Mental Health

Evidence-based medicine and complementary approaches for patient

Lesson 4

One of the most important debates on this topic is to do with the status of the evidence for the effectiveness of complementary and alternative therapies. However, whole question of what constitutes evidence is hotly contested and the disputes over it have a political as well as a 'scientific' dimension. 

Nowhere is this truer than in the field of complementary and alternative therapies. Its chief opponents argue that there is insufficient evidence for the effectiveness of many approaches. They are also less likely to be subject to regulation through enforceable national standards which would serve to protect service users.

For these critics of complementary and alternative therapies, 'evidence' normally means large-scale studies such as randomised controlled trials.

Such studies are consistent with an 'evidence-based' approach to medicine.

which has been defined as:

the conscientious, explicit and judicious use of current best evidence in making decisions about the care of individual patients.

(Sackett et al., 1996, p. 71)

The Department of Health has increasingly emphasised the role of evidence-based medicine in health policy.

Many primary care trusts argue that there is little reliable evidence for complementary therapies and there is considerable scepticism about them:

Some 40% of GPs are happy to recommend complementary therapies to their patients - indeed, 20% offer them on their premises.

But for every doctor who is on-side, there will be another who sees anything 'alternative' as so much hocus-pocus. Ask senior managers in the NHS about complementary medicine and you will probably be met with a weary smile. The new NHS, they will tell you, is about equity, evidence and accountability.

They will say that there simply isn't enough money to offer all patients complementary therapies, when in most parts of the country people still must wait more than a year for serious heart operations.

Then they will add that the evidence of efficacy for complementary medicine is still largely unsatisfactory, and that quality control and regulation are not good enough to justify the taxpayer forking out for it.

(Dixon, 2001, p. 41)

The NHS Confederation report (1997) on complementary therapies in the NHS said that the lack of information and evidence was among the main barriers to increased provision.

Supporters of complementary and alternative therapies argue that evidence does exist to show that some of the approaches can relieve symptoms of mental distress and help people recover, enabling service users/survivors to feel better without the adverse effects of conventional drug treatments.

Much of this evidence is drawn from first-hand accounts of service users/survivors who have experienced the benefits of complementary and alternative therapies, rather than from research based on larger-scale studies. It would appear, then, that people mean different things when they use the term 'evidence'.

An increasing number of supporters of complementary and alternative therapies argue the need for more funding for large-scale studies of their treatments, along the lines of a traditional evidence-based approach.

However, many also argue that the kind of research usually carried out when testing conventional medicines is not suitable for testing complementary therapies.

Holistic approaches depend a great deal on the interaction between the therapist and client, and this makes it hard to isolate the 'active ingredient' in the treatment from the context in which it is given.

The kind of alternative approaches to research advocated for complementary therapies involve the use of naturalistic or 'real-life' methods of carrying out research. 

These consider the ways in which therapies are conducted, rather than artificially standardising treatments. They also consider service users'/patients' perspectives on desirable outcomes.

One of the common criticisms of complementary and alternative therapies is that they confuse 'real' beneficial outcomes of the treatments they offer with the placebo effect, where the belief or faith in a treatment leads to improvement regardless of what the treatment involves. The importance of psychological factors such as expectations and attitudes in influencing the impact of treatments falls under the general description of 'placebo effect', which is defined as:


Placebo Effect

“The therapeutic impact of non-specific' or 'incidental' treatment ingredients, as opposed to the therapeutic impact that can be directly attributed to the specific, characteristic action of the treatment”.

(House of Lords, 2000, para. 3.19)

Placebos are commonly associated with that 'gold standard' of the traditional hierarchy of evidence - the randomised controlled trial. In drug research, for example, placebos are given to one group of people (the control group), while the drug that is being tested is given to the other group.

People involved in the research, both service users and researchers, are usually unaware of who has received the 'real' drug. This means that any differences between the two groups can be attributed to the 'active ingredient' of the drug rather than the placebo effect.

For many researchers within orthodox medical research, the placebo effect is regarded as a nuisance which hinders their research. It has generally been seen in negative terms and people who demonstrate this effect are often labelled within orthodox medicine as 'neurotic' (House of Lords, 2000).

The assumption has been that if the benefit of a treatment is shown to be 'psychological' rather than purely biological, then the existence of the illness or complaint in the first place should be called into question, or trivialised.

However, the placebo effect has also been found in relation to many health problems which are easily and 'objectively' measurable, such as blood pressure, angina, diabetes and some forms of cancer (House of Lords, 2000).

One of the most striking examples of the placebo effect was found in a study of arthroscopy This is an operation performed under general anaesthetic on people who have painful arthritic knees. It involves inserting a tiny camera into the knee joint in order to examine it, and then washing out the area to relieve pain.

In this study, the operation was performed as normal with one group of patients, while another group were only anaesthetised, and incisions made in their knee joints without any other aspects of the treatment. When these two groups were compared, both reported equal benefit from the 'procedure' they had undergone.

Rather than the procedure itself being of benefit, it appeared to be the knowledge of having had an operation and the belief in its likely effects that were most important.

Such research strongly suggests that the placebo effect should be taken more seriously and warrants more research, including within the field of complementary and alternative therapies:

(Ernst, 2000, p. I 135)

If research really showed that aromatherapy has no adverse effects and helps people through powerful non-specific (placebo) effects, the medical community should start seriously considering the power of placebos. 

The research question then shifts to how non-specific effects might be optimised so that more patients (not just those seeing an aromatherapist) can profit from them.

Even in this (worst case) scenario, research would yield clinically valuable information.

Complementary therapists are often good at giving patients individual attention, empathy and encouragement, which helps them regain self-esteem and hope. 

It may be that new disciplines which do not separate mind and body are needed to underpin research on complementary therapies.

For instance, studies on psychoneuroimmunology, a scientific discipline integrating psychology, neurology and immunology (Pert, 1986), have demonstrated that feeling better in oneself can positively affect the immune system and improve overall health.

The widespread use of complementary therapies in mental distress at an early stage is likely to help prevent problems getting worse.

They seem to be helpful in recovery from mental distress, although it is arguable that they are less useful in acute mental health crises, as they tend to require active participation by service users/cliants.

The aim of the following activity is to help you consider the potential benefits and appeal of complementary and alternative therapies for people experiencing mental distress and physical disabilities.

Some doctors have argued that there seem to be double standards in operation in relation to research into complementary therapies. 

Some conventional medicines are neither well researched nor understood, but this does not stop them being prescribed. 

Furthermore, some commentators (Goumay, 1997; Dimond, 1997) have pointed out that randomised controlled trials test treatments in artificial conditions and do not provide useful guidance for doctors working in real-life situations.

It has also been argued that there is not a level playing field for conventional and complementary therapies, as research funding is traditionally more easily obtained for conventional medical research.

However, things are changing. Late in 2002 the Department of Health's NHS Research and Development section invited applications for the Complementary and Alternative Medicine (CAM) Research Awards, available for both clinical and non-clinical researchers.

The CAM research scheme aims to develop research capacity and underpin the development of the evidence base in this field to clearly define the role and expected outcomes of these therapies.

There have also been developments specifically in the mental health field. In 2004 a national conference on mental health and complementary therapies was organised by the Prince of Wales's Foundation for Integrated Health in collaboration with the Alternative and Complementary Collaboration for Research and Development.

One of the main aims of this conference was to promote high-quality research into complementary approaches.