In addition to individual published trial analysis, there has been a meta-analysis of registration studies from the United Kingdom .
META-ANALYSIS OF PUBLISHED AND
UNPUBLISHED STUDIES
In
addition to individual published trial analysis, there has been a meta-analysis
of registration studies from the United Kingdom (Whittington et al., 2004). The authors divided the
studies into peer-reviewed published and unpublished studies residing with the
Committee on Safety of Medicines (CMS). Efficacy measures included remission,
response to treatment and depression symptom scores. Safety measures included
serious adverse events (AEs), suicide-related behaviours and discontinuation of
treatment because of AEs. The results were startling: published stud-ies
reported efficacy, but the effect was lost when assessed along with results
from unpublished studies. Overall, the authors found limited empirical support
for the use of SSRIs to treat major depressive disorder (MDD) in youth:
fluoxetine use was supported but one paroxetine and two sertraline trials had
equivo-cal or weak positive risk–benefit profiles. However, in these two cases,
the addition of unpublished data shifted the results to an unfavourable
risk–benefit profile. Data from citalopram and venlafaxine showed unfavourable
risk–benefit profiles.
The
meta-analysis is consistent with UK recommen-dations for a contraindication on
the use of all SSRIs except fluoxetine to treat childhood depression. By
contrast, the FDA has been silent on the efficacy issue focusing its attention
entirely on the question of SSRI safety with respect to treatment-emergent
suicidality.
From
a research methodology perspective, unpub-lished trial data are a source of
publication bias and render meta-analytic approaches virtually meaning-less.
Demands for an end to tolerate unpublished studies based on the so-called
proprietary rights have been advocated within US child psychiatry (Zito et al., 2004). In addition, leading
academic medi-cal journals have announced new rules restricting publication
unless trials have been registered and all relevant data are available for
review (DeAngelis et al., 2005). The
journal policy strengthens the goal of
registration of all trials in a government-sponsored database
(http://www.clinicaltrials.gov). Thus far, database compliance has been
increasing but is in need of substantial improvement especially regard-ing
completion of the field for recording the primary outcome measurement (Zarin,
Tse and Ide, 2005).
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