Benefits and harms of antipsychotic drugs in drug-naïve patients with psychosis: A systematic review.

ABSTRACT

OBJECTIVE: To study the benefits and harms of antipsychotics in drug-naïve patients with psychosis. METHODS: This study is a systematic review and meta-analysis of placebo-controlled trials. MAIN OUTCOME MEASURES: Mortality, activities of daily living, quality of life, core psychiatric events, and relapse and recovery rates. DATA SOURCES PubMed, Embase, the Cochrane Central Register of Controlled Trials (CENTRAL), two trial registers and references in potentially eligible articles. DATA EXTRACTION Two researchers extracted data independently. The outcomes were planned to be meta-analysed using Review Manager based on a fixed effect model. RESULTS: Our searches resulted in 493 unique records of which 447 were clearly not eligible. We read the full text of the 46 potentially eligible articles and found one eligible trial in drug-naïve patients, which was unreliable. It was a Chinese trial comparing olanzapine with placebo in 261 patients with first-episode schizophrenia. After 12 weeks, there was an extremely large difference favouring placebo, but the authors reported the opposite, that olanzapine was effective. CONCLUSIONS: The use of antipsychotics cannot be justified based on the evidence we currently have. Withdrawal effects in the placebo groups make existing placebo-controlled trials unreliable.