To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: DG DISPATCH - ISSSAT: Haloperidol and Trazodone No Better Than Placebo For Agitation in Alzheimer's URL: http://www.pslgroup.com/dg/1CC6F2.htm Doctor's Guide April 11, 2000
By Cameron Johnston Special to DG News
STOCKHOLM, SWEDEN - April 11, 2000 -- Elderly people with Alzheimer's disease who become agitated and irritable do not respond to drugs such as haloperidol and trazodone any better than they respond to placebo, a new study shows.
Researchers found that despite the fact that these drugs have been in use for years to manage disruptive Alzheimer's patients, they have never been subjected to critical randomly controlled evaluation to see whether -- or how beneficial -- they might be.
The findings were presented by Linda Teri, PhD, of the University of Washington, in Seattle, WA, at the 6th International Stockholm-Springfield Symposium on Alzheimer Therapy, held in Stockholm, Sweden, last week.
Previous research has shown that up to 40 per cent of people with Alzheimer's disease experience agitation and irritability.
"We selected those medications because we wanted to evaluate medications that were commonly employed in the US for the treatment of Alzheimer's disease," Dr. Teri said.
In the study, patients received haloperidol (mean 0.5 mg/day to a maximum of 30 mg) or trazodone (50 mg/day to a maximum of 300 mg). The patients received the drugs for the first week and then were gradually tapered off them. A third group was randomized to receive behavioral management -- a method for dealing with agitation Alzheimer's patients that is taught to the caregivers and which the caregivers employ when the patients became disruptive.
The patients were all had moderate to severe dementia (Mini Mental State scores of 12-15) and all had had the symptoms of the disease for an average of 4.5 years.
Four out of five patients were reported by their caregivers to have experienced irritability, agitation, restlessness, and fighting. Three-quarters of them were said to have excessive worrying, fearfulness and agitation, and more than half of them were repeatedly waking up at night. One-third had either refused treatments and/or care, and were noted for inappropriate shouting and crying out.
Dr. Teri noted, however, that these were not considered "patients in crisis" and that patients who were so disturbed that they were considered to be in crisis, were also too sick to take part in the study.
At the end of the 16 weeks, the findings were less than impressive for either medication. There were no significant differences in patient responses between either of the drugs or the behavioral modification therapy. One-third of the patients experienced an improvement with each drug, and yet 47 per cent of those patients receiving haloperidol and 46 per cent receiving trazodone get worse. Around one in five experienced no significant improvement regardless of what therapy they were receiving.
"What we found was equivalent levels of improvement across four outcome measures -- agitation, cognition, patient function and caregiver burden," Dr. Teri said. "We have struggled with these findings" she added.
The main reason patients dropped out of the haloperidol treatment group, ironically was increased agitation. The main reason they dropped out of the trazodone group was unpleasant side effects. And finally, managing the agitation without medications resulted in significant increase in caregiver burden -- the patients were withdrawn from the study because without effective drugs to calm them down, their caregivers were not able to cope with the responsibility of dealing with an aging parent, relative or patient. --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. P\S\L shall not be liable for any errors, omissions or delays in this content or any other content on its sites, newsletters or other publications, nor for any decisions or actions taken in reliance on such content. --------------------------------------------------------------------------------------------- This news story was printed from *Doctor's Guide to the Internet* located at http://www.docguide.com --------------------------------------------------------------------------------------- Return to News Story Page This site is maintained by webmaster@pslgroup.com Please contact us with any comments, problems or bugs. All contents Copyright (c) 1998 P\S\L Consulting Group Inc. All rights reserved.