NHS Choices

Fruit may be good for you, but don’t ditch the statins

NHS Choices - Behind the Headlines - Thu, 07/04/2016 - 17:30

"Daily fresh fruit lowers heart death risk as much as statins," The Daily Telegraph reports.

A study of over a half a million Chinese people found that a diet rich in fresh fruit was linked to a reduced risk of cardiovascular diseases.

But don't ditch the statins in favour of an "apple a day", if they have been recommended for you.

The study looked at people without cardiovascular disease, and did not compare fruit to statins.

Statins are prescribed for people with cardiovascular disease, or a raised chance of getting it, and fruit is not a suitable alternative to medication. The study was also carried out in a country with different lifestyles to the UK. Finally, the study did not prove that fruit caused the lower death rate in people who ate it regularly.

The effect of fresh fruit that the study found was much bigger than the effects found in previous research in Western countries. People who ate fruit every day were likely to be richer and better educated, which itself could have affected their chances of dying of cardiovascular disease (although the researchers did try to account for this). 

The study adds to evidence that people who eat fruit daily tend to be healthier, but it does not mean that fruit can be used instead of medication for people with cardiovascular disease.

Fresh fruit should be seen as an addition to statin treatment, not an alternative.

Where did the story come from?

The study was carried out by researchers from the University of Oxford, Peking University, the Chinese Academy of Medical Sciences, the Chinese National Center for Food Safety Risk Assessment, and three regional Chinese centres for disease control.

It was funded by the Wellcome Trust, the Kadoorie Charitable Foundation and the Chinese National Natural Science Foundation. The study was published in the peer-reviewed New England Journal of Medicine.

The Telegraph's reporting unhelpfully mixed information about the effect of statins in with the report of the Chinese study. It is unclear why the newspaper did this, as the Chinese study did not look at statins at all.

Although the report admitted that the researchers "do not recommend swapping statins for fruit", it may give some people the impression that statins and fruit are equally effective.

The Mail Online's reporting was clearer, as its headline mentioned that the study was in China, and results may be specific to that country.

The Daily Express' reporting was also accurate and contained an interesting quote from one of the lead researchers, who said: "We still don't know exactly what it is about fruit that appears to reduce heart attack and stroke risk."

 

What kind of research was this?

This was a large prospective cohort study, which recruited half a million volunteers in China to measure diet, health and deaths from disease. Researchers wanted to see whether the link between fruit consumption and cardiovascular disease seen in previous Western studies also applied in China. Cohort studies are good at picking out patterns of associations, but they can't prove that one thing (in this case, fruit consumption) is a cause of another (death from cardiovascular disease).

 

What did the research involve?

Researchers questioned around half a million Chinese adults about their health and diet, and took measurements including their body mass index (BMI) and blood pressure. They followed them up for seven years. After adjusting their figures to take account of confounding factors, they looked to see whether people who regularly ate fruit were less likely to have died from cardiovascular disease, or had a heart attack or stroke.

The study recruited 512,891 adults aged 35 to 74, living in different locations across China from 2004 to 2008. People underwent a battery of tests and questions; researchers recorded information about their weight, height, blood pressure, glucose level, whether they smoked or drank alcohol, their income and education level, and their diet. They filled in a food questionnaire asking how frequently they consumed food from 12 major groups, including fresh fruit and vegetables.

The researchers followed up on 451,665 people who didn't have cardiovascular disease at the start of the study, and who weren't taking any medicine to lower blood pressure. They checked whether they were still alive, and whether they'd been treated for a major coronary event such as a heart attack, and whether they'd had either an ischaemic or haemorrhagic stroke. An ischaemic stroke is when a blood clot blocks a blood vessel in the brain. A haemorrhagic stroke is when a blood vessel ruptures, causing bleeding in the brain. The latter type of stroke is more common in China than in Western countries.

Researchers ran a number of analyses on the data to try to account for factors that are known to affect the risk of heart attack and stroke (confounders) such as age, sex and smoking. They calculated the chances of having any of the major outcomes for people who ate fruit never or rarely, compared to people who ate it at least daily. They used that to estimate how many deaths might be attributed to people not eating fruit, assuming that fruit was the cause of the lower risk of death.

 

What were the basic results?

Only 18% of people in the study ate fresh fruit daily. Compared to people who rarely or never ate fresh fruit, daily fruit eaters were 40% less likely to have died of cardiovascular disease (hazard ratio [HR] 0.60, 95% confidence interval [CI] 0.54 to 0.67). They were also 34% less likely to have had a heart attack (HR 0.66, 95% CI 0.58 to 0.75), 25% less likely to have had an ischaemic stroke (HR 0.75, 95% CI 0.72 to 0.79) and 36% less likely to have had a haemorrhagic stroke (HR 0.64, 95% CI 0.56 to 0.74). 

The study also showed that people who ate fresh fruit daily had lower blood pressure and blood glucose levels at the beginning of the study, although interestingly these did not explain the differences in deaths, heart attacks and strokes. Fruit eaters were also likely to be younger, female, from urban areas, better educated, with a higher income and less likely to smoke or drink alcohol.

Assuming that fruit is the reason for the lower risk of cardiovascular death among daily fruit eaters, the researchers say, 16% of deaths from cardiovascular disease could be avoided – a whopping 560,000 deaths a year in China – if everyone ate fresh fruit daily.

 

How did the researchers interpret the results?

The researchers said: "it is difficult to establish causality reliably in observational studies of dietary factors that have such moderate relative risks and potential for confounding." In other words, they can't be sure the "moderate" differences in risk they found were down to fruit alone, and not to other factors. They say that, in particular, "residual confounding by socioeconomic status is still possible," despite their attempts to adjust figures to take account of this.

However, they say, given the healthy properties of fruit, it is plausible that it could be the cause of the lower death and disease rates seen among Chinese people who eat fruit daily.

They suggest that the weaker association between fruit consumption and cardiovascular death seen in previous studies, which have mainly been carried out in Western countries, can be explained partly because daily fruit eating is rare in China. They say this could mean that only a little fruit is needed, whereas previous studies have looked at the effect of each additional piece of fruit, in a population where daily fruit consumption is common.

 

Conclusion

The study adds to evidence that fresh fruit is likely to be good for our cardiovascular health, although we can't be sure from this study that it definitely prevents deaths, heart attacks or strokes. Observational studies cannot prove that one factor causes another, even when they are as big as this study, because other unmeasured factors could be responsible for the results. In this case, a major potential confounder that the researchers failed to take into account was whether the participants were taking any medication – they only excluded people taking blood pressure tablets.

The link with statins, made by the Telegraph, is unhelpful, confusing and unnecessary. While statins have been shown to reduce the risk of heart attacks and strokes by about the same figure – approximately one third, depending on the study – the statin studies were randomised controlled trials, which can show a causal relationship. In addition, they were carried out in Western populations with cardiovascular disease, or at risk of cardiovascular disease. These studies had little in common with this mass observational study of diet in healthy Chinese people.

However, we do know that fruit is likely to be a healthy part of a balanced diet. It's important to note that people in the study were asked about whether they ate fruit, not whether they drank fruit juice. Fruit juice often contains a lot of sugar, and misses out on the fibre found in fresh fruit. Whole fruit is likely to be healthier.

It’s also worth noting that the researchers couldn’t check for an effect of eating fresh vegetables daily, because almost everyone in China eats vegetables every day. The UK dietary recommendations are to eat five portions of fruit and vegetables a day. This research backs the idea that eating fruit regularly as part of a balanced diet is good for your heart and circulation health.

If you have been prescribed statins, then you should not stop taking them without first consulting your doctor. Adding a daily portion of fresh fruit to your diet could help to increase their effectiveness, but should not be regarded as a suitable alternative to statin treatment.

Links To The Headlines

Daily fresh fruit lowers heart death risk as much as statins. The Daily Telegraph, April 6 2016

An apple a day really CAN keep the doctor away: 100g portion of fresh fruit 'slashes risk of heart attack or stroke by a third'. Mail Online, April 6 2016

Could eating one banana a day cut your risk of dying from a heart attack by a THIRD? Daily Express, April 6 2016

Links To Science

Du H, Li L, Bennett D, et al. Fresh Fruit Consumption and Major Cardiovascular Disease in China. The New England Journal of Medicine. Published online April 7 2016

Categories: NHS Choices

'Exercise labels' should be added to food packets, expert argues

NHS Choices - Behind the Headlines - Thu, 07/04/2016 - 11:28

"Food and drinks should carry labels showing how long it would take to walk or run off the calories, a leading health expert suggests," the Daily Mail reports.

In an opinion piece in the British Medical Journal, Shirley Cramer, chief executive of the Royal Society for Public Health, argues that the current "traffic light" food labelling system is not promoting positive changes in public health.

Cramer makes the case that "activity equivalent" labelling could change people's behaviour. 

Traffic light labelling

The widely used "traffic light" food labelling system is based on concepts most of us learn very early on in our childhood: green means "good", amber means "OK", and red means "bad".

Traffic light information is provided on an item's fat content, saturated fat content, sugar content, and carbohydrate content. In short, the more green on the label, the healthier the choice.

However, a 2015 poll carried out by Populus found 41% of UK adults found current front-of-pack information confusing.

As Cramer points out, "Such information needs to be as simple as possible so that the public can easily decide what to buy and consume in the average six seconds people spend looking at food before buying." 

Activity equivalent labelling

The idea behind activity equivalent labelling is that a series of easily recognisable icons would be used to represent types of physical activities, such as brisk walking (walking fast enough to get you slightly out of breath), running, cycling, and swimming.

The icons would be combined with a number representing the number of minutes you would need to spend doing that activity to burn off the calories in the food or drink item.

Examples helpfully provided by the Daily Mail include:

  • an apple (93 calories) – this would take 21 minutes of brisk walking or 13 minutes of running to burn off
  • a can of Coca-Cola (139 calories) – this would take 32 minutes of brisk walking or 20 minutes of running to burn off
  • a 48g Snickers bar (245 calories) – this would take 56 minutes of brisk walking or 35 minutes of running to burn off
  • a 50g bowl of cornflakes served with semi-skimmed milk (263 calories) – this would take an hour of brisk walking to burn off 

Cramer makes an intriguing case that such a scheme would offer the public a carrot rather than a stick: "The public is used to being told to avoid particular drinks and to cut down on specific foods. By contrast, activity labelling encourages people to start something, rather than calling for them to stop." 

Could the scheme be introduced?

Currently, legislation regarding the mandatory labelling of food and drink is decided at the European level.

Even if there was a political will and the food and drink industry was on board, it would probably take several years for such a scheme to come into place. And that is a very big if.

There is the possibility that some forward-thinking manufacturers might adopt the scheme on a voluntary basis. If the scheme proves popular with the public, it could also boost their sales and so be a possible win-win.

Our Understanding calories page has a calorie checker widget that allows you to check the calories of more than 100,000 different products.   

Links To The Headlines

Almost an hour for a Snickers, but only 20 minutes for an apple: Labels should tell you how much exercise will burn off your food to help tackle obesity crisis, says expert. Daily Mail, April 7 2016

Activity icons 'could help healthy living’. BBC News, April 7 2016

Run 'n junk: Unhealthy snacks need exercise labels to tackle obesity. The Sun, April 7 2016

How much exercise will you need to burn off your lunch? ITV News, April 6 2016

Links To Science

Cramer S. Food should be labelled with the exercise needed to expend its calories. BMJ. Published online April 6 2016

Categories: NHS Choices

Effects of vitamin D for heart failure far from 'stunning'

NHS Choices - Behind the Headlines - Wed, 06/04/2016 - 13:45

"Vitamin D can produce 'amazing' improvements in heart function," claims The Independent about the results of a recent study, while BBC News reported suggestions the results were "stunning".

However, the study in question, which involved giving people with heart failure vitamin D supplements, did not result in better exercise capability.

Heart failure is caused by the heart failing to pump enough blood around the body at the right pressure. Your heart doesn't stop, but fails to work properly, causing symptoms of breathlessness, tiredness and ankle swelling.

Many people with the condition are also vitamin D deficient, prompting Leeds-based researchers to study whether vitamin D supplements might help the condition.

The study involved 229 participants who were randomised to receive either a daily high-dose vitamin D supplement for a year or a placebo.

People in the vitamin D group showed encouraging improvements in measures of left ventricular function, a gauge of how well blood is pumped from the heart with each heartbeat.  

But the study was unable to show any vitamin D-related improvements in the main symptoms of heart failure, and showed no improvement in walking distance.

Given that backdrop, it's a stretch to describe the hearts as "healed" – or call the results "stunning". Still, these are early days. Larger and longer-term studies may find out whether these heart changes improve the main symptoms of the condition over time.

Where did the story come from?

The study was carried out by researchers from the University of Leeds and Leeds Teaching Hospitals NHS Trust, and was funded by the Medical Research Council UK.

It was published in the peer-reviewed Journal of the American College of Cardiology.

Generally, the media reported the story accurately, though the implications of the research were arguably overhyped, possibly driven by the enthusiasm of the lead researcher in describing his team's work. 

The BBC did provide a more sober note of caution, however, quoting Professor Peter Weissberg of the British Heart Foundation, who cautioned: "the patients seemed no better at exercise.

"A much bigger study over a longer period of time is now needed to determine whether these changes in cardiac function can translate into fewer symptoms and longer lives for heart failure patients."  

What kind of research was this?

This was a double-blind randomised controlled trial (RCT) looking to see whether vitamin D3 supplements could help people with chronic heart failure.

People with heart failure are often older and can be vitamin D deficient, possibly the result of not getting enough sunlight, which stimulates vitamin D production in your skin.

The researchers wanted to see if boosting patients' vitamin D levels would help with the condition, which causes breathlessness, excess tiredness and swollen ankles.

An RCT is the best study design to find out whether vitamin D3 supplements improve chronic heart failure. The only way they can be improved is to make them larger or longer, or to pool the results of many RCTs investigating the same thing, called a meta-analysis

What did the research involve?

The research recruited 223 mostly male vitamin D-deficient adults with chronic heart failure caused by left ventricular systolic dysfunction – meaning the main pumping chamber of the heart on the left side wasn't working properly.

The researchers randomised half of the participants to take 100 micrograms of vitamin D3 supplements daily for a year, and half to take a placebo. The main measure of potential improvement was the distance the men could walk in six minutes.

A secondary measure was changes in their heart function, measured as the proportion of blood pumped from the heart – specifically, the left ventricle – on a heart scan, called the ejection fraction.

Changes in the size of the left ventricle were also monitored, although only 34 people had the two scans necessary to monitor change.

Neither the men nor those assessing their hearts or exercise for changes knew if they'd taken the placebo or vitamin D – a so-called double blind study.

The year-long study was completed by 163 people. The rest withdrew (23), died or deteriorated (28), or suffered side effects (5). 

What were the basic results?

Despite excitable headlines, the main measure of interest – the distance the participants could walk in six minutes – did not improve using vitamin D3. In fact, it was about 13 metres worse after a year.

Those in the placebo group actually walked an average of 10 metres more after a year. But the differences between placebo and vitamin D were small enough that effectively it meant they were no different from one another.

The finding that hit the headlines was a secondary measure of heart function, which improved more in people using vitamin D3 than those using a placebo, who also improved a little.

People using vitamin D improved their ejection fraction by 7.65%, from 25.6% to 33.25% over one year, while those on placebo improved by 1.36%, from 26.5% to 27.86%. Other significant changes were also seen for measures of how well the left ventricle was functioning.

No safety concerns or side effects seemed apparent in those using vitamin D3 supplements for the year.  

How did the researchers interpret the results?

The researchers concluded: "One year of 100 micrograms daily 25-OH vitamin D3 supplementation does not improve six-minute walk distance, but has beneficial effects on LV [left ventricular] structure and function in patients on contemporary optimal medical therapy. Further studies are necessary to determine whether these translate to improvements in outcomes."

They added: "New therapies for serious chronic conditions, including CHF [chronic heart failure], are often expensive, increasingly technical and frequently fail to meet the rigorous demands of large phase 3 clinical trials.

"Vitamin D might be a cheap and safe additional option for CHF patients and may have beneficial effects on multiple features of the syndrome."

Conclusion

This study showed that taking daily vitamin D3 supplements for a year did not improve the ability of people with chronic heart failure to walk further, but did improve elements of their heart function.

The study was well designed, but larger studies are needed to confirm the findings more definitively.

The main limitations of the research include the fact the main focus was on men, its relatively small size, and an absence of measures relating to the main symptoms of the condition.

The study was not able to tell us whether the heart change improvements seen enhanced quality of life in terms of breathlessness, tiredness and swollen ankles. There were no improvements seen in walking distance.

If you think you may be vitamin D deficient, talk to your doctor about whether supplements may help, or whether getting more sunlight may be an equally effective and more attractive approach.

If you take vitamin D supplements, do not take more than 25 micrograms (0.025mg) a day, as it could be harmful, though taking less than this is unlikely to cause any harm.

Links To The Headlines

Vitamin D can produce 'amazing' improvements in heart function, study finds. The Independent, April 5 2016

Vitamin D 'heals damaged hearts'. BBC News, April 4 2016

Daily dose of vitamin D 'can improve function in damaged hearts'. The Daily Telegraph, April 5 2016

Links To Science

Witte KK, Byrom R, Gierula J, et al. Effects of Vitamin D on Cardiac Function in Patients With Chronic HF: The VINDICATE Study. Journal of the American College of Cardiology. Published online April 4 2016

Categories: NHS Choices

'Dying of heartache?' Heart problems linked to bereavement

NHS Choices - Behind the Headlines - Wed, 06/04/2016 - 12:30

"You can die of a broken heart, study indicates," The Guardian reports. The study found that people who lost a partner – especially if the death was unexpected – had an increased risk of developing an irregular heartbeat up to a year after the death.

The study specifically looked at a type of heart condition called atrial fibrillation that causes an irregular and often abnormally fast heart rate. People with atrial fibrillation are at increased risk of having a stroke and, less commonly, heart failure.

The study found people whose cohabiting partner or spouse died had an increased risk of getting atrial fibrillation in the first month after the death; this is estimated to be around 41% higher than average. The risk was highest in the second week after the bereavement (90% higher than average) and gradually declined to almost the same as someone who had not been bereaved by the end of the first year.

We don't know for certain that bereavement directly caused the increased risk of atrial fibrillation. Also, despite the headlines, we don't know whether anyone in the study died. Although atrial fibrillation can raise the risk of having a stroke or getting heart failure, it is not usually life-threatening and can be treated.

Anyone who notices a sudden change in heartbeat, or a consistently fast or irregular heartbeat, should seek medical attention.  

Where did the story come from?

The study was carried out by researchers from Aarhus University in Denmark and was funded by a grant from the Lundbeck Foundation. Lundbeck is a pharmaceutical company which makes cardiovascular drugs.

The study was published in the peer-reviewed journal Open Heart. It's published on an open-access basis, so it’s free to read online.

The UK media was unable to resist the cliché about dying from a broken heart (which, to be fair, neither could we), even though the study did not include any data on deaths from atrial fibrillation after bereavement.

The leading charity for atrial fibrillation, the AF Association, reports that, "AF is also associated with a slightly increased risk of death although this is a very small risk and generally AF is not considered a life threatening disease in its own right."

However, beyond the headlines, most reported the results accurately.

Although most news sources included the relative risk figure of 41% increased risk, they did not carry the absolute percentages of people with atrial fibrillation who'd had a bereavement, which only showed a small increase in absolute risk.

 

What kind of research was this?

This was a population-based case control study. Researchers wanted to see if people with atrial fibrillation were more likely than people without to have experienced the recent death of a partner. Case control studies, especially big ones like this, are useful ways of identifying differences between people with and without a condition. However, they can't prove cause and effect.

 

What did the research involve?

Researchers identified everyone in Denmark who had been treated in hospital for a first episode of atrial fibrillation from 1995 to 2014. They then chose 10 "control" subjects for each person with atrial fibrillation, to compare them. They recorded whether each person had experienced the death of a cohabiting partner, and how recently.

After adjusting their figures to take account of confounding factors that could affect the results, they calculated the chances of having atrial fibrillation in the days, weeks and months after the death of a partner, compared to people who'd not had a bereavement.

The figures came from national Danish registries of health and civil status, which give high-quality information about people's hospital treatment, prescriptions, cohabitant status (i.e. whether they lived with a partner) and deaths.

The researchers controlled for people's age, sex, education level, civil status and whether they'd previously had cardiovascular disease, diabetes, or were taking cardiovascular medicines.

Researchers carried out additional analyses to check for the influence of these potential confounding factors. They calculated the overall chances of having atrial fibrillation for bereaved versus non-bereaved people, then calculated the chances according to time since bereavement. They also looked at whether unexpected deaths were more likely to be linked to atrial fibrillation, by calculating the likelihood of death one month before it happened, using health data.

 

What were the basic results?

The study included 88,612 people with atrial fibrillation, 19.72% of whom had experienced the bereavement of a partner. Of the 886,120 controls without atrial fibrillation, 19.07% had lost a partner. This translated into a 41% higher relative risk of atrial fibrillation in the month after the bereavement (odds ratio [OR] 1.41, 95% confidence interval [CI] 1.17 to 1.7).

The increased risk was highest 8 to 14 days after the death, and gradually declined until a year afterwards, at which point the risk was "close to that of the non-bereaved population". Risk was higher among younger people (under 60) and among those where death was unexpected. Where deaths were likely due to ill health, there was no increased risk of atrial fibrillation in the partner after the death.

 

How did the researchers interpret the results?

 

The researchers said that in their study: "The severely stressful life event of losing a partner was associated with a transiently increased risk of atrial fibrillation, which lasted for about one year. The elevated risk was especially high for those who were young and those who lost a relatively healthy partner."

They say: "residual confounding cannot be ruled out" because they were unable to include lifestyle factors, physical activities and family history of atrial fibrillation. However, they say they believe the risk of any of these factors affecting the results is small, "as we cannot think of any possible confounder that could cause a transiently increased risk of atrial fibrillation shortly after bereavement."

They discuss two possible ways in which bereavement could trigger atrial fibrillation. They suggest that acute stress could influence heart rate directly via the sympathetic nervous system, and promote the release of inflammatory substances called cytokines. They also say that factors such as drinking more alcohol, not sleeping, eating a poor diet and doing less physical activity could be a cause both of AF, and a direct response to bereavement.

 

Conclusion

The study found that people were more likely to have AF for the first time in the weeks immediately after a bereavement, but that this raised risk does not last. Despite the headlines, this does not mean that anyone who's had a bereavement is at immediate risk of "dying of a broken heart". Atrial fibrillation is treatable and not usually life-threatening.

Because this was an observational study, we cannot rule out the possibility that factors such as family history of atrial fibrillation or lifestyle factors could have affected the results, although the researcher's conclusion that this is a small possibility seems reasonable. The size of the study, and its use of big national databases, adds to its value.

It's not surprising to learn that people may be at increased risk of ill health immediately after the death of a partner, which is one of the most distressing events we are likely to face. The study gives us more reason to look after people who have been bereaved, as their health is vulnerable during this time.

Anyone with symptoms of atrial fibrillation, such as a very fast or irregular heartbeat, should see their GP. Anyone with chest pain and symptoms of a heart attack, such as pain travelling from your chest to your arms, jaw or neck, and shortness of breath, should call an ambulance and take an aspirin while they are waiting for it to arrive.

Links To The Headlines

You can die of a broken heart, study indicates. The Guardian, April 6 2016

What became of the broken-hearted? They may have died, scientists say. The Daily Telegraph, April 6 2016

You really CAN die of a broken heart: Stress from the death of a partner found to trigger potentially fatal heart rhythm. Daily Mail, April 6 2016

You really could die from a broken heart claims new study. Daily Mirror, April 6 2016

Links To Science

Graff S, Fenger-Grøn M, Christensen B, et al. Long-term risk of atrial fibrillation after the death of a partner. Open Heart. Published online April 5 2016

Categories: NHS Choices

Choir singing may boost immunity in people affected by cancer

NHS Choices - Behind the Headlines - Tue, 05/04/2016 - 14:30

"Being in a choir could help the body fight cancer by boosting the immune system," the Daily Mail reports. 

The study involved 193 people from Wales who were affected by cancer in some way. This included people with a history of cancer, carers for people with cancer, and bereaved people who had lost someone to the disease.

The researchers had them take part in a 70-minute choir rehearsal.

Findings showed a decrease in stress levels and improvement in mood after the singing session compared to before. Levels of immune and inflammatory proteins that boost the body's ability to fight serious illness were also found to increase.

There are a number of limitations to the study.

Participants were already part of a choir – so clearly already found enjoyment in group singing – and there was no control group. The study also only assessed a single session, so we don't know whether effects would be replicated at other sessions.

The majority of the study population was made up of older white Welsh women, so the results may not be applicable to other populations.

Also, changes in levels of immune proteins alone are no evidence that this will "beat cancer". A longer follow-up period would be required to assess this claim.

Still, the results do support the opinion that taking part in a physical group activity you enjoy – whether it is singing, dancing, or joining a walking group – may improve both physical and mental wellbeing.

 

Where did the story come from?

The study was carried out by researchers from the Royal College of Music, Imperial College London, University College London and Tenovus Cancer Care (a Welsh cancer charity). Funding for the study was provided by Tenovus Cancer Care.

The study was published in the peer-reviewed medical journal ecancermedicalscience on an open-access basis, so you can read it for free online.

While the study was generally reported accurately by the UK media, many of the headlines overstated the findings. For example, The Daily Telegraph's headline "Singing in choir could help beat cancer" is currently unsupported by the available evidence.

That said, the Telegraph did provide an insightful quote from Diane Raybouldone, of the study participants, who is reported as saying that, "Singing in the choir is about more than just enjoyment, it genuinely makes you feel better. The choir leaders play a huge part of course, but so does the support of the other choir members, the inspirational programme and uplifting songs."

The science news website EurekAlert contains a link to a short video produced by the research team.

 

What kind of research was this?

This was a preliminary single arm (non-comparative) trial investigating whether people affected by cancer can benefit from singing in a choir.

The two main aims of the study were to compare changes across time in three different groups of people affected by cancer (carers, bereaved people and patients) and to assess whether responses differed between groups, to see if singing could be more beneficial to some than others.

While the study has found a link, it cannot prove that singing is responsible for any outcomes measured – mostly because there's no control group to compare against. However, as this is described as a preliminary study, it seems that more research will follow.

 

What did the research involve?

The researchers recruited five choirs in South Wales to participate in the study. Members of the choir were invited to take part if they were either a current carer of someone with cancer, a bereaved carer, or someone with cancer themselves – though not currently undergoing any cancer treatment, such as chemotherapy or radiotherapy. 

To participate in the study, people had to have attended at least one choir session and be over the age of 18.

Participants were to take part in the 70-minute choir rehearsal, which consisted of warm-up exercises, learning new songs as a group and singing familiar songs.

In the week before the rehearsal session, participants answered demographic and psychological questions in the form of a self-administered questionnaire, including assessments of:

  • wellbeing – using the Warwick-Edinburgh Mental Wellbeing Scale
  • anxiety and depression – using the Hospital Anxiety and Depression Scale
  • social function – using the Connor-Davidson Resilience Scale

Then, immediately before and after the rehearsal, visual analogue scales were filled in to assess mood and stress; this involved choosing a point on a line that runs from 0 (none) to 10 (extremely). Saliva samples were then taken for analysis of biological measures, such as levels of the stress hormone cortisol and cytokines, which are involved in the immune response.

 

What were the basic results?

There were 193 people in the study; the majority were white and female. Groups were split as below:

  • carers (72)
  • bereaved carers (66)
  • people with cancer (55)

On average, participants did not have symptoms of depression and had average levels of wellbeing. The study found a decrease in levels of the stress hormone cortisol and an increase in cytokines after the singing session compared to before, across all five of the centres and among all three groups.

Mood was seen to significantly improve overall and stress levels were found to decrease. Mood particularly improved for those with a lower state of mental wellbeing beforehand, and stress appeared to decrease the most in those who were initially more anxious and had higher depression levels.

No significant differences were observed across groups for psychological or biological measures.

 

How did the researchers interpret the results?

The researchers conclude: "This study demonstrates associations between singing and reduced negative and increased positive effect, reduced cortisol, oxytocin and beta-endorphin and increased levels of cytokines. This is the first study to demonstrate the widespread immune effects of singing, in particular its effects on cytokines."

They go on to say: "However, it would be of interest to ascertain whether such changes could be sustained with repeated exposure to the intervention over a longer time-span and with more specific patient groups. Such research could identify whether the psychosocial benefits of a communal activity such as group singing could lead to enhanced immune function in patients and carers affected by cancer."

 

Conclusion

This was a preliminary trial to assess whether singing in a choir can have a beneficial effect on the health and wellbeing of people affected by cancer.

The study found a decrease in stress levels and improvement in mood across all study groups after the single singing session, compared with before. The levels of immune and inflammatory proteins that boost the body's ability to fight serious illness were also found to increase.

This study, however, has some important limitations, many of which have been stated by the authors.

One is that it sampled a small population of mainly white women – who were already part of a choir, and therefore presumably already found enjoyment from singing. This reduces the generalisability to other groups. 

The study was uncontrolled, with no comparison group. It is possible that some of the results may have been seen even in the absence of singing; for example, if they had used the 70 minutes just to relax.

Participants in the study were a self-selected group who had low stress levels at the start of the study. Therefore, the same effect may not be seen in those who have higher stress levels.

The assessments were made only before and after a single singing session. We don’t know whether the same results would be replicated on repeat singing sessions, or for how long the effects would be sustained.

We also don't know whether any observed effects could be the result, not of singing itself, but of socialising and being together with other people in a group. It would be interesting to see whether the same results would be seen if an individual sang alone in their house, for example.

Despite the optimistic media headlines – changes in levels of immune proteins alone are no evidence that singing could "beat cancer".

Dr Ian Lewis of Tenovus Cancer Care said these are exciting findings: "We have been building a body of evidence over the past six years to show that singing in a choir can have a range of social, emotional and psychological benefits, and now we can see it has biological effects too."

It is too early to say whether these early findings have any solid foundation and many questions remain unanswered. More research will be needed to confirm these early findings. However, there is no harm in getting together with others and enjoying some singing, whether you have been affected by cancer or not.

A quick trawl of your favourite search engine should find a range of opportunities to take part in group activities, many of which are designed for older people who may be feeling isolated.

Read more about connecting with others when you are older

Links To The Headlines

Being in a choir could help the body fight cancer by boosting the immune system. Daily Mail, March 5 2016

Singing in choir could help beat cancer. The Daily Telegraph, March 5 2016

Choir singing helps to boost immune system in cancer patients. ITV News, March 5 2016

Could singing in a CHOIR help keep cancer at bay? Daily Express, March 5 2016

Links To Science

Fancourt D, Williamon A, Carvalho LA, et al. Singing modulates mood, stress, cortisol, cytokine and neuropeptide activity in cancer patients and carers. ecancermedicaljournal. Published online April 5 2016

Categories: NHS Choices

New drug 'effective' for those with intolerable statin side effects

NHS Choices - Behind the Headlines - Mon, 04/04/2016 - 13:55

"A breakthrough drug can slash levels of bad cholesterol by half without the side effects of statins," the Daily Mail reports.

Statins are a class of drug used to reduce high cholesterol levels, they are often given to people thought to be at risk of heart disease or stroke.

A complaint from some people who take statins is that they seem to trigger muscle pains and spasms. In some cases, these side effects are so troublesome that a person stops taking the drug all together.

This study included almost 500 people who previously had muscle problems when they tried several types of statin.

They were randomised to take either low-dose atorvastatin or inactive placebo, and were unaware of which drug they were taking. The researchers found just under half reported muscle problems when taking the statin only.

These people were then randomised to take two alternative non-statin drugs – oral ezetimibe or the new injected drug evolocumab. Overall, researchers found the latter was better at reducing cholesterol.

One practical consideration regarding evolocumab is its cost. The drug is expensive: a year's supply is reported to cost £4,450.

The National Institute for Health and Care Excellence (NICE) is reported to be making a final decision about whether evolocumab should be offered on the NHS and, if so, in what circumstances.

People should continue to take their statins as prescribed, but anyone with unexplained muscle aches and pains should report these to their doctor. Lowering the dose or trying a different type of statin may help relieve these symptoms.

Where did the story come from?

The study was carried out by researchers from the University of Amsterdam School of Medicine at Mount Sinai in the US and various other institutions worldwide.

Funding was provided by Amgen, which produces the cholesterol-lowering medication evolocumab, sold under the tradename Repatha™.

According to the researchers, Amgen was "involved in the design and conduct of the study, selected the investigators, monitored the trial, and collected and managed the trial data. The sponsor participated in the decision to publish the study and committed to publication of the results prior to unblinding the trial."

The study was published in the peer-reviewed journal JAMA on an open-access basis, so you can read it for free online.

There is also an accompanying editorial (also free) written by independent experts, which provides a useful second opinion about the implications of the research.

The Daily Mail's reporting of the study is accurate, but its claim that, "Breakthrough treatment could get NHS green light by end of the month" is possibly overoptimistic.

In contrast, The Daily's Telegraph reporting of the study is somewhat confusing and misleading.

The Telegraph said: "Statins really do cause painful muscle cramps, scientists have found, vindicating hundreds of thousands of people who have repeatedly claimed to have suffered debilitating side effects" which seems to imply that doctors don't recognise these types of side effects. This is simply not the case: these are known side effects that are highlighted in the product literature.

It remains a puzzle as to why people taking statins experience these types of side effects – as yet, no plausible biological explanation has been found.  

What kind of research was this?

This randomised controlled trial was conducted in two phases. Researchers aimed to see whether statins do cause muscle symptoms and then compare the fat (lipid) lowering ability of two alternative non-statin medications.

Statins are well established to be effective drugs for lowering cholesterol, but muscle-related adverse effects such as pain and weakness have often been reported. This risk is recognised by the medical profession.

Subsequently, people who have experienced muscle-related effects need to look for alternative treatments. Approaches may include using very low-dose statins, giving statins intermittently, or alternatively giving non-statin treatments.

Non-statin options include ezetimibe, which limits the absorption of cholesterol, and a new group of drugs called proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors. Evolocumab (given by injection) is a PCSK9 inhibitor that has recently been approved by medical regulators for use in the UK.

A randomised controlled trial is the best way of looking at the safety and effectiveness of treatments. 

What did the research involve?

The trial was conducted in two phases. The first phase compared atorvastatin – usually the first-choice statin medication – with inactive placebo, looking at muscle-related side effects. The second phase compared the non-statin drugs ezetimibe and evolocumab for their cholesterol-lowering effects.

The trial specifically included people previously unable to tolerate a normal statin dose because of muscle pains.

They went through a four-week washout period in which they took no medication. They were then randomised to either inactive placebo or a "re-challenge" with atorvastatin (20mg) for 10 weeks.

During this time neither participants nor researchers knew which drug they were taking. The drugs were then stopped and they had another two-week washout period before they were switched to the alternative drug (placebo or atorvastatin).

After phase one, those who had experienced muscle-related effects using atorvastatin were eligible to enter phase two – the 24-week trial of oral ezetimibe versus injected evolocumab.

This trial was also double blind, and involved people either taking a dummy tablet or having a dummy injection, depending on which treatment they were assigned to.

In phase one the main study endpoint was therefore the incidence of muscle-related side effects. The main study endpoint at phase two was changes in low-density lipoprotein (LDL) – "bad" – cholesterol, though any side effects were also reported.  

What were the basic results?

A total of 492 people entered phase one of the study, most of whom had been intolerant of at least three different statins in the past. Overall, 42.6% of these people experienced muscle-related side effects with atorvastatin, but not placebo.

Somewhat oddly, around a quarter reported muscle-related side effects while using the placebo but not atorvastatin. The remainder either had symptoms with both or neither.

A person had a significantly higher risk of developing muscle-related side effects while taking atorvastatin than placebo.

The main results relate to the effectiveness of the two alternatives. A total of 218 people entered phase two.

Overall, evolocumab lowered LDL cholesterol significantly more than ezetimibe – an absolute difference of 37%.

There was no significant difference in the muscle-related symptoms of these two drugs, which were reported by 29% of people taking ezetimibe and 21% of people taking evolocumab.  

How did the researchers interpret the results?

The researchers concluded: "Among patients with statin intolerance related to muscle-related adverse effects, the use of evolocumab compared with ezetimibe resulted in a significantly greater reduction in LDL-C levels after 24 weeks." 

Conclusion

The main results of this study relate to the lipid-lowering effects of two alternative non-statin medications. However, it highlights the muscle-related adverse effects that can occur with statins.

The study is carefully designed and has many strengths, including:

  • a washout period between drugs to remove any residual effects
  • double-blind design throughout so people didn't know what they were taking
  • sufficient duration for each phase of the study (10 and 24 weeks) to allow effects to develop
  • a good sample size – the researchers calculated beforehand how many people would need to be recruited to enable them to reliably detect differences between the groups

There are some points to keep in mind, however.

This study isn't able to inform us of the overall incidence of muscle aches and pains when people take statins. A specific sample of people was recruited to the study, and they had already reported muscle problems when taking several statins previously.

It can then tell us that when these people took low-dose atorvastatin and placebo in a double-blinded manner, just under a half of them experienced these problems when taking the statin only. This suggests that these were effects definitely related to the statin.

However, that's not to say the remaining half had previously imagined these effects – they could have had effects with other statins or with higher doses than the 20mg taken here.

The muscle-related side effects of statins are already well known. Product literature notes side effects of muscle aches, pains and weakness, and the potential risk of developing the serious condition rhabdomyolysis. This is where muscle fibres are broken down and released into the bloodstream, which can damage the kidneys. Doctors are advised to use statins with caution in people with a history of muscle weakness or rhabdomyolysis.

Statins are highly effective and relatively safe drugs, and are the medication of first choice for lowering cholesterol. Ezetimibe is currently only recommended by the regulatory body NICE for people who cannot take a statin.

Evolocumab has only recently been licensed for the treatment of people who cannot take statins, or in combination with a statin if a statin alone is ineffective at reducing cholesterol.

NICE issued draft guidance at the end of last year that did not recommend this drug if other lipid-lowering treatments could be taken. However, the final version of the guidance, which may say something different, is expected some time this year.

People should continue to take their statins as prescribed, but anyone with unexplained muscle aches and pains should report these to their doctor.

Often, lowering the dose or switching to an alternative type of statin can help prevent side effects. Lifestyle changes such as eating a healthy diet and taking regular exercise can also help lower your cholesterol.

Links To The Headlines

Drug to beat cholesterol WITHOUT statin side effects: Breakthrough treatment could get NHS green light by end of the month. Daily Mail, April 3 2016

Statins do cause muscle pain, scientists conclude. The Daily Telegraph, April 3 2016

Links To Science

Nissen SE, Stroes E, Dent-Acosta R, et al. Efficacy and Tolerability of Evolocumab vs Ezetimibe in Patients With Muscle-Related Statin Intolerance - The GAUSS-3 Randomized Clinical Trial. JAMA. Published online April 3 2016

Categories: NHS Choices

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