A Cochrane review [Abstract] 1 included 5 studies. The overall results showed no improvement in agitation. There is some evidence that haloperidol helps to control aggression (Behave-AD scale, aggression subscore, WMD -0.92, 95% CI -1.75 to -0.09). Adverse reactions (mainly extrapyramidal symptoms) and dropouts were more frequent among haloperidol treated patients. Higher doses of haloperidol (more than 2 mg/day) may be more effective in controlling aggression, but they cause more adverse effects than lower doses.
A topic in Clinical Evidence 2 summarizes the results of one systematic review including 2 RCTs with a total of 402 patients, comparing haloperidol and risperidone. Similar proportions of patients had improvement in agitation. One of the RCTs (n=344) assessed adverse effects and found that haloperidol increased the frequency (22% vs 15%, p=0.023) and the severity of extrapyramidal symptoms (Extrapyramidal Symptoms Rating Scale score: mean +1.6 vs -0.3, p<0.05) compared to risperidone.
The authors conclude that haloperidol cannot be recommended for routine use in the control of agitated dementia.
Comment: The quality of evidence is downgraded by imprecise results (sparse data) and inconsistency (heterogeneity of patients, interventions and outcomes).
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