to bridge the gap between public health schools and public health practitioners so that public health professionals can improve their knowledge in their working environment.
This document provides the following:
- explanation of practice-based teaching
- instructions for implementing of practice-based teaching, eg hints and tips for organising and evaluating session
- practical examples
- suggestions for building links between public health practitioners and professional public health education and training
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