Conclusion fluoxetine is superior to placebo

Unformatted text preview: ion Fluoxetine is superior to placebo, irrespective of the analytical approach use, whereas the results obtained v. TCAs depend on the approach used.Hence, the results should be interpreted in this light. Declaration of interest P.Bech is Head of a World Health Organization Collaborating Centre for psychometrics. J.P.Boissel,P.Cialdella,M.C.Haugh, and A. Hours were financed by APRET, a nonprofit research organisation, for this project.M. A.Birkett and G.D.Tollefson are employed by Eli Lilly and Company. Previously published meta-analyses of selective serotonin reuptake inhibitors (SSRIs) v. tricyclic antidepressants (TCAs) or placebo (Anderson & Tomenson, 1994; Greenberg et al, 1994; Anderson, 1998) were based on published data only and did not analyse data for all randomised patients (the intention-to-treat approach) since these were not available in the published reports. The only previous meta-analysis with this approach was reported by Bech & Cialdella (1992). In the present analysis we used the Eli Lilly and Company (Lilly) fluoxetine database and included patients from published and unpublished randomised clinical short-term trials of fluoxetine. A protocol described our objectives, inclusion and exclusion criteria for trials, and the analyses to be performed. We used different analytical approaches for completers and noncompleters. Our objectives were to obtain quantitative estimates of the fluoxetine treatment effect compared with: (a) placebo; (b) TCAs; and (c) to analyse the reasons for early discontinuation from treatment. MATERIAL AND METHOD Types and sources of data In keeping with our original protocol all randomised clinical trials completed and analysed up to the end of December 1992 (the Lilly fluoxetine database) that satisfied the selection criteria were included. After this date, no pertinent trials comparing fluoxetine with placebo or TCAs were added to the database. We analysed the trials performed in the USA (USA trials) separately from those performed elsewhere (Canada and Europe; non-USA trials) because the psychiatric methods and clinical trial procedures were sufficiently different in the USA compared with elsewhere, and this could be a source of heterogeneity between the trials (Ansseau, 1992). I...
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