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INSIDE HEALTH

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Programme 5.

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TX: 29.07.14Ìý 2100-2130

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PRESENTER:Ìý MARK PORTER

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PRODUCER:Ìý PAMELA RUTHERFORD

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Porter

Coming up today:Ìý Blood clots - we have an exclusive interview with a leading expert concerned that tens, and possibly hundreds of thousands of people in NHS hospitals are being given blood thinning drugs they don’t need. Might you be one of them?

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Kidney stones - I talk to one of the specialists involved in a trial into a new tablet based approach to relieving what is widely regarded as the most painful condition in medicine.

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And drug driving - as of March next year driving under the influence of drugs, including some commonly prescribed medicines, will be treated by the courts in the same way as alcohol. I will be finding out what that is actually going to mean for drivers.

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But first new research suggesting that doctors have been getting it wrong when it comes to treating bad backs. The largest trial to date of paracetamol for back pain has caused quite a stir after suggesting that Britain’s most popular painkiller doesn’t help.

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Esther Williamson is a Research Fellow at the University of Oxford.

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Williamson

This research was looking at the use of paracetamol for patients who presented to their GP or I think also physios and chiropractors with an acute episode of low back pain.Ìý And they essentially evaluated the use of paracetamol in this patient group because paracetamol is the first drug of choice in all the international guidelines for the management of acute or a recent onset of low back pain.Ìý And they found that whether you took paracetamol regularly or as you needed it it was no better than just taking a placebo or a dummy pill and that it didn’t help people to recover better and it didn’t impact their pain or their disability levels.

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Porter

Basically it didn’t work.

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Williamson

Exactly.

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Porter

So how did it get into the guidelines in the first place? ÌýOne would like to think that they were evidence based.Ìý Is this the first time someone’s actually looked at this?

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Williamson

No it’s not the first time it’s been looked at but certainly the studies to date have been a lot smaller than this so that’s really one of the strengths of this research is that it’s a really large study with 1600 patients so we can be confident in the findings.Ìý And I think the sort of total sum of participants who’d been in previous research was only about half that number, so actually the previous studies weren’t as good quality.Ìý But when guidelines are made people need to make decisions on the best available evidence, so they also drew from evidence in other conditions as well, so things like post-operative pain and headache where paracetamol had been shown to be effective.

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Porter

A lot of people listening to this may find the fact that a painkiller doesn’t help back pain as counterintuitive, why do we think paracetamol’s not effective?

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Williamson

Well we’re not entirely sure because it has been shown to be effective in these other conditions.Ìý So the big question then is really why is back pain different to other sorts of pain and we don’t actually know the answers to that.Ìý I mean paracetamol is very good at reducing fever and we know that there’s obviously no fever when you present with acute low back pain, it’s thought that maybe it does work on some of the chemicals released during the inflammation process but maybe people who come in with episodes of low back pain don’t actually have a lot of inflammation in their tissues, so maybe that’s another reason why it doesn’t work.Ìý But obviously it is quite confusing because anti-inflammatories are also used for acute low back pain which would be working via that mechanism, so I think the simple answer is that we really don’t know.

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Porter

Let’s be clear about what the study found.Ìý The study showed that paracetamol had no benefit over placebo…

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Williamson

That’s right.

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Porter

… but did placebo itself have a significant benefit?

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Williamson

Yes, well that’s the thing is that actually all the patients in this study recovered really well, so by about 12 weeks 85% of the cohort had recovered and this is actually a lot better than a lot of other previously published back pain studies. ÌýSo you could say that actually the placebo tablet worked just as well as the paracetamol.Ìý And I have heard some suggestions – well if that’s the case what does it matter if people take paracetamol if it seems to be working even if it is just as a placebo?Ìý But I would probably say to that that really patients shouldn’t be taking medicine that we know isn’t affecting them just as a placebo.Ìý The other important thing about this study was that all the patients got an advice session with a health professional where they were given advise about their back pain, about not resting, about staying active and continuing their normal daily activities, reassurance that back pain is not serious and that most people recover well.Ìý And the authors also raised the point that maybe actually this element of the treatment was really important to these patients, so the patients who got the placebo drug also got this advice and maybe that’s what facilitated the good recovery within the group.

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Porter

Do you think we’ll see a change in the guidelines accordingly, given that this is such a large study?

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Williamson

It has been suggested by some people in the field that it’s too soon to change the guidelines, that it shouldn’t be changed just on the basis of one study.Ìý But it is a really big study, it’s a well conducted study and if you look at the patients that appear in the study they do seem similar to say the patients that would present to primary care within the UK.Ìý So it maybe that people will ask for this to be replicated in another country, just to confirm the findings, but really on the basis of this study I would say serious consideration does need to be given to the guidelines.

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Porter

Esther Williamson. GP Margaret McCartney is in our Glasgow studio and has been listening to that. Margaret, Esther made the point that advice is a key part of managing simple back pain but much of that is counterintuitive too?

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McCartney

Absolutely and I think what we know more than anything is that time and time again we keep getting it wrong with the management of back pain.Ìý When I was a medical student I clearly remember going to see a patient in his home where he was doing the standard treatment for low back pain which was lying on a hard board 24 hours a day for about a week, now god only knows how much harm that did but that kind of thing was very much in standard practice then and we now know that that’s one of the worst things you can do for back pain, you want to keep as mobile as you possibly can.Ìý But it took a long time for that evidence to come through, contrary to the amount of time that we spent giving people the wrong advice.

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Porter

The cynic in me wonders what happens if we do nothing – what happens if we just tell a patient that they’ve got simple back pain and it’s going to get better and send them away?

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McCartney

This is the big question and one that hasn’t been properly addressed in this trial, through no fault of their own but what I think we really need to get is more of these so-called three armed trials where you don’t just compare a placebo to the active drug, the paracetamol, but you have another group where you don’t use any tablets at all but you use the same good advice that was used for all the other patients in terms of telling someone that their back pain is likely to get better anyway, that their activity levels should try and remain up because that is going to help them, we give them all the usual advice, reassurance and information about back pain and its normal pattern so that we can find out what the actual effect is of the tablet, do you actually need the tablet to get the placebo effect or can you get the placebo effect, that caring effect, through other means, through information, advice and physical activity.Ìý And that’s the big question because the problem is that the placebo effect is real, people do get a benefit from placebos but I don’t have any placebos to prescribe to give people that effect without the paracetamol in it.

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Porter

What would you prescribe to someone then who came to see you now with back pain that’s bothering them enough to keep them awake at night or something, what sort of medicines are you going to use?

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McCartney

Well for the kind of typical pain we’re talking about here, someone that’s got acute back pain, that’s short term rather than long term, I think the first thing to do is to take a history, talk to your patient, find out what’s going on and what they would like and what they would want.Ìý I think a lot of people are probably not going to want paracetamol after this, that there is some evidence that says that anti-inflammatories are better than placebo for low back pain, so we could offer that…

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Porter

These are ibuprofen type drugs?

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McCartney

Things like ibuprofen but they have a different side effect profile – gastric irritation being one of them.Ìý They’re also not great with a lot of other drugs, so that’s another consideration.Ìý But the big recommendation for me would be to keep active, we’ve got lots of exercise sheets we can use, we’ve got physiotherapists we can call on as be, my best advice would be to try and keep active as much as you can and of course to return and see us if things are not improving as we’d expect them to.

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Porter

Thank you Margaret. And there is a link to the paracetamol study, as well as more information on managing back pain, on the Inside Health page of the Radio 4 website.

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Earlier this month we were contacted by a specialist about his concerns that too many patients in NHS hospitals are being given blood thinning drugs they don’t need.

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It’s part of a recent initiative introduced to reduce preventable deaths from bloods clots, where hospitals get financial incentives to assess every patient’s risk.Ìý But might over-zealous use of anti-coagulants be doing more harm than good? Dr Ander Cohen, a Consultant Vascular Physician at Guy’s and St Thomas’s Hospitals, thinks so.

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Cohen

There are two types of blood clots, there are blood clots that form in the veins and they’re known as deep vein thrombosis or pulmonary embolism and there’s another type of blood clot that forms in the arteries, the arteries of the legs and might cause gangrene or the arteries around the heart and might cause a heart attack or in arteries in the brain and might cause a stroke.Ìý

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Porter

And the risk we’re looking at in hospitalised patients is that of the venous type, the deep vein thrombosis, and that typically occurs where – where would you notice it?

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Cohen

Typically a deep vein thrombosis occurs in the legs, it’s thought to start in the lower legs round the calf and you may or may not get some calf swelling and if you get some calf swelling it can be treated but many of them are silent and they’re the dangerous ones because they don’t have any symptoms and then they progress and break off and travel up the leg, through the heart and into the lungs and can cause a pulmonary embolus which can be something mild or it can be instantly fatal.Ìý So there’s a great range of symptoms and signs.

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Porter

How common are deep vein thrombosis and the complications like PE – pulmonary embolus?

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Cohen

Well they’re very common, deep vein thrombosis occurs in about 10-20% of medical patients and 20-30% of surgical patients.Ìý But most of those clots are handled by the body, they are absorbed and they don’t cause problems but a significant number go on and cause symptoms and perhaps problems with the lungs and may even kill you.Ìý And it is the commonest preventable cause of in-hospital death, so to put it into perspective we worry a lot about hospital infections but there’s probably 20 deaths from venous thrombosis for every one death from hospital infection.

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Porter

So looking across the year in NHS hospitals, what sort of toll might we be talking about?

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Cohen

We think there are about 60,000 deaths a year in the UK from venous thrombosis.Ìý It’s the third most common cause of cardiovascular death after heart attacks and strokes.Ìý And we know that probably about 30-40,000 of those clots are related to hospitalisation and we know that roughly about 25,000 of those are preventable.Ìý And that’s why we have such a strong push to bring in preventive therapy.

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Porter

Now the National Institute for Health and Care Excellence highlighted this as a big problem a while ago and said look more needs to be done, these deaths are preventable, so can you explain what happens now when someone goes into hospital?

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Cohen

Well when someone goes into hospital now they have a mandatory risk assessment and this uses the NICE risk assessment tool and on the basis of that patients are determined to be either at risk or not at risk and if they’re at risk therapy is recommended.

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Porter

And that therapy would be?

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Cohen

For the majority of patients that therapy is something to thin the blood and usually that’s an anti-coagulant drug or a blood thinning drug given in a small dose.Ìý That is by far the most effective therapy, that’s the therapy that we know not only reduces deaths from blood clots in the lungs but also reduces total mortality, which is the gold standard of any preventive therapy.Ìý And other patients who perhaps have risk of bleeding we don’t want to thin their blood and we use mechanical methods like stockings and compression pumps but there’s no evidence that these have any effect on dying from blood clots and they certainly seem to have no effect on total mortality.

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Porter

Are you happy at the moment we’re hitting the right patients with the right medicines?

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Cohen

No I’m not happy because I’ve recently reviewed the NICE risk assessment tool and it seems that we’re giving or assessing at least one in five patients of being at risk when they’re not at risk.Ìý And so what the NICE tool has done is that it has recognised that certain patients are at risk but the criteria are too broad and sadly some of them are not evidence based.Ìý And when I check the NICE detailed information they were able to give some evidence for some risk factors but there are important risk factors where there was no evidence in their document and these are the patients I’m worried about.

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Porter

So what has happened effectively in the last few years is that the pendulum’s swung from where we were probably underusing these medicines and there were preventable deaths to now we’re overusing them in some groups.Ìý Which groups are you concerned about?

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Cohen

Well I’m concerned about a number of groups.Ìý First of all the NICE risk assessment tool says that patients with diseases like endocrine diseases…

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Porter

Hormone problems.

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Cohen

Hormone problems – so diabetes, thyroid, adrenal problems and so on – and patients with metabolic disorders and the typical metabolic disorders are things like hypercholesterolemia and gout, it says they’re at risk and there’s no evidence for this, there’s no clear evidence that these patients are at risk, nor is there any evidence, most importantly, that if we treat that risk that it makes any difference.

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Porter

But just looking at the list you give – the examples you’ve given me there, I mean high cholesterol levels, common problem in the UK, diabetes, very common problem, thyroid another common issue – these are problems that a lot of patients may well have.

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Cohen

Yeah, so what we’ve found is that in the UK about 20%, maybe 25% of medical patients are said to be at risk when there’s no evidence that they’re at risk.Ìý And most importantly even if there is some risk it’s very minor and there’s no evidence that giving blood thinning drugs has any effect whatsoever.

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Porter

So put simply the one in five medical patients, and they make up over half of all hospital admissions, so we’re talking one in 10 possibly of all hospital admissions are being given these drugs inappropriately?

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Cohen

We think so.

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Porter

And the downside of that is what?Ìý Obviously these drugs don’t come without risks presumably.

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Cohen

Of course whenever you thin the blood we know that it reduces deaths from blood clots but it also leads to an increase in bleeding, about a 50% increase in bleeding.

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Porter

And that bleeding might be what – what sort of problem?

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Cohen

Well it could be any type of bleeding, it could be minor bleeding like nuisance bleeding but it could be more serious bleeding like bleeding from the lungs or the bowel or even into the brain.Ìý And all this is described as a result of using small doses of blood thinning drugs.

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Porter

So you don’t have a problem with the fact that hospitals are being financially rewarded for screening for blood clots, that’s a good thing but it’s not a good thing if they’re using the wrong screening tool, that’s the issue.

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Cohen

That is the issue and it’s not just the thing with hormonal diseases and metabolic diseases, the only research in the cardiac area has been in heart failure and heart attacks and yet the risk assessment tool talks about cardiac diseases.

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Porter

So any heart problem?

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Cohen

Any heart problem.Ìý Same with respiratory diseases, the research has been on obstructive pulmonary disease and some patients with fibrotic lung disease but it talks about any respiratory disease.

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Porter

So maybe even asthma, if you went in with asthma…

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Cohen

Exactly and there’s – the evidence for asthma is very poor.Ìý To me this hasn’t been thought out clearly by people who know about the subject.

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Porter

Dr Ander Cohen who has questioned the NICE risk assessment tool in an article in the latest edition of the British Journal of Haematology. We put his concerns to NICE who sent us this comment:

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NICE Statement

Following a recent review decision a rapid update of the guideline for reducing the risk of venous thromboembolism is now scheduled.Ìý All new relevant evidence will now be considered for review by a NICE committee and the recommendations could change.Ìý Details of the update will be made available on the NICE website.

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As is the current guidance for preventing blood clots in hospitals.

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If you drive then there is no excuse for not being familiar with the law regarding drink driving. But what about driving under the influence of drugs both legal and prescribed? New legislation which comes into force next March sets out threshold levels for 16 different drugs – eight illegal ones such as cannabis and cocaine and eight prescription medicines including sleeping tablets and some strong painkillers. And as with the legal blood alcohol limit exceeding these thresholds will result in prosecution.

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Now no one wants to share the road with people who are high on cocaine, or stoned on cannabis, but what about otherwise law abiding citizens taking prescribed medicines?

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Kim Wolff is an addiction scientist at King’s College London and Chair of the expert panel that advised the Department of Transport.

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Wolff

So there are medicines involved in this and this is because they are also quite powerful drugs and many of them are misused as well as legitimately prescribed – which include the benzodiazepines and there are six of those included in the legislation and include drugs like diazepam and oxazepam.Ìý And then we have the medicinal opioids like morphine and methadone.

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Porter

Now morphine’s an interesting one because of course one of the most commonly used painkillers in the UK is codeine and codeine’s converted in the body, it’s a milder painkiller, but it’s converted in the body to morphine, is that going to be an issue?

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Wolff

No I think we’ve looked specifically at morphine as the stronger opioid, as you’ve said, and there is evidence that this drug can cause impairment to drivers but we’ve left codeine out of the legislation because it’s a much milder opiate and there isn’t the evidence that suggests that it’s as risky when driving.

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Porter

Now it varies very much from drug to drug but what sort of effects are these – I mean looking at, for instance, some of the licenced medicines – what sort of effects might they have on a driver’s ability to drive that would mean that he or she was more likely to have a crash?

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Wolff

Well they’re wide ranging in terms of the debilitating effects.Ìý I think sedation is a commonly cited, reaction time tends to be slowed down, concentration tends to be impaired, an inability to stay in lane when driving on a motorway for instance.

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Porter

Because it’s very difficult, isn’t it, I mean looking at the effects of alcohol and the law regarding alcohol and driving, alcohol affects different people in different ways, you can – some people can drink more than others and still remain below the limit and the standard advice is don’t drink and drive but that’s not going to be possible if you’re on a prescription medicine and you might think well I’ve been taking this painkiller for a long time it’s unlikely to impair me but you could technically be breaking the law if you’re on a high dose.

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Wolff

Well part of the new legislation involves something called the Medical Defence, which means that if you are legitimately prescribed a medication that’s included in the legislation then you are able to provide this evidence to demonstrate that you are compliant.Ìý And I think the important thing here is compliant with your prescription, so if you’re taking it in the way that’s being advised by the prescriber then you have a medical defence, if you’re taking it in a non-compliant way then the legislation will not support you.

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Porter

How are people going to be tested for these drugs?Ìý I mean looking at a list here you’ve got 16 drugs in the two groups, I mean they’re all very different, there isn’t one device that can test for all of those that I’m aware of.

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Wolff

There isn’t one device, you’re right, and this is a complicated area, so there will be two levels of tests – there will be the drugaliser test, which will be a screening device that can be taken at the roadside or in the police station, followed by a confirmatory test, which will be a blood sample and it’s the blood sample that will form the basis of the new legislation.

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Porter

You’ve highlighted 16 drugs and medicines initially in the legislation but as somebody who prescribes medicines regularly I know that there are lots of other drugs that impair people’s ability to drive – some types of antidepressants, maybe even some types of the over-the-counter sedative antihistamines that people take for hay fever.

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Wolff

Yes of course you’re right and I think the main point to make here is that we’re at the very beginning of this legislation and as far as I’m aware there is a view that the legislation will be reviewed regularly.Ìý So you’re right in terms of the antihistamines, some of these – especially the older antihistamines – are very sedating and they would be a cause for concern.Ìý So I think those are a drug that are under review.

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Porter

Do we have any idea of the scale of the problem?Ìý Presumably we have data from accidents and when people are tested but that’s likely to be the tip of the iceberg to the scale of the problem.

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Wolff

Well there are tests that we carry out in drivers who are suspected of being impaired or who have been involved in road traffic accidents and as you would imagine alcohol is the most commonly found substance, followed by cannabis and then cocaine and these are the drugs that the government has concentrated on in terms of the new legislation.Ìý But benzodiazepine drugs, the drugs that are used for sedation, are the most common medicinal compound found in our drivers who are involved in road traffic accidents.

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Porter

So this is diazepam and some of the older fashioned sleeping tablets like temazepam.

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Wolff

Exactly, yes oxazepam.

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Porter

But just because you’re not liable to prosecution and you’re taking your medicine appropriately doesn’t mean you’re safe to drive does it and perhaps we should be thinking that way, that if people are taking these drugs they need to be careful.

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Wolff

I think that’s a very good point to make and as part of the new legislation there will be an awareness campaign, so that people are aware that some of the drugs they take, even for very good reason, impair their behaviour and their driving.

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Porter

And presumably there has to be an awareness campaign aimed at people like me – GPs who are prescribing these drugs – so that we can warn patients?

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Wolff

Exactly and I believe there have been some guidelines developed especially for that, so that GPs and other healthcare professionals are aware of the risk of these drugs themselves.

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Porter

Kim Wolff. And you will find a full list of the drugs included in the new legislation on our website, head for bbc.co.uk/radio4 and click on I for Inside Health. Where you will also find details of how to get in touch.

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Laurence Moore wrote in to ask about developments in the treatment of kidney stones. He has a pea sized stone that is not suitable for lithotripsy – breaking the stone up by blasting it with ultra-sound. He wants to know if there is anything he can take to help him pass it?

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Stones can form anywhere in the renal tract but most are found in the kidneys or the ureters – the pipes that connect the kidneys to the bladder. And they tend to cause most pain when they get stuck twixt the two, as Francesco knows all too well.

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Francesco

Well the first time was three years ago, I had the big pain and…

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Porter

Describe the pain for me.

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Francesco

Well describe the pain, it’s something really horrible you feel inside, you cannot touch it, you don’t know what to do because you cannot find any position because you want to sleep, you cannot sleep, you go on a walk you cannot walk, if you want sit but you cannot sit.Ìý Really painful.Ìý I’ve got one stone on the right, it’s big and two stones on the left.Ìý That one on the left are really, really quiet, they stay there, they’re sleeping probably but that one on the right is really, really naughty and really upset.

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Porter

To find out what can be done to help people like Francesco and Laurence I went to the Stone Unit at Guy’s Hospital in London to meet Consultant Urologist Kay Thomas.

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Thomas

Well the vast majority are treated by just watching the patient, waiting for the stone to pass spontaneously, probably about three quarters of the patients we’ll do that.

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Porter

When you say pass spontaneously that means into the bladder and basically comes out – you pee it into the loo?

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Thomas

Yeah I mean from the patient’s point of view it’s quite a painful process but it does avoid them needing any intervention from us.Ìý If the stone is large or located closer to the kidney, rather than the bladder, then their chance of passing it by themselves goes down and that’s when they need some intervention either with lithotripsy or uritroscopy, which is passing a small telescope up the ureter with the patient asleep and breaking up the stone using a laser.

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Porter

Our listener’s got a four millimetre stone, so which is not suitable for lithotripsy for some reason, what about other options in terms of medical non-surgical management, is there any medicines the patients can take to help?

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Thomas

There are two main categories of drug that have been used, alpha blocker and calcium channel blockers, which work in a different way but have the same effect of relaxing the smooth muscle which is the muscle in the tube draining the kidney to the bladder.Ìý And it’s hoped that they would facilitate the stone passing by itself by relaxing the muscle.Ìý There is a national trial which has just finished looking at whether these are more beneficial than having no treatment at all.

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Porter

They’re used acutely to provide relief but might they be used on a daily basis to help somebody pass the stone as well?

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Thomas

Yes so once they’re given to the patient in A&E they’d be sent home with a two or four week course of treatment.Ìý The longest period of time you’d want to leave someone waiting for their stone to pass is six weeks, so in most hospitals the patient should be seen within two to four weeks to check they’ve passed the stone because if they haven’t they would need one of the treatments.Ìý So it’s not a new trial but it is a big trial and it’s the first UK one and probably the quality of the evidence is better than some of the trials that have been published previously.

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Porter

And the stones are formed of what?

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Thomas

The majority are calcium and something called oxalate, which bind together.

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Porter

When you see calcium it’s a sort of scale that you might get in the bottom of your kettle, precipitating out.

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Thomas

Yeah, yeah.

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Porter

What do you do with somebody once they’ve been diagnosed with a stone in terms of preventing them getting another one, are they at risk of recurrent stones?

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Thomas

They’ve got a 50% recurrence risk overall, obviously it’ll depend slightly on the type of stone and the individual patient but roughly 50%.Ìý Hydration is the most common reason for people forming stones or lack of hydration.

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Porter

So they’ve got concentrated urine?

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Thomas

Yeah, so they’re not drinking enough, the urine’s very dark and particularly over this sort of season we see a lot of patients because of the hot weather.

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Porter

So the hot weather can precipitate their troubles?

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Thomas

Yes, yeah.

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Porter

So your advice would be that they should be drinking plenty to keep their urine dilute but there’s not a lot else that they can do other than hope?

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Thomas

There are some dietary modifications, so depending what their stone’s made of they can look at their diet.Ìý So good fluid intake, fruit and vegetables, fibre, moderating the weight so obesity and diabetes can lead to stones, all of those help to prevent stone disease in general.Ìý And then there are rarer stones that have very specific dietary advice.Ìý Previously people with calcium oxalate stones were told to reduce their calcium but that probably isn’t correct advice anymore because people need calcium for healthy bones and teeth and actually the oxalate part of the calcium oxalate stone is probably more important.Ìý So we give advice in foods containing oxalate, for example strawberries, nuts, chocolate, red wine, rhubarb – so often patients look slightly horrified because they’re all quite nice foods.

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Porter

So you’d be excluding those from the diet going forward?

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Thomas

No everything in moderation.Ìý So if patients eat a lot of those foods then they should moderate their intake, but no they shouldn’t exclude them completely.

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Porter

Thank heavens for that, urologist Kay Thomas.

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Just time to tell you about next week when I will be revealing why the ancient art of blood-letting is still being used today. And I will be finding out what degree of ultra-violet protection is offered by dark or black skin – do you need to be as liberal with the sunscreen? Join me then to find out.

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ENDS