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8-0917-4
Oxygen treatment for cluster headache attacks at different flow rates: a double-blind, randomized, crossover study
Thijs H. T. DirkxEmail e, Danielle Y. P. Haane and Peter J. Koehler
The full paper is at the link above.
Quote:Abstract
Background
Cluster headache attacks can, in many patients, be successfully treated with oxygen via a non-rebreather mask. In previous studies oxygen at flow rates of both 7 L/min and 12 L/min was shown to be effective. The aim of this study was to compare the effect of 100% oxygen at different flow rates for the treatment of cluster headache attacks.
Methods
In a double-blind, randomized, crossover study, oxygen naïve cluster headache patients, treated attacks with oxygen at 7 and 12 L/min. The primary outcome measure was the percentage of attacks after which patients (treating at least 2 attacks/day) were painfree after 15 min, in the first two days of the study. Secondary outcome measures were percentage of successfully treated attacks, percentage of attacks after which patients were painfree, drop in VAS score and patient preference in all treatment periods (14 days).
Results
Ninety-eight patients were enrolled, 70 provided valid data, 56 used both flow rates. These 56 patients recorded 604 attacks, eligible for the primary analysis. An exploratory analysis was conducted using all eligible attacks of 70 patients who provided valid data. We could only include 5 patients, treating 27 attacks on the first two days of the study, for our primary outcome, which did not show a significant difference (p = 0.180). Patients tended to prefer 12 L/min (p = 0.005). Contradicting this result, more patients were painfree using 7 L/min (p = 0.039). There were no differences in side effects or in our other secondary outcome measures. The exploratory analysis showed an odds ratio of being painfree using 12 L/min of 0.73 (95% CI 0.52–1.02) compared to 7 L/min (p = 0.061) as scored on a 5-point scale. The average drop in score on this 5-point scale, however, was equal between groups. Also slightly more patients noticed, no or not much, relief on 7 L/min, and found 12 L/min to be effective in all their attacks.
Conclusion
There is lack of evidence to support differences in the effect of oxygen at a flow rate of 12 L/min compared to 7 L/min. More patients were painfree using 7 L/min, but our other outcome measures did not confirm a difference in effect between flow rates. As most patients prefer 12 L/min and treatments were equally safe, this could be used in all patients. It might be more cost-effective, however, to start with 7 L/min and, if ineffective, to switch to 12 L/min.
Simply incredible that research is still ongoing with such low flow rates, especially with it resulting in the conclusion that 7lpm is better for getting people to a pain free state than 12lpm, which defies all our experience here. But it is very telling how they got to that conclusion.
They started out with 98 patients, but once they had done their exclusions to remove what they thought would impact their results, they were down to a grand total of FIVE patients. But at least they recognized that this showed the result had "little significant experience".
But sadly most medical people who will read this article will only read the abstract and use it to base their treatment of people with CH at 7lpm.
Whilst I fully appreciate that doing CH research will not be at all easy, especially when they were recruiting people who hadn't used oxygen before and seeming to focus on episodic people who naturally will experience their CH cycles ending, I have my doubts about the design of this trial, the results and the interpretation of the results based on very small sample sizes.
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