High-flow oxygen for treatment of cluster headache: a randomized trial.
BACKGROUND
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.


OBJECTIVE
To ascertain whether high-flow inhaled oxygen was superior to placebo in the acute treatment of cluster headache.


METHODS
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.


METHODS
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.


METHODS
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.


RESULTS
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.


CONCLUSIONS
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.


BACKGROUND
isrctn.org Identifier: ISRCTN94092997.
Cohen
Anna S
AS
Headache Group, Institute of Neurology, The National Hospital for Neurology and Neurosurgery, Queen Square London, England.
Burns
Brian
B
Goadsby
Peter J
PJ
D000328:Adult; D000368:Aged; D003027:Cluster Headache / Q000628:therapy*; D018592:Cross-Over Studies; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010102:Oxygen Inhalation Therapy / Q000379:methods; D055815:Young Adult