Efficacy and Safety of Neuroleptics in Behavioral Disorders Associated With Dementia
J Clin Psychiatry 1998;59(10):550-561
© Copyright 2014 Physicians Postgraduate Press, Inc.
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Background: Neuroleptics are commonly used to treat behavioral disorders
associated with dementia. However, their safety and efficacy have not been well
established in these patients.
Method: A meta-analysis of randomized, controlled (either placebo or
active drug), double-blind trials published since 1966 (N = 16; 499 treated, 112 active
controls, and 123 placebo) was conducted. Data were collected on proportion of patients
with clinically significant improvement, significant side effects, and dropout rates.
Results: Pooled mean percentages of patients who improved (95% CI): all
neuroleptics, 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 (mean
difference = 25%, 13% to 37%), but pooled mean dropout rates were not different (mean
difference = 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 placebo
in this population, and the efficacy rate is equivalent to the side effect rate. Comparing
different neuroleptics shows they have similar efficacy, side effects, and dropout rates.
Further study to determine more specific drug-responsive behaviors is needed to maximize
benefits of these drugs.