The Royal Society of Edinburgh is pleased to respond to the House of Lords Science and Technology Committee request for comments on Complementary and Alternative Medicine. The RSE is Scotland’s premier learned society, comprising Fellows elected on the basis of their distinction, from the full range of academic disciplines, and from industry, commerce and the professions. This response has been compiled with the assistance of a number of Fellows with experience in this area.

It has been estimated that up to one third of people in the UK resort to alternative medicine at one time or another and while the reasons are many, there are two that are pertinent. Firstly a general distrust in Science and as a consequence a lack of belief in orthodox scientific medical practice. Secondly dissatisfaction and impatience with the family doctor who, sometimes, cannot provide the time for consultation and support required by many of the public. Alternative medicine, therefore, appears to offer some solution to both.

While many of the therapies listed under the Committee’s definition of complementary and alternative medicine are based on superstition it should be recognised that, prior to the early nineteenth century, the drug arm of conventional medicine was entirely herbal. Thus, the Royal Botanic Garden in Edinburgh was founded as the source of herbals for the Royal Infirmary. The use of animal extracts in medicine has equally travelled the road of starting with impure preparations (e.g. thyroid and adrenal gland extracts) and work on antibiotics is probably the most notable example of the success of this approach in this century. The distinction, therefore, between conventional and alternative medicine is often overemphasised and, in some cases, the former largely represents a developmental progression of the latter.

The specific areas of consideration are addressed below:

Evidence What is the role of patient satisfaction in evaluating the effectiveness of complementary and alternative treatments, and in determining availability? Do all medical and health care interventions have to be backed by the evidence of controlled clinical trials and by orthodox scientific thinking?

Patient satisfaction is clearly of critical importance in evaluating the effect of any treatment - conventional or orthodox. However, patient satisfaction can be measured and in the field of allergy and asthma there are a number of validated "quality of life" questionnaires. More generally, in social sciences there is also a substantial body of published material on critically assessed and proven methods for assessing personal satisfaction and ‘quality of life’. Unorthodox/unconventional practitioners could readily use these instruments to evaluate patient satisfaction scientifically.

It is well known that the suggestion, especially by a doctor, that a particular form of treatment is effective can be very powerful, especially where injections are involved or where the supposed benefits are reinforced by a caring physician who has built up a strong personal relationship with the patient. This remains the principal argument for insisting on the double-blind placebo-controlled trial for evaluating a new drug or treatment. The placebo effect is often very strong, a good example is with controlled trials of chronic asthma where patients receiving placebo treatment invariably improve, but only for a short period of time. This placebo response represents a true biological phenomenon, possibly mediated through links between the central nervous and immunological systems. Claims which are based on the placebo effect must not be used as evidence of the value of a particular form of treatment. The need for vigorous validation of a medical advance applies equallyto diagnostic procedures. These, like new drugs, require scientific validation. Diagnostic techniques must be reliable and reproducible even when they are carried out by independent operators at different times in different places.

Although practitioners of alternative or complementary allergy treatment may work from a different theoretical perspective, there is a growing recognition that the evaluation of their work can and should include clinical trials comparable to those required by conventional medical and veterinary practice (particularly with the development of agencies such as the National Institute for Clinical Excellence (NICE) and the Scottish Health Technology Assessment Committee (SHTAC)). In conventional medicine credibility is only achieved when there are consistent confirmatory reports by physicians and other investigators, i.e. not just those investigators who are themselves committed advocates of the treatment method. If double-blind trials cannot be carried out, biochemical tests or other methods of assessment should be developed and validated. Positive findings in diagnosis or therapy should always be repeatable by other clinical scientists. Proper drug evaluation ensures that correct doses can be identified, clinical effectiveness monitored and side-effects rapidly identified. Therapeutic drugs all come with appropriate warnings and advice regarding their safe use. This applies particularly to pregnancy and childhood.

Information What are the best sources of information for patients and doctors regarding complementary and alternative medicine? Is it desirable or possible to control the quality of public information available on such treatments?

There are many sources of information for doctors regarding complementary and alternative medicine. For example, the British Medical Journal (BMJ) is running a series of articles on complementary medicine which will be published as a book in spring 2000. It is more difficult, however, for patients. They are overwhelmed with media articles and the information is inconsistent and confusing. Although there is a case for controlling the quality of public information it is difficult to see how this can be achieved, especially with the development of the Internet. It is also questionable whether this is desirable in a free and pluralistic society.

Unsubstantiated claims, however, should not be permitted and the public should not be exposed to uncontrolled advertising. There is evidence of aggressive advertising by some manufacturers of alternative medicine, with products marketed deceptively on many occasions.

Research Should research funding for evaluations of complementary and alternative medicine be increased? If so, where should the extra money come from? What types of additional research would be most useful?

There should be more research of complementary medicines (and in particular traditional Chinese medicine) to seek more evidence of their efficacy and safety. However, money for such research should not come from the already limited budget available for research on conventional therapies or training. The major pharmaceutical companies may also object to extensive public funding of trials since they spend millions on comparable research and development on orthodox medical products.

Before deciding what types of additional research would be most useful it is essential that conventional and alternative practitioners agree on research protocols and approaches. In the allergy field it has been shown that evaluation of alternative treatments by conventional practitioners has failed to resolve critical issues, and evaluation of alternative treatments by alternative practitioners has been criticised for lack of stringency. For example, in the USA in 1992 Congress established within the NIH an Office on Alternative Medicines to evaluate alternative remedies. In 1993 the Office gave 30 research grants, but only nine of these resulted in published material and five of these nine were in journals which the US Library of Medicine did not recognise. Nevertheless, there is no reason why such research should not follow the same principles as research into conventional therapies. Researchers at the Glasgow Homeopathic Hospital have pioneered an approach and published their results in journals such as the BMJ and Lancet. This approach is to be applauded.

Training Should the increased interest in complementary and alternative medicine be reflected in medical training and training of other healthcare professionals?

If treatments are found to be useful by accepted methods of validation then they will become part of medical orthodoxy and bring with them their own training programmes. Until this can be done, it is unlikely they will have a formal place in already overcrowded medical and veterinary curriculum. If such courses are developed, however, they should be validated nationally. In addition, if a practitioner wished to learn and practice a particular form of alternative medicine it should be possible for this to be obtained from an appropriate college or institution through a nationally validated post-graduate study.

Regulation and risk Are there areas of complementary and alternative medicine where lack of regulation causes unacceptable risk to the public? Are there practicable forms of regulation that would provide protection without unduly restricting patient choice?

Regulation is important. If a claim for use and efficiency is made (e.g. on a label or in accompanying literature), then the failure of a treatment could harm patients with certain conditions unless an effective treatment is substituted, and introduced, early in their condition.

In addition, in some herbal medicines ignorance concerning the correct dose, often compounded by a lack of knowledge about chemical composition and the unavailability of any antidote, means that ingestion can be hazardous (especially for children and during pregnancy). In acupuncture, the haphazard placing of needles can also be potentially dangerous. For example, the point ‘Gall Bladder 21’ is close to the dome of the pleura and those unwary of human anatomy may cause a pneumothorax. Its has been suggested that acupuncture should only be practised by those qualified in medicine, or trained in human anatomy.

When considering the standards which need to be applied to medicines there are two important considerations: (i) What is in the preparation? (ii) Does it actually help defined diseases or symptoms? In terms of the composition of a preparation, it is not unreasonable to require that alternative medicine show and state the content and potency of what it administers (e.g. through some form of bioassay), especially for extracts that contain potentially toxic components. In terms of effectiveness, if a claim for use and efficiency is made, then the alternative medicine should be required to demonstrate efficacy and to test safety in similar fashion to that demanded by the Committee on Safety of Medicines.

In addition, the Committee might consider whether or not appropriate insurance should be mandatory for alternative practitioners. This would allow financial recompense by patients for potential damages incurred.

NHS provision Should public healthcare attempt to integrate elements of complementary and alternative medicine into the mainstream of healthcare? How might this be done? Should access to complementary and alternative treatment through the NHS be limited to those areas that have (a) an established evidence base and (b) formal regulatory systems, and can minimum required standards of evidence and regulation be defined?

Access to complementary and alternative treatment through the NHS should be limited to those areas which have established predefined standards of evidence and formal regulatory systems. A Working Party could be established to define the standards of evidence and regulation required.

Some complementary and alternative medicine is already provided by the NHS in some areas, for example some types of counselling and stress therapy are provided by clinical psychologists under the NHS; many physiotherapists offer acupuncture routinely on the NHS and homeopathy has been provided in Glasgow (and the West of Scotland) through an NHS service.

Further information is available from the Research Officer, Dr Marc Rands