ArticlesSuboccipital steroid injections for transitional treatment of patients with more than two cluster headache attacks per day: a randomised, double-blind, placebo-controlled trial
Introduction
Cluster headache is probably the most severe primary headache disorder1 and is characterised by attacks of strong periorbital pain with ipsilateral autonomic signs, recurring at intervals ranging from once every 2 days to eight times a day.2 In episodic cluster headache, attacks occur in phases for weeks or months separated by remissions.3 About 10% of patients develop chronic cluster headache and have ongoing attacks.3
Management of cluster headache usually necessitates a combination of acute and prophylactic treatments.2, 4 The mainstay of acute treatment is subcutaneous sumatriptan5 or oxygen inhalation.6 Most patients respond to treatment, but sumatriptan is restricted to two injections a day to avoid overmedication, and an oxygen cylinder is difficult to carry around. Prophylactic drugs, mainly verapamil7, 8, 9 and lithium,2 are used to reduce the frequency of attacks and sustain improvement. Transitional or add-on prophylaxis might be useful to suppress attacks rapidly at the beginning of a cluster while waiting for the delayed efficacy of long-term preventative drugs (ie, verapamil and lithium), or for patients presenting with frequent daily attacks. Although no randomised trials have been undertaken, oral steroids are considered to be efficient5, 10, 11 and are widely used, but they might induce rebound attacks on weaning off12 and have potential serious side-effects even with short-term use.13 Suboccipital steroid injections (SSI) targeting the greater occipital nerve have been proposed as an alternative to oral steroids.14, 15, 16, 17, 18 Only one randomised, controlled trial of SSI for cluster headache has been published,19 with highly positive results, but 15 of the 23 patients included had fewer than two attacks a day at baseline. SSI are not included in the European guidelines for the treatment of cluster headache.5
We have used SSI with cortivazol20 for more than 10 years in our clinic for the transitional treatment of cluster headache. Cortivazol has a powerful affinity for the glucocorticoid receptor and a long half-life.21 We aimed to assess the efficacy and safety of SSI with cortivazol in addition to usual care in patients with frequent daily attacks, stratified by type of cluster headache (episodic or chronic).
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Study design and patients
We did a 90 day, single-centre, double-blinded, randomised, add-on, placebo-controlled trial. We screened all patients who presented with cluster headache to the Emergency Headache Centre in Paris, France, between November, 2008, and July, 2009. We enrolled adults aged 18–65 years who met the international classification of headache disorders (ICHD-II) diagnostic criteria for episodic (3.1.1) or chronic (3.2.1) cluster headache3 and had a mean of more than two attacks per 24 h in the 3 days
Results
Figure 2 shows the trial profile. We enrolled 28 patients with episodic cluster headache and 15 with chronic cluster headache (table 1). All 43 patients received at least one dose of study drug and were included in the intention-to-treat analysis.
The treatment groups were well matched (table 1). The mean number of daily attacks at baseline was 3·7 (SD 1·3) for patients in the cortivazol group and 4·3 (1·8) for controls. There was no difference between the groups in duration of the phase of
Discussion
We show that repeated SSI with cortivazol is effective compared with placebo for transitional treatment of cluster headache in patients who have frequent daily attacks. Although patients injected with cortivazol had fewer attacks per day during the first 15 days of the study, by day 30 both groups had similar results. A potential explanation for this outcome is that concomitant treatment with verapamil became efficacious and patients with episodic cluster headache in both groups entered
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