Publications

BACKGROUND

Agitation includes wandering, crying out, abusive vocalization, and assaultive behavior and occurs in up to 70% of patients with dementia. Although the neuroleptic haloperidol has been used for decades to control disruptive behavior in psychotic and demented patients, the effectiveness of this drug for agitated dementia remains in question. The first meta-analysis on the effectiveness of haloperidol for agitated dementia, published in 1990, was limited in scope and was unable to provide clear guidelines for the use of haloperidol for demented patients who are agitated. Meta-analyses in 1998 and 2000 examined haloperidol compared with other neuroleptics as well as with placebo and omitted a number of databases, including non-English language publications. To determine the effect of haloperidol, compared with placebo, in the control of agitated dementia and to make recommendations for future research in this area a more widely based, yet more highly focussed review was carried out.

OBJECTIVES

The main objective was to determine whether evidence supports the use of haloperidol to treat agitation in demented patients.

SEARCH STRATEGY

The CDCIG Specialized Register was searched to identify all available reports on haloperidol treatment of agitated dementia.

SELECTION CRITERIA

We examined randomized, placebo-controlled trials, with concealed allocation, where subjects' dementia and agitation were assessed. Trials involving treatment of less than one week were not included.

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 or average differences were calculated. 4. Only 'intention to treat' data were included. Where a cross-over design was employed (Devanand, 1998), only the initial phase of the study was used to compare haloperidol versus placebo. 5. Sensitivity analysis was applied to heterogeneity of results and to gauge the effect of the included studies of small sample size. 6. In addition to the overall meta-analysis, individual analyses of the reports were carried out to examine the effect of degree of dementia, dose of haloperidol, and duration of therapy on agitated dementia. Analysis included the following groups: All patients treated with haloperidol compared with placebo.

MAIN RESULTS

There were five included trials. All studies stated "intention to treat" analysis of their results. Three studies were from the United States, and two studies were from Europe. Two studies examined patients with various forms of dementia, and three studies included only patients with diagnosed Alzheimer's dementia. 1. Overall meta-analysis of the response of agitated patients to haloperidol, compared with controls, showed no improvement in agitation. There is some evidence that haloperidol helps to control aggression. Adverse reactions and dropouts were more frequent among haloperidol treated patients, compared with controls. This meta-analysis provided no information about the relationship between the degree of dementia, the kind of agitation manifested, or the dosage and duration of therapy with haloperidol and response to treatment of demented patients with agitation. 2. The results of this meta-analysis were too broad to permit specific recommendations for treatment of agitated dementia with haloperidol. 3. Higher dose haloperidol, or prolonged haloperidol (12 weeks compared with 3 - 6 weeks) was associated with increased side effects, largely related to Parkinsonian symptoms of rigidity and bradykinesia.

REVIEWER'S CONCLUSIONS

1. Haloperidol appeared to provide no improvement in agitation among demented patients compared with placebo, but side effects were frequent. 2. Dropout rates were higher for haloperidol compared with placebo treated patients, suggesting that side effects led to discontinuation of treatment in some patients. 3. Because of the wide focus of this meta-analysis, not enough information was provided to permit recommendations linking haloperidol treatment of agitated dementia to degree of dementia, manifestations of agitation, or dosage and duration of treatment of haloperidol. 4. Individual analysis of reports indicated that higher dose haloperidol (more than 2 mg per day) may have been more effective than lower dose haloperidol (less than 2 mg per day) in controlling aggression, but not other manifestations of agitation, among patients with mild to moderate dementia. 5. Similar analysis suggested that prolonged therapy with haloperidol (more than 3 - 6 wks) or higher dosage (more than 2 mg per day) was more likely to result in side effects than were short term therapy (3 weeks) or lower dose haloperidol (less than 2 mg per day). 6. The reports provided too little information to permit interpretation of the effect of degree or type of dementia on response to haloperidol. Except for a favorable response of aggression to haloperidol, no other manifestations of agitated dementia were found to have improved following therapy with haloperidol, compared with controls.

OBJECTIVE

To evaluate an innovative approach to maintaining physical, cognitive, and social functioning in frail, elderly nursing home residents at risk for transfer from a minimal care unit.

SUBJECTS/SETTING

Nineteen Russian-speaking residents of the Jewish Home in San Francisco who were newly enrolled in an on-site adult day care program.

METHODS

A formal evaluation of the program employed a repeated measures design with assessments at baseline and at Months 2, 3, 4, 6, and 9. Outcomes included stability of living situation, functional status, physical and mental health, cognitive functioning, sense of well-being and quality of life, and satisfaction with the program.

RESULTS

During this period, the cohort was medically stable and, although some evidenced cognitive decline, there was little change in their functional status. Nearly all of the residents reported improvement from baseline in some aspects of their lives, with the greatest proportions reporting positive changes in social support and quality of life.

CONCLUSIONS

Findings from this evaluation suggest that activities programming using the model described here may enhance the quality of life for some nursing home residents and enable them to remain in the least restrictive, as well as the least costly, living situation possible.

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.

BACKGROUND

Agitation affects up to 70% of older people with dementia. Valproic acid has been used for the past 10 years to control agitation in dementia, but no systematic review of the effectiveness of this drug has been published to date. The current study examines three randomized, placebo-controlled trials of the effect of valproic acid on older people with dementia who were agitated.

OBJECTIVES

To determine whether evidence supports the use of valproic acid in the treatment of agitation of people with dementia.

SEARCH STRATEGY

Trials were identified from a last updated search of the Specialized Register of the Cochrane Dementia and Cognitive Improvement Group on 10 July 2003 using the terms ("agitat*" or "distur*" or "behavi*" or "aggress*") and "valproic" or "valproate" or "divalpro*." This Register contains articles from all major health care databases and many ongoing trials databases and is regularly updated. The reviewers contacted the authors of publications and drug companies manufacturing valproic acid for additional information.

SELECTION CRITERIA

Randomized, placebo-controlled trials with concealed allocation where agitation and dementia of participants were assessed

DATA COLLECTION AND ANALYSIS

1. Two reviewers extracted data from published trials. 2. Odds ratios of average differences were calculated. 3. Only "intention to treat" analyses were included. 4. Analysis compared participants treated with valproic acid with controls.

MAIN RESULTS

Meta-analysis of the pooled results of the included trials could not be performed because of the following problems. In Porsteinsson 2001, although the physicians having direct responsibility for patient care were blinded, a non-blinded physician, who had no direct contact with these physicians, adjusted divalproex sodium dosage on the basis of reports from blinded raters. Therefore, because the physician who controlled therapy knew which patients were receiving divalproex, the trial did not satisfy the criterion of concealed allocation. In Tariot 2001, 54% of the treated patients dropped out compared with 29% of control patients. Of all treated patients, 22% dropped out because of adverse effects, and the study had to be discontinued prematurely. The third trial (Sival 2002) had a cross-over design. No results from the first phase of the study were available, and although the statistical section stated, "the t-test for independent samples is used to analyze the two-period cross-over trial", because the samples were not independent - they are the same patients in the treatment and placebo groups - a question must be raised about the correctness of the analyses. The type of valproate used in the trials varied - one used short-acting sodium valproate, one long-acting divalproex sodium, and the third early-onset acting divalproex sodium. Average doses differed (480mg/d - 1000mg/d), as did duration of therapy (3 wks - 6 wks), and ways of evaluating patients and their response to therapy. A limited meta-analysis, pooling the results concerning adverse effects (Porsteinsson 2001, Tariot 2001) revealed the following: Sedation occurred more frequently in patients treated with valproic acid than in controls Urinary tract infection was more common among patients treated with valproic acid than controls Because of differences in identifying adverse effects it was not possible to pool other observations concerning adverse effects between the two studies that were examined.

REVIEWERS' CONCLUSIONS

The trials reviewed should be regarded as preliminary. Individual reports suggest that low dose sodium valproate is ineffective in treating agitation among demented patients, and that high dose divalproex sodium is associated with an unacceptable rate of adverse effects. More research on the use of valproate preparations for agitation of people with dementia is needed. On the basis of current evidence, valproate preparations cannot be recommended for the treatment of agitation in dementia.

BACKGROUND

Nursing homes provide care for the elderly who require medical, nursing or rehabilitation services. Legislation for the public health model of mental health care for nursing home residents in the USA was enacted in 1987.

OBJECTIVE

To determine whether the USA act regulating psychiatric care for nursing homes may be applied in Israel.

METHODS

Publications analyzing the outcome of the USA regulations demonstrate improved care as reflected by decrease in restraints and better use of psychotropic compounds. The shortcomings as well as benefits of the USA legislation are tested as to their relevance to the specific economic, environmental and medical issues in Israel.

CONCLUSIONS

The adoption of USA legal acts regulating nursing home residents' psychiatric care may not be feasible in Israel. However, quality of care in nursing homes can be significantly improved if such regulations were "tailored" to Israel's unique structure of nursing homes.