Haloperidol, an antipsychotic drug that's widely used in hospitals to treat delirium in critically ill patients, is no more effective than a placebo, a new study contends.
Delirium is common in critically ill patients, and those who develop the condition are up to three times more likely to die within the next six months than those who do not.
Delirium also adds to the stress and discomfort of both patients and their families.
In this study, British researchers looked at 141 critically ill patients on breathing machines who received either haloperidol (Haldol) or a placebo.
Over 14 days, treatment with haloperidol had no effect on the number of days that patients had delirium.
Over 28 days, getting treated with haloperidol failed to reduce death rates, time spent on ventilators, or the length of time patients spent in the hospital or in critical care, according to the study, which was published online Aug. 20 in The Lancet Respiratory Medicine.
Patients who received haloperidol did seem to require less sedation than those given a placebo. According to the researchers, that suggests that the drug may help to ease short-term agitation.
However, even though there is "limited eveidence" in its favor, "increasing numbers of patients are being exposed to haloperidol for the management of delirium," study leader Dr. Valerie Page, of Watford General Hospital, said in a journal news release. "Our results suggest a commonly used haloperidol dose regimen does not decrease delirium in critically ill patients requiring mechanical ventilation, when commenced early during ICU stay."
"Our results do not support the idea that haloperidol modifies duration of delirium in critically ill patients," Page said.
One expert said a closer examination of the use of the drug is welcome.
"Given the cocktail of sedating medications critically ill patients receive, the addition of another -- haloperidol in this case -- must warrant benefit," said Dr. Bradley Flansbaum, a hospitalist at Lenox Hill Hospital in New York City.
However, in the new trial "the patients had outcomes no different than placebo," he said.
"Should critically ill folks receive haloperidol? For acute episodes of agitation or cognitive [mental] impairment -- yes, assuming no contraindications to the drug."
But when it comes to using haloperidol for routine prevention of delirium, the answer to that question is "no," Flansbaum added.
Another expert writing in an editorial in the journal agreed.
"Although haloperidol is used commonly, its use to treat delirium does not seem to be justified," wrote Dr. Yoanna Skrobik, critical care chair at the University of Montreal.
Skrobik questioned whether delirium even needs to be treated with drugs.
"Only non-pharmacological prevention measures have been shown to reduce its occurrence in critically ill patients," she said. "Non-pharmacological interventions are effective in numerous psychiatric and psychological disturbances. The challenge lies in the distress delirium symptoms cause in caregivers. We should be asking ourselves, are we treating the patients or our own discomfort?"