Cookies on this website

We use cookies to ensure that we give you the best experience on our website. If you click 'Accept all cookies' we'll assume that you are happy to receive all cookies and you won't see this message again. If you click 'Reject all non-essential cookies' only necessary cookies providing core functionality such as security, network management, and accessibility will be enabled. Click 'Find out more' for information on how to change your cookie settings.

BACKGROUND: Agitation occurs in up to 70% of demented patients. Haloperidol has been used for decades to control agitation in dementia, but its effectiveness remains unclear. Previous meta-analyses examined only English language publications or compared haloperidol with other drugs rather than with placebo. To study the effectiveness of haloperidol a more widely based review was performed. OBJECTIVES: To determine whether evidence supported the use of haloperidol in agitated dementia. SEARCH STRATEGY: The CDCIG Specialized Register which contains references from medical databases (MEDLINE, EMBASE, PsycInfo and CINAHL) as well as from many trials databases was searched on 26 July 2000 to identify reports of randomised controlled trials on haloperidol treatment of agitation in dementia. SELECTION CRITERIA: Randomized, placebo-controlled trials, with concealed allocation, where subjects' dementia and agitation were assessed. DATA COLLECTION AND ANALYSIS: 1. Two reviewers extracted data from included trials 2. Data were pooled where possible, and analysed using appropriate statistical methods 3. Odds ratios of average differences were calculated 4. Only 'intention to treat' data were included 5. Analysis included haloperidol treated patients, compared with placebo MAIN RESULTS: The five included trials led to the following results: 1. There was no significant improvement in agitation among haloperidol treated patients, compared with controls. 2. Aggression decreased among patients with agitated dementia treated with haloperidol; other aspects of agitation were not affected significantly in treated patients, compared with controls. 3. Although two studies showed increased dropouts due to adverse effects among haloperidol patients, there was no significant difference in dropout rates, comparing all haloperidol treated patients with controls. 4. The data were insufficient to examine response to treatment in relation to length of treatment, degree of dementia, age or sex of patients, and cause of dementia. REVIEWER'S CONCLUSIONS: 1. Evidence suggests that haloperidol was useful in the control of aggression, but was associated with increased side effects; there was no evidence to support the routine use of this drug for other manifestations of agitated dementia. 3. Similar dropout rates among haloperidol and placebo treated patients suggested that poorly controlled symptoms, or other factors, may be important in causing treatment discontinuation. 4. Variations in degree of dementia, dosage and length of haloperidol treatment, and in ways of assessing response to treatment suggested caution in the interpretation of reported effects of haloperidol in the management of agitated dementia. 4. The present study confirmed that haloperidol should not be used routinely to treat patients with agitated dementia. Treatment of agitated dementia with haloperidol should be individualized and patients should be monitored for side effects of therapy.

Original publication




Journal article


Cochrane database syst rev

Publication Date



Aggression, Anti-Dyskinesia Agents, Dementia, Haloperidol, Humans, Psychomotor Agitation, Randomized Controlled Trials as Topic