“Signs of autism can be detected in six-month-old babies by measuring brain activity,” the Daily Mail has reported. While the Mail was correct, the research has not yet proved to be a perfect diagnostic test.

This and other related headlines are based on a study that assessed the brain activity of 104 infants aged 6-10 months as they watched an image of an adult’s face whose eyes moved from looking away from them, to directly at the infant, then away again. Researchers called these eye movements ‘dynamic eye-gaze shifts’. They then assessed whether differences in brain activity in response to the eye-gaze shifts were related to autism developing in the same children at three years.

Children who did not develop autism showed large spikes in brain activity when they saw the ‘gaze shifts’. Much smaller spikes in brain activity were detected in the infants who went on to develop autism, raising the prospect that autism could be identified earlier than is currently clinically possible.

However, this test was not 100% accurate. Some babies showing low brain activity spikes did not go on to develop autism and vice versa. As the groups overlap, there cannot be a simple and useful cut-off value to predict autism.

Developing and refining this type of test into something that can be routinely used to detect autism in infants is likely to take some time and will certainly require more research on larger groups of infants with autism and unselected healthy infants too.

 

Where did the story come from?

The study was carried out by a collaboration of researchers from English, Canadian and Australian universities and was funded by the UK Medical Research Council. It was published in the peer-reviewed science journal Current Biology.

The media reporting of this story was generally well balanced. Many stories included quotes from the study authors that a definitive test would take time to develop and that the current assessment is not 100% effective.

 

What kind of research was this?

This study was a prospective longitudinal study investigating whether the brain function of infants aged 6-10 months differed in response to viewing faces that changed the direction of their gaze. The researchers then looked at whether these brain function differences could predict a diagnosis of autism at three years of age.

The authors report that there are currently no reliable methods of predicting autism in infants younger than about two years of age. Current diagnosis relies on the detection of behavioural symptoms of autism that typically develop in a child’s second or third year. Behaviours associated with autism include impairments in social skills and communication, and the presence of rigid, stereotyped and repetitive behaviours.

The authors say previous research shows typical infants’ sensitivity to eye gaze in the first year of life predicts a range of social and communication skills that emerge later. Detecting autism at an early age could potentially lead to ways of better supporting the child during early development, improving their wellbeing and life chances.

 

What did the research involve?

The researcher recruited a group of 104 infants - 54 at risk of autism because of a family history of the condition and 50 controls, with no family history of autism. The infants were followed from 6-10 months through to three years of age.

The researchers measured the 6 to 10-month-old infants’ response to changing images of faces. They did this by recording event-related potentials (ERPs), which are a measure of brain electrical activity in response to a thought or perception. In this study, ERPs were used to measure the perception of a face changing between looking directly at the infant and then away from them. The researchers called this ‘dynamic gaze-shift stimuli’.

The researchers also tracked the eyes of the infants to examine the amount of time they spent looking at the eye region of the faces they were shown. This allowed the researchers to assess whether different responses to the eye gaze were due to differences in attention to the eye region or whether brain functions were more important.

The researchers reported that dynamic gaze-shift stimuli are more likely to engage wider social brain mechanisms than static images as they mimic a real social interaction more closely. However, researchers compared their dynamic gaze results with that from ‘static gaze’, (images of a face whose eyes were looking at, or away from, the infant) to see how they compared to each other.

The brain activity levels of infants at risk of autism were contrasted with the controls. The researchers then looked at how the brain function differences at 6-10 months related to a later diagnosis of autism. An independent team assessed whether the infants had autism at two and three years old.

 

What were the basic results?

The brain activity of the control group showed large spikes of activity in response to eye gaze changes when the face image held a gaze toward, compared to away from, the infant. The brain activity spikes of infants at risk of autism were significantly smaller in response to the same stimulus.

The differences in brain activity of the control group verse at risk group were not restricted to the dynamic gaze results. Similar results were seen when static images were used.

The researchers found that those who did not go on to develop autism at three years of age showed large spikes in brain activity relating to the changes in eye gaze at 6-10 months. Crucially, those that did develop autism showed significantly smaller spikes in brain activity. The static image test did not predict a later diagnosis of autism.

Eye tracking information was available for 93 of the 104 infants. There was no difference in the time at-risk infants and control infants spent looking at the faces’ eyes relative to other areas of the face.

 

How did the researchers interpret the results?

The authors conclude that ‘brain function measures can successfully differentiate groups of infants at risk [of autism] from low-risk control within the first year of life'. They go on to say that ‘response to dynamic gaze shifts during the first year of life distinguished the group of infants who later develop autism’.

 

Conclusion

This small study highlights a potential method of identifying children who are likely to develop autism at 6-11 months, much earlier than the current method of diagnosis. The authors suggest this could potentially pave the way for more selective targeting of early intervention efforts and procedures to these children, increasing their life chances.

While this study provides intriguing results it is important to bear in mind some practical limitations. For instance, while the average differences between the brain function of the infants that went on to develop autism compared to those that did not were significantly different, individual values from the two groups did overlap. This means that there is probably no useful clinical cut-off value to predict autism. Similarly, the researchers do not describe how the controls were selected or report how good the test was at diagnosing autism, known as the ‘test sensitivity’. Reporting these key results would have helped us better assess the accuracy and importance of these findings.

Much larger studies would be needed to establish a suitable brain activity level to use to identify as child as 'likely to develop autism'. These studies could better assess the natural variation in brain activity from a large group of infants. Similarly, it is unlikely a future autism assessment would rely on a single test, such as dynamic eye gaze, but would instead use a combination of tests.

The uncertainty about what cut-off values to use, and the drawbacks of using a single predictive test, makes the development of an early identification test more complex. It may be some time before a predictive test is routinely available to identify infants likely to develop autism earlier than is currently possible.

Links To The Headlines

Autism: Brainwaves 'show risk from age of six months'. BBC News, January 27 2012

Signs of autism 'can be detected in six-month-old babies' by measuring brain activity. Daily Mail, January 27 2012

Signs of autism at six months. The Daily Telegraph, January 27 2012

Early test to detect autism. The Independent, January 27 2012

Links To Science

Elsabbagh M, Mercure E, Hudry K, et al. Infant neural sensitivity to dynamic eye gaze is associated with later emerging autism. Current Biology. 2012;22:1-5

‘More than a million cancer carers may be missing out on vital support,’ the Daily Mirror and other newspapers have reported today. The news reports are based on a survey carried out for Macmillan Cancer Support, which identified that among 386 people who provided five or more hours of care a week to someone with cancer, around half had no support of any kind.
 
There are more than 1 million carers of people with cancer in the UK, and more than 6 million carers of all kinds. The report detailed the impact of the apparent lack of support on carers’ mental health, relationships and finances, finding that just 5% say they have received a local authority carer’s assessment, which enables them to access practical, emotional and financial support.

 

What is the caring role for people supporting others who have cancer? 

The ‘More than a Million’ report published by Macmillan is based on the results of a survey carried out by Ipsos MORI. The charity said that around one in seven people had given some unpaid informal support to a person with cancer in the past 12 months and that around one in 50 could currently be described as carers of people with cancer. The survey was carried out between May and August 2011 and it asked questions to identify carers among 18,449 people interviewed face-to-face. They then polled 386 of these people who were identified as carers of people with cancer.

The survey found that, as with all carers, most carers of people with cancer were women (62%) mostly aged between 45 and 54. The carers most often supported a member of their family such as a parent (23%) or a spouse or partner (17%), but surprisingly 31% said they cared for a friend or neighbour. In this research, being a carer was defined as giving at least five hours of support a week, or giving one to four hours with it affecting their lives in some way. Despite meeting this definition, only 43% of the people surveyed actually considered themselves to be carers (51% said that they would not consider themselves carers). You can find out more who is considered a carer at Carers Direct: what is a carer? 

The type of care given is varied, and includes emotional support for someone with cancer and helping with errands such as shopping and collecting prescriptions and helping with transportation. On average, the carers surveyed gave almost 15 hours of support per week and 81% said that being a carer impacted on other aspects of their life. The impacts included effects on:

• emotional wellbeing and mental health
• social life
• relationships
• working life
• finances

 

Do carers receive adequate support?

Owing to the different ways being a carer can affect outside life, the survey considered many different types of support a carer of someone with cancer may need. The survey found that most of the support that carers receive is informal, coming from their family (44%) or friends (28%). Some carers (20%) received support from their GP or another person working within the NHS. However, half of carers polled said they received no support. The survey revealed that the type of support carers wanted was training on how to give care, and someone to provide emotional support. The carers also wanted more information on the general support available to them.

It is important to note that entitlement to a carer’s assessment is based on them being considered as giving ‘regular and substantial care’ to the person they look after. The report defined carers as those caring for more than five hours a week. While there is no legal definition for what this entails, it could explain why some carers have never had an assessment.

 

What is a local authority carer’s assessment?

A local authority carer’s assessment allows carers of all types to discuss with social services the help they need to maintain health and a balance between caring and other life commitments. The Macmillan Cancer Support report said that out of the people they surveyed, only 11% said they had received support from social services or local authorities and only five per cent have had a carer's assessment. If you are looking after someone, social services are obliged to consider the different issues that can affect your caring role to assess your needs. 

 

What other sources of help are available for carers?

The Carers Direct helpline (0808 802 0202) is a free and confidential helpline for carers (living in England) needing help or advice on their caring role or on the needs of the person they are caring for. Carers Direct can also be contacted by mail, email and live, online webchat. You can also use Carers Direct to find addresses, phone numbers and websites for carers’ services near you.
 
Macmillan Cancer Support recognises the needs of people living with cancer and their carers. In the survey, 72% of carers named at least one service or activity that they thought Macmillan offers to carers and over a third said they had used at least one of these services. These included contact with Macmillan nurses and gaining information and advice through the Macmillan website.

Links To The Headlines

Millions of cancer carers missing out on benefits. The Daily Telegraph, January 27 2012

More than a million cancer carers may be missing out on vital support, charity reveals. Daily Mirror, January 27 2012

Carers 'missing out on support', says charity. BBC News, January 27 2012

Women concerned about French-made PIP breast implants can find all the latest NHS information about the issue on this page.

Worries about the implants have emerged since news of a major investigation into them in France was widely covered in the media in December 2011.

It is thought that around 40,000 women in the UK have the implants, with about 95% of them having been provided privately for purely cosmetic reasons.

 

What’s the problem?

The French implants caused global concern after it was revealed they contained industrial silicone rather than medical-grade fillers and that they may be more prone to rupture and leakage. Initially reports also linked the implants to a rare form of cancer known as ALCL. This cancer link has been now been firmly discounted by medical experts here and in Europe.

 

What type of implants are involved?

The implants involved are called Poly Implant Prosthèse (PIP) and were made, starting in 2001, by a French company of the same name.

The marketing, distribution and use of the PIP implants was suspended in March 2010 after regulators found that the manufacturers were using silicone intended for industrial use, and not medical-grade silicone fillers. It is reported that the company used a cheap type of silicone gel intended for making mattresses.

 

Do the implants have to be removed early?

Most breast implants need to be removed or replaced after 10-15 years.

An expert committee was set up recently to examine the specific risks associated with PIP implants. It concluded that as yet there was not enough evidence to recommend their early removal.

However, the committee said the NHS would remove and replace the implants without charge if patients that the NHS had operated on remained concerned. The government expects the private sector to follow suit.

NHS medical director Professor Sir Bruce Keogh, who led the expert review group, said: “On the basis of the information we have, we do not think it is necessary to recommend the routine removal of these implants.

“But we understand that some women will be very concerned so we support the government’s position that the NHS will support removal of PIP implants if the patient has concerns and, with her doctor, she decides that it is right to do so.”

 

How many people are affected?

More than 300,000 PIP implants have been sold globally in 65 countries over the past 12 years. Europe was a major market but more than half of the implants went to South America.

In the UK, 40,000 women are thought to have the implants. Private clinics fitted 95% of these for women seeking cosmetic breast augmentation. The remaining 5% were fitted on the NHS.

The NHS provides breast implants only where there is clinical need. For example, women who have a mastectomy (breast removal surgery) as part of treatment for breast cancer are often offered implants as part of reconstructive surgery.
 

What happens if I got a PIP implant through the NHS?

Women who received a PIP implant from the NHS will be contacted to let them know they have one.

If you are worried, you should book a consultation with your specialist or GP. They will offer clinical advice on the best way forward. This could include an examination using scans, such as MRI, to look for any signs that the implant may have ruptured.

The NHS will support removal and replacement of PIP implants if a woman and her doctor decide that it is the right thing to do. The secretary of state has made clear that patients' concerns must be put first.

 

What if I got a PIP implant privately?

The following private clinics have said they will replace PIP implants free if clinically necessary: Holly House, Highgate Hospitals, Make Yourself Amazing (MYA Cosmetic Surgery), Ramsay Health Care, Spire Healthcare, BMI Healthcare, Nuffield Healthcare and HCA International. The Transform medical group has said it will remove the implants free for its patients who had them fitted since 2001 and The Hospital Group said it would offer free removal to patients it operated on from 2001-2009; both will charge for replacements.

If a private clinic that provided PIP implants no longer exists or refuses to help, then, so long as you are entitled to NHS services, the NHS will cover the cost of the removal of PIP implants if your doctor agrees there is a clinical need. This would not include the replacement of private cosmetic implants.

 

What’s the evidence around the safety of PIP implants?

During December 2011 UK media had originally focused on a possible link between PIP implants and a rare type of cancer called anaplastic large cell lymphoma (ALCL). This arose after a French woman with PIP implants developed the cancer and died. However, after reviewing the evidence, the expert group conducting the review agreed that there was no link with cancer.

More recently, attention has focused on the rupture rate of the implants, and whether the unapproved gel filling of PIP implants could have a toxic effect.

The review has specifically looked at these issues, and found:

• From the “patchy” data available, the review panel was not able to tell whether the rupture rate for PIPs is higher than for other types of implant.
• From the implants that have been tested there appears to be no risk of dangerous toxic effects in the event of a rupture.
• The review group said it could not be certain that the manufacturer did not change the content of the implants, so could not completely rule out the possibility that some might contain toxic substances. 

 

What is a rupture and what are the signs?

A rupture is a split that occurs in the implant’s casing. A rupture can be caused if:

• the implant’s shell gets weaker over time
• the implant is damaged during the operation
• there is a flaw in the implant
• the breast is injured

If you have any of the following signs or symptoms, you should discuss them with your GP, who will refer you to a specialist:

• lumpiness of the breast
• lumpiness or swelling in the area around the breast
• change in shape of the breast
• deflation of the breast
• redness
• tenderness of the breast
• swelling of the breast
• pain or sensitivity

 

Is the situation being investigated further?

Yes, the Department of Health has set up two reviews to look at how the PiP situation occurred and the issue of regulating the cosmetic surgery industry as a whole.

The first review will be led by Lord Howe and will address a number of specific issues, including:

• what information about PiP implants was available from routine systems for reporting adverse events
• what external concerns about PiP implants were brought to the attention of regulators, and when
• how these concerns and any related information were handled
• what information was shared between MHRA and counterpart agencies abroad 
• what action was taken to safeguard and advise patients
• whether action was sufficiently prompt and appropriate

The report is due to be submitted to the Health Secretary by the end of March 2012.

The second review will look at whether the cosmetic surgery industry needs to be regulated, and if so how this should happen. It be led by Professor Sir Bruce Keogh, the NHS Medical Director, who said:

“I am working with experts from the plastic surgery field to look at what we can do to make sure people who choose to have cosmetic surgery and other cosmetic procedures are safe.

“I will be looking at all aspects of regulation – at the regulation of implants and fillers, at whether the people who carry out cosmetic interventions have the right skills, at whether the clinics look after the care and welfare of their patients."

The extensive report is due to be submitted by March 2013.

In France, Jean-Claude Mas, head of Poly Implant Prosthese, has been charged with causing involuntary injury. He was released on bail after being arrested on January 26.

Links To The Headlines

No Routine Removal For PIP Breast Implants. Sky News, January 6 2012

NHS will remove implants free of charge for their patients but private clinics must pay for operations themselves, Government says. Daily Mail, January 6 2012

Government will pay for women who had breast implants on NHS to have them removed. The Daily Telegraph, January 6 2012

Clinics 'should remove implants'. BBC News, January 6 2012

“Working eleven hours a day can lead to severe depression,” Metro has today reported. According to the newspaper, staff who put in 11 or more hours a day at the office are twice as likely to suffer a severe bout of depression than those working just eight.

This news is based on a study that examined the working habits of over 2,000 UK civil servants and how their working related to major depressive symptoms in the six years that followed. After accounting for other factors linked to depression, the researchers found that working 11 or more hours a week was associated with a 2.5 times increase the odds of experiencing a major depressive episode compared with their colleagues working the Civil Service’s standard seven to eight hours a day.

This research has found a link between working overtime and the risk of subsequent major depressive episodes. However, the relationship is complicated and this research cannot concretely tell whether or not overtime actually causes depression. Verifying this potential link would probably require controlled studies looking at whether or not cutting back work hours proves effective at reducing people’s risk of depression.

Also, this study found strong links between financial status, seniority and a reduced risk of major depression, making the influence of working hours harder to judge. Overall, it is likely that several factors work together to cause depression and the role working hours play in this is unclear.

 

Where did the story come from?

The study was carried out by researchers from Queen Mary’s of the University of London, University College of London, the University of Bristol, McGill University in Canada, and the Finnish Institute of Occupational Health. The research was funded by the Medical Research Council, the British Heart Foundation, the Stroke Association and the US National Institutes of Health.

The study was published in the peer-reviewed scientific journal PLoS ONE.

The study was covered appropriately in the media, although headlines that suggested working overtime definitely causes depression are not supported by the research. The Daily Mail, The Daily Telegraph and The Independent all reported, in both their headlines and main story, that the research found an association or link between overtime and the risk of depression.

 

What kind of research was this?

This was a prospective cohort study that examined the association between people’s number of hours worked a day and their risk of going on to experience a major depressive episode (MDE).

This research analysed data from a large well-known cohort study, called the Whitehall II study, which examined how work related to health in over 10,000 London based civil servants. This particular analysis on depression included full-time workers who were free from any psychiatric disorders and still employed at the time of the study’s follow-up period.

Prospective cohort studies have the advantage of ensuring that the exposure of interest (in this case, working hours) precedes the outcome of interest (experiencing MDE). This is one of several criteria needed to show causality. It is not, however, sufficient on its own to prove that the number of hours worked leads to or causes depression.

 

What did the research involve?

At the start of the study (known as the baseline) participants completed a survey that included questions on:

• job characteristics: including hours worked, degree of work stress, strain and social support
• socio-demographic factors: including sex, age, marital states and socio-economic status
• health-related behaviours: including alcohol consumption and smoking status
• physical health: including the presence of a longstanding illness or coronary heart disease

Participants were divided into four groups based on their working hours:

• those who worked seven to eight hours a day (the standard civil service day)
• those who worked nine hours a day (classed as one hour of overtime a day)
• those who worked 10 hours a day (classed as two hours of overtime a day)
• those who worked 11 to 12 hours a day (classed as three to four hours of overtime a day)

Approximately six years later they completed another interview that included a clinical health examination. At this interview, researchers determined whether or not participants had experienced a MDE during the previous year.

Researchers then analysed the data to assess how the odds of experiencing MDE in the two groups working the fewest and most hours. This analysis adjusted for possible confounding factors, including the baseline job characteristics, socio-demographic, health-related and physical health factors outlined above, in several separate analyses.

 

What were the basic results?

In all, 2,123 participants were included in the study. Those included in this study tended to be younger than those participating in the general Whitehall II cohort, and more likely to be male, married and from higher occupational grades. Participants were also more likely to experience low work strain than the Whitehall II cohort, and less likely to have a chronic disease or be a smoker.

Of the included participants:

• 52% worked a standard seven to eight-hour day
• 21% worked a nine-hour day
• 16% worked a 10-hour day
• 11% worked an 11- to 12-hour day

Employees with the longest working days were more likely to be male, married, from higher occupational grades, have more active jobs and high social support at work compared to those who worked the standard seven to eight-hour day. In addition, they tended to drink more alcohol than the recommended daily limits and to be ex-smokers.

Of the 2,123 participants, 66 experienced a major depressive episode; this is equivalent to a 3.1% rate of depression. When assessing MDE risk, and adjusting for multiple potential confounding variables, the researchers found that employees who worked 11 to 12 hours a day had 2.52 time the odds of experiencing MDE compared to those who worked the standard seven to eight hours a day (Odds ratio [OR] 2.5, 95% confidence interval [CI] 1.12 to 5.65).

Other factors that were associated with increased odds of MDE were:

• sex: females were just over twice as likely to experience MDE compared to males (OR 2.08, 95% CI 1.25 to 3.46)
• presence of a chronic physical disease (OR 2.30, 95% CI 1.41 to 3.78)
• moderate alcohol consumption, compared to teetotallers (OR 2.68, 95% CI 1.05 to 6.82)
• lower occupational grades (grades 4-5), compared to the highest grade, which is grade 1 (grade 5: OR 4.53, 95% CI 1.47 to 13.90; grade 4: OR 3.19, 95% CI 1.02 to 9.99)

Factors that were not associated with increased odds of MDE included:

• marital status
• smoking status
• high alcohol use
• job strain
• social support at work

 

How did the researchers interpret the results?

The researchers conclude that, ‘working overtime predicted the onset of a major depressive episode in a middle-aged cohort of British civil servants’. They add that this association held after adjusting for ‘a range of socio-demographic, lifestyle and work-related factors at baseline.’

 

Conclusion

This was a large cohort study that examined the association between the number of hours worked a day and the risk of subsequent major depressive disorder. It found that, after an adjusted analysis, those who worked three to four hours of overtime a day at the start of the study had a 2.5 fold increase in the chance they would go on to experience MDE.

The size and prospective nature of this cohort study mean that we can be quite confident in the results. There are, however, several limitations to the study that should be considered before insisting that our work hours are cut back. These include:

• The participants in this study were a specific subgroup of an already specific cohort group. Generalising these results to non-urban, non-civil service workers may not be appropriate. The researchers call for further research to determine whether this association can be found in non-civil service contexts.
• This study only included workers with no history of psychological disorders. It is unclear how work hours influence mental health in people with a history of psychological disorders.
• Working hours were assessed only at the start of the study. It is possible that these conditions changed in the six years between the first and second interviews. This could have distorted the results.
• There were a limited number of MDE cases in the cohort. This makes it impossible to determine the role specific factors play in this association.
• Despite news reports to the contrary, the researchers say that this study cannot offer plausible explanations of why long working hours are associated with the development of depression. The say that ‘intervention studies are needed to examine whether interventions designed to reduce working hours would alter depression risk in working populations’.
• The rate of depression found in this study being 3.1%. While those with longer workdays were found to have 2.5 times greater odds of MDE, this is still a low rate overall. Additionally, this rate is lower than the general population rate of depression, which the authors estimate to be approximately 5%.
• This study confirmed a strong link between occupational grade and depression, with higher socioeconomic status associated with a reduced risk of major depression. This had to be carefully adjusted for in the analysis.
• Major depressive episodes involve a specific range of depressive symptoms, but people can also experience milder forms of depression that will not meet the criteria for this diagnosis.

Overall, this research indicates that a very specific subset of civil servants were at increased risk of experiencing a major depressive episode. It is likely that several factors work together as ‘causes’ of depression and so the researchers were correct to avoid saying that they had found a cause.

Links To The Headlines

Working 11 hours a day can lead to severe depression, says study. Metro, January 26 2012

Three hours' extra work a day doubles risk of depression. The Independent, January 26 2012

People who work 11 hours are twice as likely to suffer depression. The Daily Telegraph, January 26 2012

Long work day a shortcut to depression as those spending over 11 hours in the office 'face higher risk'. Daily Mail, January 26 2012

Links To Science

Virtanen M, Stansfeld SA, Fuhrer R, Ferrie JE, Kivima M. Overtime Work as a Predictor of Major Depressive Episode: A 5-Year Follow-Up of the Whitehall II Study. PLoS One 2012; 7(1):e30719.

Heart attack deaths have halved in less than a decade, according to a major study of over 800,000 patients in England. The research has been extensively reported, with news sources suggesting a range of possible reasons, such as better treatments and a reduction in numbers of people smoking.

As the study itself points out, many developed countries have seen reductions in heart-related death over the last 40 years, but it is unclear whether the trend is due to better treatment following a heart attack or steps designed to prevent heart attacks in the first place. This new study found that in England the death rate from heart attacks halved between 2002 and 2010. The researchers calculated that just over half this decline was caused by fewer people having heart attacks and just under half by more people who had heart attacks surviving.

This major, well-conducted study indicates some good news – that fewer heart attacks have occurred in recent years and of those that did occur, fewer were fatal. This encouraging trend is seen in both sexes and all geographical regions. As the authors conclude, further research is needed to determine the specific factors that have resulted in these declines, but the evidence suggests that they are caused by healthier lifestyles, better prevention for those at risk and improved medical treatment for heart attack patients. 

However, the findings are not all good news: the study also found that in contrast to the middle aged, heart attack rates have changed relatively little in both young people and the very old. They suggest that rising rates of obesity and diabetes in younger people may eventually contribute to a ‘levelling off’ of the decline in heart attack rates.

 

Where did the story come from?

The study was carried out by researchers from the University of Oxford’s Department of Public Health. The individual authors were funded by various institutions, including the Medical Research Council and the British Heart Foundation. Part of the research was funded by the National Institute for Health Research. The study was published in the peer-reviewed British Medical Journal. Newspapers generally covered the research accurately and appropriately.

 

What kind of research was this?

This study examined recent trends in heart attack rates and deaths from heart attacks, with specific focus on the influence of factors such as sex, age and geographical region. To do so it used information about heart attacks in over 800,000 people, taken from a national database of hospital and mortality records. It also looked at whether any drop in heart attack deaths was primarily due to those people having heart attacks now having a lower risk of dying, or whether it was due to fewer people now experiencing heart attacks.

The authors point out that while many developed countries have seen a decline in heart attack deaths since the 1970s, in England at least, reasons for this decline are not fully understood: it is hard to tell whether increased prevention or improved treatment is primarily responsible. Given this lack of clarity the researchers attempted to examine whether the trend was due to people having fewer heart attacks or to those having heart attacks being less likely to die.

 

What did the research involve?

The researchers obtained data from national datasets on both hospital admissions and mortality statistics. From this data they were able to include all residents in England who had had a heart attack (or acute myocardial infarction) between 2002 and 2010, as defined by diagnostic codes applied to patient records during treatment. They categorised heart attacks as either fatal (defined as death occurring within 30 days of admission) or non-fatal. To study regional differences they obtained regional data.

Using standard statistical methods they calculated both the new heart attack rate (incidence or event rates) and heart attack death rate (mortality rate) per 100,000 of the population. They did so according to age group and sex, and for each year and each region. They used these figures to calculate the changes in heart attack mortality rates during this period and also the relative contributions of ‘event rates’ (i.e. the number of heart attacks) and ‘case fatality rates’ (i.e. the number of deaths among people who had heart attacks).

 

What were the basic results?

The researchers found that from 2002-10 in England, 840,175 people of all ages were admitted to hospital with heart attack or died suddenly from a heart attack. Some 61% of heart attack patients were men, and 39% were women. The main findings are listed below:

• During this period the mortality rate from heart attacks fell by 50% in men and by 53% in women when the results were ‘age standardised’, i.e. adjusted to account for the changing age structure of the population.
• The greatest rate of decline in events occurred in men and women aged 65-74, and the lowest decline was among those aged 30-54 and 85 or older.
• In men, rates of heart attacks, deaths due to heart attack, and overall death all declined. The average annual rates of decline were, respectively, 4.8% (95% confidence interval [CI] 3.0% to 6.5%), 3.6% (CI 3.4% to 3.7%) and 8.6% (CI 5.4% to 11.6%).
• In women, the corresponding rate reductions were 4.5% (CI 1.7% to 7.1%), 4.2% (CI 4.0% to 4.3%) and 9.1% (CI 4.5% to 13.6%).
• The researchers then calculated how far the decline in  heart attack deaths was caused by lower heart attack rates and how far by the chances of surviving after a heart attack. Reductions in the number of new cases were estimated to account for 57% of the reduction in deaths among men and 52% among women. The chance of surviving a heart attack was estimated to account for 43% of the drop in deaths in men, and 48% in women.
• The relative contributions of these two factors differed by age, sex and geographical region.

 

How did the researchers interpret the results?

They point out that just over half the decline in deaths from heart attacks over the period can be attributed to a fall in people experiencing heart attacks and just under half to improved survival rates when people did experience a heart attack.

However, the researchers say that it is possible there has been no ‘real improvement’ in heart attack rates in younger people and the very old. They say that rising rates of obesity and diabetes may be contributing to a ‘levelling off’ of the decline in numbers of heart attacks.

They suggest that the decline in the numbers of heart attacks could be explained by lifestyle changes and the use of preventative drugs in those at risk, although further research is needed to gain a clearer understanding of the specific elements of prevention and treatment that have contributed to the fall in death rates.

 

Conclusion

The strengths of this study lie in its very large size and its complete national coverage. One possible limitation is its reliance on the accuracy of routine data and diagnosis codes used from English hospitals, although, as the authors point out, research has shown high accuracy rates for this type of data.

It should be noted that although the study shows a fall in heart attacks and also in death rates among heart attack patients, it does not tell us the precise causes of either. The fall in heart attacks is likely to be linked to healthier lifestyles, earlier detection and a better management of risk factors such as high blood pressure in people at risk. Also, the study only examined deaths from heart attacks and the definition of this has changed over the years, so the researchers say that they could not report on changes in hospital admissions as the diagnostic coding for this has also changed.

Overall, while we cannot fully explain the drop in heart attack deaths observed in this report, the good news is that the trend is clearly going in the right direction.

Links To The Headlines

Heart attacks deaths 'halved'. BBC News, January 26 2012

Heart attack deaths halve in a decade: research. The Daily Telegraph, January 26 2012

The curious case of the vanishing killer. The Independent, January 26 2012

Heart attack deaths fall by 50%. The Guardian, January 26 2012

Heart attack deaths have halved over a decade. Daily Mirror, January 26 2012

Number of deaths from a heart attack halve in ten years. Metro, January 26 2012

Deaths from heart attacks halved. Daily Express, January 26 2012

Links To Science

Smolina K, Wright FL, Rayner M, Goldacre MJ. Determinants of the decline in mortality from acute myocardial infarction in England between 2002 and 2010: linked national database study. BMJ 2012;344:d8059

Related editorial

Tunstall-Pedoe H. The decline in coronary heart disease; did it fall or was it pushed?. BMJ 2012;344:d7809

Vitamin D was in the headlines today, with many papers reporting that a quarter of all toddlers are deficient in the nutrient and that childhood rickets is on the rise. The vitamin plays several important roles in the body, including regulating the balance of nutrients needed for strong, healthy bones.

The vitamin has fallen under the spotlight as Chief Medical Officer for England, Professor Dame Sally Davies, is reportedly contacting health professionals to highlight the need to prescribe vitamin D supplements to at-risk groups. There are already extensive guidelines on circumstances where people should take vitamin D supplements, but the move seems designed to increase use of the pills, which are available on prescription, or even free to individuals with a raised risk of deficiency.

An independent advisory committee is also researching and reviewing current recommendations on vitamin D, but the results of this extensive analysis are not expected until early 2014.

While vitamin D deficiency may have increased in recent years, rickets is still a rare condition. That said, it is entirely preventable and vitamin D supplementation can be of great importance to at-risk groups such as toddlers and young children.

 

What is vitamin D and why do we need it?

Vitamin D plays an essential role in maintaining good health. It has several important functions, including helping to regulate the amount of calcium and phosphate in the body. These substances are needed to keep bones and teeth healthy.

Without adequate vitamin D, bones can become thin, brittle and misshapen. In extreme cases this can lead to rickets in children, a condition involving a softening of the bones that can lead to fractures and deformity. In adults softening of the bones is usually called osteomalacia, and may cause pain and muscle weakness.

Vitamin D has many other important roles in the body including regulating cell growth, neuromuscular and immune function, and reduction of inflammation. Even years after its discovery, there is still ongoing research examining the various other functions vitamin D might perform in the body.

According to the Scientific Advisory Committee on Nutrition (SACN) – a group of experts that advises the government about all aspects of nutrition – some evidence suggests that vitamin D may be important in preventing other diseases including cancer, cardiovascular disease and multiple sclerosis, although it points out further research is needed before any definite conclusions can be drawn.

 

How can I get vitamin D?

The best source of vitamin D is sunlight on the skin. The vitamin forms under the skin in reaction to a type of ultraviolet ray called UVB. UVB rays are more powerful in the summer, and experts advise exposing the skin to regular, short periods of sun during the summer months, without sunscreen, which blocks UVB rays. However, it is important to ensure that the skin does not burn.

Vitamin D is also found in a small number of foods but it is difficult to obtain enough vitamin D from diet alone. Good sources of vitamin D include oily fish (such as salmon and sardines), eggs, cheese and meat. In the UK, all margarines and infant formula milks are fortified with vitamin D. It is also added to other foods such as breakfast cereals, soya and some dairy products, but usually only in small amounts.

Breastfed babies get their vitamin D from their mother’s breastmilk, which makes it especially important that breastfeeding women have adequate vitamin D levels of their own.

Vitamin D is also available in supplement form. Women and children participating in Healthy Start can get free supplements containing vitamin D. Some doctors sell supplements or supply them free of charge to those not eligible for Healthy Start.

 

Who needs vitamin D supplements?

The current advice is that most people should be able to get all the vitamin D they need by getting enough sun and eating a healthy balanced diet. However, the Department of Health says the following people may be at risk of vitamin D deficiency and recommends they take daily vitamin supplements:

• all pregnant and breastfeeding women
• all children aged six months to five years old
• all people aged 65 or over
• people who are not exposed to much sun – for example people who are housebound and those who cover up their skin for cultural reasons
• people who have darker skin, such as people of African Caribbean and south Asian origin. Their bodies are unable to produce vitamin D as easily

You can buy single vitamin D supplements at most pharmacies and supermarkets. Pregnant women who take vitamin D as part of a multivitamin should avoid supplements containing vitamin A (retinol), which can be harmful in pregnancy.

 

Can too much vitamin D be harmful?

The Department of Health says that taking 25 micrograms (0.025mg) or less a day of vitamin D supplements is unlikely to cause any harm.

 

Is rickets really on the rise?

Yes. In 2007 SACN  published an update paper on vitamin D which, it said, highlighted “the prevalence of low vitamin D status throughout the UK population and the re-emergence of rickets in certain subgroups”.

However, while it would appear that a relatively high proportion of children do not get enough vitamin D, rickets is still a rare disease in the UK and there is certainly not an epidemic of the condition, as might be supposed by reading some news articles. That said, the condition is entirely preventable, and so there is a need to ensure parents and children have access to vitamin D supplements wherever appropriate, such as through the Healthy Start scheme.

 

What will happen next?

Last year the government launched a review of vitamin D supplementation, which is due to report in the next few years. In the meantime, Dame Sally is reportedly contacting health professionals to ensure they offer advice on vitamin D supplementation to those at risk, so that they can avoid health problems associated with deficiencies of this important nutrient.

Links To The Headlines

Experts review vitamin D advice. BBC News, January 25 2012

Vitamin D awareness in decline, say doctors. The Guardian, January 25 2012

A quarter of UK toddlers are lacking Vitamin D. The Independent, January 25 2012

Rickets returns as 1 in 4 toddlers found to be lacking in vitamin D. Daily Mirror, January 25 2012

Vitamin D deficiency in UK a 'major problem'. The Daily Telegraph, January 25 2012

The idea that regularly eating fried foods causes heart attacks is a ‘myth’, The Daily Telegraph has today reported.

The newspaper has panned conventional wisdom based on a large Spanish study investigating how people’s fried food consumption was linked to their risk of events such as heart attacks and episodes of heart pain. To study the relationship researchers surveyed over 40,000 people on how much fried food they ate during the previous year, looking at any episodes related to coronary heart disease over an average period of 11 years.

In this particular setting the researchers found no link between consuming food fried in olive or sunflower oils and the risk of heart disease (the UK’s biggest killer) or death from any cause. However, while such a phenomenon could exist in the context of this specific group of people eating a specific type of diet, the research does not support the idea that fried food is generally harmless, or that it represents diets among the UK population. For example, most participants reported eating a relatively small amount of fried food each day, much less than might be typically found in a fry-up or a fast food meal. In short, it is not clear whether the same study conducted in the UK would have the same results.

Many news sources have reported the results in an accurate, measured way. However, The Daily Telegraph’s account has been somewhat overcooked, as the study did not look at the impact of factors such as frying with other types of fats, reusing oils several times (as is the case in most fast food outlets), or consuming fried snacks high in salt, sugar or calories.

 

Where did the story come from?

The study was carried out by a collaboration of researchers from Spanish universities and other health organisations based in Spain. It was funded by Spain’s FIS Fund for Health Research and published in the peer-reviewed British Medical Journal.

Media reports were generally balanced, with many making the point that the study was primarily concerned with a Mediterranean diet containing olive oil, which is typically very different from the dietary patterns in the UK. This limits how relevant this study is to the UK population. Many news sources also rightly warn against assuming that the study results suggested that consuming large amounts of fried foods is not harmful. The Telegraph included a picture of a full English breakfast, which is not a recognised part of a Mediterranean dietary pattern.

 

What kind of research was this?

This prospective cohort study investigated the association between people’s consumption of fried foods and their risk of experiencing coronary heart disease events such as heart attacks and heart pain (angina) which require surgery. It was conducted in a Spanish population.

Previous research has shown fried foods have been associated with high blood pressure, obesity and low levels of ‘good’ cholesterol (high-density lipoproteins or HDL cholesterol). However, existing studies into the association of fried food and coronary heart disease provided mixed results, the authors report.

When food is fried the nutritional content changes; water is lost and fat is absorbed, increasing the calorie content of the food. During frying, the oils also deteriorate and change into other forms, especially when reused, as is often the case in fried fast food outlets. This process leads to a loss of unsaturated fats and an increase in harmful trans fats.

A prospective cohort study is a good way of investigating whether fried foods are linked to heart disease because you can be sure the consumption of the food occurred before the development of the disease. However, the limitation is that you cannot be certain that fried foods caused a disease because its development may be influenced by numerous other factors, some measured in the research and some not.

The best type of study to definitively assess this link would be a large randomised controlled trial, providing it could be performed ethically. However, given the cost and complexity of such a task, this approach may ultimately be impractical.

 

What did the research involve?

The participants were Spaniards enrolled in a research project called the European Prospective Investigation into Cancer and Nutrition (the EPIC-Spain cohort). The analysed cohort consisted of 40,757 adults aged between 29 and 69 who were recruited between 1992 and 1996. They were followed up for an average of 11 years to see what diseases they developed and what they died of.

When enrolled, participants were asked by trained interviewers to complete a questionnaire about the food they consumed over a typical week during the previous 12 months. Only foods consumed at least twice a month were recorded.

The study’s authors report that this method had previously been shown to be accurate (validated) at assessing the diet of Spanish people. The type of oil used for frying (olive oil versus sunflower oil or other vegetable oils) was recorded and then checked again after two years. No further information on diet was collected at a later date.

At enrolment, the researchers also recorded non-dietary variables. These included demographic variables such as age and sex as well as educational level, body mass index (BMI), smoking and physical activity levels. Participants were also asked if they had coronary heart disease, diabetes, high blood pressure, cancer or angina or had experienced a heart attack or stroke in the past.

For the analysis, people were divided into four groups depending on their level of fried food consumption. The researchers specifically analysed how consuming fried food was linked to the chance of having a coronary heart disease event and dying from any cause (known as all-cause mortality) and how these varied for the four groups.

The analysis was adjusted for a large number of factors, including energy intake, educational level, smoking and physical activity. This statistical technique aims to minimise the effect these external factors have on the association of interest, in this case between fried food and heart disease.

 

What were the basic results?

An average of 138g of fried food was consumed daily, including 14g of oil used for frying. About 7% of the total amount of food consumed was fried. Of the total amount of fried food consumed, 24% (34g/day) was fish, 22% (31g/day) meat, 21% (30g/day) potatoes, and 11% (15g/day) eggs. Almost two thirds (62%) of participants used olive oil for frying, the rest used sunflower oil or other vegetable oils.

During the 11-year follow up, 606 definite cases of heart disease were recorded (466 heart attacks and 140 episodes of angina requiring surgery) and 1,135 deaths from all causes.

Fried food consumption was not associated with the risk of coronary heart disease after adjusting for possible confounders. There was also no association between fried fat consumption and death from all causes. These findings were no different in those who fried using olive oil compared to sunflower oil or other vegetable oils.

In the study, coronary heart disease events were defined as definite, probable and possible depending how they were assessed. The researchers first analysed their data using only the definite cases of coronary heart disease and found no association between fried food and these cases. The same result was found when they combined the definite coronary heart disease cases with those that were less certain (probable and possible groups).

 

How did the researchers interpret the results?

The researchers concluded that within the EPIC-Spanish cohort they found ‘no association between consumption of fried food and risk of coronary heart disease or all-cause mortality’.

They point out that their results are ‘directly applicable only to Mediterranean countries with frying methods similar to those in Spain’ and state that oil (mainly olive and sunflower) rather than solid fat is used for frying in Spain. They also point out that the majority of fried food eaten in Spain is not necessarily fast food.

They also make the important point that ‘frying with other types of fats, reusing oils several times, or consuming fried snacks high in salt may still be harmful’.

 

Conclusion

This study found no association between how often people ate fried food and their risk of coronary heart disease or death from any cause in a large Spanish cohort.

This study has strengths, including using a valid method of assessing diet, a large sample size and long follow-up time, but also has significant limitations. The following limitations should be considered when interpreting the findings of this study:

• The study looked at frying using olive oil or sunflower oil in the context of a Mediterranean diet. The authors make the important point that frying with other types of fats or reusing oils several times may still be harmful. Reusing oils is common in fast food preparation in the UK, and so this study does not show that consuming this type of food is not linked to heart disease.
• Diet was measured only when the participants were first enrolled. Any changes in diet after this will be missed and could lead to an association being masked because of error in the classification of fried food consumption.
• Fried food consumption was self-reported using a computerised questionnaire and so there may have been under-reporting given that many people perceive it to be unhealthy and may want to partially conceal the amount they eat. This could potentially hide an association.
• The study did not assess the extent to which the oils were reused, assuming that this was not common in foods consumed in the home. Hence, the effects of foods fried in reused oils are still unknown and may warrant further research as reusing oils is known to make them more harmful, the authors report.
• This study cannot separate the effect of the food from the cooking method. For example, the beneficial effect of omega 3 fatty acids from fish compared with the effect of frying this fish in oil that may be harmful. Therefore, the food itself blurs the link between the cooking method and disease. It is not clear whether the same results would be found if the study was conducted on the UK diet, which is generally considered less healthy than the Mediterranean diet.
• This study cannot say that consuming fried foods at a higher level than their highest consumption group (249.6g/day) does not increase risk of heart disease.

Bearing in mind the limitations, this study showed that there may not be a link between consuming foods fried in olive oil or vegetable oil and coronary heart disease in Spanish adults consuming a typical Mediterranean diet. The relevance of this to the UK is limited due to differences in diet and the type of fried foods consumed in the two countries.

It is important to note that frying foods with other types of fats, particularly saturated fats such as lard or butter, reusing oils several times, or consuming fried snacks high in salt may still be harmful.

Links To The Headlines

Fried food 'fine for heart' if cooked with olive oil. BBC News, January 25 2012

Fried food heart risk 'a myth'. The Daily Telegraph, January 25 2012

You'll be oil right. The Sun, January 25 2012

Links To Science

Guallar-Castillón P, Rodríguez-Artalejo F, Lopez-Garcia E et al. Consumption of fried foods and risk of coronary heart disease: Spanish cohort of the European Prospective Investigation into Cancer and Nutrition study. BMJ 2012;344:e363

A groundbreaking stem cell trial offers hope for millions with progressive conditions that end in sight loss, the Daily Mail has today reported. The high profile study was covered in different ways by news sources, with The Independent going as far to say patients had been ‘cured’ by a stem cell ‘miracle’.

The news is based on a small but important clinical trial that tested the safety of using human embryonic stem cells. The trial treated two people with progressive eye conditions affecting the macula, the part of the eye responsible for central vision. One patient had age-related macular degeneration, a common cause of visual loss in older adults. The other patient had Stargardt’s macular dystrophy, a rare hereditary disease that causes macular degeneration in adolescence. Both patients had end-stage disease with severe central vision loss.

In the study researchers developed stem cells into cell types found within the eye and carefully injected the cells into specific locations within the eye. After monitoring patients for four months the researchers found that neither patient had problems with abnormal cell growth, tumours, graft rejection or other safety issues. They also reported improvements in their vision, although not complete reversal of their conditions.

While certainly impressive, this small trial was designed to help establish the safety of the procedure, not whether it was effective. As such it helps support the safety of the treatment but it is far too early to declare the treatment as a ‘cure’ for blindness.

 

Where did the story come from?

The study was carried out by researchers from The University of California and the biotechnology company, Advanced Cell Technology in the US. The study was published in the peer-reviewed medical journal The Lancet.

BBC News reported this research well, highlighting that it was a small, preliminary safety study and that further follow-up is needed. The Independent’s headline was misleading, as this study did not demonstrate that a patient’s blindness was cured. However, within the main body of its article the newspaper made it clear that the study was a small trial to assess safety rather than effectiveness. The Daily Mail also said that it was a safety trial and their reporting was appropriate.

 

What kind of research was this?

This clinical study looked at the safety of transplanting human embryonic stem cells into two people with different types of eye disease: one person with Stargardt’s macular dystrophy and one person with dry age-related macular degeneration.

Age-related macular degeneration (AMD) is an eye condition that affects the macula, which is the central part of the retina found across the back of the eyeball. The macula is responsible for central vision. The condition is most often seen in people over the age of 65, and is the most common cause of visual loss in the developed world.

AMD is usually described as being dry or wet. Dry AMD, as the person in this study had, is the most common and less severe form and means that there is gradual degeneration of the retinal cells. It may or may not lead to complete visual loss. If there is progression to the more severe form, wet AMD, the condition also involves abnormal blood vessels growing within the retina (in an attempt to try and supply blood to the damaged macula). These abnormal vessels are fragile and can swell and bleed into the eye causing considerable damage to the macula and loss of vision over a comparatively short space of time. This study did not include people with wet AMD.

Stargardt’s macular dystrophy is a rare, inherited form of macular degeneration. Progressive vision loss usually starts before the age of 20 years, and as there is currently no available treatment. The condition usually leads to complete loss of central vision at a young age.

Stem cells have the ability to develop into various cell types. In this study the researchers used a type of stem cell derived from human embryonic tissue, which had then been developed into retinal cells. The researchers said that there were potential side effects of using these cells, included the cells dividing in an uncontrolled manner, forming tissue in the wrong position, and causing an immune rejection.

As is normal when developing new treatments, the researchers were carrying out a safety study to make sure the treatment was safe for humans. For their trial they used only one person with Stargardt’s disease and one person with dry AMD. As there were only two people in this study, with no control or comparison group, it is not possible to say how effective this treatment is at this stage. Larger follow-up trials would be needed to determine how effective treatment with this technology actually is.

 

What did the research involve?

The researchers recruited two people experiencing the end stage of their disease, which had left them with central vision loss but no other eye problems. They also had a cancer-free medical history and were able to undergo the immunosuppression needed for the treatment. They were also judged as psychologically suitable to participate in the first trial of this type involving eye stem cell treatment.

The researchers made human embryonic stem cells develop into retinal cells, using mouse skin cells to grow them on. The researchers then purified the cells so that there were no mouse cells remaining and then selected patches of retinal cells. They had already determined the best way to handle and store these cells in previous experimental work.

The two participants received immunosuppressive treatment the week before their transplant and for an additional 12 weeks. The researchers prepared a 1ml solution containing a known number of the retinal cells. They chose a specific area of the retina on which to inject these cells. Each patient had cells injected into one eye only, which is a common practice for trials of new treatments that could potentially damage the eyes.

 

What were the basic results?

The researchers were able to make retinal cells that were over 99% pure. As the cells had previously been exposed to animal cells, they tested the cells extensively for any contamination, including animal and human viruses.

They did not see any excessive or abnormal growth of the transplanted cells in either patient or any tumour formation. The transplanted cells were growing in the correct place, except one cell in the patient with Stargardt’s macular dystrophy. However, this cell was not dividing. There was no clinically detectable inflammation in the eyes of either patient and no signs of cataract, glaucoma, retinal detachment or increased pressure in the eye. Neither patient experienced pain or sensitivity to light.

The researchers could see that the cell transplant had survived in the patient with Stargardt’s macular dystrophy, and the amount of pigment in these cells increased from one week after the transplant up until the third month. Pigment is crucial for vision as it allows light entering the eye to be absorbed and converted into signals relayed to the brain.

Both patients showed functional improvement in their sight following treatment, despite not seeing anatomical evidence that the cells had survived in the patient with AMD. The patient with Stargardt’s macular degeneration could only determine hand motions before the treatment but after two weeks could count fingers using their treated eye. Her vision continued to improve over the next three months.

 

How did the researchers interpret the results?

The researchers say that the therapeutic use of human embryonic stem cells poses daunting challenges but that their results provide clinical evidence suggesting that human embryonic stem cells might safely be transplanted into human patients.

They say that so far, "the cells seem to have transplanted into both patients without abnormal proliferation, tumour formation, graft rejection or any untoward pathological reactions or safety signals". However, they add that continued follow-up and further study is needed.

This study tested the safety of these cells in people who had end-stage dry AMD and Stargardt’s macular degeneration. The researchers said that the ultimate therapeutic goal is to treat people earlier in the hope of increasing the likelihood of being able to safeguard their vision.

 

Conclusion

This was a small clinical trial that assessed the safety of using stem cell technology to treat one person with Stargardt’s macular dystrophy and one person with dry age-related macular degeneration. Specifically, it looked at the use of retinal cells that had been made from human embryonic stem cells.

The primary focus of this research was to see whether this procedure would be safe, not whether it was effective. The researchers found that neither of the patients had problems with abnormal cell growth, tumour formation, graft rejection or any other pathological reaction or safety issues, all of which are potential problems in this type of treatment.

The researchers followed the patients over four months but say that further follow-up is needed to observe the long-term effects of this treatment.

Although measuring the effectiveness of the treatment – whether it improved vision – was not the main aim of this study, both patients showed some improvement in vision. However, it should not be assumed that the treatment is effective, as it is not possible to say whether these improvements would be sustained in the long term. As only two people were treated, the response of a variety of people with central vision loss would have to be assessed in a larger trial.

This careful research has demonstrated that this type of transplant could be safe in the short term, and paves the way for larger trials under carefully controlled conditions. However, it is far too early to say whether this treatment could be a cure for blindness, as The Independent suggested.

Links To The Headlines

A glimpse of hope as blind are given stem cell jab to give back sight. Daily Mail, January 24 2012

Advanced Cell Technology: Stem cell retinal implants safe. BBC News, January 24 2012

Once they were blind, now they see. Patients cured by stem cell 'miracle'. The Independent, January 24 2012

Links To Science

Schwartz SD, Hubschman JP, Heilwell G et al. Embryonic stem cell trials for macular degeneration: a preliminary report. The Lancet, January 23 2012

“Magic mushrooms could one day be prescribed for depression,” The Independent has today reported. The newspaper said the approach is based on potentially using its chemical properties to trigger positive memories during psychotherapy.

A number of newspapers have reported similar news, which is based on research led by the former government drugs adviser Professor David Nutt. For example, the Daily Mirror reported that the use of psilocybin, the active ingredient in magic mushrooms, is being considered as part of therapy for depression.

These claims are based on a pair of research studies, one published today and another to be published in the near future. The study published today looked at brain activity in 30 people using a special type of MRI scan to help establish how psilocybin causes sensations such as hallucinations. The research compared the brain’s workings when given psilocybin and a placebo. It found that the psychoactive compound decreased activity in various brain areas and that greater decreases were linked to more intense experiences.

Crucially, this exploratory study was not a clinical trial or an examination of the effect psilocybin has on people with depression. Therefore, it is not possible to say from this research whether psilocybin could have benefits for people with depression. Also, importantly, the possible harms of using this drug, either in the short or long term have not been studied here.

 

Where did the story come from?

The study was carried out by researchers from Imperial College London and the University of Bristol.  It was funded by a range of research and policy foundations: The Beckley Foundation, The Neuropsychoanalysis Foundation, Multidisciplinary Association for Psychedelic Studies, and The Heffter Foundation.

The study was published in the peer-reviewed scientific journal Proceedings of the National Academy of Sciences (PNAS).

The headlines featured in The Daily Telegraph and The Independent suggested that magic mushrooms are being considered as a treatment for depression. The study itself looked at how the brain was affected by a hallucinogenic chemical in the mushrooms, rather than using them in a medicinal manner.

As this study did not look at whether psilocybin had any beneficial effects for depression, it will take further study to see whether it does have any beneficial effect and if it is safe.

It has been reported that a related trial looking at the psychological impact of psilocybin is to be published in the near future, although Behind the Headlines cannot verify the nature of this research and its findings until the research paper is available.

Metro had correctly reported the current research’s finding that psilocybin reduces blood flow. However, its headline suggesting the drug ‘narrows the mind’ is misleading and confusing.

 

What kind of research was this?

This brain imaging study used a special type of MRI scan called functional MRI (fMRI) that measures brain activity by detecting changes in blood flow. Researchers used this to look at how a psychedelic chemical found in magic mushrooms affected the brain activity of 30 healthy volunteers who did not have depression.

The researchers said that although the hallucinogenic chemical has been reported to cause ‘profound existential experiences’ that can leave a long-lasting impression, little is known about how psilocybin actually affects the brain.

The volunteers in this study had experienced hallucinogens before and did not have depression. Therefore, it is not possible to say whether these people would have exactly the same experience as people who had current or past depression, or people who had never experienced the sensation of hallucinating. This was not a clinical trial and did not look at the effects of the drug on depression.

 

What did the research involve?

The study recruited five women and 10 men who had previously used a hallucinogenic drug and had no history of any psychiatric disorder, substance dependence or cardiovascular disease. The volunteers had an average age of 34 years.

The volunteers first had a normal MRI scan taken to look at the structure of their brain. They then had functional MRI scans to look at blood flow within their brains while they received an infusion of either a placebo, in the first scan, or psilocybin in the second scan. These infusions were administered six minutes after the scan began, and took 60 seconds to be delivered. The functional scans took 18 minutes and during this time the volunteers were asked to relax and stare at a cross.

Before the infusion, five minutes after, and 12 minutes after, the volunteers were asked to rate their feelings from 0-10, where a score of 10 represented ‘extremely intense effects’. After each scan the volunteers were asked to rate how much they experienced 19 different aspects of hallucination. These subjective effects included, for example, seeing geometric patterns, feeling that their sense of time was altered, and feeling unusual body sensations.

The researchers looked at the pattern of blood flow (a marker of brain activity) before and after the infusions.

The researchers additionally performed functional brain scans on a further 15 volunteers, using a slightly different type of functional MRI scan that measures the amount of oxygen in the blood going to and from the brain as a measure of brain activity.

 

What were the basic results?

The researchers found that the volunteers’ subjective experiences started towards the beginning of the infusion period and peaked after four minutes.

The researchers found that psilocybin caused a decrease in blood flow in several areas of the brain compared to placebo. They also found that there were decreases in flow to around 16 brain areas in the cortex (the outer brain structures) and three subcortical (the inner brain structures) brain areas.

The researchers plotted the decrease in blood flow against how intense the volunteers said their experience was. They found the greater the decreases in blood flow, the more intense the subjective effects. They found similar changes in activity when using the second type of functional brain scan, but additionally found decreases in activity in some areas of the brain involved in vision.

The researchers say that there may be other ways the drug could have affected the blood-brain signal on the functional scans, such as by changing how the volunteers were breathing. To test this the researchers asked the volunteers to hold their breath. They found the same differences persisted between the psilocybin scan and the placebo scan, suggesting that this was not the case.

 

How did the researchers interpret the results?

The researchers say psilocybin decreased brain blood flow and oxygen levels in a manner that correlated with its subjective effects. They highlight two key brain areas that showed the decreased activity pattern: the middle prefrontal cortex and the back of the cingulate cortex. These areas are thought to play a role in decision making, social behaviour and processing emotions and memories. The researchers say that greater activity has been found to occur within the middle prefrontal cortices of people with depression, and that this activity can be reduced by treatment for depression.

The authors propose that decreased activity of key brain areas with psilocybin may permit an ‘unconstrained style of cognition’.

 

Conclusion

This experimental study took functional MRI scans of 30 volunteers and looked at the differences in brain activity when they received the hallucinogenic magic mushroom extract psilocybin and when they received a placebo.

They found that brain blood flow was reduced in various brain areas and that the greater the decrease in blood flow, the greater the intensity of the subjective experience of the volunteer when they received the hallucinogen.

Although one of the brain areas that showed decreased blood flow also tends to show higher than normal activity in the brains of people with depression, this study did not directly look at the effect or possibility of using psilocybin in people with depression. Furthermore, this study recruited people who had taken hallucinogens before, so the results do not reflect the population as a whole.

As this was not a clinical trial it is not possible to say from this study whether psilocybin, in combination with psychotherapy or not, would have any beneficial effect for people with depression. Also, importantly, the possible harms of using this drug, either in the short or long term, have not been studied here.

Links To The Headlines

Magic mushrooms 'could treat depression'. The Daily Telegraph, January 24 2012

Could magic mushrooms help the fight against depression?. The Independent, January 24 2012

Magic mushrooms may help with depression, say leading scientists. The Guardian, January 24 2012

Magic mushrooms discovered to narrow the mind, not expand it. Metro, January 24 2012

Magic mushrooms ingredient 'could help treat depression'. Daily Mirror, January 24 2012

Links To Science

Carhart-Harrisa RL, Erritzoea D, Williams T et al. Neural correlates of the psychedelic state as determined by fMRI studies with psilocybin. PNAS, Published online before print January 23 2012

“A healthy fruit and vegetables diet could help guard against one of the deadliest cancers,” the Daily Express has today reported. The newspaper says this is due to “a potent super-nutrient” found in these foods.

This story is based on research into a chemical called luteolin that is found in a wide variety of plants. The substance has already been found to reduce the growth of bowel cancer cells in the laboratory, and this new study attempted to confirm how it disrupted these cancer cells. In particular, the researchers concentrated on a cellular process that blocks cells from dying naturally and causes cancers to form. After testing luteolin on bowel cancer cells the researchers found that it interfered with this process, which effectively helps to control a cell’s life and death.

The Daily Express has reported that a luteolin-rich diet prevents cancer, but this research was carried out in cells in the laboratory, and did not test the effect of the compound in humans. Also, the luteolin used in this research was in a highly concentrated pure dose, and not from dietary sources. The study demonstrates how pure luteolin reduces the growth of bowel cancer cells in the laboratory, but does not show that a diet high in luteolin-containing vegetables can prevent cancer.

However, there is a great deal of existing research supporting a link between fruit and vegetables and benefits such as a reduced risk of bowel cancer. On this basis, there is already enough evidence to recommend including fruit and vegetables as part of a balanced diet.

 

Where did the story come from?

The study was carried out by researchers from Hallym University and other institutions throughout Korea. The research was funded by the Korean Ministry of Education, Science and Technology.

The study was published in the peer-reviewed open-access medical journal BMC Gastroenterology.

By itself, this study is not enough to support headlines claiming that a diet high in fruit and vegetables can prevent bowel cancer. Rather than examining the health effects of eating luteolin-containing foods it tested a dose of pure luteolin on bowel cancer cells grown in a laboratory. It is premature to link these laboratory-based results to dietary intake of luteolin.

 

What kind of research was this?

This was a laboratory study that examined the effect of a common plant compound called luteolin on bowel cancer cells. Luteolin is a type of plant pigment called a ‘flavonoid’, and it has antioxidant and suspected anti-cancer properties.

The researchers performing this study had previously shown that luteolin can stop bowel cancer cells in the laboratory from dividing, and can cause them to die. They thought that luteolin may do this by interfering with a particular biochemical chain of events called the ‘IGF-IR pathway’, which is known to be overactive in bowel cancer cells. This pathway causes cancerous cells to grow and divide, and prevents them from dying off naturally as healthy cells do.

This research was conducted in a laboratory setting, and did not involve any human participants. Its aim was to identify the effects of luteolin on bowel cancer cells, as a very early step in determining whether this chemical or a similar one might be used as a cancer treatment. It did not assess the potential cancer-preventing effects of eating luteolin-containing vegetables and herbs.

 

What did the research involve?

The researchers first grew human colon cancer cells in the laboratory, starved them for one day, and then divided them into four groups:

• group 1 was exposed to luteolin but no insulin-like growth factor I (IFG-I), which is known to activate the IGF-IR pathway under study
• group 2 was exposed to luteolin and IGF-I
• group 3 was exposed to IGF-I, but no luteolin
• group 4 was exposed to neither luteolin nor IGF-I

The researchers then measured and compared the number of cancer cells present after one, two and three days, across all the exposure groups. The researchers compared the average number of cells, and determined whether or not there was a statistically significant difference in the number of cells present in each group.

The researchers also carried out a variety of experiments to determine what components of the IGF-IR pathway luteolin interferes with.

 

What were the basic results?

When assessing the effect of luteolin on the growth of bowel cancer cells, the researchers found that the cells exposed to only IGF-I significantly increased in number, while those exposed to only luteolin significantly reduced in number. The group exposed to both luteolin and IGF-I showed the same reduction in the number of cells as the luteolin-only group, implying that luteolin interferes with the effect of IGF-I.

They also found that luteolin reduces the secretion of a protein called IGF-II by the cancer cells, reduces the amount of a key protein in the signalling pathway and interferes with several chemical processes in the signalling pathway. All of these actions reduce the activity of the cancer-related IGF-IR signalling pathway.

 

How did the researchers interpret the results?

The researchers say that luteolin reduced the activity of a key signalling pathway that is overactive in bowel cancer cells, and that this may account for the reduction of cell growth and increase in natural cell death seen in these cells when exposed to luteolin. They say that further animal studies are necessary to determine whether or not luteolin can be developed into an effective therapy for bowel cancer.

 

Conclusion

This research studied luteolin, which is a plant compound that can reduce growth and induce death of bowel cancer cells in the laboratory. The research seems to have pinpointed the specific signalling pathway through which this occurs. It did not, however, examine the impact of luteolin-rich diets on bowel cancer in people, and based on these results it cannot be assumed that eating vegetables containing this compound can prevent or slow cancer.

Laboratory-based studies carried out in cells are a necessary first step in identifying a potential new disease treatment. The mechanism through which luteolin may prevent cancer cell growth has been identified, and the next step would be further studies in animals. If these animal studies suggest that luteolin is safe and beneficial, limited trials in humans would then be needed to assess its effect on human disease. In short, this study represents an extremely early stage of research, and it will be several years before its results could result in any new treatments in humans.

It is important to remember that this study used pure luteolin, and not dietary sources of the compound. The effect of dietary luteolin on cancer is not clear from this research.

Systematic reviews of observational studies have found a link between eating a diet high in plant foods and a reduced risk of bowel cancer. Therefore, despite the limitations of the current study, a diet high in fruit and vegetables is certainly a healthy choice, and is recommended by schemes such as 5 A DAY.

Links To The Headlines

How a diet packed with fruit and veg can ward off cancer. Daily Express, January 23 2012

Links To Science

Young Lim D, Jin Cho H, Kim J et al. Luteolin decreases IGF-II production and downregulates insulin-like growth factor-I receptor signaling in HT-29 human colon cancer cells. BMC Gastroenterology 2012, 12:9