Efficacy and Safety of Neuroleptics in Behavioral Disorders Associated With Dementia

Background: Neuroleptics are commonly used to treat behavioral disordersassociated with dementia. However, their safety and efficacy have not been wellestablished in these patients.

Method: A meta-analysis of randomized, controlled (either placebo oractive drug), double-blind trials published since 1966 (N = 16; 499 treated, 112 activecontrols, and 123 placebo) was conducted. Data were collected on proportion of patientswith clinically significant improvement, significant side effects, and dropout rates.

Results: Pooled mean percentages of patients who improved (95% CI): allneuroleptics, 64% (54% to 74%); low potency, 63% (54% to 72%); moderate potency, 70% (56%to 85%); moderate-high potency, 62% (49% to 75%); and high potency, 69% (49% to 90%).Thus, no differences in efficacy existed between different potencies of neuroleptics.Therapeutic effect (neuroleptic minus placebo) was only 26% (14% to 38%).Treatment-emergent side effects were more common for neuroleptics vs. placebo (meandifference = 25%, 13% to 37%), but pooled mean dropout rates were not different (meandifference = 4%, -7% to 14%). Neither weighting by clinical trial quality (3 raters;weighted agreement, 83% to 92%) nor exclusion of poor quality trials changed the results.

Conclusion: Neuroleptics have small but significant efficacy over placeboin this population, and the efficacy rate is equivalent to the side effect rate. Comparingdifferent neuroleptics shows they have similar efficacy, side effects, and dropout rates.Further study to determine more specific drug-responsive behaviors is needed to maximizebenefits of these drugs.