The Other Medicine: Programme Two

FORD
These stories of apparently miraculous cures come up again and again from patients who have responded dramatically to a CAM treatment. And until recently experiences like this were ignored by researchers or dismissed as anecdote not evidence, but do they have to be mutually exclusive ?

Research-practitioner George Lewith thinks not, and that more emphasis should be placed on patients' stories if we're to better understand the subtleties that might govern if and why a therapy is working.

LEWITH
One of the questions which would be very relevant to ask is what is it about complementary medicine that you really value? What is this subtle thing that you're telling us and how can we measure it? Maybe they value the process of having somebody sympathise with them about their pain. Maybe they value the process of being cared for. Maybe they feel something is being done. Maybe it's more subtle than that, maybe their pain may not be getting better but there maybe something very subtle about their wellbeing that's getting better. Because this is a kind of general phenomena.

FORD
And yet you can see that your critics would take that up and say well this is so airy fairy, even the patients don't know, they just say well I feel a bit better, yet it isn't scientific at all.

LEWITH
Well if you've got a proper diagnosis and you're dealing with a benign condition and you don't have an acute remedy or a competent conventional treatment to offer and you can make your patients better then that's a pretty good treatment really. There's lots of homeopathy being sold in the shops, you can walk into any high street chemist you get homeopathy. The evidence for homeopathy in clinical trials is a bit flaky and it's probably more positive than negative but it isn't strong.

FORD
But the dissolution of a substance in so much water that it doesn't exist anymore, which is what homeopathy seems to be, is very questionable presumably - scientifically.

LEWITH
It's scientifically very questionable because we don't have a mechanism but we have lots of people buying homeopathic remedies, lots of people saying that they feel much better on it and these often aren't stupid people. So what's happening? They're perceiving a benefit which we're picking up in our studies but we're finding very difficult to demonstrate in clinical trials.

FORD
This patient-centred approach to research isn't new but it's still rare says Iain Chalmers, who fears that research questions need to address the needs and concerns of the patient, as much as those of the researcher.

CHALMERS
Researchers left to themselves sometimes address questions which aren't important to patients and even if they choose a question which is important to patients they may not address it in a way that's helpful to the patients at the end of the line. One example is some comparisons of epidural analgesia during labour - pain relief during labour - with alternatives to epidural analgesia where out of about 12 trials only two asked women what pain they were experiencing during their labour and the researchers were into measuring things to four decimal places in the urine and in their blood.

FORD
It sounds quite extraordinary that they could actually overlook that this might be happening to a patient who happened to be a woman.

CHALMERS
It's quite extraordinary and that's why I think it's quite important for patients themselves to help researchers design better control trials, better research, asking sensible questions, important questions, regardless of whether those questions are of any interest to industry or not.

McPHERSON
If we do artificial treatments then there's a very high risk we're going to show no effect. But if we trust practitioners and set up a trial that is modelled on good acupuncture then those risks are minimised.

FORD
Many CAM practitioners view researchers with scepticism and more than a little suspicion. But acupuncturist Hugh McPherson, who worked with scientist Kate Thomas in Sheffield, says practitioners have to get involved in order to ensure that research is based on therapies as they are practised in the real world.

McPHERSON
Real practitioners, everyday practitioners, need to be involved in research in order to set the agenda and to argue for the sort of acupuncture that we do, rather than sit back, see other people doing research and of course there are a lot of people who have not very much idea about acupuncture, if we set up acupuncture trials because they perhaps have accessed a patient or they have a particularly good idea - Oh why don't we try acupuncture for such and such. And I think it's much better for us as practitioners to be involved because we can help guide which conditions we should be targeting first, how to treat them and set up a trial design which is going to show the sorts of benefits of our treatments.

THOMAS
It's a big risk for these practitioners. The back pain trial we were doing with acupuncturists was probably three months into the beginning of the trial when Hugh McPherson turned to me and he said - This trial might not show that acupuncture works. And it was the first time it had really hit him that it might not because like other practitioners they believe in what they do. And it struck me then at that point what a big risk people are taking to be involved in these kind of trials and I'm full of admiration that they do so and I think it's just important that they understand that if people from outside - like myself - or researchers are going to come in and evaluate what they're doing that we're going to evaluate it in its optimum form, as it's practised by them in its best form and the measures that we're going to use are ones that feel appropriate to them. And so they feel it's been a fair test because that's all they're asking for at the end of the day. I don't think they're against having what they do tested, I think they're very wary of it not being a fair test.

FORD
How you carry out a trial in complementary or alternative medicine is one part of the story. What happens with the results is another.

SMITH
With medical research you can get anything published, there are so many journals and have been for a long time. Nobody knows exactly how many there are but there's probably something like 15 to 20,000 and you - to be honest you can get any rubbish published, you just go down and down and down and down the food chain, as we call it.

FORD
Where a study is published doesn't just confer prestige but these days can also influence further funding of more studies. Mainstream medical journals are not exactly awash with CAM papers but an increasingly steady trickle appear in publications like the Lancet and the British Medical Journal, where Richard Smith was until recently, editor.

SMITH
My impression is that we have many more studies of complementary medicine submitted to us, that probably 10 to 15 years ago we got hardly any, whereas now we might get 20, 30, 40 a year, we get about 8,000 papers a year submitted to us, so it's still a comparatively small proportion of everything that's submitted. So I suppose we get about 30 or 40 a year, we probably publish 5 to 10 a year. We know that our readers are very interested in complementary medicine, although there are some of them that continue to be strongly biased against it, there are many more who want to be open-minded on the subject. A point I think it's important to make - I do feel there's sometimes a bit of a Catch 22 for researchers in complementary medicine because orthodox practitioners say to them you need to do research to establish whether your treatments work but then it can be very difficult to get the funds to do the research. But without funding and without professional support it can be difficult to do good research and good trials.

ERNST
If you cost clinical trials in complementary medicine they come out very often more expensive than in conventional medicine. For instance, if you do a trial with acupuncture you need acupuncturists and you need repeated treatments and it's rarely possible to do a trial under say £200,000 and that's a lot of money in complementary medicine. We've actually surveyed what medical charities dedicate to complementary medicine and what indeed the NHS dedicates towards research of complementary medicine, in both cases it's far less than 1%. Compare this with 25% of the population using it this is dismal, this is very disappointing.

FORD
In spite of the cost, thousands of studies have been published on a wide variety of treatments, in a range of journals. And yet for every study that says one thing, another seems to say the exact opposite. But then why should CAM be treated differently from the rest of science? There may be as, Edzard Ernst suggests, only room for a scientific approach when it comes to doing a trial, but interpreting the data is still controversial. More opinion than fact.

However, there's another shadow looming over the growing mountain of research papers. And that's the question of mechanism. Sooner or later, says Kate Thomas, when enough papers conclude that something does work, it still leads to the even bigger question - how does a therapy work? It's a scientific odyssey that has created and destroyed careers and is something we'll explore more closely in next week's programme.

THOMAS
That's the challenge for the scientific community really - how far do we need to know the precise mechanisms of action before we can accept the evidence that they seem to be working? And I suspect we're in for a bit of a challenge. The more we use conventional methods and demonstrate that complementary therapies are working and giving benefit the more we'll be called upon to answer the question about how and why.

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