Post 23: 17 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
What's New from the National Library for Health
Latest Systematic Reviews
Shipman SA, et al. Screening for developmental dysplasia of the hip: a systematic literature review for the US Preventive Services Task Force. Pediatrics. 2006 Mar;117(3):e557-76.
BACKGROUND: Developmental dysplasia of the hip (DDH) represents a spectrum of anatomic abnormalities that can result in permanent disability.
OBJECTIVE: We sought to gather and synthesize the published evidence regarding screening for DDH by primary care providers.
METHODS: We performed a systematic review of the literature by using a best-evidence approach as used by the US Preventive Services Task Force. The review focused on screening relevant to primary care in infants from birth to 6 months of age and on interventions used in infants before 1 year of age.
RESULTS: The literature on screening and interventions for DDH suffers from significant methodologic shortcomings. No published trials directly link screening to improved functional outcomes. Clinical examination and ultrasound identify somewhat different groups of newborns who are at risk for DDH. A significant proportion of hip abnormalities identified through clinical examination or ultrasound in the newborn period will spontaneously resolve. Very few studies examine the functional outcomes of patients who have undergone therapy for DDH. Because of the high rate and unpredictable nature of spontaneous resolution of DDH and the absence of rigorous comparative studies, the effectiveness of interventions is not known. All surgical and nonsurgical interventions have been associated with avascular necrosis of the femoral head, the most common and most severe harm associated with all treatments of DDH.
CONCLUSIONS: Screening with clinical examination or ultrasound can identify newborns at increased risk for DDH, but because of the high rate of spontaneous resolution of neonatal hip instability and dysplasia and the lack of evidence of the effectiveness of intervention on functional outcomes, the net benefits of screening are not clear.
Latest Reports
Creating the future: Modernising careers for salaried dentists in primary care: Stakeholder consultation response report
Department of Health; NHS Partners
London : Department of Health, 2006
49p.
This is the outcome of the consultation on modernising careers for salaried dentists in England. The report provides an analysis of consultation responses, key findings and an analysis of quantitative data. The Department of Health's response to the consultation is also available.
Developing the annual health check in 2006-07 : Have your say
Healthcare Commission
London : Healthcare Commission, 2006
80p.
The Healthcare Commission undertakes independent and patient-centred assessments of the performance of healthcare organisations, within a framework of national standards and targets set by Government. On March 31 2005, it launched the annual health check, an entirely new approach to assessing the performance of NHS organisations. The annual health check replaces the previous system of 'star' ratings and will provide a much richer picture of health and healthcare in England. This consultation document sets out its proposals for assessing the performance of healthcare organisations in England in 2006-07 and asks for comments on the different aspects of our approach.
Reducing crime: an overview analysis
Home Office, Strategic Policy Team
London : Home Office, 2006
41p.
This is a high-level summary of the types of offences and offender responsible for the majority of crime levels.
Partial regulatory impact assessment: Our health, our care, our say white paper
Department of Health
London : DoH, 2006
64p.
This partial regulatory impact assessment provides the Government's considered early
assessment of the likely impact of the policy initiatives set out in the 'Our Health, Our Care, Our
Say: A new direction for community services' white paper, published on 30 January 2005.
Final declaration: Important information for trusts
Healthcare Commission
London : Healthcare Commission, 2006
31p.
This document provides important information to help NHS trusts to prepare for the submission of final declarations by 4 May 2006. In particular, it provides new guidance on the Healthcare
Commission's assessment and scoring, and clarifies key aspects of previous guidance.
Mixing private and public service providers and specialization
Gersbach H
Co-Halonen-Akatwijuka M
University of Bristol, Centre for Market and Public Organisation
Bristol : CMPO, 2006
41p.
(Working Paper No. 05/131)
We analyze the reform of public sector welfare services such as education. In this paper we compare a mix of private and a public service provider with full privatization. In both cases the suppliers specialize in serving particular customer types. In the mixed institution the government sets the public fee such that service quality does not deteriorate and the price of the private supplier is anchored at comparatively low level. Under full privatization, however, prices escalate to the highest possible level. As a consequence, consumer welfare is higher with a mixed institution – unless the proportion of low-cost customers is high. The mixed institution can also accommodate wealth constraints of customers to some extent.
Caring for people after they have had a stroke: A follow-up survey of patients
Healthcare Commission; Picker Institute Europe
London : Healthcare Commission, 2006
56p.
(Survey of patients 2006)
The HC has published a survey of stroke patients, 'Caring for people after they have had a
stroke', which shows the satisfaction that patients feel about the care they receive following a
stroke declines after leaving hospital. This survey is the latest in a series of HC assessments of
stroke care, which included a survey of patients in hospital and a clinical audit covering all English hospitals. Together, these studies show that while more people are gaining access to specialist stroke care, more still needs to be done to improve rehabilitation outside hospital and access to specialist units. Over 850 stroke patients took part in the survey, which has enabled the HC to follow the experience of stroke patients from hospital through to their return home.
Making a difference: safe and secure data sharing between health and adult social care
staff
Department of Health; Cabinet Office, Better Regulation Executive
London : DoH, 2006
24p.
Produced detailing a joint project by the Cabinet Office’s Better Regulation Executive and the
Department of Health (DH), recommending practical changes that reduce or remove unnecessary burdens on frontline staff caused by the way information is shared across the healthcare sector. It intends to streamline current processes while not relaxing existing controls over the security and confidentiality of patient information. A number of outcomes to be implemented over the next year are specified:
The Law Society, the Association of British Insurers and the Association of Personal Injury
Lawyers will work with their members to reduce the number of requests for patient records in
support of personal injury claims below £10,000, aiming to reduce annual requests by up to
300,000.
By December, a single information sharing protocol will be developed that reduces the amount of legislation and guidance, enabling health and social care staff to exchange information more
appropriately and effectively.
By September, the DH will issue guidance promoting consistent interpretation of legislation on
Mental Capacity Act code of practice
Department for Constitutional Affairs
London : DCA, 2006
32p.
The Mental Capacity Act 2005 (the Act) provides a statutory framework for acting and making
decisions on behalf of individuals who lack the mental capacity to do so for themselves. The Act
specifies the principles that must be applied by everyone who is working with or caring for adults who lack capacity. It also provides options for those who may choose to plan and make provision for a future time when they may lack capacity. Whilst the Act sets out the legal framework, the Code of Practice (the Code) provides guidance and information for those acting under its terms and applying its provisions on a daily basis. As there are many situations that can arise when caring or working with those who may lack capacity, the Code incorporates good practice along with the flexibility to apply the principles to the particular circumstances of the situation.
Mental Capacity Act draft code of practice
Department for Constitutional Affairs
London : DCA, 2006
184p.
The Mental Capacity Act 2005 (the Act) provides a statutory framework for acting and making
decisions on behalf of individuals who lack the mental capacity to do so for themselves. The Act
specifies the principles that must be applied by everyone who is working with or caring for adults who lack capacity. It also provides options for those who may choose to plan and make provision for a future time when they may lack capacity. Whilst the Act sets out the legal framework, the Code of Practice (the Code) provides guidance and information for those acting under its terms and applying its provisions on a daily basis. As there are many situations that can arise when caring or working with those who may lack capacity, the Code incorporates good practice along with the flexibility to apply the principles to the particular circumstances of the situation.
Modelling poverty by not modelling poverty: An application of a simultaneous hazards
approach to the UK
Aassve A
Co-Burgess S; Dickson M; Propper C
London School of Economics, Centre for Analysis of Social Exclusion
London : CASE, 2006
70p.
(CASEpaper 106)
Pursues an economic approach to analysing poverty. This requires a focus on the variables that
individuals can influence, such as forming or dissolving a union or having children. The paper
argues that this indirect approach to modelling poverty is the right way to bring economic tools to bear on the issue. In the implementation of this approach, the report has a focus on endogenous demographic and employment transitions as the driving forces behind changes in poverty. It constructs a dataset covering event histories over a long window and estimate five simultaneous hazards with unrestricted correlated heterogeneity. The model fits the demographic and poverty data reasonably well. It investigates the important parameters and processes for differences in individuals’ poverty likelihood. Employment, and particularly employment of disadvantaged women with children, is important.
Dynamics of school attainment of England's ethnic minorities
Wilson D
Co-Burgess S; Briggs A
London School of Economics, Centre for Analysis of Social Exclusion
London : CASE, 2006
64p.
(CASEpaper 105)
Exploits a universe dataset of state school students in England with linked test score records to
document the evolution of attainment through school for different ethnic groups. The analysis
yields a number of striking findings. First, shows that, controlling for personal characteristics, all
minority groups make greater progress than white students over secondary schooling. Second,
much of this improvement occurs in the high-stakes exams at the end of compulsory schooling.
Third, shows that for most ethnic groups, this gain is pervasive, happening in almost all schools in which these students are found. Addresses some of the usual factors invoked to explain
attainment gaps: poverty, language, school quality, and teacher influence. Concludes that our
findings are more consistent with the importance of factors like aspirations and attitudes.
Choice: Will more choice improve outcomes in education and health care? The evidence from economic research
Burgess S
Co-Propper C; Wilson D
University of Bristol, Centre for Market and Public Organisation
Bristol : CMPO, 2005
40p.
Extending choice in public services is currently a popular policy. For education it is proposed by both Labour and the Conservatives. For health care it is proposed in some form by all parties. In this report,we provide a summary of the evidence from economic research on whether more choice will improve outcomes in these two key public services.
Building and managing facilities for public services
Bennett J
Co-Iossa I
University of Bristol, Centre for Market and Public Organisation
Bristol : CMPO, 2005
32p.
(CMPO Working Paper Series No. 05/137)
We model alternative institutional arrangements for building and managing facilities for provision of public services, including the use of the Private Finance Initiative (PFI), by exploring the effects on innovative investment activity by providers. The desirability of bundling the building and management operations is analyzed, and it is considered whether it is optimal to allocate ownership to the public or the private sector. We also examine how the case for PFI is affected by the (voluntary or automatic) transfer of ownership from the private to the public sector when the contract expires. Asset specificity and service-demand risk play critical roles.
Extending choice in English health care: The implications of the economic evidence
Propper C
Co-Wilson D; Burgess S
University of Bristol, Centre for Market and Public Organisation
Bristol : CMPO, 2005
22p.
(CMPO Working Paper Series No. 05/133)
Extending choice in health care is currently popular amongst English, and other, politicians. Those promoting choice make an appeal to a simple economic argument. Competitive pressure helps make private firms more efficient and consumer choice acts as a major driver for efficiency. Giving service users the ability to choose applies competitive pressure to health care providers and, analogously with private markets, they will raise their game to attract business. The paper subjects this assumption to the scrutiny provided by a review of the theoretical and empirical economic evidence on choice in health care. The review considers several interlocking aspects of the current English choice policy: competition between hospitals, the responsiveness of patients to greater choice, the provision of information and the use of fixed prices. The paper concludes that there is neither strong theoretical nor empirical support for competition, but that there are cases where competition has improved outcomes. The paper ends with a discussion of the implications of this literature for policies to promote competition in the English NHS.
Health supplier quality and the distribution of child health
Propper C
Co-Rigg J; Burgess S
ALSPAC Study Team; University of Bristol, Centre For Market and Public Organisation
Bristol : CMPO, 2005
46p.
(CASE Working Paper No.102, CMPO Working Paper No. 05/123)
There is emerging evidence to suggest that initial differentials between the health of poor and more affluent children in the UK do not widen over early childhood. One reason may be that through the universal public funded health care system all children have access to equally effective primary care providers. This paper examines this explanation. The analysis has two components. It first examines whether children from poorer families have access to general practitioners of a similar quality to children from richer families. It then examines whether the quality of primary care to which a child has access has an impact on their health at birth and on their health during early childhood. The results suggest that children from poor families do not have access to markedly worse quality primary care, and further, that the quality of primary care does not appear to have a large effect on differentials in child health in early childhood.
Hidden Harm: Responding to the needs of children of problem drug users: Executive
summary of the report of an Inquiry by the Advisory Council on the Misuse of Drugs
Home Office, Advisory Council on the Misuse of Drugs
London : Home Office, 2005
16p.
This inquiry by the Advisory Council on the Misuse of Drugs focused on parents or guardians
whose drug use had serious negative consequences for their children. The summary estimates
the scale of the problem and makes rcommendations.
Hidden Harm: Responding to the needs of children of problem drug users
Home Office, Advisory Council on the Misuse of Drugs
London : Home Office, 2005
92p.
This inquiry by the Advisory Council on the Misuse of Drugs focused on parents or guardians
whose drug use had serious negative consequences for their children.
http://www.fade.nhs.uk/pit/questionnaire-text.pdf
Government's response to Hidden harm report on parental drug misuse
Department for Education and Skills
London : DfES, 2005
40p.
This inquiry by the Advisory Council on the Misuse of Drugs focused on parents or guardians
whose drug use had serious negative consequences for their children.
Labour market disadvantage amongst disabled people: A longitudinal perspective
Rigg JA
London School of Economics, Centre for Analysis of Social Exclusion
London : CASE, 2005
38p.
(CASEPaper 103)
Considerable cross-sectional evidence has highlighted the lower employment rates and earnings
amongst disabled people in Britain. But very little is known about the progression of disabled
people in employment. This study uses data from the Labour Force Survey (LFS) to examine the labour market progression of disabled people in Britain along several dimensions: earnings
growth, lowpay transition probabilities, changes in labour market participation, the rate of training and the rate of upward occupational mobility. The analysis also explores the extent of
heterogeneity in the labour market progression of disabled people with respect to differences in
age, education, occupation and disability severity.
The evidence indicates that the earnings trajectories of disabled people lag behind those for non-
disabled people, especially for men. The median annual change in earnings is 1.4 percent lower
for disabled men and 0.6 percent lower for disabled women compared to non-disabled men and
women respectively. Moreover, disabled people are approximately three times more likely to exit work than their non-disabled counterparts, a difference that increases markedly for more-severely disabled people. The evidence highlights the need for policy to tackle the barriers that disabled people face in the workplace, not merely in access to jobs.
Parallel lives? Ethnic segregation in schools and neighbourhoods
Burgess S
Co-Wilson D; Lupton R
London School of Economics, Centre for Analysis of Social Exclusion
London : CASE, 2005
48p.
Provides evidence on the extent of ethnic segregation experienced by children across secondary
schools and neighbourhoods (wards). Using 2001 Schools Census and Population Census data
we employ the indices of dissimilarity and isolation and compare patterns of segregation across
nine ethnic groups, and across Local Education Authorities in England. Looking at both schools
and neighbourhoods, the report finds high levels of segregation for the different groups, along
with considerable variation across England. Finds consistently higher segregation for South Asian
pupils than for Black pupils. For most ethnic groups children are more segregated at school than
in their neighbourhood. Analyses the relative degree of segregation and show that high
population density is associated with high relative school segregation.
Non-residential fatherhood and child involvement: Evidence from the millennium cohort
study
Kiernan KA
London School of Economics, Centre for Analysis of Social Exclusion
London : CASE, 2005
22p.
(CASEPaper 100)
Fifteen per cent of British babies are now born to parents who are neither cohabiting nor married. Little is known about non-residential fatherhood that commences with the birth of a child. Here, we use the Millennium Cohort Study to examine a number of aspects of this form of fatherhood. Firstly, considers the extent to which these fathers were involved with or acknowledged their child at the time of the birth. Secondly, identifies the characteristics that differentiate parents who continue to live apart from those who move in together. Thirdly, for the fathers who moved in with the mother and their child the reprt enquires whether they differ in the extent of their engagement in family life compared with fathers who have been living with the mother since birth. Finally, for fathers who were living apart from their child when the child was 9 months old the report assesses the extent to which they were in contact, contributed to their maintenance and were involved in their child’s life at this time.
Parental investment in childhood and later adult well-being: Can more involved parents
offset the effects of socioeconomic disadvantage?
Hango D
London School of Economics, Centre for Analysis of Social Exclusion
London : CASE, 2005
34p.
(CASEReport 98)
Parental involvement in their children’s lives can have a lasting impact on wellbeing. More
involved parents convey to their children that they are interested in their development, and this in turn signals to the child that their future is valued. However, what happens in socio-economically disadvantaged homes? Can the social capital produced by greater parental involvement counteract some of the harmful effects of less financial capital? These questions are examined on the National Child Development Study; a longitudinal study of children born in Britain in 1958. Results on a sample of children raised in two parent families suggest that parental involvement does matter, but that it depends on when it and poverty are measured, as well as the type of involvement and the gender of the parent. Father interest in education has the strongest impact on earlier poverty, especially at age 11. Meanwhile, both father and mother interest in school at age 16 have the largest direct impact on education. The frequency of outings with mother at age 11 also has a larger direct impact on education than outings with father, however, neither compare with the reduction in the poverty effect as a result of father interest in school.
Evidence from Journals
Choi-Kwon S, et al. Fluoxetine treatment in poststroke depression, emotional incontinence, and anger proneness: a double-blind, placebo-controlled study. Stroke. 2006 Jan;37(1):156-61. Epub 2005 Nov 23.
BACKGROUND AND PURPOSE: The efficacy and safety of the selective serotonin reuptake inhibitor fluoxetine have rarely been studied in the treatment of poststroke emotional disturbances.
METHODS: Stroke patients (152) who had poststroke depression (PSD), emotional incontinence (PSEI), or anger proneness (PSAP) were studied. PSD was evaluated by Beck Depression Inventory and Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, PSEI by Kim's criteria, and PSAP was assessed by Spielberger Trait Anger Scale. Subjects were randomly given either fluoxetine 20 mg/day (n=76) or placebo (n=76) for 3 months. Follow-up evaluations were done 1, 3, and 6 months after the beginning of the treatment. The primary outcome measurement was the scores of emotional disturbances at each follow-up assessment. The secondary outcome measurements were the percentage changes of the scores and the subjective responses of the patients.
RESULTS: Although patients in the fluoxetine group more often dropped out because of adverse effects, fluoxetine administration was generally safe. Fluoxetine significantly improved PSEI and PSAP, whereas no definitive improvement of PSD was found. Improvement of PSAP was noted even at 3 months after the discontinuation of the treatment.
CONCLUSIONS: Fluoxetine is efficacious in the treatment of PSEI and PSAP. Its effect on PSD is not solidly confirmed.
Shahinian VB, et al. Risk of the "androgen deprivation syndrome" in men receiving androgen deprivation for prostate cancer. Arch Intern Med. 2006 Feb 27;166(4):465-71.
BACKGROUND: Androgen deprivation therapy for prostate cancer has been associated with a spectrum of adverse effects, such as depression, memory difficulties, and fatigue, termed the androgen deprivation syndrome. Primary care physicians providing follow-up care for men with prostate cancer will be faced with managing these effects. We therefore sought to estimate the incidence of these effects and, by using a control group, ascertain whether these effects were related to androgen deprivation itself.
METHODS: We assessed the risk of physician diagnoses of depression, cognitive impairment, or constitutional symptoms in Medicare data following androgen deprivation using a sample of 50 613 men with incident prostate cancer and 50 476 men without cancer, from 1992 through 1997, in the linked Surveillance, Epidemiology, and End Results-Medicare database. Cox proportional hazards regression was used to adjust for confounding variables.
RESULTS: Of men surviving at least 5 years after diagnosis, 31.3% of those receiving androgen deprivation developed at least 1 depressive, cognitive, or constitutional diagnosis compared with 23.7% in those who did not (P<.001). After adjustment for variables such as comorbidity, tumor characteristics, and age, the risks associated with androgen deprivation were substantially reduced or abolished: relative risk (RR) for depression diagnosis, 1.08 (95% confidence interval [CI], 1.02-1.15); RR for cognitive impairment, 0.99 (95% CI, 0.94-1.04); and RR for constitutional symptoms, 1.17 (95% CI, 1.13-1.22). CONCLUSION: Depressive, cognitive, and constitutional disorders occur more commonly in patients receiving androgen deprivation, but this appears to be primarily because patients receiving androgen deprivation are older and have more comorbid conditions and more advanced cancers.
Latest Questions to the Primary Care Question Answering Service
Assessment and Diagnosis
Do you start aspirin and dipyramidole straight after a TIA or should one wait for a CT scan?
In someone suspected of having a pulmonary embolism should they be given heparin straightaway or wait for a definate diagnosis?
A man of 59 - with moderate symptoms of benign prostatic hypertrophy and a normal PSA in 2004 - has asked me about the effectiveness [ sensitivity and specificity] of a 'new' genetic screening test for carcinoma of the prostate - UPM3. Can you help please?
Cancer
Will co-proxamol still be available for use in palliative care patients, where it can be very useful?
Cardiovascular disease
Are CoQ10 vitamins advised for patients taking statins, as advised in the Daily Mail article yesterday?
Can warfarin increase glucometer readings in diabetic people?
How long before & after a dental extraction should a patient stop clopidogrel or aspirin. What is the evidence base?
Causes Risks and Prevention
In the prison setting we see many patients who have been using Zolpidem and Zopiclone hypnotics illicitly for many months. Is there any need to withdraw these patients from these drugs slowly?
What are the risks of using ibuprofen in pregnancy?
What evidence is there surrounding the efficacity of early pregnancy (ie before 20 weeks gestation) education?
At what corrected age should a pre term infant receive BCG SSI vaccine ?
After an uncomplicated Caesarian Section, how long should a woman wait before trying to conceive again?
Is there a link between having a positive lupus anticoagulant and developing S.L.E. ? A patient of mine had a positive lupus anticoagulant detected on a thrombophilia screen and also suffers generalised arthralgia. What are the chances he will develop S.L.E.?
Child health
Is the appropriate treatment for Molluscum Contagiosum in a 3 year old to do nothing? What are the alternative treatments and are they more likely to produce scarring?
What is the best evidence based practice to treat chilhood obesity for under 5's?
Complementary medicine
Is there any clinical evidence to suggest Matol is effective and safe in the treatment of psoriasis?
Mental health
Is there any evidence that self help techniques, or the use of a support group or organisation can help in the management of cyclothymia? if so could you inform me what resources are available. Many thanks
Musculoskeletal disease
In patients with hip arthritis is intra articular hyalurinidase (hyaluronic acid) effective for pain control or prevention of arthroplasty?
Neurological disease
What evidence based sleep clinic tool / training are there?
Obesity
What is the evidence for dietary aids to aid weight loss? I'm interested in products patients can buy as opposed to prescribable drugs or interventions such as dieting or surgery.
Hitting the Headlines - Evidence Behind the Press Stories
'The drug that could reverse heart disease'
A statin (rosuvastatin) could reverse the build up of fatty deposits in the arteries that can trigger coronary heart disease, reported seven newspapers (14 March 2006). The newspapers accurately reported on an uncontrolled trial which showed promising results. Further research is needed to assess whether the treatment actually saves lives and reduces heart attacks.
-
Rosuvastatin (Crestor), a cholesterol lowering drug, could reverse the build up of fatty deposits inside the arteries (atherosclerosis) that lead to heart attacks, strokes and coronary heart disease reported seven newspapers, 14 March 2006 (1-7).
-
The newspaper articles were based on the findings of the ASTEROID study, which assessed the build up of atherosclerosis in 349 patients with moderate heart disease before and after 24 months of treatment with a higher than normal dose of the drug rosuvastatin (8). Treatment with the statin significantly reduced the total build up of fatty deposits, decreased low density lipoprotein cholesterol levels (LDL-C) and increased high density lipoprotein cholesterol levels (HDL-C) over the 24 month treatment period.
-
The newspapers all reported the findings of the study broadly accurately, and six (1-6) highlighted the fact that further research is needed to assess whether the observed reduction in atheroscelerosis translates into a clinically meaningful reduction in mortality and morbidity from coronary heart disease.
Evaluation of the evidence base for 'the drug that could reverse heart disease'
Where does the evidence come from?
The study was led by Dr S Nissen from the Department of Cardiovascular Medicine, Cleveland Clinic Foundation, Cleveland, USA on behalf of the ASTEROID Investigators (A Study to Evaluate the Effect of Rosuvastatin on Intravascular Ultrasound-Derived Coronary Atheroma Burden). The study was sponsored by AstraZeneca (the manufacturers of rosuvastatin), who were involved in the design, conduct and analysis of the study in conjunction with the study investigators.
What were the authors' objectives?
The primary objective was to assess whether high dose statin therapy could regress coronary atheroscelerosis as determined by intravascular ultrasound imaging (IVUS). Secondary objectives were to assess the effects on both low and high density lipoprotein cholesterol levels (LDL-C and HDL-C).
What was the nature of the evidence?
The evidence comes from a prospective, open-label pre-post study, the ASTEROID trial, which enrolled 507 people at different centres across the USA, Canada, Australia and Europe. The trial enrolled people who required coronary angiography or abnormal functional studies for a clinical indication, who had no more than three months statin therapy in the previous 12 months, and had at least 20% angiographic luminal diameter narrowing in any coronary vessel. People who had more than 50% luminal narrowing, uncontrolled triglyceride levels or poorly controlled diabetes were not enrolled into the study.
What interventions were examined in the research?
Intravascular ultrasound (IVUS) was used to assess the extent of atherosclerosis in participants at baseline, after which they received 40 mg rosuvastatin daily (most statins are more commonly prescribed in doses of 10mg or 20mg/day) for a treatment period of 24-months. Participants continued to take their usual prescribed medication such as aspirin, angiotensin-converting enzyme inhibitors, organic nitrates or beta-blockers in addition to the statin therapy. At 24 months treatment, all active study participants underwent repeat IVUS examination. Videotapes containing baseline and follow-up information were analysed in a randomised and blinded manner.
What were the findings?
In total, 349 participants completed the study and provided data that were included in the analysis. After two years of treatment, mean LDL-C levels decreased significantly by 53% from 130 mg/dL to 61 mg/dL, and mean HDL-C levels increased significantly by 15% from 43 mg/dL to 49 mg/dL. The overall change in build up of fatty deposits showed a significant median reduction of 6.8%. Adverse events associated with treatment were relatively infrequent and similar to those observed in other statin trials.
What were the authors' conclusions?
The authors' concluded that high dose statin therapy using rosuvastatin in patients with pre existing coronary heart disease, can regress (partially reverse) the build up of fatty deposits in the coronary arteries. Further studies are needed to determine the effect of the observed changes on clinical outcomes.
How reliable are the conclusions?
This study was reasonably well designed and well orchestrated. Overall, whilst the results from this preliminary study look promising, the authors' are right to highlight the need for further randomised controlled trials to determine the effect of the observed changes on clinical outcomes.
The investigators specified a priori the outcome measures of interest and the sample size. The outcome assessments were conducted in a randomised and blinded fashion. In addition, clear inclusion criteria were specified for participant eligibility and concomitant interventions. The handling of withdrawals and drop-outs from the study was explicitly documented and there were no significant baseline differences between participants who completed the study and those who dropped-out. However, this was a pre-post study that may potentially be subject to a number of biases. The use of surrogate outcome measures means that it cannot be ascertained whether the potential reduction in atherosclerosis translates into a clinically meaningful drop in mortality and morbidity from coronary heart 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 two related systematic reviews which are currently being completed identified on the Cochrane Database of Systematic Reviews (CDSR) (9-10) and six reviews identified on the Database of Abstracts of Reviews of Effects (DARE) (11-16).
References and resources
1. The drug that could reverse heart disease. Daily Mail, 14 March 2006, p10.
2. Wonder heart drug 'cleans out' arteries. The Sun, 14 March 2006, p4.
3. Heart disease may be reversible. The Independent, 14 March 2006, p5.
4. One pill a day to beat heart disease. The Times, 14 March 2006, p1.
5. Heart drug is found to turn clock back on furred arteries. Daily Telegraph, 14 March 2006, p1.
6. Drug that reverses heart disease. Daily Express, 14 March 2006, p1.
7. Cholesterol treatment boost for AstraZeneca. The Guardian, 14 March 2006, p27.
11. Wilt TJ, Bloomfield HE, MacDonald R, Nelson D, Rutks I, Ho M, Larsen G, McCall A, Pineros S, Sales A. Effectiveness of statin therapy in adults with coronary heart disease. Archives of Internal Medicine 2004;164(13):1427-1436. [DARE Abstract]
12. Kang S, Wu Y, Li X. Effects of statin therapy on the progression of carotid atherosclerosis: a systematic review and meta-analysis. Atherosclerosis 2004;177(2):433-442. [DARE Abstract]
13. Law MR, Wald NJ, Rudnicka AR. Quantifying effect of statins on low density lipoprotein cholesterol, ischaemic heart disease, and stroke: systematic review and meta-analysis. BMJ 2003;326:1423-1427. [DARE Abstract]
14. Vrecer M, Turk S, Drinovec J, Mrhar A. Use of statins in primary and secondary prevention of coronary heart disease and ischemic stroke: meta-analysis of randomized trials. International Journal of Clinical Pharmacology and Therapeutics 2003;41(12):567-557. [DARE Abstract]
15. Amarenco P, Labreuche J, Lavallee P, Touboul PJ. Statins in stroke prevention and carotid atherosclerosis: systematic review and up-to-date meta-analysis. Stroke 2004;35(12):2902-2909. [DARE Provisional Abstract]
16. Briel M, Studer M, Glass TR, Bucher HC. Effects of statins on stroke prevention in patients with and without coronary heart disease: a meta-analysis of randomized controlled trials. American Journal of Medicine 2004;117(8):596-606. [DARE Provisional Abstract]
Consumer information
Previous Hitting the Headlines summaries on this topic
Heart drug could save 10,000 lives every year. Hitting the Headlines archive, 5th July 2002.
'Statin drugs could cut heart attacks by third'. Hitting the Headlines archive, 27th September 2005.Document of the Week from the National Library for Health
Use of opinion leaders may be beneficial, particularly in specialised groups.
Implementation Science published this study into the benefits of recruiting opinion leaders as health care change agents.
The authors found that although the effectiveness of opinion leaders in health care has not been thoroughly tested, opinion leaders could be useful for supporting change in health care delivery, particularly in groups with members of the same specialism.
What's New from the National Library for Health
WWW Conference 2006, 23 -26 May, Edinburgh
The World Wide Web Conference is the global event to bring together the key influencers, decision makers, technologists, businesses and standards bodies shaping the future of the web. Key speakers from the NHS and NICE will be present to discuss the impact of the web on health.
0 Comments:
Post a Comment
<< Home