Fonnebo, Vinjar, Grimsgaard, Sameline, Walach, Harald, Ritenbaugh, Cheryl, Norheim, Arne Johan, MacPherson, Hugh, Lewith, George, Launso, Laila, Koithan, Mary, Falkenberg, Torkel, Boon, Heather and Aickin, Mikel (2007) Researching complementary and alternative treatments - the gatekeepers are not at home. BMC Medical Research Methodology. 7. -. ISSN 1471-2288Full text available as:
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.
|Copyright, Publisher and Additional Information:||© 2007 Fønnebø et al; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.|
|Keywords:||WHOLE SYSTEMS RESEARCH, NATIONAL-SURVEY, PROSTATE-CANCER, CLINICAL-TRIALS, UNITED-STATES, MEDICINE, ACUPUNCTURE, CARE, PSYCHOTHERAPY, POPULATION|
|Academic Units:||The University of York > Health Sciences (York)|
|Depositing User:||Sherpa Assistant|
|Date Deposited:||11 Aug 2007 22:17|
|Last Modified:||17 Oct 2013 14:16|