High dose intravenous methylprednisolone in cluster headache patients non responders to oral therapy

Introduction High dose verapamil is the recommended first choice drug in the prophylaxis of episodic and chronic cluster headache. Oral corticosteroids are often concurrently prescribed with the initiation of verapamil prophylaxis in order to quickly obtain a reduction in cluster headache (CH) attacks. To date, literature is scarce regarding the efficacy of intravenous methylprednisolone in CH patients non responders to oral preventive therapy. The aim of the study was to assess the efficacy and safety of high dose intravenous methylprednisolone in a cohort of cluster headache (CH) patients not responders to oral preventive therapy. Methods We screened all CH patients referring to Headache Center of the University of Turin (Italy) between 2006 and 2013. A standardized combined therapy of verapamil 320 mg daily and oral prednisone 50 mg daily was prescribed at the beginning of each cluster active period (CAP). After 3 weeks of oral therapy, patients not responders (attacks with a frequency more than one every other day) were hospitalized in Day Hospital regimen and treated with intravenous methylprednisolone (500 mg/day iv for 5 days), in association with verapamil. Twenty nine CH patients (26 males, 3 females, 42.8± 29.8 years) were treated with this protocol, during 42 CAPs. Data on headache characteristics were collected using headache diaries. Results Minor adverse events were reported by 11.9% of CH patients (skin flushes during infusion, mild increase in blood pressure, gastric symptoms, hyperglycemia, insomnia, and agitation). After 5 days of iv therapy, in 35 CAPs out of 42 (83.3%) the patients were headache-free, whilst in 3 CAPs (7.1%) a reduction (> 50%) in the number of daily attacks was observed. No clinical benefit was reported in the remaining CAPs. In 85.6% of CAPs, no recurrence of cluster headache was observed at 6-months follow-up visits. Discussion and conclusions Intravenous methylprednisolone is an efficacious and reproducible treatment in CH patients non responders to oral therapy. Given the acceptable tolerability profile, this approach can play a useful role in the management of cluster headache, allowing a rapid pain relief in an otherwise highly disabling disease. Confirmatory RCTs and large prospective cohort studies are needed to fully assess the efficacy and safety of this treatment in CH patients.