Cluster headache is an excruciatingly painful primary headache syndrome, with attacks
of unilateral pain and cranial autonomic symptoms. The current licensed treatment
for acute attacks is subcutaneous sumatriptan.
To ascertain whether high-flow inhaled oxygen was superior to placebo in the acute
treatment of cluster headache.
A double-blind, randomized, placebo-controlled crossover trial of 109 adults (aged
18-70 years) with cluster headache as defined by the International Headache Society.
Patients treated 4 headache episodes with high-flow inhaled oxygen or placebo, alternately.
Patients were randomized to the order in which they received the active treatment
or placebo. Patients were recruited and followed up between 2002 and 2007 at the National
Hospital for Neurology and Neurosurgery, London, England.
Inhaled oxygen at 100%, 12 L/min, delivered by face mask, for 15 minutes at the start
of an attack of cluster headache or high-flow air placebo delivered alternately for
4 attacks.
The primary end point was to render the patient pain free, or in the absence of a
diary to have adequate relief, at 15 minutes. Secondary end points included rendering
the patient pain free at 30 minutes, reduction in pain up to 60 minutes, need for
rescue medication 15 minutes after treatment, overall response to the treatment and
overall functional disability, and effect on associated symptoms.
Fifty-seven patients with episodic cluster headache and 19 with chronic cluster headache
were available for the analysis. For the primary end point the difference between
oxygen, 78% (95% confidence interval, 71%-85% for 150 attacks) and air, 20% (95% confidence
interval, 14%-26%; for 148 attacks) was significant (Wald test, chi(5)(2) = 66.7,
P < .001). There were no important adverse events.
Treatment of patients with cluster headache at symptom onset using inhaled high-flow
oxygen compared with placebo was more likely to result in being pain-free at 15 minutes.
isrctn.org Identifier: ISRCTN94092997.