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Alternative therapy - what the doctor ordered?

Financial Times, 21 May 2005

If 30 years ago you had told a friend you were seeing a homeopath about your chronic fatigue, depression or eczema, chances are that you'd have been thought dangerously eccentric. Twenty years ago, you'd have been seen as crazy, desperate, or both. Ten years ago, your friends might have smiled benignly at your free-spirited hippy tendencies. And now? Nobody would turn a hair. In fact, your friends are probably doing it too. In seeking out an alternative medical answer, you'd be up there at the height of fashion.

We are embracing complementary and alternative therapy as never before. A recent report from the US Institute of Medicine found that a third of Americans routinely use complementary or alternative medicines (therapies outside mainstream medicine used either alongside or instead of orthodox treatment), spending over $27bn in the process. In the UK, marketing companies estimate that between a quarter and a half of UK adults have used alternative therapies within the past year. During my work as a GP, patients tell me daily how herbal remedies have helped with stress or headaches - so the complementary message is not lost on doctors either. It is estimated that 20 per cent of GPs' practices offer some form of complementary medicine and medical schools are increasingly including such medicine in the undergraduate curriculum.

Indeed, the NHS has even gone so far as to employ a "healer" who practices reiki - in which the practitioner claims to channel energy into the patient by placing their hands on specific parts of the body - at the paediatric oncology ward at Middlesex.

But many enthusiasts for complementary medicine express frustration that doctors are not embracing alternative practice more. Prince Charles, a long-standing supporter of alternative therapies, has issued via his Foundation for Integrated Health a booklet to all GPs in Britain, urging us to open our minds to what complementary medicine can achieve.

Many conventional medics remain sceptical, even hostile. Why? It is true that there have been warnings about potentially serious side effects from certain Chinese medicines and that St John's Wort can interact adversely with medication such as the contraceptive pill - but there is very little evidence that complementary medicine does any harm. In any case, many conventional medicines produce side effects and we accept those.

So if patients are not put at risk by turning to alternative treatments, feel that they benefit from them and, what's more, pay for them from their own wallet, what is the problem? Are we doctors simply guilty of being too territorial? Worse, does this mean that we are failing to listen to and believe the testimonials of our patients?

All of which leads many to ask: is 21st century medicine simply too hung up on having scientific proof that a therapy works before doctors will prescribe it?

The standard of evidence that modern medicine has come to expect is indeed high. The gold standard is the randomised, double-blind controlled trial. It is simple but deadly in its ability to sort therapeutic wheat from chaff. Patients are randomly divided into two groups, which should be as closely matching as possible. One group is given the active compound; the remainder is given a placebo: either an identical-looking sham treatment, or an older treatment, for comparison. The "double blind" refers to the fact that neither the patient nor the doctor knows which "treatment" the patient is receiving. The outcomes are then measured, the treatments revealed and conclusions drawn, published and debated.

Clinical trials may seem a simple enough concept, but only in recent decades has evidence-based medicine - the need to prove that treatments work - become the norm. There have always been efforts to do clinical trials, such as James Lind's work, published in 1753, on the role of fruit in preventing scurvy, but in the main, medics rarely felt the need to rationalise treatment in this way. Before evidence-based medicine became a buzz phrase, doctors based their decisions on a mixture of conventional wisdom, personal experience, instinct, sporadic teachings, unusual cases remembered and the drugs and equipment to hand. "Why bother to prove it?" went the unsaid philosophy. "We know this way works."

It often didn't, however, and thankfully, medical practice today has abandoned many of the procedures that used to be a matter of clinical routine. Frontal lobotomy, for example, was performed globally tens of thousands of times in the decades following the second world war. A device used to break ice was hammered into the skull through the roof of the eye socket: it was then swung to sever the prefrontal lobes of the brain. It was a brutal operation, performed for a variety of mental illnesses - and it didn't work.

With the operation commonplace, some became sceptical. The Columbia-Greystone project was set up in 1947 to assess the outcome of lobotomies: they concluded that about a third of those operated on improved. However, this was the same number as could have been reasonably expected to improve through time and chance alone. Additionally, the surgery was also shown to cause harm to the emotions and personality. It was subsequently abandoned and no one misses it.

Blood-letting nowadays is only done for a rare type of iron overload, hemochromatosis. However, in the 19th century, it was used as both a preventative and a cure for most ills, including fever, pleurisy, gout and "madness".

When the patient felt faint and had a weakened pulse afterwards this was viewed as a sign of improvement - as the "bad blood" was let out - rather than a side effect of the "treatment". It took years before it was realised that those who had been "blood-let" were far more likely to contract infections and die than those who had not.

Similarly, grommets, tonsillectomies and hysterectomies were the typical grist of surgical lists just 20 years ago, until studies proved there were more effective, less invasive treatments. These operations now make far fewer appearances on operating list schedules. Finding that things do not work can be as valuable as finding that things do.

In my field of general practice, evidence-based medicine has brought marked changes to my day-to-day work. Fifteen years ago, people suffering from back pain were recommended to see it out while lying flat on a stiff board. Strong evidence from random clinical trials has shown that this was actually harmful. We now advise people with low back pain to stay as mobile as possible. Instead of dishing out penicillin at the merest sore throat, we now know that antibiotics are, in the main, useless for it.

And it is not just conventional medicine that has been diligently researched. There has also been good evidence from random clinical trials for complementary therapies. For example, cranberries are often cited in folklore as good for treating cystitis. To test whether they were truly effective in treating urinary infections in women, a study was set up. To make the trial a double blind, both the people taking part in it and the people running it would have to be unaware of whether or not the patients were getting real cranberry juice.

So the manufacturers made a drink coloured and flavoured exactly like cranberry juice - but without any real cranberry juice in it. The study concluded that regularly drinking 300mls of cranberry juice cocktail a day resulted in a reduction in urinary infections of about half, and similar results have since been reproduced. So conventionally trained doctors like me now recommend cranberry juice to women.

There have been numerous studies published on the effectiveness of St John's Wort, a herbal remedy for depression. It appears to work at least as well as the selective serotonin re-uptake inhibitor class of antidepressants for mild, moderate and, most recently, moderate to severe depression. So I usually offer that as a choice to my patients.

Similarly, pain clinics routinely use acupuncture for certain treatments when typical doses and types of painkillers have failed to make much of an impact. Nursing homes use lemon balm aromatherapy oils, because high standard trials have shown they reduce agitation and improve quality-of-life scores for their patients.

When I recommend a seemingly "alternative" option like this, I know I am recommending something that has at least some proof from clinical trials, and which passes the essential, basic test: the risk of harm has been examined and found to be clearly outweighed by the potential gain. But recommending such remedies hardly makes me a New Age hippy of a GP. Really, as soon as a treatment, whatever its provenance, is proven like this, it becomes mainstream and "alternative" no longer. Think of aspirin, derived from the willow tree, or digoxin from the foxglove.

That's all very well for the alternative therapies that have achieved the gold standard, but, our critics would say, what about the rest?

Although there have been many studies of complementary medicines, there has been nothing like the volume dedicated to orthodox medicines. Funding for trials is patchy; with Medical Research Council grants being limited, charities are relied on to step into the breach. Less glamorous research may fail to find enough cash. So, many of the studies into complementary therapies fall short of the conclusive gold standard.

Feverfew, for example, looks promising as a migraine preventative, but the studies done so far are not of sufficient power to allow us confidently to recommend it.

However, alternative therapies are an increasingly popular option for patients where conventional medicine has failed, produces unacceptable side effects or simply is not trusted. If the treatments work for the patients, is scientific proof strictly necessary?

Dr Bob Leckridge is a doctor who has decided to trust, as he says, what he sees with his own eyes. He was a conventional GP before deciding to train in homeopathy. He now works full time as a homeopathic physician in Glasgow Homeopathic Hospital.

"What convinced me was the personal experiences of my patients, who would come back and say that the homeopathic remedy worked for them: I had something to give patients for whom you would worry about side effects - for example babies or pregnant women. I make a pragmatic choice in using homeopathy and I have seen things - improvements in disabled children's lives when they have used homeopathy - that I can't otherwise explain."

Dr Leckridge says that audits done in homeopathic hospitals show that two-thirds of patients say that after homeopathy their condition "has improved to the extent that it has made a difference in their daily lives".

However, it is not clear whether it is the homeopathic remedy or the nature of the doctor and the process of the consultation that actually makes the difference. One way to test this would be to randomly divide half the patients seen in the homeopathic setting to either a homeopathic treatment or placebo, where neither the doctor nor patient knew which was which. An analysis of outcomes would then show whether the remedy or the process of the consultation had made the difference.

Dr Leckridge is not aware of any studies so far of this nature. However, he says, “the real issue is that it is about what you choose to measure. We use randomised controlled trials to support intervention by looking for a small change in tissue, or biometrics, but I don’t think that the evidence will ever be that strong for homeopathy.

"If we can ask if the patient is healthier in their daily lives as a result of treatment, then that would be more useful. For example, we know that there are studies which show that tests of lung function (in patients with chronic bronchitis) don't always correlate with quality-of-life scores. This says that there is more at work than just drugs. The thing about randomised controlled trials is that you can't control for human factors - because of course it matters about [the patient's] reaction to the therapist."

Professor Edzard Ernst, at the Peninsula Medical School, which has bases in Devon and Cornwall, is the UK's only Professor of Complementary Medicine. He thinks that proven complementary medicines should have a place in the NHS. But, he says, "the fact that some people [who practice alternative therapies] say that complementary medicines can't be tested is rather significant.

"Homeopaths pride themselves on positive, randomised controlled trials but shoot holes in the methodology when they don't agree with the outcomes. Nobody says that the method of randomised controlled trials are perfect, but I have yet to see something better. Even claims that homeopathy defies the clinical trial altogether - in my view this is incorrect. You can always divide treatments into one or another for testing, even the type of trial where you only need one patient is tedious, [when a single patient is assessed before and after a treatment] but it is valid. In general, if complementary medicines have an effect, they also have fewer side effects than orthodox treatments. However, they have less effect on disease overall."

When patients say they have benefited from alternative therapies, might they just be responding to the placebo effect? Professor Ernst says: “In research, the placebo effect is simply a nuisance. But in clinical practice, it is effective and there is nothing wrong with a practitioner maximising the effect - but I would never advocate lying to a patient or using something that was only a placebo, with no known active effect. The important point is that all treatments generate placebo effects. So we don't need placebos to profit from the placebo effect."

So if the placebo is good enough, why bother searching for scientific proof of the remedy itself? If complementary therapies can make us feel better and improve our quality of life - shouldn't we just do it? It's a seductive line of argument, but to take that attitude would be to go back to the dark days of blood-letting. Evidence-based medicine is a huge advance; the advance not merely of scientific rationale over self-belief, passion and simple good intentions - but it is also a retreat of ancient medical arrogance. We doctors have been forced to accept that things we thought were "common sense" were not.

It has long been known that after a heart attack, death can be caused by the heart going into abnormal rhythms. So it is common sense to use protective, anti-arrythmic drugs? Wrong. Sir Iain Chalmers, now editor of the James Lind Library, calculated that in the US between 20,000 and 70,000 lives were lost in the late 1980s because a certain type of cardiac drug, such as Lorcainide was used. Instead of saving patients, it was killing them.

Champions of alternative medicine often accuse conventional doctors of arrogance, because we will not listen to our patients and embrace more of those treatments for which there is anecdotal but not scientific evidence. However, our resistance stems from the fact that we have had to learn to be humble in the face of proof. That is a lesson that some alternative practioners still have to learn.

I will continue to recommend complementary therapies - but only those which are proven. My hope is that the division between orthodox and complementary medicine will one day be erased. But that will only come about if alternative medicine evolves in the same evidence-based way as orthodox medicine has - rightly - been forced to.


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