Hospital patients dying of thirst; Paracetamol; Saturated fats; Baclofen and alcoholism

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Headlines this week claim that 'thousands of patients die in hospital of thirst' but did the authors of the study actually analyse hydration?

Mark Porter investigates the evidence for using Baclofen to treat alcoholism and hears how it helped a listener to stop drinking 6-8 bottles of wine a day.

Why did NICE question the use of Paracetamol - the UK's favourite painkiller - in the treatment of osteoarthritis?

And are saturated fats really bad for us?

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28 minutes

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Wed 23 Apr 2014 15:30

Programme Transcript - Inside Health

Downloaded from www.bbc.co.uk/radio4 

THE ATTACHED TRANSCRIPT WAS TYPED FROM A RECORDING AND NOT COPIED FROM AN ORIGINAL SCRIPT.  BECAUSE OF THE RISK OF MISHEARING AND THE DIFFICULTY IN SOME CASES OF IDENTIFYING INDIVIDUAL SPEAKERS, THE BBC CANNOT VOUCH FOR ITS COMPLETE ACCURACY.

 

 

INSIDE HEALTH

           

Programme 14.

 

TX:  22.04.14  2100-2130

 

PRESENTER:  MARK PORTER

 

PRODUCER:  ERIKA WRIGHT

 

 

Porter

Coming up today:  Saturated fats - you can’t have missed the recent hoo-hah. Accepted wisdom has it that a diet rich in these animal based fats is bad for our hearts. So why has a major study, funded by the British Heart Foundation, failed to find any evidence to support this? And what does it mean for the nation’s dietary habits?

 

We return for another look at paracetamol. It is widely regarded as a safe and effective painkiller. So why was the National Institute of Health and Care Excellence on the verge of advising people with arthritis not to take it to ease their aches and pains?

 

And medication to help problem drinkers. Earlier in this series we debated whether doctors should be making more use of medicines to help people addicted to alcohol. I will be looking at a new alternative.

 

Clip

I was drinking anywhere between six and eight bottles of wine a day and perhaps even one to two bottles of vodka and baclofen reduced it to pretty much nothing and made a huge difference to my life and I kind of wanted to make other people aware of it.

 

Porter

More from Inside Health listener George later.  But first, are patients in NHS hospitals really dying of thirst? That is the impression you are likely to get after reading this week’s headlines prompted by the publication of new research commissioned by NHS Improving Quality.  It claims at least a thousand patients are dying unnecessarily every month in English hospitals from acute kidney injury, a problem that can be exacerbated by dehydration. And the media seem to have drawn their own conclusions: The Times chose this headline:

 

The Times headline (read)

 “One thousand patients die in hospital every month from thirst.”

 

Porter

While the Telegraph preferred:

 

The Telegraph headline (read)

 “Thousands die of thirst and poor care in the NHS.”

 

Porter

Either way, hardly confidence inspiring if you have a loved one in hospital at the moment. 

 

Professor Donal O’Donaghue is a kidney specialist at Salford Royal NHS Foundation Trust and one of the authors of the study.  What did he think of the coverage?

 

O’Donaghue

I think it’s important to get this into perspective and when we look at acute kidney injury as a safety issue it’s clear that considerably more people are dying from predictable and avoidable acute kidney injury.  I would like to see a more sophisticated discussion about fluid status and medicines and the complexity of the vulnerable population that we now see being admitted to hospital and then you can, I think, see it in broad context.

 

Porter

Because what the headlines suggest is that people are dying simply of thirst, that they’re not being offered enough water in their beds and it’s really not quite that simple is it?

 

O’Donaghue

So our data don’t look at thirst or hydration at all, so we can’t say that for sure.  What we can say is that in a very, very small percentage of people they do die of thirst and those are extraordinary cases.  And I think we are at risk of oversimplification in the sense of this is dying of thirst…

 

Porter

But that’s essentially how your study’s been reported by the lay media, not your fault, I’m saying, I’m just saying that that’s how they’ve reported it so it’s not accurate is it?

 

O’Donaghue

But I think it should be framed in that early kidney dysfunction is easily addressable.  And it’s the same population that we see repeatedly, it’s the vulnerable elderly population who are most at risk.  Having said that one in 25 people under the age of 40 admitted to hospital acutely unwell have an episode of acute kidney injury and that significantly increases their length of stay and increases their risk of dying.

 

Porter

But to some extent Donal that’s not a surprise, I mean if you’re going in to hospital under the age of 40 one suspects you’re going in for a pretty serious reason quite often, it might be a road traffic accident, it might be a very serious infection, so it’s not surprising that 4% of these or around that figure will have something going wrong with their kidneys, it might not be anything to do with the hydration they’re getting in a hospital is my point.

 

O’Donaghue

I think almost certainly this is multi-factorial, so it’s the amount of fluid being pumped through to the kidney.  So it’s the particular drugs people are on as well as their overall fluid status.

 

Porter

Well listening to this in our Glasgow studio is Dr Margaret McCartney.  Margaret, we’re perhaps not giving kidneys the priority they need, is that a fair criticism?

 

McCartney

Well I have several issues really with this paper.  The research paper that was published last night and this morning really was a case notes based paper, paper based, analyse that looked at hospital records coding and then looked at blood tests that had been done in patients before and after hospital.  And had made conclusions based on those kind of numbers.  So patients weren’t actually talked to, the doctors weren’t actually talked to, the individual cases in each of those wasn’t analysed and understandably you’re talking about thousands and thousands and thousands of notes.  But to me it makes it quite difficult to know what the meaning of these changes were, were the changes in kidney function because of tests that had been done, new drugs that had been started and there wasn’t actually an acute kidney injury but it was more a reflection of chronic kidney disease, which is a much more long term thing.

 

Porter

Donal, I mean you’re looking at the numbers but you can’t – unless you follow each patient, their individual story, you can’t be sure about whether these were preventable or not can you?

 

O’Donaghue

Every single case needs to be looked at in some detail before you can know whether there were avoidable factors – absolutely agree with that.  And absolutely would not want people to go away with the idea that we can get rid of acute kidney injury by simply giving people access to fluids or even giving them drips.  What the paper’s saying and what I’m saying is that this is part of the issue and there are a significant proportion of people – thousands – that would benefit from high quality basic care and it would reduce their risks because acute kidney injury is a complex issue and it’s usually associated with perhaps a reduction in effective circulating volume, drugs that can be deleterious to the kidney and perhaps not realising that the person whose kidney function goes off is actually sicker than the person whose kidney function doesn’t go off and requires an increased attention to detail.  And that would definitely reduce the mortality that we’re currently seeing.

 

McCartney

What I’m really concerned is that people will be looking at this and thinking that all cases of renal failure are avoidable and of course it’s not easy when also NICE and one of their headlines from last year had actually said that acute kidney injury was completely preventable, which just isn’t true.  And I think it’s really unfair to people who are reading that who are getting an unfair view really of what acute kidney failure is, how much of it can be prevented, what we can try and mitigate against and what we can’t, it’s not just a case of giving fluids and everything will be fine, I think it’s much more complex than that.

 

Porter

Dr Margaret McCartney and Professor Donal O’Donaghue thank you both very much. And you will find a link to the original study, and some of the resulting coverage, on the Inside Health page of the Radio 4 website.

 

Now paracetamol - the UK’s favourite painkiller. Back in February the National Institute for Health and Care Excellence had planned to advise against the use of paracetamol in people with the most common form of arthritis, osteoarthritis, but in a last minute U turn the drug was given a reprieve. But why was NICE so concerned? After all, paracetamol is widely regarded by doctors as one of the safest painkillers. What does NICE know that the rest of us don’t?

 

James Cave is editor of The Drug and Therapeutics Bulletin.

 

Cave

I too was taken aback, as I think the MHRA were, which is the Medicines Health Regulatory Authority and so…

 

Porter

Whose job it is to look after the safety of medicines.

 

Cave

Precisely, so they’ve gone off – running off to see what’s going – all this is about.  And the side effects were actually very similar to the side effects you get from the other class of drugs we use in arthritis, namely the anti-inflammatories, so this was heart disease.

 

Porter

And that’s one reason why we’re very wary about using them but I didn’t think that applied to paracetamol.

 

Cave

Well nor did I and I think this is where it’s all got a bit murky.  I think what happened was that NICE quite rightly said let’s have another look at all the drugs we use in arthritis, let’s have a really good look because obviously since they last did their guidance in 2008 time has moved on, some drugs have come off patent and are now much cheaper.  So they did a really thorough review and whilst they were doing that they began to look at studies that seemed to show that paracetamol not only was not as good as some of the drugs like ibuprofen but actually had a similar adverse effect on the patients taking them.  And they sort of I think were a bit taken aback themselves by that so they then said let’s look into this.  Now the problem with paracetamol, it’s one of those drugs that’s been around since the year dot and we don’t have good placebo controlled trials where we’ve tested in people and said how does it compare.  And as a consequence we just have often historic data. 

 

So where I think NICE have gone down perhaps a little bit of a cul-de-sac here is they’ve said we must find some evidence.  So they picked up one or two very large, what we call, population studies and said let’s look at those and see what paracetamol is doing to people in those.  Now the problem with those population studies is what you do there is you say let’s take all the patients we’ve got with paracetamol, take all the patients who are taking other drugs like ibuprofen and look and see what happened to them by looking back.  Now that is fine if both the sets of populations are the same because then any difference between the outcomes between the two groups will be down to the drugs they’re taking.  But of course in population studies often that’s not the case…

 

Porter

Hindsight – you’re looking back.

 

Cave

Exactly and the population study they used, which was a fantastic study, I think it had 19 million patients worth of data but it was general practice data and if I’m a GP and I see a patient who’s fail and elderly and I think you’ve got arthritis I’m not going to offer you ibuprofen because I’m worried about the side effects, so I’m probably going to offer you paracetamol because you are frail and elderly.  And of course that means you’re then more likely to find that those are the patients that if you follow them up for 10 years are the ones that actually have heart attacks and strokes, not because of the paracetamol but because they’re frail and elderly to begin with.

 

Now I have real problems with this because I think they have probably got the data wrong, they’ve relied on one or two population based studies to form the bedrock of their analysis and I think that’s shaky.

 

Porter

But the fact that they’ve gone back to reconsider their decision is reassuring to the rest of the doctors and presumably to patients who are taking paracetamol that if there is a problem it’s not quite as big as they thought it might be.

 

Cave

It’s reassuring and it’s also unheard of.  And we now have a NICE guidance rather like a mint with a hole, I mean there’s literally a NICE guidance at the moment with a great hole in the middle of it when it comes to drug treatment.  Now I think what I would like to say is that actually the NICE – the rest of the NICE guidance is actually very good, we don’t manage osteoarthritis very well, we have not yet got the message across that for patients with arthritis exercise is key, most people with knee pain actually think oh I’d better not exercise because my knees are worn out but actually the evidence is that exercise is really important and weight loss for people who need to lose weight.

 

Porter

Okay, GP hat on – James – a patient of yours comes in, I’m taking paracetamol regularly for my arthritic knees, let’s say, I’m quite happy on it, it’s working well, not causing me any problems – what are you going to say to them?

 

Cave

Carry on.

 

Porter

Dr James Cave, Editor of the Drug and Therapeutics Bulletin.

 

Now while NICE was casting aspersions on a popular painkiller, new research elsewhere was doing the opposite and questioning the dangers posed by an established threat – saturated fats.

A meta-analysis of 72 studies found no convincing evidence that a diet rich in these animal based fats increased the risk of heart disease. Or that switching to supposedly healthier polyunsaturated fats like omega-3 and 6 protected the heart (at least in supplement form).

 

The media jumped on the findings with much of the coverage questioning the validity of the long held belief that cutting back on foods like lard and butter and switching to vegetable oils and margarine is good for your heart.

 

But is that what the study actually suggested? And should the findings lead to a change in the dietary guidelines, as suggested by one of the lead researchers?

 

Bruce Griffin is Professor of Nutritional Metabolism at the University of Surrey and Professor Jeremy Pearson is Medical Director of the British Heart Foundation who part funded the research.  So was he happy with the way the media reported the findings?

 

Pearson

Not particularly.  All the biology suggests that increasing saturated fat in your diet is more likely to be bad for you because it puts bad cholesterol up.  So I think the shortcoming of the study is not the problem of the authors, they did the best job they could, it’s the fact that the totality of the evidence isn’t wonderful and detecting an accurate signal from dietary studies done several years ago is not straightforward.  So they did their best but they didn’t find anything and indeed they were surprised they didn’t find the answer that I would have expected.  So the problem I think with the way the press effectively translated this was they took home the message they wanted to, which you can go away and eat as much saturated fat as you like and it won’t do you any harm, that’s not actually what the paper said. 

 

Porter

Professor Bruce Griffin, what was your take on it?

 

Griffin

I think the conclusion overstates the outcome in suggesting that it’s time to reappraise dietary guidelines which are based on 60 years of evidence based medicine.  We have incontrovertible data to link saturated fat to blood cholesterol.  The media usually want a very straightforward and simple answer and meta-analysis does provide a convenient summary, in a way, but it should be appreciated that meta-analysis do not provide definitive answers.  And in the case of dietary fats, both saturated and polyunsaturated fats, I think this message is misleading in this case and can be quite damaging in terms of the public health message.

 

Pearson

Yeah you know why the newspapers do it, it sells newspapers.

 

Griffin

It sells newspapers.

 

Pearson

Because we’d all like to think golly we can eat all these things that we were told we were not allowed to eat and we really rather like to do it and that’s why they do it.  But that doesn’t make it accurate.

 

Porter

Jeremy, this study was part-funded by the British Heart Foundation and it involved researchers from the University of Oxford, Cambridge, the MRC, I mean it’s a pretty impressive bunch of people, are you saying that the evidence is not out there or they looked in the wrong place because something seems to have gone awry.  If I was doing a big study like this I’d want a more conclusive result than that or hoping to get one.

 

Pearson

Yeah I think my view is that the evidence isn’t out there and to just put it one more phase – if you’re putting together results of lots of previous studies, rather than doing one of your own, usually I think if you find a positive result it’s probably real, if you don’t find a positive result it doesn’t mean that there isn’t one out there but you just haven’t found it. 

 

Porter

Okay, let’s look at this from the other direction Bruce Griffin, how convinced are we that there’s a direct correlation between saturated fat intake and heart disease, what evidence is out there to convince us of that?

 

Griffin

There is an enormous amount of evidence, I mean this goes back to the 1950s when we – some of the original metabolic ward studies that looked at the relationship between feeding saturated and polyunsaturated fats in a very controlled environment, in a hospital environment, in patients they could show that saturated fat increased blood cholesterol.  That was then supported by some very large cross-cultural studies, which have been heavily criticised, and this led to the development of equations, predictive equations, that allowed us to predict how dietary fat would influence blood cholesterol and those equations have been used for many, many years with good effect.  So we’re pretty confident that there’s a strong relationship between saturated fat and blood cholesterol.

 

Pearson

Can I just jump in there very briefly?  Of course we shouldn’t be concentrating on one item of a diet, we eat food, we don’t eat just saturated fat or just sugar or just salt.  And what you need is a balance.

 

Griffin

The classic example would be some dairy products which are high in saturated fat and for that reason have been restricted.  When you actually feed some of these dairy products, particularly something like cheese that is rich in saturated fat, you don’t see it elevating blood cholesterol because there’s an interaction between the fat and the saturated fat and say the protein or the calcium in that product and it affects the biological response to that particular food.  That’s why it’s artificial in a way to make guidelines, dietary guidelines on the basis of a particular nutrient, an individual nutrient, we really have to be moving more towards understanding the effects of whole diets and dietary patterns.

 

Porter

I understand that but saturated fat has long been held up as the thing that we should not be eating, now Bruce has said that he’s fairly convinced that the evidence linking that to raised cholesterol levels, just remind us how convinced you are that raised cholesterol levels lead to increased risk of heart disease and stroke.

 

Pearson

Okay, that’s incontrovertible as well I think, I think that was Bruce’s word wasn’t it?  In the sense that not only is the association absolutely barn door obvious that if you raise cholesterol you raise the risk of heart disease that’s all over the world, any population but also we know that any intervention that lowers cholesterol lowers risk, so the two are directly related and causally.

 

Griffin

And I think unfortunately this study examined supplements instead of real foods and then concluded that dietary guidelines should be reappraised.  That’s a flaw of this meta-analysis in that they’re concluding upon dietary guidelines when a large part of the evidence is coming from supplements, that’s oils given in capsules.  Supplements do what it says on the tin – they’re a supplement on top of habitual diet and in many instances can produce what – an effect more like a drug than that of diet.

 

Porter

Jeremy, so put this in a very simple thing – what this study can’t measure is what it’s like switching someone from pies and chips to a healthy Mediterranean diet, that’s not what it’s done effectively.

 

Pearson

No it hasn’t.

 

Porter

And yet we know it’s the Mediterranean diet, it’s switching to the Mediterranean diet that’s healthy rather than necessarily cutting down all of those individual factors?

 

Pearson

Absolutely right and that study didn’t set out to test that and it couldn’t and it didn’t show that but I think you’re exactly right, the conclusion is you should eat a balanced diet with all the kind of things that you know, as well as I do, more fruit, less red meat, whatever.  But ultimately you need to take choice of that in your diet and you need to be aware of what it’s doing to you, so that whatever diet you choose to eat you should actually be aware of the level of risk you have.

 

Porter

Mmmm but that’s easier said than done if the best research can’t clarify if individual components like fats are good or bad for you. But thank you to Jeremy Pearson and Bruce Griffin for trying.

 

Our report back in February on using medication to treat alcohol addiction prompted listener George to get in touch:

 

George

Well I e-mailed you because you were doing a piece about drug treatments for alcoholism and I have been using baclofen for some time and I felt that it was something that needed to be mentioned.  It’s a drug that seems to be being ignored by general medical profession and it certainly has worked extremely well for myself.  I kind of wanted to make other people aware of it.

 

Porter

How did you come across it?

 

George

Well a friend of mine who’d had enough of me because it had got so bad, out of pure desperation looked up on the internet, is there a cure for alcoholism, and about four or five listings down in Google there was a small piece about baclofen.  I actually went to see my doctor about it and I had to be quite insistent to try and get him to take it seriously and eventually luckily he did.

 

Porter

How much were you drinking and what difference has the baclofen made?

 

George

I was drinking anywhere between six and eight bottles of wine a day and perhaps even one to two bottles of vodka.  So it was quite a lot and was having a devastating effect on me.  And baclofen initially reduced it to pretty much nothing, these days I will occasionally have a few pints of cider and it essentially just removes the physical cravings but also the psychological cravings that you have and the mental is probably the hardest one to get over.  Baclofen takes that away, it’s not nearly so important, you don’t live for alcohol, not every waking moment is taken up thinking about where you’re going to get your next fix from.

 

Porter

So how did a drug originally designed to be used to relieve muscle spasms end up being used to help people like George? Baclofen acts on some of the same receptors in the brain as alcohol and a number of people have experimented with the drug. The best known was cardiologist Olivier Ameisen who tried it on himself, and wrote a best-selling book about his experiences entitled The End of my Addiction.

 

Anne Lingford-Hughes is Professor of Addiction Biology at Imperial College, London.

 

Lingford-Hughes

The main group that’s done a lot of work both in animal models and humans are based in Italy but in addition to that a French surgeon Ameisen who has taken baclofen himself and written quite extensively, including publishing a book, about his experience and how it helped him.  So there’s been a lot around in the literature and on the web and therefore I think not only doctors but patients are therefore very aware of it.

 

Porter

Where are we in terms of quality evidence, I mean looking at this from a hard nose – is there good data to suggest that baclofen can help?

 

Lingford-Hughes

The major trial is based in Italy, Addolorato’s group, published in the Lancet a few years ago that studied alcoholic patients with cirrhosis and they wanted to be sober.

 

Porter

So these are quite poorly patients…

 

Lingford-Hughes

These are… exactly… and that’s…

 

Porter

With liver damage, severe liver damage.

 

Lingford-Hughes

Exactly and that’s quite an important point because in that study they showed that baclofen was helpful in pretty much doubling the rates of abstinence.

 

Porter

From what to what?

 

Lingford-Hughes

It’s was about 20-40%.  There was also a trial done in the US subsequently to that which was another good quality trial and they didn’t find that baclofen showed any effectiveness.  What’s important to understand is that American trials and European based trials are very different.  So the European trials were recruited from a clinic, they were also already quite sick and they needed medication to help them stop drinking alcohol.  The American trial recruit by advert, many of them didn’t want to be sober, only about 24%, 25%, they were less severely dependent, they didn’t need medication to help them stop drinking, they were less anxious.  So they were a population with less problems due to their alcohol.  And because they’re both good quality trials with different populations, so what this is telling the community and this is how I interpret it is that the place for baclofen is with people who are quite severely dependent, are likely to need medication to help them stop drinking, may have liver damage, in fact it may be that those with quite severe liver damage do quite well.

 

Porter

Do you use baclofen yourself in your practice?

 

Lingford-Hughes

I do yes, I started some years ago and I did select for those that were more severely dependent with anxiety problems and I’ve had some good success with it, patients have done very well on it but also some people who it hasn’t helped at all.

 

Porter

Is it about promoting abstinence or is this about controlling your drinking?

 

Lingford-Hughes

My interpretation of the Italian and the US trial is that it’s about abstinence.  So the American trial where the majority didn’t want to be sober, they just wanted to control their drinking, that’s where baclofen didn’t show any effect.  So I’ve taken from this that actually it is not a drug to take whilst you are drinking with the aim of stopping drinking.  And nor is it a drug to take because you want to control your drinking that you think oh if I take this pill then I don’t need to worry, it will control my drinking for me.  People acquiring this drug without being in an integrated treatment system, without seeing a counsellor, an alcohol worker, that’s not how the drug should be used.

 

Porter

What about dosing, there seems to be some variance in the dosage used?  The French surgeon that you referred to taking very high doses himself.

 

Lingford-Hughes

So both those American and Italian trials were done at 10 milligrams three times a day, so…

 

Porter

Which is the sort of dose we’d use to treat spasticity as well.

 

Lingford-Hughes

Exactly, exactly.  There’s no reason to think that that is the right dose to treat alcoholism.  But that’s what was used originally.  A subsequent trial of which a partial analysis was published showed that 20 milligrams three times a day, so double that amount, was looked as though it could be more effective, there was an issue of the number of patients.  However, people have reported that over about 80, 90 milligrams some people can get some side effects.  I have treated somebody up to 120 milligrams with no difficulties at all, I’ve had somebody on 30 who got quite sedated on it.  So you cannot go on one case alone.  We actually don’t know what is the right dose, we don’t know enough about the levels of the drug in people with alcohol problems, does it make a difference if you are very – have a very damaged liver or not.  That’s one issue.  We don’t know whether the receptors in the brain are different in patients with alcohol problems compared to those who are not.  There are so many unanswered questions.

 

Porter

This is a subject that’s been discussed a lot on internet forums, there are books, newspaper articles, does that put you, as a clinician working in this area, under some pressure?

 

Lingford-Hughes

The difficulties sometime comes when they arrive at clinic maybe with a book or a large printout of information that maybe isn’t as correct or evidence based as it should be.  And therefore their expectations are that they may get a certain dose of the drug or even may get a drug such as baclofen, so the personal quandary for me often is because it is out there that 270 milligrams was needed by some individuals or 140 milligrams by others, patients want to escalate their dose to that level but as a clinician I know that there is greater risk of side effects at that level.  And actually we don’t have any evidence to suggest that 270 milligrams is better than 60 milligrams.

 

Porter

What are the downsides other than the drug possibly not helping with your alcohol dependence?

 

Lingford-Hughes

Well the main side effect people experience is sedation.  You can overcome that by reducing the dose, you do seem to become a bit more tolerant to it.  But I’ve also had patients who don’t get sedated at all.  The other worries that people have brought forward is maybe if you’re looking like at a white blank wall you can see various things in it, so your eyes are playing tricks on you, a few people have described that kind of phenomena.  Another downside of the publicity has been that people have been buying it off the internet and obviously that has the risk of they don’t quite know what they’re taking, depending on where the drug has come from.  I’ve known people buy it in another country and then bring it in.  And using a drug without a prescription or without being part of a broader treatment package and knowing what dose and how to take it can have obvious dangers.

 

Porter

Professor Anne Lingford-Hughes. And there are a number of ongoing trials looking at this use of baclofen, the first of which is due to report some time next year.

 

That is it for this series, but we will back in July so please do get in touch if there is a health issue that you think we should be looking into. You can email us at insidehealth@bbc.co.uk. Until then, goodbye.

ENDS