Researching complementary and alternative treatments--the gatekeepers are not at home.
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.


CONCLUSIONS
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.


CONCLUSIONS
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.
Fønnebø
Vinjar
V
National Research Center in Complementary and Alternative Medicine, Faculty of Medicine, University of Tromsø, N-9037 TROMSØ, Norway. Vinjar.Fonnebo@fagmed.uit.no
Grimsgaard
Sameline
S
Walach
Harald
H
Ritenbaugh
Cheryl
C
Norheim
Arne Johan
AJ
MacPherson
Hugh
H
Lewith
George
G
Launsø
Laila
L
Koithan
Mary
M
Falkenberg
Torkel
T
Boon
Heather
H
Aickin
Mikel
M
D035843:Biomedical Research; D000529:Complementary Therapies / Q000009:adverse effects / Q000331:legislation & jurisprudence / Q000706:statistics & numerical data; D006801:Humans; D012449:Safety