Thursday, 28 February 2013

Roche Accu-Chek - Glucose meter

crabsallover highlightskey pointscomments / links.
Reposted from: Accu-chek & Accu-chek Aviva Nano Blood Glucose Meter

Excellent portable glucose meter. 10 test strips and 12 Lancets plus all the kit. View the demo.

Crabsallover 5.8 mmol/L

Eating nuts and olive oil can reduce the risk of a heart attack

reposted from:
crabsallover highlightskey pointscomments / links.

"Mediterranean diet 'cuts strokes and heart attacks in at-risk groups'," The Guardian advises. Along with much of the global media, The Guardian reports on a study that found that eating a diet rich in fruit, vegetables, fish, olive oil and nuts cuts the risk of heart disease and stroke by 30%.
The story is based on an impressive trial looking at the effects of a Mediterranean diet on people at risk of heart disease and stroke, compared with a standard low-fat diet.
Researchers found that after nearly five years people who followed a Mediterranean diet supplemented with either extra-virgin olive oil or mixed nuts were around 30% less likely to have had a heart attack or stroke, or to have died from one.
It should be noted that the number of strokes, heart attacks and deaths that occurred in the study was fairly small. Nevertheless, this large and well-conducted study supports previous research on the benefits of a Mediterranean-style diet for the heart and circulation. 

Where did the story come from?

The study was carried out by researchers from academic institutions across Spain, including the Universities of Barcelona, Valencia, Malaga and Navarra. It was funded by the Spanish government and other public sources.
Olive oil and nuts used in the trial were donated by commercial sources of these foods. Many of the researchers disclosed grants and fees for work done with agricultural and food industry firms and groups, as is common for research in this field.
It was published in the peer-reviewed New England Journal of Medicine.
The study did not compare the Mediterranean diet with statins, as The Daily Telegraph and Daily Mail's headlines imply. The claim that this diet is better than a drug appears to be an opinion of one of the researchers, rather than a statement of fact.
The current study cannot be used as a way of assessing the effectiveness of statins, not least because some of the people in the Mediterranean diet intervention group were also taking statins.

What kind of research was this?

This was a randomised controlled trial (RCT) involving people at risk of cardiovascular disease. It compared the effects of two variations of the 'Mediterranean diet' – one with extra-virgin olive oil and one with nuts – with a standard low-fat diet.
As the authors point out, previous research has suggested the Mediterranean diet may protect against heart disease and stroke. Helpfully, in this study the researchers have defined what they consider a Mediterranean diet to be and, as the paper is open access, you can view their Mediterranean dietary recommendations for free online.
A well-conducted RCT is the best way of examining the effects of a particular intervention (in this case a Mediterranean diet) compared with a control condition (in this case a standard low-fat diet) on a health outcome.
Randomisation helps iron out other factors that may affect cardiovascular risk, balancing them out between groups. For example, many observational studies of specific diets have been conducted. However, observational studies cannot necessarily prove that the particular diet was responsible for the outcomes seen. This is because people who choose to eat a healthier diet may also choose other healthier lifestyle options, such as exercising more or drinking less alcohol.

What did the research involve?

The trial began in October 2003. Eligible participants included men aged 55-80 and women aged 60-80. Participants did not have a history of heart attack or stroke, but were considered to be at future risk of having cardiovascular disease.
This was because they either had type 2 diabetes or at least three of the following major risk factors for cardiovascular disease:
  • smoking
  • high blood pressure
  • high cholesterol
  • being overweight or obese
  • having a family member who developed heart disease at a young age
Participants were randomly assigned to one of three groups:
  • one group was advised to follow a Mediterranean diet supplemented with extra-virgin olive oil
  • a second group was advised to follow a Mediterranean diet supplemented with mixed nuts (walnuts, almonds and hazelnuts)
  • the third control group were advised to follow a low-fat diet
Participants in the two Mediterranean diet groups received extra olive oil or nuts at no cost, while those in the control group received free non-food gifts.
All of the groups received a dietary training session at baseline (study start). The Mediterranean groups received further sessions every three months afterwards. This included an assessment of their adherence to the diet, while the low-fat group received a leaflet each year for the first three years explaining the low fat diet. In October 2006, this protocol was amended and the control group got the same intensity of diet advice and assessment as the other two groups.
Participants also filled in a general medical questionnaire, a food frequency questionnaire and a physical activity questionnaire every year. Their weight, height and waist circumference was measured. The researchers also measured certain biomarkers (chemicals in the blood or urine) in random subgroups of participants in the Mediterranean diet groups at one, three and five years to see if they were sticking to the advice to supplement their diet with extra-virgin olive oil or nuts.
Over the period of the study, they looked at the main (primary) outcome of interest, which was the number of participants who had suffered either a heart attack or stroke or who had died from any cardiovascular cause. Other (secondary) outcomes the researchers examined were the number of people who had suffered these individual events and those who had died from any cause. They obtained this information from:
  • repeated contact with participants
  • contact with family doctors
  • yearly review of medical records
  • the national death index
The researchers initially estimated they would need a sample of 9,000 participants to detect any significant differences in outcomes between the groups. However, this figure was recalculated in April 2008 to 7,400 participants.

What were the basic results?

A total of 7,447 people were enrolled in the trial. The researchers report that the people in the two Mediterranean diet groups said they adhered to their diets, which was confirmed by biomarkers in the blood or urine.
After an average follow-up of 4.8 years, they found that in total 288 people either had a heart attack, stroke or died from a cardiovascular event. Of these:
  • 96 (3.8%) events occurred in the Mediterranean diet group with extra olive oil
  • 83 (3.4%) occurred in the Mediterranean diet group with extra nuts
  • 109 (4.4%) occurred in the control group on a standard low-fat diet
After adjusting for baseline risk factors (such as diabetes), the researchers calculated that, compared with those who followed the standard low-fat diet, those assigned to a Mediterranean diet with extra-virgin olive oil had a 30% reduced risk of suffering a heart attack, stroke or dying from a cardiovascular event (hazard ratio 0.70, 95% confidence interval (CI), 0.54 to 0.92).
Similarly, those assigned a Mediterranean diet with nuts had a 28% reduced risk of suffering a heart attack, stroke or dying from a cardiovascular event (hazard ratio 0.72, 95% CI 0.54 to 0.96).
No diet-related adverse effects were reported.

How did the researchers interpret the results?

The researchers say that among people at high cardiovascular risk, a Mediterranean diet supplemented with olive oil or nuts reduced the number of cardiovascular events over the study period.
They suggest there is a "synergy" in the diet's nutrient-rich foods that fosters favourable changes to some risk factors, including blood fats, insulin sensitivity and inflammation. However, they say that in this trial olive oil and nuts were probably responsible for most of the benefits.


The results of this randomised controlled trial appear to confirm previous studies that there are benefits to following a Mediterranean diet. The trial has many strengths, including its large size, long period of follow-up, thorough assessment of medical outcomes (including reviewing medical records and having contact with the family doctor), and careful attempts to assess whether the diets were being followed.
As this is a randomised controlled trial, it should also balance out other health and lifestyle differences between the groups that may influence cardiovascular risk. This avoids the limitations of many previous diet observational studies, where participants choose which diet to follow.
However, there are still several limitations to bear in mind:
  • The protocol for the control groups was changed halfway through the trial. This group did not receive the same intensity of dietary advice as the other two groups, a factor which could have affected their compliance with the diet.
  • Despite careful attempts at screening and measuring biomarkers, it is still difficult to know how far participants stuck to their assigned diets.
  • The control group had a higher dropout rate (11.3%) compared with the Mediterranean diet groups (4.9%).
  • The participants were at high risk of cardiovascular disease at study start, but had not yet suffered any cardiovascular events. It is not certain if the results are generalisable to other groups, including those with no risk factors for cardiovascular disease and those who have already suffered from a heart attack or stroke.
The 30% reduction in risk may sound impressive but, as the authors point out, these results mean that following a Mediterranean diet would mean that about three major cardiovascular events would be avoided per 1,000 person-years. This means that if 1,000 people at high risk of cardiovascular disease ate a Mediterranean diet for one year, there would be three fewer 'events' (such as stroke) than there would be if they ate a standard low-fat diet.
Despite these limitations, this large and well-conducted study adds to the body of previous research on the benefits of a Mediterranean style diet for the heart and circulation.

Analysis by Bazian. Edited by NHS Choices. Follow Behind the Headlines on Twitter.

Links To The Headlines

Mediterranean diet 'as good as statins'. The Daily Telegraph, February 25 2013

Links To Science

Estruch R, Ros E, Salas-Salvadó J, et al. Primary Prevention of Cardiovascular Disease with a Mediterranean Diet. The New England Journal of Medicine. Published online February 25 2013

Tuesday, 19 February 2013

'Fizzy drink tax' to stop UK being 'fat man of Europe' - Health News - NHS Choices

'Fizzy drink tax' to stop UK being 'fat man of Europe' - Health News - NHS Choices

reposted from:
crabsallover highlightskey pointscomments / links.

What were the main findings of the report?

The report has 10 key recommendations which include actions that would need to be taken by health professionals and ways to make healthier choices easier. The key recommendations are as follows:

  • Education and training programmes for healthcare professionals: 

The report says that Royal Colleges, Faculties and other professional clinical bodies should promote targeted education and training programmes within the next two years. These should help to train healthcare professionals working in both general practice and hospital care to ensure that they ‘make every contact count’. This means sensitive recognition and appropriate referral and management for overweight and obese patients.

  • Weight management services: 

It is recommended that the departments of health in the four UK nations should together invest at least £100 million in each of the next three financial years to increase provision of weight management services across the country, to mirror the provision of smoking cessation services (£88.2 million was spent on smoking services in 2011/12). This is recommended to include both early intervention programmes and greater provision for management of severe obesity, including bariatric (weight loss) surgery. The report says that adjustments could then be made to the Quality and Outcomes Framework, providing incentives for GPs to refer patients to such services.

  • Nutritional standards for food in hospitals: 

Within the next 18 months food-based standards should be introduced in all UK hospitals in line with those put in place for schools in England in 2006. Commissioners should work with a delivery agent similar to the Children’s Food Trust to put these measures into place.

  • Increasing support for new parents: 

The health visitor service in England should be extended to include delivering basic food preparation skills to new mothers and fathers, and to guide appropriate food choices which will ensure nutritionally balanced meals, encourage breastfeeding and using existing guidance in the Personal Child Health Record as a tool to support this.

  • Nutritional standards in schools: 

The existing mandatory food- and nutrient-based standards in England should be applied to all schools including free schools and academies. From the 2014/15 academic year, this should be accompanied by a new requirement on all schools to provide food skills, including cooking and growing – alongside a sound theoretical understanding of the long-term effects of food on health and the environment.

  • Fast food outlets near schools: 

In its first 18 months of operation, Public Health England should undertake an audit of local authority licensing and catering arrangements with the intention of developing formal recommendations on reducing the proximity of fast food outlets to schools, colleges, leisure centres and other places where children gather.

  • Junk food advertising:

A ban on advertising of foods high in saturated fats, sugar and salt before the television watershed of 9pm, and an agreement from commercial broadcasters that they will not allow these foods to be advertised via internet ‘on-demand’ services, such as ‘catch-up’ internet streamed TV services.

  • Sugary drinks tax:

A duty should be piloted on all sugary soft drinks, initially for one year, increasing the price by at least 20%. The authors say that estimates suggest a duty of just 20p per litre could generate revenue of approximately £1 billion per year, which could theoretically be used to provide weight management programmes across the country. It is suggested the tax would be an experimental measure for one year, looking at the effects and then seeing what impact it has upon consumption patterns and producer/retailer responses.

  • Food labelling: 

In the next year, major food manufacturers and supermarkets should agree a unified system of traffic light food labelling (to be based on percentage of calories for men, women, children and adolescents) and visible calorie indicators for restaurants, especially fast food outlets.

  • Travel and green spaces: 

Public Health England should guide Directors of Public Health in working with Local Authorities to encourage active travel and protect or increase green spaces to make the healthy option the easy option. In all four nations, local authority planning decisions should be subject to a mandatory health impact assessment to evaluate their potential impact upon the populations’ health.

Monday, 18 February 2013

Introduction of flexible sigmoidoscopy screening into the NHS Bowel Cancer Screening Programme

Introduction of flexible sigmoidoscopy screening into the NHS Bowel Cancer Screening Programme

I phoned 0800 707 60 60 today about access to flexible sigmoidoscopy. I was advised it had been rolled out in some parts of Surrey and Kent only. She suggested I call back later in year about Dorset rollout or ask my GP to authorise the test or contact them for further details.

Thursday, 14 February 2013

DC's Improbable Science reviews Bad Pharma

reposted from:
crabsallover highlightskey pointscomments / links.

DC's (David Colquhoun) Improbable Science says .... "It’s weird that medicine, the most caring profession, is more corrupt than any other branch of science.  The reason, needless to say, is money. Well, money and vanity.  The publish or perish mentality of senior academics encourages dishonesty. It is a threat to honest science. Ben Goldacre’s book 'Bad Pharma' shows the consequences: harm to patients and huge wastage of public money. Read it. Do something."

Tamiflu in BMJ 2003 to 2012 timeline

reposted from: BMJ Timeline
crabsallover highlightskey pointscomments / links.

Tamiflu in the BMJ: This interactive timeline shows articles about Tamiflu which were published in the BMJ, between 2003 and 2012.

A review of unpublished regulatory information from trials of neuraminidase inhibitors (Tamiflu - oseltamivir and Relenza - zanamivir) for influenza

reposted from: Cochrane Summaries
Jefferson T, Jones MA, Doshi P, Del Mar CB, Heneghan CJ, Hama R, Thompson MJ. Neuraminidase inhibitors for preventing and treating influenza in healthy adults and children. Cochrane Database of Systematic Reviews 2012, Issue 1. Art. No.: CD008965. DOI: 10.1002/14651858.CD008965.pub3

crabsallover highlightskey pointscomments / links.

Jefferson T, Jones MA, Doshi P, Del Mar CB, Heneghan CJ, Hama R, Thompson MJ

Published Online: 
October 17, 2012
We decided to update and amalgamate our reviews on the antiviral drugs zanamivir and oseltamivir for influenza on the basis of the manufacturers' reports to regulators (called clinical study reports) and regulators' comments (which we called regulatory information). Clinical study reports are extensive documents with exhaustive details of the trial protocol, methods and results. In view of the unresolved discrepancies in the data presented in published trial reports and of the substantial risk publication bias in this area, we elected not to use data from journal articles. Availability of documents generated by national and regional regulatory bodies during licensing processes in the UK, USA, continental Europe and Japan, partial trial reports from the manufacturers of oseltamivir and from the European regulator European Medicines Agency (EMA), enabled us to verify information from the trials. The authors have been unable to obtain the full set of clinical study reports or obtain verification of data from the manufacturer of oseltamivir (Roche) despite five requests between June 2010 and February 2011. No substantial comments were made by Roche on the protocol of our Cochrane Review which has been publicly available since December 2010. Based on our assessments of the documents we could obtain, we came to the conclusion that there were substantial problems with the design, conduct and availability of information from many of the trials. Due to these concerns we decided not to proceed with a meta-analysis of all the oseltamivir data as we had intended. Instead we carried out analyses of effects on symptoms (shortens them by 21 hours or so) and hospitalisations (no evidence of effect) of people with influenza-like illness ('flu') on data from all the people enrolled in treatment trials of oseltamivir. Other outcomes could not be assessed due to unavailability of data for all the people enrolled in treatment trials of oseltamivir.  Our independent analysis concurs with the conservative conclusions regarding the effects of both drugs by the US Food and Drug Administration (FDA). The FDA only allowed claims of effectiveness of both drugs for the prevention and treatment of symptoms of influenza and not on other effects (such as interruption of person-to-person spread of the influenza virus or prevention of pneumonia). There is evidence to suggest that both drugs are associated with harms (oseltamivir: nausea, vomiting; zanamivir: probably asthma). The FDA described the overall performance of both drugs as "modest". We expect full clinical study reports containing study protocol, reporting analysis plan, statistical analysis plan and individual patient data to clarify outstanding issues. These full clinical study reports are at present unavailable to us.
HideAbstract (click to read)
Planning for outbreaks of influenza is a high priority public health issue for national governments. Neuraminidase inhibitors (NIs) are thought to help reduce the symptoms of influenza with several possible mechanisms proposed. NIs have been stockpiled with a view to their widespread use in the event of a pandemic. However, the evidence base for this class of agents remains a source of debate. In a previous review we have documented substantial risks of publication bias of trials of NIs for influenza (60% of patient data from phase III treatment trials of oseltamivir have never been published) and reporting bias in the published trials. Our confidence in the conclusions of previous versions of this review has been subsequently undermined. Since we have become aware of a large number of unpublished trials of NIs in the management of influenza, this review updates and merges existing reviews in this area.
To review clinical study reports of placebo-controlled randomised trials, regulatory comments and reviews ('regulatory information') of the effects of the NIs oseltamivir and zanamivir for influenza in all age groups and appraise trial programmes, rather than single studies.
Clinical study reports are very detailed, unpublished clinical trial data containing in-depth descriptions of protocol rationale, methodsanalysis plans, trial results and organisational documents (such as contracts). A series of clinical studies designed and conducted by one sponsor represents a trial programme of a drug indication (for example treatment of influenza).
Search strategy: 
We searched trial registries, cross-referencing published and unpublished sources and corresponded with manufacturers and regulators. We searched the archives of the US Food and Drug Administration (FDA) and European and Japanese regulators. The evidence in this review reflects searches to obtain relevant information up to 12 April 2011.
Selection criteria: 
We included regulatory information based on assessments of randomised controlled trials (RCTs) conducted in people of any age who had either confirmed or suspected influenza, or who had been exposed to influenza in the local community or place of residence. We included information which had been made available by our deadline.
Data collection and analysis: 
We indexed regulatory information in two purpose-built instruments and reconstructed trials using CONSORT statement-based templates. To progress to Stage 2 (full analysis) we sought manufacturer explanations of discrepancies in the data. GlaxoSmithKline (GSK) offered us individual patient data and responded to our queries, but Roche did not provide us with complete clinical studyreports. In Stage 2 we intended to analyse trials with validated data (i.e. assuming our validation questions aimed at clarifying omissions and discrepancies were resolved). No studies progressed to Stage 2. We carried out analyses of the effects of oseltamivir on time to first alleviation of symptoms and hospitalisations using the intention-to-treat (ITT) population and tested five hypotheses generated post-protocol publication.
Main results: 
We included and analysed data from 25 studies (15 oseltamivir and 10 zanamivir studies). We could not use data from a further 42 studies due to insufficient information or unresolved discrepancies in their data. The included trials were predominantly conducted in adults during influenza seasons in both hemispheres. A small number of studies were conducted in older people residing in care homes and in people with underlying respiratory diseases. The studies had adequate randomisation and blinding procedures, but imbalances in the analysis populations available (ITT influenza-infected) left many of the studies at risk of attrition bias. All the studies were sponsored by manufacturers of NIs. Time to first alleviation of symptoms in people with influenza-like illness symptoms (i.e. ITTpopulation) was a median of 160 hours (range 125 to 192 hours) in the placebo groups and oseltamivir shortened this by around 21 hours (95% confidence interval (CI) -29.5 to -12.9 hours, P < 0.001; five studies) but there was no evidence of effect on hospitalisations based on seven studies with a median placebo group event rate of 0.84% (range 0% to 11%): odds ratio (OR) 0.95; 95% CI 0.57 to 1.61, P = 0.86). These results are based on the comprehensive ITT population data and are unlikely to be biased. A post-protocol analysis showed that participants randomised to oseltamivir in treatment trials had a reduced odds being diagnosed with influenza (OR 0.83; 95% CI 0.73 to 0.94, P = 0.003; eight studies), probably due to an altered antibody response. Zanamivir trials showed no evidence of this. Due to limitations in the design, conduct and reporting of the trial programme, the data available to us lacked sufficient detail to credibly assess a possible effect of oseltamivir on complications and viral transmission. We postponedanalysis of zanamivir evidence because of the offer of individual patient data (IPD) from its manufacturer. The authors have been unable to obtain the full set of clinical study reports or obtain verification of data from the manufacturer of oseltamivir (Roche) despite five requests between June 2010 and February 2011. No substantial comments were made by Roche on the protocol of our Cochrane Review which has been publicly available since December 2010.
Authors' conclusions: 
We found a high risk of publication and reporting biases in the trial programme of oseltamivir. Sub-population analyses of the influenza infected population in the oseltamivir trial programme are not possible because the two arms are non-comparable due to oseltamivir's apparent interference with antibody production. The evidence supports a direct oseltamivir mechanism of action on symptoms but we are unable to draw conclusions about its effect on complications or transmission. We expect full clinical studyreports containing study protocol, reporting analysis plan, statistical analysis plan and individual patient data to clarify outstanding issues. These full clinical study reports are at present unavailable to us.