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Review: thioridazine is not more effective than placebo or other neuroleptic drugs in elderly patients with dementia

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Question In elderly patients with dementia, is thioridazine effective and safe and does it improve cognitive outcomes?

Data sources

Studies were identified by searching Medline, EMBASE/Excerpta Medica, PsycLIT, CINAHL, and the Cochrane Group Register of Clinical trials using the terms thioridazine, Melleril, dementia, and old age; and by reviewing additional published and unpublished studies.

Study selection

Studies were selected if they were randomised trials of thioridazine (used for ≥1 dose) compared with placebo, no treatment, an alternative drug, or behavioural intervention in patients with a degenerative dementia. Studies were excluded from the analysis if treatment allocation was not concealed.

Data extraction

Data were extracted on patient characteristics, allocation procedure, study quality, blinding, interventions used, dropouts, analysis methods, drug safety, institutionalisation, death, and pre-treatment and post-treatment dementia assessment scores. Dementia was assessed using behavioural, clinical global impression, functional performance, and cognitive scales.

Main results

51 studies were identified. 10 studies met the inclusion criteria; 7 studies had sufficient data for inclusion in the analysis. These 7 studies (published between 1973 and 1992) were double blind; ranged from 3 to 8 weeks duration, included between 30 and 610 patients with mean ages between 73 and 80 years; used thioridazine doses between 10 and 200 mg; and …

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