Summary: | 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).
|