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

Researching complementary and alternative treatments--the gatekeepers are not at home
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.
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.
agents, biomedical research, adverse effects, patients, treatment, safety, complementary therapies, humans, research, norway, utilization, legislation & jurisprudence, report, methods
1471-2288
6pp
Fonnebo, Vinjar
8a6a4201-badd-458d-b652-32080f04b31b
Grimsgaard, Sameline
d030ff07-b0c8-485a-84f3-05d47e1f1c2f
Walach, Harald
b6c1f873-105c-4825-9b9b-2a3cf9dc4fb2
Ritenbaugh, Cheryl
30b79ebe-6868-4ade-a051-464b654c3b77
Norheim, Arne Johan
32c423ce-6af4-48b2-98b1-0c8f7d2405ca
MacPherson, Hugh
6485cd22-1dc3-4600-9e00-d3187e981663
Lewith, George
0fc483fa-f17b-47c5-94d9-5c15e65a7625
Launso, Laila
2cd32cf4-5541-418f-a771-2ced8e103d13
Koithan, Mary
d32d29ed-b8b9-4dd0-b815-1baa61bb96c3
Falkenberg, Torkel
38b7bd1d-039e-4acf-bd3b-a40e7c81d7a9
Boon, Heather
cfb4982c-c21b-4e11-a41b-ccf468f325ef
Aickin, Mikel
6483d0d4-8494-47cd-8c94-137b1d6c3583
Fonnebo, Vinjar
8a6a4201-badd-458d-b652-32080f04b31b
Grimsgaard, Sameline
d030ff07-b0c8-485a-84f3-05d47e1f1c2f
Walach, Harald
b6c1f873-105c-4825-9b9b-2a3cf9dc4fb2
Ritenbaugh, Cheryl
30b79ebe-6868-4ade-a051-464b654c3b77
Norheim, Arne Johan
32c423ce-6af4-48b2-98b1-0c8f7d2405ca
MacPherson, Hugh
6485cd22-1dc3-4600-9e00-d3187e981663
Lewith, George
0fc483fa-f17b-47c5-94d9-5c15e65a7625
Launso, Laila
2cd32cf4-5541-418f-a771-2ced8e103d13
Koithan, Mary
d32d29ed-b8b9-4dd0-b815-1baa61bb96c3
Falkenberg, Torkel
38b7bd1d-039e-4acf-bd3b-a40e7c81d7a9
Boon, Heather
cfb4982c-c21b-4e11-a41b-ccf468f325ef
Aickin, Mikel
6483d0d4-8494-47cd-8c94-137b1d6c3583

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 (7), 6pp. (doi:10.1186/1471-2288-7-7).

Record type: Article

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.

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More information

Published date: 11 February 2007
Keywords: agents, biomedical research, adverse effects, patients, treatment, safety, complementary therapies, humans, research, norway, utilization, legislation & jurisprudence, report, methods

Identifiers

Local EPrints ID: 61784
URI: http://eprints.soton.ac.uk/id/eprint/61784
ISSN: 1471-2288
PURE UUID: fb3a42ba-b304-48d6-8134-5f0c6de946ed

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Date deposited: 10 Sep 2008
Last modified: 15 Mar 2024 11:28

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Contributors

Author: Vinjar Fonnebo
Author: Sameline Grimsgaard
Author: Harald Walach
Author: Cheryl Ritenbaugh
Author: Arne Johan Norheim
Author: Hugh MacPherson
Author: George Lewith
Author: Laila Launso
Author: Mary Koithan
Author: Torkel Falkenberg
Author: Heather Boon
Author: Mikel Aickin

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