Saturday, 14 January 2006 - 10:22 AMMedication-Free Research in Early Episode Schizophrenia: Evidence of Harm?
Purpose: In early episode schizophrenia spectrum disorders, antipsychotic treatment is nearly universal. This study uses meta-analysis techniques to integrate evidence addressing the questions of whether: (a) initial medication treatment results in long-term benefits to clients, and (b) if short periods of medication-free research in early episode schizophrenia result in demonstrable long-term harm to human subjects. Method: Studies were included if a majority of subjects had a first or second schizophrenia spectrum, used a quasi-experimental or random assignment design in which at least one group received standard antipsychotic medications and one group a time-limited trial without antipsychotic treatment, with a minimum of one-year results. Effect-sizes were calculated and combined using standard meta-analytic procedures. Results: Only 7 studies with 745 subjects met inclusion criteria and were available for analysis. Individual study effects ranged from r = �0.21 to r = 0.14, producing a weighted mean effect size estimate of r = �0.11, suggesting a small effect size advantage for non-drug treatment. However, this effect was not statistically different from zero (SE=.081, Z= -1.358, n.s., fixed effects 95% CI: -.27, .05), indicating inadequate evidence to conclude that either initial antipsychotic treatment or its absence exhibits a long-term advantage. Implications: Good-quality evidence suggests a small but not statistically significant advantage for an initial trial without antipsychotic medications in early episode schizophrenia spectrum disorders. The evidence does not support a conclusion of long-term harm resulting from short-term postponement of medications. Initial medication-free trial periods also resulted in a reduction in the proportion of clients receiving long-term medication maintenance treatment. The long-standing presumption of long-term benefit from initial antipsychotic treatment in early schizophrenia is not solidly founded on evidence from controlled studies. Therefore, an ethical prohibition of carefully conducted early-episode schizophrenia research involving a short non-antipsychotic medication trial period on grounds of �withholding proven treatment' is untenable. The divergence of these results with popular belief and current clinical practice underscores the importance of social work's active participation in the �critical community' of science (Popper, 1965 (1963)). Recent evidence has substantiated concerns for the introduction of bias through pharmaceutical company sponsorship of medical research (e.g., Berkelman, Li, & Gross, 2003). Removing bias from mental health knowledge requires a willingness to rigorously assess fundamental assumptions combined with a commitment to developing best client-centered treatments (Bola, 2003).
References Berkelman, J. E., Li, Y., & Gross, C. P. (2003). Scope and impact of financial conflicts of interest in biomedical research. Journal of the American Medical Association, 289(4), 454-465. Bola, J. R. (2003). Integrity and bias in academic psychiatry. The British Journal of Psychiatry, 185(5), 464. Popper, K. R. (1965 (1963)). Conjectures and refutations: The growth of scientific knowledge. New York: Basic Books.
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