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N-of-1 Trials in CAM: The New Frontier for Generating Practice-Based Evidence?

Authors: Dr Joanne Bradbury, Prof Sandra Grace and Dr Cathy Avila

A system of healthcare that does not recognise traditional complementary and alternative medicines (CAM) fails to meet community needs and arguably also the government duty of care to its citizenry. A lack of evidence for CAM is an argument often used to defend the exclusion of CAM from government policies, such as Medicare and more recently the Government Rebate for Private Health Insurers, but this argument equally calls for the development of a stronger evidence base for CAM.

A recent overview (i.e. a systematic review of systematic reviews) reported that there was a lack of high quality evidence for CAM therapies in any health condition. ‘High quality’ in this report referred only to evidence using a systematic review methodology. In reality, the majority of CAM interventions have not been evaluated using randomised controlled trial designs and therefore are not likely to appear in systematic reviews.

The knowledge about CAM interventions has historically been passed down through oral traditions, based on multi-generational direct observations. However, in a world where evidence trumps tradition, CAM needs a suitable scientific methodology to drive the generation of high-quality evidence. If CAM practitioners could demonstrate that they practise scientifically, then critics would need to argue with the evidence, not the politics.

‘There is no alternative medicine. There is only scientifically proven, evidence-based medicine supported by solid data or unproven medicine, for which scientific evidence is lacking’ (Fontanarosa & Lundberg, 1998).

N-of-1 trials have been classified as level 1 evidence. They are the most appropriate method for determining treatment effectiveness for an individual because they are a rigorous methodology that is able to control for bias, and also can be aggregated to provide group level evidence. N-of-1 trials and, in a wider sense, all single-case experimental designs (SCEDs), could provide a clear scientific methodological framework that could help the CAM professions, to overcome many of the barriers that have prevented evidence generation to support CAM practice. These include the complex nature of CAM interventions, the extended time spent with patients,limited CAM research expertise and lack of research funding to conduct large scale clinical trials.

SCEDs can be designed around individual needs, which is consistent with the principles of patient-centred care and the ‘holistic’ approach taken by most CAM practitioners. CAM practitioners often see patients with complex, chronic, or subclinical conditions. It is not unusual for a CAM practitioner to hear that their patient was told by their doctor that there is nothing further that medicine can offer them. CAM practitioners who treat holistically are generally focussing on the whole person, not the presenting symptoms of the disease or condition.

While N-of-1 trials and SCEDs methodology have much to offer, there are many methodological issues that need to be addressed in order to apply these methodologies in clinical pracitce. However, SCEDs are adaptive and can often be modified to meet individual trial considerations. If, for example, an intervention is likely to have a curative or long-term sustained effect, or a long metabolic half-life, a multiple baseline design (MBD) could be used to avoid long ‘wash out’ periods where the patient is not receiving any treatment at all.

In summary, if CAM practitioners across Australia were to embrace N-of-1 trials and SCED methodologies in their practices where appropriate, the CAM professions would benefit from the roll-out of high quality level 1 evidence. The strong evidence base that could arise from the wide spread use of such methodologically rigorous clinical research could have a vast impact on the CAM professions, one patient at a time!

About the Authors

Dr Joanne Bradbury is a Senior Lecturer, Evidence Based Healthcare, School of Health and Human Sciences, Southern Cross University. She is an academic researcher with expertise in methodological design and statistical analysis. Research interests include nutrition and complementary medicine, stress and mental health.

Prof. Sandra Grace is Professor of Osteopathy at Southern Cross University. Her roles include enhancing the scholarship and practice of osteopathy through teaching, student supervision, research and publications. Current research projects include: interprofessional education and practice, primary heatlh care service delivery, education for global citizenship, clinical reasoning in osteopathy, benchmarking for quality in osteopathic clinical assessments.

Dr Catharine Avila is a complementary medicine researcher with a background in clinical naturopathy. For the last 18 years she has worked with Southern Cross University as a clinic supervisor, lecturer and researcher and  recently took on a part time role in the CM industry working in product development and regulation for Bio Concepts Pty Ltd.

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