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.
Results?
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…
Covering
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]
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