Three-armed trials including placebo and no-treatment groups may be subject to publication bias: systematic review.

<h4>Background</h4>It has been argued that placebos may not have important clinical impacts in general. However, there is increasing evidence of a publication bias among trials published in journals. Therefore, we explored the potential for publication bias in randomized trials with acti...

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Main Authors: Yun Hyung Koog, Seo Ryang We, Byung-Il Min
Format: Article
Language:English
Published: Public Library of Science (PLoS) 2011-01-01
Series:PLoS ONE
Online Access:https://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0020679&type=printable
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author Yun Hyung Koog
Seo Ryang We
Byung-Il Min
author_facet Yun Hyung Koog
Seo Ryang We
Byung-Il Min
author_sort Yun Hyung Koog
collection DOAJ
description <h4>Background</h4>It has been argued that placebos may not have important clinical impacts in general. However, there is increasing evidence of a publication bias among trials published in journals. Therefore, we explored the potential for publication bias in randomized trials with active treatment, placebo, and no-treatment groups.<h4>Methods</h4>Three-armed randomized trials of acupuncture, acupoint stimulation, and transcutaneous electrical stimulation were obtained from electronic databases. Effect sizes between treatment and placebo groups were calculated for treatment effect, and effect sizes between placebo and no-treatment groups were calculated for placebo effect. All data were then analyzed for publication bias.<h4>Results</h4>For the treatment effect, small trials with fewer than 100 patients per arm showed more benefits than large trials with at least 100 patients per arm in acupuncture and acupoint stimulation. For the placebo effect, no differences were found between large and small trials. Further analyses showed that the treatment effect in acupuncture and acupoint stimulation may be subject to publication bias because study design and any known factors of heterogeneity were not associated with the small study effects. In the simulation, the magnitude of the placebo effect was smaller than that calculated after considering publication bias.<h4>Conclusions</h4>Randomized three-armed trials, which are necessary for estimating the placebo effect, may be subject to publication bias. If the magnitude of the placebo effect is assessed in an intervention, the potential for publication bias should be investigated using data related to the treatment effect.
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spelling doaj-art-bdc66d299c9949918d14170cda0d71f72025-08-20T03:28:06ZengPublic Library of Science (PLoS)PLoS ONE1932-62032011-01-0165e2067910.1371/journal.pone.0020679Three-armed trials including placebo and no-treatment groups may be subject to publication bias: systematic review.Yun Hyung KoogSeo Ryang WeByung-Il Min<h4>Background</h4>It has been argued that placebos may not have important clinical impacts in general. However, there is increasing evidence of a publication bias among trials published in journals. Therefore, we explored the potential for publication bias in randomized trials with active treatment, placebo, and no-treatment groups.<h4>Methods</h4>Three-armed randomized trials of acupuncture, acupoint stimulation, and transcutaneous electrical stimulation were obtained from electronic databases. Effect sizes between treatment and placebo groups were calculated for treatment effect, and effect sizes between placebo and no-treatment groups were calculated for placebo effect. All data were then analyzed for publication bias.<h4>Results</h4>For the treatment effect, small trials with fewer than 100 patients per arm showed more benefits than large trials with at least 100 patients per arm in acupuncture and acupoint stimulation. For the placebo effect, no differences were found between large and small trials. Further analyses showed that the treatment effect in acupuncture and acupoint stimulation may be subject to publication bias because study design and any known factors of heterogeneity were not associated with the small study effects. In the simulation, the magnitude of the placebo effect was smaller than that calculated after considering publication bias.<h4>Conclusions</h4>Randomized three-armed trials, which are necessary for estimating the placebo effect, may be subject to publication bias. If the magnitude of the placebo effect is assessed in an intervention, the potential for publication bias should be investigated using data related to the treatment effect.https://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0020679&type=printable
spellingShingle Yun Hyung Koog
Seo Ryang We
Byung-Il Min
Three-armed trials including placebo and no-treatment groups may be subject to publication bias: systematic review.
PLoS ONE
title Three-armed trials including placebo and no-treatment groups may be subject to publication bias: systematic review.
title_full Three-armed trials including placebo and no-treatment groups may be subject to publication bias: systematic review.
title_fullStr Three-armed trials including placebo and no-treatment groups may be subject to publication bias: systematic review.
title_full_unstemmed Three-armed trials including placebo and no-treatment groups may be subject to publication bias: systematic review.
title_short Three-armed trials including placebo and no-treatment groups may be subject to publication bias: systematic review.
title_sort three armed trials including placebo and no treatment groups may be subject to publication bias systematic review
url https://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0020679&type=printable
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AT byungilmin threearmedtrialsincludingplaceboandnotreatmentgroupsmaybesubjecttopublicationbiassystematicreview