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Open Access Highly Accessed Debate

Researching complementary and alternative treatments – the gatekeepers are not at home

Vinjar Fønnebø1*, Sameline Grimsgaard2, Harald Walach3, Cheryl Ritenbaugh4, Arne Johan Norheim1, Hugh MacPherson5, George Lewith6, Laila Launsø1, Mary Koithan47, Torkel Falkenberg8, Heather Boon9 and Mikel Aickin7

Author Affiliations

1 National Research Center in Complementary and Alternative Medicine, Faculty of Medicine, University of Tromsø, N-9037 TROMSØ, Norway

2 Clinical Research Center, University Hospital of North Norway, N-9038 TROMSØ, Norway

3 School of Social Sciences & Samueli Institute, University of Northampton, Boughton Green Rd, Northampton NN2 7AL, UK

4 Department of Family & Community Medicine, University of Arizona, 1450 North Cherry Avenue, Tucson, AZ 85719, USA

5 Department of Health Sciences, University of York, Heslington, York YO10 5DD, UK

6 Complementary Medicine Research Unit, Primary Medical Care, Aldermoor Health Centre, Aldermoor Close, Southampton SO16 5ST, UK

7 Program in Integrative Medicine, University of Arizona, PO Box 245153, Tucson, AZ 85724-5153, USA

8 Center for Studies of Complementary Medicine, Department of Nursing and the division of International Health (IHCAR), Department of Public Health Sciences, Karolinska Institutet, Alfred Nobels Allé 23, S-141 83 Huddinge, Sweden

9 Leslie Dan Faculty of Pharmacy, University of Toronto, 19 Russell Street Toronto, Ontario, M5S 2S2, Canada

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BMC Medical Research Methodology 2007, 7:7  doi:10.1186/1471-2288-7-7

Published: 11 February 2007

Abstract

Background

To explore the strengths and weaknesses of conventional biomedical research strategies and methods as applied to complementary and alternative medicine (CAM), and to suggest a new research framework for assessing these treatment modalities.

Discussion

There appears to be a gap between published studies showing little or no efficacy of CAM, and reports of substantial clinical benefit from patients and CAM practitioners. This "gap" might be partially due to the current focus on placebo-controlled randomized trials, which are appropriately designed to answer questions about the efficacy and safety of pharmaceutical agents. In an attempt to fit this assessment strategy, complex CAM treatment approaches have been dissected into standardized and often simplified treatment methods, and outcomes have been limited.

Unlike conventional medicine, CAM has no regulatory or financial gatekeeper controlling their therapeutic "agents" before they are marketed. Treatments may thus be in widespread use before researchers know of their existence. In addition, the treatments are often provided as an integrated 'whole system' of care, without careful consideration of the safety issue.

We propose a five-phase strategy for assessing CAM built on the acknowledgement of the inherent, unique aspects of CAM treatments and their regulatory status in most Western countries. These phases comprise:

1. Context, paradigms, philosophical understanding and utilization

2. Safety status

3. Comparative effectiveness.

4. Component efficacy

5. Biological mechanisms.

Summary

Using the proposed strategy will generate evidence relevant to clinical practice, while acknowledging the absence of regulatory and financial gatekeepers for CAM. It will also emphasize the important but subtle differences between CAM and conventional medical practice.