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Individual patient data meta-analysis of acupuncture for chronic pain: protocol of the acupuncture trialists' collaboration

Individual patient data meta-analysis of acupuncture for chronic pain: protocol of the acupuncture trialists' collaboration
Individual patient data meta-analysis of acupuncture for chronic pain: protocol of the acupuncture trialists' collaboration
Background: The purpose of clinical trials of acupuncture is to help clinicians and patients make decisions about treatment. Yet this is not straightforward: some trials report acupuncture to be superior to sham (placebo) acupuncture while others show evidence that acupuncture is superior to usual care but not sham, and still others conclude that acupuncture is no better than usual care. Meta-analyses of these trials tend to come to somewhat indeterminate conclusions. This appears to be because, until recently, acupuncture research was dominated by small trials of questionable quality. The Acupuncture Trialists' Collaboration, a group of trialists, statisticians and other researchers, was established to synthesize patient-level data from several recently published large, high-quality trials.

Methods: There are three distinct phases to the Acupuncture Trialists Collaboration: a systematic review to identify eligible studies; collation and harmonization of raw data; statistical analysis. To be eligible, trials must have unambiguous allocation concealment. Eligible pain conditions are osteoarthritis; chronic headache (tension or migraine headache); shoulder pain; and non-specific back or neck pain. Once received, patient-level data will undergo quality checks and the results of prior publications will be replicated. The primary analysis will be to determine the effect size of acupuncture. Each trial will be evaluated by analysis of covariance with the principal endpoint as the dependent variable and, as covariates, the baseline score for the principal endpoint and the variables used to stratify randomization. The effect size for acupuncture from each trial - that is, the coefficient and standard error from the analysis of covariance - will then be entered into a meta-analysis. We will compute effect sizes separately for comparisons of acupuncture with sham acupuncture, and acupuncture with no acupuncture control for each pain condition. Other analyses will investigate the impact of different sham techniques, styles of acupuncture or frequency and duration of treatment sessions.

Discussion: Individual patient data meta-analysis of high-quality trials will provide the most reliable basis for treatment decisions about acupuncture. Above all, however, we hope that our approach can serve as a model for future studies in acupuncture and other complementary therapies.
1745-6215
Vickers, Andrew J.
e39cb4e7-1e87-47c3-a19e-c643ae9c884e
Cronin, Angel M.
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Maschino, Alexandra C.
0110c8e5-202a-4903-b0a1-d12dfea3cdf7
Lewith, George
0fc483fa-f17b-47c5-94d9-5c15e65a7625
MacPherson, Hugh
6485cd22-1dc3-4600-9e00-d3187e981663
Victor, Norbet
4ea11d32-7c4a-43ca-8ee0-41ee1a7ef587
Sherman, Karen J.
deb97429-5af6-4328-bede-ca755bf5f1da
Witt, Claudia
f27fbad0-b9ca-40db-966e-aac72d04e4b3
Linde, Klaus
72a255e6-2da6-4fd6-b9d9-452fba23de4d
Acupuncture Trialists' Collaboration
Vickers, Andrew J.
e39cb4e7-1e87-47c3-a19e-c643ae9c884e
Cronin, Angel M.
0f581bb0-a980-460d-839d-6300af97a5a2
Maschino, Alexandra C.
0110c8e5-202a-4903-b0a1-d12dfea3cdf7
Lewith, George
0fc483fa-f17b-47c5-94d9-5c15e65a7625
MacPherson, Hugh
6485cd22-1dc3-4600-9e00-d3187e981663
Victor, Norbet
4ea11d32-7c4a-43ca-8ee0-41ee1a7ef587
Sherman, Karen J.
deb97429-5af6-4328-bede-ca755bf5f1da
Witt, Claudia
f27fbad0-b9ca-40db-966e-aac72d04e4b3
Linde, Klaus
72a255e6-2da6-4fd6-b9d9-452fba23de4d

Vickers, Andrew J., Cronin, Angel M., Maschino, Alexandra C., Lewith, George, MacPherson, Hugh, Victor, Norbet, Sherman, Karen J., Witt, Claudia and Linde, Klaus , Acupuncture Trialists' Collaboration (2010) Individual patient data meta-analysis of acupuncture for chronic pain: protocol of the acupuncture trialists' collaboration. Trials, 11 (90). (doi:10.1186/1745-6215-11-90).

Record type: Article

Abstract

Background: The purpose of clinical trials of acupuncture is to help clinicians and patients make decisions about treatment. Yet this is not straightforward: some trials report acupuncture to be superior to sham (placebo) acupuncture while others show evidence that acupuncture is superior to usual care but not sham, and still others conclude that acupuncture is no better than usual care. Meta-analyses of these trials tend to come to somewhat indeterminate conclusions. This appears to be because, until recently, acupuncture research was dominated by small trials of questionable quality. The Acupuncture Trialists' Collaboration, a group of trialists, statisticians and other researchers, was established to synthesize patient-level data from several recently published large, high-quality trials.

Methods: There are three distinct phases to the Acupuncture Trialists Collaboration: a systematic review to identify eligible studies; collation and harmonization of raw data; statistical analysis. To be eligible, trials must have unambiguous allocation concealment. Eligible pain conditions are osteoarthritis; chronic headache (tension or migraine headache); shoulder pain; and non-specific back or neck pain. Once received, patient-level data will undergo quality checks and the results of prior publications will be replicated. The primary analysis will be to determine the effect size of acupuncture. Each trial will be evaluated by analysis of covariance with the principal endpoint as the dependent variable and, as covariates, the baseline score for the principal endpoint and the variables used to stratify randomization. The effect size for acupuncture from each trial - that is, the coefficient and standard error from the analysis of covariance - will then be entered into a meta-analysis. We will compute effect sizes separately for comparisons of acupuncture with sham acupuncture, and acupuncture with no acupuncture control for each pain condition. Other analyses will investigate the impact of different sham techniques, styles of acupuncture or frequency and duration of treatment sessions.

Discussion: Individual patient data meta-analysis of high-quality trials will provide the most reliable basis for treatment decisions about acupuncture. Above all, however, we hope that our approach can serve as a model for future studies in acupuncture and other complementary therapies.

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More information

Published date: 28 September 2010

Identifiers

Local EPrints ID: 176105
URI: http://eprints.soton.ac.uk/id/eprint/176105
ISSN: 1745-6215
PURE UUID: 05968486-1c14-445c-a04d-d370811fc779

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Date deposited: 03 Mar 2011 11:37
Last modified: 08 Jan 2022 08:39

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Contributors

Author: Andrew J. Vickers
Author: Angel M. Cronin
Author: Alexandra C. Maschino
Author: George Lewith
Author: Hugh MacPherson
Author: Norbet Victor
Author: Karen J. Sherman
Author: Claudia Witt
Author: Klaus Linde
Corporate Author: Acupuncture Trialists' Collaboration

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