Usually randomized, double-blind, placebo-controlled trials are considered the best study design to truly answer a research question. But sometimes they are inappropriate.
Do you ever think we will see placebo used in a study on bacterial meningitis?
When a standard well accepted treatment exists, it is usually thought unethical to use placebo. This is where non-inferiority or equivalence trials come in- i.e. comparing a new drug to existing therapy.
But perhaps they grown them tougher in Michigan…
This randomized, double-blind, placebo-controlled trial compared haloperidol 2.5mg IV to matching placebo for ED patients with acute headache. The primary outcome measure was the change in VAS at 60 minutes.
118 patients were enrolled at a single large ED in Michigan. The trial was stopped after an unplanned interim analysis. A little bit naughty…
The reported pain dropped 4.77 units in the haloperidol group and only 1.87 in the placebo arm. Treatment with rescue ketorolac 30mg IV was required in 78% of the time with placebo and 31% with haloperidol. There were few side effects of haloperidol that were easily treated.
Ok, I willing to believe that haloperidol is better than nothing...thanks…
McCoy JJ, Aldy K, Arnall E, Peterson J. Treatment of headache in the Emergency Department: haloperidol in the acute setting (THE-HA Study): A randomized clinical trial. J Emerg Med. 2020;59:12-20. [link to article]