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Placebo stories

Here are three interesting placebo stories.

  1. This study shows the impact of the perceived cost a treatment on the outcome. 82 volunteers were given electric shocks to see how much pain they could stand. Half of them were then given a brochure about a new painkiller which cost $2.50 a pill. The other half were given a brochure about a new painkiller which cost 10 cents. They were all then given the painkiller they’d read about and given electric shocks again. In the $2.50-price group, 85 percent of subjects experienced a reduction in pain after taking the placebo. In the 10 cent group, 61 percent said the pain was less.
  2. Recently there was a report which analysed the trials conducted on four commonly prescribed anti-depressants. It came to the conclusion that these modern anti-depressants were actually no more effective than placebo. That’s not that they didn’t help anyone. It’s just that placebos helped people just as much. This is an important point. The anti-depressants helped most of the people who took them. The placebos did too.
  3. Here’s a third story. This one dates back to the 1950s and concerns a case published in the Journal of Projective Techniques and Personality Assessment. This patient was terminally ill with a cancer of the lymph nodes. He heard about a new drug called Krebiozen and managed to persuade his doctors to give him it. To everyone’s total amazement within 10 days all signs of the disease, including his massively swollen lymph nodes, had disappeared and he was discharged from hospital cured. However, reports of Krebiozen failing and actually being useless began to circulate and the patient, who kept up with the reports rapidly went downhill and was re-admitted two months later again in a terminal state. His doctors decided to carry out an experiment. They told him the newspaper reports were wrong and the problem was the drug wasn’t strong enough. More than that they told him they had ordered up a new “super strength” version of the drug but it would take a couple of days to arrive. His anticipation heightened his optimism. They then injected him with sterile water. Once again he experienced a miraculous recovery and stayed well until the American Medical Association announced “Nationwide tests show Krebiozen to be a worthless drug for the treatment of cancer”. Within days, he became dejected and died.

What do you think about these stories?

The placebo effect is not understood. Often placebos are seen as some kind of pretend medicine, probably because of the kinds of experiments mentioned in the first and third stories where the person taking the placebo is deliberately tricked. But the effects are not pretend. The volunteers receiving the more expensive placebo really did experience less pain. The patient with the lymphatic cancer even more tragically showed how the placebo effect reversed his pathology and how the loss of the belief (an essential component of the placebo effect) led to a rapid death. Nothing pretend about that. So that’s the first thing we should understand about the placebo effect – it’s real, and it’s significant. In fact some people say we should change the name of the placebo effect and call it the self-healing effect. That’s what placebo studies reveal – the capacity of the human body to self-heal.

The study of the anti-depressants reveals another important point. With belief in a treatment the treatment can be effective. It’s not just belief in placebos where we see this. It’s also true of pharmacological drugs and even of surgical operations. Without belief, any treatment is less likely to work. I’ve seen this frequently as a doctor. If a patient doesn’t believe in a particular pain killer or blood pressure pill or whatever, it doesn’t work for them. Similarly, if someone is convinced a drug will harm them, it’s highly likely it will.

I don’t think any doctor should use a treatment he or she does not believe in. No doctor should trick a patient. Trust is essential if belief in treatments is going to extend beyond the short term. And from the point of view of the patient, beware of agreeing to any treatment you believe will harm you, or which you don’t believe will help. If you’re in that position, ask the doctor, and others who you trust, for their advice and support to help you clarify your beliefs about the proposed treatment.

What do you think? Do these stories surprise you? Do they change what you think about medical treatments?

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I use movie clips a lot when teaching. I’ve posted a bit about some of the movies I use before (put “how we cope – learning from the movies” into the search box at the top right of this blog to see some examples). People now often suggest movies I might want to see because they show something about human character, about coping mechanisms or some of the ways in which things go wrong. Today, a colleague at work lent me “Control“.

It’s the movie based on the autobiography of Ian Curtis, the Joy Division singer’s widow. I was never really a Joy Division fan but I do still really like some of their songs. It’s no secret that this is a depressing movie. Ian Curtis hanged himself at just 23 years old. I found it a very powerful story, not least because it tells of a young man’s struggle with epilepsy. Convulsions are very scary to witness if you’ve never seen one before and the way they appear so suddenly and so completely take over a person’s life for a few seconds or minutes is always very dramatic. Ian Curtis couldn’t deal with having this complete loss of control and an experience of somebody he knew dying from an epileptic seizure probably magnified his fear of the disease and the terror that the next fit may well be his last. As the band begins to find success, his marriage begins to drift and he starts an affair he with a Romanian woman. In short, his life begins to unravel on all fronts at once. You might think success (selling more records, getting concert dates, becoming famous) would be a positive but to Ian it felt that he was being sucked empty by it. He gave his everything into his music and his performances but felt that success brought demands for more and more. He was losing control of his own life.

It was all too much and he committed suicide aged 23.

We all need to feel that we have some control in life. How much control varies between individuals and it alters at different points in life. But everyone I’ve ever met needs some sense of being in control of at least some important part of life. What a lot of people miss though is that we almost always have choices, and even though we find ourselves in circumstances outwith our control we can still choose how to respond. When it feels as if the choices have run out, it’s a very, very hard place.

I posted recently about change. Well in the face of too much change it can feel as if our choices have run out. But you know what? I don’t think they ever do. It’s just that sometimes it takes someone who loves us, or cares about us, to help us realise that.

It strikes me this is an important part of the practice of medicine – not just treating diseases, but helping people to see, and to make, more positive choices. A doctor can only do that if he or she understands the relationship between a patient’s illness and their life.

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It’s an old adage in medicine – “First do no harm”. I really think this must be our first consideration when thinking of all therapeutic interventions. The first question I have is what harm might it do? The next question is what good might it do? Then it’s a matter of weighing the one against the other. Is the potential pay-off worth running the risk of the possible harm?

When I started as a General Practitioner it was common for us to do serial injections of tiny amounts of allergens to reduce somebody’s allergic disease symptoms. Hay fever and allergies to house dust mite were probably the commonest allergies treated. A series of injections would sometimes bring some relief from sneezing, runny noses, itchy eyes and so on. The trouble was, that the potential harm turned out to be sudden death. Not that it ever happened to any of my patients, but the authorities rightly decided that the risk of death was too high a price to pay for possible relief from itchy eyes and runny noses, so they withdrew the treatment from GPs.

Well today there was a report about GlaxoSmithKline having evidence that one of their drugs (seroxat) increased the suicide risk in under-18s but they didn’t tell the authorities about this concern for a long time. This created the false belief that it was a safe drug when it wasn’t. Prescribers were likely to fall at the first hurdle – the first do no harm hurdle. What makes this case worse is that they also had evidence that their seroxat wasn’t even effective in treating depression in the under-18s so prescribers then fell at the second hurdle too.

It’s not good enough.

In this time of pushing drug solutions for all health problems through claiming that published trial evidence (usually paid for by the drug manufacturers) will reliably guide doctors, this type of bad behaviour by the drug companies undermines trust and shakes the very foundations of Evidence Based Medicine.

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Can I just take a minute to clear something up?

This is an issue that comes up for me with patients probably every week if not most days. It’s about pain. Many patients present to the doctor with a main problem which is about pain. The way doctors are trained is to focus on making a diagnosis. Now, that’s a good idea. I always tell people we can’t figure out what might help until we understand what’s wrong. But the problem arises with the dominant medical paradigm, which is known as the “biomedical model”. This model has been around for three or four hundred years now and it focuses on the concept of disease as a lesion. By lesion I mean something objective which can be observed, or measured.

Two problems arise from this rather mechanical model. First is that if a lesion can’t be found the patient’s symptoms tend to be dismissed as psychological (or worse – pretended!) Anyone who understands health and illness will know that this is nonsense. You don’t need to find a lesion to accept, understand and attempt to alleviate a human being’s suffering. Second is that symptoms and lesions do not exist within a linear relationship.

Pardon?

Well, let me take the example of pain. Let’s imagine someone has a disease where we can see and measure the lesion – cancer would be a good example. There is no simple relationship between the cancer and the amount of pain a person experiences. Two people with the same cancer of the same size in the same part of the body can have utterly different experiences of pain. And any one person can have a cancer that changes size (getting bigger or smaller) without any significant change in their experience of pain.

There is no direct, linear relationship between a pain and a lesion.

Strangely, a lot of people don’t understand that (and I include a lot of doctors there) but it should never be forgotten. Pain needs to be addressed, understood, and managed as pain. It cannot be understood, and managed effectively as a manifestation of a lesion.

This is the value of a holistic, patient-centred approach to illness. The focus is on the person and their experience, not exclusively on their lesions. Pain is real. It doesn’t become unreal in the absence of a lesion.

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Here’s another study which shows the health benefits of writing about your experience. We all use narrative to make sense of our lives, so you’ll understand that writing about our experiences can help us to do just that – to makes sense of our experience. However, more than that, narrative is a creative, expressive act. It’s a way of affirming our existence, connecting to others and of growing. It helps us to develop.

In this study 71 patients with cancer were asked to write about “How has cancer changed you, and how do you feel about those changes?”

After the writing assignment, about half of the cancer patients said the exercise had changed their thinking about their illness, while 35 percent reported that writing changed the way they felt about their illness. Three weeks after the writing exercise, the effect had been maintained. Writing had the biggest impact on patients who were younger and recently diagnosed.

Changing how you think and how you feel changes your everyday experience so it’s no surprise these respondents reported improvements in the quality of their lives.

It’s interesting  to note how important it is to write about feelings to get the good effect –

“Thoughts and feelings, or the cognitive processing and emotions related to cancer, are key writing elements associated with health benefits,’’ said Nancy P. Morgan, director of the center’s Arts and Humanities Program. “Writing about only the facts has shown no benefit.”

One final point worth noting is that whilst, as you may have expected, many wrote that the experience of cancer had been life-changing, perhaps what is more surprising is that many made statements about the gains which they had obtained from the cancer experience.

One patient wrote: “Don’t get me wrong, cancer isn’t a gift, it just showed me what the gifts in my life are.”

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A study by Professor Kirsch and colleagues of Hull University has set a bit of a cat amongst the Pharma pigeons. It’s a pretty technical study but in summary what they did was got access to all the trial data submitted to the FDA by drug companies applying for licences for the big four new generation antidepressants – fluoxetine, venlafaxine, nefazodone, and paroxetine. This data, by the way, included trials which were not published but which they obtained access to through a Freedom of Information application.

What they found was that there was no evidence the drugs were more effective than placebo in patients with moderate or severe depression. They did show that the worse the depression at the outset of the trial, the greater the effect of the drug over placebo, but they did a fascinating analysis which showed that the explanation for this was likely to be the decreased placebo response in more severely depressed patients.

Given these are drugs with well known side effects and dangers, and that some 16.2 million prescriptions for these drugs were made in England in 2006, this study comes as something of a shock.

The responses to this study are even more interesting. Most experts and authorities quoted on the news items today have made the point that we all know that talking therapies work for depressed patients but that drugs are prescribed because there are insufficient numbers of therapists available. This is a shocking explanation. Drugs as a substitute for people. What’s the problem? Insufficient funds for the provision of enough therapists? Seems so. So why do we prefer to spend literally millions on drugs which probably don’t work instead? The answer lies partly in the way medicine is currently delivered. The priority is given to drugs. You can’t placebo control human care or loving attention. Maybe it’s time we began to change our priorities and save the drugs for when therapeutic relationships are not enough.

Does this study mean that people taking antidepressants should stop them because they are useless? NO. The problem with all this so-called “evidence” which comes from highly artificial clinical trials which seek to remove the human factors and average out the results to the point of dismissing the range of difference within the study group is that it fails to show us who might benefit most from a particular treatment. Within these studies are individuals who are substantially improved by the drug, and others for whom taking the drug was of no benefit at all. However, it is reasonable to assume that drugs alone are not enough. Depressed people need more care than mere pharmaceutical care.

Does it mean that we should invest in trying to treat depression with alternatives to drugs? YES. It’s about time we gave clinical priority to people in medicine, investing in sufficient numbers of well-trained doctors, nurses and therapists to give ill people the time and attention they need to become well – if possible, without the risks of prescribed medicines.

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Here’s an interesting study which split stroke patients into three groups – one group listened to music of their choice, one to audio books and the third didn’t listen to anything other than the sounds around them.

After three months, verbal memory improved by 60% in the music group, compared with18% in the audio book group, and 29% in the non-listeners. Focused attention – the ability to control and perform mental operations and resolve conflicts – improved by 17% in the music group, but not at all in the other two groups. In addition, patients in the music group were less likely to be depressed, or confused.

The researchers point out that

during the first weeks and months after stroke, the patients typically spend about three-quarters of their time each day in non-therapeutic activities, mostly in their rooms, inactive and without interaction, even although this time-window is ideal for rehabilitative training from the point of view of brain plasticity. “Our research shows for the first time that listening to music during this crucial period can enhance cognitive recovery and prevent negative mood, and it has the advantage that it is cheap and easy to organise.”

What a great idea! And how interesting. I’ve often felt that a lot of hospital time for patients is empty and involves no explicit therapeutic intervention. Yes, the physical environment of the hospital, if well designed, can contribute a therapeutic influence, but not many hospitals are designed that way, and even in the ones that are, it strikes me as a good idea to fill more of the patients’ average day with therapeutic interventions.

This final paragraph in the BBC’s report of this work really struck me –

Dr Isabel Lee, of The Stroke Association, welcomed the research. However, she said: “Further research into the effect of music on stroke patients needs to be undertaken before any widespread use, as presently the mechanisms of any effect remain unclear.”

Really? We’d better not allow stroke patients to choose to listen to music they like until we understand the “mechanism of action”? Has it come to this? Is this an important thing for science to discover? How music works???

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fruit bowl

Another excellent episode of the BBC’s Horizon tonight looked at communities around the world where people live longer and live more healthily.

There were different characteristics in the different communities. The first place the programme focused on was Okinawa and the American doctors who were studying the longevity phenomenon there highlighted the Okinawan’s diet. What immediately grabbed me was the focus on how colourful their diet was. I think that’s a good indicator of a healthy diet. The browner the diet, the poorer it’s likely to be. I don’t know if you’ve ever watched any of the rather awful Gillian McKeith’s programmes about diet, but she gets her victims to observe their entire week’s food piled high on a single table. It’s done in a way that’s designed to disgust and it works, but one thing has always struck me about the unhealthy diets on those tables – they are so BROWN!

So here’s one tip for living longer – have a colourful diet! (Oh, let me make clear, I mean naturally colourful, not food that’s been coloured artificially with chemicals!)

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On the BBC’s Horizon programme about longevity, there was one characteristic shared by all the communities of long living people which they studied – it was the sense that they were connected to something greater than themselves, expressed either through adherence to particular religious beliefs, or, at least, to having a sense of meaning, or purpose in life. The books I’ve read about happiness often stress this feature too.

In one community, the main characteristic highlighted was their healthy, colourful diet; in another it was their commitment to regular exercise and in a third it was a genetic factor prevalent through close knit marriages. But all three shared this characteristic of feeling that life had a purpose, or rather that their individual lives were meaningful. How interesting that this is the one common feature – not something physical at all, but something social and cultural. Turns out the communities we live in are important after all – no man is an island!

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Francis Peabody of Harvard, way back in 1925 said –

The secret of the care of the patient is in caring for the patient.

I showed a group of medical students a video of a consultation I’d had with a patient. She had strong ideas about her illness and what she would or wouldn’t accept as a treatment. Patients with such clear and strong opinions are frequently viewed by doctors as “difficult” and sure enough the medical students didn’t like her. They admitted as much. Now, nobody can like everybody, and no doctor will be able to like all of his or her patients, so what’s important is that a doctor is self-aware and knows what feelings he has about a particular patient.

The physician’s internal state, his state of tension, enters into and strongly influences his clinical judgements and actions.

(How Doctors Think)

This is why I write this blog – to encourage people to become self-aware, for without self-awareness we cannot make conscious choices. Doctors have a special duty to be heroes not zombies. But let me say this, too, it’s not enough for a doctor to just be self-aware, if a doctor does not honestly care about his or her patients, then it’s time for that doctor to find another job. If I ever have to consult a doctor, I want one who, frankly, gives a damn! (about ME!)

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