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Lorazepam Rescue in a Cancer Delirium Trial: An Allowed Treatment Is Not a Randomized Comparison

A trial comparing olanzapine with haloperidol allowed individualized lorazepam rescue, so it cannot determine lorazepam’s independent efficacy.

A trial comparing olanzapine with haloperidol allowed individualized lorazepam rescue, so it cannot determine lorazepam’s independent efficacy.

What was randomized

The study analyzed 98 patients with advanced cancer and delirium. It compared two antipsychotics and found no statistically significant advantage for olanzapine in response rate or time to response. The trial stopped early for futility. Lorazepam could be administered when immediate intervention was needed for safety or distress, without a predetermined schedule.

Why rescue treatment complicates interpretation

Randomization applied to the antipsychotic arms, not to receiving lorazepam. Patients requiring rescue might have differed in severity and clinical circumstances. Improvement after rescue therefore cannot be treated as a controlled test of benzodiazepine treatment for delirium. The absence of a placebo group and incomplete daily delirium screening were additional limitations. In a clinical-record review, distinguish the assigned treatment, rescue indications, medication timing, and measured response before attributing the outcome to a single drug.

Source paper

Original analysis of the supplied journal article, identified as PMC7066704.

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