Individual patient data meta-analysis of acupuncture for chronic pain: protocol of the Acupuncture Trialists' Collaboration

<p>Abstract</p> <p>Background</p> <p>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 other...

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Main Authors: Sherman Karen J, Victor Norbert, Macpherson Hugh, Lewith George, Maschino Alexandra C, Cronin Angel M, Vickers Andrew J, Witt Claudia, Linde Klaus
Format: Article
Language:English
Published: BMC 2010-09-01
Series:Trials
Online Access:http://www.trialsjournal.com/content/11/1/90
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author Sherman Karen J
Victor Norbert
Macpherson Hugh
Lewith George
Maschino Alexandra C
Cronin Angel M
Vickers Andrew J
Witt Claudia
Linde Klaus
author_facet Sherman Karen J
Victor Norbert
Macpherson Hugh
Lewith George
Maschino Alexandra C
Cronin Angel M
Vickers Andrew J
Witt Claudia
Linde Klaus
author_sort Sherman Karen J
collection DOAJ
description <p>Abstract</p> <p>Background</p> <p>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.</p> <p>Methods</p> <p>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.</p> <p>Discussion</p> <p>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.</p>
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spelling doaj.art-4ac5b6d0dcb94bb9ad324ba013decc052022-12-22T00:27:36ZengBMCTrials1745-62152010-09-011119010.1186/1745-6215-11-90Individual patient data meta-analysis of acupuncture for chronic pain: protocol of the Acupuncture Trialists' CollaborationSherman Karen JVictor NorbertMacpherson HughLewith GeorgeMaschino Alexandra CCronin Angel MVickers Andrew JWitt ClaudiaLinde Klaus<p>Abstract</p> <p>Background</p> <p>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.</p> <p>Methods</p> <p>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.</p> <p>Discussion</p> <p>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.</p>http://www.trialsjournal.com/content/11/1/90
spellingShingle Sherman Karen J
Victor Norbert
Macpherson Hugh
Lewith George
Maschino Alexandra C
Cronin Angel M
Vickers Andrew J
Witt Claudia
Linde Klaus
Individual patient data meta-analysis of acupuncture for chronic pain: protocol of the Acupuncture Trialists' Collaboration
Trials
title Individual patient data meta-analysis of acupuncture for chronic pain: protocol of the Acupuncture Trialists' Collaboration
title_full Individual patient data meta-analysis of acupuncture for chronic pain: protocol of the Acupuncture Trialists' Collaboration
title_fullStr Individual patient data meta-analysis of acupuncture for chronic pain: protocol of the Acupuncture Trialists' Collaboration
title_full_unstemmed Individual patient data meta-analysis of acupuncture for chronic pain: protocol of the Acupuncture Trialists' Collaboration
title_short Individual patient data meta-analysis of acupuncture for chronic pain: protocol of the Acupuncture Trialists' Collaboration
title_sort individual patient data meta analysis of acupuncture for chronic pain protocol of the acupuncture trialists collaboration
url http://www.trialsjournal.com/content/11/1/90
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