Researchers Find "Clear Evidence" for Prednisone as Adjuvant in Episodic Cluster Headache
A study led by researchers at several headache centers in Germany reports finding clear evidence that prednisone, in conjunction with the use of verapamil, is effective in cluster headache. They recommend that all patients with cluster headache receive prednisone at the start of an episode.
Although some physicians already prescribe prednisone initial short-term therapy of episodic cluster headaches before preventive medication such as verapamil becomes effective, until now the strategy had not been tested in large randomized trials, the authors wrote.
"We aimed to access the safety and efficacy of this treatment approach," they wrote.
Cluster headaches, also known as "suicide headaches" because patients often say they consider killing themselves because of the pain, are intensely painful and usually occur on one side, usually including trigeminal autonomic symptoms, and last 15 to 180 minutes.
The lead author is Mark Obermann, MD, associate professor, University of Duisburg-Essen, Germany, and director of the Center for Neurology at Asklepios Hospitals Seesen. The study was published in The Lancet.
He and the team reported that adjunctive oral prednisone appeared to significantly reduce cluster headache attacks in the multicenter, randomized, double-blind trial. Patients in the treatment group received 100-mg oral prednisone for 5 days followed by tapering of 20 mg every 3 days, or matching placebo (17 days total exposure). All patients received oral verapamil for long-term prevention, starting with 40 mg 3 times daily and increasing to 120 mg 3 times daily by day 19; patients then continued with verapamil 120 mg throughout the study.
Between April 5, 2013, and January 11, 2018, a total of 116 patients were randomly assigned (57 patients to prednisone and 59 patients to placebo). Participants in the prednisone group had a mean of 7.1 (standard deviation 6.5) attacks within the first week compared with 9.5 (6.0) attacks in the placebo group (difference -2.4 attacks, 95% confidence interval -4.8 to -0.03; P = 0.002).
Patients who received the corticosteroid had 25% fewer attacks in the first week of therapy compared with patients in the placebo control group.
Two serious adverse events occurred, both in the placebo group (inguinal hernia and severe deterioration of cluster headache). A total of 270 adverse events were observed: in the prednisone group, 37 (71%) of 52 patients reported 135 adverse events (most common were headache, palpitations, dizziness, and nausea); and in the placebo group, 39 (71%) of 55 patients had 135 adverse events (most common were nausea, dizziness, and headache). (See Obermann M, Nagel S, Ose C, et al. Safety and efficacy of prednisone versus placebo in short-term prevention of episodic cluster headache: a multicentre, double-blind, randomised controlled trial. Lancet Neurol. 2021;20(1)29-37; https://www.thelancet.com/journals/laneur/article/PIIS1474-4422(20)30363-X/fullt.)