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Testing therapies

Updated Monday, 20th October 2008

Elaine Weatherley-Jones asks whether science can bring its demands for evidence to the world of complementary and alternative therapies

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When people decide to go and see a Complementary and Alternative Medicine (CAM) therapist, how do they make that decision? Do they weigh up all the available scientific evidence and come to a logical conclusion about what's likely to work for their particular problems or are there other reasons for choosing something outside mainstream medicine?

If people look for scientific evidence for CAM then they may well, at the moment, be disappointed to find that there isn't much information that tells them what CAM works for what disease or disorder. This is partly because, compared to conventional medicine, there hasn't yet been enough research to prove the effectiveness of treatments, but it's also because there are some difficulties in applying the methods of conventional medical research to CAM treatments.

There are a number of causes for this, of which three are most important:

  • The underlying systems that describe health and illness and inform the aims of treatment
  • The mechanisms by which treatment is believed to work
  • The nature of the CAM consultation which is acknowledged to have potential psychotherapeutic qualities in its own right

Firstly, CAM systems describe and treat health and disease in a fundamentally different way from conventional medicine. In conventional medicine, illness is seen as a breakdown of part or parts of a complex and sophisticated biomedical machine. Conventional treatment aims to return the dysfunctional organs or systems to a state of health by removing parts that are diseased or by providing drugs to fulfil a function that the body is failing to do, such as prescribing insulin for diabetes or antibiotics for a bacterial infection.

 

In contrast, CAM systems such as homeopathy, acupuncture and medical herbalism see illness as a reflection of a breakdown of the body's own natural self-regulating, healing systems. In homeopathy, the vital force is said to be responsible for maintaining health, combating disease by recruiting the body's natural tendency to cure itself. In the homeopathy model, disease occurs when the vital force is not working efficiently to keep the balance of health. In homeopathy, treatment is aimed at stimulating the vital force such that it is powerful enough to stimulate the natural healing powers of the body to overcome disease and restore health. In the Traditional Chinese Medicine (TCM) view, including Chinese herbalism and acupuncture, a balance between Yin and Yang forces is required to maintain health. The flow of qi (or chi) – an energy force – through invisible meridians in the body is said to maintain the balance of these forces and illness occurs when qi cannot flow properly through the meridians. In TCM, treatment is aimed at restoring the balance of Yin and Yang and getting the flow of qi working properly.

So, we can see that CAM views a human being as more than a collection of physical (and psychological) parts. As Stephen Gascoigne writes in The Manual of Conventional Medicine for Alternative Practitioners: "The essence of alternative medical thought is that there is a vitalistic principle behind and encompassing any physical object", explaining that "vitalistic" means that there are "objects which are non-physical in part or whole". The vital force of homeopathy and qi of TCM are non-physical – it's impossible to see them, no matter how powerful an electron microscope was used. Qi and the vital force are ideas that are put forward to explain how the body heals itself.

From the point of view of producing scientific evidence then, we have a problem – as we can't detect the qi or vital force using the usual scientific techniques, then we can't directly prove or disprove the existence of them. Some modern scientists reject such vitalist philosophies saying that they belong to the centuries before we understood the biophysical nature of disease and, now that we have this knowledge, such theories are redundant.

This may seem to leave us in a difficult position as far as testing CAM therapies and their effects on people, but even though we can't prove whether or not the underlying forces that restore health exist, we can test scientifically whether they have an effect on the body. For conventional medicine, it is possible to describe precisely how the medicines act on the body's cells, nerves, organs and systems; for CAM we can only look at the effects that the vital force or qi have on these indirectly by seeing whether the treatments cause changes in cells and structures of the human body.

In 2004, Iris Bell and colleagues, in an article published in the International Journal of Neuroscience, described research that showed that the alpha brain waves in people with fibromyalgia (a painful disorder of muscles) were changed by homeopathic medicine. In 2004, Joos and colleagues, reporting research in the journal Digestion, studied patients with Crohn's disease (a painful, inflammatory disease of the digestive system). They found that lab tests of the guts of people treated with acupuncture showed there was less inflammation in their digestive systems than in the people who had dummy acupuncture.

As well as looking at the physical effects of CAM on people being tested, the effects of CAM can also be tested indirectly by literally looking down a microscope at the effects of treatments in a test tube, rather than a human body: a number of researchers have looked at what are called "ultra-high dilutions". These are solutions in which the substance that was originally dissolved has been diluted so much that there is unlikely to be anything of the original substance left in the solution. Homeopathic medicines are made in this way and sceptics claim they can't possibly have any effect because they're so diluted.

Despite this, when Belon and his colleagues reported research in 2004 in the journal Inflammation Research, they showed that ultra-high dilutions of histamine (which is a protein involved in allergic reactions and causes, for example, inflammation of the breathing tubes in asthma) are active in influencing human cell activity.

Although their research was not on homeopathy directly, it shows that the types of dilutions used in homeopathic medicines can still be active despite appearing to have been diluted out of existence. So although it's possible to show that homeopathy and acupuncture have effects on the body's cells we cannot show exactly the means by which this works when a person takes a homeopathic medicine, a TCM herbal medicine or has acupuncture.

What other methods does science offer us to look at CAM treatments and are they a suitable way of looking at CAM and its effects? One of the most excellent tools of medical research is the randomised double-blind controlled trial (RCT).

In the field of medical research RCTs are intended as a fair comparison of different treatments. They can be used to test a new drug and to see whether it's any more effective than a dummy pill by giving some people a dummy pill and others the real pill (without anyone apart from the researchers knowing who gets what) and seeing if there's any difference between groups of people in terms of who gets better. The RCT is known as the "gold standard" of medical research and has allowed many thousands of new drugs to be tested.

So can we apply this gold standard test to CAM? This would at first seem a very obvious and useful thing to do – compare people who get real acupuncture to people who get "pretend" or dummy acupuncture, or compare people who get real homeopathic medicines to people who get identical, but completely inactive, placebo pills. Some people do use this method to study the effects of CAM, but people who are knowledgeable about the CAM practices themselves, both practitioners and researchers are concerned about the placebo RCT and challenge whether it's really testing the treatment.

This is because of two major features of CAM therapies – firstly that each person treated has a different treatment – treatment isn't determined by the name of the person's disease, but rather by how that person is showing disturbances in the vital force, or the qi. The second major problem for doing the placebo RCT in CAM is that most CAM consultations are lengthy and people talk at length and in depth about their problems. Recently, Cartwright and Torr reported in the Journal of Health Psychology what other researchers have also been finding about people who go to CAM practitioners - that the patient-practitioner relationship is important and central to the healing process.

This is particularly true in cases of chronic, or long-standing, disease. Of course, this is also true of conventional medicine, but researchers are finding that there's something different in the CAM consultation. Many people with long-standing problems turn to CAM because mainstream medicine doesn't have any answers to their problem, or because they're not happy at the thought of taking prescribed medicine for a long time, possibly the rest of their lives. Once people have begun to consult CAM practitioners, they may find that they change their views of health and illness and find that the wider benefits they experience from the process of having treatment is more important than whether the treatment worked for their original problem.

When we turn back to the question of whether we can research CAM using the scientific tool of the placebo RCT, we're faced with the problem that it's very difficult to tease out the effect of the consultation from the medicine: the consultation affects the extent to which the specific treatment works and when the patient goes back for a follow-up treatment, the nature and content of the consultation will be affected by how the specific treatment acted on the patient.

So the two parts of CAM – the characteristic effect of the acupuncture/homeopathic medicine/herbal medicine and the incidental effects of the patient-practitioner relationship (that is so valued by patients) are inextricably linked in most cases of long-standing disease. Trying to use the placebo RCT to scientifically study them means that, because we can't factor out the 'placebo effect', we end up with results from research that are difficult to interpret or are misleading in their conclusions.

Initially, this seems to leave us in an unsatisfactory position in terms of applying scientific methods of study to CAM – it's not possible with conventional science to test whether the underlying principles exist and we can't use the best tool of modern medical science to test whether, in a real-life treatment situation, the treatments are better than a 'placebo effect'. It is some consolation that we can test whether the treatments have an effect on the body's cells and systems. Is there any other science that will help us test CAM and come up with some satisfactory answers?

Yes! One way to do this is, rather than use a placebo RCT – which is essentially asking the question "Is the treatment better than placebo?" – we can compare two treatments – compare acupuncture to routine GP care for lower back pain and see whether one's as good as the other. This asks a different question: "Which of the two treatments is better?" and this may well be a question that's more relevant to patients, acupuncturists and doctors than whether the treatment is different from a placebo effect. Another way that science can ask questions about CAM is to use the methods from medical anthropology, psychology and sociology to understand what's going on not only in the outcomes of treatment, but also the processes that happen in the consultations and between them.

We can then understand many things about these processes including what's important to people about the experience of having CAM, how this is different from conventional medicine and what impact this has on whether they get better. Researchers are already working in these fields and results of such science will help us devise more sophisticated clinical trials of CAM.

For example, researchers in Wisconsin (Barrett and colleagues) interviewed patients who'd had CAM treatments and asked them about the experience. Patients told them they liked the more holistic approach of CAM and felt more powerful in terms of decisions about treatment and controlling their own lives than with conventional medicine. Other research, by Thorne and colleagues, has found that for some, CAM is seen as part of people's self-care and taking personal responsibility for their own health, especially for those with long-term problems.

Scientists using MRI scans of people undergoing acupuncture treatment have shown that the principles of Traditional Chinese Medicine (TCM) acupuncture are backed up by modern science (Parrish and colleagues): according to TCM acupuncture, stimulation of specific points is part of the treatment for problems in areas of the body that are apparently unconnected.

For example, stimulating a TCM point "BL60" can be part of the treatment for visual problems. BL60 is on the outside of the ankle. Using functional magnetic resonance imaging (fMRI), scientists have shown that putting acupuncture needles in BL60 does indeed stimulate that part of the brain that is to do with visual functioning. Putting acupuncture needles in other points (eg Spleen 6, which has nothing to do with treating visual problems) doesn't alter the visual functioning part of the brain.


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Updated October 2008 to correct the reference to histamine in the plural.

 

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