Complementary and alternative medicine whole systems research: Beyond identification of inadequacies of the RCT

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Summary

Complementary and alternative medicine (CAM) often consists of whole systems of care (such as naturopathic medicine or traditional Chinese medicine (TCM)) that combine a wide range of modalities to provide individualised treatment. The complexity of these interventions and their potential synergistic effect requires innovative evaluative approaches. Model validity, which encompasses the need for research to adequately address the unique healing theory and therapeutic context of the intervention, is central to whole systems research (WSR). Classical randomised controlled trials (RCTs) are limited in their ability to address this need. Therefore, we propose a mixed methods approach that includes a range of relevant and holistic outcome measures. As the individual components of most whole systems are inseparable, complementary and synergistic, WSR must not focus only on the “active” ingredients of a system. An emerging WSR framework must be non-hierarchical, cyclical, flexible and adaptive, as knowledge creation is continuous, evolutionary and necessitates a continuous interplay between research methods and “phases” of knowledge. Finally, WSR must hold qualitative and quantitative research methods in equal esteem to realize their unique research contribution. Whole systems are complex and therefore no one method can adequately capture the meaning, process and outcomes of these interventions.

Section snippets

Why whole systems research?

Assessing the efficacy of whole systems is more complex than assessing the efficacy of single modalities or treatments. The fundamental challenge is to acknowledge all key components of the intervention as a network, consequently none of the components can be considered in isolation. Research methods that focus on the identification of “active” ingredients of an intervention through reductionist strategies are rarely appropriate for whole systems.3

Classical randomised controlled trials (RCTs)

Model validity: a unique consideration for whole systems research

A key component of WSR is the requirement for model validity. Model validity encompasses the need for the research to adequately address the unique healing theory and therapeutic context of the intervention that is being assessed.5 Cassidy6 describes model validity as paradigm fit and suggests that a paradigm fit exists if the explanatory model of the system under investigation and the research design are aligned. This requirement is not unique to CAM or to whole systems, but must be considered

Design strategies to evaluate whole systems

Approaches to evaluate CAM whole systems may be described as variations of the RCT design, such as the adaptations suggested by Ernst.8 The Institute of Medicine9 similarly suggests adaptations of RCTs to assess the effectiveness of CAM, but also includes other study designs, such as observational studies. Ernst's suggestions, however, are limited to the assessment of single CAM modalities, and while the Institute of Medicine recognizes that many CAM approaches are delivered as whole systems,

Moving forward

Several strategies to evaluate CAM whole systems have been presented; however, the question still remains—how do we know if whole systems are effective? While individualised data are necessary, a means to interpret these data as a whole is clearly needed in order to strengthen the evidence required for uptake in practice. The complex and individualised nature of whole systems suggests that one well-designed, multi-method study is not sufficient to indicate effectiveness. A determination of

Conclusion

How best to study whole systems of health care is an issue that is not unique to CAM, it also applies to complex interventions in conventional health care, such as multidisciplinary chronic care, patient-centred primary care, psychotherapy, and palliative care. While WSR is potentially very costly, its advancement will assist in understanding the role of all components of the effectiveness of any intervention, including sensitivity to the philosophical assumptions on which an intervention is

References (28)

  • Institute of Medicine

    Complementary and alternative medicine in the United States. Board on population health and public health practice. Chapter 4. Need for innovative designs in research on CAM and conventional medicine

    (2005)
  • A.J. Vickers et al.

    Acupuncture for chronic headache in primary care: large, pragmatic, randomised trial

    BMJ

    (2004)
  • UK BEAM Trial Team

    United Kingdom back pain exercise and manipulation (UK BEAM) randomised trial: effectiveness of physical treatments for back pain in primary care

    BMJ

    (2004)
  • B.C. Johnston et al.

    n-of-1 randomized controlled trials: an opportunity for complementary and alternative medicine evaluation

    J Altern Complement Med

    (2005)

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