Oxygen therapy for cluster headache. A mask comparison trial. A single-blinded, placebo-controlled, crossover study

Abstract

Purpose The purpose of this article is to investigate possible differences in effect between three types of masks in the acute treatment of cluster headache (CH). Patients and methods Fifty-seven CH patients according to ICHD-II-criteria participated in a single-blinded, semi-randomized, placebo-controlled, crossover inpatient study, and 102 CH attacks were treated with 100% oxygen delivered by demand valve oxygen (DVO), Optimask or simple mask (15 liters/min) or placebo delivered by DVO for 15 minutes. Primary endpoint: Two-point decrease of pain on a five-point rating scale within 15 minutes. Results Only 10 CH patients had multiple attacks and reached the point of placebo. There were no significant differences between masks in the primary endpoints ( p = 0.412). After 15 minutes 48% had a two-point decrease using the DVO compared to 45% with placebo ( p = 0.867). After 30 minutes 68% were pain free or had pain relief using DVO and 45% by placebo ( p = 0.061). The DVO was preferred by 62% compared to 5% and 33% for simple mask ( p < 0.0001) and Optimask ( p = 0.061). In the first attack the DVO was significantly better at achieving pain relief at 15 minutes ( p = 0.018). Treatment with DVO or Optimask reduced the need for rescue medication compared to the simple mask (23%, 19%, 50%, respectively). No treatment-related adverse events were observed. Conclusion The primary endpoint with pain relief at 15 minutes was non-significant; however, a post hoc analysis of the first attack significantly favored DVO. Further, therapy by Optimask and DVO resulted in a decreased need for rescue medication. We recommend that CH patients be offered DVO or Optimask before oxygen therapy is abandoned.

Survey Analysis of the Use, Effectiveness, and Patient‐Reported Tolerability of Inhaled Oxygen Compared With Injectable Sumatriptan for the Acute Treatment of Cluster Headache

“…The changing of flow rates during the attack was not queried in this survey, though the success of the demand valve system may speak to this point. The demand valve system provides an oxygen flow rate based on respiratory rate and tidal volume and may have benefits over the classic NRB mask in level of effectiveness, response time, patient preference, and reduced need for rescue medication . The success of the demand valve system (in the present study it was 93.3% effective) may in part be influenced by its innovation and purported increased efficacy.…”

“…The success of the demand valve system (in the present study it was 93.3% effective) may in part be influenced by its innovation and purported increased efficacy. Indeed, use of a demand valve set up was considered in the high placebo (21% oxygen, 79% nitrogen) response in a mask comparison study . An unexpected finding from the present analysis was the good efficacy of nasal cannula (NC) in oxygen delivery.…”

“…Though there are no existing studies directly comparing oxygen flow rates, the need for higher flow rates in some patients is generally accepted. Indeed, there has been an evolution in oxygen flow rates in the literature – earlier headache trials operating with rates of 6 or 7 L/min and more recent clinical trials using rates between 12 and 15 L/min . The current American Headache Society (AHS) guideline recommends oxygen flow rates between 6 and 12 L/min; Specialists at the Dartmouth Headache Center recommend 10 to 15 L/min .…”

Cluster Headache Clinical Phenotypes: Tobacco Nonexposed (Never Smoker and No Parental Secondary Smoke Exposure as a Child) versus Tobacco‐Exposed: Results from the United States Cluster Headache Survey

“…Regardless of tobacco exposure history, the overall response to both abortive and preventive medication was poor across both subgroups, except for inhaled oxygen and injectable sumatriptan, with almost equal responses. Several previous studies have actually suggested a more positive response to oxygen in smokers, but the compared nonsmoking population was probably not truly tobacco nonexposed so interpretation of the data is difficult . It is important to note that the majority of both the nonexposed and exposed survey responders had never been prescribed any of the typically defined CH preventive medications.…”

Economics of Inhaled Oxygen Use as an Acute Therapy for Cluster Headache in the United States of America

“…Studies report that most patients experience complete or nearly complete relief within 15‐20 minutes of high‐flow oxygen inhalation with a non‐rebreather mask. This is accompanied by a reduction in the need for a rescue analgesic and increased positive effects on associated autonomic symptoms . Evidence‐based clinical guidelines in several countries, including the USA, recommend the administration of oxygen through a non‐rebreather facemask at a flow rate of 6‐15 L/minute for up to 20 minutes for termination of an attack .…”