Lessons learned from Restoring Study 329: transparent reporting, open databases and network meta-analyses as the way forward

Study 329 is a poster-child for the so-called crisis in evidence-based medicine. Published in 2001 by the Journal for the American Academy of Adolescent Psychiatry (JAACAP), this doubleblind, randomized controlled trial sponsored by GlaxoSmithKline compared paroxetine, imipramine and placebo in the...

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Main Authors: Barber, S, Cipriani, A
Format: Journal article
Published: SAGE Publications 2016
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author Barber, S
Cipriani, A
author_facet Barber, S
Cipriani, A
author_sort Barber, S
collection OXFORD
description Study 329 is a poster-child for the so-called crisis in evidence-based medicine. Published in 2001 by the Journal for the American Academy of Adolescent Psychiatry (JAACAP), this doubleblind, randomized controlled trial sponsored by GlaxoSmithKline compared paroxetine, imipramine and placebo in the treatment of adolescent major depression. The authors concluded that ‘paroxetine is generally well tolerated and effective for major depression in adolescents’. A nebulous statement, but apparently supported by a significant improvement in a variety of widely used and validated scores for depression. According to the results from this study, psychiatrists who prescribe paroxetine to a 15-year-old with major depression are practising evidence-based medicine. Or at least they were, until a major re-analysis in 2015 found no difference between paroxetine and placebo when only outcome measures pre-specified in the original study protocol were considered (Le Noury et  al., 2015).
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spelling oxford-uuid:b0524f9d-6500-42a3-b439-546cd5dd290f2022-03-27T03:55:36ZLessons learned from Restoring Study 329: transparent reporting, open databases and network meta-analyses as the way forwardJournal articlehttp://purl.org/coar/resource_type/c_dcae04bcuuid:b0524f9d-6500-42a3-b439-546cd5dd290fSymplectic Elements at OxfordSAGE Publications2016Barber, SCipriani, AStudy 329 is a poster-child for the so-called crisis in evidence-based medicine. Published in 2001 by the Journal for the American Academy of Adolescent Psychiatry (JAACAP), this doubleblind, randomized controlled trial sponsored by GlaxoSmithKline compared paroxetine, imipramine and placebo in the treatment of adolescent major depression. The authors concluded that ‘paroxetine is generally well tolerated and effective for major depression in adolescents’. A nebulous statement, but apparently supported by a significant improvement in a variety of widely used and validated scores for depression. According to the results from this study, psychiatrists who prescribe paroxetine to a 15-year-old with major depression are practising evidence-based medicine. Or at least they were, until a major re-analysis in 2015 found no difference between paroxetine and placebo when only outcome measures pre-specified in the original study protocol were considered (Le Noury et  al., 2015).
spellingShingle Barber, S
Cipriani, A
Lessons learned from Restoring Study 329: transparent reporting, open databases and network meta-analyses as the way forward
title Lessons learned from Restoring Study 329: transparent reporting, open databases and network meta-analyses as the way forward
title_full Lessons learned from Restoring Study 329: transparent reporting, open databases and network meta-analyses as the way forward
title_fullStr Lessons learned from Restoring Study 329: transparent reporting, open databases and network meta-analyses as the way forward
title_full_unstemmed Lessons learned from Restoring Study 329: transparent reporting, open databases and network meta-analyses as the way forward
title_short Lessons learned from Restoring Study 329: transparent reporting, open databases and network meta-analyses as the way forward
title_sort lessons learned from restoring study 329 transparent reporting open databases and network meta analyses as the way forward
work_keys_str_mv AT barbers lessonslearnedfromrestoringstudy329transparentreportingopendatabasesandnetworkmetaanalysesasthewayforward
AT cipriania lessonslearnedfromrestoringstudy329transparentreportingopendatabasesandnetworkmetaanalysesasthewayforward