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RCP/NCCAM

Can alternative medicine be integrated into mainstream care?

The issues surrounding the integration of complementary/alternative medicine (CAM) into mainstream medicine were explored at a conference on January 23 and 24 organised by the Royal College of Physicians of London )RCP) and the National Centre for Complementary and Alternative Medicine (NCCAM) at the United States National Institutes of Health. The conference, the second on CAM to be organised by the RCP, was held at the RCP's headquarters in London. Jo Barnes (teaching and research fellow, School of Pharmacy, University of London) reports on the highlights of the two-day meeting

CAM
Teaching CAM
Regulating CAM
Researching CAM
Clinical evidence for CAM
Royal support
Life after the Lords report on CAM

CAM

Discussing United Kingdom medical perceptions of complementary/alternative medicine (CAM), Dr GEORGE LEWITH (University of Southampton) said that several studies had shown that marked proportions of UK doctors used CAM for their patients and/or made referrals to CAM.

He had surveyed members and fellows of the RCP to determine their use of CAM. Because of a low response rate (23 per cent; n=2,875), the results needed to be interpreted with caution, but nevertheless, 32 per cent of respondents practised CAM and 41 per cent referred patients to CAM.

CAM practice and referral appeared to be similar in private practice and in the National Health Service, and was most common in palliative care and pain. Female respondents had more positive attitudes to CAM than did male respondents. Overall, respondents thought that more evaluation of CAM was required, that CAM was not just a fad, that CAM should not be available on the NHS, and that it was not necessarily important that physicians knew about their patients using CAM treatments.

There was a distinct level of practice of CAM among hospital physicians, and this required an undergraduate and postgraduate educational strategy.

Development of NCCAM

The NCCAM had been developed in response to public need, said Dr STEPHEN STRAUSS. The main reasons why health maintenance organisations in the US added CAM treatments to the care available were that members and employers requested it and law or mandate required it. Clinical effectiveness was a less important reason, which suggested that politics and finance made decisions about CAM use rather than proper health care policy.

The NCCAM's mandate was the broad one of conducting basic and applied research and providing research training in CAM therapies. The funds allocated by the US government to NCCAM were rapidly increasing and were around US$90m for this fiscal year. Strategic areas for NCCAM were investing in research, training CAM investigators, expanding outreach and facilitating integration. The aim was to integrate those therapies that were proven safe and effective and which could be professionalised.

There were, however, several challenges to a CAM research enterprise. Examples were a lack of product and practice standards, the complex and global array of treatment modalities that made up CAM, a lack of scientific tradition in CAM, and a shortage of competent investigators. The conventional approach to research was “molecules, mice, man”, but in CAM, treatments were already being used and a different strategy was needed. The NCCAM's research priorities were closely linked to those of the NIH, such as, cancer, degenerative diseases, and women's health.

The NCCAM had several centres of excellence, including centres that focused on preclinical and clinical research with botanicals (herbal products) to explore their constituents, mechanisms of action and therapeutic effects. For example, researchers at Johns Hopkins university were investigating the effects of PC-SPES, a combination of eight herbal drugs, in phase 1/11 studies in prostate cancer. Preclinical and phase 1/11 studies were also under way in the area of interactions between herbal and conventional drugs.

Randomised, placebo-controlled, multicentre studies currently being funded by the NCCAM were looking at St John's wort in depression (compared with sertraline and placebo), shark cartilage in non-small-cell lung cancer, Ginkgo biloba in prevention of dementia, acupuncture for osteoarthritis pain and glucosamine and/or chondroitin in osteoarthritis.

The NCCAM was willing to take chances in areas that were not robustly embedded in science, but where CAM therapies raised important public health issues, and in highly contentious and provocative areas where conventional medicine was currently inadequate. For example, the Gonzalez regimen, a cocktail of different treatments, was being investigated in cancer. “However, we have to be willing to accept that some modalities may be proven ineffective, just as we look forward to establishing effective treatments,” Dr Strauss warned.

Whys and wherefores

Dr JOHN ASTIN (University of Maryland school of medicine, US) discussed what patients wanted from CAM and why. Surveys had shown wide variation in the proportions of people in developed countries using CAM approaches, but this might be partly explained by different definitions of CAM.

High levels of CAM use tended to occur among individuals with chronic conditions, particularly where pain was a central component (such as arthritis, low back problems and headaches), mental health problems (particularly anxiety, depression and insomnia), cancer and AIDS. A substantial amount of CAM use also appeared to be for health maintenance, wellness and prevention of disease. Dr Astin summarised the profile of a CAM user on the basis of his national study that had explored why patients used CAM (JAMA 1998;279:1548-53). The study had indicated that CAM users tended to:

Be better educated
Be of poorer health status
Have a belief in body, mind and spirit in health
Have had a transformational life experience
Have a commitment to values of environmentalism, feminism, personal growth psychology and spirituality, love of the foreign and exotic
Be reporting anxiety, back problems, chronic pain or urinary tract problems

However, Dr Astin emphasised that while certain patterns had been observed, the reasons why patients used CAM were highly variable and complex and should not be over-simplified. Some questions that still needed answering in this area concerned:

The relationship between CAM use and health status
The role played by the media and the internet play in influencing choice to use CAM
Whether CAM users were more likely to be psychologically distressed
The extent of CAM use among ethnic minority populations

A typical consultation?

Professor ADRIAN FURNHAM (University College London) questioned whether it was possible to generalise about a typical consultation with a CAM practitioner. In his view, it was probably not possible even to define a typical consultation with an acupuncturist, let alone generalise across CAM consultations. “Consultations are so varied that any differences are only stereotypical, misleading or meaningless,” he said. Nevertheless, he gave examples of how a consultation with a CAM practitioner might differ from one with a conventional health-care professional (see Table 1). This was, however, “dangerous, inappropriate speculation”, he emphasised. But several of these hypotheses about differences between consultations could be tested if the question truly needed to be answered.

Teaching CAM

During a panel session focusing on the teaching of complementary/alternative medicine to conventional health care professionals, Dr FRANK SIMON (director of undergraduate medical education policy and standards, American Medical Association) said that 88 per cent of US medical schools had either core or elective teaching in CAM.

Dr Simon said that, in his view, four points needed to be covered in educating conventional health care professionals in CAM. They were:

the ability to talk to patients openly about CAM treatments
the development of a rational approach to assessing the effectiveness of CAM
the ability to provide information to patients about CAM
the need to communicate effectively with CAM providers (eg, acupuncturists)

Answering a question about whether philosophies of certain CAM treatments, eg, yin-yang, should be taught, Dr DAVID KORN (Association of American Medical Colleges) said: “We don't teach students that the earth is flat, or that the earth is the centre of the cosmos.”

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Regulating CAM

In a session on regulation and certification of CAM, Mr SIMON MILLS (University of Exeter) said that many CAM practitioners in the UK were unregulated, in contrast to most other European Union countries and the US, where few health care activities were allowed without state regulation. Although most therapies had set up professional bodies, some had several and standards differed. The report of the House of Lords Select Committee on Science and Technology (PJ, December 2, 2000, p808) had recommended that CAM professions with more than one organisational body should bring them together.

Referring to conventional health care professionals who practised CAM therapies, Mr Mills said that the House of Lords report recommended that patients should be treated to standards comparable to those set out for that particular therapy by the appropriate (single) CAM regulatory body.

Mr Mills suggested that greater co-operation and respect between conventional and CAM practitioners would lead to better communication with patients.

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Researching CAM

Professor STEPHEN HOLGATE (University of Southampton, and adviser to the House of Lords Select Committee) discussed the recommendations for research made in the House of Lords report. He said there had been much controversy in reaching the “consensus” in the report, but that there had been no controversy over the need for more research in CAM. “But what we need to do now is decide how to do this,” he said.

The report concluded that much CAM research was of poor quality. Reasons included inadequate funding, methodological difficulties, lack of training in principles and methods of research and a poor research infrastructure. The report had recommended that there should be a central research strategy and “pump-priming” funding from the Medical Research Council and the NHS research and development directorate to create a few centres of excellence. Also, companies manufacturing products used in CAM should more heavily invest in research. He emphasised that “an essential step for CAM is launching a critical mass of research activity”.

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Clinical evidence for CAM

In a conference session on clinical evidence in CAM, Professor JOS KLEIJNEN (NHS Centre for Reviews and Dissemination, University of York) presented the Cochrane Collaboration's view of CAM research. He said that personal judgment about what was truth had to be used and applied to assessing clinical evidence.

The Cochrane Collaboration was an international non-profit organisation that prepared, maintained and promoted the accessibility of systematic up-to-date reviews of health-care interventions. There were around 50 Cochrane review groups (CRGs) and several Cochrane fields, one of which was complementary medicine (CM) which spanned all CRGs. The Cochrane CM field co-ordinated the search for randomised clinical trials (RCTs) of CAM for the preparation of Cochrane reviews on CAM.

Cochrane reviews were not only about RCTs but also about the best available evidence. They were an excellent source of evidence because they were systematic, allowed readers to submit comments on possible errors or areas for improvement, and were updated with new evidence. The key issue was whether health care interventions were effective. The type of treatment (conventional or CAM) was irrelevant.

A matter of trust

Dr KLAUS LINDE (Centre for Complementary Medicine Research, Munich, Germany) questioned whether conclusions of systematic reviews could be trusted. While his credo was that systematic review was the best tool to get an overview of the available scientific evidence on a defined topic, this was not the same as trust. Preconditions for trusting in systematic reviews were that they should be objective (ie, different people carrying out the review would get the same results and draw the same conclusions) and valid (ie, they would answer relevant questions for health providers and patients).

Systematic reviews addressing the same questions could draw different conclusions. Six reviews asking the question “is hypericum [St John's wort] better than placebo in depression?” had drawn similar conclusions despite having different inclusion criteria for studies included in the review. However, systematic reviews of acupuncture for back pain had shown several discrepancies, including differences in the assessment of methodological quality of individual studies included in the reviews, and in reviewers' interpretations of the conclusions of individual studies.

Concluding, Dr Linde stated that although his credo had not changed, the use of transparent and systematic methods did not automatically mean that results were “true”. The problem was not unique to CAM. Unless there were clear, predefined hypotheses, systematic reviews should be interpreted primarily as “annotated bibliographies”. Systematic reviews in CAM provided only limited guidance for routine practice due to deficiencies in primary research, such as the heterogeneity of interventions, doubtful internal and external validity of studies, insufficient follow-up and inadequate detail in publications. The priority for research should be on pragmatic but rigorous primary studies.

LI-160 study

Professor JONATHAN DAVIDSON (Duke University medical centre, US) summarised new trials of St John's wort involving patients with depression. Since the Cochrane review of St John's wort (The Cochrane Library, Issue 4, Oxford: Update Software; 2000), there had been five placebo-controlled trials, four controlled trials comparing St John's wort with standard antidepressant drugs, and one three-arm study involving both placebo and standard antidepressant controls. Most, but not all, of these studies had reported positive results for St John's wort in that it was superior to placebo or equivalent to standard antidepressants.

Professor Davidson emphasised the importance of long-term studies. He described the US National Institute of Mental Health's multicentre (n=13) three-arm trial of the St John's wort extract LI-160 (Lichtwer Pharma AG, Germany) compared with placebo and sertraline. The selection of the extract was important; the US government had selected LI-160 as the product of the highest quality available. The study had involved an eight-week “efficacy phase” followed by an 18-week “maintenance phase”. There were strict inclusion and exclusion criteria and, as well as standard outcome measures used in studies in depression, the trial included questionnaires on participants' beliefs about their depression. The randomised, triple-blind, triple-dummy study also included the option to increase the dose incrementally to ensure that a lack of response was not due to inadequate dosing. Furthermore, quality assurance for the study had been intensive. For example, physicians had to be certified to administer the Hamilton Depression Scale (the primary outcome measure) and were reviewed throughout the study, and sessions between investigators and participants were recorded on video.

Royal support

In a video message to the conference, the PRINCE OF WALES told the conference that the concept of integrating alternative medicine into mainstream care was close to his heart. Better welfare of patients could be more clearly achieved by integrated health care, maximising both mainstream and CAM approaches. But it made sense to evaluate CAM. Value for money was important. The US had had a head start with the NCCAM, and he would like to encourage a similar initiative in the UK. It was encouraging that the RCP had taken such an active interest in the area.

Life after the Lords report on CAM

A second conference on integrated health care was held on January 29, organised by the Foundation for Integrated Medicine. Entitled “Meeting the challenge: life after the Lords report”, the conference was planned to consider the implications of the House of Lords Select Committee on Science and Technology's report on complementary and alternative medicine (PJ, December 2, 2000, p808). The 140-page report set out major recommendations for action which could have a far-reaching impact in the development of integrated conventional and complementary health services in the UK.

The meeting began with an address from Lord WALTON (chairman of the House of Lords inquiry into CAM). Referring to regulation of complementary medicine practitioners, he suggested that acupuncture and herbal medicine could be regulated but other therapies needed to develop in terms of voluntary self-regulation as a first step towards statutory regulation. There was a strong case for regulation of all herbal medicines to bring these products under the control of the Medicines Control Agency. A new European Union directive on traditional use was in preparation.

Commenting on a section of the report focusing on the research base in CAM, Lord Walton emphasised the “singular lack of research and lack of research funding available”. The report had recommended that the Government should establish several centres of excellence and provide pump-priming funds to fund centres where research could be carried out. Some centres already exist, but more provision was needed across the country.

Mr STEPHEN GORDON (general secretary, European Council for Classical Homoeopathy), giving a CM practitioner's view of the House of Lords report, said that while the report was overall a good one, it did contain some “sceptical and patronising turns of phrase”. It would have been useful to have been able to give feedback on the report before publication. In particular, it had been a mistake to classify therapies into numbered groups, since any attempt at classification would be beset with problems. Also, the proposed regulation of herbal products potentially represented a restriction to practice. “Developments must be watched very carefully,” he warned. By contrast, he welcomed the strong recommendation in the report with regard to training of physicians and other conventional health care professionals who offered CAM therapies.

Giving a general medical practitioner's perspective on the House of Lords report, Dr MICHAEL DIXON (chairman, NHS Alliance) described the report as “liberating” and predicted that it would change attitudes in both conventional medicine and CAM. It was important to support the move towards integrated medicine. There was a need for a national board that could formulate a national policy for CM research. If the Government did not do this, then those present at the meeting should to ensure that the agenda went forward.

Ms MELINDA LETTS (chairman, Long Term Medical Conditions Alliance), giving the patient's view, said that patients' wishes included the ability to make informed decisions, and liaison and communication between conventional and CAM practitioners. She drew attention to the paradox that surrounds people's views of conventional medicines and complementary medicines. People assumed that complementary medicines were safe because they were not pharmaceutical products, and purchased them from health food stores with only a glance at the label. Some people distrusted the pharmaceutical industry, but the industry could only bring medicines to market after the most stringent tests. She referred to the requirement that patient information leaflets be included with conventional medicines and stated that there was a strong case for manufacturers of complementary medicines to do the same.

Mr MICHAEL FOX (Foundation for Integrated Medicine) emphasised the importance of encouraging the Government to respond quickly to the report and not to let it be “kicked into the long grass”. It was reassuring that reaction to the report had been positive and its recommendations widely accepted. The report built on the discussion document “Integrated healthcare: a way forward for the next five years?” produced by the foundation in 1998.