Primary outcome measuresBMJ 2009; 339 doi: https://doi.org/10.1136/bmj.b3368 (Published 18 August 2009) Cite this as: BMJ 2009;339:b3368
- Simon G A Brown, professor, emergency medicine1
Andreae and Andreae recommend that future trials of antihistamines in anaphylaxis should use a primary outcome of “whether antihistamines result in reduced mortality.”1
Given that death from anaphylaxis is rare, and that fewer than half of deaths from anaphylaxis occur before reaching emergency medical care, this outcome is not useful.
Perhaps we should first establish, using prospective observational studies in both hospital and community settings, the clinical outcomes with a simple protocol of supportive care including adrenaline and fluid resuscitation.
The results of such studies may remove the need for a clinical trial of antihistamines. Alternatively, they may suggest alternative, clinically relevant primary outcomes for a placebo controlled trial of antihistamines—for example, the incidence of adverse effects or delayed phase (“biphasic”) reactions, or both.
Cite this as: BMJ 2009;339:b3368
Competing interests: None declared.