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Meta-analysis of randomised controlled trials of fluoxetine v. placebo and tricyclic antidepressants in the short-term treatment of major depression

Frederiksborg General Hospital, Hilleroed, Denmark

P. CIALDELLA, MD, M. C. HAUGH, PhD, A. HOURS, MD and J. P. BOISSEL, MD

Service de Pharmacologie Clinique, Lyon, France

M. A. BIRKETT, BSc and G. D. TOLLEFSON, PhD

Psychopharmacology Clinical Research, Eli Lilly and Co, Indianapolis, Indiana, USA

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 non-profit research organisation, for this project. M. A. Birkett and G. D. Tollefson are employed by Eli Lilly and Company.

Correspondence: Dr P. Bech, Psychiatric Research Unit, Frederiksborg General Hospital, Dyrehavevej 48, DK-3400 Hilleroed, Denmark

Background Previous meta-analyses of fluoxetine as an antidepressant have many methodological problems, including diagnosis of major depression, validity of outcome measures and lack of intention-to-treat analyses.

Aims To provide an estimate of the effect of fluoxetine compared with placebo and tricyclic antidepressants (TCAs), and to investigate reasons for early discontinuation from acute treatment.

Method Randomised trials were analysed using both intention-to-treat, efficacy and end-point.

Results Fluoxetine was superior to placebo but effect size was low. In trials comparing fluoxetine v. TCA, the results for all trials and for the USA trials showed a trend in favour of fluoxetine. Those for the non-USA trials showed a trend in favour of TCA. When combined, the results showed that significantly fewer patients on fluoxetine discontinued treatment because of adverse events.

Conclusion 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.

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