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Publication Bias in Antipsychotic Trials: An Analysis of Efficacy Comparing the Published Literature to the US Food and Drug Administration Database

Figure 2

Forest plot of effect size (Hedges's g) values for FDA-registered premarketing trials of second-generation antipsychotics.

The black horizontal bars highlight the four unpublished trials, three of which demonstrated no statistically significant advantage for the drug over placebo. The fourth unpublished trial showed that the drug was superior to placebo but statistically inferior to the active comparator haloperidol. Below the first dotted horizontal line, subtotal effect size and confidence interval values are shown for the subset of published trials and for the subset of unpublished trials. The difference in effect size between the published and unpublished trials was statistically significant (see text). Below the second dotted horizontal line, the FDA-based effect size is shown for all trials combined (0.44). The effect sizes shown for iloperidone trials 3000, 3004, and 3005 are based on the full sample of patients recruited, i.e., those with either schizophrenia or schizoaffective disorder, as opposed to the subset of patients with schizophrenia only (see text for details).

Figure 2